Share Article
- Fourth Quarter Product Sales of
- Full Year 2017 Product Sales of
- Full Year 2017 Diluted EPS of
- Full Year 2017 Non-GAAP Diluted EPS of
Full year 2017 total revenues were
Three Months Ended | Twelve Months Ended | |||||||||||
December 31, | December 31, | |||||||||||
(In millions, except per share amounts) | 2017 | 2016 | 2017 | 2016 | ||||||||
Product sales | $ | 5,837 | $ | 7,216 | $ | 25,662 | $ | 29,953 | ||||
Royalty, contract and other revenues | 112 | 104 | 445 | 437 | ||||||||
Total revenues | $ | 5,949 | $ | 7,320 | $ | 26,107 | $ | 30,390 | ||||
Net income (loss) attributable to Gilead | $ | (3,865 | ) | $ | 3,108 | $ | 4,628 | $ | 13,501 | |||
Non-GAAP net income* | $ | 2,343 | $ | 3,585 | $ | 11,654 | $ | 15,713 | ||||
Diluted earnings / (loss) per share** | $ | (2.96 | ) | $ | 2.34 | $ | 3.51 | $ | 9.94 | |||
Non-GAAP diluted earnings per share* | $ | 1.78 | $ | 2.70 | $ | 8.84 | $ | 11.57 |
* | Non-GAAP net income and non-GAAP diluted earnings per share exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses, and the impact of Tax Reform. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 8, 9 and 10. |
** | Shares used in loss per share calculation for the three months ended December 31, 2017 exclude 13 million shares from dilutive equity awards. |
___________________________________
(1) Refer to page 3 for details.
Product Sales
Total product sales for the fourth quarter of 2017 were
Total product sales during 2017 were
Antiviral Product Sales
Antiviral product sales, which include sales of our HIV, chronic
hepatitis B (HBV) and chronic hepatitis C (HCV) products, were
-
HIV and HBV product sales for the fourth quarter of 2017 were
$3.7 billion compared to$3.4 billion for the same period in 2016 and$14.2 billion for the full year 2017 compared to$12.9 billion in 2016. The increases were primarily driven by the continued uptake of our tenofovir alafenamide (TAF)-based products, Genvoya® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir alafenamide 10 mg), Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg) and Odefsey® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir alafenamide 25 mg). -
HCV product sales, which consist of Harvoni® (ledipasvir 90
mg/sofosbuvir 400 mg), Sovaldi® (sofosbuvir 400 mg), Epclusa®
(sofosbuvir 400 mg/velpatasvir 100 mg) and Vosevi®
(sofosbuvir 400 mg/velpatasvir 100 mg/voxilaprevir 100 mg), were
$1.5 billion for the fourth quarter of 2017 compared to$3.2 billion for the same period in 2016 and$9.1 billion for the full year 2017 compared to$14.8 billion in 2016. The declines were across all major markets.
Other Product Sales
Other product sales, which include Letairis® (ambrisentan),
Ranexa® (ranolazine) and AmBisome® (amphotericin B
for liposome injection), were
Operating Expenses
Three Months Ended | Twelve Months Ended | |||||||||||
December 31, | December 31, | |||||||||||
(In millions) | 2017 | 2016 | 2017 | 2016 | ||||||||
Research and development (R&D) expenses | $ | 1,150 | $ | 1,208 | $ | 3,734 | $ | 5,098 | ||||
Non-GAAP R&D expenses* | $ | 845 | $ | 959 | $ | 3,291 | $ | 3,749 | ||||
Selling, general and administrative (SG&A) expenses | $ | 1,252 | $ | 992 | $ | 3,878 | $ | 3,398 | ||||
Non-GAAP SG&A expenses* | $ | 923 | $ | 938 | $ | 3,363 | $ | 3,194 |
* | Non-GAAP R&D and SG&A expenses exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 8, 9 and 10. |
During the fourth quarter of 2017, compared to the same period in 2016:
-
R&D expenses decreased primarily due to the 2016 impacts of ongoing
milestone payments and an impairment charge related to in-process R&D
(IPR&D), partially offset by Gilead’s purchase of
Cell Design Labs, Inc. (Cell Design Labs ) in 2017. - Non-GAAP R&D expenses* decreased primarily due to the 2016 impact of ongoing milestone payments.
