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- Product Sales of
- Antiviral Product Sales of
Product Sales
Product sales increased 14 percent to
Antiviral Franchise
Antiviral product sales increased 14 percent to
- AtriplaSales of Atripla increased 10 percent to
$904.0 million for the second quarter of 2012, up from$822.0 million for the second quarter of 2011, reflecting sales growth of 12 percent in the U.S. and 5 percent inEurope .
- TruvadaSales of Truvada increased 10 percent to
$785.9 million for the second quarter of 2012, up from$711.3 million for the second quarter of 2011, reflecting sales growth of 18 percent in the U.S. and 2 percent inEurope .
- VireadSales of Viread® (tenofovir
disoproxil fumarate) increased 16 percent to
$215.4 million for the second quarter of 2012, up from$185.7 million for the second quarter of 2011, reflecting sales growth of 27 percent in the U.S. partially offset by a decrease of 2 percent inEurope .
- Complera/EvipleraSales of Complera/Eviplera
increased 40 percent to
$72.9 million during the second quarter of 2012 from$52.2 million for the first quarter of 2012. Complera was approved in the U.S. inAugust 2011 , and Eviplera was approved in theEuropean Union inNovember 2011 .
Letairis
Sales of Letairis® (ambrisentan) increased 38 percent to
Ranexa
Sales of Ranexa® (ranolazine) increased 11 percent to
Other Products
Sales of other products were
Royalty, Contract and Other Revenues
Royalty, contract and other revenues were
Research and Development
Research and development (R&D) expenses for the second quarter of 2012
were
Selling, General and Administrative
Selling, general and administrative (SG&A) expenses in the second
quarter of 2012 were
Interest Expense and Other Income (Expense), Net
Interest expense for the second quarter of 2012 was
Net Foreign Currency Exchange Impact
The net foreign currency exchange impact on second quarter 2012 product
sales and pre-tax earnings was an unfavorable
Cash,
As of June 30, 2012, Gilead had
Corporate Highlights
Antiviral Franchise
In April, Gilead announced interim data from the Phase 2 ATOMIC study
examining a 12-week course of treatment with the investigational
once-daily nucleotide GS-7977 plus pegylated interferon and ribavirin
(RBV) in treatment-naïve patients with genotype 1 chronic hepatitis C
virus (HCV) infection. The study found that 90 percent of patients
achieved a 12-week sustained virologic response (SVR12), defined as
maintaining undetectable viral load 12 weeks after the completion of
therapy. These findings were presented at the 47th Annual
Meeting of the
Also in April, Gilead announced interim data from the Phase 2 ELECTRON study examining GS-7977 plus RBV in treatment-naïve patients with genotype 1 chronic HCV infection. Of the 25 patients who completed 12 weeks of treatment, 88 percent achieved a four-week sustained virologic response (SVR4). Three patients experienced viral relapse. These findings were presented at EASL.
Lastly in April, Gilead announced interim results from the Phase 2 QUANTUM study examining a 12-week duration of GS-7977 plus RBV in treatment-naïve patients. Twenty-five patients were randomized to the 12-week treatment arm: 19 genotype 1 patients; four genotype 3 patients; and two genotype 2 patients. At the four-week post-treatment time period, data were available for 17 genotype 1 patients. Of these, 59 percent achieved SVR4 and 41 percent experienced viral relapse. Additionally, seven of the patients who reached the eight-week post-treatment time period, and who achieved SVR4, remained HCV RNA undetectable.
In May, Gilead announced that the
Also in May, Gilead announced that the Marketing Authorisation
Application (MAA) for cobicistat had been validated by the
In June, Gilead announced that its NDA and MAA for elvitegravir, an
integrase inhibitor for the treatment of HIV-1 infection in
treatment-experienced patients, had been submitted to the
Oncology Franchise
In May, Gilead announced that the first patient had been dosed in a Phase 3 clinical trial evaluating the efficacy and safety of GS-1101 in combination with rituximab in previously treated chronic lymphocytic leukemia patients. GS-1101 is an investigational, first-in-class specific inhibitor of the phosphoinositide-3 kinase delta isoform.
