Chiasma (CHMA) 10-Q 5 Nov 20 2020 Q3 Quarterly report Financial data

Cover Page

Cover Page - shares	9 Months Ended
	Sep. 30, 2020	Nov. 02, 2020
Cover [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Amendment Flag	false
Document Period End Date	Sep. 30, 2020
Document Fiscal Year Focus	2020
Document Fiscal Period Focus	Q3
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		57,804,095
Trading Symbol	CHMA
Security Exchange Name	NASDAQ
Title of 12(b) Security	Common Stock

Condensed Consolidated Balance

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Current assets
Cash and cash equivalents	$ 72,840	$ 27,855
Marketable securities	83,917	64,520
Accounts receivable	179
Inventory	8,942
Prepaid expenses and other current assets	5,383	3,881
Total current assets	171,261	96,256
Property and equipment, net	581	334
Other assets	2,419	2,236
Restricted cash	20,300
Total assets	194,561	98,826
Current liabilities
Accounts payable	7,149	3,253
Accrued expenses	10,275	7,576
Other current liabilities	722	546
Total current liabilities	18,146	11,375
Deferred royalty obligation	63,529
Long-term liabilities	2,548	1,682
Total liabilities	84,223	13,057
Commitments and contingencies (Note 11)
Stockholders' equity:
Common stock, $0.01 par value; authorized 125,000,000 shares at September 30, 2020 and December 31, 2019; issued and outstanding 57,804,095 shares at September 30, 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	0
Additional paid-in capital	437,659	358,245
Accumulated other comprehensive income	6	37
Accumulated deficit	(327,905)	(272,934)
Total stockholders' equity	110,338	85,769
Total liabilities and stockholders' equity	$ 194,561	$ 98,826

Condensed Consolidated Balanc_2

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2020	Dec. 31, 2019
Statement of Financial Position [Abstract]
Common stock, par value	$ 0.01	$ 0.01
Common stock, shares authorized	125,000,000	125,000,000
Common stock, shares issued	57,804,095	42,078,416
Common stock, shares outstanding	57,804,095	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		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Product revenue, net	$ 142		$ 142
Cost of goods sold	3		3
Gross profit	139		139
Operating expenses:
Selling, general and administrative	13,048	$ 4,116	31,295	$ 9,210
Research and development	4,523	4,110	22,320	16,103
Total operating expenses	17,571	8,226	53,615	25,313
Loss from operations	(17,432)	(8,226)	(53,476)	(25,313)
Interest and other income, net	1,122	549	1,648	1,074
Interest expense	(2,126)		(3,033)
Loss before income taxes	(18,436)	(7,677)	(54,861)	(24,239)
Provision for income taxes	21	6	110	34
Net loss	$ (18,457)	$ (7,683)	$ (54,971)	$ (24,273)
Earnings per share
Basic	$ (0.30)	$ (0.20)	$ (1.13)	$ (0.77)
Diluted	$ (0.30)	$ (0.20)	$ (1.13)	$ (0.77)
Weighted-average shares outstanding:
Basic	61,459,491	38,490,768	48,685,024	31,569,731
Diluted	61,459,491	38,490,768	48,685,024	31,569,731

Condensed Consolidated Statem_2

Condensed Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Statement of Comprehensive Income [Abstract]
Net loss	$ (18,457)	$ (7,683)	$ (54,971)	$ (24,273)
Other comprehensive income (loss):
Unrealized gain (loss) on available for sale securities, net	(20)	(3)	(31)	65
Total other comprehensive income (loss):	(20)	(3)	(31)	65
Comprehensive loss	$ (18,477)	$ (7,686)	$ (55,002)	$ (24,208)

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)	65
Net loss	(24,273)
Ending balance at Sep. 30, 2019	96,740	$ 420	357,158	49	(260,887)
Ending balance, shares at Sep. 30, 2019		42,005,465
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 offering, net	32,233	$ 73	32,160
Issuance of common stock in follow-on offering, 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
Stock-based compensation	944		944
Exercise of stock options	10	$ 1	9
Exercise of stock options, shares		61,811
Issuance of common stock in follow-on offering, net	52,343	$ 101	52,242
Issuance of common stock in follow-on offering, net, shares		10,166,427
Other comprehensive income (loss)	(3)			(3)
Net loss	(7,683)				(7,683)
Ending balance at Sep. 30, 2019	96,740	$ 420	357,158	49	(260,887)
Ending balance, shares at Sep. 30, 2019		42,005,465
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)	(31)
Net loss	(54,971)
Ending balance at Sep. 30, 2020	110,338	$ 578	437,659	6	(327,905)
Ending balance, shares at Sep. 30, 2020		57,804,095
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)			0	(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
Stock-based compensation	1,345		1,345
Exercise of stock options	13		13
Exercise of stock options, shares		5,399
Issuance of common stock and pre-funded warrants in follow-on offering, 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	0	$ 4	(4)
Issuance of common stock from cashless warrant exercise , shares		404,764
Other comprehensive income (loss)	(20)			(20)
Net loss	(18,457)				(18,457)
Ending balance at Sep. 30, 2020	$ 110,338	$ 578	$ 437,659	$ 6	$ (327,905)
Ending balance, shares at Sep. 30, 2020		57,804,095

