Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 14, 2019 | Jun. 29, 2018 | |
Document and Entity Information | |||
Entity Registrant Name | Dova Pharmaceuticals Inc. | ||
Entity Central Index Key | 1,685,071 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Filer Category | Accelerated Filer | ||
Document Type | 10-K | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2,018 | ||
Document Fiscal Period Focus | FY | ||
Amendment Flag | false | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | true | ||
Entity Ex Transition Period | true | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 25,679,266 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Public Float | $ 392,411,990 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets | ||
Cash and equivalents | $ 104,566 | $ 94,846 |
Accounts receivables, net | 612 | 0 |
Inventory, net | 4,390 | 0 |
Prepaid Expense and Other Assets, Current | 2,239 | 1,471 |
Total current assets | 111,807 | 96,317 |
Furniture and equipment, net | 362 | 62 |
Total assets | 112,169 | 96,379 |
Current liabilities | ||
Accounts payable | 781 | 1,263 |
Accrued expenses | 11,935 | 2,520 |
Accrued interest | 79 | 1,005 |
Due to related party | 35 | 97 |
Early exercise liability, related party | 0 | 100 |
Note payable, short-term | 0 | 30,212 |
Current portion of long-term debt | 6,667 | 0 |
Total current liabilities | 19,497 | 35,197 |
Deferred revenue | 2,373 | 0 |
Long-term debt | 13,941 | 0 |
Total liabilities | 35,811 | 35,197 |
Commitments and contingencies | ||
Stockholders' equity | ||
Common stock, $0.001 par value; 100,000,000 shares authorized; 28,204,098 and 25,652,457 shares issued and outstanding as of December 31, 2018 and 2017, respectively | 28 | 26 |
Additional paid-in capital | 205,757 | 118,301 |
Accumulated deficit | (129,427) | (57,145) |
Total stockholders' equity | 76,358 | 61,182 |
Total liabilities and stockholders' equity | 112,169 | $ 96,379 |
Undesignated preferred stock | ||
Stockholders' equity | ||
Preferred stock, value | $ 0 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Common stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 28,204,098 | 25,652,457 |
Common stock, shares outstanding | 28,204,098 | 25,652,457 |
Series A preferred stock | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 0 | 0 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Undesignated preferred stock | ||
Preferred stock, par value (in dollars per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue: | ||||||||||
Revenue | $ 2,842 | $ 2,929 | $ 4,584 | $ 0 | $ 10,355 | $ 0 | ||||
Operating expenses: | ||||||||||
Cost of product sales | 291 | 370 | 519 | 0 | 1,180 | 0 | ||||
Research and development | 5,533 | 4,847 | 4,508 | 3,416 | $ 2,714 | $ 5,426 | $ 3,293 | $ 4,276 | 18,304 | 15,710 |
Selling, general and administrative | 16,064 | 17,031 | 18,565 | 10,261 | 6,454 | 4,185 | 1,905 | 955 | 61,921 | 13,499 |
Total operating expenses | 21,888 | 22,248 | 23,592 | 13,677 | 9,168 | 9,611 | 5,198 | 5,231 | 81,405 | 29,209 |
Loss from operations | (19,046) | (19,319) | (19,008) | (13,677) | (9,168) | (9,611) | (5,198) | (5,231) | (71,050) | (29,209) |
Other income (expense) | ||||||||||
Other income, net | 275 | 342 | (195) | 222 | 243 | 224 | (14) | 33 | 644 | 486 |
Interest expense | (561) | (546) | (454) | (315) | (375) | (336) | (295) | (226) | (1,876) | (1,232) |
Total other expenses, net | (286) | (204) | (649) | (93) | (132) | (112) | (309) | (193) | (1,232) | (746) |
Net loss | $ (19,332) | $ (19,523) | $ (19,657) | $ (13,770) | $ (9,300) | $ (9,723) | $ (5,507) | $ (5,424) | $ (72,282) | $ (29,955) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.69) | $ (0.69) | $ (0.70) | $ (0.52) | $ (0.36) | $ (0.38) | $ (0.32) | $ (0.31) | $ (2.60) | $ (1.40) |
Weighted average common shares outstanding, basic and diluted (in shares) | 28,204,098 | 28,203,222 | 28,194,046 | 26,589,192 | 25,652,457 | 25,290,709 | 17,332,257 | 17,332,257 | 27,803,175 | 21,435,369 |
Product sales, net | ||||||||||
Revenue: | ||||||||||
Revenue | $ 2,842 | $ 2,929 | $ 1,957 | $ 0 | $ 7,728 | $ 0 | ||||
Other revenue | ||||||||||
Revenue: | ||||||||||
Revenue | $ 0 | $ 0 | $ 2,627 | $ 0 | $ 2,627 | $ 0 |
Consolidated Statement of Stock
Consolidated Statement of Stockholders' Equity - USD ($) $ in Thousands | Total | IPO | Common stock | Common stockIPO | Additional paid-in capital | Additional paid-in capitalIPO | Accumulated deficit | Series A preferred stock |
Balance, beginning of the period at Dec. 31, 2016 | $ 6,795 | $ 17 | $ 33,967 | $ (27,190) | $ 1 | |||
Balance, beginning of the period (in shares) at Dec. 31, 2016 | 17,332,257 | 982,714 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock-based compensation | 5,633 | 5,633 | ||||||
Conversion of preferred stock into common stock | $ 4 | (3) | $ (1) | |||||
Conversion of preferred stock into common stock (in shares) | 3,242,950 | (982,714) | ||||||
Issuance of common stock in connection with stock offering, net of offering costs | 5,077,250 | |||||||
Issuance of common stock in connection with stock offering, net of offering costs | $ 78,709 | $ 5 | $ 78,704 | |||||
Net loss | (29,955) | (29,955) | ||||||
Balance, end of the period at Dec. 31, 2017 | 61,182 | $ 26 | 118,301 | (57,145) | $ 0 | |||
Balance, end of the period (in shares) at Dec. 31, 2017 | 25,652,457 | 0 | ||||||
Increase (Decrease) in Stockholders' Equity [Roll Forward] | ||||||||
Stock-based compensation | 12,490 | 12,490 | ||||||
Exercise of stock compensation awards (in shares) | 51,641 | |||||||
Exercise of stock compensation awards | 239 | 239 | ||||||
Issuance of common stock in connection with stock offering, net of offering costs | 2,500,000 | |||||||
Issuance of common stock in connection with stock offering, net of offering costs | 74,729 | $ 2 | 74,727 | |||||
Net loss | (72,282) | (72,282) | ||||||
Balance, end of the period at Dec. 31, 2018 | $ 76,358 | $ 28 | $ 205,757 | $ (129,427) | $ 0 | |||
Balance, end of the period (in shares) at Dec. 31, 2018 | 28,204,098 | 0 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Cash flows from operating activities | ||
Net loss | $ (72,282,000) | $ (29,955,000) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Research and development-licenses acquired, expensed | 0 | 1,000,000 |
Non-cash research and development expenses | 0 | 10,481,000 |
Depreciation | 32,000 | 0 |
Depreciation | 35,000 | 0 |
Amortization of debt discount and debt issuance costs | 646,000 | 0 |
Stock-based compensation | 12,490,000 | 5,633,000 |
Changes in operating assets and liabilities: | ||
Accounts receivable, net | (612,000) | 0 |
Inventory | (4,390,000) | 0 |
Prepaid expenses | (768,000) | (1,434,000) |
Accounts payable | (482,000) | 1,106,000 |
Accrued expenses | 10,280,000 | 1,404,000 |
Accrued interest | (926,000) | 854,000 |
Due to related party | (62,000) | 12,000 |
Deferred revenue | 2,373,000 | 0 |
Net cash used in operating activities | (53,666,000) | (10,899,000) |
Cash flows from investing activities | ||
Purchase of fixed assets | (367,000) | (62,000) |
Purchase of research and development licenses | 0 | (1,000,000) |
Net cash used in investing activities | (367,000) | (1,062,000) |
Cash flows from financing activities | ||
Payment of note payable | (31,077,000) | 0 |
Debt issuance costs | (38,000) | 0 |
Proceeds from the issuance of debt | 20,000,000 | 0 |
Payment of offering cost in connection with issuance of Series A preferred stock | 0 | (711,000) |
Proceeds from exercise of stock options | 139,000 | 100,000 |
Proceeds from the issuance of common stock | 80,000,000 | 86,313,000 |
Payment of offering cost in connection with issuance of common stock | (5,271,000) | (7,604,000) |
Net cash provided by financing activities | 63,753,000 | 78,098,000 |
Net increase in cash and equivalents | 9,720,000 | 66,137,000 |
Cash and equivalents at the beginning of the year | 94,846,000 | 28,709,000 |
Cash and equivalents at the end of the year | 104,566,000 | 94,846,000 |
Supplemental disclosure of cash flow information: | ||
Cash paid for interest | 2,156,000 | 377,000 |
Supplemental disclosure of noncash investing and financing activities: | ||
Shares issued from the early exercise of options | 100,000 | 0 |
Change in note payable | $ 0 | $ 16,572,000 |
Organization and description of
Organization and description of business operations | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Organization and description of business operations | Organization and description of business operations Dova Pharmaceuticals, Inc. (“Dova”) was originally formed as PBM AKX Holdings, LLC, a limited liability company formed under the laws of the State of Delaware on March 24, 2016 (“Inception”). PBM AKX Holdings, LLC changed its name to Dova Pharmaceuticals, LLC by filing a Certificate of Amendment to its Certificate of Formation with the State of Delaware on June 15, 2016 . Dova converted from a limited liability company to a corporation on September 15, 2016 . Dova is a pharmaceutical company focused on acquiring, developing and commercializing drug candidates for diseases that are treated by specialist physicians, with an initial focus on addressing thrombocytopenia, a disorder characterized by a low blood platelet count. On May 21, 2018 , the U.S. Food and Drug Administration (“FDA”) approved DOPTELET (avatrombopag), which is an orally administered thrombopoietin receptor agonist for the treatment of thrombocytopenia in adult patients with chronic liver disease (“CLD”) scheduled to undergo a procedure. The consolidated financial statements of the Company include the results of operations for the years ended December 31, 2018 and December 31, 2017 . Forward stock split On June 16, 2017 , the Company effected a 3.3 -for-one forward stock split of the Company’s common stock. No fractional shares were issued in connection with the stock split. The par value and other terms of the common stock were not affected by the stock split. All share and per share amounts, including stock options, have been retroactively adjusted in these consolidated financial statements for all periods presented to reflect the 3.3 -for-one forward stock split. Further, exercise prices of stock options have been retroactively adjusted in these consolidated financial statements for all periods presented to reflect the 3.3 -for-one forward stock split. The number of shares of the Company’s preferred stock were not affected by the forward stock split; however, the conversion ratios have been adjusted to reflect the forward stock split. Amendment and restatement of certificate of incorporation and bylaws On July 5, 2017 , the Company filed an Amended and Restated Certificate of Incorporation (the “Amended Certificate”) and Amended and Revised Bylaws (“Amended Bylaws”) with the Secretary of State of the State of Delaware in connection with the closing of the Company’s initial public offering (the “IPO”). The Amended Certificate amends and restates in its entirety the Company’s Amended and Restated Certificate of Incorporation, as amended, and the Amended Bylaws amend and restate, in their entirety, the Company’s Bylaws. Collectively, the Amended Certificate and the Amended Bylaws, among other things: (i) authorize 100,000,000 shares of common stock; (ii) eliminate all references to the previously existing series of preferred stock; and (iii) authorize 10,000,000 shares of undesignated preferred stock that may be issued from time to time by the Board in one or more series. |
Significant accounting policies
Significant accounting policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Significant accounting policies | Significant accounting policies Basis of presentation and principles of consolidation The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). Liquidity and capital resources The Company has incurred substantial operating losses since inception and expects to continue to incur significant operating losses for the foreseeable future and may never become profitable. As of December 31, 2018 and December 31, 2017, the Company had accumulated deficits of $129.4 million and $57.1 million , respectively. Since inception, the Company has financed its operations through the issuance of equity and debt with net aggregate proceeds of $238.0 million. Although the Company began generating revenue from product sales of DOPTELET in June 2018, the Company does not expect product revenue to be sufficient to satisfy its operating needs for several years, if ever. As of December 31, 2018 and December 31, 2017, the Company had cash and equivalents of $104.6 million and $94.8 million , respectively. As of the filing of the 2017 Form 10-K, substantial doubt existed about the Company’s ability to continue as a going concern. The 2017 financial statements were prepared on a going concern basis, which contemplated the realization of assets and satisfaction of liabilities in the normal course of business. The 2017 financial statements did not include any adjustments relating to the recoverability and classification of recorded assets amounts or the amounts and classification of liabilities that might have resulted from the outcome of that uncertainty. On February 27, 2018, the Company completed an underwritten public offering of 2,500,000 shares of its common stock with net proceeds of approximately $74.7 million , after deducting underwriting discounts and commissions and other offering expenses (Note 6). In addition, on April 17, 2018, the Company and its wholly owned subsidiary, AkaRx (collectively “Co-Borrowers”), entered into a Loan and Security Agreement with Silicon Valley Bank (“Term Loan”) pursuant to which the Co-Borrowers borrowed $20.0 million (Note 9). Additionally, on May 21, 2018 DOPTELET was approved by FDA and on June 4, 2018, the Company began commercial sales of DOPTELET. Based on its current cash position, as well as its forecast of future cash flows, the Company believes that it has adequate cash and equivalents to continue to fund operations in the normal course of business for at least the next 12 months. Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s consolidated financial statements relate the valuation of stock options, and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one reportable segment, i.e., the development and commercialization of DOPTELET for the treatment of thrombocytopenia. All of the Company's assets and revenue are in the United States. The Company relies primarily on six specialty distributors to purchase and supply the majority of DOPTELET. These six pharmaceutical specialty distributors accounted for greater than 90% of all DOPTEET net product sales in the year ended December 31, 2018 and accounted for predominantly all of the Company’s outstanding accounts receivables from product sales as of December 31, 2018. The loss of one or more of these specialty distributors as a customer could negatively impact the commercialization of DOPTELET. Cash and equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and equivalents include cash held in banks and money market mutual funds and are classified as Level 1 investments. Inventory Inventory acquired prior to receipt of the FDA approval for DOPTELET was expensed as research and development ("R&D") expense as incurred. The Company began capitalizing inventory upon receipt of FDA approval on May 21, 2018 . Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory consists of work-in-process, and DOPTELET finished goods. The Company currently purchases inventory from Eisai under a long term supply agreement (see Note 4) for work in progress and finished drug product and is the greater of a fixed payment per tablet or a payment calculated in the mid-single digit percentages of net sales of DOPTELET. The Company reduces its inventory to net realizable value for potentially excess, dated or obsolete inventory based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life. At December 31, 2018 , the Company determined that no write downs to inventory for potentially excess, dated or obsolete inventory were required. The Company’s inventory at December 31, 2018 consists of $1.7 million of work in progress and $1.7 million of finished goods. Research and development prepaid and accrued expenses As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its R&D efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. During the course of a clinical trial, the Company adjusts its rate of clinical trial expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. The Company’s clinical trial prepaid and accrual expense is dependent upon the timely and accurate reporting of fee billings and pass-through expenses from contract research organizations and other third-party vendors as well as the timely processing of any change orders from the contract research organizations. Concentrations of credit risk and off-balance sheet risk Cash and equivalents are financial instruments that are potentially subject to concentrations of credit risk. The Company’s cash and equivalents are deposited in accounts at large financial institutions, and amounts may exceed federally insured limits. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash and equivalents are held. The Company has no financial instruments with off-balance sheet risk of loss. Risk and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of results of clinical trials and reaching milestones, uncertainty of market acceptance of the Company’s products, competition from substitute products and larger companies, protection of proprietary technology, strategic relationships, and dependence on key individuals. Products developed by the Company require approvals from FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the products will receive the necessary approvals for future indications of DOPTELET. If the Company is denied approval, approval is delayed, or the Company is unable to maintain approval, it could have a materially adverse impact on the Company. The Company has expended and will continue to expend substantial funds to conduct research, development, and clinical testing of its product candidates. The Company also will also expend additional funds to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds to conduct research and development activities and commercialize its products. Additional funds may not be available on acceptable terms, if at all. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs or alter its product commercialization plans, which may materially and adversely affect its business, financial condition, and operations. Research and development costs R&D expenses for the year ended December 31, 2018 include direct and indirect R&D costs. Direct R&D costs consist principally of external costs, such as fees paid to investigators, consultants, central laboratories and clinical research organizations, including costs incurred in connection with clinical trials, and related clinical trial fees and all employee-related expenses for those employees working in R&D functions, including stock-based compensation for R&D personnel. Indirect R&D costs include insurance or other indirect costs related to the Company’s R&D function to specific product candidates. The Company expenses pre-approval inventory as R&D until regulatory approval is received. Property and Equipment Property and equipment, which consists mainly of furniture and computers, are carried at cost less accumulated depreciation. Depreciation is computed over the estimated useful lives of the respective assets, generally one to five years, using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is reflected in operations in the period realized. Fair value measurement ASC 820, Fair Value Measurements , provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The carrying amount of the Company’s financial instruments, including cash and equivalents and accounts payable approximate their fair values. As of December 31, 2018 and 2017 , the carrying amount of the Note approximates fair value as its interest rate approximates current market rates that could be obtained by the Company with a similar guarantee by PBM Capital Investments, LLC (Level 2 inputs). No transfer of assets between Level 1 and Level 2 of the fair value hierarchy occurred during the year ended December 31, 2018 . Revenue recognition Effective January 1, 2018 , the Company adopted the provisions of Accounting Standard Codification (“ASC”) Topic 606, Revenue from Contracts with Customers. The guidance provides a unified model to determine how revenue is recognized. Product sales The Company is currently approved to sell DOPTELET in the United States market. The product is distributed through an exclusive distribution model with Integrated Commercialization Solutions (“ICS”). ICS sells DOPTELET to a limited number of specialty pharmacies (“customers”), who have agreements in place with the Company. Patients and healthcare providers purchase the product from the specialty pharmacy providers. (See Note 8 “Significant agreements and contracts” for more information on the Company’s agreement with ICS). The Company recognizes revenue on product sales when the control of the Company’s product passes to its customers, which occurs at a point in time, upon delivery to the customers, or over time depending on the nature of the contract. The Company has determined that the delivery of its product to its customers constitutes a single performance obligation as there are no other promises to deliver goods or services. Shipping and handling activities are considered to be fulfillment activities and are not considered to be a separate performance obligation. The Company has assessed the existence of a significant financing component in the agreements with its customers. The trade payment terms with its customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, government chargebacks, discounts and rebates, and other incentives, such as voluntary patient assistance, and other fee for service amounts that are detailed within contracts between the Company and its customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable or a current liability. These reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. Revenue from product sales is recorded after considering the impact of the following variable consideration amounts at the time of revenue recognition: Trade discounts and distribution fees : Trade discounts relate to prompt settlement discounts provided to ICS and the customers. Distribution fees include fees paid to ICS for the distribution of the product (which is based on a percentage of sales). In addition, the Company compensates its customers for data and other activities. The Company has determined that such services received to date are not distinct from its sale of products and may not reasonably represent fair value for these services. Therefore, estimates of these payments are recorded as a reduction of revenue based on contractual terms. Product returns : Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company based on the product’s expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as within accrued expenses on the condensed consolidated balance sheets. The Company currently estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has not received any returns to date. Government rebates and chargebacks : The Company contracts with Medicaid, Medicare, U.S. Department of Veterans Affairs, 340b entities and other government agencies (“Government Payors”) so that DOPTELET will be eligible for purchase by, or partial or full reimbursement from, such Government Payors. The Company estimates the rebates, chargebacks and discounts it will provide to Government Payors and deducts these estimated amounts from its gross product revenue at the time the revenue is recognized. The Company estimates these reserves based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company estimates the rebates, chargebacks and discounts that it will provide to Government Payors based upon (i) the government-mandated discounts applicable to government-funded programs, (ii) information obtained from its customers and (iii) information obtained from other third parties regarding the payor mix for DOPTELET. The Company’s liability for these rebates consists of estimates of claims for the current year and estimated future claims that will be made for product shipments that have been recognized as revenue but remain in the distribution channel inventories at the end of each reporting period. Other incentives : Other incentives which the Company offers include voluntary patient assistance and assurance programs, such as a co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets. Strategic agreements The Company’s other revenue consists of revenue from the Company’s strategic agreements for the development and commercialization of DOPTELET. The terms of the agreements typically include non-refundable upfront fees, payments based upon achievement of milestones and eventually revenue from the commercialized product. These agreements usually have both fixed and variable consideration. Non-refundable upfront fees are considered fixed, while milestone payments and revenue from the commercialized product are identified as variable consideration. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under these agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606. The Company’s performance obligations include intellectual property rights, development services, and services associated with regulatory submission and approval processes. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. As part of the accounting for these arrangements, the Company develops assumptions that require judgment to determine the estimated selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the selling price on a standalone basis, which may include forecasted revenue, development timelines, and probabilities of regulatory success. The Company allocates the total transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation. If the right to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the right when the right is transferred to the customer, and the customer can use and benefit from the right. For rights that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. At the inception of the arrangement, the Company evaluates whether the development milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. Stock-based compensation The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company historically has been a private company and lacks company-specific historical and implied volatility information. Therefore, the most significant subjective assumptions are management’s estimates of the expected volatility and the expected term of the award. The Company estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. Due to the lack of historical exercise history, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to nonemployees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. Prior to the IPO, the fair values of the shares of common stock underlying the Company options were estimated on each grant date by the Company. In order to determine the fair value, the Company considered, among other things, contemporaneous valuations of the Company’s common stock and preferred stock, the Company’s business, financial condition and results of operations, including related industry trends affecting its operations; the likelihood of achieving a liquidity event, such as an IPO, or sale, given prevailing market conditions; the lack of marketability of the Company’s common stock; the market performance of comparable publicly traded companies; and U.S. and global economic and capital market conditions. Since the IPO, the fair value of the common stock underlying the Company’s options has been based upon the closing price of the Company’s common stock on the grant date. Income taxes On September 15, 2016 , Dova converted from an LLC to a C-corporation. Prior to September 15, 2016 , Dova Pharmaceuticals, LLC elected to be taxed as a partnership. Therefore, Dova was not subject to income taxes until its conversion to a C-corporation on September 15, 2016 . AkaRx was subject to income taxes from April 1, 2016 through December 31, 2016 . For the 2016 tax year, Dova and AkaRx did not file consolidated or combined federal and state income tax returns. Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. 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 would more likely than not be realized assuming examination by the taxing authority. 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. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Tax Income , states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis difference expected to reverse as global intangible low-taxed income (“GILTI”) in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI as a period expense in the year the tax is incurred. Net loss per share Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same. The computations of diluted net loss per common share for the years ended December 31, 2018 and 2017 did not include stock options to purchase 2,613,228 and 2,128,641 shares of common stock, respectively, and did not include restricted stock units to purchase 3,521 and 0 shares of common stock, respectively, as the inclusion of these securities would have been antidilutive. Recent accounting pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-2, Leases (Topic 842), which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the estimated term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases. The Company will adopt ASU 2016-2 in the first quarter of 2019. The Company is in the process of finalizing the impact of adoption of the ASU on its consolidated financial statements, and it has determined that the most significant change will be related to the recognition of right-of-use assets and lease liabilities on the Company’s balance sheet for real estate operating leases. In May 2017, the FASB issued ASU 2017-9, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting, which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The Company adopted ASU 2017-9 as of January 1, 2018 . The adoption of this standard did not impact the Company’s consolidated financial statements and disclosures. In June 2018, the FASB issued ASU 2018-7, “Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for share-based payments granted to nonemployees for goods and services. Under the ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. The changes take effect for public companies for fiscal years starting after December 15, 2018, including interim periods within that fiscal year. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company expects that the adoption of this ASU would not have a material impact on the Company’s consolidated financial st |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Balance Sheet Components | Balance Sheet Components Prepaid expenses and other current assets December 31, 2018 2017 Insurance $ 627 $ 425 Deposits 385 28 Software 343 34 Clinical trials 315 767 Prepaid other 569 217 Prepaid expenses and other current assets $ 2,239 $ 1,471 Furniture and equipment, net December 31, 2018 2017 Leasehold improvements $ 224 $ — Furniture and equipment 33 66 Tooling 136 — 393 66 Less: accumulated depreciation 31 4 Furniture and equipment, net $ 362 $ 62 Accrued expenses December 31, 2018 2017 DOPTELET purchases $ 2,828 $ — Employee related 2,175 902 Rebates and other sales deductions 1,838 956 Clinical trials 1,574 — Selling and marketing 1,282 — Other 2,238 662 Accrued expenses $ 11,935 $ 2,520 |
