Cover Page
Cover Page - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Feb. 26, 2021 | Jun. 30, 2020 | |
Cover [Abstract] | |||
Document Type | 10-K | ||
Entity Interactive Data Current | Yes | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2020 | ||
Document Fiscal Year Focus | 2020 | ||
Document Fiscal Period Focus | FY | ||
Entity Registrant Name | Chiasma, Inc. | ||
Entity Central Index Key | 0001339469 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity File Number | 001-37500 | ||
Entity Tax Identification Number | 76-0722250 | ||
Entity Incorporation, State or Country Code | DE | ||
Document Annual Report | true | ||
Document Transition Report | false | ||
ICFR Auditor Attestation Flag | false | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Shell Company | false | ||
Entity Filer Category | Non-accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Common Stock, Shares Outstanding | 57,843,577 | ||
Entity Public Float | $ 195,166,166 | ||
Trading Symbol | CHMA | ||
Security Exchange Name | NASDAQ | ||
Title of 12(b) Security | Common Stock, $0.01 par value | ||
Entity Address, Address Line One | 140 Kendrick Street, Building C East | ||
Entity Address, City or Town | Needham | ||
Entity Address, State or Province | MA | ||
Entity Address, Postal Zip Code | 02494 | ||
City Area Code | 617 | ||
Local Phone Number | 928-5300 | ||
Documents Incorporated by Reference | DOCUMENTS INCORPORATED BY REFERENCE The registrant intends to file a definitive proxy statement pursuant to Regulation 14A within 120 days of the end of the fiscal year ended December 31, 2020. Portions of such definitive proxy statement are incorporated by reference into Part III of this Annual Report on Form 10-K. |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Current Assets | ||
Cash and cash equivalents | $ 15,462 | $ 27,855 |
Marketable securities | 119,959 | 64,520 |
Accounts receivable | 538 | |
Inventory | 10,955 | |
Prepaid expenses and other current assets | 6,444 | 3,881 |
Total current assets | 153,358 | 96,256 |
Property and equipment, net | 534 | 334 |
Other assets | 1,883 | 2,236 |
Restricted cash | 20,563 | |
Total assets | 176,338 | 98,826 |
Current liabilities | ||
Accounts payable | 4,240 | 3,253 |
Accrued expenses | 11,858 | 7,576 |
Other current liabilities | 633 | 546 |
Total current liabilities | 16,731 | 11,375 |
Deferred royalty obligation | 63,548 | |
Long-term liabilities | 4,274 | 1,682 |
Total liabilities | 84,553 | 13,057 |
Commitments and Contingencies (Note 15) | ||
Stockholders’ equity: | ||
Common stock, $0.01 par value; authorized 125,000,000 shares at December 31, 2020 and December 31, 2019; issued and outstanding 57,815,596 shares at December 31, 2020 and 42,078,416 shares at December 31, 2019 | 578 | 421 |
Preferred stock, $0.01 par value; authorized 5,000,000 shares; none outstanding | ||
Additional paid-in capital | 438,920 | 358,245 |
Accumulated other comprehensive income | 37 | |
Accumulated deficit | (347,713) | (272,934) |
Total stockholders’ equity | 91,785 | 85,769 |
Total liabilities and stockholders' equity | $ 176,338 | $ 98,826 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2020 | Dec. 31, 2019 |
Statement Of Financial Position [Abstract] | ||
Common stock, par value | $ 0.01 | $ 0.01 |
Common stock, shares authorized | 125,000,000 | 125,000,000 |
Common stock, shares issued | 57,815,596 | 42,078,416 |
Common stock, shares outstanding | 57,815,596 | 42,078,416 |
Preferred stock, par value | $ 0.01 | $ 0.01 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Statement [Abstract] | |||
Product revenue, net | $ 1,106 | ||
Cost of goods sold | 61 | ||
Gross profit | 1,045 | ||
Operating expenses: | |||
Selling, general and administrative | 44,892 | $ 15,122 | $ 9,974 |
Research and development | 26,802 | 22,457 | 22,362 |
Total operating expenses | 71,694 | 37,579 | 32,336 |
Loss from operations | (70,649) | (37,579) | (32,336) |
Interest and other income, net | 1,826 | 1,543 | 1,044 |
Interest expense | (5,872) | ||
Loss before income taxes | (74,695) | (36,036) | (31,292) |
Provision (benefit) for income taxes | 84 | 284 | (31) |
Net loss | $ (74,779) | $ (36,320) | $ (31,261) |
Earnings per share | |||
Basic | $ (1.43) | $ (1.06) | $ (1.28) |
Diluted | $ (1.43) | $ (1.06) | $ (1.28) |
Weighted-average shares outstanding: | |||
Basic | 52,234,945 | 34,204,284 | 24,399,706 |
Diluted | 52,234,945 | 34,204,284 | 24,399,706 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Income (Loss) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Statement Of Income And Comprehensive Income [Abstract] | |||
Net loss | $ (74,779) | $ (36,320) | $ (31,261) |
Other comprehensive income (loss): | |||
Unrealized gain (loss) on available for sale securities, net | (37) | 53 | 43 |
Total other comprehensive income (loss): | (37) | 53 | 43 |
Comprehensive loss | $ (74,816) | $ (36,267) | $ (31,218) |
Consolidated Statements of Stoc
Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands | Total | Common Stock [Member] | Additional Paid-in Capital [Member] | Accumulated Other Comprehensive Income (Loss) [Member] | Accumulated Deficit [Member] |
Beginning balance at Dec. 31, 2017 | $ 62,474 | $ 244 | $ 267,642 | $ (59) | $ (205,353) |
Beginning balance, shares at Dec. 31, 2017 | 24,381,605 | ||||
Stock-based compensation | 2,730 | 2,730 | |||
Exercise of stock options | 37 | $ 1 | 36 | ||
Exercise of stock options, shares | 74,515 | ||||
Additional paid-in capital on account of vested portion of restricted stock | 101 | 101 | |||
Other comprehensive income (loss) | 43 | 43 | |||
Net loss | (31,261) | (31,261) | |||
Ending balance at Dec. 31, 2018 | 34,124 | $ 245 | 270,509 | (16) | (236,614) |
Ending balance, shares at Dec. 31, 2018 | 24,456,120 | ||||
Stock-based compensation | 3,270 | 3,270 | |||
Exercise of stock options | 50 | $ 2 | 48 | ||
Exercise of stock options, shares | 192,711 | ||||
Issuance of common stock in follow-on offerings, net | 84,576 | $ 174 | 84,402 | ||
Issuance of common stock in follow-on offering, net, shares | 17,429,585 | ||||
Additional paid-in capital on account of vested portion of restricted stock | 16 | 16 | |||
Other comprehensive income (loss) | 53 | 53 | |||
Net loss | (36,320) | (36,320) | |||
Ending balance at Dec. 31, 2019 | 85,769 | $ 421 | 358,245 | 37 | (272,934) |
Ending balance, shares at Dec. 31, 2019 | 42,078,416 | ||||
Stock-based compensation | 5,074 | 5,074 | |||
Exercise of stock options | $ 279 | $ 2 | 277 | ||
Exercise of stock options, shares | 207,416 | 207,416 | |||
Issuance of common stock and pre-funded warrants in follow-on offerings, net | $ 75,479 | $ 151 | 75,328 | ||
Issuance of common stock and pre-funded warrants in follow-on offering, net , shares | 15,125,000 | ||||
Issuance of common stock from cashless warrant exercise | $ 4 | (4) | |||
Issuance of common stock from cashless warrant exercise, shares | 404,764 | ||||
Other comprehensive income (loss) | (37) | $ (37) | |||
Net loss | (74,779) | (74,779) | |||
Ending balance at Dec. 31, 2020 | $ 91,785 | $ 578 | $ 438,920 | $ (347,713) | |
Ending balance, shares at Dec. 31, 2020 | 57,815,596 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Operating Activities: | |||
Net loss | $ (74,779) | $ (36,320) | $ (31,261) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | |||
Depreciation | 172 | 55 | 88 |
Stock-based compensation | 5,020 | 3,270 | 2,730 |
Accretion on marketable securities, net | (6) | (515) | (440) |
Non-cash lease expense | 509 | 319 | |
Amortization of debt discount and issuance costs | 330 | ||
Change in fair value of embedded derivative liability | (1,200) | ||
Provision (benefit) for deferred income taxes | (4) | (22) | 16 |
Non-cash interest expense | 5 | ||
Loss on disposal of property and equipment | 29 | ||
Changes in operating assets and liabilities: | |||
Accounts receivable | (538) | ||
Inventory | (10,901) | ||
Prepaid expenses and other current assets | (2,364) | (1,420) | 471 |
Insurance recovery (Note 15) | 18,288 | ||
Accounts payable and accrued expenses | 6,167 | 111 | 4,349 |
Settlement liability (Note 15) | (18,750) | ||
Other assets | (289) | (107) | 9 |
Other current and long-term liabilities | 2,557 | 50 | (58) |
Net cash used in operating activities | (75,326) | (35,012) | (24,091) |
Investing Activities: | |||
Purchase of marketable securities | (145,341) | (99,726) | (38,010) |
Maturities of marketable securities | 89,871 | 64,376 | 62,227 |
Purchases of property and equipment | (372) | (307) | (6) |
Net cash provided by (used in) investing activities | (55,842) | (35,657) | 24,211 |
Financing Activities: | |||
Proceeds from the issuance of common stock and pre- funded warrants, net | 75,479 | 84,576 | |
Exercise of stock options | 279 | 50 | 37 |
Payments under license termination agreement | (1,700) | ||
Proceeds from short-term borrowing | 1,675 | ||
Payments of short-term borrowing | (838) | (837) | |
Proceeds from deferred royalty obligation, net | 64,418 | ||
Net cash provided by (used in) financing activities | 139,338 | 85,464 | (1,663) |
Net increase (decrease) in cash, cash equivalents and restricted cash | 8,170 | 14,795 | (1,543) |
Cash, cash equivalents and restricted cash, beginning of year | 27,855 | 13,060 | 14,603 |
Cash, cash equivalents and restricted cash, end of year | 36,025 | 27,855 | 13,060 |
Reconciliation of cash, cash equivalents and restricted cash reported within the consolidated balance sheets | |||
Cash and cash equivalents | 15,462 | 27,855 | 13,060 |
Restricted cash | 20,563 | ||
Cash, cash equivalents and restricted cash, end of year | 36,025 | 27,855 | 13,060 |
Supplemental disclosures of cash flow information: | |||
Cash paid for interest on deferred royalty obligation | 17 | ||
Cash paid for income taxes | $ 188 | $ 380 | $ 333 |
Nature of Business
Nature of Business | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Nature of Business | 1. Nature of Business Chiasma, Inc. is a commercial-stage are focused on developing and commercializing oral therapies to improve the lives of patients who face challenges associated with their existing treatments for rare and serious chronic disease. Employing our proprietary Transient Permeability Enhancer technology platform, we seek to develop oral medications that are currently available only as injections. On June 26, 2020, we received approval from the U.S. Food and Drug Administration (“FDA”) of our oral octreotide capsules product candidate, MYCAPSSA, for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. We commenced our U.S. commercial launch of MYCAPSSA in September 2020. Acromegaly is a rare and debilitating condition that results in the body’s production of excess growth hormone. Octreotide is an analog of somatostatin, a natural inhibitor of growth hormone secretion. Octreotide capsules have been granted orphan designation in the United States and the European Union for the treatment of acromegaly. We conducted an international Phase 3 clinical trial, referred to as MPOWERED, of oral octreotide capsules for the maintenance treatment of adult patients with acromegaly to support regulatory approval in the European Union by the European Medicines Agency (“EMA”). The MPOWERED trial was a global, randomized, open-label and active-controlled 15-month trial initially designed to enroll up to 150 patients. The EMA requested that a minimum of 80 patients who are responders to octreotide capsules per the protocol following the six-month In April 2019, we completed an underwritten public offering of we completed a follow-on public offering of common stock in which we In April 2020, we entered into an Open Market Sales Agreement (“ATM Agreement”) for “at the market offerings” with Jefferies LLC (“Jefferies”), under which we may offer and sell from time to time, shares of our common stock having an aggregate offering price of up to $60.0 million through Jefferies, acting as our sales agent or principal. To date, we have not sold any common stock under the ATM Agreement. In April 2020, we entered into a Revenue Interest Financing Agreement (the “Revenue Interest Financing Agreement”) with Healthcare Royalty Partners IV, L.P. (“HCR”) for up to $75.0 million. As of September 30, 2020, we have received aggregate proceeds of $65.0 million, less certain transaction expenses (see Note 9). In July 2020, we completed an underwritten public offering of 15,125,000 shares of common stock and pre-funded warrants (the “Pre-Funded Warrants”) to purchase an aggregate of 5,000,000 shares of common stock. The public offering price was $4.00 per share of common stock. We received aggregate net proceeds of approximately $75.5 million after deducting underwriting fees and offering expenses. The Pre-Funded Warrants are immediately exercisable at an exercise price per share of $0.0001. We have incurred substantial operating losses since inception, and we expect our operating losses and negative operating cash flows to continue for the foreseeable future. We are heavily dependent on the commercial success of MYCAPSSA in the United States and the regulatory approval and subsequent commercial success of MYCAPSSA in the European Union, both of which may never occur. We plan to invest in our U.S. commercial launch and the manufacturing of octreotide capsules for market consumption including capsules as a treatment for acromegaly in the European Union. We currently expect our existing cash, cash equivalents and marketable securities to fund our operations for at least one year after the date these consolidated financial statements are issued. Successful transition to attaining profitable operations is dependent upon achieving a level of revenues adequate to support our cost structure. We plan to continue to fund our losses from operations and capital funding needs from existing balances of cash, cash equivalents and marketable securities and potentially through additional equity financings. We may also opportunistically consider license and collaboration agreements with potential partners or convertible debt financing to the extent such sources are identified and available. If our anticipated U.S. revenues are insufficient to fund our operations to attaining and sustaining profitability, additional financing may be required. Such financing, if required, may not be available on a timely basis on terms acceptable to us, or at all. If we are not able to secure adequate additional funding when required, we may be forced to make reductions in spending, extend payment terms with suppliers, suspend or curtail our development opportunities, or it may negatively impact our ability to adequately fund or delay our potential commercial preparations or launch readiness outside the United States if the MPOWERED trial results are positive and MYCAPSSA is approved by the EMA. Any of these actions could materially harm our business, results of operations and future prospects. Failure to successfully commercialize octreotide capsules in acromegaly will prevent us from achieving profitability and positive cash flows, which could raise significant concerns about our continued viability as a business. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Principles of Consolidation and Basis of Presentation The accompanying consolidated financial statements include the accounts of Chiasma, Inc. and its subsidiaries and are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and are stated in U.S. dollars. The consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. All intercompany balances and transactions have been eliminated in consolidation. Use of estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes during the reporting period. We base these estimates and assumptions on historical experience when available, and on various factors that we believe to be reasonable under the specific circumstances. Significant estimates relied upon in preparing the accompanying consolidated financial statements include, but are not limited to, recognition of product revenues, accounting for stock-based compensation, income taxes, the fair value of embedded derivative and our deferred royalty obligation and accounting for certain accruals. We assess the above estimates on an ongoing basis; however, actual results could materially differ from those estimates. Cash Equivalents Cash equivalents consist of highly liquid instruments which mature within three months or less from the date of purchase. Marketable Securities Our investments primarily consist of commercial paper and corporate and government debt securities. These marketable securities are classified as available-for-sale, and as such, are reported at fair value on our consolidated balance sheets. Unrealized holding gains and losses are reported within accumulated other comprehensive income as a separate component of stockholders’ equity. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, together with interest on securities, are included in interest and other income, net, on our consolidated statements of operations. If a decline in the fair value of a marketable security below our cost basis is determined to be other than temporary, such marketable security is written down to its estimated fair value as a new cost basis and the amount of the write-down is included in earnings as an impairment charge. The cost of securities sold is based on the specific identification method. Accounts Receivable Our accounts receivable consist of amounts due from one specialty pharmacy (the “customer”) for sales of MYCAPSSA and which have standard payments terms. We extend credit to our customer based on our evaluation of the customer’s financial condition. Accounts receivable are stated at amounts due net of applicable prompt pay discounts and other adjustments. We assess the need for an allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due and the customer’s ability to pay its obligation. Based on a review of these factors, as of December 31 , 2020, we determined that an allowance for doubtful accounts was not required. Concentrations of credit risk Financial instruments that potentially subject us to significant concentration of credit risk consist primarily of cash, cash equivalents, marketable securities, and accounts receivable. During the year ended December 31, 2020, one customer comprised 100% of our accounts receivable and product revenues. We routinely maintain deposits in financial institutions in excess of government insured limits. Management believes that we are not exposed to significant credit risk as our deposits are held at financial institutions that management believes to be of high credit quality and we have not experienced any significant losses in these deposits. We regularly invest excess operating cash in deposits with major financial institutions and money market funds and in notes issued by the U.S. government, as well as in fixed income investments and bond funds, both of which can be readily purchased and sold using established markets. We believe that the market risk arising from our holdings of these financial instruments is mitigated based on the fact that many of these securities are either government backed or of high credit rating. Inventory Prior to FDA approval of MYCAPSSA, all costs related to the manufacturing of MYCAPSSA that could potentially be available to support the planned U.S. commercial launch were charged to research and development expense in the period incurred. Generally, inventory may be capitalized if it is probable that future revenues will be generated from the sale of the inventory and that these revenues will exceed the cost of the inventory. Through the FDA approval date of MYCAPSSA, we expensed all of our manufacturing costs due to the high risk inherent in drug development and uncertainty as to whether MYCAPSSA would be approved. We began to capitalize our manufacturing-related costs to inventory starting July 1, 2020. We capitalize the costs to manufacture our products incurred after regulatory approval when, based on our judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. In connection therewith, we value our inventories at the lower of cost or estimated net realizable value. We determine the cost of our inventories, which includes amounts related to active pharmaceutical ingredient (“API”), and other raw materials, third party manufacturing costs and other overhead costs, on a first-in, first-out basis. Inventories that may be used for either research and development or commercial sale are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is intended to be used for research and development, it is expensed as research and development once that determination is made. On a quarterly basis, we review inventory quantities on hand and analyze the provision for excess and obsolete inventory based primarily on remaining product shelf life and our estimated sales forecast which is based on anticipated future demand. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, and patient usage. Our estimates of future product demand may prove to be imprecise and changes in estimates will result in a change to the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in demand could have a significant impact on the value of our inventory and results of operations. Foreign currency translation We use the U.S. dollar as our functional currency. Monetary assets and liabilities denominated in foreign currency are re-measured at current rates and non-monetary assets denominated in foreign currency are recorded at historical exchange rates. Realized and unrealized exchange gains or losses from transactions and re-measurement adjustments are reflected in other income, net, in the accompanying consolidated statements of operations. Comprehensive income (loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Other than reported net income, comprehensive income (loss) includes unrealized gains and losses on available for sale securities, which are disclosed in the accompanying consolidated statements of comprehensive income (loss). There were no reclassifications out of comprehensive income (loss) for the years ended December 31, 2020, 2019 or 2018. Segment information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, our Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. We view our operations and manage our business in one operating segment. Other assets Other assets consist of right of use assets, long-term restricted deposits, prepayments, and deferred tax assets. Restricted cash Restricted cash consists of $20.0 million that we are required to maintain in securitized cash and investment accounts under the Revenue Interest Financing Agreement, interest-bearing money market accounts held as security deposits against bank guarantees, and amounts related to our co-pay assistance program. Property and equipment Property and equipment are stated at cost, net of accumulated depreciation and amortization. Expenditures for maintenance and repairs are charged to operations as incurred, whereas major betterments are capitalized as additions to property and equipment. Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the assets, as follows: Asset Category Estimated Useful Lives Computer equipment and software 3 years Office furniture and equipment 7—17 years (mainly 7) Machinery and equipment 5 — 7 years Leasehold improvements The lesser of lease term or estimated useful lives Impairment of long-lived assets We review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, we compare the carrying amounts of the assets to their undiscounted expected future cash flows the assets are expected to generate and to be recognized. The amount of impairment loss to be recognized is the excess of the carrying value over the fair value of the related asset. We did not record any impairments during the years ended December 31, 2020, 2019 and 2018. Deferred Royalty Obligation We treat the deferred royalty obligation, as discussed further in Note 9, as a debt obligation, amortized under the effective interest rate method over the estimated life of the agreement. We recognize interest expense thereon using the effective rate, which is based on our current estimates of future revenues over the life of the arrangement. In connection therewith, we periodically assess our expected revenues using internal projections, impute interest on the carrying value of the deferred royalty obligation, and record interest expense using the effective interest rate. To the extent our estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will account for any such changes by adjusting the effective interest rate on a prospective basis, with a corresponding impact to the reclassification of our deferred royalty obligation between short- and long-term. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs requires that we make estimates that could impact the short-term and long-term classification of such costs, as well as the period over which such costs will be amortized. Revenue Recognition In accordance with accounting guidance for revenue recognition, we recognize revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine to be within the scope of such guidance, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services that we transfer to the customer. For a further discussion of accounting for net product revenue see Note 3 . Research and development Research and development costs are expensed as incurred. Research and development costs include payroll and personnel expense, consulting costs, external contract research and development expenses, raw materials, drug product manufacturing costs, and allocated overhead including depreciation and amortization, rent, and utilities. Research and development costs that are paid in advance of performance are capitalized as a prepaid expense and amortized over the service period as the services are provided. Clinical trial costs Clinical trial costs are a component of research and development expenses. We accrue and expense clinical trial activities performed by third parties on an evaluation of the progress to completion of specific tasks using data such as hours spent in performance of services, patient enrollment, clinical site activation, and other information provided to us by our vendors. We make estimates of our clinical trial accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us. If timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we assess our estimates of accrued expenses accordingly. Patent costs Patent costs are expensed as incurred as their realization is uncertain. These costs are classified as general and administrative in the accompanying consolidated statements of operations. Advertising and Product Promotion Costs Advertising and product promotion costs are included in selling, general and administrative expenses and were $5.3 million during the year ended December 31, 2020. We did not incur any advertising and promotion costs in the years ended December 31, 2019 and 2018, respectively. Advertising and product promotion costs are expensed as incurred. Stock-based compensation We account for all stock-based compensation to employees and nonemployees based on their fair values on the date of grant. For stock-based awards with only service conditions, we recognize compensation on a straight-line basis over the requisite service period, which is usually the vesting period of the award, net of any actual forfeitures. We determine the fair value of stock options by using the Black-Scholes option pricing model. This model requires the input of several assumptions such as the expected option term, the expected risk-free interest rate over the expected option term, the expected volatility of our stock price over the expected option term, and the expected dividend yield over the expected option term. The computation of expected volatility is based on an average historical share price volatility based on an analysis of reported data for a peer group of comparable publicly traded companies, which were selected based upon industry similarities. The interest rate for periods within the expected term of the award is based on the U.S. Treasury risk-free interest rate in effect at the time of grant. The expected lives of the options were estimated using the simplified method. Income taxes The consolidated financial statements reflect provisions for federal, state, local and foreign income taxes. Deferred tax assets and liabilities represent future tax consequences of temporary differences between the financial statement carrying amounts and the tax basis of assets and liabilities and for loss carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is recorded when it is more likely than not that some or all of the deferred tax assets will not be realized. We determine whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. We account for interest and penalties related to uncertain tax positions as part of our other expenses in the accompanying consolidated financial statements. Leases We determine if an arrangement is a lease at inception. We have operating leases for our office spaces and certain automobiles. Right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The right-of-use asset also includes direct costs incurred and is reduced by lease incentives. Lease agreements with lease and non-lease components are accounted for separately. As our leases do not provide an implicit rate, we use an estimated incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. We recognize operating lease expense on a straight-line basis over the lease term. Contingent liabilities In the normal course of business, we are subject to proceedings, lawsuits, and other claims and assessments. We assess the likelihood of any adverse judgments or outcomes to these matters as well as potential ranges of probable losses. A determination of the amount of reserves required, if any, for these contingencies is made after careful analysis of each individual issue. The required reserves may change in the future due to new developments in each matter or changes in approach such as a change in settlement strategy in dealing with these matters. We record charges for the losses we anticipate incurring in connection with litigation and claims against us when we conclude a loss is probable and we can reasonably estimate these losses. Earnings per share We compute basic earnings per share by dividing net loss by the weighted average number of common shares outstanding for the period. We compute diluted earnings per common share after giving consideration to all potentially dilutive common shares, including stock options and warrants outstanding during the period, except where the effect of such non-participating securities would be antidilutive. Recently issued accounting pronouncements In June 2016, the Financial Accounting Standards Board issued new guidance which will require more timely recording of credit losses on loans and other financial instruments held by financial institutions and other organizations. The new guidance requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. The new guidance also requires enhanced disclosures regarding significant estimates and judgments used in estimating credit losses. On January 1, 2020, we adopted this standard. The adoption of this standard did not have a material impact on our consolidated financial statements. |
Product Revenue, Net
Product Revenue, Net | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Product Revenue, Net | 3. Product Revenue, Net We began selling MYCAPSSA in September 2020. We currently sell MYCAPSSA in the United States to a specialty pharmacy, which dispenses the product directly to patients. We recognize revenue when the customer obtains control of the product, which occurs at a point in time, when delivery of the product has occurred. Revenue Reserves for Variable Consideration Revenue from sales of MYCAPSSA are recorded at the net sales price, which is the amount of consideration we expect to receive in exchange for transferring the product to a customer (“transaction price”). This transaction price for product sales includes variable consideration for which reserves are established and which may result from discounts, returns, chargebacks, rebates, co-pay or co-insurance assistance and other allowances that are offered within contracts with our customer and payors. We estimate the amount of variable consideration that should be included in the transaction price under the expected value method for all sales deductions other than trade discounts, which are estimated under the most likely amount method. These provisions represent our best estimate of the amount of consideration to which we are entitled. Actual amounts of consideration ultimately received may differ from these estimates. If actual results in the future vary from our estimates, we will adjust these estimates, which would affect net product revenue and earnings in the period such changes in estimates become known. Trade Discounts and Specialty Pharmacy Fees : we provide customary discounts to our customer for prompt payment, the terms for which are explicitly stated in our contract with such customer. We record these discounts as a reduction of revenue with a corresponding reduction to accounts receivable. In addition, we also pay fees for data and distribution services from our specialty pharmacy. We have determined that such fees are not for a distinct good or service and, accordingly, are being recorded as a reduction of product revenue and a component of accrued expenses. Government Rebates: We are subject to discount obligations under state Medicaid programs, Medicare, and other government programs. Additionally, in the future we may contract with various private payor organizations, primarily insurance companies and pharmacy benefit managers, for the payment of rebates with respect to utilization of MYCAPSSA. Provisions for government rebates are based on the estimated amount of rebates and incentives to be claimed on the related sales from the period. These reserves are recorded in the same period in which the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability that is included in accrued expenses in our consolidated balance sheet. For Medicare, we must also 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 currently consists of estimates of claims that we have not yet received associated with product that has been recognized as revenue. Other Incentives/Patient Assistance Programs: Product Returns : We offer customers a limited right of return for unopened damaged or defective product, and, under certain circumstances, for unopened product for a limited time before its expiration date. We estimate the amount of product revenues that may be returned by customers and record this estimate as a reduction of revenue in the period in which the related product revenue is recognized. We currently estimate our provision for sales returns based on our expectations and adjust the transaction price with such estimate at the time of sale to our customer. Once sufficient history has been collected for product returns, we will utilize that history to inform our estimate assumption. The following table summarizes activity in each of the above product revenue allowances and reserve categories for year ended December 31, 2020: Discounts and Fees Rebates and Other Incentives Returns Total ($ in thousands) Balance, January 1, 2020 $ — $ — $ — $ — Provision 80 142 1 223 Payments or credits (64 ) (12 ) — (76 ) Balance, December 31, 2020 $ 16 $ 130 $ 1 $ 147 |