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
Non-GAAP Financial Information
Gilead has presented certain financial information in accordance with U.S. GAAP (GAAP) and also on a non-GAAP basis for the second quarter of 2012 and 2011. Management believes this non-GAAP information is useful for investors, taken in conjunction with Gilead's GAAP financial statements, because management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of Gilead's operating results as reported under U.S. GAAP. A reconciliation between GAAP and non-GAAP financial information is provided in the table on page 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 2012 financial results, including the possibility
that its full year 2012 guidance may be revised at a later date;
Gilead's ability to sustain growth in revenues for its antiviral,
cardiovascular and respiratory franchises; unpredictable variability of
Tamiflu royalties and the strong relationship between this royalty
revenue and global pandemic planning and supply; the availability of
funding for state ADAPs and their ability to purchase at levels to
support the number of patients that rely on 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 that the proportion of patients who
maintain a sustained virologic response 4 and 12 weeks post-treatment
will not be as favorable as the sustained virologic response rates
reported in this press release and the possibility of unfavorable
results from additional arms of the ATOMIC, ELECTRON and QUANTUM studies
and subsequent clinical trials involving GS-7977 and RBV and GS-7977
plus pegylated interferon and RBV; the levels of inventory held by
wholesalers and retailers which may cause fluctuations in Gilead's
earnings; Gilead's ability to submit NDAs and MAAs for new product
candidates in the timelines currently anticipated, including GS-7977 for
the treatment of HCV; Gilead's ability to receive regulatory approvals
in a timely manner or at all, for new and current products, including
Quad, cobicistat or elvitegravir; Gilead's ability to successfully
commercialize its products, including Complera/Eviplera; Gilead's
ability to successfully develop its respiratory, cardiovascular and
oncology franchises; safety and efficacy data from clinical studies may
not warrant further development of Gilead's product candidates,
including GS-7977 and GS-1101; the potential for additional austerity
measures in European countries that may increase the amount of discount
required on Gilead's products; 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;
Gilead's ability to advance Pharmasset's product pipeline or develop an
all-oral antiviral regimen for HCV; and other risks identified from time
to time in Gilead's reports filed with the
Truvada, Viread, Hepsera, Complera, Eviplera, Emtriva, AmBisome,
Letairis, Cayston, Ranexa and Volibris areregistered trademarks
of
Atripla is a registered trademark of
Tamiflu is a registered trademark of
For more information on
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED STATEMENTS OF INCOME (unaudited) (in thousands, except per share amounts) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||
| Revenues: | ||||||||||||||||
| Product sales | $ | 2,321,240 | $ | 2,039,588 | $ | 4,529,582 | $ | 3,903,166 | ||||||||
| Royalty, contract and other revenues | 83,946 | 97,665 | 158,053 | 160,181 | ||||||||||||
| Total revenues | 2,405,186 | 2,137,253 | 4,687,635 | 4,063,347 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods sold | 617,345 | 533,863 | 1,198,276 | 1,007,974 | ||||||||||||
| Research and development | 396,244 | 282,403 | 854,455 | 536,849 | ||||||||||||
| Selling, general and administrative | 332,505 | 304,269 | 775,626 | 599,837 | ||||||||||||
| Total costs and expenses | 1,346,094 | 1,120,535 | 2,828,357 | 2,144,660 | ||||||||||||
