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- Product Sales of
- GAAP Loss of
- Non-GAAP Diluted EPS of
- Revised Full Year 2019 Guidance -
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
(In millions, except per share amounts) | 2019 | 2018 | 2019 | 2018 | |||||||||
Product sales | $ | 5,516 | $ | 5,455 | $ | 16,323 | $ | 15,996 | |||||
Royalty, contract and other revenues | 88 | 141 | 247 | 336 | |||||||||
Total revenues | $ | 5,604 | $ | 5,596 | $ | 16,570 | $ | 16,332 | |||||
Net income (loss) attributable to Gilead | $ | (1,165 | ) | $ | 2,097 | $ | 2,690 | $ | 5,452 | ||||
Non-GAAP net income | $ | 2,224 | $ | 2,403 | $ | 6,813 | $ | 6,855 | |||||
Diluted earnings (loss) per share | $ | (0.92 | ) | $ | 1.60 | $ | 2.10 | $ | 4.15 | ||||
Non-GAAPdiluted earnings per share | $ | 1.75 | $ | 1.84 | $ | 5.33 | $ | 5.22 | |||||
___________________________________ Note: Non-GAAP financial information excludes acquisition-related, up-front collaboration and licensing, stock-based compensation and other expenses, fair value adjustments of equity securities and discrete tax charges or benefits associated with changes in tax related laws and guidelines. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 7 through 9. |
Product Sales
Total product sales for the third quarter of 2019 were
- HIV product saleswere
$4.2 billion for the third quarter of 2019 compared to$3.7 billion for the same period in 2018. The increase was primarily driven by higher sales volume as a result of the continued uptake of Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir alafenamide 25 mg). - Chronic hepatitis C virus (HCV) product sales were
$674 million for the third quarter of 2019 compared to$902 million for the same period in 2018. The decline was primarily due to competitive dynamics. - Yescarta®(axicabtagene ciloleucel) generated
$118 million in sales during the third quarter of 2019 compared to$75 million for the same period in 2018. The increase was driven by a higher number of therapies provided to patients and the continued expansion inEurope . -
Other product sales, which include products from chronic hepatitis B virus (HBV), cardiovascular, oncology and other categories inclusive of Vemlidy® (tenofovir alafenamide 25 mg), Viread® (tenofovir disoproxil fumarate 300 mg), Letairis® (ambrisentan 5 mg and 10 mg), Ranexa® (ranolazine 500 mg and 1000 mg), Zydelig® (idelalisib 150 mg), AmBisome® (amphotericin B liposome for injection 50 mg/vial) and Cayston® (aztreonam for inhalation solution 75 mg/vial), were
$522 million for the third quarter of 2019 compared to$751 million for the same period in 2018. The decrease was primarily due to the expected declines in Ranexa and Letairis sales after generic entries in 2019.
Operating Expenses
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
(In millions) | 2019 | 2018 | 2019 | 2018 | |||||||||
Research and development expenses (R&D) | $ | 4,990 | $ | 939 | $ | 7,207 | $ | 3,068 | |||||
Non-GAAP R&D expenses | $ | 954 | $ | 844 | $ | 2,741 | $ | 2,579 | |||||
Selling, general and administrative expenses (SG&A) | $ | 1,052 | $ | 948 | $ | 3,177 | $ | 2,925 | |||||
Non-GAAP SG&A expenses | $ | 967 | $ | 852 | $ | 2,944 | $ | 2,576 | |||||
During the third quarter of 2019, compared to the same period in 2018:
-
R&D expenses increased primarily due to up-front collaboration and licensing expenses of
$3.92 billion related to Gilead’s global research and development collaboration agreement with Galapagos. Furthermore, R&D expenses and non-GAAP R&D expenses increased primarily due to increased investment in Gilead’s oncology programs, HIV programs and research projects. -
SG&A expenses and non-GAAP SG&A expenses increased primarily due to higher promotional expenses in
the United States and expenses associated with the expansion of Gilead’s business inJapan andChina .