Investments
Investments | 12 Months Ended |
Dec. 31, 2020 | |
Investments All Other Investments [Abstract] | |
Investments | 4. Investments Our investments consisted of the following as of December 31, 2020 and 2019: As of December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value ($ in thousands) Money market funds $ 29,392 $ — $ — $ 29,392 Corporate notes 11,347 — (1 ) 11,346 Commercial paper 98,030 8 (8 ) 98,030 U.S. treasury securities 12,582 1 — 12,583 Total $ 151,351 $ 9 $ (9 ) $ 151,351 As of December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value ($ in thousands) Money market funds $ 23,012 $ — $ — $ 23,012 Corporate notes 45,584 20 — 45,604 Commercial paper 20,899 17 — 20,916 Total $ 89,495 $ 37 $ — $ 89,532 As of December 31, 2020, we consider the unrealized losses in our investment portfolio to be temporary in nature and not due to credit losses. We have the ability to hold such investments until recovery of the fair value. We utilize the specific identification method in computing realized gains and losses. We had no realized gains and losses on our available-for-sale securities for the years ended December 31, 2020, 2019 or 2018. The fair values of our investments by classification in our consolidated balance sheets as of December 31, 2020 and 2019 were as follows: As of December 31, 2020 2019 ($ in thousands) Cash and cash equivalents $ 10,829 $ 25,012 Marketable securities 119,959 64,520 Restricted cash 20,563 — Total $ 151,351 $ 89,532 Cash and cash equivalents in the table above exclude cash of $4.6 million and $2.8 million as of December 31, 2020 and 2019, respectively. The contractual maturity dates of all of our investments are less than one year. |
Fair Value Measurements and Fai
Fair Value Measurements and Fair Value of Financial Instruments | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements and Fair Value of Financial Instruments | 5. Fair Value Measurements and Fair Value of Financial Instruments Certain assets and liabilities are reported at fair value on a recurring basis. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. The fair value accounting guidance requires that assets and liabilities carried at fair value be classified and disclosed in one of the following three categories: Level 1— Quoted prices in active markets for identical assets or liabilities that we have the ability to access at the measurement date. Level 2— Inputs other than quoted prices in active markets that are observable for the asset or liability, either directly or indirectly. Level 3— Inputs that are unobservable for the asset or liability. 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 exercised by us 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. The following tables summarize the fair value measurements of our financial instruments as of December 31, 2020 and 2019: Fair Value Measurements at December 31, 2020 Description Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Financial assets ($ in thousands) Cash equivalents and restricted cash: Money market funds $ 29,392 $ — $ — $ 29,392 Commercial paper — 2,000 — 2,000 Total cash equivalents and restricted cash $ 29,392 $ 2,000 $ — $ 31,392 Marketable securities: U.S. treasury securities $ — $ 12,583 $ — $ 12,583 Corporate notes — 11,346 — 11,346 Commercial paper — 96,030 — 96,030 Total marketable securities $ — $ 119,959 $ — $ 119,959 Total $ 29,392 $ 121,959 $ — $ 151,351 Financial liabilities Derivative liabilities $ — $ — $ 1,900 $ 1,900 Fair Value Measurements at December 31, 2019 Description Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Financial assets ($ in thousands) Cash equivalents: Money market funds $ 23,012 $ — $ — $ 23,012 Corporate notes — 2,000 — 2,000 Total cash equivalents $ 23,012 $ 2,000 $ — $ 25,012 Marketable securities: Corporate notes $ — $ 43,604 $ — $ 43,604 Commercial paper — 20,916 — 20,916 Total marketable securities $ — $ 64,520 $ — $ 64,520 Total $ 23,012 $ 66,520 $ — $ 89,532 Our cash equivalents and restricted cash are composed of money market funds, as well as U.S. treasury securities, corporate notes and commercial paper with maturity dates of 90 days or less from the date of purchase. We measure these investments at fair value. The fair value of cash equivalents and restricted cash held in money market funds is determined based on Level 1 inputs. Items classified as Level 2 within the valuation hierarchy consist of U.S. treasury securities, corporate notes and commercial paper. We estimate the fair values of these marketable securities by taking into consideration valuations obtained from independent pricing services, which normally derive security prices from recently reported trades for identical or similar securities, making adjustments based upon other significant observable market transactions. At the end of each reporting period, we perform quantitative and qualitative analysis of prices received from third parties to determine whether prices are reasonable estimates of fair value. After completing our analysis, we did not adjust or override any fair value measurements provided by our pricing services as of December 31, 2020 or 2019. In certain cases where there is limited activity or less transparency around inputs to valuation, the related assets or liabilities are classified as Level 3. We recorded derivative liabilities associated with our deferred royalty obligation, as discussed further in Note 9. These derivative liabilities are measured at fair value using an option pricing Monte Carlo simulation model and is included as a component of the deferred royalty obligation. The embedded derivative liabilities are subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of interest and other income, net. The assumptions used in the option pricing Monte Carlo simulation model include: (1) the expected net sales of MYCAPSSA; (2) our risk-adjusted discount rate that includes a company specific risk premium; (3) our cost of debt; (4) volatility; (5) the probability and timing of a change in control occurring during the term of the instrument; and (6) the probability and timing of an event of default during the term of the instrument. We did not have any Level 3 assets or liabilities being measured at fair value on a recurring basis as of December 31, 2019 . The following table sets forth a summary of the changes in the fair value of the embedded derivative liabilities for the year ended December 31, 2020: ($ in thousands) Fair Value Measurement of Embedded Derivative using Significant Unobservable Inputs (Level 3) Balance, January 1, 2020 $ — Additions during the period 3,100 Change in fair value during the period (1,200 ) Balance, December 31, 2020 $ 1,900 |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Inventory | 6. Inventory Our inventory of MYCAPSSA consisted of the following as of December 31, 2020: ($ in thousands) December 31, 2020 Raw materials and supplies $ 6,786 Work in process 3,857 Finished goods 312 Total inventory $ 10,955 |
Property and Equipment
Property and Equipment | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment | 7. Property and Equipment Property and equipment consisted of the following as of December 31, 2020 and 2019: As of December 31, 2020 2019 ($ in thousands) Computer equipment and software $ 553 $ 431 Office furniture and equipment 358 108 Machinery and equipment 115 115 Property and equipment, at cost 1,026 654 Less accumulated depreciation (492 ) (320 ) Property and equipment, net $ 534 $ 334 Depreciation expense was $0.2 million, $0.1 million and $0.1 million for the years ended December 31, 2020, 2019 and 2018, respectively. |
Accrued Expenses
Accrued Expenses | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Accrued Expenses | 8. Accrued Expenses Accrued expenses consisted of the following as of December 31, 2020 and 2019: As of December 31, 2020 2019 ($ in thousands) Accrued payroll and employee benefits $ 4,900 $ 1,872 Accrued selling, general, administrative and other expenses 3,830 1,485 Accrued research and development expenses 3,128 4,219 Total accrued expenses $ 11,858 $ 7,576 |
Deferred Royalty Obligation
Deferred Royalty Obligation | 12 Months Ended |
Dec. 31, 2020 | |
Deferred Royalty Obligation [Abstract] | |
Deferred Royalty Obligation | 9. Deferred Royalty Obligation In April 2020, we entered into the Revenue Interest Financing Agreement with HCR whereby HCR will receive payments from us at a tiered percentage (the “Applicable Tiered Percentage”) of future net revenues of MYCAPSSA and any of our other future products, including worldwide net product sales and upfront payments and milestones received from third parties under license agreements (the “Revenue Interests”). Under the terms of the agreement, we received $25.0 million, less certain transaction expenses, from HCR in April 2020 and an additional $25.0 million in July 2020 following the FDA approval of MYCAPSSA. In September 2020 HCR’s rights to receive the Revenue Interests shall terminate on the date on which HCR has received payments equal to 195% of the funded portion of the Investment Amount including the aggregate of all payments made to HCR as of such date, unless the Revenue Interest Financing Agreement is terminated earlier. If HCR has not received payments equal to the 195% of the funded portion of the Investment Amount by the ten-year anniversary of the initial closing date and no event of default has occurred or is ongoing, among other things, we shall pay HCR an amount equal to the funded portion of the Investment Amount plus a specific annual rate of return in the low to mid-teens less payments previously received. If a change of control of the Company occurs, we must immediately repay HCR the total amount actually funded (including unfunded amounts conditionally eligible to be funded) plus a change of control premium, the amount of which is variable up to 95% based on timing and circumstances of such change of control. Upon the occurrence of an event of default, including the withdrawal, suspension or other termination of the FDA approval of MYCAPSSA as a treatment for acromegaly that continues for 60 days that prevents us from marketing MYCAPSSA, HCR may accelerate payments due under the agreement to the . If HCR has not received 60% of the funded portion of the Investment Amount by September 30, 2023 or 100% of the funded portion of the Investment Amount by September 30, 2024, we must make cash payments sufficient to gross HCR up to such minimum amounts. Further, the Revenue Interest Financing Agreement requires us to maintain a minimum of $20.0 million in securitized cash and investment accounts, which we recorded as restricted cash in the consolidated balance sheet, during any quarter that the trailing four quarters of net revenue of MYCAPSSA is below a certain threshold. Our obligations under the Revenue Interest Financing Agreement are secured by a first priority perfected security interest in all of our Chiasma, Inc. cash and cash equivalents (as defined in the Revenue Interest Financing Agreement), all present and future net revenues of MYCAPSSA and all MYCAPSSA-related assets. We have evaluated the terms of the deferred royalty obligation and concluded that the features of the Investment Amount are similar to those of a debt instrument. Accordingly, we have accounted for the transaction as long-term debt. We have evaluated the terms of the debt and determined that the repayment upon a change of control of up to 195% of the funded portion of the Investment Amount, less any payments made to date, is an embedded derivative that requires bifurcation from the debt instrument and fair value recognition. In addition, we have determined that the repayment upon an event of default of 195% of the funded portion of the Investment Amount, less any payments made to date, upon an event of default is an embedded derivative that requires bifurcation from the debt instrument and fair value recognition. We determine the fair value of the derivatives using an option pricing Monte Carlo simulation model taking into account the probability and timing of a change of control and an event of default occurring and potential repayment amounts and timing of such payments that would result under various scenarios, as further described in Note 5. The embedded derivative liabilities were recorded at fair value of $3.1 million at inception, with the remaining proceeds received from HCR allocated to the carrying value of the debt resulting in a debt discount that will be amortized over the estimated term of the obligation using the effective interest method. The aggregate fair value of the embedded derivative as of December 31, 2020 is $1.9 million and is presented in deferred royalty obligation in the consolidated balance sheet. We remeasure the embedded derivative to fair value each reporting period until the termination of the Revenue Interest Financing Agreement. Such changes in fair value are recorded as interest and other income, net in the consolidated statement of operations. The effective interest rate as of December 31, 2020 was approximately 17%. In connection with the deferred royalty obligation, we incurred debt issuance costs totaling $0.6 million during the year ended December 31, 2020. Debt issuance costs have been netted against the deferred royalty obligation and are being amortized over the estimated term of the obligation using the effective interest method, adjusted on a prospective basis for changes in the underlying assumptions and inputs. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs requires that we make estimates that could impact the short- and long-term classification of these costs, as well as the period over which these costs will be amortized. The carrying value of the deferred royalty obligation was $63.5 million as of December 31, 2020. The fair value of the deferred royalty obligation was $82.1 million as of December 31, 2020 and was measured using Level 3 inputs. The estimated fair value was calculated using an option pricing Monte Carlo simulation model with inputs consistent with those used in determining the embedded derivative values as described in Note 5 . |
Earnings per Share of Common St
Earnings per Share of Common Stock | 12 Months Ended |
Dec. 31, 2020 | |
Earnings Per Share [Abstract] | |
