Cover Page
Cover Page - shares | 6 Months Ended | |
Jun. 30, 2020 | Aug. 05, 2020 | |
Cover [Abstract] | ||
Document Type | 10-Q | |
Document Quarterly Report | true | |
Document Transition Report | false | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2020 | |
Document Fiscal Year Focus | 2020 | |
Document Fiscal Period Focus | Q2 | |
Entity Registrant Name | CHIASMA, INC | |
Entity Central Index Key | 0001339469 | |
Entity File Number | 001-37500 | |
Entity Tax Identification Number | 76-0722250 | |
Entity Incorporation, State or Country Code | DE | |
Current Fiscal Year End Date | --12-31 | |
Entity Interactive Data Current | Yes | |
Entity Current Reporting Status | Yes | |
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 | |
Entity Shell Company | false | |
Entity Filer Category | Accelerated Filer | |
Entity Small Business | false | |
Entity Emerging Growth Company | true | |
Entity Ex Transition Period | true | |
Entity Common Stock, Shares Outstanding | 57,802,283 | |
Trading Symbol | CHMA | |
Security Exchange Name | NASDAQ | |
Title of 12(b) Security | Common Stock |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Current assets | ||
Cash and cash equivalents | $ 52,194 | $ 27,855 |
Marketable securities | 14,893 | 64,520 |
Prepaid expenses and other current assets | 3,741 | 3,881 |
Total current assets | 70,828 | 96,256 |
Property and equipment, net | 617 | 334 |
Other assets | 2,521 | 2,236 |
Restricted cash | 20,000 | |
Total assets | 93,966 | 98,826 |
Current liabilities | ||
Accounts payable | 7,079 | 3,253 |
Accrued expenses | 8,148 | 7,576 |
Other current liabilities | 716 | 546 |
Total current liabilities | 15,943 | 11,375 |
Deferred royalty obligation | 24,601 | |
Long-term liabilities | 1,444 | 1,682 |
Total liabilities | 41,988 | 13,057 |
Commitments and contingencies (Note 9) | ||
Stockholders' equity: | ||
Common stock, $0.01 par value; authorized 125,000,000 shares at June 30, 2020 and December 31, 2019; issued and outstanding 42,268,932 shares at June 30, 2020 and 42,078,416 shares at December 31, 2019 | 423 | 421 |
Preferred stock, $0.01 par value; authorized 5,000,000 shares; none outstanding | ||
Additional paid-in capital | 360,977 | 358,245 |
Accumulated other comprehensive income | 26 | 37 |
Accumulated deficit | (309,448) | (272,934) |
Total stockholders' equity | 51,978 | 85,769 |
Total liabilities and stockholders' equity | $ 93,966 | $ 98,826 |
Condensed Consolidated Balanc_2
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Jun. 30, 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 | 42,268,932 | 42,078,416 |
Common stock, shares outstanding | 42,268,932 | 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 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Operating expenses: | ||||
General and administrative | $ 10,665 | $ 2,644 | $ 18,247 | $ 5,094 |
Research and development | 9,672 | 5,522 | 17,797 | 11,993 |
Total operating expenses | 20,337 | 8,166 | 36,044 | 17,087 |
Loss from operations | (20,337) | (8,166) | (36,044) | (17,087) |
Interest and other income, net | 128 | 341 | 526 | 525 |
Interest expense | (907) | (907) | ||
Loss before income taxes | (21,116) | (7,825) | (36,425) | (16,562) |
Provision for income taxes | 12 | 15 | 89 | 28 |
Net loss | $ (21,128) | $ (7,840) | $ (36,514) | $ (16,590) |
Earnings per share | ||||
Basic | $ (0.50) | $ (0.25) | $ (0.86) | $ (0.59) |
Diluted | $ (0.50) | $ (0.25) | $ (0.86) | $ (0.59) |
Weighted-average shares outstanding: | ||||
Basic | 42,267,507 | 31,597,698 | 42,227,601 | 28,051,856 |
Diluted | 42,267,507 | 31,597,698 | 42,227,601 | 28,051,856 |
Condensed Consolidated Statem_2
Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Statement of Comprehensive Income [Abstract] | ||||
Net loss | $ (21,128) | $ (7,840) | $ (36,514) | $ (16,590) |
Other comprehensive income (loss): | ||||
Unrealized gain (loss) on available for sale securities, net | 23 | 50 | (11) | 68 |
Total other comprehensive income (loss): | 23 | 50 | (11) | 68 |
Comprehensive loss | $ (21,105) | $ (7,790) | $ (36,525) | $ (16,522) |
Condensed Consolidated Statem_3
Condensed 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, 2018 | $ 34,124 | $ 245 | $ 270,509 | $ (16) | $ (236,614) |
Beginning balance, shares at Dec. 31, 2018 | 24,456,120 | ||||
Stock-based compensation | 622 | 622 | |||
Exercise of stock options | 3 | 3 | |||
Exercise of stock options, shares | 33,839 | ||||
Additional paid in capital on account of vested portion of restricted stock | 16 | 16 | |||
Other comprehensive income (loss) | 18 | 18 | |||
Net loss | (8,750) | (8,750) | |||
Ending balance at Mar. 31, 2019 | 26,033 | $ 245 | 271,150 | 2 | (245,364) |
Ending balance, shares at Mar. 31, 2019 | 24,489,959 | ||||
Beginning balance at Dec. 31, 2018 | 34,124 | $ 245 | 270,509 | (16) | (236,614) |
Beginning balance, shares at Dec. 31, 2018 | 24,456,120 | ||||
Other comprehensive income (loss) | 68 | ||||
Net loss | (16,590) | ||||
Ending balance at Jun. 30, 2019 | 51,129 | $ 318 | 303,963 | 52 | (253,204) |
Ending balance, shares at Jun. 30, 2019 | 31,777,227 | ||||
Beginning balance at Mar. 31, 2019 | 26,033 | $ 245 | 271,150 | 2 | (245,364) |
Beginning balance, shares at Mar. 31, 2019 | 24,489,959 | ||||
Stock-based compensation | 627 | 627 | |||
Exercise of stock options | 26 | 26 | |||
Exercise of stock options, shares | 24,110 | ||||
Issuance of common stock in follow-on offerings, net | 32,233 | $ 73 | 32,160 | ||
