Document and Entity Information
Document and Entity Information - USD ($) $ in Millions | 12 Months Ended | ||
Dec. 31, 2018 | Feb. 28, 2019 | Jun. 30, 2018 | |
Document And Entity Information [Abstract] | |||
Document Type | 10-K | ||
Amendment Flag | false | ||
Document Period End Date | Dec. 31, 2018 | ||
Document Fiscal Year Focus | 2018 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | MLNT | ||
Entity Registrant Name | MELINTA THERAPEUTICS, INC. /NEW/ | ||
Entity Central Index Key | 0001461993 | ||
Current Fiscal Year End Date | --12-31 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Smaller Reporting Company | true | ||
Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Public Float | $ 180.3 | ||
Entity common stock, shares outstanding (in shares) | 11,229,897 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Assets | ||
Cash and equivalents | $ 81,808 | $ 128,387 |
Receivables (See Note 3) | 22,485 | 7,564 |
Inventory | 41,341 | 10,825 |
Prepaid expenses and other current assets | 3,848 | 2,988 |
Total current assets | 149,482 | 149,764 |
Property and equipment, net | 1,586 | 1,596 |
Intangible assets, net | 229,196 | 7,500 |
Other assets (including restricted cash of $200 in both periods) | 61,326 | 1,413 |
Total assets | 441,590 | 160,273 |
Current liabilities | ||
Accounts payable | 16,765 | 7,405 |
Accrued expenses (See Note 3) | 33,924 | 24,041 |
Deferred purchase price and other liabilities (See Note 14) | 78,394 | 0 |
Accrued interest on notes payable | 4,485 | 284 |
Warrant liability | 38 | 0 |
Total current liabilities | 133,606 | 31,730 |
Long-term liabilities | ||
Notes payable, net of debt discount | 110,476 | 39,555 |
Deferred revenue | 0 | 10,008 |
Other long-term liabilities | 7,444 | 6,644 |
Total long-term liabilities | 117,920 | 56,207 |
Total liabilities | 251,526 | 87,937 |
Commitments and Contingencies (Note 10) | ||
Shareholders' Equity | ||
Preferred stock; $.001 par value; 5,000,000 shares and none authorized; no shares issued or outstanding at December 31, 2018 and December 31, 2017 | 0 | 0 |
Common stock; $.001 par value; 80,000,000 shares authorized; 11,204,050 and 4,399,788 issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 11 | 4 |
Additional paid-in capital | 909,896 | 644,991 |
Accumulated deficit | (719,843) | (572,659) |
Total shareholders’ equity | 190,064 | 72,336 |
Total liabilities and shareholders’ equity | $ 441,590 | $ 160,273 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Statement of Financial Position [Abstract] | ||
Restricted cash | $ 200 | $ 200 |
Preferred stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized (in shares) | 5,000,000 | 0 |
Preferred stock, shares issued (in shares) | 0 | 0 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in usd per share) | $ 0.001 | $ 0.001 |
Common stock, shares authorized (in shares) | 80,000,000 | 80,000,000 |
Common stock, shares issued (in shares) | 11,204,050 | 11,204,050 |
Common stock, shares outstanding (in shares) | 4,399,788 | 4,399,788 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenue | |||
Revenue | $ 96,430 | $ 33,864 | $ 0 |
Operating expenses | |||
Cost of goods sold | 41,057 | 0 | 0 |
Research and development | 55,409 | 49,475 | 49,791 |
Goodwill impairment | 25,088 | 0 | 0 |
Selling, general and administrative | 133,312 | 63,325 | 19,410 |
Total operating expenses | 254,866 | 112,800 | 69,201 |
Loss from operations | (158,436) | (78,936) | (69,201) |
Other income (expenses) | |||
Interest income | 730 | 155 | 30 |
Interest expense | (43,179) | (3,608) | (3,390) |
Interest expense on convertible promissory notes (See Note 4) | 0 | (4,016) | (1,016) |
Change in fair value of tranche assets and liabilities | 0 | 0 | (1,313) |
Change in fair value of warrant liability | 33,226 | 335 | 781 |
Loss on extinguishment of debt | (2,595) | (607) | 0 |
Grant income | 5,828 | 0 | 0 |
Other income and expense | 1,904 | 98 | 177 |
Gain on loss contract reversal | 5,330 | 0 | 0 |
Bargain purchase gain | 0 | 27,663 | 0 |
Total other income (expense), net | 1,244 | 20,020 | (4,731) |
Net loss | (157,192) | (58,916) | (73,932) |
Accretion of convertible preferred stock dividends | 0 | (19,259) | (21,117) |
Net loss available to common shareholders | $ (157,192) | $ (78,175) | $ (95,049) |
Basic and diluted net loss per share (in usd per share) | $ (17.12) | $ (109.28) | $ (20,600.13) |
Basic and diluted weighted average shares outstanding (in shares) | 9,181,668 | 715,369 | 4,614 |
Product sales, net | |||
Revenue | |||
Revenue | $ 46,580 | $ 0 | $ 0 |
Contract research | |||
Revenue | |||
Revenue | 11,677 | 13,959 | 0 |
License | |||
Revenue | |||
Revenue | $ 38,173 | $ 19,905 | $ 0 |
Consolidated Statements of Shar
Consolidated Statements of Shareholders' Equity - USD ($) $ in Thousands | Total | Ordinary Shares | Common Stock | Additional Paid-In Capital | Accumulated Deficit |
Beginning balance (in shares) at Dec. 31, 2015 | 4,595 | 0 | |||
Beginning balance at Dec. 31, 2015 | $ (222,099) | $ 0 | $ 217,712 | $ (439,811) | |
Share-based compensation | 2,515 | 2,515 | |||
Common stock forfeitures (in shares) | (1) | ||||
Common stock forfeitures | 0 | ||||
Number of options exercised (in shares) | 725 | ||||
Stock option exercises | 65 | 65 | |||
Net loss | (73,932) | (73,932) | |||
Ending balance (in shares) at Dec. 31, 2016 | 5,319 | 0 | |||
Ending balance at Dec. 31, 2016 | (293,451) | $ 0 | 220,292 | (513,743) | |
Share-based compensation | 6,450 | 6,450 | |||
Stock repurchase (in shares) | (8) | ||||
Stock repurchase | 1,123 | 1,123 | |||
Number of options exercised (in shares) | 0 | 172 | |||
Stock option exercises | 88 | 88 | |||
Vesting of restricted stock grants (in shares) | 12,400 | ||||
Conversion of convertible preferred stock, debt & warrants into common stock (in shares) | 2,286,722 | ||||
Conversion of convertible preferred stock, debt & warrants into common stock | 291,228 | $ 2 | 291,226 | ||
Business combination, issuance of common of shares (in shares) | (5,311) | 2,100,494 | |||
Acquisition of businesses | 125,814 | $ 2 | 125,812 | ||
Net loss | (58,916) | (58,916) | |||
Ending balance (in shares) at Dec. 31, 2017 | 0 | 4,399,788 | |||
Ending balance at Dec. 31, 2017 | 72,336 | $ 4 | 644,991 | (572,659) | |
Deferred revenue adjustment upon adoption of accounting standard (See Note 2) | 10,008 | 10,008 | |||
Share-based compensation | 3,674 | 3,674 | |||
Vesting of restricted stock grants (in shares) | 10,920 | ||||
Business combination, issuance of common of shares (in shares) | 0 | 1,865,301 | |||
Acquisition of businesses | 145,963 | $ 2 | 145,961 | ||
Issuance of common shares upon exercise of options and warrants (in shares) | 0 | 40 | |||
Issuance of common shares upon exercise of options | 3 | 3 | |||
Common stock issued during period (in shares) | 4,928,000 | ||||
Issuance of common shares | 115,272 | $ 5 | 115,267 | ||
Net loss | (157,192) | (157,192) | |||
Ending balance (in shares) at Dec. 31, 2018 | 0 | 11,204,049 | |||
Ending balance at Dec. 31, 2018 | $ 190,064 | $ 11 | $ 909,896 | $ (719,843) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Operating activities | |||
Net loss | $ (157,192) | $ (58,916) | $ (73,932) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization | 16,901 | 451 | 497 |
Bargain purchase gain | 0 | (27,663) | 0 |
Change in fair value of tranche assets and liabilities | 0 | 0 | 1,313 |
Non-cash interest expense | 25,673 | 5,091 | 2,010 |
Share-based compensation | 3,465 | 6,450 | 2,515 |
Change in fair value of warrant liability | (33,226) | (335) | (781) |
Change in fair value for IDB contingent liabilities | (8,817) | 0 | 0 |
Loss on extinguishment of debt | 2,595 | 607 | 0 |
Reversal of loss contract | (5,330) | 0 | 0 |
Provision for inventory obsolescence | 8,042 | 0 | 0 |
Write off of deferred equity finance costs | 0 | 0 | 969 |
Asset impairment | 26,076 | 0 | 0 |
Other | 0 | 70 | 0 |
Changes in operating assets and liabilities: | |||
Receivables | (5,044) | (3,140) | 43 |
Inventory | (17,541) | (10,825) | 0 |
Prepaid expenses and other current assets | 2,180 | 600 | (1,461) |
Accounts payable | 8,285 | (1,269) | (21) |
Accrued expenses | 1,445 | 12,014 | (1,840) |
Accrued interest on notes payable | 4,202 | 110 | (14) |
Deferred revenues | 0 | 1,000 | 0 |
Deposits on future inventory purchases | (40,773) | 0 | 0 |
Other non-current assets and liabilities | (2,486) | 157 | 122 |
Net cash used in operating activities | (171,545) | (75,598) | (70,580) |
Investing activities | |||
Cash acquired in merger with Cempra, Inc. | 0 | 161,410 | 0 |
IDB acquisition | (166,382) | 0 | 0 |
Purchases of intangible assets | (2,000) | (5,500) | 0 |
Purchases of property and equipment | (1,690) | (849) | (463) |
Net cash provided by (used in) investing activities | (170,072) | 155,061 | (463) |
Proceeds from financing (see Note 4): | |||
Proceeds from the issuance of notes payable | 111,421 | 38,844 | 44,111 |
Costs associated with the issuance of notes payable | (6,455) | 0 | 0 |
Proceeds from the issuance of warrants | 33,264 | 0 | 0 |
Proceeds from the issuance of royalty agreement | 1,472 | 0 | 0 |
Purchase of notes payable disbursement option | (7,609) | 0 | 0 |
Proceeds from issuance of common stock, net, to lender | 51,452 | 0 | 0 |
Other financing activities: | |||
Proceeds from issuance of common stock, net | 155,273 | 0 | 0 |
Proceeds from the issuance of convertible promissory notes | 0 | 24,526 | 0 |
Payment of debt extinguishment fees | (2,150) | (1,240) | 0 |
IDB acquisition deferred payments | (1,633) | 0 | 0 |
Proceeds from the exercise of stock options, net of cancellations | 3 | 88 | 65 |
Proceeds from the issuance of convertible preferred stock | 0 | 0 | 13,625 |
Payment of preferred stock issuance costs | 0 | 0 | (9) |
Repayment of notes payable | (40,000) | (24,503) | (5,498) |
Net cash provided by financing activities | 295,038 | 37,715 | 52,294 |
Net change in cash and equivalents | (46,579) | 117,178 | (18,749) |
Cash, cash equivalents and restricted cash at beginning of the period | 128,587 | 11,409 | 30,158 |
Cash, cash equivalents and restricted cash at end of the period (See Note 4) | 82,008 | 128,587 | 11,409 |
Supplemental cash flow information | |||
Cash paid for interest | 13,259 | 2,326 | 2,411 |
Cash received from exchange of state tax credits, net | 0 | 283 | 207 |
Non-cash investing and financing activities | |||
Accrued purchases of fixed assets | 10 | 2,155 | 12 |
Accrued notes payable issuance costs | $ 0 | $ 0 | $ 475 |
Nature of the Business
Nature of the Business | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of the Business | NATURE OF THE BUSINESS Melinta Therapeutics, Inc. (the “Company,” “we,” “us,” “our,” or “Melinta,” the registrant previously known as Cempra, Inc.) is a commercial-stage pharmaceutical company focused on discovering, developing and commercializing differentiated anti-infectives for the acute care and community settings to meet critical medical needs in the treatment of bacterial infectious diseases. Melinta is headquartered in New Haven, Connecticut, with locations in Lincolnshire, Illinois, Morristown, New Jersey and Chapel Hill, North Carolina. We have four products: (i) delafloxacin as the active pharmaceutical ingredient and distributed under the brand name Baxdela™, (ii) meropenem and vaborbactam as the active pharmaceutical ingredients and distributed under the brand name Vabomere™ (“Vabomere”), (iii) oritavancin as the active pharmaceutical ingredient and distributed under the brand name Orbactiv® (“Orbactiv”) and (iiii) minocycline as the active pharmaceutical ingredient and distributed under the brand name Minocin® for injection and line extensions of such products. Our stock is traded on the Nasdaq market under the symbol “MLNT.” The accompanying consolidated financial statements have been prepared assuming Melinta Therapeutics, Inc. (the “Company,” “we,” “us,” “our,” or “Melinta”) will continue as a going concern. We are not currently generating revenue from operations that is sufficient to cover our operating expenses and do not anticipate generating revenue sufficient to offset operating costs in the short-term. We have incurred losses from operations since our inception and had an accumulated deficit of $719,843 as of December 31, 2018 , and we expect to incur substantial expenses and further losses in the short term for the development and commercialization of our product candidates and approved products. In addition, we have substantial commitments in connection with our acquisition of the infectious disease business of The Medicines Company ("Medicines") that we completed in January 2018, including payments related to deferred purchase price consideration, assumed contingent liabilities and the purchase of inventory. And, there are certain financial-related covenants under our Deerfield Facility, as amended in January 2019, including requirements that we (i) file an Annual Report on Form 10-K for the year ending December 31, 2019, with an audit opinion without a going concern qualification, (ii) maintain a minimum cash balance of $40,000 through March 2020, and thereafter, a balance of $25,000 , and (iii) achieve net revenue from product sales of at least $63,750 for the year ending December 31, 2019. (See Note 4 to the consolidated financial statements for further details on the Deerfield Facility.) Our future cash flows are dependent on key variables such as our ability to access additional capital under our Vatera and Deerfield credit facilities, our ability to secure a working capital revolver, which is allowed under the Deerfield Facility and required under the Vatera facility, and most importantly, the level of sales achievement of our four marketed products. Our current operating plans include assumptions about our projected levels of product sales growth in the next 12 months in relation to our planned operating expenses. Revenue projections are inherently uncertain but have a higher degree of uncertainty in an early-stage commercial launch, which we have in Baxdela and Vabomere, where there is not yet a robust sales history. While we have a plan to achieve the current expected sales levels of our products, we are unable to conclude based on applying the requirements of FASB Accounting Standards Codification 205-40, Presentation of Financial Statements - Going Concern (“ASC 205”) that such revenue is “probable” (as defined under this accounting standard). In addition, given our forecasted product sales are not deemed probable under ASC 205, our ability to draw the additional $50,000 of capacity under the Deerfield Facility, which is conditional based on meeting certain sales-based milestones before the end of 2019, is also not considered to be probable under the accounting guidance. As such, we are not able to conclude under ASC 205 that the actions discussed below will be effectively implemented and, therefore, our current operating plans, existing cash and cash collections from existing revenue arrangements and product sales may not be sufficient to fund our operations for the next 12 months. As such, we believe there is substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments relating to the recoverability and classification of liabilities that might be necessary should we be unable to continue as a going concern. In the fourth quarter of 2018, the Company took actions to reduce its operating spend, including a reduction to the workforce of approximately 20.0% and a decision to begin to wind down its research and discovery function. To provide additional operating capital, in December 2018, the Company entered into a Senior Subordinated Convertible Loan Agreement (the “Loan Agreement”) with Vatera Healthcare Partners LLC and Vatera Investment Partners LLC (together, “Vatera”) pursuant to which Vatera committed to provide $135,000 over a period of five months, subject to the satisfaction of certain conditions (see Note 4). We drew $75,000 under this facility in February 2019, and we plan to draw the remaining $60,000 by early July 2019. As of December 31, 2018, the Company had $81,808 in cash and cash equivalents. In addition to drawing the additional $60,000 available under the Vatera Facility, in the next several months, we plan to put a working capital revolver in place for up to $20,000 , which is permitted under the Deerfield Facility (see Note 4) and required under the Vatera Loan Agreement (we must establish a working capital revolver of at least $10,000 in order to draw the final $35,000 tranche under the Vatera Loan Agreement in July 2019). We are also exploring options to modify the terms of certain liabilities to increase our liquidity over the next 12 to 18 months. Finally, if our cash collections from revenue arrangements, including product sales, and other financing sources are not sufficient, we plan to control spending and would take further actions to adjust the spending level for operations if required. However, there is no guarantee that we will be successful in executing any or all of these initiatives. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Principles of Consolidation and Basis of Presentation —The accompanying consolidated financial statements include the accounts and results of operations of Melinta and its wholly-owned subsidiaries. The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. We have changed the presentation of income from our contract with the Biomedical Advanced Research and Development Authority of the U.S. Department of Health and Human Services (“BARDA”) (see Grant Income discussion below) to conform to the 2018 presentation of revenue under Topic 606. Accordingly, grant income reported in 2018 has been moved from "Contract research" in Revenue to "Grant income" in Other income (expense). As we adopted Topic 606 using the modified retrospective method, we did not change the presentation of 2017 grant income. In addition, on February 20, 2019, the board approved a 1-for-5 reverse split of our common stock, which was effective February 22, 2019. All share, share price and per share amounts presented have been adjusted to reflect these values as if the reverse split had occurred at the beginning of the earliest period presented. Use of Estimates —The preparation of these consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Cash and Cash Equivalents —We consider all highly liquid investments with original maturities of three months or less at time of purchase to be cash equivalents. We invest excess cash primarily in money market funds. Trade and Other Receivables —Trade receivables consist of amounts billed for product shipments. Receivables for product shipments are recorded as shipments are made and title to the product is transferred to the customer. Other receivables consist of amounts billed, and amounts earned but unbilled, under our licensing agreements and our contracts with BARDA. Receivables for license agreements are recorded as we achieve the requirements of the agreements, and receivables under the BARDA contracts are recorded as qualifying research activities are conducted and invoices from our vendors are paid. Unbilled receivables are also recorded based upon work estimated to have been completed for which we have not paid vendor invoices. We carry our receivables net of an allowance for doubtful accounts. On a periodic basis, we evaluate our receivables for collectability. We have recorded an allowance for doubtful accounts of $26 for specifically identified receivables that may not be fully collectible. Concentration of Credit Risk —Concentration of credit risk exists with respect to cash and cash equivalents and receivables. We maintain our cash and cash equivalents with federally insured financial institutions, and at times, the amounts may exceed the federally insured deposit limits. To date, we have not experienced any losses on our deposits of cash and cash equivalents. We believe that we are not exposed to significant credit risk due to the financial position of the depository institutions in which deposits are held. A significant portion of our trade receivables is due from three large wholesaler customers for our products, which constitute 46% , 32% and 15% , respectively, of our trade receivable balance at December 31, 2018 . Inventory —Inventory is stated at the lower of cost or estimated net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material costs, third-party manufacturing costs, overhead—principally the cost of managing our manufacturers—and related transportation costs. We capitalize inventory upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense. We review inventories on hand at least quarterly and record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value. As of December 31, 2018 , we had recorded $7,070 reserves for our inventory. Activity in our inventory reserve account is summarized below: Beginning Balance as of January 1, 2018 Charges to Cost of Goods Sold Inventory Discards Ending Balance as of December 31, 218 $ — $ 8,042 $ (972 ) $ 7,070 Fair Value of Financial Instruments —The carrying amounts of our financial instruments, which include cash and cash equivalents, tax credit and other receivables, accounts payable, accrued expenses, notes payable, and preferred stock warrants, approximated their fair values at December 31, 2018 and 2017 . Debt Issuance Costs —Debt issuance costs represent legal and other direct costs incurred in connection with our notes payable. These costs were recorded as a contra-liability included in the notes payable line item and amortized as a non-cash component of interest expense using the effective interest method over the term of the note. Property and Equipment —Property and equipment are recorded at cost less accumulated depreciation and are depreciated using the straight-line method over their estimated useful lives. Leasehold improvements are amortized over the shorter of their useful lives or the remaining term of the lease. Major improvements are capitalized, while repair and maintenance costs, which do not improve or extend the useful lives of the respective assets, are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the balance sheets and any resulting gain or loss is credited or charged to income. Depreciation periods for our property and equipment are as follows: Type Period Laboratory equipment 5 years Furniture and fixtures 5 years Office equipment 3 years Leasehold improvements Shorter of useful life or lease life Purchased software 3 years Goodwill and Intangible Assets —Intangible assets consist of capitalized milestone payments for the licenses we use to make our products and the fair value of identifiable intangible assets, including in-process research and development (“IPR&D”), acquired in the IDB transaction. Given the uncertainty of forecasts of future revenue for our products, we amortize the cost of intangible assets on a straight-line basis over the estimated economic life of each asset, generally the exclusivity period of each associated product. IPR&D is reclassified to intangible assets (developed product rights) once the associated product has received approval by the appropriate regulatory agency. Amortization for these developed product rights does not begin until both the associated product has received approval and sales have commenced. We will recognize amortization for our intangible assets over periods of approximately 10 to 17 years, commencing with the launch of the products. As of December 31, 2017, product right intangible assets were $7,500 . Amortization had not yet commenced as product launch occurred in early 2018. As of December 31, 2018, gross product right intangible assets and the related accumulated amortization were $245,529 and $16,332 . Amortization of intangible assets, which is included in cost of goods sold, was $16,332 for the year ended December 31, 2018 . No intangible asset amortization was recorded in 2017. For each of the years ending December 31, 2019 , through December 31, 2023 , we expect to recognize amortization expense of $16,603 , with approximately $125,113 to be recognized thereafter. In addition, there is $21,069 of developed product rights primarily related to Vabomere that will begin amortization over approximately 10 years when the launch of Vabomere in Europe has occurred. Goodwill and indefinite-lived assets, including IPR&D, are not amortized, but are subject to an impairment review annually and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeded the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value. Prior to reclassifying an IPR&D asset to a definite-lived intangible asset, we perform an impairment analysis. We test goodwill, IPR&D and indefinite-lived assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If we conclude it is more likely than not that the fair value of the asset under review is less than its carrying amount, a quantitative impairment test is performed. In December 2018, we performed our annual impairment test for goodwill. As a result, we concluded that the implied value of goodwill was negative, and we recorded an impairment adjustment of $25,088 in December 2018 to reduce our goodwill value to zero . This was driven primarily by the sustained decrease in the Melinta's stock price over the course of the previous year, and since we operate as one single operating unit, the market capitalization of the Company is a strong indicator of fair value. Impairment of Long-Lived Assets —Long-lived assets consist primarily of property and equipment and intangible assets with a definite life. We record impairment losses on long-lived assets used in operations when events and circumstances indicate that the carrying amount of an asset or group of assets may not be fully recoverable at the lowest level of identifiable cash flows, which is each product line. If impairment indicators are present, we assess whether the future estimated undiscounted cash flows attributable to the assets in question are greater than their carrying amounts. If these future estimated cash flows are less than carrying value, we then measure an impairment loss for the amount that carrying value exceeds fair value of the assets. In the year ended December 31, 2018 , we recorded expense of $988 in research and development expenses related to the write-off of in-process validation costs for manufacturing projects that we abandoned during the year. We did not have a corresponding impairment expense in 2017 or 2016. During the fourth quarter of 2018, impairment indicators were present for our product rights intangible assets, so we prepared undiscounted cash flows attributable to each product to assess whether or not the intangible assets were impaired. The impairment indicators related to revised product sales forecasts, which were lower than those initially developed in connection of the acquisition of the assets. While we concluded that the intangible assets were not impaired because the undiscounted cash flows exceeded the carrying value, if revenue forecasts decrease again in the future, there is a risk that we may conclude that one or more of the intangible assets are impaired in a future period. Revenue Recognition —On January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-9, Revenue from Contracts with Customers (“Topic 606”), and all related amendments. For further information regarding the adoption of Topic 606, see the “Adoption of Topic 606” section of this Note 2. Topic 606 outlines a single comprehensive model to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The core principle of this new revenue recognition guidance is that a company will recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. Topic 606 defines the following five-step process to achieve this core principle, and in doing so, it is possible that significant judgment and estimates may be required within the revenue recognition process. 1. identify the contract(s) with a customer; 2. identify the performance obligations in the contract; 3. determine the transaction price; 4. allocate the transaction price to the performance obligations in the contract; and 5. recognize revenue when (or as) the entity satisfies a performance obligation. The new guidance only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including the consideration of whether it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, we assess the goods or services promised within each contract and determine those that are performance obligations; the assessment includes the evaluation of whether each promised good or service is distinct within the context of the contract. Under Topic 606, we recognize revenue separately for performance obligations that are “distinct.” Performance obligations are considered to be distinct if (a) the customer can benefit from the license or services either on its own or together with other resources that are readily available to the customer, and (b) our promise to transfer the license or services is separately identifiable from other promises in the contract. If a license or service is not individually distinct, we combine the license or service with other promised licenses and/or services until we identify a bundle of licenses and/or services that together are distinct. We recognize, as revenue, the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In determining the transaction price, we consider all forms of variable consideration, which can take various forms, including, but not limited to, prompt-pay discounts, rebates, credits, and milestone payments. We estimate variable consideration using either the “expected value” or “most likely amount” method, depending on which method better predicts the amount of consideration to which we will be entitled. The expected value method is a probability-weighted approach that considers all possible outcomes while the most likely approach uses the single most likely amount in a range of possible outcomes. We apply a variable consideration constraint to the estimated transaction price if we conclude that it is probable that there is a risk of significant reversal of revenue once the uncertainty related to the variable consideration is resolved. Under the guidance of Topic 606, we recognize revenue for each performance obligation when the customer obtains control of the product and we have satisfied each of our respective obligations. Control is defined as the ability of the customer to direct the use of and obtain substantially all the benefits of the asset. In addition, as of December 31, 2018 , we do not have any contract assets or liabilities and our contracts do not have any significant financing components. And, we have not capitalized contract origination costs. Licensing Arrangements We enter into license and collaboration agreements for the research and development and/or commercialization of therapeutic products. The terms of these agreements may include nonrefundable licensing fees, funding for research, development and manufacturing, milestone payments and royalties on any product sales derived from the collaborations in exchange for the delivery of licenses and rights to sell our products within specified territories outside the United States. In the determination of whether our license and collaboration agreements are accounted for under Topic 606 or Accounting Standards Classification (“ASC”) 808, Contract Accounting , we first assess whether or not the partner in the arrangement is a customer. If the partner in the arrangement is deemed a customer as it relates to some or all of our performance obligations, then the consideration associated with those performance obligations is accounted for as revenue under Topic 606. Our license agreements may include contingent or variable consideration based upon the achievement of regulatory- and sales-based milestones and future royalties based on a percentage of the partner’s net product sales. Our performance obligations to deliver distinct licenses are recognized at a point in time. Milestone payments from licensees that are contingent and/or variable upon future regulatory events and product sales are not considered probable of being achieved until the milestones are earned and, therefore, the contingent revenue is subject to significant risk of reversal. As such, we constrain this variable consideration and do not include it in the transaction price (or recognize the revenue related to these milestones) until such time that the contingencies are resolved and generally recognized at a point in time. In addition, under the sales- or usage- based royalty exception in Topic 606, we do not estimate, at the onset of the arrangement, the variable consideration from future royalties or sales-based milestones. Instead, we wait to recognize royalty revenue until the future sales occur. In September 2018, we entered into a license agreement with Menarini, which grants to Menarini the exclusive right to market Vabomere, Orbactiv and Minocin for injection in 68 countries in Europe, Asia-Pacific and the Commonwealth of Independent States. The agreement includes an upfront license fee of €17,000 (which we received in October 2018), a milestone payment of €15,000 upon European marketing approval for Vabomere, potential regulatory- and sales-based milestones, and sales-based royalties. Menarini received European marketing approval in November 2018, and we received the €15,000 milestone payment in the fourth quarter of 2018. We determined that Menarini is a customer and we should account for the agreement under Topic 606. We identified one performance obligation under the agreement, the delivery of the licensed rights. In addition, we agreed to supply the products to Menarini in the future at a cost that is consistent with our other similar licensing arrangements. We provided Menarini immediate access to the licensed rights and, as such, we allocated the upfront payment entirely to the license and recognized revenue at the point in time when the licensed rights were delivered, in September 2018. We will recognize any future contingent consideration, including regulatory and sales-based milestone payments and royalty revenue, at such time when the milestones or royalties have been achieved. Menarini received European marketing approval in November 2018, so we recognized the €15,000 milestone payment as revenue in the fourth quarter of 2018. Adoption of Topic 606 We adopted Topic 606 on January 1, 2018, using the modified retrospective method applied to those contracts which were not complete as of January 1, 2018. Results for reporting periods beginning after January 1, 2018, are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with legacy U.S. GAAP under ASC 605. In our adoption of Topic 606, we did not use practical expedients. In addition, we have considered the nature, amount and timing of our different revenue sources. Accordingly, the disaggregation of revenue from contracts with customers is reflected in different captions within the consolidated statement of operations. For our Eurofarma distribution arrangements under which revenue was previously deferred, revenue is now recognized at the point in time when the license is granted and has benefit to Eurofarma. These deferred revenues were originally expected to be recognized in future periods over the period of time over which we supplied Baxdela under the supply arrangement, which could have lasted up to 10 years or longer. The cumulative effect of the adoption was recognized as a decrease to opening accumulated deficit and a decrease to deferred revenue of $10,008 on January 1, 2018. The effect of the adoption of Topic 606 on our consolidated balance sheet is as follows: Balance at December 31, 2017 Adjustments Due to Topic 606 Balance at January 1, 2018 Liabilities: Deferred revenue $ 10,008 $ (10,008 ) $ — Shareholders’ equity: Accumulated deficit $ (572,659 ) $ 10,008 $ (562,651 ) In connection with the adoption of Topic 606, we no longer recognize grant income as revenue (see Grant Income discussion below), but there was no change to the timing of historical recognition. Also, there was no change to the timing of recognition of contract revenue under our licensing agreements. For product sales, recognition of revenue under Topic 605 would have been the same as under Topic 606 for the year ended December 31, 2018, as we have established sufficient sales history to analyze trends in revenue constraints. In addition, the initial stocking of product in connection with product launches in the first quarter of 2018 was sold through to end customers before the end of 2018, establishing a fixed transaction price for these sales to wholesalers. We have no outstanding performance obligations as of December 31, 2018 , related to our licensing arrangements. Although we have agreements in place to supply our drug products to our partners once they achieve regulatory approval in their respective territories, we concluded that the option to purchase our products from us is not a material right. All performance obligations under our licensing arrangements were satisfied historically at a point in time. Variable consideration in the form of regulatory and sales-based milestones, which are payable under the terms of our licensing arrangements, has been constrained because of the risk of significant revenue reversal as in our revenue recognition policy included in this Note 2. Further, we recognize contract research revenue from Menarini as we incur the reimbursable development costs. Product Sales Product Year Ended December 31, 2018 Baxdela $ 6,485 Vabomere 7,416 Orbactiv 22,951 Minocin for injection 9,728 Total product sales, net $ 46,580 Beginning in January 2018, as a result of both the acquisition of IDB and the launch of Baxdela, we distribute Baxdela, Vabomere, Orbactiv, and Minocin for injection products commercially in the United States. While we sell some of our products directly to certain hospitals and clinics, the majority of our product sales are made to wholesale customers who subsequently resell our products to hospitals or certain medical centers, as well as specialty pharmacy providers and other retail pharmacies. The wholesaler places orders with us for sufficient quantities of our products to maintain an appropriate level of inventory based on their customers’ historical purchase volumes and demand. We recognize revenue once we have transferred physical possession of the goods and the wholesaler obtains legal title to the product and accepts responsibility for all credit and collection activities with the resale customer. In addition, we enter into arrangements with health care providers that purchase our products from wholesalers—as well as payers and certain other customers—that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of our products. The transaction price that we recognize as revenue reflects the amount we expect to be entitled to in connection with the sale and transfer of control of product to our customers. Variable consideration is only included in the transaction price, to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. At the time that our customers take control of the product, which is when our performance obligation under the sales contracts is complete, we record product revenues net of applicable reserves for various types of variable consideration based on our estimates of channel mix. The types of variable consideration in our product revenue are as follows: • Prompt pay discounts • Product returns • Chargebacks and rebates • Fee-for-service • Government rebates • Commercial payer and other rebates • Group purchasing organization (“GPO”) administration fees • MelintAssist voluntary patient assistance programs In determining the amounts of certain allowances and accruals, we must make significant judgments and estimates. For example, in determining these amounts, we estimate hospital demand, buying patterns by hospitals, hospital systems and/or group purchasing organizations from wholesalers and the levels of inventory held by wholesalers and customers. Making these determinations involves analyzing third party industry data to determine whether trends in historical channel distribution patterns will predict future product sales. We receive data periodically from our wholesale customers on inventory levels and historical channel sales mix, and we consider this data when determining the amount of the allowances and accruals for variable consideration. The amount of variable consideration is estimated by using either of the following methods, depending on which method better predicts the amount of consideration to which we are entitled: a) The “expected value” is the sum of probability-weighted amounts in a range of possible consideration amounts. Under Topic 606, an expected value may be an appropriate estimate of the amount of variable consideration if we have many contracts with similar characteristics. b) The “most likely amount” is the single most likely amount in a range of possible consideration amounts (i.e., the single most likely outcome of the contract). Under Topic 606, the most likely amount may be an appropriate estimate of the amount of variable consideration if the contract has only two possible outcomes (i.e., either achieve or don’t achieve a threshold specified in a contract). The method selected is applied consistently throughout the contract when estimating the effect of an uncertainty on an amount of variable consideration. In addition, we consider all the information (historical, current, and forecasts) that is reasonably available to us and shall identify a reasonable number of possible consideration amounts. The relevant factors used in this determination include, but are not limited to, current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. In assessing whether a constraint is necessary, we consider both the likelihood and the magnitude of the revenue reversal. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The specific considerations we use in estimating these amounts related to variable consideration associated with our products are as follows: Prompt Pay Discounts – We provide wholesale customers with certain discounts if the wholesaler pays within the payment term, which is generally between 30 and 60 days. Product returns – Generally, our customers have the right to return any unopened product during the 18-month period beginning six months prior to the labeled expiration date and ending 12 months after the labeled expiration date. Where historical rates of return exist, we use history as a basis to establish a returns reserve for product shipped to wholesalers. For our newly launched products, for which we currently do not have history of product returns, we estimate returns based on third-party industry data for comparable products in the market. As we distribute our products and establish historical sales over a longer period of time (i.e., two years), we will be able to place more reliance on historical purchasing and return patterns of our customers when evaluating our reserves for product return. At the end of each reporting period for any of our products, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. In the year ended December 31, 2018 , we increased our returns reserve by $1,700 due to risk factors that were present primarily in connection with the initial stocking of inventory for the launch of our new products. Chargebacks – Although we primarily sell products to wholesalers in the United States, we typically enter into agreements with medical centers, either directly or through GPOs acting on behalf of their hospital members, in connection with the hospitals’ purchases of products. Based on these agreements, most of our hospital customers have the right to receive a discounted price for products and volume-based rebates on product purchases. In the case of discounted pricing, we typically provide a credit to our wholesale customers (i.e., chargeback), representing the difference between the customer’s acquisition list price and the discounted price. Fees-for-service – We offer discounts and pay certain wholesalers service fees for sales order management, data, and distribution services which are explicitly stated at contractually determined rates in the customer’s contracts. In assessing if the consideration paid to the customer should be recorded as a reduction of the transaction price, we determine whether the payment is for a distinct good or service or a combination of both. Since our wholesaler fees are not specifically identifiable, we do not consider the fees separate from the wholesaler's purchase of the product. Additionally, wholesaler services generally cannot be provided by a third party. Because of these factors, the consideration paid is considered a reduction of revenue. We estimate our fee-for-service accruals and allowances based on wholesalers' purchases, demand pull-through, wholesaler inventory levels and the applicable discount rate. Government Rebates – We participate in three rebate programs under various government programs: Medicaid, TRICARE and Medicare Part D. At the time of the sale it is not known what the government rebate rate will be, but historical rates are used to estimate the current period accrual. Medicaid – The Medicaid Drug Rebate Program is a program that includes The Centers for Medicare and Medicaid Services, State Medicaid agencies, and participating drug manufacturers that helps to offset the federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. The Medicaid Drug Rebate Program is jointly funded by the states and the federal government. The program reimburses hospitals, physicians, and pharmacies for providing care to qualifying recipients who cannot finance their own medical expenses. TRICARE – TRICARE is a benefit established by law as the health care program for uniformed service members, retired service members, and their families. We must pay the Department of Defense (“DOD”) refunds for drugs entered into the normal commercial chain of transactions that end up as prescriptions given to TRICARE beneficiaries and paid for by the DOD. The refund amount is the portion of the price of the drug sold by us that exceeds the federal ceiling price. Refunds due to TRICARE are based solely on utilization of pharmaceutical agents dispensed through a TRICARE Retail Pharmacy to DOD beneficiaries. Medicare Part D – We maintain contracts with Managed Care Organizations (“MCOs”) that administer prescription benefits for Medicare Part D. MCOs either own pharmacy benefit managers (“PBMs”) or contract with several PBMs to fulfill prescriptions for patients enrolled under their plans. As patients obtain their prescriptions, utilization data are reported to the MCOs, which generally submit claims for rebates quarterly. Commercial Payer and Other Rebates – We contract with certain private payer organiza |
