Press Releases
July 21, 2009
Gilead Sciences Announces Record Second Quarter 2009 Financial Results
Product Sales
Product sales increased 29 percent to a record
Antiviral Franchise
Antiviral product sales increased 26 percent to
- Truvada
Truvada sales increased 18 percent to
- Atripla
Atripla sales increased 60 percent to
- Other Antiviral Products
Other antiviral product sales, including Viread® (tenofovir
disoproxil fumarate), Hepsera® (adefovir dipivoxil) and
Emtriva® (emtricitabine), decreased six percent to
Letairis
Sales of Letairis® (ambrisentan) for the treatment of
pulmonary arterial hypertension increased 79 percent to
Ranexa
Sales of Ranexa® (ranolazine) for the treatment of chronic
angina were
Royalty, Contract and Other Revenues
Royalty, contract and other revenues resulting primarily from
collaborations with corporate partners were
Research and Development
Research and development (R&D) expenses in the second quarter of 2009
were
Selling, General and Administrative
Selling, general and administrative (SG&A) expenses in the second
quarter of 2009 were
Net Foreign Currency Exchange Impact
The net foreign currency exchange impact on second quarter 2009 revenues
and pre-tax earnings, which includes revenues and expenses generated
from outside
Cash,
As of
Acquisition of CV Therapeutics
In
Adoption of New Accounting Pronouncements
On
On
Product and Pipeline Update
Antiviral Franchise
In
Cardiovascular Franchise
In
In
Also in May, Gilead announced that the company’s Marketing Authorisation
Application (MAA) for regadenoson, an investigational pharmacologic
stress agent for radionuclide myocardial perfusion imaging, was
validated and accepted for review by the
Respiratory Franchise
In
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
Non-GAAP net income attributable to Gilead and net income attributable
to Gilead per diluted share for the three and six months ended
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 sustain
growth in revenues for its antiviral and cardiovascular franchises;
unpredictable variability of Tamiflu royalties and the strong
relationship between this royalty revenue and global pandemic planning
and supply; Gilead’s ability to receive regulatory approvals in a timely
manner or at all, for new and current products, including GS 9350, a
single-tablet fixed-dose regimen containing elvitegravir, GS 9350 and
Truvada, darusentan, ambrisentan for pulmonary hypertension,
regadenoson, or aztreonam lysine; Gilead’s ability to successfully
commercialize any products that receive regulatory approvals; Gilead’s
ability to successfully develop its respiratory and cardiovascular
franchises; initiating and completing clinical trials may take longer or
cost more than expected; fluctuations in the foreign exchange rate of
the U.S. dollar that may reduce or eliminate the favorable foreign
currency exchange impact on Gilead’s future revenues and pre-tax
earnings; our ability to consummate additional purchases under our share
repurchase program due to changes in our stock price, corporate or other
market conditions; risks and uncertainties related to Gilead’s ability
to successfully integrate the products and employees of Gilead and CV
Therapeutics, including its ability to increase sales of CV
Therapeutics’ approved products and its ability to advance pipeline
programs; and other risks identified from time to time in Gilead’s
reports filed with the
Gilead directs readers to its Annual Report on Form 10-K for the year
ended
Truvada, Viread, Hepsera, AmBisome, Letairis and Ranexa are