Condensed Consolidated Statem_4

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Operating Activities:
Net loss	$ (54,971)	$ (24,273)
Adjustments to reconcile net loss to net cash provided by (used in) operating activities:
Depreciation	122	42
Stock-based compensation	3,813	2,193
Accretion on marketable securities, net	(71)	(414)
Non-cash lease expense	376	135
Amortization of debt discount and issuance costs	171
Change in fair value of embedded derivative liability	(1,060)
Benefit for deferred income taxes	(8)	(18)
Changes in operating assets and liabilities:
Accounts receivable	(179)
Inventory	(8,913)
Prepaid expenses and other current assets	(1,500)	(526)
Insurance Recovery (Note 11)		18,288
Accounts payable and accrued expenses	7,690	(1,924)
Settlement Liability (Note 11)		(18,750)
Other assets	(688)	53
Other current and long-term liabilities	920	(67)
Net cash used in operating activities	(54,298)	(25,261)
Investing Activities:
Purchases of marketable securities	(92,879)	(97,000)
Maturities of marketable securities	73,522	43,051
Purchases of property and equipment	(369)	(140)
Net cash used in investing activities	(19,726)	(54,089)
Financing Activities:
Proceeds from the issuance of common stock and pre-funded warrants, net	75,479	84,576
Exercise of stock options	250	39
Proceeds from short-term borrowing		1,675
Payments of short-term borrowing	(838)	(335)
Proceeds from deferred royalty obligation, net	64,418
Net cash provided by financing activities	139,309	85,955
Net increase in cash, cash equivalents and restricted cash	65,285	6,605
Cash, cash equivalents and restricted cash, beginning of period	27,855	13,060
Cash, cash equivalents and restricted cash, end of period	93,140	19,665
Reconciliation of cash, cash equivalents and restricted cash reported within the condensed consolidated balance sheets
Total cash, cash equivalents and restricted cash	$ 93,140	$ 19,665

Description of Business and Sum

Description of Business and Summary of Significant Accounting Policies	9 Months Ended
	Sep. 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 - , 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 public offering of 7,263,158 shares of common stock at $4.75 per share for aggregate net proceeds of approximately $32.2 million after underwriting fees and offering expenses. In August 2019, we completed a 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. As of September 30, 2020, we have received aggregate In July 2020, we completed an underwritten public offering of 15,125,000 shares of common stock and pre-funded “Pre-Funded . The public offering price was $4.00 per share of common stock. We received after deducting Pre-Funded 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 U.S. commercial launch and, the manufacturing of octreotide capsules for market consumption, including in manufacturing scale-up activities, and continuing the open label extension portion of our international Phase 3 CHIASMA OPTIMAL clinical trial of octreotide capsules in acromegaly and our international Phase 3 MPOWERED clinical trial of octreotide capsules in acromegaly for participants outside the United States. In addition, if the MPOWERED trial results are positive, we plan to prepare and submit a marketing authorization application, or MAA, to the European Medicines Agency, or EMA, seeking potential regulatory approval of octreotide capsules as a treatment for acromegaly in the European Union 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 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 s 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. 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 September 30, 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 and marketable securities, and accounts receivable. During the three months ended September 30, 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 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 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”), a first-in, first-out 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. Deferred Royalty Obligation We treat the deferred royalty obligation, as discussed further in Note 7 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 2. 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, recognition of product revenues, 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 Financial Accounting Standards Board

Product Revenue, Net

Product Revenue, Net	9 Months Ended
	Sep. 30, 2020
Revenue from Contract with Customer [Abstract]
Product Revenue, Net	2. 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 the product is received by them. 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 co-insurance Trade Discounts and Specialty Pharmacy Fees customer contract customer oo Government and Payor Rebates: 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 condensed 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 for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in distribution channel inventories at the end of the reporting period. Other Incentives/Patient Assistance Programs: co-pay co-insurance co-payments co-insurance co-pay co-insurance Product Returns We The following table summarizes activity in each of the above product revenue allowances and reserve categories for the nine months ended September 30, 2020: Discounts and Fees Rebates and Other Returns Total ($ in thousands) Balance, January 1, 2020 $ — $ — $ — $ — Provision 17 26 1 44 Payments or credits — — — — Balance, September 30, 2020 $ 17 $ 26 $ 1 $ 44