Balance Sheet Components
Balance Sheet Components | 12 Months Ended |
Dec. 31, 2018 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | BALANCE SHEET COMPONENTS Cash, Cash Equivalents and Restricted Cash— Cash, cash equivalents and restricted cash, as presented on the Consolidated Statements of Cash Flows, consisted of the following: As of December 31, 2018 2017 Cash and cash equivalents $ 81,808 $ 128,387 Restricted cash (included in Other assets) 200 200 Total cash, cash equivalents and restricted cash shown in the Consolidated Statements of Cash Flows $ 82,008 $ 128,587 Accounts receivable —Accounts receivable consisted of the following: As of December 31, 2018 2017 Trade receivables $ 11,509 $ — Contracted services 10,293 7,202 Other receivables 683 362 Total receivables $ 22,485 $ 7,564 Inventory —Inventory consisted of the following: As of December 31, 2018 2017 Raw materials $ 24,507 $ 5,545 Work in process $ 11,700 $ 181 Finished goods 12,204 5,099 Gross value of inventory $ 48,411 $ 10,825 Less: valuation reserves $ (7,070 ) $ — Total inventory $ 41,341 $ 10,825 We review inventories on hand at least quarterly and record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value. As of December 31, 2018 , we had established reserves for our inventory totaling $7,070 . Property and Equipment, Net —Property and equipment, net consisted of the following: As of December 31, 2018 2017 Laboratory equipment $ 3,387 $ 3,339 Manufacturing equipment 178 65 Office equipment 1,062 604 Purchased software 860 860 Furniture and fixtures 390 390 Leasehold improvements 4,943 4,869 Assets in development 301 437 Property and equipment, gross 11,121 10,564 Less-accumulated depreciation (9,535 ) (8,968 ) Property and equipment, net $ 1,586 $ 1,596 Depreciation expense relating to property and equipment was $570 and $451 in each of the years ended December 31, 2018 and 2017 , respectively. Other Assets —Other assets consisted of the following: As of December 31, 2018 2017 Deerfield disbursement option (see Note 4) $ 7,608 $ — Long-term inventory deposits 51,127 — Other assets 2,391 1,213 Restricted cash 200 200 Total other assets $ 61,326 $ 1,413 The long-term inventory deposits relate primarily to prepayments we are required to make under long-term contracts for the manufacture and delivery of Vabomere inventory, which requires extended lead-times. Accrued Expenses —Accrued expenses consisted of the following: As of December 31, 2018 2017 Accrued contracted services $ 2,909 $ 5,596 Payroll-related expenses 15,585 9,885 Professional fees 3,598 3,621 Accrued royalty payments 2,052 2,040 Accrued sales allowances 5,630 — Accrued other 4,150 2,899 Total accrued expenses $ 33,924 $ 24,041 Accrued contracted services are primarily comprised of amounts owed to third-party clinical research organizations and contract manufacturers for research and development work performed on behalf of Melinta, and amounts owed to third-party marketing organizations for work performed to support the commercialization of our four products. Accrued payroll-related expenses are primarily comprised of accrued employee termination benefits, bonuses and vacation. |
Financing Arrangements
Financing Arrangements | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Financing Arrangements | NOTE 4 – FINANCING ARRANGEMENTS Melinta’s outstanding debt balances consisted of the following as of December 31, 2018 and 2017 : As of December 31, 2018 2017 Principal balance under loan agreements $ 118,752 $ 40,000 Debt discount and deferred financing costs for loan agreements (8,276 ) (445 ) Total long-term debt, net of current maturities $ 110,476 $ 39,555 2014 Loan Agreement In December 2014, we entered into an agreement with a lender pursuant to which we borrowed an initial term loan amount of $20,000 (the “2014 Loan Agreement”). In December 2015, pursuant to the achievement of certain milestones with respect to the terms in the 2014 Loan Agreement, we borrowed an additional term loan advance in the amount of $10,000 . We were obligated to make monthly payments in arrears of interest only, at a rate of the greater of 8.25% or the sum of 8.25% plus the prime rate minus 4.5% per annum, commencing on January 1, 2015, and continuing on the first day of each successive month thereafter through and including June 1, 2016. Commencing on July 1, 2016, and continuing on the first day of each month through and including the maturity date of June 1, 2018, we were required to make consecutive equal monthly payments of principal and interest. In June 2017, we repaid the entire outstanding balance under the 2014 Loan Agreement (see discussion below under “2017 Loan Agreement”). In the years ended December 30, 2018 and 2017, we recognized $0 and $1,229 of interest expense, respectively, related to the 2014 Loan Agreement. 2017 Loan Agreement On May 2, 2017, we entered into a Loan and Security Agreement with a new lender (the “2017 Loan Agreement”). Under the 2017 Loan Agreement, the lender made available to us up to $80,000 in debt financing and up to $10,000 in equity financing. The 2017 Loan Agreement bore an annual interest rate equal to the greater of 8.25% or the sum of 8.25% plus the prime rate minus 4.5%. We were also required to pay the lender an end-of-term fee upon the termination of the arrangement. If the outstanding principal was at or below $40,000 , the 2017 Loan Agreement required interest-only monthly payments for 18 months from the funding of the first tranche, at which time we would have had the option to pay the principal due or convert the outstanding loan to an interest plus royalty-bearing note. On June 28, 2017, we drew the first tranche of financing under the 2017 Loan Agreement, the gross proceeds of which were $30,000 . We used the proceeds to retire amounts outstanding under the 2014 Loan Agreement. In August 2017, we drew the second tranche of financing, receiving $10,000 . We retired the 2017 Loan Agreement in January 2018 (see discussion below). Deerfield Facility On January 5, 2018 (the “Agreement Date”), in connection with the IDB acquisition, we entered into the Deerfield Facility (the “Deerfield Facility”) with affiliates of Deerfield Management Company, L.P. (collectively, “Deerfield”). Pursuant to the terms of the Deerfield Facility, which was later amended in January 2019 (see discussion below), Deerfield agreed to loan us $147,774 as an initial disbursement (the “Term Loan”). The Deerfield Facility also provides us the right to draw from Deerfield additional disbursements up to $50,000 (the “Disbursement Option”), which may be made available upon the satisfaction of certain conditions, such as our having achieved annualized net sales of at least $75,000 before the end of 2019. The option to draw the additional $50 million expires on January 4, 2020. We agreed to pay Deerfield an upfront fee and a yield enhancement fee, both equal to 2.0% of the principal amount of the funds disbursed pursuant to the Deerfield Facility. The Term Loan bears interest at a rate of 11.75% , while funds distributed pursuant to the Disbursement Option will bear interest at a rate of 14.75% . We are also required to pay Deerfield an exit fee of 2.0% of the amount of any loans on the payment, repayment, redemption or prepayment thereof (later amended to 4% , as discussed below under Deerfield Facility Amendment). The principal of the Term Loan must be paid by January 5, 2024 . The Deerfield Facility requires the outstanding principal amount of the Term Loan and any loans drawn pursuant to the Disbursement Option to be repaid in equal monthly cash amortization payments between the fourth and the sixth anniversary of the Agreement Date. The Term Loan and any loans drawn pursuant to the Disbursement Option are not permitted to be prepaid prior to January 6, 2021 , under the terms of the Deerfield Facility and are subject to certain prepayment fees for prepayments occurring on or after such date. In addition, the Deerfield Facility permits us to secure a revolving credit line of up to $20,000 from a different lender, subject to working capital balances. Deerfield holds a first lien on all our assets, including our intellectual property, except for working capital accounts, for which they hold a second lien while any revolving credit line with a different lender is in place. The Deerfield Facility, while it is outstanding, limits our ability to raise debt financing in future periods outside of the $20,000 revolver permitted thereunder, to sell any assets, enter into partnerships, enter into any other debt, enter into capital leases, or pay dividends (however, as amended, it permits the execution of the Vatera Loan Agreement, discussed below). The Deerfield Facility, as amended, has a financial maintenance covenant requiring us to maintain a minimum cash balance of $40,000 through March 2020, and thereafter of $25,000 , at all times, a requirement that we achieve net product sales of at least $63,750 during 2019, and other normal covenants, including periodic financial reporting and a restriction on the payment of dividends. In connection with the Deerfield Facility, we issued 625,569 shares of our common stock to Deerfield at a price of $67.50 on January 5, 2018, pursuant to a Securities Purchase Agreement. We received proceeds of $42,226 from this issuance of common stock. We received total proceeds of $190,000 from the Term Loan and the issuance of common stock together. We used these proceeds to fund the IDB acquisition, to retire the $40,000 of principal balance outstanding under the 2017 Loan Agreement and to fund ongoing working capital requirements and other general corporate expenses. As a result, we recognized a debt extinguishment loss of $2,595 , comprised of prepayment penalties and exit fees related to retiring the 2017 Loan Agreement totaling $2,150 and unamortized debt issuance costs of $445 . In connection with the Deerfield Facility and the Securities Purchase Agreement, we entered into the following freestanding instruments, with Deerfield as a counterparty, on January 5, 2018: • Term Loan with stated principal of $147,774 with a 11.75% interest rate; • Disbursement Option for additional draw of up to $50,000 ; • 625,569 shares of our common stock; • Warrants to purchase 758,573 shares of our common stock with a purchase price of $82.50 and expiration date of January 5, 2025 (the “Warrants”); and • Rights to royalty payments equal to between 2.0% and 3.0% of certain U.S. sales of Vabomere for a period of 7 years, ending on December 31, 2024, as further described below (the “Royalty Agreement”). For accounting purposes, because there are multiple freestanding instruments within the arrangement to which we are required to assign value under U.S. GAAP, we performed a valuation to determine the allocation of the gross proceeds of $190,000 to the five financial instruments listed above. We first calculated the fair value of the warrants, and then we allocated the remaining proceeds across the other four instruments using the relative fair value approach. The relative fair values of these financial instruments, which approximated their respective fair values as of the Agreement Date, were as follows: Liabilities / (Assets) Term Loan $ 111,421 Warrants 33,263 Royalty Agreement 1,472 Disbursement Option (7,608 ) Common Stock Consideration 51,452 Total Consideration $ 190,000 The terms of these instruments and the methodology and assumptions used to value each of them are discussed below. Term Loan The relative fair value of the term loan was estimated to be $111,421 using a discounted cash flow model (Level 3 inputs). We used a risk-adjusted discount rate of 19.8% . In connection with the Deerfield Facility, we paid $6,455 of upfront term loan fees and legal debt issuance costs. For accounting purposes, we elected to allocate these upfront fees and costs all to the term loan, leaving a net carrying value of $104,966 . The upfront fees and costs were recorded as debt discount and are being amortized as additional interest expense over the term of the loan. In addition, a 2.0% exit fee of $2,956 is payable as the loan principal payments are made. Therefore, total required future cash payments are $150,730 (term loan principal of $147,774 plus exit fee of $2,956 ). The exit fee cost is also being amortized as additional interest expense over the life of the loan. The total cost of all items (cash-based interest payments, upfront fees and costs, and the 2.0% exit fee) is being expensed as interest expense using an effective interest rate of 21.4% . During the years ended December 31, 2018 and 2017 , we recorded cash interest expense and term loan accretion expense of $17,460 and $5,510 , and $0 and $0 , respectively. All amounts were recorded as interest expense in our statement of operations. The accretion of the principal of the term loan and the future payments, including the 2.0% exit fee due at the end of the term, and excluding the 11.75% rate applied to the $147,774 note per the form of the Deerfield Facility, are as follows: Beginning Balance Accretion of Interest Expense Principal Payments and Exit Fee Ending Balance January 5 - December 31, 2018 $ 104,966 $ 5,510 $ — $ 110,476 Year Ending December 31, 2019 110,476 7,135 — 117,611 Year Ending December 31, 2020 117,611 8,638 — 126,249 Year Ending December 31, 2021 126,249 10,799 — 137,048 Year Ending December 31, 2022 137,048 9,827 (69,084 ) 77,791 Year Ending December 31, 2023 77,791 3,846 (75,365 ) 6,272 Year Ending December 31, 2024 6,272 9 (6,281 ) — Total $ 45,764 $ (150,730 ) Warrants Under the terms of the Deerfield Facility, we issued Warrants to Deerfield to purchase 758,573 shares of common stock with an exercise price of $82.50 and a term of seven years. The holders of the Warrants may exercise the Warrants for cash, on a cashless basis or through a reduction of an amount of principal outstanding under the Term Loan or any subsequent disbursements pursuant to the Disbursement Option. In connection with certain major transactions (as defined therein), the holders may have the option to convert the Warrants, in whole or in part, into the right to receive the transaction consideration payable upon consummation of such major transaction in respect of a number of shares of common stock of the Company equal to the Black-Scholes value of the Warrants, as defined therein, and in the case of other major transactions, the holders may have the right to exercise the Warrants, in whole or in part, for a number of shares of common stock of the Company equal to the Black-Scholes value of the Warrants. We used the Black-Scholes option-pricing model to estimate the fair value of the Warrants (Level 3 inputs), which resulted in a fair value of $33,263 on the Agreement Date. To measure the Warrants at January 5, 2018 , the assumptions used in the Black-Scholes option-pricing model were: the price of the common stock on January 5, 2018 , an expected life of 7.0 years, a risk-free interest rate of 2.4% and an expected volatility of 50.0% . We classified the Warrants as a liability in our balance sheet and are required to remeasure the carrying value of these Warrants to fair value at each balance sheet date, with adjustments for changes in fair value recorded in Other income or expense in our statements of operations. To remeasure the Warrants at December 31, 2018 , the assumptions used in the Black-Scholes option-pricing model were: the price of our common stock on December 31, 2018 , an expected life of 6.0 years, a risk-free interest rate of 2.55% and an expected volatility of 50.0% . The fair value of the Warrants at December 31, 2018 , was $38 , resulting in a gain during the years ended December 31, 2018 , of $33,226 . Royalty Agreement In connection with the Deerfield Facility, we entered into a Royalty Agreement with Deerfield, pursuant to which we agreed to make royalty payments equal to 3.0% (or 2.0% , following the satisfaction of all our obligations under the Deerfield Facility and other loan documents) of annual U.S. sales of Vabomere exceeding $75,000 ( $74,178 for 2018 ) and less than or equal to $500,000 for a seven -year period. To determine the fair value of the obligation under the Royalty Agreement, we applied a Monte Carlo simulation model to our revenue forecasts for Vabomere, which was discounted using an adjusted weighted average cost of capital (“WACC”). The WACC incorporated our estimated senior unsecured discount rate, our expected tax rate, and our estimated cost of equity, and then was adjusted for operational leverage. On January 5, 2018 , we estimated the fair value of the royalty liability under the Royalty Agreement to be $1,472 . Over the seven-year term, we will accrete the royalty liability using an effective interest rate of 42.9% and reduce the liability for any royalty payments made to Deerfield. During the year ended December 31, 2018 , we recorded accretion expense of $758 . At the end of each quarter, we are required to prospectively revise the rate of accretion if there are any significant changes in our long-term sales forecasts. During the quarter ended December 31, 2018 , we did not identify any significant changes in our sales forecasts and, accordingly, did not revise the rate of accretion. As we have not yet reached the $75,000 sales threshold for annual sales of Vabomere, we have not made any royalty payments to Deerfield. Disbursement Option The Disbursement Option allows us to draw additional funds up to $50,000 once we achieve annual net product sales of at least $75,000 . The annual net sales target is measured by using the sales result for the preceding six months and multiplying by two. The disbursement must be drawn within two years from the effective date of the transaction and requires quarterly interest payments at a rate of 14.75% and requires the principal amount outstanding to be repaid in equal monthly cash payments between the fourth and the sixth anniversary of the effective date of the agreement. We calculated the fair value of the Disbursement Option using a discounted cash flow model (Level 3 inputs), under which estimated cash flows were discounted using a risk-adjusted rate that aligns with the lender’s estimated credit risk to disburse the $50,000 . We estimated the relative fair value of the Disbursement Option to be $7,608 as of the effective date of the transaction, which we recorded as a long-term asset on our balance sheet to be carried at that value until settlement. Common Stock Consideration Pursuant to the terms of the Securities Purchase Agreement, we issued 625,569 shares of our common stock to Deerfield at a price of $67.50 on January 5, 2018 . Based on our closing stock price on January 5, 2018 , of $82.25 (Level 1 input), the fair value of this consideration was $51,452 , which was recorded as additional paid-in capital in stockholders’ equity. Deerfield Facility Amendment On January 14, 2019, in conjunction with the Vatera Loan Agreement (discussed below),we entered into an amendment to the Deerfield Facility (the “Deerfield Facility Amendment”). The Deerfield Facility Amendment was a condition (among other conditions) to funding the Vatera Facility. The amendments set forth in the Deerfield Facility Amendment, except for specified amendments described below which were immediately effective, became effective upon the funding of the initial $75,000 disbursement under the Vatera Facility in February 2019. The Deerfield Facility Amendment(i) modifies the definition of “change of control” under the Deerfield Facility to permit Vatera Healthcare Partners LLC ("VHP"), Vatera Investment Partners LLC ("VIP" and, together with VHP, "Vatera") and their respective affiliates to own 50% or more of the equity interests in the Company on a fully diluted basis; (ii) modifies the definition of “Indebtedness” under the Deerfield Facility to exclude certain specific payments under (x) the Agreement and Plan of Merger, dated as of December 3, 2013, among the Medicines Company, Rempex Pharmaceuticals, Inc. and the other parties thereto and (y) the Purchase and Sale Agreement, dated as of November 28, 2017, between The Medicines Company and Melinta Therapeutics, Inc.; (iii) modifies the definition of “Permitted Indebtedness” under the Deerfield Facility to permit the payment of a certain amount of the interest on the Convertible Loans (described below) in cash; (iv) eliminates the requirement that the Company’s audited financial statements for the fiscal year ending December 31, 2018, be delivered without an explanatory paragraph expressing doubt as to the Company’s status as a going concern; (v) reduces the net sales covenant set forth in the Deerfield Facility for all periods after December 31, 2018, by 15% ; (vi) requires the Company to hold a minimum cash balance of $40,000 through March 31, 2020, and thereafter $25,000 (the current requirement); (vii) increases the exit fee under the Deerfield Facility from 2% to 4% ; and (viii) makes certain other technical modifications, including to accommodate the Vatera Facility and the Vatera Convertible Loans. Under the terms of the Deerfield Facility Amendment, $74,000 in principal amount of the loans under the Deerfield Facility (the “Deerfield Convertible Loan”) are convertible into shares of the Company’s common stock at Deerfield’s option at any time and evidenced by a convertible note (the “Deerfield Convertible Note”), subject to the 4.985% Ownership Cap as described below. The conversion price for the Deerfield Convertible Loan (the “Deerfield Convertible Loan Conversion Price”) is the greater of (i) $5.15 , which is the minimum initial conversion price, subject to adjustment for stock splits (including a reverse split), stock combinations or similar transactions, and (ii) 95.0% of the lesser of (A) the closing price of the Company’s common stock on the trading day immediately preceding the conversion date and (B) the arithmetic average of the volume weighted average price of the Company’s common stock on each of the three trading days immediately preceding the conversion date. A lender’s ability to convert its portion of the Deerfield Convertible Loan is subject to a restriction that no lender will be permitted to convert such portion if it would result in such lender and its affiliates beneficially owning more than 4.985% of the total number of shares of the Company’s common stock outstanding (the “ 4.985% Ownership Cap”). However, that will not prevent a lender from periodically converting its portion of the loan up to the 4.985% Ownership Cap and then selling the shares such that up to $74,000 of the loan is converted over time. However, no lender may, without the approval of a majority of the Company’s board of directors, sell or dispose, in a pre-arranged single transaction or series of related transactions any shares of the Company’s common stock issued upon conversion of the Deerfield Convertible Loan to any person or group if such lender knows, in advance of effecting such transaction or series of related transactions, that such transferee holds, or after giving effect to such sale would hold, in excess of 15.0% of the issued and outstanding shares of the Company’s common stock. This 15.0% limitation does not apply if the sale is part of a tender offer or exchange offer made to all stockholders of the Company, or otherwise is in connection with a merger or other business combination transaction and also does not restrict the ability of any lender to transfer all or any portion of the Deerfield Convertible Note in accordance with its terms or to sell any shares of the Company’s common stock that have been issued upon conversion of the Deerfield Convertible Loan in open-market transactions. The Deerfield Convertible Loan continues to be secured by the collateral and the liens granted pursuant to the Deerfield Facility and related loan documents. The Deerfield Facility Amendment also amended the Deerfield Warrants to replace the 9.985% ownership cap set forth therein with a 4.985% Ownership Cap. As a result, the Company is subject to a restriction on its ability to satisfy interest due and payable through the issuance of the Company’s common stock to the extent that, upon such issuance, a holder, its affiliates and any “group” of which such holder is a member would beneficially own greater than 4.985% of the outstanding shares of the Company’s common stock. The Deerfield Facility Amendment also provides that the Deerfield Registration Rights Agreement will cover the shares of the Company’s common stock issuable upon conversion of the $5,000 of convertible loans that will be deemed funded by Deerfield upon the initial funding under the Vatera Loan Agreement (See Vatera Loan Agreement below). In addition to the funding of the initial $75,000 disbursement under the Vatera Facility, the effectiveness of the Deerfield Facility Amendment also was subject to the satisfaction (or waiver) of other customary conditions, In addition, the Company is required at all times after the effective date of the Deerfield Facility Amendment to reserve and keep available a sufficient number of shares of common stock for the purpose of enabling the Company to issue all of the underlying shares of common stock issuable pursuant to the Deerfield Convertible Note. Vatera Loan Agreement On December 31, 2018, we entered into a Senior Subordinated Convertible Loan Agreement (the “Loan Agreement”) with Vatera for $135,000 , and on January 14, 2019, we amended the Loan Agreement pursuant to which, among other things, Deerfield will be deemed to have funded an additional $5,000 of senior subordinated convertible loans (the "Convertible Loans") under the Vatera Loan Agreement as consideration for entering into the Deerfield Facility Amendment. No amount was drawn under the Loan Agreement as of December 31, 2018, as its effectiveness was contingent upon the satisfaction of several conditions. The proceeds of the Convertible Loans will be used for working capital and other general corporate purposes. The Convertible Loans are senior unsecured obligations of the Company and are contractually subordinated to the obligations under the Deerfield Facility. Interest on the Convertible Loans is 5% per year and will be paid in arrears at the end of each fiscal quarter, with 50% of such interest paid in cash and the remaining 50% of such interest paid in kind by increasing the principal balance of the outstanding Convertible Loans in an amount equal thereto (which increase will bear interest once added to such principal balance). The maturity date of the Convertible Loans is January 6, 2025. The Convertible Loans are convertible at Vatera's option into shares of convertible preferred stock of the Company at a conversion rate of 1.25 shares of preferred Stock per one thousand dollars. The preferred stock is further convertible at Vatera's option into shares of common stock of the Company at a rate of 100 shares of common stock per one share of preferred stock (the “Common Stock Conversion Rate”). At Vatera's option, the Convertible Loans are also directly convertible into common stock at an initial conversion rate equal to the Loan Conversion Rate multiplied by the Common Stock Conversion Rate. The preferred stock is non-participating, convertible preferred stock, with no dividend rights (other than to participate in common stock dividends on the Company’s common stock on an as-converted basis) or voting rights, and is senior to the common stock upon liquidation (with a liquidation preference equal to the Conversion Amount for the converted loans, as it may thereafter be adjusted pursuant to the Certificate of Designations (plus, if applicable, the amount of any declared but unpaid dividends on such shares of preferred stock)). An exit fee (the “Interim Exit Fee”) of 1% of the aggregate amount of Convertible Loans funded under the Loan Facility is payable upon repayment or conversion of such funded amount (payable in preferred stock in the case of conversion). In addition, an exit fee (the “Final Exit Fee” and, together with the Interim Exit Fee, the “Exit Fee”) of 3% on the portion of the aggregate committed amount of Convertible Loans not drawn by the Company under the Loan Facility is payable on any repayment in full or conversion in full of the Convertible Loans (payable in preferred stock in the case of conversion). Subject to the satisfaction (or waiver) of the conditions precedent set forth in the Loan Agreement, as amended, $75,000 of Convertible Loans may be drawn in a single draw on or prior to February 25, 2019, up to $25,000 of additional Convertible Loans may be drawn in a single draw after March 31, 2019, but on or prior to June 30, 2019, and up to $35,000 of additional Convertible Loans may be drawn in a single draw after June 30, 2019, but on or prior to July 10, 2019. Among the conditions precedent, the Loan Agreement required the approval of the shareholders of Melinta of measures to ensure the number of authorized shares of common stock was sufficient to accommodate the potential conversion of the Convertible Loans and approval of the issuance of the Convertible Loans, in accordance with Nasdaq rules. On January 19, 2019 , at a Special Meeting of the shareholders, the shareholders approved both a reverse stock split and an increase of the authorized shares, as well as the issuance of the Convertible Notes. Melinta drew the first tranche of $75,000 on February 22, 2019. |
License Agreements
License Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
License Agreements | LICENSE AGREEMENTS Eurofarma In December 2014 , we entered into a Series 3-B Convertible Preferred Stock Purchase Agreement (the “Stock Purchase Agreement) and concurrent Distribution Agreement (the “Distribution Agreement”) and Supply Agreement (the “Supply Agreement”) with Eurofarma Laboratorios S.A. (“Eurofarma”). The Distribution Agreement and Supply Agreement, collectively, are referred to as the “Commercial Agreements.” Pursuant to the Stock Purchase Agreement, we agreed to issue to Eurofarma 1,052,474 shares of Series 3-B Convertible Preferred Stock at the purchase price of $13.301985 per share. Melinta received the proceeds of $14,000 from this stock sale on January 6, 2015, and thus, the purchaser’s right to the shares of Series 3-B Convertible Preferred Stock began accruing on that date. Under the Distribution Agreement, we appointed Eurofarma as our sole and exclusive distributor of Baxdela formulations in Brazil for use in various indications and Eurofarma agreed to commercialize Baxdela in Brazil for those indications. Eurofarma paid us $1,000 under the Distribution Agreement in January 2015. An additional $2,000 will be due upon the earlier of (i) approval of pricing to sell Baxdela in Brazil and (ii) Eurofarma’s first commercial sale of Baxdela in Brazil. We recorded approximately $6,000 of Series 3-B Convertible Preferred Stock and approximately $9,008 of deferred revenue in January 2015, the period when the funding provided by these agreements was received and the Series 3-B Convertible Preferred Stock was issued. Under ASC 605, the deferred revenue would be recognized as product is delivered under the Commercial Agreements. In August 2017, Melinta and Eurofarma entered into an amendment to the distribution and supply agreement to extend the licensed territory to substantially all of Central America and South America for upfront consideration of $1,000 (the “Eurofarma Amendment”) as well as other regulatory based milestones when and if they occur. Because the Eurofarma Amendment did not significantly change the nature of the deliverables under the arrangement, management concluded that it did not constitute a material modification of the original arrangement. As such, the $9,008 of deferred revenue recorded in connection with the original agreement was appropriately deferred as of December 31, 2017 , as we had not yet commenced commercial supply of Baxdela for the territory (Brazil). In addition, because the Eurofarma Amendment was negotiated at arms’ length, it was deemed to be a separate arrangement from the original contract. The Eurofarma Amendment has multiple elements, including the delivery of the license and the exclusive supply of Baxdela with respect to the licensed territories. We concluded that there was no standalone value for the delivered license in the Eurofarma Amendment; accordingly, the consideration of $1,000 was recorded as deferred revenue. Under ASC 605, we would commence recognition of the revenue when we begin to deliver under the supply agreement. We adopted Topic 606 on January 1, 2018, using the modified retrospective method applied to those contracts which were not complete as of January 1, 2018. In our adoption of Topic 606, we did not use practical expedients. In addition, we have considered the nature, amount and timing of our different revenue sources. Accordingly, the disaggregation of revenue from contracts with customers is reflected in different captions within the consolidated statement of operations. For our Eurofarma distribution arrangements under which revenue was previously deferred, revenue is now recognized at the point in time when the license is granted and has benefit to Eurofarma. These deferred revenues were originally expected to be recognized in future periods over the period of time over which we supplied Baxdela under the supply arrangement, which could have lasted up to 10 years or longer. The cumulative effect of the adoption was recognized as a decrease to opening accumulated deficit and a decrease to deferred revenue of $10,008 on January 1, 2018. In October 2018, Eurofarma received approval to sell Baxdela in Argentina, and, accordingly, we recognized milestone revenue of $500 . Because the approval of Baxdela in Argentina was the first approval of Baxdela outside of the United States, we also recorded a milestone payable to Wakunaga of $1,200 . Menarini In February 2017, we executed a license agreement with A. Menarini Industrie Farmaceutiche Riunite S.r.l. (“Menarini”), a leading pharmaceutical company in Western Europe, under which we licensed rights to commercialize Baxdela in certain European, Asia-Pacific (except for Japan) and other rest-of-world territories (the “Agreement”). Pursuant to the terms and conditions of the Agreement, Menarini is entitled to exclusive rights to obtain product approval, procure supply from us and to commercialize Baxdela in the licensed territories, and we are entitled to receive regulatory, commercial and sales-based milestones as well as sales-based royalties on future net sales of Baxdela. In addition, we agreed with Menarini to share jointly in the future development cost of Baxdela. We received $19,905 upon the execution of the Agreement. On an ongoing basis, we receive reimbursement for 50% of the costs incurred for efforts to expand the applicable indications for Baxdela, and we may receive up to approximately €90,000 for regulatory, commercial and sales-based milestones as well as sales-based royalties on future sales of Baxdela. At the time the agreement was entered into, we identified two deliverables: the delivery of the Baxdela license to Menarini and the right to a related sublicense. While we are also providing development services in connection with the expansion of applicable indications for Baxdela, we are under no obligation to perform such services. In the event that we perform development services related to other indications of Baxdela, Menarini has the option to obtain the results of such services by reimbursing us for 50% of our related costs, and we have determined that Menarini’s option is not priced at a significant and incremental discount. To the extent that we are reimbursed for development services, such amounts will be recognized separately from the initial license. The agreement also states a separate Supply Agreement will be entered into at a future date under which Menarini will purchase Baxdela products from us until it can commence its own manufacturing. The pricing of Baxdela products under the Supply Agreement will not be at a significant, incremental discount. And, as noted above, we are entitled to receive up to approximately €90,000 for regulatory, commercial and sales-based milestones as well as royalties on future sales of Baxdela. We will recognize any future milestone payment received as revenue when Menarini achieves the milestone. For immediate use of the license and right to the sublicense, Menarini is able to leverage the information contained within the Baxdela NDAs, which were filed by us with the FDA in October 2016 for ABSSSI, to prepare the regulatory filings in the licensed territories. And, while the FDA approval was received in June 2017, regulatory approval in many of the licensed territories is not contingent upon U.S. FDA approval. We recognized $19,905 , the consideration that was fixed and determinable at the inception of the agreement, upon delivery of the license and right to the sublicense in the first quarter of 2017, and we will recognize revenue associated with the development services as they are provided to Menarini. In the year ended December 31, 2018 , we recognized revenue totaling $11,325 related to the development services. Of that amount, we have received $7,316 in cash payments; the balance of $4,009 is recorded in Receivables as of December 31, 2018 . In connection with the Agreement, we paid Wakunaga Pharmaceutical Co. Ltd. (“Wakunaga”) $1,590 , which was credited toward our future payment obligations under the license agreement we have with them for certain intellectual property underlying Baxdela. See Note 10 “Commitments and Contingencies” for further information on our license agreement with Wakunaga. This expense was recorded in the year ended December 31, 2017 , in selling, general and administrative expense, which is where we record all expenses related to intellectual property that are generated by events and activities outside our research and development activities. In this case, the payment was triggered by the receipt of upfront licensing fees from Menarini. In September 2018, we entered into a license agreement with Menarini, which grants to Menarini the exclusive right to market Vabomere, Orbactiv and Minocin for injection in 68 countries in Europe, Asia-Pacific and the Commonwealth of Independent States. The agreement includes an upfront license fee of €17,000 (which we received in October 2018), a milestone payment of €15,000 upon European marketing approval for Vabomere (which Menarini received in November 2018 and which we received in January 2019), potential regulatory- and sales-based milestones, and sales-based royalties. We determined that Menarini is a customer and we should account for the agreement under Topic 606. We identified one performance obligation under the agreement, the delivery of the licensed rights. In addition, we agreed to supply the products to Menarini at a cost that we concluded did not incorporate a significant incremental discount. We provided Menarini immediate access to the licensed rights and, as such, we allocated the upfront payment entirely to the license and recognized revenue at the point in time when the licensed rights were delivered, in September 2018. We will recognize any future contingent consideration, including milestone payments or royalty revenue, at such time when the milestones or royalties have been achieved. |
Fair Value Measurements
Fair Value Measurements | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | FAIR VALUE MEASUREMENTS The provisions of the accounting standard for fair value define fair value as the price 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. The transaction of selling an asset or transferring a liability is a hypothetical transaction at the measurement date, considered from the perspective of a market participant who holds the asset or owes the liability. Therefore, the objective of a fair value measurement is to determine the price that would be received when selling an asset or paid to transfer a liability (an exit price) at the measurement date. This standard classifies the inputs used to measure fair value into the following hierarchy: Level 1 —Unadjusted quoted prices in active markets for identical assets or liabilities. Level 2 —Unadjusted quoted prices in active markets for similar assets or liabilities, or unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or inputs other than quoted prices that are observable for the asset or liability. Level 3 —Unobservable inputs for the asset or liability. The following table lists our assets and liabilities that are measured at fair value and the level of inputs used to measure their fair value at December 31, 2018 and 2017 . The money market fund is included in cash & cash equivalents on the balance sheet; the other items are in the captioned line of the balance sheet. As of December 31, 2018 Level 1 Level 2 Level 3 Total Assets: Money market fund $ 32,883 $ — $ — $ 32,883 Total assets at fair value $ 32,883 $ — $ — $ 32,883 Liabilities: Current royalty contingent consideration from IDB acquisition $ — $ — $ (1,006 ) $ (1,006 ) Long-term royalty contingent consideration from IDB acquisition — — (4,708 ) (4,708 ) Warrant liability — — (38 ) (38 ) Total liabilities at fair value $ — $ — $ (5,752 ) $ (5,752 ) As of December 31, 2017 Level 1 Level 2 Level 3 Total Assets: Money market fund $ 76,777 $ — $ — $ 76,777 Total assets at fair value $ 76,777 $ — $ — $ 76,777 The following tables summarize the changes in fair value of our Level 3 liabilities for the years ended December 31, 2018 and 2017 : Level 3 Liabilities Fair Value at December 31, Accretion Recorded in interest Expense Change in Unrealized Gains (Losses) (Issuances) Settlements, Net Net Transfer (In) Out of Level 3 Fair Value at December 31, Current royalty contingent consideration from IDB acquisition $ — $ (1,055 ) $ (1,151 ) $ 1,200 $ — $ (1,006 ) Long-term royalty contingent consideration from IDB acquisition $ — $ (5,489 ) $ 11,468 $ (10,687 ) $ — $ (4,708 ) Contingent milestone payment $ — (4,015 ) (1,500 ) (24,485 ) 30,000 $ — Warrant liability $ — $ — $ 33,225 $ (33,263 ) $ — $ (38 ) Total liabilities at fair value $ — $ (10,559 ) $ 42,042 $ (67,235 ) $ 30,000 $ (5,752 ) Level 3 Liabilities Fair Value at December 31, Accretion Recorded in interest Expense Change in Unrealized Gains (Losses) Reclassification to APIC Net Transfer (In) Out of Level 3 Fair Value at December 31, Preferred stock warrants $ (674 ) $ — $ 335 $ 339 $ — $ — Total liabilities at fair value $ (674 ) $ — $ 335 $ 339 $ — $ — |
Shareholders' Equity