Cash,
As of
Revised Full Year 2019 Guidance
Gilead revised its full year 2019 guidance, initially provided on
(In millions, except percentages and per share amounts) | Initially Provided February 4, 2019 Reiterated May 2, 2019 | Updated July 30, 2019 | Updated October 24, 2019 |
Product Sales | $21,300 - $21,800 | $21,600 - $22,100 | $21,800 - $22,100 |
Non-GAAP | |||
Product Gross Margin | 85% - 87% | 85% - 87% | 85% - 87% |
R&D Expenses | $3,600 - $3,800 | $3,600 - $3,800 | $3,700 - $3,800 |
SG&A Expenses | $3,900 - $4,100 | $3,900 - $4,100 | $4,000 - $4,100 |
Effective Tax Rate | 20.0% - 21.0% | 20.0% - 21.0% | 20.0% - 21.0% |
Diluted EPS Impact of Acquisition-related, Up-front Collaboration and Licensing, Stock-based Compensation and Other Expenses | $1.40 - $1.50 | $3.90 - $4.00 | $3.90 - $4.00 |
Corporate Highlights, Including the Announcement of:
-
Appointment of
Andrew Dickinson as Chief Financial Officer, effectiveNovember 1, 2019 . -
Appointment of
Merdad Parsey as Chief Medical Officer, effectiveNovember 1, 2019 . -
Launch of RADIAN Initiative to meaningfully address new HIV infections and deaths from AIDS-related illnesses in
Eastern Europe andCentral Asia , in collaboration with theElton John AIDS Foundation . -
Closing of the global research and development collaboration agreement with Galapagos announced in
July 2019 . -
Collaboration with
Renown Institute for Health Innovation (Renown) to collect and analyze genetic and electronic health data to enhance the understanding of nonalcoholic steatohepatitis (NASH) and potentially inform development of treatment options for the disease.
Product and Pipeline Updates, Including the Announcement of:
- Presentation of Week 52 data from the Phase 3 FINCH 1 and FINCH 3 trials of filgotinib, an investigational, oral, selective JAK1 inhibitor, for the treatment of moderately-to-severely active rheumatoid arthritis (RA), which are consistent with and support the efficacy, safety and tolerability profiles demonstrated in the week 12 and 24 analyses presented earlier this year.
-
Submission of the new drug application for filgotinib for the treatment of adults with RA to the
Japanese Ministry of Health, Labor and Welfare (MHLW). -
Presentation of data at the IDWeek 2019 conference, which included:
- Results from the DISCOVER trial evaluating Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25 mg) for HIV pre-exposure prophylaxis (PrEP), which showed significant improvements in key measures of bone and renal safety parameters in a subset of study participants who switched from Truvada for PrEP® (emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) to Descovy for PrEP™.
-
A release of the latest data demonstrating that major metropolitan areas in
the United States with the highest use of PrEP experienced the greatest decreases in new HIV diagnoses.
-
Approval of a PrEP indication for Descovy by the
U.S. Food and Drug Administration (FDA ). Descovy for PrEP is indicated to reduce the risk of sexually acquired HIV-1 infection in adults and adolescents weighing at least 35 kg who are HIV-negative and at-risk for sexually acquired HIV, excluding individuals at-risk from receptive vaginal sex. - European Medicines Agency’s (EMA) validation of the marketing authorization application for filgotinib for the treatment of adults with RA; the application is now under evaluation by the agency.
-
Approval of Biktarvy by the
China National Medical Products Administration for the treatment of HIV-1 infection in adults without present or past evidence of viral resistance to the integrase inhibitor class, emtricitabine or tenofovir. -
Plans to bolster cell therapy manufacturing capabilities with a new 67,000-square-foot viral vector facility in
Oceanside, California . The new site builds on existing state-of-the-art manufacturing capabilities to deliver innovative cell therapies for people with cancer, including Yescarta, and investigational T-cell receptor and tumor neoantigen targeting cell therapies.
Non-GAAP Financial Information
The information presented in this document has been prepared 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 through 9.
