Press Releases
April 30, 2015
Gilead Sciences Announces First Quarter 2015 Financial Results
- ~90,000 U.S. and EU Patients Initiated Treatment on Sovaldi or Harvoni -
- Product Sales of
- Non-GAAP EPS of
- Revised 2015 Full Year Guidance -
| Three Months Ended | |||||||
| March 31, | |||||||
| (In millions, except per share amounts) | 2015 | 2014 | |||||
| Product sales | $ | 7,405 | $ | 4,871 | |||
| Royalty, contract and other revenues | 189 | 128 | |||||
| Total revenues | $ | 7,594 | $ | 4,999 | |||
| Net income attributable to Gilead | $ | 4,333 | $ | 2,227 | |||
| Non-GAAP net income attributable to Gilead | $ | 4,604 | $ | 2,488 | |||
| Diluted EPS | $ | 2.76 | $ | 1.33 | |||
| Non-GAAP diluted EPS | $ | 2.94 | $ | 1.48 | |||
Product Sales
Total product sales for the first quarter of 2015 were
Antiviral Product Sales
Antiviral product sales increased to
Other Product Sales
Other product sales, which include Letairis®, Ranexa®
and AmBisome®, were
Operating Expenses
During the first quarter of 2015, compared to the same period in 2014:
- Non-GAAP research and development (R&D) expenses increased primarily due to the continued progression and expansion of Gilead's clinical studies, particularly phase 3 studies in the liver disease and oncology areas.
- Non-GAAP selling, general and administrative (SG&A) expenses increased primarily due to growth in our business including commercial expansion for our hepatitis C virus (HCV) products.
| Three Months Ended | |||||||
| March 31, | |||||||
| (In millions) | 2015 | 2014 | |||||
| Non-GAAP research and development expenses | $ | 651 | $ | 558 | |||
| Non-GAAP selling, general and administrative expenses | $ | 600 | $ | 500 | |||
Note: Non-GAAP R&D and SG&A expenses exclude amounts related to acquisition, restructuring, stock-based compensation and other.
Cash,
As of
Revised 2015 Full Year Guidance
Gilead updated its full year 2015 guidance, which it initially provided
on
| (In millions, except percentages and per share amounts) |
Initially Provided |
Updated |
||
| Net Product Sales | $26,000 - $27,000 | $28,000 - $29,000 | ||
| Non-GAAP* | ||||
| Product Gross Margin | 87% - 90% | 87% - 90% | ||
| R&D | $3,000 - $3,300 | $3,000 - $3,300 | ||
| SG&A | $3,000 - $3,300 | $3,000 - $3,300 | ||
| Effective Tax Rate | 18.0% - 20.0% | 18.0% - 20.0% | ||
| Diluted EPS Impact of Acquisition-Related, Restructuring, Stock-Based Compensation Expenses and Other | $0.82 - $0.87 | $0.82 - $0.87 | ||
| * Non-GAAP product gross margin, R&D and SG&A expenses and effective tax rate exclude amounts related to acquisition, restructuring, stock-based compensation and other. | ||||
Product & Pipeline Updates Announced by
Antiviral Program
-
Announced that the
Japanese Ministry of Health, Labour and Welfare approved Sovaldi for the suppression of viremia in patients with genotype 2 chronic HCV infection with or without compensated cirrhosis. Sovaldi is indicated for use in combination with ribavirin (RBV) for 12 weeks. Sovaldi (in combination with RBV) is the first all-oral, interferon-free treatment regimen for genotype 2 HCV infection. -
Presentation of data at the 22nd Conference on Retroviruses and
Opportunistic Infections included announcement of:
- Positive results from a Phase 3 clinical trial evaluating the once-daily single tablet regimen Harvoni for the treatment of genotypes 1 or 4 chronic HCV infection among patients co-infected with HIV. In the trial, 96 percent of HCV patients achieved a sustained virologic response 12 weeks after completing therapy (SVR12). Patients who achieve SVR12 are considered cured of HCV infection.
- Positive 48-week results from two Phase 3 studies (Studies 104 and 111) evaluating an investigational once-daily single tablet regimen containing tenofovir alafenamide (TAF) for the treatment of HIV-1 infection in treatment-naïve adults. TAF is a novel nucleotide reverse transcriptase inhibitor that has demonstrated high antiviral efficacy at a dose 10 times lower than Gilead’s Viread, as well as improved renal and bone laboratory parameters, in clinical trials.