Shareholders' Equity | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Stockholders' Equity | SHAREHOLDERS' EQUITY At December 31, 2018 , our certificate of incorporation, as amended, authorizes us to issue up to 80,000,000 shares of $0.001 par value common stock and 5,000,000 shares of $0.001 par value preferred stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of our shareholders. Holders of our common stock are not entitled to receive dividends, unless declared by the board of directors. There have been no dividends declared to date. We have reserved and keep available out of our authorized but unissued common stock a sufficient number of shares of common stock to execute the conversion of all issued and outstanding warrants and stock options. On January 19, 2019, our shareholders voted to approve a reverse stock split and on February 20, 2019, our board authorized a one-for-five reverse split, which was effective on February 22, 2019. Earnings per share and all share information in this Annual Report on Form 10-K have been adjusted to reflect the split. On January 5, 2018, we issued 662,740 shares of common stock to Medicines as part of the purchase price of IDB (see Note 14 for further discussion). We also issued 625,569 shares of common stock and warrants to purchase 758,573 shares of common stock to Deerfield as part of the Deerfield Facility (see Note 4 for further discussion). In conjunction with the IDB transaction, we received $40,000 in additional equity financing from existing and new investors, in exchange for which we issued 576,992 shares of common stock. Further, in May 2018, we issued 4,928,000 shares of common stock to new and existing investors in a follow-on public offering for proceeds, net of issuance costs, of $115,273 . And, during the year ended December 31, 2018 , we issued 10,920 shares of common stock for restricted stock units that vested in the period. Warrants We have warrants to purchase our common stock outstanding at December 31, 2018 , as follows: Issued Warrants Outstanding Exercise Price Expiration February 2012 8 $ 86,670.35 February 2019 December 2014 6,757 $ 166.50 December 2024 December 2015 1,351 $ 166.50 December 2024 January 2018 758,573 $ 82.50 January 2025 Total 766,689 |
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 2006 Stock Plan —Upon closing the merger with Cempra, Inc. (“Cempra”) on November 3, 2017, Melinta assumed the 2006 Stock Plan, which had been adopted by Cempra in January 2006 (the “2006 Plan”). The 2006 Plan provided for the granting of incentive share options, nonqualified share options and restricted shares to Company employees, representatives and consultants. As of December 31, 2018 , there were options for an aggregate of 2,344 shares issued and outstanding under the 2006 Plan. During the period January 1, 2018, to December 31, 2018 , 11,328 options were forfeited; there was no other activity during the period. 2011 Equity Incentive Plan —Upon closing the merger with Cempra on November 3, 2017, Melinta assumed the 2011 Equity Incentive Plan, which had been adopted by Cempra in October 2011 (the “2011 Incentive Plan”). On January 1, 2018, under the evergreen feature of the 2011 Incentive Plan, the authorized shares under the 2011 Incentive Plan increased by 175,991 to 523,889 . In April 2018, we awarded 321,193 shares to employees with an exercise price of $37.25 and a grant date fair value of $27.05 . On June 12, 2018, the shareholders approved the adoption of the 2018 Stock Incentive Plan (the “2018 Plan”) (see below). With the adoption of the 2018 Plan, the 2011 Incentive Plan was frozen. At December 31, 2018 , there were 304,883 shares outstanding under the 2011 Incentive Plan and no shares available to award as either options or restricted stock units. Private Melinta 2011 Equity Incentive Plan —In November 2011, the Melinta board of directors adopted the 2011 Equity Incentive Plan (“Melinta 2011 Plan”). The Melinta 2011 Plan provided for the granting of incentive stock options, nonqualified options, stock grants, and stock-based awards to employees, directors, and consultants of the Company. On November 3, 2017, in conjunction with the merger with Cempra, all outstanding options under the Melinta 2011 Plan converted to 146,499 options to purchase common shares of Cempra (re-named Melinta in the merger), the Melinta 2011 Plan was frozen and authorized shares under the Melinta 2011 Plan were reduced to 146,499 . Any grants under the Melinta 2011 Plan that expire or are forfeited will reduce the authorized shares under the plan. As of December 31, 2018 , we had 97,706 shares of common stock reserved under the Melinta 2011 Plan for issuance upon exercise of stock options. 2018 Stock Incentive Plan —On April 20, 2018, we granted stock options to purchase 173,053 shares of common stock under the 2018 Plan at an exercise price of $37.25 and an average grant date fair value of $27.65 , as measured on June 12, 2018, the date the grants received shareholder approval. The grants were subject to, and contingent upon, shareholder approval of the 2018 Plan at the annual meeting in June 2018. On June 12, 2018, the shareholders approved the 2018 Plan, which was initially authorized with 400,000 shares. Under the evergreen feature of the 2018 Plan, these authorized shares may be increased on January 1 of each of the first three years following the year in which the 2018 Plan was adopted by the lesser of (i) 4% of the outstanding shares of the Company on the last day of the immediately preceding fiscal year, or (ii) such number of shares determined by the compensation committee of the board of directors. Upon approval of the 2018 Plan in June 2018, the fair value of the stock options granted on April 20, 2018, was established at $28.71 , which is the basis for the expense recognition. An additional 128,920 options were granted at various dates between May 2018 and December 2018, with a weighted-average exercise price of $26.80 and a weighted-average fair value of $18.35 . The 2018 Plan replaces the 2011 Incentive Plan, and no further equity awards will be granted from the 2011 Incentive Plan, which has been frozen. Any shares that are undelivered as a result of outstanding awards under the 2011 Incentive Plan expiring or being canceled, forfeited or settled in cash without the delivery of the full number of shares to which the award related will become available for grant under the 2018 Plan. As of December 31, 2018 , there were 235,323 shares available for awards under the 2018 Plan. In connection with his appointment as interim Chief Executive Officer in October 2018, Mr. Johnson received an option to purchase 30,000 common shares at a strike price of $14.00 and a grant date fair value of $4.75 , and a grant of 10,000 restricted stock units. The options will vest ratably over 12 months, and the restricted stock units will cliff vest after 12 months. On February 19, 2019, the shareholders of Melinta approved a one-for-five reverse stock split, effective on February 22, 2019, which had the effect of reducing all existing awards by a factor of five and increasing all strike prices by a factor of five. All share and per share amounts in this Annual Report on Form 10-K have been adjusted to reflect this reverse stock split. In addition, they approved the addition of 400,000 shares to the authorized shares for the 2018 Plan for grants to our chief executive officer and the addition of 600,000 shares for awards for executive management and other employees. Inducement Grants —On November 3, 2017, Melinta granted Daniel Wechsler, our former President and Chief Executive Officer, an option to purchase 110,196 shares of common stock, at a strike price of $58.25 per share and a grant date fair value of $41.80 , and 36,732 restricted stock units, pursuant to the option and restricted stock unit inducement agreements made with Mr. Wechsler. Both grants were to vest over four years, 25% after one year and then ratably monthly over the remaining 36 months . In October 2018, our board of directors appointed John H. Johnson as Interim Chief Executive Officer to succeed Daniel Wechsler, who stepped down from his role as President, CEO and director to pursue other opportunities. In connection therewith, Mr. Wechsler forfeited all of his inducement grant stock options and all but 9,183 of his restricted stock units, which vested on December 31, 2018 . On September 21, 2018, Melinta granted Peter J. Milligan, our recently appointed Chief Financial Officer, an option to purchase 74,000 shares of common stock, at a strike price of $22.50 per share and a grant date fair value of $16.55 , pursuant to the option inducement agreement made with Mr. Milligan. The grant will vest over four years, 25% after one year and then ratably monthly over the remaining 36 months . Stock Option Activity —The exercise price of each stock option issued under all of the stock plans is specified by the board of directors at the time of grant, but cannot be less than 100% of the fair market value of the stock on the grant date. In addition, the vesting period is determined by the board of directors at the time of the grant and specified in the applicable option agreement. Our practice is to issue new shares upon the exercise of options. All options granted under either the 2018 Plan, the 2011 Incentive Plan or the Melinta 2011 Plan during the years ended December 31, 2018 and 2017 , were granted with exercise prices not less than the fair market value of our common stock on the grant date, as approved by our board of directors. A summary of the stock option activity under the 2006 Plan is presented in the table below: Number of Options Weighted Average Exercise Price Weighted Average Contractual Term (in years) Aggregate Intrinsic Value Outstanding - November 3, 2017 13,672 $ 54.00 1.2 Outstanding - December 31, 2017 13,672 54.00 1.1 $ 342 Forfeited (11,328 ) $ 54.41 Outstanding - December 31, 2018 2,344 $ 52.25 1.4 $ — Exercisable - December 31, 2018 2,344 $ 52.25 1.4 $ — Vested and expected to vest at December 31, 2018 2,344 $ 52.25 1.4 $ — A summary of the stock-option activity under the 2011 Incentive Plan is presented in the table below: Number of Options Weighted Average Exercise Price Weighted Average Contractual Term (in years) Aggregate Intrinsic Value Outstanding - November 3, 2017 149,060 $ 300.10 6.2 Exercised (172 ) 78.15 Forfeited (1,289 ) 140.00 Expired (3,056 ) 322.05 Outstanding - December 31, 2017 144,543 $ 301.30 3.9 $ 113 Granted 321,193 37.25 Exercised (40 ) 78.05 Forfeited (78,513 ) 46.80 Expired (89,660 ) 312.85 Outstanding - December 31, 2018 297,523 $ 79.95 8.8 $ — Exercisable - December 31, 2018 51,328 $ 278.30 6.2 $ — Vested and expected to vest at December 31, 2018 297,521 $ 79.95 8.8 $ — A summary of the stock-option activity under the Melinta 2011 Plan is presented in the table below: Number of Options Weighted Average Exercise Price Weighted Average Contractual Term (in years) Aggregate Intrinsic Value Outstanding - December 31, 2015 4,362,836 $ 3.00 8.5 Granted 1,240,499 3.55 Exercised (31,685 ) 2.05 Canceled/expired (331,209 ) 3.85 Outstanding - December 31, 2016 5,240,441 3.10 7.9 Granted 1,830,199 2.40 Exercised (26,366 ) 3.60 Canceled/expired (797,571 ) 2.55 Conversion (6,102,901 ) (2 ) Outstanding - December 31, 2017 143,802 $ 129.40 7.9 Exercised (25,480 ) (1 ) 135.05 (1 ) Canceled/expired (20,616 ) (1 ) 151.90 (1 ) Outstanding - December 31, 2018 97,706 (1 ) $ 123.15 (1 ) 5.1 $ — Exercisable - December 31, 2018 81,419 (1 ) $ 124.15 (1 ) 4.5 $ — Vested and expected to vest at December 31, 2018 97,703 (1 ) $ 123.15 (1 ) 5.1 $ — (1) Amounts are after conversion (2) Options outstanding on November 3, 2017, were converted to options to purchase common shares of Cempra (re-named Melinta in the merger) at a 0.0229 conversion ratio The weighted-average grant-date per share fair value of options granted under the Melinta 2011 Plan during the years ended December 31, 2018 , 2017 and 2016 was $0.00 , $1.30 , and $2.15 , respectively ( $0.00 , $37.00 and $31.60 , respectively, after conversion and re-valuation on November 3, 2017). The total fair value of options that vested under the Melinta 2011 Plan during the years ended December 31, 2018 , 2017 and 2016 , was approximately $690 , $2,900 and $2,300 , respectively. The intrinsic value of options exercised in 2018 was not material. A summary of the stock-option activity under the 2018 Plan is presented in the table below: Number of Options Weighted Average Exercise Price Weighted Average Contractual Term (in years) Aggregate Intrinsic Value Outstanding - December 31, 2017 — Granted 301,973 32.80 Canceled/expired (76,650 ) 37.41 Outstanding - December 31, 2018 225,323 $ 31.21 9.5 $ — Exercisable - December 31, 2018 14,402 $ 29.20 8.9 $ — Vested and expected to vest at December 31, 2018 225,323 $ 31.21 9.5 $ — The weighted-average grant-date per share fair value of options granted under the 2018 Plan during the years ended December 31, 2018 , 2017 and 2016 was $27.65 , $0.00 and $0.00 , respectively. The total fair value of options that vested under the 2018 Plan during the years ended December 31, 2018 , 2017 and 2016 , was approximately $285 , $0 and $0 , respectively. The following table summarizes certain information about all options outstanding as of December 31, 2018 : Options Outstanding Options Exercisable Exercise Price Number of Options Weighted Average Remaining Contractual Term (in years) Number of Options Weighted Average Remaining Contractual Term (in years) $10.60 - $25.00 147,720 9.8 5,000 9.8 $25.01 - $50.00 402,896 9.3 18,150 8.5 $50.01 - $75.00 8,004 5.7 7,504 5.6 $75.01 - $100.00 31,826 4.4 28,639 4.0 $100.01 - $125.00 31,569 6.8 17,697 5.6 $125.01 - $1,085.75 74,875 5.0 72,188 4.9 696,890 149,178 Stock-Based Compensation —We use a Black-Scholes option-pricing model for determining the estimated fair value for stock-based awards. The Black-Scholes option-pricing model requires the use of the subjective assumptions in order to determine the fair value of stock-based awards. On November 3, 2017 , in conjunction with the merger with Cempra, all outstanding options under the Melinta 2011 Plan converted to 732,499 options to purchase common shares of Cempra (re-named Melinta in the merger). For accounting purposes, this was treated as a modification of the awards, generating a remeasurement of the estimated fair value of all vested and unvested Melinta 2011 Plan outstanding stock awards on the day of the stock conversion. After taking into consideration the terms of the Melinta 2011 Plan, the total remeasured estimated fair value of $2,362 on November 3, 2017 , for the vested stock options was immediately recorded as additional stock-based compensation expense in the fourth quarter of 2017, since the options were fully vested and had no future service requirement. The remeasured fair value of the unvested options of $2,476 is being recognized as expense over the remaining service period of each grant. On November 3, 2017 , all outstanding stock options issued under the assumed 2006 Plan and 2011 Incentive Plan were remeasured to estimated fair value on the day assumed by Melinta. The estimated fair value of $2,626 on the day of acquisition of the acquired vested stock options related to prior service periods was recorded as additional purchase price for the acquisition of Cempra (see Note 14). The remeasured fair values will be used to record stock-based compensation expense for the unvested shares over the remaining service period for each grant. Due to the different remaining contractual terms and remaining vesting periods of outstanding stock options on the day of merger from both the assumed 2011 Incentive Plan and Melinta 2011 Plan, a range of Black-Scholes assumptions were used to estimate the fair value on November 3, 2017. The range of assumptions used to value stock option grants for all plans—plus the vested stock option grants under the Melinta 2011 Plan which were remeasured on the merger date—were as follows: 2018 2017 2016 Risk-free interest rate 2.6% - 3.1% 1.8% - 2.1% 1.5 % Weighted-average volatility 84.8% - 85.6% 87.5% - 108.1% 67.1 % Expected term - employee awards (in years) 1.0 - 6.1 3.1 - 6.1 6.0 Forfeiture rate — % — % — % Dividend yield 0.00 % 0.00 % 0.00 % The range of assumptions used calculate the estimated value of the acquire vested stock options under the 2006 Plan and the 2011 Equity Plan that was recorded as additional purchase price for the acquisition of Cempra at the merger date were as follows (the wide range of volatility was due to the various remaining expected terms for the options, some of which were less than one year): November 3, 2017 Risk-free interest rate 1.2% - 2.0% Weighted-average volatility 51.0% - 147.4% Expected term - employee awards (in years) 0.2-5.6 Forfeiture rate 0.00 % Dividend yield 0.00 % • Risk-Free Interest Rate— The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the time of grant for zero coupon U.S. Treasury notes with maturities approximately equal to the option’s expected term. • Weighted-average Volatility —After the merger with Cempra, all outstanding options are to purchase common shares of Cempra (re-named Melinta in the merger). Since these shares are publicly traded, we primarily used the historical volatility information for the publicly traded shares. Prior to the merger, the Company had been privately held since inception. Therefore, there was no specific historical or implied volatility information available. Accordingly, prior to the merger, we determine volatility based on an average of reported volatility of selected peer companies in the pharmaceutical and biotechnology industry in a similar stage of development. • Expected Term —Our historical exercise behavior for previous grants does not provide a reasonable estimate for future exercise activity for employees who have been awarded stock options in the past three years. Therefore, the average expected term was calculated using the simplified method, as defined by GAAP, for estimating the expected term. • Forfeiture Rate —On January 1, 2016 , Melinta adopted the guidance in ASU 2016-9, Improvements to Employee Share-Based Payment Accounting, and changed its accounting policy for stock-based compensation to recognize stock option forfeitures as they occur rather than estimating an expected amount of forfeitures. • Expected Dividend Yield —We have never declared or paid any cash dividends and do not expect to pay any cash dividends in the foreseeable future. In 2016 and 2017, Cempra issued time-vested restricted stock units (RSUs) from the 2011 Incentive Plan to certain employees, subject to continuous service with us at the vesting time. When vested, the grants represented the right to be issued the number of shares of our common stock that is equal to the number of RSUs granted. On November 3, 2017 , all outstanding RSUs issued under the acquired 2011 Incentive Plan were remeasured to fair value on the day acquired by Melinta. The estimated fair value of $834 on day of acquisition related to the prior service periods for unvested RSUs was recorded as additional purchase price for the acquisition of Cempra (see Note 3). After the merger, certain Cempra employees were terminated. Under their severance agreements and equity award clauses, the vesting of 16,400 RSUs was accelerated on the date of termination. In accordance with ASC 718, $573 of additional compensation expense was recognized in the fourth quarter of 2018 , with the accelerated vesting. 12,400 common shares under the accelerated awards were issued in 2018 , and 4,000 common shares will be issued in 2019 for the remaining accelerated awards. A summary of the activity related to our RSUs (except for the inducement grant discussed above) is as follows: Number of Restricted Stock Units Outstanding Weighted Average Fair Value Balance - November 3, 2017 40,400 $ 58.25 Vested and issued (12,400 ) 58.25 Forfeited (600 ) 58.25 Balance - December 31, 2017 27,400 58.25 Granted 10,000 14.00 Vested and issued (10,920 ) 58.25 Forfeited (5,120 ) 58.25 Balance - December 31, 2018 21,360 32.75 Vested at December 31, 2018 4,000 $ 58.25 Stock-based compensation reported in our statements of operations was as follows: Year Ended December 31, 2018 2017 2016 Cost of goods sold $ 48 $ — $ — Research and development 750 651 1,169 General and administrative 2,667 5,799 1,346 Total $ 3,465 $ 6,450 $ 2,515 Stock-based compensation expense for our manufacturing-related employees of $209 was capitalized in inventory as a component of overhead expense and recognized as cost of goods sold based on inventory turns. No related tax benefits associated with stock-based compensation expense have been recognized and no related tax benefits have been realized from the exercise of stock options due to our net operating loss carryforwards. Total aggregate unrecognized stock-based compensation cost under all the plans and inducement grants as of December 31, 2018 and the Melinta 2011 Plan on December 31, 2017 , was $9,783 and $4,703 , respectively. The unrecognized stock-based compensation as of December 31, 2018 , will be recognized over a weighted-average period of 3.4 years . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | INCOME TAXES The Company utilizes the liability method of accounting for income taxes and deferred taxes which are determined based on the differences between the financial statements and tax basis of assets and liabilities given the provisions of the enacted tax laws. In assessing the realizability of the deferred tax assets, the Company considered whether it is more likely than not that some portion or all of the deferred tax assets will not be realized through the generation of future taxable income. In making this determination, the Company assessed all of the evidence available at the time including recent earnings, forecasted income projections, and historical financial performance. The Company has fully reserved deferred tax assets as a result of this assessment. The income tax expenses (benefits) from continuing operations are summarized as follows: 2018 2017 Federal: Current $ — $ — Deferred — — — — State: Current (139 ) (103 ) Deferred — — (139 ) (103 ) Total $ (139 ) $ (103 ) The provision for income taxes differs from income taxes computed at the federal statutory tax rates for the years ended December 31, 2018 and 2017 , due to the following items (presented as benefits/(expenses)): 2018 2017 Federal Statutory rate 21.0 % 34.0 % State income taxes, net of federal income tax benefit 17.7 0.2 Bargain purchase gain — 15.9 Transaction cost — (2.3 ) Interest expense — (2.3 ) Impact of change in fair value of tranche assets and liabilities 4.4 2.0 Other permanent differences (0.2 ) (2.0 ) Federal tax rate change — (75.3 ) Change in valuation allowance (14.1 ) 28.0 Research and development tax credits 1.2 3.3 Prior year adjustment (1.0 ) — Section 382 adjustment (28.9 ) — Other — (1.3 ) Effective income tax rate 0.1 % 0.2 % On November 3, 2017, we completed our tax-free merger with Cempra. To reflect the opening balance sheet deferred tax assets and liabilities of Cempra, we recorded a net deferred tax asset of $107,688 offset with valuation allowance of $107,688 . (See Note 3 for further information regarding the merger.) During the fourth quarter, we completed a Section 382 study and reduced the opening balance sheet deferred tax assets and liabilities by $101,195 which was offset with a valuation allowance of $101,195 to record the reduction of the tax attributes from the section 382 analysis. On December 22, 2017, the Tax Cuts and Jobs Act of 2017 (the “Act”) was signed into law making significant changes to the Internal Revenue Code. Changes include, but not limited to, a corporate tax decrease from 34% to 21% effective for tax years beginning after December 31, 2017, limitation of the business interest deduction, modification of the net operating loss deduction, reduction of the business tax credit for qualified clinical testing expenses for certain drugs for rare diseases or conditions, and acceleration of depreciation for certain assets placed into service after September 27, 2017. On December 22, 2017, the SEC staff issued Staff Accounting Bulletin No. 118 (“SAB 118”), which provides guidance on accounting for the tax effects of the Tax Act. SAB 118 provides a measurement period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740, Income Taxes . In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Tax Act for which the accounting under ASC 740 is complete. To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but it is able to determine a reasonable estimate, it must record and provisional estimate in the financial statement. During the fourth quarter, we completed accounting for the impact of the Act, and, as a result of purchase accounting adjustments, have recorded $83,007 as an additional income tax expense offset with $83,007 tax benefit from the change in the valuation allowance. The $83,007 of income tax expense included an adjustment of $82,013 related to the reduction of certain tax attributes as a result of the Section 382 analysis completed in 2018. The tax effects of the temporary differences and net operating losses that give rise to significant portions of deferred tax assets are as follows (in thousands): 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 94,596 $ 172,481 Tax credit carryforwards 7,409 24,924 Deferred revenue — 3,364 Fixed assets 677 593 Stock compensation expense 2,195 2,503 Intangibles 12,026 3,978 Interest expense carryforward 7,617 — Others 4,273 2,151 Total deferred tax assets 128,793 209,994 Less valuation allowance (128,793 ) (209,994 ) Net deferred tax assets $ — $ — We have established a full valuation allowance because we do not believe that it is more likely than not that we will generate sufficient taxable income to realize the deferred tax assets nor recognize any benefits from our net operating losses, tax credits, and other deferred tax assets. For the year ended December 31, 2018 , our valuation allowance increased by $22,443 , excluding the deferred tax asset valuation allowance of $101,195 associated with the Cempra opening balance sheet adjustment and $2,449 from the adoption of Topic 606. We have determined that our ability to utilize our previously generated federal net operating losses and federal tax credits would be limited under Sections 382 and 383 of the Internal Revenue Code (“Section 382”). The limitations under Section 382 apply if an ownership change, as defined by Section 382, occurs. Generally, an ownership change occurs when certain shareholders increase their aggregated ownership by more than 50 percentage points over their lowest ownership percentage in a testing period (typically three years ). We determined that certain deferred tax assets will be subject to Section 382 limitations due to previous ownership changes, specifically associated with our recapitalization in 2012 and from the November 2017 tax-free merger with Cempra. During the fourth quarter of 2018, we adjusted total Cempra deferred tax assets by $101,195 and recorded a corresponding valuation allowance of $101,195 as a result of Section 382 limitations pursuant to the study performed. Also during the fourth quarter of 2018, we adjusted total Melinta deferred tax assets by $26,126 and recorded a corresponding valuation allowance of $26,126 as a result of Section 382 limitations pursuant to the study performed. As of December 31, 2018 , we had approximately $267,597 of gross Federal net operating loss carryforwards and $7,409 in tax credit carryforwards that are available to offset taxable income in the future. The tax credit carryforwards will begin to expire in 2037 . The federal net operating loss carryforwards begin to expire in 2020 . State net operating loss carryforwards and tax credit carryforwards, on a tax-effected basis and net of federal tax benefits, are $38,401 and $5,010 , respectively. The state net operating loss carryforwards begin to expire in 2020 . The Company files its tax returns as prescribed by the tax laws of the jurisdictions in which it operates. With few exceptions, the major jurisdictions subject to examination by the relevant tax authorities, and open tax years, stated as the Company's fiscal years, are as follows: Jurisdiction Open Tax Years U.S. Federal 2015 - 2017 U.S. State 2014 - 2017 ASC 740, Income Taxes , prescribes a recognition threshold and measurement attribute for the financial statement recognition and measurement of a tax position taken or expected to be taken in a tax return. Only tax positions that meet the more-likely-than-not recognition threshold at the effective date may be recognized. As of December 31, 2018 , we did not have any unrecognized tax benefits. To the extent penalties and interest would be assessed on any underpayment of income tax, our policy is that such amounts would be accrued and classified as a component of income tax expense in the financial statements. To date, we have not recorded any such interest or penalties. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | COMMITMENTS AND CONTINGENCIES Operating Leases We are a lessee under lease agreements, as follows: • a lease for our principal research facility at 300 George Street, New Haven, Connecticut, that expires in August 2021; • a lease for our administrative facility at 300 Tri-State International, Lincolnshire, Illinois, that expires in March 2022; • A lease for our administrative office at 44 Whippany Road, Morristown, New Jersey, that expires in February 2024; and • three leases for our office facilities at 6320 Quadrangle Drive, Chapel Hill, North Carolina, the last of which expires in March 2021. One of the spaces under lease in Chapel Hill has been sub-leased through the termination date of the lease, March 2021. The terms of the Connecticut lease provide for even rental payments over the life of the lease; the terms of the other leases provide for rental payments on a graduated scale. We are required to pay a proportionate share of building operating expenses for all locations. We recognize rent expense on a straight-line basis over the noncancelable lease term of each lease. We also lease vehicles for many of our field-based employees, principally sales representatives. At December 31, 2018, we had approximately 210 leased vehicles. Rent expense under operating leases for facilities, vehicles and equipment was $1,747 , $907 and $690 for the years ended December 31, 2018 , 2017 and 2016, respectively. As of December 31, 2018, minimum operating lease payments under noncancelable leases (as amended) were as follows: Amounts 2019 $ 2,796 2020 2,710 2021 2,327 2022 1,233 2023 and thereafter 886 Total future minimum payments * $ 9,952 *Minimum payments have not been reduced by minimum sublease rentals of $271 due in the future under noncancelable subleases In May 2017, we entered into a master fleet agreement with Automotive Rentals, Inc. (“ARI”) under which we lease vehicles for certain field-based employees. Under the master fleet agreement, each vehicle is leased under a separate lease agreement for a term of up to four years. All other terms of the individual leases are essentially identical. In connection with the fleet agreement, in June 2017, we issued to ARI a $200 letter of credit, which auto-renews annually. As of December 31, 2018 , we had vehicles under lease with annual minimum lease payments totaling approximately $1,091 . We have determined that these vehicle leases are operating leases under current U. S. GAAP because (i) we have no right to purchase the vehicles at any time, (ii) the future minimum lease payments are less than 90% of the fair value of the vehicles at the time of lease and (iii) our use of the vehicles does not exceed 75% of the vehicles useful lives. Accordingly, we are recognizing the lease payments as expense as incurred. License Agreements with Future Payments We are parties to several license agreements, under which we will be required to make payments based on the achievement of agreed-upon milestones or circumstances. As of December 31, 2018 , we were not obligated to make any of the future payments discussed below. Yale University . In December 2001, we entered into an exclusive license agreement with Yale University (“Yale”) under which we obtained an exclusive right to use certain technology related to the high-resolution X-ray crystal structure of a 50S ribosome through the term of Yale’s patent rights on such technology. In return, we issued 61 shares of our common stock. The fair value of the shares of $35 was charged to operations in 2001. In September 2004 and December 2009, the license agreement was amended to include additional 50S ribosome technology and 70S ribosome technology owned by Yale, and we paid Yale license fees of $15 upon each amendment. We use the licensed technology in our ESKAPE pathogen program. We are obligated to certain diligence requirements and have the right to grant sublicenses to third parties, although Yale is entitled to a portion of payments received from the sublicensees. Under the license agreement, we may be required to make payments to Yale of up to $900 upon achieving certain regulatory approval milestones for each of the first three products developed under the license. In accordance with the license agreement, Yale is also entitled to receive percentage royalty payments in the single digits based on net sales, if any, of products using the subject matter of the license. Upon the occurrence of certain events, Yale has the right to terminate the license agreement upon 60 days’ written notice to us, should we fail to make a material payment under the agreement, commit a material breach of the agreement, fail to carry insurance required by the agreement, cease to carry on our business, or become subject to bankruptcy or a similar insolvency event. We have the right to terminate the license agreement upon 90 days’ written notice to Yale. Unless earlier terminated, the agreement will continue in effect until the last of the licensed patents expires. Medical Research Council . In March 2005, we entered into an exclusive license agreement with the Medical Research Council (“MRC”) under which we acquired rights to certain patent applications and other intellectual property related to the high-resolution X-ray crystal structure of a 30S ribosome through the term of the MRC’s patent rights on such technology. Upon entering into the license agreement, we paid the MRC a license fee of $10 . We use the licensed technology in our ESKAPE pathogen program. We are obligated to certain diligence requirements and have the right to grant sublicenses to third parties. Under the license agreement, we may be required to pay the MRC an aggregate of $610 upon the achievement of specified development and regulatory approval milestones for a pharmaceutical product and $100 for a diagnostic product. In accordance with the license agreement, the MRC is also entitled to receive percentage royalty payments in the single digits based on net sales, if any, of licensed pharmaceutical and diagnostic products. We and the MRC have the right to terminate the license agreement upon 30 days’ written notice if the other party commits a material breach of the agreement or an insolvency event occurs with respect to the other party, and the MRC may terminate the agreement if we challenge the protection of the licensed patent rights and know-how. Unless earlier terminated, the term of the agreement continues until the expiration of the last to expire claim of the licensed patent rights on a country-by-country basis. Wakunaga Pharmaceutical Co., Ltd . In May 2006, we and Wakunaga executed a license agreement under which we acquired rights to certain patents, patent applications, and other intellectual property related to Baxdela. To date, we have made $11,600 of nonrefundable payments to Wakunaga. Under the license, we have the right to grant sublicenses, although Wakunaga is entitled to a substantial portion of non-royalty income received from a sublicense of the Wakunaga technology. Pursuant to an amendment of the license agreement in November 2012, and later amended in May 2017, the future payments under the license agreement were adjusted. The license agreement, as amended, provided for potential additional future payments of up to $9,000 to Wakunaga upon the achievement of specified development and regulatory milestones, in addition to potential future sales milestone payments, and tiered royalty payments in the single digits on net sales, if any, of the licensed product. Of the $9,000 , we paid Wakunaga $1,590 in March 2017 in connection with our license and collaboration agreement with Menarini (see Note 5) and we owed $6,000 in June 2017 in connection with the FDA approval of Baxdela, of which we paid $4,000 in 2017; the remaining $2,000 was paid in June 2018. In addition, we have paid Wakunaga $200 in connection with licensing and milestone payments we received from Eurofarma. Wakunaga has certain termination rights, should we fail to perform our obligations under the agreement, we become subject to bankruptcy or similar events, or our business is transferred or sold and the successor requires us to terminate a substantial part of our development activities under the agreement. We have the right to terminate the license for cause upon six months’ written notice to Wakunaga. Unless earlier terminated, the license agreement will continue in effect on a country-by-country and product‑by‑product basis until we is no longer required to pay any royalties, which is the later of the date the manufacture, use or sale of a licensed product in a country is no longer covered by a valid patent claim, or a specified number of years following the first commercial sale in such country. The remaining $1,210 of license payments became due when Eurofarma received approval to market Baxdela in Argentina. The payment has been recorded in accrued liabilities as of December 31, 2018 , and paid in the first quarter of 2019. CyDex Pharmaceuticals, Inc . In November 2010, we entered into a license and supply agreement with CyDex Pharmaceuticals, Inc. (now a wholly-owned subsidiary of Ligand Pharmaceuticals Incorporated, both hereafter referred to as Ligand) under which we obtained an exclusive right, under certain patents and patent applications, to use Ligand’s beta sulfobutyl cyclodextrin, Captisol, in our development and commercialization of a Baxdela product. In addition, under the terms of the license agreement, we obtained a nonexclusive license to Ligand’s Captisol data package. Upon entering into the license agreement, we made a nonrefundable payment of $300 to Ligand. In January 2011, May 2013, October 2016 and July 2017, we made milestone payments to Ligand under the agreement of $150 , $500 , $1,500 and $1,500 , respectively. We are obligated to certain diligence requirements and have the right to grant sublicenses to third parties. The license agreement provides for payments of up to $600 to Ligand upon the achievement of future development and commercial milestones, and obligations to make percentage royalty payments in the single digits based on net sales, if any, of the licensed product. Additionally, we have agreed to purchase our requirements of Captisol from Ligand for use in a Baxdela product, with pricing established pursuant to a tiered pricing schedule. Ligand has certain rights to terminate the agreement following a cure period, should we fail to perform our obligations under the agreement. In addition, Ligand may terminate the agreement immediately if we fail to pay milestones or royalties due under the agreement or if we become subject to bankruptcy or similar events. We have the right to terminate the license upon 90 days’ written notice to Ligand. Unless earlier terminated, the agreement will continue in effect until the expiration of our obligation to pay royalties. Such obligation expires, on a country-by-country basis, over a specified number of years following the expiration date of the last valid claim of a licensed product in the country of sale; if there has never been a valid claim of a licensed product in the country of sale, then such number of years after the first sale of the licensed product in such country. Radezolid . In December 2014, we entered into a license agreement with a contract research organization (“CRO”) for the development and commercialization of Radezolid in topical formulations for a variety of dermatological indications. Melinta retains the option to co-develop or fully regain rights to Radezolid upon completion of specific development milestones. In March 2016 and February 2017, we paid milestones totaling $900 and $450 , respectively, to the CRO under this license agreement, which was recorded as an expense when paid. In addition, in 2017 we agreed to reimburse the CRO up to $250 of certain development expenses, of which we have paid $154 through December 31, 2018. Commitments Assumed in the Merger with Cempra, Inc. Optimer Pharmaceuticals, Inc. (now owned by Merck). In March 2006, Cempra entered into a Collaborative Research and Development and License Agreement with Optimer, a biotechnology company focused on discovering, developing and commercializing innovative anti-infective products. Under this agreement, we obtained access to a library of over 500 macrolide compounds, including solithromycin. Optimer was acquired by Cubist in October 2013, which in turn was acquired by Merck in 2015. Optimer granted us an exclusive license to these compounds in all countries of the world except the member-nations of the Association of Southeast Asian Nations (“ASEAN”)—which are Brunei, Cambodia, Indonesia, Laos, Malaysia, Myanmar (Burma), the Philippines, Singapore, Thailand and Vietnam—with the right to sublicense, under Optimer’s patents and know-how related to certain macrolide and ketolide antibiotics and related proprietary technology. The exclusivity of our license is potentially subject to the U.S. government’s right to obtain a non-exclusive, irrevocable, royalty-free, paid-up right to practice and have practiced certain patents worldwide. As partial consideration for granting us such license, we issued shares of our common stock to Optimer. We also have an obligation to make additional payments upon achievement of specified development, regulatory and commercialization milestones. The aggregate amount of such milestone payments we may need to pay is based in part on the number of products developed under the agreement. The aggregate amount would be $27,500 if four products are developed and gain FDA approval. Additional limited milestone payments would be due if we develop more than four products. In July 2010 and July 2012, Cempra made $500 and $1,000 milestone payments, respectively, to Optimer after our successful completion of the Phase 1 and Phase 2 trials for oral solithromycin. If we decide to pursue further development of solithromycin, we will owe a milestone payment of $9,500 upon FDA approval of solithromycin. We are also obligated to make tiered, mid-single-digit royalty payments to Optimer based on annual net sales of licensed products outside the ASEAN countries, which royalties are subject to reduction in the event additional licenses are obtained from third parties in order to practice our rights under the agreement and/or we are required to grant a compulsory license to a third party. The agreement also includes the grant of an exclusive license to Optimer and its affiliates, with rights of sublicense, under our patents and other intellectual property in any products covered by the agreement to permit Optimer to develop and/or commercialize such products in ASEAN countries. In consideration of such license, Optimer will pay us $1,000 in milestone payments for the first two products that receive regulatory approval or have a first commercial sale in any ASEAN country, as well as tiered, mid-single-digit royalty payments based on net sales of such products, which royalties are subject to reduction in the event additional licenses are obtained from third parties in order to practice Optimer’s rights under the agreement and/or Optimer is required to grant a compulsory license to a third party. The agreement also included a collaborative research program, to be performed by the parties, which was completed on March 31, 2008. Subject to certain exceptions, on a country-by-country and product-by-product basis, a party’s rights and obligations under the agreement continue until the later of: (i) the expiration of the last to expire patent rights of a covered product in the applicable country or (ii) 10 years from the first commercial sale of a covered product in the applicable country. As