Investments

Investments	9 Months Ended
	Sep. 30, 2020
Investments, All Other Investments [Abstract]
Investments	3. Investments Our investments consisted of the following as of September 30, 2020 and December 31, 2019: As of September 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value ($ in thousands) Money market funds $ 32,697 $ — $ — $ 32,697 Corporate notes 16,796 1 (1 ) 16,796 Commercial paper 88,191 8 (3 ) 88,196 U.S. treasury securities 21,525 1 — 21,526 Total $ 159,209 $ 10 $ (4 ) $ 159,215 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 September 30, 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 available-for-sale The fair values of our investments by classification in our condensed consolidated balance sheets as of September 30, 2020 and December 31, 2019 were as follows: September 30, 2020 December 31, 2019 ($ in thousands) Cash and cash equivalents $ 54,998 $ 25,012 Marketable securities 83,917 64,520 Restricted cash 20,300 — Total $ 159,215 $ 89,532 Cash and cash equivalents in the table above exclude cash of $17.8 million and $2.8 million as of September 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	9 Months Ended
	Sep. 30, 2020
Fair Value Disclosures [Abstract]
Fair Value Measurements of Financial Instruments	4. 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 September 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 $ 32,697 $ — $ — $ 32,697 U.S. treasury s ecuriti es — 8,499 — 8,499 Corporate notes — 3,605 — 3,605 Commercial paper — 30,497 — 30,497 Total cash equivalents $ 32,697 $ 42,601 $ — $ 75,298 Marketable securities: U.S. treasury ecuriti es $ 13,027 $ — $ — $ 13,027 Corporate notes — 13,191 — 13,191 Commercial paper — 57,699 — 57,699 Total marketable securities 13,027 70,890 — 83,917 Total $ 45,724 $ 113,491 $ — $ 159,215 Financial liabilities Derivative liabilities $ — $ — $ 2,040 $ 2,040 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 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 held in money market 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 September 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 7. 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 for the three months ended September 30, 2020: ($ in thousands) Fair Value Measurement of Balance, June 30, 2020 $ 1,308 Additions during the period 1,792 Change in fair value during the period (1,060 ) Balance, September 30, 2020 $ 2,040

Inventory

Inventory	9 Months Ended
	Sep. 30, 2020
Inventory Disclosure [Abstract]
Inventory	5. Inventory Our inventory of MYCAPSSA consisted of the following as of September 30, 2020: ($ in thousands) September 30, 2020 Raw materials and supplies $ 6,745 Work in process 1,879 Finished goods 318 Total inventory $ 8,942 We began to capitalize inventory on July 1, 2020 following FDA approval of MYCAPSSA.

Accrued Expenses

Accrued Expenses	9 Months Ended
	Sep. 30, 2020
Payables and Accruals [Abstract]
Accrued Expenses	6. Accrued Expenses As of September 30, 2020 and December 31, 2019, accrued expenses consisted of the following: September 30, 2020 December 31, 2019 ($ in thousands) Accrued research and development expenses $ 3,895 $ 4,219 Accrued selling, general, administrative and other expenses 3,209 1,485 Accrued payroll and employee benefits 3,171 1,872 Total accrued expenses $ 10,275 $ 7,576

Deferred Royalty Obligation

Deferred Royalty Obligation	9 Months Ended
	Sep. 30, 2020
Text Block [Abstract]
Deferred Royalty Obligation	7. 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 we received an additional $15.0 million upon meeting conditions related to commercial drug supply availability and first commercial sale of MYCAPSSA . We are also entitled to receive an additional $10.0 million in early 2022 subject to the achievement of a revenue milestone and customary closing conditions. In exchange for the total investment amount (“Investment Amount”) received, HCR will receive a tiered royalty starting in the low double digits on worldwide annual net revenues of MYCAPSSA and any other future products, subject to step-downs upon the achievement of certain annual revenues. 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 60 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 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 4. The aggregate fair value of the embedded derivative as of September 30, 2020 is $2.0 million and is presented in deferred royalty obligation in the condensed 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, The effective interest rate as of September 30, 2020 was approximately 17%. In connection with the deferred royalty obligation, we incurred debt issuance costs totaling $0.6 million during the nine months ended September 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 September 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 4

Earnings per Share of Common St

Earnings per Share of Common Stock	9 Months Ended
	Sep. 30, 2020
Earnings Per Share [Abstract]
Earnings per Share of Common Stock	8. Earnings per Share of Common Stock We include our outstanding shares of common stock and Pre-Funded Pre-Funded

Warrants

Warrants	9 Months Ended
	Sep. 30, 2020
Text Block [Abstract]
Warrants	9. Warrants A summary of warrants activity for the nine months ended September 30, 2020 is presented below. Description Exercise Price Expiration Date Balance, Warrants Warrants Balance, 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 $ 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

