Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies The accompanying consolidated financial statements reflect the application of certain significant accounting policies as described below and elsewhere in these notes to the consolidated financial statements. Reclassifications Certain prior year amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations. In first quarter of 2017, the company concluded that it was appropriate to classify costs associated with medical affairs as research and development to better align with Bioverativ’s organizational structure. Previously, such costs had been classified as selling, general and administrative. As a result, the amounts that were previously presented in selling, general and administrative were reclassified in research and development for the years ended December 31, 2016 and 2015. For the Years Ended December 31, (In millions) 2016 2015 Medical reclassification $ 31.2 $ 50.8 Use of Estimates The preparation of our condensed consolidated financial statements requires us to make estimates, judgments, and assumptions that may affect the reported amounts of assets, liabilities, equity, revenues and expenses, and related disclosure of contingent assets and liabilities. On an on-going basis we evaluate our estimates, judgments and methodologies. We base our estimates on historical experience and on various other assumptions that are believed to be reasonable, the results of which form the basis for making judgments about the carrying values of assets, liabilities and equity and the amount of revenues and expenses. Actual results may differ from these estimates under different assumptions or conditions. Cash and Cash Equivalents We consider only those investments which are highly liquid, readily convertible to cash and that mature within three months from date of purchase to be cash equivalents. The carrying values of money market funds approximate fair value due to their short-term maturities. Accounts Receivable The majority of accounts receivable arise from product sales and primarily represent amounts due from specialty pharmacies, hemophilia treatment centers, public and private hospitals and independent specialty distributors as well as contract manufacturing and royalty revenue from Sobi. The company monitors the financial performance and creditworthiness of its customers so that the company can properly assess and respond to changes in their credit profile. The company provides reserves against trade receivables for estimated losses that may result from a customer’s inability to pay. Amounts determined to be uncollectible are charged or written‑off against the reserve. Concentration of Credit Risk CVS Health Corporation (CVS), a specialty pharmacy and ASD Specialty Healthcare (ASD), a specialty distributor, individually represent 13% and 12%, respectively, of outstanding accounts receivable for the year ended December 31, 2017; CVS, ASD and Accredo Health Incorporated, a specialty pharmacy, individually represent 24%, 14% and 11%, respectively, of outstanding accounts receivable for the year ended December 31, 2016. Other than these significant customers, concentration of credit risk with respect to receivables, which are typically unsecured, are largely mitigated due to the wide variety of customers. The majority of accounts receivable arise from product sales in the United States and Japan and have standard payment terms which generally require payment within 30 to 90 days. The company monitors the financial performance and creditworthiness of its customers so that the company can properly assess and respond to changes in their credit profile. The company continues to monitor these conditions and assess their possible impact on its business. Inventory Inventories are stated at the lower of cost or market with cost based on the first‑in, first‑out (FIFO) method. Inventory that can be used in either the production of clinical or commercial products is expensed as research and development costs when selected for use in a clinical manufacturing campaign. Capitalization of Inventory Costs The company capitalizes inventory costs associated with its products prior to regulatory approval, when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. In determining whether or not to capitalize such costs, the company evaluates, among other factors, information regarding the drug candidate’s safety and efficacy, the status of regulatory submissions and communications with regulatory authorities and the outlook for commercial sales, including the existence of current or anticipated competitive drugs and the availability of reimbursement. In addition, the company evaluates risks associated with manufacturing the drug candidate and the remaining shelf‑life of the inventories. Obsolescence and Unmarketable Inventory The company periodically reviews its inventories for excess or obsolescence and write‑down obsolete or otherwise unmarketable inventory to its estimated net realizable value. Property, Plant and Equipment Property, plant and equipment are carried at cost, subject to review for impairment whenever events or changes in circumstances indicate that the carrying amount of the asset may not be recoverable. The cost of normal, recurring, or periodic repairs and maintenance activities related to property, plant and equipment are expensed as incurred. The cost for planned major maintenance activities, including the related acquisition or construction of assets, is capitalized if the repair will result in