Q3 2017 Earnings Results October 26, 2017 Forward-Looking - - PowerPoint PPT Presentation
Q3 2017 Earnings Results October 26, 2017 Forward-Looking - - PowerPoint PPT Presentation
Q3 2017 Earnings Results October 26, 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
Forward-Looking Statements
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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 YescartaTM, 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.
Q3 2017 Earnings Call Agenda
Introduction Sung Lee, VP, Investor Relations Commentary Q&A John Milligan, President and CEO Robin Washington, EVP and CFO Jim Meyers, EVP, Commercial Operations Also: Kevin Young, COO Norbert Bischofberger, EVP, R&D and CSO Alessandro Riva, EVP, Oncology Therapeutics
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Table of Contents
Discussion Slide #
John Milligan, President and CEO Kite Update and YescartaTM Launch
6 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 HIV
24 – 32
HCV
33 – 37
Appendix
38 – 50 4
John Milligan, Ph.D.
President and CEO
Kite Acquisition and Yescarta™ Approval
♦ Establishes Gilead’s leadership in cell therapy ♦ YescartaTM 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
♦ Over 40 abstracts accepted
– NASH – Hepatitis C – Hepatitis B
♦ 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
Strong Data Presence at 2017 AASLD Meeting
7
American Association for the Study of Liver Diseases
(October 20-24, 2017)
Reaching People in New Geographies: China
♦ On September 25, Gilead announced approval
- f 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
8
♦ 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
Bictegravir/F/TAF
♦ Bictegravir is a novel integrase inhibitor
─ In development as a single-tablet regimen with F/TAF
♦ All four Phase 3 studies met the primary objective of non-inferiority
9
♦ 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
B/F/TAF
Robin Washington
EVP and CFO
$7,500* $7,320 $6,505 $7,141 $6,512 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
Total Revenues
11
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.
$ in millions
Q3 2017 down 13% from Q3 2016
$2.75 $2.70 $2.23 $2.56 $2.27 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
Non-GAAP Diluted EPS
12
Note: Non-GAAP diluted EPS excludes acquisition-related, up-front collaboration, stock-based compensation and other expenses.
Q3 2017 down 17% from Q3 2016
Financial Highlights: Q3 2017
(in millions, except percentages and per share amounts)
* Other Products comprised primarily of Letairis, Ranexa, AmBisome, Zydelig, Cayston and Lexiscan. **Non-GAAP costs and expenses, net income and diluted EPS exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses.
13
Q3 2016 Q2 2017 Q3 2017
YoY Change QoQ Change
Net Product Sales
$7,405 $7,046 $6,402 (14%) (9%) Antiviral Products 6,841 6,439 5,843 (15%) (9%) HCV 3,325 2,868 2,197 (34%) (23%) HIV and HBV 3,516 3,571 3,646 4% 2% Other Products* 564 607 559 (1%) (8%)
Non-GAAP Costs and Expenses**
$2,679 $2,531 $2,372 (11%) (6%) COGS 918 892 821 (11%) (8%) Product Gross Margin 88% 87% 87% R&D 981 812 745 (24%) (8%) SG&A 780 827 806 3% (3%) Operating Margin 64% 65% 64% Effective Tax Rate 22% 25% 26%
Non-GAAP Net Income**
$3,677 $3,372 $2,990 (19%) (11%)
Non-GAAP Diluted EPS**
$2.75 $2.56 $2.27 (17%) (11%)
Diluted Shares
1,339 1,317 1,319 (1%)
Financial Highlights: Nine Months Ended September 30
(in millions, except percentages and per share amounts)
* Other Products comprised primarily of Letairis, Ranexa, AmBisome, Zydelig, Cayston and Lexiscan. **Non-GAAP costs and expenses, net income and diluted EPS exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses.
