Cover
Cover - shares | 9 Months Ended | |
Sep. 30, 2022 | Oct. 31, 2022 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2022 | |
Document Transition Report | false | |
Entity File Number | 000-23186 | |
Entity Registrant Name | BIOCRYST PHARMACEUTICALS, INC. | |
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 | 186,423,835 | |
Entity Central Index Key | 0000882796 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2022 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Assets | ||
Cash and cash equivalents | $ 246,899 | $ 504,389 |
Restricted cash | 1,444 | 3,345 |
Investments | 179,959 | 3,212 |
Trade receivables | 42,610 | 29,413 |
Inventory | 27,019 | 15,791 |
Prepaid expenses and other current assets | 11,070 | 9,986 |
Total current assets | 509,001 | 566,136 |
Property and equipment, net | 8,464 | 8,714 |
Long-term investments | 34,332 | 6,829 |
Other assets | 6,797 | 6,472 |
Total assets | 558,594 | 588,151 |
Liabilities and Stockholders’ Deficit | ||
Accounts payable | 8,622 | 27,808 |
Accrued expenses | 69,265 | 72,670 |
Deferred revenue | 1,554 | 1,421 |
Lease financing obligation | 2,196 | 1,819 |
Total current liabilities | 81,637 | 103,718 |
Lease financing obligation | 5,968 | 5,962 |
Royalty financing obligations | 489,781 | 449,375 |
Secured term loan | 223,867 | 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 – 186,411 as of September 30, 2022 and 184,350 as of December 31, 2021 | 1,864 | 1,843 |
Additional paid-in capital | 1,138,654 | 1,098,498 |
Accumulated other comprehensive (loss) income | (98) | 177 |
Accumulated deficit | (1,383,079) | (1,207,504) |
Total stockholders’ deficit | (242,659) | (106,986) |
Total liabilities and stockholders’ deficit | $ 558,594 | $ 588,151 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2022 | Dec. 31, 2021 |
Statement of Financial Position [Abstract] | ||
Preferred stock par value (in usd 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 usd per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 450,000,000 | 450,000,000 |
Common stock, shares, issued (in shares) | 186,411,000 | 184,350,000 |
Common stock, shares, outstanding (in shares) | 186,411,000 | 184,350,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Revenues | ||||
Total revenues | $ 75,827 | $ 40,994 | $ 191,282 | $ 110,012 |
Expenses | ||||
Cost of product sales | 3,543 | 591 | 4,025 | 6,811 |
Research and development | 52,740 | 49,971 | 180,090 | 145,279 |
Selling, general and administrative | 36,919 | 34,992 | 109,218 | 83,431 |
Royalty | 70 | 24 | 73 | 34 |
Total operating expenses | 93,272 | 85,578 | 293,406 | 235,555 |
Loss from operations | (17,445) | (44,584) | (102,124) | (125,543) |
Interest and other income | 1,760 | 9 | 2,423 | 48 |
Interest expense | (24,775) | (14,115) | (72,634) | (40,514) |
Foreign currency losses, net | (538) | (111) | (583) | (274) |
Loss before income taxes | (40,998) | (58,801) | (172,918) | (166,283) |
Income tax expense | 1,522 | 0 | 2,657 | 0 |
Net loss | (42,520) | (58,801) | (175,575) | (166,283) |
Foreign currency translation adjustment | 695 | 28 | 877 | 114 |
Unrealized loss on available for sale investments | (808) | (1) | (1,152) | (3) |
Comprehensive loss | $ (42,633) | $ (58,774) | $ (175,850) | $ (166,172) |
Basic net loss per common share (in usd per share) | $ (0.23) | $ (0.33) | $ (0.95) | $ (0.93) |
Diluted net loss per common share (in usd per share) | $ (0.23) | $ (0.33) | $ (0.95) | $ (0.93) |
Weighted average shares outstanding, basic (in shares) | 186,180 | 179,106 | 185,566 | 178,199 |
Weighted average shares outstanding, diluted (in shares) | 186,180 | 179,106 | 185,566 | 178,199 |
Product sales, net | ||||
Revenues | ||||
Total revenues | $ 75,213 | $ 39,141 | $ 189,647 | $ 90,442 |
Royalty revenue | ||||
Revenues | ||||
Total revenues | 600 | 322 | 1,487 | (447) |
Milestone revenue | ||||
Revenues | ||||
Total revenues | 0 | 0 | 0 | 15,000 |
Collaborative and other research and development | ||||
Revenues | ||||
Total revenues | $ 14 | $ 1,531 | $ 148 | $ 5,017 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Cash flows from operating activities: | ||
Net loss | $ (175,575) | $ (166,283) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 1,041 | 606 |
Stock-based compensation expense | 29,419 | 26,140 |
Non-cash interest expense on royalty financing obligations and secured term loan and amortization of debt issuance costs | 55,119 | 36,440 |
Amortization of premium/discount on investments | (818) | 35 |
Changes in operating assets and liabilities: | ||
Receivables | (13,827) | (17,579) |
Inventory | (11,263) | (6,630) |
Prepaid expenses and other assets | (1,132) | (3,460) |
Accounts payable and accrued expenses | (27,639) | 16,692 |
Interest payable | 6,345 | 3,884 |
Deferred revenue | 329 | 457 |
Net cash used in operating activities | (138,001) | (109,698) |
Cash flows from investing activities: | ||
Acquisitions of property and equipment | (825) | (1,277) |
Purchase of investments | (244,283) | 0 |
Sales and maturities of investments | 39,655 | 28,201 |
Net cash (used in) provided by investing activities | (205,453) | 26,924 |
Cash flows from financing activities: | ||
Net proceeds from common stock issued under stock-based compensation plans | 10,756 | 12,250 |
Net proceeds from secured term loans | 73,072 | 0 |
Net cash provided by financing activities | 83,828 | 12,250 |
Effect of exchange rate on cash, cash equivalents, and restricted cash | 235 | 69 |
Decrease in cash, cash equivalents and restricted cash | (259,391) | (70,455) |
Cash, cash equivalents and restricted cash at beginning of period | 507,734 | 274,348 |
Cash, cash equivalents and restricted cash at end of period | $ 248,343 | $ 203,893 |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Deficit - USD ($) $ in Thousands | Total | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income | Accumulated Deficit |
Balance at Dec. 31, 2020 | $ (19,262) | $ 1,769 | $ 1,002,408 | $ 3 | $ (1,023,442) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (64,284) | (64,284) | |||
Other comprehensive income (loss) | 179 | 179 | |||
Employee stock purchase plan sales, net | 723 | 2 | 721 | ||
Exercise of stock options, net | 2,177 | 6 | 2,171 | ||
Stock-based compensation expense | 5,479 | 5,479 | |||
Balance at Mar. 31, 2021 | (74,988) | 1,777 | 1,010,779 | 182 | (1,087,726) |
Balance at Dec. 31, 2020 | (19,262) | 1,769 | 1,002,408 | 3 | (1,023,442) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (166,283) | ||||
Balance at Sep. 30, 2021 | (147,044) | 1,798 | 1,040,769 | 114 | (1,189,725) |
Balance at Mar. 31, 2021 | (74,988) | 1,777 | 1,010,779 | 182 | (1,087,726) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (43,198) | (43,198) | |||
Other comprehensive income (loss) | (95) | (95) | |||
Exercise of stock options, net | 4,574 | 10 | 4,564 | ||
Stock-based compensation expense | 7,632 | 7,632 | |||
Balance at Jun. 30, 2021 | (106,075) | 1,787 | 1,022,975 | 87 | (1,130,924) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (58,801) | (58,801) | |||
Other comprehensive income (loss) | 27 | 27 | |||
Employee stock purchase plan sales, net | 1,241 | 1 | 1,240 | ||
Exercise of stock options, net | 3,535 | 10 | 3,525 | ||
Stock-based compensation expense | 13,029 | 13,029 | |||
Balance at Sep. 30, 2021 | (147,044) | 1,798 | 1,040,769 | 114 | (1,189,725) |
Balance at Dec. 31, 2021 | (106,986) | 1,843 | 1,098,498 | 177 | (1,207,504) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (74,196) | (74,196) | |||
Other comprehensive income (loss) | 9 | 9 | |||
Employee stock purchase plan sales, net | 1,504 | 1 | 1,503 | ||
Exercise of stock options, net | 5,853 | 12 | 5,841 | ||
Stock-based compensation expense | 9,601 | 9,601 | |||
Balance at Mar. 31, 2022 | (164,215) | 1,856 | 1,115,443 | 186 | (1,281,700) |
Balance at Dec. 31, 2021 | (106,986) | 1,843 | 1,098,498 | 177 | (1,207,504) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (175,575) | ||||
Balance at Sep. 30, 2022 | (242,659) | 1,864 | 1,138,654 | (98) | (1,383,079) |
Balance at Mar. 31, 2022 | (164,215) | 1,856 | 1,115,443 | 186 | (1,281,700) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (58,859) | (58,859) | |||
Other comprehensive income (loss) | (171) | (171) | |||
Exercise of warrants | 3 | 3 | |||
Exercise of stock options, net | 145 | 145 | |||
Stock-based compensation expense | 9,865 | 9,865 | |||
Balance at Jun. 30, 2022 | (213,232) | 1,859 | 1,125,453 | 15 | (1,340,559) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (42,520) | (42,520) | |||
Other comprehensive income (loss) | (113) | (113) | |||
Employee stock purchase plan sales, net | 1,357 | 1 | 1,356 | ||
Exercise of stock options, net | 1,896 | 4 | 1,892 | ||
Stock-based compensation expense | 9,953 | 9,953 | |||
Balance at Sep. 30, 2022 | $ (242,659) | $ 1,864 | $ 1,138,654 | $ (98) | $ (1,383,079) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Deficit (Parenthetical) shares in Thousands | 3 Months Ended |
Jun. 30, 2022 shares | |
Statement of Stockholders' Equity [Abstract] | |
Exercise of stock options, net (in shares) | 51 |
Exercise of warrants (in shares) | 253 |
Significant Accounting Policies
Significant Accounting Policies and Concentrations of Risk | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
Significant Accounting Policies and Concentrations of Risk | 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 and incorporated in Delaware in 1991, and its headquarters is located in Durham, North Carolina. The Company integrates the disciplines of biology, crystallography, medicinal chemistry and computer modeling to discover and develop small molecule pharmaceuticals through the process known as structure-guided drug design. 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. ORLADEYO has also received regulatory approvals in multiple global markets. The Company is commercializing ORLADEYO in each of these territories directly or through distributors, except in Japan where Torii Pharmaceutical Co., Ltd., the Company’s collaborative partner, has the exclusive right to commercialize ORLADEYO for the prevention of HAE attacks in exchange for certain milestone and royalty payments to the Company. In addition to its approval in the United States, peramivir injection has received regulatory approvals in Canada, Australia, Japan, Taiwan and Korea. Based on the Company’s expectations for revenue and operating expenses, the Company believes its financial resources available at September 30, 2022 will be sufficient to fund its operations for at least the next 12 months. The Company has sustained operating losses for the majority of its corporate history and expects that its 2022 expenses will exceed its 2022 revenues. The Company expects to continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing operations. The Company’s liquidity needs will be largely determined by the success of operations in regard to the successful commercialization of its products and the progression of its product candidates in the future. The Company regularly evaluates other opportunities to fund future operations, including: (1) securing or increasing U.S. Government funding of its programs, including obtaining procurement contracts; (2) out-licensing rights to certain of its products or product candidates, pursuant to which the Company would receive cash milestone payments; (3) raising additional capital through equity or debt financings or from other sources, including royalty or other monetization transactions; (4) obtaining additional product candidate regulatory approvals, which would generate revenue, milestone payments and cash flow; (5) reducing spending on one or more research and development programs, including by discontinuing development; and/or (6) restructuring operations to change its overhead structure. The Company may issue securities, including common stock, preferred stock, depositary shares, purchase contracts, warrants, debt securities and units, through private placement transactions or registered public offerings in the future. The Company’s future liquidity needs, and ability to address those needs, will largely be determined by the success of its products and product candidates; the timing, scope and magnitude of its research and development and commercial expenses; and key developments and regulatory events and its decisions in the future. 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-Q and do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. There were no adjustments other than normal recurring adjustments. These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2021 and the notes thereto included in the Company’s 2021 Annual Report on Form 10-K. Interim operating results are not necessarily indicative of operating results for the full year. The balance sheet as of December 31, 2021 has been derived from the audited consolidated financial statements included in the Company’s most recent Annual Report on Form 10-K. 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 readily apparent from other sources. Actual results could differ from those estimates. Revenue Recognition Pursuant to Accounting Standards Codification (“ASC”) Topic 606, the Company recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 includes provisions within a five step model that includes (i) identifying the contract with a customer, (ii) identifying the performance obligations in the contract, (iii) determining the transaction price, (iv) allocating the transaction price to the performance obligations, and (v) recognizing revenue when, or as, an entity satisfies a performance obligation. 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, sales of peramivir to the Company’s licensing partners and sales of RAPIVAB to the U.S. Department of Health and Human Services (“HHS”) under the Company’s procurement contract. In the United States, the Company ships ORLADEYO directly to patients through a single specialty pharmacy, which is considered its customer. In the European Union, United Kingdom and elsewhere, the Company sells ORLADEYO to specialty distributors as well as hospitals and pharmacies, which collectively are considered its customers. 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 be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Government and Managed Care Rebates . The Company contracts with government agencies and managed care organizations or, collectively, third-party payors, so that ORLADEYO will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company's contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payor mix, and (iv) product distribution information obtained from the Company's specialty pharmacy. Chargebacks . Chargebacks are discounts that occur when certain contracted customers, pharmacy benefit managers, insurance companies, and government programs purchase directly from the Company’s specialty pharmacy. These customers purchase the Company’s product under contracts negotiated between them and the Company’s specialty pharmacy. The specialty pharmacy, in turn, charges back to the Company the difference between the price the specialty pharmacy paid and the negotiated price paid by the contracted customers, which may be higher or lower than the specialty pharmacy’s purchase price from the Company. The Company estimates chargebacks and adjusts gross product revenues and accounts receivable based on the estimates at the time revenues are recognized. Co-payment assistance and patient assistance programs . Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Based upon the terms of the program and co-payment assistance utilization reports received from the specialty pharmacy, the Company is able to estimate the co-payment assistance amounts, which are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue. The Company also offers a patient assistance program that provides free drug product, for a limited period of time, to allow a patient’s insurance coverage to be established. Based on patient assistance program utilization reports provided by the specialty pharmacy, the Company records gross revenue of the product provided and a full reduction of the revenue amount for the free drug discount. Product returns . The Company does not provide contractual return rights to its customers, except in instances where the product is damaged or defective. Non-acceptance by the patient of shipped drug product by the specialty pharmacy is reflected as a reversal of sales in the period in which the sales were originally recorded. Reserves for estimated non-acceptances by patients are recorded as a reduction of revenue in the period that the related revenue is recognized, as well as a reduction to accounts receivable. Estimates of non-acceptance are based on quantitative information provided by the specialty pharmacy. Collaborative and Other Research and Development Arrangements and Royalties The Company has collaboration and license agreements with a number of third parties, as well as research and development agreements with certain government entities. The Company’s primary sources of revenue from these collaborative and other research and development arrangements are license, service and royalty revenues. 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 further continuing performance obligations or the Company has completed the performance obligations under the terms of the agreement. Arrangements that involve the delivery of more than one performance obligation are initially evaluated as to whether the intellectual property licenses granted by the Company represent distinct performance obligations. If they are determined to be distinct, the value of the intellectual property licenses would be recognized up front while the research and development service fees would be recognized as the performance obligations are satisfied. For performance obligations based on services performed, the Company measures progress using an input method based on the effort it expends or costs it incurs toward the satisfaction of the performance obligation in relation to the total estimated effort or costs. Variable consideration is assessed at each reporting period as to whether it is not subject to significant future reversal and, therefore, should be included in the transaction price at the inception of the contract. If a contract includes a fixed or minimum amount of research and development support, this also would be included in the transaction price. Changes to collaborations, such as the extensions of the research term or increasing the number of targets or technology covered under an existing agreement, are assessed for whether they represent a modification or should be accounted for as a new contract. For contracts with multiple performance obligations, revenue is allocated to each performance obligation based on its relative standalone selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services. If a standalone selling price is not directly observable, then the Company estimates the standalone selling price using either an adjusted market assessment approach or an expected cost plus margin approach, representing the amount that the Company believes the market is willing to pay for the product or service. Analyzing the arrangement to identify performance obligations requires the use of judgment, and each may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. 