Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The Company operates in one segment considering the nature of the Company’s products and services, class of customers, methods used to distribute the products and the regulatory environment in which the Company operates. Principles of Consolidation The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The consolidated financial statements include the accounts of Kadmon Holdings, Inc. and its domestic and international subsidiaries, all of which are wholly owned. Interim Financial Statements The accompanying financial statements have been prepared in accordance with GAAP for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In management’s opinion, the financial statements include all adjustments (consisting of normal recurring accruals) necessary in order to make the financial statements not misleading. Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the final results that may be expected for the year ended December 31, 2018. These unaudited financial statements should be read in conjunction with the audited financial statements in Item 15 of the Company’s Annual Report on Form 10-K for the year ended December 31, 2017. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements. Actual results could differ from those estimates. Critical accounting policies The Company’s significant accounting policies are disclosed in the audited financial statements included in Item 8 of the Annual Report on Form 10-K as of and for the year ended December 31, 2017. Since the date of such financial statements, there have been no changes to the Company’s significant accounting policies, other than those described below. Investment in Equity Securities Equity securities consist of investments in common stock of companies traded on public markets (Note 10). These shares are carried on the Company’s balance sheet at fair value based on the closing price of the shares owned on the last trading day before the balance sheet of this report. Fluctutations in the underlying bid price of the shares result in unrealized gains or losses. In accordance with FASB ASC 321, Investments – Equity Securities (“ASC 321”), the Company recognizes these fluctuations in value as other expense (income). For investments sold, the Company recognizes the gains and losses attributable to these investments as realized gains or losses in other expense (income). Revenue Recognition The Company adopted FASB ASC 606, Revenue from Contracts with Customers (“ASC 606”), on January 1, 2018 using the modified retrospective method for all contracts not completed as of the date of adoption – i.e., by recognizing the cumulative effect of initially applying ASC 606 as an adjustment to the opening balance of stockholders’ equity at January 1, 2018. For contracts that were modified before the effective date, the Company reflected the aggregate effect of all modifications when identifying performance obligations and allocating transaction price in accordance with practical expedient ASC 606-10-65-1-(f)-4. The reported results for 2018 reflect the application of ASC 606 guidance while the reported results for 2017 were prepared under the guidance of ASC 605, Revenue Recognition (“ASC 605”), which is also referred to herein as the "previous guidance". The adoption of ASC 606 represents a change in accounting principle that will more closely align revenue recognition with the delivery of the Company's services and will provide financial statement readers with enhanced disclosures. Therefore, the comparative information prior to January 1, 2018 has not been adjusted and continues to be reported under ASC 605. The details of significant changes and quantitative impact of the changes are set out below. The Company recognizes revenue in accordance with ASC 606, the core principle of which 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 to receive in exchange for those goods or services. To achieve this core principle, five basic criteria must be met before revenue can be recognized: (1) identify the contract with a customer; (2) identify the performance obligations in the contract; (3) determine the transaction price; (4) allocate the transaction price to performance obligations in the contract; and (5) recognize revenue when or as the Company satisfies a performance obligation. Disaggregation of Revenue The following table summarizes revenue from contracts with customers for the three and nine months ended September 30, 2018 (in thousands): Three Months Ended Nine Months Ended September 30, 2018 September 30, 2018 Product sales $ 198 $ 633 Other revenue 174 531 Total revenue $ 372 $ 1,164 Product Sales The Company markets a portfolio of branded and generic ribavirin products used as part of a combination treatment for chronic HCV infection (Ribasphere RibaPak and Ribasphere) and also distributes products in a variety of other therapeutic areas, including tetrabenazine for the treatment of chorea associated with Huntington’s disease. These contracts typically include a single promise to deliver a fixed amount of product to the customer with payment due within 30 days of shipment. Revenues are recognized when control of the promised goods is transferred to the customer, in an amount that reflects the consideration the Company expects to be entitled to in exchange for those goods. As is typical in the pharmaceutical industry, gross product sales are subject to a variety of deductions, primarily representing rebates, chargebacks, returns, and discounts to government agencies, wholesalers, and managed care