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2016 2017
Change
Net Product Sales
$22,737 $19,825 (13%) Antiviral Products 21,150 18,123 (14%) HCV 11,605 7,641 (34%) HIV and HBV 9,545 10,482 10% Other Products* 1,587 1,702 7%
Non-GAAP Costs and Expenses**
$7,600 $7,342 (3%) COGS 2,554 2,456 (4%) Product Gross Margin 89% 88% R&D 2,790 2,446 (12%) SG&A 2,256 2,440 8% Operating Margin 67% 64% Effective Tax Rate 20% 25%
Non-GAAP Net Income**
$12,128 $9,311 (23%)
Non-GAAP Diluted EPS**
$8.87 $7.06 (20%)
Diluted Shares
1,369 1,319 (4%)
$5,062 $4,931 $4,450 $4,982 $4,542
$1,412 $1,415 $1,266 $1,399 $1,197 $931 $870 $661
$665 $663
Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
U.S Europe Other Int'l
$3,516 $3,366 $3,265 $3,571 $3,646 $3,325 $3,229 $2,576 $2,868 $2,197
Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
HIV and HBV HCV Other
Total Product Sales
15
By Therapeutic Area By Geography
Q3 2017 down 14% from Q3 2016
$7,405 $7,216 $6,377 $7,046 $7,405 $7,216 $6,377 $7,046
*Other comprised primarily of Letairis, Ranexa, AmBisome, Zydelig, Cayston and Lexiscan.
*
$ in millions $6,402 $6,402
$981 $959 $889 $812 $745 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
Non-GAAP R&D Expenses
Key Metrics
- YoY decrease primarily
due to the 2016 impact of a $200 million milestone expense associated with Nimbus
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Q3 2017 down 24% from Q3 2016
Note: Non-GAAP R&D expenses exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses.
$ in millions
$780 $938 $807 $827 $806 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
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Non-GAAP SG&A Expenses
Note: Non-GAAP SG&A expenses exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses.
Q3 2017 up 3% from Q3 2016
Key Metrics
- YoY increase primarily due to
higher marketing expenses partially offset by lower Branded Prescription Drug (BPD) fee
- P&L impact of BPD fee:
BPD Fee $M 2015 Actual $414 2016 Actual $270 2017 Estimate $350-$450
$ in millions
- Jun. 30,
2017
- Sep. 30,
2017
Cash, Cash Equivalents & Marketable Securities $36,576 $41,360 Operating Cash Flows During the Quarter * $3,526 $2,694 Inventories $1,408 $1,144 Days Sales Outstanding (Accounts Receivable) 42 42 Share Repurchases During the Quarter $130 $153 Interest Expense and Other Income (Expense), net (non-GAAP)** ($139) ($123) Diluted Shares Used in Per Share Calculation for the Quarter 1,317 1,319 Basic Shares Outstanding 1,307 1,306 18
(in millions, except days sales outstanding)
Other Select Financial Information
* Operating cash flows during the quarter ended June 30, 2017 and September 30, 2017 reflect the impact of adoption of Accounting Standards Update 2016-09 “Improvements to Employee Share-Based Payment Accounting.” ** Non-GAAP Interest Expense and Other Income (Expense), net excludes acquisition-related expenses.
Return of Capital to Shareholders
♦ Cash dividend program
- Paid quarterly dividend in Q3 2017 of $0.52 per share
- Declared Q4 2017 quarterly dividend of $0.52 per share, payable December 28, 2017 to
stockholders of record as of the close of business on December 15, 2017
♦ Share repurchase program
- Repurchased $153 million of stock and retired 2.0 million shares at an average price of $76.02 in
- pen market repurchases in Q3 2017
- $8.2 billion of the January 2016 $12 billion share repurchase program remaining as of
September 30, 2017
- Since 2012, repurchased approximately 21% of shares outstanding (over 322 million shares)
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20
Q3 2017 Share Activity
A $12 billion share repurchase program was authorized in January 2016, which we began in Q2 2016. Under this program, we have repurchased a total of 47.6 million shares with an average purchase price of $80.91 in open market repurchases. As of September 30, 2017, $8.2 billion remains outstanding under the January 2016 program.