future economic benefits. Prior to the separation, Property, plant and equipment comprised of assets whereby a majority of its use was dedicated to the hemophilia business. The company generally depreciates or amortizes the cost of its property, plant and equipment using the straight‑line method over the estimated useful lives of the respective assets, which are summarized as follows: Asset Category Useful Lives Land Not depreciated Buildings 15 to 40 years Leasehold Improvements Lesser of the useful life or the term of the respective lease Furniture and Fixtures 5 to 7 years Machinery and Equipment 5 to 20 years Computer Software and Hardware 3 to 5 years Acquired Intangibles Acquired intangibles include product rights, patents and in-process research and development (IPR&D) acquired in a business combination. IPR&D represents the fair value of research and development assets that have not reached technological feasibility. The value assigned to acquired IPR&D is determined by estimating the costs to develop the acquired technology into a commercial product, estimating revenue and costs associated with the product, adjusting the net cash flows for probability of success and discounting to present value. The estimated net cash flows consider the relevant market sizes and growth factors, expected trends in technology and the nature and expected timing of new product introductions by us and our competitors. The rates utilized to discount the net cash flows to their present value are commensurate with the stage of development of the projects and uncertainties in the economic estimates used in the projections. In estimating the probability of success, we utilize data regarding similar assets events from several sources, including industry studies and our own experience. Upon the acquisition of intangible assets, we complete an assessment of whether our acquisition constitutes the purchase of a single asset or a group of assets. We consider multiple factors in this assessment, including the nature of the technology acquired, the presence or absence of separate cash flows, the development process and stage of completion, quantitative significance and our rationale for entering into the transaction. If we acquire a business as defined under applicable accounting standards, then the acquired IPR&D is capitalized as an intangible asset. If we acquire an asset or group of assets that do not meet the definition of a business, then the acquired IPR&D is expensed on its acquisition date if it has no future alternative use. Future costs to develop these assets are recorded to research and development as they are incurred. We perform a qualitative assessment to determine whether any indicators for impairment exist. As a result of the assessment, the company concluded the carrying value of our acquired IPR&D exceeds its fair value. Acquired product rights and patents are recorded at fair value, assigned an estimated useful life, and are amortized over their estimated useful lives of approximately twelve years. See Note 9, Intangible Assets . Amortization is included in cost of sales in the consolidated statements of income. Goodwill Goodwill represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets when accounted for as a business combination using the purchase method of accounting. Goodwill is not amortized, but reviewed for impairment. Goodwill is reviewed annually and whenever events or changes in circumstances indicate that the carrying value of the goodwill might not be recoverable. We compare the fair value of our reporting unit to its carrying value. If the carrying value of the net assets assigned to the reporting unit exceeds the fair value of our reporting unit, then we would need to determine the implied fair value of our reporting unit’s goodwill. If the carrying value of our reporting unit’s goodwill exceeds its implied fair value, then we would record an impairment loss equal to the difference. As described above in Note 1, Nature of Business and Basis of Preparation , we operate in one operating segment which we consider our only reporting unit. Impairment of Long‑Lived Assets Long‑lived assets to be held and used, including property, plant and equipment and definite‑lived intangible assets, are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of the assets or asset group may not be recoverable. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the assets, the assets are written‑down to their fair values. Long‑lived assets to be disposed of are carried at fair value less costs to sell. Contingent Consideration The consideration for our acquisition includes future payments that are contingent upon the occurrence of various events. We recorded a liability for such contingent payments at fair value on the acquisition date. We estimated the fair value of contingent consideration through valuation models that incorporate probability-adjusted assumptions related to the likelihood of achieving the milestones and making related payments. Our contingent consideration is remeasured each reporting period. Changes in the fair value of our contingent consideration are recognized in our condensed consolidated statements of income. Changes in the fair value of the contingent consideration can result from changes to one or multiple inputs, including changes to the discount rates, changes in the probability of certain clinical events, regulatory approval, and the amount or timing of development and sales based milestones. Discount rates in our valuation