FOSTER CITY, Calif.--(BUSINESS WIRE)--Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the third quarter ended September 30, 2016. The financial results that follow represent a year-over-year comparison of third quarter 2016 to the third quarter 2015. Total revenues were $7.5 billion in 2016 compared to $8.3 billion in 2015. Net income was $3.3 billion or $2.49 per diluted share in 2016 compared to $4.6 billion or $3.06 per diluted share in 2015. Non-GAAP net income, which excludes amounts related to acquisition-related, up-front collaboration, stock-based compensation and other expenses, was $3.7 billion or $2.75 per diluted share in 2016 compared to $4.8 billion or $3.22 per diluted share in 2015.
| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| (In millions, except per share amounts) | 2016 | 2015 | 2016 | 2015 | |||||||||||
| Product sales | $ | 7,405 | $ | 8,211 | $ | 22,737 | $ | 23,742 | |||||||
| Royalty, contract and other revenues | 95 | 84 | 333 | 391 | |||||||||||
| Total revenues | $ | 7,500 | $ | 8,295 | $ | 23,070 | $ | 24,133 | |||||||
| Net income attributable to Gilead | $ | 3,330 | $ | 4,600 | $ | 10,393 | $ | 13,425 | |||||||
| Non-GAAP net income* | $ | 3,677 | $ | 4,836 | $ | 12,128 | $ | 14,285 | |||||||
| Diluted earnings per share | $ | 2.49 | $ | 3.06 | $ | 7.59 | $ | 8.73 | |||||||
| Non-GAAP diluted earnings per share* | $ | 2.75 | $ | 3.22 | $ | 8.87 | $ | 9.29 | |||||||
* Non-GAAP net income and non-GAAP diluted earnings per share 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 7 and 8.
Product Sales
Total product sales for the third quarter of 2016 were $7.4 billion compared to $8.2 billion for the same period in 2015. Product sales for the third quarter of 2016 were $5.1 billion in the United States, $1.4 billion in Europe, $452 million in Japan and $479 million in other locations. Product sales for the third quarter of 2015 were $5.6 billion in the United States, $1.7 billion in Europe, $454 million in Japan and $504 million in other locations.
Antiviral Product Sales
Antiviral product sales, which include primarily products in Gilead’s HIV and liver disease areas, were $6.8 billion for the third quarter of 2016 compared to $7.7 billion for the same period in 2015.
- HIV and other antiviral product sales were $3.5 billion compared to $2.9 billion for the same period in 2015. The increase was primarily due to 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) and Epclusa® (sofosbuvir 400 mg/velpatasvir 100 mg), were $3.3 billion compared to $4.8 billion for the same period in 2015. The decline was due to lower sales of Harvoni and Sovaldi, partially offset by sales of Epclusa, which was launched in the United States and Europe in June and July 2016, respectively.
Other Product Sales
Other product sales, which include Letairis® (ambrisentan), Ranexa® (ranolazine) and AmBisome® (amphotericin B liposome for injection), were $564 million for the third quarter of 2016 compared to $509 million for the same period in 2015.
Operating Expenses
| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| (In millions) | 2016 | 2015 | 2016 | 2015 | |||||||||||
| Research and development expenses (R&D) | $ | 1,141 | $ | 743 | $ | 3,890 | $ | 2,257 | |||||||
|
Non-GAAP research and development expenses* |
$ | 981 | $ | 713 | $ | 2,790 | $ | 2,066 | |||||||
| Selling, general and administrative expenses (SG&A) | $ | 831 | $ | 903 | $ | 2,406 | $ | 2,360 | |||||||
| Non-GAAP selling, general and administrative expenses* | $ | 780 | $ | 850 | $ | 2,256 | $ | 2,211 | |||||||
* 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 7 and 8.
During the third quarter of 2016, compared to the same period in 2015:
- Research and development expenses and non-GAAP research and development expenses* increased primarily due to the overall progression of Gilead’s clinical studies, including a $200 million milestone expense associated with Gilead’s purchase of Nimbus Apollo, Inc.
- Selling, general and administrative expenses and non-GAAP selling, general and administrative expenses* decreased primarily due to lower branded prescription drug fee expense.
