Cover
Cover - shares | 3 Months Ended | |
Mar. 31, 2023 | Apr. 28, 2023 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Mar. 31, 2023 | |
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 | 188,934,787 | |
Entity Central Index Key | 0000882796 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2023 | |
Document Fiscal Period Focus | Q1 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets | ||
Cash and cash equivalents | $ 155,136 | $ 304,767 |
Restricted cash | 1,463 | 1,472 |
Investments | 243,022 | 119,543 |
Trade receivables | 48,639 | 50,599 |
Inventory, net | 27,466 | 27,533 |
Prepaid expenses and other current assets | 15,157 | 12,586 |
Total current assets | 490,883 | 516,500 |
Property and equipment, net | 8,376 | 8,617 |
Long-term investments | 3,432 | 18,077 |
Other assets | 7,046 | 6,806 |
Total assets | 509,737 | 550,000 |
Liabilities and Stockholders’ Deficit | ||
Accounts payable | 6,254 | 14,356 |
Accrued expenses | 75,212 | 87,565 |
Deferred revenue | 1,200 | 1,224 |
Lease financing obligation | 2,491 | 2,369 |
Total current liabilities | 85,157 | 105,514 |
Lease financing obligation | 5,934 | 5,804 |
Royalty financing obligations | 514,411 | 501,655 |
Secured term loan | 232,522 | 231,624 |
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 – 188,883 as of March 31, 2023 and 187,906 as of December 31, 2022 | 1,889 | 1,879 |
Additional paid-in capital | 1,177,192 | 1,158,118 |
Accumulated other comprehensive income | 585 | 26 |
Accumulated deficit | (1,507,953) | (1,454,620) |
Total stockholders’ deficit | (328,287) | (294,597) |
Total liabilities and stockholders’ deficit | $ 509,737 | $ 550,000 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2023 | Dec. 31, 2022 |
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) | 188,883,000 | 187,906,000 |
Common stock, shares, outstanding (in shares) | 188,883,000 | 187,906,000 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Revenues | ||
Revenues | $ 68,778 | $ 49,923 |
Expenses: | ||
Cost of product sales | 931 | 236 |
Research and development | 48,388 | 65,360 |
Selling, general and administrative | 47,867 | 34,282 |
Royalty | 7 | 2 |
Total operating expenses | 97,193 | 99,880 |
Loss from operations | (28,415) | (49,957) |
Interest and other income | 3,378 | 54 |
Interest expense | (27,396) | (23,837) |
Foreign currency losses, net | (229) | (177) |
Loss before income taxes | (52,662) | (73,917) |
Income tax expense | 671 | 279 |
Net loss | (53,333) | (74,196) |
Foreign currency translation adjustment | 59 | 78 |
Unrealized gain (loss) on available for sale investments | 500 | (69) |
Comprehensive loss | $ (52,774) | $ (74,187) |
Basic net loss per common share (in usd per share) | $ (0.28) | $ (0.40) |
Diluted net loss per common share (in usd per share) | $ (0.28) | $ (0.40) |
Weighted average shares outstanding, basic (in shares) | 188,509 | 184,898 |
Weighted average shares outstanding, diluted (in shares) | 188,509 | 184,898 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Cash flows from operating activities: | ||
Net loss | $ (53,333) | $ (74,196) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 405 | 317 |
Inventory obsolescence | 236 | 0 |
Stock-based compensation expense | 14,007 | 9,601 |
Non-cash interest expense on royalty financing obligations and secured term loan and amortization of debt issuance costs | 20,216 | 19,003 |
Amortization of premium/discount on investments | (1,385) | 30 |
Changes in operating assets and liabilities: | ||
Receivables | 2,019 | (7,048) |
Inventory | 131 | (354) |
Prepaid expenses and other assets | (2,547) | (2,320) |
Accounts payable and accrued expenses | (27,226) | (22,908) |
Deferred revenue | (35) | 75 |
Net cash used in operating activities | (47,512) | (77,800) |
Cash flows from investing activities: | ||
Acquisitions of property and equipment | (160) | (406) |
Purchase of investments | (148,637) | (38,066) |
Sales and maturities of investments | 41,688 | 0 |
Net cash used in investing activities | (107,109) | (38,472) |
Cash flows from financing activities: | ||
Net proceeds from common stock issued under stock-based compensation plans | 5,077 | 7,356 |
Net cash provided by financing activities | 5,077 | 7,356 |
Effect of exchange rate on cash, cash equivalents, and restricted cash | (96) | 40 |
Decrease in cash, cash equivalents and restricted cash | (149,640) | (108,876) |
Cash, cash equivalents and restricted cash at beginning of period | 306,239 | 507,734 |
Cash, cash equivalents and restricted cash at end of period | $ 156,599 | $ 398,858 |
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, 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 | 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, 2022 | (294,597) | 1,879 | 1,158,118 | 26 | (1,454,620) |
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Net loss | (53,333) | (53,333) | |||
Other comprehensive income | 559 | 559 | |||
Employee stock purchase plan sales, net | 1,575 | 2 | 1,573 | ||
Exercise of stock options, net | 3,502 | 8 | 3,494 | ||
Stock-based compensation expense | 14,007 | 14,007 | |||
Balance at Mar. 31, 2023 | $ (328,287) | $ 1,889 | $ 1,177,192 | $ 585 | $ (1,507,953) |
Consolidated Statements of St_2
Consolidated Statements of Stockholders' Deficit (Parenthetical) - shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Statement of Stockholders' Equity [Abstract] | ||
Employee stock purchase plan sales, net (in shares) | 176 | 115 |
Exercise of stock options, net (in shares) | 801 | 1,108 |
Significant Accounting Policies
Significant Accounting Policies and Concentrations of Risk | 3 Months Ended |
Mar. 31, 2023 | |
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 and commercializes novel, oral, small-molecule medicines. The Company focuses on oral treatments for 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. (“Torii”), 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 March 31, 2023 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 2023 expenses will exceed its 2023 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 largely be 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) out-licensing rights to certain of its products or product candidates, pursuant to which the Company would receive cash milestone payments; (2) raising additional capital through equity or debt financings or from other sources, including royalty or other monetization transactions; (3) obtaining additional product candidate regulatory approvals, which would generate revenue, milestone payments and cash flow; (4) reducing spending on one or more research and development programs, including by discontinuing development; (5) restructuring operations to change its overhead structure; and/or (6) securing U.S. Government funding of its programs, including obtaining procurement contracts. 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. The Company has made certain presentation changes relative to its revenue, which management considers fundamental to understanding the Company’s current business and financial performance related to its primary product, ORLADEYO, including expanded international sales of ORLADEYO, relative to the Company’s other sources of revenue. Accordingly, certain disaggregated revenue information has been provided in this Note 1 and “Note 2—Revenue” to these consolidated financial statements. These presentation changes have been applied to prior year revenue amounts for consistency and comparability. These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2022 and the notes thereto included in the Company’s 2022 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, 2022 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. Significant estimates in the Company’s consolidated financial statements have been made relative to the calculation of net product sales, the ORLADEYO and Factor D inhibitors royalty financing obligations, inventory reserves, certain accruals, primarily related to the Company’s research and development expenses, the valuation of stock options 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 The Company recorded the following revenues for the three months ended March 31, 2023 and 2022: Three Months Ended March 31, 2023 2022 Product sales, net $ 68,166 $ 49,546 Collaborative and other revenues 612 377 Total revenues $ 68,778 $ 49,923 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 products 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 Revenues 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 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 $12 and $23 as of March 31, 2023 and December 31, 2022, respectively, reflects royalty revenue paid by Shionogi & Co., Ltd. (“Shionogi”) designated for interest on the PhaRMA Senior Secured 14.0% Notes due on December 1, 2020 (the “PhaRMA Notes”) issued by JPR Royalty Sub LLC, a wholly-owned subsidiary of the Company. Additionally, restricted cash of $1,451 and $1,449 as of March 31, 2023 and December 31, 2022, 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 March 31, 2023, 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 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’s inventories primarily relate to ORLADEYO. Additionally, the Company’s inventories include RAPIVAB and peramivir. 