registered 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, | ||||||||||||||||
| 2009 | 2008 | 2009 | 2008 | ||||||||||||||
| Revenues: | |||||||||||||||||
| Product sales | $ | 1,568,378 | $ | 1,217,216 | $ | 3,015,958 | $ | 2,358,522 | |||||||||
| Royalty, contract and other revenues | 78,777 | 60,909 | 161,657 | 177,755 | |||||||||||||
| Total revenues | 1,647,155 | 1,278,125 | 3,177,615 | 2,536,277 | |||||||||||||
| Costs and expenses: | |||||||||||||||||
| Cost of goods sold | 383,045 | 265,684 | 712,459 | 505,532 | |||||||||||||
| Research and development | 241,638 | 176,542 | 430,417 | 331,843 | |||||||||||||
| Selling, general and administrative | 261,411 | 219,533 | 465,362 | 414,490 | |||||||||||||
| Purchased in-process research and development | - | 10,851 | - | 10,851 | |||||||||||||
| Total costs and expenses | 886,094 | 672,610 | 1,608,238 | 1,262,716 | |||||||||||||
| Income from operations | 761,061 | 605,515 | 1,569,377 | 1,273,561 | |||||||||||||
| Interest and other income, net | 12,923 | 14,026 | 17,081 | 36,726 | |||||||||||||
| Interest expense (1) | (18,484 | ) | (16,428 | ) | (35,155 | ) | (32,429 | ) | |||||||||
| Income before provision for income taxes | 755,500 | 603,113 | 1,551,303 | 1,277,858 | |||||||||||||
| Provision for income taxes (1) | 186,355 | 170,490 | 395,582 | 358,810 | |||||||||||||
| Net income (2) | 569,145 | 432,623 | 1,155,721 | 919,048 | |||||||||||||
| Net loss attributable to noncontrolling interest (2) | 2,253 | 2,160 | 4,789 | 4,035 | |||||||||||||
| Net income attributable to Gilead (2) | $ | 571,398 | $ | 434,783 | $ | 1,160,510 | $ | 923,083 | |||||||||
| Net income per share attributable to Gilead common stockholders - basic (2) | $ | 0.63 | $ | 0.47 | $ | 1.28 | $ | 1.00 | |||||||||
| Net income per share attributable to Gilead common stockholders - diluted (2) | $ | 0.61 | $ | 0.45 | $ | 1.24 | $ | 0.96 | |||||||||
| Shares used in per share calculation - basic | 905,611 | 922,796 | 907,684 | 925,455 | |||||||||||||
| Shares used in per share calculation - diluted | 934,478 | 965,663 | 938,500 | 966,087 | |||||||||||||
| Notes: | |||||||||||||||||
| (1) | On January 1, 2009, Gilead adopted FSP APB 14-1 on a retrospective basis for its convertible senior notes and reflected additional after-tax interest expense of $8.5 million and $8.0 million for the three months ended June 30, 2009 and 2008, respectively, and reflected additional after-tax interest expense of $16.8 million and $15.9 million for the six months ended June 30, 2009 and 2008, respectively. | ||||||||||||||||
| (2) | On January 1, 2009, Gilead adopted SFAS 160 and presented on a retrospective basis its noncontrolling interest (formerly minority interest) as net loss attributable to noncontrolling interest which is a component of consolidated net income. | ||||||||||||||||
| GILEAD SCIENCES, INC. | |||||||||||||||||
| RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION | |||||||||||||||||
| (unaudited) | |||||||||||||||||
| (in thousands, except per share amounts) | |||||||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||||||
| June 30, | June 30, | ||||||||||||||||
| 2009 | 2008 | 2009 | 2008 | ||||||||||||||
| Net income attributable to Gilead (GAAP) | $ | 571,398 | $ | 434,783 | $ | 1,160,510 | $ | 923,083 | |||||||||
| Acquisition-related transaction costs | 8,165 | - | 8,165 | - | |||||||||||||
| Acquisition-related amortization of inventory mark-up | 2,659 | - | 2,659 | - | |||||||||||||
| Acquisition-related amortization of purchased intangibles | 8,909 | - | 8,909 | - | |||||||||||||
