Document and Entity Information
Document and Entity Information - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Mar. 08, 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 | ||
Entity Registrant Name | ARATANA THERAPEUTICS, INC. | ||
Entity Central Index Key | 0001509190 | ||
Current Fiscal Year End Date | --12-31 | ||
Trading Symbol | petx | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Voluntary Filers | No | ||
Entity Current Reporting Status | Yes | ||
Entity Filer Category | Accelerated Filer | ||
Entity Small Business | true | ||
Entity Emerging Growth Company | false | ||
Entity Shell Company | false | ||
Entity Common Stock, Shares Outstanding | 48,974,228 | ||
Entity Public Float | $ 172,128,753 |
Consolidated Balance Sheets
Consolidated Balance Sheets - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Current assets: | ||
Cash and cash equivalents | $ 41,431 | $ 66,868 |
Short-term investments | 1,240 | 747 |
Accounts receivable, net | 2,204 | 2,406 |
Inventories | 11,425 | 13,576 |
Prepaid expenses and other current assets | 1,827 | 1,642 |
Total current assets | 58,127 | 85,239 |
Property and equipment, net | 693 | 1,166 |
Goodwill | 40,846 | 41,295 |
Intangible assets, net | 6,099 | 6,616 |
Restricted cash | 351 | 350 |
Other long-term assets | 320 | 526 |
Total assets | 106,436 | 135,192 |
Current liabilities: | ||
Accounts payable | 911 | 7,451 |
Accrued expenses and other current liabilities | 4,646 | 3,712 |
Licensing and collaboration commitment | 7,000 | |
Current portion – loans payable | 17,333 | |
Total current liabilities | 5,557 | 35,496 |
Loans payable, net | 19,492 | |
Other long-term liabilities | 57 | 70 |
Total liabilities | 5,614 | 55,058 |
Commitments and contingencies (Notes 6 and 16) | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 100,000,000 shares authorized at December 31, 2018 and December 31, 2017, and 48,048,914 and 42,532,725 issued and outstanding at December 31, 2018 and December 31, 2017, respectively | 48 | 43 |
Treasury stock, at cost; 94,107 and 80,916 shares at December 31, 2018 and December 31, 2017, respectively | (1,175) | (1,107) |
Additional paid-in capital | 350,745 | 321,599 |
Accumulated deficit | (241,238) | (233,316) |
Accumulated other comprehensive loss | (7,558) | (7,085) |
Total stockholders' equity | 100,822 | 80,134 |
Total liabilities and stockholders' equity | $ 106,436 | $ 135,192 |
Consolidated Balance Sheets (Pa
Consolidated Balance Sheets (Parenthetical) - $ / shares | Dec. 31, 2018 | Dec. 31, 2017 |
Consolidated Balance Sheets [Abstract] | ||
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 100,000,000 | 100,000,000 |
Common stock, shares issued | 48,048,914 | 42,532,725 |
Common stock, shares outstanding | 48,048,914 | 42,532,725 |
Treasury stock, shares | 94,107 | 80,916 |
Consolidated Statements of Oper
Consolidated Statements of Operations - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Revenues | |||
Total revenues | $ 35,412 | $ 25,573 | $ 38,551 |
Costs and expenses | |||
Cost of product sales | 6,783 | 16,387 | 3,139 |
Royalty expense | 3,865 | 1,821 | 106 |
Research and development | 6,855 | 15,126 | 30,462 |
Selling, general and administrative | 28,780 | 28,897 | 27,342 |
Amortization of intangible assets | 517 | 350 | 379 |
Impairment of intangible assets | 7,448 | 7,942 | |
In-process research and development | 500 | ||
Total costs and expenses | 47,300 | 70,029 | 69,370 |
Loss from operations | (11,888) | (44,456) | (30,819) |
Other income (expense) | |||
Interest income | 666 | 449 | 385 |
Interest expense | (3,391) | (3,481) | (3,396) |
Other income (expense), net | (109) | (22) | 255 |
Total other expense | (2,834) | (3,054) | (2,756) |
Net loss | $ (14,722) | $ (47,510) | $ (33,575) |
Net loss per share, basic and diluted | $ (0.32) | $ (1.17) | $ (0.95) |
Weighted average shares outstanding, basic and diluted | 46,606,855 | 40,494,301 | 35,273,228 |
Licensing and Collaboration [Member] | |||
Revenues | |||
Total revenues | $ 23,326 | $ 5,913 | $ 38,233 |
Product Sales [Member] | |||
Revenues | |||
Total revenues | $ 12,086 | $ 19,660 | $ 318 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Consolidated Statements of Comprehensive Loss [Abstract] | |||
Net loss | $ (14,722) | $ (47,510) | $ (33,575) |
Other comprehensive income (loss): | |||
Foreign currency translation adjustment | (473) | 2,777 | (542) |
Other comprehensive income (loss) | (473) | 2,777 | (542) |
Comprehensive loss | $ (15,195) | $ (44,733) | $ (34,117) |
Consolidated Statements of Chan
Consolidated Statements of Changes in Stockholders' Equity - USD ($) $ in Thousands | Common Stock Outstanding [Member] | Additional Paid-In Capital [Member] | Accumulated Deficit [Member] | Accumulated Other Comprehensive Loss [Member] | Treasury Stock At Cost [Member] | Total |
Balance at Dec. 31, 2015 | $ 35 | $ 263,941 | $ (152,018) | $ (9,320) | $ (1,088) | $ 101,550 |
Balance, shares at Dec. 31, 2015 | 34,563,816 | |||||
At-the-Market issuance of common stock, net of issuance costs | $ 2 | 14,323 | 14,325 | |||
At-the-Market issuance of common stock, net of issuance costs, shares | 1,629,408 | |||||
Compensation expense related to stock options and restricted awards | 8,476 | 8,476 | ||||
Vesting of restricted stock awards, shares | 301,559 | |||||
Vesting of stock awards early exercised | 31 | 31 | ||||
Vesting of stock awards early exercised, shares | 71,021 | |||||
Issuance of common stock related to option exercises | 138 | 138 | ||||
Issuance of common stock related to option exercises, shares | 42,118 | |||||
Other comprehensive income (loss) | (542) | (542) | ||||
Net loss | (33,575) | (33,575) | ||||
Balance at Dec. 31, 2016 | $ 37 | 286,909 | (185,593) | (9,862) | (1,088) | 90,403 |
Balance, shares at Dec. 31, 2016 | 36,607,922 | |||||
At-the-Market issuance of common stock, net of issuance costs | $ 1 | 2,714 | 2,715 | |||
At-the-Market issuance of common stock, net of issuance costs, shares | 546,926 | |||||
Registered direct offering of common stock, net of $273 of issuance costs | $ 5 | 24,398 | 24,403 | |||
Registered direct offering of common stock, net of $273 of issuance costs, shares | 5,000,000 | |||||
Compensation expense related to stock options and restricted awards | 7,331 | (213) | 7,118 | |||
Vesting of restricted stock awards, shares | 293,978 | |||||
Repurchase of common stock | (19) | (19) | ||||
Repurchase of common stock, shares | (2,690) | |||||
Vesting of stock awards early exercised, shares | 438 | |||||
Issuance of common stock related to option exercises | 247 | 247 | ||||
Issuance of common stock related to option exercises, shares | 86,151 | |||||
Other comprehensive income (loss) | 2,777 | 2,777 | ||||
Net loss | (47,510) | (47,510) | ||||
Balance at Dec. 31, 2017 | $ 43 | 321,599 | (233,316) | (7,085) | (1,107) | 80,134 |
Balance, shares at Dec. 31, 2017 | 42,532,725 | |||||
At-the-Market issuance of common stock, net of issuance costs | $ 5 | 24,218 | 24,223 | |||
At-the-Market issuance of common stock, net of issuance costs, shares | 5,144,244 | |||||
Compensation expense related to stock options and restricted awards | 4,913 | 4,913 | ||||
Vesting of restricted stock awards, shares | 380,427 | |||||
Repurchase of common stock | (68) | (68) | ||||
Repurchase of common stock, shares | (13,191) | |||||
Issuance of common stock related to option exercises | 15 | 15 | ||||
Issuance of common stock related to option exercises, shares | 4,709 | |||||
ASC 606 adoption adjustment | 6,800 | 6,800 | ||||
Other comprehensive income (loss) | (473) | (473) | ||||
Net loss | (14,722) | (14,722) | ||||
Balance at Dec. 31, 2018 | $ 48 | $ 350,745 | $ (241,238) | $ (7,558) | $ (1,175) | $ 100,822 |
Balance, shares at Dec. 31, 2018 | 48,048,914 |
Consolidated Statements of Ch_2
Consolidated Statements of Changes in Stockholders' Equity (Parenthetical) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Consolidated Statements of Changes in Stockholders' Equity [Abstract] | |||
At-the-Market issuance of common stock, issuance cost | $ 171 | $ 73 | $ 262 |
Registered direct offering of common stock, issuance costs | $ 273 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Cash flows from operating activities | |||
Net loss | $ (14,722) | $ (47,510) | $ (33,575) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Stock-based compensation expense | 4,913 | 7,118 | 8,476 |
Depreciation and amortization expense | 990 | 1,162 | 991 |
Impairment of intangible assets | 7,448 | 7,942 | |
Gain on deconsolidation of a variable interest entity | (276) | ||
Non-cash interest expense | 1,018 | 512 | 478 |
Market value adjustments to inventories | 2,650 | 741 | 5,186 |
(Gain) loss on disposition of property and equipment | (30) | 2 | |
Changes in operating assets and liabilities: | |||
Accounts receivable, net | 202 | (2,319) | (27) |
Inventories | (499) | (3,187) | (15,010) |
Prepaid expenses and other current assets | (185) | 335 | (771) |
Other assets | 188 | 88 | (5) |
Accounts payable | (6,540) | 62 | 6,182 |
Accrued expenses and other liabilities | 924 | (2,605) | 2,084 |
Licensing and collaboration commitment | (200) | 7,000 | |
Net cash used in operating activities | (11,261) | (38,185) | (11,323) |
Cash flows from investing activities | |||
Milestone payments for intangible assets | (6,000) | (1,000) | |
Purchases of property and equipment, net | (1) | (72) | |
Purchase of investments | (4,218) | (3,731) | (229,836) |
Proceeds from maturities of investments | 3,725 | 3,980 | 288,287 |
Cash contributed as investment in a noncontrolled entity | (94) | ||
Net cash provided by (used in) investing activities | (493) | (5,752) | 57,285 |
Cash flows from financing activities | |||
Payments for debt issuance costs | (210) | ||
Payments on loans payable | (36,500) | (3,500) | |
Payment for loans payable final payment fee, termination fee and other fees | (1,343) | (165) | |
Taxes paid for awards vested under equity incentive plans | (68) | (19) | |
Proceeds from stock option exercises | 15 | 247 | 138 |
Proceeds from issuance of common stock, net of commissions and underwriter fees | 24,394 | 27,463 | 14,587 |
Payments for common stock issuance costs | (171) | (345) | (93) |
Net cash provided by (used in) financing activities | (13,673) | 23,471 | 14,632 |
Effect of exchange rate on cash | (9) | 27 | (42) |
Net decrease in cash, cash equivalents and restricted cash | (25,436) | (20,439) | 60,552 |
Cash, cash equivalents and restricted cash, beginning of period | 67,218 | 87,657 | 27,105 |
Cash, cash equivalents and restricted cash, end of period | 41,782 | 67,218 | 87,657 |
Supplemental disclosure of cash flow information | |||
Cash paid for interest | $ 3,965 | 2,966 | $ 2,911 |
Supplemental disclosure of noncash investing and financing activities: | |||
Stock issuance costs included in accounts payable | $ 48 |
The Company and Basis of Presen
The Company and Basis of Presentation | 12 Months Ended |
Dec. 31, 2018 | |
The Company and Basis of Presentation [Abstract] | |
The Company and Basis of Presentation | 1. The Company and Basis of Presentation The Company Aratana Therapeutics, Inc., including its subsidiaries (the “Company,” or “Aratana”) was incorporated on December 1, 2010 under the laws of the State of Delaware. The Company is a pet therapeutics company focused on the development and commercialization of innovative therapeutics for dogs and cats. The Company has one operating segment: pet therapeutics. Since its inception, the Company has devoted substantially all of its efforts to research and development, recruiting management and technical staff, building an infrastructure for commerci a lization of its ther a peutics and therapeutic candidates, acquiring operating assets and raising capital. The Company is subject to risks common to companies in the biotechnology and pharmaceutical industries. There can be no assurance that the Company’s licensing efforts will identify viable therapeutic candidates, that the Company’s research and development will be successfully completed, that adequate protection for the Company’s technology will be obtained, that any therapeutics developed will obtain necessary government regulatory approval or that any approved therapeutics will be commercially viable. The Company operates in an environment of substantial competition from other animal health companies. In addition, the Company is dependent upon the services of its employees and consultants, as the well as third-party contract research organizations and manufacturers and collaborators. Basis of Presentation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”) and on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations and has an accumulated deficit of $241,238 as of December 31, 2018. The Company expects to continue to generate operating losses for the foreseeable future. The Company believes that its cash, cash equivalents and short-term investments at December 31, 2018, will be sufficient to fund operations for at least one year from the issuance of these consolidated financial statements . The Company expects continued investment related to commercial activities, including procuring of inventories needed to supply the marketplace, investing to further support adoption and awareness of the Company’ s marketed products and payment of milestones related to approval and commencement of commercial sales. As a result, if the Company cannot generate sufficient cash flow from operations in the future, the Company will seek to fund its operations through corporate collaborations and licensing arrangements, or other sources, such as public or private equity and further debt financings. If the Company is not able to raise additional capital on terms acceptable to it, or at all, as and when needed, the Company would be forced to delay, reduce, or eliminate certain research and development programs, reduce or eliminate discretionary operating expenses or grant rights to develop and market therapeutics or therapeutic candidates that it would otherwise prefer to develop and market itself, which could otherwise adversely affect its business prospects. The Company’s failure to raise capital, as and when needed, would have a negative impact on its financial condition and its ability to pursue its business strategies as this capital is necessary for it to perform the research and development and commercial activities required to generate future revenue streams. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 12 Months Ended |
Dec. 31, 2018 | |
Summary of Significant Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Consolidation The Company’s consolidated financial statements include its financial statements, and those of its wholly-owned US subsidiary and a foreign subsidiar y through its dissolution date in December 2018, and in prior periods, they also include a consolidated variable interest entity through the deconsolidation date in December 2016. Intercompany balances and transactions are eliminated in consolidation. In December 2018, the Company’s foreign subsidiary was dissolved, and the dissolution did not have a material impact on the consolidated financial statements. To determine if the Company holds a controlling financial interest in an entity, the Company first evaluates if it is required to apply the variable interest entity (“VIE”) model to the entity. Where the Company holds current or potential rights that give it the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance combined with a variable interest that gives it the right to receive potentially significant benefits or the obligation to absorb potentially significant losses, the Company is the primary beneficiary of that VIE. When changes occur to the design of an entity, the Company reconsiders whether it is subject to the VIE model. The Company continuously evaluates whether it is the primary beneficiary of a consolidated VIE and upon determination that the Company no longer remains the primary beneficiary, the Company deconsolidates the entity and a gain or loss is recognized upon deconsolidation. In December 2016, the Company concluded that it was no longer the primary beneficiary of a previously consolidated VIE and no longer consolidates the entity. The Company recognized a gain of $276 on deconsolidation of the VIE in other income (expense) in the quarter ended December 31, 2016. The Company ’s remaining non-controlling investment in the VIE is not material. Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. Cash and Cash Equivalents The Company classifies all highly liquid investments with stated maturities of three months or less from the date of purchase as cash equivalents . Cash equivalents consisted of certificates of deposit (“CDs”) at December 31, 2018 and 2017 . Restricted Cash T he Company has posted collateral to Square 1 Bank N.A., a division of the Pacific Western Bank, to collateralize corporate credit card services. The Company classifies the collateral as restricted cash. Short-term Investments Short-term investments in 2018 and 2017 included CDs with original maturities greater than three months but less than 12 months . Marketable Securities The Company classifies all highly liquid investments with stated maturities of greater than three months from the date of purchase as marketable securities. The Company determines the appropriate classification of investments in marketable securities at the time of purchase and re-evaluates such designation at each consolidated balance sheet date. The Company classifies and accounts for marketable securities as available-for-sale. The Company did not hold securities with stated maturities greater than 12 months as of December 31, 2018 or 2017. The Company reports available-for-sale investments at fair value as of each consolidated balance sheet date and records any unrealized gains and losses as a component of stockholders’ equity. The cost of securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense) in the consolidated statements of operations. If any adjustment to fair value reflects a decline in the value of the investment, the Company considers available evidence to evaluate the extent to which the decline is “other than temporary” and recognizes the impairment by releasing other comprehensive income to the consolidated statement of operations. There were no such adjustments necessary during the years ended December 31, 2018 and 2017. Accounts Receivable, Net Accounts receivable are uncollateralized customer obligations due under normal trade terms generally requiring payment within 30 days of the invoice date. The Company provides an allowance for doubtful accounts equal to the estimated losses that will be incurred in collection of accounts receivable. This estimate is based on the current review of existing receivables and historical experience in the industry. The allowance and associated accounts receivable are reduced when the receivables are determined to be uncollectible. To date, the Company’s historical reserves and write-offs have not been significant. The Company also provides an allowance for estimated returns which is established based on the Company’s analysis of industry standards and its own history of actual returns. Inventories The Company states inventories at the lower of cost and net realizable value and consist of raw materials, work-in-process and finished goods. Cost is determined by the average cost method for raw materials and standard cost for work-in-process and finished goods, which approximates actual cost. Pre-Launch Inventories The Company may scale-up and make commercial quantities of certain of its product candidates prior to the date it anticipates that such products will receive final United States Food and Drug Administration (“FDA”)/United States Department of Agriculture (“USDA”) approval. The scale-up and commercial production of pre-launch inventories involves the risk that such products may not be approved for marketing by the FDA/USDA on a timely basis, or ever. Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expense during the period the costs are incurred. Specifically, the Company has determined that for FDA-regulated product candidates there is a probable future commercial use and future economic benefit upon the receipt of the three major technical section complete letters from the FDA’s Center for Veterinary Medicine (“CVM”). For USDA product candidates, the Company has determined there is a probable future commercial use and future economic benefit upon the receipt of a conditional license from the USDA’s Center for Veterinary Biologics. The Company makes at least quarterly reassessments of the probability of regulatory approval and useful life of the pre-launch inventory, and determines whether such inventory continues to have a probable future economic benefit. Property and Equipment, Net The Company records property and equipment at historical cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the following estimated useful lives: Laboratory and office equipment 3 – 10 years Computer software and equipment 3 – 5 years Furniture 3 – 7 years Vehicles 3 – 5 years Leasehold improvements 3 – 10 years Leasehold improvements are amortized over the shorter of the life of the related asset or the term of the lease. Expenditures for repairs and maintenance of assets are charged to expense as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their useful lives. When property and equipment are disposed of, the cost and respective accumulated depreciation and amortization are removed from the accounts. Any gain or loss on disposal is recorded in the consolidated statements of operations in other income (expense). Depreciation expense and gains or losses on disposal of property and equipment are classified within the corresponding operating expense categories in the consolidated statements of operations. Goodwill Goodwill relates to amounts that arose in connection with the Company’s business combinations and represents the difference between the purchase price and the estimated fair value of the identifiable tangible and intangible net assets when accounted for using the acquisition method of accounting. Goodwill is not amortized, but is subject to periodic review for impairment. T he Company tests goodwill at the reporting unit level for impairment on an annual basis and between annual tests, if events and circumstances indicate impairment may exist. Events that would indicate impairment and trigger an interim impairment assessment include, but are not limited to, current economic and market conditions, including a decline in market capitalization, a significant adverse change in legal factors, business climate or operational performance of the business and an adverse action or assessment by a regulator. Intangible Assets , Net The Company’s intangible assets, net consist of intellectual property rights acquired for currently marketed products (amortized intangibles). All of the Company’s amortized intangibles were recorded in connection with the Company’s business combinations or approval/post-approval milestone payments made under the Company’s license agreements. The Company’s intangible assets are recorded at fair value at the time of their acquisition. The Company amortizes intangible assets over their estimated useful lives once the acquired technology is developed into a commercially viable product. The estimated useful lives of the individual categories of intangible assets are based on the nature of the applicable intangible asset and the expected future cash flows to be derived from the intangible asset. Amortization of intangible assets with finite lives is recognized over the time the intangible assets are estimated to contribute to future cash flows. The Company amortizes finite-lived intangible assets using the straight-line method as revenues cannot be reasonably estimated. Foreign Currency Since the acquisition of Okapi Sciences in 2014 and through the date of dissolution of the foreign subsidiary in December 2018 , the Company was exposed to effects of foreign currency from translation. Prior to July 1, 2018, the functional currency of the Company’s foreign subsidiaries was the local currency of the country where the subsidiari es were located. Transactions in foreign currencies were translated into the relevant functional currency at the rate of exchange at the date of the transaction. Transaction gains and losses were recognized in other income (expense) in the consolidated statements of operations. The results of operations for subsidiaries were translated into the United States Dollar , the Company’s reporting currency, at the average rates of exchange during the period, with the subsidiaries’ balance sheets translated at the rates accumulated at the balance sheet date. The cumulative effect of these exchange rate adjustments was included in a separate component of other comprehensive income (loss) in the consolidated balance sheets. Gains and losses arising from intercompany foreign currency transactions were included in loss from operations unless the gains and losses ar o se from long-term investments in subsidiaries. Gains and losses from long-term investments in subsidiaries were included in a separate component of other comprehensive income (loss). Effective July 1, 2018, as a result of s ignificant changes in economic facts and circumstances in the operations of the foreign subsidiary, the functional currency of the Company’s foreign subsidiary was changed from the local currency to the United States Dollar . Effective as of the date of the change, t ranslation adjustments for prior periods were not removed from equity and the translated amounts for nonmonetary assets at the end of the prior period became the accounting basis for those assets in the period of the change and subsequent periods. Subsequent gains or losses from the remeasurement of monetary assets and liabilities of the foreign subsidiary were recorded in earnings through the date of its dissolution. Deferred Public Of fering and At-the-Market Offering Costs The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process equity financings as other assets until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should it no longer be considered probable that the equity financing will be consummated, the deferred offering costs would be expensed immediately as a charge to operating expenses in the consolidated statements of operations. The Company recorded $0 and $76 of deferred equity offering costs as of December 31, 2018 and 2017, respectively. Debt Issuance Costs , Net Debt issuance costs, net represent legal and other direct costs related to the Company’s Loan and Security Agreement which was terminated in December 2018 upon full repayment of outstanding obligations (Note 10). These costs were recorded as an offset to the carrying value of loans payable in the consolidated balance sheet at the time they were incurred and were amortized to interest expense through the scheduled final principal payment date. Upon the Company’s repayment of its loans payable, all remaining debt issuance costs were recognized in interest expense in the consolidated statements of operations. Revenue from Contracts with Customers Effective January 1, 2018, the Company adopted the Accounting Standards Codification Topic (“ASC”) 606 “Revenue from Contracts with Customers” (“ASC 606”) using the modified retrospective transition method. Prior to January 1, 2018, the Company recognized revenue using the guidance of ASC 605 “Revenue Recognition” (“ASC 605”). The Company recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled to in exchange for those goods or services. The Company determines revenue recognition from contracts with customers as follows: · identify the contract(s); · identify the performance obligations in the contract(s); · determine the transaction price; · allocate the transaction price to the performance obligations in the contract; and · recognize revenue wh en (or as) the Company satisfies a performance obligation. The Company’s principal revenue streams and their respective accounting treatments are discussed below and further in Note 3, “Revenue” : (i) Product Sales, Net The Company sells its products to its customers who could either be the end users (such as veterinarians, clinics, or animal hospitals) of the product or distributors who subsequently resell the Company’s products to end users. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, upon delivery to the customer. The Company’s delivery of its products to customers constitutes a single performance obligation as there are no other promises to deliver goods or services beyond what is specified in each accepted customer order. Product sales are recorded net of applicable reserves for variable consideration, including product returns, allowances, discounts, and rebates . Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price) which includes estimates of variable consideration for which reserves are established. Components of variable consideration include product returns, allowances, discounts, and rebates. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (generally, for credits that the Company issues for free goods provided by distributors to end customers in conjunction with promotional programs) or a current liability (generally, reserves for products that remained in the distribution channel inventories at each reporting period end that the Company expects the distributors will provide to end customers free of charge in conjunction with promotional programs). These estimates take into consideration a range of possible outcomes for the expected value (probability-weighted estimate) or relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Product Returns Consistent with the industry practice, the Company generally offers customers a limited right of return of damaged or expired product that has been purchased from the Company or the Company’s distributors in exchange for an unexpired product or credit, depending on contractual arrangements with distributors and terms and conditions of the sale of its products. Exchanges or credit due to expiry are typically allowed for a period of six months after the product’s expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records these estimates as a reduction of product revenues in the period in which the related product revenues are recognized, as well as within accrued expenses and other current liabilities in the consolidated balances sheets. The Company currently estimates product return liabilities using available industry data, its own sales data and data provided by the Company’s distributors such as the inventories remaining in the distribution channel. The Company has received an immaterial amount of returns to date and believes that returns of its products in future periods will be minimal. The Company does not record a return asset associated with the returned damaged or expired goods because such asset is deemed to be fully impaired at the time of product return. Sales Discounts and Allowances The Company compensates its distributors for sales order management, data and distribution and other services through sales discounts and allowances. However, such services are not distinct from the Company’s sale of products to distributors and, therefore, these discounts and allowances are recorded as a reduction of revenue in the consolidated statements of operations, as well as a reduction to accounts receivable, net in the consolidated balance sheets. (ii) Licensing and Collaboration Revenues Revenues derived from product out-licensing arrangements typically consist of an initial non-refundable, up-front payment at inception of the license, subsequent milestone payments contingent on the achievement of certain regulatory, development and commercial milestones, and royalties on the net sales of the Company’s products. Licenses of Intellectual Property If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the contract, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Milestones Revenues from achievement of milestones generally represent a form of variable consideration as the payments are likely to be contingent on the occurrence of future events. The Company estimates milestones probable to be achieved and includes in the transaction price based on either the expected value (probability-weighted estimate) method or most likely amount method. The most likely amount method is used by the Company for milestone payments with a binary outcome (i.e., the Company receives all or none of the milestone payment). Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The estimated milestone-related variable consideration is only recognized as revenue when the related performance obligation is satisfied and the Company determines that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods (i.e. variable consideration constraint). At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing and collaboration revenues and earnings in the period of adjustment. For milestones that are not able to overcome the variable consideration constraint, that are not considered probable or that are determined to be sales-based or usage royalties, as described later, the Company recognizes revenue when the milestones are achieved. Sales-Based Royalty Revenues The Company’s sales-based royalty revenues consist of sales-based milestones or a percentage of net sales royalties. The Company recognizes sales-based royalties related to the Company’s out-licensed intellectual property when (or as) the later of the following events occurs: · the sale occurs; or · the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). Sales-based royalty revenues recorded by the Company are based on the licensee’s or sub-licensee’s sales that occurred during the relevant period. To the extent the licensee’s or sub-licensee’s actual sales are not known at the time the Company reports its financial results, the Company estimates the amount of royalty revenue earned during the relevant period. Differences between actual and estimated royalty revenues, if any, are adjusted in the period in which they become known. To date, royalty revenues reported by the Company have been based on actual sales information received by the Company, and no material adjustments have been made in subsequent periods. Royalty revenue is included in licensing and collaboration revenue in the consolidated statements of operations. The Company recognizes revenue from sales-based milestones when the milestones are achieved. Research and Development Costs Research and development costs are expensed as incurred. Included in research and development costs are wages, stock-based compensation and employee benefits, and other operational costs related to the Company’s research and development activities, including facility-related expenses, external costs of outside contractors engaged to conduct both preclinical and clinical studies and allocation of corporate costs. If IPR&D is acquired in an asset purchase, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense as they are incurred. Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are recorded as selling, general and administrative expenses as incurred, as recoverability of such expenditures is uncertain. Shipping Shipping costs are included in cost of product sales. Sales Tax The Company collects and remits taxes assessed by various governmental authorities. These taxes may include sales, use and value added taxes. These taxes are recorded on a net basis and are excluded from revenues. Accounting for Stock-Based Compensation The Company’s stock-based compensation program grants awards that may consist of stock options and restricted stock awards. The fair values of stock option grants are determined as of the date of grant using the Black-Scholes option pricing method. This method incorporates the fair value of the Company’s common stock at the date of each grant and various assumptions such as the risk-free interest rate, expected volatility based on the volatility of the Company’s common stock price , expected dividend yield, and expected term of the options. The fair values of restricted stock awards are determined based on the fair value of the Company’s common stock. The fair values of the stock-based awards are then expensed over the requisite service period, which is generally the award’s vesting period. The Company classifies stock-based compensation expense in the consolidated statements of operations in the same manner in which the respective award recipient’s payroll costs are classified. For stock-based awards granted to consultants and nonemployees, compensation expense is recognized over the period during which services are rendered by such consultants and nonemployees until completed. At the end of each financial reporting period prior to completion of the service, the value of these awards is re-measured using the then-current fair value of the Company’s common stock and updated assumption inputs in the Black-Scholes option pricing model. Comprehensive Loss In addition to the Company’s net loss, comprehensive loss for the years ended December 31, 2018, 2017 and 2016, includes foreign currency translation adjustments related to the translation of foreign subsidiaries’ balance sheets. Net Loss Per Share The Company follows the two-class method when computing net loss per share, as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Restricted stock awards granted by the Company entitle the holder of such awards to dividends declared or paid by the Board of Directors, regardless of whether such awards are unvested, as if such shares were outstanding common shares at the time of the dividend. However, the unvested restricted stock awards are not entitled to share in the residual net assets (deficit) of the Company. Accordingly, in periods in which the Company reports a net loss or a net loss attributable to common stockholders resulting from preferred stock dividends, accretion or modifications, net losses are not allocated to participating securities. The Company reported a net loss in each of the years ended December 31, 2018, 2017 and 2016. Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities, including outstanding stock options. Diluted net loss per share is computed by dividing the diluted net loss by the weighted average number of shares of common stock, including potential dilutive shares of common stock assuming the dilutive effect of potentially dilutive securities. For periods in which the Company has reported net losses, diluted net loss per share is the same as basic net loss per share, since their impact would be anti-dilutive to the calculation of net loss per share. Diluted net loss per share is the same as basic net loss per share for each of the years ended December 31, 2018, 2017 and 2016. Concentration of Credit Risk and of Significant Suppliers and Customers Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments and accounts receivable. At December 31, 2018 and 2017, all of the Company’s fixed income marketable securities were invested in CDs insured by the Federal Deposit Insurance Corporation. The Company also generally maintains balances in various operating accounts in excess of federally insured limits at two accredited financial institutions. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Concentrations of credit risk with respect to accounts receivable, which are typically unsecured, are somewhat mitigated due to the wide variety of customers (large animal health companies, distributors, and veterinarians) purchasing the Company’s products. All of the Company’s accounts receivable arise from product sales sold by the Company in the United States and have standard payment terms which generally require payment within 30 days and licensing and collaboration revenue which require payment withi n 60 days. The Company monitors the financial health performance and credit worthiness of its customers so it can properly assess and respond to changes in their credit profile. The Company continues to monitor these conditions and assess their possible impact on it business. As of December 31, 2018 and 2017 , accounts receivable from Elanco Animal Health, Inc. (“Elanco”) accounted for 52% and 64% of the Company’s accounts receivable, net , respectively . As of December 31, 2017, accounts receivable from one distributor accounted for 15% of the Company’s accounts receivable, net. Revenues from one customer, Elanco, accounted for all licensing and collaboration revenue for the years ended December 31, 2018 and 2017, and approximately 66% and 23% of total revenues for the year s ended December 31, 2018 and 2017, respectively. During the year ended December 31, 2017, sales of finished goods to Elanco accounted for 79% of the Company’s net product sales. The Company is dependent on a combination of national and regional distributors for its product sales of ENTYCE. The Company’s product sales to two distributors accounted for more than 10% each and 26% collectively of the Company’s net product sales for the year ended December 31, 2018. The Company is also dependent on a small number of third-party manufacturers to supply active pharmaceutical ingredients (“API”) and formulated drugs for research and development activities in its programs and commercial supply, which would be adversely affected by a significant interruption in supply. Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. A fair value hierarchy based on three levels of inputs, of w |
Revenue
Revenue | 12 Months Ended |
Dec. 31, 2018 | |
Revenue [Abstract] | |
Revenue | 3 . Revenue Adoption of ASC 606 On January 1, 2018, the Company adopted ASC 606 using the modified retrospective method applied to those contracts that were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with the Company’s historic accounting under ASC 605. The Company recorded a net reduction of $6,800 , net of $0 tax, to the opening balance of accumulated deficit within stockholders’ equity, and a corresponding reduction to licensing and collaboration commitment as of January 1, 2018, due to the cumulative impact of adopting ASC 606, with the impact solely related to the Company’s variable consideration within its Collaboration Agreement (as defined below) with Elanco . Under previous guidance of ASC 605, this commitment was fully deferred and recognized as a liability until such time as payments under the obligation were made, or any unpaid portion would have been recognized as revenue when the commitment expired on December 31, 2018. Under ASC 606, this obligation is accounted for as variable consideration. At the adoption date, the Company recorded a contract liability based on the amount of the obligation expected to be paid, which was $200 . This amount was determined based on management estimates, which included consideration of Elanco’s development plan. Since inception of the arrangement, no amounts had been paid out or submitted to the Company for reimbursement. Had the Company still applied ASC 605 for the year ended December 31, 2018, revenues would have been $6,800 higher as compared to revenues recognized under ASC 606. Disaggregated Revenues The following table presents the Company’s revenues disaggregated by revenue source. All product sales are derived from United States sources and sales taxes are excluded from revenues. Year Ended December 31, 2018 2017 (1) 2016 (1) Revenues Licensing and collaboration revenue GALLIPRANT $ 23,326 $ 5,433 $ 38,000 Other — 480 233 Total licensing and collaboration revenue 23,326 5,913 38,233 Product sales NOCITA $ 7,511 $ 2,782 $ 148 ENTYCE 4,575 1,311 — GALLIPRANT — 15,526 — Other — 41 170 Total product sales 12,086 19,660 318 Total revenues $ 35,412 $ 25,573 $ 38,551 (1) Prior period amounts have not been adjusted under the modified retrospective method of ASC 606 and are reported under ASC 605. Product Sales The Company generates product sales revenues primarily by selling its marketed therapeutics directly to end users (such as veterinarians, clinics, or animal hospitals) and distributors. Direct to end user sales revenues consist primarily of NOCITA sales, and distributor product sales revenues consist primarily of ENTYCE sales. As of December 31, 2018 and 2017, reserves for product returns related to NOCITA and ENTYCE were $222 and $90 , respectively. Licensing and Collaboration Revenue The Company generates licensing and collaboration revenue solely from the Elanco Collaboration, License, Development and Commercialization Agreement (as amended, the “Collaboration Agreement”) and Co-Promotion Agreement (collectively, “the Elanco Agreements”) as follows: · sales-based royalties from the Elanco Agreements consisting of a percentage of net sales of GALLIPRANT by Elanco that are recognized as revenue as the underlying sales of GALLIPRANT are made by Elanco; · sales-based royalties from the Collaboration Agreement consisting of sales-based milestones of GALLIPRANT by Elanco that are recognized as revenue if and when the sales threshold is achieved by Elanco; · regulatory milestones from the Collaboration Agreement that are recognized as revenue if and when achieved; and · variable consideration related to the Collaboration Agreement licensing and collaboration commitment (contract liability) that is recognized as revenue when it is not subject to variable consideration constraint. Reconciliation of Contract Balances The change in contract liability balances for the year ended December 31, 2018, was as follows: Licensing and Collaboration Commitment 2018 As of January 1, $ 7,000 ASC 606 adoption (6,800) Revenue recognized (200) Payments made — As of the end of period, $ — The Company recorded a net reduction of $6,800, net of $0 tax, to the opening balance of accumulated deficit within stockholders' equity as of January 1, 2018, due to the cumulative impact of adopting ASC 606. Unsatisfied Performance Obligations As of the adoption date of ASC 606 and December 31, 2018, the Company had no unsatisfied performance obligations. Significant Judgments The Company’s significant judgments relate to the updating of the transaction price and variable consideration of the Collaboration Agreement. The Company used current facts and circumstances to calculate the updated transaction price using the expected value (probability - weighted estimate). Facts and circumstances considered included the status of the Elanco development plan for GALLIPRANT as of December 31, 2018. Practical Expedients and Exemptions The Company has deemed that there is no significant financing component present in the agreements with the Company’s customers as trade payment terms with its customers do not exceed one year. The Company expenses sales commissions when incurred because the amortization period would have been one year or less. These costs are recorded within selling, general and administrative expenses. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value of Financial Assets and Liabilities [Abstract] | |
Fair Value of Financial Assets and Liabilities | 4. Fair Value of Financial Assets and Liabilities Financial Assets and Liabilities Measured at Fair Value on a Recurring Basis The carrying values and estimated fair values of the Company’s financial assets which are measured at fair value on a recurring basis was as follows: Fair Value Measurements as of Carrying December 31, 2018 Using: Value Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Certificates of deposit $ 9,424 $ — $ 9,424 $ — $ 9,424 Short-term investments: Short-term marketable securities - certificates of deposit 1,240 — 1,240 — 1,240 $ 10,664 $ — $ 10,664 $ — $ 10,664 Fair Value Measurements as of Carrying December 31, 2017 Using: Value Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Certificates of deposit $ 8,964 $ — $ 8,964 $ — $ 8,964 Short-term investments: Short-term marketable securities - certificates of deposit 747 — 747 — 747 $ 9,711 $ — $ 9,711 $ — $ 9,711 The financial assets above are measured at fair value using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3). Certain estimates and judgments are required to develop the fair value amounts shown above. The fair value amounts shown above are not necessarily indicative of the amounts that the Company would realize upon disposition, nor do they indicate the Company’s intent or ability to dispose of the financial instrument. The following methods and assumptions were used to estimate the fair value of each material class of financial instrument: · Cash equivalents – the fair value of the cash equivalents has been determined to be amortized cost given the short duration of the securities. · Marketable securities (short-term) – the fair value of marketable securities has been determined to be amortized cost given the short duration of the securities. The Company had no financial liabilities measured at fair value on a recurring basis as of December 31, 2018 and 2017. Financial Assets and Liabilities that are not Measured at Fair Value on a Recurring Basis The carrying values and estimated fair values of the Company’s financial liabilities which are not measured at fair value on a recurring basis was as follows: December 31, 2017 Carrying Value Fair Value Liabilities: Loans payable (Level 2) $ 36,825 $ 36,973 The Company had no financial liabilities not measured at fair value on a recurring basis as of December 31, 2018. The financial liabilities above were measured at fair value using quoted prices in active markets for identical assets (Level 1); significant other observable inputs (Level 2); and significant unobservable inputs (Level 3). Certain estimates and judgments were required to develop the fair value amounts. The fair value amount shown above is not necessarily indicative of the amounts that the Company would realize upon disposition, nor does it indicate the Company’s intent or ability to dispose of the financial instrument. The fair value of loans payable was estimated using discounted cash flow analysis discounted at current rates. The Company had no financial assets not measured at fair value on a recurring basis as of December 31, 2018 and 2017. The carrying value of i ntellectual property rights acquired for in-process research and development was $0 as of December 31, 2018, and no impairment was recognized for the year ended December 31, 2018. The Company had intangible assets that were written down to fair value during the years ended December 31, 2017 and 2016. Fair value was determined using an income approach, specifically, the multi-period excess earnings method, a form of a discounted cash flow method. The Company started with a forecast of all the expected net cash flows associated with the asset and then it applied an asset-specific discount rate to arrive at a net present value amount. Some of the more significant estimates and assumptions inherent in this approach include: the amount and timing of the projected net cash flows, which includes the expected impact of competitive legal and/or regulatory forces on the product and the impact of technological risk associated with IPR&D intangible assets; the discount rate, which seeks to reflect the various risks inherent in the projected cash flows; and the tax rate, which seeks to incorporate the geographic diversity of the projected cash flows. |
Investments
Investments | 12 Months Ended |
Dec. 31, 2018 | |
Investments [Abstract] | |
Investments | 5. Investments Marketable Securities Marketable securities consisted of the following: December 31, 2018 Gross Gross Amortized Unrealized Unrealized Fair Cost Losses Losses Value Short-term marketable securities: Certificates of deposit $ 1,240 $ — $ — $ 1,240 Total $ 1,240 $ — $ — $ 1,240 December 31, 2017 Gross Gross Amortized Unrealized Unrealized Fair Cost Losses Losses Value Short-term marketable securities: Certificates of deposit $ 747 $ — $ — $ 747 Total $ 747 $ — $ — $ 747 At December 31, 2018 and 2017, short-term marketable securities consisted of investments that mature within one year. Short-term marketable securities are recorded as short-term investments in the consolidated balance sheets. |
Inventories
Inventories | 12 Months Ended |
Dec. 31, 2018 | |
Inventories [Abstract] | |
Inventories | 6. Inventories Inventories are stated at the lower of cost and net realizable value and consisted of the following: December 31, 2018 December 31, 2017 Raw materials $ 242 $ 1,132 Work-in-process 8,999 12,322 Finished goods 2,184 122 $ 11,425 $ 13,576 During the year ended December 31, 2018, the Company recognized inventory valuation adjustment losses in cost of product sales in the amount of $2,650 f rom the application of the lower of cost and net realizable value . The losses primarily related t o ENTYC E i nventories that were written down to net realizable value . Unfavorable outcomes of the Company’s ENTYCE commercialization efforts could result in additional inventory write downs in future periods. As of December 31, 2018, ENTYCE inventories amounted to $10,708 . As of December 31, 2017, raw materials included $777 of GALLIPRANT inventories. As part of the manufacturing transfer of GALLIPRANT (Note 12), the Company transferred these raw materials to Elanco , and was reimbursed for the raw materials by Elanco during 2018 . During the year ended December 31, 2017, the Company recognized an inventory valuation loss related to these raw materials in the amount of $347 from the application of lower of cost and net realizable value in the research and development expenses. Additionally, during the year ended December 31, 2017, the Company recognized an inventory valuation loss in the amount of $394 from the application of lower of cost and net realizable value in cost of product sales. The loss related to GALLIPRANT inventories that were written off. During the year ended December 31, 2016, the Company recognized an inventory valuation loss in the amount of $2,532 from the application of lower of cost and net realizable value in cost of product sales. The loss related to BLONTRESS and TACTRESS inventories that were written off and pre-launch GALLIPRANT inventories written down to market value due to terms agreed upon in the Elanco collaboration agreement (Note 12). Additionally, the Company expensed as research and development expenses $2,639 of previously capitalized process validation batches of ENTYCE intended to be used as commercial launch inventories and $1,983 of costs incurred related to manufacturing of ENTYCE under a firm purchase commitment due to the Company concluding at that time that the future commercial use and future economic benefit could no longer be reasonably determined. As of December 31, 2018, the Company had non-cancellable open orders for the purchase of inventories of $1,974 , which are expected to be paid in the next 12 months . |
