United states securities and exchange commission
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Table of Contents BIOGEN INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued) F- 73 Revenues by product are summarized as follows: For the Years Ended December 31, 2017 2016 2015 (In millions) United States Rest of World Total United States Rest of World Total United States Rest of World Total Multiple Sclerosis (MS): TECFIDERA $ 3,294.0 $ 920.0 $ 4,214.0 $ 3,169.4 $ 798.7 $ 3,968.1 $ 2,908.2 $ 730.2 $ 3,638.4 AVONEX 1,593.6 557.9 2,151.5 1,675.3 638.2 2,313.5 1,790.2 840.0 2,630.2 PLEGRIDY 295.5 198.8 494.3 305.0 176.7 481.7 227.1 111.4 338.5 TYSABRI 1,113.8 859.3 1,973.1 1,182.9 780.9 1,963.8 1,103.1 783.0 1,886.1 FAMPYRA — 91.6 91.6 — 84.9 84.9 — 89.7 89.7 ZINBRYTA — 52.7 52.7 — 7.8 7.8 — — — Spinal Muscular Atrophy: SPINRAZA 657.0 226.7 883.7 4.6 — 4.6 — — — Hemophilia: ELOCTATE 42.2 6.2 48.4 445.2 68.0 513.2 308.3 11.4 319.7 ALPROLIX 21.0 5.0 26.0 268.0 65.7 333.7 208.9 25.6 234.5 Other product revenues: FUMADERM — 39.6 39.6 — 45.9 45.9 — 51.4 51.4 BENEPALI — 370.8 370.8 — 100.6 100.6 — — — FLIXABI — 9.0 9.0 — 0.1 0.1 — — — Total product revenues $ 7,017.1 $ 3,337.6 $10,354.7 $ 7,050.4 $ 2,767.5 $ 9,817.9 $ 6,545.8 $ 2,642.7 $ 9,188.5 Geographic Information The following tables contain certain financial information by geographic area: December 31, 2017 (In millions) U.S. Europe Asia Other Total Product revenues from external customers $ 7,017.1 $ 2,844.8 $ 160.1 $ 332.7 $10,354.7 Revenues from anti-CD20 therapeutic programs $ 1,475.6 $ 0.6 $ — $ 83.0 $ 1,559.2 Other revenues from external customers $ 249.5 $ 67.8 $ 42.7 $ — $ 360.0 Long-lived assets $ 1,226.9 $ 1,948.2 $ 5.2 $ 2.1 $ 3,182.4 December 31, 2016 (In millions) U.S. Europe Asia Other Total Product revenues from external customers $ 7,050.4 $ 2,237.2 $ 217.3 $ 313.0 $ 9,817.9 Revenues from anti-CD20 therapeutic programs $ 1,249.5 $ 1.9 $ — $ 63.1 $ 1,314.5 Other revenues from external customers $ 224.7 $ 71.5 $ 20.2 $ — $ 316.4 Long-lived assets $ 1,272.3 $ 1,221.1 $ 7.0 $ 1.4 $ 2,501.8 December 31, 2015 (In millions) U.S. Europe Asia Other Total Product revenues from external customers $ 6,545.8 $ 2,165.7 $ 143.7 $ 333.3 $ 9,188.5 Revenues from anti-CD20 therapeutic programs $ 1,269.8 $ 3.5 $ — $ 65.9 $ 1,339.2 Other revenues from external customers $ 142.0 $ 31.2 $ 62.9 $ — $ 236.1 Long-lived assets $ 1,296.5 $ 881.7 $ 7.7 $ 1.7 $ 2,187.6 Revenues from Anti-CD20 Therapeutic Programs Approximately 13%, 11% and 12% of our total revenues in 2017, 2016 and 2015, respectively, are derived from our collaboration agreement with Genentech. For additional information on our collaboration with Genentech, please read Note 20, Collaborative and Other Relationships, to these consolidated financial statements. Table of Contents BIOGEN INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued) F- 74 Significant Customers We recorded revenues from two wholesalers accounting for 34% and 21% of gross product revenues in 2017, 35% and 22% of gross product revenues in 2016, and 34% and 26% of gross product revenues in 2015, respectively. Other As of December 31, 2017, 2016 and 2015, approximately $1,215.7 million, $545.5 million and $161.5 million, respectively, of our long-lived assets were related to the construction of our large-scale biologics manufacturing facility in Solothurn, Switzerland. As of December 31, 2017, 2016 and 2015, approximately $707.1 million, $643.6 million and $684.9 million, respectively, of our long-lived assets were related to our manufacturing facilities in Denmark. For additional information on our large-scale biologics manufacturing facility in Solothurn, Switzerland, please read Note 11, Property, Plant and Equipment, to these consolidated financial statements. 