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 probable at the inception of the agreement and (ii) the Company has a right to payment. Any milestone payments received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. 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 months or less at the time of purchase. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. Restricted Cash Restricted cash of $21 and $1,924 as of September 30, 2022 and December 31, 2021, respectively, reflects royalty revenue paid by Shionogi designated for interest on the PhaRMA Notes (defined in Note 6). Additionally, restricted cash of $1,423 and $1,421 as of September 30, 2022 and December 31, 2021, respectively, reflects collateral for a letter of credit the Company is required to maintain associated with the lease execution and build-out of its Birmingham research facilities. Investments The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may consist of U.S. Government and government agency securities, money market and mutual fund investments, certificates of deposits, municipal and corporate notes and bonds, and commercial paper, among others. The Company’s investment policy requires it to purchase high-quality marketable securities with a maximum individual maturity of three years and requires an average portfolio maturity of no more than 12 months. Some of the securities in which the Company invests may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, the Company schedules its investments with maturities that coincide with expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, the Company does not believe it has a material exposure to interest rate risk arising from its investments. Generally, the Company’s investments are not collateralized. The Company has not realized any significant losses from its investments. The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are reflected in interest and other income in the Consolidated Statements of Comprehensive Loss and are determined using the specific identification method with transactions recorded on a settlement date basis. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term. At September 30, 2022, the Company believes that the cost of its investments is recoverable in all material respects. 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-party distributors, hospitals and pharmacies in the European Union, United Kingdom and elsewhere and have standard payment terms that generally require payment within 30 to 90 days. 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 adjust its receivables for the effects of a significant financing component at contract inception if it expects to collect the receivables in one year or less from the time of sale. The Company provides reserves against trade receivables for estimated losses that may result from a customer's inability to pay. Receivables are evaluated to determine if any reserve or allowance should be recorded based on consideration of the current economic environment, expectations of future economic conditions, specific circumstances and the Company’s own historical collection experience. Amounts determined to be uncollectible are charged or written-off against the reserve. 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-in, first-out (FIFO) basis. Raw materials and work-in-process include all inventory costs prior to packaging and labelling, including raw material, active product ingredient, and the drug product. Finished goods include packaged and labelled products. 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 experience spoilage of its raw materials and supplies. The Company’s determination that a valuation reserve might be required, in addition to the quantification of such reserve, requires it to utilize significant judgment. 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 years. Laboratory equipment, office equipment, and software are depreciated over a life of five years. Furniture and fixtures are depreciated over a life of seven years. Leasehold improvements are amortized over their estimated useful lives or the expected lease term, whichever is less. In accordance with U.S. GAAP, the Company periodically reviews its property and equipment for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Property and equipment to be disposed of are reported at the lower of carrying amount or fair value less cost to sell. Accrued Expenses The Company generally enters into contractual agreements with third-party vendors who provide research and development, manufacturing, distribution, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing, and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when it determines an obligation has been incurred, regardless of the timing of the invoice. This process involves reviewing open contracts and purchase orders, communicating with applicable Company personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued expenses include (i) fees paid to clinical research organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials; (ii) fees paid to investigative sites in connection with clinical trials; (iii) fees paid to contract manufacturers in connection with the production of the Company’s raw materials, drug substance, drug products, and product candidates; and (iv) professional fees. The Company bases its expenses related to clinical trials on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. As of September 30, 2022 and December 31, 2021, the carrying value of accrued expenses approximates their fair value due to their short-term settlement. 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 also include costs related to excess or obsolete inventory adjustment charges. Research and Development Expenses The Company’s research and development costs are charged to expense when incurred. Research and development expenses include all direct and indirect development costs related to the development of the Company’s portfolio of product candidates. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as expense when the related goods are delivered or the related services are performed. Research and development expenses include, among other items, personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by CROs, materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. Most of the Company’s manufacturing and clinical and preclinical studies are performed by third-party CROs. Costs for studies performed by CROs are accrued by the Company over the service periods specified in the contracts, and estimates are adjusted, if required, based upon the Company’s ongoing review of the level of services actually performed. Additionally, the Company has license agreements with third parties, such as Albert Einstein College of Medicine of Yeshiva University (“AECOM”), Industrial Research, Ltd. (“IRL”), and the University of Alabama at Birmingham (“UAB”), which require fees related to sublicense agreements or maintenance fees. The Company expenses sublicense payments as incurred unless they are related to revenues that have been deferred, in which case the expenses are deferred and recognized over the related revenue recognition period. The Company expenses maintenance payments as incurred. Deferred collaboration expenses represent sublicense payments, paid to the Company’s academic partners upon receipt of consideration from various commercial partners, and other consideration paid to the Company’s academic partners for modification to existing license agreements. These deferred expenses would not have been incurred without receipt of such payments or modifications from the Company’s commercial partners and are being expensed in proportion to the related revenue being recognized. The Company believes that this accounting treatment appropriately matches expenses with the associated revenue. 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 $3,476 and $11,555 for the three and nine months ended September 30, 2022, respectively, and $1,492 and $4,696 for the three and nine months ended September 30, 2021, respectively. 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 September 30, 2022. The Company accounts for lease obligations in accordance with ASU 2016-02: Leases (Topic 842) , which requires a lessee to recognize a right-of-use asset and a lease liability on its balance sheet for most operating leases. 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 Sheets represent payments over the lease term, which includes renewal options for certain real estate leases that the Company is 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 months or less was not material. 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 made any residual value guar |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue The Company recorded the following revenues (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Product sales, net: ORLADEYO $ 65,395 $ 36,711 $ 179,492 $ 76,023 RAPIVAB 6,953 2,430 7,290 7,165 Peramivir 2,865 — 2,865 7,254 Total product sales, net 75,213 39,141 189,647 90,442 Royalty revenue 600 322 1,487 (447) Milestone revenue — — — 15,000 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 14 1,531 148 5,017 Total collaborative and other research and development revenues 14 1,531 148 5,017 Total revenues $ 75,827 $ 40,994 $ 191,282 $ 110,012 |
Investments
Investments | 9 Months Ended |
Sep. 30, 2022 | |
Investments [Abstract] | |
Investments | 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 in the fair value hierarchy as defined in U.S. GAAP. These valuations are based on observable direct and indirect inputs, primarily quoted prices of similar, but not identical, instruments in active markets or quoted prices for identical or similar instruments in markets that are not active. These fair values are obtained from independent pricing services which utilize Level 2 inputs. September 30, 2022 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 205,133 $ 284 $ 5 $ (1,074) $ 204,348 Corporate debt securities 7,337 37 — (64) 7,310 Certificates of deposit 2,655 10 — (32) 2,633 Total investments $ 215,125 $ 331 $ 5 $ (1,170) $ 214,291 December 31, 2021 Amortized Accrued Gross Gross Estimated 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 September 30, 2022 and December 31, 2021: September 30, 2022 December 31, 2021 Maturing in one year or less $ 179,959 $ 3,212 Maturing after one year through two years 34,332 6,829 Total investments $ 214,291 $ 10,041 |
Trade Receivables
Trade Receivables | 9 Months Ended |
Sep. 30, 2022 | |
Receivables [Abstract] | |
Trade Receivables | Trade Receivables Product Sales Receivables from product sales are recorded for amounts due to the Company related to sales of ORLADEYO and RAPIVAB. At September 30, 2022 and December 31, 2021, receivables related to sales of ORLADEYO were $39,565 and $27,384, respectively. At September 30, 2022 and December 31, 2021, receivables related to sales of RAPIVAB were $28 and $49, respectively. No reserve or allowance amounts were recorded as of both September 30, 2022 and December 31, 2021. Collaborations Receivables from collaborations were as follows (in thousands): September 30, 2022 Billed Unbilled Total U.S. Department of Health and Human Services $ 293 $ 243 $ 536 Shionogi & Co. Ltd. 1,893 — 1,893 Royalty receivables from partners 588 — 588 Total receivables $ 2,774 $ 243 $ 3,017 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 |
Inventory
Inventory | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory At September 30, 2022 and December 31, 2021, the Company’s inventory primarily related to ORLADEYO. Additionally, inventory included RAPIVAB and peramivir, which is manufactured for the Company’s partners. The Company’s inventories consisted of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 8,419 $ 5,658 Work-in-process 15,364 9,669 Finished goods 3,481 709 Total inventory $ 27,264 $ 16,036 Reserves (245) (245) Total inventory, net $ 27,019 $ 15,791 |
Royalty Monetizations
Royalty Monetizations | 9 Months Ended |
Sep. 30, 2022 | |
Advance Royalties [Abstract] | |
Royalty Monetizations | Royalty Monetizations RAPIACTA Overview On March 9, 2011, the Company completed a $30,000 financing transaction to monetize certain future royalty and milestone payments under the Company’s agreement with Shionogi (the “Shionogi Agreement”), pursuant to which Shionogi licensed from the Company the rights to market RAPIACTA in Japan and Taiwan. The Company received net proceeds of $22,691 from the transaction after transaction costs of $4,309 and the establishment of a $3,000 interest reserve account by JPR Royalty Sub LLC, a wholly-owned subsidiary of the Company (“Royalty Sub”), available to help cover interest shortfalls in the future. All of the interest reserve account has been fully utilized with the September 2012 interest payment. As part of the transaction, the Company entered into a purchase and sale agreement dated as of March 9, 2011 with Royalty Sub, whereby the Company transferred to Royalty Sub, among other things, (i) its rights to receive certain royalty and milestone payments from Shionogi arising under the Shionogi Agreement and (ii) the right to receive payments under a Japanese yen/U.S. dollar foreign currency hedge arrangement (as further described below, the “Currency Hedge Agreement”) put into place by the Company in connection with the transaction. Royalty payments are paid by Shionogi in Japanese yen, and any milestone payments will be paid in U.S. dollars. The Company’s collaboration with Shionogi was not impacted as a result of this transaction. Non-Recourse Notes Payable On March 9, 2011, Royalty Sub completed a private placement to institutional investors of $30,000 in aggregate principal amount of its PhaRMA Senior Secured 14.0% Notes due on December 1, 2020 (the “PhaRMA Notes”). The PhaRMA Notes were issued by Royalty Sub under an Indenture, dated as of March 9, 2011 (the “Indenture”), by and between Royalty Sub and U.S. Bank National Association, as Trustee. Principal and interest on the PhaRMA Notes are payable from, and are secured by, the rights to royalty and milestone payments under the Shionogi Agreement transferred by the Company to Royalty Sub and payments, if any, made to Royalty Sub under the Currency Hedge Agreement. The PhaRMA Notes bear interest at 14% per annum, payable annually in arrears on September 1st of each year. The Company remains entitled to receive any royalties and milestone payments related to sales of peramivir by Shionogi following repayment of the PhaRMA Notes. Royalty Sub’s obligations to pay principal and interest on the PhaRMA Notes are obligations solely of Royalty Sub and are without recourse to any other person, including the Company, except to the extent of the Company’s pledge of its equity interests in Royalty Sub in support of the PhaRMA Notes. The Company may, but is not obligated to, make capital contributions to a capital account that may be used to redeem, or on up to one occasion pay any interest shortfall on, the PhaRMA Notes. In September 2014, Royalty Sub was unable to pay the accrued interest obligation due September 3, 2013. Under the terms of the Indenture, Royalty Sub’s inability to pay the full amount of interest payable in September 2013 by the next succeeding payment date for the PhaRMA Notes, which was September 1, 2014, constituted an event of default. Accordingly, the PhaRMA Notes and related accrued interest have been classified as current liabilities on the December 31, 2014 balance sheet and thereafter. As a result of the event of default under the PhaRMA Notes, the holders of the PhaRMA Notes may foreclose on the collateral securing the PhaRMA Notes and the equity interest in Royalty Sub and exercise other remedies available to them under the Indenture in respect of the PhaRMA Notes. In such event, the Company may not realize the benefit of future royalty payments that might otherwise accrue to it following repayment of the PhaRMA Notes and it might otherwise be adversely affected. Due to the non-recourse nature of the PhaRMA Notes, in the event of any potential foreclosure, the primary impact to the Company would be the loss of future royalty payments, if any, from Shionogi and legal costs associated with retiring the PhaRMA Notes. The PhaRMA Notes had a final legal maturity date of December 1, 2020, at which time the outstanding principal amount of the PhaRMA Notes of $30,000, together with accrued and unpaid interest of $20,614, was due in full. Non-Recourse Notes Payable – Debt Extinguishment During 2021, the royalty-bearing patents associated with RAPIACTA in Japan expired. Accordingly, the Company evaluated the current circumstances of the PhaRMA Notes, including (i) their non-recourse nature relative to the Company, (ii) the current state of default since September 1, 2014 and the legal maturity on December 1, 2020 and (iii) the loss of patent protection relative to RAPIACTA in Japan, upon which any significant repayment of the PhaRMA Notes is predicated. As a result, the Company determined that it was no longer the financial obligor, and as a result, the principal balance of $30,000 and associated accrued interest payable balance of $25,838 were written off, resulting in a gain on extinguishment recorded in other income (expense) for the year ended December 31, 2021. ORLADEYO and Factor D