Property and Equipment, Net
Property and Equipment, Net | 12 Months Ended |
Dec. 31, 2018 | |
Property and Equipment, Net [Abstract] | |
Property and Equipment, Net | 7. Property and Equipment, Net Property and equipment, net consisted of the following: December 31, 2018 December 31, 2017 Laboratory and office equipment $ 173 $ 173 Computer equipment and software 2,046 2,046 Furniture 135 135 Total property and equipment 2,354 2,354 Less: Accumulated depreciation and amortization (1,661) (1,188) Property and equipment, net $ 693 $ 1,166 Depreciation and amortization expense was $473 , $812 and $609 for the years ended December 31, 2018, 2017 and 2016, respectively. During the year ended December 31, 2017, the Company recognized impairment charges of $317 related to equipment previously used in its former San Diego, California, property in cost of products sales. No significant gains/losses on disposal of property and equipment were recognized during the years ended December 31, 2018, 2017 and 2016. |
Goodwill
Goodwill | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets [Abstract] | |
Goodwill | 8. Goodwill Goodwill is recorded as an indefinite-lived asset and is not amortized for financial reporting purposes but is tested for impairment on an annual basis or when indications of impairment exist. No goodwill impairment losses have been recognized to date. Goodwill is not expected to be deductible for income tax purposes. The Company completed its annual goodwill impairment testing during the third quarter of 2018. The Company elected to bypass the qualitative assessment. The Company determined as of the testing date that it consisted of one operating segment which is comprised of one reporting unit. In performing the quantitative goodwill impairment test , the Company determined that its fair value, determined to be its market capitalization, was greater than its carrying value, determined to be stockholders’ equity. Based on this result, the Company determined there was no impairment of goodwill as of the annual testing date. Goodwill as of December 31, 2018, was as follows: Gross Impairment Net Carrying Value Losses Carrying Value Goodwill $ 40,846 $ — $ 40,846 The change in the net book value of goodwill for the years ended December 31, 2018 and 2017, was as follows: 2018 2017 As of January 1, $ 41,295 $ 39,382 Effect of foreign currency exchange (449) 1,913 As of the end of the period, $ 40,846 $ 41,295 |
Intangible Assets, Net
Intangible Assets, Net | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets [Abstract] | |
Intangible Assets, Net | 9. Intangible Assets, Net The change in the net book value of intangible assets for the years ended December 31, 2018 and 2017, was as follows: 2018 2017 As of January 1, $ 6,616 $ 7,639 Additions (Note 12) — 6,000 Amortization expense (517) (350) Effect of foreign currency exchange — 775 Impairment — (7,448) As of the end of the period, $ 6,099 $ 6,616 The Company recognized amortization expense of $517 , $350 and $379 for the years ended December 31, 2018, 2017 and 2016 , respectively. Amortization expense of intangible assets for each of the five succeeding years as of December 31, 2018, was as follows: Year Ending December 31, 2019 $ 516 2020 516 2021 516 2022 516 2023 $ 516 Unamortized Intangible Assets As of both December 31, 2018 and 2017, the net carrying value of the Company’s unamortized intangible assets was $0 , which includes asset impairment charges of $24,213 . Impairment of Unamortized Intangible Assets AT-006 ( eprociclovir ) and AT-008 ( rabacfosadine ) During the fourth quarter of 2017, the Company determined that events and changes in circumstances indicated that the IPR&D intangible assets might be impaired. During the Company’s development program prioritization review, which included the consideration of a number of factors, including the Company’s inability to raise additional capital in November 2017, the Company decided to further delay the development of AT-006 and AT-008. Due to this delay the Company revisited all assumptions used in measuring the fair values of AT-006 and AT-008. This interim review resulted in fair values of these intangibles being less than their carrying values which resulted in an impairment charge of $7,448 , which was recorded during the fourth quarter of 2017, reducing the carrying values of both AT-006 and AT-008 to $0 . AT-007 (Feline immunodeficiency virus) The Company had been considering out-licensing or internally advancing the AT-007 program for feline immunodeficiency virus since an impairment expense of $8,717 was recorded in 2015. Due to the return of the AT-006 global rights from Elanco in May 2016 (Note 12) and ensuing development program portfolio prioritization, including consideration of the Company ’s focus on commercial launch activities to support its recently approved products, the Company decided to discontinue the development of AT-007 during the second quarter of 2016. This resulted in an impairment charge of $2,229 , which was recorded during the second quarter of 2016, reducing the carrying value of AT-007 to $0 . Amortized Intangible Assets Amortized intangible assets as of December 31, 2018, were as follows: Gross Net Weighted Carrying Accumulated Carrying Average Value Amortization Value Useful Life Intellectual property rights for currently marketed products $ 7,000 $ 901 $ 6,099 14.1 Years Amortized intangible assets as of December 31, 2017, were as follows: Gross Net Weighted Carrying Accumulated Carrying Average Value Amortization Value Useful Life Intellectual property rights for currently marketed products $ 7,000 $ 384 $ 6,616 14.1 Years Intellectual property rights for formerly marketed products 38,652 38,652 — N/A $ 45,652 $ 39,036 $ 6,616 Accumulated amortization includes both amortization expense and asset impairment charges. Asset impairment charges through December 31, 2018 and 2017 were $25,390 and $9,185 for BLONTRESS and TACTRESS, respectively. Unfavorable estimates of the Company’s therapeutics’ market opportunities or u nfavorable outcomes of the Company’s development activities , expected future cash flows and estimated useful lives could result in impairment charges in future periods. Intellectual Property Rights for Currently Marketed Products As of December 31, 2018 and 2017, intellectual property rights for currently marketed products relate to intangible assets capitalized for NOCITA, GALLIPRANT and ENTYCE in conjunction with approval/post-approval milestone payments made under the Company's licensing agreements. Impairment of Amortized Intangible Assets Since the acquisition of Vet Therapeutics, Inc. (October 2013), the Company performed various scientific and clinical activities to gain further knowledge around the science and efficacy of BLONTRESS and TACTRESS. BLONTRESS In the third quarter of 2015, the Company noted that scientific studies suggested that BLONTRESS was not as specific to the target as previously expected. The Company ’s market research and interactions with veterinary oncologists indicated that high specificity, including binding and depletion, will likely be necessary to drive wide adoption of monoclonal antibody therapy given that canine B-cell is generally chemotherapy sensitive. Furthermore, the Company was aware of other emerging therapies that would compete in the B-cell lymphoma market, and believed that products with break-through benefit will dominate the market. Given those scientific results and competitive assessment, the Company recorded an impairment expense of $20,228 in 2015. In the fourth quarter of 2016, the Company received final data from the Mini B-CHOMP study, which evaluated an abbreviated chemotherapy (CHOP) protocol in dogs with B-cell lymphoma. The results confirmed that BLONTRESS did not seem to be adding significant progression-free survival in canine B-cell lymphoma. While BLONTRESS remained commercially available, the Company deemed the results of Mini B-CHOMP study and the updated commercial expectations as a result of the Mini B-CHOMP study results, as indicators of potential impairment of its finite-lived intangible asset BLONTRESS during the fourth quarter of 2016. The Company performed impairment testing for the intangible asset BLONTRESS as of December 31, 2016, and recorded an impairment expense of $5,162 during the fourth quarter of 2016, resulting in a net carrying value of $0 for BLONTRESS. TACTRESS In the third quarter of 2015, the Company ’s interim analysis of the clinical results indicated that TACTRESS did not seem to be adding significant progression free survival in canine T-cell lymphoma; those results were confirmed in the final study results in July 2016. In addition, scientific studies suggested that TACTRESS was not as specific to the target as expected. Given those clinical and scientific results, the Company no longer believed that TACTRESS would capture the desired T-cell lymphoma market opportunity and recorded an impairment expense of $8,634 in 2015. While TACTRESS remained commercially available, the use by oncologists had been more limited than the Company anticipated, resulting in sales during the second quarter of 2016, being significantly lower than forecasted. The Company deemed the events and market projections described above to be indicators of potential impairment of its finite-lived intangible asset TACTRESS during the second quarter of 2016. The Company performed impairment testing for the intangible asset TACTRESS as of June 30, 2016, and recorded an impairment expense of $551 during the second quarter of 2016, resulting in a net carrying value of $0 for TACTRESS . |
Debt
Debt | 12 Months Ended |
Dec. 31, 2018 | |
Debt [Abstract] | |
Debt | 10. Debt Loan and Security Agreements Effective as of October 16, 2015, the Company and Vet Therapeutics, Inc., (the “ Borrowers ”), entered into a Loan and Security Agreement (“Loan Agreement”), with the Pacific Wes tern Bank, as a collateral agent and Oxford Finance, LLC, (the “Lenders”), pursuant to which the Lenders agreed to make available to the Company term loan in an aggregate principal amount up to $35,000 and a revolving credit facility in an aggregate principal amount up to $5,000 subject to certain conditions to funding. The term loan and the revolving credit facility b ore interest per annum at the greater of (i) 6.91% or (ii) 3.66% plus the prime rate. Effective as of July 31, 2017, the Borro wers and the Lenders entered into a second amendment to the Loan Agreement (the “Second Amendment”). The terms of the Second Amendment, among other things, extend ed the maturity date of the existing revolving credit facility to October 16, 2019 (the “Revolving Line Maturity Date”), with amortized equal repayments of the principal outstanding under the revolving credit facility beginning November 1, 2018, and provide d a six -month interest only period for the term loans, starting on the date of the Second Amendment. At the closing of the Second Amendment, the Company paid the Lenders an amendment fee of $150 and a facility fee of $60 . The Company was obligated to pay a new termination fee equal to $165 upon the earliest to occur of the Revolving Line Maturity Date, the acceleration of the revolving credit facility or the termination of the revolving credit facility. The existing termination fee of $165 was due upon the original revolving maturity date, October 16, 2017 , and was paid on October 17, 2017. The Company wa s obligated to pay a final payment fee equal to 3.30% of the principal amount of the term loan upon repayment. On December 21, 2018, the Company repaid in full all outstanding indebtedness and terminated all commitments and obligations under its Loan Agreement between the Borrowers and the Lenders. The Company’s payment to the Lenders under the Loan Agreement , which included outstanding principal and interest balances as well as the final payment fee and the termination fee, was $20,610 , and satisfie d all of the Company’s debt obligations. The Company did not incur any early termination penalties as a result of the repayment of indebtedness or termination of the Loan Agreement . In connection with the repayment of outstanding indebtedness by the Company , the Borro wers were automatically and permanently released from all security interests, mortgages, liens and encumbrances under the Loan Agreement. During the years ended December 31, 2018, 2017 and 2016 , the Company recognized interest expense of $3,391 , $3,481 a nd $3,396 , respectively. Amortization of debt issuance costs and accretion of final payment and termination fees, recognized as interest expense, w ere $994 , $513 and $477 for the years ended December 31, 2018, 201 7 and 201 6 , respectively. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 12 Months Ended |
Dec. 31, 2018 | |
Accrued Expenses and Other Current Liabilities [Abstract] | |
Accrued Expenses and Other Current Liabilities | 11. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: December 31, 2018 December 31, 2017 Payroll and related expenses $ 2,587 $ 2,314 Professional fees 353 208 Royalty expense 812 718 Interest expense — 249 Research and development costs 73 5 Accrued loss on a firm purchase commitment 72 — Other 749 218 Total $ 4,646 $ 3,712 |
Agreements
Agreements | 12 Months Ended |
Dec. 31, 2018 | |
Agreements [Abstract] | |
Agreements | 12. Agreements RaQualia Pharma Inc. (“RaQualia”) On December 27, 2010, the Company entered into two Exclusive License Agreements with RaQualia (as amended, the “RaQualia Agreements”) that granted the Company global rights, subject to certain exceptions for injectables in Japan, Korea, China and Taiwan for development and commercialization of licensed animal health products for compounds RQ-00000005 (ENTYCE, also known as AT-002) and RQ-00000007 (GALLIPRANT, also known as AT-001). The Company will be required to pay RaQualia remaining milestone payments associated with GALLIPRANT and ENTYCE of up to $4,000 and $3,000 , respectively, upon the Company’s achievement of certain development, regulatory and commercial milestones, as the well as mid-single digit royalties on the Company’s or the Company’s sublicensee’s product sales. The Company achieved milestones totaling $0 , $6,000 and $5,500 during the years ended December 31, 2018, 2017, and 2016, respectively. Milestones achieved in 2017 were capitalized as intangible assets and milestones achieved in 2016 were expensed within research and development expenses. As of December 31, 2018, the Company had paid $11,500 in milestone payments since execution of the RaQualia Agreements, and no milestone payments were accrued. It is possible that a milestone related to the RaQualia Agreements will be achieved within the next the twelve months totaling $2,000 . Pacira Pharmaceuticals, Inc. (“Pacira”) On December 5, 2012, the Company entered into an Exclusive License, Development, and Commercialization Agreement with Pacira (the “Pacira License Agreement”) that granted the Company global rights for development and commercialization of licensed animal health products for NOCITA (also known as AT-003). On the same date, the Company also entered into a supply agreement with Pacira (the “Pacira Supply Agreement”, and together with the Pacira License Agreement, the “Pacira Agreements”). On July 5, 2018 (the “Effective Date”), the Company and Pacira entered into an amendment and restatement of the Pacira License Agreement (“A&R License Agreement”) and an amendment and restatement of the Pacira Supply Agreement (the “A&R Supply Agreement”). Under the A&R Supply Agreement, Pacira has agreed to manufacture and supply the licensed product in a 10 mL vial size in addition to the 20 mL vial size that is currently supplied to the Company. The supply price for the 10 mL vial size will remain fixed until December 31, 2021. Prior to December 31, 2021, the Company and Pacira have agreed to negotiate in good faith the applicable terms related to the 10 mL vial, including the price, for after December 31, 2021. If the Company and Pacira are unable to reach agreement, then as of January 1, 2022, and on each anniversary thereafter during the term of the A&R Supply Agreement, the price for the 10 mL vial will be automatically increased by a low single-digit percentage. The A&R License Agreement amended various sections of the Pacira License Agreement, including milestone payments and royalties, to incorporate the introduction of the 10 mL vial size. Prior to December 31, 2021, the Company will not be obligated to pay any royalty payments to Pacira on the sales of the 10 mL vial and thereafter, the Company and Pacira have agreed to negotiate in good faith the applicable terms relating to the 10 mL vial in accordance with the A&R Supply Agreement. The tiered royalties on the Company’s product sales of 20 mL vials remain unchanged. In addition, the A&R License Agreement reduces the annual net sales thresholds for achieving each of the potential commercial milestone payments owed to Pacira. The remaining $40,000 of commercial milestones per the A&R License Agreement begin to be triggered once NOCITA annual net sales reach $50,000 with the final tier being owed to Pacira once NOCITA annual net sales reach $250,000 . Further, the A&R License Agreement lowered the minimum annual revenue payment to be provided to Pacira by the Company and delayed by one year the first period in which this minimum annual revenue payment requirement would be triggered such that the period is now expected to commence on January 1, 2023. The definition of a competing product was specified and narrowed to those injectable analgesic products preventing pain for at least forty-eight to seventy-two hours post-surgery as an active pharmaceutical ingredient (“API”) labeled for the control of post-operative pain for surgical veterinary use. The term of the A&R License Agreement was extended with the initial term commencing as of the new Effective Date. The Company achieved milestones totaling $0 , $0 and $2,000 during the years ended December 31, 2018, 2017 and 2016, respectively. Of the $2,000 in achieved milestones in 2016, $1,000 was capitalized as intangible assets and the other $1,000 was expensed within research and development expenses. As of December 31, 2018, the Company had paid $2,500 in milestone payments since execution of the Pacira Agreements, and no milestone payments were accrued. The Company does not expect to achieve any milestones related to the A&R Agreement in the next the twelve months. Elanco BLONTRESS On December 6, 2012, Vet Therapeutics entered into an Exclusive Commercial License Agreement with Elanco (formerly Novartis Animal Health, Inc.) (the “Elanco BLONTRESS Agreement”) under which Vet Therapeutics granted a commercial license to Elanco for BLONTRESS for the United States and Canada. On January 2, 2015, the Company was granted a full product license from the USDA for BLONTRESS. The approval resulted in a $3,000 milestone payment being earned and due to the Company per the terms of the Elanco BLONTRESS Agreement. During the first quarter of 2015, the Company recognized $3,000 of licensing revenue related to the milestone payment. On February 24, 2015, the Company and Elanco agreed to terminate the Elanco BLONTRESS Agreement. In consideration for the return of the commercial license granted to Elanco, the Company paid Elanco $2,500 in March 2015, and was to be required to pay an additional $500 upon the first commercial sale by the Company. At that time the Company determined that it was probable that the $500 payment will be paid, and recorded the $500 as a current liability in the first quarter of 2015. The first commercial sale occurred in March 2016. The Company recorded the $3,000 owed to Elanco as a reduction in revenues received from Elanco as the payment was to re-acquire rights that the Company had previously licensed to Elanco. On February 25, 2016, the Company and Elanco agreed to amend the terms related to the $500 payment due upon the first commercial sale by the Company. Under the amended terms, upon the first commercial sale in March 2016, the Company was required to pay quarterly a royalty per vial sold until $500 in royalties were paid or the end of two years. After two years, the Company would have been required to pay Elanco $500 plus 10% interest, compounded annually against any unpaid balance, less any royalties paid during the two years. If during the two years following the first commercial sale the Company withdrew BLONTRESS from the market and ceased all commercialization, the remaining royalty and related interest would no longer be payable. On November 13, 2017, the Company withdrew BLONTRESS from the market and ceased all commercialization making the remaining royalty and interest no longer payable. During the year ended December 31, 2017, the Company recognized $480 in licensing and collaboration revenue due to the derecognition of the remaining balance of the liability. GALLIPRANT On April 22, 2016, the Company entered into a Collaboration Agreement pursuant to which the Company granted Elanco rights to develop, manufacture, market and commercialize the Company’s products based on licensed grapiprant rights and technology, including GALLIPRANT (collectively, “Grapiprant Products”). Pursuant to the Collaboration Agreement, Elanco will have exclusive rights globally outside the United States and co-promotion rights with the Company in the United States during the term of the Collaboration Agreement. Under the terms of the Collaboration Agreement, the Company received a non-refundable, non-creditable upfront payment of $45,000 . The Company is entitled to a $4,000 milestone payment upon European approval of a Grapiprant Product for the treatment of pain and inflammation, another $4,000 payment upon achievement of a development milestone related to the manufacturing of a Grapiprant Product from an alternate supply source, and payments up to $75,000 upon the achievement of certain sales milestones, of which $15,000 was achieved in 2018. The sales milestone payments are subject to a one -third reduction for each year the occurrence of the milestone is not achieved beyond December 31, 2021, with any non-occurrence beyond December 31, 2023, cancelling out the applicable milestone payment obligation entirely. The Collaboration Agreement also provides that Elanco will pay the Company royalty payments on a percentage of net sales in the mid-single to low double digits. The Company was responsible for all development activities required to obtain the first registration or regulatory approval for a Grapiprant Product for use in dogs in each of the European Union (“the EU Product Registration”) and the United States, and Elanco was responsible for all other development activities. First registration for a Grapiprant Product in the United States was achieved before the completion of the Collaboration Agreement and EU Product Registration was achieved in January 2018. In addition, the Company and Elanco agreed to pay 25% and 75% , respectively, of all third-party development fees and expenses through December 31, 2018, in connection with preclinical and clinical trials necessary for any additional registration or regulatory approval of Grapiprant Products, provided that the Company’s contribution to such development fees and expenses was capped at $7,000 (“R&D Cap”), which was recorded as licensing and collaboration commitment liability in the consolidated balance sheets at December 31, 2017. Upon adoption of ASC 606 (Note 3), the Company relieved $6,800 of its licensing and collaboration commitment liability. The licensing and collaboration commitment liability balance was update d at each reporting date to reflect current facts and circumstances. The remaining bal a nce of $200 was recognized as licensing and collaboration revenue in the consolidated statements of operations in the fourth quarter of 2018 . Commencing on the effective date of the Collaboration Agreement, the Company was responsible for the manufacture and supply of all of Elanco’s reasonable requirements of API and/or finished Grapiprant Products under the supply terms agreed upon pursuant to the Collaboration Agreement. However, Elanco retained the ability to assume all or a portion of the manufacturing responsibility during the term of the Collaboration Agreement. On April 28, 2017, the Company and Elanco entered into an amendment (the “Amendment”) to the Collaboration Agreement. Under the Amendment, Elanco agreed to submit binding purchase orders to the Company, within 15 days of the effective date of the Amendment, for certain finished Grapiprant Products to be produced from certain batches of API the Company had agreed to purchase from its third-party manufacturer (the “API Batches”). In addition, Elanco agreed to pay the Company for the API Batches within 30 days after the Company provides Elanco with proof of payment to the manufacturer for such API Batches. The Amendment provides that, in the event Elanco provided notice of its intent to assume responsibility for manufacturing, Elanco would assume all responsibilities of the Company with respect to any undelivered API, including paying the third-party manufacturer for such undelivered API. In July 2017, pursuant to Sections 8.2.2 and 10.1(c) of the Collaboration Agreement, as amended, Elanco provided the Company notice of its intent to assume responsibility for manufacturing of the Grapiprant Products and its intent to assume the applicable regulatory approvals. In September 2017, the Company and Elanco finalized the transfer of the applicable regulatory approvals in the United States and the responsibility for manufacturing of Grapiprant Products to Elanco. In connection with this assumption of manufacturing responsibility, Elanco compensated the Company $10,832 for certain Grapiprant Product inventories and manufacturing considerations. During the year ended December 31, 2017, the Company recognized $1,000 of licensing and collaboration revenues and $6,099 of product sales related to the assumption of manufacturing responsibility by Elanco. On April 22, 2016, in connection with the Collaboration Agreement, the Company entered into a Co-Promotion Agreement (the “Co-Promotion Agreement”) with Elanco to co-promote Grapiprant Products in the United States. Under the terms of the Co-Promotion Agreement, Elanco has agreed to pay the Company, as a fee for promotional services performed and expenses incurred by the Company under the Co-Promotion Agreement, (i) 25% of the gross margin on net sales of Grapiprant Product sold in the United States under the Collaboration Agreement prior to December 31, 2018, and (ii) a mid-single digit percentage of net sales of Grapiprant Product in the United States after December 31, 2018 through 2028 (unless extended by mutual agreement). The Company concluded that the Collaboration Agreement and Co-Promotion Agreement represent a multiple-element arrangement, and evaluated if deliverables in the arrangement represent separate units of accounting. The Company identified the following deliverables under the agreement: (i) a royalty-bearing, sub-licensable, development, manufacturing and commercialization license; (ii) manufacturing and supply services; (iii) participation in a joint manufacturing