-
SG&A expenses increased primarily due to acquisition-related costs
associated with Gilead’s acquisition of
Kite Pharma, Inc. (Kite).
For 2017 compared to 2016:
-
R&D expenses decreased primarily due to the 2016 impacts of impairment
charges related to IPR&D, ongoing milestone payments, up-front
collaboration expenses related to Gilead’s license and collaboration
agreement with
Galapagos NV and Gilead’s purchase ofNimbus Apollo, Inc. , partially offset by Gilead’s purchase ofCell Design Labs in 2017. - Non-GAAP R&D expenses* decreased primarily due to the 2016 impact of ongoing milestone payments.
- SG&A expenses increased primarily due to acquisition-related costs associated with Gilead’s acquisition of Kite.
- Non-GAAP SG&A expenses* increased primarily due to higher branded prescription drug fee expense.
Provision for Income Taxes and Tax Reform
Provision for income taxes was
Non-GAAP provision for income taxes excludes the estimated charge of
Cash,
As of
Full Year 2018 Guidance
Gilead provided its full year 2018 guidance:
(In millions, except percentages and per share amounts) | Provided February 6, 2018 |
Net Product Sales | $20,000 - $21,000 |
Non-GAAP* | |
Product Gross Margin | 85% - 87% |
R&D Expenses | $3,400 - $3,600 |
SG&A Expenses | $3,400 - $3,600 |
Effective Tax Rate | 21.0% - 23.0% |
Diluted EPS Impact of Acquisition-related, Up-front Collaboration, Stock-Based Compensation and Other Expenses | $1.41 - $1.51 |
* | Non-GAAP Product Gross Margin, R&D and SG&A expenses and effective tax rate exclude acquisition-related, up-front collaboration, stock-based compensation and other expenses, and changes to our estimates relating to Tax Reform during 2018. A reconciliation between GAAP and non-GAAP full year 2018 guidance is provided in the tables on page 11. |
Corporate Highlights
-
Announced that Executive Chairman
John C. Martin , PhD will transition from his current role of Executive Chairman to Chairman of the Board of Directors effectiveMarch 9, 2018 . -
Announced the acquisition of
Cell Design Labs , gaining new technology platforms that will enhance research and development efforts in cellular therapy. -
Announced the launch of the Gilead COMPASS (COMmitment to Partnership
in Addressing HIV/AIDS in Southern States)
Initiative, a 10-year,
$100 million commitment to support organizations working to address the HIV/AIDS epidemic in the SouthernUnited States . -
Announced the promotion of
Alessandro Riva , MD, to Executive Vice President, Oncology Therapeutics, with responsibility for Gilead’s hematology and oncology programs, including cell therapy research and development.
Product & Pipeline Updates announced by Gilead during the Fourth Quarter of 2017 include:
HIV and Liver Diseases Programs
-
Presented data at The Liver Meeting® 2017 which included
the announcement of:
- Results from a Phase 2, randomized, placebo-controlled trial evaluating two doses of GS-0976, an oral, investigational inhibitor of Acetyl-CoA carboxylase, in patients with nonalcoholic steatohepatitis (NASH). The data demonstrate that the higher dose of GS-0976 (20 mg taken orally once daily) when administered for 12 weeks was associated with statistically significant reductions in hepatic steatosis (buildup of fat in the liver) and a noninvasive marker of fibrosis compared to placebo.
- Results from an open-label Phase 2 study evaluating once-daily Harvoni for 12 weeks among HCV genotype 1 patients with severe renal impairment (creatinine clearance ≤ 30 mL/min). 100 percent of patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12), including patients with compensated cirrhosis and those who had failed prior treatment.
- Results from an open-label Phase 2 study evaluating once-daily Epclusa for 12 weeks among 79 liver transplant patients with genotype 1-4 chronic HCV infection. Treatment with Epclusa resulted in an overall SVR12 rate of 96 percent, including patients with cirrhosis and prior treatment failure, and was well tolerated.
- Updated results from two Phase 3 studies demonstrating improved long-term bone and renal safety in HBV-infected patients 48-weeks after switching from Viread® (tenofovir disoproxil fumarate 300mg) to Vemlidy® (tenofovir alafenamide 25mg).
