Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 26, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
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 | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 67,243,772 | |
Entity Central Index Key | 0001634432 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 81,793 | $ 57,032 |
Marketable securities | 21,072 | |
Accounts receivable | 2,895 | 2,289 |
Inventory | 1,116 | 1,993 |
Prepaid expenses and other current assets | 1,555 | 1,157 |
Total current assets | 87,359 | 83,543 |
Property and equipment, net | 237 | 291 |
Right of use asset, net | 647 | 789 |
Intangible asset, net | 21,344 | 25,110 |
Goodwill | 7,256 | 7,256 |
Other assets | 803 | 649 |
Total assets | 117,646 | 117,638 |
Current liabilities: | ||
Accounts payable | 1,588 | 3,331 |
Accrued and other current liabilities | 17,772 | 20,962 |
Total current liabilities | 19,360 | 24,293 |
Long-term debt, net | 7,274 | |
Warrant liability | 3,965 | 4,127 |
Supply agreement liability, noncurrent | 11,556 | 15,947 |
Other long-term liabilities | 923 | 1,080 |
Total liabilities | 43,078 | 45,447 |
Commitments and contingencies (Note 8) | ||
Stockholders' equity: | ||
Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at September 30, 2020 and December 31, 2019 | 44 | 44 |
Ordinary shares, $0.01 par value, 600,000,000 shares authorized; 66,893,964 and 54,205,852 shares issued and outstanding at September 30, 2020 and December 31, 2019 | 669 | 542 |
Additional paid-in capital | 367,467 | 332,085 |
Accumulated deficit | (293,612) | (260,483) |
Accumulated other comprehensive income | 3 | |
Total stockholders' equity | 74,568 | 72,191 |
Total liabilities and stockholders' equity | $ 117,646 | $ 117,638 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
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 | 66,893,964 | 54,205,852 |
Ordinary shares, shares outstanding | 66,893,964 | 54,205,852 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Revenues: | ||||
Total revenues | $ 8,071 | $ 5,684 | $ 22,505 | $ 16,106 |
Cost and expenses: | ||||
Cost of sales (excluding amortization of intangible asset) | 408 | 1,001 | 1,770 | 2,836 |
Selling, general and administrative | 9,221 | 12,806 | 29,262 | 37,088 |
Research and development | 6,771 | 7,552 | 20,475 | 22,874 |
Amortization of intangible asset | 1,255 | 1,255 | 3,766 | 3,766 |
Total cost and expenses | 17,655 | 22,614 | 55,273 | 66,564 |
Operating loss | (9,584) | (16,930) | (32,768) | (50,458) |
Other income (expense), net: | ||||
Unrealized gain on fair value of warrants | 6,949 | 3,202 | 162 | 10,079 |
Income from field services agreement | 1,725 | 5,466 | ||
Expense from field services agreement | (1,672) | (5,659) | ||
Interest expense | (523) | (776) | ||
Other (expense) income, net | (1) | 576 | 253 | 1,869 |
Total other income (expense), net | 6,425 | 3,831 | (361) | 11,755 |
Loss before income taxes | (3,159) | (13,099) | (33,129) | (38,703) |
Income tax expense | 0 | (691) | 0 | (1,768) |
Net loss | (3,159) | (13,790) | (33,129) | (40,471) |
Other comprehensive loss: | ||||
Unrealized loss on marketable securities | (3) | |||
Comprehensive loss | (3,159) | (13,790) | (33,132) | (40,471) |
Net loss attributable to ordinary shareholders: | ||||
Basic | (3,159) | (13,790) | (33,129) | (40,471) |
Diluted | $ (10,108) | $ (16,992) | $ (33,129) | $ (50,550) |
Net loss per share attributable to ordinary shareholders: | ||||
Basic (in dollars per share) | $ (0.06) | $ (0.25) | $ (0.60) | $ (0.75) |
Diluted (in dollars per share) | $ (0.18) | $ (0.31) | $ (0.60) | $ (0.91) |
Weighted-average shares used in computing net loss per share attributable to ordinary shareholders: | ||||
Basic (in shares) | 56,105,155 | 54,192,710 | 54,883,975 | 54,174,629 |
Diluted (in shares) | 57,404,652 | 54,540,646 | 54,883,975 | 55,844,719 |
Product | ||||
Revenues: | ||||
Total revenues | $ 8,053 | $ 5,677 | $ 22,468 | $ 16,083 |
Royalty | ||||
Revenues: | ||||
Total revenues | $ 18 | $ 7 | $ 37 | $ 23 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity - USD ($) $ in Thousands | Ordinary SharesIssuance of shares, Public offering | Ordinary SharesATM Facility | Ordinary SharesMaximum | Ordinary Shares | Deferred Shares | Additional Paid-In CapitalIssuance of shares, Public offering | Additional Paid-In CapitalATM Facility | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income | Issuance of shares, Public offering | ATM Facility | Total |
Balance at beginning of period at Dec. 31, 2018 | $ 541 | $ 44 | $ 323,402 | $ (211,032) | $ 112,955 | ||||||||
Balance (in shares) at Dec. 31, 2018 | 54,122,074 | 40,000 | |||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||
Net loss | (40,471) | (40,471) | |||||||||||
Stock-based compensation | 7,070 | 7,070 | |||||||||||
Exercise of stock options | $ 1 | 178 | 179 | ||||||||||
Exercise of stock options (in shares) | 43,841 | ||||||||||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 1 | (92) | (92) | ||||||||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 39,937 | ||||||||||||
Balance at end of period at Sep. 30, 2019 | $ 542 | $ 44 | 330,558 | (251,503) | 79,641 | ||||||||
Balance (in shares) at Sep. 30, 2019 | 54,205,852 | 40,000 | |||||||||||
Balance at beginning of period at Jun. 30, 2019 | $ 542 | $ 44 | 328,416 | (237,713) | 91,289 | ||||||||
Balance (in shares) at Jun. 30, 2019 | 54,186,268 | 40,000 | |||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||
Net loss | (13,790) | (13,790) | |||||||||||
Stock-based compensation | 2,175 | 2,175 | |||||||||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 1 | (33) | (33) | ||||||||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 19,584 | ||||||||||||