Stock-based Compensation

Stock-based Compensation	9 Months Ended
	Sep. 30, 2020
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Stock-based Compensation	10. 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 allows the grant of incentive stock options, nonqualified stock options, and restricted stock to employees, directors, and nonemployees of the Company initially up to 3,566,296 shares of common stock. In connection with the adoption of the 2015 Plan, no further option grants were permitted under the 2008 Plan and any expirations, cancellations, or terminations under the 2008 Plan are available for issuance under the 2015 Plan. On January 1, 2020, the number of shares reserved and available for issuance under the 2015 Plan increased by 1,683,136 shares of common stock pursuant to a provision in the 2015 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 September 30, 2020, the total number of shares authorized for stock award plans is 9,775,418 of which 1,179,160 remain available for grant. There are 8,243,861 stock options outstanding as of September 30, 2020. Stock-based compensation for the three and nine months ended September 30, 2020 and 2019 consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 ($ in thousands) Selling, general and administrative $ 1,079 $ 702 $ 3,092 $ 1,373 Research and development 237 242 721 820 Total $ 1,316 $ 944 $ 3,813 $ 2,193 Stock-based compensation of $29,000 was capitalized into inventory for the three and nine months ended September 30, 2020. Stock-based compensation capitalized into inventory is recognized as cost of goods sold when the related product is sold. 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: Nine Months Ended September 30, 2020 2019 Expected volatility 85 % 97 % Expected term (years) 6.2 6.0 Risk-free interest rate 0.97 % 2.03 % Expected dividend yield 0 % 0 % We granted approximately 2,135,300 stock options in the nine months ended September 30, 2020. The weighted-average grant date fair value per share of stock options granted during the nine months ended September 30, 2020 was $3.36. We granted approximately 1,832,000 stock options in the nine months ended September 30, 2019. The weighted-average grant date fair value per share of options granted during the nine months ended September 30, 2019 was $5.05.

Commitments and Contingencies

Commitments and Contingencies	9 Months Ended
	Sep. 30, 2020
Commitments and Contingencies Disclosure [Abstract]
Commitments and Contingencies	11. Commitments and Contingencies Manufacturing Commitments As of September 30, 2020, we had outstanding manufacturing commitments, including the acquisition of API, in the aggregate amount of million of which $ million is expected to be incurred in with the remainder to be incurred throughout . 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 , ed

Leases

Leases	9 Months Ended
	Sep. 30, 2020
Leases [Abstract]
Leases	12. 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 Nine Months Ended 2020 2019 2020 2019 ($ in thousands) The components of lease expense were as follows: Operating lease expense $ 170 $ 58 $ 505 $ 159 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 $ 205 $ 54 $ 476 $ 154 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 28 $ — $ 122 $ 113 September 30, 2020 ($ in thousands) Supplemental balance sheet information related to leases was as follows: Right-of-use $ 1,118 Other current liabilities $ 622 Long-term liabilities 645 Total lease liabilities $ 1,267 Weighted average remaining lease term—operating leases 24 Weighted average discount rate—operating leases 10.8 % Our lease right-of-use Future lease payments under noncancelable leases as of September 30, 2020 are as follows: ($ in thousands) Remainder of 2020 $ 186 2021 726 2022 497 2023 7 Total future minimum lease payments 1,416 Less: imputed interest (149 ) Total $ 1,267

Description of Business and S_2

Description of Business and Summary of Significant Accounting Policies (Policies)	9 Months Ended
	Sep. 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 s
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.
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 September 30, 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 and marketable securities, and accounts receivable. During the three months ended September 30, 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 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 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”), a first-in, first-out 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.
Deferred Royalty Obligation	Deferred Royalty Obligation We treat the deferred royalty obligation, as discussed further in Note 7
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 2.
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, recognition of product revenues, 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 Financial Accounting Standards Board

Product Revenue, Net (Tables)

Product Revenue, Net (Tables)	9 Months Ended
	Sep. 30, 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 the nine months ended September 30, 2020: Discounts and Fees Rebates and Other Returns Total ($ in thousands) Balance, January 1, 2020 $ — $ — $ — $ — Provision 17 26 1 44 Payments or credits — — — — Balance, September 30, 2020 $ 17 $ 26 $ 1 $ 44

Investments (Tables)

Investments (Tables)	9 Months Ended
	Sep. 30, 2020
Investments, All Other Investments [Abstract]
Schedule of Investments	Our investments consisted of the following as of September 30, 2020 and December 31, 2019: As of September 30, 2020 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value ($ in thousands) Money market funds $ 32,697 $ — $ — $ 32,697 Corporate notes 16,796 1 (1 ) 16,796 Commercial paper 88,191 8 (3 ) 88,196 U.S. treasury securities 21,525 1 — 21,526 Total $ 159,209 $ 10 $ (4 ) $ 159,215 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 September 30, 2020 and December 31, 2019 were as follows: September 30, 2020 December 31, 2019 ($ in thousands) Cash and cash equivalents $ 54,998 $ 25,012 Marketable securities 83,917 64,520 Restricted cash 20,300 — Total $ 159,215 $ 89,532