- Announced detailed 48-week results from a Phase 3 study evaluating the efficacy and safety of switching virologically suppressed HIV-1 infected adult patients from a multi-tablet regimen containing a boosted protease inhibitor (bPI) to a fixed-dose combination of bictegravir (50 mg) (BIC), a novel investigational integrase strand transfer inhibitor, and emtricitabine/tenofovir alafenamide (200/25 mg) (FTC/TAF), a dual-NRTI backbone. In the ongoing study, BIC/FTC/TAF was found to be statistically non-inferior to regimens containing bPIs and demonstrated no treatment-emergent resistance at 48 weeks. The data were presented at IDWeek 2017.
-
Announced a new licensing agreement with the
Medicines Patent Pool (MPP), aUnited Nations -backed public health organization, to expand access to BIC upon regulatory approval inthe United States . Through this agreement, MPP can sub-license rights to BIC to generic drug companies inIndia ,China andSouth Africa to manufacture therapies containing BIC for distribution in 116 low- and middle-income countries.
Oncology and Cell Therapy Programs
-
Announced updated results from the ongoing Phase 1/2 ZUMA-3 study of
KTE-C19, a CD19 chimeric antigen receptor T (CAR T) cell therapy,
which is investigational, for the treatment of adult patients with
relapsed or refractory acute lymphoblastic leukemia (ALL). With a
minimum of eight weeks of follow-up, 71 percent of ALL patients
(n=17/24) who received a single infusion of KTE-C19 achieved complete
tumor remission (complete remission (CR) or CR with incomplete
hematological recovery). The ZUMA-3 study results were presented in an
oral session at the Annual Meeting of the
American Society of Hematology . -
Announced long-term follow-up data from the ZUMA-1 study of Yescarta™
(axicabtagene ciloleucel) in patients with refractory large B-cell
lymphoma. With a minimum follow-up of one year after a single infusion
of Yescarta (median follow-up of 15.4 months), 42 percent of patients
continued to respond to therapy, including 40 percent with a complete
remission. Detailed results from this updated analysis were
simultaneously presented at the Annual Meeting of the
American Society of Hematology , and published inThe New England Journal of Medicine . -
Announced that
U.S. Food and Drug Administration has granted regular approval to Yescarta, the first CAR T cell therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma, high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma).
Non-GAAP Financial Information
The information presented in this document has been prepared by Gilead in accordance with U.S. generally accepted accounting principles (GAAP), unless otherwise noted as non-GAAP. Management believes 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 GAAP. Non-GAAP measures may be defined and calculated differently by other companies in the same industry. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 8, 9, 10 and 11.
Conference Call
At
A replay of the webcast will be archived on the company’s website for
one year, and a phone replay will be available approximately two hours
following the call through
About Gilead
Forward-looking Statements
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 2018 financial results; Gilead’s ability to
sustain growth in revenues for its antiviral and other programs; the
risk that private and public payers may be reluctant to provide, or
continue to provide, coverage or reimbursement for new products,
including Vosevi, Yescarta, Epclusa, Harvoni, Genvoya, Odefsey, Descovy
and Vemlidy; austerity measures in European countries that may increase
the amount of discount required on Gilead’s products; 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
and geographic regions and decreases in treatment duration; availability
of funding for state AIDS Drug Assistance Programs (ADAPs); continued
fluctuations in ADAP 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
All forward-looking statements are based on information currently available to Gilead, and Gilead assumes no obligation to update any such forward-looking statements.