models represent a measure of the weighted average cost of capital of the target associated with settling the liability. The period over which we discount our contingent consideration is based on the current development stage of the product candidates and our specific development plan for that product candidate. In estimating the probability of success, we utilize data regarding similar milestone events from several sources, including industry studies and our own experience. These fair value measurements are based on significant inputs not observable in the market. Significant judgment is employed in determining the appropriateness of these assumptions as of the acquisition date and for each subsequent period. Accordingly, changes in assumptions could have a material impact on the amount of contingent consideration expense we record in any given period. Non-designated Foreign Currency Contracts Currency forward contracts are used as a part of our strategy to manage exposure related to foreign currency denominated monetary assets and liabilities. These currency forward contracts are not designated as cash flow, fair value or net investment hedges. The currency forward contracts are marked-to-market with changes in fair value recorded to other income (expense) and are entered into for periods consistent with currency transaction exposures, generally less than one year. Translation of Foreign Currencies The functional currency for the company’s non‑U.S. subsidiaries is their local currency. For non‑U.S. subsidiaries that transact in a functional currency other than the U.S. dollar, assets and liabilities are translated at current rates of exchange at the balance sheet date. Income and expense items are translated at the average foreign exchange rates for the period. Adjustments resulting from the translation of the financial statements of non‑U.S. operations into U.S. dollars are excluded from the determination of net income and are recorded in accumulated other comprehensive income, a separate component of equity. Contingencies We are currently involved in various claims and legal proceedings. Loss contingency provisions are recorded if the potential loss from any claim, asserted or unasserted, or legal proceeding is considered probable and the amount can be reasonably estimated or a range of loss can be determined. These accruals represent management’s best estimate of probable loss. Disclosure also is provided when it is reasonably possible that a loss will be incurred or when it is reasonably possible that the amount of a loss will exceed the recorded provision. On a quarterly basis, we review the status of each significant matter and assess its potential financial exposure. Significant judgment is required in both the determination of probability and the determination as to whether an exposure is reasonably estimable. Because of uncertainties related to these matters, accruals are based only on the best information available at the time. As additional information becomes available, we reassess the potential liability related to pending claims and litigation and may change our estimates. These changes in the estimates of the potential liabilities could have a material impact on our consolidated results of operations and financial position. Revenue Recognition The company recognizes revenue when all of the following criteria are met: persuasive evidence of an arrangement exists; delivery has occurred or services have been rendered; the price to the customer is fixed or determinable; and collectability is reasonably assured. Product Revenues We sell mainly to specialty pharmacies, hemophilia treatment centers, public and private hospitals and independent specialty distributors. Any discounts offered to these customers are reflected as on‑invoice discounts. We also sell to specialty distributors who receive both on‑invoice discounts as well as chargebacks for sales to various U.S. government agencies such as U.S. Public Health Service (PHS). Provisions for rebates, chargebacks to distributors, and discounts are provided for at the time the related sales are recorded, and are reflected as a reduction of sales. Reserves established for these discounts and allowances are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). Our estimates take into consideration our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. Actual amounts may ultimately differ from our estimates. If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment. To date historical adjustments have not been material. Product revenue reserves are categorized as follows: discounts and contractual adjustments. Discounts include trade term discounts and volume discounts. Trade term discounts relate to estimated obligations for credits to be granted to customers for remitting payment on their purchases within established incentive periods. Volume discounts are earned as customers reach certain tier levels based upon their purchases. Contractual adjustments primarily relate to Medicaid and PHS discounts. Product returns are insignificant and mainly resulting from product damaged in transit or incorrectly shipped. Collaborations Our development and commercialization arrangement with Sobi represents a collaborative arrangement because both Sobi and us are active participants and exposed to significant risks and rewards of the arrangement. Where we are the principal on sales transactions with third parties, we recognize revenue, cost of sales, including royalty cost of sales, and operating