Press Releases
January 31, 2007
Gilead Sciences Announces Fourth Quarter and Full Year 2006 Financial Results
- Record Full Year Total Revenues of $3.03 Billion, Up 49 Percent
over 2005 -
- Record Full Year Product Sales of $2.59 Billion, Up 43 Percent
over 2005 -
- Fourth Quarter Net Loss Per Share of $(3.62); Fourth Quarter Non-GAAP Net Income Per Share of $0.78, excluding Purchased In-Process
Research and Development Charge -
FOSTER CITY, Calif.--(BUSINESS WIRE)--Jan. 31, 2007--Gilead Sciences, Inc. (Nasdaq:GILD) announced today its results of operations for the fourth quarter and full year of 2006. Total revenues for the fourth quarter of 2006 were $899.2 million, up 48 percent compared to total revenues of $609.3 million for the fourth quarter of 2005, while full year total revenues exceeded $3 billion for the first time. Net loss for the fourth quarter of 2006 was $1.67 billion, or $(3.62) per share, which included an acquisition-related charge of $2.04 billion for purchased in-process research and development (IPR&D) and after-tax stock-based compensation expense of $24.9 million reflecting the impact of the adoption of the Financial Accounting Standards Board's Statement No. 123 (revised 2004), "Share Based Payment" (SFAS 123R) on January 1, 2006. Net income for the fourth quarter of 2005 was $281.6 million, or $0.59 per diluted share. Non-GAAP net income for the fourth quarter of 2006 was $372.8 million, or $0.78 per diluted share, which excluded the impact of the purchased IPR&D charges. Non-GAAP net income for the fourth quarter of 2005 was $256.5 million, or $0.54 per diluted share, which excluded the tax benefit realized from the repatriation of foreign earnings under the American Jobs Creation Act.
Product Sales
Product sales were a record $768.1 million for the fourth quarter of 2006, up 56 percent over the same period in 2005, marking more than three years of consecutive quarterly product sales growth. For 2006, product sales were $2.59 billion compared to $1.81 billion in 2005, a 43 percent increase. This growth continued to be driven primarily by Gilead's HIV product franchise, including the strong uptake of Atripla(TM) (efavirenz 600 mg/ emtricitabine 200 mg/ tenofovir disoproxil fumarate 300 mg) following its launch in July 2006 in the United States, and continued strong performance of Truvada(R) (emtricitabine and tenofovir disoproxil fumarate) and Viread(R) (tenofovir disoproxil fumarate), as well as Hepsera(R) (adefovir dipivoxil).
HIV Franchise
HIV product sales were $642.4 million in the fourth quarter of 2006, a 67 percent increase from $384.8 million for the same period in 2005. For 2006, HIV product sales were $2.13 billion, an increase of 52 percent when compared to 2005.
-- Truvada
Truvada sales were $337.1 million for the fourth quarter of 2006, a 76 percent increase from $191.1 million in the fourth quarter of 2005. For 2006, Truvada sales were $1.19 billion, more than double the Truvada sales of $567.8 million in 2005. Truvada sales accounted for 52 percent of Gilead's total HIV product sales in the fourth quarter of 2006 and 56 percent for the full year, reflecting its strong position as the NRTI backbone of choice in the United States, as well as rapid and significant uptake in key European territories during 2006.
-- Viread
Viread sales were $159.5 million in the fourth quarter of 2006, a 13 percent decrease from $182.4 million in the fourth quarter of 2005. For 2006, Viread sales were $689.4 million compared to $778.8 million for 2005, a decrease of 11 percent. The decrease in the quarter and full year product sales was driven primarily by patients switching from a Viread-containing regimen to one containing Truvada in countries where Truvada is available, partially offset by sales volume increases in Latin America.
-- Atripla
Atripla sales were $137.4 million in the fourth quarter of 2006, an increase of 101 percent from $68.4 million in the third quarter of 2006, the quarter in which the product was launched.