Gilead owns or has rights to various trademarks, copyrights and trade
names used in our business, including the following: GILEAD®,
ATRIPLA® is a registered trademark of
For more information on
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) (in millions, except per share amounts) | ||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Revenues: | ||||||||||||||||
Product sales | $ | 5,837 | $ | 7,216 | $ | 25,662 | $ | 29,953 | ||||||||
Royalty, contract and other revenues | 112 | 104 | 445 | 437 | ||||||||||||
Total revenues | 5,949 | 7,320 | 26,107 | 30,390 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of goods sold | 1,256 | 1,075 | 4,371 | 4,261 | ||||||||||||
Research and development expenses | 1,150 | 1,208 | 3,734 | 5,098 | ||||||||||||
Selling, general and administrative expenses | 1,252 | 992 | 3,878 | 3,398 | ||||||||||||
Total costs and expenses | 3,658 | 3,275 | 11,983 | 12,757 | ||||||||||||
Income from operations | 2,291 | 4,045 | 14,124 | 17,633 | ||||||||||||
Interest expense | (297 | ) | (265 | ) | (1,118 | ) | (964 | ) | ||||||||
Other income (expense), net | 132 | 140 | 523 | 428 | ||||||||||||
Income before provision for income taxes | 2,126 | 3,920 | 13,529 | 17,097 | ||||||||||||
Provision for income taxes | 5,962 | 821 | 8,885 | 3,609 | ||||||||||||
Net income (loss) | (3,836 | ) | 3,099 | 4,644 | 13,488 | |||||||||||
Net income (loss) attributable to noncontrolling interest | 29 | (9 | ) | 16 | (13 | ) | ||||||||||
Net income (loss) attributable to Gilead | $ | (3,865 | ) | $ | 3,108 | $ | 4,628 | $ | 13,501 | |||||||
Net income (loss) per share attributable to Gilead common stockholders - basic | $ | (2.96 | ) | $ | 2.36 | $ | 3.54 | $ | 10.08 | |||||||
Shares used in per share calculation - basic | 1,307 | 1,316 | 1,307 | 1,339 | ||||||||||||
Net income (loss) per share attributable to Gilead common stockholders - diluted | $ | (2.96 | ) | $ | 2.34 | $ | 3.51 | $ | 9.94 | |||||||
Shares used in per share calculation - diluted | 1,307 | 1,327 | 1,319 | 1,358 | ||||||||||||
Cash dividends declared per share | $ | 0.52 | $ | 0.47 | $ | 2.08 | $ | 1.84 |
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) (in millions, except percentages and per share amounts) | ||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Cost of goods sold reconciliation: | ||||||||||||||||
GAAP cost of goods sold | $ | 1,256 | $ | 1,075 | $ | 4,371 | $ | 4,261 | ||||||||
Acquisition-related – amortization of purchased intangibles | (283 | ) | (214 | ) | (912 | ) | (844 | ) | ||||||||
Stock-based compensation expenses(1) | (12 | ) | (3 | ) | (24 | ) | (14 | ) | ||||||||
Other(2) | 5 | 2 | (13 | ) | 11 | |||||||||||
Non-GAAP cost of goods sold | $ | 966 | $ | 860 | $ | 3,422 | $ | 3,414 | ||||||||
Product gross margin reconciliation: | ||||||||||||||||
GAAP product gross margin | 78.5 | % | 85.1 | % | 83.0 | % | 85.8 | % | ||||||||
Acquisition-related – amortization of purchased intangibles | 4.8 | % | 3.0 | % | 3.6 | % | 2.8 | % | ||||||||
Stock-based compensation expenses(1) | 0.2 | % | — | % | 0.1 | % | — | % | ||||||||
Other(2) | (0.1 | )% | — | % | 0.1 | % | — | % | ||||||||
Non-GAAP product gross margin(6) | 83.5 | % | 88.1 | % | 86.7 | % | 88.6 | % | ||||||||
Research and development expenses reconciliation: | ||||||||||||||||
GAAP research and development expenses | $ | 1,150 | $ | 1,208 | $ | 3,734 | $ | 5,098 | ||||||||
Up-front collaboration expenses | — | — | — | (373 | ) | |||||||||||
Acquisition-related expenses – acquired IPR&D | (222 | ) | — | (222 | ) | (400 | ) | |||||||||