Balance at end of period at Sep. 30, 2019 | $ 542 | $ 44 | 330,558 | (251,503) | 79,641 | ||||||||
Balance (in shares) at Sep. 30, 2019 | 54,205,852 | 40,000 | |||||||||||
Balance at beginning of period at Dec. 31, 2019 | $ 542 | $ 44 | 332,085 | (260,483) | $ 3 | 72,191 | |||||||
Balance (in shares) at Dec. 31, 2019 | 54,205,852 | 40,000 | |||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||
Net loss | (33,129) | (33,129) | |||||||||||
Stock-based compensation | 5,594 | 5,594 | |||||||||||
Issuance of warrants and beneficial conversion feature related to the Loan Agreement | 2,457 | 2,457 | |||||||||||
Issuance of shares, net of offering costs | $ 111 | $ 14 | $ 23,009 | $ 4,738 | $ 23,120 | $ 4,752 | |||||||
Issuance of shares, net of offering costs (in shares) | 11,111,111 | 1,400,000 | |||||||||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 2 | (416) | (414) | ||||||||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 177,001 | ||||||||||||
Unrealized loss on marketable securities | $ (3) | (3) | |||||||||||
Balance at end of period at Sep. 30, 2020 | $ 669 | $ 44 | 367,467 | (293,612) | 74,568 | ||||||||
Balance (in shares) at Sep. 30, 2020 | 66,893,964 | 40,000 | |||||||||||
Balance at beginning of period at Jun. 30, 2020 | $ 544 | $ 44 | 337,734 | (290,453) | 47,869 | ||||||||
Balance (in shares) at Jun. 30, 2020 | 54,355,957 | 40,000 | |||||||||||
Increase (Decrease) in Stockholders' Equity | |||||||||||||
Net loss | (3,159) | (3,159) | |||||||||||
Stock-based compensation | 2,070 | 2,070 | |||||||||||
Issuance of shares, net of offering costs | $ 109 | $ 14 | $ 23,009 | $ 4,738 | $ 23,118 | $ 4,752 | |||||||
Issuance of shares, net of offering costs (in shares) | 11,111,111 | 1,400,000 | |||||||||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 2 | (84) | (82) | ||||||||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 26,896 | ||||||||||||
Balance at end of period at Sep. 30, 2020 | $ 669 | $ 44 | $ 367,467 | $ (293,612) | $ 74,568 | ||||||||
Balance (in shares) at Sep. 30, 2020 | 66,893,964 | 40,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flow - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (33,129) | $ (40,471) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Change in fair value of warrant liability | (162) | (10,079) |
Stock-based compensation | 5,594 | 7,070 |
Amortization of intangible asset | 3,766 | 3,766 |
Accretion of discounts on marketable securities | (53) | (251) |
Amortization of debt discounts and debt issuance costs | 406 | |
Depreciation | 64 | 56 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (606) | (1,736) |
Inventory | 493 | 1,212 |
Prepaid expenses and other current assets | (256) | 2,157 |
Other assets | 230 | (970) |
Accounts payable | (1,743) | 777 |
Accrued and other liabilities | (7,738) | (4,709) |
Net cash used in operating activities | (33,134) | (43,178) |
Cash flows from investing activities: | ||
Purchases of property and equipment | (10) | (42) |
Purchases of marketable securities | (44,766) | |
Maturities of marketable securities | 21,122 | 4,400 |
Net cash provided by (used in) investing activities | 21,112 | (40,408) |
Cash flows from financing activities: | ||
Proceeds from long-term debt, net | 9,325 | |
Proceeds from issuance of ordinary shares, net | 23,120 | |
Proceeds from issuance of ordinary shares in connection with at-the-market offering | 4,752 | |
Proceeds from exercise of stock options | 179 | |
Payments related to tax withholding for net-share settled equity awards | (414) | (92) |
Net cash provided by financing activities | 36,783 | 87 |
Net increase (decrease) in cash and cash equivalents | 24,761 | (83,499) |
Cash and cash equivalents-beginning of period | 57,032 | 122,490 |
Cash and cash equivalents-end of period | 81,793 | $ 38,991 |
Supplemental disclosures of cash flow information: Cash paid during the year for: | ||
Interest | 370 | |
Income taxes other, net of refunds | $ 695 |
Organization
Organization | 9 Months Ended |
Sep. 30, 2020 | |
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 (levoketoconazole) and veldoreotide. Recorlev is a cortisol synthesis inhibitor currently being studied for the treatment of endogenous Cushing's syndrome. Veldoreotide is a next-generation somatostatin analog being investigated for potential applications in conditions amenable to somatostatin receptor activation, such as acromegaly. Both levoketoconazole and veldoreotide have received orphan designation from the FDA and the European Medicines Agency (“EMA”). In January 2018, Strongbridge Ireland Limited, one of our wholly-owned subsidiaries, acquired the U.S. and Canadian rights to Macrilen (macimorelin), the first and only oral drug approved by the FDA for the diagnosis of patients with adult growth hormone deficiency. We launched Macrilen in the United States in July 2018. In December 2018, we sold Strongbridge Ireland Limited to Novo Nordisk Healthcare AG (“Novo”) for $145 million plus the right to receive tiered royalties on net sales of Macrilen through 2027. In addition, Strongbridge U.S. Inc., another of our wholly-owned subsidiaries, entered into an agreement with Novo Nordisk Inc. (“NNI”), a subsidiary of Novo, pursuant to which NNI funded the costs of 23 of our field-based employees to provide full-time ongoing services to NNI, including the promotion of Macrilen in the United States, for a period of three years . Novo also purchased 5.2 million of our ordinary shares at a purchase price of $7.00 per share. In December 2019, we reached an agreement with Novo to terminate the services agreement. We received a $6 million payment in connection with such termination and we no longer provide services to Novo. Liquidity We believe that our cash and cash equivalents of $81.8 million at September 30, 2020, 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. |