Issuance of common stock in follow-on offerings, net, shares | 7,263,158 | ||||
Other comprehensive income (loss) | 50 | 50 | |||
Net loss | (7,840) | (7,840) | |||
Ending balance at Jun. 30, 2019 | 51,129 | $ 318 | 303,963 | 52 | (253,204) |
Ending balance, shares at Jun. 30, 2019 | 31,777,227 | ||||
Beginning balance at Dec. 31, 2019 | 85,769 | $ 421 | 358,245 | 37 | (272,934) |
Beginning balance, shares at Dec. 31, 2019 | 42,078,416 | ||||
Stock-based compensation | 1,162 | 1,162 | |||
Exercise of stock options | 232 | $ 2 | 230 | ||
Exercise of stock options, shares | 186,925 | ||||
Other comprehensive income (loss) | (34) | (34) | |||
Net loss | (15,386) | (15,386) | |||
Ending balance at Mar. 31, 2020 | 71,743 | $ 423 | 359,637 | 3 | (288,320) |
Ending balance, shares at Mar. 31, 2020 | 42,265,341 | ||||
Beginning balance at Dec. 31, 2019 | 85,769 | $ 421 | 358,245 | 37 | (272,934) |
Beginning balance, shares at Dec. 31, 2019 | 42,078,416 | ||||
Other comprehensive income (loss) | (11) | ||||
Net loss | (36,514) | ||||
Ending balance at Jun. 30, 2020 | 51,978 | $ 423 | 360,977 | 26 | (309,448) |
Ending balance, shares at Jun. 30, 2020 | 42,268,932 | ||||
Beginning balance at Mar. 31, 2020 | 71,743 | $ 423 | 359,637 | 3 | (288,320) |
Beginning balance, shares at Mar. 31, 2020 | 42,265,341 | ||||
Stock-based compensation | 1,335 | 1,335 | |||
Exercise of stock options | 5 | 5 | |||
Exercise of stock options, shares | 3,591 | ||||
Other comprehensive income (loss) | 23 | 23 | |||
Net loss | (21,128) | (21,128) | |||
Ending balance at Jun. 30, 2020 | $ 51,978 | $ 423 | $ 360,977 | $ 26 | $ (309,448) |
Ending balance, shares at Jun. 30, 2020 | 42,268,932 |
Condensed Consolidated Statem_4
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Operating Activities: | ||
Net loss | $ (36,514) | $ (16,590) |
Adjustments to reconcile net loss to net cash provided by (used in) operating activities: | ||
Depreciation | 73 | 29 |
Stock-based compensation | 2,497 | 1,249 |
Accretion on marketable securities, net | (94) | (278) |
Non-cash lease expense | 247 | 87 |
Amortization of debt discount and issuance costs | 63 | |
Benefit for deferred income taxes | (8) | (13) |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other current assets | (127) | 1,093 |
Insurance Recovery (Note 9) | 18,288 | |
Accounts payable and accrued expenses | 5,762 | (1,237) |
Settlement Liability (Note 9) | (18,750) | |
Other assets | (689) | 54 |
Other current and long-term liabilities | (162) | (40) |
Net cash used in operating activities | (28,952) | (16,108) |
Investing Activities: | ||
Purchases of marketable securities | (8,927) | (40,382) |
Maturities of marketable securities | 58,637 | 31,750 |
Purchases of property and equipment | (356) | (14) |
Net cash provided by (used in) investing activities | 49,354 | (8,646) |
Financing Activities: | ||
Proceeds from the issuance of common stock, net | 32,233 | |
Exercise of stock options | 237 | 29 |
Payments of short-term borrowing | (838) | |
Proceeds from deferred royalty obligation, net | 24,538 | |
Net cash provided by financing activities | 23,937 | 32,262 |
Net increase in cash, cash equivalents and restricted cash | 44,339 | 7,508 |
Cash, cash equivalents and restricted cash, beginning of period | 27,855 | 13,060 |
Cash, cash equivalents and restricted cash, end of period | 72,194 | 20,568 |
Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets | ||
Total cash, cash equivalents and restricted cash | $ 72,194 | $ 20,568 |
Description of Business and Sum
Description of Business and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Description of Business and Summary of Significant Accounting Policies | 1. Description of Business and Summary of Significant Accounting Policies Chiasma, Inc. is a commercial stage biopharmaceutical company incorporated in 2001 under the laws of the State of Delaware. Chiasma, Inc. is headquartered in Massachusetts and has two wholly owned subsidiaries; Chiasma (Israel) Ltd., and Chiasma Securities Corp, collectively referred to as “the Company,” “we,” “us,” “our” or “Chiasma”. We 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 Transient Permeability Enhancer (“TPE”) 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 . Our planned U.S. commercial launch of MYCAPSSA is expected to commence in the fourth quarter of 2020. Acromegaly is a rare and debilitating condition that is caused by 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 retain worldwide rights to develop and commercialize octreotide capsules. We are currently conducting 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 is a global, randomized, open-label and active-controlled 15-month six run-in In April 2019, we completed an underwritten follow-on 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. The initial funding of $25.0 million, less certain transaction expenses, was completed in April 2020 and the second funding of $25.0 million, less certain transaction expenses, was completed in July 2020 (see Note 6). In July 2020, we completed an underwritten public offering of 15,125,000 shares of common stock and pre-funded “Pre-Funded less Pre-Funded are 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 continue to invest in our commercial launch, the manufacturing of octreotide capsules for market consumption, as well as invest in manufacturing scale-up in July 2020, we completed an underwritten public offering of our