| Restructuring expenses | 17,792 | - | 17,792 | - | |||||||||||||
| Stock-based compensation expenses | 39,961 | 26,409 | 70,249 | 52,410 | |||||||||||||
| Purchased in-process research and development expense | - | 7,769 | - | 7,769 | |||||||||||||
| Net income attributable to Gilead (Non-GAAP) | $ | 648,884 | $ | 468,961 | $ | 1,268,284 | $ | 983,262 | |||||||||
| Net income per share attributable to Gilead common stockholders - diluted (GAAP) | $ | 0.61 | $ | 0.45 | $ | 1.24 | $ | 0.96 | |||||||||
| Acquisition-related transaction costs |
0.01 |
- | 0.01 | - | |||||||||||||
| Acquisition-related amortization of inventory mark-up |
0.00 |
- |
0.00 |
- | |||||||||||||
| Acquisition-related amortization of purchased intangibles | 0.01 | - | 0.01 | - | |||||||||||||
| Restructuring expenses | 0.02 | - | 0.02 | - | |||||||||||||
| Stock-based compensation expenses | 0.04 | 0.03 | 0.07 | 0.05 | |||||||||||||
| Purchased in-process research and development expense | - | 0.01 | - | 0.01 | |||||||||||||
| Net income per share attributable to Gilead common stockholders - diluted (Non-GAAP) (1) | $ | 0.69 | $ | 0.48 | $ | 1.35 | $ | 1.02 | |||||||||
| Shares used in per share calculation - diluted (GAAP) | 934,478 | 965,663 | 938,500 | 966,087 | |||||||||||||
| Effect of SFAS 123R | 28 | 2,403 | 397 | 2,223 | |||||||||||||
| Shares used in per share calculation - diluted (Non-GAAP) | 934,506 | 968,066 | 938,897 | 968,310 | |||||||||||||
| Research and development expenses (GAAP) | $ | 241,638 | $ | 176,542 | $ | 430,417 | $ | 331,843 | |||||||||
| Restructuring expenses | (11,251 | ) | - | (11,251 | ) | - | |||||||||||
| Stock-based compensation expenses | (24,321 | ) | (15,370 | ) | (41,276 | ) | (32,265 | ) | |||||||||
| Research and development expenses (Non-GAAP) | $ | 206,066 | $ | 161,172 | $ | 377,890 | $ | 299,578 | |||||||||
| Selling, general and administrative expenses (GAAP) | $ | 261,411 | $ | 219,533 | $ | 465,362 | $ | 414,490 | |||||||||
| Acquisition-related transaction costs | (8,165 | ) | - | (8,165 | ) | - | |||||||||||
| Restructuring expenses | (12,855 | ) | - | (12,855 | ) | - | |||||||||||
| Stock-based compensation expenses | (27,189 | ) | (18,657 | ) | (48,025 | ) | (36,204 | ) | |||||||||
| Selling, general and administrative expenses (Non-GAAP) | $ | 213,202 | $ | 200,876 | $ | 396,317 | $ | 378,286 | |||||||||
| Note: | |||||||||||||||||
| (1) Amounts may not sum due to rounding | |||||||||||||||||
| GILEAD SCIENCES, INC. | |||||||
| CONDENSED CONSOLIDATED BALANCE SHEETS | |||||||
| (in thousands) | |||||||
| June 30, | December 31, | ||||||
| 2009 | 2008 | ||||||
| (unaudited) | (Note 2) | ||||||
| Cash, cash equivalents and marketable securities | $ | 2,898,446 | $ | 3,239,639 | |||
| Accounts receivable, net | 1,242,899 | 1,023,397 | |||||
| Inventories | 969,971 | 927,868 | |||||
| Property, plant and equipment, net | 697,426 | 528,799 | |||||
| Intangible assets (1) | 1,570,790 | 123,008 | |||||
| Other assets (3) | 1,007,560 | 1,094,120 | |||||
| Total assets | $ | 8,387,092 | $ | 6,936,831 | |||
| Current liabilities | $ | 1,777,882 | $ | 1,220,992 | |||
| Long-term liabilities (3)(4) | 1,295,241 | 1,250,256 | |||||
| Stockholders’ equity (3)(4) | 5,313,969 | 4,465,583 | |||||
| Total liabilities and stockholders’ equity | $ | 8,387,092 | $ | 6,936,831 | |||
| Note: | |||||||
| (1) | In April 2009, Gilead acquired CV Therapeutics for $1.39 billion. Gilead allocated the purchase price in accordance with SFAS 141R and recorded $951.2 million in intangible assets relating to marketable products, which constituted a significant portion of the purchase price allocation. | ||||||