Fair Value Measurements of Fi_2

Fair Value Measurements of Financial Instruments (Tables)	9 Months Ended
	Sep. 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 September 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 $ 32,697 $ — $ — $ 32,697 U.S. treasury s ecuriti es — 8,499 — 8,499 Corporate notes — 3,605 — 3,605 Commercial paper — 30,497 — 30,497 Total cash equivalents $ 32,697 $ 42,601 $ — $ 75,298 Marketable securities: U.S. treasury ecuriti es $ 13,027 $ — $ — $ 13,027 Corporate notes — 13,191 — 13,191 Commercial paper — 57,699 — 57,699 Total marketable securities 13,027 70,890 — 83,917 Total $ 45,724 $ 113,491 $ — $ 159,215 Financial liabilities Derivative liabilities $ — $ — $ 2,040 $ 2,040 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	The following table sets forth a summary of the changes in the fair value of the embedded derivative for the three months ended September 30, 2020: ($ in thousands) Fair Value Measurement of Balance, June 30, 2020 $ 1,308 Additions during the period 1,792 Change in fair value during the period (1,060 ) Balance, September 30, 2020 $ 2,040

Inventory (Tables)

Inventory (Tables)	9 Months Ended
	Sep. 30, 2020
Inventory Disclosure [Abstract]
Schedule of Inventory, Current	Our inventory of MYCAPSSA consisted of the following as of September 30, 2020: ($ in thousands) September 30, 2020 Raw materials and supplies $ 6,745 Work in process 1,879 Finished goods 318 Total inventory $ 8,942

Accrued Expenses (Tables)

Accrued Expenses (Tables)	9 Months Ended
	Sep. 30, 2020
Payables and Accruals [Abstract]
Schedule of Accrued Expenses	As of September 30, 2020 and December 31, 2019, accrued expenses consisted of the following: September 30, 2020 December 31, 2019 ($ in thousands) Accrued research and development expenses $ 3,895 $ 4,219 Accrued selling, general, administrative and other expenses 3,209 1,485 Accrued payroll and employee benefits 3,171 1,872 Total accrued expenses $ 10,275 $ 7,576

Warrants (Tables)

Warrants (Tables)	9 Months Ended
	Sep. 30, 2020
Text Block [Abstract]
Summary of warrants activity	A summary of warrants activity for the nine months ended September 30, 2020 is presented below. Description Exercise Price Expiration Date Balance, Warrants Warrants Balance, 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 $ 0.0001 No expiration — 5,000,000 — 5,000,000 3,567,015 5,000,000 (410,642 ) 8,156,373

Stock-based Compensation (Tabl

Stock-based Compensation (Tables)	9 Months Ended
	Sep. 30, 2020
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Schedule of Stock-based Compensation	Stock-based compensation for the three and nine months ended September 30, 2020 and 2019 consisted of the following: Three Months Ended September 30, Nine Months Ended September 30, 2020 2019 2020 2019 ($ in thousands) Selling, general and administrative $ 1,079 $ 702 $ 3,092 $ 1,373 Research and development 237 242 721 820 Total $ 1,316 $ 944 $ 3,813 $ 2,193
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: Nine Months Ended September 30, 2020 2019 Expected volatility 85 % 97 % Expected term (years) 6.2 6.0 Risk-free interest rate 0.97 % 2.03 % Expected dividend yield 0 % 0 %

Leases (Tables)

Leases (Tables)	9 Months Ended
	Sep. 30, 2019
Leases [Abstract]
Summary of Operations in Leased Facilities	Three Months Ended Nine Months Ended 2020 2019 2020 2019 ($ in thousands) The components of lease expense were as follows: Operating lease expense $ 170 $ 58 $ 505 $ 159 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 $ 205 $ 54 $ 476 $ 154 Right-of-use assets obtained in exchange for lease obligations: Operating leases $ 28 $ — $ 122 $ 113 September 30, 2020 ($ in thousands) Supplemental balance sheet information related to leases was as follows: Right-of-use $ 1,118 Other current liabilities $ 622 Long-term liabilities 645 Total lease liabilities $ 1,267 Weighted average remaining lease term—operating leases 24 Weighted average discount rate—operating leases 10.8 %
Schedule of Future Lease Payments Under Noncancelable Leases	Future lease payments under noncancelable leases as of September 30, 2020 are as follows: ($ in thousands) Remainder of 2020 $ 186 2021 726 2022 497 2023 7 Total future minimum lease payments 1,416 Less: imputed interest (149 ) Total $ 1,267 18