common stock and Pre-Funded 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, the anticipated $15.0 million of additional funding from HCR following the first commercial sale of MYCAPSSA and potentially through 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. Basis of Presentation We have prepared the accompanying unaudited condensed consolidated financial statements pursuant to the rules and regulations of the SEC regarding interim financial reporting. Accordingly, certain information and footnote disclosures required by accounting principles generally accepted in the United States (“U.S. GAAP”) for annual financial statements have been condensed or omitted. The information included in this quarterly report on Form 10-Q 10-K year-end Cash Equivalents Cash equivalents consist of highly liquid instruments that 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, 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. Concentrations of credit risk Financial instruments that potentially subject us to significant concentration of credit risk consist primarily of cash, cash equivalents and marketable securities. 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 U.S. 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 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. The manufacturing-related costs incurred following our June 26, 2020 FDA approval of MYCAPSSA were immaterial to our condensed consolidated financial statements. We will begin 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 and other raw materials, third party manufacturing costs and other overhead costs, on a first-in, first-out Prospectively, on a quarterly basis, we will 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. Deferred Royalty Obligation We treat the deferred royalty obligation, as discussed further Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed 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 condensed consolidated financial statements include, but are not limited to, accounting for stock-based compensation, income taxes, the fair value of embedded derivatives 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. Recently Issued Accounting Pronouncements In June 2016, the FASB 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 condensed consolidated financial statements. |
Investments
Investments | 6 Months Ended |
Jun. 30, 2020 | |
Investments, All Other Investments [Abstract] | |
Investments | 2. Investments Our investments consisted of the following as of June 30, 2020 and December 31, 2019: As of June 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value ($ in thousands) Money market funds $ 61,918 $ — $ — $ 61,918 Corporate notes 10,095 7 — 10,102 Commercial paper 10,228 19 — 10,247 U.S. treasury shares 2,999 — — 2,999 Total $ 85,240 $ 26 $ — $ 85,266 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 June 30, 2020, we consider those securities that are in an unrealized loss position as available-for-sale The fair values of our investments by classification in our condensed consolidated balance sheets as of June 30, 2020 and December 31, 2019 were as follows: June 30, 2020 December 31, 2019 ($ in thousands) Cash and cash equivalents $ 50,373 $ 25,012 Marketable securities 14,893 64,520 Restricted cash 20,000 — Total $ 85,266 $ 89,532 Cash and cash equivalents in the table above exclude cash of $1.8 million and $2.8 million as of June 30, 2020 and December 31, 2019, respectively. The contractual maturity dates of all of our investments are less than one year. |
Fair Value Measurements of Fina
Fair Value Measurements of Financial Instruments | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements of Financial Instruments | 3. Fair Value Measurements of Financial Instruments Certain assets and liabilities are reported at fair value on a recurring basis. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants at the measurement date. The fair value accounting guidance requires that assets and liabilities carried at fair value be classified and disclosed in one of the following three categories: • Level 1 • Level 2 • Level 3 To the extent that valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by us in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. The fair value measurements of our financial instruments are summarized in the table below: Fair Value Measurements at June 30, 2020 Description Quoted Prices in Active Markets for Identical Assets (Level 1) Significant Other Observable Inputs (Level 2) Significant Unobservable Inputs (Level 3) Total Financial assets ($ in thousands) Cash equivalents: Money market funds $ 61,918 $ — $ — $ 61,918 U.S. treasury shares 2,999 — — 2,999 Corporate notes — 2,457 — 2,457 Commercial paper — 2,999 — 2,999 Total cash equivalents $ 64,917 $ 5,456 $ — $ 70,373 Marketable securities: Corporate notes $ — $ 7,645 $ — $ 7,645 Commercial paper — 7,248 — 7,248 Total marketable securities — 14,893 — 14,893 Total $ 64,917 $ 20,349 $ — $ 85,266 Financial liabilities Derivative liabilities $ — $ — $ 1,308 $ 1,308 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 are composed of money market funds and U.S. treasury shares and are classified as Level 1 assets under the fair value hierarchy as these assets have been valued using quoted market prices in active markets and do not have any restrictions on redemption. Our marketable securities consist of corporate notes and commercial paper and are