Conference Call
The live webcast of the call can be accessed at Gilead’s Investors page at http://investors.gilead.com/. Please connect to the website at least 15 minutes prior to the start of the call to allow adequate time for any software download that may be required to listen to the webcast. Alternatively, please call 877-359-9508 (U.S.) or 224-357-2393 (international) and dial the conference ID 6094972 to access the call. Telephone replay will be available approximately two hours after the call through
About
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 2019 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; 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 as well as purchases by retail pharmacies and other non-wholesaler locations with whom Gilead has no inventory management agreements 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 our products; an uncertain global macroeconomic environment; 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; 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 realize the potential benefits of collaborations or licensing arrangements, including with Galapagos and Renown; Gilead’s ability to submit new drug applications for new product candidates in the timelines currently anticipated, including a new drug application to
All forward-looking statements are based on information currently available to Gilead and Gilead assumes no obligation to update or supplement any such forward-looking statements other than as required by law. Any forward-looking statements speak only as of the date hereof or as of the dates indicated in the statements.
Gilead owns or has rights to various trademarks, copyrights and trade names used in its business, including the following: GILEAD®,
LEXISCAN® is a registered trademark of
For more information on
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (unaudited) (in millions, except per share amounts) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Revenues: | ||||||||||||||||
Product sales | $ | 5,516 | $ | 5,455 | $ | 16,323 | $ | 15,996 | ||||||||
Royalty, contract and other revenues | 88 | 141 | 247 | 336 | ||||||||||||
Total revenues | 5,604 | 5,596 | 16,570 | 16,332 | ||||||||||||
Costs and expenses: | ||||||||||||||||
Cost of goods sold | 1,035 | 1,086 | 2,992 | 3,283 | ||||||||||||
Research and development expenses | 4,990 | 939 | 7,207 | 3,068 | ||||||||||||
Selling, general and administrative expenses | 1,052 | 948 | 3,177 | 2,925 | ||||||||||||
Total costs and expenses | 7,077 | 2,973 | 13,376 | 9,276 | ||||||||||||
Income (loss) from operations | (1,473 | ) | 2,623 | 3,194 | 7,056 | |||||||||||
Interest expense | (250 | ) | (264 | ) | (752 | ) | (820 | ) | ||||||||
Other income (expense), net | 222 | 305 | 817 | 547 | ||||||||||||
Income (loss) before provision (benefit) for income taxes | (1,501 | ) | 2,664 | 3,259 | 6,783 | |||||||||||
Provision (benefit) for income taxes | (333 | ) | 565 | 584 | 1,326 | |||||||||||
Net income (loss) | (1,168 | ) | 2,099 | 2,675 | 5,457 | |||||||||||
Net income (loss) attributable to noncontrolling interest | (3 | ) | 2 | (15 | ) | 5 | ||||||||||
Net income (loss) attributable to Gilead | $ | (1,165 | ) | $ | 2,097 | $ | 2,690 | $ | 5,452 | |||||||
Net income (loss) per share attributable to Gilead common stockholders - basic | $ | (0.92 | ) | $ | 1.62 | $ | 2.12 | $ | 4.19 | |||||||