-- Emtriva
Emtriva(R)(emtricitabine) sales were $8.5 million for the fourth quarter of 2006, a decrease of 24 percent from $11.2 million in the fourth quarter of 2005. For 2006, Emtriva sales were $36.4 million, a decrease of 23 percent from $47.5 million in 2005. Emtriva sales volume has decreased primarily from patients switching from an Emtriva-containing regimen to one containing Truvada in countries where Truvada is available.
AmBisome for Severe Fungal Infections
Sales of AmBisome(R)(amphotericin B) liposome for injection for the fourth quarter of 2006 were $58.3 million, an increase of five percent from $55.6 million for the fourth quarter of 2005. For 2006, AmBisome sales were $223.0 million, an increase of one percent from $220.8 million for 2005.
Hepsera for Chronic Hepatitis B
Hepsera sales were $65.9 million for the fourth quarter of 2006, a 29 percent increase from $51.2 million for the fourth quarter of 2005. For 2006, Hepsera sales were $230.5 million, an increase of 24 percent compared to $186.5 million in 2005. The increase in sales in the fourth quarter and full year of 2006 compared to the same periods of 2005 was primarily driven by strong volume growth in Europe.
Royalty, Contract and Other Revenue
For the fourth quarter of 2006, royalty, contract and other revenue resulting primarily from collaborations with corporate partners totaled $131.1 million, an increase of 13 percent, compared to $115.8 million in the fourth quarter of 2005. For 2006, royalty, contract and other revenue was $437.9 million, approximately twice the $219.1 million recognized in 2005. The increase in revenue during the fourth quarter and full year of 2006 compared to the same periods of 2005 was driven primarily by the recognition of Tamiflu(R) (oseltamivir phosphate) royalties from F. Hoffmann-La Roche Ltd (Roche) of $113.2 million and $364.6 million, respectively. Higher royalties were recognized from Roche for the fourth quarter and full year of 2006 as compared to the same periods of 2005 primarily due to the higher Tamiflu sales recorded by Roche, as well as the elimination of a contractual cost of goods adjustment that had historically reduced the amount of Tamiflu royalties recognized by Gilead.
"We are pleased to have achieved a very solid fourth quarter in 2006, including total revenues of almost $900 million," said John F. Milligan, PhD, Executive Vice President and Chief Financial Officer of Gilead. "Our total revenues for the full year 2006 have exceeded $3 billion, up 49 percent from 2005. This revenue growth is a result of continued strong uptake of Atripla, robust U.S. and international sales of Truvada, the solid performance of both Hepsera and AmBisome in increasingly competitive markets, and considerable growth in royalties recognized from worldwide Tamiflu sales. Significant total revenues coupled with our diligent focus on managing operating expenses have resulted in a record $1.2 billion in operating cash flow for the year."
Research and Development
Research and development (R&D) expenses for the fourth quarter of 2006 were $111.6 million, which included stock-based compensation expense of $14.1 million, compared to R&D expenses of $68.8 million for the same quarter in 2005. R&D expenses for 2006 were $383.9 million, which included stock-based compensation expense of $52.2 million, compared to R&D expenses of $277.7 million for 2005. The higher R&D expenses in the fourth quarter and full year of 2006 were primarily due to increased headcount, increased contract services and clinical study expenses from our clinical product development and research activities relating to our HIV and hepatitis programs and newly-acquired programs in respiratory and cardiopulmonary areas via the acquisitions of Corus Pharma, Inc. (Corus) and Myogen, Inc. (Myogen), as well as stock-based compensation expense from Gilead's adoption of SFAS 123R. These higher expenses were partially offset by lower milestone payments made to Japan Tobacco Inc. in 2006 compared to 2005 related to the licensing and development of Gilead's lead integrase inhibitor candidate, GS 9137, as well as a $15.0 million payment to Emory University (Emory) in 2005 in connection with the amendment of Gilead's license agreement with Emory related to the company's obligation to develop emtricitabine for the hepatitis B indication.