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 labeling, including raw material, active product ingredient, and the drug product. Finished goods include packaged and labeled 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. During the quarter ended March 31, 2023, the Company evaluated its inventory levels and associated expiration dating relative to the latest sales forecasts for ORLADEYO and RAPIVAB and estimated those inventories at risk of obsolescence. Accordingly, the Company recorded an increase to the inventory valuation reserve of $236 for a total reserve of $1,413 as of March 31, 2023. 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 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 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, which can include assumptions such as expected patient enrollment, site activation and estimated project duration. 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. If the Company does not identify costs that it has begun to incur or if it underestimates or overestimates the level of these costs, actual expenses could differ from such estimates. As of March 31, 2023 and December 31, 2022, 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, as well as termination fees and other commitments associated with discontinued programs. 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 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. The Company groups its research and development expenses into two major categories: direct expenses and indirect expenses. Direct expenses consist of compensation for research and development personnel and costs of outside parties to conduct laboratory studies, develop manufacturing processes and manufacture the product candidate, conduct and manage clinical trials, as well as other costs related to the Company’s clinical and preclinical studies. Additionally, direct expenses consist of those costs necessary to discontinue and close out a development program |
Revenue
Revenue | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Revenue | Revenue The Company recorded the following revenues (in thousands): Three Months Ended March 31, 2023 2022 ORLADEYO: U.S. $ 60,849 $ 43,935 Outside of U.S. 7,565 5,769 Total ORLADEYO 68,414 49,704 Other revenues 364 219 Total revenues $ 68,778 $ 49,923 ORLADEYO revenues represent total revenues from product sales, collaborative revenues and royalties. Other revenues primarily relate to the Company’s galidesivir development contracts with BARDA/HHS and NIAID/HHS and product sales and royalties for peramivir injection (RAPIVAB/RAPIACTA/PERAMIFLU). |
Investments
Investments | 3 Months Ended |
Mar. 31, 2023 | |
Investments [Abstract] | |
Investments | InvestmentsThe 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. March 31, 2023 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 242,246 $ 160 $ 69 $ (585) $ 241,890 Corporate debt securities 3,362 13 — (21) 3,354 Certificates of deposit 1,224 7 — (21) 1,210 Total investments $ 246,832 $ 180 $ 69 $ (627) $ 246,454 December 31, 2022 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 129,940 $ 427 $ — $ (996) $ 129,371 Corporate debt securities 6,093 37 — (38) 6,092 Certificates of deposit 2,163 23 — (29) 2,157 Total investments $ 138,196 $ 487 $ — $ (1,063) $ 137,620 The following table summarizes the scheduled maturity for the Company’s investments at March 31, 2023 and December 31, 2022: March 31, 2023 December 31, 2022 Maturing in one year or less $ 243,022 $ 119,543 Maturing after one year through two years 3,432 18,077 Total investments $ 246,454 $ 137,620 |
Trade Receivables
Trade Receivables | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023 and December 31, 2022, receivables related to sales of ORLADEYO were $47,403 and $41,508, respectively. At March 31, 2023 and December 31, 2022, receivables related to sales of RAPIVAB were $145 and $823, respectively. No reserve or allowance amounts were recorded as of March 31, 2023 and December 31, 2022. Collaborations Receivables from collaborations were as follows (in thousands): March 31, 2023 Billed Unbilled Total U.S. Department of Health and Human Services, net $ 286 $ 284 $ 570 Royalty receivables from partners 521 — 521 Total receivables $ 807 $ 284 $ 1,091 December 31, 2022 Billed Unbilled Total U.S. Department of Health and Human Services, net $ 7,218 $ 284 $ 7,502 Royalty receivables from partners 741 — 741 Other collaborations — 25 25 Total receivables $ 7,959 $ 309 $ 8,268 As of both March 31, 2023 and December 31, 2022, the Company maintained a reserve of $437 related to royalties associated with Green Cross. |
Inventory
Inventory | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory At March 31, 2023 and December 31, 2022, 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): March 31, 2023 December 31, 2022 Raw materials $ 8,869 $ 8,906 Work-in-process 15,613 14,990 Finished goods 4,397 4,814 Total inventory $ 28,879 $ 28,710 Reserves (1,413) (1,177) Total inventory, net $ 27,466 $ 27,533 |
Royalty Monetizations
Royalty Monetizations | 3 Months Ended |
Mar. 31, 2023 | |
Advance Royalties [Abstract] | |
Royalty Monetizations | Royalty Monetizations 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. 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 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 was permitted to be incurred under the terms of the Athyrium Credit Agreement (as defined in Note 7 herein) through its payoff and termination on April 17, 2023 or, subsequent to that date, the Company’s Loan Agreement (the “Pharmakon Loan Agreement”) with BioPharma Credit Investments V (Master) LP and BPCR Limited Partnership, as lenders, and BioPharma Credit PLC, as collateral agent for the lenders, as applicable. Refer to Note 7 and Note 12, respectively, for further details on the Athyrium Credit Agreement and the Pharmakon Loan Agreement. The restrictions under the Royalty Purchase Agreements 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 March 31, 2023, there was no significant impact on the amount and timing of expected royalties to be made under the RPI Royalty Purchase Agreements based on the Company’s latest forecasts related to its R&D programs and ORLADEYO sales. The following table shows the activity within the Royalty financing obligations account (in thousands) as well as the effective interest rate as of March 31, 2023: 2020 RPI 2021 RPI OMERS Total Balance as of December 31, 2022 $ 164,981 $ 173,651 $ 163,023 $ 501,655 Deferred financing costs — — — — Non-cash Interest expense on Royalty financing obligations 9,309 5,680 4,329 19,318 Royalty revenues paid and payable (6,038) (524) — (6,562) Balance as of March 31, 2023 $ 168,252 $ 178,807 $ 167,352 $ 514,411 Effective interest rate 22.4 % 13.1 % 10.6 % 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 | 3 Months Ended |
Mar. 31, 2023 | |
Debt Disclosure [Abstract] | |
Debt | Debt Credit Agreement On December 7, 2020, the Company entered into a $200,000 Credit Agreement (the “Athyrium 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 were guarantors to the Athyrium Credit Agreement. The Athyrium Credit Agreement provided 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 March 31, 2023. 