Summary of significant accounti
Summary of significant accounting policies and basis of presentation | 9 Months Ended |
Sep. 30, 2020 | |
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 nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. 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, 2019 filed with the U.S. Securities and Exchange Commission on February 28, 2020 (the “2019 Annual Report”). Our significant accounting policies are described in Note 2 of the notes to the audited consolidated financial statements included in our 2019 Annual Report. Since the date of those financial statements, there have been no changes to our significant accounting policies. Reclassifications The consolidated financial statements contain certain reclassifications within our consolidated statements of cash flow for the nine months ended September 30, 2019 due to an immaterial incorrect classification of investments in marketable securities and the related impact on investing activities. 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 stockholders’ 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 in our outstanding term loan agreement. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as of September 30, 2020 and 2019, as they would be anti-dilutive: September 30, 2020 2019 Warrants 7,100,643 1,803,253 Stock options issued and outstanding 10,146,820 10,001,799 Unvested RSUs 1,355,660 990,700 Conversion feature of our outstanding term loan agreement 1,339,285 — Recent accounting pronouncements – not yet adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments. current other-than-temporary impairment model. The standard is effective for smaller reporting companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022. We do not expect the adoption of this standard to have a material impact on our financial statements or internal controls. |
Revenue recognition
Revenue recognition | 9 Months Ended |
Sep. 30, 2020 | |
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 period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses on the consolidated balance sheet. For Medicaid, accruals are based on estimates of future Medicaid beneficiary utilization applied to the Medicaid unit rebate formula established by the Center for Medicaid and Medicare Services. Manufacturers of pharmaceutical products are responsible for 70% of the patient’s cost of branded prescription drugs related to the Medicare Part D Coverage Gap. In order to estimate the cost to us of this Medicare coverage gap responsibility, we estimate the number of patients in the prescription drug coverage gap for whom we will owe an additional liability under the Medicare Part D program. Our liability for these rebates consists of estimates of claims for the current quarter and estimated future claims that will be made for Keveyis transactions that have been recognized as revenue, but remains in the Customer’s inventory at the end of each reporting period. 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 | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020 Level I Level II Level III Total Cash equivalents 58,299 — — 58,299 Marketable securities — — — — Total assets $ 58,299 $ — $ — $ 58,299 Warrant liability — — 3,965 3,965 Total liabilities $ — $ — $ 3,965 $ 3,965 As of December 31, 2019 Level I Level II Level III Total Cash equivalents 56,544 — — 56,544 Marketable securities — 21,072 — 21,072 Total assets $ 56,544 $ 21,072 $ — $ 77,616 Warrant liability — — 4,127 4,127 Total liabilities $ — $ — $ 4,127 $ 4,127 The following table presents a reconciliation of our level 3 warrant liability (in thousands): As of September 30, 2020 Balance as of December 31, 2019 $ 4,127 Unrealized gain on fair value of warrants for nine months ended September 30, 2020 (162) Balance as of September 30, 2020 $ 3,965 |
Intangible assets and goodwill
Intangible assets and goodwill | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020 Beginning of Period Amortization End of Period Keveyis $ 25,110 $ (3,766) $ 21,344 Goodwill 7,256 — 7,256 Total $ 32,366 $ (3,766) $ 28,600 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 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 $3.8 million for the three and nine months ended September 30, 2020 and 2019, respectively. |
Long-term debt
Long-term debt | 9 Months Ended |
Sep. 30, 2020 | |
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 may borrow an additional $10 million under the Loan Agreement (the “Second Loan”), at any time between October 1, 2020 and December 31, 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 of up 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 September 30, 2020 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 the lower of (a) $2.24, or (b) 20% above the effective price of any bona fide equity financing of Strongbridge prior to December 31, 2020, subject to the terms and conditions described in the Loan Agreement. We have accounted for this term as a beneficial conversion feature, and the fair value is recorded into Additional paid-in capital. In connection with the execution of the Loan Agreement, we issued to Avenue a warrant to purchase up to an aggregate of 267,390 ordinary shares at an exercise price (the “Exercise Price”) equal to the lower of (i) $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) or (ii) the effective price of any bona fide equity financing prior to December 31, 2020 (subject to certain adjustments described in the warrant). The warrant will be exercisable, in full or in part, at any time prior to five years following the issue date. We have accounted for this warrant as equity, and the fair value is recorded into Additional paid-in capital. Under the terms of the Loan Agreement, if we borrow the Second 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 Second Loan divided by the Exercise Price, rounded down to the nearest whole share. 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. 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 2020 — 2021 — 2022 $ 2,917 2023 5,000 2024 2,083 Total future payments $ 10,000 |