Earnings per Share of Common Stock | 10. Earnings per Share of Common Stock We include or outstanding shares of common stock and Pre-Funded Warrants in our calculation of the basic weighted-average shares outstanding. We include the Pre-Funded Warrants as their exercise price of $0.0001 per share is negligible and they are fully vested and exercisable at any time after the original issuance date. All other common stock warrants outstanding and stock options have been excluded from the computation of diluted weighted-average shares outstanding because such securities would have an anti-dilutive impact due to net losses reported during the years ended December 31, 2020, 2019 and 2018. Since we have reported a net loss for the years ended December 31, 2020, 2019 and 2018, diluted net loss per share is the same as basic net loss per share for those periods. |
Warrants
Warrants | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Warrants | 11. Warrants A summary of our common stock warrants activity for the year ended December 31, 2020 is presented below. Description Exercise Price Expiration Date Balance, December 31, 2019 Warrants Issued Warrants Exercised Balance, December 31, 2020 October 2012 Warrants $ 0.0910 10/22/2022 829,686 — (205,321 ) 624,365 March 2013 Warrants $ 0.0910 3/28/2022 829,686 — (205,321 ) 624,365 December 2014 Warrants $ 9.1320 12/16/2024 923,527 — — 923,527 February 2015 Warrants $ 9.1320 12/16/2024 984,116 — — 984,116 July 2020 Pre-Funded Warrants $ 0.0001 No expiration — 5,000,000 — 5,000,000 3,567,015 5,000,000 (410,642 ) 8,156,373 As described in Note 1, in July 2020 in connection with an underwritten public offering, we issued Pre-Funded Warrants to purchase an aggregate of 5,000,000 shares of common stock which are immediately exercisable at an exercise price per share of $0.0001. |
Stock Incentive Plan
Stock Incentive Plan | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock Incentive Plan | 12. Stock Incentive Plan In 2008, our Board of Directors adopted the 2008 Stock Incentive Plan (the “2008 Plan”), which provided for the grant of incentive stock options, nonqualified stock options, and restricted stock to our employees, directors, and nonemployees up to 3,547,741 shares of common stock. Option awards expire 10 years from the grant date and generally vest over four years In July 2015, we approved the 2015 Stock Option and Incentive Plan (the “2015 Plan”), which became effective upon our IPO. The 2015 Plan allows the grant of incentive stock options, nonqualified stock options, restricted stock, and other stock-based awards to employees, directors, and nonemployees of Chiasma up to 3,566,296 shares of common stock. In connection with the adoption of the 2015 Plan, no further option grants are permitted under the 2008 Plan and any expirations, cancellations, or terminations under the previous plan are available for issuance under the 2015 Plan. On January 1, 2021 and 2020, the number of shares reserved and available for issuance under the 2015 Stock Plan increased by 2,312,623 and 1,683,136 shares of common stock, respectively, pursuant to a provision in the 2015 Stock Plan that provides that the number of shares reserved and available for issuance will automatically increase each January 1, beginning on January 1, 2016, by 4% of the number of shares of common stock issued and outstanding on the immediately preceding December 31 or such lesser number as determined by the compensation committee of the Board of Directors. As of December 31, 2020, the total number of shares authorized for stock award plans is 9,775,418 of which 1,033,460 remain available for grant. There are 8,378,060 stock options outstanding as of December 31, 2020. The fair value of each stock option issued was estimated at the date of grant using the Black-Scholes option model with the following weighted-average assumptions: For the Years Ended December 31, 2020 2019 2018 Expected volatility 85 % 97 % 77 % Expected term (years) 6.2 6.0 6.2 Risk-free interest rate 0.93 % 1.93 % 2.72 % Expected dividend yield 0 % 0 % 0 % A summary of option activity as of December 31, 2020 and the year then ended is presented below: Number of Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding, December 31, 2019 6,489,692 $ 5.01 7.3 $ 8,166,882 Granted 2,307,500 $ 4.63 Exercised (207,416 ) $ 1.35 Forfeited / Expired (211,716 ) $ 5.47 Outstanding, December 31, 2020 8,378,060 $ 4.98 7.2 $ 5,611,109 Exercisable, December 31, 2020 4,774,332 $ 4.98 6.0 $ 4,634,332 Vested and expected to vest, December 31, 2020 8,378,060 $ 4.98 7.2 $ 5,611,109 The weighted-average grant date per-share fair value of stock options granted during 2020, 2019 and 2018 was $3.32, $4.79 and $1.06, respectively. The aggregate intrinsic value of stock options exercised during the years ended December 31, 2020, 2019 and 2018 was approximately $0.7 million, $1.0 million and $0.2 million, respectively. At December 31, 2020, there was $12.2 million of unrecognized compensation cost related to stock options, which is expected to be recognized over a weighted-average period of 3.0 years. Stock-based compensation expense for 2020, 2019 and 2018 consisted of the following: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) General and administrative $ 4,082 $ 2,243 $ 1,412 Research and development 938 1,027 1,318 Total $ 5,020 $ 3,270 $ 2,730 Stock-based compensation of $54,000 was capitalized into inventory for the year ended December 31, 2020. Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold. During 2015, two directors exercised options to purchase an aggregate of 122,644 shares of common stock of which 116,258 of the shares were issued as restricted stock as they were exercised prior to full vesting. The proceeds from the issuance of the restricted stock was historically presented as a liability within the consolidated balance sheet, since we had the right to repurchase the unvested portion of the restricted stock following termination of the services of their holder. The liability was released to additional paid-in capital per the original vesting schedule of the options. The restricted shares fully vested during the year ended December 31, 2019. |
License Agreement
License Agreement | 12 Months Ended |
Dec. 31, 2020 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
License Agreement | 13. License Agreement In December 2012, we signed a license agreement with F. Hoffmann-La Roche Ltd. and Hoffmann-La Roche Inc. (collectively “Roche”), which was effective in January 2013, and granted Roche an exclusive, non-transferable license to our intellectual property related to octreotide capsules. In July 2014, Roche terminated the license agreement. Subsequent to the termination, we purchased from Roche API supplies to continue the development and manufacturing of octreotide capsules as well as Roche’s proposed trade name for octreotide capsules for an aggregate amount of $5.1 million payable in three equal annual installments of $1.7 million beginning in 2016. We made the final $1.7 million annual payment in March 2018. Roche has no remaining rights to octreotide capsules and we retain all rights to octreotide capsules and all related intellectual property. We have no further financial or operational obligations to Roche. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | 14. Income Taxes Our loss before provision (benefit) for income taxes for the years ended December 31, 2020, 2019 and 2018 consisted of the following: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) Domestic $ (75,102 ) $ (36,407 ) $ (31,477 ) Foreign 407 371 185 Total $ (74,695 ) $ (36,036 ) $ (31,292 ) The components of income tax provision (benefit) consisted of the following for the years ended December 31, 2020, 2019 and 2018: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) Current provision for income taxes: U.S. $ 61 $ 18 $ 12 Foreign 27 288 (59 ) Total current provision for income taxes 88 306 (47 ) Deferred tax provision (benefit) - foreign (4 ) (22 ) 16 Total deferred provision (benefit) for income taxes (4 ) (22 ) 16 Total provision (benefit) for income taxes $ 84 $ 284 $ (31 ) A reconciliation setting forth the differences between our effective tax rates and the U.S. federal statutory tax rate is as follows: For the Years Ended December 31, 2020 2019 2018 U.S. federal tax provision at statutory rate 21.0 % 21.0 % 21.0 % State and local tax, net of federal benefit 6.2 % 5.6 % 5.3 % Foreign rate differences 0.0 % 0.1 % 0.2 % Non-deductible foreign stock compensation (0.1 %) (0.3 %) (0.4 %) Effect of other permanent differences (0.1 %) (0.5 %) (0.3 %) Uncertain tax positions 0.1 % (0.4 %) 0.2 % Change in valuation allowance (2.4 %) (26.1 %) (26.0 %) Section 382 limitation of net operating loss (24.9 %) 0.0 % 0.0 % Other adjustments 0.0 % (0.2 %) 0.1 % Effective tax rate (0.1 %) (0.8 %) 0.1 % Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income and for tax carryforwards. Significant components of our deferred tax assets and liabilities as of December 31, 2020 and 2019 are as follows: As of December 31, 2020 2019 ($ in thousands) Deferred tax assets: Federal and state net operating loss carryforwards $ 55,220 $ 54,269 Intangible and other related assets 439 379 Accrued expenses 29 710 Stock compensation 3,505 2,180 Lease liability 244 325 Other 168 18 Total deferred tax assets 59,605 57,881 Deferred tax liabilities: Right of use asset (209 ) (291 ) Total deferred tax liabilities (209 ) (291 ) Valuation allowance (59,358 ) (57,560 ) Net deferred tax assets $ 38 $ 30 When realization of a deferred tax asset is more likely than not to occur, the benefit related to the deductible temporary differences attributable to operations is recognized as a reduction of income tax expense. Valuation allowances are provided against deferred tax assets when, based on all available evidence, it is considered more likely than not that some portion or all of the recorded deferred tax assets will not be realized in future periods. We cannot be certain that future U.S. taxable income will be sufficient to realize our deferred tax assets. Accordingly, a full valuation allowance has been provided against our U.S. net deferred tax assets. The valuation allowance increased by $1.8 million and $9.4 million in 2020 and 2019, respectively. The increases in 2020 and 2019 were primarily the result of an increase in net operating loss (“NOL”) carryforwards. At December 31, 2020, we had U.S. Federal and state NOL carryforwards totaling approximately $288.6 million and $234.4 million, respectively, that expire at various dates through 2038 with the exception of the Federal NOLs generated after December 31, 2017 of approximately $132.8 million which have an unlimited carryover period. At December 31, 2020, we had no Israeli NOL carryforwards. Under Section 382 of the Internal Revenue Code of 1986, as amended, substantial changes in our ownership may limit the amount of NOL carryforwards that can be utilized annually in the future to offset our U.S. Federal taxable income. Specifically, this limitation may arise in the event of a cumulative change in our ownership of more than 50% within any three-year period. We have determined that we experienced an ownership change for purposes of Section 382 in August 2005, May 2008, February 2015, and July 2020. These ownership changes resulted in annual limitations to the amount of NOL carryforwards that can be utilized to offset future taxable income, if any, at the U.S. Federal level. The annual limit is approximately $1.1 million for 2020, and each year thereafter. As a result of these Section 382 ownership changes, approximately $96.7 million of our Federal NOLs will expire unutilized. If we perform a Section 382 study in the future and conclude that have in fact undergone an ownership change, our NOL carryforwards may be substantially limited. The 2017 Tax Reform Act allowed us to receive our U.S. Federal alternative minimum tax credit carryforward in the form of a refund beginning in 2019 that we expected would go utilized. Accordingly, we recorded a receivable $0.5 million for the U.S. Federal alternative minimum tax credit refund in the accompanying consolidated balance sheet as of December 31, 2019. We received the refund during the year ended December 31, 2020. Our Israeli subsidiary has been recognized as a research and development company by the Head of the Israeli Administration of Industrial Research and Development and is entitled to tax benefits by virtue of the “beneficiary enterprise” status granted to part of its business activities under the Israeli Law for the Encouragement of Capital Investments 1959. The tax benefits include reduced tax rates on the research and development portion of its income during the first ten years of the benefit period (commenced in 2008). We benefit from a 16% tax rate for its income derived from research and development activities. Our tax rate on income from non-research and development activities is 23.0%. The continued application of the tax benefits is subject to certain conditions as defined by Israeli law. As part of the transition tax provision, we have a deemed repatriation of all of our undistributed earnings as of December 31, 2019. However, our subsidiary’s earnings, if distributed, would still be subject to local withholding tax and state income taxes. The subsidiary has undistributed earnings of approximately $ 2.0 million as of December 31, 2020 , which is considered to be permanently reinvested in the operations of the subsidiary. If the earnings were to be distributed to the U.S. parent, they would be subject to Israeli withholding and state income tax liabilities. The unrecognized deferred tax liability is approximately $ 0.2 million. We file U.S. federal, various state and Israeli income tax returns. The associated tax filings remain subject to examination by applicable tax authorities for a certain length of time following the tax year to which those filings relate. As we are in a loss carry-forward position, we are generally subject to U.S. Federal and state examinations for all years for which the Company generated losses that are included in the available losses carried forward to the current period. As of December 31, 2020, a summary of the tax years that remain subject to examination in our taxing jurisdictions is as follows: United States 2003 and forward Israel 2016 and forward We have reviewed the tax positions taken, or to be taken, in our tax returns for all tax years currently open to examination by a taxing authority. We have recorded minimal interest or penalties related to uncertain tax positions. We remain subject to examination until the statute of limitations expires for each respective tax jurisdiction. The statute of limitations will be open with respect to these tax positions until 2021. A reconciliation of the beginning and ending amount of our unrecognized tax benefits is as follows: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) Uncertain tax position at the beginning of year $ 568 $ 391 $ 471 Additions for uncertain tax positions of prior year 43 177 — Reductions for settlements with taxing authorities (72 ) — — Reductions for lapses of the applicable statutes of limitations — — (80 ) Uncertain tax position at the end of the year $ 539 $ 568 $ 391 On March 27, 2020, the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was signed into law. The CARES act included several income tax provisions such as the ability to carryback NOLs generated after December 31, 2017 and before January 1, 2021 and a temporary increase to the annual IRC Section 163(j) limitation. The income tax provisions included in the CARES act did not have a material impact on our income tax provision for the year ended December 31, 2020. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2020 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 15. Commitments and Contingencies Manufacturing Commitments As of December 31, 2020, we had outstanding manufacturing commitments, including the acquisition of API, in the aggregate amount of $20.3 million, of which $17.8 million, is expected to be incurred in 2021 with the remaining to be incurred throughout 2022. The payments on these orders will occur following the deliveries of the API or completion of the manufacturing services. Legal Proceedings On June 9, 2016, Chiasma, Inc. and certain of our current and former officers were named as defendants in a purported federal securities class action lawsuit filed in the United States District Court for the District of Massachusetts, styled Gerneth v. Chiasma, Inc., et al . An amended complaint was filed by the lead plaintiff on February 10, 2017 challenging our statements regarding our first Phase 3 clinical trial methodology and results, and our ability to obtain FDA approval for octreotide capsules, in violation of Sections 11 and 15 of the Securities Act of 1933. The amended complaint added as defendants current and former members of our board of directors, as well as the investment banks that underwrote our initial public offering on July 15, 2015. The plaintiff sought an unspecified amount of compensatory damages on behalf of himself and members of a putative shareholder class, including interest and reasonable costs and expenses incurred in litigating the action, and any other relief the court determines is appropriate. The defendants filed a motion to dismiss the amended complaint on March 27, 2017 and o approval of the settlement. The litigation insurance settlement recovery and litigation settlement liability were settled during the three months ended June 30, 2019. |