Inhibitors On December 7, 2020, the Company and RPI 2019 Intermediate Finance Trust (“RPI”) entered into a Purchase and Sale Agreement (the “2020 RPI Royalty Purchase Agreement”), pursuant to which the Company sold to RPI the right to receive certain royalty payments from the Company for a purchase price of $125,000 in cash (the “2020 RPI Royalty Sale”). Under the 2020 RPI Royalty Purchase Agreement, RPI is entitled to receive tiered, sales-based royalties on net product sales of ORLADEYO in the United States and certain key European markets (collectively, the “Key Territories”), and other markets where the Company sells ORLADEYO directly or through distributors (collectively, the “Direct Sales”) in an amount equal to: (i) 8.75% of aggregate annual net sales of ORLADEYO for annual net sales up to $350,000 and (ii) 2.75% of annual net sales for annual net sales between $350,000 and $550,000. No royalty payments are payable on annual Direct Sales over $550,000. In addition, RPI will be entitled to receive 1.0% of global net sales, if any, of BCX9930. Under the 2020 RPI Royalty Purchase Agreement, RPI is also entitled to receive a tiered revenue share on ORLADEYO sublicense revenue or net sales by licensees outside of the Key Territories (the “Other Markets”) equal to: (i) 20% of the proceeds received by the Company for upfront license fees and development milestones for ORLADEYO in the Other Markets; (ii) 20% of proceeds received on annual net sales of up to $150,000 in the Other Markets; and (iii) 10% of proceeds received by the Company on annual net sales between $150,000 and $230,000 in the Other Markets. No royalty payments are payable on annual net sales above $230,000 in the Other Markets. On November 19, 2021, the Company and RPI entered into (i) a Purchase and Sale Agreement (the “2021 RPI Royalty Purchase Agreement” and together with the 2020 RPI Royalty Purchase Agreement, the “RPI Royalty Purchase Agreements”), pursuant to which the Company sold to RPI the right to receive certain royalty payments from the Company for a purchase price of $150,000 in cash, and (ii) a Purchase and Sale Agreement with OCM IP Healthcare Holdings Limited, an affiliate of OMERS Capital Markets (“OMERS”) (the “OMERS Royalty Purchase Agreement” and collectively with the RPI Royalty Purchase Agreements, the “Royalty Purchase Agreements”), pursuant to which the Company sold to OMERS the right to receive certain royalty payments from the Company for a purchase price of an additional $150,000 in cash. Under the 2021 RPI Royalty Purchase Agreement, RPI is entitled to receive tiered, sales-based royalties on Direct Sales in an amount equal to: (i) 0.75% of aggregate annual net sales of ORLADEYO for annual net sales up to $350,000 and (ii) 1.75% of annual net sales of ORLADEYO for annual net sales between $350,000 and $550,000. No royalty payments are payable on Direct Sales over $550,000. RPI 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 3.0% of proceeds received by the Company on annual net sales of up to $150,000 in the Other Markets, and (iii) 2.0% of proceeds received by the Company on annual net sales between $150,000 and $230,000 in the Other Markets. No royalty payments are payable on annual net sales above $230,000 in the Other Markets. Under the 2021 RPI Royalty Purchase Agreement, RPI is also entitled to receive tiered, sales-based royalties on net product sales of BCX9930 and another earlier stage Factor D inhibitor (BCX10013) in an amount equal to: (i) 3.0% of worldwide aggregate annual net sales up to $1,500,000 and (ii) 2.0% of worldwide aggregate annual net sales between $1,500,000 and $3,000,000. No royalty payments are payable on annual net sales above $3,000,000. RPI is also entitled to receive tiered profit share amounts of up to 3.0% from certain other permitted sales in certain other markets. The royalties payable under the 2021 RPI Royalty Purchase Agreement are in addition to the royalties payable to RPI under the 2020 RPI Royalty Purchase Agreement. Under the OMERS Royalty Purchase Agreement, commencing with the calendar quarter beginning October 1, 2023, OMERS will be entitled to receive tiered, sales-based royalties on Direct Sales in an amount equal to: (i) 7.5% of aggregate annual net sales of ORLADEYO for annual net sales up to $350,000 and (ii) 6.0% of annual net sales of ORLADEYO for annual net sales between $350,000 and $550,000 (with no royalty payments payable on annual Direct Sales over $550,000) (the “Regime A Royalty Rate”). If annual Direct Sales for calendar year 2023 reach a specified amount set forth in the OMERS Royalty Purchase Agreement, then for each calendar quarter beginning on or after January 1, 2024, OMERS will be entitled to receive the Regime A Royalty Rate. If annual Direct Sales for calendar year 2023 are less than the specified amount, OMERS will be entitled to receive tiered, sales-based royalties on Direct Sales in an amount equal to: (i) 10.0% of aggregate annual net sales of ORLADEYO for annual net sales up to $350,000 and (ii) 3.0% of annual net sales of ORLADEYO for annual net sales between $350,000 and $550,000 (with no royalty payments payable on annual Direct Sales over $550,000) (the “Regime B Royalty Rate”). 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 in the Other Markets, and (iii) 10.0% of proceeds received by the Company on annual net sales between $150,000 and $230,000 in the Other Markets. No royalty payments are payable on annual net sales above $230,000 in the Other Markets. OMERS is also entitled to receive profit share amounts of up to 10% from certain other permitted sales in certain other markets. Under the 2020 RPI Royalty Purchase Agreement, the Company is required to make royalty payments of amounts owed to RPI each calendar quarter following the first commercial sale of ORLADEYO in any country. Under the 2021 RPI Royalty Purchase Agreement, the Company is required to make payments to RPI in respect of net sales or sublicense revenue in each calendar quarter from and after October 1, 2021. Under the OMERS Royalty Purchase Agreement, the Company will be required to make payments to OMERS is respect of net sales or sublicense revenue in each calendar quarter from and after October 1, 2023. OMERS will no longer be entitled to receive any payments on the date in which aggregate payments actually received by OMERS equals either 142.5% or 155.0% of the $150,000 purchase price, depending on sales levels in calendar year 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-party audits of royalties paid under the Royalty Purchase Agreements, and restrictions on the ability of the Company or any of its subsidiaries to incur indebtedness other than certain royalty sales and as is permitted to be incurred under the terms of the Company’s Credit Agreement with Athyrium Opportunities III Co-Invest 1 LP. Refer to Note 7 for further details on the Credit Agreement. The restrictions on the ability of the Company or any of its subsidiaries to incur indebtedness are eliminated after the achievement of certain specified milestones in the Royalty Purchase Agreements. The cash consideration obtained pursuant to the Royalty Purchase Agreements is recorded in “Royalty financing obligations” on the Company’s Consolidated Balance Sheets. 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. During the three months ended September 30, 2022, the Company adjusted its forecasts related to its R&D programs and ORLADEYO sales. Accordingly, this impacted the amount and timing of expected royalties to be made under the RPI Royalty Purchase Agreements. As a result, the effective interest rate related to the 2020 RPI Royalty Purchase Agreement decreased from 25.5% to 23.1%, and the effective interest rate related to the 2021 RPI Royalty Purchase Agreement decreased from 12.1% to 11.0%. Additionally, the effective interest rate related to the OMERS Agreement increased from 8.5% to 10.6%. The following table shows the activity within the Royalty financing obligations account (in thousands) as well as the effective interest rate as of September 30, 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 Non-cash Interest expense on Royalty financing obligations 10,462 6,020 3,224 19,706 Royalty revenues paid and payable (5,764) (501) — (6,265) Balance as of June 30, 2022 $ 157,702 $ 164,809 $ 155,155 $ 477,666 Non-cash Interest expense on Royalty financing obligations 9,938 4,903 3,619 18,460 Royalty revenues paid and payable (5,837) (508) — (6,345) Balance as of September 30, 2022 $ 161,802 $ 169,204 $ 158,774 $ 489,781 Effective interest rate 23.1 % 11.0 % 10.6 % Deferred issuance costs pursuant to the Royalty financing obligations, which consist primarily of advisory and legal fees, totaled $8,531 as of September 30, 2022. The Royalty financing obligations liabilities and the associated deferred issuance costs are amortized using the effective interest method over the term of the arrangement, in accordance with the respective guidance. Concurrent with entering into the 2021 RPI Royalty Purchase Agreement, the Company and RPI entered into a Common Stock Purchase Agreement (the “Common Stock Purchase Agreement”), pursuant to which the Company sold common stock to RPI for a premium of $4,269. This premium has been deferred and is being amortized through interest expense using the effective interest method over the term of the applicable arrangement. Refer to Note 9 for further details on the common stock sale premium. |
Debt
Debt | 9 Months Ended |
Sep. 30, 2022 | |
Debt Disclosure [Abstract] | |
Debt | Debt Credit Agreement On December 7, 2020, the Company entered into a $200,000 Credit Agreement (the “Credit Agreement”) with Athyrium Opportunities III Co-Invest 1 LP (“Athyrium”), as lender and as administrative agent for the lenders. Certain of the Company’s direct and indirect subsidiaries are guarantors to the Credit Agreement. The Credit Agreement provides for an initial term loan in the principal amount of $125,000 (the “Term A Loan”), which was received by the Company on December 7, 2020 and is recorded in “Secured term loan” on the Company’s balance sheet as of September 30, 2022. The Company used a portion of the proceeds from the Term A Loan to repay $43,298 of outstanding indebtedness, including accrued interest, under its prior credit facility with MidCap Financial Trust. The Credit Agreement also provided for two additional term loans, at the Company’s option, in the respective principal amounts of $25,000 (the “Term B Loan”) and $50,000 (the “Term C Loan” and, collectively with the Term A Loan and the Term B Loan, the “Term Loans”). Having achieved all required revenue-based milestones, the Company exercised its option to draw upon the additional funding available under the Credit Agreement, borrowing the principal amounts of $25,000 under the Term B Loan and $50,000 under the Term C Loan. Both the Term B Loan and the Term C Loan were funded on July 29, 2022 in the aggregate principal amount of $75,000. The Term B Loan and the Term C Loan are subject to all the provisions under the Credit Agreement. On November 19, 2021, the Company entered into an amendment to the Credit Agreement (i) to permit the Company to enter into the 2021 RPI Royalty Purchase Agreement, the OMERS Royalty Purchase Agreement, and the other definitive documentation related thereto and to perform its obligations thereunder; (ii) to require the Company to pay to Athyrium, for the account of the lenders, a make-whole premium plus certain fees set forth in the Credit Agreement in the event that the Company did not draw the Term B Loan or the Term C Loan, as applicable, by the end of the applicable period available to draw the Term B Loan or the Term C Loan, subject to certain exceptions set forth in the Credit Agreement; and (iii) to require the Company to pay to Athyrium, for the account of the lenders, a make-whole premium plus certain fees set forth in the Credit Agreement in the event that the Company either (x) terminated the commitments in respect of the Term B Loan or the Term C Loan, as applicable, on or prior to the end of the applicable period available to draw the Term B Loan or the Term C Loan, or (y) prepays or repays, or is required to prepay or repay, voluntarily or pursuant to mandatory prepayment obligations under the Credit Agreement (e.g., 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), all of the then-outstanding Term Loans, in each case, subject to certain exceptions set forth in the Credit Agreement. 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 full fiscal quarters following December 7, 2020, the Company has the option to make the applicable interest payment in-kind (a “PIK Interest Payment”) by capitalizing the entire amount of interest accrued during the applicable interest period with the unpaid original principal amount outstanding on the last day of such period. The Term Loans will bear interest at a rate equal to the three-month LIBOR rate, which shall be no less than 1.75% and no more than 3.50% (“LIBOR”), plus 8.25%, or for each interest period in which a PIK Interest Payment is made, LIBOR plus 10.25%. The three-month LIBOR was 2.31% as of June 28, 2022, the LIBOR measurement date for the three-month interest period beginning July 1, 2022. Accordingly, this LIBOR rate plus 10.25% was used to record interest expense for the three months ended September 30, 2022. The three-month LIBOR was 3.67% as of September 28, 2022, the LIBOR measurement date for the three-month interest period beginning October 1, 2022. As the LIBOR rate exceeds the LIBOR cap of 3.50%, the 3.50% cap plus 10.25% will be used to record interest expense for the three-month interest period beginning October 1, 2022. 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. The Company may make voluntary prepayments in whole or in part. Prepayments are subject to a premium equal to, (i) with respect to any voluntary prepayment and certain mandatory prepayments paid on or prior to the second anniversary of the applicable Term Loan borrowing date, the amount, if any, by which (a) the sum of (1) 102.00% of the principal amount of the Term Loan being prepaid plus (2) the present value of all interest that would have accrued on the principal amount of the Term Loan being prepaid through and including the second anniversary of the date of the borrowing of such Term Loan, plus 0.50%, exceeds (b) the principal amount of the Term Loan being prepaid; (ii) with respect to any prepayment made between the second and third anniversaries of the applicable Term Loan borrowing date, 2.00% of the principal amount of the Term Loan being prepaid; (iii) with respect to any prepayment made between the third and fourth anniversaries of the applicable Term Loan borrowing date, 1.00% of the principal amount of the Term Loan being prepaid; and (iv) with respect to any prepayment made after the fourth anniversary of the applicable Term Loan borrowing date, 0.00% of the principal amount of the Term Loan being prepaid. Upon the prepayment or repayment, including at maturity, of all or any of the Term Loans, the Company is obligated to pay an exit fee in an amount equal to 2.00% of the principal amount of the Term Loans prepaid or repaid. In addition, each Term Loan is subject to a 1.00% commitment fee at its respective borrowing date. 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 Test Date occurring immediately after the Term C Loan is drawn, if applicable, the Company may not permit consolidated net revenues from ORLADEYO sales in the United States for the four-fiscal quarter period ending on such Test Date to be less than the specified amounts set forth in the Credit Agreement (collectively, the “Revenue Tests”). If the Company fails to satisfy the Revenue Tests as of any Test Date, it will have a one-time right (the “Cure Right”) to repay in full the entire amount of the Term C Loan outstanding at such time together with all accrued and unpaid interest thereon plus the prepayment premium, exit fee, and any other fees or amounts payable under the Credit Agreement at such time. In addition, the Credit Agreement contains a minimum liquidity covenant requiring the Company to maintain at all times, as applicable, at least $15,000 of unrestricted cash and cash equivalents if only the Term A Loan has been drawn; at least $20,000 of unrestricted cash and cash equivalents if the Term B Loan has been drawn but the Term C Loan has not been drawn; and at least $15,000 (or, if the Cure Right has been exercised, $20,000) of unrestricted cash and cash equivalents if the Term C Loan has been drawn, subject to certain exceptions. 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 September 30, 2022, the Company had total borrowings of $200,000 under the Credit Agreement. Quarterly interest payments under the Credit Agreement for the nine months ended September 30, 2022 and 2021 totaled $15,311 and $11,815, respectively, and have been designated and accounted for as PIK Interest Payments and added to the outstanding principal balance of the borrowing. As of September 30, 2022, borrowings, including the PIK Interest Payments, totaled $232,376. The principal balance of the borrowings, including PIK amounts, is accruing interest at an effective rate of 12.68%. The fair value of the debt approximates its carrying value based on prevailing interest rates as of the balance sheet date and is considered as Level 2 in the fair value hierarchy. During the three months ended September 30, 2022, the Company incurred deferred debt fees and issuance costs associated with the Term B and Term C Loans of $3,428. As of September 30, 2022, deferred debt fees and issuance costs associated with all Term Loans under the Credit Agreement totaled $12,509 and are being amortized as interest expense on an effective interest rate method over the remaining term of the Term Loans. When utilizing the effective interest method, in periods in which PIK interest is designated and those amounts are added to the outstanding principal balance of the borrowing, the amortization of the deferred debt fees and issuance costs is accretive. Deferred financing amortization of $(597) and $(369), was recognized for the nine months ended September 30, 2022 and 2021, respectively. The Credit Agreement contains two provisions that, if deemed probable, would create the recognition of an embedded feature; however, at this time, the Company does not believe either provision is probable. |