Accrued and other current liabi
Accrued and other current liabilities | 9 Months Ended |
Sep. 30, 2020 | |
Accrued and other current liabilities | |
Accrued and other current liabilities | 7. Accrued and other current liabilities Accrued and other current liabilities consist of the following (in thousands): September 30, December 31, 2020 2019 Consulting and professional fees $ 4,916 $ 4,335 Supply agreement - current portion 4,391 2,773 Accrued sales allowances 2,495 2,990 Employee compensation 3,628 4,452 Accrued taxes 1,164 1,892 Severance 333 2,968 Lease liability - current portion 405 374 Accrued royalties 301 806 Other 139 372 Total accrued and other current liabilities $ 17,772 $ 20,962 |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and contingencies | |
Commitments and contingencies | 8. Commitments and contingencies (a) Commitments to Taro Pharmaceuticals Industries Ltd. As of September 30, 2020, our remaining obligation under the Supply Agreement (see note 5) was $19.0 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 | 9 Months Ended |
Sep. 30, 2020 | |
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 did not incur income any tax expense for the three and nine months ended September 30, 2020. CARES Act The CARES Act allows companies to defer payments of employer Social Security payroll taxes that are otherwise owed for wage payments made after March 27, 2020 through December 31, 2020. Fifty percent of the taxes deferred are required to be paid by December 31, 2021 with the remaining fifty percent required to be paid by December 31, 2022. As of September 30, 2020, we have accrued $151,000 of Social Security payroll taxes that will be deferred under the CARES Act. We expect to continue to defer payroll taxes through the end of the year and pay them as described above. |
Ordinary shares
Ordinary shares | 9 Months Ended |
Sep. 30, 2020 | |
Ordinary shares. | |
Ordinary shares | 10. Ordinary Shares Equity transactions On September 21, 2020, we sold 11,111,111 ordinary shares in a public offering at a price to the public of $2.25 per ordinary share for net proceeds of approximately $23.4 million, after deducting underwriting discounts and commissions and offering expenses payable by us. On October 15, 2020 we sold an additional 349,808 ordinary shares to the underwriters of our September 2020 public offering in connection with their partial exercise of their option to purchase additional shares to cover over-allotments at a price of $2.25 per ordinary share for net proceeds of approximately $0.7 million, after deducting underwriting discounts and commissions and offering expenses payable by us. We entered into an equity distribution agreement with JMP Securities LLC (“JMP”) on April 28, 2017, pursuant to which we may sell, at our option, from time to time, up to an aggregate of $40 million of our ordinary shares through JMP, as sales agent. We will pay JMP a commission 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 have provided JMP with customary indemnification rights. During the nine months ended September 30, 2020, we sold an aggregate of 1,400,000 ordinary shares under the ATM facility at an average selling price of $3.50 per share, resulting in net proceeds of approximately $4.8 million after payment of fees to JMP of $147,000. As of September 30, 2020, we have approximately $26 million available for sale under our ATM facility. Warrants Our outstanding warrants as of September 30, 2020 are as follows: Warrants Outstanding Exercise Expiration Warrants Warrants September 30, Classification Price Date Issued Exercised 2020 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 (1) 5/19/2025 267,390 — 267,390 9,338,500 7,100,643 (1) Exercise price is lower of (i) $1.87 per share or (ii) the effective price of any bona fide equity financing prior to December 31, 2020. |
Stock-based compensation
Stock-based compensation | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020, 1,379,403 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 September 30, 2020, 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 September 30, 2020, A summary of our outstanding stock options as of September 30, 2020 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, 2020 9,192,684 $ 6.58 5.96 $ 164 Granted 2,516,500 $ 2.94 Forfeited and cancelled (1,562,364) $ 12.30 Exercised — $ — Outstanding—September 30, 2020 10,146,820 $ 4.80 6.89 $ 195 Vested and exercisable—September 30, 2020 5,827,571 $ 5.67 5.62 $ 29 Restricted stock units We grant RSUs to employees and to members of our board of directors. RSUs that are granted to employees vest two 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 $0.7 million and $0.5 million for the three months ended September 30, 2020 and 2019, respectively, and $1.7 million and $1.3 million for the nine months ended September 30, 2020 and 2019, respectively. As of September 30, 2020, the total unrecognized compensation expense related to unvested RSUs is $2.5 million, which we expect to recognize over an estimated weighted-average period of 1.39 years. A summary of