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8-K - 8-K - GILEAD SCIENCES INCform8-kq114earningspressre.htm


CONTACTS:
Investors
 
 
Media
 
Robin Washington
 
 
Amy Flood
 
(650) 522-5688
 
 
(650) 522-5643
 
 
 
 
 
 
Patrick O'Brien
 
 
 
 
(650) 522-1936    
 
 
 
 
 
 
 
 
For Immediate Release


GILEAD SCIENCES ANNOUNCES FIRST QUARTER 2014 FINANCIAL RESULTS

- Product Sales of $4.87 billion -
- Sovaldi Sales of $2.27 billion -
- Non-GAAP EPS of $1.48 per share -
- Reiterates Full Year 2014 Guidance -

Foster City, CA, April 22, 2014 - Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results of operations for the quarter ended March 31, 2014. Total revenues for the first quarter of 2014 increased to $5.00 billion from $2.53 billion for the first quarter of 2013. Product sales increased to $4.87 billion for the first quarter of 2014 compared to $2.39 billion for the first quarter of 2013. Net income for the first quarter of 2014 was $2.23 billion, or $1.33 per diluted share compared to $722.2 million, or $0.43 per diluted share for the first quarter of 2013. Non-GAAP net income for the first quarter of 2014, which excludes acquisition-related, restructuring and stock-based compensation expenses, was $2.49 billion, or $1.48 per diluted share compared to $801.9 million, or $0.48 per diluted share for the first quarter of 2013.
 
Three Months Ended
 
March 31,
(In thousands, except per share amounts)
2014
 
2013
Product sales
$
4,870,974

 
$
2,393,568

Royalty, contract and other revenues
127,982

 
138,067

Total revenues
$
4,998,956

 
$
2,531,635

 
 
 
 
Net income attributable to Gilead
$
2,227,410

 
$
722,186

Non-GAAP net income attributable to Gilead
$
2,487,809

 
$
801,943

 
 
 
 
Diluted EPS
$
1.33

 
$
0.43

Non-GAAP diluted EPS
$
1.48

 
$
0.48


Product Sales
Compared to the first quarter of 2013, U.S. product sales for the first quarter of 2014 increased to $3.63 billion from $1.40 billion and Europe product sales increased to $1.02 billion from $818.3 million.

- more -

Gilead Sciences, Inc. 333 Lakeside Drive Foster City, CA 94404 USA
www.gilead.com
phone (650) 574-3000 facsimile (650) 578-9264
 


April 22, 2014
 
2

Antiviral Product Sales
Antiviral product sales increased to $4.51 billion for the first quarter of 2014, up from $2.06 billion for the first quarter of 2013 largely due to sales of Sovaldi® (sofosbuvir 400 mg), which launched in December 2013, and increases in sales of Stribild® (elvitegravir 150 mg/cobicistat 150 mg/emtricitabine 200 mg/tenofovir disoproxil fumarate 300 mg) and Complera/Eviplera® (emtricitabine 200 mg/rilpivirine 25 mg/tenofovir disoproxil fumarate 300 mg). This increase was partially offset by a decrease in wholesaler and sub-wholesaler inventories in the United States associated primarily with our HIV products, which also impacted antiviral product sales in the first quarter of 2014 compared to the fourth quarter of 2013.
 
 
Three Months Ended
 
 
 
 
March 31,
 
 
(In thousands, except percentages)
 
2014
 
2013
 
% Change
Antiviral product sales
 
$
4,508,497

 
$
2,061,078

 
119
 %
Sovaldi
 
2,274,349

 

 
 %
Atripla
 
779,594

 
877,073

 
(11
)%
Truvada
 
759,700

 
700,242

 
8
 %
Complera/Eviplera
 
250,733

 
148,189

 
69
 %
Stribild
 
215,271

 
92,148

 
134
 %
Viread
 
210,625

 
210,332

 
 %

Cardiovascular Product Sales
Cardiovascular product sales increased to $234.5 million for the first quarter of 2014, up from $214.4 million for the first quarter of 2013 primarily driven by strong Ranexa® (ranolazine) sales.
 
 
Three Months Ended
 
 
 
 
March 31,
 
 
(In thousands, except percentages)
 
2014
 
2013
 
% Change
Cardiovascular product sales
 
$
234,503

 
$
214,393

 
9
%
Letairis
 
122,885

 
118,107

 
4
%
Ranexa
 
111,618

 
96,286

 
16
%

Operating Expenses and Other
During the first quarter of 2014, compared to the same period in 2013:
Non-GAAP research and development (R&D) expenses increased due to the progression of Gilead's clinical studies, particularly in oncology and HIV.
Non-GAAP selling, general and administrative (SG&A) expenses increased to support the expansion of Gilead's business, particularly in hepatitis C virus (HCV) and in preparation for the anticipated launch of idelalisib.
 