a result, the final expiration date of the Optimer license is indeterminable until the last such patents issue and results of potential patent extensions are known, or each of the first commercial sales are made, as applicable. Upon expiration of the agreement with respect to a particular product and country, the licenses granted in the agreement with respect to such product and country will remain in effect and convert to a perpetual, unrestricted, fully-paid, royalty-free, worldwide license. Either party may terminate the agreement (i) in the event of a material breach by the other party, subject to prior notice and the opportunity to cure, (ii) in the event the other party fails to use diligent efforts to develop and commercialize products in its respective territory, or if the other party makes a determination not to develop and commercialize at least one product under the agreement, or (iii) in the event of the other party’s bankruptcy. In the case of these terminations, the terminating party can elect that all licenses granted by the other party survive, subject to continuing royalty, payment and other obligations. Additionally, either party may terminate the agreement for any reason upon 30 days’ prior written notice, in which case the non-terminating party can elect that all licenses granted by the other party survive, subject to continuing royalty, payment, and other obligations. The Scripps Research Institute . Effective June 12, 2012, Cempra entered into a license agreement with The Scripps Research Institute (“TSRI”), whereby TSRI licensed rights to us, with rights of sublicense, to make, use, sell, and import products for human or animal therapeutic use that use or incorporate one or more macrolides as an active pharmaceutical ingredient and is covered by certain patent rights owned by TSRI claiming technology related to copper-catalyzed ligation of azides and acetylenes. The rights licensed to us are exclusive as to the People’s Republic of China (excluding Hong Kong), South Korea and Australia, and are non-exclusive in all other countries worldwide, except ASEAN, which are not included in the territory of the license. Under the terms of the agreement with TSRI, Cempra paid a one-time only, non-refundable license issue fee in the amount of $350 which was charged to research and development expense in the second quarter of 2012. Our rights under the agreement are subject to certain customary rights of the U.S. government that arise or result from TSRI’s receipt of research support from the U.S. government. Cempra was also obligated to pay annual maintenance fees to TSRI in the amount of (i) $50 each year for the first three years (beginning on the first anniversary of the agreement), and (ii) $85 each year thereafter (beginning on the fourth anniversary of the agreement). Each calendar year’s annual maintenance fees will be credited against sales royalties due under the agreement for such calendar year. Under the terms of the agreement, we must pay TSRI low single-digit percentage royalties on the net sales of the products covered by the TSRI patents for the life of the TSRI patents, a low single-digit percentage of non-royalty sublicensing revenue received with respect to countries in the nonexclusive territory and a mid-single-digit percentage of sublicensing revenue received with respect to countries in the exclusive territory, with the sublicensing revenue royalty in the exclusive territory and the sales royalties subject to certain reductions under certain circumstances. TSRI is eligible to receive milestone payments of up to $1,100 with respect to regulatory approval in the exclusive territory and first commercial sale, in each of the exclusive territory and nonexclusive territory, of the first licensed product to achieve those milestones that is based upon each macrolide covered by the licensed patents. Each milestone is payable once per each macrolide. Each milestone payment made to TSRI with respect to a particular milestone will be creditable against any payment due to TSRI with respect to any sublicense revenues received in connection with the achievement of such milestone. Pursuant to the terms of the Optimer Agreement, any payments made to TSRI under this license for territories subject to the Optimer Agreement can be deducted from any sales-based royalty payments due under the Optimer Agreement up to a certain percentage reduction of the royalties due to Optimer. Under the terms of the agreement, we are also required to pay additional fees on royalties, sublicensing and milestone payments if we, an affiliate with TSRI, or a sublicensee challenges the validity or enforceability of any of the patents licensed under the agreement. Such increased payments would be required until all patent claims subject to challenge are invalidated in the particular country where such challenge was mounted. The term of the license agreement (and the period during which we must pay royalties to TSRI in a particular country for a particular product) will end, on a country-by-country and product-by-product basis, at such time as no patent rights licensed from TSRI cover a particular product in the particular country. TSRI may terminate the agreement in the event (i) we fail to cure any non-payment or default on our indemnity or insurance obligations, (ii) we declare insolvency or bankruptcy, (iii) if we are convicted of a felony relating to the development, manufacture, use, marketing, distribution or sale of any products licensed under the agreement, (iv) we fail to cure any underreporting or underpayment by a certain amount in any 12-month period, or (v) we fail to cure any default on any other obligation under the agreement. We may terminate the agreement with or without cause upon written notice. In the event of such termination, (i) all licenses granted to us will terminate except in the case of any sublicensee that was not the cause of the termination, is not in default on its obligations under its sublicense, and that pays any unpaid amounts owed by us under the agreement with respect to the sublicense, and (ii) we may complete any work in progress and sell any completed inventory on hand for a period of time after termination. BARDA . In May 2013, Cempra entered into an agreement with the BARDA for the evaluation and development of solithromycin for the treatment of bacterial infections in pediatric populations and infections caused by bioterror threat pathogens, specifically anthrax and tularemia. The agreement is a cost-plus fixed fee development contract, with a base performance segment valued at approximately $18,700 , and four optional work segments that BARDA may request in its sole discretion. If all 4 option segments are requested, the cumulative value of the agreement would be approximately $68,200 and the estimated period of performance would be until approximately May 2018. Three of the options are cost plus fixed fee arrangements, and one option is a cost sharing arrangement for which we are responsible for a designated portion of the costs associated with that work segment. The period of performance for the base performance segment was May 2013 through February 2016. BARDA exercised the second option in November 2014. The value of the second option work segment is approximately $16,000 and the period of performance was November 2014 through April 2017. In February 2016, BARDA exercised the third option work segment of the agreement, which is intended to fund a Phase 2/3 study of intravenous, oral capsule and oral suspension formulations of solithromycin in pediatric patients from two months old to 17 years with CABP. This option is a cost sharing arrangement under which BARDA will contribute $25,500 and we will be responsible for an additional designated portion of the costs associated with the work segment. In September 2016, the contract was modified to increase the third option work segment by $8,000 for increased manufacturing work related to the development of a second supply source for solithromycin. The amendment raises the value of the third option work segment to approximately $33,500 . In the first quarter of 2018, we agreed with BARDA to terminate the agreement and wind down the study of solithromycin. We continued to incur expenses--and receive BARDA grant income--into the fourth quarter of 2018, when the study and BARDA both terminated. Toyama Chemical Co., Ltd . Under our agreement with Optimer, we have global rights (other than ASEAN countries) to solithromycin. In May 2013, Cempra entered into a license agreement with Toyama whereby it licensed to Toyama the exclusive right, with the right to sublicense, to make, use and sell any product in Japan that incorporates solithromycin as its sole API for human therapeutic uses, other than for ophthalmic indications or any condition, disease or affliction of the ophthalmic tissues. Toyama also has a nonexclusive license in Japan and certain other countries, with the right to sublicense, to manufacture or have manufactured API for solithromycin for use in manufacturing such products, subject to limitations and obligations of the concurrently executed supply agreement discussed below. Toyama has granted us certain rights to intellectual property generated by Toyama under the license agreement with respect to solithromycin or licensed products for use with such products outside Japan or with other solithromycin-based products inside or outside Japan. Toyama has successfully completed a Phase 1 trial in healthy Japanese volunteers, a Phase 1 trial to measure solithromycin levels in the upper respiratory tract, and a Phase 2trial in CABP. In December 2016, Toyama initiated Phase 3 trials in patients infected with CABP and other respiratory infections. Toyama and we are sharing the results of our respective development activities. As consideration for the execution of the license agreement, Toyama paid us an upfront payment of $10,000 . Toyama is also obligated to pay us up to an aggregate of $60,000 in milestone payments, depending on the achievement of various regulatory, patent, development and commercial milestones. The first of these milestones was achieved in the third quarter of 2014 for which Cempra received a payment of $10,000 from Toyama. In March 2015, Cempra recognized a $10,000 milestone from Toyama based on the Japan Patent Office issuing a Decision of Allowance for our patent covering certain crystal forms of solithromycin in Japan, which payment was received in April 2015. In October 2016, Cempra received a $10,000 milestone payment when Toyama decided to progress to Phase 3 studies. Under the terms of the license agreement, Toyama must also pay us a royalty equal to a low-to-high first double decimal digit percentage of net sales, subject to downward adjustment in certain circumstances. The term of the license agreement (and the period during which Toyama must pay royalties under the license agreement) will end, on a product-by-product basis, at the later of: (i) such time as no patent rights under the agreement cover a particular licensed product in Japan; (ii) 15 years after such product is first launched in Japan, or (iii) the first commercial sale in Japan by a third party of a generic equivalent of such licensed product. Toyama may terminate the license agreement (i) at any time, with or without cause, upon advance notice to us, (ii) upon the occurrence of any serious adverse effect in any human clinical trial of any licensed product that would significantly impact the long term commercial viability of a licensed product in Japan, or (iii) upon our failure to obtain the issuance of certain patents or file for U.S. regulatory approvals by certain dates, or to continue certain key clinical trials. We may terminate the license agreement if Toyama or any of its sublicensees is convicted of a felony relating to the development, manufacture, use, marketing, distribution or sale of a licensed product, or upon Toyama’s failure to (i) initiate certain clinical trials in Japan by certain dates, (ii) obtain regulatory approval in Japan within a certain period of completing certain clinical trials in Japan, (iii) launch and commercialize approved licensed products in Japan within a certain period of approval, (iv) use commercially reasonable efforts to market and sell licensed products, or (v) achieve expected benchmarks for net sales of licensed products. Either party may terminate the license agreement due to the other party’s insolvency or for uncured material breach. As part of the license agreement, Toyama and Cempra also entered into a supply agreement, whereby we will be the exclusive supplier (with certain limitations) to Toyama and its sublicensees of API for solithromycin for use in licensed products in Japan, as well as the exclusive supplier to Toyama and its sublicensees of finished forms of solithromycin to be used in clinical trials in Japan. Pursuant to the supply agreement, Toyama will pay us for such clinical supply of finished product and all supplies of API for solithromycin for any purpose, other than the manufacture of products for commercial sale in Japan, at prices equal to our costs. All API for solithromycin supplied by us to Toyama for use in the manufacture of finished product for commercial sale in Japan will be ordered from us at fixed prices determined by our agreement, which currently exceeds our expected cost to supply such API. Accordingly, we recorded $5,330 as part of the Cempra merger fair value adjustments upon assuming this agreement. The supply agreement will continue until the expiration or termination of the license agreement. Either party may terminate the supply agreement for an uncured material breach or in the event of insolvency of the other party, with Toyama’s right to terminate for our breach subject to certain further conditions in the case of our failure to supply API for solithromycin or clinical supply. On September 26, 2018, Cempra Pharmaceuticals, Inc. (“CPI”), a wholly-owned subsidiary of Melinta and Toyama entered into the following agreements related to the development of solithromycin : (i) Amendment No. 2 to the Exclusive License and Development Agreement, dated as of May 8, 2013 and amended as of September 26, 2013, by and between CPI and Toyama, (ii) Amendment to the Quality Agreement effective as of February 1, 2017 by and among CPI, Fujifilm Finechemicals Co., Ltd. (“FFFC,” now known as Fujifilm Wako Pure Chemical Corporation (“FFWK”), and Toyama, and (iii) Agreement to Assign the API Manufacturing and Supply Agreement, entered into as of December 16, 2015, by and between CPI and FFFC. In addition, the parties terminated the Supply Agreement between CPI and Toyama dated May 8, 2013, which related to supply of the active pharmaceutical ingredient used in the manufacture of solithromycin (“API”) and clinical supply. These agreements are referred to collectively as the "Amended Toyama Arrangement." Under the terms of the Amended Toyama Arrangement, CPI is legally relieved of all obligations related to the supply of API or clinical supply to Toyama, which resulted in the extinguishment of the $5,330 long-term liability, representing the fair value of the loss contract upon our merger with Cempra in November 2017. We recognized this gain in other income in the statement of operations in September 2018. In consideration for this relief, Cempra granted Toyama the right to manufacture and procure such API and clinical supply, and forfeited rights to all future milestone payments related to Toyama’s development of solithromycin in Japan. In addition, Melinta will be entitled to receive royalties on sales of solithromycin by Toyama if and when the product receives regulatory approval in Japan, at a rate generally between 4% and 6% of net sales. The amended terms have been treated as a contract modification, and under the sales- or usage- based royalty exception in Topic 606, we do not estimate variable consideration from future royalties. As such, we will not recognize royalty revenue under this arrangement until the future sales occur and royalties are earned. FUJIFILM Finechemicals Co., Ltd . In January 2016, Cempra entered into a supply agreement with FUJIFILM Finechemicals Co., Ltd., which is intended to provide us with solithromycin in sufficient quantities and at reasonable prices to ensure we meet our obligation to Toyama under the supply agreement. We may be subject to a minimum purchase obligation for a designated number of years in the event of the successful completion of a manufacturing facility to be built and validation studies to be conducted by FFFC that could run to $80,000 in the aggregate, which expense would be reduced by any supply sold to Toyama. The agreement’s initial term runs until December 16, 2025 . After the end of the initial term, and at the end of each year thereafter, the term will autom |
Benefit Plan
Benefit Plan | 12 Months Ended |
Dec. 31, 2018 | |
Retirement Benefits [Abstract] | |
Benefit Plan | BENEFIT PLAN We have a 401(k) Plan in which all of our employees are eligible to participate. Each year, we may, but are not required to, make matching contributions to the 401(k) Plan. For the years ended December 31, 2018 , 2017 and 2016, we made matching contributions to the 401(k) Plan of $1,961 , $475 and $306 , respectively. |
Related Party Transactions
Related Party Transactions | 12 Months Ended |
Dec. 31, 2018 | |
Related Party Transactions [Abstract] | |
Related Party Transactions | RELATED PARTY TRANSACTIONS We use various software tools in the research and development discovery process. These tools are licensed at market rates from a company owned by Dr. William Jorgensen. Dr. Jorgensen is a founder of the Company and is the spouse of our Chief Scientific Officer. Total fees paid to Dr. Jorgensen’s company were $40 , $40 and $43 for the years ended December 31, 2018 and 2017 and 2016, respectively. Dr. Thomas Koestler was our non-executive Chairman of the Board prior to the merger with Cempra, continues to serve on our board of directors and is a consultant to our largest investor, Vatera Healthcare Partners LLC. Dr. Koestler received compensation for his role in the amount of $58 and $126 for the years ended December 31, 2018 and 2017 , respectively. In addition, during the years ended December 31, 2018 and 2017, we granted options to purchase 6,820 and 333 shares, respectively, with exercise prices of $37.25 and $104.85 , respectively. In 2018 and 2017, we recorded $73 and $151 , respectively, of share-based compensation related to these options. Dr. Koestler stepped down as Chairman of the Board in November 2017, in conjunction with the merger with Cempra, but remains on our board as a director. Vatera is a significant investor in the company. Kevin Ferro, one of our directors and chairman of the Board, serves as the chief executive officer and managing member of Vatera Capital Management LLC, the current manager of Vatera Healthcare Partners LLC, and Dr. Koestler, one of our directors, serves as a consultant to Vatera Healthcare Partners LLC. On December 31, 2018, we entered into a Senior Subordinated Convertible Loan Agreement (the “Loan Agreement”) with Vatera pursuant to which Vatera committed to provide $135,000 over a period of five months, subject to the satisfaction of certain conditions (see Note 4 to the consolidated financial statements). This agreement was approved by shareholders at a Special Meeting held on February 19, 2019. On February 22, 2019, we drew $75,000 in the first tranche of the Loan Agreement. |
Selected Quarterly Data (Unaudi
Selected Quarterly Data (Unaudited) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Selected Quarterly Data (Unaudited) | SELECTED QUARTERLY DATA (Unaudited) Quarter Ended March 31, June 30, September 30, December 31, Revenue $ 14,841 $ 12,022 $ 34,078 $ 35,489 Operating expenses: Cost of goods sold 7,686 10,989 13,393 8,989 Research and development 16,129 15,813 13,065 10,402 Goodwill impairment — — — 25,088 Selling, general and administrative 34,624 34,946 34,287 29,455 Loss from operations (43,598 ) (49,726 ) (26,667 ) (38,445 ) Total Other Income (Expense), net 14,166 (6,054 ) (1,193 ) (5,675 ) Net loss $ (29,432 ) $ (55,780 ) $ (27,860 ) $ (44,120 ) Accretion of preferred dividends — — — — Net loss available to shareholders $ (29,432 ) $ (55,780 ) $ (27,860 ) $ (44,120 ) Net loss per share - basic and diluted $ (4.76 ) $ (6.92 ) $ (2.49 ) $ (3.94 ) Weighted average shares used in calculating basic and diluted net loss per share 6,184 8,059 11,203 11,204 Quarter Ended March 31, June 30, September 30, December 31, Revenue $ 22,463 $ 3,979 $ 3,191 $ 4,231 Operating expenses: Research and development 12,917 14,075 10,884 11,599 Selling, general and administrative 7,973 7,699 10,304 37,349 Loss from operations 1,573 (17,795 ) (17,997 ) (44,717 ) Total Other (Income) Expense, net 1,647 2,631 1,639 (25,937 ) Net loss $ (74 ) $ (20,426 ) $ (19,636 ) $ (18,780 ) Accretion of preferred dividends (5,720 ) (5,721 ) (5,720 ) (2,098 ) Net loss available to shareholders $ (5,794 ) $ (26,147 ) $ (25,356 ) $ (20,878 ) Net loss per share - basic and diluted $ (1,040.78 ) $ (4,420.46 ) $ (4,286.73 ) $ (7.40 ) Weighted average shares used in calculating basic and diluted net loss per share 6 6 6 2,821 |
Business Combinations
Business Combinations | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
Business Combinations | BUSINESS COMBINATIONS Acquisition of the Infectious Disease Business On January 5, 2018 , we completed the acquisition of the IDB, in which we acquired a group of antibiotic drug products and certain other assets from Medicines, including 100% of the capital stock of certain subsidiaries and the pharmaceutical products containing (i) meropenem and vaborbactam as the active pharmaceutical ingredient and distributed under the brand name Vabomere, (ii) oritavancin as the active pharmaceutical ingredient and distributed under the brand name Orbactiv and (iii) minocycline as the active pharmaceutical ingredient and distributed under the brand name Minocin for injection and line extensions of such products. The integration of the acquired products within our existing portfolio further strengthens our ability to serve the needs of providers treating patients with serious bacterial infections across the healthcare delivery continuum. In addition to the products acquired in the IDB transaction, we hired approximately 135 individuals from Medicines to our team. The new team members bring with them significant experience specific to infectious diseases and better position us to effectively execute our commercial and other activities. The acquisition was financed using borrowings under the Deerfield Facility and additional equity financing from existing and new investors. See Note 4 for further information regarding these financing arrangements. Expenses related to legal and other services in connection with the IDB acquisition were $2,339 and $2,617 in the years ended December 31, 2018 and 2017, respectively. The expenses incurred in the year ended December 31, 2018 , included 1,320 related to certain transition services that Medicines agreed to provide to us to facilitate transition and integration of the IDB. The transition services included the temporary provision of facilities and equipment for newly hired personnel, assistance with finance functions and support in connection with the transition of the supply, sale and distribution of the products to our third-party logistics provider. The transition services were substantially complete at the end of 2018. The consideration paid to Medicines consisted of a cash payment of $166,383 and 662,740 shares of our common stock, which was calculated by dividing $50,000 by $75.45 , representing 90% of the volume weighted average price of the common stock for the trailing ten trading day period ending three trading days prior to the closing date. In addition, subject to the terms and conditions of the IDB purchase agreement, we are required to make two additional payments of $25,000 on each of the twelve and eighteen-month anniversaries of the closing date (January and July 2019, respectively), and we will pay royalties to Medicines on certain net sales of the acquired antibiotic products. The purchase price, including non-cash consideration, for the acquisition of IDB is as follows (except for the initial cash payment, these items have been treated as non-cash investing activity in the condensed consolidated statement of cash flows, and will be treated as financing activity when the remaining items are paid in cash): • Cash of $166,383 , including a net working capital adjustment of $1,383 ; • Common stock of $54,510 ; • Deferred consideration of $38,541 , representing the present value of two payments of $25,000 each due in January and July 2019; and • Contingent consideration of $12,271 , representing the fair value of sales-based royalty payments. We recorded the contingent consideration related to the sales-based royalty payments at fair value, and, during 2018, we were accreting the amount to the estimated aggregate amounts payable to Medicines, $354,000 , based on an effective interest of rate of 49% , which is in line with the effective interest rate, 43% , used to accrete the royalty liability associated with the Deerfield Facility. During the year ended December 31, 2018 , we recorded $6,544 , respectively, of non-cash interest expense related to the accretion of the fair value of sales-based royalty payments. As of December 31, 2018 , $2,784 of the royalty liability is currently due and has been reclassified out of current deferred purchase price and recorded either as a credit offset to receivables (up to the amount due from Medicines) or in accrued liabilities. At the end of the fourth quarter of 2018, we updated our estimate of the remaining aggregate amounts of royalty payable to Medicines for future periods to approximately $60,000 . We recorded the updated fair value of $5,714 at December 31, 2018 ( $1,006 and $4,708 , in short-term and long-term liabilities, respectively). We recorded $10,317 of favorable net fair value adjustments to operating expenses in the fourth quarter of 2018. As of December 31, 2018, we have finalized the valuation for the acquisition. The goodwill resulting from the acquisition largely consists of the estimated value of IDB’s assembled and trained workforce, our expected future product sales, synergies resulting from combining IDB products with our existing product offering and IDB’s going concern value. The following table sets forth our final of the purchase price allocation. Current assets $ 33,725 Goodwill 25,088 Intangible assets 236,819 Non-current assets 9,486 Current liabilities (32,837 ) Non-current liabilities (576 ) Total purchase price $ 271,705 We believe that the historical values of IDB’s current assets and current liabilities (except for certain inventory items, which we stepped up in value) approximate their fair values based on the short-term nature of such items. The current liabilities include a contingent liability of $24,485 , representing the probability-weighted present value of a $30,000 milestone payment payable third parties upon the approval of Vabomere in Europe. During the year ended December 31, 2018 , we recorded $4,015 of non-cash accretion, included within interest expense, of this contingent payment and a fair value adjustment of $1,500 in the fourth quarter of 2018 when Vabomere received approval in Europe. The accretion is based on an effective interest rate of 20.9% which is consistent with the interest rate associated with the Deerfield Facility. We recorded the two $25,000 deferred payments to Medicines at fair value, and we are accreting them to $50,000 based on an effective interest rate of 21.1% . During the year ended December 31, 2018 , we recorded $8,847 of non-cash accretion, included within interest expense, of these deferred payments. At December 31, 2018 , the carrying value of the short-term deferred payments was $47,388 . The following table sets forth the components of identifiable intangible assets acquired and their estimated useful lives as of the date of the acquisition: Average useful life Fair value Developed product rights 13 to 17 years $ 216,960 In-process research and development Indefinite 19,859 Total intangible assets $ 236,819 During the year ended December 31, 2018 , we recorded $16,332 of amortization expense related to the developed product rights. In the fourth quarter of 2018, we transferred our in-process research and development balance of $19,859 to developed product rights (intangible assets) because the related product, Vabomere, received regulatory approval in Europe. We will begin amortizing the intangible asset over its estimated useful life when sales of Vabomere commence in Europe, anticipated to be sometime in 2019 or 2020. At December 31, 2018 , the carrying value of all our developed product rights was $221,276 . For the year ended December 31, 2018 , IDB added $40,096 of revenue and $1,938 of grant income, respectively, to our consolidated results. It is impracticable to measure the effect IDB had on our net loss for the year ended December 31, 2018 , because IDB has been integrated into our existing operations and is not accounted for separately. Since the date of the acquisition, IDB’s results are reflected in our consolidated financial statements. Goodwill Impairment As noted above, we initially recorded goodwill of $25,088 at the date of the acquisition. In December 2018, we performed our annual impairment assessment. Due to the decrease in the market price of the Company's stock during 2018, our market capitalization was significantly below the carrying value of our net assets. Given that we operate as one reporting unit, the market capitalization reflects the value that the public markets attribute to our equity. After further fair value analysis and testing, including considering control premiums, we concluded that goodwill was impaired and had a current fair value of $0 . Accordingly, we recognized impairment of our goodwill totaling $25,088 in the fourth quarter of 2018. We determined that there is no impairment of the acquired IDB identified intangible assets based on the undiscounted forecasted cash flows associated with each of the acquired intangible assets. Merger with Cempra Cempra’s results have been reflected in our condensed consolidated financial statements since the date of the merger on November 3, 2017. As a result of the merger, Cempra's operations contributed $3,465 and $870 of grant income to our consolidated results of operations in the years ended December 31, 2018 and 2017, respectively. We incurred $256 and $9,119 of acquisition-related expense (excluding severance) in the years ended December 31, 2018 and 2017, respectively, related to the merger with Cempra. Pro Forma Financial Information The following table provides unaudited supplemental pro forma information as if the acquisition of IDB and the Cempra merger took place at the beginning of fiscal 2017. 2017 Pro forma revenue $ 67,617 Pro forma net loss $ (264,909 ) The unaudited supplemental pro forma consolidated results reflect the historical financial information of Melinta, Medicine’s IDB and Cempra, adjusted to give effect to the IDB acquisition and the Cempra merger as if they had occurred as of the beginning of fiscal 2017 and 2016, respectively, primarily for the following adjustments: • Effects of Topic 606. • Additional interest expense and accretion related to the financing of the business combinations. • Additional accretion expense related to the IDB acquisition. • Additional accretion on deferred and contingent payments and additional amortization of intangible assets recognized as part of the business combinations. • Elimination of historical nonrecurring transaction costs and severance related to the business combinations. • The remeasurement gain on the warrant liability (using $33,226 for the year ended December 31, 2018 ). • Elimination of the bargain purchase gain in the Cempra merger of $27,663 . • Elimination of the tax valuation allowance reversals recorded by IDB. In addition, excluded from the supplemental pro forma information was $10,497 of nonrecurring IDB acquisition costs (debt extinguishment costs, inventory fair value step-up amortization, and transaction and severance costs) recorded during the year ended December 31, 2018 . |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | NET LOSS PER SHARE Basic net loss attributable to common shareholders per share is computed by dividing the net loss attributable to common shareholders by the weighted-average number of common shares outstanding for the period. During periods where we might earn net income, we would allocate to participating securities a proportional share of net income determined by dividing total weighted-average participating securities by the sum of the total weighted-average common shares and participating securities (the “two-class method”). Our preferred stock, if any, participates in any dividends declared by us and are therefore considered to be participating securities. Participating securities have the effect of diluting both basic and diluted earnings per share during periods of income. During periods where we incurred net losses, we allocate no loss to participating securities because they have no contractual obligation to share in our losses. We computed diluted loss per common share after giving consideration to the dilutive effect of stock options and warrants that are outstanding during the period, except where such nonparticipating securities would be antidilutive. Because we have reported net losses for the years ended December 31, 2018 , 2017 and 2016 , diluted net loss per common share is the same as basic net loss per common share for those periods. The weighted-average shares outstanding, reported loss per share and potential dilutive common share equivalents for the periods prior to November 3, 2017, the date of the Cempra merger, have been retrospectively adjusted to reflect historical weighted-average number of common shares outstanding multiplied by the exchange ratio established in the merger agreement. All shares have also been adjusted to reflect the one-for-five reverse stock split that was effective on February 22, 2018. During 2017 and 2016, we had shares of convertible preferred stock outstanding which earned dividends at a rate of 8% per year. Our net loss attributable to common shareholders for those years was adjusted to reflect the accretion of dividends on the convertible preferred stock before computing net loss per share. The following potentially dilutive securities (in common stock equivalent shares) have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported: December 31, 2018 2017 2016 Options to purchase common stock 696,890 412,211 120,007 Preferred stock warrants — — 6,331 Unvested restricted stock 17,360 64,132 — Common stock warrants 766,691 11,913 9 Convertible preferred stock — — 1,166,029 1,480,941 488,256 1,292,376 |
Severance
Severance | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring and Related Activities [Abstract] | |
Severance | SEVERANCE In connection with the merger with Cempra, several employees were terminated under established individual employment plans and a corporate-wide severance plan. The legacy Cempra entity had put in place a severance plan that provided severance benefits to employees who, in connection with a change-in-control event, either were terminated or resigned due to having a diminished role going forward with the combined company. Most of the affected employees were notified that they would be terminated in connection with the change-in-control event in advance of the merger, and the Company recognized the associated severance costs when the liability became probable, which was after the merger closed. The postemployment benefits for the individuals include continued salary and benefits for a period of time determined by historical length of service to, and role with, the Company (up to six months for non-executives, 18 months for executives, and 24 months for the CEO), outplacement services and contractual or prorated bonuses. While all the affected employees were notified before or immediately after the merger, some of the termination dates were extended into 2018 . In addition to the severance costs incurred in connection with the Cempra merger, the Company incurs additional severance costs as part of its on-going operations. In October 2018, our Board of Directors appointed John H. Johnson as Interim Chief Executive Officer to succeed Daniel Wechsler, who stepped down from his role as President, CEO and director to pursue other opportunities. In connection with Mr. Wechsler's termination from the Company, we recorded total severance-related payments of approximately $1,469 (before the adjustment to net present value) in Q4 2018, which will be paid over 18 months. He will also receive a pro-rata bonus for 2018, to be paid in the first quarter of 2019. In November 2018, the Board of Directors approved a plan to reduce our operating expenses, principally through an approximately 20% reduction in headcount. In addition to the severance expense recorded in the fourth quarter of 2018 for Daniel Wechsler, we recorded a fourth quarter 2018 net charge of $5,894 post-employment benefit costs. The remainder of the total 2018 severance expense was incurred in the first three quarters of 2018 as part of the company’s on-going operations. In addition to severance payments, terminated employees will receive a pro-rated bonus for 2018 to be paid in the first quarter of 2019 (except some contractual bonus payments which were or will be paid out at the time of termination). A summary of merger and non-merger activity in our severance accrual (included in accrued expenses or long-term liabilities on the consolidated balance sheets) is below. Balance - December 31, 2016 $ — Severance accruals (recorded in SG&A) 6,383 Severance liability acquired in Cempra merger 769 Severance payments (431 ) Balance - December 31, 2017 $ 6,721 Severance accruals (recorded in SG&A) 12,371 Severance payments (9,325 ) Balance - December 31, 2018 $ 9,767 On December 31, 2018 , $9,390 was included in accrued expenses and $377 was included in long-term liabilities. We also recognized $407 and $1,547 of additional stock-based compensation expense related to the acceleration of equity awards for terminated employees under ASC 718 as severance expense during the years ended December 31, 2018 and 2017, respectively. The 2018 stock-based compensation expense includes $174 for the acceleration of Mr. Wechsler's first-year vesting of his incentive RSU award. The acceleration of the first-year vesting was considered a modification and accounted for as a new award at a fair value of $174 . The cumulative stock-based compensation expense for the original awards recorded through the third quarter of 2018 of $486 was reversed in the fourth quarter of 2018. In the second quarter of 2018, we vacated a significant portion of our office facilities in Chapel Hill, North Carolina. As a consequence, we recorded an estimated lease exit liability of $556 . The lease exit liability was determined by computing the fair value of the remaining lease payments, net of any projected sub-lease rentals. A summary of activity in our lease liability is below. Balance - December 31, 2017 $ — Fair value of lease liability recognized 556 Lease termination adjustment (233 ) Termination fee 136 Less: payments (391 ) Balance - December 31, 2018 $ 68 |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies - (Policies) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Principles of Consolidation and Basis of Presentation | Principles of Consolidation and Basis of Presentation —The accompanying consolidated financial statements include the accounts and results of operations of Melinta and its wholly-owned subsidiaries. The consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”). All intercompany balances and transactions have been eliminated in consolidation. |
Use of Estimates | Use of Estimates —The preparation of these consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. |
Cash and Cash Equivalents | Cash and Cash Equivalents —We consider all highly liquid investments with original maturities of three months or less at time of purchase to be cash equivalents. We invest excess cash primarily in money market funds. |
Receivables | Trade and Other Receivables —Trade receivables consist of amounts billed for product shipments. Receivables for product shipments are recorded as shipments are made and title to the product is transferred to the customer. Other receivables consist of amounts billed, and amounts earned but unbilled, under our licensing agreements and our contracts with BARDA. Receivables for license agreements are recorded as we achieve the requirements of the agreements, and receivables under the BARDA contracts are recorded as qualifying research activities are conducted and invoices from our vendors are paid. Unbilled receivables are also recorded based upon work estimated to have been completed for which we have not paid vendor invoices. We carry our receivables net of an allowance for doubtful accounts. On a periodic basis, we evaluate our receivables for collectability. We have recorded an allowance for doubtful accounts of $26 for specifically identified receivables that may not be fully collectible. |
Concentration of Credit Risk | Concentration of Credit Risk —Concentration of credit risk exists with respect to cash and cash equivalents and receivables. We maintain our cash and cash equivalents with federally insured financial institutions, and at times, the amounts may exceed the federally insured deposit limits. To date, we have not experienced any losses on our deposits of cash and cash equivalents. We believe that we are not exposed to significant credit risk due to the financial position of the depository institutions in which deposits are held. |
Inventory | Inventory —Inventory is stated at the lower of cost or estimated net realizable value. Inventory is valued on a first-in, first-out basis and consists primarily of material costs, third-party manufacturing costs, overhead—principally the cost of managing our manufacturers—and related transportation costs. We capitalize inventory upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense. We review inventories on hand at least quarterly and record provisions for estimated excess, slow-moving and obsolete inventory, as well as inventory with a carrying value in excess of net realizable value. |
Fair Value of Financial Instruments | Fair Value of Financial Instruments —The carrying amounts of our financial instruments, which include cash and cash equivalents, tax credit and other receivables, accounts payable, accrued expenses, notes payable, and preferred stock warrants, approximated their fair values at December 31, 2018 and 2017 . |
Debt Issuance Costs | Debt Issuance Costs —Debt issuance costs represent legal and other direct costs incurred in connection with our notes payable. These costs were recorded as a contra-liability included in the notes payable line item and amortized as a non-cash component of interest expense using the effective interest method over the term of the note. |
Property and Equipment | Property and Equipment —Property and equipment are recorded at cost less accumulated depreciation and are depreciated using the straight-line method over their estimated useful lives. Leasehold improvements are amortized over the shorter of their useful lives or the remaining term of the lease. Major improvements are capitalized, while repair and maintenance costs, which do not improve or extend the useful lives of the respective assets, are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the balance sheets and any resulting gain or loss is credited or charged to income. Depreciation periods for our property and equipment are as follows: Type Period Laboratory equipment 5 years Furniture and fixtures 5 years Office equipment 3 years Leasehold improvements Shorter of useful life or lease life Purchased software 3 years |