Cash, Cash Equivalents and Marketable Securities
As of September 30, 2016, Gilead had $31.6 billion of cash, cash equivalents and marketable securities compared to $24.6 billion as of June 30, 2016. This increase was primarily due to the issuance of $5.0 billion aggregate principal amount of senior unsecured notes in September 2016. Cash flow from operating activities was $4.3 billion for the quarter. During the third quarter and the first nine months of 2016, Gilead utilized $1.0 billion and $10.0 billion on stock repurchases, respectively.
Full Year 2016 Guidance Reiterated
Gilead reiterates its full year 2016 guidance, as revised on July 25, 2016:
| (In millions, except percentages and per share amounts) |
Updated July 25, 2016
Reiterated November 1, 2016 |
|
| Net Product Sales | $29,500 - $30,500 | |
| Non-GAAP* | ||
| Product Gross Margin | 88% - 90% | |
| R&D Expenses | $3,600 - $3,800 | |
| SG&A Expenses | $3,100 - $3,300 | |
| Effective Tax Rate | 18.0% - 20.0% | |
| Diluted EPS Impact of Acquisition-related, Up-front Collaboration, Stock-based Compensation and Other Expenses | $1.47 - $1.53 | |
* 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. A reconciliation between GAAP and non-GAAP full year 2016 guidance is provided in the tables on page 9.
Corporate Highlights
- Announced that Kelly A. Kramer was appointed to the company’s Board of Directors and Audit Committee. Ms. Kramer is currently Executive Vice President and Chief Financial Officer of Cisco Systems, Inc.
- Announced that Gilead entered into a partnership with the World Health Organization (WHO) to provide $20 million in funding and drug donations over five years to expand access to diagnostic services and treatment for visceral leishmaniasis (VL). As part of this collaboration, Gilead will donate 380,000 vials of AmBisome to meet the needs of WHO to treat VL in key endemic countries, including Bangladesh, Ethiopia, India, Nepal, South Sudan and Sudan.
Product and Pipeline Updates announced by Gilead during the Third Quarter of 2016 include:
- Announced that the European Commission granted marketing authorization for once-daily Truvada® (emtricitabine 200 mg/tenofovir disoproxil 245 mg) in combination with safer-sex practices to reduce the risk of sexually acquired HIV-1 infection among uninfected adults at high risk, a strategy known as pre-exposure prophylaxis, or PrEP. Truvada was approved by the European Medicines Agency in 2005 for use in combination with other antiretroviral agents for the treatment of HIV-1 infection in adults aged 18 years and over, and is currently the most prescribed antiretroviral medicine in Europe as part of combination therapy.
- Announced that the European Commission granted marketing authorization for Epclusa, the first pan-genotypic, single tablet regimen for the treatment of adults with genotype 1-6 chronic hepatitis C virus (HCV) infection. Epclusa for 12 weeks was authorized for use in patients without cirrhosis or with compensated cirrhosis (Child-Pugh A), and in combination with ribavirin (RBV) for patients with decompensated cirrhosis (Child-Pugh B or C). Epclusa is also the first single tablet regimen approved for the treatment of patients with HCV genotype 2 and 3, without the need for RBV. Physicians also have the flexibility to consider the addition of RBV for genotype 3 infected patients with compensated cirrhosis. The marketing authorization followed an accelerated review procedure by the European Medicines Agency, reserved for medicinal products expected to be of major public health interest.
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 7, 8 and 9.
Conference Call
At 4:30 p.m. Eastern Time today, Gilead’s management will host a conference call and a simultaneous webcast to discuss results from its third quarter 2016 as well as provide a general business update. To access the webcast live via the internet, please connect to the company’s website at www.gilead.com/investors 15 minutes prior to the conference call to ensure adequate time for any software download that may be needed to hear the webcast. Alternatively, please call 1-877-359-9508 (U.S.) or 1-224-357-2393 (international) and dial the conference ID 82848433 to access the call.
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 November 3, 2016. To access the phone replay, please call 1-855-859-2056 (U.S.) or 1-404-537-3406 (international) and dial the conference ID 82848433.
About Gilead
Gilead Sciences is a biopharmaceutical company that discovers, develops and commercializes innovative therapeutics in areas of unmet medical need. The company’s mission is to advance the care of patients suffering from life-threatening diseases. Gilead has operations in more than 30 countries worldwide, with headquarters in Foster City, California.