classified as Level 2 assets under the fair value hierarchy as these assets were primarily determined 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 June 30, 2020 or December 31, 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 6, of $1.3 million during the three months ended June 30, 2020. There was no change in the fair value of the derivative liabilities during the three months ended June 30, 2020. These derivative liabilities are measured at fair value using an option pricing Monte Carlo simulation model and is included as a component of the deferred royalty obligation. The embedded derivative liabilities are subject to remeasurement at the end of each reporting period, with changes in fair value recognized as a component of interest and other income, net. The assumptions used in the option pricing Monte Carlo simulation model include: (1) the expected net sales of MYCAPSSA and any of our other future products; (2) our risk-adjusted discount rate that includes a company specific risk premium; (3) our cost of debt; (4) volatility; (5) the probability and timing of a change in control occurring during the term of the instrument; and (6) the probability and timing of an event of default during the term of the instrument. We did not have any Level 3 assets or liabilities being measured at fair value on a recurring basis as of December 31, 2019. |
Earnings per Share of Common St
Earnings per Share of Common Stock | 6 Months Ended |
Jun. 30, 2020 | |
Earnings Per Share [Abstract] | |
Earnings per Share of Common Stock | 4. Earnings per Share of Common Stock All common stock warrants and stock options have been excluded from the computation of diluted weighted-average shares outstanding because such securities would have an anti-dilutive impact due to net losses reported during the three and six months ended June 30, 2020 and 2019. |
Accrued Expenses
Accrued Expenses | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | 5. Accrued Expenses As of June 30, 2020 and December 31, 2019, accrued expenses consisted of the following: June 30, 2020 December 31, 2019 ($ in thousands) Accrued research and development expenses $ 3,498 $ 4,219 Accrued general, administrative and other expenses 2,413 1,485 Accrued payroll and employee benefits 2,237 1,872 Total accrued expenses $ 8,148 $ 7,576 |
Deferred Royalty Obligation
Deferred Royalty Obligation | 6 Months Ended |
Jun. 30, 2020 | |
Text Block [Abstract] | |
Deferred Royalty Obligation | 6. 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. We are entitled to receive an additional $ million upon conditions related to commercial drug supply availability and first commercial sale of MYCAPSSA, subject to customary closing conditions. We are also entitled to receive an additional $ million in early 2022 subject to the achievement of a revenue 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 mid-teens up to % 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 sixty days that prevents us from marketing MYCAPSSA, HCR may accelerate payments due under the agreement to the 195% of the funded portion of the Investment Amount. If HCR has not received 60% of the funded portion of the of the funded portion million in securitized cash and investment accounts, which we recorded as restricted cash in the condensed 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 of up to 195% of the Investment Amount, less any payments made to date, upon a change of control is an embedded derivative that requires bifurcation from the debt instrument and fair value recognition. In addition, we have determined that the repayment 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 3. The aggregate fair value of the embedded derivative is $ 1.3 million and is pre sent The effective interest rate as of June 30, 2020 was approximately 18 %. In connection with the deferred royalty obligation, we incurred debt issuance costs totaling $ 0.6 million in the six months ended June 30, 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, as presented on the condensed consolidated balance sheet, approximates fair value as of June 30, 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 3. |
Warrants
Warrants | 6 Months Ended |
Jun. 30, 2020 | |
Text Block [Abstract] | |
Warrants | 7. Warrants As of December 31, 2019, there were 3,567,015 common stock warrants outstanding with exercise prices ranging from $0.09 per share to $9.13 per share. Such warrants were issued between October 2012 and February 2015 with expiration dates ranging from March 2022 December 2024 Pre-Funded are |
Stock-based Compensation
Stock-based Compensation | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock Incentive Plan | 8. Stock-based Compensation In 2008, our board of directors adopted the 2008 Stock Incentive Plan (the “2008 Plan”), which provided for the grant of incentive stock options, nonqualified stock options, and restricted stock to employees, directors, and nonemployees of the Company up to 3,547,741 shares of common stock. Option awards expire 10 years from the grant date and generally vest over four years but vesting conditions can vary at the discretion of our board of directors. In July 2015, the Company approved the 2015 Stock Option and Incentive Plan (the “2015 Plan”), which became effective upon our initial public offering. The 2015 Plan allow s Stock-based compensation for the three and six months ended June 30, 2020 and 2019 consisted of the