The purchase agreement and rela
The purchase agreement and related transactions | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
The purchase agreement and related transactions | The purchase agreement and related transactions Purchase agreement with Eisai Dova entered into a Purchase Agreement dated March 29, 2016 with Eisai for all of the issued and outstanding shares of the capital stock of AkaRx. The terms of the Purchase Agreement included (i) an up-front payment of $5.0 million that was paid at closing and funded by a capital contribution by the Company’s sole member, PBM Capital Investments, LLC, (ii) milestone payments up to $135.0 million in the aggregate based on annual net sales of avatrombopag, and (iii) a commitment to negotiate in good faith to secure a long-term supply agreement with Eisai to govern manufacturing support and the purchase of avatrombopag from Eisai until the later of March 30, 2021 or the third anniversary of the commercialization of avatrombopag. The transaction was accounted for as an asset acquisition pursuant to ASU 2017-1, Business Combinations (Topic 805), Clarifying the Definition of a Business, as the majority of the fair value of the assets acquired was concentrated in a group of similar assets, and the acquired assets did not have outputs or employees. The assets acquired under the Purchase Agreement included a license to avatrombopag, other associated intellectual property, inventory, documentation and records, and related materials. The potential milestone payments based on annual net sales are not yet considered probable, and no milestone payments have been accrued at December 31, 2018 or December 31, 2017 . Long-term supply agreement with Eisai In June 2017, the Company entered into a supply agreement with Eisai, pursuant to which the Company agreed to purchase finished drug product of DOPTELET from Eisai and Eisai agreed to supply finished drug product of DOPTELET. The initial term of the agreement will expire on May 31, 2021. After the initial term, the supply agreement may be renewed by mutual agreement of the parties. During the initial term, Eisai is the Company’s exclusive supplier of finished drug product of DOPTELET, except that the Company has the right to terminate the exclusivity early by payment to Eisai of a fee calculated based on the Company’s forecasted purchases of DOPTELET during the remainder of the initial term. In addition, in the event that Eisai fails to deliver substantially all of the finished drug product due to the Company under the agreement, the Company may elect to seek alternative supply arrangements so long as such failure remains uncured, subject to certain exceptions. The aggregate payments to Eisai under the supply agreement for finished drug product will be the greater of a fixed payment per tablet or a payment calculated in the mid-single digit percentages of net sales of DOPTELET. Amended and Restated Transition Services Agreement with Eisai and an Additional Work Order On October 1, 2018 , the Company and Eisai entered into an Amended and Restated Transition Services Agreement (the “Amended TSA”) and an Additional Work Order (“Work Order”), dated as of April 1, 2018 , pursuant to which Eisai has agreed to provide services to the Company after the expiration of the original Transition Services Agreement by and between Eisai and the Company, dated March 30, 2016 (the "TSA"), which expired on March 31, 2018 . Under the Work Order, Eisai has agreed to provide certain regulatory, CMC, nonclinical, clinical pharmacology, and statistical services to the Company in order to support the Company's new drug application and marketing authorization application to the European Medicines Agency for the period from April 1, 2018 through June 30, 2019 . Pursuant to the Amended TSA, the Company is obligated to pay Eisai for services provided by Eisai personnel based on a fixed payment schedule. To the extent that service fees and out-of-pocket costs payable by the Company to Eisai under the Amended TSA exceed $51.0 million, the Company's obligation to pay milestone payments under the Eisai Purchase Agreement will be reduced. As of December 31, 2018 , the Company has incurred $31.9 million under the TSA and the Amended TSA. The Company may terminate the services provided under the Amended TSA on a service-by-service basis or the agreement in its entirety upon 60-days’ written notice. The Amended TSA may also be terminated (i) by mutual consent, (ii) by either party upon 60-days’ written notice if the other party materially breaches the agreement, (iii) by either party in the event of the other party’s bankruptcy, insolvency or certain similar occurrences and (iv) by either party in the event that such party is unable to perform its obligations under the agreement as a result of events outside of its reasonable control. Eisai note and security agreement On March 30, 2016 , the Company issued a Note to Eisai, which had an interest rate of 5% per annum, and enabled the Company to finance payments due to Eisai under the TSA for all costs incurred through December 31, 2017. The principal amount of the Note was increased on a quarterly basis by the amount of unpaid service fees and out-of-pocket expenses due and owed to Eisai under the TSA. The total aggregate spend through this Note was $31.1 million and on March 16, 2018 , this principal balance along with accumulated interest of $1.3 million was repaid in full. License agreement with Astellas Pharma Inc. The primary intellectual property related to avatrombopag is licensed from Astellas Pharma Inc. (“Astellas”) on an exclusive, worldwide basis under the terms of a license agreement that the Company acquired from Eisai under the Purchase Agreement. Under the terms of the license agreement, the Company is required to make payments upon the achievement of certain milestones. On September 21, 2017 , upon the submission of the NDA, the Company became obligated to make a milestone payment of $1.0 million within 30 days, which was expensed and included in research and development expense. The milestone payment of $1.0 million was made on October 20, 2017 . The Company will be required to make additional aggregate milestone payments of up to $4.0 million to Astellas if certain other regulatory milestones are achieved. In addition, the Company will be required to pay Astellas tiered royalties ranging from the mid to high single digits on net sales of avatrombopag. No amounts have been accrued for any potential milestone payments as the payments were not deemed probable. Unless earlier terminated, this license agreement with Astellas will expire on a country-by-country and product-by-product basis upon the latest of (i) the expiration of the last-to-expire claim of the licensed patents, (ii) the expiration of any government-granted marketing exclusivity period for avatrombopag, and (iii) 10 years after the last date of launch of avatrombopag to have occurred in any country. Thereafter, the term of the license agreement may be extended for successive one -year terms if the Company notifies Astellas in writing of its desire to extend such term at least three months before it is otherwise set to expire. |
Related party agreements
Related party agreements | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related party agreements | Related party agreements Dova and AkaRx management services agreements On April 1, 2016 , Dova and AkaRx each entered into a Services Agreement (each, an “SA”) with PBM Capital Group, LLC. Pursuant to the terms of each of the SAs, which have terms of 12 months each (and are automatically renewable for successive one -year periods), PBM Capital Group, LLC will render advisory and consulting services to Dova and AkaRx. Services provided under the SAs may include certain scientific and technical, accounting, operations and back office support services. In consideration for these services, Dova and AkaRx are each obligated to pay PBM Capital Group, LLC a monthly management fee of $25,000 . On March 30, 2018 , the SA agreement between AkaRx and PBM Capital Group, LLC was terminated. Effective April 1, 2018 , the monthly management fee for the SA between Dova and PBM Capital Group, LLC was reduced to $17,400 . For the years ended December 31, 2018 and December 31, 2017 , the Company incurred expenses under the SAs of $306,600 and $600,000 , respectively, which were included in selling, general and administrative expenses. As of December 31, 2018 and December 31, 2017 , the Company owed PBM Capital Group, LLC and its affiliates approximately $34,800 and $97,000 , respectively. |
Stockholders' equity
Stockholders' equity | 12 Months Ended |
Dec. 31, 2018 | |
Stockholders' Equity Note [Abstract] | |
Stockholders' equity | Stockholders’ equity Series A preferred stock Between September 19, 2016 and November 18, 2016 , the Company closed on the sale of an aggregate of 982,714 shares of Series A preferred stock for gross proceeds of $29.0 million (at a purchase price of $29.51 per share). The Series A preferred stock was entitled to non-cumulative, non-compounding dividends at 8.0% per annum (based on the original issue price), when, as and if any dividends are declared by the Board. Each share of Series A preferred stock was convertible, at the option of the holder and at any time, into a number of fully paid and non-assessable shares of common stock determined by dividing the Series A Original Issue Price by the Series A Conversion Price in effect at the time of conversion. The Series A preferred stock was mandatorily convertible under certain conditions (i) when the Company issued shares of common stock in a public offering generating gross proceeds of at least $60.0 million to the Company, at a price per share of at least $17.88 , or (ii) by majority vote of the then outstanding shares of Series A preferred stock. The Series A Conversion Price was $8.94 and was subject to adjustment based on events including the issuance of additional equity securities, certain dividends and distributions, mergers and reorganizations, and stock splits and combinations. The Series A preferred stock was not mandatorily redeemable and did not embody an unconditional obligation to settle in a variable number of equity shares. As such, the Series A preferred stock was classified as permanent equity on the consolidated balance sheet. The holders’ contingent redemption right in the event of certain deemed liquidation events did not preclude permanent equity classification. Further, the Series A preferred stock was considered an equity-like host for purposes of assessing embedded derivative features for potential bifurcation. The embedded conversion feature is considered to be clearly and closely related to the associated preferred stock host instrument and therefore was not bifurcated from the equity host. The contingent put right upon certain deemed liquidation events was not clearly and closely related to the associated preferred stock host instrument but did not meet the definition of a derivative and therefore was not bifurcated from the equity host. Upon the closing of the IPO on July 5, 2017 , all outstanding shares of the Company’s Series A convertible preferred stock were automatically converted into 3,242,950 shares of the Company’s common stock. Common Stock On July 5, 2017 , the Company closed its IPO, which resulted in the issuance and sale of 5,077,250 shares of its common stock at a public offering price of $17.00 per share, generating net proceeds of approximately $78.7 million after deducting underwriting discounts and other offering costs. On February 27, 2018 , the Company completed an underwritten public offering of 2,500,000 shares of its common stock at an offering price of $32.00 per share. Net proceeds raised by the Company from the offering were approximately $74.7 million , after deducting underwriting discounts and commissions and other offering expenses. Common stockholders are entitled to dividends as and when declared by the board of directors, subject to the rights of holders of all classes of stock outstanding having priority rights as to dividends. There have been no dividends declared to date. Each share of common stock is entitled to one vote. |
Stock-based compensation
Stock-based compensation | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-based compensation | Stock-based compensation Options The Company maintains the Amended and Restated 2017 Equity Incentive Plan (“2017 Equity Incentive Plan”). The 2017 Equity Incentive Plan provides for the grant of incentive stock options to employees, and for the grant of nonstatutory options, restricted stock awards, restricted stock unit awards, stock appreciation rights, performance-based stock awards and other forms of stock awards to employees, including officers, consultants and directors. The 2017 Equity Incentive Plan also provides for the grant of performance-based cash awards to employees, including officers, consultants and directors. The Company’s stock options generally vest as follows: 25% after 12 months of continuous services and the remaining 75% on a ratable basis over a 36-month period from 12 months after the grant date. Stock options granted during the 12 months ended December 31, 2018 and 2017 have a maximum contractual term of 10 years. On December 19, 2018 , the Board adopted an amendment to the Company’s 2017 Equity Incentive Plan (as amended, the “Amended Plan”), which became effective immediately, pursuant to which the Company reserved 1,250,000 shares of the Company’s common stock for issuance as inducement awards (the “Inducement Pool”). The only persons eligible to receive grants of Awards (as defined below) from the Inducement Pool are individuals who satisfy the standards for inducement grants under Nasdaq Marketplace Rule 5635(c)(4) and the related guidance under Nasdaq IM 5635-1, including individuals who were not previously an employee or director of the Company or are following a bona fide period of non-employment, in each case as an inducement material to such individual’s agreement to enter into employment with the Company. An “Award” is any right to receive the Company’s common stock from the Inducement Pool, consisting of nonstatutory stock options and restricted stock unit awards. Options granted under the Inducement Plan may have terms of up to ten years. Consistent with the Amended Plan, options granted generally vest over four years and vest at a rate of 25% upon the first anniversary of the issuance date and 1/48th per month thereafter. There have been no issuances from the Inducement Pool for the year ended December 31, 2018 . The Company has initially reserved 4,285,250 shares of common stock for issuance under the Amended Plan, which is the sum of (1) 2,000,000 new shares from the IPO Plan, plus (2) the number of shares reserved for issuance under the Company’s 2017 Plan at the time the IPO Plan became effective, plus (3) any shares subject to outstanding stock options or other stock awards that would have otherwise returned to the 2017 Plan (such as upon the expiration or termination of a stock award prior to exercise). The number of shares of common stock reserved for issuance under the Amended Plan will automatically increase on January 1 each year, for a period of ten years, from January 1, 2018 through January 1, 2027, by 4% of the total number of shares of the Company’s common stock outstanding on December 31 of the preceding calendar year, or a lesser number of shares as may be determined