ROCKVILLE, Md., Apr 24, 2012 (BUSINESS WIRE) --Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced financial
results for the quarter ended March 31, 2012, and provided recent
highlights.
"We continue to see quarter-to-quarter progress in BENLYSTA sales," said
H. Thomas Watkins, President and Chief Executive Officer. "A growing
body of evidence from our market research indicates that BENLYSTA is
making a difference for patients with systemic lupus - and that
rheumatologists who have the most experience with BENLYSTA are the ones
who are most impressed with its efficacy. As lupus-treating physicians
gain experience with BENLYSTA, we believe their use of BENLYSTA will
expand to greater numbers of patients."
FINANCIAL RESULTS
HGS reported revenues for the quarter ended March 31, 2012 of $47.1
million, compared with revenues of $26.6 million for the same period in
2011. Revenues included $31.2 million recognized from sales of BENLYSTA,
$6.1 million recognized from sales and deliveries of raxibacumab to the
U.S. Strategic National Stockpile and $9.1 million recognized from
manufacturing and development services other than raxibacumab.
The Company reported a net loss of $93.5 million ($0.47 per share) for
the first quarter of 2012, compared with a net loss of $131.0 million
($0.69 per share) for the first quarter of 2011. The decreased net loss
for the current quarter, compared with the same quarter last year, is
primarily due to revenue from BENLYSTA sales and decreased research and
development expenses, partially offset by increased commercial
collaboration expenses related to BENLYSTA.
As of March 31, 2012, cash and investments totaled $798.7 million, of
which $719.2 million was unrestricted and available for operations. This
compares with cash and investments totaling $881.4 million as of
December 31, 2011, of which $801.2 million was unrestricted and
available for operations.
"HGS continues to have a strong financial position," said David P.
Southwell, Executive Vice President and Chief Financial Officer.
"BENLYSTA will continue to be our company's most important driver of
growth for the next several years. Supporting its worldwide commercial
progress and further development remain our most important financial
priority."
HIGHLIGHTS OF RECENT PROGRESS
BENLYSTA Sales Continue to Progress
BENLYSTA gross sales for the first quarter of 2012 totaled $35.6
million. After gross-to-net adjustments of $4.4 million, net sales of
BENLYSTA for the quarter totaled $31.2 million, compared with $25.7
million in the quarter ended December 31, 2011. During the first
quarter, BENLYSTA average weekly gross sales for the last four weeks of
March were $2.94 million, compared with $2.76 million and $2.52 million
for the preceding four-week periods, respectively.
The number of accounts ordering BENLYSTA continues to increase. HGS
sales data suggest that more than 50% of key accounts have initiated
treatment of at least one patient with BENLYSTA as of the end of March
2012. Among the community-based accounts that are the largest infusing
practices, approximately 80% have begun to purchase BENLYSTA. Among the
top 50 key hospital accounts, more than 80% have begun to purchase
BENLYSTA.
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 U.S. Strategic National
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 $123 million received through
March 31, 2012. 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).
Darapladib: Two Global Phase 3 Trials Ongoing in More than
28,000 Patients
GSK's Phase 3 program for darapladib continues to progress. Darapladib
is the first in a new class of drugs that directly inhibits the
biological activity of an enzyme known as lipoprotein-associated
phospholipase A2 (Lp-PLA2). Two pivotal Phase 3 trials are evaluating
whether darapladib can reduce the risk of adverse cardiovascular events
such as heart attack or stroke in patients with chronic coronary heart
disease (CHD) and acute coronary syndrome (ACS). GSK has completed the
enrollment of over 13,000 patients into the study in patients who have
suffered an ACS event. The other study is evaluating darapladib in about
15,800 patients with CHD. Darapladib was discovered by GSK based on HGS
technology. HGS will receive 10% royalties on worldwide sales if
darapladib is commercialized, and has a 20% co-promotion option in North
America and Europe.
Albiglutide: GSK Announces Further Data from Phase 3 Trials
GlaxoSmithKline (GSK) announced on April 3, 2012, that it has reviewed
primary endpoint data from seven of eight Phase 3 studies designed to
evaluate the efficacy and safety of albiglutide, versus placebo and
active controls, in type 2 diabetes. GSK said that the data reviewed to
date support progression to regulatory submissions of albiglutide as a
possible once-weekly treatment for this disease.
Albiglutide was created by HGS using its proprietary albumin-fusion
technology, and was licensed to GSK in 2004. HGS is entitled to fees and
milestone payments that could amount to as much as $183 million -
including $33.0 million received to date - in addition to single-digit
net royalties on worldwide sales if albiglutide is commercialized.
