Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2021 | Aug. 02, 2021 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Jun. 30, 2021 | |
Document Transition Report | false | |
Entity File Number | 001-37569 | |
Entity Registrant Name | Strongbridge Biopharma plc | |
Entity Incorporation, State or Country Code | L2 | |
Entity Tax Identification Number | 98-1275166 | |
Entity Address, Address Line One | 900 Northbrook Drive | |
Entity Address, Address Line Two | Suite 200 | |
Entity Address, City or Town | Trevose | |
Entity Address, State or Province | PA | |
Entity Address, Postal Zip Code | 19053 | |
City Area Code | 610 | |
Local Phone Number | 254-9200 | |
Title of 12(b) Security | Ordinary shares | |
Trading Symbol | SBBP | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 67,828,952 | |
Entity Central Index Key | 0001634432 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q2 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 63,774 | $ 87,522 |
Accounts receivable | 3,581 | 2,801 |
Inventory | 1,101 | 1,103 |
Prepaid expenses and other current assets | 1,666 | 926 |
Total current assets | 70,122 | 92,352 |
Property and equipment, net | 183 | 216 |
Right-of-use asset, net | 489 | 597 |
Intangible asset, net | 17,577 | 20,088 |
Goodwill | 7,256 | 7,256 |
Other assets | 1,193 | 591 |
Total assets | 96,820 | 121,100 |
Current liabilities: | ||
Accounts payable | 635 | 1,483 |
Accrued and other current liabilities | 22,039 | 19,648 |
Current portion of long-term debt, net | 708 | |
Total current liabilities | 23,382 | 21,131 |
Long-term debt, net | 17,002 | 17,114 |
Warrant liability | 5,036 | 4,941 |
Supply agreement liability, noncurrent | 6,471 | 11,556 |
Other long-term liabilities | 538 | 753 |
Total liabilities | 52,429 | 55,495 |
Commitments and contingencies (Note 8) | ||
Shareholders' equity: | ||
Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at June 30, 2021 and December 31, 2020 | 44 | |
Ordinary shares, $0.01 par value, 600,000,000 shares authorized; 67,722,319 and 67,243,772 shares issued and outstanding at June 30, 2021 and December 31, 2020 | 677 | 672 |
Additional paid-in capital | 374,327 | 370,447 |
Accumulated deficit | (330,613) | (305,558) |
Total shareholders' equity | 44,391 | 65,605 |
Total liabilities and shareholders' equity | $ 96,820 | $ 121,100 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 2021 | Dec. 31, 2020 |
Consolidated Balance Sheets | ||
Deferred shares, par value (in dollars per share) | $ 1.098 | $ 1.098 |
Deferred shares, shares authorized | 40,000 | 40,000 |
Deferred shares, shares issued | 40,000 | 40,000 |
Deferred shares, shares outstanding | 40,000 | 40,000 |
Ordinary shares, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Ordinary shares, shares authorized | 600,000,000 | 600,000,000 |
Ordinary shares, shares issued | 67,722,319 | 67,243,772 |
Ordinary shares, shares outstanding | 67,722,319 | 67,243,772 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Revenues: | ||||
Total revenues | $ 10,042 | $ 7,760 | $ 18,424 | $ 14,434 |
Cost and expenses: | ||||
Cost of sales (excluding amortization of intangible asset) | 467 | 393 | 878 | 1,362 |
Selling, general and administrative | 15,988 | 9,638 | 26,934 | 20,041 |
Research and development | 5,397 | 6,152 | 11,235 | 13,704 |
Amortization of intangible asset | 1,255 | 1,255 | 2,511 | 2,511 |
Total cost and expenses | 23,107 | 17,438 | 41,558 | 37,618 |
Operating loss | (13,065) | (9,678) | (23,134) | (23,184) |
Other expense, net: | ||||
Interest expense | (810) | (253) | (1,592) | (253) |
Unrealized gain (loss) on fair value of warrants | 680 | (7,367) | (95) | (6,787) |
Other (expense) income, net | (45) | 26 | (233) | 254 |
Total other expense, net | (175) | (7,594) | (1,920) | (6,786) |
Loss before income taxes | (13,240) | (17,272) | (25,054) | (29,970) |
Income tax expense | (1) | 0 | (1) | 0 |
Net loss | (13,241) | (17,272) | (25,055) | (29,970) |
Other comprehensive loss: | ||||
Unrealized loss on marketable securities | (6) | (3) | ||
Comprehensive loss | (13,241) | (17,278) | (25,055) | (29,973) |
Net loss attributable to ordinary shareholders: | ||||
Basic | (13,241) | (17,272) | (25,055) | (29,970) |
Diluted | $ (13,921) | $ (17,272) | $ (25,055) | $ (29,970) |
Net loss per share attributable to ordinary shareholders: | ||||
Basic (in dollars per share) | $ (0.20) | $ (0.32) | $ (0.37) | $ (0.55) |
Diluted (in dollars per share) | $ (0.21) | $ (0.32) | $ (0.37) | $ (0.55) |
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders: | ||||
Basic (in shares) | 67,653,659 | 54,302,325 | 67,569,136 | 54,266,675 |
Diluted (in shares) | 67,921,260 | 54,302,325 | 67,569,136 | 54,266,675 |
Consolidated Statement of Share
Consolidated Statement of Shareholders' Equity - USD ($) $ in Thousands | Deferred Shares | Ordinary SharesMaximum | Ordinary Shares | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Total |
Balance at beginning of period at Dec. 31, 2019 | $ 44 | $ 542 | $ 332,085 | $ (260,483) | $ 3 | $ 72,191 | |
Balance (in shares) at Dec. 31, 2019 | 40,000 | 54,205,852 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | (29,970) | (29,970) | |||||
Stock-based compensation | 3,524 | 3,524 | |||||
Issuance of warrants and beneficial conversion feature related to the Loan Agreement | 2,457 | 2,457 | |||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 2 | (332) | (330) | ||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 150,105 | ||||||
Unrealized loss on marketable securities | (3) | (3) | |||||
Balance at end of period at Jun. 30, 2020 | $ 44 | $ 544 | 337,734 | (290,453) | 47,869 | ||
Balance (in shares) at Jun. 30, 2020 | 40,000 | 54,355,957 | |||||
Balance at beginning of period at Mar. 31, 2020 | $ 44 | $ 542 | 333,768 | (273,181) | 6 | 61,179 | |
Balance (in shares) at Mar. 31, 2020 | 40,000 | 54,247,501 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | (17,272) | (17,272) | |||||
Stock-based compensation | 1,773 | 1,773 | |||||
Issuance of warrants and beneficial conversion feature related to the Loan Agreement | 2,457 | 2,457 | |||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 2 | (264) | (262) | ||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 108,456 | ||||||
Unrealized loss on marketable securities | $ (6) | (6) | |||||
Balance at end of period at Jun. 30, 2020 | $ 44 | $ 544 | 337,734 | (290,453) | 47,869 | ||
Balance (in shares) at Jun. 30, 2020 | 40,000 | 54,355,957 | |||||
Balance at beginning of period at Dec. 31, 2020 | $ 44 | $ 672 | 370,447 | (305,558) | 65,605 | ||
Balance (in shares) at Dec. 31, 2020 | 40,000 | 67,243,772 | |||||
Balance at end of period at Mar. 31, 2021 | $ 44 | $ 675 | 372,500 | (317,372) | 55,847 | ||
Balance (in shares) at Mar. 31, 2021 | 40,000 | 67,545,369 | |||||
Balance at beginning of period at Dec. 31, 2020 | $ 44 | $ 672 | 370,447 | (305,558) | 65,605 | ||
Balance (in shares) at Dec. 31, 2020 | 40,000 | 67,243,772 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | (25,055) | (25,055) | |||||
Stock-based compensation | 4,359 | 4,359 | |||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 5 | (699) | (694) | ||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 419,079 | ||||||
Cancellation of deferred shares | $ (44) | 44 | |||||
Cancellation of deferred shares (in shares) | (40,000) | ||||||
Exercise of stock options | $ 1 | 138 | $ 138 | ||||
Exercise of stock options (in shares) | 48,157 | 48,157 | |||||
Issuance of shares, net of expenses | $ 1 | 38 | $ 38 | ||||
Issuance of shares, net of expenses (in shares) | 11,311 | ||||||
Balance at end of period at Jun. 30, 2021 | $ 677 | 374,327 | (330,613) | 44,391 | |||
Balance (in shares) at Jun. 30, 2021 | 67,722,319 | ||||||
Balance at beginning of period at Mar. 31, 2021 | $ 44 | $ 675 | 372,500 | (317,372) | 55,847 | ||
Balance (in shares) at Mar. 31, 2021 | 40,000 | 67,545,369 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net loss | (13,241) | (13,241) | |||||
Stock-based compensation | 2,082 | 2,082 | |||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 2 | (299) | (297) | ||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 176,950 | ||||||
Cancellation of deferred shares | $ (44) | 44 | |||||
Cancellation of deferred shares (in shares) | (40,000) | ||||||
Balance at end of period at Jun. 30, 2021 | $ 677 | $ 374,327 | $ (330,613) | $ 44,391 | |||
Balance (in shares) at Jun. 30, 2021 | 67,722,319 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flow - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Cash flows from operating activities: | ||
Net loss | $ (25,055) | $ (29,970) |
Adjustments to reconcile net loss income to net cash used in operating activities: | ||
Stock-based compensation | 4,359 | 3,524 |
Amortization of intangible asset | 2,511 | 2,511 |
Change in fair value of warrant liability | 95 | 6,787 |
Amortization of debt discounts and debt issuance costs | 596 | |
Accretion of discounts on marketable securities | (53) | |
Depreciation | 43 | 43 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (780) | (596) |
Inventory | (601) | 294 |
Prepaid expenses and other current assets | (740) | (757) |
Other assets | 109 | 314 |
Accounts payable | (848) | (1,374) |
Accrued and other liabilities | (2,909) | (8,098) |