following: Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 ($ in thousands) General and administrative $ 1,060 $ 360 $ 2,013 $ 671 Research and development 275 267 484 578 Total $ 1,335 $ 627 $ 2,497 $ 1,249 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: Six Months Ended June 30, 2020 2019 Expected volatility 85 % 98 % Expected term (years) 6.2 6.0 Risk-free interest rate 1.11 % 2.09 % Expected dividend yield 0 % 0 % We granted approximately 1,736,900 stock options in the six months ended June 30, 2020. The weighted-average grant date fair value per share of stock options granted during the six months ended June 30, 2020 was $3.32. We granted approximately 1,533,000 stock options in the six months ended June 30, 2019. The weighted-average grant date fair value per share of options granted during the six months ended June 30, 2019 was $5.19. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2020 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 9. Commitments and Contingencies Manufacturing Commitments As of June 30, 2020, we had outstanding manufacturing commitments, including the acquisition of API, in the aggregate amount of $25.2 million of which $9.2 million is expected to be incurred in 2020 with the remainder to be incurred throughout 2021. The payments on these commitments will occur following the deliveries of the API or completion of the manufacturing services. 2019 Litigation Settlement On June 9, 2016, Chiasma, Inc. and certain of our current and former officers were named as defendants in a purported federal securities class action lawsuit filed in the United States District Court for the District of Massachusetts, styled Gerneth v. Chiasma, Inc., et al |
Leases
Leases | 6 Months Ended |
Jun. 30, 2020 | |
Leases [Abstract] | |
Leases | 10. Leases We determine if an arrangement is a lease at inception. We have operating leases for our office spaces and certain automobiles. Right-of-use right-of-use non-lease Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 ($ in thousands) The components of lease expense were as follows: Operating lease expense $ 171 $ 57 $ 335 $ 104 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 $ 199 $ 55 $ 271 $ 100 Right-of-use Operating leases $ — $ 86 $ 94 $ 113 June 30, 2020 ($ in thousands) Supplemental balance sheet information related to leases was as follows: Right-of-use $ 1,220 Other current liabilities $ 623 Long-term liabilities 785 Total lease liabilities $ 1,408 Weighted average remaining lease term—operating leases 26 Months Weighted average discount rate—operating leases 10.8 % Our lease right-of-use Future lease payments under noncancelable leases as of June 30, 2020 are as follows: ($ in thousands) Remainder of 2020 $ 388 2021 715 2022 487 Total future minimum lease payments 1,590 Less: imputed interest (182 ) Total $ 1,408 |
Description of Business and S_2
Description of Business and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2020 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation We have prepared the accompanying unaudited condensed consolidated financial statements pursuant to the rules and regulations of the SEC regarding interim financial reporting. Accordingly, certain information and footnote disclosures required by accounting principles generally accepted in the United States (“U.S. GAAP”) for annual financial statements have been condensed or omitted. The information included in this quarterly report on Form 10-Q 10-K year-end |
Cash Equivalents | Cash Equivalents Cash equivalents consist of highly liquid instruments that 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, 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. |
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 and marketable securities. 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 U.S. 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 |
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. The manufacturing-related costs incurred following our June 26, 2020 FDA approval of MYCAPSSA were immaterial to our condensed consolidated financial statements. We will begin 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 and other raw materials, third party manufacturing costs and other overhead costs, on a first-in, first-out Prospectively, on a quarterly basis, we will 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. |
Deferred Royalty Obligation | Deferred Royalty Obligation We treat the deferred royalty obligation, as discussed further |
Use of Estimates | Use of Estimates The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed 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 condensed consolidated financial statements include, but are not limited to, accounting for stock-based compensation, income taxes, the fair value of embedded derivatives 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. |
Recently Issued Accounting Pronouncements | Recently Issued Accounting Pronouncements In June 2016, the FASB 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 condensed consolidated financial statements. |
Investments (Tables)
Investments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Investments, All Other Investments [Abstract] | |