subcommittee; and (iv) services associated with obtaining the EU Product Registration. The Company performed an assessment and concluded that the license had stand-alone value from the other undelivered elements in the arrangement. The Company’s best estimate of the selling price for the manufacturing subcommittee and the EU Product Registration services were immaterial and, therefore, no consideration was allocated to these deliverables. Under the manufacturing and supply services terms, Elanco was obligated to pay for any future orders at a price per unit representative of market value, and, therefore, no upfront consideration was allocated to this deliverable. Under the ASC 605 guidance, t he Company allocated $38,000 of the $45,000 upfront payment to the license, and recognized $38,000 of licensing and collaboration revenue during the quarter ended June 30, 2016. The Company allocated $7,000 of upfront consideration to the R&D Cap, which was recorded as licensing and collaboration commitment liability in the consolidated balance sheet as a current liability at December 31, 2017. T he Company earned sales milestones totaling $15,000 , $0 and $0 during the years ended December 31, 2018, 2017, and 2016, respectively. As of December 31, 2018, the Company had been paid $15,000 in milestone payments since the effective date of the Collaboration Agreement, and no milestone payments were accrued. The Company will recognize revenue from any additional milestones if and when they are achieved by Elanco. Advaxis Inc. (“Advaxis”) On March 19, 2014, the Company entered into an Exclusive License Agreement with Advaxis (the “Advaxis Agreement”) that granted the Company global rights for development and commercialization of licensed animal health products for Advaxis’ ADXS-cHER2 for the treatment of osteosarcoma in dogs (“AT-014”) and three additional cancer immunotherapy products for the treatment of three other types of cancer. The Company will be required to pay Advaxis remaining milestone payments of up to an additional $6,000 in clinical and regulatory milestones for each of the four products, assuming approvals in both cats and dogs, in both the United States and the European Union. In addition, the Company agreed to pay up to $28,500 in commercial milestones, as the well as tiered royalties ranging from mid-single digit to 10% on the Company’s product sales, if any. As of December 31, 2018, the Company had not accrued or paid any milestone payments since execution of the Advaxis Agreement. T he Company does not expect to achieve any milestones related to the Advaxis Agreement in the next the twelve months. VetStem BioPharma, Inc. (“VetStem”) On June 12, 2014, the Company entered into an Exclusive License Agreement with VetStem (as amended, the “VetStem Agreement”) that granted the Company the exclusive United States rights for commercialization and development of VetStem’s allogeneic stem cells being developed for the treatment of pain and inflammation of canine osteoarthritis. The Company achieved milestones totaling $0 , $250 and $450 during the years ended December 31, 2018, 2017 and 2016, respectively, which were expensed within research and development expenses. In January 2018, the Company exercised its ri ght to terminate the VetStem Agreement, and on April 19, 2018, the termination became effective. During the year ended December 31, 2018, the Company did not incur any development expenses or milestones . As a result of the termination of the VetStem Agreement, the Company does not anticipate having to reimburse any further development expenses or make milestone payments to VetStem. Though the date of the termination of the VetStem Agreement , the Company had paid $1,000 in milestone payments and no royalty payments since execution of the VetStem Agreement and no milestone payments or royalties were accrued. Atopix Therapeutics Ltd. (“Atopix”) On October 10, 2014, the Company entered into an Exclusive License Agreement with Atopix (the “Atopix Agreement”) that granted the Company an exclusive global license for development and commercialization of animal health products containing the API included in Atopix’s CRTH2 antagonist product for the treatment of atopic dermatitis. Under the terms of the Atopix Agreement, the Company paid an initial license fee of $1,000 . On the date of acquisition, the licensed technology had not reached technological feasibility in animal health indications and had no alternative future use in the field of animal health. Accordingly, in-process research and development of $1,000 was expensed upon acquisition. The Company will be required to pay Atopix remaining milestone payments of up to an additional $4,000 in clinical and regulatory milestones, assuming approvals in both cats and dogs, in both the United States and the European Union, as the well as tiered royalties in the mid-single digits on the Company’s product sales, if any. The Company achieved no milestones during the years ended December 31, 2018, 2017 and 2016. As of December 31, 2018, the Company had paid $500 in milestone payments and no royalty payments since execution of the Atopix Agreement and no milestone payments or royalties were accrued. The Company does not expect to achieve any milestones related to the Atopix Agreement in the next the twelve months. AskAt Inc. (“AskAt”) AT-019 On February 28, 2018, the Company entered into an Exclusive License Agreement with AskAt (the “AskAt Agreement”) that granted the Company an exclusive global license for development and commercialization of compound AT-019 in the field of animal health. Under the terms of the AskAt Agreement, the Company paid an initial upfront license fee of $500 in the second quarter of 2018. The AskAt Agreement was accounted for as an asset acquisition. On the date of acquisition, the licensed technology had not reached technological feasibility in animal health indications and had no alternative future use in the field of animal health. Accordingly, in-process research and development expense of $500 was recorded upon acquisition in the first quarter of 2018 and paid in the second quarter of 2018. The Company will be required to pay remaining milestone payments of up to $15,500 upon the Company’s achievement of milestones, including $3,000 of development/regulatory milestones and $12,500 of commercial milestones as the well as tiered single digit royalties on the Company’s product sales, if any. The commercial milestones owed to AskAt under the AskAt Agreement begin to be triggered upon the first commercial sale with the final tier being owed to AskAt once annual net sales reach $100,000 . Milestones, at the discretion of the Company, can be paid 50% in cash and 50% in a number of the Company’s shares as determined per the terms of the AskAt Agreement. The Company achieve d no milestones during the year ended December 31, 2018 . As of December 31, 2018, the Company had not accrued or paid any milestone or royalty payments since execution of the AskAt Agreement. The Company does not expect to achieve any milestones related to the AskAt Agreement in the next twelve months. Collaboration and Option Agreement On February 28, 2018, in connection with the AskAt Agreement, the Company entered into Collaboration and Option Agreement (the “COA”) with AskAt for animal health research, including an option agreement for multiple therapeutic candidates with potential in pain, allergy and cancer. D uring the first quarter of 2018, the Company paid an initial upfront option fee of $500 under the terms of the COA, which was recognized as research and development expense in the consolidated statements of operations. In December 2018, the Company exercised its right to terminate the COA, and on February 18, 2019, the termination became effective. As a result of the termination of the COA, the Company does not anticipate make any further COA - related payments to AskAt. Government and Other Incentive Programs The Company has received payments from various government and other incentive programs. Generally, under these programs the Company could be obligated to repay any payments received if certain criteria are not met or certain actions are taken by the Company. The Company could be required to repay up to $854 under these incentive programs as of December 31, 2018. The Company has determined these contingencies to be within its control and will only account for repayment(s) if it becomes probable that the Company will be obligated to repay as result of its actions. |
Common Stock
Common Stock | 12 Months Ended |
Dec. 31, 2018 | |
Common Stock [Abstract] | |
Common Stock | 13. Common Stock Authorized Common Stock As of December 31, 2018 and 2017, the authorized number shares of common stock was 100,000,000 , par value $0.001 per share. Common Stock Outstanding As of December 31, 2018 and 2017, there were 48,048,914 and 42,532,725 shares of the Company’s common stock outstanding respectively, net of 535,599 and 491,861 shares of unvested restricted common stock, respectively. Treasury Stock As of December 31, 2018 and 2017, there were 94,107 and 80,916 shares of the Company’s common stock held as treasury stock at a cost of $1,175 and $1,107 , respectively. During the years ended December 31, 2018, 2017 and 2016, 13,191 , 2,690 and 0 shares of restricted stock at a cost of $5.17 , $6.88 and $0 per share, respectively, were withheld to satisfy employee tax withholding obligations arising in conjunction with the vesting of restricted stock pursuant to the Company’s 2013 Incentive Award Plan (the “2013 Plan”). Voting Rights Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. Common stockholders are entitled to receive dividends, as may be declared by the Board of Directors, if any. As of December 31, 2018 and 2017, the Board of Directors had not declared any dividends in any period. Stock-Based Awards During the years ended December 31, 2018 and 2017, the Company issued common stock pursuant to the 2013 Plan (Note 14). During the years ended December 31, 2018 and 2017, the Company did not reacquire any unvested shares of common stock from its terminated employees that had been issued upon the exercise of a stock option prior to its vesting. Shelf Registration Statement On August 4, 2017, the Company filed a shelf registration statement on Form S-3 (Reg. No. 333-219681) (the “Shelf Registration Statement”) with the SEC. The Shelf Registration Statement was declared effective by the SEC on August 16, 2017. The Shelf Registration Statement allows the Company to offer and sell, from time to time, up to $100,000 of common stock, preferred stock, debt securities, warrants, units or any combination of the foregoing in one or more future public offerings. The terms of any future offering would be determined at the time of the offering and would be subject to market conditions and approval by the Company’s Board of Directors. Any offering of securities covered by the Shelf Registration Statement will be made only by means of a written prospectus and prospectus supplement authorized and filed by the Company. At-the-Market Offerings Cowen and Company, LLC On December 18, 2017, the Company entered into a Sales Agreement (“Cowen Sales Agreement”) with Cowen and Company, LLC (“Cowen”) pursuant to which the Company may sell from time to time, at its option, up to an aggregate of $50,000 of shares of its common stock through Cowen, as sales agent. Any sales of the shares of common stock would be made under the Company’s effective Registration Statement on Form S-3 (Reg. No. 333-219681), by means of ordinary brokers’ transactions on the Nasdaq Global Market or otherwise. Additionally, under the terms of the Cowen Sales Agreement, the shares of common stock may be sold at market prices, at negotiated prices or at prices related to the prevailing market price. The Company has agreed to pay Cowen a commission of 3% of the gross proceeds from the sale of such shares of common stock. During the year ended December 31, 2018, the Company sold 5,144,244 shares of common stock for aggregate net proceeds of $24,223 , after deducting commission fees of $754 and issuance costs of $171 . As of the date of this filing, approximately $24,852 of shares of common stock remained available for sale under the Cowen Sales Agreement. Barclays Capital Inc. (“Barclays”) On October 16, 2015, the Company entered into a sales agreement with Barclays pursuant to which the Company could sell from time to time, at its option, up to an aggregate of $52,000 of shares of its common stock through Barclays, as sales agent. Sales of the shares of common stock were made under the Company’s then effective registration statement on Form S-3 (Reg. No. 333-197414), by means of ordinary brokers’ transactions on the Nasdaq Global Market or otherwise. Additionally, under the terms of the Barclays sales agreement, the shares of common stock could be sold at market prices, at negotiated prices or at prices related to the prevailing market price. The Company paid Barclays a commission of 2.75% of the gross proceeds from the sale of the shares of common stock. On April 28, 2017, the Company terminated its Barclays sales agreement. As of that date, the Company sold an aggregate of approximately $18,000 of the $52,000 available to be sold under the Barclays sales agreement. Registered Direct Offering On May 3, 2017, the Company entered into a Placement Agency Agreement (“PAA”) with Barclays, pursuant to which Barclays agreed to serve as placement agent for an offering of shares of common stock. In conjunction with the PAA, on May 3, 2017, the Company also entered into a Securities Purchase Agreement with certain investors for the sale by the Company of 5,000,000 shares of common stock at a purchase price of $5.25 per share (the “Offering”). The shares of common stock were offered and sold pursuant to the Company’s previously filed and then effective registration statement on Form S-3 (File No. 333-197414) and a related prospectus supplement. The Company agreed to pay Barclays an aggregate fee equal to 6.0% of the gross proceeds received by the Company from the Offering. The Offering closed on May 9, 2017 , and the Company received aggregate net proceeds from the Offering of approximately $24,400 , after deducting placement agent fees of $1,575 and offering expenses of $273 . |
Stock-Based Awards
Stock-Based Awards | 12 Months Ended |
Dec. 31, 2018 | |
Stock-Based Awards [Abstract] | |
Stock-Based Awards | 14. Stock-Based Awards 2010 Equity Incentive Plan In 2010, the Company’s Board of Directors adopted the 2010 Equity Incentive Plan (the “2010 Plan”). The 2010 Plan provided for the Company to sell or issue common stock or restricted common stock and to grant incentive stock options or nonqualified stock options for the purchase of common stock with a maximum term of ten years to employees, members of the Board of Directors and consultants of the Company. With the adoption and approval of the 2013 Plan, no further awards will be granted from the 2010 plan. Stock Options Activity related to stock options for the year ended December 31, 2018, was as follows: Weighted Shares Weighted Average Issuable Average Remaining Aggregate Under Exercise Contractual Intrinsic Options Price Term Value (In Years) Outstanding as of December 31, 2017 57,394 $ 4.22 5.11 $ 73 Granted — — Exercised — — Forfeited — — Expired (4,011) 5.57 Outstanding as of December 31, 2018 53,383 $ 4.12 4.10 $ 107 Options vested and expected to vest as of December 31, 2018 53,383 $ 4.12 4.10 $ 107 Options exercisable as of December 31, 2018 53,383 $ 4.12 4.10 $ 107 For the years ended December 31, 2018, 2017 , and 2016 , the total intrinsic value of options exercised was $0 , $53 and $180 , respectively. For the years ended December 31, 2018, 2017 and 2016 , the total fair value of awards vested during the period was $0 , $8 and $209 , respectively. The Company received cash proceeds of $0 , $3 and $9 from the exercise of stock options for the years ended December 31, 2018, 2017 and 2016 , respectively, none of which were from the early exercise of stock options. 2013 Incentive Award Plan In 2013, the Company’s Board of Directors adopted and stockholders approved the 2013 Plan which became effective upon the day prior to the effective date of the Company’s initial public offering. The 2013 Plan as of December 31, 2018 allows for the issuance of up to 6,832,405 shares of common stock, plus any additional shares represented by the 2010 Plan that are forfeited or lapse unexercised. The number of shares of common stock that may be issued under the plan is also subject to an annual increase on January 1 st of each calendar year beginning in 2014 and ending in 2023, equal to the lesser of (i) 1,203,369 shares, (ii) 4% of the shares of common stock outstanding on the final day of the immediately preceding calendar year and (iii) an amount determined by the Board of Directors. As of December 31, 2018, there were 1,829,915 shares available for future grant under the 2013 Plan. On January 1, 2019, the annual increase was determined to be 1,203,369 . The 2013 Plan is administered by the Compensation Committee of the Board of Directors, which selects the individuals eligible to receive awards, determines or modifies the terms and condition of the awards granted, accelerates the vesting schedule of any award and generally administers and interprets the 2013 Plan. The 2013 Plan permits the granting of incentive and nonqualified stock options, with terms of up to ten years and the granting of restricted stock, restricted stock units, performance stock awards, dividend equivalent rights, stock payments (i.e. unrestricted stock), cash bonuses and stock appreciation rights to employees, consultants, and non-employee directors. Stock Options During the year ended December 31, 2018, the Company granted under the 2013 Plan stock options for the purchase of 798,000 shares of common stock to certain employees and non-employee directors. The vesting conditions for most of these awards are time-based, and the awards typically vest 25% after one year and monthly thereafter for the next 36 months. Awards typically expire after 10 years. Activity related to stock options for the year ended December 31, 2018, was as follows: Weighted Shares Weighted Average Issuable Average Remaining Aggregate Under Exercise Contractual Intrinsic Options Price Term Value (in Years) Outstanding as of December 31, 2017 2,557,143 $ 11.45 7.41 $ 794 Granted 798,000 4.84 Exercised (4,709) 3.14 Forfeited (151,603) 6.24 Expired (84,430) 17.18 Outstanding as of December 31, 2018 3,114,401 $ 9.86 6.85 $ 2,047 Options vested and expected to vest as of December 31, 2018 3,114,401 $ 9.86 6.85 $ 2,047 Options exercisable as of December 31, 2018 1,961,944 $ 12.40 5.82 $ 755 For the years ended December 31, 2018, 2017 and 2016 , the weighted average grant date fair value of stock options granted was $3.16 , $5.13 and $2.99 , respectively. For the years ended December 31, 2018, 2017 and 2016 , the total intrinsic value of options exercised was $9 , $185 and $38 , respectively. For the years ended December 31, 2018, 2017 and 2016 , the total fair value of awards vested during the period was $3,178 , $ 4,424 and $ 5,380 , respectively. The Company received cash proceeds of $15 , $244 and $129 from the exercise of stock options for the years ended December 31, 2018, 2017 and 2016 , respectively. Restricted Common Stock The Company’s 2013 Plan provides for the award of restricted common stock. The Company has granted restricted common stock typically with time-based vesting conditions, having terms of between several months and three years . Since 2016, the awards granted to executives typically vest in 12 quarterly installments of 8.33% per quarter for three years. The awards granted to non-executives typically vest in three annual installments of 33.3% each year for three years. Awards granted to consultants typically vest in accordance with the expected length of the consulting arrangement. Unvested shares of rest ricted common stock may not be sold or transferred by the holder. These restrictions lapse according to the time-based vesting. Activity related to restricted stock for the year ended December 31, 2018, was as follows: Weighted Average Grant Shares Date Fair Value Unvested restricted common stock as of December 31, 2017 491,861 $ 7.59 Issued 486,000 4.83 Vested (380,427) 7.34 Forfeited (61,835) 5.59 Unvested restricted common stock as of December 31, 2018 535,599 $ 5.50 For the years ended December 31, 2018, 2017 and 2016 , the weighted average grant date fair value of restricted common stock granted was $4.83 , $7.85 and $3.95 , respectively. For the years ended December 31, 2018, 2017 and 2016 , the total fair value of restricted common stock vested was $1,897 , $2,065 and $1,559 , respectively. The Company received no proceeds for any of the restricted common stock granted during the years ended December 31, 2018, 2017 and 2016 . Stock-Based Compensation The fair value of each stock option award is estimated using the Black-Scholes option-pricing model. The expected volatility of the Company’s common stock is estimated based on historical volatility of the Company’s common stock. The expected term of the Company’s stock options has been determined utilizing the “simplified” method as the Company has insufficient historical experience for option grants overall, rendering existing historical experience irrelevant to expectations for current grants. The risk-free interest rate is determined by reference to the United States Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The relevant data used to determine the value of the stock option grants, presented on a weighted average basis, was as follows: Year Ended December 31, 2018 2017 2016 Risk-free interest rate 2.53 % 1.99 % 1.52 % Expected term (in years) 6.0 6.0 6.2 Expected volatility 72 % 75 % 77 % Expected dividend yield — % — % — % Compensation expense related to restricted stock granted to employees and non-employee directors is equal to the fair value of the Company’s common stock on date of grant, multiplied by the number of shares of restricted common stock issued. Compensation expense related to restricted stock granted to non-employees is equal to the excess, if any, of the fair value of the Company’s common stock on date of vesting over the original purchase price per share, multiplied by the number of shares of restricted common stock vesting. The Company recorded stock-based compensation expense related to stock options and restricted stock as follows: Year Ended December 31, 2018 2017 2016 Research and development $ 655 $ 916 $ 1,069 Cost of product sales and inventories 115 153 116 Selling, general and administrative 4,143 6,049 7,291 $ 4,913 $ 7,118 $ 8,476 As of December 31, 2018, the Company had an aggregate of $3,562 and $2,308 of unrecognized stock-based compensation expense for options outstanding and restricted stock awards, respectively, which is expected to be recognized over 2.36 years and 1.65 years, respectively. |
Net Loss Per Share
Net Loss Per Share | 12 Months Ended |
Dec. 31, 2018 | |
Net Loss Per Share [Abstract] | |
Net Loss Per Share | 15. Net Loss Per Share Basic and diluted net loss per share was calculated as follows: Year Ended December 31, 2018 2017 2016 Numerator: Net loss $ (14,722) $ (47,510) $ (33,575) Denominator: Weighted average shares outstanding, basic and diluted 46,606,855 40,494,301 35,273,228 Net loss per share, basic and diluted $ (0.32) $ (1.17) $ (0.95) Stock options for the purchase of 3,167,784 , 2,614,537 and 2,317,449 shares of common stock and 535,599 , 491,861 and 461,463 of unvested restricted stock awards were excluded from the computation of diluted net loss per share for the years ended December 31, 2018, 2017 and 2016 , respectively, because these stock-based awards had an anti-dilutive impact due to the net loss incurred for the period. |
Commitments and Contingencies
Commitments and Contingencies | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies [Abstract] | |
Commitments and Contingencies | 16. Commitments and Contingencies Operating Leases Future minimum lease payments for operating leases as of December 31, 2018, were as follows: Year Ending December 31, 2019 $ 441 2020 450 2021 75 2022 — 2023 — Thereafter — Total $ 966 The Company leases facilities and certain operating equipment under operating leases expiring through 2021 . The Company incurred rent expense of $445 , $725 and $726 for the years ended December 31, 2018, 2017 and 2016 , respectively. Litigation From time to time, the Company may become subject to legal proceedings, claims and litigation arising in the ordinary course of business, including those related to patents, product liability and government investigations. The Company is not presently a party to any litigation which it believes to be material, and is not aware of any pending or threatened litigation against the Company which it believes could have a material effect on its financial statements. The Company accrues contingent liabilities when it is probable that a future liability has been incurred and such liability can be reasonably estimated. Indemnification Agreements In the ordinary course of business, the Company may provide indemnifications of varying scope and terms to customers, vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements, from services to be provided by the Company, or from intellectual property infringement claims made by third parties. In addition, the Company has entered into indemnification agreements with all of its executive officers and members of its Board of Directors. These agreements, among other things, require the Company or will require the Company to indemnify each director ( and in certain potential scenarios, their applicable venture capital funds ) and executive officer to the fullest extent permitted by Delaware law, including indemnification of expenses such as attorneys’ fees, judgments , fines and settlement amounts incurred by the director or executive officer in any action or proceeding, including any action or proceeding by or in right of the Company, arising out of the person’s services as a director or executive officer. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, not readily quantifiable. To date, the Company has not incurred any material costs as a result of such indemnifications. The Company does not believe that the outcome of any claims under indemnification arrangements will have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2018 or 2017 . |
Income Taxes
Income Taxes | 12 Months Ended |
Dec. 31, 2018 | |
Income Taxes [Abstract] | |