Net cash used in operating activities | (23,220) | (27,375) |
Cash flows from investing activities: | ||
Sales and maturities of marketable securities | 21,122 | |
Purchases of property and equipment | (10) | |
Net cash (used in) provided by investing activities | (10) | 21,122 |
Cash flows from financing activities: | ||
Payments related to tax withholding for net-share settled equity awards | (694) | (330) |
Proceeds from long-term debt, net | 9,460 | |
Proceeds from exercise of stock options | 138 | |
Proceed from issuance of ordinary shares in connection with at-the-market offering, net | 38 | |
Net cash (used in) provided by financing activities | (518) | 9,130 |
Net (decrease) increase in cash and cash equivalents | (23,748) | 2,877 |
Cash and cash equivalents-beginning of period | 87,522 | 57,032 |
Cash and cash equivalents-end of period | 63,774 | 59,909 |
Supplemental disclosures of cash flow information: Cash paid during the year for: | ||
Interest | 997 | 118 |
Income taxes other, net of refunds | $ 1,301 | $ 531 |
Organization
Organization | 6 Months Ended |
Jun. 30, 2021 | |
Organization | |
Organization | 1. Organization We are a global, commercial-stage biopharmaceutical company focused on the development and commercialization of therapies for rare diseases with significant unmet needs. Our first commercial product is Keveyis (dichlorphenamide), the first and only treatment approved by the U.S. Food and Drug Administration (the “FDA”) for hyperkalemic, hypokalemic, and related variants of primary periodic paralysis (“PPP”), a group of rare hereditary disorders that cause episodes of muscle weakness or paralysis. We have two clinical-stage product candidates for rare endocrine diseases, Recorlev and veldoreotide. Recorlev (levoketoconazole), the pure 2S,4R enantiomer of the enantiomeric pair comprising ketoconazole, is a next-generation steroidogenesis inhibitor being investigated as a chronic therapy for adults with endogenous Cushing’s syndrome. Veldoreotide is a next-generation somatostatin analog being investigated for potential applications in conditions amenable to somatostatin receptor activation. Both levoketoconazole and veldoreotide have received orphan designation from the FDA and the European Medicines Agency (“EMA”) Liquidity We believe that our cash and cash equivalents of $63.8 million at June 30, 2021, will be sufficient to allow us to fund planned operations for at least 12 months beyond the issuance date of these unaudited consolidated financial statements. We may never achieve profitability, and unless and until we do, we will continue to need to raise additional capital. We plan to continue to fund our operations and capital funding needs through equity or debt financing along with revenues from Keveyis. There can be no assurances, however, that additional funding will be available on terms acceptable to us. Transaction Agreement with Xeris Pharmaceuticals, Inc. On May 24, 2021, we announced that we had signed an agreement to be acquired by Xeris Pharmaceuticals, Inc. (“Xeris”). Upon close of the transaction, the businesses of Xeris and Strongbridge Biopharma plc (“Strongbridge”) will be combined under a new entity to be called Xeris Biopharma Holdings, Inc The agreement, including the maximum aggregate amount payable under the contingent value rights (the “CVRs”), values Strongbridge at approximately $267 million based on the closing price of Xeris common stock of $3.47 on May 21, 2021, and Strongbridge’s fully diluted share capital. Under the terms of the agreement, at closing, Strongbridge shareholders will receive a fixed exchange ratio of 0.7840 shares of Xeris Biopharma Holdings common stock for each Strongbridge ordinary share they own. Based on the closing price of Xeris common stock on May 21, 2021, this represents approximately $2.72 per Strongbridge ordinary share and a 12.9% premium to the closing price of Strongbridge ordinary shares on May 21, 2021. Strongbridge shareholders will also receive 1 non-tradeable CVR for each Strongbridge ordinary share they own, worth up to an additional $1.00 payable in cash or Xeris Biopharma Holdings common stock, or a combination of cash and additional common stock or a combination of cash and additional common stock at Xeris Biopharma Holdings’ sole election. The transaction is expected to close early in the fourth quarter of 2021, subject to the satisfaction of closing conditions. The transaction, which has been unanimously approved by the boards of directors of both companies is expected to close early in the fourth quarter of 2021, subject to the satisfaction of closing conditions. Upon close of the transaction, the current Xeris stockholders are expected to own approximately On July 2, 2021, Xeris Biopharma Holdings filed with the SEC a registration statement on Form S-4, to register the Xeris Biopharma Holdings common stock to be issued in connection with the transaction, which also constitutes the joint proxy statement of Strongbridge and Xeris under Section 14(a) of the Securities Exchange Act of 1934. Upon the effectiveness of the Form S-4, we intend to solicit shareholders for their approval of the merger with Xeris. In connection with this transaction, we have incurred, and will continue to incur, transaction-related costs. A portion of those costs are contingent on the transaction closing, such as investment banking fees, and employee related costs. For the six months ended June 30, 2021, we have incurred In addition, all of our outstanding restricted stock units will vest immediately prior to the closing of this transaction, and all of our outstanding stock options will vest immediately prior to the closing of this transaction and be converted into options to purchase Xeris Biopharma Holdings common stock. |
Summary of significant accounti
Summary of significant accounting policies and basis of presentation | 6 Months Ended |
Jun. 30, 2021 | |
Summary of significant accounting policies and basis of presentation | |
Summary of significant accounting policies and basis of presentation | 2. Summary of significant accounting policies and basis of presentation Basis of presentation These unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). The unaudited consolidated financial statements reflect all adjustments, which include only normal recurring adjustments that are, in the opinion of management, necessary to present a fair statement of the operating results and financial position for the periods presented. The preparation of the unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures in the consolidated financial statements. Actual results could differ from those estimates. Results for the six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. These unaudited consolidated financial statements should be read in conjunction with the accounting policies and notes to the audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission on March 3, 2021 (the “2020 Annual Report”). Our significant accounting policies are described in Note 2 of the notes to the audited consolidated financial statements included in our 2020 Annual Report. Since the date of those financial statements, there have been no changes to our significant accounting policies. Leases We account for leases in accordance with Accounting Standards Codification Topic 842, Leases i.e. Operating leases where we are the lessee are included in Right of use (“ROU”) assets and Accrued and other current liabilities and Other long-term liabilities on our Consolidated Balance Sheets. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. Key estimates and judgments include how we determined (1) the discount rate we use to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. Because our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Our incremental borrowing rate for a lease is the rate of interest we would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The lease term for all of our leases includes the noncancellable period of the lease. Lease payments included in the measurement of the lease asset or liability are comprised of our fixed payments. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. We monitor for events or changes in circumstances that require a reassessment of a lease. If a reassessment results in the remeasurement of a lease liability, a corresponding adjustment is made to the carrying amount of the corresponding ROU asset unless doing so would reduce the carrying amount of the ROU asset to an amount less than zero. In that case, the amount of the adjustment that would result in a negative ROU asset balance is recorded in profit or loss. We have elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less. We recognize the lease payments associated with our short-term leases as an expense on a straight-line basis over the lease term. Variable lease payments associated with these leases are recognized and presented in the same manner as for all of our other leases. Cash, cash equivalents and marketable securities We consider all short-term highly liquid investments with an original maturity at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents consist of account balances at banks and money market accounts, respectively. We occasionally invest our excess cash balances in marketable debt securities of highly rated financial institutions. We seek to diversify our investments and limit the amount of investment concentrations for individual institutions, maturities and investment types. We classify marketable debt securities as available-for-sale and, accordingly, record such securities at fair value. We classify these securities as current assets as these investments are available to us for use in funding current operations. There were Unrealized gains and losses on marketable debt securities are recorded as a separate component of Accumulated other comprehensive income (loss) included in shareholders’ equity. Segment information Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions on how to allocate resources and assess performance. We view our operations and manage our business in one operating segment. Net loss per share Basic net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of ordinary shares outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted-average number of ordinary shares outstanding for the period, including any dilutive effect from outstanding stock options or other equity-based instruments. Shares used in the diluted net loss per share calculations exclude anti-dilutive ordinary share equivalents, which currently consist of outstanding stock options, unvested restricted stock units (“RSUs”), equity-classified warrants and the conversion feature of our outstanding term loan agreement. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the six months ending June 30, 2021 and 2020, as they would be anti-dilutive: The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the six months ending June 30, 2021 and 2020, as they would be anti-dilutive: June 30, 2021 2020 Warrants 7,368,033 7,100,643 Stock options issued and outstanding 8,260,473 10,499,222 Unvested RSUs 2,800,425 1,090,300 Conversion feature of our outstanding term loan agreement 1,339,285 1,339,285 Recent accounting pronouncements – not yet adopted Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments |
Revenue recognition
Revenue recognition | 6 Months Ended |
Jun. 30, 2021 | |
Revenue recognition | |
Revenue recognition | 3. Revenue recognition Product sales, net We sell Keveyis to one specialty pharmacy provider (the “Customer”), who is the exclusive distributor of Keveyis in the United States. The Customer subsequently resells Keveyis to patients, most of whom are covered by payors that may provide for government-mandated or privately negotiated rebates with respect to the purchase of Keveyis. Revenues from sales of Keveyis are recognized when we satisfy a performance obligation by transferring control of the product to the Customer. Transfer of control occurs upon receipt of the product by the Customer. We expense incremental costs related to the set-up of contracts with the Customer when incurred, as these costs do not meet the criteria for capitalization. Reserves for variable consideration Revenues from sales of Keveyis are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established and that result from rebates, co-pay assistance and other allowances that are offered between us and the patients’ payors. There is variable consideration reserve for returns as we do not accept returns of Keveyis. These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the Customer) or a current liability (if the amount is payable to a party other than the Customer). Where appropriate, these estimates may take into consideration a range of possible outcomes that are probability-weighted for relevant factors such as our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted buying and payment patterns of the Customer. Overall, these reserves reflect our best estimates of the amount of consideration to which we are entitled based on the terms of the contract. The amount of variable consideration that is 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 our estimates. We reassess our estimates on an ongoing basis. If actual results in the future vary from our estimates, we will adjust our estimates. Any such adjustments would affect net product revenue and earnings in the period such variances become known. Trade Discount Funded Co-pay Assistance Program Government Rebates Temporary Supply and Patient Assistance Programs : We provide free Keveyis to uninsured patients who satisfy pre-established criteria for either the Temporary Supply Program or the Patient Assistance Program. Patients who meet the Temporary Supply Program eligibility criteria may receive a temporary supply of free Keveyis for no more than 60 days while there is a determination of the patient’s third-party insurance, prescription drug benefit or other third-party coverage for Keveyis. The Patient Assistance Program provides free Keveyis for up to 12 months to uninsured patients who satisfy pre-established criteria for financial need. We do not recognize any revenue related to these free products and the associated costs are classified in selling, general and administrative expenses in our consolidated statements of operations and comprehensive loss. |
Fair value measurements
Fair value measurements | 6 Months Ended |
Jun. 30, 2021 | |
Fair value measurements | |
Fair value measurements | 4. Fair value measurements We record financial assets and liabilities at fair value. Because of their short-term nature, the amounts reported in the balance sheet for cash, accounts receivable and accounts payable approximate fair value. The guidance requires fair value measurements to maximize the use of “observable inputs.” The three-level hierarchy of inputs to measure fair value are as follows: Level 1: Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities. Because of their short-term nature, the amounts reported in the balance sheet for cash and accounts payable approximate fair value. Level 2: Significant observable inputs other than Level 1 prices such as quoted prices in markets that are not active, or inputs that are observable, either directly or indirectly, for substantially the full term of the asset or liability Level 3: Prices or valuation techniques that require inputs that are both significant to the fair value measurement and unobservable ( i.e. We did not have any transfers between the different levels. The following table presents our assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands): As of June 30, 2021 Level I Level II Level III Total Cash equivalents 62,668 — — 62,668 Total assets $ 62,668 $ — $ — $ 62,668 Warrant liability — — 5,036 5,036 Total liabilities $ — $ — $ 5,036 $ 5,036 As of December 31, 2020 Level I Level II Level III Total Cash equivalents 86,775 — — 86,775 Total assets $ 86,775 $ — $ — $ 86,775 Warrant liability — — 4,941 4,941 Total liabilities $ — $ — $ 4,941 $ 4,941 The following table presents a reconciliation of our level 3 warrant liability (in thousands): As of June 30, 2021 Balance as of December 31, 2020 $ 4,941 Unrealized loss on fair value of warrants for six months ended June 30, 2021 95 Balance as of June 30,2021 $ 5,036 |
Intangible assets and goodwill
Intangible assets and goodwill | 6 Months Ended |
Jun. 30, 2021 | |
Intangible asset and goodwill | |
Intangible assets and goodwill | 5. Intangible asset and goodwill The following represents the balance of our intangible asset and goodwill as follows (in thousands): As of June 30, 2021 Beginning of Period Amortization End of Period Keveyis $ 20,088 $ (2,511) $ 17,577 Goodwill 7,256 — 7,256 Total $ 27,344 $ (2,511) $ 24,833 Our finite-lived intangible asset consists of acquired developed product rights obtained from our acquisition of Keveyis (dichlorphenamide) from a subsidiary of Taro Pharmaceutical Industries Ltd. (“Taro”). Pursuant to the terms of the Asset Purchase Agreement and Supply Agreement that we entered into with Taro in December 2016, we paid Taro an upfront payment in two installments of $1 million in December 2016 and $7.5 million in March 2017, and will pay an aggregate of $7.5 million in potential milestone payments upon the achievement of certain product sales targets. Taro has agreed to continue to manufacture Keveyis for us under an exclusive supply agreement through the orphan exclusivity period. We are obligated to purchase from Taro certain annual minimum amounts of product totaling approximately $29 million over a six-year period. We have concluded that the supply price payable by us exceeds fair value and, therefore, have used a discounted cash flow method with a probability assumption to value the payments in excess of fair value at $29.3 million, for which we have recorded an intangible asset and corresponding liability. This liability is being reduced as we purchase inventory over the term of the Supply Agreement that we entered into with Taro. In addition, we incurred transaction costs of $2.4 million. The transaction resulted in the recording of an intangible asset of $40.2 million. This asset is being amortized over an eight-year period using the straight-line method. We recorded amortization expense of $1.3 million and $2.5 million for the three and six months ended June 30, 2021, and 2020. |
Long-term debt
Long-term debt | 6 Months Ended |
Jun. 30, 2021 | |
Long-term debt | |
