Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2017 | Mar. 02, 2018 | Jun. 30, 2017 | |
Document And Entity Information [Abstract] | |||
Entity Registrant Name | Flex Pharma, Inc. | ||
Entity Central Index Key | 1,615,219 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Smaller Reporting Company | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2017 | ||
Document Fiscal Year Focus | 2,017 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Common Stock, Shares Outstanding | 17,972,166 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 39.7 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 19,186,036 | $ 22,416,040 |
Marketable securities | 14,129,723 | 38,658,933 |
Accounts receivable | 10,385 | 12,181 |
Inventory | 431,891 | 454,132 |
Prepaid expenses and other current assets | 777,102 | 925,983 |
Total current assets | 34,535,137 | 62,467,269 |
Property and equipment, net | 331,040 | 556,315 |
Other assets | 0 | 64,800 |
Restricted cash | 126,595 | 126,595 |
Total assets | 34,992,772 | 63,214,979 |
Current liabilities: | ||
Accounts payable | 2,004,440 | 1,192,183 |
Accrued expenses and other current liabilities | 3,712,221 | 2,587,573 |
Deferred revenue | 72,188 | 88,344 |
Deferred rent, current portion | 58,821 | 21,095 |
Total current liabilities | 5,847,670 | 3,889,195 |
Deferred rent, net of current portion | 39,214 | 8,398 |
Total liabilities | 5,886,884 | 3,897,593 |
Stockholders' equity: | ||
Preferred stock, $0.0001 par value; 10,000,000 shares authorized at December 31, 2017 and December 31, 2016; none issued or outstanding at December 31, 2017 and December 31, 2016 | 0 | 0 |
Common stock, $0.0001 par value; 100,000,000 shares authorized at December 31, 2017 and December 31, 2016, 17,972,166 and 17,970,590 shares issued at December 31, 2017 and December 31, 2016, respectively, and 17,797,178 and 16,773,798 shares outstanding at December 31, 2017 and December 31, 2016, respectively | 1,780 | 1,678 |
Additional paid-in capital | 140,184,630 | 135,962,935 |
Accumulated other comprehensive loss | (1,247) | (1,614) |
Accumulated deficit | (111,079,275) | (76,645,613) |
Total stockholders' equity | 29,105,888 | 59,317,386 |
Total liabilities and stockholders' equity | $ 34,992,772 | $ 63,214,979 |
CONSOLIDATED BALANCE SHEET (PAR
CONSOLIDATED BALANCE SHEET (PARENTHETICAL) - $ / shares | Dec. 31, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Preferred stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 |
Preferred stock, authorized (shares) | 10,000,000 | 10,000,000 |
Preferred stock, issued (shares) | 0 | 0 |
Preferred stock, shares outstanding (shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized (shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (shares) | 17,972,166 | 17,970,590 |
Common stock, shares outstanding (shares) | 17,797,178 | 16,773,798 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Income Statement [Abstract] | |||
Net product revenue | $ 1,260,973 | $ 989,918 | $ 0 |
Other revenue | 13,526 | 20,745 | 0 |
Total revenue | 1,274,499 | 1,010,663 | 0 |
Costs and expenses: | |||
Cost of product revenue | 506,530 | 662,747 | 0 |
Research and development | 16,989,911 | 20,378,161 | 12,749,379 |
Selling, general and administrative | 18,503,684 | 19,855,987 | 16,464,279 |
Total costs and expenses | 36,000,125 | 40,896,895 | 29,213,658 |
Loss from operations | (34,725,626) | (39,886,232) | (29,213,658) |
Interest income, net | 291,964 | 393,109 | 72,028 |
Net loss | (34,433,662) | (39,493,123) | (29,141,630) |
Net loss attributable to common stockholders | $ (34,433,662) | $ (39,493,123) | $ (29,141,630) |
Net loss per share attributable to common stockholders - basic and diluted (in usd per share) | $ (1.99) | $ (2.43) | $ (2.08) |
Weighted-average number of common shares outstanding — basic and diluted (shares) | 17,260,626 | 16,233,985 | 14,032,916 |
CONSOLIDATED STATEMENTS OF COMP
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Statement of Comprehensive Income [Abstract] | |||
Net loss | $ (34,433,662) | $ (39,493,123) | $ (29,141,630) |
Other Comprehensive gain (loss): | |||
Unrealized gain (loss) on available-for-sale securities | 367 | 23,040 | (24,654) |
Comprehensive loss | $ (34,433,295) | $ (39,470,083) | $ (29,166,284) |
CONSOLIDATED STATEMENTS OF CONV
CONSOLIDATED STATEMENTS OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY - USD ($) | Total | Preferred Stock | Common Stock | Additional Paid-In Capital | Accumulated Other Comprehensive Loss | Accumulated Deficit | Series A Preferred Stock | Series A Preferred StockPreferred Stock | Series A Preferred StockCommon Stock | Series A Preferred StockAdditional Paid-In Capital | Series B Preferred Stock | Series B Preferred StockPreferred Stock | Series B Preferred StockCommon Stock | Series B Preferred StockAdditional Paid-In Capital |
Preferred stock, shares outstanding, beginning balance at Dec. 31, 2014 | 0 | 15,775,221 | 14,078,647 | |||||||||||
Equity, beginning balance at Dec. 31, 2014 | $ (6,538,340) | $ 0 | $ 221 | $ 1,472,299 | $ 0 | $ (8,010,860) | $ 15,637,032 | $ 25,394,135 | ||||||
Common stock, shares outstanding, beginning balance at Dec. 31, 2014 | 2,215,711 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Conversion of preferred stock to common stock (shares) | (15,775,221) | 3,683,637 | (14,078,647) | 3,287,471 | ||||||||||
Conversion of preferred stock to common stock | $ 15,637,032 | $ (15,637,032) | $ 368 | $ 15,636,664 | $ 25,394,135 | $ (25,394,135) | $ 329 | $ 25,393,806 | ||||||
Issuance of stock/IPO proceeds, net of issuance costs (shares) | 5,491,191 | |||||||||||||
Issuance of stock/IPO proceeds, net of issuance costs | 79,860,185 | $ 549 | 79,859,636 | |||||||||||
Vesting of restricted common stock (shares) | 1,016,328 | |||||||||||||
Vesting of restricted common stock | $ 0 | $ 102 | (102) | |||||||||||
Issuance of common stock from option exercises (shares) | 47,280 | 47,280 | ||||||||||||
Issuance of common stock from option exercises | $ 408,321 | $ 5 | 408,316 | |||||||||||
Stock-based compensation expense | 6,597,359 | 6,597,359 | ||||||||||||
Unrealized gain (loss) on available-for-sale securities | (24,654) | (24,654) | ||||||||||||
Net loss | (29,141,630) | (29,141,630) | ||||||||||||
Preferred stock, shares outstanding, ending balance at Dec. 31, 2015 | 0 | 0 | 0 | |||||||||||
Equity, ending balance at Dec. 31, 2015 | 92,192,408 | $ 0 | $ 1,574 | 129,367,978 | (24,654) | (37,152,490) | $ 0 | $ 0 | ||||||
Common stock, shares outstanding, ending balance at Dec. 31, 2015 | 15,741,618 | |||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Vesting of restricted common stock (shares) | 1,023,664 | |||||||||||||
Vesting of restricted common stock | $ 0 | $ 102 | (102) | |||||||||||
Issuance of common stock from option exercises (shares) | 8,516 | 8,516 | ||||||||||||
Issuance of common stock from option exercises | $ 22,098 | $ 2 | 22,096 | |||||||||||
Stock-based compensation expense | 6,572,963 | 6,572,963 | ||||||||||||
Unrealized gain (loss) on available-for-sale securities | 23,040 | 23,040 | ||||||||||||
Net loss | $ (39,493,123) | (39,493,123) | ||||||||||||
Preferred stock, shares outstanding, ending balance at Dec. 31, 2016 | 0 | 0 | 0 | 0 | ||||||||||
Equity, ending balance at Dec. 31, 2016 | $ 59,317,386 | $ 0 | $ 1,678 | 135,962,935 | (1,614) | (76,645,613) | $ 0 | $ 0 | ||||||
Common stock, shares outstanding, ending balance at Dec. 31, 2016 | 16,773,798 | 16,773,798 | ||||||||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||||||||
Issuance of stock/IPO proceeds, net of issuance costs (shares) | 0 | |||||||||||||
Vesting of restricted common stock (shares) | 1,021,804 | |||||||||||||
Vesting of restricted common stock | $ 0 | $ 102 | (102) | |||||||||||
Issuance of common stock from option exercises (shares) | 1,576 | 1,576 | ||||||||||||
Issuance of common stock from option exercises | $ 2,632 | $ 0 | 2,632 | |||||||||||
Stock-based compensation expense | 4,219,165 | 4,219,165 | ||||||||||||
Unrealized gain (loss) on available-for-sale securities | 367 | 367 | ||||||||||||
Net loss | $ (34,433,662) | (34,433,662) | ||||||||||||
Preferred stock, shares outstanding, ending balance at Dec. 31, 2017 | 0 | 0 | 0 | 0 | ||||||||||
Equity, ending balance at Dec. 31, 2017 | $ 29,105,888 | $ 0 | $ 1,780 | $ 140,184,630 | $ (1,247) | $ (111,079,275) | $ 0 | $ 0 | ||||||
Common stock, shares outstanding, ending balance at Dec. 31, 2017 | 17,797,178 | 17,797,178 |
CONSOLIDATED STATEMENT OF CONVE
CONSOLIDATED STATEMENT OF CONVERTIBLE PREFERRED STOCK AND STOCKHOLDERS' EQUITY (PARENTHETICAL) | 12 Months Ended |
Dec. 31, 2015USD ($) | |
Statement of Stockholders' Equity [Abstract] | |
Issuance costs | $ 7,998,871 |
CONSOLIDATED STATEMENT OF CASH
CONSOLIDATED STATEMENT OF CASH FLOWS - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Operating activities | |||
Net loss | $ (34,433,662) | $ (39,493,123) | $ (29,141,630) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation expense | 324,548 | 277,231 | 49,881 |
Stock-based compensation expense | 4,219,165 | 6,572,963 | 6,597,359 |
Amortization and accretion on investments | (68,139) | 16,161 | 9,523 |
Other non-cash items | 1,781 | 3,434 | 4,123 |
Changes in operating assets and liabilities: | |||
Restricted cash | 0 | 240 | (27) |
Accounts receivable | 1,796 | (12,181) | 0 |
Inventory | 22,241 | (454,132) | 0 |
Prepaid expenses and other current assets | 148,881 | (17,409) | (538,178) |
Other assets | 64,800 | (64,800) | 100,103 |
Accounts payable | 819,357 | 309,437 | 621,393 |
Accrued expenses and other current liabilities | 1,124,648 | 746,879 | 1,570,216 |
Deferred revenue | (16,156) | 88,344 | 0 |
Deferred rent | 68,542 | (9,475) | (18,881) |
Other long term liabilities | 0 | (15,442) | 0 |
Net cash used in operating activities | (27,722,198) | (32,051,873) | (20,746,118) |
Investing activities | |||
Purchases of marketable securities | (32,987,697) | (38,682,081) | (39,397,769) |
Proceeds from maturities and sales of marketable securities | 57,585,413 | 26,995,324 | 12,398,295 |
Purchases of property and equipment | (113,498) | (559,378) | (265,617) |
Proceeds from sales of property and equipment | 5,344 | 5,255 | 0 |
Net cash provided by (used in) investing activities | 24,489,562 | (12,240,880) | (27,265,091) |
Financing activities | |||
Proceeds from initial public offering, net of offering costs | 0 | 0 | 80,435,430 |
Proceeds from exercise of common stock | 2,632 | 22,098 | 8,321 |
Proceeds from early exercise of common stock | 0 | 0 | 400,000 |
Net cash provided by financing activities | 2,632 | 22,098 | 80,843,751 |
Net (decrease) increase in cash and cash equivalents | (3,230,004) | (44,270,655) | 32,832,542 |
Cash and cash equivalents at beginning of period | 22,416,040 | 66,686,695 | 33,854,153 |
Cash and cash equivalents at end of period | 19,186,036 | 22,416,040 | 66,686,695 |
Supplemental cash flow information | |||
Property and equipment purchases included in accounts payable and accrued expense | 0 | 7,100 | 106,680 |
IPO issuance costs paid in cash through December 31, 2014 | $ 0 | $ 0 | $ 575,245 |
Organization and operations
Organization and operations | 12 Months Ended |
Dec. 31, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and operations | Organization and operations The Company Flex Pharma, Inc. (the "Company") is a biotechnology company that is developing innovative and proprietary treatments for muscle cramps, spasms and spasticity associated with severe neurological conditions and exercise-associated muscle cramps. The Company's lead drug product candidate, FLX-787, is currently being studied in an exploratory Phase 2 clinical trial in Australia in patients with multiple sclerosis, or MS, and in two Phase 2 clinical trials in the United States. One Phase 2 clinical trial in the United States is in patients with motor neuron disease, or MND, primarily with amyotrophic lateral sclerosis, or ALS, who suffer from muscle cramps. FLX-787 is being developed for ALS under fast track designation which was granted by the Food and Drug Administration in July 2017. The other Phase 2 clinical trial in the United States is in patients with Charcot-Marie-Tooth disease, or CMT, who suffer from muscle cramps. In 2016, the Company launched its consumer product, HOTSHOT ® , to prevent and treat exercise-associated muscle cramps. FLX-787, HOTSHOT and the Company's other drug product candidates are based on a mechanism of action the Company describes as chemical neurostimulation. The Company believes chemical neurostimulation to be a process in which a molecule, such as FLX-787, acts topically on the surfaces of the mouth, throat, esophagus and stomach to produce a sensory signal by activating nerves in those tissues. That signal is thought to ultimately result in a beneficial effect. Specifically, the Company's product candidates activate certain receptors known as transient receptor potential ion channels in primary sensory neurons producing a signal believed to inhibit neuronal circuits and thereby reduce hyperexcitability in the neurons that fire muscles. Reduced alpha-motor neuron hyperexcitability in spinal cord circuits is thought to suppress repetitive firing of alpha-motor neurons, thereby preventing or reducing muscle cramps and spasms, and potentially reducing reflex hyperexcitability and therefore spasticity. The Company operates as two reportable segments, Consumer Operations and Drug Development. See Note 15 for additional discussion and information on the Company's reportable segments. The Company is subject to risks common to companies in the biotechnology and consumer products industries, including, but not limited to, risks of failure of pre-clinical studies and clinical trials, the need to obtain marketing approval for its drug product candidates, the need to successfully commercialize and gain market acceptance of its drug product candidates and its consumer products, dependence on key personnel, protection of proprietary technology, compliance with government regulations and development by competitors of alternative products. In February 2015, the Company sold 5,491,191 shares of common stock (inclusive of 91,191 shares of common stock sold by the Company pursuant to the exercise of an overallotment option granted to the underwriters in connection with the offering) through an underwritten initial public offering ("IPO") at a price of $16.00 per share. The aggregate net proceeds received by the Company from the offering were approximately $79,900,000 , after deducting underwriting discounts and commissions and offering expenses payable by the Company of approximately $8,000,000 (See Note 2). Liquidity The Company has incurred an accumulated deficit of $111,079,275 from February 26, 2014 (inception) through December 31, 2017 , and will require substantial additional capital to fund its research and development and expenses related to its consumer brand and HOTSHOT. The Company had cash, cash equivalents and marketable securities of $33,315,759 at December 31, 2017 . The Company's operating plan assumes: (1) the efforts of the Company's Drug Development segment are focused on the support and completion of current clinical trials; (2) reduced spending, compared to the prior year, by the Consumer Operations segment, including reduced marketing spend; and (3) limited headcount additions and corporate expenditures. Based on the Company's implemented operating plan, the Company believes that its existing cash, cash equivalents and marketable securities will be sufficient to allow the Company to fund its current operating plan for at least 12 months from the date the financial statements are issued. Management expects the Company to incur a loss for the foreseeable future. The Company's ability to achieve profitability in the future is dependent upon the successful development, approval and commercialization of its drug product candidates, and achieving a level of revenues adequate to support the Company's cost structure. The Company may never achieve profitability, and unless and until it does, the Company will continue to need to raise additional capital. Management intends to fund future operations through additional private or public debt or equity offerings, and may seek additional capital through arrangements with collaborators or from other sources. There can be no assurances, however, that additional funding will be available on terms acceptable to the Company, or at all. If the Company is unable to raise additional capital in sufficient amounts or on acceptable terms, the Company may have to significantly delay, scale back or discontinue the development or commercialization of one or more of it’s drug product candidates or sell or license assets in the Drug Development and Consumer Operations segments. |
Summary of significant accounti