Shares used in per share calculation - basic | 1,267 | 1,296 | 1,271 | 1,302 | ||||||||||||
Net income (loss) per share attributable to Gilead common stockholders - diluted | $ | (0.92 | ) | $ | 1.60 | $ | 2.10 | $ | 4.15 | |||||||
Shares used in per share calculation - diluted | 1,267 | 1,307 | 1,278 | 1,313 | ||||||||||||
Cash dividends declared per share | $ | 0.63 | $ | 0.57 | $ | 1.89 | $ | 1.71 | ||||||||
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, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Cost of goods sold reconciliation: | ||||||||||||||||
GAAP cost of goods sold | $ | 1,035 | $ | 1,086 | $ | 2,992 | $ | 3,283 | ||||||||
Acquisition-related – amortization of purchased intangibles | (266 | ) | (301 | ) | (822 | ) | (902 | ) | ||||||||
Stock-based compensation expenses(1) | (10 | ) | (15 | ) | (37 | ) | (49 | ) | ||||||||
Other(2) | — | 1 | — | 1 | ||||||||||||
Non-GAAP cost of goods sold | $ | 759 | $ | 771 | $ | 2,133 | $ | 2,333 | ||||||||
Product gross margin reconciliation: | ||||||||||||||||
GAAP product gross margin | 81.2 | % | 80.1 | % | 81.7 | % | 79.5 | % | ||||||||
Acquisition-related – amortization of purchased intangibles | 4.8 | % | 5.5 | % | 5.0 | % | 5.6 | % | ||||||||
Stock-based compensation expenses | 0.2 | % | 0.3 | % | 0.2 | % | 0.3 | % | ||||||||
Non-GAAP product gross margin(5) | 86.2 | % | 85.9 | % | 86.9 | % | 85.4 | % | ||||||||
Research and development expenses reconciliation: | ||||||||||||||||
GAAP research and development expenses | $ | 4,990 | $ | 939 | $ | 7,207 | $ | 3,068 | ||||||||
Up-front collaboration and licensing expenses | (3,960 | ) | — | (4,251 | ) | (160 | ) | |||||||||
Acquisition-related – other costs | — | 3 | — | (22 | ) | |||||||||||
Stock-based compensation expenses(1) | (74 | ) | (99 | ) | (215 | ) | (304 | ) | ||||||||
Other(2) | (2 | ) | 1 | — | (3 | ) | ||||||||||
Non-GAAP research and development expenses | $ | 954 | $ | 844 | $ | 2,741 | $ | 2,579 | ||||||||
Selling, general and administrative expenses reconciliation: | ||||||||||||||||
GAAP selling, general and administrative expenses | $ | 1,052 | $ | 948 | $ | 3,177 | $ | 2,925 | ||||||||
Acquisition-related – other costs | — | (8 | ) | — | (23 | ) | ||||||||||
Stock-based compensation expenses(1) | (78 | ) | (84 | ) | (227 | ) | (317 | ) | ||||||||
Other(2) | (7 | ) | (4 | ) | (6 | ) | (9 | ) | ||||||||
Non-GAAP selling, general and administrative expenses | $ | 967 | $ | 852 | $ | 2,944 | $ | 2,576 | ||||||||
Operating margin reconciliation: | ||||||||||||||||
GAAP operating margin | (26.3 | )% | 46.9 | % | 19.3 | % | 43.2 | % | ||||||||
Up-front collaboration and licensing expenses | 70.7 | % | — | % | 25.7 | % | 1.0 | % | ||||||||
Acquisition-related – amortization of purchased intangibles | 4.7 | % | 5.4 | % | 5.0 | % | 5.5 | % | ||||||||
Acquisition-related – other costs | — | % | 0.1 | % | — | % | 0.3 | % | ||||||||
Stock-based compensation expenses | 2.9 | % | 3.5 | % | 2.9 | % | 4.1 | % | ||||||||
Other(2) | 0.2 | % | — | % | — | % | 0.1 | % | ||||||||
Non-GAAP operating margin(5) | 52.2 | % | 55.9 | % | 52.8 | % | 54.2 | % | ||||||||
Other income (expense), net reconciliation: | ||||||||||||||||
GAAP other income (expense), net | $ | 222 | $ | 305 | $ | 817 | $ | 547 | ||||||||
Unrealized gains from equity securities, net | (58 | ) | (168 | ) | (312 | ) | (149 | ) | ||||||||
Non-GAAP other income (expense), net | $ | 164 | $ | 137 | $ | 505 | $ | 398 | ||||||||
