Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 22, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Document Annual Report | true | ||
Document Period End Date | Dec. 31, 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 Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
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 | ||
ICFR Auditor Attestation Flag | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 190,614,601 | ||
Entity Common Stock, Shares Outstanding | 67,510,620 | ||
Entity Central Index Key | 0001634432 | ||
Current Fiscal Year End Date | --12-31 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 87,522 | $ 57,032 |
Marketable securities | 21,072 | |
Accounts receivable | 2,801 | 2,289 |
Inventory | 1,103 | 1,993 |
Prepaid expenses and other current assets | 926 | 1,157 |
Total current assets | 92,352 | 83,543 |
Property and equipment, net | 216 | 291 |
Right-of-use asset, net | 597 | 789 |
Intangible asset, net | 20,088 | 25,110 |
Goodwill | 7,256 | 7,256 |
Other assets | 591 | 649 |
Total assets | 121,100 | 117,638 |
Current liabilities: | ||
Accounts payable | 1,483 | 3,331 |
Accrued and other current liabilities | 19,648 | 20,962 |
Total current liabilities | 21,131 | 24,293 |
Long-term debt, net | 17,114 | |
Warrant liability | 4,941 | 4,127 |
Supply agreement liability, noncurrent | 11,556 | 15,947 |
Other long-term liabilities | 753 | 1,080 |
Total liabilities | 55,495 | 45,447 |
Commitments and contingencies (Note 10) | ||
Shareholders' equity: | ||
Deferred shares, $1.098 par value, 40,000 shares authorized, issued and outstanding at December 31, 2020 and December 31, 2019 | 44 | 44 |
Ordinary shares, $0.01 par value, 600,000,000 shares authorized; 67,243,772 and 54,205,852 shares issued and outstanding at December 31, 2020 and December 31, 2019 | 672 | 542 |
Additional paid-in capital | 370,447 | 332,085 |
Accumulated deficit | (305,558) | (260,483) |
Accumulated other comprehensive income | 3 | |
Total shareholders' equity | 65,605 | 72,191 |
Total liabilities and shareholders' equity | $ 121,100 | $ 117,638 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 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 | 67,243,772 | 54,205,852 |
Ordinary shares, shares outstanding | 67,243,772 | 54,205,852 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive (Loss) Income - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Revenues: | |||
Total revenues | $ 30,731 | $ 21,712 | $ 18,027 |
Cost and expenses: | |||
Cost of sales (excluding amortization of intangible asset) | 2,212 | 3,822 | 3,986 |
Selling, general and administrative | 40,867 | 49,058 | 63,336 |
Research and development | 25,795 | 30,903 | 25,441 |
Amortization of intangible asset | 5,022 | 5,022 | 7,187 |
Total cost and expenses | 73,896 | 88,805 | 99,950 |
Operating loss | (43,165) | (67,093) | (81,923) |
Other (expense) income, net: | |||
Interest expense | (1,336) | (12,515) | |
Unrealized (loss) gain on fair value of warrants | (814) | 11,386 | 16,337 |
Income from field services agreement | 12,616 | ||
Expense from field services agreement | (6,652) | ||
Loss on extinguishment of debt | (21,549) | ||
Gain on sale of subsidiary | 130,832 | ||
Other income, net | 225 | 2,060 | 1,205 |
Total other (expense) income, net | (1,925) | 19,410 | 114,310 |
(Loss) income before income taxes | (45,090) | (47,683) | 32,387 |
Income tax benefit (expense) | 15 | (1,768) | (536) |
Net (loss) income | (45,075) | (49,451) | 31,851 |
Other comprehensive loss: | |||
Unrealized (loss) gain on marketable securities | (3) | 3 | |
Comprehensive (loss) income | (45,078) | (49,448) | 31,851 |
Net (loss) income attributable to ordinary shareholders: | |||
Basic | (45,075) | (49,451) | 31,851 |
Diluted | $ (45,075) | $ (60,837) | $ 15,514 |
Net (loss) income per share attributable to ordinary shareholders: | |||
Basic (in dollars per share) | $ (0.78) | $ (0.91) | $ 0.69 |
Diluted (in dollars per share) | $ (0.78) | $ (1.10) | $ 0.31 |
Weighted-average shares used in computing net (loss) income per share attributable to ordinary shareholders: | |||
Basic (in shares) | 57,976,472 | 54,182,499 | 46,297,088 |
Diluted (in shares) | 57,976,472 | 55,383,030 | 49,724,503 |
Product | |||
Revenues: | |||
Total revenues | $ 30,670 | $ 21,676 | $ 18,027 |
Royalty | |||
Revenues: | |||
Total revenues | $ 61 | $ 36 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Ordinary SharesMaximum | Ordinary Shares | Deferred Shares | Additional Paid-In Capital | Accumulated Deficit | Accumulated Other Comprehensive Income (Loss) | Total |
Balance at beginning of period at Dec. 31, 2017 | $ 401 | $ 44 | $ 230,524 | $ (242,883) | $ (11,914) | ||
Balance (in shares) at Dec. 31, 2017 | 40,149,812 | 40,000 | |||||
Increase (Decrease) in Stockholders' Equity | |||||||
Net (loss) income | 31,851 | 31,851 | |||||
Stock-based compensation | 7,807 | 7,807 | |||||
Issuance of warrants and beneficial conversion feature related to the Loan Agreement | 7,663 | 7,663 | |||||
Exercise of stock options | $ 1 | 96 | 96 | ||||
Issuance of shares, net of offering costs | $ 66 | 42,038 | 42,104 | ||||
Issuance of shares, net of offering costs (in shares) | 6,537,586 | ||||||
Issuance of shares to Novo | $ 52 | 22,331 | 22,383 | ||||
Issuance of shares to Novo (in shares) | 5,242,000 | ||||||
Issuance of shares to CRG | $ 7 | 2,798 | 2,805 | ||||
Issuance of shares to CRG (in shares) | 656,929 | ||||||
Exercise of warrants | $ 14 | 10,619 | 10,633 | ||||
Exercise of warrants (in shares) | 1,384,062 | ||||||
Exercise of stock options (in shares) | 50,654 | ||||||
Ordinary shares issued, net of shares withheld for employee taxes | $ 1 | (474) | (473) | ||||
Ordinary shares issued, net of shares withheld for employee taxes (in shares) | 101,031 | ||||||
Balance at end 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) income | (49,451) | (49,451) | |||||
Stock-based compensation | 8,597 | 8,597 | |||||
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 | ||||||
Unrealized (loss) gain on marketable securities | $ 3 | 3 | |||||
Balance at end 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) income | (45,075) | (45,075) | |||||
Stock-based compensation | 7,381 | 7,381 | |||||
Issuance of warrants and beneficial conversion feature related to the Loan Agreement | 2,924 | 2,924 | |||||
Issuance of shares, net of offering costs | $ 128 | 28,473 | 28,601 | ||||
Issuance of shares, net of offering costs (in shares) | 12,860,919 | ||||||
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) gain on marketable securities | $ (3) | (3) | |||||
Balance at end of period at Dec. 31, 2020 | $ 672 | $ 44 | $ 370,447 | $ (305,558) | $ 65,605 | ||
Balance (in shares) at Dec. 31, 2020 | 67,243,772 | 40,000 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flow - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Cash flows from operating activities: | |||
Net (loss) income | $ (45,075) | $ (49,451) | $ 31,851 |
Adjustments to reconcile net (loss) income to net cash used in operating activities: | |||
Stock-based compensation | 7,381 | 8,597 | 7,807 |
Amortization of intangible asset | 5,022 | 5,022 | 7,187 |
Change in fair value of warrant liability | 814 | (11,386) | (16,337) |
Amortization of debt discounts and debt issuance costs | 714 | 1,484 | |
Accretion of discounts on marketable securities | (53) | (385) | |
Depreciation | 85 | 77 | 46 |
Gain on sale of subsidiary | (130,832) | ||
Loss on extinguishment of debt | 21,549 | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | (512) | (663) | (42) |
Inventory | 1,067 | 1,618 | (3,437) |
Prepaid expenses and other current assets | 231 | 3,079 | (3,028) |
Other assets | 73 | (798) | 381 |
Accounts payable | (1,848) | 2,153 | (63) |
Accrued and other liabilities | (6,033) | (2,647) | (1,142) |
Net cash used in operating activities | (38,134) | (44,784) | (84,576) |
Cash flows from investing activities: | |||
Sales and maturities of marketable securities | 21,122 | 35,500 | |
Purchases of property and equipment | (10) | (74) | (326) |
Purchases of marketable securities | (56,187) | ||
Payment for acquisitions | (24,655) | ||
Proceeds from sale of subsidiary | 159,311 | ||
Net cash provided by (used in) investing activities | 21,112 | (20,761) | 134,330 |
Cash flows from financing activities: | |||
Proceeds from issuance of ordinary shares, net | 28,601 | 42,104 | |
Proceeds from long-term debt, net | 19,325 | 44,930 | |
Payments related to tax withholding for net-share settled equity awards | (414) | (92) | (473) |
Payment for loss on extinguishment of debt | (9,990) | ||
Repayment of long-term debt | (85,000) | ||
Proceeds from share subscription to Novo | 22,383 | ||
Proceeds from exercise of warrants | 1,176 | ||
Proceeds from exercise of stock options | 179 | 96 | |
Net cash provided by financing activities | 47,512 | 87 | 15,226 |
Net increase (decrease) in cash and cash equivalents | 30,490 | (65,458) | 64,980 |
Cash and cash equivalents-beginning of period | 57,032 | 122,490 | 57,510 |
Cash and cash equivalents-end of period | 87,522 | 57,032 | 122,490 |
Supplemental disclosures of cash flow information: Cash paid during the year for: | |||
Interest | 622 | 11,122 | |
Income taxes other, net of refunds | 722 | 419 | 1 |
Supplemental non-cash financing activities: | |||
Issuance of shares to settle debt | $ 2,805 | ||
Changes in unrealized gain on marketable securities | $ 6 | $ 3 |
Organization
Organization | 12 Months Ended |
Dec. 31, 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 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 $87.5 million at December 31, 2020 will be sufficient to allow us to fund planned operations for at least 12 months beyond the issuance date of these 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 | 12 Months Ended |