Income Taxes | 17. Income Taxes The components of loss from continuing operations before income tax expense or benefit were as follows: Year Ended December 31, 2018 2017 2016 United States $ (14,398) $ (38,920) $ (29,959) Non-United States (324) (8,590) (3,616) Loss from continuing operations $ (14,722) $ (47,510) $ (33,575) The Company recorded no income tax expense or benefit during years ended December 31, 2018, 2017 and 2016. A reconciliation of the United States federal statutory income tax rate to the Company’s effective income tax rate was as follows: Year Ended December 31, 2018 2017 2016 Federal statutory income tax rate 21.0 % 34.0 % 34.0 % State income taxes, net of federal tax benefit 2.4 6.9 3.2 Non-deductible expenses (1.1) (0.1) 0.2 Stock-based compensation (3.9) (1.8) (1.5) Research credits 3.1 1.3 5.0 TCJA — (42.8) — Other 0.1 (5.0) — Change in valuation allowance (21.6) 7.5 (40.9) Total — % — % — % Net deferred tax assets consisted of the following: Year Ended December 31, 2018 2017 2016 Net operating loss carry forwards $ 25,811 $ 31,061 $ 27,244 Capitalized start-up costs 4,181 5,052 5,990 Tax credit carry forwards 4,019 3,737 2,996 Intangibles, net 2,633 2,915 2,072 Capitalized research and development, net 4,359 6,083 10,005 Other temporary differences 4,512 5,922 7,940 Total deferred tax assets 45,515 54,770 56,247 Valuation allowance (45,386) (54,636) (56,116) Net deferred tax assets 129 134 131 Depreciation (129) (134) (131) Total deferred tax liabilities (129) (134) (131) Net deferred tax liability $ — $ — $ — As of December 31, 2018, the Company had net operating loss carryforwards for federal and state income tax purposes of $106,846 and $104,241 , respectively, which begin to expire in fiscal year 2031 and 2020 , respectively. $13,852 of federal net operating loss carryforward was generated in 2018 and may be carried forward indefinitely. As of December 31, 2018, the Company had federal and state research and development tax credit carryforwards of $3,206 and $1,029 , respectively, which begin to expire in fiscal year 2031 and until utilized, respectively. Management of the Co mpany has evaluated the positive and negative evidence bearing upon the realizability of its deferred tax assets, which are comprised principally of net operating loss carryforwards and research and development credits. Under the applicable accounting standards, management has considered the Company’s history of losses and concluded that it is more likely than not that the Company will not recognize the benefits of its deferred tax assets. Accordingly, a full valuation allowance of the net deferred tax asset had been established at December 31, 2018 and 2017. Utilization of the net operating loss and research and development credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 due to ownership change limitations that have occurred previously or that could occur in the future. These ownership changes may limit the amount of net operating loss and research and development credit carryforwards that can be utilized annually to offset future taxable income and tax, respectively. Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2018, 2017 and 2016, were as follows: Year Ended December 31, 2018 2017 2016 Valuation allowance as of beginning of year $ 54,636 $ 56,116 $ 46,885 Changes due to operations, TCJA and other tax rates (9,250) (1,480) 9,231 Valuation allowance as of end of year $ 45,386 $ 54,636 $ 56,116 The Company has not recorded any amounts for unrecognized tax benefits as of December 31, 2018 and 2017. The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. The Company’s major taxing jurisdiction is the United States (federal and states). In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. The Company’s tax years are still open under statute from 2015 to present, although prior tax years are subject to examination and adjustments to the extent utilized in future years. The Company’s policy is to record interest and penalties related to income taxes as part of its income tax expense in the consolidated statements of operations. The TCJA was enacted on December 22, 2017, a tax reform bill which, amount other items, reduces the current corporate federal tax rate to 21% from 35% . The rate reduction is effective January 1, 2018. ASC Topic 740, Accounting for Income Taxes (“ASC 740”), requires companies to recognize the effect of tax law changes in the period of enactment even though the effective date for most provisions is for tax years beginning after December 31, 2018, or in the case of certain other provisions of the law, January 1, 2018. Accordingly, the Company remeasured its United States deferred tax assets and liabilities as of December 31, 2017, to reflect the reduced rate that is expected to apply in future periods when these deferred taxes will reverse, resulting in an estimated reduction of the Company’s net deferred tax assets by approximately $20.3 million , which was offset by a corresponding change in the valuation allowance. The TCJA includes numerous provisions, such as limitation of deduction for executive compensation, that could impact the Company’s United States deferred tax assets, which are subject to a full valuation allowance. The SEC issued Staff Accounting Bulletin No. 118 (“SAB 118”) on December 22, 2017. SAB 118 measurement period from a registrant’s reporting period that includes the TCJA’s enactment date to allow the registrant sufficient time to obtain, prepare and analyze information to complete the accounting required under ASC 740 . The Company had completed its accounting for the TCJA in the fourth quarter of 2018, which did not result in a material adjustment to its deferred tax assets and the related valuation allowance. |
Selected Quarterly Financial Da
Selected Quarterly Financial Data | 12 Months Ended |
Dec. 31, 2018 | |
Selected Quarterly Financial Data [Abstract] | |
Selected Quarterly Financial Data | 18. Selected Quarterly Financial Data (unaudited) Selected unaudited quarterly financial data for each of the quarters in the years ended December 31, 2018 and 2017 (in thousands, except share and per share data), was as follows: 2018 First Second Third Fourth Quarter Quarter Quarter Quarter Net revenues $ 4,043 $ 4,908 $ 21,555 (1) $ 4,906 Gross profit (2) 3,507 3,603 19,383 2,136 Net income (loss) (2) (8,548) (6,373) 8,833 (8,634) Weighted average shares outstanding, basic 44,788,068 46,258,395 47,310,408 48,027,220 Weighted average shares outstanding, diluted 44,788,068 46,258,395 47,485,384 48,027,220 Net income (loss) per share, basic and diluted $ (0.19) $ (0.14) $ 0.19 $ (0.18) __________________ (1) Net revenues in the third quarter or 2018 reflect the impact of $15,000 of licensing and collaboration revenue related to GALLIPRANT sales milestone earned from Elanco, as further described in Note 12 to the consolidated financial statements included elsewhere in this 2018 Annual Report. (2) Net loss in the second and fourth quarter of 2018 and net income in the third quarter of 2018 and gross profit in the second, third and fourth quarter of 2018 reflect the impact of inventory valuation adjustment losses in cost of product sales in the amounts of $335 , $883 and $1,432 , respectively , as further described in Note 6 to the consolidated financial statements included elsewhere in this 2018 Annual Report. _ 2017 First Second Third Fourth Quarter Quarter Quarter Quarter Net revenues (1) $ 3,795 $ 5,158 $ 6,163 (2) $ 10,457 (3) Gross profit 701 1,467 2,473 4,545 Net loss (12,612) (10,380) (8,920) (15,598) (4) Weighted average shares outstanding, basic and diluted 36,711,601 40,206,042 42,445,553 42,493,514 Net loss per share, basic and diluted $ (0.34) $ (0.26) $ (0.21) $ (0.37) _________________ (1) Net revenues reflect the impact of the product launch of GALLIPRANT which commercial sales began in the first quarter of 2017 and which sales of finished goods in the amount of $15,526 to Elanco ended in the fourth quarter of 2017. (2) Net revenues in the third quarter or 2017 reflect the impact of $1,000 of licensing and collaboration revenue related to the assumption of manufacturing responsibility by Elanco as further described in Note 12 to the consolidated financial statements included elsewhere in this 2018 Annual Report . (3) Net revenues in the fourth quarter of 2017 reflect the impact of revenues recognized related to the withdrawal of BLONTRESS from the market and the related derecognition of the remaining balance of the liability of $480 as further described in Note 12 to the consolidated financial statements included elsewhere in this 2018 Annual Report , and the impact of commercial sales of ENTYCE which began in the fourth quarter of 2017. (4) Net loss in the fourth quarter of 2017 reflects the impact of an intangible asset impairment charge of $7,448 related to AT-006 and AT-008 as further described in Note 9 to the consolidated financial statements included elsewhere in this 2018 Annual Report. |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policy) | 12 Months Ended |
Dec. 31, 2018 | |
Summary of Significant Accounting Policies [Abstract] | |
Consolidation | Consolidation The Company’s consolidated financial statements include its financial statements, and those of its wholly-owned US subsidiary and a foreign subsidiar y through its dissolution date in December 2018, and in prior periods, they also include a consolidated variable interest entity through the deconsolidation date in December 2016. Intercompany balances and transactions are eliminated in consolidation. In December 2018, the Company’s foreign subsidiary was dissolved, and the dissolution did not have a material impact on the consolidated financial statements. To determine if the Company holds a controlling financial interest in an entity, the Company first evaluates if it is required to apply the variable interest entity (“VIE”) model to the entity. Where the Company holds current or potential rights that give it the power to direct the activities of a VIE that most significantly impact the VIE’s economic performance combined with a variable interest that gives it the right to receive potentially significant benefits or the obligation to absorb potentially significant losses, the Company is the primary beneficiary of that VIE. When changes occur to the design of an entity, the Company reconsiders whether it is subject to the VIE model. The Company continuously evaluates whether it is the primary beneficiary of a consolidated VIE and upon determination that the Company no longer remains the primary beneficiary, the Company deconsolidates the entity and a gain or loss is recognized upon deconsolidation. In December 2016, the Company concluded that it was no longer the primary beneficiary of a previously consolidated VIE and no longer consolidates the entity. The Company recognized a gain of $276 on deconsolidation of the VIE in other income (expense) in the quarter ended December 31, 2016. The Company ’s remaining non-controlling investment in the VIE is not material. |
Use of Estimates | Use of Estimates The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates, judgments and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting period. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from those estimates. |
Cash And Cash Equivalents | Cash and Cash Equivalents The Company classifies all highly liquid investments with stated maturities of three months or less from the date of purchase as cash equivalents . Cash equivalents consisted of certificates of deposit (“CDs”) at December 31, 2018 and 2017 . |
Restricted Cash | Restricted Cash T he Company has posted collateral to Square 1 Bank N.A., a division of the Pacific Western Bank, to collateralize corporate credit card services. The Company classifies the collateral as restricted cash. |
Short-term Investments | Short-term Investments Short-term investments in 2018 and 2017 included CDs with original maturities greater than three months but less than 12 months . |
Marketable Securities | Marketable Securities The Company classifies all highly liquid investments with stated maturities of greater than three months from the date of purchase as marketable securities. The Company determines the appropriate classification of investments in marketable securities at the time of purchase and re-evaluates such designation at each consolidated balance sheet date. The Company classifies and accounts for marketable securities as available-for-sale. The Company did not hold securities with stated maturities greater than 12 months as of December 31, 2018 or 2017. The Company reports available-for-sale investments at fair value as of each consolidated balance sheet date and records any unrealized gains and losses as a component of stockholders’ equity. The cost of securities sold is determined on a specific identification basis, and realized gains and losses are included in other income (expense) in the consolidated statements of operations. If any adjustment to fair value reflects a decline in the value of the investment, the Company considers available evidence to evaluate the extent to which the decline is “other than temporary” and recognizes the impairment by releasing other comprehensive income to the consolidated statement of operations. There were no such adjustments necessary during the years ended December 31, 2018 and 2017. |
Accounts Receivable, Net | Accounts Receivable, Net Accounts receivable are uncollateralized customer obligations due under normal trade terms generally requiring payment within 30 days of the invoice date. The Company provides an allowance for doubtful accounts equal to the estimated losses that will be incurred in collection of accounts receivable. This estimate is based on the current review of existing receivables and historical experience in the industry. The allowance and associated accounts receivable are reduced when the receivables are determined to be uncollectible. To date, the Company’s historical reserves and write-offs have not been significant. The Company also provides an allowance for estimated returns which is established based on the Company’s analysis of industry standards and its own history of actual returns. |
Inventories | Inventories The Company states inventories at the lower of cost and net realizable value and consist of raw materials, work-in-process and finished goods. Cost is determined by the average cost method for raw materials and standard cost for work-in-process and finished goods, which approximates actual cost. |
Pre-Launch Inventories | Pre-Launch Inventories The Company may scale-up and make commercial quantities of certain of its product candidates prior to the date it anticipates that such products will receive final United States Food and Drug Administration (“FDA”)/United States Department of Agriculture (“USDA”) approval. The scale-up and commercial production of pre-launch inventories involves the risk that such products may not be approved for marketing by the FDA/USDA on a timely basis, or ever. Inventory costs associated with product candidates that have not yet received regulatory approval are capitalized if the Company believes there is probable future commercial use and future economic benefit. If the probability of future commercial use and future economic benefit cannot be reasonably determined, then pre-launch inventory costs associated with such product candidates are expensed as research and development expense during the period the costs are incurred. Specifically, the Company has determined that for FDA-regulated product candidates there is a probable future commercial use and future economic benefit upon the receipt of the three major technical section complete letters from the FDA’s Center for Veterinary Medicine (“CVM”). For USDA product candidates, the Company has determined there is a probable future commercial use and future economic benefit upon the receipt of a conditional license from the USDA’s Center for Veterinary Biologics. The Company makes at least quarterly reassessments of the probability of regulatory approval and useful life of the pre-launch inventory, and determines whether such inventory continues to have a probable future economic benefit. |
Property and Equipment, Net | Property and Equipment, Net The Company records property and equipment at historical cost less accumulated depreciation and amortization. Depreciation and amortization expense is recognized using the straight-line method over the following estimated useful lives: Laboratory and office equipment 3 – 10 years Computer software and equipment 3 – 5 years Furniture 3 – 7 years Vehicles 3 – 5 years Leasehold improvements 3 – 10 years Leasehold improvements are amortized over the shorter of the life of the related asset or the term of the lease. Expenditures for repairs and maintenance of assets are charged to expense as incurred. Costs of major additions and betterments are capitalized and depreciated on a straight-line basis over their useful lives. When property and equipment are disposed of, the cost and respective accumulated depreciation and amortization are removed from the accounts. Any gain or loss on disposal is recorded in the consolidated statements of operations in other income (expense). Depreciation expense and gains or losses on disposal of property and equipment are classified within the corresponding operating expense categories in the consolidated statements of operations. |
Goodwill | Goodwill Goodwill relates to amounts that arose in connection with the Company’s business combinations and represents the difference between the purchase price and the estimated fair value of the identifiable tangible and intangible net assets when accounted for using the acquisition method of accounting. Goodwill is not amortized, but is subject to periodic review for impairment. T he Company tests goodwill at the reporting unit level for impairment on an annual basis and between annual tests, if events and circumstances indicate impairment may exist. Events that would indicate impairment and trigger an interim impairment assessment include, but are not limited to, current economic and market conditions, including a decline in market capitalization, a significant adverse change in legal factors, business climate or operational performance of the business and an adverse action or assessment by a regulator. |
Intangible Assets, Net | Intangible Assets , Net The Company’s intangible assets, net consist of intellectual property rights acquired for currently marketed products (amortized intangibles). All of the Company’s amortized intangibles were recorded in connection with the Company’s business combinations or approval/post-approval milestone payments made under the Company’s license agreements. The Company’s intangible assets are recorded at fair value at the time of their acquisition. The Company amortizes intangible assets over their estimated useful lives once the acquired technology is developed into a commercially viable product. The estimated useful lives of the individual categories of intangible assets are based on the nature of the applicable intangible asset and the expected future cash flows to be derived from the intangible asset. Amortization of intangible assets with finite lives is recognized over the time the intangible assets are estimated to contribute to future cash flows. The Company amortizes finite-lived intangible assets using the straight-line method as revenues cannot be reasonably estimated. |
Foreign Currency | Foreign Currency Since the acquisition of Okapi Sciences in 2014 and through the date of dissolution of the foreign subsidiary in December 2018 , the Company was exposed to effects of foreign currency from translation. Prior to July 1, 2018, the functional currency of the Company’s foreign subsidiaries was the local currency of the country where the subsidiari es were located. Transactions in foreign currencies were translated into the relevant functional currency at the rate of exchange at the date of the transaction. Transaction gains and losses were recognized in other income (expense) in the consolidated statements of operations. The results of operations for subsidiaries were translated into the United States Dollar , the Company’s reporting currency, at the average rates of exchange during the period, with the subsidiaries’ balance sheets translated at the rates accumulated at the balance sheet date. The cumulative effect of these exchange rate adjustments was included in a separate component of other comprehensive income (loss) in the consolidated balance sheets. Gains and losses arising from intercompany foreign currency transactions were included in loss from operations unless the gains and losses ar o se from long-term investments in subsidiaries. Gains and losses from long-term investments in subsidiaries were included in a separate component of other comprehensive income (loss). Effective July 1, 2018, as a result of s ignificant changes in economic facts and circumstances in the operations of the foreign subsidiary, the functional currency of the Company’s foreign subsidiary was changed from the local currency to the United States Dollar . Effective as of the date of the change, t ranslation adjustments for prior periods were not removed from equity and the translated amounts for nonmonetary assets at the end of the prior period became the accounting basis for those assets in the period of the change and subsequent periods. Subsequent gains or losses from the remeasurement of monetary assets and liabilities of the foreign subsidiary were recorded in earnings through the date of its dissolution. |
Deferred Public Offering And At-The-Market Offering Costs | Deferred Public Of fering and At-the-Market Offering Costs The Company capitalizes certain legal, accounting and other third-party fees that are directly associated with in-process equity financings as other assets until such financings are consummated. After consummation of the equity financing, these costs are recorded in stockholders’ equity as a reduction of additional paid-in capital generated as a result of the offering. Should it no longer be considered probable that the equity financing will be consummated, the deferred offering costs would be expensed immediately as a charge to operating expenses in the consolidated statements of operations. The Company recorded $0 and $76 of deferred equity offering costs as of December 31, 2018 and 2017, respectively. |
Debt Issuance Costs, Net | Debt Issuance Costs , Net Debt issuance costs, net represent legal and other direct costs related to the Company’s Loan and Security Agreement which was terminated in December 2018 upon full repayment of outstanding obligations (Note 10). These costs were recorded as an offset to the carrying value of loans payable in the consolidated balance sheet at the time they were incurred and were amortized to interest expense through the scheduled final principal payment date. Upon the Company’s repayment of its loans payable, all remaining debt issuance costs were recognized in interest expense in the consolidated statements of operations. |
Revenue from Contracts with Customers | Revenue from Contracts with Customers Effective January 1, 2018, the Company adopted the Accounting Standards Codification Topic (“ASC”) 606 “Revenue from Contracts with Customers” (“ASC 606”) using the modified retrospective transition method. Prior to January 1, 2018, the Company recognized revenue using the guidance of ASC 605 “Revenue Recognition” (“ASC 605”). The Company recognizes revenue when its customer obtains control of the promised goods or services, in an amount that reflects the consideration which the Company expects to be entitled to in exchange for those goods or services. The Company determines revenue recognition from contracts with customers as follows: · identify the contract(s); · identify the performance obligations in the contract(s); · determine the transaction price; · allocate the transaction price to the performance obligations in the contract; and · recognize revenue wh en (or as) the Company satisfies a performance obligation. The Company’s principal revenue streams and their respective accounting treatments are discussed below and further in Note 3, “Revenue” : (i) Product Sales, Net The Company sells its products to its customers who could either be the end users (such as veterinarians, clinics, or animal hospitals) of the product or distributors who subsequently resell the Company’s products to end users. Revenues from product sales are recognized when the customer obtains control of the Company’s product, which occurs at a point in time, upon delivery to the customer. The Company’s delivery of its products to customers constitutes a single performance obligation as there are no other promises to deliver goods or services beyond what is specified in each accepted customer order. Product sales are recorded net of applicable reserves for variable consideration, including product returns, allowances, discounts, and rebates . Reserves for Variable Consideration Revenues from product sales are recorded at the net sales price (transaction price) which includes estimates of variable consideration for which reserves are established. Components of variable consideration include product returns, allowances, discounts, and rebates. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable (generally, for credits that the Company issues for free goods provided by distributors to end customers in conjunction with promotional programs) or a current liability (generally, reserves for products that remained in the distribution channel inventories at each reporting period end that the Company expects the distributors will provide to end customers free of charge in conjunction with promotional programs). These estimates take into consideration a range of possible outcomes for the expected value (probability-weighted estimate) or relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts. The amount of variable consideration included in the transaction price may be constrained and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known. Product Returns Consistent with the industry practice, the Company generally offers customers a limited right of return of damaged or expired product that has been purchased from the Company or the Company’s distributors in exchange for an unexpired product or credit, depending on contractual arrangements with distributors and terms and conditions of the sale of its products. Exchanges or credit due to expiry are typically allowed for a period of six months after the product’s expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records these estimates as a reduction of product revenues in the period in which the related product revenues are recognized, as well as within accrued expenses and other current liabilities in the consolidated balances sheets. The Company currently estimates product return liabilities using available industry data, its own sales data and data provided by the Company’s distributors such as the inventories remaining in the distribution channel. The Company has received an immaterial amount of returns to date and believes that returns of its products in future periods will be minimal. The Company does not record a return asset associated with the returned damaged or expired goods because such asset is deemed to be fully impaired at the time of product return. Sales Discounts and Allowances The Company compensates its distributors for sales order management, data and distribution and other services through sales discounts and allowances. However, such services are not distinct from the Company’s sale of products to distributors and, therefore, these discounts and allowances are recorded as a reduction of revenue in the consolidated statements of operations, as well as a reduction to accounts receivable, net in the consolidated balance sheets. (ii) Licensing and Collaboration Revenues Revenues derived from product out-licensing arrangements typically consist of an initial non-refundable, up-front payment at inception of the license, subsequent milestone payments contingent on the achievement of certain regulatory, development and commercial milestones, and royalties on the net sales of the Company’s products. Licenses of Intellectual Property If the license to the Company’s intellectual property is determined to be distinct from the other performance obligations identified in the contract, the Company recognizes revenue from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license. For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees. The Company will evaluate the measure of progress each reporting period and, if necessary, adjust the measure of performance and related revenue recognition. Milestones Revenues from achievement of milestones generally represent a form of variable consideration as the payments are likely to be contingent on the occurrence of future events. The Company estimates milestones probable to be achieved and includes in the transaction price based on either the expected value (probability-weighted estimate) method or most likely amount method. The most likely amount method is used by the Company for milestone payments with a binary outcome (i.e., the Company receives all or none of the milestone payment). Milestone payments that are not within the control of the Company or the customer, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The estimated milestone-related variable consideration is only recognized as revenue when the related performance obligation is satisfied and the Company determines that it is probable that there will not be a significant reversal of cumulative revenue recognized in future periods (i.e. variable consideration constraint). At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price. Any such adjustments are recorded on a cumulative catch-up basis, which would affect licensing and collaboration revenues and earnings in the period of adjustment. For milestones that are not able to overcome the variable consideration constraint, that are not considered probable or that are determined to be sales-based or usage royalties, as described later, the Company recognizes revenue when the milestones are achieved. Sales-Based Royalty Revenues The Company’s sales-based royalty revenues consist of sales-based milestones or a percentage of net sales royalties. The Company recognizes sales-based royalties related to the Company’s out-licensed intellectual property when (or as) the later of the following events occurs: · the sale occurs; or · the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied). Sales-based royalty revenues recorded by the Company are based on the licensee’s or sub-licensee’s sales that occurred during the relevant period. To the extent the licensee’s or sub-licensee’s actual sales are not known at the time the Company reports its financial results, the Company estimates the amount of royalty revenue earned during the relevant period. Differences between actual and estimated royalty revenues, if any, are adjusted in the period in which they become known. To date, royalty revenues reported by the Company have been based on actual sales information received by the Company, and no material adjustments have been made in subsequent periods. Royalty revenue is included in licensing and collaboration revenue in the consolidated statements of operations. The Company recognizes revenue from sales-based milestones when the milestones are achieved. |
