Q3 2017 Earnings Results October 26, 2017
Forward-Looking Statements The projected financial results presented in the following slides represent management's estimates of Gilead’s future financial results. 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 2017 financial results; Gilead’s ability to sustain growth in revenues for its antiviral and other programs; the risk that estimates of patients with HCV or anticipated patient demand may not be accurate; the risk that private and public payers may be reluctant to provide, or continue to provide, coverage or reimbursement for new products, including Yescarta TM , Vosevi, Vemlidy, Epclusa, Descovy, Odefsey and Genvoya; Gilead’s ability to successfully commercialize Yescarta and advance Kite’s product pipeline and any difficulties or unanticipated expenses in connection with integrating the companies; the potential for increased pricing pressure globally and contracting pressure as well as decreased volume and market share from additional competitive HCV launches; a larger than anticipated shift in payer mix to more highly discounted payer segments and geographic regions and decreases in treatment duration; availability of funding for state AIDS Drug Assistance Programs (ADAPs) and Veterans Administration (VA); continued fluctuations in ADAP and VA purchases driven by federal and state grant cycles which may not mirror patient demand and may cause fluctuations in Gilead’s earnings; market share and price erosion caused by the introduction of generic versions of Viread and Truvada outside the United States; potential amendments to the Affordable Care Act or other government action that could have the effect of lowering prices or reducing the number of insured patients; the possibility of unfavorable results from clinical trials involving investigational compounds; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead’s earnings; Gilead’s ability to submit new drug applications and receive regulatory approval for new product candidates in the timelines currently anticipated or at all, including for BIC/FTC/TAF; Gilead’s ability to successfully develop its oncology, inflammation, cardiovascular and respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead’s product candidates; Gilead’s ability to pay dividends or complete its share repurchase program due to changes in its stock price, corporate or other market conditions; fluctuations in the foreign exchange rate of the U.S. dollar that may cause an unfavorable foreign currency exchange impact on Gilead’s future revenues and pre-tax earnings; and other risks identified from time to time in Gilead’s reports filed with the U.S. Securities and Exchange Commission (SEC). In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Actual results may differ significantly from these estimates. You are urged to consider statements that include the words may, will, would, could, should, might, believes, estimates, projects, potential, expects, plans, anticipates, intends, continues, forecast, designed, goal, or the negative of those words or other comparable words to be uncertain and forward-looking. Gilead directs readers to its press releases, Quarterly Report on Form 10-Q for the quarter ended June 30, 2017 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 any such forward-looking statements. This presentation includes 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 statements, 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
Q3 2017 Earnings Call Agenda Introduction Sung Lee, VP, Investor Relations Commentary John Milligan, President and CEO Robin Washington, EVP and CFO Jim Meyers, EVP, Commercial Operations Q&A Also: Kevin Young, COO Norbert Bischofberger, EVP, R&D and CSO Alessandro Riva, EVP, Oncology Therapeutics 3
Table of Contents Discussion Slide # John Milligan, President and CEO 6 Kite Update and Yescarta TM Launch AASLD Update 7 B/F/TAF Update 9 Robin Washington, EVP and CFO Income Statement Performance 11 – 17 Cash Flow and Return of Capital to Shareholders 18 – 20 2017 Guidance 21 – 22 Jim Meyers, EVP Commercial Operations 24 – 32 HIV HCV 33 – 37 38 – 50 Appendix 4
John Milligan, Ph.D. President and CEO
Kite Acquisition and Yescarta ™ Approval ♦ Establishes Gilead’s leadership in cell therapy ♦ Yescarta TM approved in the U.S. on October 18, 2017 for adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy • Collaborating with academic cancer centers to finalize training and complete certification before launch ♦ Marketing Authorization in Europe is anticipated in the first half of 2018 ♦ Working to expand manufacturing capacity into Europe ♦ Number of studies in other b-cell malignancies, earlier lines of therapy and solid tumors are planned and ongoing 6
Strong Data Presence at 2017 AASLD Meeting ♦ Over 40 abstracts accepted American Association – NASH for the Study of Liver – Hepatitis C Diseases – Hepatitis B (October 20-24, 2017) ♦ NASH - Late breaker – LB-9: Acetyl-CoA carboxylase (ACC) inhibitor GS-0976 leads to significant improvements in MRI-PDFF in a phase 2, randomized, placebo-controlled trial of patients with NASH ♦ Hepatitis C – High cure rates in difficult-to-cure patient populations treated with sofosbuvir-based regimens ♦ Hepatitis B – Improved long-term bone and renal safety following switch to Vemlidy from Viread 7
Reaching People in New Geographies: China ♦ On September 25, Gilead announced approval of Sovaldi by the China Food and Drug Administration for the treatment of adults and adolescents (aged 12 to 18 years) infected with HCV genotype 1, 2, 3, 4, 5 or 6 as a component of a combination antiviral treatment regimen ♦ Sovaldi is Gilead’s first product launch in China • Expectation of private market launch in early December. Small enterprise footprint focused on medical education and market access ♦ Gilead is also studying Harvoni and Epclusa in clinical trials at sites across China, where 10 million people are estimated to be living with HCV ♦ Potential for approval of six medicines in China over the next two years including: Harvoni and Epclusa for HCV, Vemlidy for HBV, Genvoya, Descovy, and B/F/TAF for HIV 8
Bictegravir/F/TAF ♦ Bictegravir is a novel integrase inhibitor ─ In development as a single-tablet regimen with B/F/TAF F/TAF ♦ All four Phase 3 studies met the primary objective of non-inferiority ♦ 0% resistance development was observed in all four studies at week 48 ♦ Data for treatment-naïve patients from Study 1489 and 1490 shared at the IAS Conference on HIV Science in Paris, July 2017 ♦ Data for virologically suppressed patients who switched from boosted protease inhibitor-based regimens (Study 1878) shared at the IDWeek 2017 conference in San Diego, October 2017 ♦ U.S. PDUFA date February 12, 2018 MAA submitted and was validated by the European Medicines Agency in July 2017 9
Robin Washington EVP and CFO
Total Revenues Q3 2017 down 13% from Q3 2016 $ in millions $7,500* $7,320 $7,141 $6,512 $6,505 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Note: FX impact to revenues was favorable $59 million QoQ (0.8%). *Q3 16 revenues benefited from a favorable adjustment of $332 million to rebate reserves primarily related to our TDF-based regimens. 11
Non-GAAP Diluted EPS Q3 2017 down 17% from Q3 2016 $2.75 $2.70 $2.56 $2.27 $2.23 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 Note: Non-GAAP diluted EPS excludes acquisition-related, up-front collaboration, stock-based compensation and other expenses. 12
Recommend
More recommend
