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8-K - FORM 8-K - HUMAN GENOME SCIENCES INC | c15959e8vk.htm |
Exhibit 99
PRESS RELEASE |
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Media Contacts:
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Investor Contacts: | |
Susannah Budington
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Claudine Prowse, Ph.D. | |
Director, Corporate Public Relations
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Executive Director, Investor Relations | |
301-545-1062
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301-315-1785 | |
Jerry Parrott
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Peter Vozzo | |
Vice President, Corporate Communications
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Senior Director, Investor Relations | |
301-315-2777
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301-251-6003 |
HUMAN GENOME SCIENCES ANNOUNCES FIRST QUARTER 2011 FINANCIAL RESULTS AND KEY DEVELOPMENTS
| In March 2011, the FDA approved BENLYSTA® for the treatment of systemic lupus |
| A decision from the European Medicines Agency is expected in the second half of 2011; preparations for a European launch are on track |
ROCKVILLE, Maryland April 28, 2011 Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced
financial results for the quarter ended March 31, 2011, and provided highlights of recent key
developments.
With the approval and U.S. launch of BENLYSTA for the treatment of systemic lupus, HGS has
achieved its goal of becoming a fully commercial biopharmaceutical company, said H. Thomas
Watkins, President and Chief Executive Officer. BENLYSTA will be the most important driver of our
growth over the next several years.
FINANCIAL RESULTS
HGS reported revenues for the quarter ended March 31, 2011 of $26.6 million, compared with revenues
of $46.5 million for the same period in 2010. Revenues primarily included $14.0 million recognized
from sales and deliveries of raxibacumab to the U.S. Strategic
National Stockpile, and $11.3 million recognized from manufacturing and development services other
than raxibacumab. The decrease in revenues reflected $27.6 million recognized from the ZALBIN
agreement with Novartis in the quarter ended March 31, 2010.
The Company reported a net loss for the first quarter of 2011 of $131.0 million ($0.69 per share),
compared with a net loss of $47.9 million ($0.26 per share) for the first quarter of 2010. The
increased net loss for the current quarter, compared with the same quarter last year, is primarily
due to the $50.0 million upfront license fee paid to FivePrime Therapeutics, Inc. (agreement
discussed below), lower revenue recognized in 2011 from research and development collaborative
agreements, and increased selling, general and administrative expenses related to the
commercialization of BENLYSTA.
As of March 31, 2011, cash and investments totaled $797.0 million, of which $717.3 million was
unrestricted and available for operations. 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.
HGS continues to have a strong cash position to fund the global commercial launch and further
development of BENLYSTA, as well as investment in other areas of our product pipeline, said David
P. Southwell, Executive Vice President and Chief Financial Officer.
HIGHLIGHTS OF RECENT PROGRESS
BENLYSTA®: FDA Approval Received March 2011; U.S. Launch Off to Good Start; European Decision
Expected Second Half 2011; Preparation for European Launch on Track
On March 9, 2011, HGS and GSK announced FDA approval of BENLYSTA (belimumab) as the first new drug
for systemic lupus in more than 50 years. At an HGS Analyst and Investor Meeting in New York on
April 14, the Company reported that product has been shipped to distributors and patients are now
receiving BENLYSTA treatment in the U.S. HGS and GSK expect to receive a European decision on
BENLYSTA in the second half of 2011, and preparations for a European launch are on track.
In February 2011, The Lancet published results of the BLISS-52 Phase 3 study of BENLYSTA in
autoantibody-positive patients with active systemic lupus erythematosus. BLISS-52 was one of two
pivotal Phase 3 studies of BENLYSTA.