Lease Obligations
Lease Obligations | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Lease Obligations | 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 September 30, 2022. Renewal options for the Company's leases range from 1 to 5 years in length and begin from 2023 through 2026. Aggregate lease expense under operating leases was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Aggregate lease expense $ 634 $ 393 $ 1,854 $ 1,306 Other supplemental information related to leases was as follows: As of September 30, 2022 As of December 31, 2021 Weighted average remaining lease term 8.4 years 9.2 years Weighted average discount rate 10.9% 11.2% 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 September 30, 2022 As of December 31, 2021 Assets: Operating lease assets, net Other Assets $ 6,797 $ 6,472 Liabilities: Current operating lease liabilities Lease financing obligation – current liabilities $ 2,196 $ 1,819 Non-current operating lease liabilities Lease financing obligation – long-term liabilities 5,968 5,962 Total operating lease liabilities $ 8,164 $ 7,781 Operating lease assets are recorded net of accumulated amortization of $3,874 and $2,626 as of September 30, 2022 and December 31, 2021, respectively. Cash paid for amounts included in the measurement of lease liabilities was $615 and $1,796 for the three and nine months ended September 30, 2022, respectively, and $306 and $1,125 for the three and nine months ended September 30, 2021, respectively. Maturities of operating lease liabilities as of September 30, 2022, are as follows (in thousands): 2022 (remaining) $ 684 2023 2,334 2024 1,785 2025 1,441 2026 651 Thereafter 6,734 Total lease payments 13,629 Less imputed interest (5,465) Total $ 8,164 |
Stockholders' Equity
Stockholders' Equity | 9 Months Ended |
Sep. 30, 2022 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders ’ Equity Sales of Common Stock On April 24, 2020, the Company filed a shelf registration statement on Form S-3 with the SEC. This shelf registration statement became effective on May 14, 2020 and allows the Company to sell up to $500,000 in securities, including common stock, preferred stock, depositary shares, purchase contracts, warrants, debt securities, and units, from time to time at prices and on terms to be determined at the time of sale. On March 1, 2021, the Company filed an automatic shelf registration statement on Form S-3 with the SEC. This shelf registration statement became effective automatically upon filing and allows the Company to sell an indeterminate number of securities, including common stock, preferred stock, depositary shares, purchase contracts, warrants, debt securities, and units, from time to time at prices and on terms to be determined at the time of sale. On November 19, 2021, concurrent with the Company entering into the 2021 RPI Royalty Purchase Agreement, the Company and RPI entered into the Common Stock Purchase Agreement, pursuant to which the Company issued 3,846,154 |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Stock-Based Compensation As of September 30, 2022, the Company had three stock-based employee compensation plans: the Amended and Restated Stock Incentive Plan (“Incentive Plan”), the Amended and Restated Inducement Equity Incentive Plan (“Inducement Plan”) and the Amended and Restated Employee Stock Purchase Plan (“ESPP”). The Incentive Plan was most recently amended and restated on April 18, 2022 and approved by the Company’s stockholders on June 7, 2022. The Inducement Plan was most recently amended and restated by the Board of Directors on August 26, 2022. The ESPP was most recently amended and restated on April 1, 2021 and approved by the Company’s stockholders on May 25, 2021. Stock-based compensation expense of $29,421 ($23,687 of expense related to the Incentive Plan, $4,604 of expense related to the Inducement Plan, and $1,130 of expense related to the ESPP) was recognized during the nine months ended September 30, 2022, while $26,140 ($19,973 of expense related to the Incentive Plan, $5,025 of expense related to the Inducement Plan and $1,142 of expense related to the ESPP) was recognized during the nine months ended September 30, 2021. There was approximately $100,171 of total unrecognized compensation expense related to non-vested stock option and restricted stock unit awards granted by the Company as of September 30, 2022. As of September 30, 2022, the Company expected to recognize that expense as follows: $10,707 during the remainder of 2022, $35,987 in 2023, $31,537 in 2024, $19,524 in 2025 and $2,416 in 2026. In addition, the Company has outstanding performance-based stock options and restricted stock unit awards for which no compensation expense is recognized until “performance” has occurred and the award vests. 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 common stock at the date of grant. Commencing March 1, 2011, stock option awards and restricted stock units granted to employees generally vest 25% each year until fully vested after four years. In December 2014, the Company issued 1,250 performance-based stock options. These awards vest upon successful completion of specific development milestones. As of September 30, 2022, 85% of these grants have vested. In January 2022, the Company issued 221 performance-based restricted stock unit awards. Contingent upon successful achievement of specific commercial or operational objectives in 2022, the awards become eligible for vesting at 50% on the first anniversary of the grant date and 25% on each of the second and third anniversaries of the grant date, until fully vested after three years. Stock option awards and restricted stock unit awards granted to non-employee directors of the Company generally vest over one year. Stock option awards granted to new non-employee directors when they first join the Company’s Board of Directors generally vest, subject to the terms of the Incentive Plan, in 36 equal monthly installments over a three-year period measured from the grant date. All stock option awards have contractual terms of 10 years. Restricted stock unit awards granted to new non-employee directors when they first join the Company's Board of Directors generally vest, subject to the terms of the Incentive Plan, in three equal annual installments beginning on the first anniversary of the grant date. The vesting and exercise provisions of all awards granted under the Incentive Plan are subject to acceleration in the event of certain stockholder-approved transactions, or upon the occurrence of a change in control as defined in the Incentive Plan. Related activity under the Incentive Plan is as follows: Awards Options Weighted Balance December 31, 2021 3,651 28,685 $ 7.90 Plan amendment 8,000 — — Restricted stock unit awards granted (681) — — Restricted stock unit awards cancelled 218 — — Stock option awards granted (813) 813 11.10 Stock option awards exercised — (1,334) 5.65 Stock option awards cancelled 787 (787) 10.02 Balance September 30, 2022 11,162 27,377 $ 8.04 For stock option awards granted under the Incentive Plan during the first nine months of 2022 and 2021, the fair value was estimated on the date of grant using a Black-Scholes option pricing model and the assumptions noted in the table following the next subsection. The weighted average grant date fair value of these awards granted during the first nine months of 2022 and 2021 was $7.78 and $8.11, respectively. The fair value of the stock option awards is amortized to expense over the vesting periods using a straight-line expense attribution method. For restricted stock units granted under the Incentive Plan, the fair value of the awards was determined based on the market value of the Company’s shares on the grant date. The weighted average grant date fair value of these awards granted during the first nine months of 2022 and 2021 was $13.18 and $10.17, respectively. The fair value of the restricted stock unit awards is amortized to expense over the vesting periods using a straight-line expense attribution method. 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 years and are subject to the terms and conditions of the Inducement Plan. Each stock option has a term of 10 years. The vesting and exercise provisions of all awards granted under the Inducement Plan are subject to acceleration in the event of certain stockholder-approved transactions, or upon the occurrence of a change in control as defined in the Inducement Plan. Related activity under the Inducement Plan is as follows: Awards Options Weighted Balance December 31, 2021 900 4,408 $ 6.20 Plan amendment 1,926 — — Restricted stock unit awards granted (424) — — Restricted stock unit awards cancelled 2 — — Stock option awards granted (1,381) 1,381 13.84 Stock option awards exercised — (196) 3.77 Stock option awards cancelled 323 (323) 7.02 Balance September 30, 2022 1,346 5,270 $ 8.28 For stock option awards granted under the Inducement Plan during the first nine months of 2022 and 2021, the fair value was estimated on the date of grant using a Black-Scholes option pricing model and the assumptions noted in the table below. The weighted average grant date fair value of these awards granted during the first nine months of 2022 and 2021 was $9.72 and $9.74, respectively. The fair value of the stock option awards is amortized to expense over the vesting periods using a straight-line expense attribution method. For restricted stock units granted under the Inducement Plan, the fair value of the awards was determined based on the market value of the Company’s shares on the grant date. The weighted average grant date fair value of these awards granted during the first nine months of 2022 was $13.38. The fair value of the restricted stock unit awards is amortized to expense over the vesting periods using a straight-line expense attribution method. No restricted stock unit awards were granted under the Inducement Plan during the first nine months of 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 nine months of 2022 and 2021, respectively. The expected life is based on the average of the assumption that all outstanding stock option awards will be exercised at full vesting and the assumption that all outstanding stock option awards will be exercised at the midpoint of the current date (if already vested) or at full vesting (if not yet vested) and the full contractual term. The expected volatility represents the historical volatility on the Company’s publicly traded common stock. The Company has assumed no expected dividend yield, as dividends have never been paid to stock or option holders and will not be paid for the foreseeable future. The weighted average risk-free interest rate is the implied yield currently available on zero-coupon government issues with a remaining term equal to the expected term. Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors under the 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 2.9 % 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 5,792 shares remain available for purchase as of September 30, 2022. Eligible employees may authorize up to 15% of their salary to purchase common stock at the lower of 85% of the beginning or 85% of the ending price during six-month purchase intervals. No more than 3 shares may be purchased by any one employee at the six-month purchase dates, and no employee may purchase stock having a fair market value at the commencement date of $25 or more in any one calendar year. During the nine months ended September 30, 2022, and 2021, the Company issued 260 and 316 shares under the ESPP, respectively. Compensation expense for shares purchased under the ESPP related to the purchase discount and the “look-back” option were determined using a Black-Scholes option pricing model. |
Collaborative and Other Relatio
Collaborative and Other Relationships | 9 Months Ended |
Sep. 30, 2022 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative and Other Relationships | Collaborative and Other Relationships National Institute of Allergy and Infectious Diseases . In September 2013, NIAID/HHS contracted with the Company for the development of galidesivir as a treatment for Marburg virus disease and subsequently, Yellow Fever and Ebola virus disease. On September 15, 2021, the Company entered into an amendment to pay for certain additional costs, including additional manufacturing development costs and overhead, and to change the total value of the contract, as amended, to $47,315 from $45,931. This is the commencement of closing out the contract. All options under the contract have been awarded. In August 2020, NIAID/HHS awarded the Company a contract, with potential aggregate funding of up to $43,908 if all contract options are exercised, to manufacture and evaluate the safety, efficacy and tolerability of galidesivir. NIAID/HHS made an initial award of $6,326 to the Company under this contract. Biomedical Advanced Research and Development Authority . In March 2015, BARDA/HHS awarded the Company a contract for the continued development of galidesivir as a potential treatment for diseases caused by RNA pathogens, including filoviruses. This BARDA/HHS contract includes a base contract of $16,265 to support galidesivir drug manufacturing, as well as $22,855 in additional development options that can be exercised by the government, bringing the potential value of the contract to $39,120. As of September 30, 2022, a total of $20,574 has been awarded under exercised options within this contract. The most recent development option was completed as of September 30, 2022. The contracts with NIAID/HHS and BARDA/HHS are cost-plus-fixed-fee contracts. 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. The Company expects all government funding for its galidesivir program to expire in 2022. U.S. Department of Health and Human Services . In September 2018, HHS awarded the Company a $34,660 contract for the procurement of up to 50,000 doses of RAPIVAB (peramivir injection) over a five-year period. On August 25, 2022, the Company announced that HHS had exercised its remaining option under the contract to purchase 10,000 doses of RAPIVAB for $6,932. As of September 30, 2022, the Company has delivered a total of 39,980 RAPIVAB doses of the 50,000 RAPIVAB doses available under the contract with HHS for a total of $27,714. Torii Pharmaceutical Co., Ltd . On November 5, 2019, the Company entered into a Commercialization and License Agreement with Torii (the “Torii Agreement”), granting Torii the exclusive right to commercialize ORLADEYO for the prevention of HAE attacks in Japan. 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 triggered a $15,000 milestone payment from Torii to the Company, which was received in 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 be reduced by more than 50% of the amount that otherwise would have been payable to the Company in the applicable calendar quarter. Torii’s royalty payment obligations commenced upon the first commercial sale of ORLADEYO in Japan and expire upon the later of (i) the ten 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 upfront consideration to the identified performance obligations using estimation approaches to determine the standalone selling prices under ASC Topic 606. Specifically, in determining the value related to the license, a valuation approach utilizing risk adjusted discounted cash flow projections was used, and an expected cost plus margin approach was utilized for the other performance obligations. Shionogi & Co., Ltd . In February 2007, the Company entered into an exclusive license agreement with Shionogi to develop and commercialize peramivir in Japan for the treatment of seasonal and potentially life-threatening human influenza. Under the terms of the agreement, Shionogi obtained rights to injectable formulations of peramivir in Japan. The Company developed peramivir under a license from UAB and will owe sublicense payments to UAB on any future milestone payments and/or royalties received by the Company from Shionogi. In October 2008, the Company and Shionogi amended the license agreement to expand the territory covered by the agreement to include Taiwan. Shionogi has commercially launched peramivir under the commercial name RAPIACTA in Japan and Taiwan. Green Cross Corporation . In June 2006, the Company entered into an agreement with Green Cross to develop and commercialize peramivir in Korea. Under the terms of the agreement, Green Cross is responsible for all development, regulatory, and commercialization costs in Korea and the Company is entitled to share in profits resulting from the sale of peramivir in Korea, including the sale of peramivir to the Korean government for stockpiling purposes. Furthermore, Green Cross will pay the Company a premium over its cost to supply peramivir for development and any future marketing of peramivir products in Korea. Albert Einstein College of Medicine of Yeshiva University and Industrial Research, Ltd . In June 2000, the Company licensed a series of potent inhibitors of purine nucleoside phosphorylase from AECOM and IRL (together, the “Licensors”). The lead product candidate from this collaboration is forodesine. The Company has obtained worldwide exclusive rights to develop and ultimately distribute this, or any other, product candidate that might arise from research on these inhibitors. The Company has the option to expand the agreement to include other inventions in the field made by the investigators or employees of the Licensors. Under this agreement, as amended and restated, the Company has agreed to use commercially reasonable efforts to develop these drugs, to pay certain milestone payments for each licensed product (which range in the aggregate from $1,400 to almost $4,000 per indication) for future development and single digit royalties on net sales of any resulting product made by the Company, and to share a portion of future payments received from other third-party partners, if any. In addition, the Company has agreed to pay annual license fees, which can range from $150 to $500, that are creditable against actual royalties and other payments due to the Licensors. The Licensors have also granted the Company an exclusive worldwide license of galidesivir for any antiviral use. The University of Alabama at Birmingham . The Company currently has agreements with UAB for influenza neuraminidase and complement inhibitors. Under the terms of these agreements, UAB performed specific research for the Company in return for research payments and license fees. UAB has granted the Company certain rights to any discoveries in these areas resulting from research developed by UAB or jointly developed by UAB with the Company. The Company has agreed to pay single digit royalties on sales of any resulting product and to share in future payments received from other third-party partners. The Company has completed the research under the UAB agreements. These two agreements each have an initial 25-year term, are automatically renewable for five-year terms throughout the life of the last patent and are terminable by the Company upon three months’ notice and by UAB under certain circumstances. Upon termination, both parties shall cease using the other parties’ proprietary and confidential information and materials, the parties shall jointly own joint inventions and UAB shall resume full ownership of all UAB licensed products. There is currently no activity between the Company and UAB on these agreements, but when the Company licenses this technology, such as in the case of the Shionogi and Green Cross collaborations, or commercializes products related to these programs, the Company will owe sublicense fees or royalties on amounts received. |