Long-term debt | 6. Long-term debt On May 19, 2020, we entered into a $30 million Term Loan Agreement (the “Loan Agreement”) with Avenue Venture Opportunities Fund L.P. (“Avenue”), as administrative agent and collateral agent, and the lenders named therein and from time to time a party thereto (the “Lenders”). Pursuant to the terms of the Loan Agreement, our wholly-owned subsidiary, Strongbridge U.S. Inc. (the “Borrower”) borrowed $10 million (the “Initial Loan”) from the Lenders at closing. As a result of achieving positive top-line data for Recorlev in our Phase 3 LOGICS clinical trial in September 2020, we borrowed an additional $10 million under the Loan Agreement (the “Second Loan”) on December 30, 2020. The remaining $10 million tranche (the “Third Loan”) will become available to us between October 1, 2021 and March 31, 2022 if we achieve FDA approval of Recorlev and subject to Avenue’s investment committee approval. The Loan Agreement has a four-year term, no minimum revenue or cash balance financial covenants and an interest-only period for 24 months that can increase to 36 months assuming we receive FDA approval of Recorlev. Amounts borrowed under the Loan Agreement accrue interest at a floating rate per annum (based on a year of 365 days ) equal to the sum of (a) the greater of (x) the Prime Rate reported in The Wall Street Journal on the last business day of the month that immediately precedes the month in which the interest will accrue, and (y) 3.25% , plus (b) 6.75% . The interest rate as of June 30, 2021 was 10% . We paid a commitment fee of $200,000 ( 1% of the amounts of the Initial Loan and the Second Loan ) at closing. We are also required to pay the Lenders a final payment fee upon repayment or prepayment of any loans made under the Loan Agreement in accordance with the terms and conditions of the Loan Agreement. Under the terms of the Loan Agreement, we may prepay all or a portion of the outstanding principal amount of any loans outstanding under the Loan Agreement at any time upon prior notice to the Lenders subject to a prepayment premium (which reduces after the first year) and the payment of the pro rata portion of the final payment fee (to the extent not already paid) based on the amount of loans being prepaid. In certain circumstances, including a change of control and certain asset sales or licensing transactions, we may be required to prepay all or a portion of loans outstanding, and, to the extent required under the terms of the Loan Agreement, the applicable prepayment premium and final payment fee. As security for our obligations under the Loan Agreement, we entered into a security agreement with Avenue, pursuant to which we granted a lien on substantially all of our assets, including intellectual property, to the Secured Parties (as such term is defined in the Loan Agreement). Avenue has the right to convert up to $3 million of the aggregate principal amount of any loans outstanding under the Loan Agreement into ordinary shares at a price per share of $2.24. We have accounted for this term as a beneficial conversion feature, and the fair value is recorded in Additional paid-in capital. This amount is recorded as a debt discount and classified as a contra-liability on the consolidated balance sheet and amortized to interest expense over the term of the loan. In connection with the execution of both the Loan Agreement and the Second Loan, we issued to Avenue warrants to purchase up to an aggregate of 267,390 ordinary shares at an exercise price (the “Exercise Price”) of $1.87 (which is equal to the five-day volume weighted average price as of the trading day immediately prior to execution of the financing agreement) for each of the tranches of debt, respectively. The warrants are exercisable, in full or in part, at any time prior to five years following the issue date for both tranches of the loan. We have accounted for these warrants as equity, and the fair value is recorded into Additional paid-in capital. This amount is recorded as a debt discount and classified as a contra-liability on the consolidated balance sheet and amortized to interest expense over the term of the loan. If we borrow the Third Loan, we will be required to issue to the Lenders or their designees additional warrants to purchase ordinary shares equal to an aggregate of 5% of the Third Loan divided by the Exercise Price, rounded down to the nearest whole share. Loan Amendment On July 23, 2021, Strongbridge, the Borrower and Avenue entered into an amendment (the “Loan Amendment”) to the Loan Agreement. Under the Term Loan Agreement, Strongbridge granted to Avenue an option to convert up to Future principal payments due under the Loan Agreement, if the interest payment only period is not extended beyond the current 24-month period, are as follows (in thousands): Principal Payments 2021 $ — 2022 5,833 2023 10,000 2024 4,167 Total future payments $ 20,000 |
Accrued and other current liabi
Accrued and other current liabilities | 6 Months Ended |
Jun. 30, 2021 | |
Accrued liabilities | |
Accrued and other current liabilities | 7. Accrued and other current liabilities Accrued and other current liabilities consist of the following (in thousands): June 30, December 31, 2021 2020 Consulting and professional fees $ 7,311 $ 2,754 Accrued sales allowances 5,588 4,312 Supply agreement - current portion 5,085 4,391 Employee compensation 2,972 5,749 Accrued royalties 499 301 Lease liability - current portion 437 415 Other 139 72 Accrued taxes 8 1,161 Severance — 493 Total accrued and other current liabilities $ 22,039 $ 19,648 |
Commitments and contingencies
Commitments and contingencies | 6 Months Ended |
Jun. 30, 2021 | |
Commitments and contingencies | |
Commitments and contingencies | 8. Commitments and contingencies (a) Commitments to Taro Pharmaceuticals Industries Ltd. As of June 30, 2021, our remaining obligation under the Supply Agreement (see Note 5) was $14.1 million. The agreement with Taro may extend beyond the orphan exclusivity period unless terminated by either party pursuant to the terms of the agreement. If terminated by Taro at the conclusion of the orphan exclusivity period, we have the right to manufacture the product on our own or have the product manufactured by a third party on our behalf. We are also required to reimburse Taro for its royalty obligation resulting from its sale of Keveyis to us. (b) Indemnifications In the ordinary course of business and in connection with the sale of assets and businesses and other transactions, we often agree to indemnify our counterparties against certain liabilities that may arise in connection with a transaction or that are related to events and activities prior to or following a transaction, such as breaches of contracts, unfavorable tax consequences and employee liabilities. If a counterparty were to make a successful indemnification claim against us, we may be required to reimburse the loss and such amount could be material to our consolidated financial statements. Where appropriate, the obligation for such indemnifications is recorded as a liability. Because these agreements generally do not specify the maximum amount of indemnification a counterparty may be entitled to, the overall maximum amount of our potential indemnification liability under these agreements cannot be reasonably estimated. However, we believe that the likelihood of a material liability being triggered under these indemnification obligations is not probable at this time. |
Income taxes
Income taxes | 6 Months Ended |
Jun. 30, 2021 | |
Income taxes | |
Income taxes | 9. Taxes Income Taxes Deferred tax assets and liabilities are recognized for the future tax consequences of differences between the carrying amounts and tax bases of assets and liabilities and operating loss carryforwards and other attributes using enacted rates expected to be in effect when those differences reverse. Valuation allowances are provided against deferred tax assets that are not more likely than not to be realized. We assess our ability to realize deferred tax assets. Changes in future earnings projections, among other factors, may cause us to adjust our valuation allowance on deferred tax assets. Any such adjustments would impact our income tax expense in the period in which it is determined that these factors have changed. We recorded income tax expense of $1,000 for the three and six months ended June 30, 2021 and did not record an expense for the three and six months ended June 30, 2020. |
Ordinary shares
Ordinary shares | 6 Months Ended |
Jun. 30, 2021 | |
Ordinary shares. | |