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 Athyrium 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 “Athyrium Term Loans”). Having achieved all required revenue-based milestones, the Company exercised its option to draw upon the additional funding available under the Athyrium 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 were subject to all the provisions under the Athyrium Credit Agreement. On November 19, 2021, the Company entered into an amendment to the Athyrium Credit Agreement to, among other things, (i) 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) require the Company to pay to Athyrium, for the account of the lenders, a make-whole premium plus certain fees set forth in the Athyrium Credit Agreement in the event that the Company prepaid or repaid, or was required to prepay or repay, voluntarily or pursuant to mandatory prepayment obligations under the Athyrium 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 Athyrium Term Loans, in each case, subject to certain exceptions set forth in the Athyrium Credit Agreement. The Athyrium Credit Agreement provided for quarterly interest-only payments until the maturity date, with the unpaid principal amount of the outstanding Athyrium Term Loans due and payable on the maturity date. For each of the first eight full fiscal quarters following December 7, 2020, the Company had 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 Athyrium Term Loans accrued interest at a rate equal to the three-month LIBOR rate, which was 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 was made, LIBOR plus 10.25%. The quarter ended December 31, 2022 was the last period eligible for the PIK Interest Payment designation. The Athyrium Term Loans accrued interest at an effective interest rate of 11.88% for the three months ended March 31, 2023 compared to 12.17% for the three months ended March 31, 2022. The three-month LIBOR was 4.73% as of December 28, 2022, the LIBOR measurement date for the three-month interest period beginning January 1, 2023. As the LIBOR rate exceeded the LIBOR cap of 3.50%, the 3.50% cap plus 8.25%, or 11.75%, was used to record interest expense for the three-month interest period ended March 31, 2023. Subject to certain exceptions, the Athyrium Credit Agreement would have required the Company to make mandatory prepayments of the Athyrium 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 could have made voluntary prepayments in whole or in part. Prepayments were 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 Athyrium Term Loans, the Company was obligated to pay an exit fee in an amount equal to 2.00% of the principal amount of the Athyrium Term Loans prepaid or repaid. In addition, each Term Loan was subject to a 1.00% commitment fee at its respective borrowing date. The Athyrium Credit Agreement also contained 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 limited 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 was drawn, the Company could 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 Athyrium Credit Agreement (collectively, the “Revenue Tests”). If the Company failed to satisfy the Revenue Tests as of any Test Date, it would have had 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 Athyrium Credit Agreement at such time. In addition, the Athyrium Credit Agreement contained 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 had been drawn; at least $20,000 of unrestricted cash and cash equivalents if the Term B Loan had been drawn but the Term C Loan had 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 had been drawn, subject to certain exceptions. A failure to comply with the covenants in the Athyrium Credit Agreement could have permitted the lenders under the Athyrium 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 Athyrium Credit Agreement were secured by a security interest in, subject to certain exceptions, substantially all of the Company’s assets. As of March 31, 2023, the Company had total borrowings of $200,000 under the Athyrium Credit Agreement. Quarterly interest payments under the Athyrium Credit Agreement for the three months ended March 31, 2023 and 2022 totaled $7,142 and $4,321, respectively. From Term Loan inception through December 31, 2022, the quarterly interest payments were designated and accounted for as PIK Interest Payments and added to the outstanding principal balance of the borrowing. The quarter ended December 31, 2022 was the last period eligible for the PIK Interest Payment designation. As of March 31, 2023, borrowings, including the PIK Interest Payments, totaled $240,452. The principal balance of the borrowings, including PIK amounts, accrued interest at an effective rate of 11.88% for the three months ended March 31, 2023. 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. As of March 31, 2023, deferred debt fees and issuance costs associated with all Athyrium Term Loans under the Athyrium Credit Agreement totaled $11,930 and are being amortized as interest expense on an effective interest rate method over the remaining term of the Athyrium Term Loans. Deferred financing amortization of $898 and $(167), was recognized for the three months ended March 31, 2023 and 2022, respectively. When utilizing the effective interest method, in periods in which PIK interest was designated and added to the outstanding principal balance of the borrowing, the amortization of the deferred debt fees and issuance costs was accretive. On April 17, 2023, the Company entered into the Pharmakon Loan Agreement and used the proceeds of an initial loan thereunder to, among other things, to repay the outstanding indebtedness under the Athyrium Credit Agreement. See “Note 12—Subsequent Events” for additional information about the Pharmakon Loan Agreement. |
Lease Obligations
Lease Obligations | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023. Renewal options for the Company's leases range from 1 to 5 years in length and begin from 2024 through 2027. Aggregate lease expense under operating leases was as follows (in thousands): Three Months Ended March 31, 2023 2022 Aggregate lease expense $ 727 $ 594 Other supplemental information related to leases was as follows: As of March 31, 2023 As of December 31, 2022 Weighted average remaining lease term 7.8 years 8.1 years Weighted average discount rate 10.8% 11.0% All of the Company’s leases qualify as operating leases. The following table summarizes the presentation in the Consolidated Balance Sheets of the Company’s operating leases: Balance Sheet Location As of March 31, 2023 As of December 31, 2022 Assets: Operating lease assets, net Other Assets $ 7,046 $ 6,806 Liabilities: Current operating lease liabilities Lease financing obligation – current liabilities $ 2,491 $ 2,369 Non-current operating lease liabilities Lease financing obligation – long-term liabilities 5,934 5,804 Total operating lease liabilities $ 8,425 $ 8,173 Operating lease assets are recorded net of accumulated amortization of $4,878 and $4,349 as of March 31, 2023 and December 31, 2022, respectively. Cash paid for amounts included in the measurement of lease liabilities was $705 and $574 for the three months ended March 31, 2023, and 2022, respectively. Maturities of operating lease liabilities as of March 31, 2023, are as follows (in thousands): 2023 (remaining) $ 2,137 2024 2,175 2025 1,711 2026 824 2027 613 Thereafter 6,161 Total lease payments 13,621 Less imputed interest (5,196) Total $ 8,425 |
Stockholders' Equity
Stockholders' Equity | 3 Months Ended |
Mar. 31, 2023 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' Equity | Stockholders ’ Equity Sales of Common Stock 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 shares of the Company’s common stock to RPI for an aggregate purchase price of $50,000, at a price of $13.00 per share, calculated based on the 20-day volume weighted average price. The $13.00 per share price represented a premium of $1.11 over the closing price of $11.89 of the Company’s common stock on November 17, 2021, the last trading day prior to the execution of the Common Stock Purchase Agreement. The premium of $4,269 paid by RPI on the purchase of the Company’s common stock has been deferred and is being amortized as a component of interest expense of the 2021 RPI royalty financing obligation. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Share-Based Compensation | Stock-Based Compensation As of March 31, 2023, 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 24, 2023, subject to stockholder approval at the Company’s annual meeting of stockholders to be held on June 13, 2023. The Inducement Plan was most recently amended and restated by the Company’s 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. The Company recorded the following stock-based compensation expense (in thousands): Three Months Ended March 31, 2023 2022 Incentive Plan $ 11,061 $ 8,078 Inducement Plan 2,475 1,225 ESPP 471 298 Stock-based compensation expense $ 14,007 $ 9,601 There was approximately $139,166 of total unrecognized compensation expense related to non-vested stock option and restricted stock unit awards granted by the Company as of March 31, 2023. As of March 31, 2023, the Company expected to recognize that expense as follows: $38,098 during the remainder of 2023, $46,800 in 2024, $35,358 in 2025, $18,689 in 2026 and $221 in 2027. 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. 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 March 31, 2023, 85% of these grants have vested. In January 2022, the Company issued 221 performance-based restricted stock unit awards. 21 of the awards met the performance objectives in 2022 and became 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. The remaining awards were cancelled. 