by the Board. As of December 31, 2018 , 2,877,263 shares were available for grant under the Amended Plan. As of December 31, 2018 , options to purchase 3,526,433 shares of the Company’s common stock were outstanding at a weighted average exercise price of $13.25 per share. Option awards The fair value of the Company’s option awards were estimated using the assumptions below: For the year ended For the year ended December 31, December 31, 2018 2017 Exercise price $6.07 - $33.47 $3.73 - $26.70 Risk-free rate of interest 2.41% - 3.18% 1.71% - 2.23% Term (years) 5.0 - 7.2 5.2 - 7.1 Expected stock price volatility 63.60% - 87.67% 87.21% - 89.38% The following table summarizes the Company’s stock option activity under the 2017 Plan and Amended Plan for the year ended December 31, 2018 : Total options Weighted average Weighted average Aggregate Outstanding as of December 31, 2016 — $ — — $ — Employee options granted 2,128,641 7.9 9.4 44,481,000 Outstanding as of December 31, 2017 2,128,641 — 9.4 44,481,000 Employee options granted 2,302,650 15.75 9.4 1,888,000 Employee options exercised (51,641 ) 4.62 — — Employee options forfeited (853,217 ) 7.17 — — Outstanding as of December 31, 2018 3,526,433 $ 13.25 9.2 $ 5,200,000 Options vested and exercisable as of December 31, 2018 830,542 $ 8.61 8.4 $ 2,344,000 The aggregate intrinsic value in the above table is calculated as the difference between fair value of the Company’s closing common stock price on December 31, 2018 , or $7.58 per share, and the exercise price of the stock options that had strike prices below $7.58 per share. The weighted average grant date fair value per share of options granted during the year ended December 31, 2018 was $10.52 . The weighted average remaining contractual term of exercisable options is approximately 8.4 years at December 31, 2018 . The total fair value of options that vested under the Amended Plan during the years ended December 31, 2018 was approximately $8.2 million. No options vested during the year ended December 31, 2017 . As of December 31, 2018 , there was approximately $17.0 million of total unrecognized compensation expense, related to the unvested stock options shown in the table above, which is expected to be recognized over a weighted average period of 1.1 years . Restricted Stock Units Certain employees and consultants have been awarded restricted stock units with time-based vesting. During the year ended December 31, 2018, the Company granted 107,083 restricted stock units, with a weighted average grant date fair value of $6.07 . As of December 31, 2018, none of the restricted stock units had vested. As of December 31, 2018 , the Company had unrecognized stock-based compensation expense related to restricted stock units of approximately $0.6 million with a weighted average vesting period of approximately 0.5 years . The expense is recognized over the vesting period of the award. Stock-based compensation expense has been reported in the Company’s consolidated statements of operations for the years ended December 31, 2018 and December 31, 2017 as follows (in thousands): For the year ended For the year ended December 31, December 31, 2018 2017 Cost of product sales 292 — Research and development 2,145 1,247 Selling, general and administrative 10,053 4,386 Total stock-based compensation 12,490 5,633 |
Significant agreements and cont
Significant agreements and contracts | 12 Months Ended |
Dec. 31, 2018 | |
Revenue from Contract with Customer [Abstract] | |
Significant agreements and contracts | Significant agreements and contracts Distribution Agreement with Fosun On March 16, 2018 , the Company, through its wholly-owned subsidiary, AkaRx entered into an agreement by which it granted Shanghai Fosun Pharmaceutical Industrial Development Co., Ltd., a wholly owned subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd., (collectively, “Fosun”) the exclusive development and distribution rights of DOPTELET in mainland China and Hong Kong (“territory”). Under the terms of the agreement, Fosun will have the right to exclusively commercialize and to assist the Company with the registration of DOPTELET in the territory. Fosun is solely responsible for commercialization activities in the territory and associated expenses. The Company is responsible for supplying product at a fixed price to Fosun for the distribution of product upon approval. The agreement between Fosun and the Company is governed by a joint steering committee comprised of equal representation by the Company and Fosun and operated on a consensus basis. In the event that the parties do not agree, the Company will have deciding authority, except with respect to matters that solely affect the territory. Under the agreement, the Company received a non-refundable upfront payment of $4.5 million during the second quarter of 2018, which consisted of an upfront payment of $5.0 million , less $0.5 million that was withheld in accordance with tax withholding requirements in China and recorded as an expense during the year ended December 31, 2018 . The Company is also eligible to receive additional future payments upon the achievement of certain regulatory milestones. The Company assessed this arrangement in accordance with ASC Topic 606 and concluded that the contract counterparty, Fosun, is a customer. The Company determined the distinct, material performance obligations within this agreement consist of (1) the exclusive right to develop and commercialize DOPTELET for multiple indications in the territory, (2) the delivery of certain indication specific information, and (3) manufacture and supply of commercial product. The transaction price includes the $5.0 million up-front consideration. None of the regulatory milestones have been included in the transaction price, as all milestone amounts were fully constrained. As part of its evaluation of the constraint, the Company considered numerous factors, including that receipt of the milestones is outside the control of the Company and contingent upon success in future clinical trials and Fosun’s efforts. During the year ended December 31, 2018 , the Company recognized $2.6 million related to the up-front payment as other revenue in connection with the Fosun agreement. The amount of revenue recognized in connection with this agreement is commensurate with the deliverables provided by the Company to Fosun in achieving the performance obligation. The remaining transaction price of $2.4 million is recorded in deferred revenue as of December 31, 2018 , on the consolidated balance sheet and will be recognized upon the delivery of certain information packages for indications which are currently in development. The relative fair value of deliverables was calculated using a combination of discounted cash flow and cost avoidance models (Level 3 inputs), under which estimated cash flows were discounted using a risk-adjusted rate that aligns with publicly available information of Fosun's cost structure. Estimated cash flows were determined based on management's best estimate of the performance of DOPTELET for each indication in the territory. The $2.4 million remaining balance was calculated on June 30, 2018. Commercial Outsourcing Agreement with Integrated Commercial Solutions, LLC (“ICS”) On March 1, 2018 , the Company entered into a Commercial Outsourcing Master Services Agreement with ICS, a division of AmerisourceBergen Specialty Group, a subsidiary of AmerisourceBergen, pursuant to which ICS is the exclusive provider of various third-party logistics services to support the Company’s distribution of DOPTELET in the United States. The key services provided by ICS include logistics, warehousing, returns and inventory management, contract administration and chargebacks processing and accounts receivable management. Effective March 1, 2018 , the Company also entered into a first amendment to the Commercial Outsourcing Master Services Agreement in order for ICS to purchase and sell DOPTELET to the Company’s customers in the United States. Pursuant to the amendment, ICS will only make shipments to customers who have an executed contract with the Company. Under this arrangement, ICS places orders with the Company to maintain an appropriate level of inventory. ICS assumes all inventory risk and has sole responsibility for determining the prices at which it sells these products, subject to specified limitations in the amendment. The agreement will terminate on a date that is mutually agreed upon, in good faith, between ICS and the Company. If the Company does not attain all regulatory approvals and licenses to sell and distribute DOPTELET within one calendar year from the effective date, ICS may terminate the agreement upon 30 days written notice. Upon termination of this arrangement, ICS will be allowed to return one hundred percent of all inventory and revert to be the Company’s third-party logistics provider. Co-Promotion Agreement with Valeant Pharmaceuticals North America LLC On September 26, 2018 , the Company entered into a Co-Promotion Agreement (the "Co-Promotion Agreement") with the Salix division of Valeant Pharmaceuticals North America LLC (“Salix”), a subsidiary of Bausch Health Companies Inc., pursuant to which the Company granted Salix the exclusive right to co-promote DOPTELET to specified medical professionals in the Gastroenterology, Colorectal Surgery and Proctology fields (the “Specialty”) in the United States. Pursuant to the Co-Promotion Agreement, the Company will pay Salix a fee based on the quarterly Net Sales (as defined in the Co-Promotion Agreement) of DOPTELET to specified medical professionals in the Specialty in the United States at specified tiered percentages, ranging from Salix receiving a mid-twenties to mid-thirties percent of Net Sales in a calendar year, subject to specified adjustments. In addition, the Company has agreed to pay Salix a milestone payment of $2.5 million upon the achievement of an aggregate Net Sales amount to the Specialty. The Co-Promotion Agreement specifies that the Company will grant Salix a royalty-free right to use trademarks and copyrights relating to DOPTELET in connection with the promotion of DOPTELET in the United States. The Co-Promotion Agreement also contains provisions regarding payment terms, confidentiality and indemnification, as well as other customary provisions. The co-promotion of DOPTELET in the United States pursuant to the terms of the Co-Promotion Agreement will be supervised by a joint steering committee composed of an equal number of representatives from the Company and Salix. Under the terms of the Agreement, the Company remains responsible for the costs of maintaining regulatory approval of, manufacturing, supplying and distributing DOPTELET. Salix has also agreed to maintain at least one hundred Salix sales representatives (subject to certain adjustments) that will have the responsibility to promote DOPTELET in the Specialty in the United States. The Company did not make any milestone or royalty payments under the Co-Promotion Agreement for the year ended December 31, 2018 . |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Debt | Debt On April 17, 2018 , the Company and its wholly owned subsidiary, the Co-Borrowers, entered into a Term Loan pursuant to which the Co-Borrowers borrowed $20.0 million . The loan matures on April 17, 2021 unless the Company achieves a specified revenue milestone in which case the maturity date will be extended to April 17, 2022 . The Co-Borrowers are only required to make monthly interest payments until April 30, 2019 unless the Company achieves the specified revenue milestone in which case the interest-only period will be extended until October 31, 2019 . Following the interest-only period, the Co-Borrowers will be required to also make equal monthly payments of principal and interest for the remainder of the term. The Co-Borrowers will also be required to pay an additional final payment at maturity equal to $2.0 million if the term loan is repaid after the interest-only period or a final payment of $0.6 million if the term loan is repaid during the interest-only period. The final payment amount of $2.0 million has been recorded as a debt discount and is being accreted to the carrying value of the debt using the effective interest method. In addition, at its option, the Co-Borrowers may prepay all amounts owed under the Loan and Security Agreement (including all accrued and unpaid interest), subject to a prepayment charge if the loan has been outstanding for less than one year, which prepayment charge would be 4% of the outstanding principal amount on the date the loan is prepaid. All obligations under this agreement are guaranteed by all the assets of the Co-Borrowers, except for intellectual property and certain other assets. The agreement bears interest at the WSJ prime rate plus 1.25% per annum. In connection with the Loan and Security Agreement, the Company incurred debt issuance costs totaling approximately $38,000 . These costs are being amortized over the estimated term of the debt using the effective interest method. The Company deducted the debt issuance costs from the carrying amount of the debt as of December 31, 2018 . As of December 31, 2018 , the carrying value of the term loan was approximately $20.6 million, of which $6.7 million was due within 12 months and $13.9 million was due in greater than 12 months. The debt balance has been categorized within Level 2 of the fair value hierarchy. The carrying amount of the debt approximates its fair value based on prevailing interest rates as of the balance sheet date. The Term Loan also provides for standard indemnification of Silicon Valley Bank and contains representations, warranties and certain covenants of the Co-Borrowers. While any amounts are outstanding under the Loan and Security Agreement, the Co-Borrowers are subject to a number of affirmative and negative covenants, including covenants regarding dispositions of property, business combinations or acquisitions, incurrence of additional indebtedness and transactions with affiliates, among other customary covenants. The Co-Borrowers are also restricted from paying dividends or making other distributions or payments on their capital stock, subject to limited exceptions. As of December 31, 2018 , annual principal payments due under the Term Loan are as follows: Aggregate Minimum Payments Year (in thousands) 2019 $ 6,667 2020 10,000 2021 5,333 Total 22,000 Less unamortized debt issuance costs and final payment (1,392 ) Total $ 20,608 |
Commitments and contingencies