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 2016 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 Epclusa, Harvoni, Genvoya, Odefsey and Descovy; the potential for increased pricing pressure and contracting pressure as well as decreased volume and market share from additional competitive HCV launches, austerity measures in European countries and Japan that may increase the amount of discount required on Gilead’s products, additional negotiated discounts for patient access, shifts in payer mix to more deeply discounted government 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; the possibility of unfavorable results from clinical trials involving investigational compounds; Gilead’s ability to initiate clinical trials in its currently anticipated timeframes; 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 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; Gilead’s ability to successfully commercialize its products, including Epclusa, Harvoni, Genvoya, Odefsey and Descovy; 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; 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 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. 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. 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, 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.
Gilead owns or has rights to various trademarks, copyrights and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, AMBISOME®, CAYSTON®, COMPLERA®, DESCOVY®, EMTRIVA®, EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPSERA®, LETAIRIS®, ODEFSEY®, RANEXA®, RAPISCAN®, SOVALDI®, STRIBILD®, TRUVADA®, TYBOST®, VIREAD®, VITEKTA®, VOLIBRIS®, and ZYDELIG®.
ATRIPLA® is a registered trademark belonging to Bristol-Myers Squibb & Gilead Sciences, LLC. LEXISCAN® is a registered trademark belonging to Astellas U.S. LLC. MACUGEN® is a registered trademark belonging to Eyetech, Inc. SUSTIVA® is a registered trademark of Bristol-Myers Squibb Pharma Company. TAMIFLU® is a registered trademark belonging to Hoffmann-La Roche Inc.
For more information on Gilead Sciences, Inc., please visit www.gilead.com or call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).
|
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) (in millions, except per share amounts) |
||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales | $ | 7,405 | $ | 8,211 | $ | 22,737 | $ | 23,742 | ||||||||
| Royalty, contract and other revenues | 95 | 84 | 333 | 391 | ||||||||||||
| Total revenues | 7,500 | 8,295 | 23,070 | 24,133 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods sold | 1,129 | 1,064 | 3,186 | 2,944 | ||||||||||||
| Research and development expenses | 1,141 | 743 | 3,890 | 2,257 | ||||||||||||
| Selling, general and administrative expenses | 831 | 903 | 2,406 | 2,360 | ||||||||||||
| Total costs and expenses | 3,101 | 2,710 | 9,482 | 7,561 | ||||||||||||
| Income from operations | 4,399 | 5,585 | 13,588 | 16,572 | ||||||||||||
| Interest expense | (242 | ) | (165 | ) | (699 | ) | (458 | ) | ||||||||
| Other income (expense), net | 119 | 52 | 288 | 108 | ||||||||||||
| Income before provision for income taxes | 4,276 | 5,472 | 13,177 | 16,222 | ||||||||||||
| Provision for income taxes | 951 | 880 | 2,788 | 2,801 | ||||||||||||
| Net income | 3,325 | 4,592 | 10,389 | 13,421 | ||||||||||||
| Net loss attributable to noncontrolling interest | (5 | ) | (8 | ) | (4 | ) | (4 | ) | ||||||||
| Net income attributable to Gilead | $ | 3,330 | $ | 4,600 | $ | 10,393 | $ | 13,425 | ||||||||