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, 2022 4,206 31,179 $ 8.56 Restricted stock unit awards granted (146) — — Restricted stock unit awards cancelled 313 — — Stock option awards granted (215) 215 10.55 Stock option awards exercised — (529) 5.52 Stock option awards cancelled 437 (437) 10.32 Balance March 31, 2023 4,595 30,428 $ 8.60 For stock option awards granted under the Incentive Plan during the first three months of 2023 and 2022, 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 three months of 2023 and 2022 was $7.47 and $11.48, 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 unit awards 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 three months of 2023 and 2022 was $10.32 and $15.49, 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, 2022 947 5,341 $ 8.80 Restricted stock unit awards granted (193) — — Restricted stock unit awards cancelled 21 — — Stock option awards granted (522) 522 9.66 Stock option awards exercised — (173) 3.36 Stock option awards cancelled 260 (260) 8.62 Balance March 31, 2023 513 5,430 $ 9.06 For stock option awards granted under the Inducement Plan during the first three months of 2023 and 2022, 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 three months of 2023 and 2022 was $6.85 and $11.14, 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 unit awards 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 three months of 2023 and 2022 was $9.64 and $16.27, 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. The following table summarizes the key assumptions used by the Company to value the stock option awards granted under all plans during the first three months of 2023 and 2022, 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 Incentive and Inducement Plans 2023 2022 Expected Life in Years 5.5 5.5 Expected Volatility 84.2 % 84.1 % Expected Dividend Yield 0.0 % 0.0 % Risk-Free Interest Rate 3.7 % 1.9 % 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 5,617 shares remain available for purchase as of March 31, 2023. 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 three thousand 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 three months ended March 31, 2023, and 2022, the Company issued 176 and 115 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 | 3 Months Ended |
Mar. 31, 2023 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborative and Other Relationships | Collaborative and Other Relationships ORLADEYO 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. Peramivir Injection (RAPIVAB, RAPIACTA, PERAMIFLU) 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 the University of Alabama at Birmingham (“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. Government Collaborations The Company has previously entered into contracts with the U.S. Government, including the procurement contract with HHS for up to 50,000 doses of RAPIVAB over a five |
Subsequent Events
Subsequent Events | 3 Months Ended |
Mar. 31, 2023 | |
Subsequent Events [Abstract] | |
Subsequent Events | Subsequent Events On April 17, 2023, the Company secured $450,000 in committed financing from funds managed by Pharmakon Advisors, LP. The Company elected to draw $300,000 of the $450,000 available under the Pharmakon Loan Agreement on the closing date of the Pharmakon Loan Agreement. The remaining $150,000 of committed capital may be drawn at the Company’s option, subject to certain borrowing conditions, if requested on or prior to September 30, 2024. Net proceeds to the Company at closing were approximately $26,000 following the repayment of the Athyrium Credit Agreement and payment of fees and expenses associated with the transaction. The new five-year Pharmakon Loan Agreement bears interest at the 3-month Secured Overnight Financing Rate (“SOFR”) + 7.00% (subject to a 1.75% floor). The Company has the option to pay up to 50% of the interest on the loans advanced on the closing date in-kind for the first eighteen months of the term (subject to an increase in margin from 7.00% to 7.25%), allowing the Company to defer a portion of cash interest payments until after this period. The Pharmakon Loan Agreement contains no scheduled amortization payments, with all outstanding principal due at the maturity date in 2028. There are no financial covenants associated with the financing. |
Significant Accounting Polici_2
Significant Accounting Policies and Concentrations of Risk (Policies) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
The Company | The Company BioCryst Pharmaceuticals, Inc. (the “Company”) is a commercial-stage biotechnology company that discovers and commercializes novel, oral, small-molecule medicines. The Company focuses on oral treatments for 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. (“Torii”), 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 March 31, 2023 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 2023 expenses will exceed its 2023 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 largely be 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) out-licensing rights to certain of its products or product candidates, pursuant to which the Company would receive cash milestone payments; (2) raising additional capital through equity or debt financings or from other sources, including royalty or other monetization transactions; (3) obtaining additional product candidate regulatory approvals, which would generate revenue, milestone payments and cash flow; (4) reducing spending on one or more research and development programs, including by discontinuing development; (5) restructuring operations to change its overhead structure; and/or (6) securing U.S. Government funding of its programs, including obtaining procurement contracts. 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. The Company has made certain presentation changes relative to its revenue, which management considers fundamental to understanding the Company’s current business and financial performance related to its primary product, ORLADEYO, including expanded international sales of ORLADEYO, relative to the Company’s other sources of revenue. Accordingly, certain disaggregated revenue information has been provided in this Note 1 and “Note 2—Revenue” to these consolidated financial statements. These presentation changes have been applied to prior year revenue amounts for consistency and comparability. These financial statements should be read in conjunction with the financial statements for the year ended December 31, 2022 and the notes thereto included in the Company’s 2022 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, 2022 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 | 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. Significant estimates in the Company’s consolidated financial statements have been made relative to the calculation of net product sales, the ORLADEYO and Factor D inhibitors royalty financing obligations, inventory reserves, certain accruals, primarily related to the Company’s research and development expenses, the valuation of stock options 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 The Company recorded the following revenues for the three months ended March 31, 2023 and 2022: Three Months Ended March 31, 2023 2022 Product sales, net $ 68,166 $ 49,546 Collaborative and other revenues 612 377 Total revenues $ 68,778 $ 49,923 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 products 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 Revenues 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 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 $12 and $23 as of March 31, 2023 and December 31, 2022, respectively, reflects royalty revenue paid by Shionogi & Co., Ltd. (“Shionogi”) designated for interest on the PhaRMA Senior Secured 14.0% Notes due on December 1, 2020 (the “PhaRMA Notes”) issued by JPR Royalty Sub LLC, a wholly-owned subsidiary of the Company. Additionally, restricted cash of $1,451 and $1,449 as of March 31, 2023 and December 31, 2022, 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 March 31, 2023, 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 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’s inventories primarily relate to ORLADEYO. Additionally, the Company’s inventories include RAPIVAB and peramivir. 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 labeling, including raw material, active product ingredient, and the drug product. Finished goods include packaged and labeled 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. During the quarter ended March 31, 2023, the Company evaluated its inventory levels and associated expiration dating relative to the latest sales forecasts for ORLADEYO and RAPIVAB and estimated those inventories at risk of obsolescence. Accordingly, the Company recorded an increase to the inventory valuation reserve of $236 for a total reserve of $1,413 as of March 31, 2023. |
