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Steady quarter-to-quarter progress for BENLYSTA® sales
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HGS ended 2011 with $881 million in cash and investments
ROCKVILLE, Md.--(BUSINESS WIRE)--Feb. 27, 2012--
Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced financial
results for the quarter and full year ended December 31, 2011, and
provided highlights of recent key developments.
“The approval and launch of BENLYSTA for systemic lupus in 2011 brings
Human Genome Sciences closer to our long-standing goal of achieving
profitability and sustained growth into the future,” said H. Thomas
Watkins, President and Chief Executive Officer. “We have seen steady
quarter-to-quarter progress with BENLYSTA sales, and we believe BENLYSTA
is on its way to playing a major role in improving the standard of care
for SLE patients.”
FINANCIAL RESULTS
HGS reported revenues of $131.0 million for the year ended December 31,
2011, compared with revenues of $157.4 million for 2010. Revenues for
2011 included $52.3 million recognized from sales of BENLYSTA; $52.5
million recognized from sales and deliveries of raxibacumab to the U.S.
Strategic National Stockpile; and $22.0 million recognized from
manufacturing and development services other than raxibacumab. The
decrease in revenues for 2011 reflected $82.8 million recognized from
the ZALBIN agreement with Novartis in 2010.
The Company reported a net loss for 2011 of $381.1 million ($1.97 per
share), compared with a net loss of $233.2 million ($1.24 per share) for
2010. The increase in net loss was primarily due to increased selling,
general and administrative expenses and increased commercial
collaboration expenses related to the commercialization of BENLYSTA,
partially offset by higher product sales revenue.
As of December 31, 2011, cash and investments totaled $881.4 million, of
which $801.2 million was unrestricted and available for operations. This
includes $429.3 million in net cash from the Company’s successful public
offering of Convertible Senior Notes completed in November 2011. This
compares with cash and investments totaling $933.4 million as of
December 31, 2010, of which $853.9 million was unrestricted and
available for operations.
For the fourth quarter ended December 31, 2011, HGS reported revenues of
$45.5 million, compared with revenues of $21.3 million for the same
period in 2010. Fourth quarter 2011 revenues primarily included $25.7
million recognized from sales of BENLYSTA; $13.6 million recognized from
sales and deliveries of raxibacumab to the U.S. Strategic National
Stockpile; and $5.2 million recognized from manufacturing and
development services other than raxibacumab.
The Company’s net loss for the quarter ending December 31, 2011 was
$81.0 million ($0.41 per share), compared with a net loss of $87.6
million ($0.46 per share) for the fourth quarter of 2010. The decrease
in net loss for the current quarter, compared with the same quarter last
year, was primarily due to revenue recognized from sales of BENLYSTA and
decreased research and development expenses, partially offset by
increased cost of product sales and increased commercial collaboration
expenses related to the commercialization of BENLYSTA.
“We look forward to our first full year of BENLYSTA sales in 2012,” said
David Southwell, Executive Vice President and Chief Financial Officer.
“With $881 million in cash and investments on hand at the end of 2011,
we have a strong financial position and will continue to invest in the
successful worldwide commercialization of BENLYSTA.”
HIGHLIGHTS OF RECENT PROGRESS
BENLYSTA®: NOW AVAILABLE IN THE UNITED STATES, CANADA AND AN
INCREASING NUMBER OF EUROPEAN COUNTRIES; SALES INCREASING STEADILY
In March 2011, BENLYSTA (belimumab) was approved in the United States
for treating patients with systemic lupus erythematosus. In July 2011,
BENLYSTA was approved by the European Commission and Canada, and
it is now available in an increasing number of European countries,
including Germany, Spain, Austria, Denmark, Finland, Hungary, Norway and
Sweden.
BENLYSTA gross sales for the year ended December 31, 2011, reflecting
three full quarters on the market, totaled $59.2 million. After
gross-to-net adjustments of $6.9 million, net sales of BENLYSTA for 2011
totaled $52.3 million.
BENLYSTA gross sales totaled $29.1 million in the fourth quarter of
2011. After gross-to-net adjustments of $3.4 million, net sales of
BENLYSTA in the fourth quarter totaled $25.7 million.