 
Three Months Ended
 
 
March 31,
(In thousands)
 
2014
 
2013
Non-GAAP research and development expenses
 
$
557,805

 
$
459,976

Non-GAAP selling, general and administrative expenses
 
$
500,105

 
$
333,064

Note: Non-GAAP R&D and SG&A expenses exclude the impact of acquisition-related, restructuring and stock-based compensation expenses.


- more -


April 22, 2014
 
3

Cash, Cash Equivalents and Marketable Securities
As of March 31, 2014, Gilead had $6.86 billion of cash, cash equivalents and marketable securities compared to $2.57 billion as of December 31, 2013. This increase was primarily due to the issuance of senior unsecured notes in March 2014 for a total aggregate principal amount of $4.00 billion. These proceeds will be for general corporate purposes, which may include the repayment of debt and related payments, working capital and the repurchase of outstanding common stock under the authorized share repurchase program. During the first three months of 2013, Gilead generated $1.57 billion in operating cash flow.

Full Year 2014 Guidance
Gilead reiterates its full year 2014 guidance, initially provided on February 4, 2014, which excludes the impact of Sovaldi product sales:
(In millions, except percentages and per share amounts)
 
Provided
February 4, 2014
Net Product Sales
 
$11,300 - $11,500
Non-GAAP*
 
 
Product Gross Margin
 
75% - 77%
R&D
 
$2,200 - $2,300
SG&A
 
$2,100 - $2,200
Effective Tax Rate
 
28% - 29%
 
 
 
Diluted EPS Impact of Acquisition-Related, Restructuring and Stock-Based Compensation Expenses
 
$0.63 - $0.66
* Non-GAAP product gross margin, expenses and effective tax rate exclude the impact of acquisition-related, restructuring and stock-based compensation expenses, where applicable.

Product & Pipeline Updates Announced by Gilead During the First Quarter of 2014 Include:
Antiviral Program
The European Commission granted marketing authorization for Sovaldi in combination with other antiviral agents ribavirin and pegylated interferon alpha in all 28 countries of the European Union.
Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for a once-daily fixed-dose combination of the NS5A inhibitor ledipasvir (LDV) 90 mg and the nucleotide analog polymerase inhibitor sofosbuvir (SOF) 400 mg for the treatment of chronic hepatitis C genotype 1 infection in adults for eight or 12 weeks, depending on prior treatment history and whether they have cirrhosis. The FDA has assigned LDV/SOF a Breakthrough Therapy designation, which is granted to investigational medicines that may offer major advances in treatment over existing options. The FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of October 10, 2014.
Announced that the company’s Marketing Authorisation Application for LDV/SOF has been fully validated and is now under assessment by the European Medicines Agency. The application was submitted on February 27, 2014.

Oncology Program
Announced FDA acceptance for review of the company’s NDA for idelalisib, a targeted, oral inhibitor of PI3K delta, for the treatment of relapsed chronic lymphocytic leukemia with priority review and a target review date under PDUFA of August 6, 2014 and for the treatment of refractory indolent non-Hodgkin’s lymphoma with a standard review and a target review date under PDUFA of September 11, 2014.


- more -


April 22, 2014
 
4

Conference Call
At 4:15 p.m. Eastern Time today, Gilead's management will host a conference call and a simultaneous webcast to discuss results from its first quarter 2014 as well as provide a general business update. To access the webcast live via the internet, please connect to the company's website at www.gilead.com 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 1-844-795-1482 (U.S.) or 1-931-229-4695 (international) and dial the conference ID 17493454 to access the call.

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 April 24, 2014. To access the phone replay, please call 1-855-859-2056 (U.S.) or 1-404-537-3406 (international) and dial the conference ID 17493454.

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 transform and simplify care for people with life-threatening illnesses around the word. Headquartered in Foster City, California, Gilead has operations in North and South America, Europe and Asia-Pacific.

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 table on pages 7 and 8.

