Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2020 | Oct. 29, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Period End Date | Sep. 30, 2020 | |
Document Transition Report | false | |
Entity File Number | 001-33451 | |
Entity Registrant Name | Albireo Pharma, Inc. | |
Entity Incorporation, State or Country Code | DE | |
Entity Tax Identification Number | 90-0136863 | |
Entity Address, Address Line One | 10 Post Office Square | |
Entity Address, Address Line Two | Suite 1000 | |
Entity Address, City or Town | Boston | |
Entity Address, State or Province | MA | |
Entity Address, Postal Zip Code | 02109 | |
City Area Code | 857 | |
Local Phone Number | 254-5555 | |
Title of 12(b) Security | Common Stock | |
Trading Symbol | ALBO | |
Security Exchange Name | NASDAQ | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 19,077,247 | |
Entity Central Index Key | 0001322505 | |
Current Fiscal Year End Date | --12-31 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q3 | |
Amendment Flag | false | |
Trading Symbol | ALBO |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Sep. 30, 2020 | Dec. 31, 2019 |
Current assets: | ||
Cash and cash equivalents | $ 278,691 | $ 131,843 |
Prepaid expenses and other current assets | 8,199 | 9,956 |
Total current assets | 286,890 | 141,799 |
Property and equipment, net | 551 | 597 |
Goodwill | 17,260 | 17,260 |
Other assets | 6,401 | 5,413 |
Total assets | 311,102 | 165,069 |
Current liabilities: | ||
Accounts payable | 3,601 | 4,785 |
Accrued expenses | 16,817 | 13,486 |
Other current liabilities | 810 | 653 |
Total current liabilities | 21,228 | 18,924 |
Liability related to sale of future royalties | 64,871 | 48,714 |
Note payable, net of discount | 9,508 | |
Other long-term liabilities | 3,735 | 4,270 |
Total liabilities | 99,342 | 71,908 |
Stockholders' Equity: | ||
Common stock, $0.01 par value per share ? 30,000,000 authorized at September 30, 2020 and December 31, 2019; 19,073,498 and 12,749,443 issued and outstanding at September 30, 2020 and December 31, 2019, respectively | 190 | 127 |
Additional paid-in capital | 451,448 | 245,769 |
Accumulated other comprehensive income | 2,143 | 6,452 |
Accumulated deficit | (242,021) | (159,187) |
Total stockholders' equity | 211,760 | 93,161 |
Total liabilities and stockholders' equity | $ 311,102 | $ 165,069 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Sep. 30, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 30,000,000 | 30,000,000 |
Common stock, shares issued | 19,073,498 | 12,749,443 |
Common stock, shares outstanding | 19,073,498 | 12,749,443 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Income Statement [Abstract] | ||||
Revenue | $ 2,131 | $ 1,385 | $ 5,592 | $ 3,205 |
Operating expenses: | ||||
Research and development | 22,200 | 11,996 | 56,727 | 31,359 |
General and administrative | 11,663 | 6,010 | 28,290 | 16,788 |
Other operating (income) expense, net | (4,628) | 4,015 | (4,556) | 6,319 |
Total operating expenses | 29,235 | 22,021 | 80,461 | 54,466 |
Operating loss | (27,104) | (20,636) | (74,869) | (51,261) |
Interest expense, net | (3,639) | (1,274) | (7,965) | (3,934) |
Net loss | $ (30,743) | $ (21,910) | $ (82,834) | $ (55,195) |
Net loss per common share - basic and diluted | $ (1.96) | $ (1.73) | $ (5.54) | $ (4.47) |
Weighted-average common shares used to compute basic and diluted net loss per common share | 15,704,293 | 12,685,000 | 14,942,213 | 12,349,870 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Statement of Income and Comprehensive Income [Abstract] | ||||
Net loss | $ (30,743) | $ (21,910) | $ (82,834) | $ (55,195) |
Other comprehensive (loss) income: | ||||
Foreign currency translation adjustment | (4,031) | 3,991 | (4,309) | 6,280 |
Total other comprehensive (loss) income | (4,031) | 3,991 | (4,309) | 6,280 |
Total comprehensive loss | $ (34,774) | $ (17,919) | $ (87,143) | $ (48,915) |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Income (loss) | Accumulated Deficit | Total |
Balance at beginning of period at Dec. 31, 2018 | $ 120 | $ 214,694 | $ 4,293 | $ (96,470) | $ 122,637 |
Balance (in shares) at Dec. 31, 2018 | 11,969,928 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 1,823 | 1,823 | |||
Exercise of options and vesting of RSUs | 1,290 | 1,290 | |||
Exercise of options and vesting of RSUs (in shares) | 68,908 | ||||
Other comprehensive income (loss) | 2,298 | 2,298 | |||
Net loss | (16,657) | (16,657) | |||
Balance at end of period at Mar. 31, 2019 | $ 120 | 217,807 | 6,591 | (113,127) | 111,391 |
Balance (in shares) at Mar. 31, 2019 | 12,038,836 | ||||
Balance at beginning of period at Dec. 31, 2018 | $ 120 | 214,694 | 4,293 | (96,470) | 122,637 |
Balance (in shares) at Dec. 31, 2018 | 11,969,928 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Other comprehensive income (loss) | 6,280 | ||||
Net loss | (55,195) | ||||
Balance at end of period at Sep. 30, 2019 | $ 126 | 242,638 | 10,573 | (151,665) | 101,672 |
Balance (in shares) at Sep. 30, 2019 | 12,685,326 | ||||
Balance at beginning of period at Mar. 31, 2019 | $ 120 | 217,807 | 6,591 | (113,127) | 111,391 |
Balance (in shares) at Mar. 31, 2019 | 12,038,836 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 2,049 | 2,049 | |||
Exercise of options and vesting of RSUs | 110 | 110 | |||
Exercise of options and vesting of RSUs (in shares) | 9,123 | ||||
Issuance of common stock, net of costs | $ 6 | 20,768 | 20,774 | ||
Issuance of common stock (in shares) | 637,367 | ||||
Other comprehensive income (loss) | (9) | (9) | |||
Net loss | (16,628) | (16,628) | |||
Balance at end of period at Jun. 30, 2019 | $ 126 | 240,734 | 6,582 | (129,755) | 117,687 |
Balance (in shares) at Jun. 30, 2019 | 12,685,326 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 1,826 | 1,826 | |||
Exercise of options | 78 | 78 | |||
Other comprehensive income (loss) | 3,991 | 3,991 | |||
Net loss | (21,910) | (21,910) | |||
Balance at end of period at Sep. 30, 2019 | $ 126 | 242,638 | 10,573 | (151,665) | 101,672 |
Balance (in shares) at Sep. 30, 2019 | 12,685,326 | ||||
Balance at beginning of period at Dec. 31, 2019 | $ 127 | 245,769 | 6,452 | (159,187) | 93,161 |
Balance (in shares) at Dec. 31, 2019 | 12,749,443 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 2,381 | 2,381 | |||
Exercise of options and vesting of RSUs | 94 | 94 | |||
Exercise of options and vesting of RSUs (in shares) | 37,662 | ||||
Issuance of common stock, net of costs | $ 22 | 42,977 | 42,999 | ||
Issuance of common stock (in shares) | 2,190,750 | ||||
Other comprehensive income (loss) | 6,287 | 6,287 | |||
Net loss | (31,488) | (31,488) | |||
Balance at end of period at Mar. 31, 2020 | $ 149 | 291,221 | 12,739 | (190,675) | 113,434 |
Balance (in shares) at Mar. 31, 2020 | 14,977,855 | ||||
Balance at beginning of period at Dec. 31, 2019 | $ 127 | 245,769 | 6,452 | (159,187) | 93,161 |