our unvested RSUs as of September 30, 2020 is as follows: Number of Shares Outstanding—January 1, 2020 791,350 Granted 910,510 Forfeited (35,200) Vested (311,000) Unvested—September 30, 2020 1,355,660 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 Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Selling, general and administrative $ 1,580 $ 1,684 $ 4,130 $ 5,475 Research and development 490 491 1,464 1,595 Total stock-based compensation $ 2,070 $ 2,175 $ 5,594 $ 7,070 As of September 30, 2020, the total unrecognized compensation expense related to unvested stock options is $9.9 million, which we expect to recognize over an estimated weighted-average period of 2.52 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 nine months period ending September 30, 2020 and 2019 was estimated with the following assumptions: Nine Months Ended September 30, 2020 2019 Expected term (in years) 6.08 6.13 Risk-free interest rate .37%-1.48% 1.38%-2.61% Expected volatility 78.15%-80.74% 78.70%-80.85% Dividend rate —% —% |
Subsequent events
Subsequent events | 9 Months Ended |
Sep. 30, 2020 | |
Subsequent events | |
Subsequent Events | 12. Subsequent Events On October 15, 2020 we sold an additional 349,808 ordinary shares to the underwriters of our September 2020 public offering in connection with their partial exercise of their option to purchase additional shares to cover over-allotments at a price of $2.25 per ordinary share for net proceeds of approximately $0.7 million, after deducting underwriting discounts and commissions and offering expenses payable by us. |
Summary of significant accoun_2
Summary of significant accounting policies and basis of presentation (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
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 nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the year ending December 31, 2020. 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, 2019 filed with the U.S. Securities and Exchange Commission on February 28, 2020 (the “2019 Annual Report”). Our significant accounting policies are described in Note 2 of the notes to the audited consolidated financial statements included in our 2019 Annual Report. Since the date of those financial statements, there have been no changes to our significant accounting policies. |
Reclassifications | Reclassifications The consolidated financial statements contain certain reclassifications within our consolidated statements of cash flow for the nine months ended September 30, 2019 due to an immaterial incorrect classification of investments in marketable securities and the related impact on investing activities. |
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 stockholders’ 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 in our outstanding term loan agreement. The following potentially dilutive securities have been excluded from the computations of diluted weighted-average shares outstanding as of September 30, 2020 and 2019, as they would be anti-dilutive: September 30, 2020 2019 Warrants 7,100,643 1,803,253 Stock options issued and outstanding 10,146,820 10,001,799 Unvested RSUs 1,355,660 990,700 Conversion feature of our outstanding term loan agreement 1,339,285 — |
Recent accounting pronouncements - not yet adopted | Recent accounting pronouncements – not yet adopted In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments. current other-than-temporary impairment model. The standard is effective for smaller reporting companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2022. We do not expect the adoption of this standard to have a material impact on our financial statements or internal controls. |
Summary of significant accoun_3
Summary of significant accounting policies and basis of presentation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Summary of significant accounting policies and basis of presentation | |
Schedule of potentially dilutive securities excluded from computations of diluted weighted average shares outstanding | September 30, 2020 2019 Warrants 7,100,643 1,803,253 Stock options issued and outstanding 10,146,820 10,001,799 Unvested RSUs 1,355,660 990,700 Conversion feature of our outstanding term loan agreement 1,339,285 — |
Fair value measurements (Tables
Fair value measurements (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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 September 30, 2020 Level I Level II Level III Total Cash equivalents 58,299 — — 58,299 Marketable securities — — — — Total assets $ 58,299 $ — $ — $ 58,299 Warrant liability — — 3,965 3,965 Total liabilities $ — $ — $ 3,965 $ 3,965 As of December 31, 2019 Level I Level II Level III Total Cash equivalents 56,544 — — 56,544 Marketable securities — 21,072 — 21,072 Total assets $ 56,544 $ 21,072 $ — $ 77,616 Warrant liability — — 4,127 4,127 Total liabilities $ — $ — $ 4,127 $ 4,127 |
Schedule of reconciliation of level 3 Warrant liability | The following table presents a reconciliation of our level 3 warrant liability (in thousands): As of September 30, 2020 Balance as of December 31, 2019 $ 4,127 Unrealized gain on fair value of warrants for nine months ended September 30, 2020 (162) Balance as of September 30, 2020 $ 3,965 |
Intangible assets and goodwill
Intangible assets and goodwill (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Intangible asset and goodwill | |
Schedule of gross carrying amount of in process research and development and goodwill | The following represents the balance of our intangible asset and goodwill as follows (in thousands): As of September 30, 2020 Beginning of Period Amortization End of Period Keveyis $ 25,110 $ (3,766) $ 21,344 Goodwill 7,256 — 7,256 Total $ 32,366 $ (3,766) $ 28,600 |