Type of Activity Dollar Amount (In Millions) Shares Average Purchase Price Q1 2017 Open Market Share Repurchase $565 7,921,267 $71.34 Q2 2017 Open Market Share Repurchase $130 1,961,148 $66.29 Q3 2017 Open Market Share Repurchase $153 2,012,615 $76.02 2017 Total Open Market Share Repurchase $848 11,895,030 $71.30
Initially Provided 2/7/2017 Reiterated 5/2/2017 Updated 7/26/2017 Updated 10/26/2017 Net Product Sales* $ 22,500 – $ 24,500 $ 24,000 – $ 25,500 $ 24,500 – $ 25,500
Non-HCV Product Sales
$ 15,000 – $ 15,500 $ 15,500 – $ 16,000 $ 16,000 – $ 16,500 HCV Product Sales $ 7,500 – $ 9,000 $ 8,500 – $ 9,500 $ 8,500 – $ 9,000
Non-GAAP** Product Gross Margin 86.0% – 88.0% 86.0% – 88.0% 86.0% – 87.0% R&D Expenses $ 3,100 – $ 3,400 $ 3,200 – $ 3,400 $ 3,300 – $ 3,400 SG&A Expenses $ 3,100 – $ 3,400 $ 3,200 – $ 3,400 $ 3,300 – $ 3,400 Effective Tax Rate 25.0% – 28.0% 25.0% – 28.0% 25.0% – 27.0% Diluted EPS Impact of GAAP to Non-GAAP Adjustments*** $ 0.84 – $ 0.91 $ 0.86 – $ 0.93 $ 1.02 – $ 1.17
* This guidance is subject to a number of uncertainties including the accuracy of estimates of HCV patient starts for the remainder of 2017 and/or market share in HCV; lower than expected market share and greater price erosion as the result of the introduction of generic versions of TDF and the fixed dose combination of FTC/TDF outside the U.S; slower than anticipated growth in the HIV franchise; an increase in discounts, chargebacks and rebates due to ongoing contracts and future negotiations with commercial and government payers; a larger than anticipated shift in payer mix to more highly discounted payer segments – such as PHS, FSS, Medicaid and the VA, as well as volatility in foreign currency exchange rates. ** Non-GAAP product gross margin, expenses and effective tax rate exclude amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses. *** Includes amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP full year 2017 guidance is provided in the tables on slide 22.
Full Year 2017 Guidance
(in millions, except percentages and per share amounts)
21
Projected product gross margin GAAP to non-GAAP reconciliation:
GAAP projected product gross margin Acquisition-related expenses (1)(3) Non-GAAP projected product gross margin (2)
Projected research and development expenses GAAP to non-GAAP reconciliation:
GAAP projected research and development expenses Stock-based compensation expenses (1)(3) Acquisition-related (1) / up-front collaboration expenses Non-GAAP projected research and development expenses
Projected selling, general and administrative expenses GAAP to non-GAAP reconciliation:
GAAP projected selling, general and administrative expenses Stock-based compensation expenses (1)(3) Acquisition-related expenses-transaction costs and other (1) Non-GAAP projected selling, general and administrative expenses
Projected diluted EPS impact of acquisition-related, up-front collaboration, stock-based compensation and other expenses:
Acquisition-related(1) / up-front collaboration expenses Stock-based compensation expense(1) Projected diluted EPS impact of acquisition-related, up-front collaboration, stock-based compensation and other expenses
Updated 7/26/2017
(in millions, except percentages and per share amounts)
GAAP to Non-GAAP Reconciliation of Full Year 2017 Guidance
82% - 84% 4% - 4% 86% - 88% $3,305 - $3,615 (205) - (215)