-
Positive results from a preclinical study conducted in
collaboration with researchers at
Beth Israel Deaconess Medical Center evaluating a proprietary investigational oral TLR7 agonist and analogue of GS-9620 as part of an HIV eradication strategy. Data demonstrated that treatment with the TLR7 agonist induced transient plasma Simian Immunodeficiency Virus (SIV) RNA, as well as reduced SIV DNA in virally suppressed rhesus macaques given antiretroviral therapy (ART). In addition, the study found that after discontinuation of ART, SIV viral loads were lower among macaques that received the proprietary TLR7 agonist compared to the placebo group.
Conference Call
At
About Gilead
Non-GAAP Financial Information
Gilead has presented certain financial information in accordance with U.S. generally accepted accounting principles (GAAP) and also on a non-GAAP basis. Management believes this non-GAAP information is useful for investors, when considered in conjunction with Gilead's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead's operating results as reported under GAAP. A reconciliation between GAAP and non-GAAP financial information is provided in the tables on pages 6 and 7.
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 2015 financial results; Gilead's ability to
sustain growth in revenues for its antiviral and other programs;
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; the possibility of unfavorable
results from clinical trials involving sofosbuvir-containing products,
tenofovir alafenamide, including in combination with other products, and
GS-9620; 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, including fixed-dose combination of ledipasvir and sofosbuvir
in
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 belonging to Bristol-Myers
Squibb &
For more information on
|
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) (in millions, except per share amounts) |
||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2015 | 2014 | |||||||
| Revenues: | ||||||||
| Product sales | $ | 7,405 | $ | 4,871 | ||||
| Royalty, contract and other revenues | 189 | 128 | ||||||
| Total revenues | 7,594 | 4,999 | ||||||
| Costs and expenses: | ||||||||
| Cost of goods sold | 882 | 813 | ||||||
| Research and development expenses | 696 | 595 | ||||||
| Selling, general and administrative expenses | 645 | 548 | ||||||
| Total costs and expenses | 2,223 | 1,956 | ||||||
| Income from operations | 5,371 | 3,043 | ||||||
| Interest expense | (153 | ) | (76 | ) | ||||
| Other income (expense), net | 21 | (18 | ) | |||||
| Income before provision for income taxes | 5,239 | 2,949 | ||||||
| Provision for income taxes | 907 | 726 | ||||||
| Net income | 4,332 | 2,223 | ||||||
| Net loss attributable to noncontrolling interest | 1 | 4 | ||||||
| Net income attributable to Gilead | $ | 4,333 | $ | 2,227 | ||||
| Net income per share attributable to Gilead common stockholders - basic | $ | 2.91 | $ | 1.45 | ||||
| Net income per share attributable to Gilead common stockholders - diluted | $ | 2.76 | $ | 1.33 | ||||
| Shares used in per share calculation - basic | 1,488 | 1,537 | ||||||
| Shares used in per share calculation - diluted | 1,569 | 1,680 | ||||||
|
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION* (unaudited) (in millions, except percentages and per share amounts) |
||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2015 | 2014 | |||||||
| Cost of goods sold reconciliation: | ||||||||
| GAAP cost of goods sold | $ | 882 | $ | 813 | ||||
| Stock-based compensation expenses | (3 | ) | (3 | ) | ||||
| Acquisition related-amortization of purchased intangibles | (206 | ) | (199 | ) | ||||
| Variable interest entity consolidated costs (2) | 1 | — | ||||||