Balance (in shares) at Dec. 31, 2019 | 12,749,443 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Other comprehensive income (loss) | (4,309) | ||||
Net loss | (82,834) | ||||
Balance at end of period at Sep. 30, 2020 | $ 190 | 451,448 | 2,143 | (242,021) | 211,760 |
Balance (in shares) at Sep. 30, 2020 | 19,073,498 | ||||
Balance at beginning of period at Mar. 31, 2020 | $ 149 | 291,221 | 12,739 | (190,675) | 113,434 |
Balance (in shares) at Mar. 31, 2020 | 14,977,855 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 2,603 | 2,603 | |||
Exercise of options and vesting of RSUs | 138 | 138 | |||
Exercise of options and vesting of RSUs (in shares) | 11,166 | ||||
Issuance of warrants | 113 | 113 | |||
Other comprehensive income (loss) | (6,565) | (6,565) | |||
Net loss | (20,603) | (20,603) | |||
Balance at end of period at Jun. 30, 2020 | $ 149 | 294,075 | 6,174 | (211,278) | 89,120 |
Balance (in shares) at Jun. 30, 2020 | 14,989,021 | ||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | |||||
Stock-based compensation expense | 5,089 | 5,089 | |||
Exercise of options and vesting of RSUs | $ 1 | 1,924 | 1,925 | ||
Exercise of options and vesting of RSUs (in shares) | 84,477 | ||||
Issuance of common stock, net of costs | $ 40 | 150,360 | 150,400 | ||
Issuance of common stock (in shares) | 4,000,000 | ||||
Other comprehensive income (loss) | (4,031) | (4,031) | |||
Net loss | (30,743) | (30,743) | |||
Balance at end of period at Sep. 30, 2020 | $ 190 | $ 451,448 | $ 2,143 | $ (242,021) | $ 211,760 |
Balance (in shares) at Sep. 30, 2020 | 19,073,498 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Cash flows from operating activities: | ||
Net loss | $ (82,834) | $ (55,195) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Accretion of liability related to sale of future royalties | 7,670 | 6,179 |
Accretion of note payable discount and amortization of issuance costs | 135 | |
Depreciation and amortization | 119 | 89 |
Stock-based compensation expense | 10,073 | 5,698 |
Foreign currency adjustments | (3,968) | 8,317 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | 1,770 | (1,861) |
Other assets | 425 | (238) |
Accounts payable | (1,221) | (935) |
Accrued expenses | (3,213) | (2,397) |
Other current and long-term liabilities | (1,790) | (176) |
Net cash used in operating activities | (72,834) | (40,519) |
Cash flows from investing activities: | ||
Purchase of property, and equipment | (78) | (523) |
Net cash used in investing activities | (78) | (523) |
Cash flows from financing activities: | ||
Proceeds from issuance of note payable, net of issuance costs | 9,521 | |
Proceeds from issuance of common stock, net of issuance costs | 193,399 | 20,774 |
Proceeds from royalty agreement, net of issuance costs | 14,750 | |
Proceeds from exercise of options and vesting or RSUs | 2,156 | 1,478 |
Net cash provided by financing activities | 219,826 | 22,252 |
Effect of exchange rate changes on cash and cash equivalents | (66) | (2,429) |
Net increase (decrease) in cash and cash equivalents | 146,848 | (21,219) |
Cash and cash equivalents - beginning of period | 131,843 | 163,885 |
Cash and cash equivalents - end of period | 278,691 | 142,666 |
Supplemental disclosures of cash and non-cash activities: | ||
Warrants issued with long-term note payable | 113 | |
Deferred issuance costs included in accrued expenses | $ 34 | |
Purchase of property, plant and equipment in accounts payable | 17 | |
Right of use assets and lease obligations recorded upon amended lease agreements | $ 4,665 |
Summary of significant accounti
Summary of significant accounting policies and basis of presentation | 9 Months Ended |
Sep. 30, 2020 | |
Summary of significant accounting policies and basis of presentation | |
Summary of significant accounting policies and basis of presentation | 1. Summary of significant accounting policies and basis of presentation Organization Albireo Pharma, Inc. (the Company) is a clinical-stage biopharmaceutical company focused on the development and commercialization of novel bile acid modulators to treat orphan pediatric liver diseases and other liver and gastrointestinal diseases and disorders. The Company’s clinical pipeline includes a Phase 3 product candidate, a Phase 2 product candidate, and elobixibat, which is approved in Japan for the treatment of chronic constipation. Odevixibat, the Company’s Phase 3 lead product candidate, is in development for multiple pediatric cholestatic liver diseases, with topline results from its Phase 3 trial for the treatment of patients with progressive familial intrahepatic cholestasis (PFIC) announced in September 2020, a pivotal trial initiated for the treatment of patients with biliary atresia, and another pivotal trial for the treatment of patients with Alagille syndrome (ALGS) planned to be initiated by the end of 2020. PFIC, biliary atresia and ALGS are each a rare, life-threatening genetic disorder affecting young children. Basis of presentation The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information, and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. In the opinion of management, all adjustments (including normal recurring adjustments) considered necessary for fair presentation have been included in the Condensed Consolidated Financial Statements. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the full fiscal year, any other interim period or any future fiscal year. The Condensed Consolidated Financial Statements are prepared on a basis consistent with prior periods. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). Principles of consolidation The accompanying Condensed Consolidated Financial Statements include the accounts of the Company and its direct or indirect wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. Foreign currency translation Functional currency Items included in the financial statements of each entity comprising the Company are measured using the currency of the primary economic environment in which the entity operates (the functional currency). Transactions and balances Foreign currency transactions in each entity comprising the Company are remeasured into the functional currency of the entity using the exchange rates prevailing at the respective transaction dates. Foreign exchange gains and losses resulting from the settlement of such transactions and from the remeasurement at period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized within other operating (income) expense, net in the Condensed Consolidated Statements of Operations. The results and financial position of the Company that have a functional currency different from the USD are translated into the presentation currency as follows: a. assets and liabilities presented are translated at the closing exchange rate as of September 30, 2020 and December 31, 2019; b. income and expenses for each statement of comprehensive loss are translated at the average exchange rate for the applicable period; and c. significant transactions use the closing exchange rate on the date of the transaction. All resulting exchange differences arising from such translations are recognized directly in other comprehensive income (loss) and presented as a separate component of equity. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts of assets, liabilities, revenues and expenses reported in the financial statements and accompanying notes. Management must apply significant judgment in this process. On an ongoing basis, the Company evaluates its estimates and assumptions, including but not limited to accruals, and the accretion of interest on the monetization liability. Actual results could materially differ from these estimates. Revenue recognition Milestone Payments At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Royalties For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). In 2012, the Company entered into a license agreement (the Agreement) with EA Pharma Co., Ltd. (EA Pharma, formerly Ajinomoto Pharmaceuticals Co., Ltd.) to develop a select product candidate (elobixibat) for registration and subsequent commercialization in select markets. In conjunction with the Agreement, the Company granted EA Pharma an exclusive license to its intellectual property for development and commercialization activities in the designated field and territories. The Company has completed all of its performance obligations under the Agreement. As of September 30, 2020, the Company is eligible to receive an additional regulatory-based milestone payment under the Agreement of $5.0 million if a specified regulatory event is achieved for elobixibat. The cash payments and any other payments for milestones and royalties from EA Pharma are non-refundable, non-creditable and not subject to set-off. The Agreement will continue until the last royalty period for any product in the territory, which is defined as the period when there are no remaining patent rights or regulatory exclusivity in place for any products subject to royalties. EA Pharma may terminate the Agreement upon 180 days’ prior written notice to the Company. Either party may terminate the Agreement for the other party’s uncured material breach or insolvency and in certain other circumstances agreed to by the parties. Monetization of Future Royalties In December 2017, the Company entered into a royalty interest acquisition agreement (RIAA) with HealthCare Royalty Partners III, L.P. (HCR) pursuant to which it sold to HCR the right to receive all royalties from sales in Japan and sales milestones achieved from any covered territory potentially payable to the Company under the Agreement, up to a specified maximum “cap” amount of $78.8 million, based on the funds the Company received from HCR. In January 2018, the Company received $44.5 million from HCR, net of certain transaction expenses, under the RIAA. On June 8, 2020, the parties entered into an amendment to the RIAA pursuant to which HCR agreed to pay the Company an additional $14.8 million, net of certain transactions expenses, in exchange for the elimination of the (i) $78.8 million cap amount on HCR’s rights to receive royalties on sales in Japan and sales milestones for elobixibat in certain other territories that may become payable by EA Pharma and (ii) the $15.0 million payable to the Company if a specified sales milestone is achieved for elobixibat in Japan. The Company is obligated to make royalty interest payments to HCR under the RIAA only to the extent it receives future Japanese royalties, sales milestones or other specified payments from EA Pharma. Although the Company sold its rights to receive royalties from the sales of elobixibat in Japan, as a result of its ongoing involvement in the cash flows related to these royalties, the Company will continue to account for these royalties as revenue. The Company recorded net cash totaling $59.3 million as a liability related to sale of future royalties (royalty obligation). The royalty obligation will be amortized using the effective interest rate method. The following table shows the activity within the liability account for the nine month period ended September 30, 2020: September 30, 2020 (in thousands) Liability related to sale of future royalties—December 31, 2019 $ 55,144 Proceeds from sale of future royalties, net 14,750 Foreign currency translation loss (800) Accretion of interest expense on liability related to royalty monetization 7,670 Repayment of the liability (9,762) Liability related to sale of future royalties—September 30, 2020 $ 67,002 Less current portion classified within accrued expenses (2,131) Net ending liability related to sale of future royalties $ 64,871 The Company records estimated royalties due for the current period in accrued expenses until the payment is received from EA Pharma at which time the Company then remits payment to HCR. As royalties are remitted to HCR, the balance of the royalty obligation will be effectively repaid over the life of the RIAA. In order to determine the accretion of the royalty obligation, the Company is required to estimate the total amount of future royalty payments to be received and submitted to HCR, as noted above. The sum of these amounts less the $59.3 million proceeds the Company received will be recorded as interest expense over the life of the royalty obligation. At September 30, 2020, the Company’s estimate of its total interest expense resulted in an annual effective interest rate of approximately 20.4%. The Company periodically assesses the estimated royalty payments to HCR and to the extent such payments are greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the accretion of interest on the royalty obligation. There are a number of factors that could materially affect the amount and the timing of royalty payments, most of which are not within the Company’s control. Such factors include, but are not limited to, the rate of elobixibat prescriptions, the number of doses administered, the introduction of competing products, manufacturing or other delays, patent protection, adverse events that result in governmental health authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates as the royalties remitted to HCR are in U.S. dollars while sales of elobixibat are in Japanese yen, and sales never achieving forecasted numbers, which would result in reduced royalty payments and reduced non-cash interest expense over the life of the royalty obligation. To the extent future royalties result in an amount less than the liability, the Company is not obligated to fund any such shortfall. Recently adopted accounting pronouncements In August 2018, the FASB issued ASU “Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract.” ASU This standard aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain software (and hosting arrangements that include an software license). The guidance also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. The Company adopted this guidance in the first quarter of 2020 on a prospective basis and there was no material impact on its consolidated financial statements. |