Acquisition-related – IPR&D impairment | — | (201 | ) | — | (432 | ) | ||||||||||
Acquisition-related – other costs | (8 | ) | — | (8 | ) | — | ||||||||||
Stock-based compensation expenses(1) | (90 | ) | (47 | ) | (232 | ) | (176 | ) | ||||||||
Other(2) | 15 | (1 | ) | 19 | 32 | |||||||||||
Non-GAAP research and development expenses | $ | 845 | $ | 959 | $ | 3,291 | $ | 3,749 | ||||||||
Selling, general and administrative expenses reconciliation: | ||||||||||||||||
GAAP selling, general and administrative expenses | $ | 1,252 | $ | 992 | $ | 3,878 | $ | 3,398 | ||||||||
Acquisition-related – transaction costs | (36 | ) | — | (48 | ) | — | ||||||||||
Acquisition-related – other costs | (46 | ) | — | (46 | ) | — | ||||||||||
Stock-based compensation expenses(1) | (243 | ) | (52 | ) | (393 | ) | (190 | ) | ||||||||
Other(2) | (4 | ) | (2 | ) | (28 | ) | (14 | ) | ||||||||
Non-GAAP selling, general and administrative expenses | $ | 923 | $ | 938 | $ | 3,363 | $ | 3,194 | ||||||||
Operating margin reconciliation: | ||||||||||||||||
GAAP operating margin | 38.5 | % | 55.3 | % | 54.1 | % | 58.0 | % | ||||||||
Up-front collaboration expenses | — | % | — | % | — | % | 1.2 | % | ||||||||
Acquisition-related – amortization of purchased intangibles | 4.8 | % | 2.9 | % | 3.5 | % | 2.8 | % | ||||||||
Acquisition-related expenses – acquired IPR&D | 3.7 | % | — | % | 0.9 | % | 1.3 | % | ||||||||
Acquisition-related – IPR&D impairment | — | % | 2.7 | % | — | % | 1.4 | % | ||||||||
Acquisition-related – transaction costs | 0.6 | % | — | % | 0.2 | % | — | % | ||||||||
Acquisition-related – other costs | 0.9 | % | — | % | 0.2 | % | — | % | ||||||||
Stock-based compensation expenses(1) | 5.8 | % | 1.4 | % | 2.5 | % | 1.3 | % | ||||||||
Other(2) | (0.3 | )% | — | % | 0.1 | % | (0.1 | )% | ||||||||
Non-GAAP operating margin(6) | 54.0 | % | 62.3 | % | 61.4 | % | 65.9 | % |
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) (in millions, except percentages and per share amounts) | ||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Interest expense reconciliation: | ||||||||||||||||
GAAP interest expense | $ | (297 | ) | $ | (265 | ) | $ | (1,118 | ) | $ | (964 | ) | ||||
Acquisition-related – transaction costs | — | — | 18 | — | ||||||||||||
Non-GAAP interest expense | $ | (297 | ) | $ | (265 | ) | $ | (1,100 | ) | $ | (964 | ) | ||||
Effective tax rate reconciliation: | ||||||||||||||||
GAAP effective tax rate | 280.5 | % | 20.9 | % | 65.7 | % | 21.1 | % | ||||||||
Up-front collaboration expenses | — | % | — | % | — | % | (0.4 | )% | ||||||||
Acquisition-related – amortization of purchased intangibles | (1.1 | )% | (1.5 | )% | (1.2 | )% | (0.8 | )% | ||||||||
Acquisition-related expenses – acquired IPR&D | (2.1 | )% | — | % | (0.4 | )% | (0.4 | )% | ||||||||
Acquisition-related – transaction costs | 0.2 | % | — | % | — | % | — | % | ||||||||
Acquisition-related – other costs | 0.3 | % | — | % | — | % | — | % | ||||||||
Stock-based compensation expenses(1)(3) | 2.6 | % | — | % | 0.8 | % | — | % | ||||||||
Tax Reform impact(5) | (258.3 | )% | — | % | (40.6 | )% | — | % | ||||||||
Other(2) | 0.2 | % | — | % | — | % | — | % | ||||||||
Non-GAAP effective tax rate(6) | 22.2 | % | 19.4 | % | 24.5 | % | 19.5 | % | ||||||||
Net income (loss) attributable to Gilead reconciliation: | ||||||||||||||||
GAAP net income (loss) attributable to Gilead | $ | (3,865 | ) | $ | 3,108 | $ | 4,628 | $ | 13,501 | |||||||
Up-front collaboration expenses | — | — | — | 373 | ||||||||||||
Acquisition-related – amortization of purchased intangibles | 246 | 206 | 851 | 818 | ||||||||||||