Selling, General and Administrative
Selling, general and administrative (SG&A) expenses for the fourth quarter of 2006 were $147.1 million, which included stock-based compensation expense of $19.0 million, compared to SG&A expenses of $106.5 million for the same quarter in 2005. SG&A expenses for 2006 were $573.7 million, which included stock-based compensation expense of $70.8 million, compared to SG&A expenses of $381.3 million for 2005. The higher SG&A expenses in the fourth quarter and full year of 2006 were primarily due to increased headcount and expenses driven by our business growth, our acquisitions of Corus and Myogen, and other business development activities, as well as stock-based compensation expense from Gilead's adoption of SFAS 123R.
Purchased In-Process Research and Development
Gilead recorded total charges associated with purchased IPR&D of $2.04 billion and $2.39 billion for the fourth quarter and full year of 2006, respectively, related to the IPR&D programs acquired from Corus and Myogen.
Cash, Cash Equivalents and Marketable Securities
As of December 31, 2006, Gilead had cash, cash equivalents and marketable securities of $1.39 billion. This compared to $2.31 billion as of December 31, 2005. The decrease in cash, cash equivalents and marketable securities of $921.5 million during the year was attributable primarily to $2.74 billion in net cash paid for the acquisitions of Myogen, Corus and Raylo Chemicals Inc. (Raylo), and $201.0 million paid toward principal on Gilead's term loan, partially offset by $1.22 billion of operating cash flows generated during the year and $587.6 million of net proceeds generated from the issuance of convertible senior notes and related transactions.
Other Balance Sheet Highlights
As of December 31, 2006, inventories were $564.1 million, an increase of $347.2 million from December 31, 2005, primarily driven by the manufacture of Atripla inventory in 2006, including an increase in inventory of efavirenz, the active pharmaceutical ingredient in Sustiva(R), which we purchased from Bristol-Myers Squibb (BMS) at BMS' approximate market value of Sustiva.
Corporate Highlights
In November 2006, Gilead announced that it completed its acquisition of Raylo, a subsidiary of Germany-based specialty chemicals company Degussa AG, for a total purchase price of $133.3 million. Gilead intends to utilize this Edmonton, Alberta-based site for process research and scale-up of clinical development candidates, the manufacture of active pharmaceutical ingredients for both investigational and commercial products and chemical development activities to improve existing commercial manufacturing processes.
Also in November 2006, Gilead announced that it completed its acquisition of Myogen for a total purchase price of $2.44 billion. Myogen's lead product candidate, ambrisentan, is an orally available endothelin receptor antagonist for the potential treatment of pulmonary arterial hypertension (PAH).
In December 2006, Gilead, the International Partnership for Microbicides (IPM) and CONRAD, a cooperating agency of USAID committed to improving reproductive health by expanding the contraceptive choices of women and men, announced an agreement under which Gilead granted to IPM and CONRAD the rights to develop, manufacture and, if proven efficacious, arrange for distribution in resource-limited countries of tenofovir as a topical microbicide to prevent infection with HIV.
Product and Pipeline Highlights
"Gilead continued to make significant progress in the fourth quarter, culminating another successful year for the company," said John C. Martin, PhD, President and Chief Executive Officer of Gilead. "We, along with our partners Bristol-Myers Squibb and Merck, filed for marketing approval of Atripla in the European Union. We hope to bring this once-daily single tablet regimen to the doctors and patients with HIV who are working and living in Europe. Through the completion of two significant acquisitions, we also began developing our respiratory and cardiopulmonary franchise. In December, we completed the filing of a New Drug Application (NDA) for marketing approval of ambrisentan for the once-daily treatment of pulmonary arterial hypertension and we continue to strive to provide solutions for patients suffering from life-threatening diseases."
HIV/AIDS Franchise
In October 2006, Gilead, Bristol-Myers Squibb Company and Merck & Co., Inc. announced the submission of a Marketing Authorisation Application to the European Medicines Agency seeking approval of Atripla in the European Union.
In December 2006, Gilead announced the publication of 96-week data from an ongoing clinical trial, Study 934, in the Journal of Acquired Immune Deficiency Syndromes (JAIDS). This study compares a once-daily regimen of Viread, Emtriva and Sustiva to a twice-daily regimen of Combivir(R) (lamivudine/zidovudine) with Sustiva once daily.