Fair value of financial instrum
Fair value of financial instruments | 9 Months Ended |
Sep. 30, 2020 | |
Fair value of financial instruments | |
Fair value of financial instruments | 2. When measuring the fair value of financial instruments, the Company evaluates valuation techniques such as the market approach, the income approach and the cost approach. A three-level valuation hierarchy, which prioritizes the inputs to valuation techniques that are used to measure fair value, is based upon whether such inputs are observable or unobservable. Observable inputs reflect market data obtained from independent sources, while unobservable inputs reflect market assumptions made by the reporting entity. The three-level hierarchy for the inputs to valuation techniques is briefly summarized as follows: Level 1—Observable inputs such as quoted prices (unadjusted) for identical Level 2—Observable inputs such as quoted prices for similar Level 3—Unobservable inputs that reflect the reporting entity’s estimate of assumptions that market participants would use in pricing the asset or liability. |
Commitments and contingencies
Commitments and contingencies | 9 Months Ended |
Sep. 30, 2020 | |
Commitments and contingencies | |
Commitments and contingencies | 3. Commitments and contingencies Agreements with CROs As of September 30, 2020, the Company had various agreements with CROs for the conduct of specified research and development activities. Based on the terms of the respective agreements, the Company may be required to make future payments of up to $39.8 million to CROs upon the completion of contracted work. |
Net loss per share
Net loss per share | 9 Months Ended |
Sep. 30, 2020 | |
Net loss per share | |
Net loss per share | 4. Net loss per share Basic net loss per share, or Basic EPS, is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding. Diluted net loss per share, or Diluted EPS, is computed by dividing the net loss by the weighted average number of common shares outstanding for the period, after giving consideration to the dilutive effect of potentially dilutive common shares. For purposes of this calculation, outstanding options to purchase shares of common stock, restricted stock units and warrants are considered potentially dilutive common shares. The Company has generated a net loss in all periods presented so the Basic EPS and Diluted EPS are the same as the inclusion of the potentially dilutive securities would be anti-dilutive. The following table sets forth the computation of Basic EPS and Diluted EPS (in thousands, except for share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Basic and Diluted EPS: Numerator Net loss $ (30,743) $ (21,910) $ (82,834) $ (55,195) Denominator Weighted average number of shares outstanding 15,704,293 12,685,000 14,942,213 12,349,870 Basic and Diluted EPS $ (1.96) $ (1.73) $ (5.54) $ (4.47) The following outstanding common stock equivalents were excluded from the computation of Diluted EPS for the nine months ended September 30, 2020 and 2019 because including them would have been anti-dilutive: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Options to purchase common stock, RSUs and warrants 2,403,090 1,759,963 2,403,090 1,759,963 |
Income taxes
Income taxes | 9 Months Ended |
Sep. 30, 2020 | |
Income taxes | |
Income taxes | 5. Income taxes The Company did not record a tax provision or benefit for the nine months ended September 30, 2020 or 2019. The Company has continued to maintain a full valuation allowance against its net deferred tax assets. The Company has had an overall net operating loss position since its inception. |
Note Payable
Note Payable | 9 Months Ended |
Sep. 30, 2020 | |
Note Payable | |
Note Payable | 6. Note Payable 2020 Loan and Security Agreement On June 8, 2020, the Company entered into a Loan and Security Agreement (the Loan and Security Agreement) with the several banks and other financial institutions or entities from time to time parties to the Loan and Security Agreement, as lenders (collectively, referred to as the “Lender”), and Hercules Capital, Inc., in its capacity as administrative agent and collateral agent for itself and Lender (in such capacity, the “Agent” or “Hercules”) pursuant to which term loans of up to an aggregate principal amount of up to $80.0 million (the “Term Loans”) are available to the Company. The Loan Agreement provides for (i) an initial term loan advance of $10.0 million, which closed on June 8, 2020, and, at the Company’s option, a right to request that the Lender make an additional term loan advance to the Company in an aggregate principal amount of $5.0 million prior to December 15, 2020, (ii) subject to the achievement of certain initial performance milestones (“Performance Milestone I”), a right of the Borrower to request that the Lender make additional term loan advances to the Company in an aggregate principal amount of up to $20.0 million from January 1, 2021 through December 15, 2021 in minimum increments of $10.0 million, and (iii) subject to the Lender’s investment committee’s sole discretion, a right of the Borrower to request that the Lender make additional term loan advances to the Company in an aggregate principal amount of up to $45.0 million through March 31, 2022 in minimum increments of $5.0 million. The Company is required to pay an end of term fee (“End of Term Charge”) equal to 6.95% of the aggregate principal amount of the Term Loans advances upon repayment. The Term Loans mature on January 1, 2024, which is extendable to June 1, 2024 upon achievement of Performance Milestone I (the “Maturity Date”). The Term Loan bears interest at an annual rate equal to the greater of 9.15% and 9.15% plus the prime rate of interest minus 3.25%. Borrowings under the Loan and Security Agreement are repayable in monthly interest-only payments through January 1, 2022 and extendable to (i) July 1, 2022 upon achievement of Performance Milestone I and (ii) July 1, 2023 upon achievement of certain additional performance milestones. After the interest-only payment period, borrowings under the Loan and Security Agreement are repayable in equal monthly payments of principal and accrued interest until the Maturity Date. At the Company’s option, the Company may elect to prepay all, but not less than all, of the outstanding term loan by paying the entire