Schedule of Investments | Our investments consisted of the following as of June 30, 2020 and December 31, 2019: As of June 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value ($ in thousands) Money market funds $ 61,918 $ — $ — $ 61,918 Corporate notes 10,095 7 — 10,102 Commercial paper 10,228 19 — 10,247 U.S. treasury shares 2,999 — — 2,999 Total $ 85,240 $ 26 $ — $ 85,266 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 condensed consolidated balance sheets as of June 30, 2020 and December 31, 2019 were as follows: June 30, 2020 December 31, 2019 ($ in thousands) Cash and cash equivalents $ 50,373 $ 25,012 Marketable securities 14,893 64,520 Restricted cash 20,000 — Total $ 85,266 $ 89,532 |
Fair Value Measurements of Fi_2
Fair Value Measurements of Financial Instruments (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements of Company's Financial Instruments | The fair value measurements of our financial instruments are summarized in the table below: Fair Value Measurements at June 30, 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: Money market funds $ 61,918 $ — $ — $ 61,918 U.S. treasury shares 2,999 — — 2,999 Corporate notes — 2,457 — 2,457 Commercial paper — 2,999 — 2,999 Total cash equivalents $ 64,917 $ 5,456 $ — $ 70,373 Marketable securities: Corporate notes $ — $ 7,645 $ — $ 7,645 Commercial paper — 7,248 — 7,248 Total marketable securities — 14,893 — 14,893 Total $ 64,917 $ 20,349 $ — $ 85,266 Financial liabilities Derivative liabilities $ — $ — $ 1,308 $ 1,308 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 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | As of June 30, 2020 and December 31, 2019, accrued expenses consisted of the following: June 30, 2020 December 31, 2019 ($ in thousands) Accrued research and development expenses $ 3,498 $ 4,219 Accrued general, administrative and other expenses 2,413 1,485 Accrued payroll and employee benefits 2,237 1,872 Total accrued expenses $ 8,148 $ 7,576 |
Stock-based Compensation (Tabl
Stock-based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock-based Compensation | Stock-based compensation for the three and six months ended June 30, 2020 and 2019 consisted of the following: Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 ($ in thousands) General and administrative $ 1,060 $ 360 $ 2,013 $ 671 Research and development 275 267 484 578 Total $ 1,335 $ 627 $ 2,497 $ 1,249 |
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: Six Months Ended June 30, 2020 2019 Expected volatility 85 % 98 % Expected term (years) 6.2 6.0 Risk-free interest rate 1.11 % 2.09 % Expected dividend yield 0 % 0 % |
Leases (Tables)
Leases (Tables) | 6 Months Ended |
Jun. 30, 2020 | |
Leases [Abstract] | |
Summary of Operations in Leased Facilities | Three Months Ended June 30, Six Months Ended June 30, 2020 2019 2020 2019 ($ in thousands) The components of lease expense were as follows: Operating lease expense $ 171 $ 57 $ 335 $ 104 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 $ 199 $ 55 $ 271 $ 100 Right-of-use Operating leases $ — $ 86 $ 94 $ 113 June 30, 2020 ($ in thousands) Supplemental balance sheet information related to leases was as follows: Right-of-use $ 1,220 Other current liabilities $ 623 Long-term liabilities 785 Total lease liabilities $ 1,408 Weighted average remaining lease term—operating leases 26 Months Weighted average discount rate—operating leases 10.8 % |
Schedule of Future Lease Payments Under Noncancelable Leases | Future lease payments under noncancelable leases as of June 30, 2020 are as follows: ($ in thousands) Remainder of 2020 $ 388 2021 715 2022 487 Total future minimum lease payments 1,590 Less: imputed interest (182 ) Total $ 1,408 |
Description of Business and S_3
Description of Business and Summary of Significant Accounting Policies - Additional Information (Detail) $ / shares in Units, $ in Thousands | Jun. 26, 2020USD ($) | Jul. 31, 2020USD ($)$ / sharesshares | Apr. 30, 2020USD ($) | Aug. 31, 2019USD ($)$ / sharesshares | Jun. 30, 2019Patient | Apr. 30, 2019USD ($)$ / sharesshares | Jul. 31, 2018Patient | Jun. 30, 2020USD ($)SubsidiariesPatient | Jun. 30, 2019USD ($) | Dec. 31, 2019$ / shares |
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Number of subsidiaries owned by the company | Subsidiaries | 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 | ||||||||
Net proceeds received after underwriting fees and offering expenses | $ 52,300 | $ 32,200 | $ 32,233 | |||||||
Proceeds from deferred royalty obligation, net | $ 25,000 | $ 24,538 | ||||||||
Commercial Drug Supply And First Commercial Sale [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Proceeds from third investment amount | $ 15,000 | |||||||||
Common stock and Pre-Funded Warrants [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Net proceeds received after underwriting fees and offering expenses | $ 75,500 | |||||||||
Subsequent Event [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Stock issued during period, shares, new issues | shares | shares | 15,125,000 | |||||||||
Subsequent Event [Member] | 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 | |||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.0001 | |||||||||
Proceeds from Warrant Exercises | $ 75,500 | |||||||||
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 | 60,000 | |||||||||
Healthcare Royalty Partners IV, L.P. ("HCR") [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Maximum Proceeds Under Investment Agreement | 75,000 | |||||||||
First Funding Of Proceeds Under Investment Agreement | 25,000 | |||||||||
Second funding of proceeds under investment agreement | $ 25,000 | |||||||||