Commitments and contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and contingencies | Commitments and contingencies Office Lease On May 22, 2018, the Company entered into an Office Lease Agreement (the “Lease”) with Pine Forest 240 TT, LLC, a Delaware limited liability company (the “Landlord”), under which the Company will lease 21,745 square feet of space for its corporate headquarters located at 240 Leigh Farm Road, Durham, North Carolina. Pursuant to the Lease, the Company will effectively renew the Company’s lease of its existing 14,378 square feet of office space (the “Existing Office Space”) that the Company currently subleases from Paidian Research, Inc. pursuant to a sublease agreement, which is scheduled to expire on April 30, 2020, effective May 1, 2020. The Company also leases an additional 1,961 square feet of office space (“Suite 200”), which the Landlord delivered on October 12, 2018, and will lease an additional 5,406 square feet of office space (“Suite 215”), which the Landlord has agreed to use commercially reasonable efforts to deliver on or before August 1, 2019. Under the Lease, subject to specified exceptions, the Company will pay an initial annual base rent of (i) $51,476 , or $4,290 per month, for Suite 200, subject to an increase of approximately 2.7% per year, (ii) $145,800 , or $12,150 per month, for Suite 215, subject to an increase of approximately 2.7% per year and (iii) $387,774 , or $32,315 per month, for the Existing Office Space, subject to an increase of approximately 2.7% per year. In addition, the Company will pay its proportionate share of the Landlord’s annual operating expenses associated with the premises. The term of the Lease will continue until September 30, 2023. The Company has an option to renew the Lease for one additional term of five years. If exercised, rent during the renewal term will be at the fair market rental rate as defined in the Lease. The lease provides for a tenant improvement allowance of approximately $264,090 . As of December 31, 2018 , none of the allowance was utilized. The Company incurred rent expense of $410,384 for the year ended December 31, 2018 . There was $118,117 rent expense for the year ended December 31, 2017 . Current future minimum lease payments under the Company’s current lease obligation are $340,798 , $380,986 , $454,851 , $467,459 and $358,559 for the remainder of 2019 , 2020 , 2021 , 2022 and 2023 , respectively. Litigation The Company is not a party to any material legal proceedings and is not aware of any pending or threatened claims. From time to time, the Company may be subject to various legal proceedings and claims that arise in the ordinary course of its business activities. |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company has accumulated net losses since inception and has not recorded an income tax provision or benefit during the years ended December 31, 2018 and December 31, 2017 . A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows: For the year For the year Statutory federal income tax rate 21 % 35 % State income taxes, net of federal benefit 2 % — % Federal tax rate change — % (22 )% Non-deductible expenses (2 )% — % Incentive stock options — % (6 )% Other — % (1 )% Change in valuation allowance (21 )% (6 )% Income taxes provision (benefit) — % — % The components of the net deferred tax asset as of December 31, 2018 and 2017 are the following (in thousands): As of December 31, 2018 2017 Deferred tax assets: Domestic net operating loss carryovers $ 22,546 $ 10,266 Foreign net operating loss carryovers 72 — Tax credits 209 — Intangible assets 483 — Charitable contributions 85 16 Property and equipment (4 ) — Deferred rent 22 — Stock-based compensation 1,377 — Reserves 309 — Accrued expenses 407 — Total deferred tax assets 25,506 10,282 Less valuation allowance (25,506 ) (10,282 ) Deferred tax asset, net of valuation allowance $ — $ — On December 22, 2017 , “H.R.1”, formerly known as the “Tax Cuts and Jobs Act”, was signed into law. Among other items, H.R.1 reduces the federal corporate tax rate to 21% from the existing maximum rate of 35% , effective January 1, 2018 . As a result, the Company revalued its net deferred tax asset at the new lower tax rate. The Company has reduced the value of the deferred tax asset before valuation allowance by $6.5 million . The Tax Legislation subjects a U.S. shareholder to tax on GILTI earned by certain foreign subsidiaries. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Taxed Income , states that an entity can make an accounting policy election to either recognized deferred taxes for temporary basis differences expected to reverse as GILTI in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI in the year the tax is incurred. The Company does not have a GILTI inclusion in 2018 ; therefore, no GILTI tax has been recorded for the year ended December 31, 2018 . The Company has determined, based upon available evidence, that it is more likely than not that the net deferred tax asset will not be realized and, accordingly, has provided a full valuation allowance against its net deferred tax asset. Based on this analysis, the Company determined that a valuation allowance of $25.5 million was required as of December 31, 2018 , resulting in $0 net deferred tax assets. The Company had recorded a valuation allowance of $10.3 million and $0 net deferred tax assets as of December 31, 2017 . As of December 31, 2018 , the Company had federal net operating loss carryforwards of approximately $43.5 million that begin to expire in 2036. The Company has federal net operating losses of $55.6 million that will carryforward indefinitely. The Company has state net operating losses of $85.3 million that begin to expire in 2032. The Company has state net operating losses of $600,400 that will carryforward indefinitely. The Company has foreign net operating losses of $573,000 that will carry forward indefinitely. The Company also had federal research and development credit carryforwards of approximately $209,400 which begin to expire in 2036 and federal charitable contribution carryforwards of approximately $402,200 which begin to expire in 2021. Utilization of the net operating loss carryforwards may be subject to an annual limitation according to Section 382 of the Internal Revenue Code of 1986 as amended, and similar provisions. In connection with the Company’s recent IPO, it is possible that the Company has experienced an ownership change limitation. The Company may experience ownership changes in the future as a result of subsequent shifts in its stock ownership, some of which may be outside of its control. The Company incorporated a subsidiary in Ireland in 2017 . However, the subsidiary has had losses since inception and as such, has no undistributed earnings. At December 31, 2018 , the Company did not have any uncertain tax positions. The Company will recognize interest and penalties related to uncertain tax positions in income tax expense. As of December 31, 2018 , the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s consolidated statement of operations. The Company does not anticipate a material change to unrecognized tax benefits in the next twelve months. The 2014 and subsequent federal and state tax years for AkaRx remain open for the assessment of income taxes. 2016 was Dova’s initial tax year which remains open for the assessment of income taxes. Due to the Company’s history of losses since inception, the Company believes the probability of an assessment is unlikely. The SEC staff issued Staff Accounting Bulletin No. 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (SAB 118) which allows the Company to record provisional amounts during a measurement period which is similar to the measurement period used when accounting for business combinations. At December 31, 2017 provisional amounts were recorded related to the deferred rate change. At December 31, 2018 the measurement period has ended and the Company's accounting related to the 2017 Tax Cuts and Jobs Act is complete. The Company did not make any measurement-period adjustments related to the provisional items recorded as of December 31, 2017 . |
Employee Benefit Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Employee Benefit Plan | Employee Benefit Plan The Company maintains a defined contribution 401(k) plan available to full time employees. Employee contributions are voluntary and are determined on an individual basis, limited by the maximum amounts allowable under federal tax regulations. The Company provides an automatic matching contribution of $0.50 per $1.00 of employee contribution in to the plan up to a maximum deferral per employee of 4% of the employee's salary. The Company’s matching contributions totaled approximately $248,000 and $19,000 in matching contributions for the years ended December 31, 2018 and December 31, 2017 , respectively. |
Selected Quarterly Data
Selected Quarterly Data | 12 Months Ended |
Dec. 31, 2018 | |
Selected Quarterly Financial Information [Abstract] | |
Selected Quarterly Data | Selected Quarterly Data (unaudited, in thousands, except share and per share amounts) Quarter Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Operating expenses: Research and development $ 4,276 $ 3,293 $ 5,426 $ 2,714 Selling, general and administrative 955 1,905 4,185 6,454 Total operating expenses 5,231 5,198 9,611 9,168 Loss from operations (5,231 ) (5,198 ) (9,611 ) (9,168 ) Other income (expense) Other income (expense), net 33 (14 ) 224 243 Interest expense (226 ) (295 ) (336 ) (375 ) Total other expenses, net (193 ) (309 ) (112 ) (132 ) Net loss $ (5,424 ) $ (5,507 ) $ (9,723 ) $ (9,300 ) Net loss per share, basic and diluted $ (0.31 ) $ (0.32 ) $ (0.38 ) $ (0.36 ) Weighted average common shares outstanding, basic and diluted 17,332,257 17,332,257 25,290,709 25,652,457 Quarter Ended March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018 Revenue: Product sales, net $ — $ 1,957 $ 2,929 $ 2,842 Other revenue — 2,627 — — Total revenue, net — 4,584 2,929 2,842 Operating expenses: Cost of product sales — 519 370 291 Research and development 3,416 4,508 4,847 5,533 Selling, general and administrative 10,261 18,565 17,031 16,064 Total operating expenses 13,677 23,592 22,248 21,888 Loss from operations (13,677 ) (19,008 ) (19,319 ) (19,046 ) Other income (expense) Other income (expense), net 222 (195 ) 342 275 Interest expense (315 ) (454 ) (546 ) (561 ) Total other expenses, net (93 ) (649 ) (204 ) (286 ) Net loss $ (13,770 ) $ (19,657 ) $ (19,523 ) $ (19,332 ) Net loss per share, basic and diluted $ (0.52 ) $ (0.70 ) $ (0.69 ) $ (0.69 ) Weighted average common shares outstanding, basic and diluted 26,589,192 28,194,046 28,203,222 28,204,098 |
Significant accounting polici_2
Significant accounting policies (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Basis of presentation and principles of consolidation | Basis of presentation and principles of consolidation The Company’s consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). |
Use of estimates | Use of estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of expenses during the reporting period. The most significant estimates in the Company’s consolidated financial statements relate the valuation of stock options, and the valuation allowance for deferred tax assets resulting from net operating losses. These estimates and assumptions are based on current facts, historical experience and various other factors believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities and the recording of expenses that are not readily apparent from other sources. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected. |
Segments | Segments Operating segments are identified as components of an enterprise about which separate discrete financial information is available for evaluation by the chief operating decision-maker in making decisions regarding resource allocation and assessing performance. The Company views its operations and manages its business in one reportable segment, i.e., the development and commercialization of DOPTELET for the treatment of thrombocytopenia. All of the Company's assets and revenue are in the United States. |
Cash and cash equivalents | Cash and equivalents The Company considers all highly liquid investments purchased with original maturities of 90 days or less at acquisition to be cash equivalents. Cash and equivalents include cash held in banks and money market mutual funds and are classified as Level 1 investments. |
Inventory | Inventory Inventory acquired prior to receipt of the FDA approval for DOPTELET was expensed as research and development ("R&D") expense as incurred. The Company began capitalizing inventory upon receipt of FDA approval on May 21, 2018 . Inventory is stated at the lower of cost or estimated net realizable value with cost determined under the first-in first-out method. Inventory consists of work-in-process, and DOPTELET finished goods. The Company currently purchases inventory from Eisai under a long term supply agreement (see Note 4) for work in progress and finished drug product and is the greater of a fixed payment per tablet or a payment calculated in the mid-single digit percentages of net sales of DOPTELET. The Company reduces its inventory to net realizable value for potentially excess, dated or obsolete inventory based on an analysis of forecasted demand compared to quantities on hand and any firm purchase orders, as well as product shelf life. At December 31, 2018 , the Company determined that no write downs to inventory for potentially excess, dated or obsolete inventory were required. The Company’s inventory at December 31, 2018 consists of $1.7 million of work in progress and $1.7 million of finished goods. |
Research and development prepaid and accrued expenses | Research and development prepaid and accrued expenses As part of the process of preparing financial statements, the Company is required to estimate its expenses resulting from its obligation under contracts with vendors and consultants and clinical site agreements in connection with its R&D efforts. The financial terms of these contracts are subject to negotiations which vary contract to contract and may result in payment flows that do not match the periods over which materials or services are provided to the Company under such contracts. The Company’s objective is to reflect the appropriate clinical trial expenses in its financial statements by matching those expenses with the period in which services and efforts are expended. The Company accounts for these expenses according to the progress of the trial as measured by patient progression and the timing of various aspects of the trial. The Company determines prepaid and accrual estimates through discussion with applicable personnel and outside service providers as to the progress or state of communication of clinical trials, or other services completed. During the course of a clinical trial, the Company adjusts its rate of clinical trial expense recognition if actual results differ from its estimates. The Company makes estimates of its prepaid and accrued expenses as of each balance sheet date in its financial statements based on facts and circumstances known at that time. Although the Company does not expect its estimates to be materially different from amounts actually incurred, its understanding of status and timing of services performed relative to the actual status and timing of services performed may vary and may result in the Company reporting amounts that are too high or too low for any particular period. The Company’s clinical trial prepaid and accrual expense is dependent upon the timely and accurate reporting of fee billings and pass-through expenses from contract research organizations and other third-party vendors as well as the timely processing of any change orders from the contract research organizations. |
