q1 2017 earnings results
play

Q1 2017 Earnings Results May 2, 2017 Forward-Looking Statements The - PowerPoint PPT Presentation

Q1 2017 Earnings Results May 2, 2017 Forward-Looking Statements The projected financial results presented in the following slides represent management's estimates of Gileads future financial results. Gilead cautions readers that


  1. Q1 2017 Earnings Results May 2, 2017

  2. 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 sust ain 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 Vemlidy, Epclusa, Descovy, Odefsey and Genvoya; 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 outsid e 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; Gilead’s ability to successfully develop its oncology, i nflammation, cardiovascular and respiratory programs; safety and efficacy data from clinical studies may not warrant further development of Gilead’s product candidates, including BIC+FTC/TAF and certain HIV CAIs; Gilead’s ability to pay dividends or complete its share repurchase program due to changes i n 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 repor ts 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, Annual Report on Form 10-K for the year ended December 31, 2016 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 it s 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

  3. Q1 2017 Earnings Call Agenda Sung Lee, VP, Investor Relations Introduction Robin Washington, EVP and CFO Commentary Jim Meyers, EVP, Commercial Operations John Milligan, President and CEO Q&A Also: Norbert Bischofberger, EVP, R&D and CSO Kevin Young, COO 3

  4. Table of Contents Discussion Slide # Robin Washington, EVP and CFO 6 – 13 Income Statement Performance 14 – 16 Cash Flow and Return of Capital to Shareholders 17 – 18 2017 Guidance Jim Meyers, EVP, Commercial Operations 20 – 28 HCV 29 – 35 HIV John Milligan, President and CEO 37 – 48 Pipeline 49 – 55 Appendix 4

  5. Robin Washington EVP and CFO

  6. Financial Highlights: Q1 2017 (in millions, except percentages and per share amounts) YoY QoQ Q1 2016 Q4 2016 Q1 2017 Change Change Net Product Sales $7,681 $7,216 $6,377 (17%) (12%) Antiviral Products 7,183 6,595 5,841 (19%) (11%) HCV 4,294 3,229 2,576 (40%) (20%) HIV and HBV 2,889 3,366 3,265 13% (3%) Other Products * 498 621 536 8% (14%) Non-GAAP Costs and Expenses** $2,390 $2,757 $2,439 2% (12%) COGS 983 860 743 (24%) (14%) Product Gross Margin 87% 88% 88% R&D 769 959 889 16% (7%) SG&A 638 938 807 26% (14%) Operating Margin 69% 62% 63% Effective Tax Rate 19% 19% 25% Non-GAAP Net Income** $4,274 $3,585 $2,949 (31%) (18%) Non-GAAP Diluted EPS** $3.03 $2.70 $2.23 (26%) (17%) Diluted Shares 1,412 1,327 1,320 (7%) 0% * Other Products comprised primarily of Letairis, Ranexa, AmBisome, Zydelig, Cayston and Lexiscan. 6 **Non-GAAP costs and expenses, net income and diluted EPS exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses.

  7. Total Revenues Q1 2017 down 17% from Q1 2016 $ in millions $7,794 $7,776 $7,500 $7,320 $6,505 Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Note: FX impact to revenues was unfavorable $26 million QoQ (-0.3%) and unfavorable $87 million YoY (-1.3%). 7

  8. Non-GAAP Diluted EPS Q1 2017 down 26% from Q1 2016 $3.08 $3.03 $2.75 $2.70 $2.23 Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Note: Non-GAAP diluted EPS excludes acquisition-related, up-front collaboration, stock-based compensation and other expenses. 8

  9. Total Product Sales Q1 2017 down 17% from Q1 2016 $ in millions By Therapeutic Area By Geography $7,681 $7,681 $7,651 $7,651 $7,405 $7,405 $7,216 $7,216 $1,150 $1,661 $931 $870 $6,377 $6,377 $661 $1,412 $1,612 $1,415 $3,325 $3,986 $1,637 $4,294 $3,229 $1,266 $2,576 $5,062 $4,931 $4,889 $4,450 $4,383 $3,516 $3,366 $3,265 $3,140 $2,889 Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 * HIV and HBV HCV Other U.S Europe Other Int'l 9 *Other comprised primarily of Letairis, Ranexa, AmBisome, Zydelig, Cayston and Lexiscan.

  10. Non-GAAP R&D Expenses Q1 2017 up 16% from Q1 2016 Key Metrics $ in millions ● Higher R&D expenses in $1,040 Q1 17 compared to Q1 16 $981 $959 primarily due to the $889 purchase of a $125 million $769 U.S. FDA Priority Review Voucher in March 2017 Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Note: Non-GAAP R&D expenses exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. 10

  11. Non-GAAP SG&A Expenses Q1 2017 up 26% from Q1 2016 Key Metrics $ in millions ● Higher SG&A expenses in $938 Q1 17 compared to Q1 16 primarily due to higher net $838 $807 $780 Branded Prescription Drug (BPD) fee ● P&L impact of BPD fee: * $638 BPD Fee $M 2015 Actual $414 2016 Actual $270 2017 Estimate $350-$450 Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Note: Non-GAAP SG&A expenses exclude acquisition-related, up-front collaboration, stock- based compensation and other expenses. * Q1 16 is favorably impacted by $191 million following the receipt of preliminary 2016 IRS invoice associated with the BPD fee. The favorability is denoted by above. 11

  12. Non-GAAP Product Gross Margin Key Metrics Higher Non-GAAP ● Product Gross Margin in ** 91.5% * Q1 17 compared to Q1 16 87.2% 87.6% 88.1% 88.3% primarily due to Q1 16 litigation accrual Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Note: Non-GAAP product gross margin excludes acquisition-related, up-front collaboration, stock-based compensation and other expenses. * Q1 16 is negatively impacted by the $200 million litigation reserve. ** Q2 16 is favorably impacted by the $200 million reversal of the litigation reserve 12 recorded in Q1 16 following a favorable court decision.

  13. Non-GAAP Operating Margin Key Metrics ● Lower Non-GAAP Operating Margin in Q1 17 compared to Q1 16 69.3% 67.5% driven by lower revenues 64.3% 62.3% 62.5% and growth of operating expenses Q1 16 Q2 16 Q3 16 Q4 16 Q1 17 Note: Non-GAAP operating margin excludes acquisition-related, up-front collaboration, stock-based compensation and other expenses. 13

Download Presentation
Download Policy: The content available on the website is offered to you 'AS IS' for your personal information and use only. It cannot be commercialized, licensed, or distributed on other websites without prior consent from the author. To download a presentation, simply click this link. If you encounter any difficulties during the download process, it's possible that the publisher has removed the file from their server.

Recommend


More recommend