Ordinary shares | 10. Ordinary Shares Equity transactions We entered into an equity distribution agreement with JMP Securities LLC (“JMP”) on April 28, 2017, pursuant to which we could sell, at our option, from time to time, up to an aggregate of $40 million of our ordinary shares through JMP, as sales agent. The agreement provided for a commission to JMP equal to 3% of the gross proceeds from the sale of our ordinary shares under this at-the-market (“ATM”) facility. Pursuant to the terms of the equity distribution agreement, we reimbursed JMP for certain out-of-pocket expenses, including the fees and disbursements of counsel to JMP, incurred in connection with establishing the ATM facility and provided JMP with customary indemnification rights. During the three months ended March 31, 2021, we sold an aggregate of 11,311 ordinary shares under the ATM facility at an average selling price of $3.36 per share, resulting in net proceeds of approximately $38,000 after payment of fees to JMP of $1,100 . This equity distribution agreement was terminated on March 24, 2021. We entered into an equity distribution agreement with Jefferies LLC (“Jefferies”) on March 25, 2021, pursuant to which we may sell, at our option, from time to time, up to an aggregate of $50 million of our ordinary shares through Jefferies, as sales agent. We will pay Jefferies a commission equal to 3% of the gross proceeds from the sale of our ordinary shares under the ATM facility. Pursuant to the terms of the equity distribution agreement, we reimbursed Jefferies for certain out-of-pocket expenses, including the fees and disbursements of counsel to Jefferies, incurred in connection with establishing the ATM facility and have provided Jefferies with customary indemnification rights. For the period ended June 30, 2021, we did not sell any shares under this agreement. Warrants Our outstanding warrants as of June 30, 2021, are as follows: Warrants Outstanding Exercise Expiration Warrants Warrants June 30, Classification Price Date Issued Exercised 2021 Warrants in connection with private equity placement Liability $ 2.50 6/28/2022 7,000,000 (1,970,000) 5,030,000 Warrants in connection with Horizon and Oxford loan agreement Equity $ 2.45 12/28/2026 428,571 (267,857) 160,714 Warrants in connection with CRG loan agreement Equity $ 7.37 7/14/2024 394,289 — 394,289 Warrants in connection with CRG loan amendment in January 2018 Equity $ 10.00 1/16/2025 1,248,250 — 1,248,250 Warrants in connection with Avenue Capital loan agreement Equity $ 1.87 5/19/2025 267,390 — 267,390 Warrants in connection with Avenue Capital loan agreement Equity $ 1.87 12/30/2025 267,390 — 267,390 9,605,890 7,368,033 |
Stock-based compensation
Stock-based compensation | 6 Months Ended |
Jun. 30, 2021 | |
Stock-based compensation | |
Stock based compensation | 11. Stock-based compensation Our board of directors has adopted the 2017 Inducement Plan (the “Inducement Plan”). The Inducement Plan provides for the grant of equity-based awards to new employees. The purpose of the Inducement Plan is to attract valued employees by offering them a greater stake in our success and a closer identity with us, and to encourage ownership of our ordinary shares by such employees. The Inducement Plan became effective on February 23, 2017. As of June 30, 2021, 1,297,353 shares are available for issuance pursuant to the Inducement Plan. Our board of directors has adopted, and our shareholders have approved, the 2015 Equity Compensation Plan (the “2015 Plan”). The 2015 Plan provides for the grant of incentive stock options to our employees and any parent or subsidiary corporation’s employees, and for the grant of nonstatutory stock options, stock awards, and RSUs to our employees, directors and consultants and our parent or subsidiary corporations’ employees and consultants. The 2015 Plan became effective on September 3, 2015. As of June 30, 2021, Our board of directors has adopted, and our shareholders have approved, the Non-Employee Director Equity Compensation Plan (the “Non-Employee Director Plan”). The Non-Employee Director Plan provides for the grant of nonstatutory stock options, stock awards, and RSUs to our non-employee directors. The Non-Employee Director Plan became effective on September 3, 2015. As of June 30, 2021, A summary of our outstanding stock options as of June 30, 2021, is as follows: Options Outstanding Weighted- Average Weighted- Remaining Average Contractual Number of Exercise Term Aggregate Shares Price (Years) Intrinsic Value (in thousands) Outstanding—January 1, 2021 8,989,306 $ 4.81 6.58 $ 350 Granted 168,300 $ 2.90 Exercised (48,157) Forfeited, cancelled and expired (848,976) $ 4.31 Outstanding—June 30, 2021 8,260,473 $ 4.82 7.03 $ 847 Vested and exercisable—June 30, 2021 5,472,762 $ 5.50 6.40 $ 358 The weighted average grant date fair value of stock options granted during the six months ended June 30, 2021 and 2020 was $2.16 and $2.00, respectively. Restricted stock units We grant RSUs to employees and to members of our board of directors. RSUs that are granted to employees vest one , two or three years from the date of issuance, provided that the employee is employed by us on such vesting date. RSUs that are granted to directors’ vest on the one-year anniversary of the grant date, provided that the director continues to serve as a member of the board of directors continuously from the grant date through such one-year anniversary. All RSUs will fully vest upon a change of control of our company. If and when the RSUs vest, we will issue one ordinary share for each whole RSU that has vested, subject to satisfaction of the employee’s or director’s tax withholding obligations. The RSUs will cease to be outstanding upon the issuance of ordinary shares upon vesting. We recorded expense related to RSUs, which is included in the stock-based compensation table below, of $2.8 million and $1 million for the six months ended June 30, 2021 and 2020, respectively. As of June 30, 2021, the total unrecognized compensation expense related to unvested RSUs is $5.8 million, which we expect to recognize over an estimated weighted-average period of 1.37 years. A summary of our unvested RSUs as of June 30, 2021 is as follows: Number of Shares Outstanding—January 1, 2021 1,350,300 Granted 2,404,525 Forfeited (176,750) Vested (777,650) Unvested—June 30, 2021 2,800,425 Stock-based compensation expense We recognized stock-based compensation expense for employees and directors for stock options and RSUs as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Selling, general and administrative $ 1,586 $ 1,280 $ 3,305 $ 2,550 Research and development 496 493 1,054 974 Total stock-based compensation $ 2,082 $ 1,773 $ 4,359 $ 3,524 As of June 30, 2021, the total unrecognized compensation expense related to unvested stock options is $5.3 million, which we expect to recognize over an estimated weighted-average period of 1.94 years. In determining the estimated fair value of our service-based awards, we use the Black-Scholes option-pricing model and assumptions discussed below. Each of these inputs is subjective and generally requires significant judgment. The fair value of our service-based awards that were granted during the six months period ending June 30, 2021 and 2020 was estimated with the following assumptions: Six Months Ended June 30, 2021 2020 Expected term (in years) 6.25 6.08 Risk-free interest rate 0.59%-1.06% 0.45%-1.48% Expected volatility 80.87%-82.21% 78.15%-80.74% Dividend rate —% —% |
Summary of significant accoun_2
Summary of significant accounting policies and basis of presentation (Policies) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of significant accounting policies and basis of presentation | |
Basis of presentation | Basis of presentation These unaudited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). The unaudited consolidated financial statements reflect all adjustments, which include only normal recurring adjustments that are, in the opinion of management, necessary to present a fair statement of the operating results and financial position for the periods presented. The preparation of the unaudited consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect reported amounts and disclosures in the consolidated financial statements. Actual results could differ from those estimates. Results for the six months ended June 30, 2021 are not necessarily indicative of the results that may be expected for the year ending December 31, 2021. These unaudited consolidated financial statements should be read in conjunction with the accounting policies and notes to the audited consolidated financial statements included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed with the U.S. Securities and Exchange Commission on March 3, 2021 (the “2020 Annual Report”). Our significant accounting policies are described in Note 2 of the notes to the audited consolidated financial statements included in our 2020 Annual Report. Since the date of those financial statements, there have been no changes to our significant accounting policies. |