Goodwill and Intangible Assets | Goodwill and Intangible Assets —Intangible assets consist of capitalized milestone payments for the licenses we use to make our products and the fair value of identifiable intangible assets, including in-process research and development (“IPR&D”), acquired in the IDB transaction. Given the uncertainty of forecasts of future revenue for our products, we amortize the cost of intangible assets on a straight-line basis over the estimated economic life of each asset, generally the exclusivity period of each associated product. IPR&D is reclassified to intangible assets (developed product rights) once the associated product has received approval by the appropriate regulatory agency. Amortization for these developed product rights does not begin until both the associated product has received approval and sales have commenced. We will recognize amortization for our intangible assets over periods of approximately 10 to 17 years, commencing with the launch of the products. As of December 31, 2017, product right intangible assets were $7,500 . Amortization had not yet commenced as product launch occurred in early 2018. As of December 31, 2018, gross product right intangible assets and the related accumulated amortization were $245,529 and $16,332 . Amortization of intangible assets, which is included in cost of goods sold, was $16,332 for the year ended December 31, 2018 . No intangible asset amortization was recorded in 2017. For each of the years ending December 31, 2019 , through December 31, 2023 , we expect to recognize amortization expense of $16,603 , with approximately $125,113 to be recognized thereafter. In addition, there is $21,069 of developed product rights primarily related to Vabomere that will begin amortization over approximately 10 years when the launch of Vabomere in Europe has occurred. Goodwill and indefinite-lived assets, including IPR&D, are not amortized, but are subject to an impairment review annually and more frequently when indicators of impairment exist. An impairment of goodwill could occur if the carrying amount of a reporting unit exceeded the fair value of that reporting unit. An impairment of indefinite-lived intangible assets would occur if the fair value of the intangible asset is less than the carrying value. Prior to reclassifying an IPR&D asset to a definite-lived intangible asset, we perform an impairment analysis. We test goodwill, IPR&D and indefinite-lived assets for impairment by first assessing qualitative factors to determine whether it is more likely than not that the fair value is less than its carrying amount. If we conclude it is more likely than not that the fair value of the asset under review is less than its carrying amount, a quantitative impairment test is performed. In December 2018, we performed our annual impairment test for goodwill. As a result, we concluded that the implied value of goodwill was negative, and we recorded an impairment adjustment of $25,088 in December 2018 to reduce our goodwill value to zero . This was driven primarily by the sustained decrease in the Melinta's stock price over the course of the previous year, and since we operate as one single operating unit, the market capitalization of the Company is a strong indicator of fair value. |
Impairment of Long-Lived Assets | Impairment of Long-Lived Assets —Long-lived assets consist primarily of property and equipment and intangible assets with a definite life. We record impairment losses on long-lived assets used in operations when events and circumstances indicate that the carrying amount of an asset or group of assets may not be fully recoverable at the lowest level of identifiable cash flows, which is each product line. If impairment indicators are present, we assess whether the future estimated undiscounted cash flows attributable to the assets in question are greater than their carrying amounts. If these future estimated cash flows are less than carrying value, we then measure an impairment loss for the amount that carrying value exceeds fair value of the assets. In the year ended December 31, 2018 , we recorded expense of $988 in research and development expenses related to the write-off of in-process validation costs for manufacturing projects that we abandoned during the year. We did not have a corresponding impairment expense in 2017 or 2016. During the fourth quarter of 2018, impairment indicators were present for our product rights intangible assets, so we prepared undiscounted cash flows attributable to each product to assess whether or not the intangible assets were impaired. The impairment indicators related to revised product sales forecasts, which were lower than those initially developed in connection of the acquisition of the assets. While we concluded that the intangible assets were not impaired because the undiscounted cash flows exceeded the carrying value, if revenue forecasts decrease again in the future, there is a risk that we may conclude that one or more of the intangible assets are impaired in a future period. |
Revenue Recognition | Revenue Recognition —On January 1, 2018, we adopted Accounting Standards Update (“ASU”) 2014-9, Revenue from Contracts with Customers (“Topic 606”), and all related amendments. For further information regarding the adoption of Topic 606, see the “Adoption of Topic 606” section of this Note 2. Topic 606 outlines a single comprehensive model to use in accounting for revenue arising from contracts with customers and supersedes most current revenue recognition guidance. The core principle of this new revenue recognition guidance is that a company will recognize revenue when promised goods or services are transferred to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. Topic 606 defines the following five-step process to achieve this core principle, and in doing so, it is possible that significant judgment and estimates may be required within the revenue recognition process. 1. identify the contract(s) with a customer; 2. identify the performance obligations in the contract; 3. determine the transaction price; 4. allocate the transaction price to the performance obligations in the contract; and 5. recognize revenue when (or as) the entity satisfies a performance obligation. The new guidance only applies the five-step model to arrangements that meet the definition of a contract under Topic 606, including the consideration of whether it is probable that the entity will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. At contract inception, once the contract is determined to be within the scope of Topic 606, we assess the goods or services promised within each contract and determine those that are performance obligations; the assessment includes the evaluation of whether each promised good or service is distinct within the context of the contract. Under Topic 606, we recognize revenue separately for performance obligations that are “distinct.” Performance obligations are considered to be distinct if (a) the customer can benefit from the license or services either on its own or together with other resources that are readily available to the customer, and (b) our promise to transfer the license or services is separately identifiable from other promises in the contract. If a license or service is not individually distinct, we combine the license or service with other promised licenses and/or services until we identify a bundle of licenses and/or services that together are distinct. We recognize, as revenue, the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied. In determining the transaction price, we consider all forms of variable consideration, which can take various forms, including, but not limited to, prompt-pay discounts, rebates, credits, and milestone payments. We estimate variable consideration using either the “expected value” or “most likely amount” method, depending on which method better predicts the amount of consideration to which we will be entitled. The expected value method is a probability-weighted approach that considers all possible outcomes while the most likely approach uses the single most likely amount in a range of possible outcomes. We apply a variable consideration constraint to the estimated transaction price if we conclude that it is probable that there is a risk of significant reversal of revenue once the uncertainty related to the variable consideration is resolved. Under the guidance of Topic 606, we recognize revenue for each performance obligation when the customer obtains control of the product and we have satisfied each of our respective obligations. Control is defined as the ability of the customer to direct the use of and obtain substantially all the benefits of the asset. In addition, as of December 31, 2018 , we do not have any contract assets or liabilities and our contracts do not have any significant financing components. And, we have not capitalized contract origination costs. Licensing Arrangements We enter into license and collaboration agreements for the research and development and/or commercialization of therapeutic products. The terms of these agreements may include nonrefundable licensing fees, funding for research, development and manufacturing, milestone payments and royalties on any product sales derived from the collaborations in exchange for the delivery of licenses and rights to sell our products within specified territories outside the United States. In the determination of whether our license and collaboration agreements are accounted for under Topic 606 or Accounting Standards Classification (“ASC”) 808, Contract Accounting , we first assess whether or not the partner in the arrangement is a customer. If the partner in the arrangement is deemed a customer as it relates to some or all of our performance obligations, then the consideration associated with those performance obligations is accounted for as revenue under Topic 606. Our license agreements may include contingent or variable consideration based upon the achievement of regulatory- and sales-based milestones and future royalties based on a percentage of the partner’s net product sales. Our performance obligations to deliver distinct licenses are recognized at a point in time. Milestone payments from licensees that are contingent and/or variable upon future regulatory events and product sales are not considered probable of being achieved until the milestones are earned and, therefore, the contingent revenue is subject to significant risk of reversal. As such, we constrain this variable consideration and do not include it in the transaction price (or recognize the revenue related to these milestones) until such time that the contingencies are resolved and generally recognized at a point in time. In addition, under the sales- or usage- based royalty exception in Topic 606, we do not estimate, at the onset of the arrangement, the variable consideration from future royalties or sales-based milestones. Instead, we wait to recognize royalty revenue until the future sales occur. In September 2018, we entered into a license agreement with Menarini, which grants to Menarini the exclusive right to market Vabomere, Orbactiv and Minocin for injection in 68 countries in Europe, Asia-Pacific and the Commonwealth of Independent States. The agreement includes an upfront license fee of €17,000 (which we received in October 2018), a milestone payment of €15,000 upon European marketing approval for Vabomere, potential regulatory- and sales-based milestones, and sales-based royalties. Menarini received European marketing approval in November 2018, and we received the €15,000 milestone payment in the fourth quarter of 2018. We determined that Menarini is a customer and we should account for the agreement under Topic 606. We identified one performance obligation under the agreement, the delivery of the licensed rights. In addition, we agreed to supply the products to Menarini in the future at a cost that is consistent with our other similar licensing arrangements. We provided Menarini immediate access to the licensed rights and, as such, we allocated the upfront payment entirely to the license and recognized revenue at the point in time when the licensed rights were delivered, in September 2018. We will recognize any future contingent consideration, including regulatory and sales-based milestone payments and royalty revenue, at such time when the milestones or royalties have been achieved. Menarini received European marketing approval in November 2018, so we recognized the €15,000 milestone payment as revenue in the fourth quarter of 2018. Adoption of Topic 606 We adopted Topic 606 on January 1, 2018, using the modified retrospective method applied to those contracts which were not complete as of January 1, 2018. Results for reporting periods beginning after January 1, 2018, are presented under Topic 606, while prior period amounts are not adjusted and continue to be reported in accordance with legacy U.S. GAAP under ASC 605. In our adoption of Topic 606, we did not use practical expedients. In addition, we have considered the nature, amount and timing of our different revenue sources. Accordingly, the disaggregation of revenue from contracts with customers is reflected in different captions within the consolidated statement of operations. For our Eurofarma distribution arrangements under which revenue was previously deferred, revenue is now recognized at the point in time when the license is granted and has benefit to Eurofarma. These deferred revenues were originally expected to be recognized in future periods over the period of time over which we supplied Baxdela under the supply arrangement, which could have lasted up to 10 years or longer. The cumulative effect of the adoption was recognized as a decrease to opening accumulated deficit and a decrease to deferred revenue of $10,008 on January 1, 2018. The effect of the adoption of Topic 606 on our consolidated balance sheet is as follows: Balance at December 31, 2017 Adjustments Due to Topic 606 Balance at January 1, 2018 Liabilities: Deferred revenue $ 10,008 $ (10,008 ) $ — Shareholders’ equity: Accumulated deficit $ (572,659 ) $ 10,008 $ (562,651 ) In connection with the adoption of Topic 606, we no longer recognize grant income as revenue (see Grant Income discussion below), but there was no change to the timing of historical recognition. Also, there was no change to the timing of recognition of contract revenue under our licensing agreements. For product sales, recognition of revenue under Topic 605 would have been the same as under Topic 606 for the year ended December 31, 2018, as we have established sufficient sales history to analyze trends in revenue constraints. In addition, the initial stocking of product in connection with product launches in the first quarter of 2018 was sold through to end customers before the end of 2018, establishing a fixed transaction price for these sales to wholesalers. We have no outstanding performance obligations as of December 31, 2018 , related to our licensing arrangements. Although we have agreements in place to supply our drug products to our partners once they achieve regulatory approval in their respective territories, we concluded that the option to purchase our products from us is not a material right. All performance obligations under our licensing arrangements were satisfied historically at a point in time. Variable consideration in the form of regulatory and sales-based milestones, which are payable under the terms of our licensing arrangements, has been constrained because of the risk of significant revenue reversal as in our revenue recognition policy included in this Note 2. Further, we recognize contract research revenue from Menarini as we incur the reimbursable development costs. Product Sales Product Year Ended December 31, 2018 Baxdela $ 6,485 Vabomere 7,416 Orbactiv 22,951 Minocin for injection 9,728 Total product sales, net $ 46,580 Beginning in January 2018, as a result of both the acquisition of IDB and the launch of Baxdela, we distribute Baxdela, Vabomere, Orbactiv, and Minocin for injection products commercially in the United States. While we sell some of our products directly to certain hospitals and clinics, the majority of our product sales are made to wholesale customers who subsequently resell our products to hospitals or certain medical centers, as well as specialty pharmacy providers and other retail pharmacies. The wholesaler places orders with us for sufficient quantities of our products to maintain an appropriate level of inventory based on their customers’ historical purchase volumes and demand. We recognize revenue once we have transferred physical possession of the goods and the wholesaler obtains legal title to the product and accepts responsibility for all credit and collection activities with the resale customer. In addition, we enter into arrangements with health care providers that purchase our products from wholesalers—as well as payers and certain other customers—that provide for government mandated and/or privately negotiated rebates, chargebacks and discounts with respect to the purchase of our products. The transaction price that we recognize as revenue reflects the amount we expect to be entitled to in connection with the sale and transfer of control of product to our customers. Variable consideration is only included in the transaction price, to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. At the time that our customers take control of the product, which is when our performance obligation under the sales contracts is complete, we record product revenues net of applicable reserves for various types of variable consideration based on our estimates of channel mix. The types of variable consideration in our product revenue are as follows: • Prompt pay discounts • Product returns • Chargebacks and rebates • Fee-for-service • Government rebates • Commercial payer and other rebates • Group purchasing organization (“GPO”) administration fees • MelintAssist voluntary patient assistance programs In determining the amounts of certain allowances and accruals, we must make significant judgments and estimates. For example, in determining these amounts, we estimate hospital demand, buying patterns by hospitals, hospital systems and/or group purchasing organizations from wholesalers and the levels of inventory held by wholesalers and customers. Making these determinations involves analyzing third party industry data to determine whether trends in historical channel distribution patterns will predict future product sales. We receive data periodically from our wholesale customers on inventory levels and historical channel sales mix, and we consider this data when determining the amount of the allowances and accruals for variable consideration. The amount of variable consideration is estimated by using either of the following methods, depending on which method better predicts the amount of consideration to which we are entitled: a) The “expected value” is the sum of probability-weighted amounts in a range of possible consideration amounts. Under Topic 606, an expected value may be an appropriate estimate of the amount of variable consideration if we have many contracts with similar characteristics. b) The “most likely amount” is the single most likely amount in a range of possible consideration amounts (i.e., the single most likely outcome of the contract). Under Topic 606, the most likely amount may be an appropriate estimate of the amount of variable consideration if the contract has only two possible outcomes (i.e., either achieve or don’t achieve a threshold specified in a contract). The method selected is applied consistently throughout the contract when estimating the effect of an uncertainty on an amount of variable consideration. In addition, we consider all the information (historical, current, and forecasts) that is reasonably available to us and shall identify a reasonable number of possible consideration amounts. The relevant factors used in this determination include, but are not limited to, current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. In assessing whether a constraint is necessary, we consider both the likelihood and the magnitude of the revenue reversal. Actual amounts of consideration ultimately received may differ from our estimates. If actual results in the future vary from our estimates, we adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. The specific considerations we use in estimating these amounts related to variable consideration associated with our products are as follows: Prompt Pay Discounts – We provide wholesale customers with certain discounts if the wholesaler pays within the payment term, which is generally between 30 and 60 days. Product returns – Generally, our customers have the right to return any unopened product during the 18-month period beginning six months prior to the labeled expiration date and ending 12 months after the labeled expiration date. Where historical rates of return exist, we use history as a basis to establish a returns reserve for product shipped to wholesalers. For our newly launched products, for which we currently do not have history of product returns, we estimate returns based on third-party industry data for comparable products in the market. As we distribute our products and establish historical sales over a longer period of time (i.e., two years), we will be able to place more reliance on historical purchasing and return patterns of our customers when evaluating our reserves for product return. At the end of each reporting period for any of our products, we may decide to constrain revenue for product returns based on information from various sources, including channel inventory levels and dating and sell-through data, the expiration dates of product currently being shipped, price changes of competitive products and introductions of generic products. In the year ended December 31, 2018 , we increased our returns reserve by $1,700 due to risk factors that were present primarily in connection with the initial stocking of inventory for the launch of our new products. Chargebacks – Although we primarily sell products to wholesalers in the United States, we typically enter into agreements with medical centers, either directly or through GPOs acting on behalf of their hospital members, in connection with the hospitals’ purchases of products. Based on these agreements, most of our hospital customers have the right to receive a discounted price for products and volume-based rebates on product purchases. In the case of discounted pricing, we typically provide a credit to our wholesale customers (i.e., chargeback), representing the difference between the customer’s acquisition list price and the discounted price. Fees-for-service – We offer discounts and pay certain wholesalers service fees for sales order management, data, and distribution services which are explicitly stated at contractually determined rates in the customer’s contracts. In assessing if the consideration paid to the customer should be recorded as a reduction of the transaction price, we determine whether the payment is for a distinct good or service or a combination of both. Since our wholesaler fees are not specifically identifiable, we do not consider the fees separate from the wholesaler's purchase of the product. Additionally, wholesaler services generally cannot be provided by a third party. Because of these factors, the consideration paid is considered a reduction of revenue. We estimate our fee-for-service accruals and allowances based on wholesalers' purchases, demand pull-through, wholesaler inventory levels and the applicable discount rate. Government Rebates – We participate in three rebate programs under various government programs: Medicaid, TRICARE and Medicare Part D. At the time of the sale it is not known what the government rebate rate will be, but historical rates are used to estimate the current period accrual. Medicaid – The Medicaid Drug Rebate Program is a program that includes The Centers for Medicare and Medicaid Services, State Medicaid agencies, and participating drug manufacturers that helps to offset the federal and state costs of most outpatient prescription drugs dispensed to Medicaid patients. The Medicaid Drug Rebate Program is jointly funded by the states and the federal government. The program reimburses hospitals, physicians, and pharmacies for providing care to qualifying recipients who cannot finance their own medical expenses. TRICARE – TRICARE is a benefit established by law as the health care program for uniformed service members, retired service members, and their families. We must pay the Department of Defense (“DOD”) refunds for drugs entered into the normal commercial chain of transactions that end up as prescriptions given to TRICARE beneficiaries and paid for by the DOD. The refund amount is the portion of the price of the drug sold by us that exceeds the federal ceiling price. Refunds due to TRICARE are based solely on utilization of pharmaceutical agents dispensed through a TRICARE Retail Pharmacy to DOD beneficiaries. Medicare Part D – We maintain contracts with Managed Care Organizations (“MCOs”) that administer prescription benefits for Medicare Part D. MCOs either own pharmacy benefit managers (“PBMs”) or contract with several PBMs to fulfill prescriptions for patients enrolled under their plans. As patients obtain their prescriptions, utilization data are reported to the MCOs, which generally submit claims for rebates quarterly. Commercial Payer and Other Rebates – We contract with certain private payer organizations, primarily insurance companies and PBMs, for the payment of rebates with respect to utilization of Baxdela and contracted formulary status. We estimate these rebates and record reserves for such estimates in the same period the related revenue is recognized. Currently, the reserve for customer payer rebates considers future utilization based on third party studies of payer prescription data; the utilization is applied to product that remains in the distribution and retail pharmacy channel inventories at the end of each reporting period. As we distribute our products and establish historical sales over a longer period of time (i.e., two years), we will be able to place more reliance on historical data related to commercial payer rebates (i.e., actual utilization units) while continuing to rely on third party data related to payer prescriptions and utilization. In addition, we offer rebates to certain customers based on the volume of product purchased over an agreed period of time. GPO Administration Fees – We contract with GPOs and pay administration fees related to contracting and membership management services provided. In assessing if the consideration paid to the GPO should be recorded as a reduction in the transaction price, we determine whether the payment is for a distinct good or service or a combination of both. Since our GPO fees are not specifically identifiable, we do not consider the fees separate from the purchase of the product. Additionally, the GPO services generally cannot be provided by a third party. Because of these factors, the consideration paid is considered a reduction of revenue. MelintAssist – We offer certain voluntary patient assistance programs for prescriptions, such as savings/co-pay cards, which are intended to provide financial assistance to qualified patients with full or partial 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 we expect to receive associated with product that has been recognized as revenue but remains in the distribution and pharmacy channel inventories at the end of each reporting period. At the end of each reporting period, we adjust our allowances for cash discounts, product returns, chargebacks, fees-for-service and other rebates and discounts when believe actual experience may differ from current estimates. The following table provides a summary of activity with respect to our sales allowances and accruals during 2018: Cash Discounts Product Returns Chargebacks Fees-for- Service MelintAssist Government Rebates Commercial Rebates Admin Fee Balance as of January 1, 2018 $ — $ — $ — $ — $ — $ — $ — $ — Allowances for sales 1,184 3,664 5,792 3,240 1,224 864 1,491 476 Payments & credits issued (939 ) (694 ) (5,030 ) (2,422 ) (812 ) (171 ) (892 ) (338 ) Balance as of December 31, 2018 $ 245 $ 2,970 $ 762 $ 818 $ 412 $ 693 $ 599 $ 138 The allowances for cash discounts, bad debt, and chargebacks are recorded as contra-assets in trade receivables; the other balances are recorded in other accrued expenses. Grant Income We have several agreements with BARDA related to certain development costs for solithromycin and Vabomere. We concluded that BARDA is not a customer under Topic 606 because it does not engage with us in reciprocal transactions but, rather, provides contributions to our development efforts to encourage the development of more antibiotics for the welfare of society. As such, we view the income as a contribution and classify it within other income and expense, net, rather than in revenue. We recognize grant income under the BARDA contracts over time as qualifying research activities are conducted. In the first quarter of 2018 , we and BARDA agreed to terminate the solithromycin BARDA contract and wind down the study, which was substantially complete as of December 31, 2018. In addition, in May 2018 , we announced that we had entered into a partnership with the Combating Antibiotic Resistant Bacteria Biopharmaceutical Accelerator (“CARB-X”), under which Melinta was awarded up to $6,200 to support the development of the company’s investigational pyrrolocytosine compounds. CARB-X was established in 2016 by BARDA, the National Institute of Allergy and Infectious Diseases of the U.S. Department of Health and Human Services and the Wellcome Trust, a global charitable foundation dedicated to improving health, to accelerate pre-clinical product development in the area of antibiotic-resistant infections, one of the world’s greatest health threats. In November 2018, we decided to suspend the development of our pyrrolocytosine compounds and have accordingly suspended our partnership with CARB-X. In fiscal year 2018, we recognized $425 in grant income related to awards from CARB-X; we do not anticipate receiving any further award under this contract. |
Business Combinations | Business Combinations— We account for acquired businesses using the acquisition method of accounting. This method requires that most assets acquired and liabilities assumed be recognized as of the acquisition date. On January 1, 2018, we adopted ASU 2017-1, Business Combinations (Topic 805) Clarifying the Definition of a Business , which narrows the definition of a business and requires an entity to evaluate if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets, which would not constitute the acquisition of a business. The guidance also requires a business to include at least one substantive process and narrows the definition of outputs. There is often judgment involved in assessing whether an acquisition transaction is a business combination under Topic 805 or an acquisition of assets. In our IDB acquisition, we evaluated the transaction and concluded that the IDB qualified as a “business” under Topic 805 as it has both inputs and processes with the ability to create outputs. Among IDB’s inputs are developed product rights, in-process research and development and intellectual property across multiple classes of drugs and indications, third-party contract manufacturing agreements and tangible assets from which there is potential to create value and outputs. With respect to business combinations, we determine the purchase price, including contingent consideration, and allocate the purchase price of acquired businesses to the tangible and intangible assets acquired and liabilities assumed, based on estimated fair values. The excess of the purchase price over the identifiable assets acquired and liabilities assumed is recorded as goodwill. With respect to the purchase of assets that do not meet the definition of a business under Topic 805, goodwill is not recognized in connection with the transaction and the purchase price is allocated to the individual assets acquired or liabilities assumed based on their relative fair values. We engage a third-party professional service provider to assist us in determining the fair values of the purchase consideration, assets acquired, and liabilities assumed. Such valuations require management to make significant estimates and assumptions, especially with respect to contingent liabilities associated with the purchase price and intangible assets, such as developed product rights and in-process research and development programs. Critical estimates that we have used in valuing these elements include, but are not limited to, future expected cash flows using valuation techniques (i.e., Monte Carlo simulation models) and discount rates. Management's estimates of fair value are based upon assumptions believed to be reasonable, but which are inherently uncertain and unpredictable. We record contingent consideration resulting from a business combination at its fair value on the acquisition date. The purchase price of IDB included contingent consideration related to the achievement of future regulatory milestones, sales-based milestones associated with the products we acquired, and certain royalty payments based on tiered net sales of the acquired products. The sales-based milestones were assumed contingent liabilities from Medicines at the time of the acquisition. Changes to contingent consideration obligations can result from adjustments related, but not limited, to changes in discount rates and the number of remaining periods to which the discount rate is applied, updates in the assumed achievement or timing of any development or commercial milestone or changes in the probability of certain clinical events, changes in our forecasted sales of products acquired, the passage of time and changes in the assumed probability associated with regulatory approval. At the end of each reporting period, we revalue these obligations and record increases or decreases in their relative fair values in selling, general and administrative expenses within the accompanying consolidated statements of operations. Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period. Accordingly, any change in the assumptions described above could have a material impact on the amount we may be obligated to pay as well as the results of our consolidated results of operations in any given reporting period. |
Advertising Expense | Advertising Expense —We record advertising expenses when they are incurred. |
Segment and Geographic Information | Segment and Geographic Information —Operating segments are defined as components of an enterprise engaging in business activities for which discrete financial information is available and regularly reviewed by the chief operating decision maker in deciding how to allocate resources and in assessing performance. We operate and manage our business as one operating segment. Although substantially all of our license and contract research revenue is generated from agreements with companies that are domiciled outside of the U.S., we do not operate outside of the U.S., nor do we have any significant assets in any foreign country. See this Note 2 for further discussion of the license and contract research revenue. |
Research and Development Costs | Research and Development Costs —Research and development costs are expensed as incurred and primarily include: • employee-related expenses, which include salaries, benefits, travel and share-based compensation expense; • fees paid to consultants and clinical research organizations (“CROs”) in connection with our pre-clinical and clinical trials, and other related clinical trial costs, such as investigator grants, patient screening, laboratory work and statistical compilation and analysis; • costs related to acquiring and manufacturing clinical trial materials and costs for developing additional manufacturing sources for, and the manufacture of pre-approval inventory of, our drugs under development; • costs related to compliance with regulatory requirements; • consulting fees paid to third parties related to non-clinical research and development; • research and laboratory supplies and facility costs; and • license, research and milestone payments related to licensed technologies while the related drug is in development in the respective territory. |
Patent Costs | Patent Costs —All patent-related costs incurred in connection with filing and prosecuting patent applications are expensed to selling, general and administrative expenses as incurred, as recoverability of such expenses is uncertain. |
Stock-Based Compensation | Stock-Based Compensation — We account for share-based compensation following the provisions of ASC 718. We recognize stock-based compensation expense on a straight-line basis over the requisite service period of the individual grants, which is generally the vesting period, based on the estimated grant-date fair values. Stock options granted to employees typically vest over four years from the grant date and expire after 10 years . Stock options granted to non-employees are subject to periodic revaluation over their vesting terms. As a result, the charge to operations for non-employee options with vesting is affected each reporting period by changes in the fair value of the stock options. We have four active stock-based compensation plans, known as the Sixth Amended and Restated 2006 Stock Plan (the “2006 Plan”), the 2011 Equity Incentive Plan (the “2011 Incentive Plan”), the Melinta 2011 Equity Incentive Plan (the “Melinta 2011 Plan”) and the 2018 Stock Incentive Plan (the "2018 Plan"). Under these plans, restricted stock units, stock options and other stock-related awards may be granted to our directors, officers, employees and consultants. Stock options are granted at exercise prices not less than the estimated or actual fair market value of our common stock at the date of grant. We utilize the Black-Scholes option-pricing model for determining the estimated fair value of awards. Key inputs and assumptions include the expected term of the option, stock price volatility, risk-free interest rate, dividend yield, estimated fair value of our common stock, and exercise price. Many of the assumptions require significant judgment and any changes could have a material impact in the determination of stock-based compensation expense. We do not estimate forfeitures when recognizing compensation expense; instead, we recognize forfeitures as they occur. |
Comprehensive Loss | Comprehensive Loss —Comprehensive loss is equal to net loss as presented in the accompanying statements of operations. |
Income Taxes | Income Taxes —We utilize the asset and liability method of accounting for income taxes, as set forth in ASC 740, Income Taxes . Under this method, deferred tax assets and liabilities are recognized based on the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of assets and liabilities. A valuation allowance is established against net deferred tax assets if, based on the weight of available evidence, it is more likely than not that some or all of the net deferred tax assets will not be realized. We have recorded a full valuation allowance against deferred tax assets at each balance sheet date presented. Based on the available evidence, we do not believe that it is more likely than not that it will be able to utilize our deferred tax assets in the future. In accordance with the provisions of ASC 740, we would accrue for the estimated amount of taxes for uncertain tax positions if it is more likely than not that we would be required to pay such additional taxes. An uncertain tax position will not be recognized if it has a less than 50% likelihood of being sustained. Our policy is to recognize any interest and penalties related to income taxes in income tax expense. As of December 31, 2018 and 2017 , we had no uncertain tax positions. |
Recently Issued Accounting Pronouncements, Adopted and Not Yet Adopted | Recently Issued and Adopted Accounting Pronouncements: In March 2016, the FASB issued ASU 2016-6, Contingent Put and Call Options in Debt Instruments , which clarifies that in assessing whether an embedded contingent put or call option is clearly and closely related to the debt host, an entity is required to perform only the four-step decision sequence in ASC 815-15-25-42 (as amended by ASU 2016-6), but it does not have to separately assess whether the event that triggers its ability to exercise the contingent option is itself indexed only to interest rates or credit risk. ASU 2016-6 is effective for financial statements issued for fiscal years beginning after December 15, 2017, and interim periods within fiscal years beginning after December 15, 2018 and requires the use of a modified retrospective transition approach. We adopted this guidance on January 1, 2018; the adoption had no material impact on our financial position, operations and cash flows. In January 2017, the FASB issued ASU 2017-1, Business Combinations (Topic 805) Clarifying the Definition of a Business , which narrows the definition of a business and requires an entity to evaluate if substantially all of the fair value of the gross assets acquired is concentrated in a single identifiable asset or a group of similar identifiable assets, which would not constitute the acquisition of a business. The guidance also requires a business to include at least one substantive process and narrows the definition of outputs. This guidance is effective for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, with early adoption permitted. We adopted this guidance as of January 1, 2018. The adoption did not have a material impact on our consolidated financial statements. In January 2017, the FASB issued ASU 2017-4, Intangibles - Goodwill and Other: Simplifying the Test for Goodwill Impairment , which removes step two from the goodwill impairment test. Step two measures a goodwill impairment loss by comparing the implied fair value of a reporting unit's goodwill with the carrying amount of that goodwill. The new guidance requires an entity to perform its annual, or interim, goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount, including goodwill. An entity should recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit’s fair value, if any. The loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. Additionally, an entity should consider income tax effects from any tax-deductible goodwill on the carrying amount of the reporting unit when measuring the goodwill impairment. The standard is effective for financial statements issued for fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. We early adopted this standard in connection with our annual goodwill impairment test on December 1, 2018. Recently Issued Accounting Pronouncements Not Yet Adopted In February 2016, the FASB issued ASU 2016-2, Leases , which requires lessees to recognize assets and liabilities for most leases with terms of more than 12 months on the balance sheet but recognize expense on the income statement in a manner similar to current accounting. The standard requires a modified retrospective approach for leases that exist or are entered into after the beginning of the earliest comparative period in the financial statements and is effective for us in the first quarter of 2019. In July 2018, the FASB issued ASU No. 2018-11, Targeted Improvements - Leases (Topic 842) . This update provides an optional transition method that allows entities to elect to apply the standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, the prior comparative period’s financials will remain the same as those previously presented. We have elected to apply the guidance at the beginning of the period of adoption and not restate comparative periods. We lease fleet vehicles as well as our research and administrative facility in New Haven, Connecticut, and our office facilities in Lincolnshire, Illinois, Chapel Hill, North Carolina and Morristown, New Jersey. We are evaluating the impact of ASU 2016-2, which we plan to adopt on January 1, 2019, on our consolidated financial statements. To date, we have identified all of our leases, we have evaluated practical expedients, and we are still evaluating our discount rates to apply to the leases. We anticipate that adoption of ASU 2016-2 will result in the recognition of additional right-to-use assets and lease liabilities of between $6,500 and $8,500 . In August 2018, the FASB issued ASU 2018-13, Disclosure Framework-Changes to the Disclosure Requirements for Fair Value Measurement , which modifies or removes certain disclosure requirements in Topic 820, Fair Value Measurements . The update is effective for all entities for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2019. We are currently evaluating the impact of the adoption of this ASU on our financial statements. In August 2018, the FASB issued ASU 2018-15, Internal-Use Software (Subtopic 350-40): Customer's Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract , which provides guidance on implementation costs incurred in a cloud computing arrangement that is a service contract. The ASU amends Topic 350, Intangibles—Goodwill and Other , to include these implementation costs in its scope and clarifies that a customer should apply ASC 350-40 to determine which implementation costs should be capitalized. The update is effective for public entities for fiscal years beginning after December 15, 2019. we are currently evaluating the impact the adoption of this ASU will have on our financial statements. In November 2018, the FASB issued ASU 2018-18, Clarifying the Interaction between Topic 808 and Topic 606 , which amends ASC 808 to clarify when transactions between participants in a collaborative arrangement under ASC 808 are within the scope of ASC 606, Revenue from Contracts with Customers . The ASU provides clarity in both ASC 606 and 808 regarding when transactions between collaborative arrangement participants should be accounted for as revenue under ASC 606. The update is effective for public entities for fiscal years beginning after December 15, 2019. we are currently evaluating the impact the adoption of this ASU will have on our financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accounting Policies [Abstract] | |