principal balance and all accrued and unpaid interest thereon plus a prepayment charge equal to the following percentage of the principal amount being prepaid: 3.0% if the term loan is prepaid during the first six months following the initial closing date, 2.0% of the principal amount outstanding if the prepayment occurs after the first nine months following the Closing Date, but on or prior to 24 months following the Closing Date, and 1.0% of the principal amount outstanding at any time thereafter but prior to the Maturity Date. In connection with the Loan Agreement, the Company granted Agent a security interest The Loan Agreement also contains certain events of default, representations, warranties and non-financial covenants of the Company. Through September 30, 2020, the Company borrowed $10.0 million under the Loan Agreement and incurred $1.3 million of debt discount and issuance costs inclusive of facility fees, legal fees, End of Term Charge and fair value of the warrant. The debt discount and issuance costs are being accreted to the principal amount of debt and being amortized from the date of issuance through the Maturity Date to interest expense using the effective-interest rate method. The effective interest rate of the outstanding debt under the Loan Agreement is approximately 15.3%. As of September 30, 2020 the carrying value of the note payable consists of the following: September 30, 2020 (in thousands) Note payable, including End of Term Charge 10,695 Debt discount, net of accretion (1,187) Note payable net of discount, long-term $ 9,508 During the three and nine months ended September 30, 2020, the Company recognized $0.3 million and $0.4 million, respectively of interest expense related to the Loan Agreement. No interest expense was associated with the Loan Agreement for the three and nine months ended September 30, 2019. Estimated future principal payments due under the Loan Agreement, including the contractual End of Term Charge are as follows as of September 30, 2020: Note Principal Payments (in thousands) Remainder of 2020 $ — 2021 — 2022 4,553 2023 4,994 2024 1,148 As of September 30, 2020, based on Level 3 inputs and the borrowing rates available to the Company for loans with similar terms and consideration of the Company’s credit risk, the carrying value of the Company’s variable interest rate debt, excluding unamortized debt issuance costs, approximates fair value. Warrants Under the Loan and Security Agreement, the Company agreed to issue to Hercules warrants (the “Warrants”) to purchase a number of shares of the Company’s common stock, par value $0.01 per share (the “Common Stock”) equal to 1% of the aggregate amount of the Term Loans that are funded, as such amounts are funded. On the Closing Date, the Company issued a Warrant for 5,311 shares of Common Stock. The Warrants will be exercisable for a period of seven years from the date of the issuance of each Warrant at a per-share exercise price equal to $18.83, subject to certain adjustments as specified in the Warrants. In addition, the Company has granted to the holders of the Warrants certain registration rights. Specifically, the Company has agreed to use its commercially reasonable efforts to (i) file registration statements with the U.S. Securities and Exchange Commission within 60 days following the date of the issuance of each Warrant for purposes of registering the shares of Common Stock issuable upon exercise of the Warrants for resale by Hercules, and (ii) cause the registration statement to be declared effective as soon as practicable after filing, and in any event no later than 180 days after the date of the issuance of each Warrant. The Company accounted for the Warrants as equity instruments since they were indexed to the Company’s common stock and met the criteria for classification in stockholders’ equity. The relative fair value of the Warrants related to the first tranche funding was approximately $0.1 million, and was treated as a discount to the Term Loans. This amount is being amortized to interest expense using the effective interest method over the life of the Term Loans. The Company estimated the fair value of the Warrants using the Black-Scholes option-pricing model. |
Equity Financings
Equity Financings | 9 Months Ended |
Sep. 30, 2020 | |
Equity Financings | |
Equity Financings | 7. Equity Financings 2020 Underwritten Public Offerings On February 3, 2020, the Company completed an underwritten public offering of 2,190,750 shares of its common stock, which includes the exercise in full of the underwriters’ option to purchase additional shares. The Company received net proceeds from this offering of approximately $43.0 million, after deducting underwriting discounts, commissions and offering expenses. On September 9, 2020, the Company completed an underwritten public offering of 4,000,000 shares of its common stock. The Company received net proceeds from this offering of approximately $150.4 million, after deducting underwriting discounts and, commissions but before deducting offering expenses. |
Stock-based Compensation
Stock-based Compensation | 9 Months Ended |
Sep. 30, 2020 | |
Stock-based Compensation | |
Stock-based Compensation | 8. Stock-based Compensation For the nine months ended September 30, 2020, the Company granted 747,025 options at a weighted average exercise price of $24.78. The Company recorded the following stock-based compensation expense: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 (in thousands) (in thousands) Employee awards: Research and development expense $ 2,044 $ 742 $ 3,966 $ 2,242 General and administrative expense 3,045 1,084 6,107 3,456 Total stock-based compensation expense $ 5,089 $ 1,826 $ 10,073 $ 5,698 |
Summary of significant accoun_2
Summary of significant accounting policies and basis of presentation (Policies) | 9 Months Ended |
Sep. 30, 2020 | |
Summary of significant accounting policies and basis of presentation | |
Basis of presentation | Basis of presentation The accompanying unaudited Condensed Consolidated Financial Statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information, and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the audited consolidated financial statements and accompanying notes included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2019. In the opinion of management, all adjustments (including normal recurring adjustments) considered necessary for fair presentation have been included in the Condensed Consolidated Financial Statements. The results of operations for the three and nine months ended September 30, 2020 are not necessarily indicative of the results that may be expected for the full fiscal year, any other interim period or any future fiscal year. The Condensed Consolidated Financial Statements are prepared on a basis consistent with prior periods. Any reference in these notes to applicable guidance is meant to refer to the authoritative GAAP as found in the Accounting Standards Codification (ASC) and Accounting Standards Update (ASU) of the Financial Accounting Standards Board (FASB). |