Dec. 31, 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 and principles of consolidation The accompanying consolidated financial statements include the accounts of our wholly owned subsidiaries, Strongbridge U.S. Inc. (Trevose, Pennsylvania, United States), Strongbridge Dublin Limited (Dublin, Ireland), and Cortendo AB (Gothenburg, Sweden). All intercompany balances and transactions have been eliminated in consolidation. These audited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the FASB. Revenue recognition We follow ASC Topic 606, Revenue from Contracts with Customers within each contract, determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for net product revenue, see Note 3. Accounts Receivable Our accounts receivable represents amounts due to us from our product sales, see Note 3. We deduct the trade discount fee to our customer from our accounts receivable. We make judgments as to our ability to collect our outstanding receivables and provide an allowance for receivables when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices as well as historical payment patterns and existing economic factors. We did not have an allowance for doubtful accounts as of December 31, 2020 and 2019. Inventory and cost of sales Inventory is stated at the lower of cost or net realizable value where cost is determined using the first-in, first-out method. Cost of sales includes the cost of inventory sold, which includes third-party acquisition costs, third-party warehousing and product distribution charges. Leases We account for leases in accordance with ASC 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 Other long-term liabilities 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. Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. We must apply significant judgment in this process. Actual results could materially differ from those estimates. 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 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 as one operating segment. Concentration of credit risk and other risks and uncertainties As part of our cash and investment management processes, we perform periodic evaluations of the credit standing of the financial institutions with which we deposit our cash or purchase cash equivalents or marketable securities, and we have not sustained any credit losses from instruments held at these financial institutions. Fair value of financial instruments Fair value accounting is applied for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). We are required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurements and Disclosures the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described as follows: Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date. Level 2—Valuations based on quoted prices for similar assets or liabilities, or quoted prices in markets that are not active, and for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations that require inputs that reflect our own assumptions that are both significant to the fair value measurement and unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment we exercise in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In December 2016, we issued warrants in connection with our private placement of ordinary shares. Pursuant to the terms of the warrant agreement, we could be required to settle the warrants in cash in the event of an acquisition of the Company and, as a result, the warrants are required to be measured at fair value and reported as a liability in the consolidated balance sheet. We recorded the fair value of the warrants upon issuance using the Black-Scholes Model and are required to revalue the warrants at each reporting date with any changes in fair value recorded on our statement of operations. The valuation of the warrants is considered under Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that that are both significant to the fair value measurement and unobservable. The change in the fair value of the Level 3 warrant liabilities is reflected in the statement of operations for the years ended December 31, 2020, 2019 and 2018. Property and equipment, net Property and equipment, net, consists of office equipment such as furniture, fixtures and computers. Depreciation expense for the years ended December 31, 2020 and 2019, was not significant. The following useful lives were used for the various classifications of property and equipment, net: Amortization Periods Computer hardware 3 - 5 years Computer software 2 - 5 years Furniture and fixtures 2 - 5 years Leasehold improvements Lesser of useful life or remaining lease term Intangible assets Certain intangible assets were acquired as part of an asset purchase and have been capitalized at their acquisition date fair value. Acquired definite life intangible assets are amortized using the straight-line method over their respective estimated useful lives. We evaluate the potential impairment of intangible assets if events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. Goodwill We test goodwill for impairment on an annual basis or whenever events occur that may indicate possible impairment. This analysis requires us to make a series of critical assumptions to (1) evaluate whether any impairment exists and (2) measure the amount of impairment. Because we have one reporting unit, when testing for a potential impairment of goodwill, we are required to estimate the fair value of our business and determine the carrying value. If the estimated fair value is less than the carrying value of our business, then we are required to estimate the fair value of all identifiable assets and liabilities in a manner similar to a purchase price allocation for an acquired business. Only after this process is completed can the goodwill impairment be determined, if any. To estimate the fair value of the business, primarily a market-based approach is applied, utilizing our public market value. We did not record a charge for impairment for our goodwill for the years ended December 31, 2020, 2019, and 2018. Stock-based compensation We account for stock-based compensation awards in accordance with ASC Topic 718, Compensation—Stock Compensation We record compensation expense for service-based awards over the vesting period of the award on a straight-line basis. Compensation expense related to awards with performance-based vesting conditions is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. We estimate the fair value of our awards with service conditions using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. We have estimated the expected term of employee service-based stock options using the “simplified” method, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option, due to our lack of sufficient historical data. The risk-free interest rates for periods within the expected term of the option are based on the U.S. Treasury Bond rate with a maturity date commensurate with the expected term of the associated award. We have never paid dividends and do not expect to pay dividends in the foreseeable future. We account for forfeitures as they occur as opposed to estimating forfeitures. We record stock-based compensation expense only for those awards that are expected to vest. Income taxes On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was enacted into law in response to the COVID-19 pandemic. The CARES Act contains numerous income tax provisions, such as enhanced interest deductibility, repeal of the 80% limitation with respect to net operating losses arising in taxable years 2018-2020, and additional depreciation deductions related to qualified improvement property. The Company has concluded its analysis of these provisions as of the 2020 fiscal year-end and has determined that the CARES Act did not have a material impact on the Company’s income taxes for 2020. We recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2020, 2019 and 2018, we had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in our consolidated statements of operations and comprehensive (loss) income. Net (loss) income per share Basic net (loss) income per share is calculated by dividing the net (loss) income attributable to shareholders by the weighted-average number of ordinary shares outstanding during the period. Diluted net (loss) income per share is calculated by dividing the net (loss) income attributable to shareholders by the weighted-average number of ordinary shares outstanding for the period, including any dilutive effect from outstanding stock options and other equity-based awards. Net (loss) income per share was calculated as follows for the periods indicated below: Year Ended December 31, (in thousands, except per share data) 2020 2019 2018 Basic Net (Loss) Income Per Share Basic net (loss) income $ (45,075) $ (49,451) $ 31,851 Unrealized gain on fair value of warrants $ - $ 11,386 $ 16,337 Diluted net (loss) income $ (45,075) $ (60,837) $ 15,514 Weighted-average ordinary shares outstanding 57,976,472 54,182,499 46,297,088 Basic net (loss) income per share $ (0.78) $ (0.91) $ 0.69 Diluted Net (Loss) Income Per Share Diluted net (loss) income $ (45,075) $ (60,837) $ 15,514 Weighted-average ordinary shares outstanding 57,976,472 54,182,499 46,297,088 Dilutive warrants, stock options and RSUs - 1,200,531 3,427,415 Weighted-average shares used to compute diluted net (loss) income per share 57,976,472 55,383,030 49,724,503 Diluted net (loss) income per share $ (0.78) $ (1.10) $ 0.31 Shares used in the diluted net loss per share calculations exclude anti-dilutive ordinary share equivalents, which consist of outstanding stock options, unvested restricted stock units and warrants, if applicable. December 31, 2020 2019 2018 Warrants 7,368,033 1,803,253 1,642,539 Stock options issued and outstanding 8,989,306 9,192,684 4,444,830 Unvested RSUs 1,350,300 791,350 — Conversion feature of our outstanding term loan agreement 1,339,285 — — Recently issued accounting pronouncements In June 2016, the FASB issued ASU No. 2016-13, Financial Instruments - Credit Losses: Measurement of Credit Losses on Financial Instruments |
Revenue recognition
Revenue recognition | 12 Months Ended |
Dec. 31, 2020 | |
Revenue recognition | |
Revenue recognition | 3. Revenue recognition Product revenue, 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. Disaggregation of Revenue The following table summarizes revenue by product for each of the three years in the period ended December 31, 2020 (in thousands): Year Ended Year Ended Year Ended December 31, 2020 December 31, 2019 December 31, 2018 Products Keveyis $ 30,670 $ 21,676 $ 16,802 Macrilen — — 1,225 Total $ 30,670 $ 21,676 $ 18,027 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 : We provide the Customer with a discount that is explicitly stated in our contract and is recorded as a reduction of revenue in the period the related product revenue is recognized. In addition, we receive sales order management, data and distribution services from the Customer. To the extent the services received are distinct from our sale of Keveyis to the Customer, these payments are classified in selling, general and administrative expenses in our consolidated statement of operations and comprehensive (loss) income. Funded Co-pay Assistance Program Government Rebates 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 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 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 | 12 Months Ended |
Dec. 31, 2020 | |
Fair value measurements | |
Fair value measurements | 4. Fair value measurement 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. 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 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 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 December 31, 2020 Balance as of December 31, 2019 $ 4,127 Unrealized loss on fair value of warrants for twelve months ended December 31, 2020 814 Balance as of December 31, 2020 $ 4,941 |
Intangible assets and goodwill
Intangible assets and goodwill | 12 Months Ended |
Dec. 31, 2020 | |
Intangible asset and goodwill | |