Acquisition-related expenses – acquired IPR&D | 222 | — | 222 | 400 | ||||||||||||
Acquisition-related – IPR&D impairment | — | 198 | — | 371 | ||||||||||||
Acquisition-related – transaction costs | 24 | — | 48 | — | ||||||||||||
Acquisition-related – other costs | 36 | — | 36 | — | ||||||||||||
Stock-based compensation expenses(1)(3) | 208 | 73 | 369 | 276 | ||||||||||||
Tax Reform impact(5) | 5,490 | — | 5,490 | — | ||||||||||||
Other(2) | (18 | ) | — | 10 | (26 | ) | ||||||||||
Non-GAAP net income attributable to Gilead | $ | 2,343 | $ | 3,585 | $ | 11,654 | $ | 15,713 | ||||||||
Diluted earnings / (loss) per share reconciliation: | ||||||||||||||||
GAAP diluted earnings / (loss) per share(4) | $ | (2.96 | ) | $ | 2.34 | $ | 3.51 | $ | 9.94 | |||||||
Up-front collaboration expenses | — | — | — | 0.27 | ||||||||||||
Acquisition-related – amortization of purchased intangibles | 0.19 | 0.16 | 0.65 | 0.60 | ||||||||||||
Acquisition-related expenses – acquired IPR&D | 0.17 | — | 0.17 | 0.29 | ||||||||||||
Acquisition-related – IPR&D impairment | — | 0.15 | — | 0.27 | ||||||||||||
Acquisition-related – transaction costs | 0.02 | — | 0.04 | — | ||||||||||||
Acquisition-related – other costs | 0.03 | — | 0.03 | — | ||||||||||||
Stock-based compensation expenses(1)(3) | 0.16 | 0.06 | 0.28 | 0.20 | ||||||||||||
Tax Reform impact(5) | 4.16 | — | 4.16 | — | ||||||||||||
Other(2) | (0.01 | ) | — | 0.01 | (0.02 | ) | ||||||||||
Non-GAAP diluted earnings per share(6) | $ | 1.78 | $ | 2.70 | $ | 8.84 | $ | 11.57 |
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) (in millions, except percentages and per share amounts) | ||||||||||||||||
Three Months Ended | Twelve Months Ended | |||||||||||||||
December 31, | December 31, | |||||||||||||||
2017 | 2016 | 2017 | 2016 | |||||||||||||
Non-GAAP adjustment summary: | ||||||||||||||||
Cost of goods sold adjustments | $ | 290 | $ | 215 | $ | 949 | $ | 847 | ||||||||
Research and development expenses adjustments | 305 | 249 | 443 | 1,349 | ||||||||||||
Selling, general and administrative expenses adjustments | 329 | 54 | 515 | 204 | ||||||||||||
Interest expense adjustments | — | — | 18 | — | ||||||||||||
Total non-GAAP adjustments before tax | 924 | 518 | 1,925 | 2,400 | ||||||||||||
Income tax effect(3) | (206 | ) | (40 | ) | (389 | ) | (191 | ) | ||||||||
Tax Reform impact(5) | 5,490 | — | 5,490 | — | ||||||||||||
Other(2) | — | (1 | ) | — | 3 | |||||||||||
Total non-GAAP adjustments after tax | $ | 6,208 | $ | 477 | $ | 7,026 | $ | 2,212 |
Notes: | ||
(1) | Stock-based compensation expenses for the three and twelve months ended December 31, 2017 include $238 million associated with Gilead’s acquisition of Kite | |
(2) | Amounts related to restructuring, contingent consideration, consolidation of a contract manufacturer and/or other individually insignificant amounts | |
(3) | Income tax effect related to stock-based compensation expenses for the three and twelve months ended December 31, 2017 includes the incremental tax benefit of $31 million and $91 million, respectively, recognized from the adoption of Accounting Standards Update 2016-09 “Improvements to Employee Share-Based Payment Accounting” | |
(4) | Shares used in loss per share calculation for the three months ended December 31, 2017 exclude 13 million shares from dilutive equity awards | |
(5) | Amounts for the three and twelve months ended December 31, 2017 include an estimated charge of $5.8 billion relating to the deemed repatriation of unremitted earnings of foreign subsidiaries and an estimated benefit of $308 million relating to the re-measurement of deferred taxes | |