| Non-GAAP cost of goods sold | $ | 674 | $ | 611 | ||||
| Product gross margin reconciliation: | ||||||||
| GAAP product gross margin | 88.1 | % | 83.3 | % | ||||
| Stock-based compensation expenses | — | % | 0.1 | % | ||||
| Acquisition related-amortization of purchased intangibles | 2.8 | % | 4.1 | % | ||||
| Non-GAAP product gross margin(1) | 90.9 | % | 87.4 | % | ||||
| Research and development expenses reconciliation: | ||||||||
| GAAP research and development expenses | $ | 696 | $ | 595 | ||||
| Stock-based compensation expenses | (42 | ) | (34 | ) | ||||
| Acquisition related-contingent consideration remeasurement | (3 | ) | (3 | ) | ||||
| Non-GAAP research and development expenses | $ | 651 | $ | 558 | ||||
| Selling, general and administrative expenses reconciliation: | ||||||||
| GAAP selling, general and administrative expenses | $ | 645 | $ | 548 | ||||
| Stock-based compensation expenses | (47 | ) | (46 | ) | ||||
| Restructuring expenses | 2 | — | ||||||
| Acquisition related-amortization of purchased intangibles | — | (2 | ) | |||||
| Non-GAAP selling, general and administrative expenses | $ | 600 | $ | 500 | ||||
| Operating margin reconciliation: | ||||||||
| GAAP operating margin | 70.7 | % | 60.9 | % | ||||
| Stock-based compensation expenses | 1.2 | % | 1.6 | % | ||||
| Acquisition related-amortization of purchased intangibles | 2.7 | % | 4.0 | % | ||||
| Acquisition related-contingent consideration remeasurement | — | % | 0.1 | % | ||||
| Non-GAAP operating margin(1) | 74.7 | % | 66.6 | % | ||||
| Other income (expense) reconciliation: | ||||||||
| GAAP other income (expense), net | $ | 21 | $ | (18 | ) | |||
| Acquisition related-transaction costs | — | (2 | ) | |||||
| Non-GAAP other income (expense), net | $ | 21 | $ | (20 | ) | |||
| Note: | ||||||||
| (1) Amounts may not sum due to rounding | ||||||||
| (2) Consolidation of a contract manufacturer | ||||||||
| * Immaterial amounts are not presented in the tables above | ||||||||
|
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued)* (unaudited) (in millions, except percentages and per share amounts) |
||||||||
| Three Months Ended | ||||||||
| March 31, | ||||||||
| 2015 | 2014 | |||||||
| Effective tax rate reconciliation: | ||||||||
| GAAP effective tax rate | 17.3 | % | 24.6 |
% |
||||
| Acquisition related-amortization of purchased intangibles | (0.4 |
)% |
(1.4 |
)% |
||||
| Non-GAAP effective tax rate(1) | 16.9 | % | 23.2 |
% |
||||
| Net income attributable to Gilead reconciliation: | ||||||||
| GAAP net income attributable to Gilead | $ | 4,333 | $ | 2,227 | ||||
| Stock-based compensation expenses | 69 | 64 | ||||||
| Restructuring expenses | (2 | ) | — | |||||
| Acquisition related transaction costs | — |
(1 |
) |
|||||
| Acquisition related-amortization of purchased intangibles | 201 | 195 | ||||||
| Acquisition related-contingent consideration remeasurement | 3 | 3 | ||||||
| Non-GAAP net income attributable to Gilead | $ | 4,604 | $ | 2,488 | ||||
| Diluted earnings per share reconciliation: | ||||||||
| GAAP diluted earnings per share | $ | 2.76 | $ | 1.33 | ||||
| Stock-based compensation expenses | 0.04 | 0.04 | ||||||
| Acquisition related-amortization of purchased intangibles | 0.13 | 0.12 | ||||||
| Non-GAAP diluted earnings per share(1) | $ | 2.94 | $ | 1.48 | ||||
| Shares used in per share calculation (diluted) reconciliation: | ||||||||
| GAAP shares used in per share calculation (diluted) | 1,569 | 1,680 | ||||||
| Share impact of current stock-based compensation rules | (1 | ) | (1 | ) | ||||
| Non-GAAP shares used in per share calculation (diluted) | 1,568 | 1,679 | ||||||
| Non-GAAP adjustment summary: | ||||||||
| Cost of goods sold adjustments | $ | 208 | $ | 202 | ||||