26. Quarterly Financial Data (Unaudited) (In millions, except per share amounts) First Quarter Second Quarter Third Quarter Fourth Quarter Total Year 2017 (a) (a) (b) (c) (d) (a) (a) (e) (f) (g) (h) Product revenues, net $ 2,380.1 $ 2,639.7 $ 2,622.5 $ 2,712.4 $ 10,354.7 Revenues from anti-CD20 therapeutic programs $ 340.6 $ 397.1 $ 406.5 $ 415.0 $ 1,559.2 Other revenues $ 90.0 $ 41.6 $ 48.8 $ 179.6 $ 360.0 Total revenues $ 2,810.7 $ 3,078.4 $ 3,077.8 $ 3,307.0 $ 12,273.9 Gross profit (1) $ 2,426.1 $ 2,712.2 $ 2,707.8 $ 2,797.8 $ 10,643.9 Net income $ 747.5 $ 862.8 $ 1,226.1 $ (166.3) $ 2,670.1 Net income attributable to Biogen Inc. $ 747.6 $ 862.8 $ 1,226.1 $ (297.4) $ 2,539.1 Net income per share: Basic earnings per share attributable to Biogen Inc. $ 3.47 $ 4.07 $ 5.80 $ (1.41) $ 11.94 Diluted earnings per share attributable to Biogen Inc. $ 3.46 $ 4.07 $ 5.79 $ (1.40) $ 11.92 Weighted-average shares used in calculating: Basic earnings per share attributable to Biogen Inc. 215.6 211.9 211.4 211.5 212.6 Diluted earnings per share attributable to Biogen Inc. 215.9 212.2 211.8 212.0 213.0 Table of Contents BIOGEN INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued) F- 75 (In millions, except per share amounts) First Quarter Second Quarter Third Quarter Fourth Quarter Total Year 2016 (i) (i) (j) (i) (k) (l) Product revenues, net $ 2,309.4 $ 2,466.0 $ 2,539.6 $ 2,502.9 $ 9,817.9 Revenues from anti-CD20 therapeutic programs $ 329.5 $ 349.2 $ 317.6 $ 318.2 $ 1,314.5 Other revenues $ 87.9 $ 79.0 $ 98.6 $ 50.9 $ 316.4 Total revenues $ 2,726.8 $ 2,894.2 $ 2,955.8 $ 2,872.0 $ 11,448.8 Gross profit (1) $ 2,413.8 $ 2,523.9 $ 2,538.9 $ 2,493.5 $ 9,970.1 Net income $ 969.2 $ 1,048.4 $ 1,030.2 $ 647.9 $ 3,695.7 Net income attributable to Biogen Inc. $ 970.9 $ 1,049.8 $ 1,032.9 $ 649.2 $ 3,702.8 Net income per share: Basic earnings per share attributable to Biogen Inc. $ 4.44 $ 4.79 $ 4.72 $ 3.00 $ 16.96 Diluted earnings per share attributable to Biogen Inc. $ 4.43 $ 4.79 $ 4.71 $ 2.99 $ 16.93 Weighted-average shares used in calculating: Basic earnings per share attributable to Biogen Inc. 218.9 219.1 218.9 216.6 218.4 Diluted earnings per share attributable to Biogen Inc. 219.3 219.4 219.4 217.0 218.8 (1) Gross profit is calculated as total revenues less cost of sales, excluding amortization of acquired intangible assets. (a) Net income and net income attributable to Biogen Inc. for the first, second, third and fourth quarters of 2017 include a pre-tax charge of $353.6 million, $29.4 million, $30.4 million and $30.8 million, respectively, related to our U.S. and rest of world licenses to Forward Pharma's intellectual property, including Forward Pharma's intellectual property related to TECFIDERA. (b) Net income and net income attributable to Biogen Inc. for the second quarter of 2017 includes a pre-tax charge to research and development expense of $300.0 million for an upfront payment to BMS upon the closing of our agreement to exclusively license BIIB092. (c) Net income and net income attributable to Biogen Inc. for the second quarter of 2017 includes a pre-tax charge to acquired in-process research and development of $120.0 million for an upfront payment to Remedy upon closing of the asset purchase transaction. (d) Net income and net income attributable to Biogen Inc. for the second quarter of 2017 includes a pre-tax charge to research and development expense of $60.0 million for a developmental milestone that became payable to the former shareholders of iPierian upon dosing of the first patient in the Phase 2 PSP study for BIIB092. (e) Net income attributable to Biogen Inc., for the fourth quarter of 2017, includes a pre-tax charge to noncontrolling interest of $150.0 million for a payment to Neurimmune in exchange for a 15% reduction in royalty rates payable on potential commercial sales of aducanumab. (f) Net income and net income attributable to Biogen Inc. for the fourth quarter of 2017 includes pre-tax charges to research and development expense of $28.0 million and $50.0 million for an upfront payment and a continuation payment, respectively, to Alkermes. (g) Net income and net income attributable to Biogen Inc. for the fourth quarter of 2017 includes a pre-tax charge to research and development expense of $25.0 million for an upfront payment to Ionis upon entering into a new collaboration agreement to identify new antisense-oligonucleotide drug candidates for the treatment of SMA. (h) Net income and net income attributable to Biogen Inc. for the fourth quarter of 2017 includes $1,173.6 million related to the provisions of the 2017 Tax Act, including a $989.6 million expense under the Transition Toll Tax. Table of Contents BIOGEN INC. AND SUBSIDIARIES NOTES TO CONSOLIDATED FINANCIAL