Leases | Leases We account for leases in accordance with Accounting Standards Codification Topic 842, Leases i.e. Operating leases where we are the lessee are included in Right of use (“ROU”) assets and Accrued and other current liabilities and Other long-term liabilities on our Consolidated Balance Sheets. The lease liabilities are initially and subsequently measured at the present value of the unpaid lease payments at the lease commencement date. Key estimates and judgments include how we determined (1) the discount rate we use to discount the unpaid lease payments to present value, (2) lease term and (3) lease payments. ASC 842 requires a lessee to discount its unpaid lease payments using the interest rate implicit in the lease or, if that rate cannot be readily determined, its incremental borrowing rate. Because our leases do not provide an implicit rate, we use our incremental borrowing rate based on the information available at the lease commencement date in determining the present value of lease payments. Our incremental borrowing rate for a lease is the rate of interest we would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The lease term for all of our leases includes the noncancellable period of the lease. Lease payments included in the measurement of the lease asset or liability are comprised of our fixed payments. The ROU asset is initially measured at cost, which comprises the initial amount of the lease liability adjusted for lease payments made at or before the lease commencement date less any lease incentives received. For operating leases, the ROU asset is subsequently measured throughout the lease term at the carrying amount of the lease liability, plus (minus) any prepaid (accrued) lease payments, less the unamortized balance of lease incentives received. Lease expense for lease payments is recognized on a straight-line basis over the lease term. We monitor for events or changes in circumstances that require a reassessment of a lease. If a reassessment results in the remeasurement of a lease liability, a corresponding adjustment is made to the carrying amount of the corresponding ROU asset unless doing so would reduce the carrying amount of the ROU asset to an amount less than zero. In that case, the amount of the adjustment that would result in a negative ROU asset balance is recorded in profit or loss. We have elected not to recognize ROU assets and lease liabilities for all short-term leases that have a lease term of 12 months or less. We recognize the lease payments associated with our short-term leases as an expense on a straight-line basis over the lease term. Variable lease payments associated with these leases are recognized and presented in the same manner as for all of our other leases. |
Cash and cash equivalents | Cash, cash equivalents and marketable securities We consider all short-term highly liquid investments with an original maturity at the date of purchase of three months or less to be cash equivalents. Cash and cash equivalents consist of account balances at banks and money market accounts, respectively. |
Marketable securities | We occasionally invest our excess cash balances in marketable debt securities of highly rated financial institutions. We seek to diversify our investments and limit the amount of investment concentrations for individual institutions, maturities and investment types. We classify marketable debt securities as available-for-sale and, accordingly, record such securities at fair value. We classify these securities as current assets as these investments are available to us for use in funding current operations. There were Unrealized gains and losses on marketable debt securities are recorded as a separate component of Accumulated other comprehensive income (loss) included in shareholders’ equity. |
Segment information | Segment information Operating segments are identified as components of an enterprise for which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions on how to allocate resources and assess performance. We view our operations and manage our business in one operating segment. |
Net loss per share | Net loss per share Basic net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted average number of ordinary shares outstanding during the period. Diluted net loss per share is calculated by dividing the net loss attributable to shareholders by the weighted-average number of ordinary shares outstanding for the period, including any dilutive effect from outstanding stock options or other equity-based instruments. Shares used in the diluted net loss per share calculations exclude anti-dilutive ordinary share equivalents, which currently consist of outstanding stock options, unvested restricted stock units (“RSUs”), equity-classified warrants and the conversion feature of our outstanding term loan agreement. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the six months ending June 30, 2021 and 2020, as they would be anti-dilutive: The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the six months ending June 30, 2021 and 2020, as they would be anti-dilutive: June 30, 2021 2020 Warrants 7,368,033 7,100,643 Stock options issued and outstanding 8,260,473 10,499,222 Unvested RSUs 2,800,425 1,090,300 Conversion feature of our outstanding term loan agreement 1,339,285 1,339,285 |
Recent accounting pronouncements - not yet adopted | Recent accounting pronouncements – not yet adopted Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments |
Summary of significant accoun_3
Summary of significant accounting policies and basis of presentation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Summary of significant accounting policies and basis of presentation | |
Schedule of potentially dilutive securities excluded from computations of diluted weighted average shares outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding for the six months ending June 30, 2021 and 2020, as they would be anti-dilutive: June 30, 2021 2020 Warrants 7,368,033 7,100,643 Stock options issued and outstanding 8,260,473 10,499,222 Unvested RSUs 2,800,425 1,090,300 Conversion feature of our outstanding term loan agreement 1,339,285 1,339,285 |
Fair value measurements (Tables
Fair value measurements (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Fair value measurements | |
Schedule of fair value of financial assets by level | The following table presents our assets and liabilities that are measured at fair value on a recurring basis for the periods presented (in thousands): As of June 30, 2021 Level I Level II Level III Total Cash equivalents 62,668 — — 62,668 Total assets $ 62,668 $ — $ — $ 62,668 Warrant liability — — 5,036 5,036 Total liabilities $ — $ — $ 5,036 $ 5,036 As of December 31, 2020 Level I Level II Level III Total Cash equivalents 86,775 — — 86,775 Total assets $ 86,775 $ — $ — $ 86,775 Warrant liability — — 4,941 4,941 Total liabilities $ — $ — $ 4,941 $ 4,941 |
Schedule of reconciliation of level 3 Warrant liability | The following table presents a reconciliation of our level 3 warrant liability (in thousands): As of June 30, 2021 Balance as of December 31, 2020 $ 4,941 Unrealized loss on fair value of warrants for six months ended June 30, 2021 95 Balance as of June 30,2021 $ 5,036 |
Intangible assets and goodwill
Intangible assets and goodwill (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Intangible asset and goodwill | |
Schedule of gross carrying amount of acquired developed product rights and goodwill | The following represents the balance of our intangible asset and goodwill as follows (in thousands): As of June 30, 2021 Beginning of Period Amortization End of Period Keveyis $ 20,088 $ (2,511) $ 17,577 Goodwill 7,256 — 7,256 Total $ 27,344 $ (2,511) $ 24,833 |
Long-term debt (Tables)
Long-term debt (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Long-term debt | |
Future principal payments | Future principal payments due under the Loan Agreement, if the interest payment only period is not extended beyond the current 24-month period, are as follows (in thousands): Principal Payments 2021 $ — 2022 5,833 2023 10,000 2024 4,167 Total future payments $ 20,000 |
Accrued and other current lia_2
Accrued and other current liabilities (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Accrued liabilities | |
Schedule of accrued and other current liabilities | Accrued and other current liabilities consist of the following (in thousands): June 30, December 31, 2021 2020 Consulting and professional fees $ 7,311 $ 2,754 Accrued sales allowances 5,588 4,312 Supply agreement - current portion 5,085 4,391 Employee compensation 2,972 5,749 Accrued royalties 499 301 Lease liability - current portion 437 415 Other 139 72 Accrued taxes 8 1,161 Severance — 493 Total accrued and other current liabilities $ 22,039 $ 19,648 |
Ordinary shares (Tables)
Ordinary shares (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Ordinary shares. | |
Schedule of warrants | Warrants Outstanding Exercise Expiration Warrants Warrants June 30, Classification Price Date Issued Exercised 2021 Warrants in connection with private equity placement Liability $ 2.50 6/28/2022 7,000,000 (1,970,000) 5,030,000 Warrants in connection with Horizon and Oxford loan agreement Equity $ 2.45 12/28/2026 428,571 (267,857) 160,714 Warrants in connection with CRG loan agreement Equity $ 7.37 7/14/2024 394,289 — 394,289 Warrants in connection with CRG loan amendment in January 2018 Equity $ 10.00 1/16/2025 1,248,250 — 1,248,250 Warrants in connection with Avenue Capital loan agreement Equity $ 1.87 5/19/2025 267,390 — 267,390 Warrants in connection with Avenue Capital loan agreement Equity $ 1.87 12/30/2025 267,390 — 267,390 9,605,890 7,368,033 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 6 Months Ended |
Jun. 30, 2021 | |
Stock-based compensation | |
