Nature of Business and Basis of Preparation | 1. Nature of Business and Basis of Presentation Nature of Business Bioverativ separated from Biogen on February 1, 2017 as a result of a special dividend distribution of all the outstanding shares of common stock of Bioverativ to Biogen stockholders. The distribution was made to Biogen stockholders of record as of the close of business on January 17, 2017, who received one share of Bioverativ common stock for every two shares of Biogen common stock held as of such date. As a result of the distribution, Bioverativ became an independent public company. Bioverativ holds the assets and liabilities of Biogen’s former hemophilia business. Bioverativ is focused on the discovery, research, development and commercialization of innovative therapies for the treatment of hemophilia and other rare blood disorders. Bioverativ’s marketed products include ELOCTATE and ALPROLIX, extended half‑life factors for the treatment of hemophilia A and hemophilia B, respectively. Pursuant to a development and commercialization agreement, Bioverativ collaborates with Swedish Orphan Biovitrum AB (publ) (Sobi) to jointly develop and commercialize ELOCTATE and ALPROLIX globally. Sobi has responsibility for commercialization of ELOCTATE and ALPROLIX in Europe, Russia and certain countries in Northern Africa and the Middle East, while Bioverativ retains rights to commercialize those therapies in the United States, Japan, Canada, Australia, Latin American countries and all other markets excluding Sobi’s commercialization territory. See Note 3, Collaborations , for further information on Bioverativ’s collaboration with Sobi. Bioverativ’s pipeline includes programs in hemophilia, cold agglutinin disease, sickle cell disease, beta thalassemia, and other rare blood disorders. Basis of Presentation In the opinion of management, the accompanying unaudited condensed consolidated financial statements include all adjustments, consisting of a normal recurring nature, necessary for a fair presentation of our financial statements for interim periods in accordance with accounting principles generally accepted in the United States (U.S. GAAP). We operate as one operating segment, which is discovering, researching, developing and commercializing innovative therapies for the treatment of hemophilia and other rare blood disorders. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with our audited consolidated financial statements and the accompanying notes included in our Annual Report on Form 10-K for the year ended December 31, 2016 (2016 Form 10-K). Our accounting policies are described in the “Notes to Consolidated Financial Statements” in our 2016 Form 10-K and updated, as necessary, in our Quarterly Reports on Form 10-Q. The December 31, 2016 condensed consolidated balance sheet data presented for comparative purposes was derived from our audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for the three and nine months ended September 30, 2017, are not necessarily indicative of the operating results for the full year or for any other subsequent interim period. The accompanying unaudited condensed consolidated financial statements reflect the consolidated financial position and consolidated results of operations of the company as an independent, publicly-traded company for the period after the February 1, 2017 separation. The unaudited condensed consolidated financial statements also reflect the consolidated financial position and consolidated results of operations of the company as a consolidated reporting entity of Biogen for periods prior to the separation. During the nine months ended September 30, 2017, the company recorded certain separation related adjustments in its condensed consolidated statement of equity. The separation related adjustments primarily related to differences between assets and liabilities transferred to Bioverativ as a result of the separation and assets and liabilities reported in the company’s consolidated balance sheet as of January 31, 2017. Separation related adjustments for the nine months ended September 30, 2017 totaled $310.3 million consisting primarily of inventory and deferred tax assets retained by Biogen upon separation. Additional separation related adjustments could be recorded in future periods. Prior to the separation, the unaudited condensed consolidated financial statements were prepared on a standalone basis and were derived from Biogen’s consolidated financial statements and accounting records as if the former hemophilia business of Biogen had been standalone business. Accordingly, financial information for periods prior to the separation is shown on a carve-out basis for the hemophilia business as part of Biogen. The unaudited condensed consolidated financial statements reflected the company’s financial position, results of operations and cash flows as the business was operated as part of Biogen prior to the distribution. Prior to the separation, the unaudited condensed consolidated financial statements included the attribution of certain assets and liabilities that were historically held at the Biogen corporate level but which were specifically identifiable or attributable to the company. All intercompany transactions and accounts within the company were eliminated. All transactions between the company and Biogen were considered to be effectively settled in the unaudited condensed consolidated financial statements at the time the transaction was recorded. The total net effect of the settlement of the transactions with Biogen is reflected in the unaudited condensed