Leases
Leases | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Leases | 16. Leases We have operating leases for our office spaces and certain automobiles which are recognized as right of use assets and lease liabilities. For the Years Ended December 31, 2020 2019 ($ in thousands) The components of lease expense were as follows: Operating lease expense $ 675 $ 366 Supplemental cash flow information related to leases was as follows: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 662 $ 219 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 122 $ 1,690 For the year ended December 31, 2018, we recognized rent expense of $0.2 million. Our operating lease right-of-use assets are recorded within other assets on our consolidated balance sheets. As of December 31, 2020 2019 ($ in thousands) Supplemental balance sheet information related to leases was as follows: Operating lease right-of-use assets $ 985 $ 1,371 Other current liabilities $ 633 $ 465 Long-term liabilities 480 1,036 Total operating lease liabilities $ 1,113 $ 1,501 Weighted average remaining lease term - operating leases 21 Months 31 Months Weighted average discount rate - operating leases 10.9 % 10.8 % Future lease payments under noncancelable leases as of December 31, 2020 are as follows: ($ in thousands) 2021 $ 726 2022 497 2023 7 Total future minimum lease payments 1,230 Less: imputed interest (117 ) Total $ 1,113 |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2020 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | 17. Related Party Transactions In August 2014, we signed a consulting agreement, which was most recently amended in March 2018, with one of our investors and a representative of this investor to serve as our head of clinical. Payments for services rendered by the head of clinical were $0.1 million, $0.3 million and $0.3 million for the years ended December 31, 2020, 2019, and 2018, respectively. Related to this consulting agreement, there was $35,000 and $0.1 million of accrued liabilities as of December 31, 2020 and 2019, respectively, recorded in our consolidated balance sheets. |
Employee Benefit Plans
Employee Benefit Plans | 12 Months Ended |
Dec. 31, 2020 | |
Postemployment Benefits [Abstract] | |
Employee Benefit Plans | 18. Employee Benefit Plans Pursuant to the Israeli Severance Pay Law 1963, Israeli employees are entitled to severance pay equal to one month’s salary for each year of employment, or a portion thereof. The employees of Chiasma (Israel) Ltd. are included under Section 14 of the Severance Pay Law, under which these employees are entitled to monthly deposits, which relieve us from future obligations under this law. As a result, no assets or liabilities are recorded in the accompanying consolidated balance sheets. In addition, we make mandated monthly contributions to an Israeli government retirement benefit plan for our Israeli employees. We provide a 401(k) profit-sharing plan covering eligible U.S. employees to make tax deferred contributions, a portion of which are matched by us. All matching contributions and participant contributions vest immediately. During the years ended December 31, 2020, 2019, and 2018, we recorded expenses of $0.4 million, $0.2 million and $0.2 million, respectively, related to these employee benefit plans. |
Interest and Other Income, net
Interest and Other Income, net | 12 Months Ended |
Dec. 31, 2020 | |
Interest And Other Income [Abstract] | |
Interest and Other Income, net | 19. Interest and Other Income, net Interest and other income, net is as follows: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) (Loss) / gain on foreign currency transactions, net $ (42 ) $ (75 ) $ 37 Interest income 668 1,554 1,007 Change in fair value of derivative liabilities 1,200 — — Other income — 64 — Total $ 1,826 $ 1,543 $ 1,044 |
Quarterly Financial Data (unaud
Quarterly Financial Data (unaudited) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data (unaudited) | 20. Quarterly Financial Data (unaudited) Three Months Ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 ($ in thousands, except for per share data) Loss from operations $ (15,707 ) $ (20,337 ) $ (17,432 ) $ (17,173 ) Net loss (15,386 ) (21,128 ) (18,457 ) (19,808 ) Earnings per share Basic $ (0.36 ) $ (0.50 ) $ (0.30 ) $ (0.32 ) Diluted $ (0.36 ) $ (0.50 ) $ (0.30 ) $ (0.32 ) Three Months Ended March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019 ($ in thousands, except for per share data) Loss from operations $ (8,921 ) $ (8,166 ) $ (8,226 ) $ (12,266 ) Net loss (8,750 ) (7,840 ) (7,683 ) (12,047 ) Earnings per share Basic $ (0.36 ) $ (0.25 ) $ (0.20 ) $ (0.29 ) Diluted $ (0.36 ) $ (0.25 ) $ (0.20 ) $ (0.29 ) |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Principles of Consolidation and Basis of Presentation | Principles of Consolidation and Basis of Presentation The accompanying consolidated financial statements include the accounts of Chiasma, Inc. and its subsidiaries and are prepared in conformity with accounting principles generally accepted in the United States of America (“U.S. GAAP”) and are stated in U.S. dollars. The consolidated financial statements have been prepared on the basis of continuity of operations, realization of assets and the satisfaction of liabilities in the ordinary course of business. All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of estimates The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes during the reporting period. We base these estimates and assumptions on historical experience when available, and on various factors that we believe to be reasonable under the specific circumstances. Significant estimates relied upon in preparing the accompanying consolidated financial statements include, but are not limited to, recognition of product revenues, accounting for stock-based compensation, income taxes, the fair value of embedded derivative and our deferred royalty obligation and accounting for certain accruals. We assess the above estimates on an ongoing basis; however, actual results could materially differ from those estimates. |
Cash Equivalents | Cash Equivalents Cash equivalents consist of highly liquid instruments which mature within three months or less from the date of purchase. |
Marketable Securities | Marketable Securities Our investments primarily consist of commercial paper and corporate and government debt securities. These marketable securities are classified as available-for-sale, and as such, are reported at fair value on our consolidated balance sheets. Unrealized holding gains and losses are reported within accumulated other comprehensive income as a separate component of stockholders’ equity. The amortized cost of debt securities is adjusted for amortization of premiums and accretion of discounts to maturity. Such amortization and accretion, together with interest on securities, are included in interest and other income, net, on our consolidated statements of operations. If a decline in the fair value of a marketable security below our cost basis is determined to be other than temporary, such marketable security is written down to its estimated fair value as a new cost basis and the amount of the write-down is included in earnings as an impairment charge. The cost of securities sold is based on the specific identification method. |
Accounts Receivable | Accounts Receivable Our accounts receivable consist of amounts due from one specialty pharmacy (the “customer”) for sales of MYCAPSSA and which have standard payments terms. We extend credit to our customer based on our evaluation of the customer’s financial condition. Accounts receivable are stated at amounts due net of applicable prompt pay discounts and other adjustments. We assess the need for an allowance for doubtful accounts by considering a number of factors, including the length of time trade accounts receivable are past due and the customer’s ability to pay its obligation. Based on a review of these factors, as of December 31 , 2020, we determined that an allowance for doubtful accounts was not required. |
Concentrations of credit risk | Concentrations of credit risk Financial instruments that potentially subject us to significant concentration of credit risk consist primarily of cash, cash equivalents, marketable securities, and accounts receivable. During the year ended December 31, 2020, one customer comprised 100% of our accounts receivable and product revenues. We routinely maintain deposits in financial institutions in excess of government insured limits. Management believes that we are not exposed to significant credit risk as our deposits are held at financial institutions that management believes to be of high credit quality and we have not experienced any significant losses in these deposits. We regularly invest excess operating cash in deposits with major financial institutions and money market funds and in notes issued by the U.S. government, as well as in fixed income investments and bond funds, both of which can be readily purchased and sold using established markets. We believe that the market risk arising from our holdings of these financial instruments is mitigated based on the fact that many of these securities are either government backed or of high credit rating. |
Inventory | Inventory Prior to FDA approval of MYCAPSSA, all costs related to the manufacturing of MYCAPSSA that could potentially be available to support the planned U.S. commercial launch were charged to research and development expense in the period incurred. Generally, inventory may be capitalized if it is probable that future revenues will be generated from the sale of the inventory and that these revenues will exceed the cost of the inventory. Through the FDA approval date of MYCAPSSA, we expensed all of our manufacturing costs due to the high risk inherent in drug development and uncertainty as to whether MYCAPSSA would be approved. We began to capitalize our manufacturing-related costs to inventory starting July 1, 2020. We capitalize the costs to manufacture our products incurred after regulatory approval when, based on our judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. In connection therewith, we value our inventories at the lower of cost or estimated net realizable value. We determine the cost of our inventories, which includes amounts related to active pharmaceutical ingredient (“API”), and other raw materials, third party manufacturing costs and other overhead costs, on a first-in, first-out basis. Inventories that may be used for either research and development or commercial sale are classified as inventory until the material is consumed or otherwise allocated for research and development. If the material is intended to be used for research and development, it is expensed as research and development once that determination is made. On a quarterly basis, we review inventory quantities on hand and analyze the provision for excess and obsolete inventory based primarily on remaining product shelf life and our estimated sales forecast which is based on anticipated future demand. We build demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance, and patient usage. Our estimates of future product demand may prove to be imprecise and changes in estimates will result in a change to the provision required for excess and obsolete inventory. Accordingly, any significant unanticipated changes in demand could have a significant impact on the value of our inventory and results of operations. |
Foreign currency translation | Foreign currency translation We use the U.S. dollar as our functional currency. Monetary assets and liabilities denominated in foreign currency are re-measured at current rates and non-monetary assets denominated in foreign currency are recorded at historical exchange rates. Realized and unrealized exchange gains or losses from transactions and re-measurement adjustments are reflected in other income, net, in the accompanying consolidated statements of operations. |
Comprehensive income (loss) | Comprehensive income (loss) Comprehensive income (loss) is defined as the change in equity of a business enterprise during a period from transactions and other events and circumstances from non-owner sources. Other than reported net income, comprehensive income (loss) includes unrealized gains and losses on available for sale securities, which are disclosed in the accompanying consolidated statements of comprehensive income (loss). There were no reclassifications out of comprehensive income (loss) for the years ended December 31, 2020, 2019 or 2018. |
Segment information | Segment information Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision maker, our Chief Executive Officer, in making decisions regarding resource allocation and assessing performance. We view our operations and manage our business in one operating segment. |
Other assets | Other assets Other assets consist of right of use assets, long-term restricted deposits, prepayments, and deferred tax assets. |
Restricted Cash | Restricted cash Restricted cash consists of $20.0 million that we are required to maintain in securitized cash and investment accounts under the Revenue Interest Financing Agreement, interest-bearing money market accounts held as security deposits against bank guarantees, and amounts related to our co-pay assistance program. |
Property and equipment | Property and equipment Property and equipment are stated at cost, net of accumulated depreciation and amortization. Expenditures for maintenance and repairs are charged to operations as incurred, whereas major betterments are capitalized as additions to property and equipment. Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the assets, as follows: Asset Category Estimated Useful Lives Computer equipment and software 3 years Office furniture and equipment 7—17 years (mainly 7) Machinery and equipment 5 — 7 years Leasehold improvements The lesser of lease term or estimated useful lives |
Impairment of long-lived assets | Impairment of long-lived assets We review long-lived assets for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. When such events occur, we compare the carrying amounts of the assets to their undiscounted expected future cash flows the assets are expected to generate and to be recognized. The amount of impairment loss to be recognized is the excess of the carrying value over the fair value of the related asset. We did not record any impairments during the years ended December 31, 2020, 2019 and 2018. |
Deferred Royalty Obligation | Deferred Royalty Obligation We treat the deferred royalty obligation, as discussed further in Note 9, as a debt obligation, amortized under the effective interest rate method over the estimated life of the agreement. We recognize interest expense thereon using the effective rate, which is based on our current estimates of future revenues over the life of the arrangement. In connection therewith, we periodically assess our expected revenues using internal projections, impute interest on the carrying value of the deferred royalty obligation, and record interest expense using the effective interest rate. To the extent our estimates of future revenues are greater or less than previous estimates or the estimated timing of such payments is materially different than previous estimates, we will account for any such changes by adjusting the effective interest rate on a prospective basis, with a corresponding impact to the reclassification of our deferred royalty obligation between short- and long-term. The assumptions used in determining the expected repayment term of the deferred royalty obligation and amortization period of the issuance costs requires that we make estimates that could impact the short-term and long-term classification of such costs, as well as the period over which such costs will be amortized. |
Revenue Recognition | Revenue Recognition In accordance with accounting guidance for revenue recognition, we recognize revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine to be within the scope of such guidance, we perform the following five steps: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. We only apply the five-step model to contracts when it is probable that we will collect the consideration we are entitled to in exchange for the goods or services that we transfer to the customer. For a further discussion of accounting for net product revenue see Note 3 . |