Significant Accounting Polici_2
Significant Accounting Policies and Concentrations of Risk (Policies) | 9 Months Ended |
Sep. 30, 2022 | |
Accounting Policies [Abstract] | |
The Company | 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 and incorporated in Delaware in 1991, and its headquarters is located in Durham, North Carolina. The Company integrates the disciplines of biology, crystallography, medicinal chemistry and computer modeling to discover and develop small molecule pharmaceuticals through the process known as structure-guided drug design. 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. ORLADEYO has also received regulatory approvals in multiple global markets. The Company is commercializing ORLADEYO in each of these territories directly or through distributors, except in Japan where Torii Pharmaceutical Co., Ltd., the Company’s collaborative partner, has the exclusive right to commercialize ORLADEYO for the prevention of HAE attacks in exchange for certain milestone and royalty payments to the Company. In addition to its approval in the United States, peramivir injection has received regulatory approvals in Canada, Australia, Japan, Taiwan and Korea. Based on the Company’s expectations for revenue and operating expenses, the Company believes its financial resources available at September 30, 2022 will be sufficient to fund its operations for at least the next 12 months. The Company has sustained operating losses for the majority of its corporate history and expects that its 2022 expenses will exceed its 2022 revenues. The Company expects to continue to incur operating losses and negative cash flows until revenues reach a level sufficient to support ongoing operations. The Company’s liquidity needs will be largely determined by the success of operations in regard to the successful commercialization of its products and the progression of its product candidates in the future. The Company regularly evaluates other opportunities to fund future operations, including: (1) securing or increasing U.S. Government funding of its programs, including obtaining procurement contracts; (2) out-licensing rights to certain of its products or product candidates, pursuant to which the Company would receive cash milestone payments; (3) raising additional capital through equity or debt financings or from other sources, including royalty or other monetization transactions; (4) obtaining additional product candidate regulatory approvals, which would generate revenue, milestone payments and cash flow; (5) reducing spending on one or more research and development programs, including by discontinuing development; and/or (6) restructuring operations to change its overhead structure. The Company may issue securities, including common stock, preferred stock, depositary shares, purchase contracts, warrants, debt securities and units, through private placement transactions or registered public offerings in the future. The Company’s future liquidity needs, and ability to address those needs, will largely be determined by the success of its products and product candidates; the timing, scope and magnitude of its research and development and commercial expenses; and key developments and regulatory events and its decisions in the future. |
Basis of Presentation | 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-Q and do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. Such financial statements reflect all adjustments that are, in management’s opinion, necessary to present fairly, in all material respects, the Company’s consolidated financial position, results of operations, and cash flows. There were no adjustments other than normal recurring adjustments. These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2021 and the notes thereto included in the Company’s 2021 Annual Report on Form 10-K. Interim operating |
Use of Estimates | 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 readily apparent from other sources. Actual results could differ from those estimates. |
Revenue Recognition | Revenue Recognition Pursuant to Accounting Standards Codification (“ASC”) Topic 606, the Company recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, Topic 606 includes provisions within a five step model that includes (i) identifying the contract with a customer, (ii) identifying the performance obligations in the contract, (iii) determining the transaction price, (iv) allocating the transaction price to the performance obligations, and (v) recognizing revenue when, or as, an entity satisfies a performance obligation. 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, sales of peramivir to the Company’s licensing partners and sales of RAPIVAB to the U.S. Department of Health and Human Services (“HHS”) under the Company’s procurement contract. In the United States, the Company ships ORLADEYO directly to patients through a single specialty pharmacy, which is considered its customer. In the European Union, United Kingdom and elsewhere, the Company sells ORLADEYO to specialty distributors as well as hospitals and pharmacies, which collectively are considered its customers. 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 be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company's estimates. If actual results in the future vary from estimates, the Company adjusts these estimates, which would affect net product revenue and earnings in the period such variances become known. Government and Managed Care Rebates . The Company contracts with government agencies and managed care organizations or, collectively, third-party payors, so that ORLADEYO will be eligible for purchase by, or partial or full reimbursement from, such third-party payors. The Company estimates the rebates it will provide to third-party payors and deducts these estimated amounts from total gross product revenues at the time the revenues are recognized. These reserves are recorded in the same period in which the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability. The Company estimates the rebates that it will provide to third-party payors based upon (i) the Company's contracts with these third-party payors, (ii) the government mandated discounts applicable to government-funded programs, (iii) a range of possible outcomes that are probability-weighted for the estimated payor mix, and (iv) product distribution information obtained from the Company's specialty pharmacy. Chargebacks . Chargebacks are discounts that occur when certain contracted customers, pharmacy benefit managers, insurance companies, and government programs purchase directly from the Company’s specialty pharmacy. These customers purchase the Company’s product under contracts negotiated between them and the Company’s specialty pharmacy. The specialty pharmacy, in turn, charges back to the Company the difference between the price the specialty pharmacy paid and the negotiated price paid by the contracted customers, which may be higher or lower than the specialty pharmacy’s purchase price from the Company. The Company estimates chargebacks and adjusts gross product revenues and accounts receivable based on the estimates at the time revenues are recognized. Co-payment assistance and patient assistance programs . Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Based upon the terms of the program and co-payment assistance utilization reports received from the specialty pharmacy, the Company is able to estimate the co-payment assistance amounts, which are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue. The Company also offers a patient assistance program that provides free drug product, for a limited period of time, to allow a patient’s insurance coverage to be established. Based on patient assistance program utilization reports provided by the specialty pharmacy, the Company records gross revenue of the product provided and a full reduction of the revenue amount for the free drug discount. Product returns . The Company does not provide contractual return rights to its customers, except in instances where the product is damaged or defective. Non-acceptance by the patient of shipped drug product by the specialty pharmacy is reflected as a reversal of sales in the period in which the sales were originally recorded. Reserves for estimated non-acceptances by patients are recorded as a reduction of revenue in the period that the related revenue is recognized, as well as a reduction to accounts receivable. Estimates of non-acceptance are based on quantitative information provided by the specialty pharmacy. Collaborative and Other Research and Development Arrangements and Royalties The Company has collaboration and license agreements with a number of third parties, as well as research and development agreements with certain government entities. The Company’s primary sources of revenue from these collaborative and other research and development arrangements are license, service and royalty revenues. 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 further continuing performance obligations or the Company has completed the performance obligations under the terms of the agreement. Arrangements that involve the delivery of more than one performance obligation are initially evaluated as to whether the intellectual property licenses granted by the Company represent distinct performance obligations. If they are determined to be distinct, the value of the intellectual property licenses would be recognized up front while the research and development service fees would be recognized as the performance obligations are satisfied. For performance obligations based on services performed, the Company measures progress using an input method based on the effort it expends or costs it incurs toward the satisfaction of the performance obligation in relation to the total estimated effort or costs. Variable consideration is assessed at each reporting period as to whether it is not subject to significant future reversal and, therefore, should be included in the transaction price at the inception of the contract. If a contract includes a fixed or minimum amount of research and development support, this also would be included in the transaction price. Changes to collaborations, such as the extensions of the research term or increasing the number of targets or technology covered under an existing agreement, are assessed for whether they represent a modification or should be accounted for as a new contract. For contracts with multiple performance obligations, revenue is allocated to each performance obligation based on its relative standalone selling price. Standalone selling prices are based on observable prices at which the Company separately sells the products or services. If a standalone selling price is not directly observable, then the Company estimates the standalone selling price using either an adjusted market assessment approach or an expected cost plus margin approach, representing the amount that the Company believes the market is willing to pay for the product or service. Analyzing the arrangement to identify performance obligations requires the use of judgment, and each may be an obligation to deliver services, a right or license to use an asset, or another performance obligation. 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 probable at the inception of the agreement and (ii) the Company has a right to payment. Any milestone payments received prior to satisfying these revenue recognition criteria are recorded as deferred revenue. 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 | Cash and Cash Equivalents The Company generally considers cash equivalents to be all cash held in commercial checking accounts, certificates of deposit, money market accounts or investments in debt instruments with maturities of three months or less at the time of purchase. The carrying value of cash and cash equivalents approximates fair value due to the short-term nature of these items. |
Restricted Cash | Restricted Cash Restricted cash of $21 and $1,924 as of September 30, 2022 and December 31, 2021, respectively, reflects royalty revenue paid by Shionogi designated for interest on the PhaRMA Notes (defined in Note 6). Additionally, restricted cash of $1,423 and $1,421 as of September 30, 2022 and December 31, 2021, respectively, reflects collateral for a letter of credit the Company is required to maintain associated with the lease execution and build-out of its Birmingham research facilities. |
Investments | Investments The Company invests in high credit quality investments in accordance with its investment policy, which is designed to minimize the possibility of loss. The objective of the Company’s investment policy is to ensure the safety and preservation of invested funds, as well as maintaining liquidity sufficient to meet cash flow requirements. The Company places its excess cash with high credit quality financial institutions, commercial companies, and government agencies in order to limit the amount of its credit exposure. In accordance with its policy, the Company is able to invest in marketable debt securities that may consist of U.S. Government and government agency securities, money market and mutual fund investments, certificates of deposits, municipal and corporate notes and bonds, and commercial paper, among others. The Company’s investment policy requires it to purchase high-quality marketable securities with a maximum individual maturity of three years and requires an average portfolio maturity of no more than 12 months. Some of the securities in which the Company invests may have market risk. This means that a change in prevailing interest rates may cause the principal amount of the investment to fluctuate. To minimize this risk, the Company schedules its investments with maturities that coincide with expected cash flow needs, thus avoiding the need to redeem an investment prior to its maturity date. Accordingly, the Company does not believe it has a material exposure to interest rate risk arising from its investments. Generally, the Company’s investments are not collateralized. The Company has not realized any significant losses from its investments. The Company classifies all of its investments as available-for-sale. Unrealized gains and losses on investments are recognized in comprehensive loss, unless an unrealized loss is considered to be other than temporary, in which case the unrealized loss is charged to operations. The Company periodically reviews its investments for other than temporary declines in fair value below cost basis and whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. The Company believes the individual unrealized losses represent temporary declines primarily resulting from interest rate changes. Realized gains and losses are reflected in interest and other income in the Consolidated Statements of Comprehensive Loss and are determined using the specific identification method with transactions recorded on a settlement date basis. Investments with original maturities at date of purchase beyond three months and which mature at or less than 12 months from the balance sheet date are classified as current. Investments with a maturity beyond 12 months from the balance sheet date are classified as long-term. At September 30, 2022, the Company believes that the cost of its investments is recoverable in all material respects. |
Trade Receivables | 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-party distributors, hospitals and pharmacies in the European Union, United Kingdom and elsewhere and have standard payment terms that generally require payment within 30 to 90 days. 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 adjust its receivables for the effects of a significant financing component at contract inception if it expects to collect the receivables in one year or less from the time of sale. The Company provides reserves against trade receivables for estimated losses that may result from a customer's inability to pay. Receivables are evaluated to determine if any reserve or allowance should be recorded based on consideration of the current economic environment, expectations of future economic conditions, specific circumstances and the Company’s own historical collection experience. Amounts determined to be uncollectible are charged or written-off against the reserve. |