- $3,100 - $3,400
$0.62 - $0.67 0.22 - 0.24 $0.84 - $0.91 $3,295 - $3,640 (180) - (195) (15) - (45) $3,100 - $3,400
(1) Acquisition-related expenses, including acquisition-related amortization of intangible assets and stock-based compensation expenses, associated with Gilead’s acquisition of Kite are subject to adjustments pending completion of preliminary purchase accounting and valuation. (2) Total stock-based compensation expenses have a less than one percent impact on non-GAAP projected product gross margin. (3) Amounts include preliminary estimates of a range between $188 million and $251 million total stock-based compensation expenses associated with Gilead’s acquisition of Kite
22
82% - 84% 4% - 4% 86% - 88% $3,435 - $3,645 (235) - (245)
- $3,200 - $3,400
$0.62 - $0.67 0.24 - 0.26 $0.86 - $0.93 $3,410 - $3,655 (195) - (210) (15) - (45) $3,200 - $3,400
Initially Provided 2/7/2017; Reiterated 5/2/2017 Updated 10/26/2017
82% - 83% 4% - 4% 86% - 87% $3,755 - $3,940 (375) - (435) (80) - (105) $3,300 - $3,400 $0.72 - $0.82 0.30 - 0.35 $1.02 - $1.17 $3,535 - $3,685 (220) - (240) (15) - (45) $3,300 - $3,400
Jim Meyers
EVP, Commercial Operations
HIV
Top Prescribed HIV Regimens
25 Rank Naïve All Patients
1 Genvoya Genvoya 2 Other STR Other STR 3 Stribild Atripla 4 Complera Stribild 5 Odefsey Complera Gilead STR
U.S. Europe-5*
Rank Naïve All Patients
1 Genvoya Other STR 2 Other STR Genvoya 3 Eviplera Eviplera 4 Truvada + other 3rd Agent Atripla 5 Atripla Stribild
EU Naïve Source: Ipsos Healthcare HIV EU Scope Q3 2017. EU All Patient Source: Ipsos Healthcare HIV EU Therapy Monitor Q3 2017. US Source: Ipsos Healthcare HIV U.S. Therapy Monitor/Scope Q2 2017. *Europe-5 comprised of France, Spain, Italy, UK, and Germany.
Regimen contains a Gilead product
$461 $563 $769 $857 $988
$105 $155 $227 $258 $296 $88 $149 $251 $286 $316
Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
Genvoya Odefsey Descovy
TAF-Containing Total HIV Product Sales
26
$654 $ in millions $867 $1,247 $1,401 $1,600
Q3 2017 up 14% from Q2 2017
(Total Worldwide Product Revenues)
U.S. HIV Market Dynamics
HIV Infected Diagnosed On Antiretroviral Treatment On a Gilead HIV Product
~1,108 ~942 ~705 ~558
~85% ~75% ~79%
Sources: CDC and Ipsos Healthcare HIV U.S. Therapy Monitor/Scope Q2 2017.
27 Estimated Patients in 000’s
Base: All initiations within each quarter. Source: Ipsos Healthcare HIV U.S. Scope Q2 2017.
Gilead U.S. Share in HIV Treatment Naïve Patients
% of Naïve Patients Initiating Therapy
28
TAF Portfolio Uptake in the U.S.*
Launched Aligned Monthly TRx
Months Post Launch
Source: Based on data derived from IMS NPA Monthly. *As measured post launch for respective products.
29
TAF Portfolio Uptake in France*
Source: Based on data derived from IMS/GERS.
30 Launched Aligned Monthly Packs
Months Post Launch Packs/Month
*As measured post launch for respective products.
Atripla Triumeq (ViiV) Stribild
TAF Portfolio Uptake in Germany*
Source: Based on data derived from IMS PharmaScope.
31
Atripla Triumeq (ViiV) Stribild
Launched Aligned Monthly Packs
Months Post Launch Packs/Month
*As measured post launch for respective products.
Stribild Atripla Triumeq (ViiV)
TRx/Month
TAF Portfolio Uptake in Italy*
Packs/Month
32
Source: Based on data derived from IMS/GERS. *As measured post launch for respective products.