Summary of significant accounting policies | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of significant accounting policies | Summary of significant accounting policies Basis of presentation and use of estimates The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP"). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company's management evaluates its estimates, which include, but are not limited to, estimates related to inventory write-offs, clinical study accruals, stock-based compensation expense, and amounts of expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Prior to the Company's IPO, the Company utilized significant estimates and assumptions in determining the fair value of its common stock. The Company utilized various valuation methodologies in accordance with the framework of the 2004 and 2013 American Institute of Certified Public Accountants Technical Practice Aids, Valuation of Privately-Held Company Equity Securities Issued as Compensation , to estimate the fair value of its common stock. Each valuation methodology included estimates and assumptions that required the Company's judgment. These estimates and assumptions included a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to the Company's common stock at the time and the likelihood of achieving a liquidity event, such as an initial public offering or a sale of the Company. Significant changes to the key assumptions used in the valuations could have resulted in different fair values of common stock at each valuation date and may have materially affected the financial statements. Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: TK Pharma, Inc., a Massachusetts Securities Corporation, and Flex Innovation Group LLC, a Delaware limited liability company, which contains the Company's consumer-related operations. All significant intercompany balances and transactions have been eliminated in consolidation. Concentration of risk The Company outsources the manufacture of HOTSHOT to a single co-packer that produces bottled finished goods. The Company also sources certain raw materials from sole suppliers. A disruption in the supply of materials or the production of finished goods could significantly impact the Company's revenues in the future as alternative sources of raw materials and co-packing may not be available at commercially reasonable rates or within a reasonably short period of time. Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company and the Company's chief operating decision maker, the Company's Chief Executive Officer, view the Company's operations and manage its business as two operating segments, Drug Development and Consumer Operations (see Note 15). The Company operates in one geographic segment, the United States. Concentrations of credit risk and off-balance sheet risk Cash, cash equivalents and marketable securities are financial instruments that potentially subject the Company to concentrations of credit risk. The Company's cash, cash equivalents and marketable securities are held in accounts at financial institutions that management believes are creditworthy. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no financial instruments with off-balance sheet risk of loss. Revenue Revenue is comprised of net product revenue and other revenue. Net product revenue includes sales of HOTSHOT finished goods to e-commerce customers, specialty retailers and sports teams. Other revenue consists of payments made by customers for expedited shipping and handling, which the Company began offering during the third quarter of 2016. Revenue is recognized when persuasive evidence of an arrangement exists, delivery of the product has occurred, the sales price is fixed or determinable and collectibility is reasonably assured. For sales through September 30, 2016, the Company issued refunds to e-commerce customers, upon request, within 21 days of shipment. When the Company began selling HOTSHOT on a third-party e-commerce website in October 2016, the refund period and related deferral period increased, as the Company began offering refunds to e-commerce customers, upon request, within 30 days of delivery, for purchases subsequent to September 30, 2016. As the Company currently does not have adequate history to accurately estimate refunds, all e-commerce sales, and their related costs, are deferred and revenue is recognized once the refund period lapses. This deferral represents total deferred revenue presented on the Company's consolidated balance sheet. For specialty retailers and sports teams, the Company does not offer a right of return or refund and revenue is recognized at the time products are delivered to customers. Discounts provided to customers are accounted for as a reduction of product revenue, and were approximately $278,000 and $135,000 for the years ended December 31, 2017 and December 31, 2016 , respectively. There were no such discounts in 2015 as the Company had not yet launched HOTSHOT. Net product revenue and other revenue are presented net of taxes collected from customers and remitted to governmental authorities. The Company had no customers that represented greater than 10% of total revenue during the year ended December 31, 2017 or during the year ended December 31, 2016. All revenue was generated from sales within the United States. Accounts receivable and allowance for doubtful accounts Accounts receivable are stated at their carrying values, net of any allowances for doubtful accounts. Accounts receivable consist primarily of amounts due from specialty retailers and sports teams, for which collectibility is reasonably assured. Receivables are evaluated for collectibility on a regular basis and an allowance for doubtful accounts is recorded, if necessary. No allowance for doubtful accounts was deemed necessary at December 31, 2017 and December 31, 2016. Cost of product revenue Cost of product revenue includes the cost of raw materials utilized to produce HOTSHOT, co-packing fees, repacking fees, in-bound freight charges and warehouse and transportation costs incurred to bring HOTSHOT finished goods to salable condition. All other costs incurred after this condition is met are considered selling costs and included in selling, general and administrative expenses. Cost of product revenue also includes write-offs for inventory that has become obsolete, has a cost basis in excess of its estimated realizable value, or exceeds projected sales, as well as depreciation expense related to manufacturing equipment purchased to support production and royalty amounts payable to certain of the Company's founders on HOTSHOT sales. Inventory The Company launched HOTSHOT in the second quarter of 2016 and began capitalizing inventory costs associated with HOTSHOT in the first quarter of 2016, when it was determined that the inventory costs had probable future economic benefit. Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out ("FIFO") basis. The Company outsources the manufacture of HOTSHOT to a co-packer. Inventory at December 31, 2017 includes raw materials available for future production runs, as well as finished goods. The Company periodically analyzes its inventory levels and writes down inventory that has become obsolete, has a cost basis in excess of its estimated realizable value, or exceeds projected sales. Estimates of excess inventory consider factors such as inventory levels, production requirements, projected sales and the estimated shelf-lives of inventory components. Inventory write-offs are recorded as a component of cost of product revenue. Advertising expense Advertising expense consists of media and production costs related to print and digital advertising. All advertising is expensed as incurred. Total advertising expenses are included in selling, general and administrative and were approximately $3,566,000 and $2,936,000 for the years ended December 31, 2017 and December 31, 2016 , respectively. There were no such costs in 2015 as the Company had not yet launched HOTSHOT. Shipping and handling costs Shipping and handling costs related to the movement of inventory to the Company's co-packer and from the co-packer to the Company's third-party warehousing and fulfillment partners is capitalized as inventory and expensed as a cost of product revenue when revenue is recognized. Shipping and handling costs to move finished goods from the Company's warehousing and third-party fulfillment partners to customer locations are included in selling, general and administrative expense in the consolidated statement of operations, and were approximately $261,000 and $170,000 for the years ended December 31, 2017 and December 31, 2016 , respectively. There were no such costs in 2015 as the Company had not yet launched HOTSHOT. Property and equipment Property and equipment is stated at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred, while costs of major additions and betterments are capitalized. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss is included in the results of operations. Depreciation is recorded, once assets are placed in service, using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Asset type Estimated useful life Computers and computer equipment 3 years Laboratory equipment 3 years Manufacturing equipment 3 years Website development costs 1-2 years Impairment of long-lived assets The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value. The Company has not recognized any impairment losses through December 31, 2017 . Research and development expense Research and development costs are charged to expense as incurred in performing research and development activities. The costs include employee compensation costs, clinical study costs, external consultant costs, regulatory costs and facilities and overhead costs. Facilities and overhead costs primarily include the allocation of insurance, rent, utility and office-related expenses attributable to research and development personnel. The Company records payments made to outside vendors in advance of services performed or goods being delivered for use in research and development activities as prepaid expenses, which are expensed as services are performed or goods are delivered. Stock-based compensation expense The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation-Stock Compensation ("ASC 718"). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the statement of operations based on their grant date fair values. Compensation expense related to awards to employees with service conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to employees with performance conditions is recognized based on grant date fair value over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting date. The Company accounts for stock-based compensation arrangements with non-employees based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable, in accordance with the provisions of FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees . The measurement date for non-employee awards is generally the date performance of services required from the non-employee is complete, resulting in periodic adjustments to stock-based compensation expense during the vesting period for changes in the fair value of the awards. Stock-based compensation costs for non-employee service awards are recognized as services are provided, which is generally the vesting period, on a straight-line basis. The unvested portion of the awards is subject to re-measurement over the vesting period. The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the estimated fair value of the Company's common stock on the measurement date. Due to the lack of significant trading history for the Company's common stock, it has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the volatility for the selected companies' shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options using the "simplified" method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid, and does not expect to pay dividends in the foreseeable future. Prior to adoption of ASU No. 2016-09 Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting , share-based compensation expense was recognized net of estimated forfeitures, such that expense was recognized only for share-based awards that were expected to vest. A forfeiture rate was estimated annually and revised, if necessary, in subsequent periods if actual forfeitures differed from initial estimates. Upon adoption of ASU No. 2016-09 on January 1, 2017, the Company no longer applies a forfeiture rate and instead accounts for forfeitures as they occur. Income taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company has evaluated available evidence and concluded that the Company may not realize the benefit of its deferred tax assets; therefore a valuation allowance has been established for the full amount of the deferred tax assets. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2017 and December 31, 2016 , the Company did not have any significant uncertain tax positions. The Company's practice is to recognize interest and/or penalties related to income tax matters in income tax expense. Net loss per share attributable to common stockholders Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period, determined using the treasury stock method and the if-converted method, for convertible securities, if inclusion of these is dilutive. For years ended December 31, 2017 , December 31, 2016 and December 31, 2015 , the Company has excluded the effects of all potentially dilutive shares from the weighted-average number of common shares outstanding as their inclusion in the computation for each period would be anti-dilutive due to the net loss per share incurred by the Company. Comprehensive loss Comprehensive loss is the change in equity of a company during a period from transactions and other events and circumstances, excluding transactions resulting from investments by owners and distributions to owners. Comprehensive loss includes net loss and the change in accumulated other comprehensive loss for the period. Accumulated other comprehensive loss consisted entirely of unrealized gains and losses on available-for-sale marketable securities for the years ended December 31, 2017 , December 31, 2016 and December 31, 2015 . See the consolidated statements of comprehensive loss for relevant disclosures. The following tables summarize the changes in accumulated other comprehensive loss during the years ended December 31, 2017 , December 31, 2016 and December 31, 2015 . Balance as of December 31, 2016 $ (1,614 ) Other comprehensive gain 367 Balance as of December 31, 2017 $ (1,247 ) Balance as of December 31, 2015 $ (24,654 ) Other comprehensive gain 23,040 Balance as of December 31, 2016 $ (1,614 ) Balance as of December 31, 2014 $ — Other comprehensive loss (24,654 ) Balance as of December 31, 2015 $ (24,654 ) Recent accounting pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) . The ASU provides for a single comprehensive model for use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning after December 15, 2016 with no early adoption permitted. In July 2015, the FASB deferred the effective date of this accounting update to annual periods beginning after December 15, 2017, along with an option to permit early adoption as of the original effective date. The Company is required to adopt the standard in the ASU using one of two acceptable methods: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers, Principal versus Agent Considerations (Reporting Revenue Gross versus Net), clarifying the implementation guidance on principal versus agent considerations. Specifically, an entity is required to determine whether the nature of a promise is to provide the specified good or service itself (that is, the entity is a principal) or to arrange for the good or service to be provided to the customer by the other party (that is, the entity is an agent). The determination influences the timing and amount of revenue recognition. The effective date and transition requirements for ASU No. 2016-08 are the same as the effective date and transition requirements for ASU No. 2014-09. The Company has evaluated the adoption impact of the guidance related to the Company's sales of HOTSHOT. Based on evaluation of the Company's revenue streams, the Company has determined that the timing of recognition for e-commerce sales will change by an immaterial amount, due to e-commerce refund rights. Through December 31, 2017 and prior to adoption of the new standard, since the Company does not have an adequate history to accurately estimate refunds, all e-commerce sales and related costs have been deferred and recognized once the refund period lapses. Under the new standard, the Company will estimate the amount of potential refunds and may recognize revenue related to some of these sales earlier if it is probable that a significant revenue reversal will not occur. Adoption will not have a significant impact on revenue recognition for the company's specialty retail or sports team channels, as no right of refund or return exists. The guidance is not expected to have a material impact to the consolidated statements of operations or balance sheets in any prior or prospective reporting period. The Company has finalized its accounting policy, and has designed and implemented necessary changes to processes and controls to allow for proper recognition, presentation and disclosure upon adoption effective in the beginning of fiscal year 2018. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330) . This ASU simplifies the measurement of inventory by requiring certain inventory to be measured at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The amendments in this ASU are effective for fiscal years beginning after December 15, 2016 and for interim periods therein. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. The Company adopted this ASU as of March 31, 2017, which did not have a material impact on its condensed consolidated financial statements In February 2016, the FASB issued ASU No. 2016-02, Leases . The ASU requires lessees to recognize the assets and liabilities on their balance sheet for the rights and obligations created by most leases and continue to recognize expenses on their income statements over the lease term. It will also require disclosures designed to give financial statement users information on the amount, timing, and uncertainty of cash flows arising from leases. The guidance is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted. While the Company is currently evaluating the effect this standard will have on its consolidated financial statements and timing of adoption, the Company expects that upon adoption, it will recognize right-of-use assets and lease liabilities and those amounts could be material. The Company is still assessing the expected impact on our consolidated statements of operations and cash flows. In March 2016, the FASB issued ASU No. 2016-09, Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. This ASU simplifies the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The guidance is effective for annual reporting periods beginning after December 15, 2016, and interim periods within those annual periods. The Company adopted the new standard on January 1, 2017 and has elected to account for forfeitures as they occur. The change was applied on a modified retrospective basis with a cumulative effect adjustment to increase retained earnings by approximately $2,000 , as of January 1, 2017. In addition, upon adoption of the new standard, the Company has additional deferred tax assets related to tax deductions from excess tax benefits related to the exercise of stock options. As a result, the deferred tax assets associated with net operating losses increased by approximately $42,000 in the first quarter of 2017. The amounts are offset by a corresponding increase in the valuation allowance. As such, there is no net effect on the Company’s consolidated statements of operations for the twelve months ended December 31, 2017. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments . The update amends the guidance in ASU 230 Statement of Cash Flows, and clarifies how entities should classify certain cash receipts and cash payments on the statement of cash flows with the objective of reducing the existing diversity in practice related to eight specific cash flow issues. The amendments in this update are effective for fiscal years beginning after December 15, 2017, and interim periods within those years. Early adoption is permitted. The Company does not expect the adoption of ASU 2016-15 to have a material impact on its consolidated financial statements. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows , which amends ASU Topic 230. This update requires entities to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows. As a result, entities will no longer be required to present transfers between cash and cash equivalents and restricted cash and restricted cash equivalents in the statement of cash flows. When cash, cash equivalents, restricted cash and restricted cash equivalents are presented in more than one line item on the balance sheet, the new guidance requires a reconciliation of the totals in the statement of cash flows to the related captions in the balance sheet. Entities will also have to disclose the nature of their restricted cash and restricted cash equivalent balances. The guidance is effective for fiscal years beginning after December 15, 2017 and interim periods within those years. Early adoption is permitted. Entities are required to apply the guidance retrospectively. The new guidance will change the presentation of restricted cash in the Company's consolidated financial statements in the first quarter of 2018. In May 2017, the FASB issued ASU 2017-09, Stock Compensation (Topic 718): Scope of Modification Accounting , to provide clarity and reduce diversity in practice, cost and complexity when applying the guidance in Topic 718. The guidance is effective for fiscal years beginning after December 15, 2017 and interim periods within those years. Early adoption is permitted. The Company does not expect the adoption of this guidance to have a material effect on its consolidated financial statements and related disclosures. The Company believes that the impact of other recently issued standards that are not yet effective will not have a material effect on its consolidated financial position or results of operations upon adoption. Initial public offering On February 3, 2015, the Company completed its IPO, whereby the Company sold 5,491,191 shares of its common stock (inclusive of 91,191 shares of common stock sold by the Company pursuant to the exercise of an overallotment option granted to the underwriters in connection with the IPO) at a price of $16.00 per share. The shares began trading on The Nasdaq Global Market on January 29, 2015. The aggregate net proceeds received by the Company from the IPO were approximately $79,900,000 , after deducting underwriting discounts and commissions and other offering expenses payable by the Company. Upon the closing of the IPO, all outstanding shares of convertible preferred stock converted into 6,971,108 shares of common stock. Additionally, the Company is now authorized to issue 100,000,000 shares of common stock. Deferred IPO issuance costs, which primarily consisted of direct incremental legal and accounting fees related to the Company's IPO, were capitalized at December 31, 2014. Upon the closing of the IPO in February 2015, IPO issuance costs of $1,848,737 , as well as underwriting discounts and commissions of $6,150,134 , were offset against the IPO proceeds within additional paid-in capital. Reverse stock split In January 2015, the Company effected a one-for- 4.2825 reverse stock split of its then issued and outstanding common stock. All share and per share amounts related to issued and outstanding common stock and outstanding options exercisable for common stock included in the Company's consolidated financial statements and notes to consolidated financial statements have been retroactively adjusted for all periods presented to reflect the reverse stock split, including reclassifying an amount equal to the reduction in par value of common stock to additional paid-in capital. The conversion ratios of the Company's convertible preferred stock have also been adjusted to reflect the reverse stock split. Subsequent events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements for potential recognition or disclosure in the consolidated financial statements. Subsequent events have been evaluated through the date these consolidated financial statements were issued for potential recognition or disclosure in the consolidated financial statements (see Note 18). |
Restricted cash
Restricted cash | 12 Months Ended |
Dec. 31, 2017 | |
Cash and Cash Equivalents [Abstract] | |
Restricted cash | Restricted cash As of December 31, 2017 and December 31, 2016 , the Company had $126,595 of restricted cash in the form of a letter of credit. The Company maintains this letter of credit as a security deposit on the lease of its office space in Boston, Massachusetts (see Note 9). |
Fair value measurements
Fair value measurements | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair value measurements | Fair value measurements The Company records cash equivalents and marketable securities at fair value. ASC Topic 820, Fair Value Measurements and Disclosures established a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability. Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. The following table summarizes the cash equivalents and marketable securities measured at fair value on a recurring basis as of December 31, 2017 and December 31, 2016 : Level 1 Level 2 Level 3 Balance at December 31, 2017 Cash equivalents $ 5,046,205 $ — $ — $ 5,046,205 Marketable securities: U.S. government agency securities — 8,986,259 — 8,986,259 Commercial paper — 4,440,689 — 4,440,689 Corporate debt securities — 702,775 — 702,775 $ 5,046,205 $ 14,129,723 $ — $ 19,175,928 Level 1 Level 2 Level 3 Balance at December 31, 2016 Cash equivalents $ 11,681,074 $ — $ — $ 11,681,074 Marketable securities: U.S. government agency securities — 31,059,491 — 31,059,491 Commercial paper — 6,081,202 — 6,081,202 Corporate debt securities — 1,518,240 — 1,518,240 $ 11,681,074 $ 38,658,933 $ — $ 50,340,007 Cash equivalents and marketable securities have been initially valued at the transaction price and subsequently valued, at the end of each reporting period, utilizing third-party pricing services or other market observable data. The pricing services utilize industry standard valuation models, including both income and market based approaches and observable market inputs to determine value. The majority of the Company's cash equivalents consist of money market funds that are valued based on publicly available quoted market prices for identical securities as of December 31, 2017 . After completing its validation procedures, the Company did not adjust or override any fair value carrying amounts of as of December 31, 2017 . The carrying amounts reflected in the consolidated balance sheets for cash, accounts receivable, prepaid expenses and other current assets, accounts payable, accrued expenses and other current liabilities approximate their fair values at December 31, 2017 and 2016 , due to their short-term nature. The Company evaluates transfers between levels at the end of each reporting period. There were no transfers of assets or liabilities between Level 1 and Level 2 during the year ended December 31, 2017 or during the year ended December 31, 2016. The Company had no financial assets or liabilities that were classified as Level 3 at any point during the year ended December 31, 2017 or during the year ended December 31, 2016. |
Cash equivalents and marketable
Cash equivalents and marketable securities | 12 Months Ended |
Dec. 31, 2017 | |
Cash and Cash Equivalents [Abstract] | |
Cash equivalents and marketable securities | Cash equivalents and marketable securities The Company considers all highly liquid investments with maturities of three months or less when purchased to be cash equivalents. Cash equivalents as of December 31, 2017 and December 31, 2016 consisted of money market funds. Marketable securities as of December 31, 2017 and December 31, 2016 consisted of corporate debt securities, commercial paper and U.S. government agency securities. Management determines the appropriate classification of the securities at the time they are acquired and evaluates the appropriateness of such classifications at each balance sheet date. The Company classifies its marketable securities as available-for-sale pursuant to ASC 320, Investments – Debt and Equity Securities . Marketable securities are recorded at fair value, with unrealized gains and losses included as a component of accumulated other comprehensive income (loss) in stockholders’ equity and a component of total comprehensive income (loss) in the consolidated statement of comprehensive income (loss), until realized. Realized gains and losses are included in investment income on a specific-identification basis. There were no realized gains on marketable securities during the year ended December 31, 2017 , and there were immaterial realized gains on marketable securities during the year ended December 31, 2016 . The Company reviews marketable securities for other-than-temporary impairment whenever the fair value of a marketable security is less than the amortized cost and evidence indicates that a marketable security’s carrying amount is not recoverable within a reasonable period of time. Other-than-temporary impairments of investments are recognized in the consolidated statement of operations if the Company has experienced a credit loss, has the intent to sell the marketable security, or if it is more likely than not that the Company will be required to sell the marketable security before recovery of the amortized cost basis. Evidence considered in this assessment includes reasons for the impairment, compliance with the Company’s investment policy, the severity and the duration of the impairment and changes in value subsequent to the end of the period. Marketable securities at December 31, 2017 and December 31, 2016 consisted of the following: Amortized Cost Unrealized Gains Unrealized Losses Fair Value As of December 31, 2017 Current (due within 1 year): U.S. government agency securities $ 8,987,254 $ 38 $ (1,033 ) $ 8,986,259 Commercial paper 4,440,689 — — 4,440,689 Corporate debt securities 703,027 — (252 ) 702,775 Total $ 14,130,970 $ 38 $ (1,285 ) $ 14,129,723 Amortized Cost Unrealized Gains Unrealized Losses Fair Value As of December 31, 2016 Current (due within 1 year): U.S. government agency securities $ 31,060,710 $ 2,912 $ (4,131 ) $ 31,059,491 Commercial paper 6,081,202 — — 6,081,202 Corporate debt securities 1,518,635 — (395 ) 1,518,240 Total $ 38,660,547 $ 2,912 $ (4,526 ) $ 38,658,933 The Company held six securities that were in an unrealized loss position at both December 31, 2017 and December 31, 2016 , all of which were in a continuous loss position for less than 12 months. The aggregate fair value of securities in an unrealized loss position was $8,191,315 and $16,519,620 at December 31, 2017 and December 31, 2016 , respectively. There were no individual securities that were in a significant unrealized loss position as of December 31, 2017 or December 31, 2016 . The Company evaluated its securities for other-than-temporary impairment and considered the decline in market value for the securities to be primarily attributable to current economic and market conditions. The Company has the intent and ability to hold such securities until recovery. Based on this analysis, these marketable securities were not considered to be other-than-temporarily impaired as of December 31, 2017 . At December 31, 2017 and December 31, 2016 , all investments held by the Company were classified as current. Investments classified as current have maturities of less than one year. Investments classified as noncurrent are those that (i) have a maturity greater than one year and (ii) management does not intend to liquidate within the next year, although these funds are available for use and therefore classified as available-for-sale. |
Inventory
Inventory | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The Company began capitalizing inventory as of March 31, 2016, when it was determined that the inventory had a probable future economic benefit. Inventory has been recorded at cost as of December 31, 2017 and December 31, 2016 . Costs capitalized at December 31, 2017 and December 31, 2016 relate to HOTSHOT finished goods, as well as raw materials available to be used for future production runs. The following table presents inventory: December 31, 2017 December 31, 2016 Raw materials $ 17,411 $ 19,888 Finished goods 414,480 434,244 Total inventory $ 431,891 $ 454,132 In the second quarter of 2017, the Company completed a production run of HOTSHOT. From the second to fourth quarter of 2017, the Company wrote off materials purchased for production that were not expected to be used in future production runs, as well as expiring finished goods. In 2016, the Company wrote off raw materials purchased for production runs of HOTSHOT that were not expected to be used in future production runs, as well as finished goods not expected to be sold based upon projected sales, estimated product shelf life, the number of units produced and production level requirements. Write-offs totaled approximately $42,000 and $282,000 for the years ended December 31, 2017 and December 31, 2016 , respectively, and are included in cost of product revenue in the accompanying consolidated statement of operations. The cost of product revenue related to deferred revenue is capitalized and recorded as cost of product revenue at the time the revenue is recognized. |
Property and equipment, net
Property and equipment, net | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and equipment, net | Property and equipment, net Property and equipment, net consists of the following: December 31, 2017 December 31, 2016 Manufacturing equipment $ 421,999 $ 421,999 Computers and computer equipment 311,847 276,263 Website development costs 177,886 159,836 Laboratory equipment 13,368 13,368 Capital in progress 28,823 7,863 Total property and equipment 953,923 879,329 Accumulated depreciation (622,883 ) (323,014 ) Property and equipment, net $ 331,040 $ 556,315 Capital in progress consists of assets acquired but not yet placed into service. At December 31, 2017 capital in progress consisted of computers and computer equipment, and at December 31, 2016 capital in progress consisted of computers and website development costs. Depreciation expense was $324,548 , $277,231 and $49,881 for the years ended December 31, 2017 , December 31, 2016 , and December 31, 2015 , respectively. |
Accrued expenses and other curr
Accrued expenses and other current liabilities | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Accrued expenses and other current liabilities | Accrued expenses and other current liabilities Accrued expenses and other current liabilities consist of the following: December 31, 2017 December 31, 2016 Research and development costs $ 2,502,400 $ 938,665 Payroll and employee-related costs 874,246 1,453,665 Professional fees 227,980 153,219 Consumer product-related costs 107,595 42,024 Total $ 3,712,221 $ 2,587,573 |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies Lease commitments On April 29, 2014, the Company leased office space in Boston, Massachusetts that was scheduled to expire on August 31, 2017. In January 2017, the Company signed a lease to extend the use of the same office space from September 1, 2017 to August 31, 2019. Additionally, on October 21, 2014, the Company leased office space in New York, New York under an operating lease that was originally scheduled to expire on October 31, 2018. In March 2017, the Company commenced a plan to transition its consumer operations from New York to Boston. In connection with this transition, the Company terminated its New York office operating lease and was released from any further obligations in July 2017. As of December 31, 2017 , the minimum future lease payments under the Company's Boston operating lease was as follows: 2018 $ 466,593 2019 311,062 Total minimum lease payments $ 777,655 Rent expense is being recognized on a straight-line basis. The Company recorded approximately $522,000 , $337,000 and $253,000 of rent expense for the twelve months ended December 31, 2017 , December 31, 2016 and December 31, 2015 , respectively. Royalty agreement In March 2014, the Company entered into a royalty agreement with certain of its founders. Under the agreement, the Company agreed to pay the founders an aggregate royalty of 2% of gross sales of the Company's products in perpetuity. The Company began incurring royalty expense upon commencement of HOTSHOT sales during the second quarter of 2016. The Company recorded approximately $ 25,000 and $20,000 of royalty expense during the twelve months ended December 31, 2017 and December 31, 2016 , respectively. Royalty amounts owed to the founders as of December 31, 2017 and December 31, 2016 were approximately $ 3,000 and $4,000 . No royalty amounts were owed to the founders as of December 31, 2015. Litigation The Company is not a party to any litigation and does not have contingency reserves established for any litigation liabilities as of December 31, 2017 . |
Convertible preferred stock
Convertible preferred stock | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Convertible preferred stock | Convertible preferred stock As of December 31, 2014, the Company had authorized 16,000,000 shares of Series A convertible preferred stock ("Series A Preferred Stock"), $0.0001 par value per share, for issuance. During March, April and May 2014, the Company issued an aggregate of 15,775,221 shares of Series A Preferred Stock for $1.00 per share, resulting in net proceeds to the Company of $15,637,032 , which was also the carrying value of the Series A Preferred Stock as of December 31, 2014. As of December 31, 2014, the Company had authorized 14,500,000 shares of Series B convertible preferred stock ("Series B Preferred Stock"), $0.0001 par value per share, for issuance. From July to October 2014, the Company issued an aggregate of 14,078,647 shares of Series B Preferred Stock for $1.81 per share, resulting in net proceeds to the Company of $25,394,135 , which was also the carrying value of the Series B Preferred Stock as of December 31, 2014. In conjunction with the Company's IPO in February 2015, all shares of the Series A and Series B Preferred Stock converted into common stock. As of December 31, 2017 , there were no shares of Series A convertible preferred stock or Series B convertible preferred stock authorized. On February 3, 2015, the Company filed an amended and restated certificate of incorporation (the “Restated Certificate”) with the Secretary of State of the State of Delaware in connection with the closing of the Company’s IPO. As of December 31, 2017 , under the Restated Certificate, the Company is authorized to issue 10,000,000 shares of preferred stock ("Preferred Stock") with a par value of $0.0001 per share. The Company has not issued any shares of Preferred Stock as of December 31, 2017 . |
Common stock
