- Product Sales of $5.2 billion --
Diluted EPS of $1.54 per share -- Non-GAAP Diluted EPS of
$1.76 per share -- Reiterates Full Year 2019 Guidance
-
Gilead Sciences, Inc. (Nasdaq: GILD) announced today its results
of operations for the first quarter ended March 31, 2019. The
financial results that follow represent a year-over-year comparison
of the first quarter 2019 to the first quarter 2018. Total revenues
were $5.3 billion in 2019 compared to $5.1 billion in 2018. Net
income was $2.0 billion or $1.54 per diluted share in 2019 compared
to $1.5 billion or $1.17 per diluted share in 2018. Non-GAAP net
income was $2.3 billion or $1.76 per diluted share in 2019 compared
to $2.0 billion or $1.48 per diluted share in 2018.
Three Months Ended March 31, (In millions, except
per share amounts) 2019 2018 Product sales
$ 5,200 $ 5,001 Royalty, contract and other revenues 81 87
Total revenues $ 5,281 $ 5,088 Net income
attributable to Gilead $ 1,975 $ 1,538 Non-GAAP net income $ 2,258
$ 1,958 Diluted earnings per share $ 1.54 $ 1.17 Non-GAAP
diluted earnings per share $ 1.76 $ 1.48
Product Sales
Total product sales for the first quarter of 2019 were $5.2
billion compared to $5.0 billion for the same period in 2018.
Product sales for the first quarter of 2019 were $3.8 billion in
the United States, $882 million in Europe and $522 million in other
locations. Product sales for the first quarter of 2018 were $3.5
billion in the United States, $1.0 billion in Europe and $469
million in other locations.
___________________________________
Note: Non-GAAP financial information excludes
acquisition-related, up-front collaboration, stock-based
compensation and other expenses, fair value adjustments of equity
securities and discrete tax charges or benefits associated with
changes in tax related laws and guidelines. A reconciliation
between GAAP and non-GAAP financial information is provided in the
tables on pages 8 through 10.
- HIV product sales were $3.6
billion for the first quarter of 2019 compared to $3.2 billion for
the same period in 2018. The increase was primarily driven by
higher sales volume as a result of the continued uptake of
Biktarvy® (bictegravir 50 mg/emtricitabine 200 mg/tenofovir
alafenamide 25 mg).
- Chronic hepatitis C virus (HCV)
product sales were $790 million for the first quarter of 2019
compared to $1.0 billion for the same period in 2018. The decline
was primarily due to lower patient starts and competitive dynamics,
including a decline in price in U.S. Medicare, in 2019.
- Yescarta® (axicabtagene
ciloleucel), which was approved in the United States in October
2017 and Europe in August 2018, generated $96 million in sales
during the first quarter of 2019 compared to $40 million for the
same period in 2018. The increase was driven by an increase in the
number of therapies provided to patients.
- Other product sales, which include
products from Gilead’s chronic hepatitis B virus (HBV),
cardiovascular, oncology and other categories inclusive of Vemlidy®
(tenofovir alafenamide 25 mg), Viread® (tenofovir disoproxil
fumarate 300 mg), Letairis® (ambrisentan 5 mg and 10 mg), Ranexa®
(ranolazine 500 mg and 1000 mg), Zydelig® (idelalisib 150 mg) and
AmBisome® (amphotericin B liposome for injection 50 mg/vial), were
$696 million for the first quarter of 2019 compared to $745 million
for the same period in 2018. The decrease was primarily due to the
expected decline in Ranexa sales after generic entry in the first
quarter of 2019.
Operating Expenses
Three Months Ended March 31, (In
millions) 2019 2018 Research and
development expenses (R&D) $ 1,057 $ 937 Non-GAAP R&D
expenses $ 871 $ 814 Selling, general and administrative
expenses (SG&A) $ 1,030 $ 997 Non-GAAP SG&A expenses $ 962
$ 884
During the first quarter of 2019, compared to the same period in
2018:
- R&D expenses increased primarily
due to up-front collaboration expenses and higher investments to
support Gilead’s cell therapy programs partially offset by lower
stock-based compensation expense. Stock-based compensation expense
was higher for the first quarter of 2018 following the acquisition
of Kite Pharma, Inc. (Kite).