organizations. These deductions represent management’s best estimates of the related reserves and, as such, judgment is required when estimating the impact of these sales deductions on gross sales for a reporting period. If estimates are not representative of the actual future settlement, results could be materially affected. Other Revenue The other revenue generated by the Company is primarily related to the transition services agreement and sublease agreement with MeiraGTx Holdings plc (“MeiraGTx”) (Note 10) . The Company performed various professional services under the transition services agreement that support MeiraGTx. The Company recognizes revenue related to transition services and sublease agreements as they are performed. Contract Balances The timing of revenue recognition may differ from the timing of invoicing to customers. Accounts receivable are recorded at the invoiced amount, net of an allowance for doubtful accounts. A receivable is recognized in the period we deliver goods or provide services or when our right to consideration is unconditional. The Company has not recognized any assets for costs to obtain or fulfill a contract with a customer as of September 30, 2018 . Financial Statement Impact of Adopting ASC 606 The Company adopted ASC 606 using the modified retrospective method. The cumulative effect of applying the new guidance to all contracts with customers that were not completed as of January 1, 2018 was recorded as an adjustment to accumulated deficit as of the adoption date as shown in the following table (in thousands): As Reported Adjustments Adjusted December 31, AbbVie January 1, 2017 Agreement 2018 (unaudited) (unaudited) Cash, cash equivalents, and restricted cash $ 69,633 $ $ 69,633 Accounts receivable, net 1,186 1,186 Inventories, net 201 201 Prepaid expenses and other current assets 1,109 1,109 Fixed assets, net 4,292 4,292 Goodwill 3,580 3,580 Investments at cost 3,542 3,542 Other noncurrent assets 9 9 Total assets $ 83,552 $ $ 83,552 Accounts payable and accrued expenses $ 16,585 $ $ 16,585 Fair market value of financial instruments - current 1,952 1,952 Secured term debt - current 33,707 33,707 Deferred revenue, current 4,400 (4,400) — Deferred revenue, long term 19,617 (19,617) — Other long term liabilities 5,533 5,533 Total liabilities 81,794 (24,017) 57,777 Common stock, preferred stock, and additional paid-in capital 239,155 239,155 Accumulated deficit (237,397) 24,017 (213,380) Total stockholders’ equity 1,758 24,017 25,775 Total liabilities and stockholders’ equity $ 83,552 $ — $ 83,552 The year-end condensed balance sheet data was derived from audited consolidated financial statements, but does not include all disclosures required by GAAP. Commercial Partnership Agreement with AbbVie Inc. (“AbbVie”) On June 17, 2013, the Company entered into a series of agreements with AbbVie related to certain of the Company’s ribavirin products. Pursuant to an asset purchase agreement, as amended, the Company sold marketing authorizations and related assets for ribavirin in certain countries outside the United States. The Company received upfront payments totaling $64.0 million, and could have received additional contingent payments totaling $51.0 million based on the achievement of certain milestones. The Company did not earn any such milestones during the nine months ended September 30, 2018 . Of the $64.0 million upfront payments, $44.0 million was considered allocable to the domestic licensing arrangement and was recorded as deferred revenue to be recognized over the 10 year term of the agreement. The Company recognized $1.1 million and $3.3 million during the three and nine months ended September 30, 2017 , respectively. At December 31, 2017, $24.0 million was recorded as deferred revenue, of which $4.4 million was short ‑term. The Company is required to supply ribavirin products, maintain the marketing authorization for certain ribavirin products and maintain the intellectual property for Ribasphere and RibaPak through the term of the agreements ending December 31, 2020. The Company’s agreements with AbbVie provide AbbVie with access to various forms of intellectual property, as well as supply of product. Under the previous guidance, certain of the upfront payments under the agreements were considered allocable to a 10-year domestic license arrangement and, as a result, the associated revenue was previously deferred and recognized straight line over the life of the agreements. Under ASC 606, the Company has determined that two distinct performance obligations under the domestic license agreement exist, both of which are considered to be completed as of the date of adoption. No other material rights or enforceable rights or obligations exist under the AbbVie agreements. In conjunction with the January 1, 2018 adoption of ASC 606, the Company adjusted its accumulated deficit by $24.0 million, reflecting the recognition of $24.0 million of deferred revenue related to the domestic license agreement with AbbVie. Income Taxes The adoption of ASC 606 primarily resulted in an acceleration of revenue as of January 1, 2018, which in turn generated additional deferred tax liabilities that ultimately reduced the Company's net deferred tax asset position. As the Company fully reserves its net deferred tax assets in the jurisdictions impacted by the adoption of ASC 606, this impact was offset by a corresponding reduction to the valuation allowance. Impact of New Revenue Guidance on Financial Statement Line Items The following table compares the reported condensed consolidated balance sheet