Common stock | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Common stock | Common stock As of December 31, 2017 , the Company had authorized 100,000,000 shares of common stock, $0.0001 par value per share. Each share of common stock is entitled to one vote. The holders of common stock are also entitled to receive dividends whenever funds are legally available and when declared by the board of directors. The Company does not intend to declare dividends for the foreseeable future. Restricted common stock to founders In March 2014, the Company sold 4,553,415 shares of restricted common stock to the founders of the Company ("recipients"), for $0.0004 per share, for total proceeds of $1,950 . In April 2014, based upon anti-dilution provisions granted to the founders, an additional 867,314 shares of restricted common stock were sold to the same founders, after which the anti-dilution provisions were terminated. The restricted common stock vested 25% upon issuance, and the remaining 75% vests ratably over four years , during which time the Company has the right to repurchase the unvested shares held by a recipient if the relationship between such recipient and the Company ceases. If the relationship terminates, the Company has 90 days to repurchase unvested shares at $0.0004 . Such shares are not accounted for as outstanding until they vest. There were 5,251,075 shares of restricted common stock outstanding as of December 31, 2017 . Unvested restricted common stock awards to non-employees are re-measured at each vest date and each financial reporting date. The following is a summary of restricted common stock activity: Number of Shares Weighted-Average Grant Date Fair Value Unvested at December 31, 2016 1,185,958 $ 0.10 Issued — — Vested (1,016,304 ) 0.10 Forfeited — — Unvested at December 31, 2017 169,654 $ 0.10 The total fair value of shares vested during the twelve months ended 2017 , 2016 and 2015 was approximately $3,840,000 , $9,646,000 and $15,616,000 respectively. Restricted common stock to consultants There were no shares of restricted common stock granted to non-employee consultants and advisors during 2017 or 2015 . During 2016 , the Company granted a total of 18,194 of shares of restricted common stock to non-employee consultants and advisors. Such shares are not accounted for as outstanding until they vest. There were 12,860 shares of restricted common stock issued to consultants outstanding as of December 31, 2017 . Unvested restricted common stock awards to non-employees are re-measured at each vest date and each financial reporting date. The following is a summary of restricted common stock activity: Number of Shares Weighted-Average Grant Date Fair Value Unvested at December 31, 2016 10,834 $ 9.72 Issued — — Vested (5,500 ) 8.95 Forfeited — — Unvested at December 31, 2017 5,334 $ 10.51 The total fair value of shares vested during the twelve months ended 2017 and 2016 was approximately $22,000 and $71,000 , respectively. No shares were issued to consultants during the twelve months ended December 31, 2015 . Employee stock purchase plan In 2015, the Company's Board of Directors adopted, and the Company's stockholders approved, the 2015 Employee Stock Purchase Plan (the "ESPP"). As of the December 31, 2017 , no shares of common stock have been purchased under the ESPP. Shares reserved for future issuance The Company has reserved the following number of shares of common stock for future issuance: As of December 31, 2017 2016 Stock-based compensation awards 3,439,820 2,722,573 Vesting of restricted common stock 174,988 1,196,792 Employee stock purchase plan 534,274 354,569 Total 4,149,082 4,273,934 |
Stock-based compensation
Stock-based compensation | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based compensation | Stock-based compensation In March 2014, the Company adopted the Flex Pharma, Inc. 2014 Equity Incentive Plan (the "2014 Plan"), under which it had the ability to grant incentive stock options ("ISOs"), non-qualified stock options, restricted stock awards, restricted stock units and stock appreciation rights to purchase up to 116,754 shares of common stock. In April 2014, the Company amended the 2014 Plan to reserve for the issuance of up to 1,451,087 shares of common stock pursuant to equity awards. In September 2014, the Company further amended the 2014 Plan to reserve for the issuance of up to 2,070,200 shares of common stock pursuant to equity awards. Terms of stock award agreements, including vesting requirements, were determined by the board of directors, subject to the provisions of the 2014 Plan. For options granted under the 2014 Plan, the exercise price equaled the fair market value of the common stock as determined by the board of directors on the date of grant. No further awards will be granted under the 2014 Plan. In January 2015, the Company's board of directors adopted, and the Company's stockholders approved, the 2015 Equity Incentive Plan (the "2015 Plan"), which became effective immediately prior to the closing of the Company's IPO. The 2015 Plan provides for the grant of ISOs, nonstatutory stock options, restricted stock awards, restricted stock units, stock appreciation rights, performance-based stock awards and other stock-based awards. Additionally, the 2015 Plan provides for the grant of performance-based cash awards. ISOs may be granted only to the Company's employees. All other awards may be granted to the Company's employees, including officers, and to non-employee directors and consultants. As of December 31, 2017 , there were 859,329 shares remaining available for the grant of stock awards under the 2015 Plan. There were no stock options issued to non-employee consultants or members of the Scientific Advisory Board during 2017 . During 2016 and 2015 , the Company granted a total of 14,670 and 10,507 , respectively, of stock options to non-employee consultants and members of its Scientific Advisory Board. The options generally vest over a four -year period, and have a contractual term of ten years . The total stock-based compensation expense related to all non-employee stock options for the year ended December 31, 2017 , December 31, 2016 and December 31, 2015 was approximately $201,000 , $370,000 and $ 517,000 , respectively. The Company has awarded stock options to its employees, directors, advisors and consultants, pursuant to the plans described above. Stock options subsequent to the completion of the Company's IPO are granted with an exercise price equal to the closing market price of the Company's common stock on the date of grant. Stock options generally vest over one to four years and have a contractual term of ten years. Stock options are valued using the Black-Scholes option pricing model and compensation cost is recognized based on the resulting value over the service period. Unvested awards to non-employees are re-measured at each vest date and at each financial reporting date. The following table summarizes stock option activity for employees and non-employees for the twelve months ended December 31, 2017 : Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at December 31, 2016 2,156,250 $ 8.66 7.94 $ 1,605,684 Granted 1,059,500 4.20 Exercised (1,576 ) 1.67 Forfeited (418,642 ) 8.87 Expired (215,041 ) 10.51 Outstanding at December 31, 2017 2,580,491 $ 6.65 7.55 $ 803,600 Exercisable at December 31, 2017 1,404,844 $ 7.21 6.56 $ 692,232 Vested or expected to vest at December 31, 2017 2,580,491 $ 6.65 7.55 $ 803,600 During 2017 , 2016 and 2015 , the Company granted stock options to purchase an aggregate of 1,059,500 , 763,320 , and 994,748 shares of its common stock, respectively. The weighted-average grant date fair value of option awards granted during 2017 , 2016 and 2015 were $2.80 , $6.35 , and $8.55 , respectively. The number of stock options exercised during 2017 , 2016 and 2015 were 1,576 , 8,516 , and 47,280 , respectively. The weighted-average exercise price of options exercised during 2017 , 2016 and 2015 was $1.67 , $2.59 , and $8.63 , respectively. The total intrinsic value of options exercised during 2017 , 2016 and 2015 was $2,606 , $64,302 , and $149,386 , respectively. The intrinsic value is calculated as the difference between the fair value of the Company's common stock and the exercise price of the options at the date of exercise. The Company estimates the fair value of each stock option award on the grant date using the Black-Scholes option-pricing model based on the following assumptions regarding the fair value of the underlying Common Stock on each measurement date: Year Ended December 31, 2017 Year Ended December 31, 2016 Year Ended December 31, 2015 Expected volatility 73.87% to 81.04% 71.01% to 74.20% 72.98% to 74.94% Risk-free interest rate 1.83% to 2.40% 1.23% to 2.40% 1.62% to 2.49% Expected term 5.3 - 9.5 years 5.3 - 10 years 5.3 - 10 years Expected dividend yield 0 % 0 % 0 % Total stock-based compensation expense recognized for employee and non-employee restricted common stock, and stock options granted to employees and non-employees is included in the Company's consolidated statements of operations and comprehensive loss as follows: Year Ended December 31, 2017 Year Ended December 31, 2016 Year Ended December 31, 2015 Research and development $ 1,545,737 $ 2,435,565 $ 3,192,063 Selling, general and administrative 2,673,428 4,137,398 3,405,296 Total $ 4,219,165 $ 6,572,963 $ 6,597,359 Selling, general and administrative expense for the year ended December 31, 2016 included $285,000 related to stock options that were modified in connection with an employee termination agreement. As of December 31, 2017 , there was approximately $4,533,000 of total unrecognized compensation cost related to unvested equity awards. Total unrecognized compensation cost will be adjusted for the re-measurement of non-employee awards as well as future changes in employee and non-employee forfeitures, if any. The Company expects to recognize that cost over a remaining weighted-average period of 2.26 years . |
Income taxes
Income taxes | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Income taxes | Income taxes For the years ended December 31, 2017 , December 31, 2016 and December 31, 2015 , the Company did not record a current or deferred income tax provision or benefit. The Company's losses before income taxes for the periods presented consisted solely of domestic losses. On December 22, 2017, the President of the United States signed into law the Tax Cuts and Jobs Act tax reform legislation. This legislation makes significant changes in U.S. tax law including a reduction in the corporate tax rates, changes to net operating loss carryforwards and carrybacks, and a repeal of the corporate alternative minimum tax. The legislation reduced the U.S. corporate tax rate from the current rate of 35% to 21%. As a result of the enacted law, the Company was required to revalue deferred tax assets and liabilities at the enacted rate. This revaluation resulted in a decrease in net deferred tax assets of $12,600,000 and a corresponding reduction in the valuation allowance against these assets. There is no impact to income tax expense. The other provisions of the Tax Cuts and Jobs Act did not have a material impact on the 2017 consolidated financial statements. On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118, or SAB 118, to address the application of U.S. GAAP in situations when a registrant does not have the necessary information available, prepared, or analyzed, including computations, in reasonable detail to complete the accounting for certain income tax effects of the Tax Reform Act. The Company has recognized the provisional tax impacts related to the revaluation of the deferred tax assets and liabilities and included these amounts in its consolidated financial statements for the year ended December 31, 2017. The ultimate impact may differ from these provisional amounts due to, among other things, additional analysis, changes in interpretations and assumptions the Company has made, additional regulatory guidance that may be issued, and actions the Company may take as a result of the Tax Reform Act. The accounting is expected to be complete when the 2017 U.S. corporate income tax return is filed in 2018. The following table presents a reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate to the effective income tax rate as reflected in the consolidated financial statements: Year Ended December 31, 2017 Year Ended December 31, 2016 Year Ended December 31, 2015 Federal income tax expense at statutory rate 35.0 % 35.0 % 35.0 % State income tax, net of federal benefit 5.0 % 5.0 % 3.4 % Permanent differences (0.7 )% 0.0 % (0.2 )% Stock-based compensation (1.9 )% (2.6 )% (6.3 )% Research credits 2.2 % 1.9 % 1.8 % Other, net (1.3 )% (0.1 )% 0.4 % Payroll Tax Credit Election (0.7 )% 0.0 % 0.0 % Change in valuation allowance (1.1 )% (39.2 )% (34.1 )% Deferred rate change (36.5 )% 0.0 % 0.0 % Effective tax rate 0.0 % 0.0 % 0.0 % Deferred income tax assets and liabilities are determined based upon temporary differences between the financial reporting and tax bases of assets and liabilities and are measured using the enacted tax rates and laws that will be in effect when the differences are expected to reverse. The following table presents the significant components of the Company's deferred tax assets and liabilities: December 31, 2017 December 31, 2016 Deferred tax assets: U.S. and state net operating loss carryforwards $ 24,744,841 $ 24,322,172 Accruals and other temporary differences 202,301 529,462 Amortization 35,783 32,171 Stock-based compensation 1,591,131 1,847,441 Tax credit carryforward 1,964,189 1,423,292 Total deferred tax assets 28,538,245 28,154,538 Less valuation allowance (28,533,755 ) (28,127,611 ) Deferred tax assets 4,490 26,927 Deferred tax liabilities: Stock-based compensation (4,490 ) (23,316 ) Depreciation — (3,611 ) Accruals and other temporary differences — — Deferred tax liabilities (4,490 ) (26,927 ) Net deferred tax assets $ — $ — As of December 31, 2017 , the Company has U.S. federal net operating loss carryforwards of approximately $91,200,000 and U.S. state net operating loss carryforwards of approximately $90,400,000 ( $7,100,000 tax affected), which are available to reduce future taxable income. The Company also had federal research and development tax credit carryforwards of approximately $1,600,000 and state research and development tax credit carryforwards of approximately $428,000 , which may be used to offset future tax liabilities. The Company adopted ASU No. 2016-09, Improvements to Employee Share-Based Payment Accounting , for the quarter ended March 31, 2017. As a result of adoption, the deferred tax assets associated net operating losses increased by approximately $42,000 . These amounts were offset by a corresponding increase in the valuation allowance. The adoption of ASU 2016-09 had no impact to the Company’s consolidated statement of operations, balance sheet, or retained earnings. The Company's federal and state operating loss carryforwards and tax credit carryforwards will expire at various dates through 2037 . Under the provisions of the Internal Revenue Code, the net operating loss and tax credit carryforwards are subject to review and possible adjustment by the Internal Revenue Service and state tax authorities. Net operating loss and tax credit carryforwards may become subject to an annual limitation in the event of certain cumulative changes in the ownership interest of significant shareholders over a three-year period in excess of 50 percent, as defined under Sections 382 and 383 of the Internal Revenue Code, respectively, as well as similar state provisions. This could limit the amount of tax attributes that can be utilized annually to offset future taxable income or tax liabilities. The amount of the annual limitation is determined based on the value of the Company immediately prior to the ownership change. Subsequent ownership changes may further affect the limitation in future years. The Company has completed financings since its inception which may have resulted in a change in control as defined by Sections 382 and 383 of the Internal Revenue Code, or could result in a change in control in the future. The Company has not conducted an assessment to determine whether there may have been a Section 382 or 383 ownership changes. ASC 740 requires a valuation allowance to reduce the deferred tax assets reported if, based on the weight of available evidence, it is more likely than not that some portion or all of the deferred tax assets will not be realized. After considerations of all the evidence, both positive and negative, the Company continues to maintain a valuation allowance for the full amount of the 2017 deferred tax asset because it is more likely than not that the deferred tax asset will not be realized. The valuation allowance increased by approximately $406,000 from December 31, 2016 to December 31, 2017 , primarily due to an increase in net operating losses. The Company has no unrecognized tax benefits. Interest and penalty charges, if any, related to uncertain tax positions would be classified as income tax expenses in the accompanying consolidated statement of operations. At December 31, 2017 and 2016 , the Company had no accrued interest or penalties related to uncertain tax positions. Under the Protecting Americans from Tax Hikes Act, enacted in December 2015, certain qualified small businesses may elect to apply up to $250,000 of its federal research and development tax credit against the Social Security portion of its payroll tax liability. The Company elected the $250,000 credit on its 2016 tax return and utilized approximately $22,000 of the credit as a decrease to its payroll tax expense in 2017. |
Net loss per share
Net loss per share | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net loss per share | Net loss per share Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period, determined using the treasury stock method and the if-converted method, for convertible securities, if inclusion of these is dilutive. Because the Company has reported net losses for the periods presented, diluted net loss per common share is the same as basic net loss per common share. The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding for the periods indicated, because including them would have had an anti-dilutive impact: Year Ended December 31, 2017 Year Ended December 31, 2016 Year Ended December 31, 2015 Options to purchase common stock 2,580,491 2,156,250 1,824,973 Unvested restricted common stock 174,988 1,196,792 2,202,262 Total 2,755,479 3,353,042 4,027,235 |
Segment Information
Segment Information | 12 Months Ended |
Dec. 31, 2017 | |
Segment Reporting [Abstract] | |
Segment Information | Segment Information Effective as of the second quarter of 2016 and in connection with the launch of HOTSHOT, the Company operates as two reportable segments: • The Consumer Operations segment, which reflects the total revenue and costs and expenses related to HOTSHOT and the Company's consumer operations. • The Drug Development segment, which reflects the costs and expenses related to the Company's efforts to develop innovative and proprietary drug products to treat muscle cramps, spasms and spasticity associated with severe neurological conditions. The Company discloses information about its reportable segments based on the way that the Company's Chief Operating Decision Maker, who the Company has identified as the Chief Executive Officer, and management, organizes segments within the Company for making operating decisions and assessing financial performance. The Company evaluates the performance of its reportable segments based on revenue and operating income or loss. The accounting policies of the segments are the same as those described herein as well as those described in Note 2. Corporate and unallocated amounts that do not relate to a reportable segment have been allocated to "Corporate". No asset information has been provided for the Company's reportable segments as management does not measure or allocate such assets on a reportable segment basis. Information for the Company's reportable segments for the years ended December 31, 2017 , December 31, 2016 , and December 31, 2015 are as follows: Year Ended December 31, 2017 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 1,274,499 — — $ 1,274,499 Loss from operations $ 8,877,330 16,715,752 9,132,544 $ 34,725,626 Interest income, net $ — — 291,964 $ 291,964 Year Ended December 31, 2016 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 1,010,663 — — $ 1,010,663 Loss from operations $ 10,023,137 19,620,338 10,242,757 $ 39,886,232 Interest income, net $ — — 393,109 $ 393,109 Year Ended December 31, 2015 Consumer Operations Drug Development Corporate Consolidated Total revenue $ — — — $ — Loss from operations $ 7,892,584 12,224,692 9,096,382 $ 29,213,658 Interest income, net $ — — 72,028 $ 72,028 |