expenses on a gross basis in our income statement. We recognize payments between Sobi and us based upon their nature. These payments consist of royalty cost of sales, royalty revenue and contract manufacturing revenue. Royalty revenue and contract manufacturing revenue represent collaboration revenue in our income statement. See Note 4, Collaborations . Research and Development Expenses Research and development costs are expensed as incurred. Milestone payments prior to regulatory approval are expensed when the milestone is achieved. Payments made to counterparties on or after regulatory approval are capitalized and amortized over the remaining useful life of the related product. Amounts capitalized for such payments are included in acquired intangible assets, net of accumulated amortization. Also included in research and development expenses are allocations from Biogen. See Note 14, Related Parties. Income Taxes Deferred taxes are recognized for the future tax effects of temporary differences between financial and income tax reporting based on enacted tax laws and rates. With respect to uncertain tax positions, the company determines whether the position is more likely than not to be sustained upon examination, based on the technical merits of the position. Any tax position that meets the more‑likely‑than‑not recognition threshold is measured and recognized in the consolidated financial statements at the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. The liability relating to uncertain tax positions is classified as current in the consolidated balance sheets to the extent the company anticipates making a payment within one year. Interest and penalties associated with income taxes are classified in the income tax expense line in the consolidated statements of income. Prior to the separation, the company’s income tax expense and deferred tax balances were calculated on a separate tax return basis although the company’s operations had historically been included in the tax returns filed by the respective Biogen entities, of which the company’s business was a part. For periods subsequent to the separation, Bioverativ files tax returns on its own behalf and its income tax expense and deferred income tax balances are recorded in accordance with the company’s standalone income tax positions. Biogen and Bioverativ entered into a tax matters agreement effective as of the date of separation. Accounting for Share‑Based Compensation In connection with the separation, we adopted our own share‑based compensation plans. Outstanding Biogen CSPUs, MSUs and PUs were converted to Bioverativ RSUs and outstanding Biogen stock options were converted to Bioverativ stock options. See Note 13, Share‑Based Compensation . We charge the estimated fair value of awards against income over the requisite service period, which is generally the vesting period. Where awards are made with non‑substantive vesting periods (for instance, where a portion of the award vests upon retirement eligibility), we estimate and recognize expense based on the period from the grant date to the date on which the employee is retirement eligible. We recognize forfeitures as they occur. The fair values of our stock option grants are estimated as of the date of grant using a Black‑Scholes option valuation model. The estimated fair values of the stock options are then expensed over the options’ vesting periods. The fair values of RSUs are based on the market value of our stock on the date of grant. Compensation expense for RSUs is recognized on a straight‑line basis over the applicable service period. New Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (FASB) or other standard setting bodies that we adopt as of the specified effective date. The following new standards issued by FASB were adopted by the company on January 1, 2017: · Accounting Standards Update (ASU) No. 2015‑11, Inventory (Topic 330): Simplifying the Measurement of Inventory. The new standard applies only to inventory for which cost is determined by methods other than last-in, first-out and the retail inventory method, which includes inventory that is measured using first in, first out (FIFO) or average cost. Inventory within the scope of this standard is required to be measured at the lower of cost and net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal and transportation. The adoption of this standard did not have a material impact on our financial position, results of operations or statements of cash flows upon adoption. · ASU No. 2015-17, Income Taxes (Topic 740): Balance Sheet Classification of Deferred Taxes. The new standard requires that deferred tax assets and liabilities be classified as noncurrent in a classified statement of financial position. The adoption of this standard did not have a material impact on our financial position, results of operations or statements of cash flows upon adoption. · ASU No. 2016‑09, Compensation‑Stock Compensation (Topic 718): Improvements to Employee Share‑Based Payment Accounting. The new standard requires recognition of the income tax effects of vested or settled awards in the income statement and involves several other aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities and classification on the statement of cash flows. The adoption of this standard did not have a material impact on our financial position, results of operations or statements of cash flows upon adoption. In the fourth quarter of 2017 we adopted the following standard: · In January 2017 the FASB issued ASU