Months Post Launch
HCV
$2,040 $2,022 $1,688 $1,909 $1,410
$604 $628 $487 $591 $397 $681 $579 $401 $368 $390
Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
U.S. Europe Other Int'l
Total HCV Product Sales by Geography
34
Q3 2017 down 34% from Q3 2016
$2,197 $3,325 $3,229 $2,576
Key Metrics
U.S.:
- Sequential decrease driven primarily by
declining patient starts and the impact
- f increased competition.
Europe:
- Sequential decline was primarily due
to the recognition of deferred revenue in the second quarter related to an HCV contract as well as lower total HCV patient starts.
$2,868 $ in millions
$1,860 $1,640 $1,371 $1,382 $973
$640 $1,048 $892 $1,171 $882 $825 $541 $313 $315 $219
$123
Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
Harvoni Epclusa Sovaldi Vosevi
Total HCV Product Sales by Product
35
Q3 2017 down 34% from Q3 2016
$2,197 $3,325 $3,229 $2,576 $2,868 $ in millions
36
HCV Patient Initiations on Sofosbuvir-Based Regimens
(in thousands)
Note: Graph illustrates the estimated number of patients that started therapy with a Gilead HCV drug for each quarter. Patient numbers are subject to adjustments. Sovaldi was approved in the U.S. in December 2013 and in the EU in January 2014. Harvoni was approved in the U.S. in October 2014 and in the EU in November
- 2014. Epclusa was approved in the U.S. in June 2016 and in the EU in July 2016. In Japan, Sovaldi launched in May 2015 and Harvoni launched in September 2015.
Vosevi was approved in the U.S. and in the EU in July 2017.
88 80 75 73 65
37
U.S.
♦ Approved by the FDA on July 18, 2017 ♦ For the re-treatment of HCV infection in adults with genotype 1, 2, 3, 4, 5 or 6 previously treated with an NS5A inhibitor-containing regimen, or with genotype 1a or 3 previously treated with a sofosbuvir-containing regimen without an NS5A inhibitor ♦ $117 million in Q3 2017
Vosevi: The First Once-daily Single-Tablet HCV Regimen Approved as Salvage Therapy for Certain Patients
Europe
♦ Approved by the European Commission on July 28, 2017 ♦ For the treatment of HCV infection in patients with and without compensated cirrhosis, with all genotypes (GT1-6) of HCV infection regardless of prior therapy, including 8 weeks of treatment for HCV direct-acting antiviral (DAA)-naïve patients without cirrhosis, as well as 12 weeks of treatment for patients who have previously failed therapy with a DAA-containing regimen
Appendix Slides
HIV B/F/TAF Q1 18 Q3 18
Approval in the U.S. (PDUFA February 12, 2018) Approval in the EU
GS-9620 Q4 17
Complete 6mg cohort Phase 1 study in HIV cure
Descovy Q3 18
Complete Phase 3 study in PrEP 39
Pipeline Milestones Anticipated in 2017 – 2018
NASH, PBC, PSC, and AH Selonsertib (GS-4997) Q2 18 Q2 18 Q3 18
Complete enrollment of STELLAR 4 Phase 3 study of NASH Complete Phase 2 study in AH Complete enrollment of STELLAR 3 Phase 3 study of NASH
GS-9674 (FXR agonist) Q4 17 Q1 18 Q1 18
Interim analysis from Phase 2 study in PBC Primary endpoint analysis from Phase 2 in PSC Complete Phase 2 study in NASH
GS-0976 (ACC inhibitor) Q3 17
Complete Phase 2 study in NASH
HCV Vosevi Q3 17 Q3 17
Approved in the U.S. Approved in the EU
40