Minimum [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 0.09 | |||||||||
Maximum [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Class of Warrant or Right, Exercise Price of Warrants or Rights | $ / shares | $ 9.13 | |||||||||
MPOWERED Trial [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Number of adult acromegaly patients completed to enroll in trial | Patient | 146 | |||||||||
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] | Minimum [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Number of adult acromegaly patients expect to randomize | Patient | 80 | |||||||||
MPOWERED Trial [Member] | Maximum [Member] | ||||||||||
Nature Of Operations And Summary Of Significant Accounting Policies [Line Items] | ||||||||||
Number of adult acromegaly patients expected to enroll in trial | Patient | 150 | |||||||||
Trial period for adult acromegaly patients expected to enroll | 15 months |
Investments - Schedule of Inves
Investments - Schedule of Investments (Detail) - USD ($) $ in Thousands | 6 Months Ended | 12 Months Ended |
Jun. 30, 2020 | Dec. 31, 2019 | |
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | $ 85,240 | $ 89,495 |
Gross Unrealized Gains | 26 | 37 |
Estimated Fair Value | 85,266 | 89,532 |
Money Market Funds [Member] | ||
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | 61,918 | 23,012 |
Estimated Fair Value | 61,918 | 23,012 |
Corporate Notes [Member] | ||
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | 10,095 | 45,584 |
Gross Unrealized Gains | 7 | 20 |
Estimated Fair Value | 10,102 | 45,604 |
Commercial Paper [Member] | ||
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | 10,228 | 20,899 |
Gross Unrealized Gains | 19 | 17 |
Estimated Fair Value | 10,247 | $ 20,916 |
U.S. treasury shares [Member] | ||
Gain (Loss) on Securities [Line Items] | ||
Amortized Cost | 2,999 | |
Estimated Fair Value | $ 2,999 |
Investments - Additional Inform
Investments - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2020 | Dec. 31, 2019 | |
Investments, All Other Investments [Abstract] | |||
Realized gains and losses on available-for-sale securities | $ 0 | $ 0 | |
Cash excluded from cash and cash equivalents | $ 1,800,000 | $ 1,800,000 | $ 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 | Jun. 30, 2020 | Dec. 31, 2019 |
Net Investment Income [Line Items] | ||
Total | $ 85,266 | $ 89,532 |
Cash and Cash Equivalents [Member] | ||
Net Investment Income [Line Items] | ||
Total | 50,373 | 25,012 |
Marketable Securities [Member] | ||
Net Investment Income [Line Items] | ||
Total | 14,893 | $ 64,520 |
Restricted Cash [Member] | ||
Net Investment Income [Line Items] | ||
Total | $ 20,000 |
Fair Value Measurements of Fi_3
Fair Value Measurements of Financial Instruments - Fair Value Measurements of Company's Financial Instruments (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Cash equivalents: | ||
Total cash equivalents | $ 70,373 | $ 25,012 |
Marketable securities: | ||
Total marketable securities | 85,266 | 89,532 |
Total | 85,266 | 89,532 |
Financial liabilities | ||
Derivative liabilities | 1,308 | |
Corporate Notes [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 2,457 | 2,000 |
Marketable securities: | ||
Total marketable securities | 7,645 | 43,604 |
Commercial Paper [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 2,999 | |
Marketable securities: | ||
Total marketable securities | 7,248 | 20,916 |
Marketable Securities [Member] | ||
Marketable securities: | ||
Total marketable securities | 14,893 | 64,520 |
U.S. treasury shares [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 2,999 | |
Money Market Funds [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 61,918 | 23,012 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 64,917 | 23,012 |
Marketable securities: | ||
Total | 64,917 | 23,012 |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. treasury shares [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 2,999 | |
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Funds [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 61,918 | 23,012 |
Significant Other Observable Inputs (Level 2) [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 5,456 | 2,000 |
Marketable securities: | ||
Total | 20,349 | 66,520 |
Significant Other Observable Inputs (Level 2) [Member] | Corporate Notes [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 2,457 | 2,000 |
Marketable securities: | ||
Total marketable securities | 7,645 | 43,604 |
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member] | ||
Cash equivalents: | ||
Total cash equivalents | 2,999 | |
Marketable securities: | ||
Total marketable securities | 7,248 | 20,916 |
Significant Other Observable Inputs (Level 2) [Member] | Marketable Securities [Member] | ||
Marketable securities: | ||
Total marketable securities | 14,893 | $ 64,520 |
Significant Unobservable Inputs (Level 3) [Member] | ||
Financial liabilities | ||
Derivative liabilities | $ 1,308 |
Fair Value Measurements of Fi_4
Fair Value Measurements of Financial Instruments - Additional Information (Detail) $ in Millions | 6 Months Ended |
Jun. 30, 2020USD ($) | |
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items] | |
Increase Decrease In Derivative Liability | $ 1.3 |
Accrued Expenses - Schedule of
Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands | Jun. 30, 2020 | Dec. 31, 2019 |
Payables and Accruals [Abstract] | ||
Accrued research and development expenses | $ 3,498 | $ 4,219 |