Intangible assets and goodwill | 5. Intangible assets and goodwill The gross carrying amount of acquired developed product rights and goodwill is as follows (in thousands): As of December 31, 2020 Beginning of Period Amortization End of Period Keveyis $ 25,110 $ (5,022) $ 20,088 Goodwill 7,256 — 7,256 Total $ 32,366 $ (5,022) $ 27,344 As of December 31, 2019 Beginning of Period Amortization End of Period Keveyis $ 30,132 $ (5,022) $ 25,110 Goodwill 7,256 — 7,256 Total $ 37,388 $ (5,022) $ 32,366 Estimated amortization of our acquired developed product rights intangible asset for the five years subsequent to December 31, 2020 is as follows (in thousands): 2021 5,022 2022 5,022 2023 5,022 2024 5,022 2025 — Our finite-lived intangible asset consists of acquired developed product rights obtained from our acquisition of U.S. marketing rights to 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. We concluded that the supply price payable by us exceeds fair value and, therefore, 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 December 2016. 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. |
Long-term debt
Long-term debt | 12 Months Ended |
Dec. 31, 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 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 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 December 31, 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 $2.24. We have accounted for this term as a beneficial conversion feature, 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. 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”) at $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. The warrant will be 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 this warrant 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. 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 2021 $ — 2022 5,833 2023 10,000 2024 4,167 2025 — Total future payments $ 20,000 |
Accrued liabilities
Accrued liabilities | 12 Months Ended |
Dec. 31, 2020 | |
Accrued liabilities | |
Accrued liabilities | 7. Accrued liabilities Accrued liabilities consist of the following (in thousands): December 31, December 31, 2020 2019 Employee compensation $ 5,749 $ 4,452 Supply agreement - current portion 4,391 2,773 Accrued sales allowances 4,312 2,990 Consulting and professional fees 2,754 4,335 Accrued taxes 1,161 1,892 Severance 493 2,968 Lease liability - current portion 415 374 Accrued royalties 301 806 Other 72 372 Total accrued and other current liabilities $ 19,648 $ 20,962 |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Leases | 8. Leases We lease office space under operating leases. Our leases have initial lease terms ranging from one As of December 31, 2020, future minimum commitments under facility operating leases were as follows (in thousands): Operating leases 2021 481 2022 492 2023 207 Total minimum lease payments $ 1,180 The components of lease cost for the year ended December 31, 2020 are as follows (in thousands): Year Ended December 31, 2020 Lease costs Amortization of right-of-use assets $ 192 Interest on lease liabilities 96 Total lease cost $ 288 Amounts reported in the Consolidated Balance Sheet for leases where we are the lessee as of December 31, 2020 were as follows (in thousands): December 31, 2020 Operating Leases Right-of-use asset, net $ 597 Lease liability current $ 415 Lease liability long-term $ 665 Remaining lease term Operating leases 2 years 5 months Discount rate Operating leases 7.69% |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2020 | |
Warrants | |
Warrants | 9. Warrants Ordinary share warrants are accounted for in accordance with applicable accounting guidance provided in ASC Topic 815 , Derivatives and Hedging — Contracts in Entity’s Own Equity Warrants outstanding and warrant activity for the year ended December 31, 2020 is as follows: Warrants Outstanding Exercise Expiration Warrants Warrants December 31, 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 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 |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments and contingencies | |
Commitments and contingencies | 10. Commitments and contingencies (a) Commitments to Taro Pharmaceuticals Industries Ltd. As of December 31, 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. |
Defined contribution plan
Defined contribution plan | 12 Months Ended |
Dec. 31, 2020 | |
Defined contribution plan | |
Defined Contribution Plan | 11. Defined contribution plan Our 401(k) Employee Savings Plan (“401(k) Plan”) is available to all employees. We have elected a Safe-Harbor provision for the 401(k) Plan in which participants are always fully vested in their employer contributions. We match 100% of the first 4% of participating employee contributions. Our contributions were approximately $573,000, $818,000 and $704,000 for the years ended December 31, 2020, 2019 and 2018, respectively. Our contributions are made in cash. Our ordinary shares are not an investment option available to participants in the 401(k) Plan. |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income taxes | |
Income taxes | 12. Income taxes For the years ended December 31, 2020, 2019 and 2018, the components of income (loss) before income taxes were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Sweden $ (27) $ (1,989) $ 4,712 Ireland (36,859) (23,708) 73,409 Cayman Islands (1) — (1,587) (701) U.S. (8,204) (20,399) (45,033) Total $ (45,090) $ (47,683) $ 32,387 (1) Our Cayman Islands entity was dissolved in 2019. The components of income tax (benefit) expense for the years ended December 31, 2020, 2019 and 2018 were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Current tax (benefit) expense: Sweden $ (17) $ 1,767 $ 535 Ireland — — — U.S. Federal — — — State 2 1 1 Total current tax (benefit) expense $ (15) $ 1,768 $ 536 Deferred tax (benefit) expense: Sweden $ (8) $ — $ 12,395 Ireland (2,549) (8,484) (13,337) U.S. Federal (1,728) (7,914) (1,785) State 425 (784) (354) Change in valuation allowance 3,860 17,182 3,081 Total deferred tax (benefit) expense — — — Total tax (benefit) expense $ (15) $ 1,768 $ 536 We have net operating loss carryforwards in Ireland, Sweden and Unites States. Deferred taxes are recognized for temporary differences between the bases of assets and liabilities for financial statement and income tax purposes. The tax effect of temporary differences that give rise to significant portions of the deferred tax assets are as follows (in thousands): Year Ended December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 17,998 $ 16,283 Stock-based compensation 6,217 6,811 Lease liability 299 404 Intangible amortization 1,256 628 Other deferred activity 353 250 Tax credits 16,786 14,533 Interest disallowance 9,906 9,687 Intangibles 13,240 13,240 Total deferred tax assets 66,055 61,836 Valuation allowance (65,478) (61,617) Deferred tax assets recognized 577 219 Deferred tax liabilities: Lease liability - right-of-use (165) (219) Convertible debt (412) — Total deferred tax liabilities (577) (219) Net deferred tax assets (liabilities) $ — $ — We have evaluated the positive and negative evidence bearing upon the realizability of our deferred tax assets. Based on our history of operating losses, aside from the gain associated with the sale of our subsidiary, we have concluded that it is more likely than not that the benefit of our deferred tax assets will not be realized. The valuation allowance increased by approximately $3.9 million and $17.2 million during the years ended December 31, 2020 and 2019, respectively, due primarily to net operating losses. Our effective income tax rate differs from the ultimate parent company, Strongbridge Biopharma plc, Irish domestic statutory rate of 12.5% for the year ended December 31, 2020, 2019 and 2018. Year Ended December 31, 2020 2019 2018 Ireland statutory income tax rate 12.50 % 12.50 % 12.50 % Foreign tax differential between Sweden, U.S., Cayman Island and Ireland 1.47 1.39 7.55 Federal tax credits 5.00 7.77 (4.58) Change in valuation allowance (9.67) (36.04) 9.51 State income taxes 0.57 1.64 (1.09) Permanent differences (0.56) 2.92 4.01 Provision to return (0.01) 0.53 3.95 Sale of subsidiary — — (37.58) Net operating loss adjustment (4.09) 5.57 7.72 Stock Forfeitures/Cancellations/Expirations (5.18) — — Other — — (0.34) Effective income tax rate 0.03 % (3.72) % 1.65 % At December 31, 2020 we have approximately $72.6 million of Irish and approximately $37 thousand of Swedish net operating losses. These foreign net operating losses have an indefinite life. We also have approximately $26.3 million of U.S. federal and $26.5 million of state net operating losses. Due to recent tax reform, federal U.S. net operating losses generated after January 1, 2018 now have an indefinite life. State net operating losses begin to expire in 2031. At December 31, 2020, we had $16.6 million of U.S. federal orphan drug tax credit carryforwards, which begin to expire in 2032, and $0.2 million of U.S. federal research and development tax credit carryforwards, which begin to expire in 2031. Utilization of the NOLs may be subject to limitations under U.S. Internal Revenue Code Section 382 if there is a greater than 50% ownership change as determined under applicable regulations. We file income tax returns in Sweden, Ireland, the United States, and various states within the United States. In the normal course of business, we are subject to examination by federal, state and foreign jurisdictions, where applicable. Our tax years are still open under statute from inception to present. All open years may be examined to the extent that tax credit or net operating loss carryforwards are used in future periods. 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 December 31, 2020, we have accrued $180,000 of Social Security payroll taxes that will be deferred under the CARES Act. |
Ordinary shares
Ordinary shares | 12 Months Ended |
Dec. 31, 2020 | |
Ordinary shares. | |
Ordinary shares | 13. Ordinary shares Voting rights and privileges As of December 31, 2020, and 2019, there are 600,000,000 authorized ordinary shares and 67,243,772 and 54,205,852 outstanding ordinary shares, respectively. The holders of our ordinary shares are entitled to one vote for each ordinary share held at all meetings of shareholders without limitation and written actions in lieu of meetings. The holders are entitled to receive dividends if and when declared by our Board of Directors. No dividends have been declared or paid since our inception. The holders are entitled to share ratably in our assets available for distribution to stockholders, in the event of any voluntary or involuntary liquidation. In addition, on May 26, 2015, we issued 40,000 deferred shares with a €1.00 par value per share (US$1.098). The deferred shares are issued in order to satisfy an Irish legislative requirement to maintain a minimum level of issued share capital denominated in euro. The deferred shares carry no voting rights and are not entitled to any dividend or distribution. Equity financings 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. For the year ended December 31, 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 December 31, 2020, we have approximately $26 million available for sale under our ATM facility. Shares reserved for issuance There were 10,339,606 and 9,984,034 ordinary shares reserved for future issuance upon exercise of stock options and restricted stock vesting as of December 31, 2020 and 2019, respectively. As of December 31, 2020, we have 7,368,033 ordinary shares reserved for outstanding warrants. |
Stock-based compensation
Stock-based compensation | 12 Months Ended |
Dec. 31, 2020 | |