as of September 30, 2018 to the pro-forma amounts had the previous guidance been in effect (in thousands): As Reported Balances without adoption of ASC 606 September 30, 2018 Adjustments September 30, 2018 December 31, 2017 (unaudited) (unaudited) (unaudited) Cash, cash equivalents, and restricted cash $ 115,467 $ $ 115,467 $ 69,633 Accounts receivable, net 979 979 1,186 Inventories, net 1,063 1,063 201 Investment, equity securities 48,072 48,072 — Prepaid expenses and other current assets 2,225 2,225 1,109 Fixed assets, net 4,027 4,027 4,292 Goodwill 3,580 3,580 3,580 Investment, at cost 2,300 2,300 3,542 Other noncurrent assets 2 2 9 Total assets $ 177,715 $ — $ 177,715 $ 83,552 Accounts payable and accrued expenses $ 16,460 $ $ 16,460 $ 16,585 Fair market value of financial instruments - current 1,247 1,247 1,952 Secured term debt - current — — 33,707 Deferred revenue, current — 4,400 4,400 4,400 Deferred revenue, long term — 16,317 16,317 19,617 Other long term liabilities 4,740 4,740 5,533 Secured term debt – net of current portion and discount 27,386 27,386 — Total liabilities 49,833 20,717 70,550 81,794 Common stock, preferred stock, and additional paid-in capital 355,493 355,493 239,155 Accumulated deficit (227,611) (20,717) (248,328) (237,397) Total stockholders’ equity (deficit) 127,882 (20,717) 107,165 1,758 Total liabilities and stockholders’ equity $ 177,715 $ — $ 177,715 $ 83,552 The year-end condensed balance sheet data was derived from audited financial statements, but does not include all disclosures required by GAAP. Total reported liabilities were $20.7 million less than the pro-forma balance sheet, which assumes the Company had continued to recognize revenues under ASC 605 as of September 30, 2018 . This is due to the recognition of the deferred revenue related to the AbbVie agreement upon adoption of ASC 606. The following summarizes the significant changes on the Company’s condensed consolidated statement of operations for the three months ended September 30, 2018 as a result of the adoption of ASC 606 on January 1, 2018, which assumes the Company had continued to recognize revenues under ASC 605 (in thousands, except share and per share amounts): As Reported Three Months Ended Balances without adoption of ASC 606 Three Months Ended September 30, 2018 Adjustments September 30, 2018 September 30, 2017 (unaudited) (unaudited) (unaudited) (unaudited) Net sales $ 198 $ $ 198 $ 1,036 License and other revenue 174 1,100 1,274 1,241 Total revenue 372 1,100 1,472 2,277 Cost of sales and write-down of inventory 79 79 1,210 Research and development 11,918 11,918 11,775 Selling, general and administrative 9,668 9,668 9,121 Total other expense (income) (7,494) (7,494) 1,874 Net income (loss) attributable to common stockholders $ (13,799) $ 1,100 $ (12,699) $ (21,703) Deemed dividend on convertible preferred stock 515 515 490 Net income (loss) attributable to common stockholders $ (14,314) $ 1,100 $ (13,214) $ (22,193) Basic and diluted net income (loss) per share of common stock $ (0.13) $ 0.01 $ (0.12) $ (0.42) Weighted average basic and diluted shares of common stock outstanding 113,101,776 113,101,776 113,101,776 52,572,880 The following summarizes the significant changes on the Company’s condensed consolidated statement of operations for the nine months ended September 30, 2018 as a result of the adoption of ASC 606 on January 1, 2018, which assumes the Company had continued to recognize revenues under ASC 605 (in thousands, except share and per share amounts): As Reported Nine Months Ended Balances without adoption of ASC 606 Nine Months Ended September 30, 2018 Adjustments September 30, 2018 September 30, 2017 (unaudited) (unaudited) (unaudited) (unaudited) Net sales $ 633 $ $ 633 $ 5,070 License and other revenue 531 3,300 3,831 5,730 Total revenue 1,164 3,300 4,464 10,800 Cost of sales and write-down of inventory 626 626 2,786 Research and development 31,876 31,876 30,278 Selling, general and administrative 26,730 26,730 29,141 Total other expense (income) (44,771) (44,771) 9,863 Income tax expense (benefit) (562) (562) 316 Net income (loss) attributable to common stockholders $ (12,735) $ 3,300 $ (9,435) $ (61,584) Deemed dividend on convertible preferred stock 1,496 1,496 1,428 Net income (loss) attributable to common stockholders $ (14,231) $ 3,300 $ (10,931) $ (63,012) Basic and diluted net income (loss) per share of common stock $ (0.15) $ 0.04 $ (0.11) $ (1.25) Weighted average basic and diluted shares of common stock outstanding 92,378,205 92,378,205 92,378,205 50,331,163 The Company’s adoption of ASC 606 accelerated the recognition of revenue that was previously deferred under the AbbVie domestic license agreement, resulting in a cumulative effect adjustment to accumulated deficit on January 1, 2018. Therefore no further revenue will be recognized under the AbbVie domestic license agreement. Revenue under this agreement had previously been recognized under license and other revenue. The adoption of ASC 606 had no impact on the Company’s cash flows from operations. The aforementioned adjustments resulted in offsetting shifts in cash flows to net loss and change in deferred revenue. Transaction Price Allocated to Future Performance Obligations ASC 606 requires that the Company disclose the aggregate amount of transaction price that is allocated to performance obligations that have not yet been satisfied as of September 30, 2018 . The guidance provides certain practical expedients that limit this requirement. The Company has various contracts that meet the following practical expedients provided by ASC 606: 1. The performance obligation is part of a contract that has an original expected duration of one year or less. 2. Revenue is recognized from the satisfaction of the performance obligations in the amount billable to the customer. 