Description of Business and S_3

Description of Business and Summary of Significant Accounting Policies - Additional Information (Detail) $ / shares in Units, $ in Millions	1 Months Ended						3 Months Ended	9 Months Ended
	Jul. 31, 2020USD ($)$ / sharesshares	Apr. 30, 2020USD ($)	Aug. 31, 2019USD ($)$ / sharesshares	Jun. 30, 2019Patient	Apr. 30, 2019USD ($)$ / sharesshares	Jul. 31, 2018Patient	Sep. 30, 2020	Sep. 30, 2020USD ($)SubsidiariesPatient
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			$ 52.3		$ 32.2
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%
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 Pre Funded Warrants	$ 75.5
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]
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

Product Revenue, Net - Schedule

Product Revenue, Net - Schedule Of Product Revenue And Allowances (Detail) $ in Thousands	9 Months Ended
	Sep. 30, 2020USD ($)
Revenue from Contract with Customer [Abstract]
Balance, January 1, 2020	$ 0
Provision	17
Payments or credits	0
Balance, September 30, 2020	17
Balance, January 1, 2020	0
Provison	26
Payments or credits	0
Balance, September 30, 2020	26
Balance, January 1, 2020	0
Provision	1
Payments or credits	0
Balance, September 30, 2020	1
Balance, January 1, 2020	0
Provison	44
Payments or credits	0
Balance, September 30, 2020	$ 44

Investments - Schedule of Inves

Investments - Schedule of Investments (Detail) - USD ($) $ in Thousands	9 Months Ended	12 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Gain (Loss) on Securities [Line Items]
Amortized Cost	$ 159,209	$ 89,495
Gross Unrealized Gains	10	37
Gross Unrealized Losses	(4)
Estimated Fair Value	159,215	89,532
Money Market Funds [Member]
Gain (Loss) on Securities [Line Items]
Amortized Cost	32,697	23,012
Estimated Fair Value	32,697	23,012
Corporate Notes [Member]
Gain (Loss) on Securities [Line Items]
Amortized Cost	16,796	45,584
Gross Unrealized Gains	1	20
Gross Unrealized Losses	(1)
Estimated Fair Value	16,796	45,604
Commercial Paper [Member]
Gain (Loss) on Securities [Line Items]
Amortized Cost	88,191	20,899
Gross Unrealized Gains	8	17
Gross Unrealized Losses	(3)
Estimated Fair Value	88,196	$ 20,916
U.S. treasury securities [Member]
Gain (Loss) on Securities [Line Items]
Amortized Cost	21,525
Gross Unrealized Gains	1
Estimated Fair Value	$ 21,526

Investments - Additional Inform

Investments - Additional Information (Detail) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2020	Sep. 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	$ 17,800,000	$ 17,800,000	$ 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	Sep. 30, 2020	Dec. 31, 2019	Sep. 30, 2019
Net Investment Income [Line Items]
Cash and cash equivalents	$ 72,840	$ 27,855	$ 19,665
Marketable securities	83,917	64,520
Restricted cash	20,300
Total	159,215	89,532
Cash and Cash Equivalents [Member]
Net Investment Income [Line Items]
Cash and cash equivalents	54,998	25,012
Marketable Securities [Member]
Net Investment Income [Line Items]
Marketable securities	83,917	64,520
Total	83,917	$ 64,520
Restricted Cash [Member]
Net Investment Income [Line Items]
Restricted cash	$ 20,300