Mapatumumab: Randomized Phase 2 Combination Trial Fully
Enrolled
In March 2012, HGS completed the enrollment and initial dosing of 101
patients ahead of schedule in a randomized Phase 2 trial of mapatumumab
with Nexavar (sorafenib) in hepatocellular cancer.
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
888-312-9844 or 719-325-2111, passcode 3946943. 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 3946943. 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, raxibacumab, darapladib, albiglutide and
mapatumumab, 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, including darapladib 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.
|
|
|
|
|
|
|
HUMAN GENOME SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31,
|
|
|
|
2012
|
|
2011
|
|
|
|
(in thousands, except share and per share amounts)
|
|
Revenue:
|
|
|
|
|
|
Product sales
|
|
$
|
37,376
|
|
|
$
|
14,110
|
|
|
Manufacturing and development services
|
|
|
9,507
|
|
|
|
12,264
|
|
|
Research and development collaborative agreements
|
|
|
245
|
|
|
|
199
|
|
|
Total revenue
|
|
|
47,128
|
|
|
|
26,573
|
|
|
|
|
|
|
|
|
Costs and expenses:
|
|
|
|
|
|
Cost of product sales
|
|
|
8,279
|
|
|
|
9,999
|
|
|
Cost of manufacturing and development services
|
|
|
19,500
|
|
|
|
11,599
|
|
|
Research and development expenses
|
|
|
39,569
|
|
|
|
84,485
|
|
|
Selling, general and administrative expenses
|
|
|
40,287
|
|
|
|
35,120
|
|
|
Commercial collaboration expenses
|
|
|
15,677
|
|
|
|
3,086
|
|
|
Facility-related exit credits
|
|
|
-
|
|
|
|
(1,717
|
)
|
|
Total costs and expenses (a)
|
|
|
123,312
|
|
|
|
142,572
|
|
|
|
|
|
|
|
|
Income (loss) from operations
|
|
|
(76,184
|
)
|
|
|
(115,999
|
)
|
|
|
|
|
|
|
|
Investment income
|
|
|
1,999
|
|
|
|
3,252
|
|
|
Interest expense
|
|
|
(19,378
|
)
|
|
|
(15,276
|
)
|
|
Other income (expense)
|
|
|
68
|
|
|
|
(2,972
|
)
|
|
|
|
|
|
|
|
Income (loss) before taxes
|
|
|
(93,495
|
)
|
|
|
(130,995
|
)
|
|
Provision for income taxes
|
|
|
-
|
|
|
|
-
|
|
|
Net income (loss)
|
|
$
|
(93,495
|
)
|
|
$
|
(130,995
|
)
|
|
|
|
|
|
|
|
Basic and diluted net income (loss) per share
|
|
$
|
(0.47
|
)
|
|
$
|
(0.69
|
)
|
|
|
|
|
|
|
|
Weighted average shares outstanding, basic and diluted
|
|
|
198,972,188
|
|
|
|
189,076,628
|
|
|
|
|
|
|
|
|
(a)
|
|
Includes stock-based compensation expense of $10,790 ($0.05 per
basic and diluted share) and $6,612 ($0.03 per basic and diluted
share) for the three months ended March 31, 2012 and 2011,
respectively.
|
|
|
|
|
|
|
|
|
|
|
|
CONSOLIDATED BALANCE SHEET DATA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
As of
March 31, 2012
|
|
As of
December 31, 2011
|
|
|
|
(in thousands)
|
|
|
|
|
|
|
|
Cash, cash equivalents and investments (b)
|
|
$
|
798,680
|
|
$
|
881,434
|
|
Total assets (b)
|
|
|
1,328,170
|
|
|
1,407,576
|
|
Convertible debt (c)
|
|
|
569,028
|
|
|
561,735
|
|
Lease financing
|
|
|
252,476
|
|
|
252,105
|
|
Total stockholders' equity
|
|
|
376,672
|
|
|
456,419
|
|
|
|
|
|
|
|
|
|
(b)
|
|
Includes $79,493 and $80,193 in restricted investments as of March
31, 2012 and December 31, 2011, respectively.
|
|
|
|
|
|
(c)
|
|
Convertible senior debt at face value is $494,500 (book value
$367,330) and convertible subordinated debt at face value is
$206,736 (book value $201,698) as of March 31, 2012. 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.
|
|
|
|
|
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
Contact:
Claudine Prowse, Ph.D.
Vice President, Investor
Relations
301-610-5800