| Income from operations | 1,059,092 | 1,016,718 | 1,859,278 | 1,918,687 | ||||||||||||
| Interest expense | (88,418 | ) | (46,107 | ) | (185,688 | ) | (87,323 | ) | ||||||||
| Other income (expense), net | (1,075 | ) | 11,978 | (35,160 | ) | 25,810 | ||||||||||
| Income before provision for income taxes | 969,599 | 982,589 | 1,638,430 | 1,857,174 | ||||||||||||
| Provision for income taxes | 263,525 | 240,130 | 494,825 | 467,412 | ||||||||||||
| Net income | 706,074 | 742,459 | 1,143,605 | 1,389,762 | ||||||||||||
| Net loss attributable to noncontrolling interest | 5,490 | 3,768 | 9,915 | 7,606 | ||||||||||||
| Net income attributable to Gilead | $ | 711,564 | $ | 746,227 | $ | 1,153,520 | $ | 1,397,368 | ||||||||
| Net income per share attributable to Gilead common stockholders - basic | $ | 0.94 | $ | 0.95 | $ | 1.52 | $ | 1.77 | ||||||||
| Net income per share attributable to Gilead common stockholders - diluted | $ | 0.91 | $ | 0.93 | $ | 1.48 | $ | 1.73 | ||||||||
| Shares used in per share calculation - basic | 756,951 | 784,807 | 756,619 | 790,430 | ||||||||||||
| Shares used in per share calculation - diluted | 780,506 | 800,800 | 779,246 | 806,462 | ||||||||||||
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION (unaudited) (in thousands, except percentages and per share amounts) | ||||||||||||||||
| Three Months Ended | Six Months Ended | |||||||||||||||
| June 30, | June 30, | |||||||||||||||
| 2012 | 2011 | 2012 | 2011 | |||||||||||||
| Cost of goods sold reconciliation: | ||||||||||||||||
| GAAP cost of goods sold | $ | 617,345 | $ | 533,863 | $ | 1,198,276 | $ | 1,007,974 | ||||||||
| Stock-based compensation expenses | (2,119 | ) | (2,887 | ) | (4,220 | ) | (5,531 | ) | ||||||||
| Acquisition related-amortization of purchased intangibles | (15,836 | ) | (17,408 | ) | (31,672 | ) | (34,815 | ) | ||||||||
| Non-GAAP cost of goods sold | $ | 599,390 | $ | 513,568 | $ | 1,162,384 | $ | 967,628 | ||||||||
| Product gross margin reconciliation: | ||||||||||||||||
| GAAP product gross margin | 73.5 | % | 73.9 | % | 73.6 | % | 74.2 | % | ||||||||
| Stock-based compensation expenses | 0.1 | % | 0.1 | % | 0.1 | % | 0.1 | % | ||||||||
| Acquisition related-amortization of purchased intangibles | 0.7 | % | 0.9 | % | 0.7 | % | 0.9 | % | ||||||||
| Non-GAAP product gross margin(1) | 74.3 | % | 74.9 | % | 74.4 | % | 75.3 | % | ||||||||
| Research and development expenses reconciliation: | ||||||||||||||||
| GAAP research and development expenses | $ | 396,244 | $ | 282,403 | $ | 854,455 | $ | 536,849 | ||||||||
| Stock-based compensation expenses | (20,355 | ) | (19,420 | ) | (138,978 | ) | (36,140 | ) | ||||||||
| Restructuring expenses | (1,576 | ) | (767 | ) | (7,090 | ) | (554 | ) | ||||||||
| Acquisition related-transaction costs | (345 | ) | — | (345 | ) | (446 | ) | |||||||||
| Acquisition related-contingent consideration remeasurement | (2,570 | ) | 418 | (5,306 | ) | 418 | ||||||||||
| Non-GAAP research and development expenses | $ | 371,398 | $ | 262,634 | $ | 702,736 | $ | 500,127 | ||||||||
| Selling, general and administrative expenses reconciliation: | ||||||||||||||||
| GAAP selling, general and administrative expenses | $ | 332,505 | $ | 304,269 | $ | 775,626 | $ | 599,837 | ||||||||
| Stock-based compensation expenses | (25,929 | ) | (27,818 | ) | (147,873 | ) | (57,924 | ) | ||||||||
| Restructuring expenses | (7,251 | ) | 353 | (10,407 | ) | (1,666 | ) | |||||||||
| Acquisition related-transaction costs | (594 | ) | (365 | ) | (10,874 | ) | (743 | ) | ||||||||
| Non-GAAP selling, general and administrative expenses | $ | 298,731 | $ | 276,439 | $ | 606,472 | $ | 539,504 | ||||||||
| Operating margin reconciliation: | ||||||||||||||||