In 2011, dosing of patients was initiated in BLISS-SC, a Phase 3 trial
of the subcutaneous formulation of BENLYSTA. If successful, the
subcutaneous formulation would make it possible for patients to
self-administer BENLYSTA by injection once a week. Also in 2011, GSK
initiated dosing in a Phase 3 trial of BENLYSTA to be conducted in
China, Japan and South Korea.
Raxibacumab: Deliveries to U.S. Strategic National Stockpile
Continued Under Second BARDA Order
In July 2009, the U.S. Government exercised its option to purchase
45,000 additional doses of raxibacumab for the Stockpile for emergency
use in treating inhalation anthrax, with delivery to be completed over a
three-year period. HGS expects to receive approximately $142 million
from this second award as deliveries are completed, including
approximately $117 million received through December 31, 2011.
Raxibacumab is being developed under a contract entered into in 2006
with the Biomedical Advanced Research and Development Authority (BARDA)
of the Office of the Assistant Secretary for Preparedness and Response
(ASPR), U.S. Department of Health and Human Services (HHS).
Net Cash from Offering of Convertible Senior Notes Totals $429.3
Million
In November 2011, HGS received $429.3 million in net cash from its
offering and sale of 3.00% Convertible Senior Notes due 2018. The notes
will mature on November 15, 2018, and will bear interest at a rate of
3.00% per year, payable semiannually in arrears on May 15 and November
15 of each year, beginning on May 15, 2012.
CONFERENCE CALL
HGS management will hold a conference call to discuss this announcement
today at 4:30 PM Eastern. Investors may listen to the call by dialing
888-221-9591 or 913-312-6665, passcode 8441394. A replay of the
conference call will be available within a few hours after the call
ends. Investors may listen to the replay by dialing 888-203-1112 or
719-457-0820, confirmation code 8441394. Today’s conference call also
will be webcast and can be accessed at www.hgsi.com.
It is recommended that investors interested in listening to the live
webcast log on before the start of the call to download any software
required. Both the audio replay and the archive of the conference call
webcast will remain available for several days.
ABOUT HUMAN GENOME SCIENCES
Human Genome Sciences exists to place new therapies into the hands of
those battling serious disease.
For more information about HGS, please visit the Company’s web site at www.hgsi.com.
Health professionals and patients interested in clinical trials of HGS
products may inquire via email to clinicaltrialsinfo@hgsi.com
or by calling HGS at 1-240-314-4430.
HGS, Human Genome Sciences and BENLYSTA are trademarks of Human Genome
Sciences, Inc. Other trademarks referenced are the property of their
respective owners.
SAFE HARBOR STATEMENT
This announcement includes statements that are forward-looking within
the meaning of the Private Securities Litigation Reform Act of 1995.
These forward-looking statements include those regarding our
expectations for BENLYSTA and raxibacumab, among others. These
forward-looking statements are based on our current intentions, beliefs
and expectations regarding future events. We cannot guarantee that any
forward-looking statement will be accurate. Investors should realize
that if underlying assumptions prove inaccurate or unknown risks or
uncertainties materialize, actual results could differ materially from
our expectations. Investors are, therefore, cautioned not to place undue
reliance on any forward-looking statement. Any forward-looking statement
speaks only as of the date of this announcement, and, except as required
by law, we do not undertake to update any forward-looking statement to
reflect new information, events or circumstances.
Some important factors that could cause our actual results to differ
from our expectations in these forward-looking statements include: our
lack of commercial experience and dependence on the sales growth of
BENLYSTA; any failure to commercialize BENLYSTA successfully; the
occurrence of adverse safety events with our products; changes in the
availability of reimbursement for BENLYSTA; the inherent uncertainty of
the timing, success of, and expense associated with, research,
development, regulatory approval and commercialization of our pipeline
products and new indications for existing products; substantial
competition in our industry, including from branded and generic
products; the highly regulated nature of our business; uncertainty
regarding our intellectual property rights and those of others; the
ability to manufacture at appropriate scale, and in compliance with
regulatory requirements, to meet market demand for our products; our
substantial indebtedness and lease obligations; our dependence on
collaborations over which we may not always have full control; foreign
exchange rate valuations and fluctuations; the impact of our
acquisitions and strategic transactions; changes in the health care
industry in the U.S. and other countries, including government laws and
regulations relating to sales and promotion, reimbursement and pricing
generally; significant litigation adverse to the Company, including
product liability and patent infringement claims; our ability to attract
and retain key personnel; and increased scrutiny of the health care
industry by government agencies and state attorneys general resulting in
investigations and prosecutions.