- Non-GAAP R&D expenses increased
primarily due to higher investments to support Gilead’s cell
therapy programs.
- SG&A expenses increased primarily
due to higher promotional expenses in the United States and
expenses associated with the expansion of Gilead’s products in
Europe and Japan, partially offset by lower stock-based
compensation expense. Stock-based compensation expense was higher
for the first quarter of 2018 following the acquisition of
Kite.
- Non-GAAP SG&A expenses increased
primarily due to higher promotional expenses in the United States
and expenses associated with the expansion of Gilead’s products in
Europe and Japan.
Effective Tax Rate
The effective tax rate and non-GAAP effective tax rate in the
first quarter of 2019 were 16.3% and 16.7% compared to 24.3% and
22.8% for the same period in 2018, respectively. The decreases were
primarily due to favorable settlements with taxing authorities. For
the full year 2019, Gilead reiterates its effective tax rate
guidance and non-GAAP effective tax rate guidance to be in the
range of 21.5% - 22.5% and 20.0% - 21.0%, respectively.
Cash, Cash Equivalents and Marketable
Debt Securities
As of March 31, 2019, Gilead had $30.1 billion of cash, cash
equivalents and marketable debt securities, compared to $31.5
billion as of December 31, 2018. During the first quarter of 2019,
Gilead generated $1.4 billion in operating cash flow, repaid $750
million of debt, paid cash dividends of $817 million and utilized
$834 million on stock repurchases.
Full Year 2019 Guidance
Reiterated
Gilead reiterates its full year 2019 guidance, initially
provided on February 4, 2019. The guidance for product sales
reflects the anticipated entry of generic versions of Letairis and
Ranexa in the United States and the full year impact of generic
products containing tenofovir disoproxil fumarate in certain
European countries.
(In millions, except percentages and per share amounts)
Initially ProvidedFebruary 4, 2019 Net Product
Sales $21,300 - $21,800 Non-GAAP Product Gross Margin 85% - 87%
R&D Expenses $3,600 - $3,800 SG&A Expenses $3,900 - $4,100
Effective Tax Rate 20.0% - 21.0% Diluted EPS Impact of
Acquisition-related, Up-front Collaboration, Stock-based
Compensation and Other Expenses $1.40 - $1.50
Corporate Highlights, Including the
Announcement of:
- HepConnect, a five-year, multi-million
dollar initiative aimed at addressing the sharp increase in chronic
HCV infections fueled by the nation’s opioid crisis. In partnership
with the Harm Reduction Coalition and local organizations, the
initiative will support evidence-based solutions to meet the needs
of people most affected by the opioid crisis in Indiana, Kentucky,
North Carolina, Tennessee and West Virginia.
- The departure of Alessandro Riva, MD,
Executive Vice President, Oncology Therapeutics, who left Gilead to
become CEO of another pharmaceutical company.
- The Gilead HIV Age Positively
initiative, which will provide $17.6 million in grants to 30
organizations in the United States. This effort aims to enhance the
lives of individuals aging with HIV by focusing in three priority
areas: improving care coordination, increasing resources for better
well-being and educating and informing policies that impact people
living and aging with HIV.
Product and Pipeline Updates, Including
the Announcement of:
Inflammation Program
- Week 24 results of FINCH 1, an ongoing,
randomized, double-blind, placebo- and active-controlled Phase 3
study of filgotinib, an investigational, oral, selective JAK1
inhibitor, in adults with moderately-to-severely active rheumatoid
arthritis (RA). FINCH 1 evaluated filgotinib versus adalimumab or
placebo, on a stable background dose of methotrexate in patients
with prior inadequate response to methotrexate. The study achieved
its primary endpoint for both doses of filgotinib in the proportion
of patients achieving an American College of Rheumatology 20%
response (ACR20) compared to placebo at week 12.