Research And Development Costs | Research and Development Costs Research and development costs are expensed as incurred. Included in research and development costs are wages, stock-based compensation and employee benefits, and other operational costs related to the Company’s research and development activities, including facility-related expenses, external costs of outside contractors engaged to conduct both preclinical and clinical studies and allocation of corporate costs. If IPR&D is acquired in an asset purchase, then the acquired IPR&D is expensed on its acquisition date. Future costs to develop these assets are recorded to research and development expense as they are incurred. |
Patent Costs | Patent Costs All patent-related costs incurred in connection with filing and prosecuting patent applications are recorded as selling, general and administrative expenses as incurred, as recoverability of such expenditures is uncertain. |
Shipping | Shipping Shipping costs are included in cost of product sales. |
Sales tax | Sales Tax The Company collects and remits taxes assessed by various governmental authorities. These taxes may include sales, use and value added taxes. These taxes are recorded on a net basis and are excluded from revenues. |
Accounting For Stock Based Compensation | Accounting for Stock-Based Compensation The Company’s stock-based compensation program grants awards that may consist of stock options and restricted stock awards. The fair values of stock option grants are determined as of the date of grant using the Black-Scholes option pricing method. This method incorporates the fair value of the Company’s common stock at the date of each grant and various assumptions such as the risk-free interest rate, expected volatility based on the volatility of the Company’s common stock price , expected dividend yield, and expected term of the options. The fair values of restricted stock awards are determined based on the fair value of the Company’s common stock. The fair values of the stock-based awards are then expensed over the requisite service period, which is generally the award’s vesting period. The Company classifies stock-based compensation expense in the consolidated statements of operations in the same manner in which the respective award recipient’s payroll costs are classified. For stock-based awards granted to consultants and nonemployees, compensation expense is recognized over the period during which services are rendered by such consultants and nonemployees until completed. At the end of each financial reporting period prior to completion of the service, the value of these awards is re-measured using the then-current fair value of the Company’s common stock and updated assumption inputs in the Black-Scholes option pricing model. |
Comprehensive Loss | Comprehensive Loss In addition to the Company’s net loss, comprehensive loss for the years ended December 31, 2018, 2017 and 2016, includes foreign currency translation adjustments related to the translation of foreign subsidiaries’ balance sheets. |
Net Loss Per Share | Net Loss Per Share The Company follows the two-class method when computing net loss per share, as the Company has issued shares that meet the definition of participating securities. The two-class method determines net loss per share for each class of common and participating securities according to dividends declared or accumulated and participation rights in undistributed earnings. The two-class method requires income available to common stockholders for the period to be allocated between common and participating securities based upon their respective rights to receive dividends as if all income for the period had been distributed. Restricted stock awards granted by the Company entitle the holder of such awards to dividends declared or paid by the Board of Directors, regardless of whether such awards are unvested, as if such shares were outstanding common shares at the time of the dividend. However, the unvested restricted stock awards are not entitled to share in the residual net assets (deficit) of the Company. Accordingly, in periods in which the Company reports a net loss or a net loss attributable to common stockholders resulting from preferred stock dividends, accretion or modifications, net losses are not allocated to participating securities. The Company reported a net loss in each of the years ended December 31, 2018, 2017 and 2016. Basic net loss per share is computed by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. Diluted net loss is computed by adjusting net loss to reallocate undistributed earnings based on the potential impact of dilutive securities, including outstanding stock options. Diluted net loss per share is computed by dividing the diluted net loss by the weighted average number of shares of common stock, including potential dilutive shares of common stock assuming the dilutive effect of potentially dilutive securities. For periods in which the Company has reported net losses, diluted net loss per share is the same as basic net loss per share, since their impact would be anti-dilutive to the calculation of net loss per share. Diluted net loss per share is the same as basic net loss per share for each of the years ended December 31, 2018, 2017 and 2016. |
Concentration Of Credit Risk And Of Significant Suppliers And Customers | Concentration of Credit Risk and of Significant Suppliers and Customers Financial instruments that potentially subject the Company to concentrations of credit risk consist principally of cash, cash equivalents, short-term investments and accounts receivable. At December 31, 2018 and 2017, all of the Company’s fixed income marketable securities were invested in CDs insured by the Federal Deposit Insurance Corporation. The Company also generally maintains balances in various operating accounts in excess of federally insured limits at two accredited financial institutions. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships. Concentrations of credit risk with respect to accounts receivable, which are typically unsecured, are somewhat mitigated due to the wide variety of customers (large animal health companies, distributors, and veterinarians) purchasing the Company’s products. All of the Company’s accounts receivable arise from product sales sold by the Company in the United States and have standard payment terms which generally require payment within 30 days and licensing and collaboration revenue which require payment withi n 60 days. The Company monitors the financial health performance and credit worthiness of its customers so it can properly assess and respond to changes in their credit profile. The Company continues to monitor these conditions and assess their possible impact on it business. As of December 31, 2018 and 2017 , accounts receivable from Elanco Animal Health, Inc. (“Elanco”) accounted for 52% and 64% of the Company’s accounts receivable, net , respectively . As of December 31, 2017, accounts receivable from one distributor accounted for 15% of the Company’s accounts receivable, net. Revenues from one customer, Elanco, accounted for all licensing and collaboration revenue for the years ended December 31, 2018 and 2017, and approximately 66% and 23% of total revenues for the year s ended December 31, 2018 and 2017, respectively. During the year ended December 31, 2017, sales of finished goods to Elanco accounted for 79% of the Company’s net product sales. The Company is dependent on a combination of national and regional distributors for its product sales of ENTYCE. The Company’s product sales to two distributors accounted for more than 10% each and 26% collectively of the Company’s net product sales for the year ended December 31, 2018. The Company is also dependent on a small number of third-party manufacturers to supply active pharmaceutical ingredients (“API”) and formulated drugs for research and development activities in its programs and commercial supply, which would be adversely affected by a significant interruption in supply. |
Fair Value Measurements | Fair Value Measurements Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. A fair value hierarchy based on three levels of inputs, of which the first two are considered observable and the last is considered unobservable, is used to measure fair value: · Level 1—Quoted prices in active markets for identical assets or liabilities. · Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities , quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data. · Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques. |
Segment And Geographic Information | Segment and Geographic Information Segment Assets The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company is a pet therapeutics company developing compounds to address unmet and under-served medical needs in companion animals. All assets were held in the United States and Belgium as of December 31, 2018, 2017 and 2016. Total assets were $106,436 , $135,192 and $151,406 at December 31, 2018, 2017 and 2016, respectively. Revenues by Geographic Region Year Ended December 31, 2018 2017 2016 (Dollars in thousands) Revenues United States $ 35,412 $ 25,573 $ 38,318 Belgium — — 233 Total revenues $ 35,412 $ 25,573 $ 38,551 Long-Lived Assets, Net by Geographic Region Year Ended December 31, 2018 2017 2016 (Dollars in thousands) Long-lived assets, net United States $ 693 $ 1,166 $ 1,947 Belgium — — 1 Total long-lived assets, net $ 693 $ 1,166 $ 1,948 |
New Accounting Standards | New Accounting Standards Revenue from Contracts with Customers In May 2014, the Financial Accounting Standards Board (“FASB”) issued guidance on recognizing revenue in contracts with customers. The guidance affects any entity that either enters into contracts with customers to transfer goods or services or enters into contracts for the transfer of nonfinancial assets unless those contracts are within the scope of other standards (e.g., insurance contracts or lease contracts). This guidance superseded the revenue recognition requirements in ASC 605 and most industry-specific guidance. The core principle of the guidance is that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. The Company adopted this guidance on January 1, 2018. The impact of adoption is described further in Note 3 , “Revenue.” Leases In February 2016, the FASB issued guidance which requires, for operating leases, a lessee to recognize a right-of-use (“ROU”) asset and a lease liability, initially measured at the present value of the lease payments, in its balance sheet. The standard also requires a lessee to recognize a single lease cost, calculated so that the cost of the lease is allocated over the lease term, on a generally straight-line basis. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted and is to be applied on a modified retrospective transition. The Company adopted this guidance on January 1, 2019, using a modified retrospective approach to be applied to leases ex isting as of, or entered into after, January 1, 2019. The Company has substantially completed its review of its existing lease contracts and the impact of the new leasing standards on its consolidated financial statements. Upon adoption of the new guidance, the Company expects to recognize a lease liability and a related ROU asset, which may be material to the consolidated balance sheets. The impact of adoption of the guidance is not expected to have a material impact on the consolidated statements of operations. Compensation – Stock Compensation : Scope of Modification Accounting In May 2017, the FASB issued guidance on determining which changes to the terms or conditions of share-based payment awards require an entity to apply modification accounting. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years. The Company adopted this guidance on January 1, 2018, and the adoption did not have a material impact on its consolidated financial statements. Compensation – Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting In June 2018, the FASB issued guidance that largely aligns the accounting for share-based payment awards issued to employees and nonemployees. Under the new guidance, the existing employee guidance generally will apply to nonemployee share-based transactions, with the exception of specific guidance related to inputs to an option pricing model and the attribution of compensation cost. The cost of nonemployee awards will continue to be recorded as if the grantor had paid cash for the goods or services. In addition, the contractual term will be able to be used in lieu of an expected term in the option-pricing model for nonemployee awards. This guidance is effective for financial statements issued for fiscal years beginning after December 15, 2018, and interim periods within those fiscal years. Early adoption is permitted, including in interim periods, but no earlier than an entity’s adoption of ASC 606 . The Company adopted this guidance on January 1, 2019, and the adoption did not have a material impact on its consolidated financial statements. Intangibles – Goodwill and Other – Internal-Use Software In August 2018, the FASB issued guidance that largely aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). The guidance provides criteria for determining which implementation costs to capitalize as an asset related to the service contract and which costs to expense. The capitalized implementation costs are required to be expensed over the term of the hosting arrangement. The guidance also clarifies the presentation requirements for reporting such costs in the entity’s financial statements. The guidance is effective for financial statements issued for fiscal years beginning after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted, including adoption in any interim period. The Company is currently assessing the effect that adoption of this guidance will have on its consolidated financial statements. Fair Value Measurements In August 2018, the FASB issued guidance related to disclosure requirements for fair value measurements. This guidance eliminates, modifies and adds disclosure requirements for fair value measurements. The guidance is effective for fiscal years, and for interim periods within those fiscal years, beginning after December 15, 2019, with early adoption permitted. The Company is currently assessing the effect that adoption of this guidance will have on its consolidated financial statements. |
Summary of Significant Accoun_3
Summary of Significant Accounting Policies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Summary of Significant Accounting Policies [Abstract] | |
Estimated Useful Lives of Property, Plant and Equipment | Laboratory and office equipment 3 – 10 years Computer software and equipment 3 – 5 years Furniture 3 – 7 years Vehicles 3 – 5 years Leasehold improvements 3 – 10 years |
Schedule of Revenue by Geographic Region | Year Ended December 31, 2018 2017 2016 (Dollars in thousands) Revenues United States $ 35,412 $ 25,573 $ 38,318 Belgium — — 233 Total revenues $ 35,412 $ 25,573 $ 38,551 |
Schedule of Long-Lived Assets by Geographic Region | Year Ended December 31, 2018 2017 2016 (Dollars in thousands) Long-lived assets, net United States $ 693 $ 1,166 $ 1,947 Belgium — — 1 Total long-lived assets, net $ 693 $ 1,166 $ 1,948 |
Revenue (Tables)
Revenue (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Revenue [Abstract] | |
Disaggregation of Revenue by Source | Year Ended December 31, 2018 2017 (1) 2016 (1) Revenues Licensing and collaboration revenue GALLIPRANT $ 23,326 $ 5,433 $ 38,000 Other — 480 233 Total licensing and collaboration revenue 23,326 5,913 38,233 Product sales NOCITA $ 7,511 $ 2,782 $ 148 ENTYCE 4,575 1,311 — GALLIPRANT — 15,526 — Other — 41 170 Total product sales 12,086 19,660 318 Total revenues $ 35,412 $ 25,573 $ 38,551 (1) Prior period amounts have not been adjusted under the modified retrospective method of ASC 606 and are reported under ASC 605. |
Schedule of Change in Contract Liability Balances | 2018 As of January 1, $ 7,000 ASC 606 adoption (6,800) Revenue recognized (200) Payments made — As of the end of period, $ — |
Fair Value of Financial Asset_2
Fair Value of Financial Assets and Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Fair Value of Financial Assets and Liabilities [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | Fair Value Measurements as of Carrying December 31, 2018 Using: Value Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Certificates of deposit $ 9,424 $ — $ 9,424 $ — $ 9,424 Short-term investments: Short-term marketable securities - certificates of deposit 1,240 — 1,240 — 1,240 $ 10,664 $ — $ 10,664 $ — $ 10,664 Fair Value Measurements as of Carrying December 31, 2017 Using: Value Level 1 Level 2 Level 3 Total Assets: Cash equivalents: Certificates of deposit $ 8,964 $ — $ 8,964 $ — $ 8,964 Short-term investments: Short-term marketable securities - certificates of deposit 747 — 747 — 747 $ 9,711 $ — $ 9,711 $ — $ 9,711 |
Schedule of Liabilities not Measured at Fair Value on Recurring Basis | December 31, 2017 Carrying Value Fair Value Liabilities: Loans payable (Level 2) $ 36,825 $ 36,973 |
Investments (Tables)
Investments (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Investments [Abstract] | |
Fair Value of Available-for-Sale Marketable Securities | December 31, 2018 Gross Gross Amortized Unrealized Unrealized Fair Cost Losses Losses Value Short-term marketable securities: Certificates of deposit $ 1,240 $ — $ — $ 1,240 Total $ 1,240 $ — $ — $ 1,240 December 31, 2017 Gross Gross Amortized Unrealized Unrealized Fair Cost Losses Losses Value Short-term marketable securities: Certificates of deposit $ 747 $ — $ — $ 747 Total $ 747 $ — $ — $ 747 |
Inventories (Tables)
Inventories (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Inventories [Abstract] | |
Components of Inventories | December 31, 2018 December 31, 2017 Raw materials $ 242 $ 1,132 Work-in-process 8,999 12,322 Finished goods 2,184 122 $ 11,425 $ 13,576 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Property and Equipment, Net [Abstract] | |
Schedule Of Property And Equipment, Net | December 31, 2018 December 31, 2017 Laboratory and office equipment $ 173 $ 173 Computer equipment and software 2,046 2,046 Furniture 135 135 Total property and equipment 2,354 2,354 Less: Accumulated depreciation and amortization (1,661) (1,188) Property and equipment, net $ 693 $ 1,166 |
Goodwill (Tables)
Goodwill (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets [Abstract] | |
Summary of Goodwill | Gross Impairment Net Carrying Value Losses Carrying Value Goodwill $ 40,846 $ — $ 40,846 |
Summary of Change in the Net Book Value of Goodwill | 2018 2017 As of January 1, $ 41,295 $ 39,382 Effect of foreign currency exchange (449) 1,913 As of the end of the period, $ 40,846 $ 41,295 |
Intangible Assets, Net (Tables)
Intangible Assets, Net (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Goodwill and Intangible Assets [Abstract] | |
Change in the Net Book Value of Intangible Assets | 2018 2017 As of January 1, $ 6,616 $ 7,639 Additions (Note 12) — 6,000 Amortization expense (517) (350) Effect of foreign currency exchange — 775 Impairment — (7,448) As of the end of the period, $ 6,099 $ 6,616 |
Estimated Aggregate Amortization Expense Of Intangible Assets | Year Ending December 31, 2019 $ 516 2020 516 2021 516 2022 516 2023 $ 516 |
Summary of Amortized Intangible Assets | Amortized intangible assets as of December 31, 2018, were as follows: Gross Net Weighted Carrying Accumulated Carrying Average Value Amortization Value Useful Life Intellectual property rights for currently marketed products $ 7,000 $ 901 $ 6,099 14.1 Years Amortized intangible assets as of December 31, 2017, were as follows: Gross Net Weighted Carrying Accumulated Carrying Average Value Amortization Value Useful Life Intellectual property rights for currently marketed products $ 7,000 $ 384 $ 6,616 14.1 Years Intellectual property rights for formerly marketed products 38,652 38,652 — N/A $ 45,652 $ 39,036 $ 6,616 |
Accrued Expenses and Other Cu_2
Accrued Expenses and Other Current Liabilities (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Accrued Expenses and Other Current Liabilities [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | December 31, 2018 December 31, 2017 Payroll and related expenses $ 2,587 $ 2,314 Professional fees 353 208 Royalty expense 812 718 Interest expense — 249 Research and development costs 73 5 Accrued loss on a firm purchase commitment 72 — Other 749 218 Total $ 4,646 $ 3,712 |
Stock-Based Awards (Tables)
Stock-Based Awards (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Compensation Related Costs, Share-based Payments [Line Items] | |
Data Used To Determine Value Of Stock Option Grants | Year Ended December 31, 2018 2017 2016 Risk-free interest rate 2.53 % 1.99 % 1.52 % Expected term (in years) 6.0 6.0 6.2 Expected volatility 72 % 75 % 77 % Expected dividend yield — % — % — % |
Summary of Stock-Based Compensation Expense Related to Stock Options and Restricted Stock | Year Ended December 31, 2018 2017 2016 Research and development $ 655 $ 916 $ 1,069 Cost of product sales and inventories 115 153 116 Selling, general and administrative 4,143 6,049 7,291 $ 4,913 $ 7,118 $ 8,476 |
2010 Equity Incentive Plan [Member] | |
Compensation Related Costs, Share-based Payments [Line Items] | |
Summary of Stock Option Activity | Weighted Shares Weighted Average Issuable Average Remaining Aggregate Under Exercise Contractual Intrinsic Options Price Term Value (In Years) Outstanding as of December 31, 2017 57,394 $ 4.22 5.11 $ 73 Granted — — Exercised — — Forfeited — — Expired (4,011) 5.57 Outstanding as of December 31, 2018 53,383 $ 4.12 4.10 $ 107 Options vested and expected to vest as of December 31, 2018 53,383 $ 4.12 4.10 $ 107 Options exercisable as of December 31, 2018 53,383 $ 4.12 4.10 $ 107 |
2013 Plan [Member] | |
Compensation Related Costs, Share-based Payments [Line Items] | |
Summary of Stock Option Activity | Weighted Shares Weighted Average Issuable Average Remaining Aggregate Under Exercise Contractual Intrinsic Options Price Term Value (in Years) Outstanding as of December 31, 2017 2,557,143 $ 11.45 7.41 $ 794 Granted 798,000 4.84 Exercised (4,709) 3.14 Forfeited (151,603) 6.24 Expired (84,430) 17.18 Outstanding as of December 31, 2018 3,114,401 $ 9.86 6.85 $ 2,047 Options vested and expected to vest as of December 31, 2018 3,114,401 $ 9.86 6.85 $ 2,047 Options exercisable as of December 31, 2018 1,961,944 $ 12.40 5.82 $ 755 |
Summary of Restricted Stock Activity | Weighted Average Grant Shares Date Fair Value Unvested restricted common stock as of December 31, 2017 491,861 $ 7.59 Issued 486,000 4.83 Vested (380,427) 7.34 Forfeited (61,835) 5.59 Unvested restricted common stock as of December 31, 2018 535,599 $ 5.50 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Net Loss Per Share [Abstract] | |
Schedule of Basic and Diluted Net Income (Loss) Per Share Attributable to Common Stockholders | Year Ended December 31, 2018 2017 2016 Numerator: Net loss $ (14,722) $ (47,510) $ (33,575) Denominator: Weighted average shares outstanding, basic and diluted 46,606,855 40,494,301 35,273,228 Net loss per share, basic and diluted $ (0.32) $ (1.17) $ (0.95) |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Commitments and Contingencies [Abstract] | |
Future Minimum Lease Payments For Operating Leases | Year Ending December 31, 2019 $ 441 2020 450 2021 75 2022 — 2023 — Thereafter — Total $ 966 |
Income Taxes (Tables)
Income Taxes (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Income Taxes [Abstract] | |
Components Of Income From Continuing Operations Before Income Taxes Benefit | Year Ended December 31, 2018 2017 2016 United States $ (14,398) $ (38,920) $ (29,959) Non-United States (324) (8,590) (3,616) Loss from continuing operations $ (14,722) $ (47,510) $ (33,575) |