Respiratory and Cardiopulmonary Franchise
In December 2006, Gilead completed the submission of a New Drug Application to the U.S. Food and Drug Administration for marketing approval of ambrisentan for the once-daily treatment of PAH.
Also in December 2006, Gilead announced that its Phase III AIR-CF2 study of aztreonam lysine for inhalation for the treatment of people with cystic fibrosis who have pulmonary Pseudomonas aeruginosa met its primary efficacy endpoint, the time to need for inhaled or intravenous antibiotics, which was assessed by the onset of common symptoms predictive of a pulmonary exacerbation.
Conference Call
At 4:30 p.m. Eastern Time today, Gilead will webcast a conference call live on Gilead's website to discuss its fourth quarter 2006 results. During the call, Gilead will be discussing additional corporate, financial, statistical, product and pipeline information. That information can be found on Gilead's website at www.gilead.com under "Investors." To access the webcast via the internet, log on to www.gilead.com. Please connect to the company's website at least 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 1-800-901-5259 (U.S.) or 1-617-786-4514 (international) and dial the participant passcode 19934233 to access the call. Telephone replay is available approximately two hours after the call through February 2, 2007. To access, please call 1-888-286-8010 (U.S.) or 1-617-801-6888 (international) and dial the participant passcode 79206534. The webcast will be archived on www.gilead.com for one year.
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 worldwide. Headquartered in Foster City, California, Gilead has operations in North America, Europe and Australia.
Non-GAAP Financial Information
Non-GAAP net income and net income per diluted share for 2006 periods are presented excluding the impact of the IPR&D charges incurred in connection with the acquisitions of Corus and Myogen. Non-GAAP net income and net income per diluted share for 2005 periods are presented excluding the tax benefit realized from the repatriation of foreign earnings under the American Jobs Creation Act. Management believes this non-GAAP information is useful for investors, taken in conjunction with Gilead's GAAP financial statements, because it facilitates the comparison of current and prior period operating results after eliminating the effect of expense components that are individually material in a particular period but were not present in the prior period; additionally, management uses such information internally for its operating, budgeting and financial planning purposes. Non-GAAP financial information does not exclude stock-based compensation expense resulting from Gilead's adoption of SFAS 123R on January 1, 2006. Note 1 to the condensed consolidated statements of operations on page 6 of the attached press release continues to enable management and investors to understand the comparative impact of stock-based compensation expense on the various captions of the statements of operations in 2006. Non-GAAP information is not prepared under a comprehensive set of accounting rules and should only be used to supplement an understanding of the company's operating results as reported under GAAP.
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, which could cause actual results to differ materially. These risks and uncertainties include: our ability to successfully integrate the products and employees of Corus, Myogen and Raylo with Gilead; our ability to effectively utilize the site purchased from Raylo to improve existing commercial manufacturing processes; our ability to receive regulatory approvals, in a timely manner or at all, for new and current products, including Truvada, Atripla and ambrisentan; our ability to successfully develop our respiratory and cardiopulmonary franchise; safety and efficacy data from clinical studies of aztreonam lysine for inhalation may not warrant further development of this compound and initiating and completing clinical trials may take longer or cost more than expected; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission. 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 Annual Report on Form 10-K for the year ended December 31, 2005, its Quarterly Reports on Form 10-Q for the first, second and third quarters of 2006 and its current reports on Form 8-K. 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.
Viread, Emtriva, Truvada, AmBisome and Hepsera are registered trademarks of Gilead Sciences, Inc.
Atripla is a trademark of Bristol-Myers Squibb & Gilead Sciences, LLC.
Tamiflu is a registered trademark of F. Hoffmann-La Roche Ltd.
Sustiva is a registered trademark of Bristol-Myers Squibb Company.
Combivir is a registered trademark of GlaxoSmithKline Inc.