Concentrations of credit risk and off-balance sheet risk and Risk and Uncertainties | Concentrations of credit risk and off-balance sheet risk Cash and equivalents are financial instruments that are potentially subject to concentrations of credit risk. The Company’s cash and equivalents are deposited in accounts at large financial institutions, and amounts may exceed federally insured limits. The Company believes it is not exposed to significant credit risk due to the financial strength of the depository institutions in which the cash and equivalents are held. The Company has no financial instruments with off-balance sheet risk of loss. Risk and Uncertainties The Company’s future results of operations involve a number of risks and uncertainties. Factors that could affect the Company’s future operating results and cause actual results to vary materially from expectations include, but are not limited to, rapid technological change, uncertainty of results of clinical trials and reaching milestones, uncertainty of market acceptance of the Company’s products, competition from substitute products and larger companies, protection of proprietary technology, strategic relationships, and dependence on key individuals. Products developed by the Company require approvals from FDA or other international regulatory agencies prior to commercial sales. There can be no assurance that the products will receive the necessary approvals for future indications of DOPTELET. If the Company is denied approval, approval is delayed, or the Company is unable to maintain approval, it could have a materially adverse impact on the Company. The Company has expended and will continue to expend substantial funds to conduct research, development, and clinical testing of its product candidates. The Company also will also expend additional funds to provide for the marketing and distribution of products that receive regulatory approval. The Company may require additional funds to conduct research and development activities and commercialize its products. Additional funds may not be available on acceptable terms, if at all. If adequate funds are unavailable on a timely basis from operations or additional sources of financing, the Company may have to delay, reduce the scope of or eliminate one or more of its research or development programs or alter its product commercialization plans, which may materially and adversely affect its business, financial condition, and operations. |
Research and development costs | Research and development costs R&D expenses for the year ended December 31, 2018 include direct and indirect R&D costs. Direct R&D costs consist principally of external costs, such as fees paid to investigators, consultants, central laboratories and clinical research organizations, including costs incurred in connection with clinical trials, and related clinical trial fees and all employee-related expenses for those employees working in R&D functions, including stock-based compensation for R&D personnel. Indirect R&D costs include insurance or other indirect costs related to the Company’s R&D function to specific product candidates. The Company expenses pre-approval inventory as R&D until regulatory approval is received. |
Property and Equipment | Property and Equipment Property and equipment, which consists mainly of furniture and computers, are carried at cost less accumulated depreciation. Depreciation is computed over the estimated useful lives of the respective assets, generally one to five years, using the straight-line method. Leasehold improvements are amortized on a straight-line basis over the lesser of their useful life or the term of the lease. Maintenance and repairs are charged to expense as incurred, and improvements and betterments are capitalized. When assets are retired or otherwise disposed of, the cost and accumulated depreciation are removed from the consolidated balance sheet and any resulting gain or loss is reflected in operations in the period realized. |
Fair value measurement | Fair value measurement ASC 820, Fair Value Measurements , provides guidance on the development and disclosure of fair value measurements. Under this accounting guidance, fair value is defined as an exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or a liability. The accounting guidance classifies fair value measurements in one of the following three categories for disclosure purposes: Level 1: Quoted prices in active markets for identical assets or liabilities. Level 2: Inputs other than Level 1 prices for similar assets or liabilities that are directly or indirectly observable in the marketplace. Level 3: Unobservable inputs which are supported by little or no market activity and values determined using pricing models, discounted cash flow methodologies, or similar techniques, as well as instruments for which the determination of fair value requires significant judgment or estimation. The carrying amount of the Company’s financial instruments, including cash and equivalents and accounts payable approximate their fair values. As of December 31, 2018 and 2017 , the carrying amount of the Note approximates fair value as its interest rate approximates current market rates that could be obtained by the Company with a similar guarantee by PBM Capital Investments, LLC (Level 2 inputs). No transfer of assets between Level 1 and Level 2 of the fair value hierarchy occurred during the year ended December 31, 2018 . |
Revenue Recognition | Revenue recognition Effective January 1, 2018 , the Company adopted the provisions of Accounting Standard Codification (“ASC”) Topic 606, Revenue from Contracts with Customers. The guidance provides a unified model to determine how revenue is recognized. Product sales The Company is currently approved to sell DOPTELET in the United States market. The product is distributed through an exclusive distribution model with Integrated Commercialization Solutions (“ICS”). ICS sells DOPTELET to a limited number of specialty pharmacies (“customers”), who have agreements in place with the Company. Patients and healthcare providers purchase the product from the specialty pharmacy providers. (See Note 8 “Significant agreements and contracts” for more information on the Company’s agreement with ICS). The Company recognizes revenue on product sales when the control of the Company’s product passes to its customers, which occurs at a point in time, upon delivery to the customers, or over time depending on the nature of the contract. The Company has determined that the delivery of its product to its customers constitutes a single performance obligation as there are no other promises to deliver goods or services. Shipping and handling activities are considered to be fulfillment activities and are not considered to be a separate performance obligation. The Company has assessed the existence of a significant financing component in the agreements with its customers. The trade payment terms with its customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component. Revenue from product sales is recorded at the net sales price, which includes estimates of variable consideration for which reserves are established. Components of variable consideration include trade discounts and allowances, product returns, government chargebacks, discounts and rebates, and other incentives, such as voluntary patient assistance, and other fee for service amounts that are detailed within contracts between the Company and its customers relating to the Company’s sale of its products. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable or a current liability. These reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. Revenue from product sales is recorded after considering the impact of the following variable consideration amounts at the time of revenue recognition: Trade discounts and distribution fees : Trade discounts relate to prompt settlement discounts provided to ICS and the customers. Distribution fees include fees paid to ICS for the distribution of the product (which is based on a percentage of sales). In addition, the Company compensates its customers for data and other activities. The Company has determined that such services received to date are not distinct from its sale of products and may not reasonably represent fair value for these services. Therefore, estimates of these payments are recorded as a reduction of revenue based on contractual terms. Product returns : Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company based on the product’s expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as within accrued expenses on the condensed consolidated balance sheets. The Company currently estimates product return liabilities using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel. The Company has not received any returns to date. Government rebates and chargebacks : The Company contracts with Medicaid, Medicare, U.S. Department of Veterans Affairs, 340b entities and other government agencies (“Government Payors”) so that DOPTELET will be eligible for purchase by, or partial or full reimbursement from, such Government Payors. The Company estimates the rebates, chargebacks and discounts it will provide to Government Payors and deducts these estimated amounts from its gross product revenue at the time the revenue is recognized. The Company estimates these reserves based upon a range of possible outcomes that are probability-weighted for the estimated payor mix. These reserves are recorded in the same period the revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability, which is included in accrued expenses and other current liabilities on the condensed consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. The Company estimates the rebates, chargebacks and discounts that it will provide to Government Payors based upon (i) the government-mandated discounts applicable to government-funded programs, (ii) information obtained from its customers and (iii) information obtained from other third parties regarding the payor mix for DOPTELET. The Company’s liability for these rebates consists of estimates of claims for the current year and estimated future claims that will be made for product shipments that have been recognized as revenue but remain in the distribution channel inventories at the end of each reporting period. Other incentives : Other incentives which the Company offers include voluntary patient assistance and assurance programs, such as a co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payers. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as a component of accrued expenses and other current liabilities on the condensed consolidated balance sheets. Strategic agreements The Company’s other revenue consists of revenue from the Company’s strategic agreements for the development and commercialization of DOPTELET. The terms of the agreements typically include non-refundable upfront fees, payments based upon achievement of milestones and eventually revenue from the commercialized product. These agreements usually have both fixed and variable consideration. Non-refundable upfront fees are considered fixed, while milestone payments and revenue from the commercialized product are identified as variable consideration. In determining the appropriate amount of revenue to be recognized as it fulfills its obligations under these agreements, the Company performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation. A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606. The Company’s performance obligations include intellectual property rights, development services, and services associated with regulatory submission and approval processes. Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. As part of the accounting for these arrangements, the Company develops assumptions that require judgment to determine the estimated selling price of each performance obligation identified in the contract. The Company uses key assumptions to determine the selling price on a standalone basis, which may include forecasted revenue, development timelines, and probabilities of regulatory success. The Company allocates the total transaction price to each performance obligation based on the estimated relative standalone selling prices of the promised goods or service underlying each performance obligation. If the right to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenue from non-refundable, upfront fees allocated to the right when the right is transferred to the customer, and the customer can use and benefit from the right. For rights that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, upfront fees. The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition. At the inception of the arrangement, the Company evaluates whether the development milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until those approvals are received. |
Stock-based compensation | Stock-based compensation The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The Company historically has been a private company and lacks company-specific historical and implied volatility information. Therefore, the most significant subjective assumptions are management’s estimates of the expected volatility and the expected term of the award. The Company estimates its expected stock volatility based on the historical volatility of a publicly traded set of peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own traded stock price. Due to the lack of historical exercise history, the expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain-vanilla” options. The expected term of stock options granted to nonemployees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. Prior to the IPO, the fair values of the shares of common stock underlying the Company options were estimated on each grant date by the Company. In order to determine the fair value, the Company considered, among other things, contemporaneous valuations of the Company’s common stock and preferred stock, the Company’s business, financial condition and results of operations, including related industry trends affecting its operations; the likelihood of achieving a liquidity event, such as an IPO, or sale, given prevailing market conditions; the lack of marketability of the Company’s common stock; the market performance of comparable publicly traded companies; and U.S. and global economic and capital market conditions. Since the IPO, the fair value of the common stock underlying the Company’s options has been based upon the closing price of the Company’s common stock on the grant date. |
Income taxes | Income taxes On September 15, 2016 , Dova converted from an LLC to a C-corporation. Prior to September 15, 2016 , Dova Pharmaceuticals, LLC elected to be taxed as a partnership. Therefore, Dova was not subject to income taxes until its conversion to a C-corporation on September 15, 2016 . AkaRx was subject to income taxes from April 1, 2016 through December 31, 2016 . For the 2016 tax year, Dova and AkaRx did not file consolidated or combined federal and state income tax returns. Income taxes are recorded in accordance with ASC 740, Income Taxes (“ASC 740”), which provides for deferred taxes using an asset and liability approach. The Company recognizes deferred tax assets and liabilities for the expected future tax consequences of events that have been included in the financial statements or tax returns. Deferred tax assets and liabilities are determined based on the difference between the financial statement and tax bases of assets and liabilities using enacted tax rates in effect for the year in which the differences are expected to reverse. Valuation allowances are provided, if based upon the weight of available evidence, it is more likely than not that some or all of the deferred tax assets will not be realized. 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 would more likely than not be realized assuming examination by the taxing authority. 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. The FASB Staff Q&A, Topic 740, No. 5, Accounting for Global Intangible Low-Tax Income , states that an entity can make an accounting policy election to either recognize deferred taxes for temporary basis difference expected to reverse as global intangible low-taxed income (“GILTI”) in future years or to provide for the tax expense related to GILTI in the year the tax is incurred as a period expense only. The Company has elected to account for GILTI as a period expense in the year the tax is incurred. |