(6) | Amounts may not sum due to rounding |
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2018 FULL YEAR GUIDANCE (unaudited) (in millions, except percentages and per share amounts) | ||
ProvidedFebruary 6, 2018 | ||
Projected product gross margin GAAP to non-GAAP reconciliation: | ||
GAAP projected product gross margin | 78% - 80% | |
Acquisition-related expenses | 7% - 7% | |
Non-GAAP projected product gross margin(1) | 85% - 87% | |
Projected research and development expenses GAAP to non-GAAP reconciliation: | ||
GAAP projected research and development expenses | $3,785 - $4,050 | |
Stock-based compensation expenses(2) | (315) - (350) | |
Acquisition-related expenses / up-front collaboration expenses | (70) - (100) | |
Non-GAAP projected research and development expenses | $3,400 - $3,600 | |
Projected selling, general and administrative expenses GAAP to non-GAAP reconciliation: | ||
GAAP projected selling, general and administrative expenses | $3,865 - $4,110 | |
Stock-based compensation expenses(2) | (425) - (450) | |
Acquisition-related – other costs | (40) - (60) | |
Non-GAAP projected selling, general and administrative expenses | $3,400 - $3,600 | |
Projected diluted EPS impact of acquisition-related, up-front collaboration, stock-based compensation and other expenses(3): | ||
Acquisition-related expenses / up-front collaboration expenses | $0.91 - $0.95 | |
Stock-based compensation expenses(2) | 0.50 - 0.56 | |
Projected diluted EPS impact of acquisition-related, up-front collaboration, stock-based compensation and other expenses(3) | $1.41 - $1.51 | |
Notes: | ||
(1) Stock-based compensation expenses have a less than one percent impact on non-GAAP projected product gross margin | ||
(2) Includes stock-based compensation expenses associated with Gilead’s acquisition of Kite | ||
(3) Excludes changes to our estimates relating to Tax Reform during 2018. As a result, we are unable to project an effective tax rate on a GAAP basis |
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in millions) | |||||||
December 31, | December 31, | ||||||
2017 | 2016 (1) | ||||||
Cash, cash equivalents and marketable securities | $ | 36,694 | $ | 32,380 | |||
Accounts receivable, net | 3,851 | 4,514 | |||||
Inventories | 801 | 1,587 | |||||
Property, plant and equipment, net | 3,295 | 2,865 | |||||
Intangible assets, net | 17,100 | 8,971 | |||||
Goodwill | 4,159 | 1,172 | |||||
Other assets | 4,383 | 5,488 | |||||
Total assets | $ | 70,283 | $ | 56,977 | |||
Current liabilities | $ | 11,635 | $ | 9,218 | |||
Long-term liabilities | 38,147 | 28,396 | |||||
Stockholders’ equity(2) | 20,501 | 19,363 | |||||
Total liabilities and stockholders’ equity | $ | 70,283 | $ | 56,977 |
Notes: | ||
(1) | Derived from the audited consolidated financial statements as of December 31, 2016. Certain amounts have been reclassified to conform to current year presentation | |
(2) | As of December 31, 2017, there were 1,308 million shares of common stock issued and outstanding |
GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) (in millions) | |||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Antiviral products: | |||||||||||||||
Genvoya – U.S. | $ | 844 | $ | 485 | $ | 3,033 | $ | 1,301 | |||||||
Genvoya – Europe | 176 | 68 | 534 | 160 | |||||||||||
Genvoya – Other International | 40 | 10 | 107 | 23 | |||||||||||
1,060 | 563 | 3,674 | 1,484 | ||||||||||||
Truvada – U.S. | 631 | 604 | 2,266 | 2,384 | |||||||||||
Truvada – Europe | 117 | 200 | 644 | 913 | |||||||||||
Truvada – Other International | 49 | 64 | 224 | 269 | |||||||||||