- Week 24 results of FINCH 3, an ongoing,
randomized, double-blind, active-controlled Phase 3 study of
filgotinib in adults with moderately-to-severely active RA. FINCH 3
evaluated filgotinib in combination with methotrexate (MTX) and as
monotherapy in MTX-naïve patients. The study achieved its primary
endpoint in the proportion of patients achieving an ACR20 response
at week 24. The proportion of patients achieving the primary
endpoint of ACR20 response at week 24 was significantly higher for
filgotinib 200 mg plus MTX and filgotinib 100 mg plus MTX compared
with MTX alone.
- Interim safety information from four
studies of filgotinib for the treatment of RA. The data include 24
week results of the ongoing Phase 3 FINCH 1, 2 and 3 trials and
updated week 156 safety data from the Phase 2b DARWIN 3 long-term
extension study in patients with RA.
HIV and Liver Diseases Programs
- Data from Gilead’s research and
development programs in nonalcoholic steatohepatitis (NASH),
primary sclerosing cholangitis and viral hepatitis presented at The
International Liver Congress™ 2019 in Vienna, Austria. These data
reflect Gilead’s ongoing focus and commitment to advancing research
and patient care across the field of liver disease.
- Approval by Japan’s Ministry of Health,
Labour and Welfare (MHLW) of Biktarvy for the treatment of HIV-1
infection.
- The presentation of data at the 2019
Conference on Retroviruses and Opportunistic Infections, which
included:
- Results from the DISCOVER trial, a
two-year Phase 3 randomized, controlled, double-blind study
evaluating the safety and efficacy of the investigational use of
once-daily Descovy® (emtricitabine 200 mg/tenofovir alafenamide 25
mg) for HIV pre-exposure prophylaxis (PrEP), compared with Truvada®
(emtricitabine 200 mg and tenofovir disoproxil fumarate 300 mg) for
PrEP, in men who have sex with men and transgender women at risk
for sexually acquired HIV infection. In the trial, Descovy achieved
the primary efficacy endpoint and demonstrated non-inferiority to
Truvada. Statistically significant advantages with respect to bone
and renal laboratory parameters were observed for participants
receiving Descovy as compared with those receiving Truvada.
- Results from a Phase 2/3 study at 48
weeks, evaluating the efficacy and safety of Biktarvy in
virologically suppressed adolescents and children at least 6 years
of age who are living with HIV.
- Results from two studies evaluating the
resistance profile of Biktarvy in virologically suppressed adults
switching from dolutegravir/abacavir/lamivudine or a boosted
protease inhibitor-based regimen for the treatment of HIV-1.
- Results from two studies that support
the further development of GS-6207, an investigational, novel,
selective, first-in-class inhibitor of HIV-1 capsid function, for
potential future use as part of long-acting HIV combination
therapy. Interim blinded data from a Phase 1 study in healthy trial
participants demonstrated that single doses of GS-6207 of up to 450
mg, administered subcutaneously, achieved sustained concentration
levels and were well-tolerated.
- Results from STELLAR-4, a Phase 3,
randomized, double-blind, placebo-controlled study evaluating the
safety and efficacy of selonsertib, an investigational, once-daily,
oral inhibitor of apoptosis signal-regulating kinase 1, in patients
with compensated cirrhosis (F4) due to NASH, did not meet the
pre-specified week 48 primary endpoint of a ≥ 1-stage histologic
improvement in fibrosis without worsening of NASH.
- Approval by Japan’s MHLW of Epclusa®
(sofosbuvir 400 mg/velpatasvir 100 mg) for adults with chronic HCV
infection with decompensated cirrhosis and for patients with
chronic HCV infection without cirrhosis or with compensated
cirrhosis who have had prior treatment with a direct-acting
antiviral therapy.
- Licensing agreement and collaboration
agreement with Yuhan Corporation to co-develop novel therapeutic
candidates for the treatment of advanced fibrosis due to NASH.
Non-GAAP Financial
Information
The information presented in this document has been prepared in
accordance with U.S. generally accepted accounting principles
(GAAP), unless otherwise noted as non-GAAP. Management believes
non-GAAP information is useful for investors, when considered in
conjunction with Gilead’s GAAP financial information, 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. Non-GAAP measures may be
defined and calculated differently by other companies in the same
industry. A reconciliation between GAAP and non-GAAP financial
information is provided in the tables on pages 8 through 10.