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, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Effective tax rate reconciliation: | ||||||||||||||||
GAAP effective tax rate | 22.2 | % | 21.2 | % | 17.9 | % | 19.5 | % | ||||||||
Up-front collaboration and licensing expenses | 0.6 | % | — | % | 2.6 | % | 0.1 | % | ||||||||
Acquisition-related – amortization of purchased intangibles | (1.6 | )% | (1.5 | )% | (1.3 | )% | (1.5 | )% | ||||||||
Stock-based compensation expenses(1) | (0.4 | )% | (1.0 | )% | (0.2 | )% | (0.1 | )% | ||||||||
Unrealized gains from equity securities, net | 0.9 | % | 1.3 | % | 1.0 | % | 0.4 | % | ||||||||
Tax Reform adjustments(3) | — | % | — | % | — | % | 0.1 | % | ||||||||
Non-GAAP effective tax rate(5) | 21.7 | % | 19.9 | % | 20.1 | % | 18.5 | % | ||||||||
Net income (loss) attributable to Gilead reconciliation: | ||||||||||||||||
GAAP net income (loss) attributable to Gilead | $ | (1,165 | ) | $ | 2,097 | $ | 2,690 | $ | 5,452 | |||||||
Up-front collaboration and licensing expenses | 3,068 | — | 3,294 | 125 | ||||||||||||
Acquisition-related – amortization of purchased intangibles | 247 | 281 | 759 | 843 | ||||||||||||
Acquisition-related – other costs | — | 4 | — | 36 | ||||||||||||
Stock-based compensation expenses(1) | 133 | 184 | 385 | 546 | ||||||||||||
Unrealized gains from equity securities, net | (66 | ) | (164 | ) | (320 | ) | (146 | ) | ||||||||
Tax Reform adjustments(3) | — | — | — | (10 | ) | |||||||||||
Other(2) | 7 | 1 | 5 | 9 | ||||||||||||
Non-GAAP net income attributable to Gilead | $ | 2,224 | $ | 2,403 | $ | 6,813 | $ | 6,855 | ||||||||
Diluted earnings (loss) per share reconciliation: | ||||||||||||||||
GAAP diluted earnings (loss) per share(4) | $ | (0.92 | ) | $ | 1.60 | $ | 2.10 | $ | 4.15 | |||||||
Up-front collaboration and licensing expenses | 2.41 | — | 2.58 | 0.10 | ||||||||||||
Acquisition-related – amortization of purchased intangibles | 0.19 | 0.21 | 0.59 | 0.64 | ||||||||||||
Acquisition-related – other costs | — | — | — | 0.03 | ||||||||||||
Stock-based compensation expenses(1) | 0.10 | 0.14 | 0.30 | 0.42 | ||||||||||||
Unrealized gains from equity securities, net | (0.05 | ) | (0.13 | ) | (0.25 | ) | (0.11 | ) | ||||||||
Tax Reform adjustments(3) | — | — | — | (0.01 | ) | |||||||||||
Other(2) | 0.01 | — | — | 0.01 | ||||||||||||
Non-GAAP diluted earnings per share(5) | $ | 1.75 | $ | 1.84 | $ | 5.33 | $ | 5.22 | ||||||||
Non-GAAP adjustment summary: | ||||||||||||||||
Cost of goods sold adjustments | $ | 276 | $ | 315 | $ | 859 | $ | 950 | ||||||||
Research and development expenses adjustments | 4,036 | 95 | 4,466 | 489 | ||||||||||||
Selling, general and administrative expenses adjustments | 85 | 96 | 233 | 349 | ||||||||||||
Other income (expense), net adjustments | (58 | ) | (168 | ) | (312 | ) | (149 | ) | ||||||||
Total non-GAAP adjustments before tax | 4,339 | 338 | 5,246 | 1,639 | ||||||||||||
Income tax effect | (950 | ) | (32 | ) | (1,123 | ) | (226 | ) | ||||||||
Tax Reform adjustments(3) | — | — | — | (10 | ) | |||||||||||
Total non-GAAP adjustments after tax | $ | 3,389 | $ | 306 | $ | 4,123 | $ | 1,403 | ||||||||
____________________ | ||||||||||||||||
| Notes: | |
(1) | The decreases were primarily due to stock-based compensation expenses incurred in 2018 following Gilead’s acquisition of Kite Pharma, Inc. |
(2) | Amounts represent restructuring, contingent consideration and/or other individually insignificant amounts |