Related parties
Related parties | 12 Months Ended |
Dec. 31, 2017 | |
Related Party Transactions [Abstract] | |
Related parties | Related parties Royalty agreement In 2014, the Company entered into a royalty agreement with certain of the Company's founders under which these founders are paid a royalty of 2% , in the aggregate, of gross sales of any product sold by the Company or by any of the Company's licensees for use in the treatment of any neuromuscular disorder, and that uses, incorporates or embodies, or is made using, any of the Company's intellectual property, including any know-how. Upon the launch of HOTSHOT in the second quarter of 2016, the Company's founders began earning royalties under this agreement. Royalty amounts earned by the founders during the years ended December 31, 2017 and December 31, 2016 totaled approximately $ 25,000 and $20,000 , respectively, including approximately $ 3,000 and $4,000 not yet paid as of year end, respectively. There were no such amounts earned during the year ended December 31, 2015. Royalty expense is recorded in cost of product revenue in the consolidated statement of operations. License agreement For the period from May 2014 through July 2016, the Company licensed a portion of its office space to ECLDS, LLC, which was controlled by the Company's former Chief Executive Officer. In October 2015, the license agreement was assigned by ECLDS, LLC to a third party, that was not owned by the Company's former Chief Executive Officer, but for which a business relationship existed. In July 2016, the license agreement terminated. Under the terms of the license, the entity charged the same rental rate as that was charged to the Company. During the years ended December 31, 2016 and December 31, 2015 , the Company received approximately $32,000 , and $61,000 , respectively, in license fees from the aforementioned related party, and such amounts received have been recorded as a reduction to rent expense. |
Quarterly financial information
Quarterly financial information (unaudited) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Quarterly financial information (unaudited) | Quarterly financial information (unaudited) First Quarter Second Quarter Third Quarter Fourth Quarter Net product revenue $ 240,292 $ 330,688 $ 407,241 $ 282,752 Other revenue 2,255 4,835 6,360 76 Total revenue 242,547 335,523 413,601 282,828 Costs and expenses: Cost of product revenue 79,106 145,325 148,756 133,343 Research and development 3,914,974 4,076,220 4,739,360 4,259,357 Selling, general and administrative 4,594,716 4,990,943 4,934,937 3,983,088 Total costs and expenses 8,588,796 9,212,488 9,823,053 8,375,788 Loss from operations (8,346,249 ) (8,876,965 ) (9,409,452 ) (8,092,960 ) Interest income, net 77,854 72,342 77,339 64,429 Net loss $ (8,268,395 ) $ (8,804,623 ) $ (9,332,113 ) $ (8,028,531 ) Net loss per share attributable to common stockholders — basic and diluted $ (0.49 ) $ (0.51 ) $ (0.54 ) $ (0.46 ) Weighted-average number of common shares outstanding — basic and diluted 16,873,512 17,130,264 17,386,249 17,642,646 First Quarter Second Quarter Third Quarter Fourth Quarter Net product revenue $ — $ 112,685 $ 586,134 $ 291,099 Other revenue — — 12,940 7,805 Total revenue — 112,685 599,074 298,904 Costs and expenses: Cost of product revenue 197,020 110,931 221,090 133,706 Research and development 4,387,079 6,094,921 5,665,357 4,230,804 Selling, general and administrative 5,111,695 5,377,784 5,447,847 3,918,661 Total costs and expenses 9,695,794 11,583,636 11,334,294 8,283,171 Loss from operations (9,695,794 ) (11,470,951 ) (10,735,220 ) (7,984,267 ) Interest income, net 103,333 107,818 97,726 84,232 Net loss $ (9,592,461 ) $ (11,363,133 ) $ (10,637,494 ) $ (7,900,035 ) Net loss per share attributable to common stockholders — basic and diluted $ (0.61 ) $ (0.71 ) $ (0.65 ) $ (0.48 ) Weighted-average number of common shares outstanding — basic and diluted 15,843,532 16,105,555 16,361,617 16,619,596 |
Subsequent events
Subsequent events | 12 Months Ended |
Dec. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent events | Subsequent events The Company has completed an evaluation of all subsequent events after the balance sheet date of December 31, 2017 through the date these consolidated financial statements were issued. The Company concluded that no subsequent events have occurred that require disclosure. |
Summary of significant accoun27
Summary of significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of presentation | The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America ("GAAP"). Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the Accounting Standards Codification ("ASC") and Accounting Standards Update ("ASU") of the Financial Accounting Standards Board ("FASB"). |
Use of estimates | The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. On an ongoing basis, the Company's management evaluates its estimates, which include, but are not limited to, estimates related to inventory write-offs, clinical study accruals, stock-based compensation expense, and amounts of expenses during the reported period. The Company bases its estimates on historical experience and other market-specific or other relevant assumptions that it believes to be reasonable under the circumstances. Actual results may differ from those estimates or assumptions. Prior to the Company's IPO, the Company utilized significant estimates and assumptions in determining the fair value of its common stock. The Company utilized various valuation methodologies in accordance with the framework of the 2004 and 2013 American Institute of Certified Public Accountants Technical Practice Aids, Valuation of Privately-Held Company Equity Securities Issued as Compensation , to estimate the fair value of its common stock. Each valuation methodology included estimates and assumptions that required the Company's judgment. These estimates and assumptions included a number of objective and subjective factors, including external market conditions affecting the biotechnology industry sector, the prices at which the Company sold shares of preferred stock, the superior rights and preferences of securities senior to the Company's common stock at the time and the likelihood of achieving a liquidity event, such as an initial public offering or a sale of the Company. Significant changes to the key assumptions used in the valuations could have resulted in different fair values of common stock at each valuation date and may have materially affected the financial statements. |
Principles of consolidation | Principles of consolidation The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries: TK Pharma, Inc., a Massachusetts Securities Corporation, and Flex Innovation Group LLC, a Delaware limited liability company, which contains the Company's consumer-related operations. All significant intercompany balances and transactions have been eliminated in consolidation. |
Concentrations of risk, Concentrations of credit risk and off-balance sheet risk | Concentrations of credit risk and off-balance sheet risk Cash, cash equivalents and marketable securities are financial instruments that potentially subject the Company to concentrations of credit risk. The Company's cash, cash equivalents and marketable securities are held in accounts at financial institutions that management believes are creditworthy. The Company has not experienced any credit losses in such accounts and does not believe it is exposed to any significant credit risk on these funds. The Company has no financial instruments with off-balance sheet risk of loss. Concentration of risk The Company outsources the manufacture of HOTSHOT to a single co-packer that produces bottled finished goods. The Company also sources certain raw materials from sole suppliers. A disruption in the supply of materials or the production of finished goods could significantly impact the Company's revenues in the future as alternative sources of raw materials and co-packing may not be available at commercially reasonable rates or within a reasonably short period of time. |
Segment information | Segment information Operating segments are defined as components of an enterprise about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources and assess performance. The Company and the Company's chief operating decision maker, the Company's Chief Executive Officer, view the Company's operations and manage its business as two operating segments, Drug Development and Consumer Operations (see Note 15). The Company operates in one geographic segment, the United States. |
Revenue | Net product revenue and other revenue are presented net of taxes collected from customers and remitted to governmental authorities. Revenue Revenue is comprised of net product revenue and other revenue. Net product revenue includes sales of HOTSHOT finished goods to e-commerce customers, specialty retailers and sports teams. Other revenue consists of payments made by customers for expedited shipping and handling, which the Company began offering during the third quarter of 2016. Revenue is recognized when persuasive evidence of an arrangement exists, delivery of the product has occurred, the sales price is fixed or determinable and collectibility is reasonably assured. For sales through September 30, 2016, the Company issued refunds to e-commerce customers, upon request, within 21 days of shipment. When the Company began selling HOTSHOT on a third-party e-commerce website in October 2016, the refund period and related deferral period increased, as the Company began offering refunds to e-commerce customers, upon request, within 30 days of delivery, for purchases subsequent to September 30, 2016. As the Company currently does not have adequate history to accurately estimate refunds, all e-commerce sales, and their related costs, are deferred and revenue is recognized once the refund period lapses. This deferral represents total deferred revenue presented on the Company's consolidated balance sheet. For specialty retailers and sports teams, the Company does not offer a right of return or refund and revenue is recognized at the time products are delivered to customers. |
Revenue, discounts | Discounts provided to customers are accounted for as a reduction of product revenue, and were approximately $278,000 and $135,000 for the years ended December 31, 2017 and December 31, 2016 , respectively. |
Accounts receivable and allowance for doubtful accounts | Accounts receivable and allowance for doubtful accounts Accounts receivable are stated at their carrying values, net of any allowances for doubtful accounts. Accounts receivable consist primarily of amounts due from specialty retailers and sports teams, for which collectibility is reasonably assured. Receivables are evaluated for collectibility on a regular basis and an allowance for doubtful accounts is recorded, if necessary. |
Cost of product revenue | Cost of product revenue Cost of product revenue includes the cost of raw materials utilized to produce HOTSHOT, co-packing fees, repacking fees, in-bound freight charges and warehouse and transportation costs incurred to bring HOTSHOT finished goods to salable condition. All other costs incurred after this condition is met are considered selling costs and included in selling, general and administrative expenses. Cost of product revenue also includes write-offs for inventory that has become obsolete, has a cost basis in excess of its estimated realizable value, or exceeds projected sales, as well as depreciation expense related to manufacturing equipment purchased to support production and royalty amounts payable to certain of the Company's founders on HOTSHOT sales. |
Inventory | Inventory The Company launched HOTSHOT in the second quarter of 2016 and began capitalizing inventory costs associated with HOTSHOT in the first quarter of 2016, when it was determined that the inventory costs had probable future economic benefit. Inventory is stated at the lower of cost or estimated net realizable value, on a first-in, first-out ("FIFO") basis. The Company outsources the manufacture of HOTSHOT to a co-packer. Inventory at December 31, 2017 includes raw materials available for future production runs, as well as finished goods. The Company periodically analyzes its inventory levels and writes down inventory that has become obsolete, has a cost basis in excess of its estimated realizable value, or exceeds projected sales. Estimates of excess inventory consider factors such as inventory levels, production requirements, projected sales and the estimated shelf-lives of inventory components. Inventory write-offs are recorded as a component of cost of product revenue. |
Advertising expense | Advertising expense Advertising expense consists of media and production costs related to print and digital advertising. All advertising is expensed as incurred. |
Shipping and handling costs | Shipping and handling costs Shipping and handling costs related to the movement of inventory to the Company's co-packer and from the co-packer to the Company's third-party warehousing and fulfillment partners is capitalized as inventory and expensed as a cost of product revenue when revenue is recognized. Shipping and handling costs to move finished goods from the Company's warehousing and third-party fulfillment partners to customer locations are included in selling, general and administrative expense in the consolidated statement of operations |
Property and equipment | Property and equipment Property and equipment is stated at cost, less accumulated depreciation. Maintenance and repairs that do not improve or extend the lives of the respective assets are expensed to operations as incurred, while costs of major additions and betterments are capitalized. Upon disposal, the related cost and accumulated depreciation is removed from the accounts and any resulting gain or loss is included in the results of operations. Depreciation is recorded, once assets are placed in service, using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Asset type Estimated useful life Computers and computer equipment 3 years Laboratory equipment 3 years Manufacturing equipment 3 years Website development costs 1-2 years |
Impairment of long-lived assets | Impairment of long-lived assets The Company evaluates long-lived assets for potential impairment when events or changes in circumstances indicate the carrying value of the assets may not be recoverable. Recoverability is measured by comparing the book values of the assets to the expected future net undiscounted cash flows that the assets are expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured by the amount by which the book value of the assets exceed their fair value. |
Research and development expenses | Research and development expense Research and development costs are charged to expense as incurred in performing research and development activities. The costs include employee compensation costs, clinical study costs, external consultant costs, regulatory costs and facilities and overhead costs. Facilities and overhead costs primarily include the allocation of insurance, rent, utility and office-related expenses attributable to research and development personnel. The Company records payments made to outside vendors in advance of services performed or goods being delivered for use in research and development activities as prepaid expenses, which are expensed as services are performed or goods are delivered. |
Stock-based compensation expense | Stock-based compensation expense The Company accounts for its stock-based compensation awards to employees and directors in accordance with FASB ASC Topic 718, Compensation-Stock Compensation ("ASC 718"). ASC 718 requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the statement of operations based on their grant date fair values. Compensation expense related to awards to employees with service conditions is recognized on a straight-line basis based on the grant date fair value over the associated service period of the award, which is generally the vesting term. Compensation expense related to awards to employees with performance conditions is recognized based on grant date fair value over the remaining service period when management determines that achievement of the milestone is probable. Management evaluates when the achievement of a performance-based milestone is probable based on the relative satisfaction of the performance conditions as of the reporting date. The Company accounts for stock-based compensation arrangements with non-employees based upon the fair value of the consideration received or the equity instruments issued, whichever is more reliably measurable, in accordance with the provisions of FASB ASC Topic 505-50, Equity-Based Payments to Non-Employees . The measurement date for non-employee awards is generally the date performance of services required from the non-employee is complete, resulting in periodic adjustments to stock-based compensation expense during the vesting period for changes in the fair value of the awards. Stock-based compensation costs for non-employee service awards are recognized as services are provided, which is generally the vesting period, on a straight-line basis. The unvested portion of the awards is subject to re-measurement over the vesting period. The Company estimates the fair value of its stock options using the Black-Scholes option pricing model, which requires the input of subjective assumptions, including (a) the expected stock price volatility, (b) the expected term of the award, (c) the risk-free interest rate, (d) expected dividends and (e) the estimated fair value of the Company's common stock on the measurement date. Due to the lack of significant trading history for the Company's common stock, it has based its estimate of expected volatility on the historical volatility of a group of similar companies that are publicly traded. When selecting these public companies on which it has based its expected stock price volatility, the Company selected companies with comparable characteristics, including enterprise value, risk profiles, position within the industry, and with historical share price information sufficient to meet the expected term of the stock-based awards. The Company computes historical volatility data using the volatility for the selected companies' shares during the equivalent period of the calculated expected term of the stock-based awards. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. Due to the lack of Company specific historical option activity, the Company has estimated the expected term of its employee stock options using the "simplified" method, whereby, the expected term equals the arithmetic average of the vesting term and the original contractual term of the option. The expected term for non-employee awards is the remaining contractual term of the option. The risk-free interest rates are based on the U.S. Treasury securities with a maturity date commensurate with the expected term of the associated award. The Company has never paid, and does not expect to pay dividends in the foreseeable future. Prior to adoption of ASU No. 2016-09 Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting , share-based compensation expense was recognized net of estimated forfeitures, such that expense was recognized only for share-based awards that were expected to vest. A forfeiture rate was estimated annually and revised, if necessary, in subsequent periods if actual forfeitures differed from initial estimates. Upon adoption of ASU No. 2016-09 on January 1, 2017, the Company no longer applies a forfeiture rate and instead accounts for forfeitures as they occur. |