Conference Call
At 4:30 p.m. Eastern Time today, Gilead’s management will host a
conference call and a simultaneous webcast to discuss the company’s
financial results for the first quarter 2019 and provide a business
update. The live webcast of the call can be accessed at Gilead’s
Investor page at http://investors.gilead.com/. Please connect to
Gilead’s website at least 15 minutes prior to the start of the call
to allow adequate time for any software download that may be
required to listen to the webcast. Alternatively, please call
877-359-9508 (U.S.) or 224-357-2393 (international) and dial the
conference ID 5259422 to access the call. Telephone replay will be
available approximately two hours after the call through 8:00 p.m.
Eastern Time, May 4, 2019. To access the replay, please call
855-859-2056 (U.S.) or 404-537-3406 (international) and dial the
conference ID 5259422. The webcast will be archived on
www.gilead.com for one year.
About Gilead Sciences
Gilead Sciences, Inc. is a research-based biopharmaceutical
company that discovers, develops and commercializes innovative
medicines in areas of unmet medical need. The company strives to
transform and simplify care for people with life-threatening
illnesses around the world. Gilead has operations in more than 35
countries worldwide, with headquarters in Foster City,
California.
Forward-Looking
Statement
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 2019
financial results; Gilead’s ability to sustain growth in revenues
for its antiviral and other programs; the risk that private and
public payers may be reluctant to provide, or continue to provide,
coverage or reimbursement for new products; austerity measures in
European countries that may increase the amount of discount
required on Gilead’s products; an increase in discounts,
chargebacks and rebates due to ongoing contracts and future
negotiations with commercial and government payers; a larger than
anticipated shift in payer mix to more highly discounted payer
segments and geographic regions and decreases in treatment
duration; availability of funding for state AIDS Drug Assistance
Programs (ADAPs); continued fluctuations in ADAP purchase driven by
federal and state grant cycles as well as purchase by retail
pharmacies and other non-wholesaler locations with whom we have no
inventory management agreements may not mirror patient demand and
may cause fluctuations in Gilead’s earnings; market share and price
erosion caused by the introduction of generic versions of our
products; an uncertain global macroeconomic environment; potential
amendments to the Affordable Care Act or other government action
that could have the effect of lowering prices or reducing the
number of insured patients; 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 realize the
potential benefits of collaborations, including with Yuhan
Corporation; 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; Gilead’s ability to
successfully commercialize its products, including Yescarta; the
risk that physicians and patients may not see advantages of these
products over other therapies and may therefore be reluctant to
prescribe the products; safety and efficacy data from clinical
studies may not warrant further development of Gilead’s product
candidates, including filgotinib, selonsertib and GS-6207; Gilead’s
ability to pay dividends or complete its share repurchase program
due to changes in its stock price, corporate or other market
conditions; 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 (the 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. There may be other factors of which
Gilead is not currently aware that may affect matters discussed in
the forward-looking statements and may also cause actual results to
differ significantly from these estimates. Further, results for the
quarter ended March 31, 2019 are not necessarily indicative of
operating results for any future periods. 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 press releases,
Annual Report on Form 10-K for the year ended December 31, 2018 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 or supplement any such forward-looking statements other than
as required by law. Any forward-looking statements speak only as of
the date hereof or as of the dates indicated in the statements.
# # #
Gilead owns or has rights to various
trademarks, copyrights and trade names used in its business,
including the following: GILEAD®, GILEAD SCIENCES®, AMBISOME®,
ATRIPLA®, BIKTARVY®, CAYSTON®, COMPLERA®, DESCOVY®, EMTRIVA®,
EPCLUSA®, EVIPLERA®, GENVOYA®, HARVONI®, HEPSERA®, LETAIRIS®,
ODEFSEY®, RANEXA®, SOVALDI®, STRIBILD®, TRUVADA®, TRUVADAFORPREP®,
TYBOST®, VEMLIDY®, VIREAD®, VOSEVI®, YESCARTA® and ZYDELIG®.
LEXISCAN® is a registered trademark of Astellas
U.S. LLC. MACUGEN® is a registered trademark of Eyetech, Inc.
SYMTUZA® is a registered trademark of Janssen Sciences Ireland UC.