Stock-based compensation | |
Stock based compensation | 14. 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 December 31, 2020, 1,434,153 ordinary 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 December 31, 2020, 1,074,734 ordinary shares are available for issuance pursuant to the 2015 Plan. 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 December 31, 2020, 71,029 ordinary shares are available for issuance pursuant to the Non-Employee Director Plan. A summary of the outstanding stock options activity for the year ended December 31, 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 2,538,000 $ 2.94 Forfeited, cancelled and expired (2,741,378) $ 9.06 Outstanding—December 31, 2020 8,989,306 $ 4.81 6.58 $ 350 Vested and exercisable—December 31, 2020 5,238,832 $ 5.61 6.59 $ 83 The weighted average grant date fair value of stock options granted during the year ended December 31, 2020 and 2019 was $2.00 and $2.52, respectively. The total fair value of stock options vested during the year ended December 31, 2020 was $5.8 million. Stock-based compensation expense We recognized stock-based compensation expense for employees and non-employees in the accompanying consolidated statements of operations as follows (in thousands): Year Ended December 31, 2020 2019 2018 Selling, general and administrative $ 5,448 $ 6,552 $ 6,012 Research and development 1,933 2,045 1,795 Total stock-based compensation $ 7,381 $ 8,597 $ 7,807 As of December 31, 2020, the total unrecognized compensation expense related to unvested options was $8.5 million, which we expect to recognize over an estimated weighted-average period of 2.35 years. Included in the 2020 stock-based compensation amount is $52,000 of expenses relating to stock option modifications. In determining the estimated fair value of the stock-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 stock option awards was estimated with the following assumptions: Year Ended December 31, 2020 2019 2018 Expected term (in years) 6.08 5.57 6.11 Risk-free interest rate .37%-1.48% 1.38%-2.61% 2.25% - 3.04% Expected volatility 78.15%-81.83% 76.5%-80.85% 78.2% - 85.0% Dividend rate —% —% —% The risk-free interest rate is derived from the U.S. Federal Reserve rate in effect at the time of grant. The expected term is based on the simplified expected term calculations for similar type options. Expected volatility is based on the historical volatility of our common stock over the period commensurate with the expected life of the options. A dividend yield of zero is assumed based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. Restricted stock units We grant RSUs to employees and to members of our board of directors. RSUs that are granted to employees vest anniversary. All RSUs will fully vest upon a change of control of our company. If and when the RSUs vest, we will issue A summary of our unvested RSUs as of December 31, 2020 is as follows: Number of Shares Outstanding—January 1, 2020 791,350 Granted 910,150 Forfeited (40,200) Vested (311,000) Unvested—December 31, 2020 1,350,300 |
Segment and other information
Segment and other information | 12 Months Ended |
Dec. 31, 2020 | |
Segment and other information | |
Segment and other information | 15. Segment and other information Operating segments are identified as components of an enterprise about which separate discreet financial information is available for evaluation by the chief operating decision maker, or decision-making group, in making decisions on how to allocate resources and assess performance. We view our operations and manage our business in one operating segment. All of our sales were in the United States. The following table represents total long-lived assets by location (in thousands): December 31, December 31, 2020 2019 United States $ 216 $ 291 Total long-lived assets (1) $ 216 $ 291 (1) Long-lived assets consist of property and equipment. Customer concentration The following table presents the gross sales from customers that represented more than 10% of our gross sales included in our single operating segment: 2020 2019 Customer A 100% 100% |
Quarterly consolidated financia
Quarterly consolidated financial information (unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly consolidated financial information (unaudited) | |
Quarterly financial information (unaudited) | 16. Quarterly consolidated financial information (unaudited) This table summarizes the unaudited consolidated financial results of operations for the quarters ended: (in thousands, except per share data) March 31, June 30, September 30, December 31, 2020 Quarter Ended Net product sales $ 6,663 $ 7,752 $ 8,053 $ 8,202 Royalty revenues 11 8 18 24 Cost of sales (excluding amortization of intangible asset) 969 393 408 442 Amortization of intangible asset 1,256 1,255 1,255 1,256 Total costs and expenses 17,955 15,790 15,992 16,925 Other income (expense) 808 (7,594) 6,425 (1,564) Income tax benefit — — — 15 Net loss (12,698) (17,272) (3,159) (11,946) Net loss per ordinary share, basic (1) (0.23) (0.32) (0.06) (0.18) Net loss per ordinary share, diluted (1) (0.24) (0.32) (0.18) (0.18) (in thousands, except per share data) March 31, June 30, September 30, December 31, 2019 Quarter Ended Net product sales $ 4,333 $ 6,073 $ 5,677 $ 5,593 Royalty revenues 10 6 7 13 Cost of sales (excluding amortization of intangible asset) 813 1,022 1,001 986 Amortization of intangible asset 1,256 1,255 1,255 1,256 Total costs and expenses 18,683 20,921 20,358 19,999 Other (expense) income (1,348) 9,272 3,831 7,655 Income tax expense (677) (400) (691) — Net loss (18,434) (8,247) (13,790) (8,980) Net loss per ordinary share, basic (1) (0.34) (0.15) (0.25) (0.17) (1) Net loss per share amounts may not agree to the per share for the full year due to the use of weighted-average shares for each period. |
Summary of significant accoun_2
Summary of significant accounting policies and basis of presentation (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of significant accounting policies and basis of presentation | |
Basis of presentation and Principles of consolidation | Basis of presentation and principles of consolidation The accompanying consolidated financial statements include the accounts of our wholly owned subsidiaries, Strongbridge U.S. Inc. (Trevose, Pennsylvania, United States), Strongbridge Dublin Limited (Dublin, Ireland), and Cortendo AB (Gothenburg, Sweden). All intercompany balances and transactions have been eliminated in consolidation. These audited consolidated financial statements have been prepared in conformity with generally accepted accounting principles in the United States (“U.S. GAAP”). Any reference in these notes to applicable guidance is meant to refer to the authoritative U.S. GAAP as found in the Accounting Standards Codification (“ASC”) and Accounting Standards Update (“ASU”) of the FASB. |
Revenue recognition | Revenue recognition We follow ASC Topic 606, Revenue from Contracts with Customers within each contract, determine those that are performance obligations, and assess whether each promised good or service is distinct. We then recognize as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. For a complete discussion of accounting for net product revenue, see Note 3. |
Accounts Receivable | Accounts Receivable Our accounts receivable represents amounts due to us from our product sales, see Note 3. We deduct the trade discount fee to our customer from our accounts receivable. We make judgments as to our ability to collect our outstanding receivables and provide an allowance for receivables when collection becomes doubtful. Provisions are made based upon a specific review of all significant outstanding invoices as well as historical payment patterns and existing economic factors. We did not have an allowance for doubtful accounts as of December 31, 2020 and 2019. |
Inventory and cost of sales | Inventory and cost of sales Inventory is stated at the lower of cost or net realizable value where cost is determined using the first-in, first-out method. Cost of sales includes the cost of inventory sold, which includes third-party acquisition costs, third-party warehousing and product distribution charges. |
Leases | Leases We account for leases in accordance with ASC 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 Other long-term liabilities 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. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts in the financial statements and accompanying notes. We must apply significant judgment in this process. Actual results could materially differ from those estimates. |
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. 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 included in shareholders’ equity. |
Marketable securities | 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 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 as one operating segment. |
Concentration of credit risk and other risks and uncertainties | Concentration of credit risk and other risks and uncertainties As part of our cash and investment management processes, we perform periodic evaluations of the credit standing of the financial institutions with which we deposit our cash or purchase cash equivalents or marketable securities, and we have not sustained any credit losses from instruments held at these financial institutions. |
Fair value of financial instruments | Fair value of financial instruments Fair value accounting is applied for all financial assets and liabilities and non-financial assets and liabilities that are recognized or disclosed at fair value in the financial statements on a recurring basis (at least annually). We are required to disclose information on all assets and liabilities reported at fair value that enables an assessment of the inputs used in determining the reported fair values. ASC Topic 820, Fair Value Measurements and Disclosures the investments and is not a measure of the investment credit quality. The three levels of the fair value hierarchy are described as follows: Level 1—Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date. Level 2—Valuations based on quoted prices for similar assets or liabilities, or quoted prices in markets that are not active, and for which all significant inputs are observable, either directly or indirectly. Level 3—Valuations that require inputs that reflect our own assumptions that are both significant to the fair value measurement and unobservable. To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment we exercise in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In December 2016, we issued warrants in connection with our private placement of ordinary shares. Pursuant to the terms of the warrant agreement, we could be required to settle the warrants in cash in the event of an acquisition of the Company and, as a result, the warrants are required to be measured at fair value and reported as a liability in the consolidated balance sheet. We recorded the fair value of the warrants upon issuance using the Black-Scholes Model and are required to revalue the warrants at each reporting date with any changes in fair value recorded on our statement of operations. The valuation of the warrants is considered under Level 3 of the fair value hierarchy due to the need to use assumptions in the valuation that that are both significant to the fair value measurement and unobservable. The change in the fair value of the Level 3 warrant liabilities is reflected in the statement of operations for the years ended December 31, 2020, 2019 and 2018. |