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 2014 financial results; Gilead's ability to sustain growth in revenues for its antiviral, cardiovascular and respiratory 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, including in combination with other product candidates such as LDV; the levels of inventory held by wholesalers and retailers which may cause fluctuations in Gilead's earnings; Gilead's ability to submit NDAs 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 the fixed-dose combination of LDV/SOF and idelalisib; Gilead's ability to successfully commercialize its products, including Sovaldi, Stribild, Vitekta and Tybost; the risk that estimates of patients with HCV or anticipated patient demand may not be accurate; Gilead's ability to successfully develop its respiratory, cardiovascular and oncology/inflammation programs; safety and efficacy data from clinical studies may not warrant further development of Gilead's product candidates; 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; and other risks identified from time to time in Gilead's reports filed with the U.S. Securities and Exchange Commission (SEC). In addition, Gilead makes estimates and judgments that affect the reported amounts of assets, liabilities, revenues and expenses and related disclosures. Gilead bases its estimates on historical experience and on various other market specific and other relevant assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ significantly from these estimates. You are urged to consider statements that include the words may, will, would, could, should, might, believes, estimates, projects, potential, expects,

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April 22, 2014
 
5

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 press releases, Annual Report on Form 10-K for the year ended December 31, 2013 and other subsequent disclosure documents filed with the SEC. 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.

# # #
Gilead owns or has rights to various trademarks, copyrights and trade names used in our business, including the following: GILEAD®, GILEAD SCIENCES®, SOVALDI®, STRIBILD®, COMPLERA®, EVIPLERA®, TRUVADA®, VIREAD®, EMTRIVA®, TYBOST®, HEPSERA®, VITEKTA®, LETAIRIS®, RANEXA®, CAYSTON®, AMBISOME®, VISTIDE®, VOLIBRIS®, and RAPISCAN®.
 
ATRIPLA® is a registered trademark belonging to Bristol-Myers Squibb & Gilead Sciences, LLC. LEXISCAN® is a registered trademark belonging to Astellas U.S. LLC. MACUGEN® is a registered trademark belonging to Eyetech, Inc. SUSTIVA® is a registered trademark of Bristol-Myers Squibb Pharma Company. TAMIFLU® is a registered trademark belonging to Hoffmann-La Roche Inc.

For more information on Gilead Sciences, Inc., please visit www.gilead.com or
call the Gilead Public Affairs Department at 1-800-GILEAD-5 (1-800-445-3235).

- more -


April 22, 2014
 
6

GILEAD SCIENCES, INC.
CONSOLIDATED STATEMENTS OF INCOME
(unaudited)
(in thousands, except per share amounts)

 
 
Three Months Ended
 
 
March 31,
 
 
2014
 
2013
 Revenues:
 
 
 
 
 Product sales
 
$
4,870,974

 
$
2,393,568

 Royalty, contract and other revenues
 
127,982

 
138,067

 Total revenues
 
4,998,956

 
2,531,635

 Costs and expenses:
 
 
 
 
 Cost of goods sold
 
813,205

 
634,448

 Research and development
 
594,978

 
497,632

 Selling, general and administrative
 
548,123

 
374,296

 Total costs and expenses
 
1,956,306

 
1,506,376

 Income from operations
 
3,042,650

 
1,025,259

 Interest expense
 
(76,269
)
 
(81,787
)
 Other income (expense), net
 
(17,912
)
 
(3,324
)
 Income before provision for income taxes
 
2,948,469

 
940,148

 Provision for income taxes
 
725,882

 
222,438

 Net income
 
2,222,587

 
717,710

 Net loss attributable to noncontrolling interest
 
4,823

 
4,476

 Net income attributable to Gilead
 
$
2,227,410

 
$
722,186

 Net income per share attributable to Gilead common stockholders - basic
 
$
1.45

 
$
0.47

 Net income per share attributable to Gilead common stockholders - diluted
 
$
1.33

 
$
0.43

 Shares used in per share calculation - basic
 
1,536,525

 
1,521,372

 Shares used in per share calculation - diluted
 
1,679,871

 
1,665,060





April 22, 2014
 
7

GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION
(unaudited)
(in thousands, except percentages and per share amounts)
 
 
Three Months Ended
 
 
March 31,
 
 
2014
 
2013
Cost of goods sold reconciliation:
 
 
 
 
GAAP cost of goods sold
 
$
813,205

 
$
634,448

Stock-based compensation expenses
 
(2,642
)
 
(1,841
)
Acquisition related-amortization of purchased intangibles
 
(199,230
)
 
(21,264
)
Non-GAAP cost of goods sold
 
$
611,333

 
$
611,343

 
 
 
 
 
Product gross margin reconciliation:
 