Accrued general, administrative and other expenses | 2,413 | 1,485 |
Accrued payroll and employee benefits | 2,237 | 1,872 |
Total accrued expenses | $ 8,148 | $ 7,576 |
Deferred Royalty Obligation - A
Deferred Royalty Obligation - Additional Information (Detail) - USD ($) $ in Millions | Sep. 30, 2024 | Sep. 30, 2023 | Apr. 30, 2020 | Jun. 30, 2020 |
Healthcare Royalty Partners IV, L.P. ("HCR") [Member] | ||||
Deferred Royalty Obligation [Line Items] | ||||
Proceeds from first investment amount | $ 25 | |||
Royalty payments applicable tiered percentage | 195.00% | |||
Royalty guarantees commitments percentage | 100.00% | 60.00% | ||
Variable rate of total return | 95.00% | |||
Minimum Cash Covenant | $ 20 | |||
Food and Drug Administration [Member] | ||||
Deferred Royalty Obligation [Line Items] | ||||
Proceeds from second investment amount | 25 | |||
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 | 18.00% | |||
Debt issuance costs incurred | $ 0.6 | |||
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 | $ 1.3 | |||
Commercial Drug Supply And First Commercial Sale [Member] | ||||
Deferred Royalty Obligation [Line Items] | ||||
Proceeds from third investment amount | 15 | |||
Commercial Milestone [Member] | ||||
Deferred Royalty Obligation [Line Items] | ||||
Proceeds from fourth investment amount | $ 10 |
Warrants - Additional Informati
Warrants - Additional Information (Detail) - $ / shares | 6 Months Ended | 12 Months Ended | |
Jun. 30, 2020 | Dec. 31, 2019 | Jul. 31, 2020 | |
Class of Warrant or Right [Line Items] | |||
Warrants outstanding | 3,567,015 | 3,567,015 | |
Warrants issued | 0 | ||
Warrants exercised | 0 | ||
Subsequent Event [Member] | Pre Funded Warrant [Member] | |||
Class of Warrant or Right [Line Items] | |||
Warrants exercise price per share | $ 0.0001 | ||
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | 5,000,000 | ||
Minimum [Member] | |||
Class of Warrant or Right [Line Items] | |||
Warrants exercise price per share | $ 0.09 | ||
Warrants expiration date | Mar. 31, 2022 | ||
Maximum [Member] | |||
Class of Warrant or Right [Line Items] | |||
Warrants exercise price per share | $ 9.13 | ||
Warrants expiration date | Dec. 31, 2024 |
Stock-based Compensation - Add
Stock-based Compensation - Additional Information (Detail) - $ / shares | Jan. 01, 2020 | Jan. 01, 2016 | Jun. 30, 2020 | Jun. 30, 2019 |
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 | 1,511,498 | |||
Number of stock option outstanding | 7,916,922 | |||
Number of stock options granted | 1,736,900 | 1,533,000 | ||
Weighted average grant date fair value of stock options per share | $ 3.32 | $ 5.19 | ||
2008 Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock authorized for issuance | 3,547,741 | |||
2008 Plan [Member] | Employee Stock Option [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock options expiration period | 10 years | |||
Stock options vesting period | 4 years | |||
2015 Plan [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares of common stock authorized for issuance | 3,566,296 | |||
Increase in number of shares reserved and available for issuance | 1,683,136 | |||
Percentage of shares issued and outstanding under plan | 4.00% |
Stock-based Compensation - Sche
Stock-based Compensation - Schedule of Stock-based Compensation (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Stock-based compensation expense: | ||||
Stock-based compensation expenses | $ 1,335 | $ 627 | $ 2,497 | $ 1,249 |
General and Administrative [Member] | ||||
Stock-based compensation expense: | ||||
Stock-based compensation expenses | 1,060 | 360 | 2,013 | 671 |
Research and Development [Member] | ||||
Stock-based compensation expense: | ||||
Stock-based compensation expenses | $ 275 | $ 267 | $ 484 | $ 578 |
Stock-based Compensation - Sch
Stock-based Compensation - Schedule of Fair Value Calculation of Option Granted (Detail) | 6 Months Ended | |
Jun. 30, 2020 | Jun. 30, 2019 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Expected volatility | 85.00% | 98.00% |
Expected term (years) | 6 years 2 months 12 days | 6 years |
Risk-free interest rate | 1.11% | 2.09% |
Expected dividend yield | 0.00% | 0.00% |
Commitments and Contingencies -
Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions | Jun. 30, 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 | $ 25.2 | |
Purchase commitment for current year | $ 9.2 |
Leases - Summary of Operations
Leases - Summary of Operations in Leased Facilities (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2020 | Jun. 30, 2019 | Jun. 30, 2020 | Jun. 30, 2019 | |
Leases, Operating [Abstract] | ||||
Operating lease expense | $ 171 | $ 57 | $ 335 | $ 104 |
Operating cash flows from operating leases | 199 | 55 | 271 | 100 |
Operating leases | 0 | $ 86 | 94 | $ 113 |
Right-of-use assets | 1,220 | 1,220 | ||
Other current liabilities | 623 | 623 | ||
Long-term liabilities | 785 | 785 | ||
Total lease liabilities | $ 1,408 | $ 1,408 | ||
Weighted average remaining lease term—operating leases | 26 months | 26 months | ||
Weighted average discount rate—operating leases | 10.80% | 10.80% |
Leases - Schedule of Future Min
Leases - Schedule of Future Minimum Rental Commitments for Operating Leases (Detail) $ in Thousands | Jun. 30, 2020USD ($) |
Leases, Operating [Abstract] | |
Remainder of 2020 | $ 388 |
2021 | 715 |
2022 | 487 |
Total future minimum lease payments | 1,590 |
Less: imputed interest | (182) |
Total | $ 1,408 |