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 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, which can include assumptions such as expected patient enrollment, site activation and estimated project duration. 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. If the Company does not identify costs that it has begun to incur or if it underestimates or overestimates the level of these costs, actual expenses could differ from such estimates. As of March 31, 2023 and December 31, 2022, 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, as well as termination fees and other commitments associated with discontinued programs. 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 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. The Company groups its research and development expenses into two major categories: direct expenses and indirect expenses. Direct expenses consist of compensation for research and development personnel and costs of outside parties to conduct laboratory studies, develop manufacturing processes and manufacture the product candidate, conduct and manage clinical trials, as well as other costs related to the Company’s clinical and preclinical studies. Additionally, direct expenses consist of those costs necessary to discontinue and close out a development program, including termination fees and other commitments. These costs are accumulated and tracked by active program. Indirect expenses consist of lab supplies and services, facility expenses, depreciation of development equipment and other overhead of the Company’s research and development efforts. These costs apply to work on non-active product candidates and the Company’s discovery research efforts. |
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 $4,047 and $3,984 for the three months ended March 31, 2023, and 2022, 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 March 31, 2023. 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. Stock-based compensation cost is estimated at the grant date based on the fair value of the award and is recognized as expense on a straight-line basis over the requisite service period of the award. Determining the appropriate fair value model and the related assumptions for the model requires judgment, including estimating the life of an award, the stock price volatility, and the expected term. The Company utilizes the Black-Scholes option-pricing model to value its stock option awards and recognize compensation expense on a straight-line basis over the vesting periods. The estimation of share-based payment awards that will ultimately vest requires judgment, and to the extent actual results or updated estimates differ from the Company’s current estimates, such amounts will be recorded as a cumulative adjustment in the period estimates are revised. 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. Significant management judgment is also required in determining estimates of future stock price volatility and forfeitures to be used in the valuation of the options. Actual results, and future changes in estimates, may differ substantially from the Company’s current estimates. |
Interest Expense and Deferred Financing Costs | Interest Expense and Deferred Financing Costs Interest expense for the three months ended March 31, 2023 and 2022, was $27,396 and $23,837, respectively, and primarily relates to the royalty financing obligations (Note 6) and the secured term loan borrowing from the Athyrium Credit Agreement (Note 7). 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 $898 and $(167) for the three months ended March 31, 2023 and 2022, respectively. When utilizing the effective interest method, in periods in which PIK interest was designated and was added to the outstanding principal balance of the borrowing, the amortization of the deferred debt fees and issuance costs was accretive. The quarter ended December 31, 2022 was the last period eligible for the PIK Interest Payment designation under the Athyrium Credit Agreement. |
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 and 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. The Company accounts for uncertain tax positions in accordance with U.S. GAAP. Significant management judgment is required in determining the Company’s provision for income taxes, deferred tax assets and liabilities and any valuation allowance recorded against net deferred tax assets. The Company has recorded a valuation allowance against substantially all potential tax assets, due to uncertainties in its ability to utilize deferred tax assets, primarily consisting of certain net operating losses carried forward, before they expire. The valuation allowance is based on estimates of taxable income in each of the jurisdictions in which the Company operates and the period over which its deferred tax assets will be recoverable. Beginning in fiscal year 2021, the Company began accruing for U.S. state taxes and foreign income taxes as a result of increased nexus in both U.S. state and 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”), 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. |
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 21,641 and 28,699 shares of potential common stock for the three months ended March 31, 2023 and 2022, respectively. |
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 three months ended March 31, 2023 and 2022. |
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 and, for 2022, sales of RAPIVAB (peramivir injection) under the Company’s procurement contract with the Assistant Secretary for Preparedness and Response within HHS. ORLADEYO is distributed through an arrangement with a single specialty pharmacy in the United States, which represents the substantial majority of the ORLADEYO net product sales. 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. 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 a single source manufacturer 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 commercial product, commercial revenue and product candidates. Credit Risk Cash equivalents and investments are financial instruments that potentially subject the Company to concentration of risk to the extent recorded on the Consolidated Balance Sheets. The Company deposits excess cash with major financial institutions in the United States. Balances may 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 Pronouncements There have been no new accounting pronouncements adopted by the Company or new accounting pronouncements issued by the Financial Accounting Standards Board during the three months ended March 31, 2023, 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, 2022, that the Company believes are of significance or potential significance to the Company. |
Accounting Policies (Tables)
Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Accounting Policies [Abstract] | |
Summary of Revenues | The Company recorded the following revenues for the three months ended March 31, 2023 and 2022: Three Months Ended March 31, 2023 2022 Product sales, net $ 68,166 $ 49,546 Collaborative and other revenues 612 377 Total revenues $ 68,778 $ 49,923 The Company recorded the following revenues (in thousands): Three Months Ended March 31, 2023 2022 ORLADEYO: U.S. $ 60,849 $ 43,935 Outside of U.S. 7,565 5,769 Total ORLADEYO 68,414 49,704 Other revenues 364 219 Total revenues $ 68,778 $ 49,923 |
Revenue (Tables)
Revenue (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Revenue from Contract with Customer [Abstract] | |
Summary of Revenues | The Company recorded the following revenues for the three months ended March 31, 2023 and 2022: Three Months Ended March 31, 2023 2022 Product sales, net $ 68,166 $ 49,546 Collaborative and other revenues 612 377 Total revenues $ 68,778 $ 49,923 The Company recorded the following revenues (in thousands): Three Months Ended March 31, 2023 2022 ORLADEYO: U.S. $ 60,849 $ 43,935 Outside of U.S. 7,565 5,769 Total ORLADEYO 68,414 49,704 Other revenues 364 219 Total revenues $ 68,778 $ 49,923 |
Investments (Tables)
Investments (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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. March 31, 2023 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 242,246 $ 160 $ 69 $ (585) $ 241,890 Corporate debt securities 3,362 13 — (21) 3,354 Certificates of deposit 1,224 7 — (21) 1,210 Total investments $ 246,832 $ 180 $ 69 $ (627) $ 246,454 December 31, 2022 Amortized Accrued Gross Gross Estimated Obligations of U.S. Government and its agencies $ 129,940 $ 427 $ — $ (996) $ 129,371 Corporate debt securities 6,093 37 — (38) 6,092 Certificates of deposit 2,163 23 — (29) 2,157 Total investments $ 138,196 $ 487 $ — $ (1,063) $ 137,620 |