For more information on Gilead Sciences, 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 OPERATIONS
(unaudited)
(in thousands, except per share amounts)
Three months ended Year ended
December 31, December 31,
---------------------- ------------------------
2006 2005 2006 2005
------------ --------- ------------ -----------
Revenues:
Product sales $ 768,093 $493,426 $ 2,588,197 $1,809,299
Royalty, contract
and other revenue 131,133 115,840 437,942 219,101
------------ --------- ------------ -----------
Total revenues 899,226 609,266 3,026,139 2,028,400
Costs and expenses:
Cost of goods sold
(1) 155,289 74,144 433,320 260,326
Research and
development (1) 111,620 68,763 383,861 277,724
Selling, general
and administrative
(1)(2) 147,093 106,518 573,660 381,283
Purchased in-
process research
and development
(3) 2,038,483 - 2,394,051 -
------------ --------- ------------ -----------
Total costs and
expenses 2,452,485 249,425 3,784,892 919,333
------------ --------- ------------ -----------
Income (loss) from
operations (1,553,259) 359,841 (758,753) 1,109,067
Interest and other
income, net (2) 32,560 17,940 134,642 49,172
Interest expense (5,350) (392) (20,362) (442)
Minority interest in
joint venture 2,388 1,597 6,266 3,995
------------ --------- ------------ -----------
Income (loss) before
provision for income
taxes (1) (1,523,661) 378,986 (638,207) 1,161,792
Provision for income
taxes 141,986 97,384 551,750 347,878
------------ --------- ------------ -----------
Net income (loss) $(1,665,647) $281,602 $(1,189,957) $ 813,914
============ ========= ============ ===========
Net income (loss) per
share - basic $ (3.62) $ 0.61 $ (2.59) $ 1.79
============ ========= ============ ===========
Net income (loss) per
share - diluted $ (3.62) $ 0.59 $ (2.59) $ 1.72
============ ========= ============ ===========
Shares used in per
share calculation -
basic 460,099 458,538 459,106 454,339
============ ========= ============ ===========
Shares used in per
share calculation -
diluted (4) 460,099 479,175 459,106 474,284
============ ========= ============ ===========
---
Notes:
(1)On January 1, 2006, Gilead adopted SFAS 123R and recorded stock-
based compensation expense during the three months and year ended
December 31, 2006. The following is the stock-based compensation
expense recorded in the respective caption of the statements of
operations above:
Three months ended Year ended
December 31, 2006 December 31, 2006
--------------------- -----------------------
Stock-based
compensation
expense:
Cost of goods
sold $ 2,634 $ 10,870
Research and
development
expenses 14,055 52,163
Selling, general
and
administrative
expenses 18,993 70,793
Provision for
income taxes (10,778) (32,118)
--------- ------------
Total stock-
based
compensation
expense, net
of taxes $ 24,904 $ 101,708
========= ============
(2)Certain prior period amounts have been reclassified to be
consistent with current period presentation.
(3)For the quarter and year ended December 31, 2006, Gilead incurred
$2.04 billion and $2.39 billion, respectively, of purchased in-
process research and development as a result of the acquisitions
of Corus in August 2006 and Myogen in November 2006.
(4)The net loss per diluted share calculation for the quarter and year
ended December 31, 2006 does not include the effect of outstanding
stock options as they were antidilutive.
GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO NON-GAAP NET INCOME (LOSS)
(unaudited)
(in thousands, except per share amounts)
Below is a reconciliation of Gilead's GAAP net loss and diluted per
share amounts as reported in the attached press release. Non-GAAP
net income and net income per diluted share for 2006 periods are
presented excluding the impact of the purchased in-process research
and development charges incurred in connection with the acquisitions
of Myogen and Corus during the three months and year ended December
31, 2006. Management believes this non-GAAP information is useful
for investors, taken in conjunction with Gilead's GAAP financial
statements, because it facilitates the comparison of current and
prior period operating results after eliminating the effect of
expense components that are individually material in a particular
period but were not present in the prior period; additionally,
management uses such information internally for its operating,
budgeting and financial planning purposes. Non-GAAP financial
information does not exclude stock-based compensation expense
resulting from Gilead's adoption of SFAS 123R on January 1, 2006.