Income taxes | Income taxes Income taxes are recorded in accordance with FASB ASC Topic 740, Income Taxes ("ASC 740"), which provides for deferred taxes using an asset and liability approach. Under this method, deferred tax assets and liabilities are determined based on the difference between the financial reporting and the tax reporting basis of assets and liabilities and are measured using the enacted tax rates and laws that are expected to be in effect when the differences are expected to reverse. The Company provides a valuation allowance against net deferred tax assets unless, based upon the available evidence, it is more likely than not that the deferred tax assets will be realized. The Company has evaluated available evidence and concluded that the Company may not realize the benefit of its deferred tax assets; therefore a valuation allowance has been established for the full amount of the deferred tax assets. The Company accounts for uncertain tax positions in accordance with the provisions of ASC 740. When uncertain tax positions exist, the Company recognizes the tax benefit of tax positions to the extent that the benefit will more likely than not be realized. The determination as to whether the tax benefit will more likely than not be realized is based upon the technical merits of the tax position as well as consideration of the available facts and circumstances. As of December 31, 2017 and December 31, 2016 , the Company did not have any significant uncertain tax positions. The Company's practice is to recognize interest and/or penalties related to income tax matters in income tax expense. |
Net loss per share attributable to common stockholders | Net loss per share attributable to common stockholders Basic net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss attributable to common stockholders by the weighted-average number of common shares and dilutive common stock equivalents outstanding for the period, determined using the treasury stock method and the if-converted method, for convertible securities, if inclusion of these is dilutive. For years ended December 31, 2017 , December 31, 2016 and December 31, 2015 , the Company has excluded the effects of all potentially dilutive shares from the weighted-average number of common shares outstanding as their inclusion in the computation for each period would be anti-dilutive due to the net loss per share incurred by the Company. |
Comprehensive loss | Comprehensive loss Comprehensive loss is the change in equity of a company during a period from transactions and other events and circumstances, excluding transactions resulting from investments by owners and distributions to owners. Comprehensive loss includes net loss and the change in accumulated other comprehensive loss for the period. |
Recent accounting pronouncements | Recent accounting pronouncements In May 2014, the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606) . The ASU provides for a single comprehensive model for use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The accounting standard is effective for interim and annual periods beginning after December 15, 2016 with no early adoption permitted. In July 2015, the FASB deferred the effective date of this accounting update to annual periods beginning after December 15, 2017, along with an option to permit early adoption as of the original effective date. The Company is required to adopt the standard in the ASU using one of two acceptable methods: retrospectively to all prior reporting periods presented, with certain practical expedients permitted; or retrospectively with the cumulative effect of initially adopting the ASU recognized at the date of initial application. In March 2016, the FASB issued ASU No. 2016-08, Revenue from Contracts with Customers, Principal versus Agent Considerations (Reporting Revenue Gross versus Net), clarifying the implementation guidance on principal versus agent considerations. Specifically, an entity is required to determine whether the nature of a promise is to provide the specified good or service itself (that is, the entity is a principal) or to arrange for the good or service to be provided to the customer by the other party (that is, the entity is an agent). The determination influences the timing and amount of revenue recognition. The effective date and transition requirements for ASU No. 2016-08 are the same as the effective date and transition requirements for ASU No. 2014-09. The Company has evaluated the adoption impact of the guidance related to the Company's sales of HOTSHOT. Based on evaluation of the Company's revenue streams, the Company has determined that the timing of recognition for e-commerce sales will change by an immaterial amount, due to e-commerce refund rights. Through December 31, 2017 and prior to adoption of the new standard, since the Company does not have an adequate history to accurately estimate refunds, all e-commerce sales and related costs have been deferred and recognized once the refund period lapses. Under the new standard, the Company will estimate the amount of potential refunds and may recognize revenue related to some of these sales earlier if it is probable that a significant revenue reversal will not occur. Adoption will not have a significant impact on revenue recognition for the company's specialty retail or sports team channels, as no right of refund or return exists. The guidance is not expected to have a material impact to the consolidated statements of operations or balance sheets in any prior or prospective reporting period. The Company has finalized its accounting policy, and has designed and implemented necessary changes to processes and controls to allow for proper recognition, presentation and disclosure upon adoption effective in the beginning of fiscal year 2018. In July 2015, the FASB issued ASU No. 2015-11, Inventory (Topic 330) . This ASU simplifies the measurement of inventory by requiring certain inventory to be measured at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. The amendments in this ASU are effective for fiscal years beginning after December 15, 2016 and for interim periods therein. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. The Company adopted this ASU as of March 31, 2017, which did not have a material impact on its condensed consolidated financial statements In February 2016, the FASB issued ASU No. 2016-02, Leases . The ASU requires lessees to recognize the assets and liabilities on their balance sheet for the rights and obligations created by most leases and continue to recognize expenses on their income statements over the lease term. It will also require disclosures designed to give financial statement users information on the amount, timing, and uncertainty of cash flows arising from leases. The guidance is effective for annual reporting periods beginning after December 15, 2018, and interim periods within those years. Early adoption is permitted. While the Company is currently evaluating the effect this standard will have on its consolidated financial statements and timing of adoption, the Company expects that upon adoption, it will recognize right-of-use assets and lease liabilities and those amounts could be material. The Company is still assessing the expected impact on our consolidated statements of operations and cash flows. In March 2016, the FASB issued ASU No. 2016-09, Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. This ASU simplifies the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. The guidance is effective for annual reporting periods beginning after December 15, 2016, and interim periods within those annual periods. The Company adopted the new standard on January 1, 2017 and has elected to account for forfeitures as they occur. The change was applied on a modified retrospective basis with a cumulative effect adjustment to increase retained earnings by approximately $2,000 , as of January 1, 2017. In addition, upon adoption of the new standard, the Company has additional deferred tax assets related to tax deductions from excess tax benefits related to the exercise of stock options. As a result, the deferred tax assets associated with net operating losses increased by approximately $42,000 in the first quarter of 2017. The amounts are offset by a corresponding increase in the valuation allowance. As such, there is no net effect on the Company’s consolidated statements of operations for the twelve months ended December 31, 2017. In August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments . The update amends the guidance in ASU 230 Statement of Cash Flows, and clarifies how entities should classify certain cash receipts and cash payments on the statement of cash flows with the objective of reducing the existing diversity in practice related to eight specific cash flow issues. The amendments in this update are effective for fiscal years beginning after December 15, 2017, and interim periods within those years. Early adoption is permitted. The Company does not expect the adoption of ASU 2016-15 to have a material impact on its consolidated financial statements. In November 2016, the FASB issued ASU No. 2016-18, Statement of Cash Flows , which amends ASU Topic 230. This update requires entities to show the changes in the total of cash, cash equivalents, restricted cash and restricted cash equivalents in the statement of cash flows. As a result, entities will no longer be required to present transfers between cash and cash equivalents and restricted cash and restricted cash equivalents in the statement of cash flows. When cash, cash equivalents, restricted cash and restricted cash equivalents are presented in more than one line item on the balance sheet, the new guidance requires a reconciliation of the totals in the statement of cash flows to the related captions in the balance sheet. Entities will also have to disclose the nature of their restricted cash and restricted cash equivalent balances. The guidance is effective for fiscal years beginning after December 15, 2017 and interim periods within those years. Early adoption is permitted. Entities are required to apply the guidance retrospectively. The new guidance will change the presentation of restricted cash in the Company's consolidated financial statements in the first quarter of 2018. In May 2017, the FASB issued ASU 2017-09, Stock Compensation (Topic 718): Scope of Modification Accounting , to provide clarity and reduce diversity in practice, cost and complexity when applying the guidance in Topic 718. The guidance is effective for fiscal years beginning after December 15, 2017 and interim periods within those years. Early adoption is permitted. The Company does not expect the adoption of this guidance to have a material effect on its consolidated financial statements and related disclosures. The Company believes that the impact of other recently issued standards that are not yet effective will not have a material effect on its consolidated financial position or results of operations upon adoption. |
Subsequent events | Subsequent events The Company considers events or transactions that occur after the balance sheet date but prior to the issuance of the consolidated financial statements for potential recognition or disclosure in the consolidated financial statements. Subsequent events have been evaluated through the date these consolidated financial statements were issued for potential recognition or disclosure in the consolidated financial statements (see Note 18). |
Fair value measurements | The Company records cash equivalents and marketable securities at fair value. ASC Topic 820, Fair Value Measurements and Disclosures established a fair value hierarchy for those instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). The hierarchy consists of three levels: Level 1 – Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 – Quoted prices for similar assets and liabilities in active markets, quoted prices in markets that are not active, or inputs which are observable, directly or indirectly, for substantially the full term of the asset or liability. Level 3 – Unobservable inputs that reflect the Company’s own assumptions about the assumptions market participants would use in pricing the asset or liability in which there is little, if any, market activity for the asset or liability at the measurement date. |
Summary of significant accoun28
Summary of significant accounting policies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Accounting Policies [Abstract] | |
Depreciation over estimated useful life | Depreciation is recorded, once assets are placed in service, using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Asset type Estimated useful life Computers and computer equipment 3 years Laboratory equipment 3 years Manufacturing equipment 3 years Website development costs 1-2 years Property and equipment, net consists of the following: December 31, 2017 December 31, 2016 Manufacturing equipment $ 421,999 $ 421,999 Computers and computer equipment 311,847 276,263 Website development costs 177,886 159,836 Laboratory equipment 13,368 13,368 Capital in progress 28,823 7,863 Total property and equipment 953,923 879,329 Accumulated depreciation (622,883 ) (323,014 ) Property and equipment, net $ 331,040 $ 556,315 |
Reclassification out of Accumulated Other Comprehensive Income | The following tables summarize the changes in accumulated other comprehensive loss during the years ended December 31, 2017 , December 31, 2016 and December 31, 2015 . Balance as of December 31, 2016 $ (1,614 ) Other comprehensive gain 367 Balance as of December 31, 2017 $ (1,247 ) Balance as of December 31, 2015 $ (24,654 ) Other comprehensive gain 23,040 Balance as of December 31, 2016 $ (1,614 ) Balance as of December 31, 2014 $ — Other comprehensive loss (24,654 ) Balance as of December 31, 2015 $ (24,654 ) |
Fair value measurements (Tables
Fair value measurements (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Summary of Cash Equivalents and Marketable Securities Measured at Fair Value on a Recurring Basis | The following table summarizes the cash equivalents and marketable securities measured at fair value on a recurring basis as of December 31, 2017 and December 31, 2016 : Level 1 Level 2 Level 3 Balance at December 31, 2017 Cash equivalents $ 5,046,205 $ — $ — $ 5,046,205 Marketable securities: U.S. government agency securities — 8,986,259 — 8,986,259 Commercial paper — 4,440,689 — 4,440,689 Corporate debt securities — 702,775 — 702,775 $ 5,046,205 $ 14,129,723 $ — $ 19,175,928 Level 1 Level 2 Level 3 Balance at December 31, 2016 Cash equivalents $ 11,681,074 $ — $ — $ 11,681,074 Marketable securities: U.S. government agency securities — 31,059,491 — 31,059,491 Commercial paper — 6,081,202 — 6,081,202 Corporate debt securities — 1,518,240 — 1,518,240 $ 11,681,074 $ 38,658,933 $ — $ 50,340,007 |
Cash equivalents and marketab30
Cash equivalents and marketable securities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Cash and Cash Equivalents [Abstract] | |
Schedule of Marketable Securities | Marketable securities at December 31, 2017 and December 31, 2016 consisted of the following: Amortized Cost Unrealized Gains Unrealized Losses Fair Value As of December 31, 2017 Current (due within 1 year): U.S. government agency securities $ 8,987,254 $ 38 $ (1,033 ) $ 8,986,259 Commercial paper 4,440,689 — — 4,440,689 Corporate debt securities 703,027 — (252 ) 702,775 Total $ 14,130,970 $ 38 $ (1,285 ) $ 14,129,723 Amortized Cost Unrealized Gains Unrealized Losses Fair Value As of December 31, 2016 Current (due within 1 year): U.S. government agency securities $ 31,060,710 $ 2,912 $ (4,131 ) $ 31,059,491 Commercial paper 6,081,202 — — 6,081,202 Corporate debt securities 1,518,635 — (395 ) 1,518,240 Total $ 38,660,547 $ 2,912 $ (4,526 ) $ 38,658,933 |
Inventory (Tables)
Inventory (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Net | The following table presents inventory: December 31, 2017 December 31, 2016 Raw materials $ 17,411 $ 19,888 Finished goods 414,480 434,244 Total inventory $ 431,891 $ 454,132 |
Property and equipment, net (Ta
Property and equipment, net (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Property, Plant and Equipment [Abstract] | |
Property and equipment, net | Depreciation is recorded, once assets are placed in service, using the straight-line method over the estimated useful lives of the respective assets, which are as follows: Asset type Estimated useful life Computers and computer equipment 3 years Laboratory equipment 3 years Manufacturing equipment 3 years Website development costs 1-2 years Property and equipment, net consists of the following: December 31, 2017 December 31, 2016 Manufacturing equipment $ 421,999 $ 421,999 Computers and computer equipment 311,847 276,263 Website development costs 177,886 159,836 Laboratory equipment 13,368 13,368 Capital in progress 28,823 7,863 Total property and equipment 953,923 879,329 Accumulated depreciation (622,883 ) (323,014 ) Property and equipment, net $ 331,040 $ 556,315 |
Accrued expenses and other cu33
Accrued expenses and other current liabilities (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Payables and Accruals [Abstract] | |
Accrued expenses | Accrued expenses and other current liabilities consist of the following: December 31, 2017 December 31, 2016 Research and development costs $ 2,502,400 $ 938,665 Payroll and employee-related costs 874,246 1,453,665 Professional fees 227,980 153,219 Consumer product-related costs 107,595 42,024 Total $ 3,712,221 $ 2,587,573 |