| Research and development expenses adjustments | 45 | 37 | ||||||
| Selling, general and administrative expenses adjustments | 45 | 48 | ||||||
| Other income (expense) adjustments | — | (2 | ) | |||||
| Total non-GAAP adjustments before tax | 298 | 285 | ||||||
| Income tax effect | (28 | ) | (24 | ) | ||||
| Less: variable interest entity consolidated costs (2) | 1 | — | ||||||
| Total non-GAAP adjustments after tax attributable to Gilead | $ | 271 | $ | 261 | ||||
| Note: | ||||||||
| (1) Amounts may not sum due to rounding | ||||||||
| (2) Consolidation of a contract manufacturer | ||||||||
| * Immaterial amounts are not presented in the tables above | ||||||||
|
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (unaudited) (in millions) |
|||||||
| March 31, | December 31, | ||||||
| 2015 | 2014(1) | ||||||
| Cash, cash equivalents and marketable securities | $ | 14,514 | $ | 11,726 | |||
| Accounts receivable, net | 4,835 | 4,635 | |||||
| Inventories | 1,908 | 1,386 | |||||
| Property, plant and equipment, net | 1,765 | 1,674 | |||||
| Intangible assets, net | 10,867 | 11,073 | |||||
| Goodwill | 1,172 | 1,172 | |||||
| Other assets | 3,260 | 2,998 | |||||
| Total assets | $ | 38,321 | $ | 34,664 | |||
| Current liabilities | $ | 7,428 | $ | 5,761 | |||
| Long-term liabilities | 13,294 | 13,069 | |||||
| Equity component of currently redeemable convertible notes | 11 | 15 | |||||
| Stockholders’ equity(2) | 17,588 | 15,819 | |||||
| Total liabilities and stockholders’ equity | $ | 38,321 | $ | 34,664 | |||
| (1) Derived from the audited consolidated financial statements as of December 31, 2014. |
| (2) As of March 31, 2015, there were 1,477 million shares of common stock issued and outstanding. |
|
GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) (in millions) |
|||||||
| Three Months Ended | |||||||
| March 31, | |||||||
| 2015 | 2014 | ||||||
| Antiviral products: | |||||||
| Harvoni – U.S. | $ | 3,016 | $ | — | |||
| Harvoni – Europe | 477 | — | |||||
| Harvoni – Other International | 86 | — | |||||
| 3,579 | — | ||||||
| Sovaldi – U.S. | 421 | 2,098 | |||||
| Sovaldi – Europe | 483 | 163 | |||||
| Sovaldi – Other International | 68 | 13 | |||||
| 972 | 2,274 | ||||||
| Truvada – U.S. | 409 | 368 | |||||
| Truvada – Europe | 301 | 323 | |||||
| Truvada – Other International | 61 | 69 | |||||
| 771 | 760 | ||||||
| Atripla – U.S. | 494 | 490 | |||||
| Atripla – Europe | 194 | 237 | |||||
| Atripla – Other International | 46 | 53 | |||||
| 734 | 780 | ||||||
| Stribild – U.S. | 282 | 187 | |||||
| Stribild – Europe | 61 | 24 | |||||
| Stribild – Other International | 13 | 4 | |||||
| 356 | 215 | ||||||
| Complera / Eviplera – U.S. | 163 | 131 | |||||
| Complera / Eviplera – Europe | 145 | 109 | |||||
| Complera / Eviplera – Other International | 12 | 11 | |||||
| 320 | 251 | ||||||
| Viread – U.S. | 100 | 81 | |||||
| Viread – Europe | 80 | 84 | |||||
| Viread – Other International | 54 | 46 | |||||
| 234 | 211 | ||||||
| Other Antiviral – U.S. | 14 | 7 | |||||
| Other Antiviral – Europe | 7 | 9 | |||||
| Other Antiviral – Other International | 1 | 2 | |||||
| 22 | 18 | ||||||
| Total antiviral products – U.S. | 4,899 | 3,362 | |||||
| Total antiviral products – Europe | 1,748 | 949 | |||||
| Total antiviral products – Other International | 341 | 198 | |||||
| 6,988 | 4,509 | ||||||
| Other products: | |||||||
| Letairis | 151 | 123 | |||||
| Ranexa | 117 | 111 | |||||
| AmBisome | 85 | 92 | |||||
| Zydelig | 26 | — | |||||
| Other | 38 | 36 | |||||
| 417 | 362 | ||||||
| Total product sales | $ | 7,405 | $ | 4,871 | |||
Source:
Gilead Sciences, Inc.
Investors
Robin
Washington, 650-522-5688
Patrick O'Brien, 650-522-1936
Media
Amy
Flood, 650-522-5643