TAMIFLU® is a registered trademark of 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).
GILEAD SCIENCES, INC. CONDENSED CONSOLIDATED
STATEMENTS OF INCOME (unaudited) (in millions, except
per share amounts) Three Months Ended March
31, 2019 2018 Revenues: Product sales $
5,200 $ 5,001 Royalty, contract and other revenues 81 87
Total revenues 5,281 5,088 Costs and expenses:
Cost of goods sold 957 1,001 Research and development expenses
1,057 937 Selling, general and administrative expenses 1,030
997 Total costs and expenses 3,044 2,935
Income from operations 2,237 2,153 Interest expense (254 ) (290 )
Other income (expense), net 367 170 Income before
provision for income taxes 2,350 2,033 Provision for income taxes
382 494 Net income 1,968 1,539 Net income (loss)
attributable to noncontrolling interest (7 ) 1 Net income
attributable to Gilead $ 1,975 $ 1,538 Net income per
share attributable to Gilead common stockholders - basic $ 1.55 $
1.18 Shares used in per share calculation - basic 1,276 1,307 Net
income per share attributable to Gilead common stockholders -
diluted $ 1.54 $ 1.17 Shares used in per share calculation -
diluted 1,283 1,320 Cash dividends declared per share $ 0.63 $ 0.57
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, 2019
2018 Cost of goods sold reconciliation: GAAP
cost of goods sold $ 957 $ 1,001 Acquisition-related – amortization
of purchased intangibles (283 ) (301 ) Stock-based compensation
expenses(1) (14 ) (13 ) Non-GAAP cost of goods sold $ 660 $
687
Product gross margin reconciliation: GAAP
product gross margin 81.6 % 80.0 % Acquisition-related –
amortization of purchased intangibles 5.4 % 6.0 % Stock-based
compensation expenses(1) 0.3 % 0.3 % Non-GAAP product gross margin
87.3 % 86.3 %
Research and development expenses
reconciliation: GAAP research and development expenses $ 1,057
$ 937 Up-front collaboration expenses (126 ) — Acquisition-related
– other costs — (16 ) Stock-based compensation expenses(1) (61 )
(103 ) Other(2) 1 (4 ) Non-GAAP research and development
expenses $ 871 $ 814
Selling, general and administrative expenses
reconciliation: GAAP selling, general and administrative
expenses $ 1,030 $ 997 Acquisition-related – other costs — (6
)
Stock-based compensation expenses(1) (68 ) (104 ) Other(2)
—
(3 ) Non-GAAP selling, general and administrative expenses $ 962
$ 884
Operating margin reconciliation:
GAAP operating margin 42.4 % 42.3 % Up-front collaboration expenses
2.4 % — % Acquisition-related – amortization of purchased
intangibles 5.4 % 5.9 % Acquisition-related – other costs — % 0.4 %
Stock-based compensation expenses(1) 2.7 % 4.3 % Other(2) — % 0.1 %
Non-GAAP operating margin(3) 52.8 % 53.1 %
Other income
(expense), net reconciliation: GAAP other income (expense), net
$ 367 $ 170 Unrealized gains from equity securities, net (197 ) (45
) Non-GAAP other income (expense), net $ 170 $ 125
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, 2019 2018 Effective tax rate
reconciliation: GAAP effective tax rate 16.3 % 24.3 % Up-front
collaboration expenses 0.3 % — % Acquisition-related – amortization
of purchased intangibles
(1.0)
%
(2.3)
%
Acquisition-related – other costs — %
(0.1)
%
Stock-based compensation expenses(1) 0.1 % 0.3 % Unrealized gains
from equity securities, net 1.1 % 0.6 % Non-GAAP effective tax
rate(3) 16.7 % 22.8 %
Net income attributable to Gilead
reconciliation: GAAP net income attributable to Gilead $ 1,975
$ 1,538 Up-front collaboration expenses 98 — Acquisition-related –
amortization of purchased intangibles 260 281 Acquisition-related –
other costs — 18 Stock-based compensation expenses(1) 117 160
Unrealized gains from equity securities, net
(191)
(45)
Other(2)
(1)
6 Non-GAAP net income attributable to Gilead $ 2,258
$ 1,958
Diluted earnings per share