Inventory | 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-in, first-out (FIFO) basis. Raw materials and work-in-process include all inventory costs prior to packaging and labelling, including raw material, active product ingredient, and the drug product. Finished goods include packaged and labelled products. 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 experience spoilage of its raw materials and supplies. The Company’s determination that a valuation reserve might be required, in addition to the quantification of such reserve, requires it to utilize significant judgment. 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 Property and equipment are recorded at cost. Depreciation is computed using the straight-line method over the estimated useful lives of the assets. Computer equipment is depreciated over a life of three years. Laboratory equipment, office equipment, and software are depreciated over a life of five years. Furniture and fixtures are depreciated over a life of seven years. Leasehold improvements are amortized over their estimated useful lives or the expected lease term, whichever is less. In accordance with U.S. GAAP, the Company periodically reviews its property and equipment for impairment when events or changes in circumstances indicate that the carrying amount of such assets may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written down to their estimated fair values. Property and equipment to be disposed of are reported at the lower of carrying amount or fair value less cost to sell. |
Accrued Expenses | Accrued Expenses The Company generally enters into contractual agreements with third-party vendors who provide research and development, manufacturing, distribution, and other services in the ordinary course of business. Some of these contracts are subject to milestone-based invoicing, and services are completed over an extended period of time. The Company records liabilities under these contractual commitments when it determines an obligation has been incurred, regardless of the timing of the invoice. This process involves reviewing open contracts and purchase orders, communicating with applicable Company personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated cost incurred for the service when the Company has not yet been invoiced or otherwise notified of actual cost. The majority of service providers invoice the Company monthly in arrears for services performed. The Company makes estimates of accrued expenses as of each balance sheet date in its financial statements based on the facts and circumstances. The Company periodically confirms the accuracy of its estimates with the service providers and makes adjustments if necessary. Examples of estimated accrued expenses include (i) fees paid to clinical research organizations (“CROs”) in connection with preclinical and toxicology studies and clinical trials; (ii) fees paid to investigative sites in connection with clinical trials; (iii) fees paid to contract manufacturers in connection with the production of the Company’s raw materials, drug substance, drug products, and product candidates; and (iv) professional fees. The Company bases its expenses related to clinical trials on its estimates of the services received and efforts expended pursuant to contracts with multiple research institutions and CROs that conduct and manage clinical trials on the Company’s behalf. The financial terms of these agreements are subject to negotiation, vary from contract to contract and may result in uneven payment flows. Payments under some of these contracts depend on factors such as the successful enrollment of patients and the completion of clinical trial milestones. In accruing service fees, the Company estimates the time period over which services will be performed and the level of effort expended in each period. If the actual timing of the performance of services or the level of effort varies from the estimate, the Company will adjust the accrual accordingly. As of September 30, 2022 and December 31, 2021, the carrying value of accrued expenses approximates their fair value due to their short-term settlement. |
Cost of Product Sales | 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 also include costs related to excess or obsolete inventory adjustment charges. |
Research and Development Expenses | Research and Development Expenses The Company’s research and development costs are charged to expense when incurred. Research and development expenses include all direct and indirect development costs related to the development of the Company’s portfolio of product candidates. Advance payments for goods or services that will be used or rendered for future research and development activities are deferred and capitalized. Such amounts are recognized as expense when the related goods are delivered or the related services are performed. Research and development expenses include, among other items, personnel costs, including salaries and benefits, manufacturing costs, clinical, regulatory, and toxicology services performed by CROs, materials and supplies, and overhead allocations consisting of various administrative and facilities related costs. Most of the Company’s manufacturing and clinical and preclinical studies are performed by third-party CROs. Costs for studies performed by CROs are accrued by the Company over the service periods specified in the contracts, and estimates are adjusted, if required, based upon the Company’s ongoing review of the level of services actually performed. Additionally, the Company has license agreements with third parties, such as Albert Einstein College of Medicine of Yeshiva University (“AECOM”), Industrial Research, Ltd. (“IRL”), and the University of Alabama at Birmingham (“UAB”), which require fees related to sublicense agreements or maintenance fees. The Company expenses sublicense payments as incurred unless they are related to revenues that have been deferred, in which case the expenses are deferred and recognized over the related revenue recognition period. The Company expenses maintenance payments as incurred. |
Selling, General and Administrative Expenses | 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 $3,476 and $11,555 for the three and nine months ended September 30, 2022, respectively, and $1,492 and $4,696 for the three and nine months ended September 30, 2021, respectively. All patent related costs are expensed to selling, general and administrative expenses when incurred as recoverability of such expenditures is uncertain. |
Leases | 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 September 30, 2022. The Company accounts for lease obligations in accordance with ASU 2016-02: Leases (Topic 842) , which requires a lessee to recognize a right-of-use asset and a lease liability on its balance sheet for most operating leases. 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 Sheets represent payments over the lease term, which includes renewal options for certain real estate leases that the Company is 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 months or less was not material. 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 made any residual value guarantees related to its operating leases; therefore, the Company has no corresponding liability recorded on its Consolidated Balance Sheets. |
Stock-Based Compensation | 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, the Company has outstanding performance-based stock options and restricted stock units for which no compensation expense is recognized until “performance” is deemed to have occurred. |
Interest Expense and Deferred Financing Costs | Interest Expense and Deferred Financing Costs Interest expense for the three and nine months ended September 30, 2022 was $24,775 and $72,634, respectively, and $14,115 and $40,514 for the three and nine months ended September 30, 2021, respectively, and primarily relates to the royalty financing obligations (Note 6), the secured term loan borrowing from the Credit Agreement (Note 7) and the PhaRMA Notes (Note 6). Costs directly associated with the borrowings have been capitalized and are netted against the corresponding debt liabilities on the Consolidated Balance Sheets. These costs are being amortized to interest expense over the terms of the corresponding borrowings using the effective interest rate method. Amortization of deferred financing costs included in interest expense was $(258) and $(597) for the three and nine months ended September 30, 2022, respectively, and $(158) and $(369) for the three and nine months ended September 30, 2021, respectively. In December 2021, the PhaRMA Notes and associated accrued interest payable was written-off into other income as a debt extinguishment (Refer to “Note 6—Royalty Monetizations—RAPIACTA—Non-Recourse Notes Payable – Debt Extinguishment” for additional information regarding the debt extinguishment). |
Interest Expense and Royalty Financing Obligations | Interest Expense and Royalty Financing Obligations The royalty financing obligations are eligible to be repaid based on royalties from net sales of ORLADEYO, BCX9930, and another earlier stage Factor D inhibitor (BCX10013). Interest expense is accrued using the effective interest rate method over the estimated period each of the related liabilities will be paid. This requires the Company to estimate the total amount of future royalty payments to be generated from product sales over the life of the agreement. The Company imputes interest on the carrying value of each of the royalty financing obligations and records interest expense using an imputed effective interest rate. The Company reassesses the expected royalty payments each reporting period and accounts for any changes through an adjustment to the effective interest rate on a prospective basis. The assumptions used in determining the expected repayment term of the debt and amortization period of the issuance costs require that the Company make estimates that could impact the carrying value of each of the liabilities, as well as the periods over which associated issuance costs will be amortized. A significant increase or decrease in forecasted net sales could materially impact each of the liability balances, interest expense and the time periods for repayment. |
Income Taxes | 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, the Company began accruing foreign income taxes as a result of increased nexus in foreign jurisdictions where historically the Company had no presence. In addition, starting in 2022, amendments to Section 174 of the Internal Revenue Code of 1986, as amended (“IRC”), will no longer permit an immediate deduction for research and development expenditures in the tax year that such costs are incurred. Instead, these IRC Section 174 development costs must now be capitalized and amortized over either a five- or 15-year period, depending on the location of the activities performed. The new amortization period begins with the midpoint of any taxable year that IRC Section 174 costs are first incurred, regardless of whether the expenditures were made prior to or after July 1, and runs until the midpoint of year five for activities conducted in the United States or year 15 in the case of development conducted on foreign soil. As a result of this tax law change, the Company has recorded a U.S. state tax provision for the nine months ended September 30, 2022. |
Net Loss Per Share | 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 does not include 26,236 and 25,918 shares of potential common stock for the three and nine months ended September 30, 2022, respectively, and 28,472 and 26,131 shares of potential common stock for the three and nine months ended September 30, 2021, respectively, as their impact would be anti-dilutive. |
Accumulated Other Comprehensive Income | 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. There were no realized gains or losses reclassified out of accumulated other comprehensive income for the nine months ended September 30, 2022. For the nine months ended September 30, 2021, realized gains of $1 were reclassified out of accumulated other comprehensive loss. |
Significant Customers and Other Risks | Significant Customers and Other Risks Significant Customers The Company’s primary sources of revenue and cash flow are the sales of ORLADEYO in the United States and other global markets as well as sales of RAPIVAB (peramivir injection) under the Company's procurement contract with the Assistant Secretary for Preparedness and Response within HHS. Additionally, the Company receives reimbursement of galidesivir (formerly BCX4430) development expenses earned under cost-plus-fixed-fee contracts with BARDA/HHS and NIAID/HHS. 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 is distributing ORLADEYO in other global markets directly or through distributors, except in Japan where Torii, the Company’s collaborative partner, has the exclusive right to commercialize ORLADEYO. The Company relies on BARDA/HHS and NIAID/HHS to reimburse predominantly all of the development costs for its galidesivir program. Accordingly, reimbursement of these expenses has represented a significant portion of the Company’s collaborative and other research and development revenues. All government funding for galidesivir is expected to expire in 2022. Additionally, HHS is the primary customer for RAPIVAB, and it has exercised the remaining option for the purchase of RAPIVAB under the procurement contract with the Company. Further, the Company’s drug development activities are performed by a limited group of third-party vendors. If any of these vendors were unable to perform its services, this could significantly impact the Company’s ability to complete its drug development activities. Risks from Third-Party Manufacturing and Distribution Concentration The Company relies on single source manufacturers for active pharmaceutical ingredient and finished drug product manufacturing of product candidates in development and on a single specialty pharmacy for distribution of approved drug product in the United States. Delays or disruption in the manufacture or distribution of any product could adversely impact the future procurement stockpiling of the Company’s product candidates and commercial revenue, respectively. 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 exceed the amount of insurance provided on such deposits. The Company believes it has established guidelines for investment of its excess cash relative to diversification and maturities that maintain safety and liquidity. To minimize the exposure due to adverse shifts in interest rates, the Company maintains a portfolio of investments with an average maturity of approximately 12 months or less. The Company’s receivables from sales of ORLADEYO are primarily due from one customer, resulting in a concentration of credit risk. Sales of ORLADEYO from the Company to the specialty pharmacy only occur once an order of product has been received by the specialty pharmacy from one of its customers, which include pharmacy benefit managers, insurance companies, government programs and group purchasing organizations. The majority of the Company’s receivables from collaborations are due from the U.S. Government, for which there is no assumed credit risk. |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting PronouncementsThere have been no new accounting pronouncements adopted by the Company or new accounting pronouncements issued by the Financial Accounting Standards Board during the nine months ended September 30, 2022, as compared to the recent accounting pronouncements described in Note 1 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, that the Company believes are of s |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Revenues | The Company recorded the following revenues (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Product sales, net: ORLADEYO $ 65,395 $ 36,711 $ 179,492 $ 76,023 RAPIVAB 6,953 2,430 7,290 7,165 Peramivir 2,865 — 2,865 7,254 Total product sales, net 75,213 39,141 189,647 90,442 Royalty revenue 600 322 1,487 (447) Milestone revenue — — — 15,000 Collaborative and other research and development revenues: U.S. Department of Health and Human Services 14 1,531 148 5,017 Total collaborative and other research and development revenues 14 1,531 148 5,017 Total revenues $ 75,827 $ 40,994 $ 191,282 $ 110,012 |
Investments (Tables)
Investments (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Investments [Abstract] | |
Fair Value of the Company's Investments by Type | The following tables summarize the fair value of the Company’s investments by type. The estimated fair values of the Company’s fixed income investments are classified as Level 2 in the fair value hierarchy as defined in U.S. GAAP. These valuations are based on observable direct and indirect inputs, primarily quoted prices of similar, but not identical, instruments in active markets or quoted prices for identical or similar instruments in markets that are not active. These fair values are obtained from independent pricing services which utilize Level 2 inputs. September 30, 2022 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 205,133 $ 284 $ 5 $ (1,074) $ 204,348 Corporate debt securities 7,337 37 — (64) 7,310 Certificates of deposit 2,655 10 — (32) 2,633 Total investments $ 215,125 $ 331 $ 5 $ (1,170) $ 214,291 December 31, 2021 Amortized Accrued Gross Gross Estimated 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 |
Schedule of the Maturity of Investments | The following table summarizes the scheduled maturity for the Company’s investments at September 30, 2022 and December 31, 2021: September 30, 2022 December 31, 2021 Maturing in one year or less $ 179,959 $ 3,212 Maturing after one year through two years 34,332 6,829 Total investments $ 214,291 $ 10,041 |
Trade Receivables (Tables)
Trade Receivables (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Receivables [Abstract] | |
Summary of Receivables | Receivables from collaborations were as follows (in thousands): September 30, 2022 Billed Unbilled Total U.S. Department of Health and Human Services $ 293 $ 243 $ 536 Shionogi & Co. Ltd. 1,893 — 1,893 Royalty receivables from partners 588 — 588 Total receivables $ 2,774 $ 243 $ 3,017 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 |
Inventory (Tables)
Inventory (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The Company’s inventories consisted of the following (in thousands): September 30, 2022 December 31, 2021 Raw materials $ 8,419 $ 5,658 Work-in-process 15,364 9,669 Finished goods 3,481 709 Total inventory $ 27,264 $ 16,036 Reserves (245) (245) Total inventory, net $ 27,019 $ 15,791 |
Royalty Monetizations (Tables)
Royalty Monetizations (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Advance Royalties [Abstract] | |