| Net income per share attributable to Gilead common stockholders - basic | $ | 2.52 | $ | 3.14 | $ | 7.72 | $ | 9.11 | ||||||||
| Shares used in per share calculation - basic | 1,322 | 1,463 | 1,347 | 1,474 | ||||||||||||
| Net income per share attributable to Gilead common stockholders - diluted | $ | 2.49 | $ | 3.06 | $ | 7.59 | $ | 8.73 | ||||||||
| Shares used in per share calculation - diluted | 1,339 | 1,503 | 1,369 | 1,538 | ||||||||||||
| Cash dividends declared per share | $ | 0.47 | $ | 0.43 | $ | 1.37 | $ | 0.86 | ||||||||
|
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) (in millions, except percentages and per share amounts) |
||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Cost of goods sold reconciliation: | ||||||||||||||||
| GAAP cost of goods sold | $ | 1,129 | $ | 1,064 | $ | 3,186 | $ | 2,944 | ||||||||
| Acquisition related-amortization of purchased intangibles | (210 | ) | (207 |
) |
(630 | ) | (620 | ) | ||||||||
| Stock-based compensation expenses | (4 | ) | (3 | ) | (11 | ) | (9 | ) | ||||||||
| Other(1) | 3 | 2 | 9 | 3 | ||||||||||||
| Non-GAAP cost of goods sold | $ | 918 | $ | 856 | $ | 2,554 | $ | 2,318 | ||||||||
| Product gross margin reconciliation: | ||||||||||||||||
| GAAP product gross margin | 84.8 |
% |
87.0 |
% |
86.0 |
% |
87.6 | % | ||||||||
| Acquisition related-amortization of purchased intangibles | 2.8 |
% |
2.5 |
% |
2.8 |
% |
2.6 | % | ||||||||
| Non-GAAP product gross margin(2) |
87.6 |
% |
89.6 |
% |
88.8 |
% |
90.2 | % | ||||||||
| Research and development expenses reconciliation: | ||||||||||||||||
| GAAP research and development expenses | $ | 1,141 | $ | 743 | $ | 3,890 | $ | 2,257 | ||||||||
| Up-front collaboration expenses | (5 | ) | — | (373 | ) | — | ||||||||||
| Acquisition related expenses-acquired IPR&D | — | — | (400 | ) | (66 | ) | ||||||||||
| Acquisition related-IPR&D impairment | (117 | ) | — | (231 | ) | — | ||||||||||
| Stock-based compensation expenses | (44 | ) | (44 | ) | (129 | ) | (128 | ) | ||||||||
| Other(1) | 6 | 14 | 33 | 3 | ||||||||||||
| Non-GAAP research and development expenses | $ | 981 | $ | 713 | $ | 2,790 | $ | 2,066 | ||||||||
| Selling, general and administrative expenses reconciliation: | ||||||||||||||||
| GAAP selling, general and administrative expenses | $ | 831 | $ | 903 | $ | 2,406 | $ | 2,360 | ||||||||
| Stock-based compensation expenses | (47 | ) | (50 | ) | (138 | ) | (148 | ) | ||||||||
| Other(1) | (4 | ) | (3 | ) | (12 | ) | (1 | ) | ||||||||
| Non-GAAP selling, general and administrative expenses | $ | 780 | $ | 850 | $ | 2,256 | $ | 2,211 | ||||||||
| Operating margin reconciliation: | ||||||||||||||||
| GAAP operating margin | 58.7 |
% |
67.3 |
% |
58.9 |
% |
68.7 | % | ||||||||
| Up-front collaboration expenses | 0.1 |
% |
— |
% |
1.6 |
% |
— | % | ||||||||
| Acquisition related-amortization of purchased intangibles | 2.8 |
% |
2.5 |
% |
2.7 |
% |
2.6 | % | ||||||||
| Acquisition related expenses-acquired IPR&D | — |
% |
— |
% |
1.7 |
% |
0.3 | % | ||||||||
| Acquisition related-IPR&D impairment | 1.6 |
% |
— |
% |
1.0 |
% |
— | % | ||||||||
| Stock-based compensation expenses | 1.3 |
% |
1.2 |
% |
1.2 |
% |
1.2 | % | ||||||||
| Other(1) | (0.1 | )% | (0.2 | )% | (0.1 | )% | — | % | ||||||||
| Non-GAAP operating margin(2) | 64.3 |
% |
70.8 |
% |
67.1 |
% |
72.7 | % | ||||||||
| Notes: | ||||||||||||||||
| (1) Amounts related to consolidation of a contract manufacturer, contingent consideration and/or other individually insignificant amounts | ||||||||||||||||
| (2) Amounts may not sum due to rounding | ||||||||||||||||
|