Net loss per share | Net loss per share Net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Since the Company had a net loss in each of the periods presented, basic and diluted net loss per common share are the same. The computations of diluted net loss per common share for the years ended December 31, 2018 and 2017 did not include stock options to purchase 2,613,228 and 2,128,641 shares of common stock, respectively, and did not include restricted stock units to purchase 3,521 and 0 shares of common stock, respectively, as the inclusion of these securities would have been antidilutive. |
Recent accounting pronouncements | Recent accounting pronouncements In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU 2016-2, Leases (Topic 842), which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the estimated term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases. The Company will adopt ASU 2016-2 in the first quarter of 2019. The Company is in the process of finalizing the impact of adoption of the ASU on its consolidated financial statements, and it has determined that the most significant change will be related to the recognition of right-of-use assets and lease liabilities on the Company’s balance sheet for real estate operating leases. In May 2017, the FASB issued ASU 2017-9, Compensation—Stock Compensation (Topic 718): Scope of Modification Accounting, which clarifies when to account for a change to the terms or conditions of a share-based payment award as a modification. Under the new guidance, modification accounting is required only if the fair value, the vesting conditions, or the classification of the award (as equity or liability) changes as a result of the change in terms or conditions. The Company adopted ASU 2017-9 as of January 1, 2018 . The adoption of this standard did not impact the Company’s consolidated financial statements and disclosures. In June 2018, the FASB issued ASU 2018-7, “Improvements to Nonemployee Share-Based Payment Accounting”, which simplifies the accounting for share-based payments granted to nonemployees for goods and services. Under the ASU, most of the guidance on such payments to nonemployees would be aligned with the requirements for share-based payments granted to employees. The changes take effect for public companies for fiscal years starting after December 15, 2018, including interim periods within that fiscal year. For all other entities, the amendments are effective for fiscal years beginning after December 15, 2019, and interim periods within fiscal years beginning after December 15, 2020. Early adoption is permitted, but no earlier than an entity’s adoption date of Topic 606. The Company expects that the adoption of this ASU would not have a material impact on the Company’s consolidated financial statements. In August 2018, the FASB issued an accounting standards update which expands the scope of costs associated with cloud computing arrangements that must be capitalized. Under the new guidance, costs associated with implementing a cloud computing arrangement that is a service contract must be capitalized and expensed over the term of the hosting arrangement. The provisions of the update are effective beginning January 1, 2020 for interim and annual periods with early adoption permitted for any interim period after issuance of the update. The Company is currently assessing the timing of its adoption as well as the potential impact that the standard will have on the Company's consolidated financial statements. |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Schedule of Other Current Assets | Prepaid expenses and other current assets December 31, 2018 2017 Insurance $ 627 $ 425 Deposits 385 28 Software 343 34 Clinical trials 315 767 Prepaid other 569 217 Prepaid expenses and other current assets $ 2,239 $ 1,471 |
Property, Plant and Equipment | Furniture and equipment, net December 31, 2018 2017 Leasehold improvements $ 224 $ — Furniture and equipment 33 66 Tooling 136 — 393 66 Less: accumulated depreciation 31 4 Furniture and equipment, net $ 362 $ 62 |
Schedule of Accrued Liabilities | Accrued expenses December 31, 2018 2017 DOPTELET purchases $ 2,828 $ — Employee related 2,175 902 Rebates and other sales deductions 1,838 956 Clinical trials 1,574 — Selling and marketing 1,282 — Other 2,238 662 Accrued expenses $ 11,935 $ 2,520 |
Stock-based compensation (Table
Stock-based compensation (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Summary of assumptions used to estimate fair value of option awards | The fair value of the Company’s option awards were estimated using the assumptions below: For the year ended For the year ended December 31, December 31, 2018 2017 Exercise price $6.07 - $33.47 $3.73 - $26.70 Risk-free rate of interest 2.41% - 3.18% 1.71% - 2.23% Term (years) 5.0 - 7.2 5.2 - 7.1 Expected stock price volatility 63.60% - 87.67% 87.21% - 89.38% |
Summary of stock option activity | The following table summarizes the Company’s stock option activity under the 2017 Plan and Amended Plan for the year ended December 31, 2018 : Total options Weighted average Weighted average Aggregate Outstanding as of December 31, 2016 — $ — — $ — Employee options granted 2,128,641 7.9 9.4 44,481,000 Outstanding as of December 31, 2017 2,128,641 — 9.4 44,481,000 Employee options granted 2,302,650 15.75 9.4 1,888,000 Employee options exercised (51,641 ) 4.62 — — Employee options forfeited (853,217 ) 7.17 — — Outstanding as of December 31, 2018 3,526,433 $ 13.25 9.2 $ 5,200,000 Options vested and exercisable as of December 31, 2018 830,542 $ 8.61 8.4 $ 2,344,000 |
Schedule of stock-based compensation expense | Stock-based compensation expense has been reported in the Company’s consolidated statements of operations for the years ended December 31, 2018 and December 31, 2017 as follows (in thousands): For the year ended For the year ended December 31, December 31, 2018 2017 Cost of product sales 292 — Research and development 2,145 1,247 Selling, general and administrative 10,053 4,386 Total stock-based compensation 12,490 5,633 |
Debt (Tables)
Debt (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of annual principal payments due under term loan | As of December 31, 2018 , annual principal payments due under the Term Loan are as follows: Aggregate Minimum Payments Year (in thousands) 2019 $ 6,667 2020 10,000 2021 5,333 Total 22,000 Less unamortized debt issuance costs and final payment (1,392 ) Total $ 20,608 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Reconciliation of the statutory U.S. federal rate to the Company's effective tax rate | A reconciliation of the statutory U.S. federal rate to the Company’s effective tax rate is as follows: For the year For the year Statutory federal income tax rate 21 % 35 % State income taxes, net of federal benefit 2 % — % Federal tax rate change — % (22 )% Non-deductible expenses (2 )% — % Incentive stock options — % (6 )% Other — % (1 )% Change in valuation allowance (21 )% (6 )% Income taxes provision (benefit) — % — % |
Schedule of components of the net deferred tax asset | The components of the net deferred tax asset as of December 31, 2018 and 2017 are the following (in thousands): As of December 31, 2018 2017 Deferred tax assets: Domestic net operating loss carryovers $ 22,546 $ 10,266 Foreign net operating loss carryovers 72 — Tax credits 209 — Intangible assets 483 — Charitable contributions 85 16 Property and equipment (4 ) — Deferred rent 22 — Stock-based compensation 1,377 — Reserves 309 — Accrued expenses 407 — Total deferred tax assets 25,506 10,282 Less valuation allowance (25,506 ) (10,282 ) Deferred tax asset, net of valuation allowance $ — $ — |
Selected Quarterly Data (Tables
Selected Quarterly Data (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Selected Quarterly Financial Information [Abstract] | |
Schedule of Selected Quarterly Data | Selected Quarterly Data (unaudited, in thousands, except share and per share amounts) Quarter Ended March 31, 2017 June 30, 2017 September 30, 2017 December 31, 2017 Operating expenses: Research and development $ 4,276 $ 3,293 $ 5,426 $ 2,714 Selling, general and administrative 955 1,905 4,185 6,454 Total operating expenses 5,231 5,198 9,611 9,168 Loss from operations (5,231 ) (5,198 ) (9,611 ) (9,168 ) Other income (expense) Other income (expense), net 33 (14 ) 224 243 Interest expense (226 ) (295 ) (336 ) (375 ) Total other expenses, net (193 ) (309 ) (112 ) (132 ) Net loss $ (5,424 ) $ (5,507 ) $ (9,723 ) $ (9,300 ) Net loss per share, basic and diluted $ (0.31 ) $ (0.32 ) $ (0.38 ) $ (0.36 ) Weighted average common shares outstanding, basic and diluted 17,332,257 17,332,257 25,290,709 25,652,457 Quarter Ended March 31, 2018 June 30, 2018 September 30, 2018 December 31, 2018 Revenue: Product sales, net $ — $ 1,957 $ 2,929 $ 2,842 Other revenue — 2,627 — — Total revenue, net — 4,584 2,929 2,842 Operating expenses: Cost of product sales — 519 370 291 Research and development 3,416 4,508 4,847 5,533 Selling, general and administrative 10,261 18,565 17,031 16,064 Total operating expenses 13,677 23,592 22,248 21,888 Loss from operations (13,677 ) (19,008 ) (19,319 ) (19,046 ) Other income (expense) Other income (expense), net 222 (195 ) 342 275 Interest expense (315 ) (454 ) (546 ) (561 ) Total other expenses, net (93 ) (649 ) (204 ) (286 ) Net loss $ (13,770 ) $ (19,657 ) $ (19,523 ) $ (19,332 ) Net loss per share, basic and diluted $ (0.52 ) $ (0.70 ) $ (0.69 ) $ (0.69 ) Weighted average common shares outstanding, basic and diluted 26,589,192 28,194,046 28,203,222 28,204,098 |
Organization and description _2
Organization and description of business operations - Forward stock split (Details) - Common stock | Jun. 16, 2017shares |
Forward stock split | |
Forward stock split ratio | 3.3 |
Number of fractional shares issued (in shares) | 0 |
Organization and description _3
Organization and description of business operations - Liquidity and capital resources (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Liquidity and capital resources | |||
Accumulated deficit | $ (129,427) | $ (57,145) | |
Cash and equivalents | $ 104,566 | $ 94,846 | $ 28,709 |
Organization and description _4
Organization and description of business operations - Amendment and restatement of certificate of incorporation and bylaws (Details) - shares | Dec. 31, 2018 | Dec. 31, 2017 | Jul. 05, 2017 |
Amendment and restatement of certificate of incorporation and bylaws | |||
Common stock, shares authorized | 100,000,000 | 100,000,000 | 100,000,000 |
Preferred stock, shares authorized | 10,000,000 |
Significant accounting polici_3
Significant accounting policies - Liquidity and Capital Resources (Details) - USD ($) | Feb. 27, 2018 | Dec. 31, 2018 | Apr. 17, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Class of Stock [Line Items] | |||||
Accumulated deficit | $ (129,427,000) | $ (57,145,000) | |||
Proceeds from issuance or sale of equity and debt | 238,000,000 | ||||
Cash and equivalents | $ 104,566,000 | $ 94,846,000 | $ 28,709,000 | ||
Common stock | Over-Allotment Option | |||||
Class of Stock [Line Items] | |||||
Shares issued | 2,500,000 | ||||
Net proceeds from issuance of stock | $ 74,700,000 | ||||
Co-Borrowers | Term Loan | |||||
Class of Stock [Line Items] | |||||
Borrowing amount | $ 20,000,000 |
Significant accounting polici_4
Significant accounting policies (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($)itemsegment | Dec. 31, 2017USD ($) | |
Segments | ||
Number of operating segments | segment | 1 | |
Inventory | ||
Inventory, work in process | $ 1,700 | |
Inventory, finished goods | 1,700 | |
Accrued expenses | ||
Accrued expenses | $ 11,935 | $ 2,520 |
Concentrations of credit risk and off-balance sheet risk | ||
Number of financial instruments with off-balance sheet risk of loss | item | 0 |
Significant accounting polici_5
Significant accounting policies - Property and Equipment (Details) - Furniture and computers | 12 Months Ended |
Dec. 31, 2018 | |
Minimum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives of assets | 1 year |
Maximum | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives of assets | 5 years |
Significant accounting polici_6
Significant accounting policies - Fair Value Measurement (Details) | Dec. 31, 2018USD ($) |
Accounting Policies [Abstract] | |
Fair Value, Assets, Level 1 to Level 2 Transfers, Amount | $ 0 |
Fair Value, Assets, Level 2 to Level 1 Transfers, Amount | $ 0 |
Significant accounting polici_7
Significant accounting policies - Net loss per share (Details) - shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock Options | ||
Net loss per share | ||
Antidilutive shares | 2,613,228 | 2,128,641 |
Restricted Stock Units (RSUs) | ||
Net loss per share | ||
Antidilutive shares | 3,521 | 0 |
Balance Sheet Components - Prep
Balance Sheet Components - Prepaid expenses and other assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
Insurance | $ 627 | $ 425 |
Deposits | 385 | 28 |
Software | 343 | 34 |
Clinical trials | 315 | 767 |
Prepaid other | 569 | 217 |
Prepaid expenses and other current assets | $ 2,239 | $ 1,471 |
Balance Sheet Components - Furn
Balance Sheet Components - Furniture and equipment, net (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment, gross | $ 393 | $ 66 |
Less: accumulated depreciation | 31 | 4 |
Furniture and equipment, net | 362 | 62 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment, gross | 224 | 0 |
Furniture and equipment | ||
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment, gross | 33 | 66 |
Tooling | ||
Property, Plant and Equipment [Line Items] | ||
Furniture and equipment, gross | $ 136 | $ 0 |
Balance Sheet Components - Accr
Balance Sheet Components - Accrued expenses (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | ||
DOPTELET purchases | $ 2,828 | $ 0 |
Employee related | 2,175 | 902 |
Rebates and other sales deductions | 1,838 | 956 |
Clinical trials | 1,574 | 0 |
Selling and marketing | 1,282 | 0 |
Other | 2,238 | 662 |
Accrued expenses | $ 11,935 | $ 2,520 |
The purchase agreement and re_2
The purchase agreement and related transactions - Eisai (Details) - USD ($) $ in Thousands | Mar. 16, 2018 | Mar. 29, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Mar. 30, 2016 |
Purchase agreement and related transactions | |||||
Research and development-licenses acquired, expensed | $ 0 | $ 1,000 | |||
Outstanding borrowings | 0 | 30,212 | |||
Purchase agreement | AkaRx | Eisai | |||||
Purchase agreement and related transactions | |||||
Payment made on closing date | $ 5,000 | ||||
Capital contribution - PBM Capital | 5,000 | ||||
Maximum milestone payments due | $ 135,000 | ||||
Milestone payments accrued | 0 | $ 0 | |||
Transition services agreement | AkaRx | Eisai | |||||
Purchase agreement and related transactions | |||||
Threshold amount after which amounts in excess will be credited against milestone payments | 51,000 | ||||
Transition incurred for expenses incurred | $ 31,900 | ||||
Note and security agreement | Eisai | Notes payable | |||||
Purchase agreement and related transactions | |||||
Outstanding borrowings | $ 31,100 | ||||
Repayment of principal balance along with accumulated interest | $ 1,300 | ||||
Interest rate (as a percent) | 5.00% |
The purchase agreement and re_3
The purchase agreement and related transactions - Astellas Pharma Inc (Details) - License agreement - Astellas Pharma Inc - USD ($) $ in Millions | Oct. 20, 2017 | Sep. 21, 2017 | Dec. 31, 2018 |
License agreement with Astellas Pharma Inc | |||
Payments for milestone obligation | $ 1 | ||
Maximum milestone payments due | $ 4 | ||
Milestone payments accrued | $ 0 | ||
Agreement term | 10 years | ||
Agreement term, extensions | 1 year | ||
Termination notice period | 3 months | ||
Research and development - licenses acquired | |||
License agreement with Astellas Pharma Inc | |||
Milestone expense | $ 1 | ||
Research and development - licenses acquired | Maximum | |||