Principles of consolidation | Principles of consolidation The accompanying Condensed Consolidated Financial Statements include the accounts of the Company and its direct or indirect wholly owned subsidiaries. All intercompany balances and transactions have been eliminated in consolidation. |
Foreign currency translation | Foreign currency translation Functional currency Items included in the financial statements of each entity comprising the Company are measured using the currency of the primary economic environment in which the entity operates (the functional currency). Transactions and balances Foreign currency transactions in each entity comprising the Company are remeasured into the functional currency of the entity using the exchange rates prevailing at the respective transaction dates. Foreign exchange gains and losses resulting from the settlement of such transactions and from the remeasurement at period-end exchange rates of monetary assets and liabilities denominated in foreign currencies are recognized within other operating (income) expense, net in the Condensed Consolidated Statements of Operations. The results and financial position of the Company that have a functional currency different from the USD are translated into the presentation currency as follows: a. assets and liabilities presented are translated at the closing exchange rate as of September 30, 2020 and December 31, 2019; b. income and expenses for each statement of comprehensive loss are translated at the average exchange rate for the applicable period; and c. significant transactions use the closing exchange rate on the date of the transaction. All resulting exchange differences arising from such translations are recognized directly in other comprehensive income (loss) and presented as a separate component of equity. |
Use of estimates | Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts of assets, liabilities, revenues and expenses reported in the financial statements and accompanying notes. Management must apply significant judgment in this process. On an ongoing basis, the Company evaluates its estimates and assumptions, including but not limited to accruals, and the accretion of interest on the monetization liability. Actual results could materially differ from these estimates. |
Revenue recognition | Revenue recognition Milestone Payments At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price. Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The Company evaluates factors such as the scientific, clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining whether it is probable that a significant revenue reversal would not occur. At the end of each subsequent reporting period, the Company reevaluates the probability of achievement of all milestones subject to constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenues and earnings in the period of adjustment. Royalties For arrangements that include sales-based royalties, including milestone payments based on a level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). In 2012, the Company entered into a license agreement (the Agreement) with EA Pharma Co., Ltd. (EA Pharma, formerly Ajinomoto Pharmaceuticals Co., Ltd.) to develop a select product candidate (elobixibat) for registration and subsequent commercialization in select markets. In conjunction with the Agreement, the Company granted EA Pharma an exclusive license to its intellectual property for development and commercialization activities in the designated field and territories. The Company has completed all of its performance obligations under the Agreement. As of September 30, 2020, the Company is eligible to receive an additional regulatory-based milestone payment under the Agreement of $5.0 million if a specified regulatory event is achieved for elobixibat. The cash payments and any other payments for milestones and royalties from EA Pharma are non-refundable, non-creditable and not subject to set-off. The Agreement will continue until the last royalty period for any product in the territory, which is defined as the period when there are no remaining patent rights or regulatory exclusivity in place for any products subject to royalties. EA Pharma may terminate the Agreement upon 180 days’ prior written notice to the Company. Either party may terminate the Agreement for the other party’s uncured material breach or insolvency and in certain other circumstances agreed to by the parties. |
Monetization of future royalties | Monetization of Future Royalties In December 2017, the Company entered into a royalty interest acquisition agreement (RIAA) with HealthCare Royalty Partners III, L.P. (HCR) pursuant to which it sold to HCR the right to receive all royalties from sales in Japan and sales milestones achieved from any covered territory potentially payable to the Company under the Agreement, up to a specified maximum “cap” amount of $78.8 million, based on the funds the Company received from HCR. In January 2018, the Company received $44.5 million from HCR, net of certain transaction expenses, under the RIAA. On June 8, 2020, the parties entered into an amendment to the RIAA pursuant to which HCR agreed to pay the Company an additional $14.8 million, net of certain transactions expenses, in exchange for the elimination of the (i) $78.8 million cap amount on HCR’s rights to receive royalties on sales in Japan and sales milestones for elobixibat in certain other territories that may become payable by EA Pharma and (ii) the $15.0 million payable to the Company if a specified sales milestone is achieved for elobixibat in Japan. The Company is obligated to make royalty interest payments to HCR under the RIAA only to the extent it receives future Japanese royalties, sales milestones or other specified payments from EA Pharma. Although the Company sold its rights to receive royalties from the sales of elobixibat in Japan, as a result of its ongoing involvement in the cash flows related to these royalties, the Company will continue to account for these royalties as revenue. The Company recorded net cash totaling $59.3 million as a liability related to sale of future royalties (royalty obligation). The royalty obligation will be amortized using the effective interest rate method. The following table shows the activity within the liability account for the nine month period ended September 30, 2020: September 30, 2020 (in thousands) Liability related to sale of future royalties—December 31, 2019 $ 55,144 Proceeds from sale of future royalties, net 14,750 Foreign