Gilead Sciences, Inc

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Gilead Sciences, Inc Q4 2019 Earnings Results February 4, 2020 Forward-looking Statements The projected financial results presented in the following slides represent management's estimates of Gilead’s future financial results. Statements included in this press release that are not historical in nature are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially. These risks and uncertainties include: Gilead’s ability to achieve its anticipated full year 2020 financial results; Gilead’s ability to accelerate or sustain revenues for its antiviral and other programs; Gilead’s ability to realize the potential benefits of collaborations or licensing arrangements, including those with The Rockefeller University, Kyverna Therapeutics, Inc., Eisai Co., Ltd., Kiniksa Pharmaceuticals, Ltd. and Glympse Bio, Inc.; Gilead’s ability to initiate clinical trials in its currently anticipated timeframes; the risk that safety and efficacy data from clinical studies may not warrant further development of Gilead’s product candidates, including Yescarta in combination with mavrilimumab, 3BNC117, 10-1074, GS-6207 and product candidates evaluated for bridging fibrosis and compensated cirrhosis due to NASH; Gilead’s ability to submit new drug applications for new product candidates in the timelines currently anticipated; Gilead’s ability to receive regulatory approvals in a timely manner or at all, for new and current products, including FDA and MHLW approvals for filgotinib for the treatment of RA and FDA and European Commission approvals of KTE-X19 for the treatment of mantle cell lymphoma; Gilead’s ability to successfully commercialize its products, including expansion in China; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products; a larger than anticipated shift in payer mix to more highly discounted payer segments; market share and price erosion caused by the introduction of generic versions of Gilead products; the risk that physicians and patients may not see advantages of these products over other therapies and may therefore be reluctant to prescribe the products; and other risks identified from time to time in Gilead’s reports filed with the U.S. Securities and Exchange Commission (the SEC). In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. There may be other factors of which Gilead is not currently aware that may affect matters discussed in the forward-looking statements and may also cause actual results to differ significantly from these estimates. Further, results for the quarter and the year ended December 31, 2019 are not necessarily indicative of operating results for any future periods. Gilead directs readers to its press releases, Quarterly Report on Form 10-Q for the quarter ended September 30, 2019 and other subsequent disclosure documents filed with the SEC. Gilead claims the protection of the Safe Harbor contained in the Private Securities Litigation Reform Act of 1995 for forward-looking statements. All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements. This presentation includes U.S. GAAP and non-GAAP financial measures, a complete reconciliation between these two measures is available on the Company’s website at www.gilead.com within the investor section. Management believes this non-GAAP information is useful for investors, when considered in conjunction with Gilead’s GAAP financial information, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead’s operating results as reported under U.S. GAAP. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. 2 Table of Contents Pages Key Highlights 4 - 8 Financial Performance 9 - 26 Durable Core Business 29 - 41 Three Pillars of Gilead’s 42 - 48 Next Existing Pipeline Opportunities Chapter Strategy to Drive Additional Growth 49 - 53 Appendix 54 - 58 3 Key Highlights 4 Q4 2019 Earnings Call Highlights • Key decisions made and new corporate strategy in place to drive Gilead’s next chapter • Solid financial performance with product sales of $22.1 billion for FY 2019 (2% YoY growth), at upper end of revised guidance • Durable HIV franchise delivering all-time high of $16.4 billion for FY 2019 (12% YoY growth) and $4.6 billion for Q4 2019 (9% QoQ growth) − Biktarvy® sales of $4.7 billion for FY 2019 (300% YoY growth) and $1.6 billion in Q4 2019 (25% QoQ growth) • Successful Descovy® for PrEP launch, ~27% of individuals on PrEP in the U.S. now on Descovy • Submitted filgotinib NDA for RA and launch preparations underway in the U.S., Europe and Japan • Dividend increase