| (2) | Derived from audited consolidated financial statements at that date adjusted for retrospective application of FSP APB 14-1 and SFAS 160 per notes 3 and 4 below. | ||||||
| (3) | On January 1, 2009, Gilead adopted FSP APB 14-1 on a retrospective basis for its convertible senior notes. As of December 31, 2008, the retrospective adoption of FSP APB 14-1 decreased deferred tax assets and debt issuance costs included in other assets by an aggregate of $81.7 million, decreased convertible senior notes included in long-term liabilities by $201.8 million, and increased total stockholders’ equity by $120.1 million after a charge of $82.6 million to retained earnings. | ||||||
| (4) | On January 1, 2009, Gilead adopted SFAS 160 and reclassified its noncontrolling interest (formerly minority interest) of $193.0 million from liabilities to stockholders’ equity on a retrospective basis. | ||||||
| GILEAD SCIENCES, INC. | |||||||||||||
| PRODUCT SALES SUMMARY | |||||||||||||
| (unaudited) | |||||||||||||
| (in thousands) | |||||||||||||
|
|
|||||||||||||
| Three Months Ended | Six Months Ended | ||||||||||||
| June 30, | June 30, | ||||||||||||
| 2009 | 2008 | 2009 | 2008 | ||||||||||
| Antiviral products: | |||||||||||||
| Truvada – U.S. | $ | 285,688 | $ | 236,402 | $ | 566,685 | $ | 474,934 | |||||
| Truvada – Europe | 287,777 | 240,911 | 566,217 | 459,278 | |||||||||
| Truvada – Other International | 34,614 | 38,836 | 65,530 | 61,322 | |||||||||
| 608,079 | 516,149 | 1,198,432 | 995,534 | ||||||||||
| Atripla – U.S. | 398,044 | 312,392 | 772,176 | 618,877 | |||||||||
| Atripla – Europe | 154,835 | 37,504 | 279,614 | 51,699 | |||||||||
| Atripla – Other International | 16,263 | 5,205 | 27,235 | 8,742 | |||||||||
| 569,142 | 355,101 | 1,079,025 | 679,318 | ||||||||||
|
|
|||||||||||||
| Viread – U.S. | 67,858 | 58,414 | 137,447 | 121,482 | |||||||||
| Viread – Europe | 66,009 | 61,273 | 131,340 | 126,989 | |||||||||
| Viread – Other International | 25,058 | 30,994 | 50,743 | 54,877 | |||||||||
| 158,925 | 150,681 | 319,530 | 303,348 | ||||||||||
| Hepsera – U.S. | 22,771 | 34,581 | 48,423 | 65,856 | |||||||||
| Hepsera – Europe | 40,797 | 50,531 | 79,714 | 98,994 | |||||||||
| Hepsera – Other International | 3,506 | 5,253 | 11,651 | 8,537 | |||||||||
| 67,074 | 90,365 | 139,788 | 173,387 | ||||||||||
|
|
|||||||||||||
| Emtriva – U.S. | 3,716 | 4,106 | 7,346 | 7,944 | |||||||||
| Emtriva – Europe | 2,210 | 2,094 | 4,506 | 4,675 | |||||||||
| Emtriva – Other International | 1,170 | 1,888 | 2,420 | 3,858 | |||||||||
| 7,096 | 8,088 | 14,272 | 16,477 | ||||||||||
|
|
|
||||||||||||
| Total Antiviral products – U.S. | 778,077 | 645,895 | 1,532,077 | 1,289,093 | |||||||||
| Total Antiviral products – Europe | 551,628 | 392,313 | 1,061,391 | 741,635 | |||||||||
| Total Antiviral products – Other International | 80,611 | 82,176 | 157,579 | 137,336 | |||||||||
| 1,410,316 | 1,120,384 | 2,751,047 | 2,168,064 | ||||||||||
|
|
|
||||||||||||
| AmBisome | 73,310 | 69,768 | 137,581 | 140,796 | |||||||||
| Letairis | 44,128 | 24,686 | 83,708 | 45,023 | |||||||||
| Ranexa | 36,065 | - | 36,065 | - | |||||||||
| Other products | 4,559 | 2,378 | 7,557 | 4,639 | |||||||||
| 158,062 | 96,832 | 264,911 | 190,458 | ||||||||||
|
|
|
||||||||||||
| Total product sales | $ | 1,568,378 | $ | 1,217,216 | $ | 3,015,958 | $ | 2,358,522 | |||||
Source:
Gilead Sciences, Inc.
Robin Washington, 650-522-5688 (Investors)
Susan
Hubbard, 650-522-5715 (Investors)
Amy Flood, 650-522-5643 (Media)