currency translation loss (800) Accretion of interest expense on liability related to royalty monetization 7,670 Repayment of the liability (9,762) Liability related to sale of future royalties—September 30, 2020 $ 67,002 Less current portion classified within accrued expenses (2,131) Net ending liability related to sale of future royalties $ 64,871 The Company records estimated royalties due for the current period in accrued expenses until the payment is received from EA Pharma at which time the Company then remits payment to HCR. As royalties are remitted to HCR, the balance of the royalty obligation will be effectively repaid over the life of the RIAA. In order to determine the accretion of the royalty obligation, the Company is required to estimate the total amount of future royalty payments to be received and submitted to HCR, as noted above. The sum of these amounts less the $59.3 million proceeds the Company received will be recorded as interest expense over the life of the royalty obligation. At September 30, 2020, the Company’s estimate of its total interest expense resulted in an annual effective interest rate of approximately 20.4%. The Company periodically assesses the estimated royalty payments to HCR and to the extent such payments are greater or less than its initial estimates or the timing of such payments is materially different than its original estimates, the Company will prospectively adjust the accretion of interest on the royalty obligation. There are a number of factors that could materially affect the amount and the timing of royalty payments, most of which are not within the Company’s control. Such factors include, but are not limited to, the rate of elobixibat prescriptions, the number of doses administered, the introduction of competing products, manufacturing or other delays, patent protection, adverse events that result in governmental health authority imposed restrictions on the use of the drug products, significant changes in foreign exchange rates as the royalties remitted to HCR are in U.S. dollars while sales of elobixibat are in Japanese yen, and sales never achieving forecasted numbers, which would result in reduced royalty payments and reduced non-cash interest expense over the life of the royalty obligation. To the extent future royalties result in an amount less than the liability, the Company is not obligated to fund any such shortfall. |
Recently adopted accounting pronouncements | Recently adopted accounting pronouncements In August 2018, the FASB issued ASU “Intangibles – Goodwill and Other – Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract.” ASU This standard aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain software (and hosting arrangements that include an software license). The guidance also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. The Company adopted this guidance in the first quarter of 2020 on a prospective basis and there was no material impact on its consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies and Basis of Presentation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Summary of significant accounting policies and basis of presentation | |
Schedule of Activity within Liability Account from Inception of Royalty Transaction | September 30, 2020 (in thousands) Liability related to sale of future royalties—December 31, 2019 $ 55,144 Proceeds from sale of future royalties, net 14,750 Foreign currency translation loss (800) Accretion of interest expense on liability related to royalty monetization 7,670 Repayment of the liability (9,762) Liability related to sale of future royalties—September 30, 2020 $ 67,002 Less current portion classified within accrued expenses (2,131) Net ending liability related to sale of future royalties $ 64,871 |
Net loss per share (Tables)
Net loss per share (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Net loss per share | |
Summary of Computation of Basic EPS and Diluted EPS | The following table sets forth the computation of Basic EPS and Diluted EPS (in thousands, except for share and per share data): Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Basic and Diluted EPS: Numerator Net loss $ (30,743) $ (21,910) $ (82,834) $ (55,195) Denominator Weighted average number of shares outstanding 15,704,293 12,685,000 14,942,213 12,349,870 Basic and Diluted EPS $ (1.96) $ (1.73) $ (5.54) $ (4.47) |
Summary of Outstanding Shares Excluded from Computation of Diluted EPS | Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 Options to purchase common stock, RSUs and warrants 2,403,090 1,759,963 2,403,090 1,759,963 |
Note Payable (Tables)
Note Payable (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Note Payable | |
Schedule of the carrying value of notes payable | September 30, 2020 (in thousands) Note payable, including End of Term Charge 10,695 Debt discount, net of accretion (1,187) Note payable net of discount, long-term $ 9,508 |
Schedule of the estimated future principal payments due under the Loan Agreement | Note Principal Payments (in thousands) Remainder of 2020 $ — 2021 — 2022 4,553 2023 4,994 2024 1,148 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2020 | |
Stock-based Compensation | |
Summary of stock-based compensation expense | Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 (in thousands) (in thousands) Employee awards: Research and development expense $ 2,044 $ 742 $ 3,966 $ 2,242 General and administrative expense 3,045 1,084 6,107 3,456 Total stock-based compensation expense $ 5,089 $ 1,826 $ 10,073 $ 5,698 |
Summary of significant accoun_4
Summary of significant accounting policies and basis of presentation - Royalties (Details) - EA Pharma - License Agreement $ in Millions | 9 Months Ended |
Sep. 30, 2020USD ($) | |
Disaggregation of revenue | |
Milestone payment receivable | $ 5 |
Period of written notice required prior to termination of agreement | 180 days |
Summary of significant accoun_5
Summary of significant accounting policies and basis of presentation - Monetization of future royalties (Details) - USD ($) $ in Thousands | Jun. 08, 2020 | Jan. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Dec. 31, 2019 |
Liability related to sale of future royalties activity | |||||||
Proceeds from sale of future royalties, net | $ 14,750 | ||||||
Accretion of interest expense on liability related to royalty monetization | 7,670 | $ 6,179 | |||||
Net ending liability related to sale of future royalties | $ 64,871 | $ 48,714 | |||||
HCR | Royalty Interest Acquisition Agreement | |||||||
Summary Of Significant Accounting Policies | |||||||
Maximum royalties under monetization agreement | $ 78,800 | ||||||
Milestone payment receivable | $ 15,000 | ||||||
Liability related to sale of future royalties activity | |||||||
Liability related to the sale of future royalties - beginning balance | 55,144 | ||||||