Long-term debt (Tables)
Long-term debt (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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 2020 — 2021 — 2022 $ 2,917 2023 5,000 2024 2,083 Total future payments $ 10,000 |
Accrued and other current lia_2
Accrued and other current liabilities (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Accrued and other current liabilities | |
Schedule of accrued and other current liabilities | Accrued and other current liabilities consist of the following (in thousands): September 30, December 31, 2020 2019 Consulting and professional fees $ 4,916 $ 4,335 Supply agreement - current portion 4,391 2,773 Accrued sales allowances 2,495 2,990 Employee compensation 3,628 4,452 Accrued taxes 1,164 1,892 Severance 333 2,968 Lease liability - current portion 405 374 Accrued royalties 301 806 Other 139 372 Total accrued and other current liabilities $ 17,772 $ 20,962 |
Ordinary shares (Tables)
Ordinary shares (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Ordinary shares. | |
Schedule of warrants | Warrants Outstanding Exercise Expiration Warrants Warrants September 30, Classification Price Date Issued Exercised 2020 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 (1) 5/19/2025 267,390 — 267,390 9,338,500 7,100,643 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
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, 2020 9,192,684 $ 6.58 5.96 $ 164 Granted 2,516,500 $ 2.94 Forfeited and cancelled (1,562,364) $ 12.30 Exercised — $ — Outstanding—September 30, 2020 10,146,820 $ 4.80 6.89 $ 195 Vested and exercisable—September 30, 2020 5,827,571 $ 5.67 5.62 $ 29 |
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 Nine Months Ended September 30, September 30, 2020 2019 2020 2019 Selling, general and administrative $ 1,580 $ 1,684 $ 4,130 $ 5,475 Research and development 490 491 1,464 1,595 Total stock-based compensation $ 2,070 $ 2,175 $ 5,594 $ 7,070 |
Schedule of assumptions for estimating fair value of stock option awards | Nine Months Ended September 30, 2020 2019 Expected term (in years) 6.08 6.13 Risk-free interest rate .37%-1.48% 1.38%-2.61% Expected volatility 78.15%-80.74% 78.70%-80.85% Dividend rate —% —% |
Schedule of summary of unvested RSUs | Number of Shares Outstanding—January 1, 2020 791,350 Granted 910,510 Forfeited (35,200) Vested (311,000) Unvested—September 30, 2020 1,355,660 |
Organization - Products (Detail
Organization - Products (Details) | Sep. 30, 2020product |
Organization | |
Number of clinical-stage product candidates | 2 |
Organization - Sale of subsidia
Organization - Sale of subsidiary (Details) $ / shares in Units, shares in Millions, $ in Millions | 1 Months Ended | |
Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($)employee$ / sharesshares | |
Disposal Group, Disposed of by Sale, Not Discontinued Operations | Strongbridge Ireland Ltd. | ||
Sale of subsidiary | ||
Consideration for sale of subsidiary | $ 145 | |
Novo | ||
Sale of subsidiary | ||
Termination payment | $ 6 | |
Novo | Ordinary Shares | ||
Sale of subsidiary | ||
Issuance of shares to Novo (in shares) | shares | 5.2 | |
Price per share (in dollars per share) | $ / shares | $ 7 | |
NNI | Services Agreement | ||
Sale of subsidiary | ||
Number of employees funded by counterparty | employee | 23 | |
Term of agreement | 3 years |
Organization - Liquidity (Detai
Organization - Liquidity (Details) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Dec. 31, 2019 | |
Liquidity | ||
Cash and cash equivalents | $ 81,793 | $ 57,032 |
Substantial doubt about going concern, within one year | false |
Summary of significant accoun_4
Summary of significant accounting policies and basis of presentation - Leases (Details) | Sep. 30, 2020 |
Summary of significant accounting policies and basis of presentation | |
Operating Lease, Liability, Statement of Financial Position | sbbp:AccruedLiabilitiesAndOtherLiabilitiesCurrent us-gaap:OtherLiabilitiesNoncurrent |
Summary of significant accoun_5
Summary of significant accounting policies and basis of presentation - Marketable securities and Segment information (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2020USD ($)segment | |
Segment information | |
Marketable securities, noncurrent | $ | $ 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 | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Warrant liability | ||
Net loss per share | ||
Anti-dilutive shares of common stock (in shares) | 7,100,643 | 1,803,253 |
Stock options | ||
Net loss per share | ||
Anti-dilutive shares of common stock (in shares) | 10,146,820 | 10,001,799 |
RSUs | ||
Net loss per share | ||
Anti-dilutive shares of common stock (in shares) | 1,355,660 | 990,700 |
Conversion feature of our outstanding term loan agreement | ||
Net loss per share | ||
Anti-dilutive shares of common stock (in shares) | 1,339,285 |
Revenue recognition - Product s
Revenue recognition - Product sales (Details) | Sep. 30, 2020customer |
Revenue recognition | |
Number of specialty provider | 1 |
Revenue recognition - Reserves
Revenue recognition - Reserves (Details) $ in Millions | 9 Months Ended |
Sep. 30, 2020USD ($) | |
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 | Sep. 30, 2020 | Dec. 31, 2019 |
Assets | ||
Marketable securities | $ 21,072 | |
Liabilities | ||
Warrant liability | $ 3,965 | 4,127 |
Recurring | ||
Assets | ||
Cash equivalents | 58,299 | 56,544 |
Marketable securities | 21,072 | |
Total Assets | 58,299 | 77,616 |
Liabilities | ||
Warrant liability | 3,965 | 4,127 |
Total liabilities | 3,965 | 4,127 |
Recurring | Level I | ||
Assets | ||
Cash equivalents | 58,299 | 56,544 |
Total Assets | 58,299 | 56,544 |