 
 
 
GAAP product gross margin
 
83.3
%
 
73.5
%
Stock-based compensation expenses
 
0.1
%
 
0.1
%
Acquisition related-amortization of purchased intangibles
 
4.1
%
 
0.9
%
Non-GAAP product gross margin(1)
 
87.4
%
 
74.5
%
 
 
 
 
 
Research and development expenses reconciliation:
 
 
 
 
GAAP research and development expenses
 
$
594,978

 
$
497,632

Stock-based compensation expenses
 
(34,350
)
 
(26,875
)
Restructuring expenses
 
(145
)
 
(4,757
)
Acquisition related-contingent consideration remeasurement
 
(2,678
)
 
(6,024
)
Non-GAAP research and development expenses
 
$
557,805

 
$
459,976

 
 
 
 
 
Selling, general and administrative expenses reconciliation:
 
 
 
 
GAAP selling, general and administrative expenses
 
$
548,123

 
$
374,296

Stock-based compensation expenses
 
(45,233
)
 
(33,051
)
Restructuring expenses
 
(3
)
 
(744
)
Acquisition related-transaction costs
 
(448
)
 
(7,156
)
Acquisition related-amortization of purchased intangibles
 
(2,334
)
 
(281
)
Non-GAAP selling, general and administrative expenses
 
$
500,105

 
$
333,064

 
 
 
 
 
Operating margin reconciliation:
 
 
 
 
GAAP operating margin
 
60.9
%
 
40.5
%
Stock-based compensation expenses
 
1.6
%
 
2.4
%
Restructuring expenses
 
0.0
%
 
0.2
%
Acquisition related-transaction costs
 
0.0
%
 
0.3
%
Acquisition related-amortization of purchased intangibles
 
4.0
%
 
0.9
%
Acquisition related-contingent consideration remeasurement
 
0.1
%
 
0.2
%
Non-GAAP operating margin(1)
 
66.6
%
 
44.5
%
 
 
 
 
 
Other income (expense) reconciliation:
 
 
 
 
GAAP other income (expense), net
 
$
(17,912
)
 
$
(3,324
)
Acquisition related-transaction costs
 
(1,853
)
 

Non-GAAP other income (expense), net
 
$
(19,765
)
 
$
(3,324
)
 
 
 
 
 





April 22, 2014
 
8

GILEAD SCIENCES, INC.
RECONCILIATION OF GAAP TO NON-GAAP FINANCIAL INFORMATION - (Continued)
(unaudited)
(in thousands, except percentages and per share amounts)
 
 
Three Months Ended
 
 
March 31,
 
 
2014
 
2013
Effective tax rate reconciliation:
 
 
 
 
GAAP effective tax rate
 
24.6
 %
 
23.7
 %
Restructuring expenses
 
 %
 
(0.1
)%
Acquisition related-amortization of purchased intangibles
 
(1.4
)%
 
 %
Acquisition related-contingent consideration remeasurement
 
 %
 
(0.1
)%
Non-GAAP effective tax rate(1)
 
23.2
 %
 
23.5
 %
 
 
 
 
 
Net income attributable to Gilead reconciliation:
 
 
 
 
GAAP net income attributable to Gilead, net of tax
 
$
2,227,410

 
$
722,186

Stock-based compensation expenses
 
63,136

 
45,380

Restructuring expenses
 
148

 
5,368

Acquisition related-transaction costs
 
(975
)
 
7,156

Acquisition related-amortization of purchased intangibles
 
195,412

 
15,829

Acquisition related-contingent consideration remeasurement
 
2,678

 
6,024

Non-GAAP net income attributable to Gilead, net of tax
 
$
2,487,809

 
$
801,943

 
 
 
 
 
Diluted earnings per share reconciliation:
 
 
 
 
GAAP diluted earnings per share
 
$
1.33

 
$
0.43

Stock-based compensation expenses
 
0.04

 
0.03

Restructuring expenses
 
0.00

 
0.00

Acquisition related-transaction costs
 
(0.00
)
 
0.00

Acquisition related-amortization of purchased intangibles
 
0.12

 
0.01

Acquisition related-contingent consideration remeasurement
 
0.00

 
0.00

Non-GAAP diluted earnings per share(1)
 
$
1.48

 
$
0.48

 
 
 
 
 
Shares used in per share calculation (diluted) reconciliation:
 
 
 
 
GAAP shares used in per share calculation (diluted)
 
1,679,871

 
1,665,060

Share impact of current stock-based compensation rules
 
(911
)
 