Summary of Inventory | Activity in our inventory reserve account is summarized below: Beginning Balance as of January 1, 2018 Charges to Cost of Goods Sold Inventory Discards Ending Balance as of December 31, 218 $ — $ 8,042 $ (972 ) $ 7,070 Inventory consisted of the following: As of December 31, 2018 2017 Raw materials $ 24,507 $ 5,545 Work in process $ 11,700 $ 181 Finished goods 12,204 5,099 Gross value of inventory $ 48,411 $ 10,825 Less: valuation reserves $ (7,070 ) $ — Total inventory $ 41,341 $ 10,825 |
Schedule of Depreciation Periods for Property and Equipment | Depreciation periods for our property and equipment are as follows: Type Period Laboratory equipment 5 years Furniture and fixtures 5 years Office equipment 3 years Leasehold improvements Shorter of useful life or lease life Purchased software 3 years |
Summary of Effect of Adoption of Topic 606 on Condensed Consolidated Balance Sheet | he effect of the adoption of Topic 606 on our consolidated balance sheet is as follows: Balance at December 31, 2017 Adjustments Due to Topic 606 Balance at January 1, 2018 Liabilities: Deferred revenue $ 10,008 $ (10,008 ) $ — Shareholders’ equity: Accumulated deficit $ (572,659 ) $ 10,008 $ (562,651 ) |
Summary of Revenue from External Customers by Products and Services | Product Sales Product Year Ended December 31, 2018 Baxdela $ 6,485 Vabomere 7,416 Orbactiv 22,951 Minocin for injection 9,728 Total product sales, net $ 46,580 |
Summary Of Sales Allowances And Accruals Table | The following table provides a summary of activity with respect to our sales allowances and accruals during 2018: Cash Discounts Product Returns Chargebacks Fees-for- Service MelintAssist Government Rebates Commercial Rebates Admin Fee Balance as of January 1, 2018 $ — $ — $ — $ — $ — $ — $ — $ — Allowances for sales 1,184 3,664 5,792 3,240 1,224 864 1,491 476 Payments & credits issued (939 ) (694 ) (5,030 ) (2,422 ) (812 ) (171 ) (892 ) (338 ) Balance as of December 31, 2018 $ 245 $ 2,970 $ 762 $ 818 $ 412 $ 693 $ 599 $ 138 |
Balance Sheet Components - (Tab
Balance Sheet Components - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Balance Sheet Related Disclosures [Abstract] | |
Summary of Cash, Cash Equivalents and Restricted Cash | Cash, cash equivalents and restricted cash, as presented on the Consolidated Statements of Cash Flows, consisted of the following: As of December 31, 2018 2017 Cash and cash equivalents $ 81,808 $ 128,387 Restricted cash (included in Other assets) 200 200 Total cash, cash equivalents and restricted cash shown in the Consolidated Statements of Cash Flows $ 82,008 $ 128,587 |
Summary of Accounts Receivable | Accounts receivable consisted of the following: As of December 31, 2018 2017 Trade receivables $ 11,509 $ — Contracted services 10,293 7,202 Other receivables 683 362 Total receivables $ 22,485 $ 7,564 |
Summary of Inventory | Activity in our inventory reserve account is summarized below: Beginning Balance as of January 1, 2018 Charges to Cost of Goods Sold Inventory Discards Ending Balance as of December 31, 218 $ — $ 8,042 $ (972 ) $ 7,070 Inventory consisted of the following: As of December 31, 2018 2017 Raw materials $ 24,507 $ 5,545 Work in process $ 11,700 $ 181 Finished goods 12,204 5,099 Gross value of inventory $ 48,411 $ 10,825 Less: valuation reserves $ (7,070 ) $ — Total inventory $ 41,341 $ 10,825 |
Summary of Property and Equipment, Net | Property and equipment, net consisted of the following: As of December 31, 2018 2017 Laboratory equipment $ 3,387 $ 3,339 Manufacturing equipment 178 65 Office equipment 1,062 604 Purchased software 860 860 Furniture and fixtures 390 390 Leasehold improvements 4,943 4,869 Assets in development 301 437 Property and equipment, gross 11,121 10,564 Less-accumulated depreciation (9,535 ) (8,968 ) Property and equipment, net $ 1,586 $ 1,596 |
Summary of Other Assets | Other assets consisted of the following: As of December 31, 2018 2017 Deerfield disbursement option (see Note 4) $ 7,608 $ — Long-term inventory deposits 51,127 — Other assets 2,391 1,213 Restricted cash 200 200 Total other assets $ 61,326 $ 1,413 |
Summary of Accrued Expenses | Accrued expenses consisted of the following: As of December 31, 2018 2017 Accrued contracted services $ 2,909 $ 5,596 Payroll-related expenses 15,585 9,885 Professional fees 3,598 3,621 Accrued royalty payments 2,052 2,040 Accrued sales allowances 5,630 — Accrued other 4,150 2,899 Total accrued expenses $ 33,924 $ 24,041 |
Financing Arrangements - (Table
Financing Arrangements - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Debt Disclosure [Abstract] | |
Schedule of Outstanding Debt Balances | Melinta’s outstanding debt balances consisted of the following as of December 31, 2018 and 2017 : As of December 31, 2018 2017 Principal balance under loan agreements $ 118,752 $ 40,000 Debt discount and deferred financing costs for loan agreements (8,276 ) (445 ) Total long-term debt, net of current maturities $ 110,476 $ 39,555 |
Schedule Of Fair Value Of Financial Instruments Table | The relative fair values of these financial instruments, which approximated their respective fair values as of the Agreement Date, were as follows: Liabilities / (Assets) Term Loan $ 111,421 Warrants 33,263 Royalty Agreement 1,472 Disbursement Option (7,608 ) Common Stock Consideration 51,452 Total Consideration $ 190,000 |
Schedule Of Changes In Long Term Loan Payments Table | The accretion of the principal of the term loan and the future payments, including the 2.0% exit fee due at the end of the term, and excluding the 11.75% rate applied to the $147,774 note per the form of the Deerfield Facility, are as follows: Beginning Balance Accretion of Interest Expense Principal Payments and Exit Fee Ending Balance January 5 - December 31, 2018 $ 104,966 $ 5,510 $ — $ 110,476 Year Ending December 31, 2019 110,476 7,135 — 117,611 Year Ending December 31, 2020 117,611 8,638 — 126,249 Year Ending December 31, 2021 126,249 10,799 — 137,048 Year Ending December 31, 2022 137,048 9,827 (69,084 ) 77,791 Year Ending December 31, 2023 77,791 3,846 (75,365 ) 6,272 Year Ending December 31, 2024 6,272 9 (6,281 ) — Total $ 45,764 $ (150,730 ) |
Fair Value Measurements - (Tabl
Fair Value Measurements - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value | The following table lists our assets and liabilities that are measured at fair value and the level of inputs used to measure their fair value at December 31, 2018 and 2017 . The money market fund is included in cash & cash equivalents on the balance sheet; the other items are in the captioned line of the balance sheet. As of December 31, 2018 Level 1 Level 2 Level 3 Total Assets: Money market fund $ 32,883 $ — $ — $ 32,883 Total assets at fair value $ 32,883 $ — $ — $ 32,883 Liabilities: Current royalty contingent consideration from IDB acquisition $ — $ — $ (1,006 ) $ (1,006 ) Long-term royalty contingent consideration from IDB acquisition — — (4,708 ) (4,708 ) Warrant liability — — (38 ) (38 ) Total liabilities at fair value $ — $ — $ (5,752 ) $ (5,752 ) As of December 31, 2017 Level 1 Level 2 Level 3 Total Assets: Money market fund $ 76,777 $ — $ — $ 76,777 Total assets at fair value $ 76,777 $ — $ — $ 76,777 |
Summary of Changes in Fair Value of Level 3 Liabilities | The following tables summarize the changes in fair value of our Level 3 liabilities for the years ended December 31, 2018 and 2017 : Level 3 Liabilities Fair Value at December 31, Accretion Recorded in interest Expense Change in Unrealized Gains (Losses) (Issuances) Settlements, Net Net Transfer (In) Out of Level 3 Fair Value at December 31, Current royalty contingent consideration from IDB acquisition $ — $ (1,055 ) $ (1,151 ) $ 1,200 $ — $ (1,006 ) Long-term royalty contingent consideration from IDB acquisition $ — $ (5,489 ) $ 11,468 $ (10,687 ) $ — $ (4,708 ) Contingent milestone payment $ — (4,015 ) (1,500 ) (24,485 ) 30,000 $ — Warrant liability $ — $ — $ 33,225 $ (33,263 ) $ — $ (38 ) Total liabilities at fair value $ — $ (10,559 ) $ 42,042 $ (67,235 ) $ 30,000 $ (5,752 ) Level 3 Liabilities Fair Value at December 31, Accretion Recorded in interest Expense Change in Unrealized Gains (Losses) Reclassification to APIC Net Transfer (In) Out of Level 3 Fair Value at December 31, Preferred stock warrants $ (674 ) $ — $ 335 $ 339 $ — $ — Total liabilities at fair value $ (674 ) $ — $ 335 $ 339 $ — $ — |
Shareholders' Equity - (Tables)
Shareholders' Equity - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Equity [Abstract] | |
Summary of Warrants Outstanding | We have warrants to purchase our common stock outstanding at December 31, 2018 , as follows: Issued Warrants Outstanding Exercise Price Expiration February 2012 8 $ 86,670.35 February 2019 December 2014 6,757 $ 166.50 December 2024 December 2015 1,351 $ 166.50 December 2024 January 2018 758,573 $ 82.50 January 2025 Total 766,689 |
Stock-Based Compensation - (Tab
Stock-Based Compensation - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Stock Option Plans | A summary of the stock option activity under the 2006 Plan is presented in the table below: Number of Options Weighted Average Exercise Price Weighted Average Contractual Term (in years) Aggregate Intrinsic Value Outstanding - November 3, 2017 13,672 $ 54.00 1.2 Outstanding - December 31, 2017 13,672 54.00 1.1 $ 342 Forfeited (11,328 ) $ 54.41 Outstanding - December 31, 2018 2,344 $ 52.25 1.4 $ — Exercisable - December 31, 2018 2,344 $ 52.25 1.4 $ — Vested and expected to vest at December 31, 2018 2,344 $ 52.25 1.4 $ — A summary of the stock-option activity under the 2011 Incentive Plan is presented in the table below: Number of Options Weighted Average Exercise Price Weighted Average Contractual Term (in years) Aggregate Intrinsic Value Outstanding - November 3, 2017 149,060 $ 300.10 6.2 Exercised (172 ) 78.15 Forfeited (1,289 ) 140.00 Expired (3,056 ) 322.05 Outstanding - December 31, 2017 144,543 $ 301.30 3.9 $ 113 Granted 321,193 37.25 Exercised (40 ) 78.05 Forfeited (78,513 ) 46.80 Expired (89,660 ) 312.85 Outstanding - December 31, 2018 297,523 $ 79.95 8.8 $ — Exercisable - December 31, 2018 51,328 $ 278.30 6.2 $ — Vested and expected to vest at December 31, 2018 297,521 $ 79.95 8.8 $ — A summary of the stock-option activity under the Melinta 2011 Plan is presented in the table below: Number of Options Weighted Average Exercise Price Weighted Average Contractual Term (in years) Aggregate Intrinsic Value Outstanding - December 31, 2015 4,362,836 $ 3.00 8.5 Granted 1,240,499 3.55 Exercised (31,685 ) 2.05 Canceled/expired (331,209 ) 3.85 Outstanding - December 31, 2016 5,240,441 3.10 7.9 Granted 1,830,199 2.40 Exercised (26,366 ) 3.60 Canceled/expired (797,571 ) 2.55 Conversion (6,102,901 ) (2 ) Outstanding - December 31, 2017 143,802 $ 129.40 7.9 Exercised (25,480 ) (1 ) 135.05 (1 ) Canceled/expired (20,616 ) (1 ) 151.90 (1 ) Outstanding - December 31, 2018 97,706 (1 ) $ 123.15 (1 ) 5.1 $ — Exercisable - December 31, 2018 81,419 (1 ) $ 124.15 (1 ) 4.5 $ — Vested and expected to vest at December 31, 2018 97,703 (1 ) $ 123.15 (1 ) 5.1 $ — (1) Amounts are after conversion (2) Options outstanding on November 3, 2017, were converted to options to purchase common shares of Cempra (re-named Melinta in the merger) at a 0.0229 conversion ratio The weighted-average grant-date per share fair value of options granted under the Melinta 2011 Plan during the years ended December 31, 2018 , 2017 and 2016 was $0.00 , $1.30 , and $2.15 , respectively ( $0.00 , $37.00 and $31.60 , respectively, after conversion and re-valuation on November 3, 2017). The total fair value of options that vested under the Melinta 2011 Plan during the years ended December 31, 2018 , 2017 and 2016 , was approximately $690 , $2,900 and $2,300 , respectively. The intrinsic value of options exercised in 2018 was not material. A summary of the stock-option activity under the 2018 Plan is presented in the table below: Number of Options Weighted Average Exercise Price Weighted Average Contractual Term (in years) Aggregate Intrinsic Value Outstanding - December 31, 2017 — Granted 301,973 32.80 Canceled/expired (76,650 ) 37.41 Outstanding - December 31, 2018 225,323 $ 31.21 9.5 $ — Exercisable - December 31, 2018 14,402 $ 29.20 8.9 $ — Vested and expected to vest at December 31, 2018 225,323 $ 31.21 9.5 $ — |
Schedule of Options Outstanding | The following table summarizes certain information about all options outstanding as of December 31, 2018 : Options Outstanding Options Exercisable Exercise Price Number of Options Weighted Average Remaining Contractual Term (in years) Number of Options Weighted Average Remaining Contractual Term (in years) $10.60 - $25.00 147,720 9.8 5,000 9.8 $25.01 - $50.00 402,896 9.3 18,150 8.5 $50.01 - $75.00 8,004 5.7 7,504 5.6 $75.01 - $100.00 31,826 4.4 28,639 4.0 $100.01 - $125.00 31,569 6.8 17,697 5.6 $125.01 - $1,085.75 74,875 5.0 72,188 4.9 696,890 149,178 |
Schedule of Assumptions Used to Value Outstanding Vested And Unvested Stock Option Grants | The range of assumptions used to value stock option grants for all plans—plus the vested stock option grants under the Melinta 2011 Plan which were remeasured on the merger date—were as follows: 2018 2017 2016 Risk-free interest rate 2.6% - 3.1% 1.8% - 2.1% 1.5 % Weighted-average volatility 84.8% - 85.6% 87.5% - 108.1% 67.1 % Expected term - employee awards (in years) 1.0 - 6.1 3.1 - 6.1 6.0 Forfeiture rate — % — % — % Dividend yield 0.00 % 0.00 % 0.00 % The range of assumptions used calculate the estimated value of the acquire vested stock options under the 2006 Plan and the 2011 Equity Plan that was recorded as additional purchase price for the acquisition of Cempra at the merger date were as follows (the wide range of volatility was due to the various remaining expected terms for the options, some of which were less than one year): November 3, 2017 Risk-free interest rate 1.2% - 2.0% Weighted-average volatility 51.0% - 147.4% Expected term - employee awards (in years) 0.2-5.6 Forfeiture rate 0.00 % Dividend yield 0.00 % |
Schedule of RSUs Activity | A summary of the activity related to our RSUs (except for the inducement grant discussed above) is as follows: Number of Restricted Stock Units Outstanding Weighted Average Fair Value Balance - November 3, 2017 40,400 $ 58.25 Vested and issued (12,400 ) 58.25 Forfeited (600 ) 58.25 Balance - December 31, 2017 27,400 58.25 Granted 10,000 14.00 Vested and issued (10,920 ) 58.25 Forfeited (5,120 ) 58.25 Balance - December 31, 2018 21,360 32.75 Vested at December 31, 2018 4,000 $ 58.25 |
Schedule of Stock-Based Compensation Reported in Statements of Operations | Stock-based compensation reported in our statements of operations was as follows: Year Ended December 31, 2018 2017 2016 Cost of goods sold $ 48 $ — $ — Research and development 750 651 1,169 General and administrative 2,667 5,799 1,346 Total $ 3,465 $ 6,450 $ 2,515 |
Income Taxes - (Tables)
Income Taxes - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Tax Disclosure [Abstract] | |
Schedule of Income Tax Expense (Benefit) From Continuing Operations | The income tax expenses (benefits) from continuing operations are summarized as follows: 2018 2017 Federal: Current $ — $ — Deferred — — — — State: Current (139 ) (103 ) Deferred — — (139 ) (103 ) Total $ (139 ) $ (103 ) |
Schedule of Effective Income Tax Rate Reconciliation | The provision for income taxes differs from income taxes computed at the federal statutory tax rates for the years ended December 31, 2018 and 2017 , due to the following items (presented as benefits/(expenses)): 2018 2017 Federal Statutory rate 21.0 % 34.0 % State income taxes, net of federal income tax benefit 17.7 0.2 Bargain purchase gain — 15.9 Transaction cost — (2.3 ) Interest expense — (2.3 ) Impact of change in fair value of tranche assets and liabilities 4.4 2.0 Other permanent differences (0.2 ) (2.0 ) Federal tax rate change — (75.3 ) Change in valuation allowance (14.1 ) 28.0 Research and development tax credits 1.2 3.3 Prior year adjustment (1.0 ) — Section 382 adjustment (28.9 ) — Other — (1.3 ) Effective income tax rate 0.1 % 0.2 % |
Schedule of Temporary Difference and Net Operating Losses to Significant Portions of Deferred Tax Assets | The tax effects of the temporary differences and net operating losses that give rise to significant portions of deferred tax assets are as follows (in thousands): 2018 2017 Deferred tax assets: Net operating loss carryforwards $ 94,596 $ 172,481 Tax credit carryforwards 7,409 24,924 Deferred revenue — 3,364 Fixed assets 677 593 Stock compensation expense 2,195 2,503 Intangibles 12,026 3,978 Interest expense carryforward 7,617 — Others 4,273 2,151 Total deferred tax assets 128,793 209,994 Less valuation allowance (128,793 ) (209,994 ) Net deferred tax assets $ — $ — |
Summary of Tax Years by Jurisdiction | The Company files its tax returns as prescribed by the tax laws of the jurisdictions in which it operates. With few exceptions, the major jurisdictions subject to examination by the relevant tax authorities, and open tax years, stated as the Company's fiscal years, are as follows: Jurisdiction Open Tax Years U.S. Federal 2015 - 2017 U.S. State 2014 - 2017 |
Commitments and Contingencies -
Commitments and Contingencies - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Minimum Operating Lease Payments under Non-cancelable Leases | As of December 31, 2018, minimum operating lease payments under noncancelable leases (as amended) were as follows: Amounts 2019 $ 2,796 2020 2,710 2021 2,327 2022 1,233 2023 and thereafter 886 Total future minimum payments * $ 9,952 *Minimum payments have not been reduced by minimum sublease rentals of $271 due in the future under noncancelable subleases |
Selected Quarterly Data (Unau_2
Selected Quarterly Data (Unaudited) - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Quarterly Financial Information Disclosure [Abstract] | |
Summary of Selected Quarterly Data (Unaudited) | Quarter Ended March 31, June 30, September 30, December 31, Revenue $ 14,841 $ 12,022 $ 34,078 $ 35,489 Operating expenses: Cost of goods sold 7,686 10,989 13,393 8,989 Research and development 16,129 15,813 13,065 10,402 Goodwill impairment — — — 25,088 Selling, general and administrative 34,624 34,946 34,287 29,455 Loss from operations (43,598 ) (49,726 ) (26,667 ) (38,445 ) Total Other Income (Expense), net 14,166 (6,054 ) (1,193 ) (5,675 ) Net loss $ (29,432 ) $ (55,780 ) $ (27,860 ) $ (44,120 ) Accretion of preferred dividends — — — — Net loss available to shareholders $ (29,432 ) $ (55,780 ) $ (27,860 ) $ (44,120 ) Net loss per share - basic and diluted $ (4.76 ) $ (6.92 ) $ (2.49 ) $ (3.94 ) Weighted average shares used in calculating basic and diluted net loss per share 6,184 8,059 11,203 11,204 Quarter Ended March 31, June 30, September 30, December 31, Revenue $ 22,463 $ 3,979 $ 3,191 $ 4,231 Operating expenses: Research and development 12,917 14,075 10,884 11,599 Selling, general and administrative 7,973 7,699 10,304 37,349 Loss from operations 1,573 (17,795 ) (17,997 ) (44,717 ) Total Other (Income) Expense, net 1,647 2,631 1,639 (25,937 ) Net loss $ (74 ) $ (20,426 ) $ (19,636 ) $ (18,780 ) Accretion of preferred dividends (5,720 ) (5,721 ) (5,720 ) (2,098 ) Net loss available to shareholders $ (5,794 ) $ (26,147 ) $ (25,356 ) $ (20,878 ) Net loss per share - basic and diluted $ (1,040.78 ) $ (4,420.46 ) $ (4,286.73 ) $ (7.40 ) Weighted average shares used in calculating basic and diluted net loss per share 6 6 6 2,821 |
Business Combinations - (Tables
Business Combinations - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Business Combinations [Abstract] | |
Schedule of Initial and Current Estimate of Purchase Price Allocation of Acquired Intangible Assets and Related Deferred Tax Liabilities | The following table sets forth our final of the purchase price allocation. Current assets $ 33,725 Goodwill 25,088 Intangible assets 236,819 Non-current assets 9,486 Current liabilities (32,837 ) Non-current liabilities (576 ) Total purchase price $ 271,705 |
Schedule of Identifiable Intangible Assets Acquired and Estimated Useful Lives | The following table sets forth the components of identifiable intangible assets acquired and their estimated useful lives as of the date of the acquisition: Average useful life Fair value Developed product rights 13 to 17 years $ 216,960 In-process research and development Indefinite 19,859 Total intangible assets $ 236,819 |
Schedule of Unaudited Pro Forma Information | The following table provides unaudited supplemental pro forma information as if the acquisition of IDB and the Cempra merger took place at the beginning of fiscal 2017. 2017 Pro forma revenue $ 67,617 Pro forma net loss $ (264,909 ) |
Net Loss Per Share - (Tables)
Net Loss Per Share - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Earnings Per Share [Abstract] | |
Antidilutive Securities Excluded from Computation of Diluted Weighted Average Shares Outstanding | The following potentially dilutive securities (in common stock equivalent shares) have been excluded from the computation of diluted weighted-average shares outstanding because such securities have an antidilutive impact due to losses reported: December 31, 2018 2017 2016 Options to purchase common stock 696,890 412,211 120,007 Preferred stock warrants — — 6,331 Unvested restricted stock 17,360 64,132 — Common stock warrants 766,691 11,913 9 Convertible preferred stock — — 1,166,029 1,480,941 488,256 1,292,376 |
Severance - (Tables)
Severance - (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Restructuring and Related Activities [Abstract] | |
Summary of Activity in Severance Accrual (Included In Accrued Expenses or Long-Term Liabilities on Condensed Consolidated Balance Sheets) | A summary of merger and non-merger activity in our severance accrual (included in accrued expenses or long-term liabilities on the consolidated balance sheets) is below. Balance - December 31, 2016 $ — Severance accruals (recorded in SG&A) 6,383 Severance liability acquired in Cempra merger 769 Severance payments (431 ) Balance - December 31, 2017 $ 6,721 Severance accruals (recorded in SG&A) 12,371 Severance payments (9,325 ) Balance - December 31, 2018 $ 9,767 |
Summary of Activity in Lease Liability | summary of activity in our lease liability is below. Balance - December 31, 2017 $ — Fair value of lease liability recognized 556 Lease termination adjustment (233 ) Termination fee 136 Less: payments (391 ) Balance - December 31, 2018 $ 68 |
Nature of the Business - Narrat
Nature of the Business - Narrative (Details) | Jul. 10, 2019USD ($) | Jan. 05, 2018USD ($) | Jan. 05, 2018USD ($) | Jul. 31, 2019USD ($) | Feb. 28, 2019USD ($) | Jan. 31, 2019USD ($) | Dec. 31, 2018USD ($)product | Nov. 30, 2018 | Dec. 31, 2001USD ($) | Jun. 30, 2019USD ($) | Dec. 31, 2018USD ($)product | Jul. 31, 2019USD ($) | Dec. 31, 2018USD ($)product | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 01, 2018USD ($) |
Basis Of Presentation [Line Items] | ||||||||||||||||
Number of products | product | 4 | 4 | 4 | |||||||||||||
Accumulated deficit | $ (719,843,000) | $ (719,843,000) | $ (719,843,000) | $ (572,659,000) | $ (562,651,000) | |||||||||||
Percentage headcount reduction | 20.00% | 20.00% | ||||||||||||||
Cash and cash equivalents | 81,808,000 | $ 81,808,000 | 81,808,000 | 128,387,000 | ||||||||||||
Proceeds from the issuance of convertible promissory notes | 0 | $ 24,526,000 | $ 0 | |||||||||||||
Deerfield | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Additional debt financing available | $ 50,000,000 | |||||||||||||||
Maximum | Disbursement Option | Facility Agreement | IDB | Deerfield | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Additional debt financing available | $ 50,000,000 | |||||||||||||||
Maximum | Scenario, Forecast | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Proceeds from the issuance of convertible promissory notes | $ 35,000,000 | $ 25,000,000 | ||||||||||||||
Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Line credit maximum borrowing capacity | $ 135,000,000 | 135,000,000 | 135,000,000 | |||||||||||||
Period in which funding is provided | 5 months | |||||||||||||||
Remaining borrowing capacity | $ 60,000,000 | $ 60,000,000 | $ 60,000,000 | |||||||||||||
Working capital revolver, planned to be executed | $ 20,000,000 | |||||||||||||||
Working capital revolver required, for final tranche of loans to be issued | $ 10,000,000 | |||||||||||||||
Convertible Subordinated Debt | Scenario, Forecast | Senior Subordinated Convertible Loan Agreement | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Proceeds from issuance of debt | $ 60,000,000 | |||||||||||||||
Convertible Subordinated Debt | Scenario, Forecast | Senior Subordinated Convertible Loan Agreement, Final Tranche | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Proceeds from the issuance of convertible promissory notes | $ 35,000,000 | |||||||||||||||
Subsequent Event | Term Loan | Facility Agreement | Deerfield | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Debt covenant, minimum revenue requirement | $ 63,750,000 | |||||||||||||||
Subsequent Event | Term Loan | Debt Covenant, Period One | Facility Agreement | Deerfield | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Debt instrument covenant, minimum cash balance requirement | 40,000,000 | |||||||||||||||
Subsequent Event | Term Loan | Debt Covenant, Period Two | Facility Agreement | Deerfield | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Debt instrument covenant, minimum cash balance requirement | $ 25,000,000 | |||||||||||||||
Subsequent Event | Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | ||||||||||||||||
Basis Of Presentation [Line Items] | ||||||||||||||||
Proceeds from issuance of debt | $ 75,000,000 |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies - Narrative (Details) € in Thousands | Feb. 22, 2019 | Jan. 01, 2019USD ($) | Feb. 22, 2018 | Jan. 05, 2018 | Jan. 01, 2018USD ($) | Jan. 31, 2019EUR (€) | Dec. 31, 2018USD ($) | Nov. 30, 2018EUR (€) | Oct. 31, 2018EUR (€) | Dec. 31, 2018USD ($) | Dec. 31, 2018EUR (€) | Sep. 30, 2018USD ($)country | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)rebate_program | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | May 31, 2018USD ($) | Jan. 31, 2015USD ($) |
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Revenue | $ (35,489,000) | $ (34,078,000) | $ (12,022,000) | $ (14,841,000) | $ (4,231,000) | $ (3,191,000) | $ (3,979,000) | $ (22,463,000) | $ (96,430,000) | $ (33,864,000) | $ 0 | ||||||||||||
Other income and expense | 1,904,000 | 98,000 | 177,000 | ||||||||||||||||||||
Reverse stock split, conversion ratio for awards | 0.2 | ||||||||||||||||||||||
Allowance for doubtful accounts | $ 26,000 | 26,000 | 26,000 | ||||||||||||||||||||
Inventory reserve | 7,070,000 | 7,070,000 | 0 | 7,070,000 | 0 | ||||||||||||||||||
Intangible assets, amortization expense | 16,332,000 | 0 | |||||||||||||||||||||
Amortization expense, 2020 | 0 | 0 | 0 | ||||||||||||||||||||
Goodwill impairment | 25,088,000 | 25,088,000 | $ 0 | $ 0 | $ 0 | 25,088,000 | 0 | 0 | |||||||||||||||
Goodwill | 0 | 0 | 0 | ||||||||||||||||||||
Deferred revenue | $ 0 | 0 | 0 | 10,008,000 | 0 | 10,008,000 | $ 9,008,000 | ||||||||||||||||
Increase in product returns reserve | $ 1,700,000 | ||||||||||||||||||||||
Number of government rebate programs | rebate_program | 3 | ||||||||||||||||||||||
Grant income | $ (5,828,000) | 0 | 0 | ||||||||||||||||||||
Advertising expense | 3,878,000 | 1,234,000 | 1,066,000 | ||||||||||||||||||||
Uncertain tax positions | 0 | 0 | 0 | 0 | 0 | ||||||||||||||||||
Intellectual Property | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Amortization expense, 2019 | 16,603,000 | 16,603,000 | 16,603,000 | ||||||||||||||||||||
Amortization expense, 2020 | 16,603,000 | 16,603,000 | 16,603,000 | ||||||||||||||||||||
Amortization expense, 2021 | 16,603,000 | 16,603,000 | 16,603,000 | ||||||||||||||||||||
Amortization expense, 2022 | 16,603,000 | 16,603,000 | 16,603,000 | ||||||||||||||||||||
Amortization expense, 2023 | 16,603,000 | 16,603,000 | 16,603,000 | ||||||||||||||||||||
Amortization expense, thereafter | 125,113,000 | 125,113,000 | $ 125,113,000 | ||||||||||||||||||||
Developed product rights | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Intangible assets, useful life | 10 years | ||||||||||||||||||||||
Intangible assets, gross | 245,529,000 | 245,529,000 | $ 7,500,000 | $ 245,529,000 | 7,500,000 | ||||||||||||||||||
Intangible assets, accumulated amortization | $ 16,332,000 | $ 16,332,000 | 16,332,000 | ||||||||||||||||||||
Intangible assets, amortization expense | $ 16,332,000 | ||||||||||||||||||||||
Stock Options | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Stock options, vesting period (in years) | 4 years | ||||||||||||||||||||||
Stock options, expiration period | 10 years | ||||||||||||||||||||||
Contract research | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Revenue | $ (11,677,000) | (13,959,000) | 0 | ||||||||||||||||||||
License | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Revenue | $ (19,905,000) | (38,173,000) | (19,905,000) | 0 | |||||||||||||||||||
Vabomere | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Revenue | $ (7,416,000) | ||||||||||||||||||||||
Maximum | Intellectual Property | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Intangible assets, useful life | 17 years | ||||||||||||||||||||||
Maximum | Developed product rights | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Intangible assets, useful life | 17 years | ||||||||||||||||||||||
Minimum | Intellectual Property | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Intangible assets, useful life | 10 years | ||||||||||||||||||||||
Minimum | Developed product rights | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Intangible assets, useful life | 13 years | ||||||||||||||||||||||
ASU 2014-09 | Adjustments Due to Topic 606 | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Other income and expense | 870,000 | ||||||||||||||||||||||
Deferred revenue | $ (10,008,000) | ||||||||||||||||||||||
CARB-X | Development Of Investigational Pyrrolocytosine Compounds | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Grant income | $ 425,000 | ||||||||||||||||||||||
CARB-X | Maximum | Development Of Investigational Pyrrolocytosine Compounds | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Contract liabilities | $ 6,200,000 | ||||||||||||||||||||||
Trade Receivables | Customer Concentration Risk | Large Wholesaler Customer One | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Concentration risk percentage | 46.00% | ||||||||||||||||||||||
Trade Receivables | Customer Concentration Risk | Large Wholesaler Customer Two | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Concentration risk percentage | 32.00% | ||||||||||||||||||||||
Trade Receivables | Customer Concentration Risk | Large Wholesaler Customer Three | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Concentration risk percentage | 15.00% | ||||||||||||||||||||||
Menarini | License | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Revenue | € | € (17,000) | ||||||||||||||||||||||
Number of countries exclusive right for Menarini to market Vabomere, Orbactive and Minocin | country | 68 | ||||||||||||||||||||||
Scenario, Forecast | Developed product rights | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Intangible assets, amortization expense | $ 21,069,000 | ||||||||||||||||||||||
Scenario, Forecast | ASU 2016-02 | Maximum | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Operating lease, right-of-use asset | 8,500,000 | ||||||||||||||||||||||
Operating lease, liability | 8,500,000 | ||||||||||||||||||||||
Scenario, Forecast | ASU 2016-02 | Minimum | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Operating lease, right-of-use asset | 6,500,000 | ||||||||||||||||||||||
Operating lease, liability | $ 6,500,000 | ||||||||||||||||||||||
Europe | Menarini | Vabomere | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Revenue | € | € (15,000) | € (15,000) | |||||||||||||||||||||
Baxdela | Minimum | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Deferred revenue expected recognized period | 10 years | ||||||||||||||||||||||
Research and development | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Impairment of long-lived assets abandoned | $ 988,000 | $ 0 | $ 0 | ||||||||||||||||||||
Subsequent Event | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Reverse stock split, conversion ratio for awards | 0.2 | ||||||||||||||||||||||
Subsequent Event | Europe | Menarini | Vabomere | |||||||||||||||||||||||
Summary Of Significant Accounting Policies [Line Items] | |||||||||||||||||||||||
Revenue | € | € (15,000) |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies - Summary of Inventory (Details) - Inventory Reserve $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | |
Balance as of January 1, 2018 | $ 0 |
Charges to Cost of Goods Sold | 8,042 |
Inventory Discards | 972 |
Ending Balance as of December 31, 218 | $ 7,070 |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies - Schedule of Depreciation Periods for Property And Equipment (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Laboratory equipment | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, depreciation period | 5 years |
Furniture and fixtures | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, depreciation period | 5 years |
Office equipment | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, depreciation period | 3 years |
Purchased software | |
Property, Plant and Equipment [Line Items] | |
Property and equipment, depreciation period | 3 years |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies - Summary of Effect of Adoption of Topic 606 on Condensed Consolidated Balance Sheet (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 01, 2018 | Dec. 31, 2017 | Jan. 31, 2015 |
Liabilities | ||||
Deferred revenue | $ 0 | $ 0 | $ 10,008 | $ 9,008 |
Shareholders’ equity: | ||||
Accumulated deficit | $ (719,843) | (562,651) | $ (572,659) | |
Adoption of Topic 606 | Adjustments Due to Topic 606 | ||||
Liabilities | ||||
Deferred revenue | (10,008) | |||
Shareholders’ equity: | ||||
Accumulated deficit | $ 10,008 |
Summary of Significant Accoun_8
Summary of Significant Accounting Policies - Summary of Revenue by Product (Details) - 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 | Dec. 31, 2016 | |
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue | $ 35,489 | $ 34,078 | $ 12,022 | $ 14,841 | $ 4,231 | $ 3,191 | $ 3,979 | $ 22,463 | $ 96,430 | $ 33,864 | $ 0 |
Baxdela | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue | 6,485 | ||||||||||
Vabomere | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue | 7,416 | ||||||||||
Orbactiv | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue | 22,951 | ||||||||||
Minocin For Injection | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue | 9,728 | ||||||||||
Product sales, net | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Revenue | $ 46,580 | $ 0 | $ 0 |
Summary of Significant Accoun_9
Summary of Significant Accounting Policies - Summary of Activity with Respect to Sales Allowances and Accruals (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2018 | |
Cash Discounts | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance as of January 1, 2018 | $ 0 | |
Allowances for sales | 1,184 | |
Payments & credits issued | (939) | |
Balance as of December 31, 2018 | 0 | $ 245 |
Product Returns | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance as of January 1, 2018 | 0 | |
Allowances for sales | 3,664 | |
Payments & credits issued | (694) | |
Balance as of December 31, 2018 | 0 | 2,970 |
Chargebacks | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance as of January 1, 2018 | 0 | |
Allowances for sales | 5,792 | |
Payments & credits issued | (5,030) | |
Balance as of December 31, 2018 | 0 | 762 |
Fees-for- Service | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance as of January 1, 2018 | 0 | |
Allowances for sales | 3,240 | |
Payments & credits issued | (2,422) | |
Balance as of December 31, 2018 | 0 | 818 |
MelintAssist | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance as of January 1, 2018 | 0 | |
Allowances for sales | 1,224 | |
Payments & credits issued | (812) | |
Balance as of December 31, 2018 | 0 | 412 |
Government Rebates | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance as of January 1, 2018 | 0 | |
Allowances for sales | 864 | |
Payments & credits issued | (171) | |
Balance as of December 31, 2018 | 0 | 693 |
Commercial Rebates | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance as of January 1, 2018 | 0 | |
Allowances for sales | 1,491 | |
Payments & credits issued | (892) | |
Balance as of December 31, 2018 | 0 | 599 |
Admin Fee | ||
SEC Schedule, 12-09, Movement in Valuation Allowances and Reserves [Roll Forward] | ||
Balance as of January 1, 2018 | 0 | |
Allowances for sales | 476 | |
Payments & credits issued | (338) | |
Balance as of December 31, 2018 | $ 0 | $ 138 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Cash, Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Balance Sheet Related Disclosures [Abstract] | ||||
Cash and cash equivalents | $ 81,808 | $ 128,387 | ||
Restricted cash (included in Other assets) | 200 | 200 | ||
Total cash, cash equivalents and restricted cash shown in the Consolidated Statements of Cash Flows | $ 82,008 | $ 128,587 | $ 11,409 | $ 30,158 |
Financing Arrangements - Schedu
Financing Arrangements - Schedule of Outstanding Debt Balances (Details) - Loan Agreements - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | ||
Principal balance under loan agreements | $ 118,752 | $ 40,000 |
Debt discount and deferred financing costs for loan agreements | (8,276) | (445) |
Total long-term debt, net of current maturities | $ 110,476 | $ 39,555 |
Balance Sheet Components - Su_2
Balance Sheet Components - Summary of Accounts Receivable (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | $ 22,485 | $ 7,564 |
Trade receivables | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 11,509 | 0 |
Contracted services | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | 10,293 | 7,202 |
Other receivables | ||
Accounts, Notes, Loans and Financing Receivable [Line Items] | ||
Total receivables | $ 683 | $ 362 |
Financing Arrangements - 2014 L
Financing Arrangements - 2014 Loan Agreement (Details) - USD ($) $ in Thousands | Jan. 01, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | Dec. 31, 2014 |
Debt Instrument [Line Items] | ||||||
Interest expense | $ 0 | $ 4,016 | $ 1,016 | |||
2014 Loan Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument stated percentage | 8.25% | |||||
Interest expense | $ 0 | $ 1,229 | ||||
2014 Loan Agreement | Prime Rate | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, basis spread on variable rate | 4.50% | |||||
Term Loan | 2014 Loan Agreement | ||||||
Debt Instrument [Line Items] | ||||||
Borrowed amount | $ 10,000 | $ 20,000 |
Balance Sheet Components - Su_3
Balance Sheet Components - Summary of Inventory (Details) - USD ($) | Dec. 31, 2018 | Dec. 31, 2017 |
Balance Sheet Related Disclosures [Abstract] | ||
Raw materials | $ 24,507,000 | $ 5,545,000 |
Work in process | 11,700,000 | 181,000 |
Finished goods | 12,204,000 | 5,099,000 |
Gross value of inventory | 48,411,000 | 10,825,000 |
Less: valuation reserves | (7,070,000) | 0 |
Total inventory | $ 41,341,000 | $ 10,825,000 |
Financing Arrangements - 2017 L
Financing Arrangements - 2017 Loan Agreement (Details) - USD ($) | Jun. 28, 2017 | May 02, 2017 | May 02, 2017 | Aug. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | |||||||
Proceeds from notes payable | $ 111,421,000 | $ 38,844,000 | $ 44,111,000 | ||||
2017 Loan Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument stated percentage | 8.25% | 8.25% | |||||
Debt instrument, outstanding principal amount that requires interest only monthly payments | $ 40,000,000 | ||||||
Debt instrument, interest payment period | 18 months | ||||||
2017 Loan Agreement | Minimum | |||||||
Debt Instrument [Line Items] | |||||||
Long-term loan, effective interest rate | 8.25% | 8.25% | |||||
2017 Loan Agreement | Prime Rate | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, basis spread on variable rate | 4.50% | ||||||
Tranche One | 2017 Loan Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from notes payable | $ 30,000,000 | ||||||
Tranche Two | 2017 Loan Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Proceeds from notes payable | $ 10,000,000 | ||||||
Debt Financing | 2017 Loan Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, face amount | $ 80,000,000 | $ 80,000,000 | |||||
Equity Financing | 2017 Loan Agreement | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, face amount | $ 10,000,000 | $ 10,000,000 |
Balance Sheet Components - Su_4
Balance Sheet Components - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 11,121 | $ 10,564 |
Less-accumulated depreciation | (9,535) | (8,968) |
Property and equipment, net | 1,586 | 1,596 |
Laboratory equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 3,387 | 3,339 |
Manufacturing equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 178 | 65 |
Office equipment | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 1,062 | 604 |
Purchased software | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 860 | 860 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 390 | 390 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | 4,943 | 4,869 |
Assets in development | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $ 301 | $ 437 |
Financing Arrangements - Deerfi
Financing Arrangements - Deerfield Facility (Details) | Jan. 05, 2018USD ($)financial_instrument$ / sharesshares | Jan. 05, 2018USD ($)$ / sharesshares | Jan. 31, 2019USD ($) | Dec. 31, 2018USD ($)$ / sharesshares | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($)shares | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($) | Jan. 14, 2019 | May 02, 2017 |
Debt Instrument [Line Items] | ||||||||||||||||
Revenue | $ 35,489,000 | $ 34,078,000 | $ 12,022,000 | $ 14,841,000 | $ 4,231,000 | $ 3,191,000 | $ 3,979,000 | $ 22,463,000 | $ 96,430,000 | $ 33,864,000 | $ 0 | |||||
Common stock, shares issued (in shares) | shares | 11,204,050 | 11,204,050 | 11,204,050 | 11,204,050 | ||||||||||||
Proceeds from issuance of common stock | $ 51,452,000 | $ 0 | 0 | |||||||||||||
Payment of outstanding principal | 40,000,000 | 24,503,000 | 5,498,000 | |||||||||||||
Loss on extinguishment of debt | 2,595,000 | 607,000 | 0 | |||||||||||||
Prepayment penalties and exit fees related to debt instrument | $ 2,150,000 | $ 2,150,000 | $ 1,240,000 | $ 0 | ||||||||||||
Warrants assumed to purchase of common stock (in shares) | shares | 766,689 | 766,689 | ||||||||||||||
Financial liabilities fair value disclosure | $ 190,000,000 | $ 190,000,000 | $ 5,752,000 | $ 5,752,000 | ||||||||||||
Number of financial instruments | financial_instrument | 5 | |||||||||||||||
2017 Loan Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument stated percentage | 8.25% | |||||||||||||||
Term Loan | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Financial liabilities fair value disclosure | $ 111,421,000 | $ 111,421,000 | ||||||||||||||
Term Loan | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument, face amount | $ 147,774,000 | $ 147,774,000 | ||||||||||||||