Fair Value Measurements of Fi_3

Fair Value Measurements of Financial Instruments - Fair Value Measurements of Company's Financial Instruments (Detail) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Cash equivalents:
Total cash equivalents	$ 75,298	$ 25,012
Marketable securities:
Total marketable securities	159,215	89,532
Total	159,215	89,532
Financial liabilities
Derivative liabilities	2,040
Corporate Notes [Member]
Cash equivalents:
Total cash equivalents	3,605	2,000
Marketable securities:
Total marketable securities	13,191	43,604
Commercial Paper [Member]
Cash equivalents:
Total cash equivalents	30,497
Marketable securities:
Total marketable securities	57,699	20,916
Marketable Securities [Member]
Marketable securities:
Total marketable securities	83,917	64,520
U.S. treasury securities [Member]
Cash equivalents:
Total cash equivalents	8,499
Marketable securities:
Total marketable securities	13,027
Money Market Funds [Member]
Cash equivalents:
Total cash equivalents	32,697	23,012
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member]
Cash equivalents:
Total cash equivalents	32,697	23,012
Marketable securities:
Total	45,724	23,012
Financial liabilities
Derivative liabilities	0
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Corporate Notes [Member]
Cash equivalents:
Total cash equivalents	0
Marketable securities:
Total marketable securities	0
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Commercial Paper [Member]
Cash equivalents:
Total cash equivalents	0
Marketable securities:
Total marketable securities	0
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Marketable Securities [Member]
Marketable securities:
Total marketable securities	13,027
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | U.S. treasury securities [Member]
Cash equivalents:
Total cash equivalents	0
Marketable securities:
Total marketable securities	13,027
Quoted Prices in Active Markets for Identical Assets (Level 1) [Member] | Money Market Funds [Member]
Cash equivalents:
Total cash equivalents	32,697	23,012
Significant Other Observable Inputs (Level 2) [Member]
Cash equivalents:
Total cash equivalents	42,601	2,000
Marketable securities:
Total	113,491	66,520
Financial liabilities
Derivative liabilities	0
Significant Other Observable Inputs (Level 2) [Member] | Corporate Notes [Member]
Cash equivalents:
Total cash equivalents	3,605	2,000
Marketable securities:
Total marketable securities	13,191	43,604
Significant Other Observable Inputs (Level 2) [Member] | Commercial Paper [Member]
Cash equivalents:
Total cash equivalents	30,497
Marketable securities:
Total marketable securities	57,699	20,916
Significant Other Observable Inputs (Level 2) [Member] | Marketable Securities [Member]
Marketable securities:
Total marketable securities	70,890	$ 64,520
Significant Other Observable Inputs (Level 2) [Member] | U.S. treasury securities [Member]
Cash equivalents:
Total cash equivalents	8,499
Marketable securities:
Total marketable securities	0
Significant Other Observable Inputs (Level 2) [Member] | Money Market Funds [Member]
Cash equivalents:
Total cash equivalents	0
Significant Unobservable Inputs (Level 3) [Member]
Cash equivalents:
Total cash equivalents	0
Marketable securities:
Total	0
Financial liabilities
Derivative liabilities	2,040
Significant Unobservable Inputs (Level 3) [Member] | Corporate Notes [Member]
Cash equivalents:
Total cash equivalents	0
Marketable securities:
Total marketable securities	0
Significant Unobservable Inputs (Level 3) [Member] | Commercial Paper [Member]
Cash equivalents:
Total cash equivalents	0
Marketable securities:
Total marketable securities	0
Significant Unobservable Inputs (Level 3) [Member] | Marketable Securities [Member]
Marketable securities:
Total marketable securities	0
Significant Unobservable Inputs (Level 3) [Member] | U.S. treasury securities [Member]
Cash equivalents:
Total cash equivalents	0
Marketable securities:
Total marketable securities	0
Significant Unobservable Inputs (Level 3) [Member] | Money Market Funds [Member]
Cash equivalents:
Total cash equivalents	$ 0

Fair Value Measurements of Fi_4

Fair Value Measurements of Financial Instruments - Summary of the changes in the fair value of the embedded derivative (Detail) - Fair Value Measurement of Embedded Derivative using Significant Unobservable Inputs (Level 3) $ in Thousands	3 Months Ended
	Sep. 30, 2020USD ($)
Embedded Derivative [Line Items]
Balance, June 30, 2020	$ 1,308
Additions during the period	1,792
Change in fair value during the period	(1,060)
Balance, September 30, 2020	$ 2,040

Inventory - Schedule Of Invento

Inventory - Schedule Of Inventory Current (Detail) $ in Thousands	Sep. 30, 2020USD ($)
Inventory Disclosure [Abstract]
Raw materials and supplies	$ 6,745
Work in process	1,879
Finished goods	318
Total inventory	$ 8,942

Accrued Expenses - Schedule of

Accrued Expenses - Schedule of Accrued Expenses (Detail) - USD ($) $ in Thousands	Sep. 30, 2020	Dec. 31, 2019
Payables and Accruals [Abstract]
Accrued research and development expenses	$ 3,895	$ 4,219
Accrued selling, general, administrative and other expenses	3,209	1,485
Accrued payroll and employee benefits	3,171	1,872
Total accrued expenses	$ 10,275	$ 7,576

Deferred Royalty Obligation - A

Deferred Royalty Obligation - Additional Information (Detail) - USD ($) $ in Thousands	Sep. 30, 2024	Sep. 30, 2023	Sep. 30, 2020	Jul. 31, 2020	Apr. 30, 2020	Sep. 30, 2020	Jun. 30, 2020
Significant Unobservable Inputs (Level 3) [Member]
Deferred Royalty Obligation [Line Items]
Fair value of embedded derivative			$ 2,040			$ 2,040	$ 1,308
Healthcare Royalty Partners IV, L.P. ("HCR") [Member]
Deferred Royalty Obligation [Line Items]
Proceeds from first investment amount					$ 25,000
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					$ 20,000
Food and Drug Administration [Member]
Deferred Royalty Obligation [Line Items]
Proceeds from second investment amount				$ 25,000
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%			17.00%
Debt issuance costs incurred			$ 600			$ 600
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			2,000			2,000
Commercial Drug Supply And First Commercial Sale [Member]
Deferred Royalty Obligation [Line Items]
Proceeds from third investment amount			$ 15,000
Commercial Milestone [Member]
Deferred Royalty Obligation [Line Items]
Proceeds from fourth investment amount						$ 10,000