Property and equipment, net | Property and equipment, net Property and equipment, net, consists of office equipment such as furniture, fixtures and computers. Depreciation expense for the years ended December 31, 2020 and 2019, was not significant. The following useful lives were used for the various classifications of property and equipment, net: Amortization Periods Computer hardware 3 - 5 years Computer software 2 - 5 years Furniture and fixtures 2 - 5 years Leasehold improvements Lesser of useful life or remaining lease term |
Intangible assets | Intangible assets Certain intangible assets were acquired as part of an asset purchase and have been capitalized at their acquisition date fair value. Acquired definite life intangible assets are amortized using the straight-line method over their respective estimated useful lives. We evaluate the potential impairment of intangible assets if events or changes in circumstances indicate that the carrying amount of the assets may not be fully recoverable or that the useful lives of these assets are no longer appropriate. |
Goodwill | Goodwill We test goodwill for impairment on an annual basis or whenever events occur that may indicate possible impairment. This analysis requires us to make a series of critical assumptions to (1) evaluate whether any impairment exists and (2) measure the amount of impairment. Because we have one reporting unit, when testing for a potential impairment of goodwill, we are required to estimate the fair value of our business and determine the carrying value. If the estimated fair value is less than the carrying value of our business, then we are required to estimate the fair value of all identifiable assets and liabilities in a manner similar to a purchase price allocation for an acquired business. Only after this process is completed can the goodwill impairment be determined, if any. To estimate the fair value of the business, primarily a market-based approach is applied, utilizing our public market value. We did not record a charge for impairment for our goodwill for the years ended December 31, 2020, 2019, and 2018. |
Stock-based compensation | Stock-based compensation We account for stock-based compensation awards in accordance with ASC Topic 718, Compensation—Stock Compensation We record compensation expense for service-based awards over the vesting period of the award on a straight-line basis. Compensation expense related to awards with performance-based vesting conditions is recognized over the requisite service period using the accelerated attribution method to the extent achievement of the performance condition is probable. We estimate the fair value of our awards with service conditions using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (i) the expected stock price volatility, (ii) the expected term of the award, (iii) the risk-free interest rate and (iv) expected dividends. We have estimated the expected term of employee service-based stock options using the “simplified” method, whereby the expected term equals the arithmetic average of the vesting term and the original contractual term of the option, due to our lack of sufficient historical data. The risk-free interest rates for periods within the expected term of the option are based on the U.S. Treasury Bond rate with a maturity date commensurate with the expected term of the associated award. We have never paid dividends and do not expect to pay dividends in the foreseeable future. We account for forfeitures as they occur as opposed to estimating forfeitures. We record stock-based compensation expense only for those awards that are expected to vest. |
Income taxes | Income taxes On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (“CARES Act”) was enacted into law in response to the COVID-19 pandemic. The CARES Act contains numerous income tax provisions, such as enhanced interest deductibility, repeal of the 80% limitation with respect to net operating losses arising in taxable years 2018-2020, and additional depreciation deductions related to qualified improvement property. The Company has concluded its analysis of these provisions as of the 2020 fiscal year-end and has determined that the CARES Act did not have a material impact on the Company’s income taxes for 2020. We recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2020, 2019 and 2018, we had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in our consolidated statements of operations and comprehensive (loss) income. |
Net (loss) income per share | Net (loss) income per share Basic net (loss) income per share is calculated by dividing the net (loss) income attributable to shareholders by the weighted-average number of ordinary shares outstanding during the period. Diluted net (loss) income per share is calculated by dividing the net (loss) income attributable to shareholders by the weighted-average number of ordinary shares outstanding for the period, including any dilutive effect from outstanding stock options and other equity-based awards. Net (loss) income per share was calculated as follows for the periods indicated below: Year Ended December 31, (in thousands, except per share data) 2020 2019 2018 Basic Net (Loss) Income Per Share Basic net (loss) income $ (45,075) $ (49,451) $ 31,851 Unrealized gain on fair value of warrants $ - $ 11,386 $ 16,337 Diluted net (loss) income $ (45,075) $ (60,837) $ 15,514 Weighted-average ordinary shares outstanding 57,976,472 54,182,499 46,297,088 Basic net (loss) income per share $ (0.78) $ (0.91) $ 0.69 Diluted Net (Loss) Income Per Share Diluted net (loss) income $ (45,075) $ (60,837) $ 15,514 Weighted-average ordinary shares outstanding 57,976,472 54,182,499 46,297,088 Dilutive warrants, stock options and RSUs - 1,200,531 3,427,415 Weighted-average shares used to compute diluted net (loss) income per share 57,976,472 55,383,030 49,724,503 Diluted net (loss) income per share $ (0.78) $ (1.10) $ 0.31 Shares used in the diluted net loss per share calculations exclude anti-dilutive ordinary share equivalents, which consist of outstanding stock options, unvested restricted stock units and warrants, if applicable. December 31, 2020 2019 2018 Warrants 7,368,033 1,803,253 1,642,539 Stock options issued and outstanding 8,989,306 9,192,684 4,444,830 Unvested RSUs 1,350,300 791,350 — Conversion feature of our outstanding term loan agreement 1,339,285 — — |
Recently issued accounting pronouncements | Recently issued accounting pronouncements In June 2016, the FASB issued ASU No. 2016-13, 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) | 12 Months Ended |
Dec. 31, 2020 | |
Summary of significant accounting policies and basis of presentation | |
Schedule of useful lives of various classification of property and equipment, net | Amortization Periods Computer hardware 3 - 5 years Computer software 2 - 5 years Furniture and fixtures 2 - 5 years Leasehold improvements Lesser of useful life or remaining lease term |
Schedule of Net income (loss) per share | Year Ended December 31, (in thousands, except per share data) 2020 2019 2018 Basic Net (Loss) Income Per Share Basic net (loss) income $ (45,075) $ (49,451) $ 31,851 Unrealized gain on fair value of warrants $ - $ 11,386 $ 16,337 Diluted net (loss) income $ (45,075) $ (60,837) $ 15,514 Weighted-average ordinary shares outstanding 57,976,472 54,182,499 46,297,088 Basic net (loss) income per share $ (0.78) $ (0.91) $ 0.69 Diluted Net (Loss) Income Per Share Diluted net (loss) income $ (45,075) $ (60,837) $ 15,514 Weighted-average ordinary shares outstanding 57,976,472 54,182,499 46,297,088 Dilutive warrants, stock options and RSUs - 1,200,531 3,427,415 Weighted-average shares used to compute diluted net (loss) income per share 57,976,472 55,383,030 49,724,503 Diluted net (loss) income per share $ (0.78) $ (1.10) $ 0.31 |
Schedule of potentially dilutive securities excluded from computations of diluted weighted average shares outstanding | December 31, 2020 2019 2018 Warrants 7,368,033 1,803,253 1,642,539 Stock options issued and outstanding 8,989,306 9,192,684 4,444,830 Unvested RSUs 1,350,300 791,350 — Conversion feature of our outstanding term loan agreement 1,339,285 — — |
Revenue recognition (Tables)
Revenue recognition (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue recognition | |
Schedule of disaggregation of revenue | The following table summarizes revenue by product for each of the three years in the period ended December 31, 2020 (in thousands): Year Ended Year Ended Year Ended December 31, 2020 December 31, 2019 December 31, 2018 Products Keveyis $ 30,670 $ 21,676 $ 16,802 Macrilen — — 1,225 Total $ 30,670 $ 21,676 $ 18,027 |
Fair value measurements (Tables
Fair value measurements (Tables) | 12 Months Ended |
Dec. 31, 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 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 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 December 31, 2020 Balance as of December 31, 2019 $ 4,127 Unrealized loss on fair value of warrants for twelve months ended December 31, 2020 814 Balance as of December 31, 2020 $ 4,941 |
Intangible assets and goodwill
Intangible assets and goodwill (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Intangible asset and goodwill | |
Schedule of gross carrying amount of acquired developed product rights and goodwill | The gross carrying amount of acquired developed product rights and goodwill is as follows (in thousands): As of December 31, 2020 Beginning of Period Amortization End of Period Keveyis $ 25,110 $ (5,022) $ 20,088 Goodwill 7,256 — 7,256 Total $ 32,366 $ (5,022) $ 27,344 As of December 31, 2019 Beginning of Period Amortization End of Period Keveyis $ 30,132 $ (5,022) $ 25,110 Goodwill 7,256 — 7,256 Total $ 37,388 $ (5,022) $ 32,366 |
Schedule of estimated amortization of our acquired developed product rights intangible asset | Estimated amortization of our acquired developed product rights intangible asset for the five years subsequent to December 31, 2020 is as follows (in thousands): 2021 5,022 2022 5,022 2023 5,022 2024 5,022 2025 — |
Long-term debt (Tables)
Long-term debt (Tables) | 12 Months Ended |
Dec. 31, 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 2021 $ — 2022 5,833 2023 10,000 2024 4,167 2025 — Total future payments $ 20,000 |
Accrued liabilities (Tables)
Accrued liabilities (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accrued liabilities | |
Schedule of accrued and other current liabilities | Accrued liabilities consist of the following (in thousands): December 31, December 31, 2020 2019 Employee compensation $ 5,749 $ 4,452 Supply agreement - current portion 4,391 2,773 Accrued sales allowances 4,312 2,990 Consulting and professional fees 2,754 4,335 Accrued taxes 1,161 1,892 Severance 493 2,968 Lease liability - current portion 415 374 Accrued royalties 301 806 Other 72 372 Total accrued and other current liabilities $ 19,648 $ 20,962 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases | |
Schedule of future minimum commitments under facility operating leases | As of December 31, 2020, future minimum commitments under facility operating leases were as follows (in thousands): Operating leases 2021 481 2022 492 2023 207 Total minimum lease payments $ 1,180 |
Schedule of components of lease cost | The components of lease cost for the year ended December 31, 2020 are as follows (in thousands): Year Ended December 31, 2020 Lease costs Amortization of right-of-use assets $ 192 Interest on lease liabilities 96 Total lease cost $ 288 |
Schedule of amounts reported for leases in consolidated balance sheets | Amounts reported in the Consolidated Balance Sheet for leases where we are the lessee as of December 31, 2020 were as follows (in thousands): December 31, 2020 Operating Leases Right-of-use asset, net $ 597 Lease liability current $ 415 Lease liability long-term $ 665 Remaining lease term Operating leases 2 years 5 months Discount rate Operating leases 7.69% |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Warrants | |
Schedule of warrants | Warrants Outstanding Exercise Expiration Warrants Warrants December 31, 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 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 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income taxes | |
Schedule of components of loss before income taxes | For the years ended December 31, 2020, 2019 and 2018, the components of income (loss) before income taxes were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Sweden $ (27) $ (1,989) $ 4,712 Ireland (36,859) (23,708) 73,409 Cayman Islands (1) — (1,587) (701) U.S. (8,204) (20,399) (45,033) Total $ (45,090) $ (47,683) $ 32,387 |
Schedule of components of income tax (benefit) expense | The components of income tax (benefit) expense for the years ended December 31, 2020, 2019 and 2018 were as follows (in thousands): Year Ended December 31, 2020 2019 2018 Current tax (benefit) expense: Sweden $ (17) $ 1,767 $ 535 Ireland — — — U.S. Federal — — — State 2 1 1 Total current tax (benefit) expense $ (15) $ 1,768 $ 536 Deferred tax (benefit) expense: Sweden $ (8) $ — $ 12,395 Ireland (2,549) (8,484) (13,337) U.S. Federal (1,728) (7,914) (1,785) State 425 (784) (354) Change in valuation allowance 3,860 17,182 3,081 Total deferred tax (benefit) expense — — — Total tax (benefit) expense $ (15) $ 1,768 $ 536 |
Schedule of tax effect of temporary differences that give rise to significant portions of the deferred tax assets | The tax effect of temporary differences that give rise to significant portions of the deferred tax assets are as follows (in thousands): Year Ended December 31, 2020 2019 Deferred tax assets: Net operating loss carryforwards $ 17,998 $ 16,283 Stock-based compensation 6,217 6,811 Lease liability 299 404 Intangible amortization 1,256 628 Other deferred activity 353 250 Tax credits 16,786 14,533 Interest disallowance 9,906 9,687 Intangibles 13,240 13,240 Total deferred tax assets 66,055 61,836 Valuation allowance (65,478) (61,617) Deferred tax assets recognized 577 219 Deferred tax liabilities: Lease liability - right-of-use (165) (219) Convertible debt (412) — Total deferred tax liabilities (577) (219) Net deferred tax assets (liabilities) $ — $ — |
Schedule of effective tax rate reconciliation to statutory rate | Year Ended December 31, 2020 2019 2018 Ireland statutory income tax rate 12.50 % 12.50 % 12.50 % Foreign tax differential between Sweden, U.S., Cayman Island and Ireland 1.47 1.39 7.55 Federal tax credits 5.00 7.77 (4.58) Change in valuation allowance (9.67) (36.04) 9.51 State income taxes 0.57 1.64 (1.09) Permanent differences (0.56) 2.92 4.01 Provision to return (0.01) 0.53 3.95 Sale of subsidiary — — (37.58) Net operating loss adjustment (4.09) 5.57 7.72 Stock Forfeitures/Cancellations/Expirations (5.18) — — Other — — (0.34) Effective income tax rate 0.03 % (3.72) % 1.65 % |
Stock-based compensation (Table
Stock-based compensation (Tables) | 12 Months Ended |
Dec. 31, 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 2,538,000 $ 2.94 Forfeited, cancelled and expired (2,741,378) $ 9.06 Outstanding—December 31, 2020 8,989,306 $ 4.81 6.58 $ 350 Vested and exercisable—December 31, 2020 5,238,832 $ 5.61 6.59 $ 83 |
Schedule of stock-based compensation | We recognized stock-based compensation expense for employees and non-employees in the accompanying consolidated statements of operations as follows (in thousands): Year Ended December 31, 2020 2019 2018 Selling, general and administrative $ 5,448 $ 6,552 $ 6,012 Research and development 1,933 2,045 1,795 Total stock-based compensation $ 7,381 $ 8,597 $ 7,807 |
Schedule of assumptions for estimating fair value of stock option awards | Year Ended December 31, 2020 2019 2018 Expected term (in years) 6.08 5.57 6.11 Risk-free interest rate .37%-1.48% 1.38%-2.61% 2.25% - 3.04% Expected volatility 78.15%-81.83% 76.5%-80.85% 78.2% - 85.0% Dividend rate —% —% —% |
Schedule of summary of unvested RSUs | Number of Shares Outstanding—January 1, 2020 791,350 Granted 910,150 Forfeited (40,200) Vested (311,000) Unvested—December 31, 2020 1,350,300 |
Segment and other information (
Segment and other information (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Segment and other information | |
Schedule of long-lived assets by location | The following table represents total long-lived assets by location (in thousands): December 31, December 31, 2020 2019 United States $ 216 $ 291 Total long-lived assets (1) $ 216 $ 291 (1) Long-lived assets consist of property and equipment. |
Schedule of customer concentration | The following table presents the gross sales from customers that represented more than 10% of our gross sales included in our single operating segment: 2020 2019 Customer A 100% 100% |
Quarterly consolidated financ_2
Quarterly consolidated financial information (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly consolidated financial information (unaudited) | |
Schedule of unaudited quarterly consolidated financial information | (in thousands, except per share data) March 31, June 30, September 30, December 31, 2020 Quarter Ended Net product sales $ 6,663 $ 7,752 $ 8,053 $ 8,202 Royalty revenues 11 8 18 24 Cost of sales (excluding amortization of intangible asset) 969 393 408 442 Amortization of intangible asset 1,256 1,255 1,255 1,256 Total costs and expenses 17,955 15,790 15,992 16,925 Other income (expense) 808 (7,594) 6,425 (1,564) Income tax benefit — — — 15 Net loss (12,698) (17,272) (3,159) (11,946) Net loss per ordinary share, basic (1) (0.23) (0.32) (0.06) (0.18) Net loss per ordinary share, diluted (1) (0.24) (0.32) (0.18) (0.18) (in thousands, except per share data) March 31, June 30, September 30, December 31, 2019 Quarter Ended Net product sales $ 4,333 $ 6,073 $ 5,677 $ 5,593 Royalty revenues 10 6 7 13 Cost of sales (excluding amortization of intangible asset) 813 1,022 1,001 986 Amortization of intangible asset 1,256 1,255 1,255 1,256 Total costs and expenses 18,683 20,921 20,358 19,999 Other (expense) income (1,348) 9,272 3,831 7,655 Income tax expense (677) (400) (691) — Net loss (18,434) (8,247) (13,790) (8,980) Net loss per ordinary share, basic (1) (0.34) (0.15) (0.25) (0.17) (1) Net loss per share amounts may not agree to the per share for the full year due to the use of weighted-average shares for each period. |
Organization - Liquidity (Detai
Organization - Liquidity (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Liquidity | ||
Cash and cash equivalents | $ 87,522 | $ 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 - Accounts Receivable (Details) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2019 |
Accounts Receivable | ||
Allowance for doubtful accounts | $ 0 | $ 0 |
Summary of significant accoun_5
Summary of significant accounting policies and basis of presentation - Leases (Details) | Dec. 31, 2020 |
Summary of significant accounting policies and basis of presentation | |
Operating Lease, Liability, Statement of Financial Position | sbbp:AccruedLiabilitiesAndOtherLiabilitiesCurrent |
Operating Lease, Liability, Noncurrent, Statement of Financial Position | us-gaap:OtherLiabilitiesNoncurrent |
Summary of significant accoun_6
Summary of significant accounting policies and basis of presentation - Marketable securities and Segment information (Details) $ in Millions | 12 Months Ended |
Dec. 31, 2020USD ($)segment | |
Segment information | |
Marketable securities, noncurrent | $ | $ 0 |
Number of operating segments | segment | 1 |
Summary of significant accoun_7
Summary of significant accounting policies and basis of presentation - Property and equipment, net (Details) | 12 Months Ended |
Dec. 31, 2020 | |
Computer hardware | Minimum | |
Property and equipment, net | |
Amortization Periods | 3 years |
Computer hardware | Maximum | |
Property and equipment, net | |
Amortization Periods | 5 years |
Computer software | Minimum | |
Property and equipment, net | |
Amortization Periods | 2 years |
Computer software | Maximum | |
Property and equipment, net | |
Amortization Periods | 5 years |
Furniture and fixtures | Minimum | |
Property and equipment, net | |
Amortization Periods | 2 years |
Furniture and fixtures | Maximum | |
Property and equipment, net | |
Amortization Periods | 5 years |
Summary of significant accoun_8
Summary of significant accounting policies and basis of presentation - Goodwill (Details) | 12 Months Ended |
Dec. 31, 2020item | |
Goodwill | |
Number of reporting units | 1 |
Summary of significant accoun_9
Summary of significant accounting policies and basis of presentation - Income taxes (Details) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income taxes | |||
Accrued interest or penalties related to uncertain tax positions | $ 0 | $ 0 | $ 0 |
Interest or penalties related to uncertain tax positions | $ 0 | $ 0 | $ 0 |
Summary of significant accou_10
Summary of significant accounting policies and basis of presentation - Net loss per share (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Basic Net (Loss) Income Per Share | |||||||||||
Basic net (loss) income | $ (45,075) | $ (49,451) | $ 31,851 | ||||||||
Unrealized gain on fair value of warrants | (11,386) | (16,337) | |||||||||
Diluted net (loss) income | $ (45,075) | $ (60,837) | $ 15,514 | ||||||||
Weighted-average ordinary shares outstanding (in shares) | 57,976,472 | 54,182,499 | 46,297,088 | ||||||||
Basic (in dollars per share) | $ (0.18) | $ (0.06) | $ (0.32) | $ (0.23) | $ (0.17) | $ (0.25) | $ (0.15) | $ (0.34) | $ (0.78) | $ (0.91) | $ 0.69 |
Diluted Net (Loss) Income Per Share | |||||||||||
Diluted net (loss) income | $ (45,075) | $ (60,837) | $ 15,514 | ||||||||
Weighted-average ordinary shares outstanding (in shares) | 57,976,472 | 54,182,499 | 46,297,088 | ||||||||
Dilutive warrants, stock options and RSUs | 1,200,531 | 3,427,415 | |||||||||
Weighted-average shares used to compute diluted net (loss) income per share | 57,976,472 | 55,383,030 | 49,724,503 | ||||||||
Diluted (in dollars per share) | $ (0.18) | $ (0.18) | $ (0.32) | $ (0.24) | $ (0.78) | $ (1.10) | $ 0.31 |