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued) (unaudited) (in millions, except percentages and per share amounts) |
||||||||||||||||
| Three Months Ended | Nine Months Ended | |||||||||||||||
| September 30, | September 30, | |||||||||||||||
| 2016 | 2015 | 2016 | 2015 | |||||||||||||
| Effective tax rate reconciliation: | ||||||||||||||||
| GAAP effective tax rate | 22.2 |
% |
16.1 |
% |
21.2 |
% |
17.3 |
% |
||||||||
| Up-front collaboration expenses | — |
% |
— |
% |
(0.5 | )% | — |
% |
||||||||
| Acquisition related-amortization of purchased intangibles | (0.4 |
)% |
(0.2 | )% | (0.7 | )% | (0.4 | )% | ||||||||
| Acquisition related expenses-acquired IPR&D | — |
% |
— |
% |
(0.5 | )% | — |
% |
||||||||
| Stock-based compensation expenses | — |
% |
0.4 |
% |
— |
% |
0.1 |
% |
||||||||
| Non-GAAP effective tax rate(1) | 21.8 |
% |
16.3 |
% |
19.5 |
% |
17.0 |
% |
||||||||
| Net income attributable to Gilead reconciliation: | ||||||||||||||||
| GAAP net income attributable to Gilead | $ | 3,330 | $ | 4,600 | $ | 10,393 | $ | 13,425 | ||||||||
| Up-front collaboration expenses | 5 | — | 373 | — | ||||||||||||
| Acquisition related-amortization of purchased intangibles | 204 | 202 | 612 | 605 | ||||||||||||
| Acquisition related expenses-acquired IPR&D | — | — | 400 | 66 | ||||||||||||
| Acquisition related-IPR&D impairment | 74 | — | 173 | — | ||||||||||||
| Stock-based compensation expenses | 70 | 44 | 203 | 184 | ||||||||||||
| Other(2) | (6 | ) | (10 | ) | (26 | ) | 5 | |||||||||
| Non-GAAP net income | $ | 3,677 | $ | 4,836 | $ | 12,128 | $ | 14,285 | ||||||||
| Diluted earnings per share reconciliation: | ||||||||||||||||
| GAAP diluted earnings per share | $ | 2.49 | $ | 3.06 | $ | 7.59 | $ | 8.73 | ||||||||
| Up-front collaboration expenses | — | — | 0.27 | — | ||||||||||||
| Acquisition related-amortization of purchased intangibles | 0.15 | 0.13 | 0.45 | 0.39 | ||||||||||||
| Acquisition related expenses-acquired IPR&D | — | — | 0.29 | 0.04 | ||||||||||||
| Acquisition related-IPR&D impairment | 0.06 | — | 0.13 | — | ||||||||||||
| Stock-based compensation expenses | 0.05 | 0.03 | 0.15 | 0.12 | ||||||||||||
| Other(2) | — | (0.01 | ) | (0.02 | ) | 0.01 | ||||||||||
| Non-GAAP diluted earnings per share(1) | $ | 2.75 | $ | 3.22 | $ | 8.87 | $ | 9.29 | ||||||||
| Shares used in per share calculation (diluted) reconciliation: | ||||||||||||||||
| GAAP shares used in per share calculation (diluted) | 1,339 | 1,503 | 1,369 | 1,538 | ||||||||||||
| Share impact of current stock-based compensation rules | (1 | ) | (1 | ) | (1 | ) | (1 | ) | ||||||||
| Non-GAAP shares used in per share calculation (diluted) | 1,338 | 1,502 | 1,368 | 1,537 | ||||||||||||
| Non-GAAP adjustment summary: | ||||||||||||||||
| Cost of goods sold adjustments | $ | 211 | $ | 208 | $ | 632 | $ | 626 | ||||||||
| Research and development expenses adjustments | 160 | 30 | 1,100 | 191 | ||||||||||||
| Selling, general and administrative expenses adjustments | 51 | 53 | 150 | 149 | ||||||||||||
| Other income (expense) adjustments | — | 1 | — | 1 | ||||||||||||
| Total non-GAAP adjustments before tax | 422 | 292 | 1,882 | 967 | ||||||||||||
| Income tax effect | (74 | ) | (58 | ) | (151 | ) | (116 | ) | ||||||||
| Other(2) | (1 | ) | 2 | 4 | 9 | |||||||||||
| Total non-GAAP adjustments after tax | $ | 347 | $ | 236 | $ | 1,735 | $ | 860 | ||||||||
| Notes: | ||||||||||||||||
| (1) Amounts may not sum due to rounding | ||||||||||||||||
| (2) Amounts related to consolidation of a contract manufacturer, contingent consideration and/or other individually insignificant amounts | ||||||||||||||||