Schedule of Royalty Financing Obligations | The following table shows the activity within the Royalty financing obligations account (in thousands) as well as the effective interest rate as of September 30, 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 Non-cash Interest expense on Royalty financing obligations 10,462 6,020 3,224 19,706 Royalty revenues paid and payable (5,764) (501) — (6,265) Balance as of June 30, 2022 $ 157,702 $ 164,809 $ 155,155 $ 477,666 Non-cash Interest expense on Royalty financing obligations 9,938 4,903 3,619 18,460 Royalty revenues paid and payable (5,837) (508) — (6,345) Balance as of September 30, 2022 $ 161,802 $ 169,204 $ 158,774 $ 489,781 Effective interest rate 23.1 % 11.0 % 10.6 % |
Lease Obligations (Tables)
Lease Obligations (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Leases [Abstract] | |
Aggregate Lease Expense Under Operating Leases | Aggregate lease expense under operating leases was as follows (in thousands): Three Months Ended September 30, Nine Months Ended September 30, 2022 2021 2022 2021 Aggregate lease expense $ 634 $ 393 $ 1,854 $ 1,306 |
Other Supplemental Information Related to Leases | Other supplemental information related to leases was as follows: As of September 30, 2022 As of December 31, 2021 Weighted average remaining lease term 8.4 years 9.2 years Weighted average discount rate 10.9% 11.2% |
Balance Sheets of the Company's Operating Leases | The following table summarizes the presentation in the Consolidated Balance Sheets of the Company’s operating leases: Balance Sheet Location As of September 30, 2022 As of December 31, 2021 Assets: Operating lease assets, net Other Assets $ 6,797 $ 6,472 Liabilities: Current operating lease liabilities Lease financing obligation – current liabilities $ 2,196 $ 1,819 Non-current operating lease liabilities Lease financing obligation – long-term liabilities 5,968 5,962 Total operating lease liabilities $ 8,164 $ 7,781 |
Maturities of Operating Lease Liabilities | Maturities of operating lease liabilities as of September 30, 2022, are as follows (in thousands): 2022 (remaining) $ 684 2023 2,334 2024 1,785 2025 1,441 2026 651 Thereafter 6,734 Total lease payments 13,629 Less imputed interest (5,465) Total $ 8,164 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2022 | |
Share-Based Payment Arrangement [Abstract] | |
Stock Plan Activities | Related activity under the Incentive Plan is as follows: Awards Options Weighted Balance December 31, 2021 3,651 28,685 $ 7.90 Plan amendment 8,000 — — Restricted stock unit awards granted (681) — — Restricted stock unit awards cancelled 218 — — Stock option awards granted (813) 813 11.10 Stock option awards exercised — (1,334) 5.65 Stock option awards cancelled 787 (787) 10.02 Balance September 30, 2022 11,162 27,377 $ 8.04 Related activity under the Inducement Plan is as follows: Awards Options Weighted Balance December 31, 2021 900 4,408 $ 6.20 Plan amendment 1,926 — — Restricted stock unit awards granted (424) — — Restricted stock unit awards cancelled 2 — — Stock option awards granted (1,381) 1,381 13.84 Stock option awards exercised — (196) 3.77 Stock option awards cancelled 323 (323) 7.02 Balance September 30, 2022 1,346 5,270 $ 8.28 |
Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors Under the Plans | 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 2.9 % 0.8 % |
Significant Accounting Polici_3
Significant Accounting Policies and Concentrations of Risk (Details) - USD ($) shares in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Significant Accounting Policies and Concentration of Risk [Line Items] | |||||
Restricted cash | $ 1,444,000 | $ 1,444,000 | $ 3,345,000 | ||
Long-term investment maturity, minimum (in years) | 12 months | ||||
Advertising expense | 3,476,000 | $ 1,492,000 | $ 11,555,000 | $ 4,696,000 | |
Interest expense, debt, total | 24,775,000 | 14,115,000 | 72,634,000 | 40,514,000 | |
Amortization of debt financing costs and original issue discounts | $ (258,000) | $ (158,000) | $ (597,000) | $ (369,000) | |
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 26,236 | 28,472 | 25,918 | 26,131 | |
Reclassification from accumulated other comprehensive income, current period, before tax | $ 0 | $ (1,000) | |||
Computer Equipment | |||||
Significant Accounting Policies and Concentration of Risk [Line Items] | |||||
Property, plant and equipment, useful life (in years) | 3 years | ||||
Laboratory Equipment, Office Equipment and Software | |||||
Significant Accounting Policies and Concentration of Risk [Line Items] | |||||
Property, plant and equipment, useful life (in years) | 5 years | ||||
Furniture and Fixtures | |||||
Significant Accounting Policies and Concentration of Risk [Line Items] | |||||
Property, plant and equipment, useful life (in years) | 7 years | ||||
Maximum | |||||
Significant Accounting Policies and Concentration of Risk [Line Items] | |||||
Maturity period of high quality marketable securities (in years) | 3 years | ||||
Average maturity period of high quality marketable securities (in months) | 12 months | ||||
Maturity period of short term investment (in months) | 12 months | ||||
Royalty Receivable | |||||
Significant Accounting Policies and Concentration of Risk [Line Items] | |||||
Restricted cash | $ 21,000 | $ 21,000 | 1,924,000 | ||
Collateral for Credit | |||||
Significant Accounting Policies and Concentration of Risk [Line Items] | |||||
Restricted cash | $ 1,423,000 | $ 1,423,000 | $ 1,421,000 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 75,827 | $ 40,994 | $ 191,282 | $ 110,012 |
Product sales, net | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 75,213 | 39,141 | 189,647 | 90,442 |
Product sales, net | ORLADEYO | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 65,395 | 36,711 | 179,492 | 76,023 |
Product sales, net | RAPIVAB | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 6,953 | 2,430 | 7,290 | 7,165 |
Product sales, net | Peramivir | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 2,865 | 0 | 2,865 | 7,254 |
Royalty revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 600 | 322 | 1,487 | (447) |
Milestone revenue | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 0 | 0 | 0 | 15,000 |
Collaborative and other research and development | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | 14 | 1,531 | 148 | 5,017 |
Collaborative and other research and development | U.S. Department of Health and Human Services | ||||
Disaggregation of Revenue [Line Items] | ||||
Total revenues | $ 14 | $ 1,531 | $ 148 | $ 5,017 |
Investments- Fair Value of the
Investments- Fair Value of the Company's Investments by Type (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 215,125 | $ 9,989 |
Accrued Interest | 331 | 65 |
Gross Unrealized Gains | 5 | 0 |
Gross Unrealized Losses | (1,170) | (13) |
Estimated Fair Value | 214,291 | 10,041 |
Obligations of U.S. Government and its agencies | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 205,133 | 4,043 |
Accrued Interest | 284 | 17 |
Gross Unrealized Gains | 5 | 0 |
Gross Unrealized Losses | (1,074) | (7) |
Estimated Fair Value | 204,348 | 4,053 |
Corporate debt securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 7,337 | 4,294 |
Accrued Interest | 37 | 40 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (64) | (5) |
Estimated Fair Value | 7,310 | 4,329 |
Certificates of deposit | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 2,655 | 1,652 |
Accrued Interest | 10 | 8 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (32) | (1) |
Estimated Fair Value | $ 2,633 | $ 1,659 |
Investments - Schedule of Matur
Investments - Schedule of Maturity of Investments (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Investments [Abstract] | ||
Maturing in one year or less | $ 179,959 | $ 3,212 |
Maturing after one year through two years | 34,332 | 6,829 |
Total investments | $ 214,291 | $ 10,041 |
Trade Receivables (Details Text
Trade Receivables (Details Textual) - Trade Accounts Receivable - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable, after allowance for credit loss, total | $ 0 | $ 0 |
ORLADEYO | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable, after allowance for credit loss, total | 39,565 | 27,384 |
RAPIVAB | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable, after allowance for credit loss, total | 28 | 49 |
Green Cross Corporation | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable, after allowance for credit loss, total | $ 701 | $ 701 |
Trade Receivables - Summary of
Trade Receivables - Summary of Receivables (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | $ 3,017 | $ 1,980 |
Billed | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 2,774 | 310 |
Unbilled | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 243 | 1,670 |
U.S. Department of Health and Human Services | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 536 | 1,675 |
U.S. Department of Health and Human Services | Billed | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 293 | 5 |
U.S. Department of Health and Human Services | Unbilled | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 243 | 1,670 |
Shionogi & Co. Ltd. | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 1,893 | |
Shionogi & Co. Ltd. | Billed | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 1,893 | |
Shionogi & Co. Ltd. | Unbilled | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 0 | |
Royalty receivables from partners | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 588 | 305 |
Royalty receivables from partners | Billed | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 588 | 305 |
Royalty receivables from partners | Unbilled | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | $ 0 | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 8,419 | $ 5,658 |
Work-in-process | 15,364 | 9,669 |
Finished goods | 3,481 | 709 |
Total inventory | 27,264 | 16,036 |
Reserves | (245) | (245) |
Total inventory, net | $ 27,019 | $ 15,791 |
Royalty Monetizations (Details
Royalty Monetizations (Details Textual) - USD ($) $ in Thousands | 12 Months Ended | ||||||
Nov. 19, 2021 | Mar. 09, 2021 | Dec. 07, 2020 | Dec. 31, 2021 | Sep. 30, 2022 | Dec. 01, 2020 | Mar. 09, 2011 | |
RPI 2019 Intermediate Finance Trust | |||||||
Royalty Monetizations [Line Items] | |||||||
Shares issued, common stock, premium | $ 4,269 | ||||||
RPI 2019 Intermediate Finance Trust | ORLADEYO | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of sublicense revenue in other markets | 20% | ||||||
RPI 2019 Intermediate Finance Trust | ORLADEYO | Annual Net Sales Under $350,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in key territories | 8.75% | ||||||
RPI 2019 Intermediate Finance Trust | ORLADEYO | Annual Net Sales Between $350,000 and $550,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in key territories | 2.75% | ||||||
RPI 2019 Intermediate Finance Trust | ORLADEYO | Annual Net Sales Over $550,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in key territories | 0% | ||||||
RPI 2019 Intermediate Finance Trust | ORLADEYO | Annual Net Sales Under $150,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in other markets | 20% | ||||||
RPI 2019 Intermediate Finance Trust | ORLADEYO | Annual Net Sales Between $150,000 and $230,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in other markets | 10% | ||||||
RPI 2019 Intermediate Finance Trust | ORLADEYO | Annual Net Sales Over $230,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in other markets | 0% | ||||||
RPI 2019 Intermediate Finance Trust | BCX9930 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of global annual net sales | 1% | ||||||
RPI 2019 Intermediate Finance Trust | BCX9930 & BCX10013 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, maximum tiered profit share percentage on permitted sales in other markets | 3% | ||||||
RPI 2019 Intermediate Finance Trust | BCX9930 & BCX10013 | Annual Net Sales Over $3 Billions | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, annual net sales payment threshold | $ 3,000,000 | ||||||
RPI 2019 Intermediate Finance Trust | Future Royalties Payable | |||||||
Royalty Monetizations [Line Items] | |||||||
Proceeds from issuance of debt | $ 125,000 | ||||||
Debt issuance costs, net, total | $ 8,531 | ||||||
RPI 2021 and 2020 Intermediate Finance Trust | Future Royalties Payable | |||||||
Royalty Monetizations [Line Items] | |||||||
Proceeds from issuance of debt | $ 150,000 | ||||||
The 2021 RPI Royalty Purchase Agreement | Annual Net Sales Under $350,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in key territories | 0.75% | ||||||
The 2021 RPI Royalty Purchase Agreement | Annual Net Sales Between $350,000 and $550,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
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% | ||||||
The 2021 RPI Royalty Purchase Agreement | Annual Net Sales Under $150,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of sublicense revenue in other markets | 3% | ||||||
The 2021 RPI Royalty Purchase Agreement | Annual Net Sales Between $150,000 and $230,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of sublicense revenue in other markets | 2% | ||||||
The 2021 RPI Royalty Purchase Agreement | BCX9930 & BCX10013 | Annual Net Sales Under $1.5 Billion | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in key territories | 3% | ||||||
The 2021 RPI Royalty Purchase Agreement | BCX9930 & BCX10013 | Annual Net Sales Between $1.5 and $3 Billions | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in key territories | 2% | ||||||
The 2021 RPI Royalty Purchase Agreement | BCX9930 & BCX10013 | Annual Net Sales Over $3 Billions | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales in other markets | 0% | ||||||
OMERS Capital Markets | ORLADEYO | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of sublicense revenue in other markets | 20% | ||||||
Royalty purchase agreement, royalties, percentage of annual net sales in other markets | 10% | ||||||
Royalty purchase agreement, royalties, purchase price, amount | $ 150,000 | ||||||
OMERS Capital Markets | ORLADEYO | Minimum | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of purchase price | 142.50% | ||||||
OMERS Capital Markets | ORLADEYO | Maximum | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of purchase price | 155% | ||||||
OMERS Capital Markets | ORLADEYO | Annual Net Sales Under $350,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
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% | ||||||
OMERS Capital Markets | ORLADEYO | Annual Net Sales Between $350,000 and $550,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales | 6% | ||||||
Royalty purchase agreement, royalties, percentage of annual net sales, based on reduction in sales | 3% | ||||||
OMERS Capital Markets | ORLADEYO | Annual Net Sales Over $550,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of annual net sales | 0% | ||||||
Royalty purchase agreement, royalties, percentage of annual net sales, based on reduction in sales | 0% | ||||||
OMERS Capital Markets | ORLADEYO | Annual Net Sales Under $150,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of sublicense revenue in other markets | 20% | ||||||
OMERS Capital Markets | ORLADEYO | Annual Net Sales Between $150,000 and $230,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of sublicense revenue in other markets | 10% | ||||||
OMERS Capital Markets | ORLADEYO | Annual Net Sales Over $230,000 | |||||||
Royalty Monetizations [Line Items] | |||||||
Royalty purchase agreement, royalties, percentage of sublicense revenue in other markets | 0% | ||||||
JPR Royalty Sub LLC | PhaRMA Notes | |||||||
Royalty Monetizations [Line Items] | |||||||
Private placement of senior secured notes | $ 30,000 | ||||||
Debt instrument, interest rate, stated percentage | 14% | ||||||
Secured debt, total | $ 30,000 | ||||||
Interest payable | $ 20,614 | ||||||
Gain (loss) on extinguishment of debt, total | $ 25,838 | ||||||
JPR Royalty Sub LLC | PhaRMA Notes | Fair Value, Inputs, Level 2 | |||||||
Royalty Monetizations [Line Items] | |||||||
Notes payable, fair value disclosure | $ 30,000 | ||||||
JPR Royalty Sub LLC | Royalty Monetization | |||||||
Royalty Monetizations [Line Items] | |||||||
Debt instrument, face amount | $ 30,000 | ||||||
Proceeds from issuance of secured debt | 22,691 | ||||||
Transaction costs | 4,309 | ||||||
Interest reserve | $ 3,000 |
Royalty Monetizations - Schedul
Royalty Monetizations - Schedule of Royalty Financing Obligations (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | |
Royalty Montizations [Roll Forward] | |||
Balance | $ 477,666 | $ 464,225 | $ 449,375 |
Deferred financing costs | (34) | ||
Non-cash Interest expense on Royalty financing obligations | 18,460 | 19,706 | 19,649 |
Royalty revenues paid and payable | (6,345) | (6,265) | (4,765) |
Balance | 489,781 | 477,666 | 464,225 |
2020 RPI Royalty Agreement | |||
Royalty Montizations [Roll Forward] | |||
Balance | 157,702 | 153,004 | 147,224 |
Deferred financing costs | 0 | ||
Non-cash Interest expense on Royalty financing obligations | 9,938 | 10,462 | 10,165 |
Royalty revenues paid and payable | (5,837) | (5,764) | (4,385) |
Balance | $ 161,802 | $ 157,702 | 153,004 |
Effective interest rate | 23.10% | 25.50% | |
2021 RPI Royalty Agreement | |||
Royalty Montizations [Roll Forward] | |||
Balance | $ 164,809 | $ 159,290 | 153,377 |
Deferred financing costs | (34) | ||
Non-cash Interest expense on Royalty financing obligations | 4,903 | 6,020 | 6,327 |
Royalty revenues paid and payable | (508) | (501) | (380) |
Balance | $ 169,204 | $ 164,809 | 159,290 |
Effective interest rate | 11% | 12.10% | |
OMERS Royalty Agreement | |||
Royalty Montizations [Roll Forward] | |||
Balance | $ 155,155 | $ 151,931 | 148,774 |
Deferred financing costs | 0 | ||
Non-cash Interest expense on Royalty financing obligations | 3,619 | 3,224 | 3,157 |
Royalty revenues paid and payable | 0 | 0 | 0 |
Balance | $ 158,774 | $ 155,155 | $ 151,931 |
Effective interest rate | 10.60% | 8.50% |
Debt (Details)
Debt (Details) - USD ($) | 9 Months Ended | |||||
Sep. 28, 2022 | Jun. 28, 2022 | Dec. 07, 2020 | Sep. 30, 2022 | Sep. 30, 2021 | Jul. 29, 2022 | |
Debt Instrument [Line Items] | ||||||
Paid-in-kind interest | $ 15,311,000 | $ 11,815,000 | ||||
Debt instrument, unamortized discount (premium) and debt issuance costs, net, total | 12,509,000 | |||||