License agreement with Astellas Pharma Inc | |||
Time limit for milestone payment | 30 days |
Related party agreements (Detai
Related party agreements (Details) - USD ($) | Apr. 01, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Apr. 01, 2018 |
Related party agreements | ||||
Due to related party | $ 35,000 | $ 97,000 | ||
PBM Capital Group, LLC | Services Agreement | ||||
Related party agreements | ||||
Monthly management fees payable | $ 17,400 | |||
Expenses incurred included in selling, general and administrative expenses | 307,000 | 600,000 | ||
Due to related party | $ 35,000 | $ 97,000 | ||
Dova Pharmaceuticals | PBM Capital Group, LLC | Services Agreement | ||||
Related party agreements | ||||
Agreement term | 12 months | |||
Renewal term | 1 year | |||
Monthly management fees payable | $ 25,000 | |||
AkaRx | PBM Capital Group, LLC | Services Agreement | ||||
Related party agreements | ||||
Agreement term | 12 months | |||
Renewal term | 1 year | |||
Monthly management fees payable | $ 25,000 |
Stockholders' equity - Series A
Stockholders' equity - Series A preferred stock and common stock initial public offering (Details) - USD ($) $ / shares in Units, $ in Millions | Feb. 27, 2018 | Jul. 05, 2017 | Nov. 18, 2016 |
Series A preferred stock | |||
Class of Stock [Line Items] | |||
Shares issued | 982,714 | ||
Proceeds from issuance of Series A preferred stock | $ 29 | ||
Share price | $ 29.51 | ||
Non-cumulative, non-compounding dividends | 8.00% | ||
Conversion price | $ 8.94 | ||
Common stock | |||
Class of Stock [Line Items] | |||
Shares issued upon conversion | 3,242,950 | ||
Common stock | IPO | |||
Class of Stock [Line Items] | |||
Shares issued | 5,077,250 | ||
Share price | $ 17 | ||
Proceeds from issuance of initial public offering | $ 78.7 | ||
Common stock | Over-Allotment Option | |||
Class of Stock [Line Items] | |||
Shares issued | 2,500,000 | ||
Share price | $ 32 | ||
Net proceeds from issuance of stock | $ 74.7 | ||
Minimum | Common stock | IPO | |||
Class of Stock [Line Items] | |||
Share price | $ 17.88 | ||
Proceeds from issuance of initial public offering | $ 60 |
Stock-based compensation - Opti
Stock-based compensation - Options, additional information (Details) - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 19, 2018 | |
2017 Plan | ||
Stock-based compensation | ||
Total shares reserved for future issuance | 1,250,000 | |
IPO Plan | ||
Stock-based compensation | ||
Period in which reserved shares will increase annually | 10 years | |
Annual increase in reserved shares (as a percent) | 4.00% | |
Shares available for grant | 2,877,263 | |
IPO Plan | Common stock | ||
Stock-based compensation | ||
Total shares reserved for future issuance | 4,285,250 | |
New shares reserved for future issuance | 2,000,000 | |
Outstanding options | 3,526,433 | |
Weighted average exercise price | $ 13.25 |
Stock-based compensation - Assu
Stock-based compensation - Assumptions used to calculate fair value of options (Details) - Stock Options - $ / shares | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Minimum | ||
Assumptions used to estimate fair value of options | ||
Exercise price | $ 6.07 | $ 3.73 |
Risk-free rate of interest | 2.41% | 1.71% |
Term (years) | 5 years | 5 years 2 months 12 days |
Expected stock price volatility | 63.60% | 87.21% |
Maximum | ||
Assumptions used to estimate fair value of options | ||
Exercise price | $ 33.47 | $ 26.70 |
Risk-free rate of interest | 3.18% | 2.23% |
Term (years) | 7 years 2 months 12 days | 7 years 1 month 6 days |
Expected stock price volatility | 87.67% | 89.38% |
Stock-based compensation - Stoc
Stock-based compensation - Stock Option Activity (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock Options | Maximum | ||
Aggregate intrinsic value | ||
Exercise price | $ 33.47 | $ 26.70 |
2017 Plan and IPO Plan | Common stock | ||
Aggregate intrinsic value | ||
Share Price | $ 7.58 | |
2017 Plan and IPO Plan | Stock Options | ||
Total options outstanding | ||
Outstanding, beginning balance (in shares) | 2,128,641 | 0 |
Employee options granted (in shares) | 2,302,650 | 2,128,641 |
Outstanding, ending balance (in shares) | 3,526,433 | 2,128,641 |
Weighted average remaining contractual life (in years) | ||
Outstanding | 9 years 2 months 12 days | 0 years |
Employee options granted | 9 years 5 months | 9 years 5 months |
Aggregate intrinsic value | ||
Employee options granted | $ 1,888,000 | $ 44,481,000 |
Outstanding, ending balance | $ 5,200,000 | |
Weighted average grant date fair value | $ 10.52 | |
2017 Plan | Stock Options | ||
Total options outstanding | ||
Employee options exercised (in shares) | (51,641) | |
Employee options forfeited (in shares) | (853,217) | |
Options vested and exercisable (in shares) | 830,542 | |
Weighted average exercise price | ||
Outstanding (in dollars per share) | $ 7.90 | $ 0 |
Employee options granted (in dollars per share) | 15.75 | 7.9 |
Employee options exercised (in dollars per share) | 4.62 | |
Employee options forfeited (in dollars per share) | 7.17 | |
Outstanding (in dollars per share) | 13.25 | $ 7.90 |
Options vested and exercisable (in dollars per share) | $ 8.61 | |
Weighted average remaining contractual life (in years) | ||
Outstanding | 9 years 5 months | |
Options vested and exercisable | 8 years 5 months | |
Aggregate intrinsic value | ||
Outstanding, beginning balance | $ 0 | |
Outstanding, ending balance | 44,481,000 | $ 0 |
Options vested and exercisable | $ 2,344,000 |
Stock-based compensation - Op_2
Stock-based compensation - Option awards, additional information (Details) - USD ($) $ / shares in Units, $ in Millions | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock Options | ||
Stock-based compensation | ||
Fair value of options vested | $ 8.2 | $ 0 |
Total unrecognized compensation expense | $ 17 | |
Unrecognized compensation expense, weighted average recognition period | 1 year 1 month 6 days | |
2017 Plan and IPO Plan | Common stock | ||
Stock-based compensation | ||
Share Price | $ 7.58 | |
2017 Plan and IPO Plan | Stock Options | ||
Stock-based compensation | ||
Weighted average grant date fair value | $ 10.52 | |
2017 Plan | Stock Options | ||
Stock-based compensation | ||
Options vested and exercisable | 8 years 5 months |
Stock-based compensation - Rest
Stock-based compensation - Restricted stock units, additional information (Details) - Restricted Stock Units (RSUs) $ / shares in Units, $ in Millions | 12 Months Ended |
Dec. 31, 2018USD ($)$ / sharesshares | |
Stock-based compensation | |
Employee options granted (in shares) | shares | 107,083 |
Employee options granted (in dollars per share) | $ / shares | $ 6.07 |
Total unrecognized compensation expense | $ | $ 0.6 |
Unrecognized compensation expense, weighted average recognition period | 6 months |
Stock-based compensation - Allo
Stock-based compensation - Allocation of expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Stock-based compensation | ||
Share-based compensation expense | $ 12,490 | $ 5,633 |
Cost of Product Sales | ||
Stock-based compensation | ||
Share-based compensation expense | 292 | 0 |
Research and development | ||
Stock-based compensation | ||
Share-based compensation expense | 2,145 | 1,247 |
Selling, general and administrative | ||
Stock-based compensation | ||
Share-based compensation expense | $ 10,053 | $ 4,386 |
Significant agreements and co_2
Significant agreements and contracts (Details) - USD ($) $ in Thousands | Mar. 01, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 |
Revenue | $ 2,842 | $ 2,929 | $ 4,584 | $ 0 | $ 10,355 | $ 0 | |
Fosun Agreement | |||||||
Upfront payment received, net of tax withholding | $ 4,500 | ||||||
Total non-refundable upfront consideration including taxes withholding | 5,000 | ||||||
Taxes withheld on upfront consideration | 500 | ||||||
Revenue | 2,600 | ||||||
Deferred revenue | $ 2,400 | $ 2,400 | $ 2,400 | ||||
Commercial Outsourcing Master Services Agreement | Integrated Commercial Solutions, LLC | |||||||
Maximum time period to terminate the agreement | 1 year | ||||||
Grace period of time for terminate the agreement | 30 days | ||||||
Percentage of inventory returns upon the termination of the agreement | 100.00% |
Significant agreements and co_3
Significant agreements and contracts - Valeant Pharmaceuticals North America LLC (Details) | Sep. 26, 2018USD ($) |
Revenue from Contract with Customer [Abstract] | |
Milestone payment, upon net sales achievement | $ 2,500,000 |
Debt (Details)
Debt (Details) - Term Loan - USD ($) | Apr. 17, 2018 | Dec. 31, 2018 |
Debt Instrument [Line Items] | ||
Term loan carrying value | $ 22,000,000 | |
Co-Borrowers | ||
Debt Instrument [Line Items] | ||
Borrowing amount | $ 20,000,000 | |
Final payment at maturity if term loan is repaid after interest-only period | 2,000,000 | |
Final payment if term loan is repaid during the interest-only period | $ 600,000 | |
Percent of outstanding loan principal amount for calculation of repayment change | 4.00% | |
Debt issuance costs | 38,000 | |
Term loan carrying value | 20,600,000 | |
Carrying value of debt amount due within 12 months | 6,700,000 | |
Carrying value of debt amount due in greater than 12 months | $ 13,900,000 | |
Co-Borrowers | WSJ prime rate | ||
Debt Instrument [Line Items] | ||
Basis points spread over variable reference rate | 1.25% |
Debt - Annual Principal Payment
Debt - Annual Principal Payments (Details) - Term Loan $ in Thousands | Dec. 31, 2018USD ($) |
Debt Instrument [Line Items] | |
2,019 | $ 6,667 |
2,020 | 10,000 |
2,021 | 5,333 |
Total | 22,000 |
Less unamortized debt issuance costs and final payment | (1,392) |
Total | $ 20,608 |
Commitments and contingencies (
Commitments and contingencies (Details) | May 22, 2018USD ($)ft² | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) |
Office Lease | |||
Tenant improvement allowance | $ 264,090 | ||
Tenant allowance utilized | 0 | ||
Rent expense | 410,384 | $ 118,117 | |
Future rental payments | |||
2,019 | 341,000 | ||
2,020 | 381,000 | ||
2,021 | 455,000 | ||
2,022 | 467,459 | ||
2,023 | $ 358,559 | ||
Property at 240 Leigh Farm Road, Office Space | Pine Forest 240 TT, LLC. | |||
Office Lease | |||
Leased office space | ft² | 21,745 | ||
Existing office space | Paidian Research, Inc. | |||
Office Lease | |||
Leased office space | ft² | 14,378 | ||
Annual lease rent expense | $ 387,774 | ||
Monthly lease rent expenses | $ 32,315 | ||
Percentage of annual increase in lease rental expenses | 2.70% | ||
Suite 200 office space | Pine Forest 240 TT, LLC. | |||
Office Lease | |||
Leased office space | ft² | 1,961 | ||
Annual lease rent expense | $ 51,476 | ||
Monthly lease rent expenses | $ 4,290 | ||
Percentage of annual increase in lease rental expenses | 2.70% | ||
Suite 215 office space | Pine Forest 240 TT, LLC. | |||
Office Lease | |||
Leased office space | ft² | 5,406 | ||
Annual lease rent expense | $ 145,800 | ||
Monthly lease rent expenses | $ 12,150 | ||
Percentage of annual increase in lease rental expenses | 2.70% |
Income Taxes - Reconciliation (
Income Taxes - Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Reconciliation of the statutory U.S. federal rate to the Company's effective tax rate | ||
Statutory federal income tax rate | 21.00% | 35.00% |
State income taxes, net of federal benefit | 2.00% | 0.00% |
Federal tax rate change | 0.00% | (22.00%) |
Non-deductible expenses | (2.00%) | 0.00% |
Incentive stock options | 0.00% | (6.00%) |
Other | 0.00% | (1.00%) |
Change in valuation allowance | (21.00%) | (6.00%) |
Income taxes provision (benefit) | 0.00% | 0.00% |
Income Taxes - Deferred Taxes (
Income Taxes - Deferred Taxes (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Deferred tax assets: | ||
Domestic net operating loss carryovers | $ 22,546 | $ 10,266 |
Foreign net operating loss carryovers | 72 | 0 |
Tax credits | 209 | 0 |
Intangible assets | 483 | 0 |
Charitable contributions | 85 | 16 |
Property and equipment | (4) | 0 |
Deferred rent | 22 | 0 |
Stock-based compensation | 1,377 | 0 |
Reserves | 309 | 0 |
Accrued expenses | 407 | 0 |
Total deferred tax assets | 25,506 | 10,282 |
Less valuation allowance | (25,506) | (10,282) |
Deferred tax asset, net of valuation allowance | $ 0 | $ 0 |
Income Taxes - Additional Infor
Income Taxes - Additional Information (Details) - USD ($) | Dec. 22, 2017 | Dec. 31, 2018 | Dec. 31, 2017 |
Operating Loss Carryforwards [Line Items] | |||
Adjustment to deferred tax asset before valuation allowance | $ 6,500,000 | ||
Valuation allowance | $ 25,506,000 | $ 10,282,000 | |
Valuation allowance, net deferred tax assets | 0 | $ 0 | |
Interest and penalties accrued | 0 | ||
Domestic Tax Authority | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, subject to expiration | 43,500,000 | ||
Operating loss carryforwards, not subject to expiration | 55,600,000 | ||
State and Local Jurisdiction | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, subject to expiration | 85,300,000 | ||
Operating loss carryforwards, not subject to expiration | 600,000 | ||
Foreign Tax Authority | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, not subject to expiration | 600,000 | ||
Research Tax Credit Carryforward | Foreign Tax Authority | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, subject to expiration | 200,000 | ||
Charitable Contribution Carryforward | Foreign Tax Authority | |||
Operating Loss Carryforwards [Line Items] | |||
Operating loss carryforwards, subject to expiration | $ 400,000 |
Employee Benefit Plan (Details)
Employee Benefit Plan (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Employee Benefit Plan | ||
Employer matching contribution, as a percent of employee contribution | 50.00% | |
Defined contribution plan, employer matching contribution, aggregate amount | $ 248 | $ 19 |
Maximum | ||
Employee Benefit Plan | ||
Employer matching contribution, as a percent of employee gross pay | 4.00% |
Selected Quarterly Data (Detail
Selected Quarterly Data (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | |
Revenue: | ||||||||||
Revenue | $ 2,842 | $ 2,929 | $ 4,584 | $ 0 | $ 10,355 | $ 0 | ||||
Operating expenses: | ||||||||||
Cost of product sales | 291 | 370 | 519 | 0 | 1,180 | 0 | ||||
Research and development | 5,533 | 4,847 | 4,508 | 3,416 | $ 2,714 | $ 5,426 | $ 3,293 | $ 4,276 | 18,304 | 15,710 |
Selling, general and administrative | 16,064 | 17,031 | 18,565 | 10,261 | 6,454 | 4,185 | 1,905 | 955 | 61,921 | 13,499 |
Total operating expenses | 21,888 | 22,248 | 23,592 | 13,677 | 9,168 | 9,611 | 5,198 | 5,231 | 81,405 | 29,209 |
Loss from operations | (19,046) | (19,319) | (19,008) | (13,677) | (9,168) | (9,611) | (5,198) | (5,231) | (71,050) | (29,209) |
Other income (expense) | ||||||||||
Other income (expense), net | 275 | 342 | (195) | 222 | 243 | 224 | (14) | 33 | 644 | 486 |
Interest expense | (561) | (546) | (454) | (315) | (375) | (336) | (295) | (226) | (1,876) | (1,232) |
Total other expenses, net | (286) | (204) | (649) | (93) | (132) | (112) | (309) | (193) | (1,232) | (746) |
Net loss | $ (19,332) | $ (19,523) | $ (19,657) | $ (13,770) | $ (9,300) | $ (9,723) | $ (5,507) | $ (5,424) | $ (72,282) | $ (29,955) |
Net loss per share, basic and diluted (in dollars per share) | $ (0.69) | $ (0.69) | $ (0.70) | $ (0.52) | $ (0.36) | $ (0.38) | $ (0.32) | $ (0.31) | $ (2.60) | $ (1.40) |
Weighted average common shares outstanding, basic and diluted (in shares) | 28,204,098 | 28,203,222 | 28,194,046 | 26,589,192 | 25,652,457 | 25,290,709 | 17,332,257 | 17,332,257 | 27,803,175 | 21,435,369 |
Product sales, net | ||||||||||
Revenue: | ||||||||||
Revenue | $ 2,842 | $ 2,929 | $ 1,957 | $ 0 | $ 7,728 | $ 0 | ||||
Other revenue | ||||||||||
Revenue: | ||||||||||
Revenue | $ 0 | $ 0 | $ 2,627 | $ 0 | $ 2,627 | $ 0 |