| GAAP operating margin | 44.0 | % | 47.6 | % | 39.7 | % | 47.2 | % | ||||||||
| Stock-based compensation expenses | 2.0 | % | 2.3 | % | 6.2 | % | 2.5 | % | ||||||||
| Restructuring expenses | 0.4 | % | 0.0 | % | 0.4 | % | 0.1 | % | ||||||||
| Acquisition related-transaction costs | — | % | 0.0 | % | 0.2 | % | 0.0 | % | ||||||||
| Acquisition related-amortization of purchased intangibles | 0.7 | % | 0.8 | % | 0.7 | % | 0.9 | % | ||||||||
| Acquisition related-contingent consideration remeasurement | 0.1 | % | — | 0.1 | % | 0.0 | % | |||||||||
| Non-GAAP operating margin(1) | 47.2 | % | 50.7 | % | 47.3 | % | 50.6 | % | ||||||||
| Interest expense reconciliation: | ||||||||||||||||
| GAAP interest expense | $ | (88,418 | ) | $ | (46,107 | ) | $ | (185,688 | ) | $ | (87,323 | ) | ||||
| Acquisition related-transaction costs | — | — | 7,333 | — | ||||||||||||
| Non-GAAP interest expense | $ | (88,418 | ) | $ | (46,107 | ) | $ | (178,355 | ) | $ | (87,323 | ) | ||||
| Net income attributable to Gilead reconciliation: | ||||||||||||||||
| GAAP net income attributable to Gilead, net of tax | $ | 711,564 | $ | 746,227 | $ | 1,153,520 | $ | 1,397,368 | ||||||||
| Stock-based compensation expenses | 35,236 | 37,915 | 264,840 | 74,529 | ||||||||||||
| Restructuring expenses | 6,426 | 324 | 12,772 | 1,661 | ||||||||||||
| Acquisition related-transaction costs | 651 | 365 | 13,542 | 1,189 | ||||||||||||
| Acquisition related-amortization of purchased intangibles | 11,529 | 13,170 | 23,119 | 26,053 | ||||||||||||
| Acquisition related-contingent consideration remeasurement | 1,871 | (313 | ) | 3,873 | (313 | ) | ||||||||||
| Non-GAAP net income attributable to Gilead, net of tax | $ | 767,277 | $ | 797,688 | $ | 1,471,666 | $ | 1,500,487 | ||||||||
| Diluted earnings per share reconciliation: | ||||||||||||||||
| GAAP diluted earnings per share | $ | 0.91 | $ | 0.93 | $ | 1.48 | $ | 1.73 | ||||||||
| Stock-based compensation expenses | 0.05 | 0.05 | 0.34 | 0.09 | ||||||||||||
| Restructuring expenses | 0.01 | — | 0.02 | — | ||||||||||||
| Acquisition related-transaction costs | — | 0.00 | 0.02 | 0.00 | ||||||||||||
| Acquisition related-amortization of purchased intangibles | 0.01 | 0.02 | 0.03 | 0.03 | ||||||||||||
| Acquisition related-contingent consideration remeasurement | 0.00 | (0.00 | ) | — | (0.00 | ) | ||||||||||
| Non-GAAP diluted earnings per share(1) | $ | 0.99 | $ | 1.00 | $ | 1.89 | $ | 1.87 | ||||||||
| Shares used in per share calculation (diluted) reconciliation: | ||||||||||||||||
| GAAP shares used in per share calculation (diluted) | 780,506 | 800,800 | 779,246 | 806,462 | ||||||||||||
| Share impact of current stock-based compensation rules | (1,573 | ) | (2,010 | ) | (1,671 | ) | (1,993 | ) | ||||||||
| Non-GAAP shares used in per share calculation (diluted) | 778,933 | 798,790 | 777,575 | 804,469 | ||||||||||||
| Non-GAAP adjustment summary: | ||||||||||||||||
| Cost of goods sold adjustments | $ | 17,955 | $ | 20,295 | $ | 35,892 | $ | 40,346 | ||||||||
| Research and development expenses adjustments | 24,846 | 19,769 | 151,719 | 36,722 | ||||||||||||
| Selling, general and administrative expenses adjustments | 33,774 | 27,830 | 169,154 | 60,333 | ||||||||||||
| Interest expense adjustments | — | — | 7,333 | — | ||||||||||||
| Total non-GAAP adjustments before tax | 76,575 | 67,894 | 364,098 | 137,401 | ||||||||||||
| Income tax effect | (20,862 | ) | (16,433 | ) | (45,952 | ) | (34,282 | ) | ||||||||
| Total non-GAAP adjustments after tax | $ | 55,713 | $ | 51,461 | $ | 318,146 | $ | 103,119 | ||||||||
| Note: | ||||||||||||||||
| (1) Amounts may not sum due to rounding | ||||||||||||||||
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED BALANCE SHEETS (in thousands) | |||||||
| June 30, | December 31, | ||||||
| 2012 | 2011 | ||||||