Schedule of the Maturity of Investments | The following table summarizes the scheduled maturity for the Company’s investments at March 31, 2023 and December 31, 2022: March 31, 2023 December 31, 2022 Maturing in one year or less $ 243,022 $ 119,543 Maturing after one year through two years 3,432 18,077 Total investments $ 246,454 $ 137,620 |
Trade Receivables (Tables)
Trade Receivables (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Receivables [Abstract] | |
Summary of Receivables | Receivables from collaborations were as follows (in thousands): March 31, 2023 Billed Unbilled Total U.S. Department of Health and Human Services, net $ 286 $ 284 $ 570 Royalty receivables from partners 521 — 521 Total receivables $ 807 $ 284 $ 1,091 December 31, 2022 Billed Unbilled Total U.S. Department of Health and Human Services, net $ 7,218 $ 284 $ 7,502 Royalty receivables from partners 741 — 741 Other collaborations — 25 25 Total receivables $ 7,959 $ 309 $ 8,268 |
Inventory (Tables)
Inventory (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Inventory Disclosure [Abstract] | |
Summary of Inventories | The Company’s inventories consisted of the following (in thousands): March 31, 2023 December 31, 2022 Raw materials $ 8,869 $ 8,906 Work-in-process 15,613 14,990 Finished goods 4,397 4,814 Total inventory $ 28,879 $ 28,710 Reserves (1,413) (1,177) Total inventory, net $ 27,466 $ 27,533 |
Royalty Monetizations (Tables)
Royalty Monetizations (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
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 March 31, 2023: 2020 RPI 2021 RPI OMERS Total Balance as of December 31, 2022 $ 164,981 $ 173,651 $ 163,023 $ 501,655 Deferred financing costs — — — — Non-cash Interest expense on Royalty financing obligations 9,309 5,680 4,329 19,318 Royalty revenues paid and payable (6,038) (524) — (6,562) Balance as of March 31, 2023 $ 168,252 $ 178,807 $ 167,352 $ 514,411 Effective interest rate 22.4 % 13.1 % 10.6 % |
Lease Obligations (Tables)
Lease Obligations (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Leases [Abstract] | |
Aggregate Lease Expense Under Operating Leases | Aggregate lease expense under operating leases was as follows (in thousands): Three Months Ended March 31, 2023 2022 Aggregate lease expense $ 727 $ 594 |
Other Supplemental Information Related to Leases | Other supplemental information related to leases was as follows: As of March 31, 2023 As of December 31, 2022 Weighted average remaining lease term 7.8 years 8.1 years Weighted average discount rate 10.8% 11.0% |
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 March 31, 2023 As of December 31, 2022 Assets: Operating lease assets, net Other Assets $ 7,046 $ 6,806 Liabilities: Current operating lease liabilities Lease financing obligation – current liabilities $ 2,491 $ 2,369 Non-current operating lease liabilities Lease financing obligation – long-term liabilities 5,934 5,804 Total operating lease liabilities $ 8,425 $ 8,173 |
Maturities of Operating Lease Liabilities | Maturities of operating lease liabilities as of March 31, 2023, are as follows (in thousands): 2023 (remaining) $ 2,137 2024 2,175 2025 1,711 2026 824 2027 613 Thereafter 6,161 Total lease payments 13,621 Less imputed interest (5,196) Total $ 8,425 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2023 | |
Share-Based Payment Arrangement [Abstract] | |
Disclosure of Share-Based Compensation Arrangements by Share-Based Payment Award | The Company recorded the following stock-based compensation expense (in thousands): Three Months Ended March 31, 2023 2022 Incentive Plan $ 11,061 $ 8,078 Inducement Plan 2,475 1,225 ESPP 471 298 Stock-based compensation expense $ 14,007 $ 9,601 |
Stock Plan Activities | Related activity under the Incentive Plan is as follows: Awards Options Weighted Balance December 31, 2022 4,206 31,179 $ 8.56 Restricted stock unit awards granted (146) — — Restricted stock unit awards cancelled 313 — — Stock option awards granted (215) 215 10.55 Stock option awards exercised — (529) 5.52 Stock option awards cancelled 437 (437) 10.32 Balance March 31, 2023 4,595 30,428 $ 8.60 Related activity under the Inducement Plan is as follows: Awards Options Weighted Balance December 31, 2022 947 5,341 $ 8.80 Restricted stock unit awards granted (193) — — Restricted stock unit awards cancelled 21 — — Stock option awards granted (522) 522 9.66 Stock option awards exercised — (173) 3.36 Stock option awards cancelled 260 (260) 8.62 Balance March 31, 2023 513 5,430 $ 9.06 |
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 Incentive and Inducement Plans 2023 2022 Expected Life in Years 5.5 5.5 Expected Volatility 84.2 % 84.1 % Expected Dividend Yield 0.0 % 0.0 % Risk-Free Interest Rate 3.7 % 1.9 % |
Significant Accounting Polici_3
Significant Accounting Policies and Concentrations of Risk (Details) - USD ($) shares in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Significant Accounting Policies and Concentration of Risk [Line Items] | |||
Restricted cash | $ 1,463,000 | $ 1,472,000 | |
Long-term investment maturity, minimum (in years) | 12 months | ||
Inventory adjustments | $ 236,000 | ||
Inventory valuation reserves | 1,413,000 | 1,177,000 | |
Advertising expense | 4,047,000 | $ 3,984,000 | |
Interest expense, debt, total | 27,396,000 | 23,837,000 | |
Amortization of debt financing costs and original issue discounts | $ 898,000 | $ (167,000) | |
Antidilutive securities excluded from computation of earnings per share, amount (in shares) | 21,641 | 28,699 | |
Reclassification from accumulated other comprehensive income, current period, before tax | $ 0 | $ 0 | |
PhaRMA Notes | JPR Royalty Sub LLC | |||
Significant Accounting Policies and Concentration of Risk [Line Items] | |||
Debt instrument, interest rate, stated percentage | 14% | ||
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 | $ 12,000 | 23,000 | |
Collateral for Credit | |||
Significant Accounting Policies and Concentration of Risk [Line Items] | |||
Restricted cash | $ 1,451,000 | $ 1,449,000 |
Significant Accounting Polici_4
Significant Accounting Policies and Concentrations of Risk - Summary of Revenues (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Significant Accounting Policies and Concentration of Risk [Line Items] | ||
Revenues | $ 68,778 | $ 49,923 |
Product sales, net | ||
Significant Accounting Policies and Concentration of Risk [Line Items] | ||
Revenues | 68,166 | 49,546 |
Collaborative and other revenues | ||
Significant Accounting Policies and Concentration of Risk [Line Items] | ||
Revenues | $ 612 | $ 377 |
Revenue (Details)
Revenue (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 68,778 | $ 49,923 |
Product sales, net | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 68,166 | 49,546 |
Product sales, net | U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 60,849 | 43,935 |
Product sales, net | Outside of U.S. | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 7,565 | 5,769 |
ORLADEYO | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | 68,414 | 49,704 |
Other revenues | ||
Disaggregation of Revenue [Line Items] | ||
Revenues | $ 364 | $ 219 |
Investments- Fair Value of the
Investments- Fair Value of the Company's Investments by Type (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Marketable Securities [Line Items] | ||
Amortized Cost | $ 246,832 | $ 138,196 |
Accrued Interest | 180 | 487 |
Gross Unrealized Gains | 69 | 0 |
Gross Unrealized Losses | (627) | (1,063) |
Estimated Fair Value | $ 246,454 | $ 137,620 |
Debt Securities, Available-for-Sale, Accrued Interest, after Allowance for Credit Loss, Statement of Financial Position [Extensible Enumeration] | Investments, Long-term investments | Investments, Long-term investments |
Obligations of U.S. Government and its agencies | ||
Marketable Securities [Line Items] | ||
Amortized Cost | $ 242,246 | $ 129,940 |
Accrued Interest | 160 | 427 |
Gross Unrealized Gains | 69 | 0 |
Gross Unrealized Losses | (585) | (996) |
Estimated Fair Value | 241,890 | 129,371 |
Corporate debt securities | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 3,362 | 6,093 |
Accrued Interest | 13 | 37 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (21) | (38) |
Estimated Fair Value | 3,354 | 6,092 |
Certificates of deposit | ||
Marketable Securities [Line Items] | ||
Amortized Cost | 1,224 | 2,163 |
Accrued Interest | 7 | 23 |
Gross Unrealized Gains | 0 | 0 |
Gross Unrealized Losses | (21) | (29) |
Estimated Fair Value | $ 1,210 | $ 2,157 |
Investments - Schedule of Matur
Investments - Schedule of Maturity of Investments (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Investments [Abstract] | ||
Maturing in one year or less | $ 243,022 | $ 119,543 |
Maturing after one year through two years | 3,432 | 18,077 |
Estimated Fair Value | $ 246,454 | $ 137,620 |
Trade Receivables (Details Text