Recurring | Level II | ||
Assets | ||
Marketable securities | 21,072 | |
Total Assets | 21,072 | |
Recurring | Level III | ||
Liabilities | ||
Warrant liability | 3,965 | 4,127 |
Total liabilities | $ 3,965 | $ 4,127 |
Fair value measurements - Level
Fair value measurements - Level 3 (Details) - Warrant liability $ in Thousands | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Reconciliation of level 3: | |
Balance at beginning of period | $ 4,127 |
Unrealized gain on fair value of warrants for nine months ended September 30, 2020 | (162) |
Balance at end of period | $ 3,965 |
Intangible asset and goodwill -
Intangible asset and goodwill - Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Intangible asset and goodwill | ||||
Finite-lived intangible assets, Amortization | $ (1,255) | $ (1,255) | $ (3,766) | $ (3,766) |
Goodwill, Beginning of Period | 7,256 | |||
Goodwill, End of Period | 7,256 | 7,256 | ||
Total, Beginning of Period | 32,366 | |||
Total, End of Period | 28,600 | 28,600 | ||
Keveyis | ||||
Intangible asset and goodwill | ||||
Finite-lived intangible assets, Beginning of Period | 25,110 | |||
Finite-lived intangible assets, Amortization | (3,766) | |||
Finite-lived intangible assets, End of Period | $ 21,344 | $ 21,344 |
Intangible asset and goodwill_2
Intangible asset and goodwill - Asset purchase (Details) $ in Thousands | 1 Months Ended | 3 Months Ended | 9 Months Ended | |||
Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($)installment | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | Sep. 30, 2020USD ($) | Sep. 30, 2019USD ($) | |
In-process research and development and Goodwill | ||||||
Amortization of intangible asset | $ 1,255 | $ 1,255 | $ 3,766 | $ 3,766 | ||
Keveyis | ||||||
In-process research and development and Goodwill | ||||||
Amortization of intangible asset | $ 3,766 | |||||
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 ($) | Sep. 21, 2020 | May 19, 2020 | Sep. 30, 2020 |
Loan agreement | |||
Warrants issued (in shares) | 9,338,500 | ||
Warrants in connection with Avenue Capital loan agreement | |||
Loan agreement | |||
Warrants issued (in shares) | 267,390 | ||
Number of days used for determining weighted average price | 5 days | ||
Warrant term | 5 years | ||
Warrants in connection with Avenue Capital loan agreement | Maximum | |||
Loan agreement | |||
Warrants issued (in shares) | 267,390 | ||
Warrant exercise price (in dollars per share) | $ 1.87 | $ 1.87 | |
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 | Maximum | |||
Loan agreement | |||
Interest-only payment period | 36 months | ||
Convertible portion of debt | $ 3,000,000 | ||
Percent above effective price of equity financing used to determine share price | 20.00% | ||
Term Loan Agreement | Prime Rate | |||
Loan agreement | |||
Spread on reference interest rate (as a percent) | 6.75% | ||
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 | |||
Maximum borrowing capacity | $ 10,000,000 | ||
Commitment fee (as a percent) | 1.00% | ||
Term Loan Agreement, Second Loan | Warrants in connection with Avenue Capital loan agreement | |||
Loan agreement | |||
Percentage of loan divided by exercise price | 5.00% | ||
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 | |||
Loan agreement | |||
Percentage of loan divided by exercise price | 5.00% | ||
Ordinary Shares | Term Loan Agreement | Maximum | |||
Loan agreement | |||
Share 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 | Sep. 30, 2020 |
Future principal payments | ||
2022 | $ 2,917 | |
2023 | 5,000 | |
2024 | 2,083 | |
Total future payments | $ 10,000 | |
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 | Sep. 30, 2020 | Dec. 31, 2019 |
Accrued and other current liabilities | ||
Consulting and professional fees | $ 4,916 | $ 4,335 |
Supply agreement - current portion | 4,391 | 2,773 |
Accrued sales allowances | 2,495 | 2,990 |
Employee compensation | 3,628 | 4,452 |
Accrued taxes | 1,164 | 1,892 |
Severance | 333 | 2,968 |
Lease liability - current portion | 405 | 374 |
Accrued royalties | 301 | 806 |
Other | 139 | 372 |
Total accrued and other current liabilities | $ 17,772 | $ 20,962 |
Commitments and contingencies -
Commitments and contingencies - Commitments to Taro (Details) $ in Millions | Sep. 30, 2020USD ($) |
Acquired product rights | Keveyis | |
Other Commitments | |
Remaining obligation | $ 19 |
Income taxes (Details)
Income taxes (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Components of income tax expense (benefit) | ||||
Income tax expense | $ 0 | $ 691 | $ 0 | $ 1,768 |
COVID19, CARES Act | ||||
Components of income tax expense (benefit) | ||||
Accrued payroll taxes | $ 151 | $ 151 |
Ordinary shares - Equity transa
Ordinary shares - Equity transactions - 2020 (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 15, 2020 | Sep. 21, 2020 | Sep. 30, 2020 | Sep. 30, 2020 |
Equity transactions | ||||
Proceeds from issuance of ordinary shares, net | $ 23,120 | |||
Issuance of shares, Public offering | ||||
Equity transactions | ||||
Proceeds from issuance of ordinary shares, net | $ 23,400 | |||
Subsequent event | Over-allotment option, Underwriters | ||||
Equity transactions | ||||
Proceeds from issuance of ordinary shares, net | $ 700 | |||
Ordinary Shares | Issuance of shares, Public offering | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 11,111,111 | 11,111,111 | 11,111,111 | |
Price per share (in dollars per share) | $ 2.25 | |||
Ordinary Shares | Subsequent event | Over-allotment option, Underwriters | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 349,808 | |||
Share price (in dollars per share) | $ 2.25 |
Ordinary shares - Equity tran_2