|
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2016 FULL YEAR GUIDANCE (unaudited) (in millions, except percentages and per share amounts) |
||
|
Updated July 25, 2016
Reiterated November 1, 2016 |
||
| Projected product gross margin GAAP to non-GAAP reconciliation: | ||
| GAAP projected product gross margin | 85% - 87% | |
| Acquisition-related expenses | 3% - 3% | |
| Non-GAAP projected product gross margin(1) | 88% - 90% | |
| Projected research and development expenses GAAP to non-GAAP reconciliation: | ||
| GAAP projected research and development expenses | $4,700 - $4,945 | |
| Acquisition-related expenses / up-front collaboration expenses | (915) - (945) | |
| Stock-based compensation expenses | (185) - (200) | |
| Non-GAAP projected research and development expenses | $3,600 - $3,800 | |
| Projected selling, general and administrative expenses GAAP to non-GAAP reconciliation: | ||
| GAAP projected selling, general and administrative expenses | $3,305 - $3,515 | |
| Stock-based compensation expenses | (205) - (215) | |
| Non-GAAP projected selling, general and administrative expenses | $3,100 - $3,300 | |
| Projected diluted EPS impact of acquisition-related, up-front collaboration, stock-based compensation and other expenses: | ||
| Acquisition-related expenses / up-front collaboration expenses | $1.26 - $1.30 | |
| Stock-based compensation expenses | 0.21 - 0.23 | |
| Projected diluted EPS impact of acquisition-related, up-front collaboration, stock-based compensation and other expenses | $1.47 - $1.53 | |
| Note: | ||
| (1) Stock-based compensation expenses have a less than one percent impact on non-GAAP projected product gross margin | ||
|
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in millions) |
|||||||
| September 30, | December 31, | ||||||
| 2016 | 2015(1) | ||||||
| Cash, cash equivalents and marketable securities | $ | 31,611 | $ | 26,208 | |||
| Accounts receivable, net | 5,075 | 5,854 | |||||
| Inventories | 1,900 | 1,955 | |||||
| Property, plant and equipment, net | 2,714 | 2,276 | |||||
| Intangible assets, net | 9,386 | 10,247 | |||||
| Goodwill | 1,172 | 1,172 | |||||
| Other assets | 4,751 | 4,004 | |||||
| Total assets | $ | 56,609 | $ | 51,716 | |||
| Current liabilities | $ | 11,073 | $ | 9,890 | |||
| Long-term liabilities | 28,176 | 22,711 | |||||
| Equity component of currently redeemable convertible notes | — | 2 | |||||
| Stockholders’ equity(2) | 17,360 | 19,113 | |||||
| Total liabilities and stockholders’ equity | $ | 56,609 | $ | 51,716 | |||
| Notes: | |||||||
| (1) Derived from the audited consolidated financial statements as of December 31, 2015. Certain amounts have been reclassified to conform to current year presentation | |||||||
| (2) As of September 30, 2016, there were 1,322 million shares of common stock issued and outstanding | |||||||
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GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) (in millions) |
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| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||
| Antiviral products: | |||||||||||||||
| Harvoni – U.S. | $ | 1,084 | $ | 2,541 | $ | 3,965 | $ | 8,383 | |||||||
| Harvoni – Europe | 380 | 532 | 1,447 | 1,632 | |||||||||||
| Harvoni – Japan | 309 | 111 | 1,644 | 111 | |||||||||||
| Harvoni – Other International | 87 | 148 | 385 | 393 | |||||||||||
| 1,860 | 3,332 | 7,441 | 10,519 | ||||||||||||
| Truvada – U.S. | 573 | 561 | 1,780 | 1,470 | |||||||||||