to $0.68 from $0.63 per share, effective Q1 2020 (fifth consecutive annual increase) • Additional $5.0 billion share repurchase authorization (in addition to $3.4 billion at year-end from prior authorization, $8.4 billion in total) • 2020 Financial Guidance - product sales of $21.8 - $22.2 billion and non-GAAP diluted EPS of $6.05 - $6.45 − Starting in 2020, Gilead will no longer regularly exclude stock-based compensation expense from its non-GAAP financial information − For comparability purposes, full year 2019 non-GAAP operating income and non-GAAP diluted earnings per share would have been $10.4 billion and $6.13, respectively, had stock-based compensation expense not been excluded 5 Key Decisions Have Laid the Foundation for Change Made Kite Expanded Established Completed New Defined New Separate Operating Galapagos External Innovation Leadership Corporate Company Partnership Group Team Strategy Mar Jul Sep Oct 2020Dec 2019 6 Diverse, Highly Experienced Leadership Team Daniel O’Day Andrew Dickinson Brett A. Pletcher Christi Shaw Johanna Mercier Executive Chairman and Chief Financial Officer Executive Vice President, Chief Executive Officer, Kite Chief Commercial Officer Chief Executive Officer Corporate Affairs and General Counsel Jyoti Mehra Merdad Parsey, Taiyin Yang, PhD William A. Lee, PhD Executive Vice President, MD, PhD Executive Vice President, Executive Vice President, Human Resources Chief Medical Officer Pharmaceutical Development Research and Manufacturing 7 Anticipated Milestones Through 2021 Axi-cel Axi-cel P3 2L DLBCL data Expected iNHL approval Filgotinib Axi-cel Expected RA approvals in U.S., Europe, Japan Expected 2L DLBCL submission Filgotinib Axi-cel P3 enrollment completion for CD P2 1L DLBCL data Axi-cel Filgotinib Capsid inhibitor P2 iNHL data MANTA/MANTA-RAy enrollment completion Expected HTE submission Capsid inhibitor GLPG-19721 GLPG-16902 P1 initiation for PrEP P2 OA data P3 IPF futility analysis data Filgotinib KTE-X19 KTE-X19 P3 UC data Expected MCL approval Expected aALL approval H1 2020 H2 2020 2021 HTE – heavily treatment-experienced. 1 Optionable partner program. 2 Optioned partner program. 8 Financial Performance 9 Financial Highlights: Q4 2019 in millions, except percentages and per share amounts Q4 2018 Q3 2019 Q4 2019 YoY Change QoQ Change Product Sales $5,681 $5,516 $5,796 2% 5% HIV1 4,065 4,202 4,577 13% 9% HCV 738 674 630 (15%) (7%) Yescarta 81 118 122 51% 3% Other Products2 797 522 467 (41%) (11%) Non-GAAP Costs and Expenses3 $3,228 $2,680 $3,567 11% 33% COGS4 1,257 759 1,406 12% 85% Product Gross Margin 78% 86% 76% R&D 939 954 1,029 10% 8% SG&A 1,032 967 1,132 10% 17% Operating Margin4 44% 52% 39% Effective Tax Rate 24% 22% 25% Non-GAAP Net Income3 $1,873 $2,224 $1,653 (12%) (26%) Non-GAAP Diluted EPS3 $1.44 $1.75 $1.30 (10%) (26%) Shares used in per share calculation-diluted 1,299 1,274 1,273 (2%) 0% 1 HIV includes Atripla, Biktarvy, Complera/Eviplera, Descovy, Emtriva, Genvoya, Odefsey, Stribild, revenue share Symtuza, Truvada, and Tybost. Revenue share Symtuza represents Gilead’s revenue from cobicistat (C), FTC and TAF in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen. 2 Other products include AmBisome, Cayston, Hepsera, Letairis, Ranexa, Vemlidy, Viread, and Zydelig. 3 Non-GAAP financial information excludes acquisition-related, up-front collaboration and licensing, stock-based compensation and other expenses, fair value adjustments of equity securities and discrete tax charges or benefits associated with changes in 4 10 tax related laws and guidelines. In Q4 2019 and Q4 2018, COGS include inventory write-downs of $500 million and $410 million, respectively, for slow moving and excess raw material and work in process inventory primarily due to lower long-term demand for our HCV products. Financial Highlights: Full Year in millions, except percentages and per share amounts 2018 2019 YoY Change Product Sales $21,677 $22,119 2% HIV1 14,627 16,438 12% HCV 3,686 2,936 (20%) Yescarta 264 456 73% Other Products2 3,100 2,289 (26%) Non-GAAP Costs and Expenses3 $10,716 $11,385 6% COGS4 3,590 3,539 (1%) Product Gross Margin 83% 84% R&D 3,518 3,770 7% SG&A 3,608 4,076 13% Operating Margin4 52% 49% Effective Tax Rate 20% 21% Non-GAAP Net Income3 $8,728 $8,466 (3%) Non-GAAP Diluted EPS3 $6.67 $6.63 (1%) Shares used in per share calculation-diluted 1,308 1,277 (2%) 1 HIV includes Atripla, Biktarvy, Complera/Eviplera, Descovy, Emtriva, Genvoya, Odefsey, Stribild, revenue share Symtuza, Truvada, and Tybost.
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