reconciliation: GAAP diluted earnings per share $ 1.54 $ 1.17
Up-front collaboration expenses 0.08 — Acquisition-related –
amortization of purchased intangibles 0.20 0.21 Acquisition-related
– other costs — 0.01 Stock-based compensation expenses(1) 0.09 0.12
Unrealized gains from equity securities, net
(0.15)
(0.03 ) Non-GAAP diluted earnings per share $ 1.76 $ 1.48
Non-GAAP adjustment summary: Cost of goods
sold adjustments $ 297 $ 314 Research and development expenses
adjustments 186 123 Selling, general and administrative expenses
adjustments 68 113 Other income (expense), net adjustments
(197)
(45 ) Total non-GAAP adjustments before tax 354 505 Income tax
effect
(71)
(85 ) Total non-GAAP adjustments after tax $ 283 $ 420
____________________ Notes:
(1)
The period-over-period decrease was
primarily due to stock-based compensation expenses incurred in the
first quarter of 2018 associated with Gilead’s acquisition of
Kite
(2)
Amounts represent restructuring,
contingent consideration and/or other individually insignificant
amounts
(3)
Amounts may not sum due to rounding
GILEAD SCIENCES, INC. RECONCILIATION OF GAAP TO
NON-GAAP 2019 FULL YEAR GUIDANCE (unaudited) (in
millions, except percentages and per share amounts)
Initially ProvidedFebruary 4,
2019ReiteratedMay 2, 2019
Projected product gross margin GAAP to non-GAAP
reconciliation: GAAP projected product gross margin 80% - 81%
Acquisition-related expenses 5% - 6% Non-GAAP projected product
gross margin(1) 85% - 87%
Projected research and
development expenses GAAP to non-GAAP reconciliation: GAAP
projected research and development expenses $4,195 - $4,480
Stock-based compensation expenses (345) - (380) Up-front
collaboration expenses (250) - (300) Non-GAAP projected research
and development expenses $3,600 - $3,800
Projected
selling, general and administrative expenses GAAP to non-GAAP
reconciliation: GAAP projected selling, general and
administrative expenses $4,255 - $4,490 Stock-based compensation
expenses (355) - (390) Non-GAAP projected selling, general and
administrative expenses $3,900 - $4,100
Projected
effective tax rate GAAP to non-GAAP reconciliation: GAAP
projected effective tax rate (2) 21.5% - 22.5% Tax rate effect of
adjustments noted above (2) (1.5%) - (1.5%) Non-GAAP projected
effective tax rate 20.0% - 21.0%
Projected diluted EPS
impact of acquisition-related, up-front collaboration, stock-based
compensation and other expenses(2):
Acquisition-related expenses / up-front collaboration expenses
$0.93 - $0.97 Stock-based compensation expenses $0.47 - $0.53
Projected diluted EPS impact of acquisition-related, up-front
collaboration, stock-based compensation and other expenses(2) $1.40
- $1.50 ____________________
Notes:
(1)
Total stock-based compensation expenses have a less than one
percent impact on non-GAAP projected product gross margin
(2)
Excludes fair value adjustments of equity securities and the
associated income tax effect, as Gilead is unable to project future
fair value adjustments, and other discrete tax charges or benefits
GILEAD SCIENCES, INC. CONDENSED
CONSOLIDATED BALANCE SHEETS (unaudited) (in
millions) March 31, December 31,
2019 2018 Cash, cash equivalents and
marketable securities $ 30,125 $ 31,512 Accounts receivable, net
3,283 3,327 Inventories 898 814 Property, plant and equipment, net
4,116 4,006 Intangible assets, net 15,438 15,738 Goodwill 4,117
4,117 Other assets 4,860 4,161 Total assets $ 62,837
$ 63,675 Current liabilities $ 9,397 $ 10,605 Long-term
liabilities 31,349 31,536 Stockholders’ equity(1) 22,091
21,534 Total liabilities and stockholders’ equity $ 62,837 $
63,675 ____________________
Note:
(1)
As of March 31, 2019, there were 1,274 million shares of common
stock issued and outstanding
GILEAD SCIENCES, INC.