Research and development | Research and development Research and development costs are expensed as incurred. Research and development costs include payroll and personnel expense, consulting costs, external contract research and development expenses, raw materials, drug product manufacturing costs, and allocated overhead including depreciation and amortization, rent, and utilities. Research and development costs that are paid in advance of performance are capitalized as a prepaid expense and amortized over the service period as the services are provided. |
Clinical trial costs | Clinical trial costs Clinical trial costs are a component of research and development expenses. We accrue and expense clinical trial activities performed by third parties on an evaluation of the progress to completion of specific tasks using data such as hours spent in performance of services, patient enrollment, clinical site activation, and other information provided to us by our vendors. We make estimates of our clinical trial accrued expenses as of each balance sheet date in our financial statements based on facts and circumstances known to us. If timelines or contracts are modified based upon changes in the clinical trial protocol or scope of work to be performed, we assess our estimates of accrued expenses accordingly. |
Patent costs | Patent costs Patent costs are expensed as incurred as their realization is uncertain. These costs are classified as general and administrative in the accompanying consolidated statements of operations. |
Advertising and Product Promotion Costs | Advertising and Product Promotion Costs Advertising and product promotion costs are included in selling, general and administrative expenses and were $5.3 million during the year ended December 31, 2020. We did not incur any advertising and promotion costs in the years ended December 31, 2019 and 2018, respectively. Advertising and product promotion costs are expensed as incurred. |
Stock-based compensation | Stock-based compensation We account for all stock-based compensation to employees and nonemployees based on their fair values on the date of grant. For stock-based awards with only service conditions, we recognize compensation on a straight-line basis over the requisite service period, which is usually the vesting period of the award, net of any actual forfeitures. We determine the fair value of stock options by using the Black-Scholes option pricing model. This model requires the input of several assumptions such as the expected option term, the expected risk-free interest rate over the expected option term, the expected volatility of our stock price over the expected option term, and the expected dividend yield over the expected option term. The computation of expected volatility is based on an average historical share price volatility based on an analysis of reported data for a peer group of comparable publicly traded companies, which were selected based upon industry similarities. The interest rate for periods within the expected term of the award is based on the U.S. Treasury risk-free interest rate in effect at the time of grant. The expected lives of the options were estimated using the simplified method. |
Income taxes | Income taxes The consolidated financial statements reflect provisions for federal, state, local and foreign income taxes. Deferred tax assets and liabilities represent future tax consequences of temporary differences between the financial statement carrying amounts and the tax basis of assets and liabilities and for loss carryforwards using enacted tax rates expected to be in effect in the years in which the differences reverse. A valuation allowance is recorded when it is more likely than not that some or all of the deferred tax assets will not be realized. We determine whether it is more likely than not that a tax position will be sustained upon examination. If it is not more likely than not that a position will be sustained, none of the benefit attributable to the position is recognized. The tax benefit to be recognized for any tax position that meets the more likely than not recognition threshold is calculated as the largest amount that is more than 50% likely of being realized upon resolution of the contingency. We account for interest and penalties related to uncertain tax positions as part of our other expenses in the accompanying consolidated financial statements. |
Leases | Leases We determine if an arrangement is a lease at inception. We have operating leases for our office spaces and certain automobiles. Right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease term at the commencement date. The right-of-use asset also includes direct costs incurred and is reduced by lease incentives. Lease agreements with lease and non-lease components are accounted for separately. As our leases do not provide an implicit rate, we use an estimated incremental borrowing rate based on the information available at the commencement date in determining the present value of future payments. We recognize operating lease expense on a straight-line basis over the lease term. |
Contingent liabilities | Contingent liabilities In the normal course of business, we are subject to proceedings, lawsuits, and other claims and assessments. We assess the likelihood of any adverse judgments or outcomes to these matters as well as potential ranges of probable losses. A determination of the amount of reserves required, if any, for these contingencies is made after careful analysis of each individual issue. The required reserves may change in the future due to new developments in each matter or changes in approach such as a change in settlement strategy in dealing with these matters. We record charges for the losses we anticipate incurring in connection with litigation and claims against us when we conclude a loss is probable and we can reasonably estimate these losses. |
Earnings Per Share | Earnings per share We compute basic earnings per share by dividing net loss by the weighted average number of common shares outstanding for the period. We compute diluted earnings per common share after giving consideration to all potentially dilutive common shares, including stock options and warrants outstanding during the period, except where the effect of such non-participating securities would be antidilutive. |
Recently Issued Accounting Pronouncements | Recently issued accounting pronouncements In June 2016, the Financial Accounting Standards Board issued new guidance which will require more timely recording of credit losses on loans and other financial instruments held by financial institutions and other organizations. The new guidance requires the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions and reasonable and supportable forecasts. The new guidance also requires enhanced disclosures regarding significant estimates and judgments used in estimating credit losses. On January 1, 2020, we adopted this standard. The adoption of this standard did not have a material impact on our consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Accounting Policies [Abstract] | |
Schedule of Estimated Useful Lives of Assets | Depreciation and amortization are recorded using the straight-line method over the estimated useful lives of the assets, as follows: Asset Category Estimated Useful Lives Computer equipment and software 3 years Office furniture and equipment 7—17 years (mainly 7) Machinery and equipment 5 — 7 years Leasehold improvements The lesser of lease term or estimated useful lives |
Product Revenue, Net (Tables)
Product Revenue, Net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Revenue From Contract With Customer [Abstract] | |
Schedule Of Product Revenue And Allowances | The following table summarizes activity in each of the above product revenue allowances and reserve categories for year ended December 31, 2020: Discounts and Fees Rebates and Other Incentives Returns Total ($ in thousands) Balance, January 1, 2020 $ — $ — $ — $ — Provision 80 142 1 223 Payments or credits (64 ) (12 ) — (76 ) Balance, December 31, 2020 $ 16 $ 130 $ 1 $ 147 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Investments All Other Investments [Abstract] | |
Schedule of Investments | Our investments consisted of the following as of December 31, 2020 and 2019: As of December 31, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value ($ in thousands) Money market funds $ 29,392 $ — $ — $ 29,392 Corporate notes 11,347 — (1 ) 11,346 Commercial paper 98,030 8 (8 ) 98,030 U.S. treasury securities 12,582 1 — 12,583 Total $ 151,351 $ 9 $ (9 ) $ 151,351 As of December 31, 2019 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value ($ in thousands) Money market funds $ 23,012 $ — $ — $ 23,012 Corporate notes 45,584 20 — 45,604 Commercial paper 20,899 17 — 20,916 Total $ 89,495 $ 37 $ — $ 89,532 |
Schedule of Fair Value of Investments | The fair values of our investments by classification in our consolidated balance sheets as of December 31, 2020 and 2019 were as follows: As of December 31, 2020 2019 ($ in thousands) Cash and cash equivalents $ 10,829 $ 25,012 Marketable securities 119,959 64,520 Restricted cash 20,563 — Total $ 151,351 $ 89,532 |
Fair Value Measurements and F_2
Fair Value Measurements and Fair Value of Financial Instruments (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements of Company's Financial Instruments | The following tables summarize the fair value measurements of our financial instruments as of December 31, 2020 and 2019: Fair Value Measurements at December 31, 2020 Description Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Financial assets ($ in thousands) Cash equivalents and restricted cash: Money market funds $ 29,392 $ — $ — $ 29,392 Commercial paper — 2,000 — 2,000 Total cash equivalents and restricted cash $ 29,392 $ 2,000 $ — $ 31,392 Marketable securities: U.S. treasury securities $ — $ 12,583 $ — $ 12,583 Corporate notes — 11,346 — 11,346 Commercial paper — 96,030 — 96,030 Total marketable securities $ — $ 119,959 $ — $ 119,959 Total $ 29,392 $ 121,959 $ — $ 151,351 Financial liabilities Derivative liabilities $ — $ — $ 1,900 $ 1,900 Fair Value Measurements at December 31, 2019 Description Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Financial assets ($ in thousands) Cash equivalents: Money market funds $ 23,012 $ — $ — $ 23,012 Corporate notes — 2,000 — 2,000 Total cash equivalents $ 23,012 $ 2,000 $ — $ 25,012 Marketable securities: Corporate notes $ — $ 43,604 $ — $ 43,604 Commercial paper — 20,916 — 20,916 Total marketable securities $ — $ 64,520 $ — $ 64,520 Total $ 23,012 $ 66,520 $ — $ 89,532 |
Summary of the changes in the fair value of the embedded derivative liabilities | The following table sets forth a summary of the changes in the fair value of the embedded derivative liabilities for the year ended December 31, 2020: ($ in thousands) Fair Value Measurement of Embedded Derivative using Significant Unobservable Inputs (Level 3) Balance, January 1, 2020 $ — Additions during the period 3,100 Change in fair value during the period (1,200 ) Balance, December 31, 2020 $ 1,900 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | Our inventory of MYCAPSSA consisted of the following as of December 31, 2020: ($ in thousands) December 31, 2020 Raw materials and supplies $ 6,786 Work in process 3,857 Finished goods 312 Total inventory $ 10,955 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Property Plant And Equipment [Abstract] | |
Summary of Property and Equipment | Property and equipment consisted of the following as of December 31, 2020 and 2019: As of December 31, 2020 2019 ($ in thousands) Computer equipment and software $ 553 $ 431 Office furniture and equipment 358 108 Machinery and equipment 115 115 Property and equipment, at cost 1,026 654 Less accumulated depreciation (492 ) (320 ) Property and equipment, net $ 534 $ 334 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consisted of the following as of December 31, 2020 and 2019: As of December 31, 2020 2019 ($ in thousands) Accrued payroll and employee benefits $ 4,900 $ 1,872 Accrued selling, general, administrative and other expenses 3,830 1,485 Accrued research and development expenses 3,128 4,219 Total accrued expenses $ 11,858 $ 7,576 |
Warrants (Tables)
Warrants (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Equity [Abstract] | |
Summary of common stock warrants activity | A summary of our common stock warrants activity for the year ended December 31, 2020 is presented below. Description Exercise Price Expiration Date Balance, December 31, 2019 Warrants Issued Warrants Exercised Balance, December 31, 2020 October 2012 Warrants $ 0.0910 10/22/2022 829,686 — (205,321 ) 624,365 March 2013 Warrants $ 0.0910 3/28/2022 829,686 — (205,321 ) 624,365 December 2014 Warrants $ 9.1320 12/16/2024 923,527 — — 923,527 February 2015 Warrants $ 9.1320 12/16/2024 984,116 — — 984,116 July 2020 Pre-Funded Warrants $ 0.0001 No expiration — 5,000,000 — 5,000,000 3,567,015 5,000,000 (410,642 ) 8,156,373 |
Stock Incentive Plan (Tables)
Stock Incentive Plan (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Fair Value Calculation of Option Granted | The fair value of each stock option issued was estimated at the date of grant using the Black-Scholes option model with the following weighted-average assumptions: For the Years Ended December 31, 2020 2019 2018 Expected volatility 85 % 97 % 77 % Expected term (years) 6.2 6.0 6.2 Risk-free interest rate 0.93 % 1.93 % 2.72 % Expected dividend yield 0 % 0 % 0 % |
Summary of Stock Option Activity | A summary of option activity as of December 31, 2020 and the year then ended is presented below: Number of Stock Options Weighted- Average Exercise Price Weighted- Average Remaining Contractual Term (Years) Aggregate Intrinsic Value Outstanding, December 31, 2019 6,489,692 $ 5.01 7.3 $ 8,166,882 Granted 2,307,500 $ 4.63 Exercised (207,416 ) $ 1.35 Forfeited / Expired (211,716 ) $ 5.47 Outstanding, December 31, 2020 8,378,060 $ 4.98 7.2 $ 5,611,109 Exercisable, December 31, 2020 4,774,332 $ 4.98 6.0 $ 4,634,332 Vested and expected to vest, December 31, 2020 8,378,060 $ 4.98 7.2 $ 5,611,109 |
Schedule of Stock-based Compensation | Stock-based compensation expense for 2020, 2019 and 2018 consisted of the following: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) General and administrative $ 4,082 $ 2,243 $ 1,412 Research and development 938 1,027 1,318 Total $ 5,020 $ 3,270 $ 2,730 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Income Tax Disclosure [Abstract] | |
Summary of loss before provision (benefit) for income taxes | Our loss before provision (benefit) for income taxes for the years ended December 31, 2020, 2019 and 2018 consisted of the following: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) Domestic $ (75,102 ) $ (36,407 ) $ (31,477 ) Foreign 407 371 185 Total $ (74,695 ) $ (36,036 ) $ (31,292 ) |
Summary of Components of Income Tax Provision (Benefit) | The components of income tax provision (benefit) consisted of the following for the years ended December 31, 2020, 2019 and 2018: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) Current provision for income taxes: U.S. $ 61 $ 18 $ 12 Foreign 27 288 (59 ) Total current provision for income taxes 88 306 (47 ) Deferred tax provision (benefit) - foreign (4 ) (22 ) 16 Total deferred provision (benefit) for income taxes (4 ) (22 ) 16 Total provision (benefit) for income taxes $ 84 $ 284 $ (31 ) |
Summary of Differences Between Effective Tax Rates and U.S. Federal Statutory Tax | A reconciliation setting forth the differences between our effective tax rates and the U.S. federal statutory tax rate is as follows: For the Years Ended December 31, 2020 2019 2018 U.S. federal tax provision at statutory rate 21.0 % 21.0 % 21.0 % State and local tax, net of federal benefit 6.2 % 5.6 % 5.3 % Foreign rate differences 0.0 % 0.1 % 0.2 % Non-deductible foreign stock compensation (0.1 %) (0.3 %) (0.4 %) Effect of other permanent differences (0.1 %) (0.5 %) (0.3 %) Uncertain tax positions 0.1 % (0.4 %) 0.2 % Change in valuation allowance (2.4 %) (26.1 %) (26.0 %) Section 382 limitation of net operating loss (24.9 %) 0.0 % 0.0 % Other adjustments 0.0 % (0.2 %) 0.1 % Effective tax rate (0.1 %) (0.8 %) 0.1 % |