3. The variable consideration is allocated entirely to a wholly unsatisfied performance obligation or to a wholly unsatisfied promise to transfer a distinct good or service that forms part of a single performance obligation. The Company does not have any performance obligations, outside of the practical expedients above, that have not yet been satisfied as of September 30, 2018 and therefore there is no transaction price allocated to future performance obligations under ASC 606. Recent Accounting Pronouncements In August 2018, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2018-15, “ I ntangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract (a consensus of the FASB Emerging Issues Task Force)” , which requires customers in a cloud computing arrangement that is a service contract to follow the internal-use software guidance in Accounting Standards Codification 350-40 to determine which implementation costs to capitalize as assets. This ASU is effective for annual or any interim periods beginning after December 15, 2019. The Company does not expect the standard to have a significant impact on its consolidated financial statements, as the Company’s cloud computing contracts are not material. In June 2018, the FASB issued ASU No. 2018-07, “ Compensation – Stock Compensation” , which expands the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees, except for specific exceptions. This ASU is effective for annual or any interim periods beginning after December 15, 2018. The Company does not expect the standard to have a significant impact on its consolidated financial statements, as the fair value of the Company’s awards to nonemployees is immaterial . In May 2017, the FASB issued ASU No. 2017-09, “ Compensation – Stock Compensation” , which clarifies the guidance about which changes to the terms and conditions of a share-based payments award require an entity to apply modification accounting in Topic 718. This ASU is effective for annual or any interim periods beginning after December 15, 2017. The Company adopted this standard on January 1, 2018, which did not impact the consolidated finan cial statements as the Company has not modified the terms and conditions of any share-based payments during the year ended December 31, 2017 or the nine months ended September 30, 2018 . In January 2017, the FASB issued ASU No. 2017-04, “ Intangibles – Goodwill and Other” , which simplifies the subsequent measurement of goodwill by eliminating “Step 2” from the goodwill impairment test. Instead of performing Step 2 to determine the amount of an impairment charge, the fair value of a reporting unit will be compared with its carrying amount and an impairment charge will be recognized for the value by which the carrying amount exceeds the reporting unit’s fair value. ASU 2017-04 is effective for annual or any interim goodwill impairment tests in fiscal years beginning after December 15, 2019. Early adoption is permitted for interim or annual goodwill impairment tests performed on testing dates after January 1, 2017. The Company does not expect the standard to have a significant impact on its consolidated financial statements . In November 2016, the FASB issued ASU No. 2016-18, “ Statement of Cash Flows (Topic 230): Restricted Cash ”. This ASU requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Entities will also be required to reconcile such total amounts on the balance sheet and disclose the nature of the restrictions. The Company adopted this standard on January 1, 2018, which did not have a significant impact on its consolidated financial statements as the Company’s restricted cash balances are immaterial. In February 2016, the FASB issued ASU No. 2016 ‑02, “ Leases ”. This ASU amends the existing accounting standards for lease accounting, including requiring lessees to recognize most leases on their balance sheets. Current GAAP does not require lessees to recognize assets and liabilities arising from operating leases on the balance sheet. This guidance is effective for annual and interim reporting periods of public entities beginning after December 15, 2018, with early adoption permitted. In July 2018, the FASB issued ASU No. 2018-10, “Codification Improvements to Topic 842, Leases” and ASU 2018-11, “Leases (Topic 842): Targeted Improvements” . These ASU’s make improvements and provide clarity to several aspects of the guidance in ASC 842. The Company is in the process of implementation and expects to adopt this guidance when it becomes effective using the optional transition method allowed under the standard which does not require comparative periods to be restated. The Company expects to elect to apply practical expedients allowed under the standard, which, among other things, allows the carryforward of historical lease classifications. The Company expects that adoption of this standard will have a material impact on the Company’s consolidated balance sheets and related disclosures, as a result of recognizing a cumulative-effect adjustment reflecting right-of-use assets and lease liabilities related to its operating leases on January 1, 2019 . The Company does not expect a material impact to the consolidated statement of operations or cash flows. Prior period financial statements and related disclosures will be presented in accordance with ASC 840. |