STATEMENTS — (Continued) F- 76 (i) Net income and net income attributable to Biogen Inc. for the second, third and fourth quarters of 2016 includes additional pre-tax depreciation expense totaling $15.8 million, $15.7 million and $14.0 million, respectively, as part of our decision to cease manufacturing and vacate our small-scale biologics manufacturing facility in Cambridge, MA as well as close and vacate our warehouse space in Somerville, MA. (j) Net income and net income attributable to Biogen Inc. for the third quarter of 2016 includes a pre-tax charge to research and development expense of $75.0 million for a license fee paid to Ionis as we exercised our option to develop and commercialize SPINRAZA. (k) Net income and net income attributable to Biogen Inc. for the fourth quarter of 2016 includes a pre-tax charge to research and development expense of $50.0 million for a milestone payment due to Eisai related to the initiation of a Phase 3 trial for E2609. (l) Net income and net income attributable to Biogen Inc. for the fourth quarter of 2016 includes a pre-tax charge of $454.8 million related to our January 2017 settlement and license agreement with Forward Pharma. 27. Subsequent Events Karyopharm Therapeutics Inc. In January 2018 we acquired the exclusive worldwide rights to develop and commercialize Karyopharm Therapeutics Inc.'s (Karyopharm) investigational oral compound BIIB100 (formerly known as KPT-350) for the treatment of certain neurological and neurodegenerative conditions, primarily in ALS. We will pay Karyopharm an upfront payment of $10.0 million and we may pay Karyopharm up to $207.0 million in additional milestone payments, and potential royalties. Table of Contents F- 77 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Shareholders of Biogen Inc. Opinions on the Financial Statements and Internal Control over Financial Reporting We have audited the accompanying consolidated balance sheets of Biogen Inc. and its subsidiaries (the "Company") as of December 31, 2017 and 2016, and the related consolidated statements of income, comprehensive income, equity and cash flows for each of the three years in the period ended December 31, 2017, including the related notes (collectively referred to as the “consolidated financial statements”). We also have audited the Company's internal control over financial reporting as of December 31, 2017, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO). In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2017 and 2016, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2017 in conformity with accounting principles generally accepted in the United States of America. Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2017, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO. Basis for Opinions The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual Report on Internal Control over Financial Reporting appearing under Item 9A. Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) ("PCAOB") and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB. We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud, and whether effective internal control over financial reporting was maintained in all material respects. Our audits of the consolidated financial statements included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk. Our audits also included performing such other procedures as we considered necessary in the circumstances. We believe that our audits provide a reasonable basis for our opinions. Definition and Limitations of Internal Control over Financial Reporting A company’s internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company; (ii) provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in accordance with authorizations of management and directors of the company; and (iii) provide reasonable Table of Contents F- 78 assurance regarding prevention or timely detection of unauthorized acquisition, use, or disposition of the company’s assets that could have a material effect on the financial statements. Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate. /s/PricewaterhouseCoopers LLP Boston, Massachusetts February 1, 2018 We have served as the Company's auditor since 2003. Document Outline
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