Debt instrument stated percentage | 21.40% | 21.40% | ||||||||||||||
Debt instrument exit fee percentage | 2.00% | 2.00% | ||||||||||||||
Disbursement Option | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument stated percentage | 14.75% | 14.75% | ||||||||||||||
Financial liabilities fair value disclosure | $ 7,608,000 | $ 7,608,000 | ||||||||||||||
U S Sales Of Vabomere | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Revenue | 74,178,000 | |||||||||||||||
U S Sales Of Vabomere | Maximum | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Revenue | 500,000,000 | |||||||||||||||
U S Sales Of Vabomere | Minimum | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Revenue | $ 75,000,000 | |||||||||||||||
Revolving Credit Facility | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Line credit maximum borrowing capacity | 20,000,000 | 20,000,000 | ||||||||||||||
Common Stock | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Financial liabilities fair value disclosure | $ 51,452,000 | 51,452,000 | ||||||||||||||
Subsequent Event | Term Loan | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument exit fee percentage | 2.00% | |||||||||||||||
Deerfield | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument, disbursement | $ 50,000,000 | |||||||||||||||
Deerfield | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Common stock, shares issued (in shares) | shares | 625,569 | 625,569 | ||||||||||||||
Issued price per share (in usd per share) | $ / shares | $ 67.5 | $ 67.5 | ||||||||||||||
Proceeds from issuance of common stock | $ 42,226,000 | |||||||||||||||
Debt conversion, shares issued (in shares) | shares | 625,569 | |||||||||||||||
Warrants assumed to purchase of common stock (in shares) | shares | 758,573 | 758,573 | ||||||||||||||
Exercise price of warrant (in usd per share) | $ / shares | $ 82.50 | $ 82.50 | ||||||||||||||
Deerfield | 2017 Loan Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Payment of outstanding principal | $ 40,000,000 | |||||||||||||||
Loss on extinguishment of debt | 2,595,000 | |||||||||||||||
Unarmortized debt issuance costs | (445,000) | $ (445,000) | ||||||||||||||
Deerfield | Term Loan | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument, face amount | $ 147,774,000 | $ 147,774,000 | ||||||||||||||
Debt instrument stated percentage | 11.75% | 11.75% | ||||||||||||||
Debt instrument exit fee percentage | 2.00% | 2.00% | ||||||||||||||
Deerfield | Disbursement Option | Term Loan | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument stated percentage | 14.75% | 14.75% | ||||||||||||||
Deerfield | IDB | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Percentage of enhancement fee on principal amount | 2.00% | |||||||||||||||
Deerfield | IDB | Disbursement Option | Facility Agreement | Maximum | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument, disbursement | $ 50,000,000 | |||||||||||||||
Deerfield | U S Sales Of Vabomere | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Rights to royalty payments sales of period | 7 years | |||||||||||||||
Deerfield | U S Sales Of Vabomere | Facility Agreement | Maximum | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Rights to royalty payments percentage | 3.00% | 3.00% | ||||||||||||||
Deerfield | U S Sales Of Vabomere | Facility Agreement | Minimum | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Rights to royalty payments percentage | 2.00% | 2.00% | ||||||||||||||
Deerfield | Common Stock | Term Loan | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Proceeds from long-term lines of credit | $ 190,000,000 | |||||||||||||||
Deerfield | Subsequent Event | Term Loan | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt covenant, minimum revenue requirement | $ 63,750,000 | |||||||||||||||
Debt Covenant, Period One | Deerfield | Subsequent Event | Term Loan | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument covenant, minimum cash balance requirement | 40,000,000 | |||||||||||||||
Debt Covenant, Period Two | Deerfield | Subsequent Event | Term Loan | Facility Agreement | ||||||||||||||||
Debt Instrument [Line Items] | ||||||||||||||||
Debt instrument covenant, minimum cash balance requirement | $ 25,000,000 |
Balance Sheet Components - Narr
Balance Sheet Components - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Balance Sheet Components [Line Items] | |||
Depreciation and amortization | $ 16,901 | $ 451 | $ 497 |
Property and Equipment | |||
Balance Sheet Components [Line Items] | |||
Depreciation and amortization | $ 570 | $ 451 |
Financing Arrangements - Relati
Financing Arrangements - Relative Fair Values of Financial Instruments as of Agreement Date (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 05, 2018 |
Debt Instrument [Line Items] | ||
Financial liabilities fair value disclosure | $ 5,752 | $ 190,000 |
Disbursement Option | ||
Debt Instrument [Line Items] | ||
Financial liabilities fair value disclosure | 7,608 | |
Royalty Agreement | ||
Debt Instrument [Line Items] | ||
Financial liabilities fair value disclosure | 1,472 | |
Warrants | ||
Debt Instrument [Line Items] | ||
Financial liabilities fair value disclosure | 33,263 | |
Common Stock Consideration | ||
Debt Instrument [Line Items] | ||
Financial liabilities fair value disclosure | 51,452 | |
Term Loan | ||
Debt Instrument [Line Items] | ||
Financial liabilities fair value disclosure | $ 111,421 |
Balance Sheet Components - Su_5
Balance Sheet Components - Summary of Other Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Balance Sheet Related Disclosures [Abstract] | ||
Deerfield disbursement option (see Note 4) | $ 7,608 | $ 0 |
Long-term inventory deposits | 51,127 | 0 |
Other assets | 2,391 | 1,213 |
Restricted cash (included in Other assets) | 200 | 200 |
Total other assets | $ 61,326 | $ 1,413 |
Financing Arrangements - Term L
Financing Arrangements - Term Loan (Details) - USD ($) | 9 Months Ended | 12 Months Ended | |||
Sep. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 05, 2018 | |
Debt Instrument [Line Items] | |||||
Notes payable, noncurrent | $ 110,476,000 | $ 39,555,000 | |||
Total future cash payments | $ 150,730,000 | ||||
Interest expense | 0 | 4,016,000 | $ 1,016,000 | ||
Term Loan | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Long-term debt, fair value | $ 111,421,000 | ||||
Upfront term loan fees and legal debt issuance costs | 6,455,000 | ||||
Debt instrument exit fee percentage | 2.00% | ||||
Debt instrument exit fee | 2,956,000 | ||||
Total future cash payments | 150,730,000 | ||||
Debt instrument, face amount | $ 147,774,000 | ||||
Debt instrument stated percentage | 21.40% | ||||
Interest expense | $ 0 | 17,460,000 | |||
Accretion expense | $ 0 | $ 5,510,000 | |||
Term Loan | Facility Agreement | Deerfield | |||||
Debt Instrument [Line Items] | |||||
Debt instrument exit fee percentage | 2.00% | ||||
Debt instrument, face amount | $ 147,774,000 | ||||
Debt instrument stated percentage | 11.75% | ||||
Measurement Input, Discount Rate | Term Loan | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Fair value assumptions | 0.198 |
Balance Sheet Components - Su_6
Balance Sheet Components - Summary of Accrued Expenses (Details) $ in Thousands | Dec. 31, 2018USD ($)product | Dec. 31, 2017USD ($) |
Balance Sheet Related Disclosures [Abstract] | ||
Accrued contracted services | $ 2,909 | $ 5,596 |
Payroll-related expenses | 15,585 | 9,885 |
Professional fees | 3,598 | 3,621 |
Accrued royalty payments | 2,052 | 2,040 |
Accrued sales allowances | 5,630 | 0 |
Accrued other | 4,150 | 2,899 |
Total accrued expenses | $ 33,924 | $ 24,041 |
Number of products | product | 4 |
Financing Arrangements - Sche_2
Financing Arrangements - Schedule of Accretion of Principal Term Loan and Future Payments (Details) - USD ($) $ in Thousands | 9 Months Ended | 12 Months Ended |
Sep. 30, 2018 | Dec. 31, 2018 | |
Accretion and Future Payments of Term Loan [Roll Forward] | ||
Beginning Balance | $ 39,555 | $ 39,555 |
Accretion of Interest Expense | 45,764 | |
Principal Payments and Exit Fee | (150,730) | |
Ending Balance | 110,476 | |
January 5 - December 31, 2018 | ||
Accretion and Future Payments of Term Loan [Roll Forward] | ||
Accretion of Interest Expense | 5,510 | |
Principal Payments and Exit Fee | 0 | |
Ending Balance | 110,476 | |
Year Ending December 31, 2019 | ||
Accretion and Future Payments of Term Loan [Roll Forward] | ||
Beginning Balance | 110,476 | 110,476 |
Accretion of Interest Expense | 7,135 | |
Principal Payments and Exit Fee | 0 | |
Ending Balance | 117,611 | |
Year Ending December 31, 2020 | ||
Accretion and Future Payments of Term Loan [Roll Forward] | ||
Beginning Balance | 117,611 | 117,611 |
Accretion of Interest Expense | 8,638 | |
Principal Payments and Exit Fee | 0 | |
Ending Balance | 126,249 | |
Year Ending December 31, 2021 | ||
Accretion and Future Payments of Term Loan [Roll Forward] | ||
Beginning Balance | 126,249 | 126,249 |
Accretion of Interest Expense | 10,799 | |
Principal Payments and Exit Fee | 0 | |
Ending Balance | 137,048 | |
Year Ending December 31, 2022 | ||
Accretion and Future Payments of Term Loan [Roll Forward] | ||
Beginning Balance | 137,048 | 137,048 |
Accretion of Interest Expense | 9,827 | |
Principal Payments and Exit Fee | 69,084 | |
Ending Balance | 77,791 | |
Year Ending December 31, 2023 | ||
Accretion and Future Payments of Term Loan [Roll Forward] | ||
Beginning Balance | 77,791 | 77,791 |
Accretion of Interest Expense | 3,846 | |
Principal Payments and Exit Fee | 75,365 | |
Ending Balance | 6,272 | |
Year Ending December 31, 2024 | ||
Accretion and Future Payments of Term Loan [Roll Forward] | ||
Beginning Balance | $ 6,272 | 6,272 |
Accretion of Interest Expense | 9 | |
Principal Payments and Exit Fee | 6,281 | |
Ending Balance | $ 0 |
Financing Arrangements - Warran
Financing Arrangements - Warrants (Details) $ / shares in Units, $ in Thousands | Jan. 05, 2018$ / sharesshares | Jan. 05, 2018USD ($)$ / sharesshares | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Debt Instrument [Line Items] | |||||
Change in fair value of warrant liability | $ 33,263 | $ (33,226) | $ (335) | $ (781) | |
Fair value of warrants | 38 | ||||
Gain on fair value of warrants and conversion option | $ 33,226 | ||||
Warrants | |||||
Debt Instrument [Line Items] | |||||
Warrants issued to purchase convertible preferred stock (in shares) | shares | 758,573 | 758,573 | |||
Exercise price of warrant (in usd per share) | $ / shares | $ 82.5 | $ 82.5 | |||
Warrants expiration term (in years) | 7 years | ||||
Expected LIfe | Common Stock | |||||
Debt Instrument [Line Items] | |||||
Fair value assumptions, expected term (in years) | 7 years | 7 years | 6 years | ||
Risk Free Interest Rate | Common Stock | |||||
Debt Instrument [Line Items] | |||||
Fair value assumptions | 0.024 | 0.024 | 0.0255 | ||
Option Volatility | Common Stock | |||||
Debt Instrument [Line Items] | |||||
Fair value assumptions | 0.500 | 0.500 | 0.500 |
Financing Arrangements - Royalt
Financing Arrangements - Royalty Agreement (Details) - USD ($) | Jan. 05, 2018 | 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 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||||||||||||
Revenue | $ 35,489,000 | $ 34,078,000 | $ 12,022,000 | $ 14,841,000 | $ 4,231,000 | $ 3,191,000 | $ 3,979,000 | $ 22,463,000 | $ 96,430,000 | $ 33,864,000 | $ 0 | |
Interest expense | 43,179,000 | 3,608,000 | 3,390,000 | |||||||||
Royalty Agreement | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Percentage of royalty payments | 3.00% | |||||||||||
Estimated fair value of royalty liability | 1,472,000 | |||||||||||
Effective interest rate on royalty liability | 42.90% | |||||||||||
Interest expense | $ 758,000 | |||||||||||
Facility Agreement And Other Loan | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Percentage of royalty payments | 2.00% | |||||||||||
Product sales, net | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Revenue | 46,580,000 | $ 0 | $ 0 | |||||||||
Product sales, net | Disbursement Option | Minimum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Revenue | $ 75,000,000 | |||||||||||
U S Sales Of Vabomere | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Revenue | 74,178,000 | |||||||||||
U S Sales Of Vabomere | Minimum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Revenue | $ 75,000,000 | |||||||||||
U S Sales Of Vabomere | Maximum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Revenue | $ 500,000,000 | |||||||||||
U S Sales Of Vabomere | Royalty Agreement | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Royalty agreement, annual sales term | 7 years |
Financing Arrangements - Disbur
Financing Arrangements - Disbursement Option (Details) - USD ($) | Jan. 05, 2018 | 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 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||||||||||||
Revenue | $ 35,489,000 | $ 34,078,000 | $ 12,022,000 | $ 14,841,000 | $ 4,231,000 | $ 3,191,000 | $ 3,979,000 | $ 22,463,000 | $ 96,430,000 | $ 33,864,000 | $ 0 | |
Total assets at fair value | $ 32,883,000 | $ 76,777,000 | $ 32,883,000 | 76,777,000 | ||||||||
Deerfield | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument, disbursement | $ 50,000,000 | |||||||||||
Term Loan | Facility Agreement | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument stated percentage | 21.40% | 21.40% | ||||||||||
Term Loan | Facility Agreement | Deerfield | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument stated percentage | 11.75% | |||||||||||
Product sales, net | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Revenue | $ 46,580,000 | $ 0 | $ 0 | |||||||||
Product sales, net | IDB | Facility Agreement | Minimum | Deerfield | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Revenue | $ 75,000,000 | |||||||||||
Disbursement Option | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument stated percentage | 14.75% | |||||||||||
Total assets at fair value | $ 7,608,000 | |||||||||||
Disbursement Option | Term Loan | Facility Agreement | Deerfield | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Debt instrument stated percentage | 14.75% | |||||||||||
Disbursement Option | Product sales, net | Minimum | ||||||||||||
Debt Instrument [Line Items] | ||||||||||||
Revenue | $ 75,000,000 |
Financing Arrangements - Common
Financing Arrangements - Common Stock Consideration (Details) - USD ($) $ / shares in Units, $ in Thousands | Dec. 31, 2018 | Jan. 05, 2018 | Dec. 31, 2017 |
Debt Instrument [Line Items] | |||
Common stock, shares issued (in shares) | 11,204,050 | 11,204,050 | |
Deerfield | Facility Agreement | |||
Debt Instrument [Line Items] | |||
Common stock, shares issued (in shares) | 625,569 | ||
Issued price per share (in usd per share) | $ 67.5 | ||
Securities Purchase Agreement | Deerfield | |||
Debt Instrument [Line Items] | |||
Common stock, shares issued (in shares) | 625,569 | ||
Additional Paid-in Capital | Securities Purchase Agreement | Deerfield | |||
Debt Instrument [Line Items] | |||
Closing price of common stock shares (in usd per share) | $ 82.25 | ||
Fair value of common stock consideration | $ 51,452 |
Financing Arrangements - Deer_2
Financing Arrangements - Deerfield Facility Amendment (Details) - USD ($) | Jan. 14, 2019 | Feb. 28, 2019 | Jan. 31, 2019 | Dec. 31, 2018 | Jan. 05, 2018 |
Term Loan | Facility Agreement Amendment | |||||
Debt Instrument [Line Items] | |||||
Debt instrument exit fee percentage | 4.00% | ||||
Term Loan | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument exit fee percentage | 2.00% | ||||
Debt instrument, face amount | $ 147,774,000 | ||||
Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | Minimum | |||||
Debt Instrument [Line Items] | |||||
Debt instrument exit fee percentage | 1.00% | ||||
Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | Maximum | |||||
Debt Instrument [Line Items] | |||||
Debt instrument exit fee percentage | 3.00% | ||||
Subsequent Event | Term Loan | Facility Agreement Amendment | |||||
Debt Instrument [Line Items] | |||||
Debt instrument exit fee percentage | 4.00% | ||||
Subsequent Event | Term Loan | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument exit fee percentage | 2.00% | ||||
Subsequent Event | Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | |||||
Debt Instrument [Line Items] | |||||
Proceeds from issuance of debt | $ 75,000,000 | ||||
Deerfield | Subsequent Event | Facility Agreement Amendment | |||||
Debt Instrument [Line Items] | |||||
Debt covenant, percentage reduction in net product sales | 15.00% | ||||
Deerfield | Subsequent Event | Facility Agreement | Maximum | |||||
Debt Instrument [Line Items] | |||||
Ownership cap, percentage | 9.985% | ||||
Deerfield | Subsequent Event | Convertible Subordinated Debt | |||||
Debt Instrument [Line Items] | |||||
Common stock, issued and outstanding, percentage | 15.00% | ||||
Vatera | Convertible Subordinated Debt | |||||
Debt Instrument [Line Items] | |||||
Conversion price (in usd per share) | $ 160,000 | ||||
Deerfield | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Conversion price (in usd per share) | $ 67.5 | ||||
Deerfield | Term Loan | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument exit fee percentage | 2.00% | ||||
Debt instrument, face amount | $ 147,774,000 | ||||
Deerfield | Subsequent Event | Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | $ 5,000,000 | ||||
Deerfield | Subsequent Event | Convertible Subordinated Debt | Deerfield Convertible Loan | |||||
Debt Instrument [Line Items] | |||||
Debt instrument, face amount | $ 74,000,000 | ||||
Ownership cap, percentage | 4.985% | ||||
Conversion price (in usd per share) | $ 5.15 | ||||
Deerfield | Debt Covenant, Period One | Subsequent Event | Term Loan | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument covenant, minimum cash balance requirement | $ 40,000,000 | ||||
Deerfield | Debt Covenant, Period Two | Subsequent Event | Term Loan | Facility Agreement | |||||
Debt Instrument [Line Items] | |||||
Debt instrument covenant, minimum cash balance requirement | $ 25,000,000 |
Financing Arrangements - Vatera
Financing Arrangements - Vatera Facility Amendment (Details) | Jul. 10, 2019USD ($) | Feb. 28, 2019USD ($) | Jun. 30, 2019USD ($) | Jul. 31, 2019USD ($) | Dec. 31, 2018USD ($)$ / shares | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 14, 2019USD ($)$ / shares |
Debt Instrument [Line Items] | ||||||||
Proceeds from the issuance of convertible promissory notes | $ 0 | $ 24,526,000 | $ 0 | |||||
Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Line credit maximum borrowing capacity | $ 135,000,000 | |||||||
Debt instrument stated percentage | 5.00% | |||||||
Interest paid in cash, percentage | 50.00% | |||||||
Interest paid in kind, percentage | 50.00% | |||||||
Debt Instrument, Convertible, Conversion Ratio | 100 | |||||||
Loan conversion rate | 0.00125 | |||||||
Vatera | Convertible Subordinated Debt | ||||||||
Debt Instrument [Line Items] | ||||||||
Conversion price (in usd per share) | $ / shares | $ 160,000 | |||||||
Subsequent Event | Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Proceeds from issuance of debt | $ 75,000,000 | |||||||
Scenario, Forecast | Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Proceeds from issuance of debt | $ 60,000,000 | |||||||
Maximum | Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument exit fee percentage | 3.00% | |||||||
Maximum | Scenario, Forecast | ||||||||
Debt Instrument [Line Items] | ||||||||
Proceeds from the issuance of convertible promissory notes | $ 35,000,000 | $ 25,000,000 | ||||||
Minimum | Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument exit fee percentage | 1.00% | |||||||
Deerfield | Subsequent Event | Convertible Subordinated Debt | Senior Subordinated Convertible Loan Agreement | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | $ 5,000,000 | |||||||
Deerfield | Subsequent Event | Convertible Subordinated Debt | Deerfield Convertible Loan | ||||||||
Debt Instrument [Line Items] | ||||||||
Debt instrument, face amount | $ 74,000,000 | |||||||
Conversion price (in usd per share) | $ / shares | $ 5.15 |
License Agreements - Narrative
License Agreements - Narrative (Details) $ / shares in Units, € in Thousands, $ in Thousands | Jan. 01, 2018USD ($) | Jan. 06, 2015USD ($) | Jan. 31, 2019EUR (€) | Nov. 30, 2018EUR (€) | Oct. 31, 2018USD ($) | Oct. 31, 2018EUR (€) | Aug. 31, 2017USD ($) | Feb. 28, 2017USD ($) | Feb. 28, 2017EUR (€) | Jan. 31, 2015USD ($) | Dec. 31, 2018USD ($)shares | Dec. 31, 2018EUR (€) | Sep. 30, 2018USD ($)country | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2017USD ($)shares | Sep. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2017USD ($) | Dec. 31, 2018USD ($)shares | Dec. 31, 2017USD ($)shares | Dec. 31, 2016USD ($) | Dec. 31, 2014$ / sharesshares |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Preferred stock, shares issued (in shares) | shares | 0 | 0 | 0 | 0 | |||||||||||||||||||
Additional due under the distribution agreement | $ 2,000 | ||||||||||||||||||||||
Deferred revenue | $ 0 | $ 9,008 | $ 0 | $ 10,008 | 0 | $ 10,008 | |||||||||||||||||
License fee revenue | $ 35,489 | $ 34,078 | $ 12,022 | $ 14,841 | 4,231 | $ 3,191 | $ 3,979 | $ 22,463 | 96,430 | 33,864 | $ 0 | ||||||||||||
Eurofarma Laboratorios S.A. | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Proceeds from distribution agreement | 1,000 | ||||||||||||||||||||||
Deferred revenue | $ 9,008 | 9,008 | |||||||||||||||||||||
Eurofarma Amendment | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Deferred revenue | $ 1,000 | ||||||||||||||||||||||
Amendment to extend licensed territory for consideration | $ 1,000 | ||||||||||||||||||||||
Wakunaga Pharmaceutical Co., Ltd | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Payment of contractual obligations | 1,590 | ||||||||||||||||||||||
Minimum | Baxdela | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Deferred revenue expected recognized period | 10 years | ||||||||||||||||||||||
Menarini Agreement | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Reimbursement receivable in percentage for costs incurred | 50.00% | 50.00% | |||||||||||||||||||||
Menarini Agreement | Development Services | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Revenues | 11,325 | ||||||||||||||||||||||
Menarini Agreement | Cash Payments | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Revenues | 7,316 | ||||||||||||||||||||||
Menarini Agreement | Receivables | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Revenues | 4,009 | ||||||||||||||||||||||
Menarini Agreement | Maximum | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Milestone payment recognized as revenue | € | € 90,000 | ||||||||||||||||||||||
Series 3-B Convertible Preferred Stock Purchase Agreement | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Convertible Preferred stock with a fair value | $ 6,000 | ||||||||||||||||||||||
License | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
License fee revenue | $ 19,905 | 38,173 | $ 19,905 | $ 0 | |||||||||||||||||||
License | Eurofarma Laboratorios S.A. | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
License fee revenue | $ 500 | ||||||||||||||||||||||
License | Wakunaga Pharmaceutical Co., Ltd | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
License fee paid | $ 1,200 | ||||||||||||||||||||||
License | Menarini | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
License fee revenue | € | € 17,000 | ||||||||||||||||||||||
Number of countries exclusive right for Menarini to market Vabomere, Orbactive and Minocin | country | 68 | ||||||||||||||||||||||
License | Menarini Agreement | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
License fee revenue | $ 19,905 | ||||||||||||||||||||||
Vabomere | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
License fee revenue | $ 7,416 | ||||||||||||||||||||||
Adoption of Topic 606 | Adjustments Due to Topic 606 | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Deferred revenue | $ (10,008) | ||||||||||||||||||||||
Europe | Vabomere | Menarini | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
License fee revenue | € | € 15,000 | € 15,000 | |||||||||||||||||||||
Europe | Subsequent Event | Vabomere | Menarini | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
License fee revenue | € | € 15,000 | ||||||||||||||||||||||
Preferred Stock | Series 3-B Convertible Preferred Stock Purchase Agreement | Eurofarma Laboratorios S.A. | |||||||||||||||||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||||||||||||||||
Preferred stock, shares issued (in shares) | shares | 1,052,474 | ||||||||||||||||||||||
Preferred stock purchase price (in usd per share) | $ / shares | $ 13.301985 | ||||||||||||||||||||||
Proceeds from stock sale | $ 14,000 |
Fair Value Measurements - Sched
Fair Value Measurements - Schedule of Assets and Liabilities Measured at Fair Value (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Jan. 05, 2018 | Dec. 31, 2017 |
Assets: | |||
Total assets at fair value | $ 32,883 | $ 76,777 | |
Liabilities: | |||
Total liabilities at fair value | (5,752) | $ (190,000) | |
Current royalty contingent consideration from IDB acquisition | |||
Liabilities: | |||
Total liabilities at fair value | (1,006) | ||
Long-term royalty contingent consideration from IDB acquisition | |||
Liabilities: | |||
Total liabilities at fair value | (4,708) | ||
Warrant liability | |||
Liabilities: | |||
Total liabilities at fair value | (38) | ||
Money market fund | |||
Assets: | |||
Total assets at fair value | 32,883 | 76,777 | |
Level 1 | |||
Assets: | |||
Total assets at fair value | 32,883 | 76,777 | |
Liabilities: | |||
Total liabilities at fair value | 0 | ||
Level 1 | Current royalty contingent consideration from IDB acquisition | |||
Liabilities: | |||
Total liabilities at fair value | 0 | ||
Level 1 | Long-term royalty contingent consideration from IDB acquisition | |||
Liabilities: | |||
Total liabilities at fair value | 0 | ||
Level 1 | Warrant liability | |||
Liabilities: | |||
Total liabilities at fair value | 0 | ||
Level 1 | Money market fund | |||
Assets: | |||
Total assets at fair value | 32,883 | 76,777 | |
Level 2 | |||
Assets: | |||
Total assets at fair value | 0 | 0 | |
Liabilities: | |||
Total liabilities at fair value | 0 | ||
Level 2 | Current royalty contingent consideration from IDB acquisition | |||
Liabilities: | |||
Total liabilities at fair value | 0 | ||
Level 2 | Long-term royalty contingent consideration from IDB acquisition | |||
Liabilities: | |||
Total liabilities at fair value | 0 | ||
Level 2 | Warrant liability | |||
Liabilities: | |||
Total liabilities at fair value | 0 | ||
Level 2 | Money market fund | |||
Assets: | |||
Total assets at fair value | 0 | 0 | |
Level 3 | |||
Assets: | |||
Total assets at fair value | 0 | 0 | |
Liabilities: | |||
Total liabilities at fair value | (5,752) | ||
Level 3 | Current royalty contingent consideration from IDB acquisition | |||
Liabilities: | |||
Total liabilities at fair value | (1,006) | ||
Level 3 | Long-term royalty contingent consideration from IDB acquisition | |||
Liabilities: | |||
Total liabilities at fair value | (4,708) | ||
Level 3 | Warrant liability | |||
Liabilities: | |||
Total liabilities at fair value | (38) | ||
Level 3 | Money market fund | |||
Assets: | |||
Total assets at fair value | $ 0 | $ 0 |
Fair Value Measurements - Summa
Fair Value Measurements - Summary of Changes in Fair Value of Level 3 Liabilities (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | $ 0 | $ (674) |
Accretion Recorded in interest Expense | (10,559) | 0 |
Change in Unrealized Gains (Losses) | 42,042 | 335 |
(Issuances) Settlements, Net | (67,235) | |
Reclassification to APIC | 339 | |
Net Transfer (In) Out of Level 3 | 30,000 | 0 |
Ending balance | (5,752) | 0 |
Current royalty contingent consideration from IDB acquisition | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | |
Accretion Recorded in interest Expense | (1,055) | |
Change in Unrealized Gains (Losses) | (1,151) | |
(Issuances) Settlements, Net | 1,200 | |
Net Transfer (In) Out of Level 3 | 0 | |
Ending balance | (1,006) | 0 |
Long-term royalty contingent consideration from IDB acquisition | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | |
Accretion Recorded in interest Expense | (5,489) | |
Change in Unrealized Gains (Losses) | 11,468 | |
(Issuances) Settlements, Net | (10,687) | |
Net Transfer (In) Out of Level 3 | 0 | |
Ending balance | (4,708) | 0 |
Contingent milestone payment | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | |
Accretion Recorded in interest Expense | (4,015) | |
Change in Unrealized Gains (Losses) | (1,500) | |
(Issuances) Settlements, Net | (24,485) | |
Net Transfer (In) Out of Level 3 | 30,000 | |
Ending balance | 0 | 0 |
Warrant liability | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | 0 | |
Accretion Recorded in interest Expense | 0 | |
Change in Unrealized Gains (Losses) | 33,225 | |
(Issuances) Settlements, Net | (33,263) | |
Net Transfer (In) Out of Level 3 | 0 | |
Ending balance | (38) | 0 |
Preferred stock warrants | ||
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward] | ||
Beginning balance | $ 0 | (674) |
Accretion Recorded in interest Expense | 0 | |
Change in Unrealized Gains (Losses) | 335 | |
Reclassification to APIC | 339 | |
Net Transfer (In) Out of Level 3 | 0 | |
Ending balance | $ 0 |
Shareholders' Equity - Narrativ
Shareholders' Equity - Narrative (Details) $ / shares in Units, $ in Thousands | Feb. 22, 2019 | Feb. 22, 2018 | Jan. 05, 2018USD ($)shares | Jan. 05, 2018USD ($)shares | May 31, 2018USD ($)shares | Dec. 31, 2018USD ($)Vote$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($) |
Class of Stock [Line Items] | ||||||||
Common stock, shares authorized (in shares) | 80,000,000 | 80,000,000 | ||||||
Common stock, par value (in usd per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||
Preferred stock, shares authorized (in shares) | 5,000,000 | 0 | ||||||
Preferred stock, par value (in usd per share) | $ / shares | $ 0.001 | $ 0.001 | ||||||
Number of vote per each share of common stock | Vote | 1 | |||||||
Reverse stock split, conversion ratio for awards | 0.2 | |||||||
Dividends, common stock | $ | $ 0 | |||||||
Common stock, shares issued (in shares) | 11,204,050 | 11,204,050 | ||||||
Warrants assumed to purchase of common stock (in shares) | 766,689 | |||||||
Proceeds from issuance of common stock, net, to lender | $ | $ 51,452 | $ 0 | $ 0 | |||||
IDB | ||||||||
Class of Stock [Line Items] | ||||||||
Business combination, issuance of common of shares (in shares) | 662,740 | 662,740 | ||||||
Deerfield | Facility Agreement | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock, shares issued (in shares) | 625,569 | 625,569 | ||||||
Warrants assumed to purchase of common stock (in shares) | 758,573 | 758,573 | ||||||
Equity Financing | IDB | ||||||||
Class of Stock [Line Items] | ||||||||
Debt instrument, face amount | $ | $ 40,000 | $ 40,000 | ||||||
Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Business combination, issuance of common of shares (in shares) | 1,865,301 | 2,100,494 | ||||||
Common stock issued during period (in shares) | 4,928,000 | |||||||
Common Stock | Equity Financing | IDB | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock issued during period (in shares) | 576,992 | |||||||
Follow On Public Offer | IDB | ||||||||
Class of Stock [Line Items] | ||||||||
Proceeds from issuance of common stock, net, to lender | $ | $ 115,273 | |||||||
Follow On Public Offer | Common Stock | IDB | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock issued during period (in shares) | 4,928,000 | |||||||
Restricted Stock Units | Common Stock | ||||||||
Class of Stock [Line Items] | ||||||||
Common stock issued during period (in shares) | 10,920 | |||||||
Subsequent Event | ||||||||
Class of Stock [Line Items] | ||||||||
Reverse stock split, conversion ratio for awards | 0.2 |
Shareholders' Equity - Warrants
Shareholders' Equity - Warrants (Details) | Dec. 31, 2018$ / sharesshares |
Class of Warrant or Right [Line Items] | |
Warrants outstanding (in shares) | 766,689 |
February 2012 | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding (in shares) | 8 |
Exercise price of warrant (in usd per share) | $ / shares | $ 86,670.35 |
December 2014 | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding (in shares) | 6,757 |
Exercise price of warrant (in usd per share) | $ / shares | $ 166.5 |
December 2015 | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding (in shares) | 1,351 |
Exercise price of warrant (in usd per share) | $ / shares | $ 166.5 |
January 2018 | |
Class of Warrant or Right [Line Items] | |
Warrants outstanding (in shares) | 758,573 |
Exercise price of warrant (in usd per share) | $ / shares | $ 82.5 |
Stock-Based Compensation - 2006
Stock-Based Compensation - 2006 Stock Plan (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Nov. 03, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options for shares issued and outstanding (in shares) | 696,890 | ||
2006 Stock Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Options for shares issued and outstanding (in shares) | 2,344 | 13,672 | 13,672 |
Number of options forfeited (in shares) | 11,328 | ||
Stock options, granted (in shares) | 0 |
Stock-Based Compensation - 2011
Stock-Based Compensation - 2011 Equity Incentive Plan (Details) - 2011 Equity Incentive Plan - $ / shares | Jun. 12, 2018 | Jan. 01, 2018 | Apr. 30, 2018 | Dec. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Authorized shares, increase (in shares) | 175,991 | |||
Maximum number of shares authorized for future issuances (in shares) | 523,889 | |||
Number of options, granted (in shares) | 0 | 321,193 | ||
Exercise price (in usd per share) | $ 37.25 | |||
Weighted average fair value of options granted (in usd per share) | $ 27.05 | |||
Shares outstanding (in shares) | 304,883 | |||
Options shares available (in shares) | 0 |
Stock-Based Compensation - Priv
Stock-Based Compensation - Private Melinta 2011 Equity Incentive Plan (Details) - Private Melinta 2011 Equity Incentive Plan - shares | Nov. 03, 2017 | Dec. 31, 2018 | Nov. 02, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of stock option to purchase shares of common stock (in shares) | 146,499 | ||
Options shares available (in shares) | 732,499 | 146,499 | |
Common share options avaliable for issuance, before conversion (in shares) | 97,706 |
Stock-Based Compensation - 2018
Stock-Based Compensation - 2018 Stock Incentive Plan (Details) | Feb. 22, 2019 | Jun. 12, 2018shares | Apr. 20, 2018$ / sharesshares | Feb. 22, 2018 | Oct. 31, 2018$ / sharesshares | Apr. 30, 2018$ / sharesshares | Dec. 31, 2018$ / sharesshares | Dec. 31, 2018$ / sharesshares | Dec. 31, 2017$ / sharesshares | Dec. 31, 2016$ / shares | Feb. 21, 2019shares | Jan. 01, 2018shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Reverse stock split, conversion ratio for awards | 0.2 | |||||||||||
2018 Stock Incentive Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of options, granted (in shares) | 301,973 | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 32.80 | |||||||||||
Weighted average fair value of options granted (in usd per share) | $ / shares | $ 28.71 | |||||||||||
Maximum number of shares authorized for future issuances (in shares) | 400,000 | |||||||||||
Authorized shares increase (in shares) | 4.00% | |||||||||||
Options shares available (in shares) | 235,323 | 235,323 | ||||||||||
2018 Stock Incentive Plan | Stock Options | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Weighted average fair value of options granted (in usd per share) | $ / shares | $ 0 | $ 0 | ||||||||||
2011 Equity Incentive Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of options, granted (in shares) | 0 | 321,193 | ||||||||||
Exercise price (in usd per share) | $ / shares | $ 37.25 | |||||||||||
Weighted average fair value of options granted (in usd per share) | $ / shares | $ 27.05 | |||||||||||
Maximum number of shares authorized for future issuances (in shares) | 523,889 | |||||||||||
Options shares available (in shares) | 0 | 0 | ||||||||||
Interim Chief Executive Officer | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of options, granted (in shares) | 30,000 | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 14 | |||||||||||
Weighted average fair value of options granted (in usd per share) | $ / shares | $ 4.75 | |||||||||||
Interim Chief Executive Officer | Restricted Stock Units | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of options, granted (in shares) | 10,000 | |||||||||||
Stock Options, Grants, Period One | 2018 Stock Incentive Plan | Stock Options | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of options, granted (in shares) | 173,053 | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 37.25 | |||||||||||
Weighted average fair value of options granted (in usd per share) | $ / shares | $ 27.65 | |||||||||||
Stock Options, Grants, Period Two | 2018 Stock Incentive Plan | Stock Options | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Number of options, granted (in shares) | 128,920 | |||||||||||
Exercise price (in usd per share) | $ / shares | $ 26.80 | |||||||||||
Weighted average fair value of options granted (in usd per share) | $ / shares | $ 18.35 | |||||||||||
Subsequent Event | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Reverse stock split, conversion ratio for awards | 0.2 | |||||||||||
Subsequent Event | CEO | 2018 Stock Incentive Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Maximum number of shares authorized for future issuances (in shares) | 400,000 | |||||||||||
Subsequent Event | Executive Management And All Other Employees | 2018 Stock Incentive Plan | ||||||||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||||||||
Maximum number of shares authorized for future issuances (in shares) | 600,000 |
Stock-Based Compensation - Indu
Stock-Based Compensation - Inducement Grants (Details) - Option Inducement Agreement - $ / shares | Sep. 21, 2018 | Nov. 03, 2017 | Dec. 31, 2018 |
President and Chief Executive Officer | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of options, granted (in shares) | 110,196 | ||
Temporary equity sale price per share (in usd per share) | $ 58.25 | ||
Weighted average fair value of options granted (in usd per share) | $ 41.80 | ||
Stock options, vesting period (in years) | 4 years | ||
Stock vesting percentage | 25.00% | ||
President and Chief Executive Officer | Restricted Stock Units | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of options, granted (in shares) | 36,732 | 9,183 | |
Chief Financial Officer | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Number of options, granted (in shares) | 74,000 | ||
Weighted average fair value of options granted (in usd per share) | $ 16.55 | ||
Stock options, vesting period (in years) | 4 years | ||
Stock vesting percentage | 25.00% | ||
Exercise price (in usd per share) | $ 22.50 | ||
Tranche One | President and Chief Executive Officer | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options, vesting period (in years) | 1 year | ||
Tranche Two | President and Chief Executive Officer | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Stock options, vesting period (in years) | 36 months |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Option Activity (Details) $ / shares in Units, $ in Thousands | Jun. 12, 2018shares | Apr. 20, 2018$ / shares | Nov. 03, 2017USD ($)$ / sharesshares | Nov. 03, 2017$ / sharesshares | Apr. 30, 2018$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2018USD ($)$ / sharesshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares | Dec. 31, 2015$ / sharesshares |
Stock Option Activity, Narrative [Abstract] | ||||||||||
Exercise price percentage of fair market value | 100.00% | |||||||||
Share-based compensation | $ | $ 3,465 | $ 6,450 | $ 2,515 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||||||||||
Number of options, outstanding - ending balance (in shares) | shares | 696,890 | |||||||||
Number of options, exercisable at end of period (in shares) | shares | 149,178 | |||||||||
2006 Stock Plan | ||||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||||||||||
Number of options, outstanding - beginning balance (in shares) | shares | 13,672 | 13,672 | ||||||||
Number of options, forfeited (in shares) | shares | (11,328) | |||||||||
Number of options, outstanding - ending balance (in shares) | shares | 13,672 | 13,672 | 13,672 | 2,344 | 13,672 | |||||
Number of options, exercisable at end of period (in shares) | shares | 2,344 | |||||||||
Number of options, vested and expected to vest at end of period (in shares) | shares | 2,344 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||||||||||
Weighted average exercise price, outstanding - beginning balance | $ 54 | $ 54 | ||||||||
Weighted average exercise price, forfeited (in usd per share) | 54.41 | |||||||||
Weighted average exercise price, outstanding - ending balance | $ 54 | $ 54 | $ 54 | 52.25 | $ 54 | |||||
Weighted average exercise price, exercisable at end of period (in usd per share) | 52.25 | |||||||||
Weighted average exercise price, vested and expected to vest at end of period (in usd per share) | $ 52.25 | |||||||||
Share-based Compensation Arrangement By Share-based Payment Award, Options, Outstanding, Weighted Average Contractual Term [Abstract] | ||||||||||
Weighted average contractual term of outstanding options at end of period (in years) | 1 year 2 months 12 days | 1 year 4 months 24 days | 1 year 1 month 6 days | |||||||
Weighted average contractual term of exercisable options at end of period (in years) | 1 year 4 months 24 days | |||||||||
Weighted average contractual term, vested and expected to vest at end of period (in years) | 1 year 4 months 24 days | |||||||||
Aggregate intrinsic value, outstanding at end of period | $ | $ 342 | $ 0 | $ 342 | |||||||
Aggregate intrinsic value, exercisable at end of period | $ | 0 | |||||||||
Aggregate intrinsic value, vested and expected to vest at end of period | $ | $ 0 | |||||||||
2011 Equity Incentive Plan | ||||||||||
Stock Option Activity, Narrative [Abstract] | ||||||||||
Weighted average fair value of options granted (in usd per share) | $ 27.05 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||||||||||
Number of options, outstanding - beginning balance (in shares) | shares | 149,060 | 144,543 | ||||||||
Number of options, granted (in shares) | shares | 0 | 321,193 | ||||||||
Number of options, exercised (in shares) | shares | (172) | (40) | ||||||||
Number of options, forfeited (in shares) | shares | (1,289) | (78,513) | ||||||||
Number of options, expired (in shares) | shares | (3,056) | (89,660) | ||||||||
Number of options, outstanding - ending balance (in shares) | shares | 149,060 | 149,060 | 144,543 | 297,523 | 144,543 | |||||
Number of options, exercisable at end of period (in shares) | shares | 51,328 | |||||||||
Number of options, vested and expected to vest at end of period (in shares) | shares | 297,521 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||||||||||
Weighted average exercise price, outstanding - beginning balance | $ 300.10 | $ 301.30 | ||||||||
Weighted average exercise price, granted (in usd per share) | $ 37.25 | |||||||||
Weighted average exercise price, exercised (in usd per share) | 78.15 | 78.05 | ||||||||
Weighted average exercise price, forfeited (in usd per share) | 140 | 46.80 | ||||||||
Weighted average exercise price, expired (in usd per share) | 322.05 | 312.85 | ||||||||
Weighted average exercise price, outstanding - ending balance | $ 300.10 | $ 300.10 | $ 301.30 | 79.95 | $ 301.30 | |||||
Weighted average exercise price, exercisable at end of period (in usd per share) | 278.30 | |||||||||
Weighted average exercise price, vested and expected to vest at end of period (in usd per share) | $ 79.95 | |||||||||
Share-based Compensation Arrangement By Share-based Payment Award, Options, Outstanding, Weighted Average Contractual Term [Abstract] | ||||||||||
Weighted average contractual term of outstanding options at end of period (in years) | 6 years 2 months 12 days | 8 years 9 months 18 days | 3 years 10 months 24 days | |||||||
Weighted average contractual term of exercisable options at end of period (in years) | 6 years 2 months 12 days | |||||||||
Weighted average contractual term, vested and expected to vest at end of period (in years) | 8 years 9 months 18 days | |||||||||
Aggregate intrinsic value, outstanding at end of period | $ | $ 113 | $ 0 | $ 113 | |||||||
Aggregate intrinsic value, exercisable at end of period | $ | 0 | |||||||||
Aggregate intrinsic value, vested and expected to vest at end of period | $ | $ 0 | |||||||||
Private Melinta 2011 Equity Incentive Plan | ||||||||||
Stock Option Activity, Narrative [Abstract] | ||||||||||
Stock options, conversion ratio | 0.0229 | |||||||||