Other current liabilities | Accrued expenses and other current liabilities consist of the following: December 31, 2017 December 31, 2016 Research and development costs $ 2,502,400 $ 938,665 Payroll and employee-related costs 874,246 1,453,665 Professional fees 227,980 153,219 Consumer product-related costs 107,595 42,024 Total $ 3,712,221 $ 2,587,573 |
Commitments and contingencies (
Commitments and contingencies (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Minimum future lease payments | As of December 31, 2017 , the minimum future lease payments under the Company's Boston operating lease was as follows: 2018 $ 466,593 2019 311,062 Total minimum lease payments $ 777,655 |
Common stock (Tables)
Common stock (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Equity [Abstract] | |
Restricted common stock activity | The following is a summary of restricted common stock activity: Number of Shares Weighted-Average Grant Date Fair Value Unvested at December 31, 2016 1,185,958 $ 0.10 Issued — — Vested (1,016,304 ) 0.10 Forfeited — — Unvested at December 31, 2017 169,654 $ 0.10 The following is a summary of restricted common stock activity: Number of Shares Weighted-Average Grant Date Fair Value Unvested at December 31, 2016 10,834 $ 9.72 Issued — — Vested (5,500 ) 8.95 Forfeited — — Unvested at December 31, 2017 5,334 $ 10.51 |
Shares reserved for future issuance | The Company has reserved the following number of shares of common stock for future issuance: As of December 31, 2017 2016 Stock-based compensation awards 3,439,820 2,722,573 Vesting of restricted common stock 174,988 1,196,792 Employee stock purchase plan 534,274 354,569 Total 4,149,082 4,273,934 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of stock option activity | The following table summarizes stock option activity for employees and non-employees for the twelve months ended December 31, 2017 : Shares Weighted-Average Exercise Price Weighted-Average Remaining Contractual Term (in years) Aggregate Intrinsic Value Outstanding at December 31, 2016 2,156,250 $ 8.66 7.94 $ 1,605,684 Granted 1,059,500 4.20 Exercised (1,576 ) 1.67 Forfeited (418,642 ) 8.87 Expired (215,041 ) 10.51 Outstanding at December 31, 2017 2,580,491 $ 6.65 7.55 $ 803,600 Exercisable at December 31, 2017 1,404,844 $ 7.21 6.56 $ 692,232 Vested or expected to vest at December 31, 2017 2,580,491 $ 6.65 7.55 $ 803,600 |
Schedule of fair value assumptions | The Company estimates the fair value of each stock option award on the grant date using the Black-Scholes option-pricing model based on the following assumptions regarding the fair value of the underlying Common Stock on each measurement date: Year Ended December 31, 2017 Year Ended December 31, 2016 Year Ended December 31, 2015 Expected volatility 73.87% to 81.04% 71.01% to 74.20% 72.98% to 74.94% Risk-free interest rate 1.83% to 2.40% 1.23% to 2.40% 1.62% to 2.49% Expected term 5.3 - 9.5 years 5.3 - 10 years 5.3 - 10 years Expected dividend yield 0 % 0 % 0 % |
Summary of stock-based compensation expense | Total stock-based compensation expense recognized for employee and non-employee restricted common stock, and stock options granted to employees and non-employees is included in the Company's consolidated statements of operations and comprehensive loss as follows: Year Ended December 31, 2017 Year Ended December 31, 2016 Year Ended December 31, 2015 Research and development $ 1,545,737 $ 2,435,565 $ 3,192,063 Selling, general and administrative 2,673,428 4,137,398 3,405,296 Total $ 4,219,165 $ 6,572,963 $ 6,597,359 |
Income taxes (Tables)
Income taxes (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | |
Schedule of effective income tax rate reconciliation | The following table presents a reconciliation of income tax expense (benefit) computed at the statutory federal income tax rate to the effective income tax rate as reflected in the consolidated financial statements: Year Ended December 31, 2017 Year Ended December 31, 2016 Year Ended December 31, 2015 Federal income tax expense at statutory rate 35.0 % 35.0 % 35.0 % State income tax, net of federal benefit 5.0 % 5.0 % 3.4 % Permanent differences (0.7 )% 0.0 % (0.2 )% Stock-based compensation (1.9 )% (2.6 )% (6.3 )% Research credits 2.2 % 1.9 % 1.8 % Other, net (1.3 )% (0.1 )% 0.4 % Payroll Tax Credit Election (0.7 )% 0.0 % 0.0 % Change in valuation allowance (1.1 )% (39.2 )% (34.1 )% Deferred rate change (36.5 )% 0.0 % 0.0 % Effective tax rate 0.0 % 0.0 % 0.0 % |
Schedule of deferred tax assets and liabilities | The following table presents the significant components of the Company's deferred tax assets and liabilities: December 31, 2017 December 31, 2016 Deferred tax assets: U.S. and state net operating loss carryforwards $ 24,744,841 $ 24,322,172 Accruals and other temporary differences 202,301 529,462 Amortization 35,783 32,171 Stock-based compensation 1,591,131 1,847,441 Tax credit carryforward 1,964,189 1,423,292 Total deferred tax assets 28,538,245 28,154,538 Less valuation allowance (28,533,755 ) (28,127,611 ) Deferred tax assets 4,490 26,927 Deferred tax liabilities: Stock-based compensation (4,490 ) (23,316 ) Depreciation — (3,611 ) Accruals and other temporary differences — — Deferred tax liabilities (4,490 ) (26,927 ) Net deferred tax assets $ — $ — |
Net loss per share (Tables)
Net loss per share (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of antidilutive securities excluded from computation of earnings per share | The following potentially dilutive securities outstanding, prior to the use of the treasury stock method or if-converted method, have been excluded from the computation of diluted weighted-average shares outstanding for the periods indicated, because including them would have had an anti-dilutive impact: Year Ended December 31, 2017 Year Ended December 31, 2016 Year Ended December 31, 2015 Options to purchase common stock 2,580,491 2,156,250 1,824,973 Unvested restricted common stock 174,988 1,196,792 2,202,262 Total 2,755,479 3,353,042 4,027,235 |
Segment Information (Tables)
Segment Information (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Segment Reporting [Abstract] | |
Schedule of Segment Reporting Information | Information for the Company's reportable segments for the years ended December 31, 2017 , December 31, 2016 , and December 31, 2015 are as follows: Year Ended December 31, 2017 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 1,274,499 — — $ 1,274,499 Loss from operations $ 8,877,330 16,715,752 9,132,544 $ 34,725,626 Interest income, net $ — — 291,964 $ 291,964 Year Ended December 31, 2016 Consumer Operations Drug Development Corporate Consolidated Total revenue $ 1,010,663 — — $ 1,010,663 Loss from operations $ 10,023,137 19,620,338 10,242,757 $ 39,886,232 Interest income, net $ — — 393,109 $ 393,109 Year Ended December 31, 2015 Consumer Operations Drug Development Corporate Consolidated Total revenue $ — — — $ — Loss from operations $ 7,892,584 12,224,692 9,096,382 $ 29,213,658 Interest income, net $ — — 72,028 $ 72,028 |
Quarterly financial informati40
Quarterly financial information (unaudited) (Tables) | 12 Months Ended |
Dec. 31, 2017 | |
Quarterly Financial Information Disclosure [Abstract] | |
Schedule of quarterly financial information | First Quarter Second Quarter Third Quarter Fourth Quarter Net product revenue $ 240,292 $ 330,688 $ 407,241 $ 282,752 Other revenue 2,255 4,835 6,360 76 Total revenue 242,547 335,523 413,601 282,828 Costs and expenses: Cost of product revenue 79,106 145,325 148,756 133,343 Research and development 3,914,974 4,076,220 4,739,360 4,259,357 Selling, general and administrative 4,594,716 4,990,943 4,934,937 3,983,088 Total costs and expenses 8,588,796 9,212,488 9,823,053 8,375,788 Loss from operations (8,346,249 ) (8,876,965 ) (9,409,452 ) (8,092,960 ) Interest income, net 77,854 72,342 77,339 64,429 Net loss $ (8,268,395 ) $ (8,804,623 ) $ (9,332,113 ) $ (8,028,531 ) Net loss per share attributable to common stockholders — basic and diluted $ (0.49 ) $ (0.51 ) $ (0.54 ) $ (0.46 ) Weighted-average number of common shares outstanding — basic and diluted 16,873,512 17,130,264 17,386,249 17,642,646 First Quarter Second Quarter Third Quarter Fourth Quarter Net product revenue $ — $ 112,685 $ 586,134 $ 291,099 Other revenue — — 12,940 7,805 Total revenue — 112,685 599,074 298,904 Costs and expenses: Cost of product revenue 197,020 110,931 221,090 133,706 Research and development 4,387,079 6,094,921 5,665,357 4,230,804 Selling, general and administrative 5,111,695 5,377,784 5,447,847 3,918,661 Total costs and expenses 9,695,794 11,583,636 11,334,294 8,283,171 Loss from operations (9,695,794 ) (11,470,951 ) (10,735,220 ) (7,984,267 ) Interest income, net 103,333 107,818 97,726 84,232 Net loss $ (9,592,461 ) $ (11,363,133 ) $ (10,637,494 ) $ (7,900,035 ) Net loss per share attributable to common stockholders — basic and diluted $ (0.61 ) $ (0.71 ) $ (0.65 ) $ (0.48 ) Weighted-average number of common shares outstanding — basic and diluted 15,843,532 16,105,555 16,361,617 16,619,596 |
Organization and operations (De
Organization and operations (Details) | Feb. 03, 2015USD ($)$ / sharesshares | Feb. 28, 2015USD ($)$ / sharesshares | Dec. 31, 2017USD ($)segmentshares | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |||||
Number of reportable segments | segment | 2 | ||||
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, shares issued | shares | 0 | ||||
Proceeds from initial public offering, net of offering costs | $ 79,900,000 | $ 79,900,000 | $ 0 | $ 0 | $ 80,435,430 |
Payments of stock issuance costs | $ 8,000,000 | ||||
Accumulated deficit | 111,079,275 | $ 76,645,613 | |||
Cash, cash equivalents, and marketable securities | $ 33,315,759 | ||||
IPO | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, shares issued | shares | 5,491,191 | 5,491,191 | |||
Common stock, price per share (in usd per share) | $ / shares | $ 16 | $ 16 | |||
Over-Allotment Option | |||||
Subsidiary, Sale of Stock [Line Items] | |||||
Common stock, shares issued | shares | 91,191 | 91,191 |
Summary of significant accoun42
Summary of significant accounting policies - Narrative (Details) | Feb. 03, 2015USD ($)$ / sharesshares | Feb. 28, 2015USD ($)$ / sharesshares | Jan. 31, 2015 | Mar. 31, 2017USD ($) | Sep. 30, 2016 | Dec. 31, 2017USD ($)segmentshares | Dec. 31, 2016USD ($)shares | Dec. 31, 2015USD ($) | Dec. 31, 2017USD ($)shares | Jan. 01, 2017USD ($) |
Entity Location [Line Items] | ||||||||||
Number of operating segments | segment | 2 | |||||||||
Revenue recognition, refund period | 21 days | 30 days | ||||||||
Sale discounts | $ 278,000 | $ 135,000 | $ 0 | |||||||
Advertising expenses | 3,566,000 | 2,936,000 | 0 | |||||||
Shipping and handling costs | 261,000 | 170,000 | 0 | |||||||
Deferred tax assets | $ 0 | 0 | $ 0 | |||||||
Common stock, shares issued | shares | 0 | |||||||||
IPO proceeds, net of issuance costs | $ 79,900,000 | $ 79,900,000 | $ 0 | $ 0 | $ 80,435,430 | |||||
Common stock, number of shares issued from conversion of preferred stock (shares) | shares | 6,971,108 | |||||||||
Common stock, shares authorized (shares) | shares | 100,000,000 | 100,000,000 | 100,000,000 | |||||||
IPO issuance costs | $ 1,848,737 | |||||||||
IPO underwriting discounts and commissions | $ 6,150,134 | |||||||||
Reverse stock split conversion ratio | 0.2335 | |||||||||
IPO | ||||||||||
Entity Location [Line Items] | ||||||||||
Common stock, shares issued | shares | 5,491,191 | 5,491,191 | ||||||||
Common stock, price per share (in usd per share) | $ / shares | $ 16 | $ 16 | ||||||||
Over-Allotment Option | ||||||||||
Entity Location [Line Items] | ||||||||||
Common stock, shares issued | shares | 91,191 | 91,191 | ||||||||
United States | ||||||||||
Entity Location [Line Items] | ||||||||||
Number of geographic segments | segment | 1 | |||||||||
Retained Earnings | Accounting Standards Update 2016-09 | ||||||||||
Entity Location [Line Items] | ||||||||||
Increase to retained earnings due to new accounting principle | $ 2,000 | |||||||||
U.S. Federal and State | ||||||||||
Entity Location [Line Items] | ||||||||||
Operating loss carryforwards that will increase additional paid in capital if used to reduce income taxes payable | $ 42,000 |
Summary of significant accoun43
Summary of significant accounting policies - Depreciation Over Estimated Useful Life (Details) | 12 Months Ended |
Dec. 31, 2017 | |
Computers and computer equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Manufacturing equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 3 years |
Minimum | Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 1 year |
Maximum | Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Estimated useful life | 2 years |
Summary of significant accoun44
Summary of significant accounting policies - Summary of changes in accumulated other comprehensive loss (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Accumulated Other Comprehensive Income (Loss), Net of Tax [Roll Forward] | |||
Equity, beginning balance | $ 59,317,386 | $ 92,192,408 | $ (6,538,340) |
Other comprehensive gain (loss) | 367 | 23,040 | (24,654) |
Equity, ending balance | 29,105,888 | 59,317,386 | 92,192,408 |
Accumulated Other Comprehensive Loss | |||
Accumulated Other Comprehensive Income (Loss), Net of Tax [Roll Forward] | |||
Equity, beginning balance | (1,614) | (24,654) | 0 |
Equity, ending balance | $ (1,247) | $ (1,614) | $ (24,654) |
Restricted cash (Details)
Restricted cash (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash | $ 126,595 | $ 126,595 |
Letter of Credit | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash | $ 126,595 | $ 126,595 |
Fair value measurements (Detail
Fair value measurements (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Marketable securities: | ||
Marketable securities | $ 14,129,723 | $ 38,658,933 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 5,046,205 | 11,681,074 |
Marketable securities: | ||
Total assets | 19,175,928 | 50,340,007 |
Fair Value, Measurements, Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 5,046,205 | 11,681,074 |
Marketable securities: | ||
Total assets | 5,046,205 | 11,681,074 |
Fair Value, Measurements, Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Marketable securities: | ||
Total assets | 14,129,723 | 38,658,933 |
Fair Value, Measurements, Recurring | Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 0 |
Marketable securities: | ||
Total assets | 0 | 0 |
Fair Value, Measurements, Recurring | U.S. government agency securities | ||
Marketable securities: | ||
Marketable securities | 8,986,259 | 31,059,491 |
Fair Value, Measurements, Recurring | U.S. government agency securities | Level 1 | ||
Marketable securities: | ||
Marketable securities | 0 | 0 |
Fair Value, Measurements, Recurring | U.S. government agency securities | Level 2 | ||
Marketable securities: | ||
Marketable securities | 8,986,259 | 31,059,491 |
Fair Value, Measurements, Recurring | U.S. government agency securities | Level 3 | ||
Marketable securities: | ||
Marketable securities | 0 | 0 |
Fair Value, Measurements, Recurring | Commercial paper | ||
Marketable securities: | ||
Marketable securities | 4,440,689 | 6,081,202 |
Fair Value, Measurements, Recurring | Commercial paper | Level 1 | ||
Marketable securities: | ||
Marketable securities | 0 | 0 |
Fair Value, Measurements, Recurring | Commercial paper | Level 2 | ||
Marketable securities: | ||
Marketable securities | 4,440,689 | 6,081,202 |
Fair Value, Measurements, Recurring | Commercial paper | Level 3 | ||
Marketable securities: | ||
Marketable securities | 0 | 0 |
Fair Value, Measurements, Recurring | Corporate debt securities | ||
Marketable securities: | ||
Marketable securities | 702,775 | 1,518,240 |
Fair Value, Measurements, Recurring | Corporate debt securities | Level 1 | ||
Marketable securities: | ||
Marketable securities | 0 | 0 |
Fair Value, Measurements, Recurring | Corporate debt securities | Level 2 | ||
Marketable securities: | ||
Marketable securities | 702,775 | 1,518,240 |
Fair Value, Measurements, Recurring | Corporate debt securities | Level 3 | ||
Marketable securities: | ||
Marketable securities | $ 0 | $ 0 |
Cash equivalents and marketab47
Cash equivalents and marketable securities (Details) | 12 Months Ended | |
Dec. 31, 2017USD ($)security | Dec. 31, 2016USD ($)security | |
Cash and Cash Equivalents [Abstract] | ||
Realized gains on marketable securities | $ 0 | $ 0 |
Marketable securities: | ||
Amortized Cost | 14,130,970 | 38,660,547 |
Unrealized Gains | 38 | 2,912 |
Unrealized Losses | (1,285) | (4,526) |
Fair Value | $ 14,129,723 | $ 38,658,933 |
Number of debt securities held | security | 6 | 6 |
Aggregate fair value of debt securities in an unrealized loss position | $ 8,191,315 | $ 16,519,620 |
Current Assets | U.S. government agency securities | ||
Marketable securities: | ||
Amortized Cost | 8,987,254 | 31,060,710 |
Unrealized Gains | 38 | 2,912 |
Unrealized Losses | (1,033) | (4,131) |
Fair Value | 8,986,259 | 31,059,491 |
Current Assets | Commercial paper | ||
Marketable securities: | ||
Amortized Cost | 4,440,689 | 6,081,202 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | 0 | 0 |
Fair Value | 4,440,689 | 6,081,202 |
Current Assets | Corporate debt securities | ||
Marketable securities: | ||
Amortized Cost | 703,027 | 1,518,635 |
Unrealized Gains | 0 | 0 |
Unrealized Losses | (252) | (395) |
Fair Value | $ 702,775 | $ 1,518,240 |
Inventory (Details)
Inventory (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2017 | Dec. 31, 2016 | |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 17,411 | $ 19,888 |
Finished goods | 414,480 | 434,244 |
Total inventory | 431,891 | 454,132 |
Write-off of inventory | $ 42,000 | $ 282,000 |
Property and equipment, net (De
Property and equipment, net (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 953,923 | $ 879,329 | |
Accumulated depreciation | (622,883) | (323,014) | |
Property and equipment, net | 331,040 | 556,315 | |
Depreciation expense | 324,548 | 277,231 | $ 49,881 |
Manufacturing equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 421,999 | 421,999 | |
Computers and computer equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 311,847 | 276,263 | |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 177,886 | 159,836 | |
Laboratory equipment | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | 13,368 | 13,368 | |
Capital in progress | |||
Property, Plant and Equipment [Line Items] | |||
Total property and equipment | $ 28,823 | $ 7,863 |
Accrued expenses and other cu50
Accrued expenses and other current liabilities (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Research and development costs | $ 2,502,400 | $ 938,665 |
Payroll and employee-related costs | 874,246 | 1,453,665 |
Professional fees | 227,980 | 153,219 |
Consumer product-related costs | 107,595 | 42,024 |
Total | $ 3,712,221 | $ 2,587,573 |
Commitments and contingencies -
Commitments and contingencies - Minimum future lease payments (Details) | Dec. 31, 2017USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2,018 | $ 466,593 |