PRODUCT SALES SUMMARY (unaudited) (in
millions) Three Months Ended March 31,
2019 2018 Atripla – U.S. $ 133 $ 228
Atripla – Europe 16 51 Atripla – Other International 22 35
171 314 Biktarvy – U.S. 739 35 Biktarvy – Europe 48 —
Biktarvy – Other International 6 — 793 35
Complera / Eviplera – U.S. 44 67 Complera / Eviplera – Europe 62
109 Complera / Eviplera – Other International 9 14 115
190 Descovy – U.S. 233 274 Descovy – Europe 68 75
Descovy – Other International 41 12 342 361
Genvoya – U.S. 728 853 Genvoya – Europe 193 186 Genvoya – Other
International 94 43 1,015 1,082 Odefsey – U.S.
282 279 Odefsey – Europe 106 58 Odefsey – Other International 9
5 397 342 Stribild – U.S. 67 133 Stribild –
Europe 18 29 Stribild – Other International 11 12 96
174 Truvada – U.S. 551 507 Truvada – Europe 33 97 Truvada –
Other International 22 48 606 652 Other HIV(1)
– U.S. 11 9 Other HIV(1) – Europe 1 1 Other HIV(1) – Other
International 5 3 17 13 Revenue share –
Symtuza(2) – U.S. 42 — Revenue share – Symtuza(2) – Europe 24
7 66 7 Total HIV – U.S. 2,830 2,385 Total HIV
– Europe 569 613 Total HIV – Other International 219 172
3,618 3,170 AmBisome – U.S. 8 17 AmBisome – Europe 57
56 AmBisome – Other International 28 34 93 107
GILEAD SCIENCES, INC. PRODUCT SALES SUMMARY -
(Continued) (unaudited) (in millions)
Three Months Ended March 31, 2019
2018 Ledipasvir/Sofosbuvir(3) – U.S. $ 117 $ 234
Ledipasvir/Sofosbuvir(3) – Europe 27 56 Ledipasvir/Sofosbuvir(3) –
Other International 81 58 225 348
Letairis – U.S. 197 204
Ranexa – U.S. 155 195
Sofosbuvir/Velpatasvir(4) – U.S. 230 269 Sofosbuvir/Velpatasvir(4)
– Europe 154 198 Sofosbuvir/Velpatasvir(4) – Other International
107 69 491 536 Vemlidy – U.S. 65
47 Vemlidy – Europe 4 3 Vemlidy – Other International 32
8 101 58 Viread – U.S. 12 7 Viread –
Europe 14 30 Viread – Other International 46 60
72 97 Vosevi – U.S.
45
86
Vosevi – Europe
16
16
Vosevi – Other International
2
5
63
107
Yescarta – U.S.
90
40
Yescarta – Europe
6
—
Yescarta – Other International
—
—
96
40
Zydelig – U.S.
11
14
Zydelig – Europe
15
18
Zydelig – Other International
1
1
27
33
Other(5) – U.S.
36
29
Other(5) – Europe
20
15
Other(5) – Other International
6
62
62
106
Total product sales – U.S.
3,796
3,527
Total product sales – Europe
882
1,005
Total product sales – Other International
522
469
$ 5,200 $ 5,001 ____________________ Notes:
(1)
Includes Emtriva and Tybost
(2)
Represents Gilead’s revenue from cobicistat (C), emtricitabine
(FTC) and tenofovir alafenamide (TAF) in Symtuza
(darunavir/C/FTC/TAF), a fixed dose combination product
commercialized by Janssen Sciences Ireland UC
(3)
Amounts consist of sales of Harvoni and the authorized generic
version of Harvoni sold by Gilead’s separate subsidiary, Asegua
Therapeutics LLC
(4)
Amounts consist of sales of Epclusa and the authorized generic
version of Epclusa sold by Gilead’s separate subsidiary, Asegua
Therapeutics LLC
(5)
Includes Cayston, Hepsera and Sovaldi
View source
version on businesswire.com: https://www.businesswire.com/news/home/20190502005790/en/
InvestorsRobin Washington(650) 522-5688Sung
Lee(650) 524-7792MediaAmy Flood(650)
522-5643
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