Note 1 to the condensed consolidated statements of operations on page
6 of the attached press release continues to enable management and
investors to understand the comparative impact of stock-based
compensation expense on the various captions of the statements of
operations in 2006. Non-GAAP information is not prepared under a
comprehensive set of accounting rules and should only be used to
supplement an understanding of the company's operating results as
reported under GAAP.
Three months ended Year ended
December 31, 2006 December 31, 2006
------------------ ------------------
Net loss (GAAP) $ (1,665,647) $ (1,189,957)
Purchased in-process research
and development expense 2,038,483 2,394,051
------------------ ------------------
Net income (Non-GAAP) $ 372,836 $ 1,204,094
================== ==================
Shares used in per share
calculation - diluted (GAAP) 460,099 459,106
Dilutive securities 18,667 19,197
------------------ ------------------
Shares used in per share
calculation - diluted (Non-
GAAP) 478,766 478,303
================== ==================
Net loss per share - diluted
(GAAP) $ (3.62) $ (2.59)
================== ==================
Net income per share - diluted
(Non-GAAP) $ 0.78 $ 2.52
================== ==================
GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
December 31, December 31,
2006 2005
------------ -------------
(unaudited) (Note 1)
Cash, cash equivalents and marketable
securities (2) $ 1,389,566 $ 2,311,033
Other current assets (2) 1,492,355 781,175
Property, plant and equipment, net 361,299 242,568
Other noncurrent assets 842,761 431,540
------------ -------------
Total assets $ 4,085,981 $ 3,766,316
============ =============
Current liabilities (2) $ 805,912 $ 465,163
Long-term liabilities and minority
interest (2) 1,464,351 273,375
Stockholders' equity 1,815,718 3,027,778
------------ -------------
Total liabilities and stockholders'
equity $ 4,085,981 $ 3,766,316
============ =============
Note:
(1) Derived from audited consolidated financial statements at that
date.
(2) Certain prior period amounts have been reclassified to be
consistent with current period presentation.
GILEAD SCIENCES, INC.
PRODUCT SALES SUMMARY
(unaudited)
(in thousands)
Three months ended Year ended
December 31, December 31,
--------------------- -----------------------
2006 2005 2006 2005
---------- ---------- ----------- -----------
HIV products:
Truvada - U.S. $ 196,291 $ 149,359 $ 785,301 $ 489,802
Truvada - International 140,766 41,790 408,991 78,027
---------- ---------- ----------- -----------
337,057 191,149 1,194,292 567,829
Viread - U.S. 71,863 77,561 294,302 337,444
Viread - International 87,652 104,873 395,054 441,339
---------- ---------- ----------- -----------
159,515 182,434 689,356 778,783
Atripla - U.S. 137,192 - 205,565 -
Atripla - International 164 - 164 -
---------- ---------- ----------- -----------
137,356 - 205,729 -
Emtriva - U.S. 3,694 4,476 17,078 19,576
Emtriva - International 4,800 6,694 19,315 27,910
---------- ---------- ----------- -----------
8,494 11,170 36,393 47,486
Total HIV products - U.S. 409,040 231,396 1,302,246 846,822
Total HIV products -
International 233,382 153,357 823,524 547,276
---------- ---------- ----------- -----------
642,422 384,753 2,125,770 1,394,098
Hepsera - U.S. 27,710 23,553 97,325 82,932
Hepsera - International 38,209 27,616 133,206 103,600
---------- ---------- ----------- -----------
65,919 51,169 230,531 186,532
AmBisome 58,291 55,596 223,031 220,753
Other products 1,461 1,908 8,865 7,916
---------- ---------- ----------- -----------
Total product sales $ 768,093 $ 493,426 $2,588,197 $1,809,299
========== ========== =========== ===========
CONTACT: Gilead Sciences, Inc.
John Milligan, 650-522-5756
Susan Hubbard, 650-522-5715
SOURCE: Gilead Sciences, Inc.