Ordinary shares - Equity transactions - ATM facility (Details) - USD ($) $ / shares in Units, $ in Thousands | Apr. 28, 2017 | Sep. 30, 2020 | Sep. 30, 2020 |
Equity transactions | |||
Proceeds from issuance of ordinary shares, net | $ 23,120 | ||
ATM Facility | |||
Equity transactions | |||
Aggregate shares issuable (in dollars) | $ 40,000 | ||
Commission on gross proceeds from sale of shares (as a percent) | 3.00% | ||
Proceeds from issuance of ordinary shares, net | 4,800 | ||
Payment of fees on issuance of ordinary shares | 147 | ||
Amount available for sale | $ 26,000 | $ 26,000 | |
Ordinary Shares | ATM Facility | |||
Equity transactions | |||
Issuance of shares, net of offering costs (in shares) | 1,400,000 | 1,400,000 | |
Price per share (in dollars per share) | $ 3.50 | $ 3.50 |
Ordinary shares - Warrants (Det
Ordinary shares - Warrants (Details) - $ / shares | May 19, 2020 | Sep. 30, 2020 |
Warrants | ||
Warrants Issued (in shares) | 9,338,500 | |
Warrants Outstanding (in shares) | 7,100,643 | |
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 | ||
Warrants | ||
Warrants Issued (in shares) | 267,390 | |
Warrants Outstanding (in shares) | 267,390 | |
Warrants in connection with Avenue Capital loan agreement | Maximum | ||
Warrants | ||
Exercise Price (in dollars per share) | $ 1.87 | $ 1.87 |
Warrants Issued (in shares) | 267,390 |
Stock-based compensation - Gene
Stock-based compensation - General (Details) | Sep. 30, 2020shares |
Inducement Plan | |
Stock-based compensation | |
Number of shares available for issuance | 1,379,403 |
2015 Plan | |
Stock-based compensation | |
Number of shares available for issuance | 21,515 |
Non-Employee Director Plan | |
Stock-based compensation | |
Number of shares available for issuance | 71,029 |
Stock-based compensation - Stoc
Stock-based compensation - Stock options activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2020 | Dec. 31, 2019 | |
Summary of outstanding stock options | ||
Outstanding at beginning of period (in shares) | 9,192,684 | |
Granted (in shares) | 2,516,500 | |
Forfeited and cancelled (in shares) | (1,562,364) | |
Outstanding at end of period (in shares) | 10,146,820 | 9,192,684 |
Vested and exercisable at end of period (in shares) | 5,827,571 | |
Weighted-Average Exercise Price | ||
Granted (in dollars per share) | $ 2.94 | |
Forfeited and cancelled (in dollars per share) | 12.30 | |
Outstanding (in dollars per share) | 4.80 | $ 6.58 |
Vested and exercisable at end of period (in dollars per share) | $ 5.67 | |
Additional Disclosures - Options | ||
Weighted Average Remaining Contractual Term, Outstanding | 6 years 10 months 20 days | 5 years 11 months 15 days |
Weighted Average Remaining Contractual Term, Vested and exercisable | 5 years 7 months 13 days | |
Aggregate Intrinsic Value, Outstanding (in dollars) | $ 195 | $ 164 |
Aggregate Intrinsic Value, Vested and exercisable at end of the period (in dollars) | $ 29 |
Stock-based compensation - Rest
Stock-based compensation - Restricted stock units (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Stock-based compensation | ||||
Stock-based compensation | $ 2,070 | $ 2,175 | $ 5,594 | $ 7,070 |
RSUs | ||||
Stock-based compensation | ||||
Number of shares issued for each stock award vested | 1 | |||
Stock-based compensation | 700 | $ 500 | $ 1,700 | $ 1,300 |
Total unrecognized compensation expense | $ 2,500 | $ 2,500 | ||
Estimated weighted average period over which expense is expected to be recognized | 1 year 4 months 20 days | |||
Summary of unvested RSUs | ||||
Unvested - Beginning of period (in shares) | 791,350 | |||
Granted (in shares) | 910,510 | |||
Forfeited (in shares) | (35,200) | |||
Vested (in shares) | (311,000) | |||
Unvested - End of period (in shares) | 1,355,660 | 1,355,660 | ||
RSUs | Employee | ||||
Stock-based compensation | ||||
Vesting period | 2 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 | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Stock-based compensation expense | ||||
Total stock-based compensation | $ 2,070 | $ 2,175 | $ 5,594 | $ 7,070 |
Stock options | ||||
Stock-based compensation expense | ||||
Total unrecognized compensation expense | 9,900 | $ 9,900 | ||
Estimated weighted average period over which expense is expected to be recognized | 2 years 6 months 7 days | |||
Selling, general and administrative | ||||
Stock-based compensation expense | ||||
Total stock-based compensation | 1,580 | 1,684 | $ 4,130 | 5,475 |
Research and development | ||||
Stock-based compensation expense | ||||
Total stock-based compensation | $ 490 | $ 491 | $ 1,464 | $ 1,595 |
Stock-based compensation - Fair
Stock-based compensation - Fair value assumptions (Details) - Stock options | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Fair value assumptions | ||
Expected term (in years) | 6 years 29 days | 6 years 1 month 17 days |
Minimum Risk-free interest rate (as a percent) | 0.37% | 1.38% |
Maximum Risk-free interest rate (as a percent) | 1.48% | 2.61% |
Minimum Expected volatility (as a percent) | 78.15% | 78.70% |
Maximum Expected volatility (as a percent) | 80.74% | 80.85% |
Subsequent events (Details)
Subsequent events (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 15, 2020 | Sep. 30, 2020 |
Subsequent Event [Line Items] | ||
Proceeds from issuance of ordinary shares, net | $ 23,120 | |
Subsequent event | Over-allotment option, Underwriters | ||
Subsequent Event [Line Items] | ||
Proceeds from issuance of ordinary shares, net | $ 700 | |
Subsequent event | Over-allotment option, Underwriters | Ordinary Shares | ||
Subsequent Event [Line Items] | ||
Issuance of shares, net of offering costs (in shares) | 349,808 | |
Share price (in dollars per share) | $ 2.25 |