| Truvada – Europe | 217 | 268 | 713 | 846 | |||||||||||
| Truvada – Other International | 68 | 74 | 205 | 207 | |||||||||||
| 858 | 903 | 2,698 | 2,523 | ||||||||||||
| Sovaldi – U.S. | 363 | 692 | 1,783 | 1,728 | |||||||||||
| Sovaldi – Europe | 184 | 337 | 727 | 1,342 | |||||||||||
| Sovaldi – Japan | 143 | 343 | 516 | 405 | |||||||||||
| Sovaldi – Other International | 135 | 94 | 434 | 254 | |||||||||||
| 825 | 1,466 | 3,460 | 3,729 | ||||||||||||
| Atripla – U.S. | 486 | 597 | 1,454 | 1,640 | |||||||||||
| Atripla – Europe | 129 | 161 | 412 | 533 | |||||||||||
| Atripla – Other International | 35 | 60 | 132 | 161 | |||||||||||
| 650 | 818 | 1,998 | 2,334 | ||||||||||||
| Epclusa – U.S. | 593 | — | 657 | — | |||||||||||
| Epclusa – Europe | 40 | — | 40 | — | |||||||||||
| Epclusa – Other International | 7 | — | 7 | — | |||||||||||
| 640 | — | 704 | — | ||||||||||||
| Stribild – U.S.(1) | 525 | 422 | 1,227 | 1,068 | |||||||||||
| Stribild – Europe | 78 | 73 | 243 | 199 | |||||||||||
| Stribild – Other International | 18 | 16 | 57 | 47 | |||||||||||
| 621 | 511 | 1,527 | 1,314 | ||||||||||||
| Genvoya – U.S. | 407 | — | 816 | — | |||||||||||
| Genvoya – Europe | 46 | — | 92 | — | |||||||||||
| Genvoya – Other International | 8 | — | 13 | — | |||||||||||
| 461 | — | 921 | — | ||||||||||||
| Complera / Eviplera – U.S.(1) | 254 | 210 | 675 | 580 | |||||||||||
| Complera / Eviplera – Europe | 143 | 137 | 445 | 427 | |||||||||||
| Complera / Eviplera – Other International | 14 | 13 | 40 | 40 | |||||||||||
| 411 | 360 | 1,160 | 1,047 | ||||||||||||
| Viread – U.S. | 155 | 151 | 420 | 385 | |||||||||||
| Viread – Europe | 77 | 76 | 234 | 233 | |||||||||||
| Viread – Other International | 71 | 70 | 208 | 184 | |||||||||||
| 303 | 297 | 862 | 802 | ||||||||||||
| Odefsey – U.S. | 95 | — | 164 | — | |||||||||||
| Odefsey – Europe | 10 | — | 10 | — | |||||||||||
| 105 | — | 174 | — | ||||||||||||
| Descovy – U.S. | 65 | — | 114 | — | |||||||||||
| Descovy – Europe | 23 | — | 35 | — | |||||||||||
| 88 | — | 149 | — | ||||||||||||
| Note: |
| (1) Amounts for the three and nine months ended September 30, 2016 include a favorable adjustment of rebate reserves of $223 million and $89 million for Stribild and Complera, respectively |
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GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) (in millions) |
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| Three Months Ended | Nine Months Ended | ||||||||||||||
| September 30, | September 30, | ||||||||||||||
| 2016 | 2015 | 2016 | 2015 | ||||||||||||
| Other Antiviral – U.S. | $ | 14 | $ | 8 | $ | 36 | $ | 30 | |||||||
| Other Antiviral – Europe | 5 | 6 | 18 | 20 | |||||||||||
| Other Antiviral – Other International | — | 1 | 2 | 3 | |||||||||||
| 19 | 15 | 56 | 53 | ||||||||||||
| Total antiviral products – U.S. | 4,614 | 5,182 | 13,091 | 15,284 | |||||||||||
| Total antiviral products – Europe | 1,332 | 1,590 | 4,416 | 5,232 | |||||||||||
| Total antiviral products – Japan | 452 | 454 | 2,160 | 516 | |||||||||||
| Total antiviral products – Other International | 443 | 476 | 1,483 | 1,289 | |||||||||||
| 6,841 | 7,702 | 21,150 | 22,321 | ||||||||||||
| Other products: | |||||||||||||||
| Letairis | 215 | 181 | 593 | 508 | |||||||||||
| Ranexa | 170 | 161 | 467 | 419 | |||||||||||
| AmBisome | 91 | 88 | 262 | 276 | |||||||||||
| Zydelig | 39 | 36 | 129 | 92 | |||||||||||
| Other | 49 | 43 | 136 | 126 | |||||||||||
| 564 | 509 | 1,587 | 1,421 | ||||||||||||
| Total product sales | $ | 7,405 | $ | 8,211 | $ | 22,737 | $ | 23,742 | |||||||
