MNKD 2017 Annual Report

and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from those estimates. Management considers many factors in selecting appropriate financial accounting policies, and in developing the estimates and assumptions that are used in the preparation of the financial statements. Management must apply significant judgment in this process. The more significant estimates reflected in these accompanying consolidated financial statements include revenue recognition and gross-to-net adjustments, assessing long-lived assets for impairment, clinical trial expenses, inventory costing and recoverability, recognized loss on purchase commitment, milestone rights liability, stock-based compensation and the determination of the provision for income taxes and corresponding deferred tax assets and liabilities and the valuation allowance recorded against net deferred tax assets. Revenue Recognition — Revenue is recognized when the four basic criteria of revenue recognition are met: (1) persuasive evidence that an arrangement exists; (2) delivery has occurred or services have been rendered; (3) the fee is fixed or determinable; and (4) collectability is reasonably assured. When the accounting requirements for revenue recognition are not met, the Company defers the recognition of revenue by recording deferred revenue on the consolidated balance sheets until such time that all criteria are met. To date, the Company has had revenue from commercial sales of Afrezza, collaborations, sale of intellectual property and bulk insulin sales, which are described more fully below. Revenue Recognition – Net Revenue – Commercial Product Sales – The Company currently sells Afrezza through two channels: wholesale distributors and specialty pharmacies as further described below. The Company provides the right of return for unopened product for a period beginning six months prior to and ending twelve months after its expiration date. This right of return is provided to (1) the Company’s wholesale distributors and, through them, to its retail pharmacy customers, and (2) to its specialty pharmacies. Once the product has been prescribed and dispensed to the patient, any right of return ceases to exist. Sales of Afrezza through Wholesale Distributors - Between July 1, 2016 and December 15, 2016, the Company sold Afrezza to Integrated Commercialization Solutions Direct (“ICS”) and title and risk of loss transferred to ICS upon shipment. After December 15, 2016, ICS became a third party logistics provider and stopped taking title and risk of loss upon shipment of Afrezza to ICS. The Company sells Afrezza in the United States to wholesale pharmaceutical distributors through ICS, and ultimately to retail pharmacies, which are collectively referred to as “customers”. The current accounting guidance requires the Company to reliably estimate returns in order to recognize revenue upon shipment. While we can currently estimate returns within a range, it is not sufficiently precise to meet the current requirements. Accordingly, the Company defers recognition of revenue on Afrezza product shipments through wholesale distributors until the right of return no longer exists, which occurs at the earlier of the time Afrezza is dispensed from pharmacies to patients or expiration of the right of return. Deferred revenue is presented net of deferred product sales discounts which are further described in Gross-to-net Adjustments below. Through the third quarter of 2017, the Company recognized revenue for wholesale distributors based on Afrezza patient prescriptions dispensed as estimated by syndicated data provided by a third party. The Company also analyzed additional data points to ensure that such third-party data was reasonable, including data related to inventory movements within the channel and ongoing prescription demand. Change in Estimate – In the fourth quarter of 2017, the Company obtained new and more comprehensive data regarding the inventory in the distribution channel. This data indicated that the amount of inventory in the distribution channel was less than previously estimated. Because the new data was more comprehensive than the data that was previously available to the Company, the Company adjusted the ending gross deferred revenue balance to match the new estimate. In addition to adjusting the gross deferred revenue balance, the Company adjusted the ending balances of deferred discounts and deferred cost of goods sold. The net effect of this change was an increase to net income of $1.2 million or $0.01 basic and diluted net income (loss) per share for the year ended December 31, 2017. 87