Schedule of Components of Deferred Tax Assets and Liabilities | Significant components of our deferred tax assets and liabilities as of December 31, 2020 and 2019 are as follows: As of December 31, 2020 2019 ($ in thousands) Deferred tax assets: Federal and state net operating loss carryforwards $ 55,220 $ 54,269 Intangible and other related assets 439 379 Accrued expenses 29 710 Stock compensation 3,505 2,180 Lease liability 244 325 Other 168 18 Total deferred tax assets 59,605 57,881 Deferred tax liabilities: Right of use asset (209 ) (291 ) Total deferred tax liabilities (209 ) (291 ) Valuation allowance (59,358 ) (57,560 ) Net deferred tax assets $ 38 $ 30 |
Summary of Tax Years that Remain Subject to Examination | As of December 31, 2020, a summary of the tax years that remain subject to examination in our taxing jurisdictions is as follows: United States 2003 and forward Israel 2016 and forward |
Reconciliation of Beginning and Ending Amount of Uncertain Tax Position | A reconciliation of the beginning and ending amount of our unrecognized tax benefits is as follows: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) Uncertain tax position at the beginning of year $ 568 $ 391 $ 471 Additions for uncertain tax positions of prior year 43 177 — Reductions for settlements with taxing authorities (72 ) — — Reductions for lapses of the applicable statutes of limitations — — (80 ) Uncertain tax position at the end of the year $ 539 $ 568 $ 391 |
Leases (Tables)
Leases (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Leases [Abstract] | |
Summary of Operations in Leased Facilities | For the Years Ended December 31, 2020 2019 ($ in thousands) The components of lease expense were as follows: Operating lease expense $ 675 $ 366 Supplemental cash flow information related to leases was as follows: Cash paid for amounts included in the measurement of lease liabilities: Operating cash flows from operating leases $ 662 $ 219 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 122 $ 1,690 As of December 31, 2020 2019 ($ in thousands) Supplemental balance sheet information related to leases was as follows: Operating lease right-of-use assets $ 985 $ 1,371 Other current liabilities $ 633 $ 465 Long-term liabilities 480 1,036 Total operating lease liabilities $ 1,113 $ 1,501 Weighted average remaining lease term - operating leases 21 Months 31 Months Weighted average discount rate - operating leases 10.9 % 10.8 % |
Schedule of Future Lease Payments Under Noncancelable Leases | Future lease payments under noncancelable leases as of December 31, 2020 are as follows: ($ in thousands) 2021 $ 726 2022 497 2023 7 Total future minimum lease payments 1,230 Less: imputed interest (117 ) Total $ 1,113 |
Interest and Other Income, net
Interest and Other Income, net (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Interest And Other Income [Abstract] | |
Summary of Interest and Other Income, Net | Interest and other income, net is as follows: For the Years Ended December 31, 2020 2019 2018 ($ in thousands) (Loss) / gain on foreign currency transactions, net $ (42 ) $ (75 ) $ 37 Interest income 668 1,554 1,007 Change in fair value of derivative liabilities 1,200 — — Other income — 64 — Total $ 1,826 $ 1,543 $ 1,044 |
Quarterly Financial Data (una_2
Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2020 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly Financial Data | Three Months Ended March 31, 2020 June 30, 2020 September 30, 2020 December 31, 2020 ($ in thousands, except for per share data) Loss from operations $ (15,707 ) $ (20,337 ) $ (17,432 ) $ (17,173 ) Net loss (15,386 ) (21,128 ) (18,457 ) (19,808 ) Earnings per share Basic $ (0.36 ) $ (0.50 ) $ (0.30 ) $ (0.32 ) Diluted $ (0.36 ) $ (0.50 ) $ (0.30 ) $ (0.32 ) Three Months Ended March 31, 2019 June 30, 2019 September 30, 2019 December 31, 2019 ($ in thousands, except for per share data) Loss from operations $ (8,921 ) $ (8,166 ) $ (8,226 ) $ (12,266 ) Net loss (8,750 ) (7,840 ) (7,683 ) (12,047 ) Earnings per share Basic $ (0.36 ) $ (0.25 ) $ (0.20 ) $ (0.29 ) Diluted $ (0.36 ) $ (0.25 ) $ (0.20 ) $ (0.29 ) |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) $ / shares in Units, $ in Millions | 1 Months Ended | 9 Months Ended | 12 Months Ended | ||||
Jul. 31, 2020USD ($)$ / sharesshares | Apr. 30, 2020USD ($) | Aug. 31, 2019USD ($)$ / sharesshares | Apr. 30, 2019USD ($)$ / sharesshares | Jul. 31, 2018Patient | Sep. 30, 2020USD ($) | Dec. 31, 2020SubsidiaryPatient$ / shares | |
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
Number of subsidiaries owned by the company | Subsidiary | 2 | ||||||
Stock issued during period, shares, new issues | shares | shares | 10,166,427 | 7,263,158 | |||||
Shares issued, price per share | $ / shares | $ / shares | $ 5.50 | $ 4.75 | |||||
Proceeds from issuance of common stock | $ 52.3 | $ 32.2 | |||||
Pre Funded Warrant [Member] | |||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares | 5,000,000 | ||||||
Proceeds from Pre Funded Warrants | $ 75.5 | ||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.0001 | $ 0.0001 | |||||
Common stock and Pre-Funded Warrants [Member] | |||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
Stock issued during period, shares, new issues | shares | shares | 15,125,000 | ||||||
Shares issued, price per share | $ / shares | $ / shares | $ 4 | ||||||
Jeffries LLC ("Jeffries") [Member] | |||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
Maximum proceeds of sales of common stock under sales agreement | $ 60 | ||||||
Healthcare Royalty Partners IV, L.P. ("HCR") [Member] | |||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
Maximum proceeds under investment agreement | $ 75 | ||||||
Healthcare Royalty Partners IV, L.P. ("HCR") [Member] | First And Second Tranche [Member] | |||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
Proceeds from investment | $ 65 | ||||||
MPOWERED Trial [Member] | |||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
First trial period for adult acromegaly patients expected to randomize | 6 months | ||||||
Additional trial period for adult acromegaly patients expected to randomize | 9 months | ||||||
MPOWERED Trial [Member] | Maximum [Member] | |||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
Trial period for adult acromegaly patients expected to enroll | 15 months | ||||||
Number of adult acromegaly patients expected to enroll in trial | Patient | 150 | ||||||
MPOWERED Trial [Member] | Minimum [Member] | |||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||||||
Number of adult acromegaly patients expect to randomize | Patient | 80 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Additional Information (Detail) | 12 Months Ended | ||
Dec. 31, 2020USD ($)Segment | Dec. 31, 2019USD ($) | Dec. 31, 2018USD ($) | |
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||
Reclassifications out of comprehensive income (loss) | $ 0 | $ 0 | $ 0 |
Number of operating segments | Segment | 1 | ||
Restricted cash | $ 20,563,000 | ||
Impairment of long-lived assets | 0 | 0 | 0 |
Selling, General and Administrative Expenses [Member] | |||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||
Advertising and product promotion costs | 5,300,000 | $ 0 | $ 0 |
Securitized Cash and Investment Accounts [Member] | |||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||
Restricted cash | $ 20,000,000 | ||
Customer One [Member] | Accounts Receivable [Member] | |||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 100.00% | ||
Customer One [Member] | Product Revenue [Member] | |||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 100.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Schedule of Estimated Useful Lives of Assets (Detail) | 12 Months Ended |
Dec. 31, 2020 | |
Computer Equipment And Software [Member] | |
Property and equipment [Line Items] | |
Estimated useful lives | 3 years |
Office Furniture and Equipment [Member] | Minimum [Member] | |
Property and equipment [Line Items] | |
Estimated useful lives | 7 years |
Office Furniture and Equipment [Member] | Maximum [Member] | |
Property and equipment [Line Items] | |
Estimated useful lives | 17 years |
Machinery and equipment [Member] | Minimum [Member] | |
Property and equipment [Line Items] | |
Estimated useful lives | 5 years |
Machinery and equipment [Member] | Maximum [Member] | |
Property and equipment [Line Items] | |
Estimated useful lives | 7 years |
Leasehold Improvements | |
Property and equipment [Line Items] | |
Estimated useful lives | The lesser of lease term or estimated useful lives |
Product Revenue, Net - Schedule
Product Revenue, Net - Schedule Of Product Revenue And Allowances (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Revenue From Contract With Customer [Abstract] | |
Provision | $ 80 |
Payments or credits | (64) |
Balance, December 31, 2020 | 16 |
Provision | 142 |
Payments or credits | (12) |
Balance, December 31, 2020 | 130 |
Provision | 1 |
Balance, December 31, 2020 | 1 |
Provision | 223 |
Payments or credits | (76) |
Balance, December 31, 2020 | $ 147 |
Investments - Schedule of Inves
Investments - Schedule of Investments (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | $ 151,351 | $ 89,495 |
Gross Unrealized Gains | 9 | 37 |
Gross Unrealized Losses | (9) | |
Estimated Fair Value | 151,351 | 89,532 |
Money Market Funds [Member] | ||
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | 29,392 | 23,012 |
Estimated Fair Value | 29,392 | 23,012 |
Corporate Notes [Member] | ||
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | 11,347 | 45,584 |
Gross Unrealized Gains | 20 | |
Gross Unrealized Losses | (1) | |
Estimated Fair Value | 11,346 | 45,604 |
Commercial Paper [Member] | ||
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | 98,030 | 20,899 |
Gross Unrealized Gains | 8 | 17 |
Gross Unrealized Losses | (8) | |
Estimated Fair Value | 98,030 | $ 20,916 |
U.S. treasury securities [Member] | ||
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | 12,582 | |
Gross Unrealized Gains | 1 | |
Estimated Fair Value | $ 12,583 |
Investments - Additional Inform
Investments - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Investments All Other Investments [Abstract] | |||
Realized gains and losses on available-for-sale securities | $ 0 | $ 0 | $ 0 |
Cash excluded from cash and cash equivalents | $ 4,600,000 | $ 2,800,000 | |
Contractual maturity period of investments | 1 year |
Investments - Schedule of Fair
Investments - Schedule of Fair Value of Investments (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Net Investment Income [Line Items] | ||
Fair values of investments | $ 151,351 | $ 89,532 |
Cash and Cash Equivalents [Member] | ||
Net Investment Income [Line Items] | ||
Fair values of investments | 10,829 | 25,012 |
Marketable Securities [Member] | ||
Net Investment Income [Line Items] | ||
Fair values of investments | 119,959 | $ 64,520 |
Restricted Cash [Member] | ||
Net Investment Income [Line Items] | ||
Fair values of investments | $ 20,563 |
Fair Value Measurements and F_3
Fair Value Measurements and Fair Value of Financial Instruments - Fair Value Measurements of Company's Financial Instruments (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Cash equivalents and restricted cash: | ||
Total cash equivalents and restricted cash | $ 31,392 | |
Cash equivalents: | ||
Total cash equivalents | $ 25,012 | |
Marketable securities: | ||
Total marketable securities | 151,351 | 89,532 |
Total | 151,351 | 89,532 |
Financial liabilities | ||
Derivative liabilities | 1,900 | |
Money Market Funds [Member] | ||
Cash equivalents and restricted cash: | ||
Total cash equivalents and restricted cash | 29,392 | |
Cash equivalents: | ||
Total cash equivalents | 23,012 | |
Commercial Paper [Member] | ||
Cash equivalents and restricted cash: | ||
Total cash equivalents and restricted cash | 2,000 | |
Marketable securities: | ||
Total marketable securities | 96,030 | 20,916 |
U.S. treasury securities [Member] | ||
Marketable securities: | ||
Total marketable securities | 12,583 | |
Corporate Notes [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 2,000 | |
Marketable securities: | ||
Total marketable securities | 11,346 | 43,604 |
Marketable Securities [Member] | ||
Marketable securities: | ||
Total marketable securities | 119,959 | 64,520 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Cash equivalents and restricted cash: | ||
Total cash equivalents and restricted cash | 29,392 | |
Cash equivalents: | ||
Total cash equivalents | 23,012 | |
Marketable securities: | ||
Total | 29,392 | 23,012 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Funds [Member] | ||
Cash equivalents and restricted cash: | ||
Total cash equivalents and restricted cash | 29,392 | |
Cash equivalents: | ||
Total cash equivalents | 23,012 | |
Significant Other Observable Inputs (Level 2) [Member] | ||
Cash equivalents and restricted cash: | ||
Total cash equivalents and restricted cash | 2,000 | |
Cash equivalents: | ||
Total cash equivalents | 2,000 | |
Marketable securities: | ||
Total | 121,959 | 66,520 |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Cash equivalents and restricted cash: | ||
Total cash equivalents and restricted cash | 2,000 | |
Marketable securities: | ||
Total marketable securities | 96,030 | 20,916 |
Significant Other Observable Inputs (Level 2) [Member] | U.S. treasury securities [Member] | ||
Marketable securities: | ||
Total marketable securities | 12,583 | |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Notes [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 2,000 | |
Marketable securities: | ||
Total marketable securities | 11,346 | 43,604 |
Significant Other Observable Inputs (Level 2) [Member] | Marketable Securities [Member] | ||
Marketable securities: | ||
Total marketable securities | 119,959 | $ 64,520 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Financial liabilities | ||
Derivative liabilities | $ 1,900 |
Fair Value Measurements and F_4
Fair Value Measurements and Fair Value of Financial Instruments - Summary of the changes in the fair value of the embedded derivative liabilities (Detail) $ in Thousands | 12 Months Ended |
Dec. 31, 2020USD ($) | |
Embedded Derivative [Line Items] | |
Balance, December 31, 2020 | $ 3,100 |
Fair Value Measurement of Embedded Derivative using Significant Unobservable Inputs (Level 3) | |
Embedded Derivative [Line Items] | |
Additions during the period | 3,100 |
Change in fair value during the period | (1,200) |
Balance, December 31, 2020 | $ 1,900 |
Inventory - Schedule Of Invento
Inventory - Schedule Of Inventory Current (Detail) $ in Thousands | Dec. 31, 2020USD ($) |
Inventory Disclosure [Abstract] | |
Raw materials and supplies | $ 6,786 |
Work in process | 3,857 |
Finished goods | 312 |
Total inventory | $ 10,955 |
Property and Equipment - Summar
Property and Equipment - Summary of Property and Equipment (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 1,026 | $ 654 |
Less accumulated depreciation | (492) | (320) |
Property and equipment, net | 534 | 334 |
Computer Equipment and Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 553 | 431 |
Office Furniture and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | 358 | 108 |
Machinery and Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, at cost | $ 115 | $ 115 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Property Plant And Equipment [Abstract] | |||
Depreciation | $ 172 | $ 55 | $ 88 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Payables And Accruals [Abstract] | ||
Accrued payroll and employee benefits | $ 4,900 | $ 1,872 |
Accrued selling, general, administrative and other expenses | 3,830 | 1,485 |
Accrued research and development expenses | 3,128 | 4,219 |
Total accrued expenses | $ 11,858 | $ 7,576 |
Deferred Royalty Obligation - A
Deferred Royalty Obligation - Additional Information (Detail) - USD ($) | Sep. 30, 2024 | Sep. 30, 2023 | Sep. 30, 2020 | Jul. 31, 2020 | Apr. 30, 2020 | Dec. 31, 2020 |
Deferred Royalty Obligation [Line Items] | ||||||
Fair value of embedded derivative | $ 3,100,000 | |||||
Carrying value of the deferred royalty obligation | 63,548,000 | |||||
Significant Unobservable Inputs (Level 3) [Member] | ||||||
Deferred Royalty Obligation [Line Items] | ||||||
Fair value of embedded derivative | 1,900,000 | |||||
Fair value of the deferred royalty obligation | $ 82,100,000 | |||||
Healthcare Royalty Partners IV, L.P. ("HCR") [Member] | ||||||
Deferred Royalty Obligation [Line Items] | ||||||
Proceeds from first investment amount | $ 25,000,000 | |||||
Royalty payments applicable tiered percentage | 195.00% | |||||
Variable rate of total return | 95.00% | |||||
Minimum Cash Covenant | $ 20,000,000 | |||||
Healthcare Royalty Partners IV, L.P. ("HCR") [Member] | Forecast [Member] | ||||||
Deferred Royalty Obligation [Line Items] | ||||||
Royalty guarantees commitments percentage | 100.00% | 60.00% | ||||
Food and Drug Administration [Member] | ||||||
Deferred Royalty Obligation [Line Items] | ||||||
Proceeds from second investment amount | $ 25,000,000 | |||||