Proceeds from sale of future royalties, net | $ 14,800 | $ 44,500 | 14,750 | 59,300 | |||
Foreign currency translation gain | (800) | ||||||
Accretion of interest expense on liability related to royalty monetization | 7,670 | ||||||
Repayment of the liability | (9,762) | ||||||
Liability related to sale of future royalties - ending balance | $ 55,144 | 67,002 | $ 55,144 | ||||
Less current portion classified within accrued expenses | (2,131) | ||||||
Net ending liability related to sale of future royalties | $ 64,871 | ||||||
Annual effective interest rate | 20.40% |
Commitments and contingencies -
Commitments and contingencies - Agreements with CROs (Details) $ in Millions | Sep. 30, 2020USD ($) |
Commitments and contingencies | |
Maximum future payable under agreements with CROs | $ 39.8 |
Net loss per share - Basic EPS
Net loss per share - Basic EPS and Diluted EPS (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||||||
Sep. 30, 2020 | Jun. 30, 2020 | Mar. 31, 2020 | Sep. 30, 2019 | Jun. 30, 2019 | Mar. 31, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Basic and Diluted EPS: | ||||||||
Net loss | $ (30,743) | $ (20,603) | $ (31,488) | $ (21,910) | $ (16,628) | $ (16,657) | $ (82,834) | $ (55,195) |
Denominator | ||||||||
Weighted average number of shares outstanding | 15,704,293 | 12,685,000 | 14,942,213 | 12,349,870 | ||||
Basic and Diluted EPS | $ (1.96) | $ (1.73) | $ (5.54) | $ (4.47) |
Net loss per share - Anti-dilut
Net loss per share - Anti-dilutive shares (Details) - shares | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Options to purchase common stock, RSUs and warrants | ||||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||||
Anti-dilutive securities excluded from computation of diluted net loss per share | 2,403,090 | 1,759,963 | 2,403,090 | 1,759,963 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) $ in Millions | 9 Months Ended | |
Sep. 30, 2020 | Sep. 30, 2019 | |
Income taxes | ||
Income tax provision (benefit) | $ 0 | $ 0 |
Note Payable - Loan and Securit
Note Payable - Loan and Security Agreement (Details) - USD ($) $ in Millions | Jun. 08, 2020 | Sep. 30, 2020 |
Loan and Security Agreement, Term Loans | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity | $ 80 | |
End of term charge as a percent of principal amount | 6.95% | |
Prepayment premium, as a percent of principal, within first 6 months following closing date | 3.00% | |
Prepayment premium, as a percent of principal, between 6 months and 24 months following closing date | 2.00% | |
Prepayment premium, as a percent of principal, 24 months following closing date and before maturity date | 1.00% | |
Amount borrowed | $ 10 | |
Debt discount and issuance costs | $ 1.3 | |
Effective interest rate (as a percent) | 15.30% | |
Loan and Security Agreement, Term Loans | Minimum | ||
Debt Instrument [Line Items] | ||
Interest rate (as a percent) | 9.15% | |
Loan and Security Agreement, Term Loans | Prime Rate | ||
Debt Instrument [Line Items] | ||
Interest rate percentage added to variable rate to determine minimum annual interest rate | 9.15% | |
Spread on rate (as a percent) | (3.25%) | |
Loan and Security Agreement, Term Loan, First/Initial Tranche | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity, term loan advance | $ 10 | |
Loan and Security Agreement, Term Loan, Second Tranche | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity, term loan advance | 5 | |
Loan and Security Agreement, Term Loan, Third Tranche | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity, term loan advance | 20 | |
Minimum borrowing increments | 10 | |
Loan And Security Agreement Term Loan, Fourth Tranche | ||
Debt Instrument [Line Items] | ||
Maximum borrowing capacity, term loan advance | 45 | |
Minimum borrowing increments | $ 5 |
Note Payable - Carrying Value (
Note Payable - Carrying Value (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Debt Instrument [Line Items] | ||||
Note payable net of discount, long-term | $ 9,508 | $ 9,508 | ||
Loan and Security Agreement, Term Loans | ||||
Debt Instrument [Line Items] | ||||
Note payable, including End of Term Charge | 10,695 | 10,695 | ||
Debt discount, net of accretion | (1,187) | (1,187) | ||
Note payable net of discount, long-term | 9,508 | 9,508 | ||
Interest expense | $ 300 | $ 0 | $ 400 | $ 0 |
Note Payable - Estimated future
Note Payable - Estimated future principal payments (Details) - Loan and Security Agreement, Term Loans $ in Thousands | Sep. 30, 2020USD ($) |
Debt Instrument [Line Items] | |
2022 | $ 4,553 |
2023 | 4,994 |
2024 | $ 1,148 |
Note Payable - Warrants (Detail
Note Payable - Warrants (Details) - USD ($) $ / shares in Units, $ in Millions | Jun. 08, 2020 | Sep. 30, 2020 | Dec. 31, 2019 |
Class of Warrant or Right [Line Items] | |||
Common stock, par value | $ 0.01 | $ 0.01 | |
Loan and Security Agreement, Term Loans | |||
Class of Warrant or Right [Line Items] | |||
Number of warrants (as a percent) | 1.00% | ||
Number of warrants issued (in shares) | 5,311 | ||
Warrant exercise period | 7 years | ||
Warrants exercise price (in dollars per share) | $ 18.83 | ||
Warrant registration period | 60 days | ||
Loan and Security Agreement, Term Loans | Maximum | |||
Class of Warrant or Right [Line Items] | |||
Warrant registration period | 180 days | ||
Loan and Security Agreement, Term Loan, First/Initial Tranche | |||
Class of Warrant or Right [Line Items] | |||
Fair value of warrants | $ 0.1 |
Equity Financings (Details)
Equity Financings (Details) - USD ($) $ in Millions | Sep. 09, 2020 | Feb. 03, 2020 |
Underwritten Public Offering, February 2020 | ||
Class Of Stock [Line Items] | ||
Issuance of common stock (in shares) | 2,190,750 | |
Proceeds from sale of stock | $ 43 | |
Underwritten Public Offering, September 2020 | ||
Class Of Stock [Line Items] | ||
Issuance of common stock (in shares) | 4,000,000 | |
Proceeds from sale of stock | $ 150.4 |
Stock-based Compensation activi
Stock-based Compensation activity (Details) | 9 Months Ended |
Sep. 30, 2020$ / sharesshares | |
Stock-based Compensation | |
Options granted (in shares) | shares | 747,025 |
Weighted average exercise price - Options granted (in dollars per share) | $ / shares | $ 24.78 |
Stock-based Compensation - Stoc
Stock-based Compensation - Stock-based compensation expense (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2020 | Sep. 30, 2019 | Sep. 30, 2020 | Sep. 30, 2019 | |
Stock-based compensation | ||||
Stock-based compensation expense | $ 5,089 | $ 1,826 | $ 10,073 | $ 5,698 |
Research and Development | ||||
Stock-based compensation | ||||
Stock-based compensation expense | 2,044 | 742 | 3,966 | 2,242 |
General and Administrative | ||||
Stock-based compensation | ||||
Stock-based compensation expense | $ 3,045 | $ 1,084 | $ 6,107 | $ 3,456 |