(3) | Amounts represent measurement period adjustments relating to the enactment of the 2017 Tax Cuts and Jobs Act (Tax Reform) |
(4) | Shares used in loss per share calculation for the three months ended September 30, 2019 exclude 7 million shares from dilutive equity awards |
(5) | Amounts may not sum due to rounding |
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP 2019 FULL YEAR GUIDANCE (unaudited) (in millions, except percentages and per share amounts) | ||||||
Initially Provided February 4, 2019 Reiterated May 2, 2019 | Updated July 30, 2019 | Updated October 24, 2019 | ||||
Projected product gross margin GAAP to non-GAAP reconciliation: | ||||||
GAAP projected product gross margin | 80% - 81% | 80% - 81% | 80% - 81% | |||
Acquisition-related expenses | 5% - 6% | 5% - 6% | 5% - 6% | |||
Non-GAAP projected product gross margin(1) | 85% - 87% | 85% - 87% | 85% - 87% | |||
Projected research and development expenses GAAP to non-GAAP reconciliation: | ||||||
GAAP projected research and development expenses | $4,195 - $4,480 | $8,290 - $8,595 | $8,390 - $8,595 | |||
Stock-based compensation expenses | (345) - (380) | (290) - (325) | (290) - (325) | |||
Up-front collaboration and licensing expenses | (250) - (300) | (4,400) - (4,470) | (4,400) - (4,470) | |||
Non-GAAP projected research and development expenses | $3,600 - $3,800 | $3,600 - $3,800 | $3,700 - $3,800 | |||
Projected selling, general and administrative expenses GAAP to non-GAAP reconciliation: | ||||||
GAAP projected selling, general and administrative expenses | $4,255 - $4,490 | $4,205 - $4,440 | $4,305 - $4,440 | |||
Stock-based compensation expenses | (355) - (390) | (305) - (340) | (305) - (340) | |||
Non-GAAP projected selling, general and administrative expenses | $3,900 - $4,100 | $3,900 - $4,100 | $4,000 - $4,100 | |||
Projected effective tax rate GAAP to non-GAAP reconciliation: | ||||||
GAAP projected effective tax rate(2) | 21.5% - 22.5% | 21.5% - 22.5% | 19.0% - 20.0% | |||
Tax rate effect of adjustments noted above(2) | (1.5%) - (1.5%) | (1.5%) - (1.5%) | 1.0% - 1.0% | |||
Non-GAAP projected effective tax rate | 20.0% - 21.0% | 20.0% - 21.0% | 20.0% - 21.0% | |||
Projected diluted EPS impact of acquisition-related, up-front collaboration and licensing, stock-based compensation and other expenses(2): | ||||||
Acquisition-related expenses / up-front collaboration and licensing expenses | $0.93 - $0.97 | $3.47 - $3.51 | $3.47 - $3.51 | |||
Stock-based compensation expenses | $0.47 - $0.53 | $0.43 - $0.49 | $0.43 - $0.49 | |||
Projected diluted EPS impact of acquisition-related, up-front collaboration and licensing, stock-based compensation and other expenses(2) | $1.40 - $1.50 | $3.90 - $4.00 | $3.90 - $4.00 | |||
____________________ | ||||||
Notes: | |
(1) | Total stock-based compensation expenses have a less than one percent impact on non-GAAP projected product gross margin |
(2) | Excludes fair value adjustments of equity securities and the associated income tax effect, as Gilead is unable to project future fair value adjustments, and other discrete tax charges or benefits |
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in millions) | ||||||||
September 30, | December 31, | |||||||
2019 | 2018 | |||||||
Cash, cash equivalents and marketable securities | $ | 25,051 | $ | 31,512 | ||||
Accounts receivable, net | 3,315 | 3,327 | ||||||
Inventories | 882 | 814 | ||||||