Food and Drug Administration [Member] | Healthcare Royalty Partners IV, L.P. ("HCR") [Member] | Deferred Royalty Obligation [Member] | ||||||
Deferred Royalty Obligation [Line Items] | ||||||
Effective interest rate deferred royalty obligation | 17.00% | |||||
Debt issuance costs incurred | $ 600,000 | |||||
Food and Drug Administration [Member] | Healthcare Royalty Partners IV, L.P. ("HCR") [Member] | Significant Unobservable Inputs (Level 3) [Member] | Deferred Royalty Obligation [Member] | ||||||
Deferred Royalty Obligation [Line Items] | ||||||
Fair value of embedded derivative | 1,900,000 | |||||
Commercial Drug Supply And First Commercial Sale [Member] | ||||||
Deferred Royalty Obligation [Line Items] | ||||||
Proceeds from third investment amount | $ 15,000,000 | |||||
Commercial Milestone [Member] | ||||||
Deferred Royalty Obligation [Line Items] | ||||||
Proceeds from fourth investment amount | $ 10,000,000 |
Earnings per Share of Common _2
Earnings per Share of Common Stock - Additional Information (Detail) - $ / shares | Dec. 31, 2020 | Jul. 31, 2020 |
Pre Funded Warrant [Member] | ||
Class of Warrant or Right [Line Items] | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ 0.0001 | $ 0.0001 |
Warrants - Summary of common st
Warrants - Summary of common stock warrants activity (Detail) | 12 Months Ended |
Dec. 31, 2020$ / sharesshares | |
Disclosure Of Warrants Activity [Line Items] | |
Class of Warrant or Right, Outstanding | 3,567,015 |
Warrants Issued | 5,000,000 |
Warrants Exercised | (410,642) |
Class of Warrant or Right, Outstanding | 8,156,373 |
October 2012 Warrants | |
Disclosure Of Warrants Activity [Line Items] | |
Exercise Price | $ / shares | $ 0.0910 |
Expiration Date | Oct. 22, 2022 |
Class of Warrant or Right, Outstanding | 829,686 |
Warrants Exercised | (205,321) |
Class of Warrant or Right, Outstanding | 624,365 |
March 2013 Warrants | |
Disclosure Of Warrants Activity [Line Items] | |
Exercise Price | $ / shares | $ 0.0910 |
Expiration Date | Mar. 28, 2022 |
Class of Warrant or Right, Outstanding | 829,686 |
Warrants Exercised | (205,321) |
Class of Warrant or Right, Outstanding | 624,365 |
December 2014 Warrants | |
Disclosure Of Warrants Activity [Line Items] | |
Exercise Price | $ / shares | $ 9.1320 |
Expiration Date | Dec. 16, 2024 |
Class of Warrant or Right, Outstanding | 923,527 |
Class of Warrant or Right, Outstanding | 923,527 |
February 2015 Warrants | |
Disclosure Of Warrants Activity [Line Items] | |
Exercise Price | $ / shares | $ 9.1320 |
Expiration Date | Dec. 16, 2024 |
Class of Warrant or Right, Outstanding | 984,116 |
Class of Warrant or Right, Outstanding | 984,116 |
July 2020 Pre-Funded Warrants | |
Disclosure Of Warrants Activity [Line Items] | |
Exercise Price | $ / shares | $ 0.0001 |
Warrants Issued | 5,000,000 |
Class of Warrant or Right, Outstanding | 5,000,000 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - Pre Funded Warrant [Member] - $ / shares | Dec. 31, 2020 | Jul. 31, 2020 |
Class of Warrant or Right [Line Items] | ||
Warrants exercise price per share | $ 0.0001 | $ 0.0001 |
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 5,000,000 |
Stock Incentive Plan - Addition
Stock Incentive Plan - Additional Information (Detail) | Jan. 01, 2016 | Dec. 31, 2020USD ($)$ / sharesshares | Dec. 31, 2019USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2015Directorshares | Jan. 01, 2021shares | Jan. 01, 2020shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock authorized for issuance | 9,775,418 | ||||||
Shares of common stock available for grant | 1,033,460 | ||||||
Number of stock option outstanding | 8,378,060 | 6,489,692 | |||||
Weighted average grant date fair value of stock options per share | $ / shares | $ 3.32 | $ 4.79 | $ 1.06 | ||||
Aggregate intrinsic value of stock options exercised | $ | $ 700,000 | $ 1,000,000 | $ 200,000 | ||||
Unrecognized compensation cost related to stock options, expected to be recognized | $ | $ 12,200,000 | ||||||
Expected recognition, weighted-average period | 3 years | ||||||
Share Based Compensation Arrangement Inventory Capitalized Compensation Cost | $ | $ 54,000 | ||||||
Number of directors who exercised options to purchase common stock | Director | 2 | ||||||
Stock options exercised | 207,416 | ||||||
Directors [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options exercised | 122,644 | ||||||
2008 Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock authorized for issuance | 3,547,741 | ||||||
2015 Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock authorized for issuance | 3,566,296 | 1,683,136 | |||||
Percentage of shares issued and outstanding under plan | 4.00% | ||||||
2015 Plan [Member] | Subsequent Event | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Shares of common stock authorized for issuance | 2,312,623 | ||||||
Employee Stock Option [Member] | Directors [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Restricted stock, shares issued | 116,258 | ||||||
Employee Stock Option [Member] | 2008 Plan [Member] | |||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||||
Stock options expiration period | 10 years | ||||||
Stock options vesting period | 4 years |
Stock Incentive Plan - Schedule
Stock Incentive Plan - Schedule of Fair Value Calculation of Option Granted (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |||
Expected volatility | 85.00% | 97.00% | 77.00% |
Expected term (years) | 6 years 2 months 12 days | 6 years | 6 years 2 months 12 days |
Risk-free interest rate | 0.93% | 1.93% | 2.72% |
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Stock Incentive Plan - Summary
Stock Incentive Plan - Summary of Stock Option Activity (Detail) - USD ($) | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Beginning balance | 6,489,692 | |
Number of stock options granted | 2,307,500 | |
Number of stock options, Exercised | (207,416) | |
Number of stock options, Forfeited / Expired | (211,716) | |
Ending balance | 8,378,060 | 6,489,692 |
Number of stock options, Exercisable | 4,774,332 | |
Number of stock options, Vested and expected to vest | 8,378,060 | |
Weighted-average exercise price options outstanding, Beginning balance | $ 5.01 | |
Weighted-average exercise price options, Granted | 4.63 | |
Weighted-average exercise price options, Exercised | 1.35 | |
Weighted-average exercise price options, Forfeited / Expired | 5.47 | |
Weighted-average exercise price options outstanding, Ending balance | 4.98 | $ 5.01 |
Weighted-average exercise price options, Exercisable | 4.98 | |
Weighted-average exercise price options, Vested and expected to vest | $ 4.98 | |
Weighted- average remaining contractual term outstanding options | 7 years 2 months 12 days | 7 years 3 months 18 days |
Weighted- average remaining contractual term options, Exercisable | 6 years | |
Weighted- average remaining contractual term options, Vested and expected to vest | 7 years 2 months 12 days | |
Aggregate Intrinsic Value options outstanding | $ 5,611,109 | $ 8,166,882 |
Aggregate Intrinsic Value options, exercisable | 4,634,332 | |
Aggregate Intrinsic Value options, vested and expected to vest | $ 5,611,109 |
Stock Incentive Plan - Schedu_2
Stock Incentive Plan - Schedule of Stock-based Compensation (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expenses | $ 5,020 | $ 3,270 | $ 2,730 |
General and Administrative [Member] | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expenses | 4,082 | 2,243 | 1,412 |
Research and Development [Member] | |||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | |||
Stock-based compensation expenses | $ 938 | $ 1,027 | $ 1,318 |
License Agreement - Additional
License Agreement - Additional Information (Detail) - USD ($) $ in Millions | 1 Months Ended | ||
Mar. 31, 2018 | Mar. 31, 2016 | Dec. 31, 2016 | |
Collaborative Arrangements And Noncollaborative Arrangement Transactions [Abstract] | |||
Aggregate amount of obligation | $ 5.1 | ||
Contractual obligation, final payment made | $ 1.7 | $ 1.7 |
Income Taxes - Summary of loss
Income Taxes - Summary of loss before provision (benefit) for income taxes (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |||
Domestic | $ (75,102) | $ (36,407) | $ (31,477) |
Foreign | 407 | 371 | 185 |
Loss before income taxes | $ (74,695) | $ (36,036) | $ (31,292) |
Income Taxes - Summary of Compo
Income Taxes - Summary of Components of Income Tax Provision (Benefit) (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Current Income Tax Expense Benefit Continuing Operations [Abstract] | |||
U.S. | $ 61 | $ 18 | $ 12 |
Foreign | 27 | 288 | (59) |
Total current provision for income taxes | 88 | 306 | (47) |
Deferred tax provision (benefit) - foreign | (4) | (22) | 16 |
Total deferred provision (benefit) for income taxes | (4) | (22) | 16 |
Total provision (benefit) for income taxes | $ 84 | $ 284 | $ (31) |
Income Taxes - Summary of Diffe
Income Taxes - Summary of Differences Between Effective Tax Rates and U.S. Federal Statutory Tax (Detail) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Effective Income Tax Rate Continuing Operations Tax Rate Reconciliation [Abstract] | |||
U.S. federal tax provision at statutory rate | 21.00% | 21.00% | 21.00% |
State and local tax, net of federal benefit | 6.20% | 5.60% | 5.30% |
Foreign rate differences | 0.00% | 0.10% | 0.20% |
Non-deductible foreign stock compensation | (0.10%) | (0.30%) | (0.40%) |
Effect of other permanent differences | (0.10%) | (0.50%) | (0.30%) |
Uncertain tax positions | 0.10% | (0.40%) | 0.20% |
Change in valuation allowance | (2.40%) | (26.10%) | (26.00%) |
Section 382 limitation of net operating loss | (24.90%) | 0.00% | 0.00% |
Other adjustments | 0.00% | (0.20%) | 0.10% |
Effective tax rate | (0.10%) | (0.80%) | 0.10% |
Income Taxes - Schedule of Comp
Income Taxes - Schedule of Components of Deferred Tax Assets and Liabilities (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Deferred tax assets: | ||
Federal and state net operating loss carryforwards | $ 55,220 | $ 54,269 |
Intangible and other related assets | 439 | 379 |
Accrued expenses | 29 | 710 |
Stock compensation | 3,505 | 2,180 |
Lease liability | 244 | 325 |
Other | 168 | 18 |
Total deferred tax assets | 59,605 | 57,881 |
Deferred tax liabilities: | ||
Right of use asset | (209) | (291) |
Total deferred tax liabilities | (209) | (291) |
Valuation allowance | (59,358) | (57,560) |
Net deferred tax assets | $ 38 | $ 30 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Income Taxes [Line Items] | |||
Increase in valuation allowance | $ 1,800,000 | $ 9,400,000 | |
Net operating loss carryforwards | 132,800,000 | ||
Federal NOLs Unutilized | $ 96,700,000 | ||
Effective income from non- research and development activities | (0.10%) | (0.80%) | 0.10% |
Undistributed earnings of subsidiary | $ 2,000,000 | ||
Unrecognized deferred tax liability | 200,000 | ||
Alternative Minimum Tax [Member] | |||
Income Taxes [Line Items] | |||
Income Taxes Receivable | $ 500,000 | ||
Prior To May Two Thousand Eight Year [Member] | |||
Income Taxes [Line Items] | |||
U.S.Federal net operating loss carryforwards subject to annual limitation | 1,100,000 | ||
State and Local Jurisdiction [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 234,400,000 | ||
United States [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 288,600,000 | ||
Non-US [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 0 | ||
Israel [Member] | |||
Income Taxes [Line Items] | |||
Effective income tax rate on income from research and development activities | 16.00% | ||
Effective income from non- research and development activities | 23.00% |
Income Taxes - Summary of Tax Y
Income Taxes - Summary of Tax Years that Remain Subject to Examination (Detail) | 12 Months Ended |
Dec. 31, 2020 | |
2003 and Forward [Member] | United States [Member] | |
Income Tax Examination [Line Items] | |
Income tax examination | 2003 and forward |
2016 and Forward [Member] | Israel [Member] | |
Income Tax Examination [Line Items] | |
Income tax examination | 2016 and forward |
Income Taxes - Reconciliation o
Income Taxes - Reconciliation of Beginning and Ending Amount of Uncertain Tax Position (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Reconciliation Of Unrecognized Tax Benefits Excluding Amounts Pertaining To Examined Tax Returns Roll Forward | |||
Uncertain tax position at the beginning of year | $ 568 | $ 391 | $ 471 |
Additions for uncertain tax positions of prior year | 43 | 177 | |
Reductions for settlements with taxing authorities | (72) | ||
Reductions for lapses of the applicable statutes of limitations | (80) | ||
Uncertain tax position at the end of the year | $ 539 | $ 568 | $ 391 |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | Dec. 31, 2020 | Dec. 31, 2018 |
Loss Contingencies [Line Items] | ||
Estimated settlement liability | $ 18.8 | |
Litigation insurance settlements receivable | $ 18.3 | |
Active Pharmaceutical Ingredient [Member] | ||
Loss Contingencies [Line Items] | ||
Outstanding purchase commitment amount | $ 20.3 | |
Purchase commitment for 2021 | $ 17.8 |
Leases - Summary of Operations
Leases - Summary of Operations in Leased Facilities (Detail) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2020 | Dec. 31, 2019 | |
Leases Operating [Abstract] | ||
Operating lease expense | $ 675 | $ 366 |
Operating cash flows from operating leases | 662 | 219 |
Operating leases | 122 | 1,690 |
Operating lease right-of-use assets | 985 | 1,371 |
Other current liabilities | $ 633 | $ 465 |
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List] | us-gaap:OtherCurrentLiabilitiesMember | us-gaap:OtherCurrentLiabilitiesMember |
Long-term liabilities | $ 480 | $ 1,036 |
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List] | chma:LongTermLiabilitiesMember | chma:LongTermLiabilitiesMember |
Total operating lease liabilities | $ 1,113 | $ 1,501 |
Operating Lease, Liability, Statement of Financial Position [Extensible List] | chma:OperatingLeaseLiabilitiesMember | chma:OperatingLeaseLiabilitiesMember |
Weighted average remaining lease term - operating leases | 21 months | 31 months |
Weighted average discount rate - operating leases | 10.90% | 10.80% |
Leases - Additional Information
Leases - Additional Information (Detail) $ in Millions | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Leases Operating [Abstract] | |
Operating Leases, Rent Expense | $ 0.2 |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Rental Commitments for Operating Leases (Detail) - USD ($) $ in Thousands | Dec. 31, 2020 | Dec. 31, 2019 |
Leases Operating [Abstract] | ||
2021 | $ 726 | |
2022 | 497 | |
2023 | 7 | |
Total future minimum lease payments | 1,230 | |
Less: imputed interest | (117) | |
Total | $ 1,113 | $ 1,501 |
Related Party Transactions - Ad
Related Party Transactions - Additional Information (Detail) - USD ($) | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Related Party Transaction [Line Items] | |||
Accrued liabilities | $ 11,858,000 | $ 7,576,000 | |
Head of Clinical [Member] | |||
Related Party Transaction [Line Items] | |||
Costs incurred for services | 100,000 | 300,000 | $ 300,000 |
Accrued liabilities | $ 35,000 | $ 100,000 |
Employee Benefit Plans - Additi
Employee Benefit Plans - Additional Information (Detail) - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Chiasma (Israel) Ltd [Member] | |||
Defined Benefit Plans and Other Postretirement Benefit Plans Table Text Block [Line Items] | |||
Employee benefit plans expense | $ 0.4 | $ 0.2 | $ 0.2 |
Interest and Other Income, Ne_2
Interest and Other Income, Net - Summary of Interest and Other Income, Net (Detail) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2020 | Dec. 31, 2019 | Dec. 31, 2018 | |
Interest And Other Income [Abstract] | |||
(Loss) / gain on foreign currency transactions, net | $ (42) | $ (75) | $ 37 |
Interest income | 668 | 1,554 | 1,007 |
Change in fair value of derivative liabilities | 1,200 | ||
Other income | 64 | ||
Total | $ 1,826 | $ 1,543 | $ 1,044 |
Quarterly Financial Data (Una_3
Quarterly Financial Data (Unaudited) - Quarterly Financial Data (Detail) - 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 | |
Quarterly Financial Data [Abstract] | |||||||||||
Loss from operations | $ (17,173) | $ (17,432) | $ (20,337) | $ (15,707) | $ (12,266) | $ (8,226) | $ (8,166) | $ (8,921) | $ (70,649) | $ (37,579) | $ (32,336) |
Net loss | $ (19,808) | $ (18,457) | $ (21,128) | $ (15,386) | $ (12,047) | $ (7,683) | $ (7,840) | $ (8,750) | $ (74,779) | $ (36,320) | $ (31,261) |
Earnings per share | |||||||||||
Basic | $ (0.32) | $ (0.30) | $ (0.50) | $ (0.36) | $ (0.29) | $ (0.20) | $ (0.25) | $ (0.36) | $ (1.43) | $ (1.06) | $ (1.28) |
Diluted | $ (0.32) | $ (0.30) | $ (0.50) | $ (0.36) | $ (0.29) | $ (0.20) | $ (0.25) | $ (0.36) | $ (1.43) | $ (1.06) | $ (1.28) |