(1,716
)
Non-GAAP shares used in per share calculation (diluted)
 
1,678,960

 
1,663,344

 
 
 
 
 
Non-GAAP adjustment summary:
 
 
 
 
Cost of goods sold adjustments
 
$
201,872

 
$
23,105

Research and development expenses adjustments
 
37,173

 
37,656

Selling, general and administrative expenses adjustments
 
48,018

 
41,232

Other income (expense) adjustments
 
(1,853
)
 

Total non-GAAP adjustments before tax
 
285,210

 
101,993

Income tax effect
 
(24,811
)
 
(22,236
)
Total non-GAAP adjustments after tax
 
$
260,399

 
$
79,757

 
 
 
 
 
(1) Amounts may not sum due to rounding.
 
 
 
 




April 22, 2014
 
9

GILEAD SCIENCES, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands)
 
 
March 31,
 
December 31,
 
 
2014
 
2013(1)
 
 
(unaudited)
 
 
Cash, cash equivalents and marketable securities
 
$
6,858,901

 
$
2,570,590

Accounts receivable, net
 
3,236,195

 
2,100,286

Inventories
 
2,140,228

 
2,055,788

Property, plant and equipment, net
 
1,303,029

 
1,166,181

Intangible assets, net
 
11,707,830

 
11,900,106

Goodwill
 
1,171,561

 
1,169,023

Other assets
 
1,659,948

 
1,534,811

Total assets
 
$
28,077,692

 
$
22,496,785

 
 
 
 
 
Current liabilities
 
$
5,914,776

 
$
6,325,421

Long-term liabilities
 
8,414,955

 
4,363,032

Equity component of currently redeemable convertible notes
 
45,767

 
63,831

Stockholders’ equity(2)
 
13,702,194

 
11,744,501

Total liabilities and stockholders’ equity
 
$
28,077,692

 
$
22,496,785

(1) Derived from the audited consolidated financial statements as of December 31, 2013.
(2) As of March 31, 2014, there were 1,537,642 shares of common stock issued and outstanding.





April 22, 2014
 
10

GILEAD SCIENCES, INC.
PRODUCT SALES SUMMARY
(unaudited)
(in thousands)
 
Three Months Ended
 
March 31,
 
2014
 
2013
Antiviral products:
 
 
 
 Sovaldi – U.S.
$
2,097,791

 
$

 Sovaldi – Europe
163,691

 

 Sovaldi – Other International
12,867

 

 
2,274,349

 

 
 
 
 
 Atripla – U.S.
489,929

 
553,826

 Atripla – Europe
236,508

 
278,215

 Atripla – Other International
53,157

 
45,032

 
779,594

 
877,073

 
 
 
 
 Truvada – U.S.
367,782

 
307,861

 Truvada – Europe
323,186

 
332,027

 Truvada – Other International
68,732

 
60,354

 
759,700

 
700,242

 
 
 
 
 Complera / Eviplera – U.S.
130,426

 
103,297

 Complera / Eviplera – Europe
108,994

 
38,962

 Complera / Eviplera – Other International
11,313

 
5,930

 
250,733

 
148,189

 
 
 
 
 Stribild – U.S.
187,090

 
91,978

 Stribild – Europe
23,630

 

 Stribild – Other International
4,551

 
170

 
215,271

 
92,148

 
 
 
 
 Viread – U.S.
81,053

 
82,628

 Viread – Europe
84,065

 
88,206

 Viread – Other International
45,507

 
39,498

 
210,625

 
210,332

 
 
 
 
 Hepsera – U.S.
2,230

 
12,950

 Hepsera – Europe
7,718

 
11,223

 Hepsera – Other International
1,775

 
2,250

 
11,723

 
26,423

 
 
 
 
 Emtriva – U.S.
4,817

 
4,529

 Emtriva – Europe
1,560

 
1,751

 Emtriva – Other International
125

 
391

 
6,502

 
6,671

 
 
 
 
 Total antiviral products – U.S.
3,361,118

 
1,157,069

 Total antiviral products – Europe
949,352

 
750,384

 Total antiviral products – Other International
198,027

 
153,625

 
4,508,497

 
2,061,078

 
 
 
 
 Letairis
122,885

 
118,107

 Ranexa
111,618

 
96,286

 AmBisome
92,093

 
85,275

 Other products
35,881

 
32,822

 
362,477

 
332,490

 
 
 
 
 Total product sales
$
4,870,974

 
$
2,393,568