Hematology/Oncology Axicabtagene ciloleucel Q4 17 Q4 17 1H 18
Approval in the U.S. for aggressive NHL (PDUFA November 29) 1-year follow up data from ZUMA-1 Approval in the EU for aggressive NHL
Entospletinib Q3 17 Q3 17
Initiate Phase 2 study with R-CHOP in DLBCL Complete expansion of cohort with newly diagnosed AML patients
fit for chemotherapy Andecaliximab (GS-5745) Q3 17 Q1 18 Q1 18
Interim analysis (futility) from Phase 3 study for gastric cancer Complete Phase 2 study with nivolumab for gastric cancer Interim analysis (efficacy) from Phase 3 study for gastric cancer
Tirabrutinib (GS-4059) 2H 18
Achieve 24-week endpoint in Phase 2 combination studies in R/R
CLL
Pipeline Milestones Anticipated in 2017 – 2018
(Continued)
41
Pipeline Milestones Anticipated in 2017 – 2018
(Continued)
Inflammation/Respiratory Filgotinib 1H 18 Q2 18 Q2 18
Interim analysis from Phase 3 study in UC Complete Phase 2 study in ankylosing spondylitis Complete Phase 2 study in psoriatic arthritis
Presatovir (GS-5806) Q2 18
Complete Phase 2 study in adults with infection in upper
respiratory tract Entospletinib Q1 18
Interim analysis from Phase 2 study in cGVHD
GS-9876 Q4 17 2H 18
Complete Phase 2 study in RA Complete Phase 2 study in Sjogren’s syndrome and cutaneous
lupus erythematosus
Other
GS-5734 2H 18
Complete Phase 2 study in ebola survivors
Pipeline Product Candidates
Indication/Area HIV B/F/TAF*
HIV U.S. and EU Regulatory Submission
Descovy
PrEP
GS-9620 (TLR-7 agonist)
HIV
GS-9722 (bNAb)
HIV
Liver Diseases GS-9688 (TLR-8 agonist)
HBV NASH Alcoholic Hepatitis NASH PBC PSC
GS-0976 (ACC inhibitor)
NASH
Other GS-5734 (Nuc inhibitior)
Ebola
*Bictegravir is abbreviated B and was formerly called GS-9883. **Formerly called GS-4997.
Phase
- Reg. Sub.
Selonsertib** (ASK-1 inhibitor) GS-9674 (FXR agonist) 1 2 3
42
Pipeline Product Candidates (continued)
43
Trial Indication/Area
Hematology/Oncology
ZUMA-1 DLBCL, PMBCL & TFL EU Regulatory Submission ZUMA-5 Indolent NHL ZUMA-6 DLBCL (PD-L1 mAb) ZUMA-2 MCL ZUMA-3 Adult ALL ZUMA-4 Pediatric ALL
KITE-585 (anti-BCMA)
MM
KITE-718 (MAGE A3/A6)
Solid Tumor
Idelalisib (PI3K delta inhibitor)
R/R CLL Gastric Cancer Solid Tumors Heme Malignancies AML
Tirabrutinib** (BTK inhibitor)
B-cell Malignancies
GS-5829 (BET inhibitor)
Solid Tumors
KTE-C19 Andecaliximab* (MMP9 mAb inhibitor) Entospletinib (Syk inhibitor) 3 Phase 1 2 Axicabtagene ciloleucel
*Formerly called GS-5745. **Formerly called GS-4059. Note: ZUMA-7, ZUMA-8, Humanized anti-CD19 Control CAR (3rd Gen), KITE-796, KITE-439 are at the pre-IND stage and are not displayed.
Pipeline Product Candidates (continued)
44
Indication/Area Inflammation/Respiratory
Rheumatoid Arthritis Crohn's Disease Ulcerative Colitis Inflammatory Diseases
Presatovir* (fusion inhibitor)
RSV
Entospletinib (Syk inhibitor)
cGVHD Sjogren's Syndrome Lupus
GS-9876 (Syk inhibitor) Filgotinib (JAK1 inhibitor) Phase 1 2 3
*Formerly called GS-5806.
87.6% 88.1% 88.3% 87.3% 87.2% Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
Non-GAAP Product Gross Margin
Note: Non-GAAP product gross margin excludes acquisition-related, up-front collaboration, stock-based compensation and other expenses.