Reconciliation Of U.S. Federal Statutory Income Tax Rate To Effective Income Tax Rate | Year Ended December 31, 2018 2017 2016 Federal statutory income tax rate 21.0 % 34.0 % 34.0 % State income taxes, net of federal tax benefit 2.4 6.9 3.2 Non-deductible expenses (1.1) (0.1) 0.2 Stock-based compensation (3.9) (1.8) (1.5) Research credits 3.1 1.3 5.0 TCJA — (42.8) — Other 0.1 (5.0) — Change in valuation allowance (21.6) 7.5 (40.9) Total — % — % — % |
Net Deferred Tax Assets | Year Ended December 31, 2018 2017 2016 Net operating loss carry forwards $ 25,811 $ 31,061 $ 27,244 Capitalized start-up costs 4,181 5,052 5,990 Tax credit carry forwards 4,019 3,737 2,996 Intangibles, net 2,633 2,915 2,072 Capitalized research and development, net 4,359 6,083 10,005 Other temporary differences 4,512 5,922 7,940 Total deferred tax assets 45,515 54,770 56,247 Valuation allowance (45,386) (54,636) (56,116) Net deferred tax assets 129 134 131 Depreciation (129) (134) (131) Total deferred tax liabilities (129) (134) (131) Net deferred tax liability $ — $ — $ — |
Changes In Valuation Allowance For Deferred Tax Assets | Year Ended December 31, 2018 2017 2016 Valuation allowance as of beginning of year $ 54,636 $ 56,116 $ 46,885 Changes due to operations, TCJA and other tax rates (9,250) (1,480) 9,231 Valuation allowance as of end of year $ 45,386 $ 54,636 $ 56,116 |
Selected Quarterly Financial _2
Selected Quarterly Financial Data (Tables) | 12 Months Ended |
Dec. 31, 2018 | |
Selected Quarterly Financial Data [Abstract] | |
Schedule Of Selected Quarterly Financial Data | 2018 First Second Third Fourth Quarter Quarter Quarter Quarter Net revenues $ 4,043 $ 4,908 $ 21,555 (1) $ 4,906 Gross profit (2) 3,507 3,603 19,383 2,136 Net income (loss) (2) (8,548) (6,373) 8,833 (8,634) Weighted average shares outstanding, basic 44,788,068 46,258,395 47,310,408 48,027,220 Weighted average shares outstanding, diluted 44,788,068 46,258,395 47,485,384 48,027,220 Net income (loss) per share, basic and diluted $ (0.19) $ (0.14) $ 0.19 $ (0.18) __________________ (1) Net revenues in the third quarter or 2018 reflect the impact of $15,000 of licensing and collaboration revenue related to GALLIPRANT sales milestone earned from Elanco, as further described in Note 12 to the consolidated financial statements included elsewhere in this 2018 Annual Report. (2) Net loss in the second and fourth quarter of 2018 and net income in the third quarter of 2018 and gross profit in the second, third and fourth quarter of 2018 reflect the impact of inventory valuation adjustment losses in cost of product sales in the amounts of $335 , $883 and $1,432 , respectively , as further described in Note 6 to the consolidated financial statements included elsewhere in this 2018 Annual Report. _ 2017 First Second Third Fourth Quarter Quarter Quarter Quarter Net revenues (1) $ 3,795 $ 5,158 $ 6,163 (2) $ 10,457 (3) Gross profit 701 1,467 2,473 4,545 Net loss (12,612) (10,380) (8,920) (15,598) (4) Weighted average shares outstanding, basic and diluted 36,711,601 40,206,042 42,445,553 42,493,514 Net loss per share, basic and diluted $ (0.34) $ (0.26) $ (0.21) $ (0.37) _________________ (1) Net revenues reflect the impact of the product launch of GALLIPRANT which commercial sales began in the first quarter of 2017 and which sales of finished goods in the amount of $15,526 to Elanco ended in the fourth quarter of 2017. (2) Net revenues in the third quarter or 2017 reflect the impact of $1,000 of licensing and collaboration revenue related to the assumption of manufacturing responsibility by Elanco as further described in Note 12 to the consolidated financial statements included elsewhere in this 2018 Annual Report . (3) Net revenues in the fourth quarter of 2017 reflect the impact of revenues recognized related to the withdrawal of BLONTRESS from the market and the related derecognition of the remaining balance of the liability of $480 as further described in Note 12 to the consolidated financial statements included elsewhere in this 2018 Annual Report , and the impact of commercial sales of ENTYCE which began in the fourth quarter of 2017. (4) Net loss in the fourth quarter of 2017 reflects the impact of an intangible asset impairment charge of $7,448 related to AT-006 and AT-008 as further described in Note 9 to the consolidated financial statements included elsewhere in this 2018 Annual Report. |
The Company and Basis of Pres_2
The Company and Basis of Presentation (Narrative) (Details) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018USD ($)segment | Dec. 31, 2017USD ($) | |
The Company and Basis of Presentation [Abstract] | ||
Date of incorporation | Dec. 1, 2010 | |
Number of operating segments | segment | 1 | |
Accumulated deficit | $ | $ 241,238 | $ 233,316 |
Period in which cash, cash equivalents and short-term investments are sufficient to fund operations | 1 year |
Summary of Significant Accoun_4
Summary of Significant Accounting Policies (Narrative) (Details) | 12 Months Ended | ||
Dec. 31, 2018USD ($)itemcustomer | Dec. 31, 2017USD ($)customer | Dec. 31, 2016USD ($) | |
Summary Of Significant Accounting Policies [Line Items] | |||
Gain on deconsolidation of a variable interest entity | $ 276,000 | ||
Adjustment available-for-sale securities | $ 0 | $ 0 | |
Deferred public offering costs | $ 0 | $ 76,000 | |
Federal statutory income tax rate | 21.00% | 34.00% | 34.00% |
Number of accredited financial institutions where various operating account balances are maintained in excess of federally insured limits | item | 2 | ||
Total assets | $ 106,436,000 | $ 135,192,000 | $ 151,406,000 |
Maximum [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Federal statutory income tax rate | 35.00% | ||
Customer Concentration Risk [Member] | Elanco Animal Health, Inc. [Member] | Accounts Receivable [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 52.00% | 64.00% | |
Customer Concentration Risk [Member] | Distributor [Member] | Accounts Receivable [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Number of customers | customer | 1 | ||
Concentration risk percentage | 15.00% | ||
Product Concentration Risk [Member] | Elanco Animal Health, Inc. [Member] | Sales Revenue, Net [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Number of customers | customer | 1 | ||
Concentration risk percentage | 66.00% | 23.00% | |
Product Concentration Risk [Member] | Elanco Animal Health, Inc. [Member] | Sales Revenue, Product Line [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 79.00% | ||
Product Concentration Risk [Member] | Distributor [Member] | Sales Revenue, Net [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Number of customers | customer | 2 | ||
Concentration risk percentage | 26.00% | ||
Product Concentration Risk [Member] | Minimum [Member] | Distributor [Member] | Sales Revenue, Net [Member] | |||
Summary Of Significant Accounting Policies [Line Items] | |||
Concentration risk percentage | 10.00% |
Summary of Significant Accoun_5
Summary of Significant Accounting Policies (Estimated Useful Lives of Property, Plant and Equipment) (Details) | 12 Months Ended |
Dec. 31, 2018 | |
Laboratory and Office Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Laboratory and Office Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 10 years |
Computer Software and Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Computer Software and Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Furniture [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Furniture [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 7 years |
Vehicles [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Vehicles [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 5 years |
Leasehold Improvements [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 3 years |
Leasehold Improvements [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated useful lives | 10 years |
Summary of Significant Accoun_6
Summary of Significant Accounting Policies (Schedule of Revenue by Geographic Region) (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 | |
Segment Reporting Information [Line Items] | |||||||||||
Total revenues | $ 4,906 | $ 21,555 | $ 4,908 | $ 4,043 | $ 10,457 | $ 6,163 | $ 5,158 | $ 3,795 | $ 35,412 | $ 25,573 | $ 38,551 |
United States [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenues | $ 35,412 | $ 25,573 | 38,318 | ||||||||
Belgium [Member] | |||||||||||
Segment Reporting Information [Line Items] | |||||||||||
Total revenues | $ 233 |
Summary of Significant Accoun_7
Summary of Significant Accounting Policies (Schedule of Long-Lived Assets by Geographic Region) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Segment Reporting Information [Line Items] | |||
Total long lived assets, net | $ 693 | $ 1,166 | $ 1,948 |
United States [Member] | |||
Segment Reporting Information [Line Items] | |||
Total long lived assets, net | $ 693 | $ 1,166 | 1,947 |
Belgium [Member] | |||
Segment Reporting Information [Line Items] | |||
Total long lived assets, net | $ 1 |
Revenue (Narrative) (Details)
Revenue (Narrative) (Details) - USD ($) | Jan. 01, 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 |
Revenue from Contract with Customer [Line Items] | ||||||||||||
Accumulated deficit | $ (241,238,000) | $ (233,316,000) | $ (241,238,000) | $ (233,316,000) | ||||||||
Income tax benefit | 0 | 0 | $ 0 | |||||||||
Contract liability | $ 200,000 | 7,000,000 | 7,000,000 | |||||||||
Payments or submittal for reimbursement resulting in increase (decrease) in obligation | 0 | |||||||||||
Total revenues | 4,906,000 | $ 21,555,000 | $ 4,908,000 | $ 4,043,000 | 10,457,000 | $ 6,163,000 | $ 5,158,000 | $ 3,795,000 | 35,412,000 | 25,573,000 | $ 38,551,000 | |
Unsatisfied performance obligations | 0 | |||||||||||
Difference between Revenue Guidance in Effect before and after Topic 606 [Member] | Accounting Standards Update 2014-09 [Member] | ||||||||||||
Revenue from Contract with Customer [Line Items] | ||||||||||||
Accumulated deficit | 6,800,000 | |||||||||||
Income tax benefit | $ 0 | |||||||||||
Calculated under Revenue Guidance in Effect before Topic 606 [Member] | ||||||||||||
Revenue from Contract with Customer [Line Items] | ||||||||||||
Total revenues | 6,800,000 | |||||||||||
NOCITA and ENTYCE [Member] | ||||||||||||
Revenue from Contract with Customer [Line Items] | ||||||||||||
Reserve for product returns and allowances | $ 222,000 | $ 90,000 | $ 222,000 | $ 90,000 |
Revenue (Disaggregation of Reve
Revenue (Disaggregation of Revenue by Source) (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] | |||||||||||
Total revenues | $ 4,906 | $ 21,555 | $ 4,908 | $ 4,043 | $ 10,457 | $ 6,163 | $ 5,158 | $ 3,795 | $ 35,412 | $ 25,573 | $ 38,551 |
Licensing and Collaboration [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | $ 200 | $ 1,000 | 23,326 | 5,913 | 38,233 | ||||||
Licensing and Collaboration [Member] | GALLIPRANT [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 23,326 | 5,433 | 38,000 | ||||||||
Licensing and Collaboration [Member] | Other [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 480 | 233 | |||||||||
Product Sales [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 12,086 | 19,660 | 318 | ||||||||
Product Sales [Member] | NOCITA [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 7,511 | 2,782 | 148 | ||||||||
Product Sales [Member] | ENTYCE [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | $ 4,575 | 1,311 | |||||||||
Product Sales [Member] | GALLIPRANT [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | 15,526 | ||||||||||
Product Sales [Member] | Other [Member] | |||||||||||
Disaggregation of Revenue [Line Items] | |||||||||||
Total revenues | $ 41 | $ 170 |
Revenue (Schedule of Change in
Revenue (Schedule of Change in Contract Liability Balances) (Details) $ in Thousands | 12 Months Ended |
Dec. 31, 2018USD ($) | |
Revenue [Abstract] | |
As of January 1, | $ 7,000 |
ASC 606 adoption | (6,800) |
Revenue recognized | (200) |
Payments made | |
As of the end of period, |
Fair Value of Financial Asset_3
Fair Value of Financial Assets and Liabilities (Narrative) (Details) - USD ($) | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Fair Value, Measurements, Recurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Liabilities fair value | $ 0 | $ 0 |
Assets fair value | 10,664,000 | 9,711,000 |
Fair Value, Measurements, Nonrecurring [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Assets fair value | 0 | $ 0 |
Intellectual Property Rights Acquired For In-Process Research And Development [Member] | ||
Fair Value Assets And Liabilities Measured On Recurring And Nonrecurring Basis [Line Items] | ||
Intangible assets, fair value | 0 | |
Impairment expense | $ 0 |
Fair Value of Financial Asset_4
Fair Value of Financial Assets and Liabilities (Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis) (Details) - Fair Value, Measurements, Recurring [Member] - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Assets: | ||
Short-term marketable securities - certificates of deposit | $ 1,240 | $ 747 |
Assets, fair value | 10,664 | 9,711 |
Carrying Value [Member] | ||
Assets: | ||
Short-term marketable securities - certificates of deposit | 1,240 | 747 |
Assets, fair value | 10,664 | 9,711 |
Certificates of Deposit [Member] | ||
Assets: | ||
Cash equivalents | 9,424 | 8,964 |
Certificates of Deposit [Member] | Carrying Value [Member] | ||
Assets: | ||
Cash equivalents | 9,424 | 8,964 |
Level 2 [Member] | ||
Assets: | ||
Short-term marketable securities - certificates of deposit | 1,240 | 747 |
Assets, fair value | 10,664 | 9,711 |
Level 2 [Member] | Certificates of Deposit [Member] | ||
Assets: | ||
Cash equivalents | $ 9,424 | $ 8,964 |
Fair Value of Financial Asset_5
Fair Value of Financial Assets and Liabilities (Schedule of Liabilities not Measured at Fair Value on Recurring Basis) (Details) - Level 2 [Member] - Fair Value, Measurements, Nonrecurring [Member] $ in Thousands | Dec. 31, 2017USD ($) |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | |
Loan payable, Carrying Value | $ 36,825 |
Loan payable, Fair Value | $ 36,973 |
Investments (Fair Value of Avai
Investments (Fair Value of Available-for-Sale Marketable Securities) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 1,240 | $ 747 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | 1,240 | 747 |
Certificates of Deposit [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 1,240 | 747 |
Gross Unrealized Gains | ||
Gross Unrealized Losses | ||
Fair Value | $ 1,240 | $ 747 |
Inventories (Narrative) (Detail
Inventories (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Inventory [Line Items] | |||
Inventory valuation adjustment losses | $ 2,650 | $ 741 | $ 5,186 |
Inventories | 11,425 | 13,576 | |
Raw materials | 242 | 1,132 | |
Non-cancellable open orders | $ 1,974 | ||
Non-cancellable open orders expected to be paid, term | 12 months | ||
Research and development | $ 6,855 | 15,126 | 30,462 |
ENTYCE [Member] | |||
Inventory [Line Items] | |||
Inventories | $ 10,708 | ||
Research and development | 2,639 | ||
Manufacturing costs | 1,983 | ||
GALLIPRANT [Member] | |||
Inventory [Line Items] | |||
Inventory valuation adjustment losses | 394 | ||
Raw materials | 777 | ||
BLONTRESS, TACTRESS and GALLIPRANT [Member] | |||
Inventory [Line Items] | |||
Inventory valuation adjustment losses | $ 2,532 | ||
Elanco Animal Health, Inc. [Member] | GALLIPRANT [Member] | |||
Inventory [Line Items] | |||
Inventory valuation adjustment losses | $ 347 |
Inventories (Components of Inve
Inventories (Components of Inventories) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Inventories [Abstract] | ||
Raw materials | $ 242 | $ 1,132 |
Work-in-process | 8,999 | 12,322 |
Finished goods | 2,184 | 122 |
Total | $ 11,425 | $ 13,576 |
Property and Equipment, Net (Na
Property and Equipment, Net (Narrative) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Property Plant And Equipment [Line Items] | |||
Depreciation expense | $ 473 | $ 812 | $ 609 |
Gain (loss) on assets sold | 30 | (2) | |
San Diego, California [Member] | |||
Property Plant And Equipment [Line Items] | |||
Gain (loss) on assets sold | $ 0 | 0 | $ 0 |
Equipment [Member] | San Diego, California [Member] | |||
Property Plant And Equipment [Line Items] | |||
Impairment charges | $ 317 |
Property and Equipment, Net (Sc
Property and Equipment, Net (Schedule of Property and Equipment, Net) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Property Plant And Equipment [Line Items] | |||
Total property and equipment | $ 2,354 | $ 2,354 | |
Less: Accumulated depreciation and amortization | (1,661) | (1,188) | |
Property and equipment, net | 693 | 1,166 | $ 1,948 |
Laboratory And Office Equipment [Member] | |||
Property Plant And Equipment [Line Items] | |||
Total property and equipment | 173 | 173 | |
Computer Equipment And Software [Member] | |||
Property Plant And Equipment [Line Items] | |||
Total property and equipment | 2,046 | 2,046 | |
Furniture [Member] | |||
Property Plant And Equipment [Line Items] | |||
Total property and equipment | $ 135 | $ 135 |
Goodwill (Narrative) (Details)
Goodwill (Narrative) (Details) | 3 Months Ended | 12 Months Ended |
Sep. 30, 2018USD ($) | Dec. 31, 2018USD ($)segment | |
Goodwill and Intangible Assets [Abstract] | ||
Goodwill impairment loss | $ | $ 0 | $ 0 |
Number of reporting units | segment | 1 |
Goodwill (Summary of Goodwill)
Goodwill (Summary of Goodwill) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Goodwill and Intangible Assets [Abstract] | |||
Gross Carrying Value | $ 40,846 | ||
Impairment Losses | |||
Net Carrying Value | $ 40,846 | $ 41,295 | $ 39,382 |
Goodwill (Summary of Change in
Goodwill (Summary of Change in the Net Book Value of Goodwill) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Goodwill and Intangible Assets [Abstract] | ||
As of January 1, | $ 41,295 | $ 39,382 |
Effect of foreign currency exchange | (449) | 1,913 |
As of the end of the period, | $ 40,846 | $ 41,295 |
Intangible Assets, Net (Narrati
Intangible Assets, Net (Narrative) (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |||||
Dec. 31, 2017 | Dec. 31, 2016 | Jun. 30, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 | |
Intangible Assets [Line Items] | |||||||
Amortization of intangible assets | $ 517,000 | $ 350,000 | $ 379,000 | ||||
Net carrying value of unamortized intangible assets | $ 0 | 0 | 0 | ||||
Impairment of unamortized intangible assets | 24,213,000 | 24,213,000 | |||||
Accumulated amortization | 39,036,000 | 39,036,000 | |||||
Net carrying value | 6,616,000 | 6,616,000 | |||||
BLONTRESS [Member] | |||||||
Intangible Assets [Line Items] | |||||||
Accumulated amortization | 25,390,000 | 25,390,000 | 25,390,000 | ||||
Impairment expense | $ 5,162,000 | $ 20,228,000 | |||||
Net carrying value | $ 0 | $ 0 | |||||
TACTRESS [Member] | |||||||
Intangible Assets [Line Items] | |||||||
Accumulated amortization | 9,185,000 | $ 9,185,000 | 9,185,000 | ||||
Impairment expense | $ 551,000 | 8,634,000 | |||||
Net carrying value | 0 | ||||||
AT-006 and AT-008 [Member] | |||||||
Intangible Assets [Line Items] | |||||||
Net carrying value of unamortized intangible assets | 0 | $ 0 | |||||
Impairment of unamortized intangible assets | $ 7,448,000 | ||||||
AT-007 [Member] | |||||||
Intangible Assets [Line Items] | |||||||
Net carrying value of unamortized intangible assets | 0 | ||||||
Impairment of unamortized intangible assets | $ 2,229,000 | $ 8,717,000 |
Intangible Assets, Net (Change
Intangible Assets, Net (Change in the Net Book Value of Intangible Assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Goodwill and Intangible Assets [Abstract] | |||
As of January 1, | $ 6,616 | $ 7,639 | |
Additions (Note 12) | 6,000 | ||
Amortization expense | (517) | (350) | $ (379) |
Effect of foreign currency exchange | 775 | ||
Impairment | (7,448) | (7,942) | |
As of the end of the period, | $ 6,099 | $ 6,616 | $ 7,639 |
Intangible Assets, Net (Estimat
Intangible Assets, Net (Estimated Aggregate Amortization Expense of Intangible Assets) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Goodwill and Intangible Assets [Abstract] | |
2019 | $ 516 |
2020 | 516 |
2021 | 516 |
2022 | 516 |
2023 | $ 516 |
Intangible Assets, Net (Summary
Intangible Assets, Net (Summary of Amortized Intangible Assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
Finite-Lived Intangible Assets [Line Items] | ||
Gross carrying value | $ 45,652 | |
Accumulated amortization | 39,036 | |
Net carrying value | 6,616 | |
Intellectual Property Rights For Currently Marketed Products [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross carrying value | $ 7,000 | 7,000 |
Accumulated amortization | 901 | 384 |
Net carrying value | $ 6,099 | $ 6,616 |
Weighted average useful life | 14 years 1 month 6 days | 14 years 1 month 6 days |
Intellectual Property Rights For Formerly Marketed Products [Member] | ||
Finite-Lived Intangible Assets [Line Items] | ||
Gross carrying value | $ 38,652 | |
Accumulated amortization | $ 38,652 |
Debt (Narrative) (Details)
Debt (Narrative) (Details) - USD ($) | Dec. 21, 2018 | Jul. 31, 2017 | Oct. 16, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||||||
Repayment of debt | $ 36,500,000 | $ 3,500,000 | ||||
Interest expense | 3,391,000 | 3,481,000 | $ 3,396,000 | |||
Amortization of debt issuance costs | $ 994,000 | $ 513,000 | $ 477,000 | |||
Term Loan [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Aggregate principal amount | $ 35,000,000 | |||||
Termination commitment fee percentage | 3.30% | |||||
Revolving Line due 2017 [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Maximum borrowing capacity | $ 5,000,000 | |||||
Date of maturity | Oct. 16, 2017 | |||||
Termination fee | $ 165,000 | |||||
Term Loan And Revolving Credit Facility [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Interest rate | 6.91% | |||||
Excess interest rate over prime rate | 3.66% | |||||
Repayment of debt | $ 20,610,000 | |||||
Loan Agreement, Second Amendment [Member] | ||||||
Debt Instrument [Line Items] | ||||||
Date of maturity | Oct. 16, 2019 | |||||
Interest only payment term | 6 months | |||||
Amendment fee | $ 150,000 | |||||
Facility fee | 60,000 | |||||
Termination fee | $ 165,000 |
Accrued Expenses and Other Cu_3
Accrued Expenses and Other Current Liabilities (Schedule of Accrued Expenses and Other Current Liabilities) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 |
Accrued expenses: | ||
Payroll and related expenses | $ 2,587 | $ 2,314 |
Professional fees | 353 | 208 |
Royalty expense | 812 | 718 |
Interest expense | 249 | |
Research and development costs | 73 | 5 |
Accrued loss on a firm purchase commitment | 72 | |
Other | 749 | 218 |
Total | $ 4,646 | $ 3,712 |
Agreements (RaQualia Pharma Inc
Agreements (RaQualia Pharma Inc Narrative) (Details) - RaQualia Agreements [Member] $ in Thousands | 12 Months Ended | |||
Dec. 31, 2018USD ($) | Dec. 31, 2017USD ($) | Dec. 31, 2016USD ($) | Dec. 27, 2010USD ($)agreement | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Number of license agreements | agreement | 2 | |||
Milestones payable | $ 2,000 | |||
Milestones achieved | 0 | $ 6,000 | $ 5,500 | |
Milestones paid | $ 11,500 | |||
Maximum [Member] | GALLIPRANT [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Milestones payable | $ 4,000 | |||
Maximum [Member] | ENTYCE [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Milestones payable | $ 3,000 |
Agreements (Pacira Pharmaceutic
Agreements (Pacira Pharmaceuticals, Inc. Narrative) (Details) - USD ($) | Dec. 31, 2018 | Jul. 05, 2018 | Dec. 31, 2019 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Net carrying value of unamortized intangible assets | $ 0 | $ 0 | $ 0 | |||
Research and development | 6,855,000 | 15,126,000 | $ 30,462,000 | |||
Pacira Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestones achieved | 0 | $ 0 | 2,000,000 | |||
Net carrying value of unamortized intangible assets | 1,000,000 | |||||
Accrued milestones | 0 | $ 0 | ||||
Pacira Agreement [Member] | AT-003 [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestones paid | $ 2,500,000 | |||||
Research and development | $ 1,000,000 | |||||
Pacira A&R License Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Annual revenue payment, period delayed | 1 year | |||||
Pacira A&R License Agreement [Member] | Minimum [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Product completion, pain prevented post-surgery, hours | 48 hours | |||||
Pacira A&R License Agreement [Member] | Maximum [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Product completion, pain prevented post-surgery, hours | 72 hours | |||||
Pacira A&R License Agreement [Member] | Commercial Milestone [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestones payable | $ 40,000,000 | |||||
Scenario, Forecast [Member] | Pacira A&R License Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Milestones achieved | $ 0 | |||||
Initial Tier [Member] | Pacira A&R License Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Net sales that must be met for milestone payable | 50,000,000 | |||||
Final Tier [Member] | Pacira A&R License Agreement [Member] | ||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||
Net sales that must be met for milestone payable | $ 250,000,000 |
Agreements (Elanco BLONTRESS Na
Agreements (Elanco BLONTRESS Narrative) (Details) - USD ($) $ in Thousands | Feb. 25, 2016 | Mar. 31, 2018 | Mar. 31, 2016 | Mar. 31, 2015 | Sep. 30, 2018 | Mar. 31, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 02, 2015 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Current liability | $ 5,557 | $ 35,496 | ||||||||
Royalty expense | $ 3,865 | 1,821 | $ 106 | |||||||
BLONTRESS [Member] | Elanco Agreement [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Milestone receivable | $ 3,000 | |||||||||
Licensing and collaboration revenue | $ 15,000 | $ 3,000 | ||||||||
Cash paid for contingent consideration | $ 2,500 | |||||||||
Contingent consideration | 500 | 500 | ||||||||
Current liability | $ 500 | $ 500 | ||||||||
Payment to re-acquire rights | $ 3,000 | |||||||||
BLONTRESS [Member] | Elanco Agreement Amendment [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Licensing and collaboration revenue | $ 480 | |||||||||
Royalty expense | $ 500 | |||||||||
Agreement term | 2 years | |||||||||
Interest | 10.00% | |||||||||
BLONTRESS [Member] | Elanco Agreement Amendment [Member] | Maximum [Member] | ||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||
Royalty expense | $ 500 |
Agreements (Elanco GALLIPRANT N
Agreements (Elanco GALLIPRANT Narrative) (Details) - USD ($) | Apr. 28, 2017 | Apr. 22, 2016 | Sep. 30, 2017 | Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Jun. 30, 2016 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Jan. 01, 2018 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Licensing and collaboration commitment | $ 7,000,000 | $ 7,000,000 | $ 200,000 | |||||||||||||
ASC 606 adoption | 6,800,000 | |||||||||||||||
Total revenues | 4,906,000 | $ 21,555,000 | $ 4,908,000 | $ 4,043,000 | 10,457,000 | $ 6,163,000 | $ 5,158,000 | $ 3,795,000 | 35,412,000 | 25,573,000 | $ 38,551,000 | |||||
Contract liability | 7,000,000 | 7,000,000 | $ 200,000 | |||||||||||||
Cost of product sales | 6,783,000 | 16,387,000 | 3,139,000 | |||||||||||||
Licensing and Collaboration [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Total revenues | 200,000 | $ 1,000,000 | 23,326,000 | 5,913,000 | 38,233,000 | |||||||||||