Amortization of debt issuance costs | (597,000) | $ (369,000) | ||||
Term B And C Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, unamortized discount (premium) and debt issuance costs, net, total | 3,428,000 | |||||
MidCap Financial Services, LLC | Senior Credit Facility | ||||||
Debt Instrument [Line Items] | ||||||
Repayments of lines of credit | $ 43,298,000 | |||||
Credit Agreement | Athyrium | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 200,000,000 | |||||
Debt instrument, LIBOR floor | 1.75% | |||||
Debt instrument, LIBOR cap | 3.50% | |||||
Debt instrument, exit fee, percentage of principal | 2% | |||||
Debt instrument, commitment fee percentage | 1% | |||||
Long-term debt, gross | 200,000,000 | |||||
Long-term debt, total | $ 232,376,000 | |||||
Effective interest rate | 12.68% | |||||
Credit Agreement | Athyrium | Prior to the Second Anniversary | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee, percentage of principal voluntary payments | 102% | |||||
Debt instrument, prepayment fee, percentage of accrued interest | 0.50% | |||||
Credit Agreement | Athyrium | Between the Second and Third Anniversaries | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee, percentage of principal voluntary payments | 2% | |||||
Credit Agreement | Athyrium | Between the Third and Fourth Anniversaries | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee, percentage of principal voluntary payments | 1% | |||||
Credit Agreement | Athyrium | After Fourth Anniversary | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, prepayment fee, percentage of principal voluntary payments | 0% | |||||
Credit Agreement | Athyrium | Term Loan A Drawn | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, covenant, minimum unrestricted cash and cash equivalents | $ 15,000,000 | |||||
Credit Agreement | Athyrium | Term Loan A and B Drawn | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, covenant, minimum unrestricted cash and cash equivalents | 20,000,000 | |||||
Credit Agreement | Athyrium | Term Loans A, B and C Drawn | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, covenant, minimum unrestricted cash and cash equivalents | 15,000,000 | |||||
Credit Agreement | Athyrium | Term Loans A, B and C Drawn and Cure Right Exercised | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, covenant, minimum unrestricted cash and cash equivalents | $ 20,000,000 | |||||
Credit Agreement | Athyrium | London Interbank Offered Rate (LIBOR) | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 8.25% | |||||
Credit Agreement | Athyrium | London Interbank Offered Rate (LIBOR) | PIK Interest Payment is Made | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 10.25% | 10.25% | 10.25% | |||
Credit Agreement | Athyrium | Term A Loan | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of long-term debt, total | $ 125,000,000 | |||||
Credit Agreement | Athyrium | Term B Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 25,000,000 | |||||
Credit Agreement | Athyrium | Term C Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | 50,000,000 | |||||
Credit Agreement | Athyrium | Term B And C Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 75,000,000 |
Lease Obligations (Details Text
Lease Obligations (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | Dec. 31, 2021 | |
Lessee, Lease, Description [Line Items] | |||||
Weighted average remaining lease term (in years) | 8 years 4 months 24 days | 8 years 4 months 24 days | 9 years 2 months 12 days | ||
Weighted average discount rate | 10.90% | 10.90% | 11.20% | ||
Operating lease, right-of-use asset, accumulated amortization | $ 3,874 | $ 3,874 | $ 2,626 | ||
Operating lease, payments | $ 615 | $ 306 | $ 1,796 | $ 1,125 | |
Minimum | |||||
Lessee, Lease, Description [Line Items] | |||||
Lessee, operating lease, term of contract (in years) | 1 year | 1 year | |||
Maximum | |||||
Lessee, Lease, Description [Line Items] | |||||
Lessee, operating lease, term of contract (in years) | 5 years | 5 years |
Lease Obligations - Aggregate L
Lease Obligations - Aggregate Lease Expense Under Operating Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2022 | Sep. 30, 2021 | Sep. 30, 2022 | Sep. 30, 2021 | |
Leases [Abstract] | ||||
Aggregate lease expense | $ 634 | $ 393 | $ 1,854 | $ 1,306 |
Lease Obligations - Other Suppl
Lease Obligations - Other Supplemental Information Related to Leases (Details) | Sep. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
Weighted average remaining lease term (in years) | 8 years 4 months 24 days | 9 years 2 months 12 days |
Weighted average discount rate | 10.90% | 11.20% |
Lease Obligations -Balance Shee
Lease Obligations -Balance Sheets of the Company's Operating Leases (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Assets: | ||
Operating lease assets, net | $ 6,797 | $ 6,472 |
Other assets [extensible enumeration] | Other assets | |
Liabilities: | ||
Lease financing obligation | $ 2,196 | 1,819 |
Lease financing obligation | 5,968 | 5,962 |
Total operating lease liabilities | $ 8,164 | $ 7,781 |
Lease Obligations - Maturities
Lease Obligations - Maturities of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Sep. 30, 2022 | Dec. 31, 2021 |
Leases [Abstract] | ||
2022 (remaining) | $ 684 | |
2023 | 2,334 | |
2024 | 1,785 | |
2025 | 1,441 | |
2026 | 651 | |
Thereafter | 6,734 | |
Total lease payments | 13,629 | |
Less imputed interest | (5,465) | |
Total | $ 8,164 | $ 7,781 |
Operating lease, liability, statement of financial position [extensible enumeration] | Accrued expenses |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Nov. 19, 2021 | Nov. 17, 2021 | Apr. 24, 2020 |
Equity Disclosure [Line Items] | |||
Maximum aggregate offering price | $ 500,000 | ||
Common Stock Purchase Agreement with RPI | |||
Equity Disclosure [Line Items] | |||
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 usd per share) | $ 13 | $ 13 | |
Shares issued, price per share, premium (in usd per share) | 1.11 | ||
Shares issued, price per share, closing price (in usd per share) | $ 11.89 | ||
Shares issued, common stock, premium | $ 4,269 |
Stock-based Compensation (Detai
Stock-based Compensation (Details Textual) $ / shares in Units, shares in Thousands, $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | ||||||
Jan. 31, 2022 shares | Dec. 31, 2014 shares | Sep. 30, 2022 USD ($) plan shares | Mar. 31, 2022 shares | Sep. 30, 2021 shares | Mar. 31, 2021 shares | Sep. 30, 2022 USD ($) plan $ / shares shares | Sep. 30, 2021 USD ($) $ / shares shares | Dec. 31, 2021 shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Number of plans | plan | 3 | 3 | |||||||
Share-based payment arrangement, expense | $ 29,421 | $ 26,140 | |||||||
Total unrecognized compensation expense related to non-vested stock options and RSU awards | $ 100,171 | 100,171 | |||||||
Compensation cost expected to be recognized for remainder of fiscal year | 10,707 | 10,707 | |||||||
Compensation cost expected to be recognized next year | 35,987 | 35,987 | |||||||
Compensation cost expected to be recognized year two | 31,537 | 31,537 | |||||||
Compensation cost expected to be recognized year three | 19,524 | 19,524 | |||||||
Compensation cost expected to be recognized year four | $ 2,416 | $ 2,416 | |||||||
Employee stock purchase plan sales, net (in shares) | shares | 145 | 115 | 123 | 193 | 260 | 316 | |||
Share-Based Payment Arrangement, Option | Non-employee Directors | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Award vesting period (in years) | 1 year | ||||||||
Incentive Plan | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Share-based payment arrangement, expense | $ 23,687 | $ 19,973 | |||||||
Number of common stock shares available for purchase (in shares) | shares | 11,162 | 11,162 | 3,651 | ||||||
Incentive Plan | Share-Based Payment Arrangement, Option | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Weighted average grant date fair value stock option awards (in dollars per share) | $ / shares | $ 7.78 | $ 8.11 | |||||||
Incentive Plan | Share-Based Payment Arrangement, Option | Maximum | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Stock option awards remaining contractual term (in years) | 10 years | ||||||||
Incentive Plan | Share-Based Payment Arrangement, Option | Vest 25% Each Year Until Fully Vested | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Award vesting rights, percentage | 25% | ||||||||
Award vesting period (in years) | 4 years | ||||||||
Incentive Plan | Share-Based Payment Arrangement, Option | Thirty-six Equal Monthly Installments | Non-employee Directors | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Award vesting period (in years) | 3 years | ||||||||
Incentive Plan | Performance Shares | Vest Upon Successful Completion of Specific Development Milestones | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Award vesting rights, percentage | 85% | ||||||||
Performance-based stock options issued in period (in shares) | shares | 1,250 | ||||||||
Incentive Plan | Performance-based Restricted Stock Units | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Award vesting period (in years) | 3 years | ||||||||
Incentive Plan | Performance-based Restricted Stock Units | Vest 25% Each Year Until Fully Vested | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Award vesting rights, percentage | 25% | ||||||||
Incentive Plan | Performance-based Restricted Stock Units | Vest Upon Successful Completion of Specific Development Milestones | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Performance-based restricted stock unit awards issued (in shares) | shares | 221 | ||||||||
Incentive Plan | Performance-based Restricted Stock Units | Share-Based Payment Arrangement, Tranche One | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Award vesting rights, percentage | 50% | ||||||||
Incentive Plan | Restricted Stock Units (RSUs) | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 13.18 | $ 10.17 | |||||||
Inducement Plan | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Share-based payment arrangement, expense | $ 4,604 | $ 5,025 | |||||||
Award vesting period (in years) | 4 years | ||||||||
Weighted average grant date fair value stock option awards (in dollars per share) | $ / shares | $ 9.72 | $ 9.74 | |||||||
Expiration period (in years) | 10 years | ||||||||
Number of common stock shares available for purchase (in shares) | shares | 1,346 | 1,346 | 900 | ||||||
Inducement Plan | Vest 25% Each Year Until Fully Vested | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Award vesting rights, percentage | 25% | ||||||||
Inducement Plan | Share-Based Payment Arrangement, Option | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Expected Dividend Yield | 0% | ||||||||
Inducement Plan | Restricted Stock Units (RSUs) | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Weighted average grant date fair value (in dollars per share) | $ / shares | $ 13.38 | ||||||||
Employee Stock Purchase Plan | |||||||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||||||
Share-based payment arrangement, expense | $ 1,130 | $ 1,142 | |||||||
Number of shares of common stock authorized to be purchased (in shares) | shares | 7,975 | 7,975 | |||||||
Number of common stock shares available for purchase (in shares) | shares | 5,792 | 5,792 | |||||||
Percentage of salary to purchase common stock, maximum | 15% | ||||||||
Percentage of common stock shares, beginning | 85% | ||||||||
Percentage of common stock shares, ending | 85% | ||||||||
Maximum number of shares per employee (in shares) | shares | 3 | ||||||||
Maximum number of shares per employee, amount | $ 25 | $ 25 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock Plan Activities (Details) - $ / shares shares in Thousands | 3 Months Ended | 9 Months Ended | |||||
Sep. 30, 2022 | Jun. 30, 2022 | Mar. 31, 2022 | Sep. 30, 2021 | Jun. 30, 2021 | Mar. 31, 2021 | Sep. 30, 2022 | |
Options Outstanding | |||||||
Options outstanding, stock option awards exercised (in shares) | (390) | (51) | (1,108) | (942) | (1,056) | (593) | |
Incentive Plan | |||||||
Awards Available | |||||||
Awards available, beginning balance (in shares) | 3,651 | 3,651 | |||||
Plan amendment (in shares) | 8,000 | ||||||
Awards available, restricted stock awards granted (in shares) | (681) | ||||||
Awards available, restricted stock awards cancelled (in shares) | 218 | ||||||
Awards available, stock option awards granted (in shares) | (813) | ||||||
Awards available, stock option awards cancelled (in shares) | 787 | ||||||
Awards available, ending balance (in shares) | 11,162 | 11,162 | |||||
Options Outstanding | |||||||
Options outstanding, beginning balance (in shares) | 28,685 | 28,685 | |||||
Options outstanding, stock option awards granted ( in shares) | 813 | ||||||
Options outstanding, stock option awards exercised (in shares) | (1,334) | ||||||
Options outstanding, stock option awards cancelled (in shares) | (787) | ||||||
Options outstanding, ending balance (in shares) | 27,377 | 27,377 | |||||
Weighted Average Exercise Price | |||||||
Weighted average exercise price, beginning balance (in usd per share) | $ 7.90 | $ 7.90 | |||||
Weighted average exercise price of stock option awards granted (in usd per share) | 11.10 | ||||||
Weighted average exercise price of stock option awards exercised (in usd per share) | 5.65 | ||||||
Weighted average exercise price of stock option awards cancelled (in usd per share) | 10.02 | ||||||
Weighted average exercise price, ending balance (in usd per share) | $ 8.04 | $ 8.04 | |||||
Inducement Plan | |||||||
Awards Available | |||||||
Awards available, beginning balance (in shares) | 900 | 900 | |||||
Plan amendment (in shares) | 1,926 | ||||||
Awards available, restricted stock awards granted (in shares) | (424) | ||||||
Awards available, restricted stock awards cancelled (in shares) | 2 | ||||||
Awards available, stock option awards granted (in shares) | (1,381) | ||||||
Awards available, stock option awards cancelled (in shares) | 323 | ||||||
Awards available, ending balance (in shares) | 1,346 | 1,346 | |||||
Options Outstanding | |||||||
Options outstanding, beginning balance (in shares) | 4,408 | 4,408 | |||||
Options outstanding, stock option awards granted ( in shares) | 1,381 | ||||||
Options outstanding, stock option awards exercised (in shares) | (196) | ||||||
Options outstanding, stock option awards cancelled (in shares) | (323) | ||||||
Options outstanding, ending balance (in shares) | 5,270 | 5,270 | |||||
Weighted Average Exercise Price | |||||||
Weighted average exercise price, beginning balance (in usd per share) | $ 6.20 | $ 6.20 | |||||
Weighted average exercise price of stock option awards granted (in usd per share) | 13.84 | ||||||
Weighted average exercise price of stock option awards exercised (in usd per share) | 3.77 | ||||||
Weighted average exercise price of stock option awards cancelled (in usd per share) | 7.02 | ||||||
Weighted average exercise price, ending balance (in usd per share) | $ 8.28 | $ 8.28 |
Stock-based Compensation - Weig
Stock-based Compensation - Weighted Average Assumptions for Stock Option Awards Granted to Employees and Directors Under the Plans (Details) - Incentive Plan and Inducement Plan | 9 Months Ended | |
Sep. 30, 2022 | Sep. 30, 2021 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Expected Life in Years | 5 years 6 months | 5 years 6 months |
Expected Volatility | 84.10% | 84.20% |
Expected Dividend Yield | 0% | 0% |
Risk-Free Interest Rate | 2.90% | 0.80% |
Collaborative and Other Relat_2
Collaborative and Other Relationships (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||||||||
Aug. 25, 2022 USD ($) dose | Sep. 15, 2021 USD ($) | Nov. 05, 2019 USD ($) | Sep. 06, 2018 USD ($) dose | Sep. 30, 2013 USD ($) | Aug. 31, 2020 USD ($) | Jun. 30, 2000 USD ($) | Sep. 30, 2022 USD ($) | Sep. 30, 2021 USD ($) | Sep. 30, 2022 USD ($) dose | Sep. 30, 2021 USD ($) | Mar. 31, 2015 USD ($) | |
Collaborative and Other Relationships [Line Items] | ||||||||||||
Total revenues | $ 75,827 | $ 40,994 | $ 191,282 | $ 110,012 | ||||||||
U.S. Department of Health and Human Services | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Collaborative agreement contract value | $ 34,660 | |||||||||||
Contract term (in years) | 5 years | |||||||||||
U.S. Department of Health and Human Services | RAPIVAB | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Maximum number of products, doses | dose | 50,000 | 50,000 | ||||||||||
Number of doses delivered, doses | dose | 10,000 | 39,980 | ||||||||||
Proceeds from collaborators | $ 6,932 | $ 27,714 | ||||||||||
Torii Pharmaceutical Co. [Member] | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Total revenues | $ 22,000 | |||||||||||
Potential milestone payments receivable if regulatory approval before specified date | $ 15,000 | |||||||||||
Maximum customary reduction on royalty rate | 50% | |||||||||||
Royalty payments receivable, expiration term from first commercial (in years) | 10 years | |||||||||||
Torii Pharmaceutical Co. [Member] | Minimum | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Royalty rate if maintains sakigake designation | 20% | |||||||||||
Torii Pharmaceutical Co. [Member] | Maximum | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Royalty rate if maintains sakigake designation | 40% | |||||||||||
Base Contract | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Government contract receivable | $ 16,265 | |||||||||||
Additional Development Options | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Government contract receivable | 22,855 | |||||||||||
ASPRBARDA Contract | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Government contract receivable | $ 39,120 | |||||||||||
Proceeds from awards for research and development contracts | $ 20,574 | |||||||||||
AECOM and IRL | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
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 | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Expected receivable from awards for research and development contracts | $ 47,315 | $ 45,931 | ||||||||||
Potential aggregate maximum amount of funding | $ 43,908 | |||||||||||
Collaborative agreement contract value | $ 6,326 | |||||||||||
UAB | ||||||||||||
Collaborative and Other Relationships [Line Items] | ||||||||||||
Period of agreement (in years) | 25 years | |||||||||||
Renewable period of agreement (in years) | 5 years |