Trade Receivables (Details Textual) - Trade Accounts Receivable - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
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 | 47,403 | 41,508 |
Outside of U.S. | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable, after allowance for credit loss, total | 145 | 823 |
Green Cross Corporation | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Accounts receivable, after allowance for credit loss, total | $ 437 | $ 437 |
Trade Receivables - Summary of
Trade Receivables - Summary of Receivables (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | $ 1,091 | $ 8,268 |
Billed | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 807 | 7,959 |
Unbilled | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 284 | 309 |
U.S. Department of Health and Human Services, net | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 570 | 7,502 |
U.S. Department of Health and Human Services, net | Billed | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 286 | 7,218 |
U.S. Department of Health and Human Services, net | Unbilled | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 284 | 284 |
Royalty receivables from partners | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 521 | 741 |
Royalty receivables from partners | Billed | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 521 | 741 |
Royalty receivables from partners | Unbilled | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | $ 0 | 0 |
Other collaborations | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 25 | |
Other collaborations | Billed | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 0 | |
Other collaborations | Unbilled | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | $ 25 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 8,869 | $ 8,906 |
Work-in-process | 15,613 | 14,990 |
Finished goods | 4,397 | 4,814 |
Total inventory | 28,879 | 28,710 |
Reserves | (1,413) | (1,177) |
Total inventory, net | $ 27,466 | $ 27,533 |
Royalty Monetizations (Details
Royalty Monetizations (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | ||
Nov. 19, 2021 | Dec. 07, 2020 | Mar. 31, 2023 | |
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 | 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 | BCX10013 | Annual Net Sales Over $3 Million | |||
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 | ||
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% | ||
The 2021 RPI Royalty Purchase Agreement | Annual Net Sales Over $550,000 | |||
Royalty Monetizations [Line Items] | |||
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 | ORLADEYO | Annual Net Sales Over $230,000 | |||
Royalty Monetizations [Line Items] | |||
Royalty purchase agreement, royalties, percentage of annual net sales in other markets | 0% | ||
The 2021 RPI Royalty Purchase Agreement | BCX10013 | Annual Net Sales Under $1.5 Million | |||
Royalty Monetizations [Line Items] | |||
Royalty purchase agreement, royalties, percentage of annual net sales in key territories | 3% | ||
The 2021 RPI Royalty Purchase Agreement | BCX10013 | Annual Net Sales Between $1.5 and $3 Millions | |||
Royalty Monetizations [Line Items] | |||
Royalty purchase agreement, royalties, percentage of annual net sales in key territories | 2% | ||
The 2021 RPI Royalty Purchase Agreement | BCX10013 | Annual Net Sales Over $3 Million | |||
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% |
Royalty Monetizations - Schedul
Royalty Monetizations - Schedule of Royalty Financing Obligations (Details) $ in Thousands | 3 Months Ended |
Mar. 31, 2023 USD ($) | |
Royalty Montizations [Roll Forward] | |
Balance | $ 501,655 |
Deferred financing costs | 0 |
Non-cash Interest expense on Royalty financing obligations | 19,318 |
Royalty revenues paid and payable | (6,562) |
Balance | 514,411 |
2020 RPI Royalty Agreement | |
Royalty Montizations [Roll Forward] | |
Balance | 164,981 |
Deferred financing costs | 0 |
Non-cash Interest expense on Royalty financing obligations | 9,309 |
Royalty revenues paid and payable | (6,038) |
Balance | $ 168,252 |
Effective interest rate | 22.40% |
2021 RPI Royalty Agreement | |
Royalty Montizations [Roll Forward] | |
Balance | $ 173,651 |
Deferred financing costs | 0 |
Non-cash Interest expense on Royalty financing obligations | 5,680 |
Royalty revenues paid and payable | (524) |
Balance | $ 178,807 |
Effective interest rate | 13.10% |
OMERS Royalty Agreement | |
Royalty Montizations [Roll Forward] | |
Balance | $ 163,023 |
Deferred financing costs | 0 |
Non-cash Interest expense on Royalty financing obligations | 4,329 |
Royalty revenues paid and payable | 0 |
Balance | $ 167,352 |
Effective interest rate | 10.60% |
Debt (Details)
Debt (Details) $ in Thousands | 3 Months Ended | |||||
Dec. 07, 2020 USD ($) | Mar. 31, 2023 USD ($) | Mar. 31, 2022 USD ($) | Dec. 31, 2022 | Dec. 28, 2022 | Jul. 29, 2022 USD ($) | |
Debt Instrument [Line Items] | ||||||
Paid-in-kind interest | $ 7,142 | $ 4,321 | ||||
Debt instrument, unamortized discount (premium) and debt issuance costs, net, total | 11,930 | |||||
Amortization of debt issuance costs | $ 898 | $ 167 | ||||
MidCap Financial Services, LLC | Senior Credit Facility | ||||||
Debt Instrument [Line Items] | ||||||
Repayments of lines of credit | $ 43,298 | |||||
Credit Agreement | Athyrium | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 200,000 | |||||
Debt instrument, LIBOR floor | 1.75% | |||||
Debt instrument, LIBOR cap | 3.50% | |||||
Effective interest rate | 11.75% | |||||
Debt instrument, exit fee, percentage of principal | 2% | |||||
Debt instrument, commitment fee percentage | 1% | |||||
Long-term debt, gross | $ 200,000 | |||||
Long-term debt, total | $ 240,452 | |||||
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 | |||||
Credit Agreement | Athyrium | Term Loan A and B Drawn | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, covenant, minimum unrestricted cash and cash equivalents | 20,000 | |||||
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 | |||||
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 | |||||
Credit Agreement | Athyrium | London Interbank Offered Rate (LIBOR) | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 8.25% | |||||
Debt Instrument libor interest rate | 0.0473 | |||||
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% | |||||
Credit Agreement | Athyrium | Term A Loan | ||||||
Debt Instrument [Line Items] | ||||||
Proceeds from issuance of long-term debt, total | $ 125,000 | |||||
Credit Agreement | Athyrium | Term B Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 25,000 | |||||
Credit Agreement | Athyrium | Term C Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | 50,000 | |||||
Credit Agreement | Athyrium | Term B And C Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 75,000 | |||||
Credit Agreement | Athyrium | Term Loans | ||||||
Debt Instrument [Line Items] | ||||||
Effective interest rate | 11.88% | 12.17% |
Lease Obligations (Details Text
Lease Obligations (Details Textual) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2023 | Mar. 31, 2022 | Dec. 31, 2022 | |
Lessee, Lease, Description [Line Items] | |||
Operating lease, right-of-use asset, accumulated amortization | $ 4,878 | $ 4,349 | |
Operating lease, payments | $ 705 | $ 574 | |
Minimum | |||
Lessee, Lease, Description [Line Items] | |||
Lessee, operating lease, term of contract (in years) | 1 year | ||
Maximum | |||
Lessee, Lease, Description [Line Items] | |||
Lessee, operating lease, term of contract (in years) | 5 years |
Lease Obligations - Aggregate L
Lease Obligations - Aggregate Lease Expense Under Operating Leases (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Leases [Abstract] | ||
Aggregate lease expense | $ 727 | $ 594 |
Lease Obligations - Other Suppl
Lease Obligations - Other Supplemental Information Related to Leases (Details) | Mar. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
Weighted average remaining lease term (in years) | 7 years 9 months 18 days | 8 years 1 month 6 days |
Weighted average discount rate | 10.80% | 11% |
Lease Obligations -Balance Shee
Lease Obligations -Balance Sheets of the Company's Operating Leases (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Assets: | ||
Other assets [extensible enumeration] | Other assets | |
Operating lease assets, net | $ 7,046 | $ 6,806 |
Liabilities: | ||
Lease financing obligation | 2,491 | 2,369 |
Lease financing obligation | 5,934 | 5,804 |
Total operating lease liabilities | $ 8,425 | $ 8,173 |
Lease Obligations - Maturities
Lease Obligations - Maturities of Operating Lease Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2023 | Dec. 31, 2022 |
Leases [Abstract] | ||
2023 (remaining) | $ 2,137 | |
2024 | 2,175 | |
2025 | 1,711 | |
2026 | 824 | |
2027 | 613 | |
Thereafter | 6,161 | |
Total lease payments | 13,621 | |
Less imputed interest | (5,196) | |