Earnings per Share of Common _2

Earnings per Share of Common Stock - Additional Information (Detail)	Jul. 31, 2020$ / shares
Pre Funded Warrant [Member]
Class of Warrant or Right [Line Items]
Class of Warrant or Right, Exercise Price of Warrants or Rights	$ 0.0001

Warrants - Summary of warrants

Warrants - Summary of warrants activity (Detail) - $ / shares	9 Months Ended
	Sep. 30, 2020	Dec. 31, 2019
Disclosure Of Warrants Activity [Line Items]
Warrants Issued	5,000,000
Warrants Exercised	(410,642)
Class of Warrant or Right, Outstanding	8,156,373	3,567,015
October 2012 Warrants
Disclosure Of Warrants Activity [Line Items]
Exercise Price	$ 0.0910
Expiration Date	Oct. 22, 2022
Warrants Exercised	(205,321)
Class of Warrant or Right, Outstanding	624,365	829,686
March 2013 Warrants
Disclosure Of Warrants Activity [Line Items]
Exercise Price	$ 0.0910
Expiration Date	Mar. 28, 2022
Warrants Exercised	(205,321)
Class of Warrant or Right, Outstanding	624,365	829,686
December 2014 Warrants
Disclosure Of Warrants Activity [Line Items]
Exercise Price	$ 9.1320
Expiration Date	Dec. 16, 2024
Class of Warrant or Right, Outstanding	923,527	923,527
February 2015 Warrants
Disclosure Of Warrants Activity [Line Items]
Exercise Price	$ 9.1320
Expiration Date	Dec. 16, 2024
Class of Warrant or Right, Outstanding	984,116	984,116
July 2020 Pre-Funded Warrants
Disclosure Of Warrants Activity [Line Items]
Exercise Price	$ 0.0001
Warrants Issued	5,000,000
Warrants Exercised	0
Class of Warrant or Right, Outstanding	5,000,000	0

Warrants - Additional Informati

Warrants - Additional Information (Detail) - Pre Funded Warrant [Member]	Jul. 31, 2020$ / sharesshares
Class of Warrant or Right [Line Items]
Warrants exercise price per share | $ / shares	$ 0.0001
Class of Warrant or Right, Number of Securities Called by Warrants or Rights | shares	5,000,000

Stock-based Compensation - Add

Stock-based Compensation - Additional Information (Detail) - USD ($)	Jan. 01, 2020	Jan. 01, 2016	Sep. 30, 2020	Sep. 30, 2020	Sep. 30, 2019
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares of common stock authorized for issuance			9,775,418	9,775,418
Shares of common stock available for grant			1,179,160	1,179,160
Number of stock option outstanding			8,243,861	8,243,861
Number of stock options granted				2,135,300	1,832,000
Weighted average grant date fair value of stock options per share				$ 3.36	$ 5.05
Share Based Compensation Arrangement Inventory Capitalized Compensation Cost			$ 29,000	$ 29,000
2008 Plan [Member]
Share-based Compensation Arrangement by Share-based Payment Award [Line Items]
Shares of common stock authorized for issuance			3,547,741	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	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		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Stock-based compensation expense:
Stock-based compensation expenses	$ 1,316	$ 944	$ 3,813	$ 2,193
Selling, General and Administrative Expenses [Member]
Stock-based compensation expense:
Stock-based compensation expenses	1,079	702	3,092	1,373
Research and Development [Member]
Stock-based compensation expense:
Stock-based compensation expenses	$ 237	$ 242	$ 721	$ 820

Stock-based Compensation - Sch

Stock-based Compensation - Schedule of Fair Value Calculation of Option Granted (Detail)	9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019
Disclosure of Compensation Related Costs, Share-based Payments [Abstract]
Expected volatility	85.00%	97.00%
Expected term (years)	6 years 2 months 12 days	6 years
Risk-free interest rate	0.97%	2.03%
Expected dividend yield	0.00%	0.00%

Commitments and Contingencies -

Commitments and Contingencies - Additional Information (Detail) - USD ($) $ in Millions	Sep. 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	$ 20.1
Purchase commitment for current year	$ 3.2

Leases - Summary of Operations

Leases - Summary of Operations in Leased Facilities (Detail) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2020	Sep. 30, 2019	Sep. 30, 2020	Sep. 30, 2019
Leases, Operating [Abstract]
Operating lease expense	$ 170	$ 58	$ 505	$ 159
Operating cash flows from operating leases	205	$ 54	476	154
Operating leases	28		122	$ 113
Right-of-use assets	1,118		1,118
Other current liabilities	622		622
Long-term liabilities	645		645
Total lease liabilities	$ 1,267		$ 1,267
Weighted average remaining lease term - operating leases	24 months		24 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	Sep. 30, 2020USD ($)
Leases, Operating [Abstract]
Remainder of 2020	$ 186
2021	726
2022	497
2023	7
Total future minimum lease payments	1,416
Less: imputed interest	(149)
Total	$ 1,267