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HGS and FivePrime Therapeutics Enter into Agreement to Develop and Commercialize Novel Biologic
Drug Candidate for Cancer
In March 2011, HGS and FivePrime Therapeutics announced a collaboration to develop and
commercialize HGS1036 (formerly FP-1039) for multiple cancers. HGS1036 is a first-in-class
biologic discovered by FivePrime that targets multiple fibroblast growth factor (FGF) ligands. FGF
proteins are growth factors that play important roles in the growth and survival of a number of
solid tumors. Under the terms of the agreement, HGS has acquired rights to develop and
commercialize HGS1036 in the United States, Canada and the European Union markets, while FivePrime
retains minority co-promotion rights in the U.S. and full development and commercialization rights
in rest-of-world territories, including Asia.
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 Companys web site at www.hgsi.com. Health
professionals and patients interested in clinical trials of HGS products may inquire via e-mail to
medinfo@hgsi.com or by calling HGS at (877) 822-8472.
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, our expected timeframe for a European regulatory decision regarding
BENLYSTA and our cash position. 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.
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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; the occurrence of adverse safety events with our products; changes in the
availability of reimbursement for BENLYSTA; the inherent uncertainty of the timing and success of,
and expense associated with, research, development, regulatory approval and commercialization of
our pipeline 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; 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; 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.
CONSOLIDATED STATEMENTS OF OPERATIONS
CONSOLIDATED STATEMENTS OF OPERATIONS
Three Months Ended March 31, | ||||||||
2011 | 2010 | |||||||
(in thousands, except share and per share | ||||||||
amounts) | ||||||||
Revenue: |
||||||||
Product sales |
$ | 14,110 | $ | 13,547 | ||||
Manufacturing and development services |
12,264 | 4,121 | ||||||
Research and development collaborative agreements |
199 | 28,846 | ||||||
Total revenue |
26,573 | 46,514 | ||||||
Costs and expenses: |
||||||||
Cost of product sales |
9,999 | 7,568 | ||||||
Cost of manufacturing and development services |
11,599 | 912 | ||||||
Research and development expenses |
84,485 | 57,471 | ||||||
Selling, general and administrative expenses |
35,120 | 18,336 | ||||||
Commercial collaboration expenses |
3,086 | | ||||||
Facility-related exit credits |
(1,717 | ) | | |||||
Total costs and expenses (a) |
142,572 | 84,287 | ||||||
Income (loss) from operations |
(115,999 | ) | (37,773 | ) | ||||
Investment income |
3,252 | 4,616 | ||||||
Interest expense |
(15,276 | ) | (14,666 | ) | ||||
Other expense |
(2,972 | ) | (54 | ) | ||||
Income (loss) before taxes |
(130,995 | ) | (47,877 | ) | ||||
Provision for income taxes |
| | ||||||
Net income (loss) |
$ | (130,995 | ) | $ | (47,877 | ) | ||
Basic and diluted net income (loss) per share |
$ | (0.69 | ) | $ | (0.26 | ) | ||
Weighted average shares outstanding, basic and diluted |
189,076,628 | 186,140,744 | ||||||
(a) | Includes stock-based compensation expense of $6,612 ($0.03 per share) and $3,844 ($0.02 per share) for the three months ended March 31, 2011 and 2010, respectively. |
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CONSOLIDATED BALANCE SHEET DATA:
As of | As of | |||||||
March 31, 2011 | December 31, 2010 | |||||||
(dollars in thousands) | ||||||||
Cash, cash equivalents and investments (b) |
$ | 796,989 | $ | 933,382 | ||||
Total assets (b) |
1,195,160 | 1,315,029 | ||||||
Convertible subordinated debt (c) |
378,951 | 372,851 | ||||||
Lease financing |
250,969 | 250,516 | ||||||
Total stockholders equity |
465,220 | 585,763 |
(b) | Includes $79,700 and $79,510 in restricted investments at March 31, 2011 and December 31, 2010, respectively. | |
(c) | Convertible subordinated debt is net of unamortized debt discount of $24,889 and $30,989 as of March 31, 2011 and December 31, 2010, respectively. Convertible subordinated debt at face value is $403,840 as of March 31, 2011 and December 31, 2010. |
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