Total | $ 8,425 | $ 8,173 |
Operating lease, liability, statement of financial position [extensible enumeration] | Accrued expenses |
Stockholders' Equity (Details)
Stockholders' Equity (Details) - Common Stock Purchase Agreement with RPI - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | Nov. 19, 2021 | Nov. 17, 2021 |
Equity Disclosure [Line Items] | ||
Stock issued during period, shares, new issues (in shares) | 3,846 | |
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, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Jan. 31, 2022 shares | Dec. 31, 2014 shares | Mar. 31, 2023 USD ($) plan $ / shares shares | Mar. 31, 2022 $ / shares shares | Dec. 31, 2022 shares | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of plans | plan | 3 | ||||
Total unrecognized compensation expense related to non-vested stock options and RSU awards | $ | $ 139,166 | ||||
Compensation cost expected to be recognized for remainder of fiscal year | $ | 38,098 | ||||
Compensation cost expected to be recognized next year | $ | 46,800 | ||||
Compensation cost expected to be recognized year two | $ | 35,358 | ||||
Compensation cost expected to be recognized year three | $ | 18,689 | ||||
Compensation cost expected to be recognized year four | $ | $ 221 | ||||
Employee stock purchase plan sales, net (in shares) | 176,000 | 115,000 | |||
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] | |||||
Number of common stock shares available for purchase (in shares) | 4,595,000 | 4,206,000 | |||
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 | $ 7.47 | $ 11.48 | |||
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) | 1,250,000 | ||||
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) | 221,000 | 21 | |||
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 | $ 10.32 | 15.49 | |||
Inducement Plan | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Award vesting period (in years) | 4 years | ||||
Expiration period (in years) | 10 years | ||||
Weighted average grant date fair value stock option awards (in dollars per share) | $ / shares | $ 6.85 | 11.14 | |||
Number of common stock shares available for purchase (in shares) | 513,000 | 947,000 | |||
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 | $ 9.64 | $ 16.27 | |||
Employee Stock Purchase Plan | |||||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | |||||
Number of shares of common stock authorized to be purchased (in shares) | 7,975,000 | ||||
Number of common stock shares available for purchase (in shares) | 5,617,000 | ||||
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) | 3,000 | ||||
Maximum number of shares per employee, amount | $ | $ 25 |
Stock-based Compensation - Shar
Stock-based Compensation - Share-Based Compensation (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Share-based payment arrangement, expense | $ 14,007 | $ 9,601 |
Incentive Plan | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Share-based payment arrangement, expense | 11,061 | 8,078 |
Inducement Plan | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Share-based payment arrangement, expense | 2,475 | 1,225 |
Employee Stock Purchase Plan | ||
Share-Based Compensation Arrangement by Share-Based Payment Award [Line Items] | ||
Share-based payment arrangement, expense | $ 471 | $ 298 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock Plan Activities (Details) - $ / shares shares in Thousands | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
Options Outstanding | ||
Options outstanding, stock option awards exercised (in shares) | (801) | (1,108) |
Incentive Plan | ||
Awards Available | ||
Awards available, beginning balance (in shares) | 4,206 | |
Awards available, restricted stock awards granted (in shares) | (146) | |
Awards available, restricted stock awards cancelled (in shares) | 313 | |
Awards available, stock option awards granted (in shares) | (215) | |
Awards available, stock option awards cancelled (in shares) | 437 | |
Awards available, ending balance (in shares) | 4,595 | |
Options Outstanding | ||
Options outstanding, beginning balance (in shares) | 31,179 | |
Options outstanding, stock option awards granted ( in shares) | 215 | |
Options outstanding, stock option awards exercised (in shares) | (529) | |
Options outstanding, stock option awards cancelled (in shares) | (437) | |
Options outstanding, ending balance (in shares) | 30,428 | |
Weighted Average Exercise Price | ||
Weighted average exercise price, beginning balance (in usd per share) | $ 8.56 | |
Weighted average exercise price of stock option awards granted (in usd per share) | 10.55 | |
Weighted average exercise price of stock option awards exercised (in usd per share) | 5.52 | |
Weighted average exercise price of stock option awards cancelled (in usd per share) | 10.32 | |
Weighted average exercise price, ending balance (in usd per share) | $ 8.60 | |
Inducement Plan | ||
Awards Available | ||
Awards available, beginning balance (in shares) | 947 | |
Awards available, restricted stock awards granted (in shares) | (193) | |
Awards available, restricted stock awards cancelled (in shares) | 21 | |
Awards available, stock option awards granted (in shares) | (522) | |
Awards available, stock option awards cancelled (in shares) | 260 | |
Awards available, ending balance (in shares) | 513 | |
Options Outstanding | ||
Options outstanding, beginning balance (in shares) | 5,341 | |
Options outstanding, stock option awards granted ( in shares) | 522 | |
Options outstanding, stock option awards exercised (in shares) | (173) | |
Options outstanding, stock option awards cancelled (in shares) | (260) | |
Options outstanding, ending balance (in shares) | 5,430 | |
Weighted Average Exercise Price | ||
Weighted average exercise price, beginning balance (in usd per share) | $ 8.80 | |
Weighted average exercise price of stock option awards granted (in usd per share) | 9.66 | |
Weighted average exercise price of stock option awards exercised (in usd per share) | 3.36 | |
Weighted average exercise price of stock option awards cancelled (in usd per share) | 8.62 | |
Weighted average exercise price, ending balance (in usd per share) | $ 9.06 |
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 | 3 Months Ended | |
Mar. 31, 2023 | Mar. 31, 2022 | |
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 | 84.20% | 84.10% |
Expected Dividend Yield | 0% | 0% |
Risk-Free Interest Rate | 3.70% | 1.90% |
Collaborative and Other Relat_2
Collaborative and Other Relationships (Details) $ in Thousands | 3 Months Ended | ||
Nov. 05, 2019 USD ($) | Mar. 31, 2023 USD ($) dose | Mar. 31, 2022 USD ($) | |
Collaborative and Other Relationships [Line Items] | |||
Revenues | $ 68,778 | $ 49,923 | |
U.S. Department of Health and Human Services, net | |||
Collaborative and Other Relationships [Line Items] | |||
Contract term (in years) | 5 years | ||
U.S. Department of Health and Human Services, net | Outside of U.S. | |||
Collaborative and Other Relationships [Line Items] | |||
Maximum number of products, doses | dose | 50,000 | ||
Number of product delivered, doses | dose | 49,980 | ||
Torii Pharmaceutical Co. | |||
Collaborative and Other Relationships [Line Items] | |||
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. | Minimum | |||
Collaborative and Other Relationships [Line Items] | |||
Royalty rate if maintains sakigake designation | 20% | ||
Torii Pharmaceutical Co. | Maximum | |||
Collaborative and Other Relationships [Line Items] | |||
Royalty rate if maintains sakigake designation | 40% |
Subsequent Events (Details)
Subsequent Events (Details) - USD ($) | 3 Months Ended | |||
Apr. 17, 2023 | Jul. 17, 2023 | Mar. 31, 2023 | Mar. 31, 2022 | |
Subsequent Event [Line Items] | ||||
Paid-in-kind interest | $ 7,142,000 | $ 4,321,000 | ||
Subsequent Event | Pharmakon Advisors, LP | ||||
Subsequent Event [Line Items] | ||||
Financing receivable, committed | $ 450,000 | |||
Financing receivable, committed, amount drawn | 300,000 | |||
Financing receivable, committed, remaining amount | 150,000 | |||
Proceeds from (repayments of) accounts receivable securitization | 26,000 | |||
Paid-in-kind interest | $ 0.50 | |||
Subsequent Event | Pharmakon Advisors, LP | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | ||||
Subsequent Event [Line Items] | ||||
Debt instrument, basis spread on variable rate | 7% | |||
Subsequent Event | Pharmakon Advisors, LP | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | Minimum | ||||
Subsequent Event [Line Items] | ||||
Debt instrument, basis spread on variable rate | 7% | |||
Derivative, floor interest rate | 1.75% | |||
Subsequent Event | Pharmakon Advisors, LP | Secured Overnight Financing Rate (SOFR) Overnight Index Swap Rate | Maximum | ||||
Subsequent Event [Line Items] | ||||
Debt instrument, basis spread on variable rate | 7.25% |