2,019 | 311,062 |
Total minimum lease payments | $ 777,655 |
Commitments and contingencies52
Commitments and contingencies - Narrative (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Mar. 31, 2014 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Commitments and Contingencies Disclosure [Abstract] | |||||
Rent expense | $ 522,000 | $ 337,000 | $ 253,000 | ||
Percent of gross sales due to related parties | 2.00% | 2.00% | |||
Royalty expense | 25,000 | 20,000 | 0 | ||
Royalties payable | $ 3,000 | $ 4,000 | $ 0 |
Convertible preferred stock (De
Convertible preferred stock (Details) - USD ($) | 3 Months Ended | 4 Months Ended | 12 Months Ended | ||
May 31, 2014 | Oct. 31, 2014 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2014 | |
Class of Stock [Line Items] | |||||
Preferred stock, authorized (shares) | 10,000,000 | 10,000,000 | |||
Preferred stock, par value (in usd per share) | $ 0.0001 | $ 0.0001 | |||
Issuance of stock/IPO proceeds, net of issuance costs (shares) | 0 | ||||
Preferred stock, carrying value | $ 0 | $ 0 | |||
Series A Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Preferred stock, authorized (shares) | 16,000,000 | ||||
Preferred stock, par value (in usd per share) | $ 0.0001 | ||||
Issuance of stock/IPO proceeds, net of issuance costs (shares) | 15,775,221 | ||||
Preferred stock, carrying value | 15,637,032 | ||||
Convertible preferred stock, automatic conversion, minimum share price (in usd per share) | $ 1 | ||||
Net proceeds from issuance of convertible preferred stock | $ 15,637,032 | ||||
Series B Preferred Stock | |||||
Class of Stock [Line Items] | |||||
Preferred stock, authorized (shares) | 0 | 14,500,000 | |||
Preferred stock, par value (in usd per share) | $ 0.0001 | ||||
Issuance of stock/IPO proceeds, net of issuance costs (shares) | 14,078,647 | ||||
Preferred stock, carrying value | $ 25,394,135 | ||||
Convertible preferred stock, automatic conversion, minimum share price (in usd per share) | $ 1.81 | ||||
Net proceeds from issuance of convertible preferred stock | $ 25,394,135 |
Common stock - Narrative (Detai
Common stock - Narrative (Details) | 1 Months Ended | 12 Months Ended | |||
Apr. 30, 2014shares | Mar. 31, 2014USD ($)$ / sharesshares | Dec. 31, 2017USD ($)vote$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015USD ($)shares | |
Class of Stock [Line Items] | |||||
Common stock, shares authorized (shares) | 100,000,000 | 100,000,000 | |||
Common stock, par value (in usd per share) | $ / shares | $ 0.0001 | $ 0.0001 | |||
Common stock, number of votes per share | vote | 1 | ||||
Restricted common stock, shares sold | 0 | ||||
Stock issued under Employee Stock Purchase Plan | 0 | ||||
Unvested restricted common stock | |||||
Class of Stock [Line Items] | |||||
Restricted common stock, shares sold | 867,314 | 4,553,415 | |||
Restricted common stock, price per share (in usd per share) | $ / shares | $ 0.0004 | ||||
Proceeds from sale of restricted common stock to founders | $ | $ 1,950 | ||||
Restricted common stock, repurchase period | 90 days | ||||
Restricted common stock, repurchase price | $ / shares | $ 0.0004 | ||||
Restricted common stock, shares outstanding | 5,251,075 | ||||
Restricted common stock, fair value of shares vested | $ | $ 3,840,000 | $ 9,646,000 | $ 15,616,000 | ||
Issued, number of shares (shares) | 0 | ||||
Unvested restricted common stock | Vests upon issuance | |||||
Class of Stock [Line Items] | |||||
Restricted common stock, percent vested | 25.00% | ||||
Unvested restricted common stock | Vests ratably over four years | |||||
Class of Stock [Line Items] | |||||
Restricted common stock, percent vested | 75.00% | ||||
Restricted common stock, vesting period | 4 years | ||||
Non-employee Consultants and Advisers | Unvested restricted common stock | |||||
Class of Stock [Line Items] | |||||
Restricted common stock, shares outstanding | 12,860 | ||||
Restricted common stock, fair value of shares vested | $ | $ 22,000 | $ 71,000 | |||
Issued, number of shares (shares) | 0 | 18,194 | 0 |
Common stock - Restricted commo
Common stock - Restricted common stock activity (Details) - Unvested restricted common stock - $ / shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Beginning balance, non-vested, number of shares (shares) | 1,185,958 | ||
Issued, number of shares (shares) | 0 | ||
Vested, number of shares (shares) | (1,016,304) | ||
Forfeited, number of shares (shares) | 0 | ||
Ending balance, non-vested, number of shares (shares) | 169,654 | 1,185,958 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Beginning balance, non-vested, weighted average grant date fair value (in usd per share) | $ 0.10 | ||
Issued, weighted average grant date fair value (in usd per share) | 0 | ||
Vested, weighted average grant date fair value (in usd per share) | 0.10 | ||
Forfeited, weighted average grant date fair value (in usd per share) | 0 | ||
Ending balance, non-vested, weighted average grant date fair value (in usd per share) | $ 0.10 | $ 0.10 | |
Non-employee Consultants and Advisers | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Beginning balance, non-vested, number of shares (shares) | 10,834 | ||
Issued, number of shares (shares) | 0 | 18,194 | 0 |
Vested, number of shares (shares) | (5,500) | ||
Forfeited, number of shares (shares) | 0 | ||
Ending balance, non-vested, number of shares (shares) | 5,334 | 10,834 | |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Grant Date Fair Value [Abstract] | |||
Beginning balance, non-vested, weighted average grant date fair value (in usd per share) | $ 9.72 | ||
Issued, weighted average grant date fair value (in usd per share) | 0 | ||
Vested, weighted average grant date fair value (in usd per share) | 8.95 | ||
Forfeited, weighted average grant date fair value (in usd per share) | 0 | ||
Ending balance, non-vested, weighted average grant date fair value (in usd per share) | $ 10.51 | $ 9.72 |
Common stock - Shares reserved
Common stock - Shares reserved for future issuance (Details) - shares | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Stock [Line Items] | ||
Stock-based compensation awards | 3,439,820 | 2,722,573 |
Employee stock purchase plan | 534,274 | 354,569 |
Total | 4,149,082 | 4,273,934 |
Unvested restricted common stock | ||
Class of Stock [Line Items] | ||
Vesting of restricted common stock | 174,988 | 1,196,792 |
Stock-based compensation - Narr
Stock-based compensation - Narrative (Details) - USD ($) | 12 Months Ended | |||||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Sep. 30, 2014 | Apr. 30, 2014 | Mar. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 4,219,165 | $ 6,572,963 | $ 6,597,359 | |||
Shares granted (shares) | 1,059,500 | 763,320 | 994,748 | |||
Shares granted, weighted-average grant date fair value (in usd per share) | $ 2.80 | $ 6.35 | $ 8.55 | |||
Shares exercised (shares) | 1,576 | 8,516 | 47,280 | |||
Shares exercised, weighted average exercise price (in usd per share) | $ 1.67 | $ 2.59 | $ 8.63 | |||
Stock options exercised, intrinsic value | $ 2,606 | $ 64,302 | $ 149,386 | |||
Unrecognized compensation cost | $ 4,533,000 | |||||
Unrecognized compensation cost, recognition period | 2 years 3 months 4 days | |||||
Non-employee Stock Options | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares granted to non-employee consultants and members of the Scientific Advisory Board (shares) | 0 | 14,670 | 10,507 | |||
Stock options, vesting period | 4 years | |||||
Stock options, contractual term | 10 years | |||||
Stock-based compensation expense | $ 201,000 | $ 370,000 | $ 517,000 | |||
Options to purchase common stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options, contractual term | 10 years | |||||
Options to purchase common stock | Minimum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options, vesting period | 1 year | |||||
Options to purchase common stock | Maximum | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock options, vesting period | 4 years | |||||
Flex Pharma, Inc. 2014 Equity Incentive Plan | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Shares authorized (shares) | 2,070,200 | 1,451,087 | 116,754 | |||
Shares remaining available for grant of stock awards (shares) | 859,329 | |||||
Selling, General and Administrative Expenses [Member] | Options to purchase common stock | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Stock-based compensation expense | $ 285,000 |
Stock-based compensation - Summ
Stock-based compensation - Summary of stock option activity (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Shares | |||
Shares outstanding, beginning balance (shares) | 2,156,250 | ||
Shares granted (shares) | 1,059,500 | 763,320 | 994,748 |
Shares exercised (shares) | (1,576) | (8,516) | (47,280) |
Shares forfeited (shares) | (418,642) | ||
Shares expired (shares) | (215,041) | ||
Shares outstanding, ending balance (shares) | 2,580,491 | 2,156,250 | |
Shares exercisable (shares) | 1,404,844 | ||
Shares vested or expected to vest (shares) | 2,580,491 | ||
Weighted-Average Exercise Price | |||
Shares outstanding, beginning balance, weighted average exercise price (in usd per share) | $ 8.66 | ||
Shares granted, weighted average exercise price (in usd per share) | 4.20 | ||
Shares exercised, weighted average exercise price (in usd per share) | 1.67 | $ 2.59 | $ 8.63 |
Shares forfeited, weighted average exercise price (in usd per share) | 8.87 | ||
Shares expired, weighted average exercise price (in usd per share) | 10.51 | ||
Shares outstanding, ending balance, weighted average exercise price (in usd per share) | 6.65 | $ 8.66 | |
Shares exercisable, weighted average exercise price (in usd per share) | 7.21 | ||
Shares vested or expected to vest, weighted average exercise price (in usd per share) | $ 6.65 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Additional Disclosures [Abstract] | |||
Outstanding, weighted average remaining contractual term | 7 years 6 months 18 days | 7 years 11 months 9 days | |
Exercisable, weighted average remaining contractual term | 6 years 6 months 22 days | ||
Vested or expected to vest, weighted average remaining contractual term | 7 years 6 months 18 days | ||
Outstanding, aggregate intrinsic value | $ 803,600 | $ 1,605,684 | |
Exercisable, aggregate intrinsic value | 692,232 | ||
Vested or expected to vest, aggregate intrinsic value | $ 803,600 |
Stock-based compensation - Sche
Stock-based compensation - Schedule of fair value assumptions (Details) - Options to purchase common stock | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk-free interest rate, minimum (as a percent) | 1.83% | 1.23% | 1.62% |
Risk-free interest rate, maximum (as a percent) | 2.40% | 2.40% | 2.49% |
Expected dividend yield (as a percent) | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility (as a percent) | 73.87% | 71.01% | 72.98% |
Expected term (in years) | 5 years 3 months 18 days | 5 years 3 months 18 days | 5 years 3 months 18 days |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected volatility (as a percent) | 81.04% | 74.20% | 74.94% |
Expected term (in years) | 9 years 6 months | 10 years | 10 years |
Stock-based compensation - Su60
Stock-based compensation - Summary of stock-based compensation expense (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Employee Service Share-Based Compensation Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 4,219,165 | $ 6,572,963 | $ 6,597,359 |
Research and development | |||
Employee Service Share-Based Compensation Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | 1,545,737 | 2,435,565 | 3,192,063 |
Selling, general and administrative | |||
Employee Service Share-Based Compensation Allocation of Recognized Period Costs [Line Items] | |||
Stock-based compensation expense | $ 2,673,428 | $ 4,137,398 | $ 3,405,296 |
Income taxes - Schedule of effe
Income taxes - Schedule of effective income tax rate reconciliation (Details) | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Effective Income Tax Rate Reconciliation, Percent [Abstract] | |||
Federal income tax expense at statutory rate | 35.00% | 35.00% | 35.00% |
State income tax, net of federal benefit | 5.00% | 5.00% | 3.40% |
Permanent differences | (0.70%) | 0.00% | (0.20%) |
Stock-based compensation | (1.90%) | (2.60%) | (6.30%) |
Research credits | 2.20% | 1.90% | 1.80% |
Other, net | (1.30%) | (0.10%) | 0.40% |
Payroll Tax Credit Election | (0.70%) | 0.00% | 0.00% |
Change in valuation allowance | (1.10%) | (39.20%) | (34.10%) |
Deferred rate change | (36.50%) | 0.00% | 0.00% |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Income taxes - Schedule of defe
Income taxes - Schedule of deferred tax assets and liabilities (Details) - USD ($) | Dec. 31, 2017 | Dec. 31, 2016 |
Deferred tax assets: | ||
U.S. and state net operating loss carryforwards | $ 24,744,841 | $ 24,322,172 |
Accruals and other temporary differences | 202,301 | 529,462 |
Amortization | 35,783 | 32,171 |
Stock-based compensation | 1,591,131 | 1,847,441 |
Tax credit carryforward | 1,964,189 | 1,423,292 |
Total deferred tax assets | 28,538,245 | 28,154,538 |
Less valuation allowance | (28,533,755) | (28,127,611) |
Deferred tax assets | 4,490 | 26,927 |
Deferred tax liabilities: | ||
Stock-based compensation | (4,490) | (23,316) |
Depreciation | 0 | (3,611) |
Accruals and other temporary differences | 0 | 0 |
Deferred tax liabilities | (4,490) | (26,927) |
Net deferred tax assets | $ 0 | $ 0 |
Income taxes - Narrative (Detai
Income taxes - Narrative (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Decrease in net deferred tax asset | $ 12,600,000 | |
Net impact to income tax expense | 0 | |
Income Taxes [Line Items] | ||
Increase (decrease) in valuation allowance | 406,000 | |
Payroll tax credit | 22,000 | |
U.S. Federal | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | 91,200,000 | |
Research and development tax credit carryforwards | 1,600,000 | |
U.S. State | ||
Income Taxes [Line Items] | ||
Net operating loss carryforward | 90,400,000 | |
Operating loss carryforward tax affected | 7,100,000 | |
Research and development tax credit carryforwards | $ 428,000 | |
U.S. Federal and State | ||
Income Taxes [Line Items] | ||
Operating loss carryforwards that will increase additional paid in capital if used to reduce income taxes payable | $ 42,000 |
Net loss per share (Details)
Net loss per share (Details) - shares | 12 Months Ended | ||
Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share | 2,755,479 | 3,353,042 | 4,027,235 |
Options to purchase common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share | 2,580,491 | 2,156,250 | 1,824,973 |
Unvested restricted common stock | |||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Antidilutive securities excluded from computation of earnings per share | 174,988 | 1,196,792 | 2,202,262 |
Segment Information (Details)
Segment Information (Details) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Sep. 30, 2016USD ($) | Jun. 30, 2016USD ($) | Mar. 31, 2016USD ($) | Dec. 31, 2017USD ($)segment | Dec. 31, 2016USD ($) | Dec. 31, 2015USD ($) | |
Segment Reporting [Abstract] | |||||||||||
Number of reportable segments | segment | 2 | ||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | $ 282,828 | $ 413,601 | $ 335,523 | $ 242,547 | $ 298,904 | $ 599,074 | $ 112,685 | $ 0 | $ 1,274,499 | $ 1,010,663 | $ 0 |
Loss from operations | 8,092,960 | 9,409,452 | 8,876,965 | 8,346,249 | 7,984,267 | 10,735,220 | 11,470,951 | 9,695,794 | 34,725,626 | 39,886,232 | 29,213,658 |
Interest income, net | $ 64,429 | $ 77,339 | $ 72,342 | $ 77,854 | $ 84,232 | $ 97,726 | $ 107,818 | $ 103,333 | 291,964 | 393,109 | 72,028 |
Operating Segments | Consumer Operations | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 1,274,499 | 1,010,663 | 0 | ||||||||
Loss from operations | 8,877,330 | 10,023,137 | 7,892,584 | ||||||||
Interest income, net | 0 | 0 | 0 | ||||||||
Operating Segments | Drug Development | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 0 | 0 | 0 | ||||||||
Loss from operations | 16,715,752 | 19,620,338 | 12,224,692 | ||||||||
Interest income, net | 0 | 0 | 0 | ||||||||
Corporate | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenue | 0 | 0 | 0 | ||||||||
Loss from operations | 9,132,544 | 10,242,757 | 9,096,382 | ||||||||
Interest income, net | $ 291,964 | $ 393,109 | $ 72,028 |
Related parties (Details)
Related parties (Details) - USD ($) | 1 Months Ended | 12 Months Ended | |||
Mar. 31, 2014 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 | |
Related Party Transaction [Line Items] | |||||
Percent of gross sales due to related parties | 2.00% | 2.00% | |||
Royalty expense | $ 25,000 | $ 20,000 | $ 0 | ||
Royalties payable | $ 3,000 | 4,000 | 0 | ||
Affiliated Entity | |||||
Related Party Transaction [Line Items] | |||||
License fees received | $ 32,000 | $ 61,000 |
Quarterly financial informati67
Quarterly financial information (unaudited) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2016 | Sep. 30, 2016 | Jun. 30, 2016 | Mar. 31, 2016 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Quarterly Financial Information Disclosure [Abstract] | |||||||||||
Net product revenue | $ 282,752 | $ 407,241 | $ 330,688 | $ 240,292 | $ 291,099 | $ 586,134 | $ 112,685 | $ 0 | $ 1,260,973 | $ 989,918 | $ 0 |
Other revenue | 76 | 6,360 | 4,835 | 2,255 | 7,805 | 12,940 | 0 | 0 | 13,526 | 20,745 | 0 |
Total revenue | 282,828 | 413,601 | 335,523 | 242,547 | 298,904 | 599,074 | 112,685 | 0 | 1,274,499 | 1,010,663 | 0 |
Costs and expenses: | |||||||||||
Cost of product revenue | 133,343 | 148,756 | 145,325 | 79,106 | 133,706 | 221,090 | 110,931 | 197,020 | 506,530 | 662,747 | 0 |
Research and development | 4,259,357 | 4,739,360 | 4,076,220 | 3,914,974 | 4,230,804 | 5,665,357 | 6,094,921 | 4,387,079 | 16,989,911 | 20,378,161 | 12,749,379 |
Selling, general and administrative | 3,983,088 | 4,934,937 | 4,990,943 | 4,594,716 | 3,918,661 | 5,447,847 | 5,377,784 | 5,111,695 | 18,503,684 | 19,855,987 | 16,464,279 |
Total costs and expenses | 8,375,788 | 9,823,053 | 9,212,488 | 8,588,796 | 8,283,171 | 11,334,294 | 11,583,636 | 9,695,794 | 36,000,125 | 40,896,895 | 29,213,658 |
Loss from operations | (8,092,960) | (9,409,452) | (8,876,965) | (8,346,249) | (7,984,267) | (10,735,220) | (11,470,951) | (9,695,794) | (34,725,626) | (39,886,232) | (29,213,658) |
Interest income, net | 64,429 | 77,339 | 72,342 | 77,854 | 84,232 | 97,726 | 107,818 | 103,333 | 291,964 | 393,109 | 72,028 |
Net loss | $ (8,028,531) | $ (9,332,113) | $ (8,804,623) | $ (8,268,395) | $ (7,900,035) | $ (10,637,494) | $ (11,363,133) | $ (9,592,461) | $ (34,433,662) | $ (39,493,123) | $ (29,141,630) |
Net loss per share attributable to common stockholders - basic and diluted (in usd per share) | $ (0.46) | $ (0.54) | $ (0.51) | $ (0.49) | $ (0.48) | $ (0.65) | $ (0.71) | $ (0.61) | $ (1.99) | $ (2.43) | $ (2.08) |
Weighted-average number of common shares outstanding — basic and diluted (shares) | 17,642,646 | 17,386,249 | 17,130,264 | 16,873,512 | 16,619,596 | 16,361,617 | 16,105,555 | 15,843,532 | 17,260,626 | 16,233,985 | 14,032,916 |