consolidated statements of cash flows in periods prior to the separation as a financing activity and in the unaudited condensed consolidated balance sheet as net parent company investment. Prior to the separation, these unaudited condensed consolidated financial statements include an allocation from Biogen to us for certain research and development and selling, general and administrative costs not directly attributable to the hemophilia business of Biogen. The research and development costs include depreciation and other facility‑based expenses, regulatory affairs function, pharmacovigilance, other infrastructure and management costs supporting multiple projects. The selling, general and administrative costs include certain services provided by Biogen, which include, but are not limited to, executive oversight, treasury, finance, legal, human resources, tax planning, internal audit, financial reporting, information technology, investor relations, shared services, insurance, employee benefits and incentives and share‑based compensation. Allocated amounts have been included in research and development, selling, general and administrative and other income and expense. These expenses have been allocated to the company based on direct usage or benefit where specifically identifiable, with the remainder allocated primarily based on hours or direct costs. The company considers the expense methodology and results to be reasonable for all periods presented. However, the allocations may not be indicative of the actual expense that would have been incurred had the company operated as an independent, publicly traded company for the periods presented. In periods prior to the separation, Bioverativ’s employees participated in various benefit and share-based compensation plans maintained by Biogen. A portion of the cost of those plans was included in the company’s financial statements. However, the unaudited condensed consolidated balance sheets in periods prior to the separation did not include any equity related to share-based compensation plans. Prior to the separation, the company’s equity balance represented the excess of total assets over total liabilities, including the due to/from balances between the company and Biogen (net parent company investment) and cumulative translation adjustment. In connection with the separation, the company’s net parent company investment balance was reclassified to additional paid-in capital. 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 each of the following periods in 2016. For the Three Months Ended For the Year Ended (In millions) March 31, 2016 June 30, 2016 September 30, 2016 December 31, 2016 December 31, 2016 $ 7.7 $ 8.9 $ 7.7 $ 6.9 $ 31.2 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. Summary of Significant Accounting Policies The following represent new accounting policies that were not included in the “Notes to Consolidated Financial Statements” in our 2016 Form 10-K. 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. Acquired In-Process Research and Development (IPR&D) 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 IPR&D, 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. When performing our impairment assessment, we calculate the fair value using the same methodology as described above. If the carrying value of our acquired IPR&D exceeds its fair value, then the intangible asset is written-down to its fair value. Goodwill Goodwill represents the difference between the purchase price and the fair value of the identifiable tangible and intangible net assets when accounted for 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 Basis of Presentation , we operate in one operating segment which we consider our only reporting unit. Contingent Consideration The consideration for our acquisition includes future payments that are contingent upon the occurrence of various events. We record a liability for such contingent payments at fair value on the acquisition date. We estimate 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. 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. The following new standards have been issued by FASB but are not yet effective. 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. Our assessment of the potential impact that this standard may have on our financial position, results of operations and disclosures will be completed in the fourth quarter of 2017. 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. As of September 30, 2017, 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. We are currently evaluating the impact that this standard may have on our results of operations, financial position and disclosures. As of September 30, 2017, the adoption of this standard is not expected to have a material impact on our results of operations but may materially impact our net 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. As of September 30, 2017, 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. As of September 30, 2017, 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. 2017-04, 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. This new standard will be effective for us on January 1, 2020; however, early adoption is permitted. The adoption of this standard is not expected to have a material impact on our financial position or results of operations. 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, however early adoption is permitted. As of September 30, 2017, the adoption of this standard is not expected to have a material impact on our financial position or results of operations. |