| (unaudited) | (Note 1) | ||||||
| Cash, cash equivalents and marketable securities | $ | 2,271,674 | $ | 9,963,972 | |||
| Accounts receivable, net | 1,702,818 | 1,951,167 | |||||
| Inventories | 1,603,401 | 1,389,983 | |||||
| Property, plant and equipment, net | 811,799 | 774,406 | |||||
| Intangible assets, net | 11,751,191 | 1,062,864 | |||||
| Goodwill | 1,078,919 | 1,004,102 | |||||
| Other assets | 1,282,148 | 1,156,640 | |||||
| Total assets | $ | 20,501,950 | $ | 17,303,134 | |||
| Current liabilities | $ | 4,986,674 | $ | 2,514,790 | |||
| Long-term liabilities | 7,431,889 | 7,920,995 | |||||
| Stockholders’ equity (Note 2) | 8,083,387 | 6,867,349 | |||||
| Total liabilities and stockholders’ equity | $ | 20,501,950 | $ | 17,303,134 | |||
| Notes: |
| (1) Derived from the audited consolidated financial statements as of December 31, 2011. |
| (2) As of June 30, 2012, there were 756,153 shares of common stock issued and outstanding. |
GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY (unaudited) (in thousands) | |||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||
| June 30, | June 30, | ||||||||||||||
| 2012 | 2011 | 2012 | 2011 | ||||||||||||
| Antiviral products: | |||||||||||||||
| Atripla – U.S. | $ | 570,835 | $ | 510,237 | $ | 1,132,879 | $ | 973,004 | |||||||
| Atripla – Europe | 280,125 | 267,153 | 550,821 | 520,210 | |||||||||||
| Atripla – Other International | 53,063 | 44,602 | 107,919 | 73,290 | |||||||||||
| 904,023 | 821,992 | 1,791,619 | 1,566,504 | ||||||||||||
| Truvada – U.S. | 393,013 | 334,064 | 766,339 | 654,177 | |||||||||||
| Truvada – Europe | 328,814 | 322,007 | 650,690 | 621,163 | |||||||||||
| Truvada – Other International | 64,106 | 55,230 | 127,167 | 109,072 | |||||||||||
| 785,933 | 711,301 | 1,544,196 | 1,384,412 | ||||||||||||
| Viread – U.S. | 102,112 | 80,228 | 183,768 | 152,708 | |||||||||||
| Viread – Europe | 84,108 | 86,123 | 168,993 | 162,135 | |||||||||||
| Viread – Other International | 29,194 | 19,366 | 54,346 | 39,269 | |||||||||||
| 215,414 | 185,717 | 407,107 | 354,112 | ||||||||||||
| Complera / Eviplera – U.S. | 65,004 | — | 113,643 | — | |||||||||||
| Complera / Eviplera – Europe | 7,198 | — | 10,465 | — | |||||||||||
| Complera / Eviplera – Other International | 707 | — | 981 | — | |||||||||||
| 72,909 | — | 125,089 | — | ||||||||||||
| Hepsera – U.S. | 8,172 | 14,765 | 20,981 | 28,639 | |||||||||||
| Hepsera – Europe | 15,420 | 20,582 | 29,385 | 42,070 | |||||||||||
| Hepsera – Other International | 2,599 | 3,309 | 5,122 | 6,043 | |||||||||||
| 26,191 | 38,656 | 55,488 | 76,752 | ||||||||||||
| Emtriva – U.S. | 4,770 | 3,914 | 8,863 | 7,816 | |||||||||||
| Emtriva – Europe | 1,741 | 1,705 | 3,552 | 3,390 | |||||||||||
| Emtriva – Other International | 1,302 | 1,113 | 2,175 | 2,102 | |||||||||||
| 7,813 | 6,732 | 14,590 | 13,308 | ||||||||||||
| Total Antiviral products – U.S. | 1,143,906 | 943,208 | 2,226,473 | 1,816,344 | |||||||||||
| Total Antiviral products – Europe | 717,406 | 697,570 | 1,413,906 | 1,348,968 | |||||||||||
| Total Antiviral products – Other International | 150,971 | 123,620 | 297,710 | 229,776 | |||||||||||
| 2,012,283 | 1,764,398 | 3,938,089 | 3,395,088 | ||||||||||||
| AmBisome | 83,653 | 88,625 | 168,417 | 167,131 | |||||||||||
| Letairis | 101,634 | 73,637 | 188,922 | 135,811 | |||||||||||
| Ranexa | 95,555 | 86,077 | 178,756 | 154,370 | |||||||||||
| Other products | 28,115 | 26,851 | 55,398 | 50,766 | |||||||||||
| 308,957 | 275,190 | 591,493 | 508,078 | ||||||||||||
| Total product sales | $ | 2,321,240 | $ | 2,039,588 | $ | 4,529,582 | $ | 3,903,166 | |||||||
Source:
Gilead Sciences, Inc.InvestorsRobin Washington, 650-522-5688Patrick O'Brien, 650-522-1936MediaAmy Flood, 650-522-5643
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