Property, plant and equipment, net | 4,377 | 4,006 | ||||||
Intangible assets, net | 14,864 | 15,738 | ||||||
Goodwill | 4,117 | 4,117 | ||||||
Other assets | 6,540 | 4,161 | ||||||
Total assets | $ | 59,146 | $ | 63,675 | ||||
Current liabilities | $ | 9,567 | $ | 10,605 | ||||
Long-term liabilities | 28,843 | 31,536 | ||||||
Stockholders’ equity(1) | 20,736 | 21,534 | ||||||
Total liabilities and stockholders’ equity | $ | 59,146 | $ | 63,675 | ||||
____________________ | ||||||||
Note: | ||||||||
(1) As of September 30, 2019, there were 1,266 million shares of common stock issued and outstanding | ||||||||
GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) (in millions) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Atripla – U.S. | $ | 132 | $ | 221 | $ | 387 | $ | 723 | ||||||||
Atripla – Europe | 10 | 29 | 52 | 119 | ||||||||||||
Atripla – Other International | 7 | 8 | 33 | 79 | ||||||||||||
149 | 258 | 472 | 921 | |||||||||||||
Biktarvy – U.S. | 1,106 | 375 | 2,868 | 593 | ||||||||||||
Biktarvy – Europe | 108 | 11 | 229 | 13 | ||||||||||||
Biktarvy – Other International | 45 | — | 71 | — | ||||||||||||
1,259 | 386 | 3,168 | 606 | |||||||||||||
Complera / Eviplera – U.S. | 40 | 61 | 126 | 210 | ||||||||||||
Complera / Eviplera – Europe | 45 | 67 | 179 | 279 | ||||||||||||
Complera / Eviplera – Other International | 8 | 11 | 26 | 39 | ||||||||||||
93 | 139 | 331 | 528 | |||||||||||||
Descovy – U.S. | 256 | 310 | 735 | 895 | ||||||||||||
Descovy – Europe | 63 | 81 | 200 | 234 | ||||||||||||
Descovy – Other International | 44 | 15 | 128 | 41 | ||||||||||||
363 | 406 | 1,063 | 1,170 | |||||||||||||
Genvoya – U.S. | 761 | 921 | 2,222 | 2,678 | ||||||||||||
Genvoya – Europe | 152 | 203 | 522 | 596 | ||||||||||||
Genvoya – Other International | 65 | 52 | 229 | 144 | ||||||||||||
978 | 1,176 | 2,973 | 3,418 | |||||||||||||
Odefsey – U.S. | 317 | 323 | 865 | 905 | ||||||||||||
Odefsey – Europe | 111 | 95 | 328 | 230 | ||||||||||||
Odefsey – Other International | 8 | 5 | 27 | 15 | ||||||||||||
436 | 423 | 1,220 | 1,150 | |||||||||||||
Stribild – U.S. | 63 | 111 | 208 | 388 | ||||||||||||
Stribild – Europe | 18 | 20 | 60 | 83 | ||||||||||||
Stribild – Other International | 13 | 15 | 30 | 36 | ||||||||||||
94 | 146 | 298 | 507 | |||||||||||||
Truvada – U.S. | 688 | 665 | 1,896 | 1,821 | ||||||||||||
Truvada – Europe | 14 | 62 | 88 | 245 | ||||||||||||
Truvada – Other International | 19 | 30 | 61 | 108 | ||||||||||||
721 | 757 | 2,045 | 2,174 | |||||||||||||
Other HIV(1) – U.S. | 3 | 10 | 23 | 30 | ||||||||||||
Other HIV(1) – Europe | 1 | 2 | 3 | 6 | ||||||||||||
Other HIV(1) – Other International | 1 | 2 | 11 | 10 | ||||||||||||
5 | 14 | 37 | 46 | |||||||||||||
Revenue share – Symtuza(2) – U.S. | 68 | 8 | 165 | 8 | ||||||||||||
Revenue share – Symtuza(2) – Europe | 36 | 14 | 89 | 34 | ||||||||||||
Revenue share – Symtuza(2) – Other International | — | — | — | — | ||||||||||||
104 | 22 | 254 | 42 | |||||||||||||
Total HIV – U.S. | 3,434 | 3,005 | 9,495 | 8,251 | ||||||||||||
Total HIV – Europe | 558 | 584 | 1,750 | 1,839 | ||||||||||||
Total HIV – Other International | 210 | 138 | 616 | 472 | ||||||||||||
4,202 | 3,727 | 11,861 | 10,562 | |||||||||||||
AmBisome – U.S. | 9 | 9 | 27 | 40 | ||||||||||||
AmBisome – Europe | 57 | 59 | 174 | 170 | ||||||||||||
AmBisome – Other International | 33 | 34 | 96 | 102 | ||||||||||||
99 | 102 | 297 | 312 | |||||||||||||
GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY - (Continued) (unaudited) (in millions) | ||||||||||||||||
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2019 | 2018 | 2019 | 2018 | |||||||||||||
Ledipasvir/Sofosbuvir(3) – U.S. | $ | 54 | $ | 185 | $ | 257 | $ | 649 | ||||||||
Ledipasvir/Sofosbuvir(3) – Europe | 14 | 38 | 63 | 116 | ||||||||||||
Ledipasvir/Sofosbuvir(3) – Other International | 56 | 88 | 222 | 225 | ||||||||||||
124 | 311 | 542 | 990 | |||||||||||||
Letairis – U.S. | 121 | 241 | 522 | 689 | ||||||||||||
Ranexa – U.S. | 31 | 178 | 205 | 581 | ||||||||||||
Sofosbuvir/Velpatasvir(4) – U.S. | 282 | 225 | 731 | 733 | ||||||||||||
Sofosbuvir/Velpatasvir(4) – Europe | 118 | 136 | 428 | 502 | ||||||||||||
Sofosbuvir/Velpatasvir(4) – Other International | 116 | 116 | 341 | 278 | ||||||||||||
516 | 477 | 1,500 | 1,513 | |||||||||||||
Vemlidy – U.S. | 78 | 66 | 214 | 172 | ||||||||||||
Vemlidy – Europe | 6 | 2 | 15 | 8 | ||||||||||||
Vemlidy – Other International | 50 | 19 | 122 | 41 | ||||||||||||
134 | 87 | 351 | 221 | |||||||||||||
Viread – U.S. | 7 | 17 | 28 | 40 | ||||||||||||
Viread – Europe | 15 | 10 | 57 | 72 | ||||||||||||
Viread – Other International | 35 | 43 | 119 | 137 | ||||||||||||
57 | 70 | 204 | 249 | |||||||||||||
Vosevi – U.S. | 42 | 78 | 140 | 250 | ||||||||||||
Vosevi – Europe | 12 | 21 | 43 | 57 | ||||||||||||
Vosevi – Other International | 9 | 4 | 18 | 12 | ||||||||||||
63 | 103 | 201 | 319 | |||||||||||||
Yescarta – U.S. | 86 | 75 | 275 | 183 | ||||||||||||
Yescarta – Europe | 32 | — | 59 | — | ||||||||||||
Yescarta – Other International | — | — | — | — | ||||||||||||
118 | 75 | 334 | 183 | |||||||||||||
Zydelig – U.S. | 13 | 15 | 36 | 46 | ||||||||||||
Zydelig – Europe | 13 | 4 | 42 | 44 | ||||||||||||
Zydelig – Other International | — | 1 | 1 | 2 | ||||||||||||
26 | 20 | 79 | 92 | |||||||||||||
Other(5) – U.S. | 42 | 37 | 119 | 93 | ||||||||||||
Other(5) – Europe | (21 | ) | 19 | 96 | 75 | |||||||||||
Other(5) – Other International | 4 | 8 | 12 | 117 | ||||||||||||
25 | 64 | 227 | 285 | |||||||||||||
Total product sales – U.S. | 4,199 | 4,131 | 12,049 | 11,727 | ||||||||||||
Total product sales – Europe | 804 | 873 | 2,727 | 2,883 | ||||||||||||
Total product sales – Other International | 513 | 451 | 1,547 | 1,386 | ||||||||||||
$ | 5,516 | $ | 5,455 | $ | 16,323 | $ | 15,996 | |||||||||
____________________ | ||||||||||||||||
Notes: | |
(1) | Includes Emtriva and Tybost |
(2) | Represents Gilead’s revenue from cobicistat (C), emtricitabine (FTC) and tenofovir alafenamide (TAF) in Symtuza (darunavir/C/FTC/TAF), a fixed dose combination product commercialized by Janssen Sciences Ireland UC |
(3) | Amounts consist of sales of Harvoni and the authorized generic version of Harvoni sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC |
(4) | Amounts consist of sales of Epclusa and the authorized generic version of Epclusa sold by Gilead’s separate subsidiary, Asegua Therapeutics LLC |
(5) | Includes Cayston, Hepsera and Sovaldi. In Europe, the period-over-period changes were primarily due to adjustments recorded in 2019 for statutory rebates related to sales of Sovaldi made in prior years |
View source version on businesswire.com: https://www.businesswire.com/news/home/20191024005897/en/
Source:
Investors Robin Washington (650) 522-5688
Sung Lee (650) 524-7792
Media Amy Flood (650) 522-5643
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