45
Key Metrics
- Lower Non-GAAP Product
Gross Margin in Q3 17 compared to Q3 16 primarily due to change in product mix
64.3% 62.3% 62.5% 64.6% 63.6% Q3 16 Q4 16 Q1 17 Q2 17 Q3 17
Non-GAAP Operating Margin
Note: Non-GAAP operating margin excludes acquisition-related, up-front collaboration, stock-based compensation and other expenses.
46
Key Metrics
- Lower Non-GAAP
Operating Margin in Q3 17 compared to Q3 16 primarily driven by lower gross margin from a change in product mix and growth in SG&A expenses
- FX impact to European revenues was favorable $28 million
QoQ
47
Q3 2017 down 15% (-17% excluding FX) from Q3 2016
European Product Sales
Q3 16 Q3 17 YoY Excl FX Epclusa $40 $263 * * Truvada $217 $154 (29%) (30%) Genvoya $46 $146 217% 210% Eviplera $143 $133 (7%) (9%) Harvoni $380 $110 (71%) (72%) Atripla $129 $79 (39%) (39%) Descovy $23 $65 * * Viread $77 $55 (29%) (29%) AmBisome $52 $51 (2%) (1%) Stribild $78 $40 (49%) (49%) Odefsey $10 $37 * * Sovaldi $184 $19 (90%) (90%) Vosevi $0 $5 * * Other $33 $40 21% 15% Total $1,412 $1,197 (15%) (17%)
$1,412 $1,415 $1,266 $1,399 $1,197 Q3 16 Q4 16 Q1 17 Q2 17 Q3 17 $ in millions
* Percentage not meaningful.
98 126 145 113 101 94 87 79 70 59 72 59 32 154 256 231 50 100 150 200 250 300 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016
U.S. HCV Estimated Patient Initiations: 2001-2016
Launch of Pegylated Interferons
Source: Gilead estimates and 3rd party databases.
Launch of Protease Inhibitors Launch
- f Sovaldi
& Harvoni Patient Starts (in ‘000s)
48
Outstanding Adjusted Debt
*Adjusted Debt amount shown at face value. **Represents the last twelve months of adjusted EBITDA. Total interest expense and amortization from all issued debt is expected to be approximately $1,060 million for full year 2017. Please refer to the GAAP to non-GAAP table for a reconciliation of the non-GAAP measures presented above.
49
(in billions)
- Dec. 31,
2016
- Mar. 31,
2017
- Jun. 30,
2017
- Sep. 30,
2017 Adjusted Debt* (Senior Unsecured Notes and Floating Rate Borrowings) $26.56 $26.53 $26.50 $29.47 Total Adjusted Debt to Adjusted EBITDA** ~1.41x ~1.48x ~1.50x ~1.73x
(in billions)
GAAP to Non-GAAP Reconciliation of Outstanding Adjusted Debt and Adjusted EBITDA
1 Adjusted Debt amount shown at face value.
50
- Dec. 31,
- Mar. 31,
- Jun. 30,
- Sep. 30
2016 2017 2017 2017 Senior Unsecured Notes and Floating rate Borrowings, net $26.35 $26.32 $26.30 $29.26 Debt discounts, premiums and issuance costs 0.21 0.21 0.20 0.21 Total Adjusted Debt1 $26.56 $26.53 $26.50 $29.47 Last Twelve Months Ended
- Dec. 31,
- Mar. 31,
- Jun. 30,
- Sep. 30
2016 2017 2017 2017 Net income attributable to Gilead $13.50 $12.63 $12.22 $11.60 Add: Interest expense & Other income (expense), net 0.54 0.54 0.54 0.56 Add: Tax 3.61 3.60 3.73 3.74 Add: Depreciation 0.18 0.19 0.20 0.20 Add: Amortization 0.98 0.99 0.99 0.97 Adjusted EBITDA $18.81 $17.95 $17.68 $17.08 Adjusted Debt to Adjusted EBITDA ratio ~1.41x ~1.48x ~1.50x ~1.73x