Schedule of summary of outstanding stock options activity | Options Outstanding Weighted- Average Weighted- Remaining Average Contractual Number of Exercise Term Aggregate Shares Price (Years) Intrinsic Value (in thousands) Outstanding—January 1, 2021 8,989,306 $ 4.81 6.58 $ 350 Granted 168,300 $ 2.90 Exercised (48,157) Forfeited, cancelled and expired (848,976) $ 4.31 Outstanding—June 30, 2021 8,260,473 $ 4.82 7.03 $ 847 Vested and exercisable—June 30, 2021 5,472,762 $ 5.50 6.40 $ 358 |
Schedule of summary of unvested RSUs | Number of Shares Outstanding—January 1, 2021 1,350,300 Granted 2,404,525 Forfeited (176,750) Vested (777,650) Unvested—June 30, 2021 2,800,425 |
Schedule of stock-based compensation | We recognized stock-based compensation expense for employees and directors for stock options and RSUs as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2021 2020 2021 2020 Selling, general and administrative $ 1,586 $ 1,280 $ 3,305 $ 2,550 Research and development 496 493 1,054 974 Total stock-based compensation $ 2,082 $ 1,773 $ 4,359 $ 3,524 |
Schedule of assumptions for estimating fair value of stock option awards | Six Months Ended June 30, 2021 2020 Expected term (in years) 6.25 6.08 Risk-free interest rate 0.59%-1.06% 0.45%-1.48% Expected volatility 80.87%-82.21% 78.15%-80.74% Dividend rate —% —% |
Organization - Products (Detail
Organization - Products (Details) | Jun. 30, 2021product |
Organization | |
Number of clinical-stage product candidates | 2 |
Organization - Liquidity (Detai
Organization - Liquidity (Details) - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2021 | Dec. 31, 2020 | |
Liquidity | ||
Cash and cash equivalents | $ 63,774 | $ 87,522 |
Substantial doubt about going concern, within one year | false |
Organization - Transaction Agre
Organization - Transaction Agreement with Xeris Pharmaceuticals, Inc (Details) | May 24, 2021USD ($)patent$ / shares | May 21, 2021$ / shares | Jun. 30, 2021USD ($) |
Organization | |||
Incurred expenses | $ | $ 5,800,000 | ||
Xeris Pharmaceuticals, Inc. | Strongbridge Biopharma PLC | |||
Organization | |||
Closing price | $ | $ 267,000,000 | ||
Share price (in dollars per share) | $ 3.47 | ||
Fixed exchange ratio | 0.7840 | ||
Acquiree's per share value of consideration receivable (n dollars per share) | $ 2.72 | ||
Business acquisition premium (as percent) | 12.90% | ||
Number of contingent value rights | $ | 1 | ||
Value of contingent value rights (in dollars per share) | $ 1 | ||
Expected ownership of acquirer (as a percent) | 60.00% | ||
Expected ownership of acquiree (as a percent) | 40.00% | ||
Xeris Pharmaceuticals, Inc. | Strongbridge Biopharma PLC | Minimum | |||
Organization | |||
Value of contingent value rights (in dollars per share) | 0 | ||
Xeris Pharmaceuticals, Inc. | Strongbridge Biopharma PLC | Maximum | |||
Organization | |||
Value of contingent value rights (in dollars per share) | 1 | ||
Xeris Pharmaceuticals, Inc. | Strongbridge Biopharma PLC | Keveyis | Annual net sales in 2023 | |||
Organization | |||
Value of contingent value rights (in dollars per share) | $ 0.25 | ||
Threshold number of patents issued | patent | 1 | ||
Threshold annual net sale milestone | $ | $ 40,000,000 | ||
Xeris Pharmaceuticals, Inc. | Strongbridge Biopharma PLC | Recorlev | Annual net sales in 2023 | |||
Organization | |||
Value of contingent value rights (in dollars per share) | $ 0.25 | ||
Threshold annual net sale milestone | $ | $ 40,000,000 | ||
Xeris Pharmaceuticals, Inc. | Strongbridge Biopharma PLC | Recorlev | Annual net sales in 2024 | |||
Organization | |||
Value of contingent value rights (in dollars per share) | $ 0.50 | ||
Threshold annual net sale milestone | $ | $ 80,000,000 |
Summary of significant accoun_4
Summary of significant accounting policies and basis of presentation - Leases (Details) | Jun. 30, 2021 |
Summary of significant accounting policies and basis of presentation | |
Operating Lease, Liability, Current, Statement of Financial Position | Accrued and other current liabilities |
Operating Lease, Liability, Noncurrent, Statement of Financial Position | Other long-term liabilities |
Summary of significant accoun_5
Summary of significant accounting policies and basis of presentation - Marketable securities and Segment information (Details) $ in Millions | 6 Months Ended | |
Jun. 30, 2021USD ($)segment | Dec. 31, 2020USD ($) | |
Segment information | ||
Marketable securities, noncurrent | $ | $ 0 | $ 0 |
Number of operating segments | segment | 1 |
Summary of significant accoun_6
Summary of significant accounting policies and basis of presentation - Anti-dilutive securities (Details) - shares | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Warrant liability | ||
Net loss per share | ||
Anti-dilutive shares of common stock (in shares) | 7,368,033 | 7,100,643 |
Stock options | ||
Net loss per share | ||
Anti-dilutive shares of common stock (in shares) | 8,260,473 | 10,499,222 |
RSUs | ||
Net loss per share | ||
Anti-dilutive shares of common stock (in shares) | 2,800,425 | 1,090,300 |
Conversion feature of our outstanding term loan agreement | ||
Net loss per share | ||
Anti-dilutive shares of common stock (in shares) | 1,339,285 | 1,339,285 |
Revenue recognition - Product s
Revenue recognition - Product sales (Details) | Jun. 30, 2021customer |
Revenue recognition | |
Number of specialty provider | 1 |
Revenue recognition - Reserves
Revenue recognition - Reserves (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Reserve for returns | $ 0 |
Percentage of patient's cost of branded prescription drugs related to the Medicare Part D Coverage Gap for which manufacturers of pharmaceutical products are responsible | 70.00% |
Maximum | |
Temporary supply period | 60 days |
Financial need period | 12 months |
Fair value measurements - Asset
Fair value measurements - Assets and liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Liabilities | ||
Warrant liability | $ 5,036 | $ 4,941 |
Recurring | ||
Assets | ||
Cash equivalents | 62,668 | 86,775 |
Total Assets | 62,668 | 86,775 |
Liabilities | ||
Warrant liability | 5,036 | 4,941 |
Total liabilities | 5,036 | 4,941 |
Recurring | Level I | ||
Assets | ||
Cash equivalents | 62,668 | 86,775 |
Total Assets | 62,668 | 86,775 |
Recurring | Level III | ||
Liabilities | ||
Warrant liability | 5,036 | 4,941 |
Total liabilities | $ 5,036 | $ 4,941 |
Fair value measurements - Level
Fair value measurements - Level 3 (Details) - Warrant liability $ in Thousands | 6 Months Ended |
Jun. 30, 2021USD ($) | |
Reconciliation of level 3: | |
Balance at beginning of period | $ 4,941 |
Unrealized loss on fair value of warrants | 95 |
Balance at end of period | $ 5,036 |
Intangible asset and goodwill -
Intangible asset and goodwill - Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Intangible asset and goodwill | ||||
Finite-lived intangible assets, Amortization | $ (1,255) | $ (1,255) | $ (2,511) | $ (2,511) |
Goodwill, Beginning of Period | 7,256 | |||
Goodwill, End of Period | 7,256 | 7,256 | ||
Total, Beginning of Period | 27,344 | |||
Total, End of Period | 24,833 | 24,833 | ||
Keveyis | ||||
Intangible asset and goodwill | ||||
Finite-lived intangible assets, Beginning of Period | 20,088 | |||
Finite-lived intangible assets, Amortization | (2,511) | |||
Finite-lived intangible assets, End of Period | $ 17,577 | $ 17,577 |
Intangible asset and goodwill_2
Intangible asset and goodwill - Asset purchase (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($)installment | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | Jun. 30, 2021USD ($) | Jun. 30, 2020USD ($) | |
In-process research and development and Goodwill | ||||||
Amortization of intangible asset | $ 1,255 | $ 1,255 | $ 2,511 | $ 2,511 | ||
Keveyis | ||||||
In-process research and development and Goodwill | ||||||
Amortization of intangible asset | $ 2,511 | |||||
Acquired product rights | Keveyis | ||||||
In-process research and development and Goodwill | ||||||
Number of installment payments | installment | 2 | |||||
Installment payment | $ 7,500 | $ 1,000 | ||||
Potential milestone payments | 7,500 | |||||
Minimum amount of purchases obligated | $ 29,000 | |||||
Purchase obligation period | 6 years | |||||
Payments in excess of fair value | $ 29,300 | |||||
Transaction costs | 2,400 | |||||
Acquired product rights | $ 40,200 | |||||
Estimated life | 8 years |
Long-term debt - Agreements (De
Long-term debt - Agreements (Details) - USD ($) | May 19, 2020 | Jul. 23, 2021 | Jun. 30, 2021 | Sep. 30, 2020 |
Warrants in connection with Avenue Capital loan agreement, One | ||||
Loan agreement | ||||
Warrants issued (in shares) | 267,390 | |||
Warrant exercise price (in dollars per share) | $ 1.87 | $ 1.87 | ||
Number of days used for determining weighted average price | 5 days | |||
Warrant term | 5 years | |||
Term Loan Agreement | ||||
Loan agreement | ||||
Maximum borrowing capacity | $ 30,000,000 | |||
Loan agreement term | 4 years | |||
Minimum revenue or cash balance financial covenants | $ 0 | |||
Interest-only payment period | 24 months | |||
Number of days in a year used in calculating accrued interest | 365 days | |||
Interest rate (as a percent) | 10.00% | |||
Commitment fee | $ 200,000 | |||
Term Loan Agreement | Subsequent event | ||||
Loan agreement | ||||
Convertible portion of debt | $ 10,000,000 | |||
Conversion price (in dollars per share) | $ 2.24 | |||
Term Loan Agreement | Maximum | ||||
Loan agreement | ||||
Interest-only payment period | 36 months | |||