Weighted average fair value of options granted (in usd per share) | $ 0 | $ 1.30 | $ 2.15 | |||||||
Weighted average fair value of options granted, after conversion and revaluation (in usd per share) | $ 0 | $ 37 | $ 31.60 | |||||||
Fair value of options vested | $ | $ 2,362 | $ 690 | $ 2,900 | $ 2,300 | ||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||||||||||
Number of options, outstanding - beginning balance (in shares) | shares | 143,802 | 5,240,441 | 4,362,836 | |||||||
Number of options, granted (in shares) | shares | 1,830,199 | 1,240,499 | ||||||||
Number of options, exercised (in shares) | shares | (25,480) | (26,366) | (31,685) | |||||||
Number of options, canceled or expired (in shares) | shares | (20,616) | (797,571) | (331,209) | |||||||
Number of options, converted (in shares) | shares | (6,102,901) | |||||||||
Number of options, outstanding - ending balance (in shares) | shares | 143,802 | 97,706 | 143,802 | 5,240,441 | 4,362,836 | |||||
Number of options, exercisable at end of period (in shares) | shares | 81,419 | |||||||||
Number of options, vested and expected to vest at end of period (in shares) | shares | 97,703 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||||||||||
Weighted average exercise price, outstanding - beginning balance | $ 129.40 | $ 3.10 | $ 3 | |||||||
Weighted average exercise price, granted (in usd per share) | 2.40 | 3.55 | ||||||||
Weighted average exercise price, exercised (in usd per share) | 135.05 | 3.60 | 2.05 | |||||||
Weighted average exercise price, canceled or expired (in usd per share) | 151.90 | 2.55 | 3.85 | |||||||
Weighted average exercise price, outstanding - ending balance | $ 129.40 | 123.15 | $ 129.40 | $ 3.10 | $ 3 | |||||
Weighted average exercise price, exercisable at end of period (in usd per share) | 124.15 | |||||||||
Weighted average exercise price, vested and expected to vest at end of period (in usd per share) | $ 123.15 | |||||||||
Share-based Compensation Arrangement By Share-based Payment Award, Options, Outstanding, Weighted Average Contractual Term [Abstract] | ||||||||||
Weighted average contractual term of outstanding options at end of period (in years) | 5 years 1 month 6 days | 7 years 10 months 24 days | 7 years 10 months 24 days | 8 years 6 months | ||||||
Weighted average contractual term of exercisable options at end of period (in years) | 4 years 6 months | |||||||||
Weighted average contractual term, vested and expected to vest at end of period (in years) | 5 years 1 month 6 days | |||||||||
Aggregate intrinsic value, outstanding at end of period | $ | $ 0 | |||||||||
Aggregate intrinsic value, exercisable at end of period | $ | 0 | |||||||||
Aggregate intrinsic value, vested and expected to vest at end of period | $ | 0 | |||||||||
2018 Stock Incentive Plan | ||||||||||
Stock Option Activity, Narrative [Abstract] | ||||||||||
Weighted average fair value of options granted (in usd per share) | $ 28.71 | |||||||||
Fair value of options vested | $ | $ 285 | $ 0 | $ 0 | |||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding [Roll Forward] | ||||||||||
Number of options, outstanding - beginning balance (in shares) | shares | 0 | |||||||||
Number of options, granted (in shares) | shares | 301,973 | |||||||||
Number of options, canceled or expired (in shares) | shares | (225,323) | (76,650) | ||||||||
Number of options, outstanding - ending balance (in shares) | shares | 0 | 0 | ||||||||
Number of options, exercisable at end of period (in shares) | shares | 14,402 | |||||||||
Number of options, vested and expected to vest at end of period (in shares) | shares | 225,323 | |||||||||
Share-based Compensation Arrangement by Share-based Payment Award, Options, Outstanding, Weighted Average Exercise Price [Abstract] | ||||||||||
Weighted average exercise price, granted (in usd per share) | $ 32.80 | |||||||||
Weighted average exercise price, canceled or expired (in usd per share) | 37.41 | |||||||||
Weighted average exercise price, outstanding - ending balance | $ 31.21 | |||||||||
Weighted average exercise price, exercisable at end of period (in usd per share) | 29.20 | |||||||||
Weighted average exercise price, vested and expected to vest at end of period (in usd per share) | $ 31.21 | |||||||||
Share-based Compensation Arrangement By Share-based Payment Award, Options, Outstanding, Weighted Average Contractual Term [Abstract] | ||||||||||
Weighted average contractual term of outstanding options at end of period (in years) | 9 years 6 months | |||||||||
Weighted average contractual term of exercisable options at end of period (in years) | 8 years 10 months 24 days | |||||||||
Weighted average contractual term, vested and expected to vest at end of period (in years) | 9 years 6 months | |||||||||
Aggregate intrinsic value, outstanding at end of period | $ | $ 0 | |||||||||
Aggregate intrinsic value, exercisable at end of period | $ | 0 | |||||||||
Aggregate intrinsic value, vested and expected to vest at end of period | $ | $ 0 | |||||||||
2018 Stock Incentive Plan | Stock Options | ||||||||||
Stock Option Activity, Narrative [Abstract] | ||||||||||
Weighted average fair value of options granted (in usd per share) | $ 0 | $ 0 |
Stock-Based Compensation - Opti
Stock-Based Compensation - Options Outstanding and Exercisable, Exercise Price Ranges (Details) | 12 Months Ended |
Dec. 31, 2018$ / sharesshares | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Number of options outstanding (in shares) | 696,890 |
Number of options exercisable (in shares) | 149,178 |
$10.60 - $25.00 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares outstanding under stock option plans, exercise price range, lower range limit (in dollars per share) | $ / shares | $ 10.60 |
Shares outstanding under stock option plans, exercise price range, upper range limit (in dollars per share) | $ / shares | $ 25 |
Number of options outstanding (in shares) | 147,720 |
Options outstanding, weighted average remaining contractual term (in years) | 9 years 9 months |
Number of options exercisable (in shares) | 5,000 |
Options Exercisable, weighted average remaining contractual term (in years) | 9 years 9 months 29 days |
$25.01 - $50.00 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares outstanding under stock option plans, exercise price range, lower range limit (in dollars per share) | $ / shares | $ 25.01 |
Shares outstanding under stock option plans, exercise price range, upper range limit (in dollars per share) | $ / shares | $ 50 |
Number of options outstanding (in shares) | 402,896 |
Options outstanding, weighted average remaining contractual term (in years) | 9 years 3 months 14 days |
Number of options exercisable (in shares) | 18,150 |
Options Exercisable, weighted average remaining contractual term (in years) | 8 years 6 months 14 days |
$50.01 - $75.00 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares outstanding under stock option plans, exercise price range, lower range limit (in dollars per share) | $ / shares | $ 50.01 |
Shares outstanding under stock option plans, exercise price range, upper range limit (in dollars per share) | $ / shares | $ 75 |
Number of options outstanding (in shares) | 8,004 |
Options outstanding, weighted average remaining contractual term (in years) | 5 years 8 months 26 days |
Number of options exercisable (in shares) | 7,504 |
Options Exercisable, weighted average remaining contractual term (in years) | 5 years 7 months 2 days |
$75.01 - $100.00 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares outstanding under stock option plans, exercise price range, lower range limit (in dollars per share) | $ / shares | $ 75.01 |
Shares outstanding under stock option plans, exercise price range, upper range limit (in dollars per share) | $ / shares | $ 100 |
Number of options outstanding (in shares) | 31,826 |
Options outstanding, weighted average remaining contractual term (in years) | 4 years 5 months 12 days |
Number of options exercisable (in shares) | 28,639 |
Options Exercisable, weighted average remaining contractual term (in years) | 4 years 14 days |
$100.01 - $125.00 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares outstanding under stock option plans, exercise price range, lower range limit (in dollars per share) | $ / shares | $ 100.01 |
Shares outstanding under stock option plans, exercise price range, upper range limit (in dollars per share) | $ / shares | $ 125 |
Number of options outstanding (in shares) | 31,569 |
Options outstanding, weighted average remaining contractual term (in years) | 6 years 9 months 10 days |
Number of options exercisable (in shares) | 17,697 |
Options Exercisable, weighted average remaining contractual term (in years) | 5 years 7 months 6 days |
$125.01 - $1,085.75 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Shares outstanding under stock option plans, exercise price range, lower range limit (in dollars per share) | $ / shares | $ 125.01 |
Shares outstanding under stock option plans, exercise price range, upper range limit (in dollars per share) | $ / shares | $ 1,085.75 |
Number of options outstanding (in shares) | 74,875 |
Options outstanding, weighted average remaining contractual term (in years) | 5 years 7 days |
Number of options exercisable (in shares) | 72,188 |
Options Exercisable, weighted average remaining contractual term (in years) | 4 years 11 months 12 days |
Stock-Based Compensation - St_2
Stock-Based Compensation - Stock-Based Compensation and Value Assumptions (Details) - USD ($) $ in Thousands | Nov. 03, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Nov. 02, 2017 |
Private Melinta 2011 Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Options shares available (in shares) | 732,499 | 146,499 | |||
Fair value of options vested | $ 2,362 | $ 690 | $ 2,900 | $ 2,300 | |
Fair value of unvested options | 2,476 | ||||
2006 Stock Plan And Private Melinta 2011 Equity Incentive Plan | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Fair value of options vested | $ 2,626 |
Stock-Based Compensation - Assu
Stock-Based Compensation - Assumptions Value Outstanding Unvested Stock Option Grants and Vested Stock Option Grants Under the Melinta 2011 Plan After Remeasurement (Details) - Private Melinta 2011 Equity Incentive Plan | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Risk free interest rate, minimum | 2.60% | 1.80% | |
Risk free interest rate, maximum | 3.10% | 2.10% | |
Risk-free interest rate | 1.50% | ||
Weighted-average volatility | 67.10% | ||
Expected term - employee awards (in years) | 6 years | ||
Forfeiture rate | 0.00% | 0.00% | 0.00% |
Dividend yield | 0.00% | 0.00% | 0.00% |
Minimum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average volatility | 84.80% | 87.50% | |
Expected term - employee awards (in years) | 1 year | 3 years 1 month 6 days | |
Maximum | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Weighted-average volatility | 85.60% | 108.10% | |
Expected term - employee awards (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Stock-Based Compensation - As_2
Stock-Based Compensation - Assumptions Value Outstanding Vested Stock Option Grants (Details) - 2006 Plan And 2011 Plan | Nov. 03, 2017 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Risk free interest rate, minimum | 1.20% |
Risk free interest rate, maximum | 2.00% |
Forfeiture rate | 0.00% |
Dividend yield | 0.00% |
Minimum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted-average volatility | 51.00% |
Expected term - employee awards (in years) | 2 months 12 days |
Maximum | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |
Weighted-average volatility | 147.40% |
Expected term - employee awards (in years) | 5 years 7 months 6 days |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Units (Details) - USD ($) $ in Thousands | Nov. 03, 2017 | Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2019 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Share-based compensation | $ 3,465 | $ 6,450 | $ 2,515 | |||
Restricted Stock Units | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Estimated fair value for the unvested stock options | $ 834 | |||||
Shares vested on the date of termination | 16,400 | |||||
Share-based compensation | $ 573 | |||||
Common stock issued | 12,400 | |||||
Scenario, Forecast | Restricted Stock Units | ||||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||||
Options shares available (in shares) | 4,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of RSUs Activity (Details) - Restricted Stock Units - $ / shares | Nov. 03, 2017 | Dec. 31, 2017 | Dec. 31, 2018 |
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Number of restricted stock units outstanding, granted (in shares) | 12,400 | ||
Shares vested on the date of termination | 16,400 | ||
2011 Equity Incentive Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Number of Shares [Roll Forward] | |||
Number of restricted stock units outstanding, beginning balance (in shares) | 40,400 | 27,400 | |
Number of restricted stock units outstanding, granted (in shares) | 10,000 | ||
Number of restricted stock units outstanding, vested and issued (in shares) | (12,400) | (10,920) | |
Number of restricted stock units outstanding, forfeited (in shares | (600) | (5,120) | |
Number of restricted stock units outstanding, ending balance (in shares) | 40,400 | 27,400 | 21,360 |
Shares vested on the date of termination | 4,000 | ||
Share-based Compensation Arrangement by Share-based Payment Award, Equity Instruments Other than Options, Nonvested, Weighted Average Merger-Date Fair Value [Abstract] | |||
Weighted average merger-date fair value, beginning balance (in usd per share) | $ 58.25 | $ 58.25 | |
Weighted average merger-date fair value, granted (in usd per share) | 14 | ||
Weighted average fair value, vested and issued (in usd per share) | 58.25 | 58.25 | |
Weighted average merger-date fair value, vested (in usd per share) | 58.25 | ||
Weighted average merger-date fair value, forfeited (in usd per share) | 58.25 | 58.25 | |
Weighted average merger-date fair value, ending balance (in usd per share) | $ 58.25 | $ 58.25 | $ 32.75 |
Stock-Based Compensation - St_3
Stock-Based Compensation - Stock-Based Compensation Reported in Statements of Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation | $ 3,465 | $ 6,450 | $ 2,515 |
Cost of goods sold | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation | 48 | 0 | 0 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation | 750 | 651 | 1,169 |
General and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation | 2,667 | $ 5,799 | $ 1,346 |
Manufacturing Related Employees | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share-based compensation | $ 209 |
Stock-Based Compensation - St_4
Stock-Based Compensation - Stock-Based Compensation Expense (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted-average period over which unrecognized compensation cost is expected to be recognized | 3 years 4 months 24 days | |
Option Inducement Agreement | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized stock based compensation expense | $ 9,783 | |
Private Melinta 2011 Equity Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized stock based compensation expense | $ 4,703 |
Income Taxes - Schedule of Inco
Income Taxes - Schedule of Income Tax Expense (Benefit) From Continuing Operations (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Federal: | ||
Current | $ 0 | $ 0 |
Deferred | 0 | 0 |
Federal income tax expense (benefit) | 0 | 0 |
State: | ||
Current | (139) | (103) |
Deferred | 0 | 0 |
State income tax expense (benefit) | (139) | (103) |
Total | $ (139) | $ (103) |
Income Taxes - Schedule of Effe
Income Taxes - Schedule of Effective Income Tax Rate Reconciliation (Details) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Income Tax Disclosure [Abstract] | ||
Federal Statutory rate | 21.00% | 34.00% |
State income taxes, net of federal income tax benefit | 17.70% | 0.20% |
Bargain purchase gain | 0.00% | 15.90% |
Transaction cost | (0.00%) | (2.30%) |
Interest expense | (0.00%) | (2.30%) |
Impact of change in fair value of tranche assets and liabilities | 4.40% | 2.00% |
Other permanent differences | (0.20%) | (2.00%) |
Federal tax rate change | 0.00% | (75.30%) |
Change in valuation allowance | (14.10%) | 28.00% |
Research and development tax credits | 1.20% | 3.30% |
Prior year adjustment | (1.00%) | 0.00% |
Section 382 adjustment | (28.90%) | 0.00% |
Other | 0.00% | (1.30%) |
Effective income tax rate | 0.10% | 0.20% |
Income Taxes - Narrative (Detai
Income Taxes - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Nov. 03, 2017 | |
Income Tax Contingency [Line Items] | ||||
Deferred tax assets, net | $ 0 | $ 0 | $ 0 | $ 107,688 |
Valuation allowance | 128,793 | 128,793 | $ 209,994 | $ 107,688 |
Deferred tax assets and liabilities adjustment for Section 382 | 26,126 | |||
Valuation allowance, Section 382 adjustment | 26,126 | 26,126 | ||
Section 382 adjustments | 82,013 | |||
Tax Cuts And Jobs Act Of 2017, change In tax rate, income tax expense | 83,007 | |||
Tax Cuts And Jobs Act Of 2017, change in tax rate, income tax benefit | 83,007 | |||
Increase (decrease) in valuation allowance | 22,443 | |||
Cempra, Inc. | ||||
Income Tax Contingency [Line Items] | ||||
Valuation allowance | 101,195 | 101,195 | ||
Deferred tax assets and liabilities adjustment for Section 382 | 101,195 | |||
Adoption of Topic 606 | ||||
Income Tax Contingency [Line Items] | ||||
Valuation allowance | 2,449 | 2,449 | ||
U.S. Federal | ||||
Income Tax Contingency [Line Items] | ||||
Federal operating loss carryforwards | 267,597 | 267,597 | ||
Federal tax credit carryforwards | 7,409 | 7,409 | ||
U.S. State | ||||
Income Tax Contingency [Line Items] | ||||
Federal operating loss carryforwards | 38,401 | 38,401 | ||
Federal tax credit carryforwards | $ 5,010 | $ 5,010 |
Income Taxes - Schedule of Temp
Income Taxes - Schedule of Temporary Difference and Net Operating Losses to Significant Portions of Deferred Tax Assets (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Nov. 03, 2017 |
Deferred tax assets: | |||
Net operating loss carryforwards | $ 94,596 | $ 172,481 | |
Tax credit carryforwards | 7,409 | 24,924 | |
Deferred revenue | 0 | 3,364 | |
Fixed assets | 677 | 593 | |
Stock compensation expense | 2,195 | 2,503 | |
Intangibles | 12,026 | 3,978 | |
Interest expense carryforward | 7,617 | 0 | |
Others | 4,273 | 2,151 | |
Total deferred tax assets | 128,793 | 209,994 | |
Less valuation allowance | (128,793) | (209,994) | $ (107,688) |
Net deferred tax assets | $ 0 | $ 0 | $ 107,688 |
Commitments and Contingencies_2
Commitments and Contingencies - Operating Leases (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |||
May 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jun. 30, 2017 | |
Loss Contingencies [Line Items] | |||||
Rent expense under operating leases for facilities and equipment | $ 1,747 | $ 907 | $ 690 | ||
Fleet Agreement | Automotive Rentals, Inc. (“ARI”) | |||||
Loss Contingencies [Line Items] | |||||
Lease agreement term under the fleet agreement | 4 years | ||||
Annual minimum lease payments for vehicles | $ 1,091 | ||||
Fleet Agreement | Automotive Rentals, Inc. (“ARI”) | Maximum | |||||
Loss Contingencies [Line Items] | |||||
Percentage of future minimum lease payments | 90.00% | ||||
Percentage of maximum use of vehicles | 75.00% | ||||
Letter of Credit | Fleet Agreement | Automotive Rentals, Inc. (“ARI”) | |||||
Loss Contingencies [Line Items] | |||||
Issuance of letter of credit | $ 200 |
Commitments and Contingencies_3
Commitments and Contingencies - Schedule of Minimum Operating Lease Payments under Non-cancelable Leases (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies Disclosure [Abstract] | |
2019 | $ 2,796 |
2020 | 2,710 |
2021 | 2,327 |
2022 | 1,233 |
2023 and thereafter | 886 |
Total future minimum payments | 9,952 |
Minimum sublease rentals | $ 271 |
Commitments and Contingencies_4
Commitments and Contingencies - License Agreements with Future Payments (Details) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 152 Months Ended | ||||||||||||||||
Jul. 31, 2017USD ($) | May 31, 2017USD ($) | Mar. 31, 2017USD ($) | Feb. 28, 2017USD ($) | Oct. 31, 2016USD ($) | Mar. 31, 2016USD ($) | May 31, 2013USD ($) | Jul. 31, 2012USD ($) | Jan. 31, 2011USD ($) | Nov. 30, 2010USD ($) | Jul. 31, 2010USD ($) | Mar. 31, 2005USD ($) | Dec. 31, 2001USD ($)Productshares | Mar. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2018USD ($) | Jun. 30, 2018USD ($) | Jun. 30, 2017USD ($) | Mar. 31, 2006USD ($) | |
Contract Research Organization | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Milestone payment amount paid | $ 450,000 | $ 900,000 | ||||||||||||||||||
Reimbursement of certain development expenses | $ 154,000 | $ 154,000 | ||||||||||||||||||
Contract Research Organization | Maximum | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Reimbursement of certain development expenses | 250,000 | 250,000 | ||||||||||||||||||
License Agreements with Future Payments | Yale University (“Yale”) | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Common shares issued in exchange for license (in shares) | shares | 61 | |||||||||||||||||||
Fair value of common shares issued | $ 35,000 | |||||||||||||||||||
License fees paid | $ 15,000 | |||||||||||||||||||
Number of products developed | Product | 3 | |||||||||||||||||||
License agreement termination notice period for the company | 60 days | |||||||||||||||||||
License agreement termination notice period for Yale university | 90 days | |||||||||||||||||||
License Agreements with Future Payments | Yale University (“Yale”) | Maximum | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Payments for license agreement | $ 900,000 | |||||||||||||||||||
License Agreements with Future Payments | Cy Dex Pharmaceuticals Inc | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
License agreement termination notice period for the company | 90 days | |||||||||||||||||||
Nonrefundable payments | $ 300,000 | |||||||||||||||||||
Milestone payment amount paid | $ 1,500,000 | $ 1,500,000 | $ 500,000 | $ 150,000 | ||||||||||||||||
License Agreements with Future Payments | Cy Dex Pharmaceuticals Inc | Maximum | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Potential additional future payments upon achievement of development and regulatory milestones | $ 600,000 | |||||||||||||||||||
License Agreements with Future Payments | Medical Research Council (“MRC”) | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
License fees paid | $ 10,000 | |||||||||||||||||||
Pharmaceutical Product | License Agreements with Future Payments | Medical Research Council (“MRC”) | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Milestone payment owed upon FDA approval | 610,000 | |||||||||||||||||||
Diagnostic Product | License Agreements with Future Payments | Medical Research Council (“MRC”) | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Milestone payment owed upon FDA approval | $ 100,000 | |||||||||||||||||||
Baxdela | License Agreements with Future Payments | Wakunaga Pharmaceutical Co., Ltd | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
License agreement termination notice period for the company | 6 months | |||||||||||||||||||
Milestone payment owed upon FDA approval | $ 2,000,000 | $ 6,000,000 | ||||||||||||||||||
Nonrefundable payments | $ 11,600,000 | |||||||||||||||||||
Milestone payment amount paid | $ 4,000,000 | |||||||||||||||||||
Baxdela | License Agreements with Future Payments | Wakunaga Pharmaceutical Co., Ltd | Maximum | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Potential additional future payments upon achievement of development and regulatory milestones | $ 9,000,000 | |||||||||||||||||||
Collaborative Arrangement | Optimer Pharmaceuticals Inc | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
License agreement termination notice period for the company | 30 days | |||||||||||||||||||
Milestone payment owed upon FDA approval | $ 9,500,000 | |||||||||||||||||||
Milestone payment amount paid | $ 1,000,000 | $ 500,000 | ||||||||||||||||||
License and collaboration agreement with Menarini | Baxdela | License Agreements with Future Payments | Wakunaga Pharmaceutical Co., Ltd | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
Milestone payment amount paid | $ 1,590,000 | $ 200,000 | ||||||||||||||||||
Subsequent Event | Baxdela | License Agreements with Future Payments | Wakunaga Pharmaceutical Co., Ltd | ||||||||||||||||||||
Loss Contingencies [Line Items] | ||||||||||||||||||||
License fees paid | $ 1,210,000 |
Commitments and Contingencies_5
Commitments and Contingencies - Commitments Assumed in the Merger with Cempra Inc (Details) | Sep. 26, 2018USD ($) | Jun. 12, 2012USD ($) | Oct. 31, 2016USD ($) | Sep. 30, 2016USD ($) | Jan. 31, 2016USD ($) | Mar. 31, 2015USD ($) | May 31, 2013USD ($)Segment | Jul. 31, 2012USD ($) | Jul. 31, 2010USD ($) | Mar. 31, 2006USD ($)Product | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Sep. 30, 2014USD ($) | Jun. 30, 2012USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Jan. 01, 2018USD ($) | Feb. 29, 2016USD ($) | Jan. 31, 2015USD ($) | Nov. 30, 2014USD ($) |
Loss Contingencies [Line Items] | |||||||||||||||||||||||
License fee paid | $ 8,989,000 | $ 13,393,000 | $ 10,989,000 | $ 7,686,000 | $ 41,057,000 | $ 0 | $ 0 | ||||||||||||||||
Deferred revenue | $ 0 | 0 | 10,008,000 | $ 0 | $ 9,008,000 | ||||||||||||||||||
Gain on loss contract reversal | $ 5,330,000 | $ 0 | $ 0 | ||||||||||||||||||||
The Scripps Research Institute | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Eligible milestone payment | $ 1,100,000 | ||||||||||||||||||||||
Biomedical Advanced Research and Development Authority | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Value of cost plus fixed fee development contract with base performance segment | $ 18,700,000 | ||||||||||||||||||||||
Number of option work segments | Segment | 4 | ||||||||||||||||||||||
Cumulative value of cost plus fixed fee development contract with base performance segment of four option work segments | $ 68,200,000 | ||||||||||||||||||||||
Number of options under cost plus fixed fee arrangements | Segment | 3 | ||||||||||||||||||||||
Number of options under cost sharing arrangement without fixed fee | Segment | 1 | ||||||||||||||||||||||
Toyama Chemical | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Deferred revenue | $ 10,000,000 | ||||||||||||||||||||||
Aggregate milestone payments | $ 60,000,000 | ||||||||||||||||||||||
Milestone payment amount received | $ 10,000,000 | $ 10,000,000 | |||||||||||||||||||||
Milestone payment recognized as revenue | $ 10,000,000 | ||||||||||||||||||||||
License agreement covenant royalties receivable period after product launch | 15 years | ||||||||||||||||||||||
CPI and Toyama [Member] | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Gain on loss contract reversal | $ 5,330,000 | ||||||||||||||||||||||
FUJIFILM Finechemicals Co., Ltd. | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Aggregate milestone payments | $ 80,000,000 | ||||||||||||||||||||||
Aggregate penalties cost | $ 17,500,000 | ||||||||||||||||||||||
Collaborative Arrangement | Optimer Pharmaceuticals Inc | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Aggregate amount of milestone payment | $ 27,500,000 | ||||||||||||||||||||||
Number of products required to be developed through FDA approval | Product | 4 | ||||||||||||||||||||||
Milestone payment amount paid | $ 1,000,000 | $ 500,000 | |||||||||||||||||||||
Milestone payment owed upon FDA approval | $ 9,500,000 | ||||||||||||||||||||||
Milestone payments receivable | $ 1,000,000 | ||||||||||||||||||||||
Term of rights and obligations under agreement from first commercial sale | 10 years | ||||||||||||||||||||||
License Agreements with Future Payments | Medical Research Council (“MRC”) | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
License agreement termination period | 30 days | ||||||||||||||||||||||
License | The Scripps Research Institute | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
License fee paid | $ 350,000 | ||||||||||||||||||||||
Second Option Work | Biomedical Advanced Research and Development Authority | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Value of cost plus fixed fee development contract with base performance segment | $ 16,000,000 | ||||||||||||||||||||||
Third Option Work | Biomedical Advanced Research and Development Authority | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Value of cost plus fixed fee development contract with base performance segment | $ 33,500,000 | $ 25,500,000 | |||||||||||||||||||||
Increase in value of cost plus fixed fee development contract with base performance segment | $ 8,000,000 | ||||||||||||||||||||||
Cempra, Inc. | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Fair value adjustments upon assuming agreement | $ 5,330,000 | ||||||||||||||||||||||
Minimum | Service | The Scripps Research Institute | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Annual maintenance fees | 50,000 | ||||||||||||||||||||||
Minimum | Solithromycin | CPI and Toyama [Member] | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Percentage of royalty payments upon regulatory approval in Japan | 4.00% | ||||||||||||||||||||||
Maximum | Service | The Scripps Research Institute | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Annual maintenance fees | $ 85,000 | ||||||||||||||||||||||
Maximum | Solithromycin | CPI and Toyama [Member] | |||||||||||||||||||||||
Loss Contingencies [Line Items] | |||||||||||||||||||||||
Percentage of royalty payments upon regulatory approval in Japan | 6.00% |
Commitments and Contingencies_6
Commitments and Contingencies - Contingencies (Details) $ in Thousands | Dec. 03, 2018USD ($) | Jan. 05, 2018USD ($) | Jul. 06, 2017Lawsuit | Dec. 31, 2018USD ($) | Dec. 31, 2016Lawsuit | Dec. 18, 2018USD ($) |
Loss Contingencies [Line Items] | ||||||
Attorneys’ fees | $ 263 | |||||
Proposed common stock financing, subsequently abandoned | $ 75,000 | $ 115,272 | ||||
Claim for damages sought by company | $ 68,300 | |||||
Securities Class Action | ||||||
Loss Contingencies [Line Items] | ||||||
Number of lawsuits filed | Lawsuit | 2 | |||||
Number of lawsuits consolidated | Lawsuit | 3 | |||||
IDB | ||||||
Loss Contingencies [Line Items] | ||||||
Milestone payment payable | $ 30,000 | |||||
Medicines Company | IDB | ||||||
Loss Contingencies [Line Items] | ||||||
Milestone payment payable | 50,000 | |||||
Deferred payments recorded at fair value | $ 25,000 |
Benefit Plan - Narrative (Detai
Benefit Plan - Narrative (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Retirement Benefits [Abstract] | |||
Matching contributions | $ 1,961 | $ 475 | $ 306 |
Related Party Transactions - Na
Related Party Transactions - Narrative (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2019 | Dec. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Dr. Jorgensen's Company | License Fees | |||||
Related Party Transaction [Line Items] | |||||
Total fees paid | $ 40 | $ 40 | $ 43 | ||
Dr. Thomas Koestler | |||||
Related Party Transaction [Line Items] | |||||
Compensation to chairman | $ 58 | $ 126 | |||
Shares issued (in shares) | 6,820 | 333 | |||
Exercise price per share (in usd per share) | $ 37.25 | $ 104.85 | |||
Stock based compensation | $ 73 | $ 151 | |||
Senior Subordinated Convertible Loan Agreement | Convertible Subordinated Debt | |||||
Related Party Transaction [Line Items] | |||||
Line credit maximum borrowing capacity | $ 135,000 | $ 135,000 | |||
Period in which funding is provided | 5 months | ||||
Senior Subordinated Convertible Loan Agreement | Convertible Subordinated Debt | Subsequent Event | |||||
Related Party Transaction [Line Items] | |||||
Proceeds from issuance of debt | $ 75,000 |
Selected Quarterly Data (Unau_3
Selected Quarterly Data (Unaudited) - Summary of Selected Quarterly Data (Details) - USD ($) $ / shares in Units, $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | 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 | Dec. 31, 2016 | |
Quarterly Financial Information Disclosure [Abstract] | ||||||||||||
Revenue | $ 35,489 | $ 34,078 | $ 12,022 | $ 14,841 | $ 4,231 | $ 3,191 | $ 3,979 | $ 22,463 | $ 96,430 | $ 33,864 | $ 0 | |
Operating expenses | ||||||||||||
Cost of goods sold | 8,989 | 13,393 | 10,989 | 7,686 | 41,057 | 0 | 0 | |||||
Research and development | 10,402 | 13,065 | 15,813 | 16,129 | 11,599 | 10,884 | 14,075 | 12,917 | 55,409 | 49,475 | 49,791 | |
Goodwill impairment | $ 25,088 | 25,088 | 0 | 0 | 0 | 25,088 | 0 | 0 | ||||
Selling, general and administrative | 29,455 | 34,287 | 34,946 | 34,624 | 37,349 | 10,304 | 7,699 | 7,973 | 133,312 | 63,325 | 19,410 | |
Loss from operations | (38,445) | (26,667) | (49,726) | (43,598) | (44,717) | (17,997) | (17,795) | 1,573 | (158,436) | (78,936) | (69,201) | |
Total Other Income (Expense), net | 5,675 | 1,193 | 6,054 | (14,166) | (25,937) | 1,639 | 2,631 | 1,647 | (1,244) | (20,020) | 4,731 | |
Net loss | (44,120) | (27,860) | (55,780) | (29,432) | (18,780) | (19,636) | (20,426) | (74) | (157,192) | (58,916) | (73,932) | |
Accretion of preferred dividends | 0 | 0 | 0 | 0 | (2,098) | (5,720) | (5,721) | (5,720) | ||||
Net loss available to common shareholders | $ (44,120) | $ (27,860) | $ (55,780) | $ (29,432) | $ (20,878) | $ (25,356) | $ (26,147) | $ (5,794) | $ (157,192) | $ (78,175) | $ (95,049) | |
Net loss per share - basic and diluted (in usd per share) | $ (3.94) | $ (2.49) | $ (6.92) | $ (4.76) | $ (7.40) | $ (4,286.73) | $ (4,420.46) | $ (1,040.78) | $ (17.12) | $ (109.28) | $ (20,600.13) | |
Weighted average shares used in calculating basic and diluted net loss per share (in shares) | 11,204,000 | 11,203,000 | 8,059,000 | 6,184,000 | 2,821,000 | 6,000 | 6,000 | 6,000 | 9,181,668 | 715,369 | 4,614 |
Business Combinations - Narrati
Business Combinations - Narrative (Details) | Jan. 01, 2019USD ($) | Jan. 05, 2018USD ($)milestone$ / sharesshares | Jan. 05, 2018USD ($)milestoneinstallmentindividual$ / sharesshares | Jul. 31, 2019USD ($) | Jan. 31, 2019USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Sep. 30, 2018USD ($) | Jun. 30, 2018USD ($) | Mar. 31, 2018USD ($) | Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) |
Business Acquisition [Line Items] | |||||||||||||
Accrued royalty payments | $ 2,052,000 | $ 2,052,000 | $ 2,052,000 | $ 2,040,000 | |||||||||
Fair value adjustment recorded in operating expenses | (254,866,000) | (112,800,000) | $ (69,201,000) | ||||||||||
Nonoperating Income (Expense) | (25,673,000) | (5,091,000) | (2,010,000) | ||||||||||
Amortization expense | 16,332,000 | 0 | |||||||||||
Goodwill | 0 | 0 | 0 | ||||||||||
Goodwill impairment | 25,088,000 | 25,088,000 | $ 0 | $ 0 | $ 0 | 25,088,000 | 0 | 0 | |||||
Change in fair value of warrant liability | $ 33,263,000 | (33,226,000) | (335,000) | (781,000) | |||||||||
Developed product rights | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Amortization expense | 16,332,000 | ||||||||||||
Carrying value | 221,276,000 | 221,276,000 | 221,276,000 | ||||||||||
Scenario, Forecast | Developed product rights | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Amortization expense | $ 21,069,000 | ||||||||||||
IDB | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Percentage of capital stock of subsidiaries acquired | 100.00% | 100.00% | |||||||||||
Number of individuals added to team from Medicines Company | individual | 135 | ||||||||||||
Expenses related to legal and other services | 2,339,000 | 2,617,000 | |||||||||||
Expenses incurred related to transition and integration services | 1,320,000 | ||||||||||||
Business combination, cash payment | $ 166,383,000 | ||||||||||||
Business combination, issuance of common stock shares (in shares) | shares | 662,740 | 662,740 | |||||||||||
Business combination, issuance of common shares amount | $ 50,000,000 | ||||||||||||
Business combination, share price (usd per share) | $ / shares | $ 75.45 | $ 75.45 | |||||||||||
Percentage of weighted average price of common stock | 90.00% | ||||||||||||
Volume weighted average trading price of common stock trading days | 10 days | ||||||||||||
Number of installment | installment | 2 | ||||||||||||
Net working capital adjustment | $ 1,383,000 | ||||||||||||
Common stock | 54,510,000 | ||||||||||||
Deferred consideration | $ 38,541,000 | $ 38,541,000 | |||||||||||
Number of milestone payments | milestone | 2 | 2 | |||||||||||
Contingent consideration fair value of sales based royalty payments | $ 12,271,000 | 6,544,000 | |||||||||||
Accreating amount to estimated aggregate payable to medicines | $ 354,000,000 | $ 354,000,000 | 5,714,000 | 5,714,000 | $ 5,714,000 | ||||||||
Effective interest rate | 20.90% | 49.00% | |||||||||||
Effective interest rate on royalty liability | 43.00% | ||||||||||||
Accrued royalty payment current | 60,000,000 | 60,000,000 | $ 60,000,000 | ||||||||||
Accrued royalty payments | 2,784,000 | 2,784,000 | 2,784,000 | ||||||||||
Contingent liability current | 24,485,000 | $ 24,485,000 | 1,006,000 | 1,006,000 | 1,006,000 | ||||||||
Contingent consideration | 4,708,000 | 4,708,000 | 4,708,000 | ||||||||||
Fair value adjustment recorded in operating expenses | 10,317,000 | ||||||||||||
Milestone payment payable | 30,000,000 | ||||||||||||
Non-cash interest expense related to accretion of contingent payment | 4,015,000 | ||||||||||||
Nonoperating Income (Expense) | 1,500,000 | ||||||||||||
Revenue | 40,096,000 | ||||||||||||
Grant income | 1,938,000 | ||||||||||||
Goodwill | 25,088,000 | $ 25,088,000 | 0 | 0 | 0 | ||||||||
Goodwill impairment | 25,088,000 | ||||||||||||
Nonrecurring acquisition costs | 10,497,000 | ||||||||||||
IDB | Medicines Company | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Number of installment | installment | 2 | ||||||||||||
Effective interest rate | 21.10% | ||||||||||||
Contingent liability current | $ 47,388,000 | $ 47,388,000 | 47,388,000 | ||||||||||
Milestone payment payable | $ 50,000,000 | ||||||||||||
Non-cash interest expense related to accretion of contingent payment | 8,847,000 | ||||||||||||
Deferred payments recorded at fair value | 25,000,000 | ||||||||||||
IDB | Twelve Month Anniversaries | Scenario, Forecast | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Business combination, cash payment | $ 25,000,000 | ||||||||||||
IDB | Eighteen Month Anniversaries | Scenario, Forecast | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Business combination, cash payment | $ 25,000,000 | ||||||||||||
Cempra, Inc. | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Grant income | 3,465,000 | 870,000 | |||||||||||
Acquisition-related expense excluding severance | $ 256,000 | 9,119,000 | |||||||||||
Bargain purchase gain, elimination | $ 27,663,000 | $ 27,663,000 | |||||||||||
In-process research and development | |||||||||||||
Business Acquisition [Line Items] | |||||||||||||
Intangible assets, net | $ 19,859,000 | $ 19,859,000 |
Business Combinations - Schedul
Business Combinations - Schedule of Initial and Current Estimate of Purchase Price Allocation of Acquired Intangible Assets and Related Deferred Tax Liabilities (Details) - USD ($) | Dec. 31, 2018 | Jan. 05, 2018 |
Business Acquisition [Line Items] | ||
Goodwill | $ 0 | |
IDB | ||
Business Acquisition [Line Items] | ||
Current assets | $ 33,725,000 | |
Goodwill | $ 0 | 25,088,000 |
Intangible assets | 236,819,000 | |
Non-current assets | 9,486,000 | |
Current liabilities | (32,837,000) | |
Non-current liabilities | (576,000) | |
Total purchase price | $ 271,705,000 |
Business Combinations - Sched_2
Business Combinations - Schedule of Identifiable Intangible Assets Acquired and Estimated Useful Lives (Details) - USD ($) $ in Thousands | Jan. 05, 2018 | Dec. 31, 2018 |
Business Acquisition [Line Items] | ||
Fair value | $ 236,819 | |
In-process research and development | ||
Business Acquisition [Line Items] | ||
Indefinite lived fair value | 19,859 | |
Developed product rights | ||
Business Acquisition [Line Items] | ||
Finite lived, average useful life | 10 years | |
Finite lived fair value | $ 216,960 | |
Developed product rights | Minimum | ||
Business Acquisition [Line Items] | ||
Finite lived, average useful life | 13 years | |
Developed product rights | Maximum | ||
Business Acquisition [Line Items] | ||
Finite lived, average useful life | 17 years |
Business Combinations - Sched_3
Business Combinations - Schedule of Unaudited Pro Forma Information (Details) - IDB and Cempra, Inc $ in Thousands | 12 Months Ended |
Dec. 31, 2017USD ($) | |
Business Acquisition [Line Items] | |
Pro forma revenue | $ 67,617 |
Pro forma net loss | $ (264,909) |
Net Loss Per Share - Antidiluti
Net Loss Per Share - Antidilutive Securities Excluded from Computation of Diluted Weighted Average Shares Outstanding (Details) | Feb. 22, 2018 | Dec. 31, 2018shares | Dec. 31, 2017shares | Dec. 31, 2016shares |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Reverse stock split, conversion ratio for awards | 0.2 | |||
Dividend accrued to holders of preferred stock rate | 8.00% | 8.00% | ||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 1,480,941 | 488,256 | 1,292,376 | |
Convertible preferred stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 0 | 0 | 1,166,029 | |
Options to purchase common stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 696,890 | 412,211 | 120,007 | |
Preferred stock warrants | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 0 | 0 | 6,331 | |
Unvested restricted stock | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 17,360 | 64,132 | 0 | |
Warrant liability | ||||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||||
Antidilutive securities excluded from computation of diluted weighted average shares outstanding (in shares) | 766,691 | 11,913 | 9 |
Severance - Narrative (Details)
Severance - Narrative (Details) - USD ($) $ in Thousands | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||||
Nov. 30, 2018 | Oct. 31, 2018 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Restructuring Cost and Reserve [Line Items] | |||||||
Severance costs | $ 1,469 | ||||||
Percentage headcount reduction | 20.00% | 20.00% | |||||
Post-employment benefit costs | $ 5,894 | ||||||
Accrued expenses (See Note 3) | 33,924 | $ 33,924 | $ 24,041 | ||||
Long-term liabilities | 7,444 | 7,444 | 6,644 | ||||
Expense related to acceleration of equity awards | $ 486 | ||||||
Employee Severance | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Severance costs | 12,371 | 6,383 | |||||
Accrued expenses (See Note 3) | 9,390 | 9,390 | |||||
Long-term liabilities | $ 377 | 377 | |||||
Expense related to acceleration of equity awards | 407 | $ 1,547 | |||||
Contract Termination | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Fair value of lease liability recognized | $ 556 | $ 556 | |||||
Postemployment Benefits | Non-executives | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Postemployment benefits period of time (in months) | 6 months | ||||||
Postemployment Benefits | Executives | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Postemployment benefits period of time (in months) | 18 months | ||||||
Postemployment Benefits | CEO | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Postemployment benefits period of time (in months) | 24 months | ||||||
Restricted Stock Units | |||||||
Restructuring Cost and Reserve [Line Items] | |||||||
Expense related to acceleration vesting of incentive RSU award | $ 174 |
Severance - Summary of Activity
Severance - Summary of Activity in Severance Accrual (Included In Accrued Expenses or Long-Term Liabilities on Condensed Consolidated Balance Sheets) (Details) - USD ($) $ in Thousands | 1 Months Ended | 12 Months Ended | |
Oct. 31, 2018 | Dec. 31, 2018 | Dec. 31, 2017 | |
Restructuring Reserve [Roll Forward] | |||
Severance accruals (recorded in SG&A) | $ 1,469 | ||
Employee Severance | |||
Restructuring Reserve [Roll Forward] | |||
December 31, 2017 | $ 6,721 | $ 0 | |
Severance accruals (recorded in SG&A) | 12,371 | 6,383 | |
Severance liability acquired in Cempra merger | 769 | ||
Severance payments | (9,325) | (431) | |
December 31, 2018 | $ 9,767 | $ 6,721 |
Severance - Summary of Activi_2
Severance - Summary of Activity in Lease Liability (Details) - Contract Termination - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended |
Jun. 30, 2018 | Dec. 31, 2018 | |
Lease Liability [Roll Forward] | ||
December 31, 2017 | $ 0 | |
Fair value of lease liability recognized | $ 556 | 556 |
Lease termination adjustment | (233) | |
Termination fee | 136 | |
Less: payments | (391) | |
December 31, 2018 | $ 68 |
Uncategorized Items - mlnt-2018
Label | Element | Value |
Debt Instrument, Redemption, Period One [Member] | ||
Notes Payable, Noncurrent | us-gaap_LongTermNotesPayable | $ 104,966,000 |