No. 2017-04, Intangibles - Goodwill and Other (Topic 350): Simplifying the Test of Goodwill Impairment. This new standard simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount of that goodwill. The adoption of this standard did not have a material impact on our financial position or results of operations. The following new standards have been issued by FASB but are not yet effective as of December 31, 2017: · In May 2014 the FASB issued ASU No. 2014-09, Revenue from Contracts with Customers (Topic 606), which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. The FASB has subsequently issued amendments to ASU No. 2014-09 that have the same effective date and transition date of January 1, 2018. We expect to adopt these standards using the full retrospective method. We will apply all of the requirements of the new standards to each comparative period presented in accordance with the requirements on accounting changes. We are finalizing our assessment of the effect of adoption. Based on this assessment, we expect changes in our revenue recognition policy relating to the opt-in consideration payable by Sobi to us under our collaboration agreement with Sobi (See Note 4, Collaborations ). Currently the payment by Sobi of the opt-in consideration is recognized over the term of the commercialization period using a cross-royalty payment structure. Upon adoption of these standards, for the year ended December 31, 2016, the net present value of the remaining opt-in consideration will be recognized as revenue and note receivable. Commencing in 2017, royalty revenue will be recognized at the contractual 12% rate rather than the effective rate of 13-15%. Royalty cost of sales will be recognized at the contractual rate of 12% in North America and 17% outside North America instead of the effective rate of 10-11% and 15-16%, respectively. Upon adoption in Q1 2018, our balance sheet at December 31, 2017 is expected to increase by approximately $190 million due to the note receivable from Sobi. · In January 2016 the FASB issued ASU No. 2016-01, Financial Instruments - Overall (Subtopic 825-10): Recognition and Measurement of Financial Assets and Financial Liabilities. The new standard amends certain aspects of accounting and disclosure requirements of financial instruments, including the requirement that equity investments with readily determinable fair values be measured at fair value with changes in fair value recognized in a company's results of operations. The new standard will be effective for us on January 1, 2018. The adoption of this standard is not expected to have a material impact on our financial position or results of operations. · In February 2016 the FASB issued ASU No. 2016-02, Leases (Topic 842). The new standard requires that all lessees recognize the assets and liabilities that arise from leases on their balance sheet and disclose qualitative and quantitative information about their leasing arrangements. The new standard will be effective for us on January 1, 2019. The adoption of this standard is not expected to have a material impact on our results of operations but may impact our financial position. · In October 2016 the FASB issued ASU No. 2016-16, Income Taxes (Topic 740): Intra-Entity Transfer of Assets Other Than Inventory. This new standard eliminates the deferral of the tax effects of intra-entity transfers of an asset other than inventory. Under the new standard, entities should recognize the income tax consequences on an intra-entity transfer of an asset other than inventory when the transfer occurs. This new standard will be effective for us on January 1, 2018 and will be applied on a modified retrospective basis through a cumulative-effect adjustment directly to retained earnings as of the beginning of the period of adoption. The adoption of this standard is not expected to have a material impact on our financial position. · In November 2016 the FASB issued ASU No. 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash. The amendments in this update require that a 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. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. This new standard will be effective for us on January 1, 2018. The adoption of this standard is not expected to have a material impact on our financial position. · In January 2017 the FASB issued ASU No. 2017-01, Business Combinations (Topic 805): Clarifying the Definition of a Business. This new standard clarifies the definition of a business and provides a screen to determine when an integrated set of assets and activities is not a business. The screen requires that when substantially all of the fair value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set of assets and activities is not a business. This new standard will be effective for us on January 1, 2018, however early adoption is permitted. The adoption of this standard is not expected to have a material impact on our financial position. · In May 2017 the FASB issued ASU No. 2017-09, Compensation-Stock Compensation (Topic 718): Scope of Modification Accounting. This new standard provides clarity and reduces both (1) diversity in practice and (2) cost and complexity when applying the guidance in Topic 718, Compensation-Stock Compensation, to a change to the terms or conditions of a share-based payment award. This new standard will be effective for us on January 1, 2018. The adoption of this standard is not expected to have a material impact on our financial position or results of operations. |