Convertible portion of debt | $ 3,000,000 | |||
Term Loan Agreement | Base Rate | ||||
Loan agreement | ||||
Fixed interest rate (as a percent) | 3.25% | |||
Spread on reference interest rate (as a percent) | 6.75% | |||
Term Loan Agreement, Initial Loan | ||||
Loan agreement | ||||
Term loan | $ 10,000,000 | |||
Commitment fee (as a percent) | 1.00% | |||
Term Loan Agreement, Second Loan | ||||
Loan agreement | ||||
Term loan | $ 10,000,000 | |||
Commitment fee (as a percent) | 1.00% | |||
Term Loan Agreement, Third Loan | ||||
Loan agreement | ||||
Maximum borrowing capacity | $ 10,000,000 | |||
Term Loan Agreement, Third Loan | Warrants in connection with Avenue Capital loan agreement, One | ||||
Loan agreement | ||||
Percentage of loan divided by exercise price | 5.00% | |||
Ordinary Shares | Term Loan Agreement | ||||
Loan agreement | ||||
Conversion price (in dollars per share) | $ 2.24 |
Long-term debt - Future princip
Long-term debt - Future principal payments (Details) - USD ($) $ in Thousands | May 19, 2020 | Jun. 30, 2021 |
Future principal payments | ||
2022 | $ 5,833 | |
2023 | 10,000 | |
2024 | 4,167 | |
Total future payments | $ 20,000 | |
Term Loan Agreement | ||
Debt | ||
Interest-only payment period | 24 months |
Accrued and other current lia_3
Accrued and other current liabilities (Details) - USD ($) $ in Thousands | Jun. 30, 2021 | Dec. 31, 2020 |
Accrued liabilities | ||
Consulting and professional fees | $ 7,311 | $ 2,754 |
Accrued sales allowances | 5,588 | 4,312 |
Supply agreement - current portion | 5,085 | 4,391 |
Employee compensation | 2,972 | 5,749 |
Accrued royalties | 499 | 301 |
Lease liability - current portion | 437 | 415 |
Other | 139 | 72 |
Accrued taxes | 8 | 1,161 |
Severance | 493 | |
Total accrued and other current liabilities | $ 22,039 | $ 19,648 |
Operating Lease, Liability, Current, Statement of Financial Position | Total accrued and other current liabilities |
Commitments and contingencies -
Commitments and contingencies - Commitments to Taro (Details) $ in Millions | Jun. 30, 2021USD ($) |
Acquired product rights | Keveyis | |
Other Commitments | |
Remaining obligation | $ 14.1 |
Income taxes (Details)
Income taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Components of income tax expense (benefit) | ||||
Income tax expense | $ 1 | $ 0 | $ 1 | $ 0 |
Ordinary shares - Equity transa
Ordinary shares - Equity transactions (Details) - USD ($) | Mar. 25, 2021 | Apr. 28, 2017 | Mar. 31, 2021 | Jun. 30, 2021 |
ATM Facility, April 28, 2017 | ||||
Equity transactions | ||||
Aggregate shares issuable (in dollars) | $ 40,000,000 | |||
Commission on gross proceeds from sale of shares (as a percent) | 3.00% | |||
Proceeds from issuance of ordinary shares, net | $ 38,000 | |||
Payment of fees on issuance of ordinary shares | $ 1,100 | |||
ATM Facility, March 25, 2021 | ||||
Equity transactions | ||||
Aggregate shares issuable (in dollars) | $ 50,000,000 | |||
Commission on gross proceeds from sale of shares (as a percent) | 3.00% | |||
Ordinary Shares | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 11,311 | |||
Ordinary Shares | ATM Facility, April 28, 2017 | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 11,311 | |||
Price per share (in dollars per share) | $ 3.36 | |||
Ordinary Shares | ATM Facility, March 25, 2021 | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 0 |
Ordinary shares - Warrants (Det
Ordinary shares - Warrants (Details) - $ / shares | Jun. 30, 2021 | May 19, 2020 |
Warrants | ||
Warrants Issued (in shares) | 9,605,890 | |
Warrants Outstanding (in shares) | 7,368,033 | |
Warrants in connection with private equity placement | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 2.50 | |
Warrants Issued (in shares) | 7,000,000 | |
Warrants Exercised (in shares) | (1,970,000) | |
Warrants Outstanding (in shares) | 5,030,000 | |
Warrants in connection with Horizon and Oxford loan agreement | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 2.45 | |
Warrants Issued (in shares) | 428,571 | |
Warrants Exercised (in shares) | (267,857) | |
Warrants Outstanding (in shares) | 160,714 | |
Warrants in connection with CRG loan agreement | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 7.37 | |
Warrants Issued (in shares) | 394,289 | |
Warrants Outstanding (in shares) | 394,289 | |
Warrants in connection with CRG loan amendment in January 2018 | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 10 | |
Warrants Issued (in shares) | 1,248,250 | |
Warrants Outstanding (in shares) | 1,248,250 | |
Warrants in connection with Avenue Capital loan agreement, One | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 1.87 | $ 1.87 |
Warrants Issued (in shares) | 267,390 | |
Warrants Outstanding (in shares) | 267,390 | |
Warrants Issued Avenue Capital Loan Agreement, Two | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 1.87 | |
Warrants Issued (in shares) | 267,390 | |
Warrants Outstanding (in shares) | 267,390 |
Stock-based compensation - Gene
Stock-based compensation - General (Details) | Jun. 30, 2021shares |
Inducement Plan | |
Stock-based compensation | |
Number of shares available for issuance | 1,297,353 |
2015 Plan | |
Stock-based compensation | |
Number of shares available for issuance | 2,531,458 |
Non-Employee Director Plan | |
Stock-based compensation | |
Number of shares available for issuance | 207,247 |
Stock-based compensation - Stoc
Stock-based compensation - Stock options activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | Dec. 31, 2020 | |
Summary of outstanding stock options | |||
Outstanding at beginning of period (in shares) | 8,989,306 | ||
Granted (in shares) | 168,300 | ||
Exercised (in shares) | (48,157) | ||
Forfeited, cancelled and expired (in shares) | (848,976) | ||
Outstanding at end of period (in shares) | 8,260,473 | 8,989,306 | |
Vested and exercisable at end of period (in shares) | 5,472,762 | ||
Weighted-Average Exercise Price | |||
Granted (in dollars per share) | $ 2.90 | ||
Forfeited, cancelled and expired (in dollars per share) | 4.31 | ||
Outstanding (in dollars per share) | 4.82 | $ 4.81 | |
Vested and exercisable at end of period (in dollars per share) | $ 5.50 | ||
Additional Disclosures - Options | |||
Weighted Average Remaining Contractual Term, Outstanding | 7 years 10 days | 6 years 6 months 29 days | |
Weighted Average Remaining Contractual Term, Vested and exercisable | 6 years 4 months 24 days | ||
Aggregate Intrinsic Value, Outstanding (in dollars) | $ 847 | $ 350 | |
Aggregate Intrinsic Value, Vested and exercisable at end of the period (in dollars) | $ 358 | ||
Weighted average grant date fair value of stock options granted (in dollars per share) | $ 2.16 | $ 2 |
Stock-based compensation - Rest
Stock-based compensation - Restricted stock units (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Stock-based compensation | ||||
Stock-based compensation | $ 2,082 | $ 1,773 | $ 4,359 | $ 3,524 |
RSUs | ||||
Stock-based compensation | ||||
Number of shares issued for each stock award vested | 1 | |||
Stock-based compensation | $ 2,800 | $ 1,000 | ||
Total unrecognized compensation expense | $ 5,800 | $ 5,800 | ||
Estimated weighted average period over which expense is expected to be recognized | 1 year 4 months 13 days | |||
Summary of unvested RSUs | ||||
Unvested - Beginning of period (in shares) | 1,350,300 | |||
Granted (in shares) | 2,404,525 | |||
Forfeited (in shares) | (176,750) | |||
Vested (in shares) | (777,650) | |||
Unvested - End of period (in shares) | 2,800,425 | 2,800,425 | ||
RSUs | Employee | Vesting period one | ||||
Stock-based compensation | ||||
Vesting period | 1 year | |||
RSUs | Employee | Vesting period two | ||||
Stock-based compensation | ||||
Vesting period | 2 years | |||
RSUs | Employee | Vesting period three | ||||
Stock-based compensation | ||||
Vesting period | 3 years | |||
RSUs | Director | ||||
Stock-based compensation | ||||
Vesting period | 1 year | |||
Service period | 1 year |
Stock-based compensation - St_2
Stock-based compensation - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2021 | Jun. 30, 2020 | Jun. 30, 2021 | Jun. 30, 2020 | |
Stock-based compensation expense | ||||
Total stock-based compensation | $ 2,082 | $ 1,773 | $ 4,359 | $ 3,524 |
Stock options | ||||
Stock-based compensation expense | ||||
Total unrecognized compensation expense | 5,300 | $ 5,300 | ||
Estimated weighted average period over which expense is expected to be recognized | 1 year 11 months 8 days | |||
Selling, general and administrative | ||||
Stock-based compensation expense | ||||
Total stock-based compensation | 1,586 | 1,280 | $ 3,305 | 2,550 |
Research and development | ||||
Stock-based compensation expense | ||||
Total stock-based compensation | $ 496 | $ 493 | $ 1,054 | $ 974 |
Stock-based compensation - Fair
Stock-based compensation - Fair value assumptions (Details) - Stock options | 6 Months Ended | |
Jun. 30, 2021 | Jun. 30, 2020 | |
Fair value assumptions | ||
Expected term (in years) | 6 years 3 months | 6 years 29 days |
Minimum Risk-free interest rate (as a percent) | 0.59% | 0.45% |
Maximum Risk-free interest rate (as a percent) | 1.06% | 1.48% |
Minimum Expected volatility (as a percent) | 80.87% | 78.15% |
Maximum Expected volatility (as a percent) | 82.21% | 80.74% |