Elanco Collaboration Agreement [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Upfront nonrefundable payment received | $ 45,000,000 | |||||||||||||||
Percentage of third-party development fees and expenses to be paid | 25.00% | |||||||||||||||
Licensing and collaboration commitment | 7,000,000 | 7,000,000 | ||||||||||||||
ASC 606 adoption | 6,800,000 | |||||||||||||||
Contract liability | $ 7,000,000 | 7,000,000 | ||||||||||||||
Milestones achieved | 15,000,000 | 0 | 0 | |||||||||||||
Proceeds from milestones acheived | 15,000,000 | |||||||||||||||
Accrued milestones | 0 | 0 | ||||||||||||||
Elanco Collaboration Agreement [Member] | Maximum [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Licensing and collaboration commitment | 7,000,000 | 7,000,000 | ||||||||||||||
Contract liability | $ 7,000,000 | 7,000,000 | ||||||||||||||
Elanco Collaboration Agreement [Member] | Elanco Animal Health, Inc. [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Percentage of third-party development fees and expenses to be paid | 75.00% | |||||||||||||||
Elanco Collaboration Agreement Amendment [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Licensing and collaboration commitment | $ 38,000,000 | |||||||||||||||
Binding purchase order, submission period | 15 days | |||||||||||||||
Agreement to pay after proof of payment to manufacturer, period | 30 days | |||||||||||||||
Contract liability | $ 38,000,000 | |||||||||||||||
Licensing and collaboration revenue | $ 38,000,000 | 6,099,000 | ||||||||||||||
Elanco Collaboration Agreement Amendment [Member] | Licensing and Collaboration [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Cost of product sales | 1,000,000 | |||||||||||||||
Elanco Collaboration Agreement Amendment [Member] | Elanco Animal Health, Inc. [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Cash paid for contingent consideration | $ 10,832,000 | |||||||||||||||
Elanco Co-Promotion Agreement [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Fee for services performed and expenses incurred as a percent of gross margin to net sales | 25.00% | |||||||||||||||
Agreement for promotional services fee, expiration | Dec. 31, 2028 | |||||||||||||||
Regulatory And Development Milestones [Member] | Elanco Collaboration Agreement [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Milestone receivable | $ 4,000,000 | |||||||||||||||
European Approval Milestone [Member] | Elanco Collaboration Agreement [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Milestone receivable | 4,000,000 | |||||||||||||||
Sales Milestone [Member] | Elanco Collaboration Agreement [Member] | Grapiprant Products [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Milestone receivable | $ 75,000,000 | |||||||||||||||
Reduction for each annual occurrence milestone is not achieved | 33.33% | |||||||||||||||
GALLIPRANT [Member] | Licensing and Collaboration [Member] | ||||||||||||||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||||||||||||||
Total revenues | $ 23,326,000 | $ 5,433,000 | $ 38,000,000 |
Agreements (Advaxis Inc. Narrat
Agreements (Advaxis Inc. Narrative) (Details) - Advaxis Agreement [Member] | Mar. 19, 2014USD ($)item | Dec. 31, 2018USD ($) |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Number of products | item | 3 | |
Number of types of cancer | item | 3 | |
Accrued milestones | $ 0 | |
Milestones paid | $ 0 | |
Clinical Development And Regulatory Milestone [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Number of products | item | 4 | |
Milestones payable | $ 6,000,000 | |
Commercial Milestone [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Milestones payable | $ 28,500,000 | |
Maximum [Member] | ||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||
Fee for royalties on product sales | 10.00% |
Agreements (VetStem BioPharma,
Agreements (VetStem BioPharma, Inc. Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Research and development | $ 6,855,000 | $ 15,126,000 | $ 30,462,000 |
VetStem Agreement [Member] | |||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||
Milestones achieved | 0 | $ 250,000 | $ 450,000 |
Research and development | 0 | ||
Milestones paid | 1,000,000 | ||
Royalty payments | 0 | ||
Accrued milestones | 0 | ||
Accrued royalties | $ 0 |
Agreements (Atopix Therapeutics
Agreements (Atopix Therapeutics Ltd. Narrative) (Details) - USD ($) | Oct. 10, 2014 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Cost of product sales | $ 6,783,000 | $ 16,387,000 | $ 3,139,000 | |
In-process research and development | 500,000 | |||
Atopix Agreement [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Cost of product sales | $ 1,000,000 | |||
In-process research and development | 1,000,000 | |||
Milestones achieved | 0 | $ 0 | $ 0 | |
Milestones paid | 500,000 | |||
Royalty payments | 0 | |||
Accrued milestones | 0 | |||
Atopix Agreement [Member] | Maximum [Member] | Clinical Development And Regulatory Milestone [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Milestones payable | $ 4,000,000 | |||
AT-018 [Member] | Atopix Agreement [Member] | ||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | ||||
Accrued royalties | $ 0 |
Agreements (AskAt Inc. Narrativ
Agreements (AskAt Inc. Narrative) (Details) - USD ($) | Feb. 28, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2019 | Dec. 31, 2018 |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
In-process research and development | $ 500,000 | ||||
AskAt Agreement [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Upfront option fee | $ 500,000 | ||||
In-process research and development | $ 500,000 | ||||
Percentage of milestone payable that can be paid out in cash | 50.00% | ||||
Percentage of milestone payable that can be paid out in shares | 50.00% | ||||
Milestones achieved | 0 | ||||
Milestones paid | 0 | ||||
Royalty payments | $ 0 | ||||
AskAt Agreement [Member] | Scenario, Forecast [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Milestones achieved | $ 0 | ||||
AskAt Agreement [Member] | Clinical Development And Regulatory Milestone [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Milestones payable | $ 3,000,000 | ||||
AskAt Agreement [Member] | Commercial Milestone [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Milestones payable | 12,500,000 | ||||
AskAt Agreement [Member] | Maximum [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Milestones payable | 15,500,000 | ||||
AskAt Agreement [Member] | Minimum [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Net sales that must be met for milestone payable | $ 100,000,000 | ||||
AskAt Collaboration And Option Agreement [Member] | |||||
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |||||
Upfront option fee | $ 500,000 |
Agreements (Government And Othe
Agreements (Government And Other Incentive Programs Narrative) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Government And Other Incentive Programs [Member] | |
Research and Development Arrangement, Contract to Perform for Others [Line Items] | |
Incentive program, potential obligation to repay if certain criteria are not met | $ 854 |
Common Stock (Narrative) (Detai
Common Stock (Narrative) (Details) | Dec. 18, 2017USD ($) | May 09, 2017USD ($) | May 03, 2017$ / sharesshares | Apr. 28, 2017USD ($) | Oct. 16, 2015USD ($) | Dec. 31, 2018USD ($)$ / sharesitemshares | Dec. 31, 2017USD ($)$ / sharesshares | Dec. 31, 2016USD ($)$ / sharesshares |
Class of Stock [Line Items] | ||||||||
Common stock, authorized | shares | 100,000,000 | 100,000,000 | ||||||
Common stock, par value | $ / shares | $ 0.001 | $ 0.001 | ||||||
Common stock, shares outstanding | shares | 48,048,914 | 42,532,725 | ||||||
Unvested restricted common stock outstanding | shares | 535,599 | 491,861 | ||||||
Treasury stock, shares | shares | 94,107 | 80,916 | ||||||
Treasury stock, value | $ 1,175,000 | $ 1,107,000 | ||||||
Restricted stock withheld to satisfy employee tax withholding, shares | shares | 13,191 | 2,690 | 0 | |||||
Restricted stock withheld to satisfy employee tax withholding, per share | $ / shares | $ 5.17 | $ 6.88 | $ 0 | |||||
Number of votes for each share of common stock | item | 1 | |||||||
Dividends declared | $ 0 | $ 0 | ||||||
Value of shares issued | 24,223,000 | $ 2,715,000 | $ 14,325,000 | |||||
Shelf Registration Statement [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Aggregate stock available to sell | $ 100,000,000 | |||||||
At-the-Market Offering [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Shares issued | shares | 5,144,244 | |||||||
Proceeds from offering | $ 24,223,000 | |||||||
Placement agent fee | 754,000 | |||||||
Issuance costs | 171,000 | |||||||
Remaining stock available to sell | $ 24,852,000 | |||||||
At-the-Market Offering [Member] | Common Stock [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Aggregate stock available to sell | $ 50,000,000 | $ 52,000,000 | ||||||
Percentage of commission on gross proceeds from sale of shares | 3.00% | 2.75% | ||||||
Value of shares issued | $ 18,000,000 | |||||||
Registered Direct Offering [Member] | ||||||||
Class of Stock [Line Items] | ||||||||
Shares issued | shares | 5,000,000 | |||||||
Price per share | $ / shares | $ 5.25 | |||||||
Percentage of commission on gross proceeds from sale of shares | 6.00% | |||||||
Close date | May 9, 2017 | |||||||
Proceeds from offering | $ 24,400,000 | |||||||
Placement agent fee | 1,575,000 | |||||||
Issuance costs | $ 273,000 |
Stock-Based Awards (Narrative)
Stock-Based Awards (Narrative) (Details) | Jan. 01, 2019shares | Dec. 31, 2018USD ($)$ / sharesitemshares | Dec. 31, 2017USD ($)$ / shares | Dec. 31, 2016USD ($)$ / shares | Dec. 31, 2013shares |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Proceeds from stock option exercises | $ 15,000 | $ 247,000 | $ 138,000 | ||
Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized stock-based compensation expense for options outstanding | $ 3,562,000 | ||||
Unrecognized stock-based compensation expense, recognition period | 2 years 4 months 10 days | ||||
Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Unrecognized stock-based compensation expense, other than options | $ 2,308,000 | ||||
Unrecognized stock-based compensation expense, other than options, recognition period | 1 year 7 months 24 days | ||||
2010 Equity Incentive Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for future grant | shares | 0 | ||||
Award, expiration period | 10 years | ||||
Stock options granted | shares | |||||
2010 Equity Incentive Plan [Member] | Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate intrinsic value of options exercised | $ 0 | 53,000 | 180,000 | ||
Fair value stock awards, vested | 0 | 8,000 | 209,000 | ||
Proceeds from stock option exercises | $ 0 | 3,000 | 9,000 | ||
2013 Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Shares available for future grant | shares | 1,829,915 | ||||
Award, expiration period | 10 years | ||||
Stock options granted | shares | 798,000 | ||||
Shares authorized for issuance | shares | 6,832,405 | ||||
Increase in shares authorized | shares | 1,203,369 | ||||
Percentage increase of shares | 4.00% | ||||
2013 Plan [Member] | Stock Option [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Aggregate intrinsic value of options exercised | $ 9,000 | 185,000 | 38,000 | ||
Fair value stock awards, vested | 3,178,000 | 4,424,000 | 5,380,000 | ||
Proceeds from stock option exercises | $ 15,000 | $ 244,000 | $ 129,000 | ||
Weighted average grant date fair value of options granted | $ / shares | $ 3.16 | $ 5.13 | $ 2.99 | ||
2013 Plan [Member] | Stock Option [Member] | Certain Employees And Non-Employee Directors [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Award, expiration period | 10 years | ||||
2013 Plan [Member] | Stock Option [Member] | Certain Employees And Non-Employee Directors [Member] | Share-based Compensation Award, Tranche One [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 25.00% | ||||
2013 Plan [Member] | Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Weighted average grant date fair value, grants | $ / shares | $ 4.83 | $ 7.85 | $ 3.95 | ||
Fair value stock awards, vested, other than options | $ 1,897,000 | $ 2,065,000 | $ 1,559,000 | ||
Proceeds from the issuance of restricted stock | $ 0 | $ 0 | $ 0 | ||
2013 Plan [Member] | Restricted Stock [Member] | Executives [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Vesting number of installments | item | 12 | ||||
2013 Plan [Member] | Restricted Stock [Member] | Executives [Member] | Share-based Compensation Award, Tranche One [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 8.33% | ||||
2013 Plan [Member] | Restricted Stock [Member] | Non-Executives [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Vesting number of installments | item | 3 | ||||
2013 Plan [Member] | Restricted Stock [Member] | Non-Executives [Member] | Share-based Compensation Award, Tranche One [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting percentage | 33.30% | ||||
Minimum [Member] | 2013 Plan [Member] | Stock Option [Member] | Certain Employees And Non-Employee Directors [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 1 year | ||||
Maximum [Member] | 2013 Plan [Member] | Stock Option [Member] | Certain Employees And Non-Employee Directors [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 36 months | ||||
Maximum [Member] | 2013 Plan [Member] | Restricted Stock [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Vesting period | 3 years | ||||
Subsequent Event [Member] | 2013 Plan [Member] | |||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||||
Annual increase in shares | shares | 1,203,369 |
Stock-Based Awards (Summary of
Stock-Based Awards (Summary of Stock Option Activity) (Details) - USD ($) $ / shares in Units, $ in Thousands | 12 Months Ended | |
Dec. 31, 2018 | Dec. 31, 2017 | |
2010 Equity Incentive Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares Issuable Under Options, Outstanding as of December 31, 2017 | 57,394 | |
Shares Issuable Under Options, Granted | ||
Shares Issuable Under Options, Exercised | ||
Shares Issuable Under Options, Forfeited | ||
Shares Issuable Under Options, Expired | (4,011) | |
Shares Issuable Under Options, Outstanding as of December 31, 2018 | 53,383 | 57,394 |
Shares Issuable Under Options, Options vested and expected to vest as of December 31, 2018 | 53,383 | |
Shares Issuable Under Options, Options exercisable as of December 31, 2018 | 53,383 | |
Weighted Average Exercise Price, Outstanding as of December 31, 2017 | $ 4.22 | |
Weighted Average Exercise Price, Granted | ||
Weighted Average Exercise Price, Exercised | ||
Weighted Average Exercise Price, Forfeited | ||
Weighted Average Exercise Price, Expired | 5.57 | |
Weighted Average Exercise Price, Outstanding as of December 31, 2018 | 4.12 | $ 4.22 |
Weighted Average Exercise Price, Options vested and expected to vest as of December 31, 2018 | 4.12 | |
Weighted Average Exercise Price, Options exercisable as of December 31, 2018 | $ 4.12 | |
Weighted Average Remaining Contractual Term, Outstanding | 4 years 1 month 6 days | 5 years 1 month 10 days |
Weighted Average Remaining Contractual Term, Options vested and expected | 4 years 1 month 6 days | |
Weighted Average Remaining Contractual Term, Options exercisable | 4 years 1 month 6 days | |
Aggregate Intrinsic Value, Outstanding | $ 107 | $ 73 |
Aggregate Intrinsic Value, Options vested and expected | 107 | |
Aggregate Intrinsic Value, Options exercisable | $ 107 | |
2013 Plan [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares Issuable Under Options, Outstanding as of December 31, 2017 | 2,557,143 | |
Shares Issuable Under Options, Granted | 798,000 | |
Shares Issuable Under Options, Exercised | (4,709) | |
Shares Issuable Under Options, Forfeited | (151,603) | |
Shares Issuable Under Options, Expired | (84,430) | |
Shares Issuable Under Options, Outstanding as of December 31, 2018 | 3,114,401 | 2,557,143 |
Shares Issuable Under Options, Options vested and expected to vest as of December 31, 2018 | 3,114,401 | |
Shares Issuable Under Options, Options exercisable as of December 31, 2018 | 1,961,944 | |
Weighted Average Exercise Price, Outstanding as of December 31, 2017 | $ 11.45 | |
Weighted Average Exercise Price, Granted | 4.84 | |
Weighted Average Exercise Price, Exercised | 3.14 | |
Weighted Average Exercise Price, Forfeited | 6.24 | |
Weighted Average Exercise Price, Expired | 17.18 | |
Weighted Average Exercise Price, Outstanding as of December 31, 2018 | 9.86 | $ 11.45 |
Weighted Average Exercise Price, Options vested and expected to vest as of December 31, 2018 | 9.86 | |
Weighted Average Exercise Price, Options exercisable as of December 31, 2018 | $ 12.40 | |
Weighted Average Remaining Contractual Term, Outstanding | 6 years 10 months 6 days | 7 years 4 months 28 days |
Weighted Average Remaining Contractual Term, Options vested and expected | 6 years 10 months 6 days | |
Weighted Average Remaining Contractual Term, Options exercisable | 5 years 9 months 26 days | |
Aggregate Intrinsic Value, Outstanding | $ 2,047 | $ 794 |
Aggregate Intrinsic Value, Options vested and expected | 2,047 | |
Aggregate Intrinsic Value, Options exercisable | $ 755 |
Stock-Based Awards (Summary o_2
Stock-Based Awards (Summary of Restricted Stock Activity) (Details) - $ / shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unvested restricted common stock as of December 31, 2017, Shares | 491,861 | ||
Unvested restricted common stock as of December 31, 2018, Shares | 535,599 | 491,861 | |
Restricted Stock [Member] | 2013 Plan [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unvested restricted common stock as of December 31, 2017, Shares | 491,861 | ||
Issued, Shares | 486,000 | ||
Vested, Shares | (380,427) | ||
Forfeited, Shares | (61,835) | ||
Unvested restricted common stock as of December 31, 2018, Shares | 535,599 | 491,861 | |
Unvested restricted common stock as of December 31, 2017, Weighted Average Grant Date Fair Value | $ 7.59 | ||
Issued, Weighted Average Grant Date Fair Value | 4.83 | $ 7.85 | $ 3.95 |
Vested, Weighted Average Grant Date Fair Value | 7.34 | ||
Forfeited, Weighted Average Grant Date Fair Value | 5.59 | ||
Unvested restricted common stock as of December 31, 2018, Weighted Average Grant Date Fair Value | $ 5.50 | $ 7.59 |
Stock-Based Awards (Data Used T
Stock-Based Awards (Data Used To Determine Value Of Stock Option Grants) (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock-Based Awards [Abstract] | |||
Risk-free interest rate | 2.53% | 1.99% | 1.52% |
Expected term (in years) | 6 years | 6 years | 6 years 2 months 12 days |
Expected volatility | 72.00% | 75.00% | 77.00% |
Expected dividend yield |
Stock-Based Awards (Summary o_3
Stock-Based Awards (Summary of Stock-Based Compensation Expense Related to Stock Options and Restricted Stock) (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, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 4,913 | $ 7,118 | $ 8,476 |
Research and Development [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 655 | 916 | 1,069 |
Cost of Product Sales and Inventories [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | 115 | 153 | 116 |
Selling, General and Administrative [Member] | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Stock-based compensation expense | $ 4,143 | $ 6,049 | $ 7,291 |
Net Loss Per Share (Narrative)
Net Loss Per Share (Narrative) (Details) - shares | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Stock Options [Member] | |||
Dilutive Securities Included And Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Common stock excluded from diluted net loss per share | 3,167,784 | 2,614,537 | 2,317,449 |
Unvested Restricted Stock [Member] | |||
Dilutive Securities Included And Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | |||
Common stock excluded from diluted net loss per share | 535,599 | 491,861 | 461,463 |
Net Loss Per Share (Schedule of
Net Loss Per Share (Schedule of Basic and Diluted Net Income (Loss) Per Share Attributable to Common Stockholders) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | |||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Numerator: | |||||||||||
Net loss | $ (8,634) | $ 8,833 | $ (6,373) | $ (8,548) | $ (15,598) | $ (8,920) | $ (10,380) | $ (12,612) | $ (14,722) | $ (47,510) | $ (33,575) |
Denominator: | |||||||||||
Weighted average shares outstanding, basic and diluted | 42,493,514 | 42,445,553 | 40,206,042 | 36,711,601 | 46,606,855 | 40,494,301 | 35,273,228 | ||||
Net loss per share, basic and diluted | $ (0.18) | $ 0.19 | $ (0.14) | $ (0.19) | $ (0.37) | $ (0.21) | $ (0.26) | $ (0.34) | $ (0.32) | $ (1.17) | $ (0.95) |
Commitments and Contingencies_2
Commitments and Contingencies (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Commitments and Contingencies [Abstract] | |||
Lease expiration | Dec. 31, 2021 | ||
Rent expense | $ 445,000 | $ 725,000 | $ 726,000 |
Liability associated with indemnification obligations | $ 0 | $ 0 |
Commitments and Contingencies_3
Commitments and Contingencies (Future Minimum Lease Payments for Operating Leases) (Details) $ in Thousands | Dec. 31, 2018USD ($) |
Commitments and Contingencies [Abstract] | |
2019 | $ 441 |
2020 | 450 |
2021 | 75 |
2022 | |
2023 | |
Thereafter | |
Total | $ 966 |
Income Taxes (Narrative) (Detai
Income Taxes (Narrative) (Details) - USD ($) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Line Items] | |||
Income tax expense (benefit) | $ 0 | $ 0 | $ 0 |
Unrecognized tax benefits | $ 0 | $ 0 | |
Federal statutory income tax rate | 21.00% | 34.00% | 34.00% |
Decrease in the valuation allowance for deferred tax assets | $ 20,300,000 | ||
Federal [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 106,846,000 | ||
Operating loss carryforward, expiration | Dec. 31, 2031 | ||
Federal [Member] | Research and Development [Member] | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | $ 3,206,000 | ||
Federal [Member] | Tax Year 2018 [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | 13,852,000 | ||
State And Local Jurisdiction [Member] | |||
Income Taxes [Line Items] | |||
Net operating loss carryforwards | $ 104,241,000 | ||
Operating loss carryforward, expiration | Dec. 31, 2020 | ||
State And Local Jurisdiction [Member] | Research and Development [Member] | |||
Income Taxes [Line Items] | |||
Tax credit carryforwards | $ 1,029,000 | ||
Federal And State [Member] | Research and Development [Member] | |||
Income Taxes [Line Items] | |||
Tax credit carryforward, expiration | Dec. 31, 2031 | ||
Maximum [Member] | |||
Income Taxes [Line Items] | |||
Federal statutory income tax rate | 35.00% |
Income Taxes (Components of Inc
Income Taxes (Components of Income from Continuing Operations before Income Taxes Benefit) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Abstract] | |||
United States | $ (14,398) | $ (38,920) | $ (29,959) |
Non-United States | (324) | (8,590) | (3,616) |
Loss from continuing operations | $ (14,722) | $ (47,510) | $ (33,575) |
Income Taxes (Reconciliation of
Income Taxes (Reconciliation of U.S. Federal Statutory Income Tax Rate to Effective Income Tax Rate) (Details) | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Abstract] | |||
Federal statutory income tax rate | 21.00% | 34.00% | 34.00% |
State income taxes, net of federal tax benefit | 2.40% | 6.90% | 3.20% |
Non-deductible expenses | (1.10%) | (0.10%) | 0.20% |
Stock-based compensation | (3.90%) | (1.80%) | (1.50%) |
Research credits | 3.10% | 1.30% | 5.00% |
TCJA | (42.80%) | ||
Other | 0.10% | (5.00%) | |
Change in valuation allowance | (21.60%) | 7.50% | (40.90%) |
Total |
Income Taxes (Net Deferred Tax
Income Taxes (Net Deferred Tax Assets) (Details) - USD ($) $ in Thousands | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | Dec. 31, 2015 |
Income Taxes [Abstract] | ||||
Net operating loss carry forwards | $ 25,811 | $ 31,061 | $ 27,244 | |
Capitalized start-up costs | 4,181 | 5,052 | 5,990 | |
Tax credit carryforwards | 4,019 | 3,737 | 2,996 | |
Intangibles, net | 2,633 | 2,915 | 2,072 | |
Capitalized research and development, net | 4,359 | 6,083 | 10,005 | |
Other temporary differences | 4,512 | 5,922 | 7,940 | |
Total deferred tax assets | 45,515 | 54,770 | 56,247 | |
Valuation allowance | (45,386) | (54,636) | (56,116) | $ (46,885) |
Net deferred tax assets | 129 | 134 | 131 | |
Depreciation | (129) | (134) | (131) | |
Total deferred tax liabilities | (129) | (134) | (131) | |
Net deferred tax liability |
Income Taxes (Changes in Valuat
Income Taxes (Changes in Valuation Allowance for Deferred Tax Assets) (Details) - USD ($) $ in Thousands | 12 Months Ended | ||
Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Income Taxes [Abstract] | |||
Valuation allowance as of beginning of year | $ 54,636 | $ 56,116 | $ 46,885 |
Changes due to operations, TCJA and other tax rates | (9,250) | (1,480) | 9,231 |
Valuation allowance as of end of year | $ 45,386 | $ 54,636 | $ 56,116 |
Selected Quarterly Financial _3
Selected Quarterly Financial Data (Schedule Of Selected Quarterly Financial Data) (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended | ||||||||||
Dec. 31, 2018 | Sep. 30, 2018 | Jun. 30, 2018 | Mar. 31, 2018 | Dec. 31, 2017 | Sep. 30, 2017 | Jun. 30, 2017 | Mar. 31, 2017 | Mar. 31, 2015 | Dec. 31, 2018 | Dec. 31, 2017 | Dec. 31, 2016 | |
Selected Quarterly Financial Data [Line Items] | ||||||||||||
Net revenues | $ 4,906 | $ 21,555 | $ 4,908 | $ 4,043 | $ 10,457 | $ 6,163 | $ 5,158 | $ 3,795 | $ 35,412 | $ 25,573 | $ 38,551 | |
Gross profit | 2,136 | 19,383 | 3,603 | 3,507 | 4,545 | 2,473 | 1,467 | 701 | ||||
Net loss | $ (8,634) | $ 8,833 | $ (6,373) | $ (8,548) | $ (15,598) | $ (8,920) | $ (10,380) | $ (12,612) | $ (14,722) | $ (47,510) | $ (33,575) | |
Weighted average shares outstanding, basic | 48,027,220 | 47,310,408 | 46,258,395 | 44,788,068 | ||||||||
Weighted average shares outstanding, diluted | 48,027,220 | 47,485,384 | 46,258,395 | 44,788,068 | ||||||||
Weighted average shares outstanding, basic and diluted | 42,493,514 | 42,445,553 | 40,206,042 | 36,711,601 | 46,606,855 | 40,494,301 | 35,273,228 | |||||
Net income (loss) per share, basic and diluted | $ (0.18) | $ 0.19 | $ (0.14) | $ (0.19) | $ (0.37) | $ (0.21) | $ (0.26) | $ (0.34) | $ (0.32) | $ (1.17) | $ (0.95) | |
Impairment of intangible assets | $ 7,448 | $ 7,942 | ||||||||||
Inventory valuation adjustment losses | $ 2,650 | 741 | 5,186 | |||||||||
Product Sales [Member] | ||||||||||||
Selected Quarterly Financial Data [Line Items] | ||||||||||||
Net revenues | 12,086 | 19,660 | 318 | |||||||||
Inventory valuation adjustment losses | $ 1,432 | $ 883 | $ 335 | |||||||||
Licensing and Collaboration [Member] | ||||||||||||
Selected Quarterly Financial Data [Line Items] | ||||||||||||
Net revenues | $ 200 | $ 1,000 | $ 23,326 | 5,913 | $ 38,233 | |||||||
AT-006 and AT-008 [Member] | ||||||||||||
Selected Quarterly Financial Data [Line Items] | ||||||||||||
Net loss | $ 7,448 | |||||||||||
BLONTRESS [Member] | Elanco Agreement [Member] | ||||||||||||
Selected Quarterly Financial Data [Line Items] | ||||||||||||
Licensing and collaboration revenue | $ 15,000 | $ 3,000 | ||||||||||
BLONTRESS [Member] | Elanco Agreement Amendment [Member] | ||||||||||||
Selected Quarterly Financial Data [Line Items] | ||||||||||||
Net revenues | $ 480 | |||||||||||
Licensing and collaboration revenue | $ 480 |