797 | 868 | 3,134 | 3,566 | ||||||||||||
Harvoni – U.S. | 425 | 976 | 3,053 | 4,941 | |||||||||||
Harvoni – Europe | 121 | 363 | 704 | 1,810 | |||||||||||
Harvoni – Other International | 98 | 301 | 613 | 2,330 | |||||||||||
644 | 1,640 | 4,370 | 9,081 | ||||||||||||
Epclusa – U.S. | 262 | 934 | 2,404 | 1,591 | |||||||||||
Epclusa – Europe | 220 | 101 | 869 | 141 | |||||||||||
Epclusa – Other International | 83 | 13 | 237 | 20 | |||||||||||
565 | 1,048 | 3,510 | 1,752 | ||||||||||||
Atripla – U.S. | 314 | 444 | 1,288 | 1,898 | |||||||||||
Atripla – Europe | 76 | 108 | 335 | 520 | |||||||||||
Atripla – Other International | 50 | 55 | 183 | 187 | |||||||||||
440 | 607 | 1,806 | 2,605 | ||||||||||||
Descovy – U.S. | 276 | 112 | 958 | 226 | |||||||||||
Descovy – Europe | 77 | 34 | 226 | 69 | |||||||||||
Descovy – Other International | 12 | 3 | 34 | 3 | |||||||||||
365 | 149 | 1,218 | 298 | ||||||||||||
Odefsey – U.S. | 276 | 138 | 964 | 302 | |||||||||||
Odefsey – Europe | 45 | 17 | 132 | 27 | |||||||||||
Odefsey – Other International | 4 | — | 10 | — | |||||||||||
325 | 155 | 1,106 | 329 | ||||||||||||
Stribild – U.S. | 179 | 296 | 811 | 1,523 | |||||||||||
Stribild – Europe | 34 | 71 | 195 | 314 | |||||||||||
Stribild – Other International | 9 | 20 | 47 | 77 | |||||||||||
222 | 387 | 1,053 | 1,914 | ||||||||||||
Complera / Eviplera – U.S. | 91 | 146 | 406 | 821 | |||||||||||
Complera / Eviplera – Europe | 118 | 135 | 503 | 580 | |||||||||||
Complera / Eviplera – Other International | 13 | 16 | 57 | 56 | |||||||||||
222 | 297 | 966 | 1,457 | ||||||||||||
Viread – U.S. | 119 | 171 | 514 | 591 | |||||||||||
Viread – Europe | 36 | 68 | 238 | 302 | |||||||||||
Viread – Other International | 57 | 85 | 294 | 293 | |||||||||||
212 | 324 | 1,046 | 1,186 | ||||||||||||
Vosevi – U.S. | 150 | — | 267 | — | |||||||||||
Vosevi – Europe | 17 | — | 22 | — | |||||||||||
Vosevi – Other International | 3 | — | 4 | — | |||||||||||
170 | — | 293 | — |
GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) (in millions) | |||||||||||||||
Three Months Ended | Twelve Months Ended | ||||||||||||||
December 31, | December 31, | ||||||||||||||
2017 | 2016 | 2017 | 2016 | ||||||||||||
Sovaldi – U.S. | $ | 10 | $ | 112 | $ | 130 | $ | 1,895 | |||||||
Sovaldi – Europe | 20 | 164 | 258 | 891 | |||||||||||
Sovaldi – Other International | 87 | 265 | 576 | 1,215 | |||||||||||
117 | 541 | 964 | 4,001 | ||||||||||||
Other Antiviral – U.S. | 56 | 12 | 157 | 48 | |||||||||||
Other Antiviral – Europe | 7 | 4 | 24 | 22 | |||||||||||
Other Antiviral – Other International | 11 | — | 15 | 2 | |||||||||||
74 | 16 | 196 | 72 | ||||||||||||
Total antiviral products – U.S. | 3,633 | 4,430 | 16,251 | 17,521 | |||||||||||
Total antiviral products – Europe | 1,064 | 1,333 | 4,684 | 5,749 | |||||||||||
Total antiviral products – Other International | 516 | 832 | 2,401 | 4,475 | |||||||||||
5,213 | 6,595 | 23,336 | 27,745 | ||||||||||||
Other products: | |||||||||||||||
Letairis | 233 | 226 | 887 | 819 | |||||||||||
Ranexa | 200 | 210 | 717 | 677 | |||||||||||
AmBisome | 90 | 94 | 366 | 356 | |||||||||||
Zydelig | 39 | 39 | 149 | 168 | |||||||||||
Other | 62 | 52 | 207 | 188 | |||||||||||
624 | 621 | 2,326 | 2,208 | ||||||||||||
Total product sales | $ | 5,837 | $ | 7,216 | $ | 25,662 | $ | 29,953 |
View source version on businesswire.com: http://www.businesswire.com/news/home/20180206006337/en/
Source:
Gilead Sciences, Inc.InvestorsRobin Washington, 650-522-5688Sung Lee, 650-524-7792MediaAmy Flood, 650-522-5643
Other News
Some of the content on this page is not intended for users outside the U.S.