Summary of significant accou_11
Summary of significant accounting policies and basis of presentation - Anti-dilutive securities (Details) - shares | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Warrant liability | |||
Net loss per share | |||
Anti-dilutive shares of common stock (in shares) | 7,368,033 | 1,803,253 | 1,642,539 |
Stock options | |||
Net loss per share | |||
Anti-dilutive shares of common stock (in shares) | 8,989,306 | 9,192,684 | 4,444,830 |
RSUs | |||
Net loss per share | |||
Anti-dilutive shares of common stock (in shares) | 1,350,300 | 791,350 | |
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 - Disaggreg
Revenue recognition - Disaggregation of Revenue (Details) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020USD ($)customer | Sep. 30, 2020USD ($) | Jun. 30, 2020USD ($) | Mar. 31, 2020USD ($) | Dec. 31, 2019USD ($) | Sep. 30, 2019USD ($) | Jun. 30, 2019USD ($) | Mar. 31, 2019USD ($) | Dec. 31, 2020USD ($)customer | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Revenue by product | |||||||||||
Number of specialty provider | customer | 1 | 1 | |||||||||
Total revenues | $ 30,731 | $ 21,712 | $ 18,027 | ||||||||
Product | |||||||||||
Revenue by product | |||||||||||
Total revenues | $ 8,202 | $ 8,053 | $ 7,752 | $ 6,663 | $ 5,593 | $ 5,677 | $ 6,073 | $ 4,333 | 30,670 | 21,676 | 18,027 |
Keveyis | |||||||||||
Revenue by product | |||||||||||
Total revenues | $ 30,670 | $ 21,676 | 16,802 | ||||||||
Macrilen | |||||||||||
Revenue by product | |||||||||||
Total revenues | $ 1,225 |
Revenue recognition - Reserves
Revenue recognition - Reserves (Details) $ in Millions | 12 Months Ended |
Dec. 31, 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 | Dec. 31, 2020 | Dec. 31, 2019 |
Assets | ||
Marketable securities | $ 21,072 | |
Liabilities | ||
Warrant liability | $ 4,941 | 4,127 |
Recurring | ||
Assets | ||
Cash equivalents | 86,775 | 56,544 |
Marketable securities | 21,072 | |
Total Assets | 86,775 | 77,616 |
Liabilities | ||
Warrant liability | 4,941 | 4,127 |
Total liabilities | 4,941 | 4,127 |
Recurring | Level I | ||
Assets | ||
Cash equivalents | 86,775 | 56,544 |
Total Assets | 86,775 | 56,544 |
Recurring | Level II | ||
Assets | ||
Marketable securities | 21,072 | |
Total Assets | 21,072 | |
Recurring | Level III | ||
Liabilities | ||
Warrant liability | 4,941 | 4,127 |
Total liabilities | $ 4,941 | $ 4,127 |
Fair value measurements - Level
Fair value measurements - Level 3 (Details) - Warrant liability $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Reconciliation of level 3: | |
Balance at beginning of period | $ 4,127 |
Unrealized loss on fair value of warrants for twelve months ended December 31, 2020 | 814 |
Balance at end of period | $ 4,941 |
Intangible asset and goodwill -
Intangible asset and goodwill - Components (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Intangible asset and goodwill | |||||||||||
Finite-lived intangible assets, Amortization | $ (1,256) | $ (1,255) | $ (1,255) | $ (1,256) | $ (1,256) | $ (1,255) | $ (1,255) | $ (1,256) | $ (5,022) | $ (5,022) | $ (7,187) |
Goodwill, Beginning of Period | 7,256 | 7,256 | 7,256 | 7,256 | |||||||
Goodwill, End of Period | 7,256 | 7,256 | 7,256 | 7,256 | 7,256 | ||||||
Total, Beginning of Period | 32,366 | 37,388 | 32,366 | 37,388 | |||||||
Total, End of Period | 27,344 | 32,366 | 27,344 | 32,366 | 37,388 | ||||||
Keveyis | |||||||||||
Intangible asset and goodwill | |||||||||||
Finite-lived intangible assets, Beginning of Period | $ 25,110 | $ 30,132 | 25,110 | 30,132 | |||||||
Finite-lived intangible assets, Amortization | (5,022) | (5,022) | |||||||||
Finite-lived intangible assets, End of Period | $ 20,088 | $ 25,110 | $ 20,088 | $ 25,110 | $ 30,132 |
Intangible assets and goodwil_2
Intangible assets and goodwill - Amortization maturity schedule (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Amortization of intangible asset | |
2021 | $ 5,022 |
2022 | 5,022 |
2023 | 5,022 |
2024 | $ 5,022 |
Intangible asset and goodwill_2
Intangible asset and goodwill - Asset purchase (Details) - Acquired product rights - Keveyis $ in Millions | 1 Months Ended | |
Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($)installment | |
In-process research and development and Goodwill | ||
Number of installment payments | installment | 2 | |
Installment payment | $ 7.5 | $ 1 |
Payments in excess of fair value | 29.3 | |
Transaction costs | 2.4 | |
Acquired product rights | $ 40.2 | |
Estimated life | 8 years |
Long-term debt - Agreements (De
Long-term debt - Agreements (Details) - USD ($) $ / shares in Units, $ in Millions | May 19, 2020 | Dec. 31, 2020 | Sep. 30, 2020 |
Loan agreement | |||
Warrants issued (in shares) | 9,605,890 | ||
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 | ||
Warrants in connection with Avenue Capital loan agreement, One | Maximum | |||
Loan agreement | |||
Warrants issued (in shares) | 267,390 | ||
Term Loan Agreement | |||
Loan agreement | |||
Maximum borrowing capacity | $ 30 | ||
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 | $ 0.2 | ||
Term Loan Agreement | Maximum | |||
Loan agreement | |||
Interest-only payment period | 36 months | ||
Convertible portion of debt | $ 3 | ||
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 | ||
Commitment fee (as a percent) | 1.00% | ||
Term Loan Agreement, Second Loan | |||
Loan agreement | |||
Term loan | $ 10 | ||
Commitment fee (as a percent) | 1.00% | ||
Term Loan Agreement, Third Loan | |||
Loan agreement | |||
Maximum borrowing capacity | $ 10 | ||
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 | |||
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 | Dec. 31, 2020 |
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 liabilities (Details)
Accrued liabilities (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Accrued liabilities | ||
Employee compensation | $ 5,749 | $ 4,452 |
Supply agreement - current portion | 4,391 | 2,773 |
Accrued sales allowances | 4,312 | 2,990 |
Consulting and professional fees | 2,754 | 4,335 |
Accrued taxes | 1,161 | 1,892 |
Severance | 493 | 2,968 |
Lease liability - current portion | 415 | 374 |
Accrued royalties | 301 | 806 |
Other | 72 | 372 |
Total accrued and other current liabilities | $ 19,648 | $ 20,962 |
Operating Lease, Liability, Current, Statement of Financial Position | sbbp:AccruedLiabilitiesAndOtherLiabilitiesCurrent | sbbp:AccruedLiabilitiesAndOtherLiabilitiesCurrent |
Leases - Future minimum commitm
Leases - Future minimum commitments (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Future minimum commitments under facility operating leases: | |
2021 | $ 481 |
2022 | 492 |
2023 | 207 |
Total minimum lease payments | $ 1,180 |
Minimum | |
Leases | |
Initial lease term | 1 year |
Maximum | |
Leases | |
Initial lease term | 5 years |
Leases - Components of lease co
Leases - Components of lease cost (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Lease costs | |
Amortization of right of use assets | $ 192 |
Interest on lease liabilities | 96 |
Total lease cost | $ 288 |
Leases - Balance sheet location
Leases - Balance sheet location (Details) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Leases | ||
Right of use asset, net | $ 597 | $ 789 |
Lease liability current | $ 415 | $ 374 |
Operating Lease, Liability, Statement of Financial Position | sbbp:AccruedLiabilitiesAndOtherLiabilitiesCurrent | |
Lease liability long-term | $ 665 | |
Operating Lease, Liability, Noncurrent, Statement of Financial Position | us-gaap:OtherLiabilitiesNoncurrent | |
Remaining lease term - Operating leases | 2 years 5 months | |
Discount rate - Operating leases | 7.69% |
Warrants (Details)
Warrants (Details) - $ / shares | May 19, 2020 | Dec. 31, 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 in connection with Avenue Capital loan agreement, One | Maximum | ||
Warrants | ||
Warrants Issued (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 |
Commitments and contingencies -
Commitments and contingencies - Commitments to Taro (Details) $ in Millions | Dec. 31, 2020USD ($) |
Acquired product rights | Keveyis | |
Other Commitments | |
Remaining obligation | $ 19 |
Defined contribution plan (Deta
Defined contribution plan (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Defined contribution plan | |||
Percentage of employee's percentage contribution matched | 100.00% | ||
Percentage of employees' pay matched | 4.00% | ||
Amount contributed | $ 573 | $ 818 | $ 704 |
Income taxes - Components of in
Income taxes - Components of income (loss) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Components of income (loss) before income taxes | |||
Loss before income taxes | $ (45,090) | $ (47,683) | $ 32,387 |
Sweden | |||
Components of income (loss) before income taxes | |||
Loss before income taxes | (27) | (1,989) | 4,712 |
Ireland | |||
Components of income (loss) before income taxes | |||
Loss before income taxes | (36,859) | (23,708) | 73,409 |
Cayman Islands | |||
Components of income (loss) before income taxes | |||
Loss before income taxes | (1,587) | (701) | |
U.S. | |||
Components of income (loss) before income taxes | |||
Loss before income taxes | $ (8,204) | $ (20,399) | $ (45,033) |
Income taxes - Components of _2
Income taxes - Components of income tax (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Components of income tax expense (benefit) | |||||||
Current tax (benefit) expense | $ (15) | $ 1,768 | $ 536 | ||||
Change in valuation allowance | 3,860 | 17,182 | 3,081 | ||||
Total tax (benefit) expense | $ (15) | $ 691 | $ 400 | $ 677 | (15) | 1,768 | 536 |
Income tax expense arising from intercompany interest income | 1,800 | ||||||
Sweden | |||||||
Components of income tax expense (benefit) | |||||||
Current tax (benefit) expense | (17) | 1,767 | 535 | ||||
Deferred tax (benefit) expense | (8) | 12,395 | |||||
Income tax benefit arising from a true-up | 15 | ||||||
Ireland | |||||||
Components of income tax expense (benefit) | |||||||
Deferred tax (benefit) expense | (2,549) | (8,484) | (13,337) | ||||
U.S. | Federal | |||||||
Components of income tax expense (benefit) | |||||||
Deferred tax (benefit) expense | (1,728) | (7,914) | (1,785) | ||||
U.S. | State | |||||||
Components of income tax expense (benefit) | |||||||
Current tax (benefit) expense | 2 | 1 | 1 | ||||
Deferred tax (benefit) expense | $ 425 | $ (784) | $ (354) |
Income taxes - Deferred taxes (
Income taxes - Deferred taxes (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Deferred tax assets: | ||
Net operating loss carryforwards | $ 17,998 | $ 16,283 |
Stock based compensation | 6,217 | 6,811 |
Lease Liability | 299 | 404 |
Intangible amortization | 1,256 | 628 |
Other deferred activity | 353 | 250 |
Tax credits | 16,786 | 14,533 |
Interest disallowance | 9,906 | 9,687 |
Intangibles | 13,240 | 13,240 |
Total deferred tax assets | 66,055 | 61,836 |
Valuation allowance | (65,478) | (61,617) |
Deferred tax assets recognized | 577 | 219 |
Deferred tax liabilities: | ||
Lease liability - right-of-use | (165) | (219) |
Convertible debt | (412) | |
Total deferred tax liabilities | (577) | (219) |
Net deferred tax assets (liabilities) | ||
Increase in valuation allowance | $ 3,900 | $ 17,200 |