The foregoing list sets forth many, but not all, of the factors that
could cause actual results to differ from our expectations in any
forward-looking statement. Investors should consider this cautionary
statement, as well as the risk factors identified in our periodic
reports filed with the SEC, when evaluating our forward-looking
statements.
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HUMAN GENOME SCIENCES, INC.
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CONSOLIDATED STATEMENTS OF OPERATIONS
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Three months ended December 31,
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Twelve months ended December 31,
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2011
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2010
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2011
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2010
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(in thousands, except share and per share amounts)
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Revenue:
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Product sales
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$
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39,276
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$
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13,196
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$
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104,863
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$
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47,159
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Manufacturing and development services
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5,828
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7,517
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24,840
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22,695
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Research and development collaborative agreements
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418
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549
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1,272
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87,497
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Total revenue
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45,522
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21,262
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130,975
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157,351
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Costs and expenses:
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Cost of product sales
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13,035
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6,411
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47,061
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29,941
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Cost of manufacturing and development services
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5,709
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7,652
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28,999
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15,016
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Research and development expenses
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39,537
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45,039
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196,182
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196,370
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Selling, general and administrative expenses
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42,087
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38,341
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158,779
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106,797
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Commercial collaboration expenses
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14,217
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-
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31,222
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-
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Facility-related exit credits
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-
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(1,717
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)
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-
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Total costs and expenses (a)
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114,585
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97,443
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460,526
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348,124
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Income (loss) from operations
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(69,063
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(76,181
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(329,551
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(190,773
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Investment income
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3,161
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3,469
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12,175
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16,966
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Interest expense
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(16,497
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(15,091
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(62,056
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(59,500
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Other income (expense)
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1,377
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171
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(1,674
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)
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76
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Income (loss) before taxes
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(81,022
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)
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(87,632
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(381,106
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(233,231
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Provision for income taxes
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-
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-
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-
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-
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Net income (loss)
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$
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(81,022
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$
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(87,632
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$
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(381,106
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$
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(233,231
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Basic and diluted net income (loss) per share
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$
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(0.41
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$
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(0.46
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$
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(1.97
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$
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(1.24
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Weighted average shares outstanding, basic and diluted
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198,712,722
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188,896,481
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193,667,672
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187,791,437
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(a)
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Includes stock-based compensation expense of $10,773 ($0.05 per
basic and diluted share) and $7,627 ($0.04 per basic and diluted
share) for the three months ended December 31, 2011 and 2010,
respectively. Includes stock-based compensation expense of $35,915
($0.19 per basic and diluted share) and $25,430 ($0.14 per basic and
diluted share) for the year ended December 31, 2011 and 2010,
respectively.
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CONSOLIDATED BALANCE SHEET DATA:
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As of December 31, 2011
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As of December 31, 2010
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(in thousands)
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Cash, cash equivalents and investments (b)
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$881,434
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$933,382
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Total assets (b)
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1,407,576
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1,315,029
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Convertible debt (c)
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561,735
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372,851
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Lease financing
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252,105
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250,516
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Total stockholders' equity
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456,419
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585,763
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(b)
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Includes $80,193 and $79,510 in restricted investments at December
31, 2011 and 2010, respectively.
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(c)
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Convertible senior debt at face value is $494,500 (book value
$363,698) and convertible subordinated debt at face value is
$206,736 (book value $198,037) as of December 31, 2011. Convertible
subordinated debt at face value is $403,840 (book value $372,851) as
of December 31, 2010. No convertible senior debt was outstanding as
of December 31, 2010.
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Source: Human Genome Sciences, Inc.
Human Genome Sciences, Inc.
Media Contacts:
Susannah
Budington
Director, Corporate Public Relations
301-545-1062
or
Jerry
Parrott
Vice President, Corporate Communications
301-315-2777
or
Investor
Contacts:
Claudine Prowse, Ph.D.
Executive Director,
Investor Relations
301-315-1785
or
Peter Vozzo
Senior
Director, Investor Relations
301-251-6003