Income taxes - Effective tax ra
Income taxes - Effective tax rate (Details) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Schedule of effective tax rate of our benefit for income taxes differs from the statutory rate | |||
Ireland statutory income tax rate | 12.50% | 12.50% | 12.50% |
Foreign tax differential between Sweden, U.S., Cayman Island and Ireland | 1.47% | 1.39% | 7.55% |
Federal tax credits | 5.00% | 7.77% | (4.58%) |
Change in valuation allowance | (9.67%) | (36.04%) | 9.51% |
State income taxes | 0.57% | 1.64% | (1.09%) |
Permanent differences | (0.56%) | 2.92% | 4.01% |
Provision to return | (0.01%) | 0.53% | 3.95% |
Sale of subsidiary | (37.58%) | ||
Net operating loss adjustment | (4.09%) | 5.57% | 7.72% |
Stock Forfeitures/Cancellations/Expirations | (5.18%) | ||
Other | (0.34%) | ||
Effective income tax rate | 0.03% | (3.72%) | 1.65% |
Income taxes - NOLs (Details)
Income taxes - NOLs (Details) $ in Thousands | Dec. 31, 2020USD ($) |
Sweden | |
Operating Loss Carryforwards | |
NOLs | $ 37 |
Ireland | |
Operating Loss Carryforwards | |
NOLs | 72,600 |
U.S. | Federal | |
Operating Loss Carryforwards | |
NOLs | 26,300 |
U.S. | State | |
Operating Loss Carryforwards | |
NOLs | $ 26,500 |
Income taxes - Tax credit carry
Income taxes - Tax credit carryforwards (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
U.S. | |
Tax credit carryforward | |
Ownership change threshold (as a percent) | 50.00% |
U.S. | Orphan drug tax credit carryforward | Federal | |
Tax credit carryforward | |
Tax credit carryforward | $ 16,600 |
U.S. | Research and development tax credit carryforward | Federal | |
Tax credit carryforward | |
Tax credit carryforward | 200 |
COVID19, CARES Act | |
Tax credit carryforward | |
Accrued payroll taxes | $ 180 |
Ordinary shares - Voting rights
Ordinary shares - Voting rights and privileges (Details) | May 26, 2015$ / sharesshares | Dec. 31, 2020item$ / sharesshares | Dec. 31, 2020$ / sharesshares | Dec. 31, 2019$ / sharesshares | May 26, 2015€ / shares |
Voting rights and privileges | |||||
Ordinary shares, shares authorized | shares | 600,000,000 | 600,000,000 | 600,000,000 | ||
Ordinary shares, shares outstanding | shares | 67,243,772 | 67,243,772 | 54,205,852 | ||
Number of votes per ordinary share | item | 1 | ||||
Dividends declared (in dollars per share) | $ / shares | $ 0 | ||||
Dividends paid (in dollars per share) | $ / shares | 0 | ||||
Deferred shares, par value (in dollars/euro per share) | $ / shares | $ 1.098 | $ 1.098 | $ 1.098 | ||
Deferred Shares | |||||
Voting rights and privileges | |||||
Beneficial shares issued (in shares) | shares | 40,000 | ||||
Deferred shares, par value (in dollars/euro per share) | (per share) | $ 1.098 | € 1 | |||
Number of votes per deferred share | item | 0 |
Ordinary shares - Equity transa
Ordinary shares - Equity transactions - 2020 (Details) - USD ($) $ / shares in Units, $ in Thousands | Oct. 15, 2020 | Sep. 21, 2020 | Dec. 31, 2020 | Dec. 31, 2018 |
Equity transactions | ||||
Proceeds from issuance of ordinary shares, net | $ 28,601 | $ 42,104 | ||
Issuance of shares, Public offering | ||||
Equity transactions | ||||
Proceeds from issuance of ordinary shares, net | $ 23,400 | |||
Over-allotment option, Underwriters | ||||
Equity transactions | ||||
Proceeds from issuance of ordinary shares, net | $ 700 | |||
Ordinary Shares | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 12,860,919 | 6,537,586 | ||
Ordinary Shares | Issuance of shares, Public offering | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 11,111,111 | |||
Price per share (in dollars per share) | $ 2.25 | |||
Ordinary Shares | 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 | Oct. 15, 2020 | Apr. 28, 2017 | Dec. 31, 2020 | Dec. 31, 2018 |
Equity transactions | ||||
Proceeds from issuance of ordinary shares, net | $ 28,601 | $ 42,104 | ||
Over-allotment option, Underwriters | ||||
Equity transactions | ||||
Proceeds from issuance of ordinary shares, net | $ 700 | |||
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 | |||
Ordinary Shares | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 12,860,919 | 6,537,586 | ||
Ordinary Shares | 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 | ATM Facility | ||||
Equity transactions | ||||
Issuance of shares, net of offering costs (in shares) | 1,400,000 | |||
Price per share (in dollars per share) | $ 3.50 |
Ordinary shares - Shares reserv
Ordinary shares - Shares reserved for issuance (Details) - shares | Dec. 31, 2020 | Dec. 31, 2019 |
Stock options | ||
Shares reserved for issuance | ||
Common stock reserved for future issuance (in shares) | 10,339,606 | 9,984,034 |
Warrants issued in private equity placement or loan agreement | ||
Shares reserved for issuance | ||
Common stock reserved for future issuance (in shares) | 7,368,033 |
Stock-based compensation - Gene
Stock-based compensation - General (Details) | Dec. 31, 2020shares |
Inducement Plan | |
Stock-based compensation | |
Number of shares available for issuance | 1,434,153 |
2015 Plan | |
Stock-based compensation | |
Number of shares available for issuance | 1,074,734 |
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 | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Summary of outstanding stock options | ||
Outstanding at beginning of period (in shares) | 9,192,684 | |
Granted (in shares) | 2,538,000 | |
Forfeited, cancelled and expired (in shares) | (2,741,378) | |
Outstanding at end of period (in shares) | 8,989,306 | 9,192,684 |
Vested and exercisable at end of period (in shares) | 5,238,832 | |
Weighted-Average Exercise Price | ||
Granted (in dollars per share) | $ 2.94 | |
Forfeited, cancelled and expired (in dollars per share) | 9.06 | |
Outstanding (in dollars per share) | 4.81 | $ 6.58 |
Vested and exercisable at end of period (in dollars per share) | $ 5.61 | |
Additional Disclosures - Options | ||
Weighted Average Remaining Contractual Term, Outstanding | 6 years 6 months 29 days | 5 years 11 months 15 days |
Weighted Average Remaining Contractual Term, Vested and exercisable | 6 years 7 months 2 days | |
Aggregate Intrinsic Value, Outstanding (in dollars) | $ 350 | $ 164 |
Aggregate Intrinsic Value, Vested and exercisable at end of the period (in dollars) | $ 83 | |
Weighted average grant date fair value of stock options granted (in dollars per share) | $ 2 | $ 2.52 |
Fair value of stock options vested (in dollars) | $ 5,800 |
Stock-based compensation - St_2
Stock-based compensation - Stock-based compensation expense (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock-based compensation expense | |||
Total stock-based compensation | $ 7,381,000 | $ 8,597,000 | $ 7,807,000 |
Stock options | |||
Stock-based compensation expense | |||
Total unrecognized compensation expense | $ 8,500,000 | ||
Estimated weighted average period over which expense is expected to be recognized | 2 years 4 months 6 days | ||
Compensation expense, Stock option modification | $ 52,000 | ||
Selling, general and administrative | |||
Stock-based compensation expense | |||
Total stock-based compensation | 5,448,000 | 6,552,000 | 6,012,000 |
Research and development | |||
Stock-based compensation expense | |||
Total stock-based compensation | $ 1,933,000 | $ 2,045,000 | $ 1,795,000 |
Stock-based compensation - Fair
Stock-based compensation - Fair value assumptions (Details) - Stock options | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Fair value assumptions | |||
Expected term (in years) | 6 years 29 days | 5 years 6 months 25 days | 6 years 1 month 9 days |
Minimum Risk-free interest rate (as a percent) | 0.37% | 1.38% | 2.25% |
Maximum Risk-free interest rate (as a percent) | 1.48% | 2.61% | 3.04% |
Minimum Expected volatility (as a percent) | 78.15% | 76.50% | 78.20% |
Maximum Expected volatility (as a percent) | 81.83% | 80.85% | 85.00% |
Dividend rate (as a percent) | 0.00% | 0.00% | 0.00% |
Stock-based compensation - Rest
Stock-based compensation - Restricted stock units (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Stock-based compensation | |||
Stock-based compensation | $ 7,381 | $ 8,597 | $ 7,807 |
RSUs | |||
Stock-based compensation | |||
Number of shares issued for each stock award vested | 1 | ||
Stock-based compensation | $ 2,300 | $ 1,400 | |
Total unrecognized compensation expense | $ 1,900 | ||
Estimated weighted average period over which expense is expected to be recognized | 1 year 3 months 10 days | ||
Summary of unvested RSUs | |||
Unvested - Beginning of period (in shares) | 791,350 | ||
Granted (in shares) | 910,150 | ||
Forfeited (in shares) | (40,200) | ||
Vested (in shares) | (311,000) | ||
Unvested - End of period (in shares) | 1,350,300 | 791,350 | |
RSUs | Employee | |||
Stock-based compensation | |||
Vesting period | 2 years | ||
RSUs | Director | |||
Stock-based compensation | |||
Vesting period | 1 year | ||
Service period | 1 year |
Segment and other information -
Segment and other information - Long-lived assets (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020USD ($)segment | Dec. 31, 2019USD ($) | |
Long-lived assets by location | ||
Number of operating segments | segment | 1 | |
Property and equipment, net | $ 216 | $ 291 |
U.S. | ||
Long-lived assets by location | ||
Property and equipment, net | $ 216 | $ 291 |
Segment and other information_2
Segment and other information - Customer concentration (Details) | 12 Months Ended | |
Dec. 31, 2019 | Dec. 31, 2018 | |
Sales revenue | Customer A | Customer Concentration Risk | ||
Customer concentration | ||
Concentration (as a percent) | 100.00% | 100.00% |
Quarterly consolidated financ_3
Quarterly consolidated financial information (unaudited) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2020 | Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Dec. 31, 2019 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Total revenues | $ 30,731 | $ 21,712 | $ 18,027 | ||||||||
Cost of sales (excluding amortization of intangible assets) | $ 442 | $ 408 | $ 393 | $ 969 | $ 986 | $ 1,001 | $ 1,022 | $ 813 | 2,212 | 3,822 | 3,986 |
Amortization of intangible asset | 1,256 | 1,255 | 1,255 | 1,256 | 1,256 | 1,255 | 1,255 | 1,256 | 5,022 | 5,022 | 7,187 |
Total costs and expenses | 16,925 | 15,992 | 15,790 | 17,955 | 19,999 | 20,358 | 20,921 | 18,683 | |||
Other income (expense) | (1,564) | 6,425 | (7,594) | 808 | 7,655 | 3,831 | 9,272 | (1,348) | (1,925) | 19,410 | 114,310 |
Income tax benefit (expense) | 15 | (691) | (400) | (677) | 15 | (1,768) | (536) | ||||
Net (loss) income | $ (11,946) | $ (3,159) | $ (17,272) | $ (12,698) | $ (8,980) | $ (13,790) | $ (8,247) | $ (18,434) | $ (45,075) | $ (49,451) | $ 31,851 |
Net (loss) income per ordinary share, basic (in dollars per share) | $ (0.18) | $ (0.06) | $ (0.32) | $ (0.23) | $ (0.17) | $ (0.25) | $ (0.15) | $ (0.34) | $ (0.78) | $ (0.91) | $ 0.69 |
Net (loss) income per ordinary share, diluted (in dollars per share) | $ (0.18) | $ (0.18) | $ (0.32) | $ (0.24) | $ (0.78) | $ (1.10) | $ 0.31 | ||||
Product | |||||||||||
Total revenues | $ 8,202 | $ 8,053 | $ 7,752 | $ 6,663 | $ 5,593 | $ 5,677 | $ 6,073 | $ 4,333 | $ 30,670 | $ 21,676 | $ 18,027 |
Royalty | |||||||||||
Total revenues | $ 24 | $ 18 | $ 8 | $ 11 | $ 13 | $ 7 | $ 6 | $ 10 | $ 61 | $ 36 |