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| HUMAN GENOME SCIENCES ANNOUNCES FOURTH QUARTER AND FULL YEAR 2007 FINANCIAL RESULTS AND RECENT PROGRESS | |
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- 2008 revenue expected to grow to $160 million or more, up from $42 million in 2007 - - First HGS product sales expected with delivery of ABthrax™ to Strategic National Stockpile - - First Albuferon® Phase 3 data expected late 2008 - - Enrollment completed in randomized Phase 2 trial of HGS-ETR1 in multiple myeloma - ROCKVILLE, Maryland – February 25, 2008 – Human Genome Sciences, Inc. (NASDAQ: HGSI) today announced financial results for the quarter and full year ended December 31, 2007, and provided highlights of recent progress toward commercialization. "2007 was a year of execution for HGS, during which we delivered substantial progress toward the commercialization of our late-stage products. We are poised to achieve a number of major milestones in 2008 across our entire portfolio,” said H. Thomas Watkins, President and Chief Executive Officer, HGS. “We expect our first product sales later this year when we begin to deliver ABthrax to the U.S. Strategic National Stockpile, and our cash position remains strong. We expect to have our first Phase 3 data for Albuferon late this year, and we will complete enrollment in the Phase 3 trials of LymphoStat-B® by fall 2008. We also believe it is possible that GSK will reach decisions in 2008 regarding whether to advance darapladib and Syncria to Phase 3 development.” FINANCIAL RESULTS: CASH POSITION REMAINS STRONGHGS reported increased revenues of $41.9 million for the year ended December 31, 2007 , compared with revenues of $25.8 million for 2006. Revenues for 2007 included $28.0 million recognized from the Albuferon agreement with Novartis and $6.5 million recognized from the LymphoStat-B® agreement with GlaxoSmithKline (GSK). The Company reported a net loss for 2007 of $262.4 million ($1.95 per share), compared with a net loss of $251.2 million ($1.91 per share) for 2006. The 2007 net loss included $16.9 million ($0.13 per share) in expenses related to the licensing and collaboration agreement entered into with Aegera Therapeutics Inc. in December 2007. Including $20 million paid to Aegera Therapeutics, net cash burn for 2007 totaled $179.9 million, compared with $121.3 million in 2006. Excluding the payments to Aegera Therapeutics, the Company’s net cash burn for 2007 was in line with previous guidance. The increase in net cash burn also reflected increased clinical development costs related to the Company’s Phase 3 programs. As of December 31, 2007 , cash and investments totaled $603.8 million, of which $532.9 million was unrestricted and available for operations. This compares with cash and investments totaling $763.1 million as of the end of 2006, of which $701.9 million was unrestricted and available for operations. “Tight spending control, increased revenues and clinical development cost-sharing all played important roles in keeping net cash burn to a minimum in 2007,” said Tim Barabe, Senior Vice President and Chief Financial Officer. “We will continue this emphasis in 2008.” For the fourth quarter ended December 31, 2007 , HGS reported revenues of $12.5 million, compared with revenues of $10.0 million for the same period in 2006. Fourth quarter 2007 revenues included $8.9 million recognized from the Albuferon agreement with Novartis, and $1.6 million recognized from the LymphoStat-B agreement with GSK. The Company’s net loss in the fourth quarter of 2007 was $92.9 million ($0.69 per share), compared with a net loss of $66.9 million ($0.50 per share) in the fourth quarter of 2006. The fourth quarter 2007 net loss included $16.9 million ($0.13 per share) in expenses related to the licensing and collaboration agreement entered into with Aegera Therapeutics. HIGHLIGHTS OF RECENT PROGRESSAlbuferon®: On Track with Timeline to Phase 3 Data and Filing of Marketing ApplicationsOn November 1, 2007, HGS announced that it completed enrollment ahead of schedule in ACHIEVE 2/3, the second of two pivotal Phase 3 clinical trials of Albuferon (albinterferon alfa-2b) in combination with ribavirin in treatment-naïve patients with chronic hepatitis C. Enrollment in ACHIEVE 1 was also completed ahead of schedule, in August 2007. Albuferon is being developed by HGS and Novartis under an exclusive worldwide co-development and commercialization agreement entered into in June 2006. On January 23, 2008 , HGS announced the modification of dosing in one arm of each of its ACHIEVE clinical trials based on recommendations made by the studies’ independent Data Monitoring Committee (DMC). Patients in the Phase 3 trials who had been receiving the 1200-mcg dose are now receiving the 900-mcg dose, which HGS has viewed for some time as the dose of Albuferon most likely to be marketed. Consistent with its charter, the DMC will continue to review all adverse events on an ongoing basis as the ACHIEVE trials move forward. The final results of Phase 2 trials of Albuferon were presented at the annual meeting of the American Association for the Study of Liver Diseases in November 2007. These results suggest that the 900-mcg dose of Albuferon every two weeks demonstrated efficacy and safety comparable to Pegasys, with half the injections, improvements in quality of life and fewer missed days of work on treatment. If these results are confirmed in Phase 3, HGS believes that Albuferon could become the market-leading interferon for the treatment of hepatitis C. HGS and Novartis continue to expect to have the first Albuferon Phase 3 data available by late 2008, with all Phase 3 data available by spring 2009 to support the filing of global marketing authorization applications by fall 2009. LymphoStat-B®: Completion of Phase 3 Enrollment Expected by Fall 2008
Enrollment is progressing well in the pivotal Phase 3 trials of LymphoStat-B in patients with active SLE. HGS expects to complete enrollment of BLISS-76 and BLISS-52 by fall 2008, with Phase 3 data from both trials expected in 2009. ABthrax™: Manufacturing on Schedule to Begin Delivery Fall 2008
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HUMAN GENOME SCIENCES, INC. 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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2007 |
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2006 |
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2007 |
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2006 |
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(dollars in thousands, except share and per share amounts) |
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Revenue – R&D contracts ......................................... |
$ 12,526 |
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$ 10,011 |
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$ 41,851 |
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$ 25,755 |
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Costs and expenses: |
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Research and development (a) ................................. |
87,312 |
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48,527 |
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245,745 |
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209,242 |
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General and administrative (b) ................................. |
16,125 |
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13,959 |
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55,874 |
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53,101 |
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Facility-related and restructuring charges .................... |
– |
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12,670 |
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(3,673) |
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29,510 |
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Total costs and expenses ......................................... |
103,437 |
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75,156 |
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297,946 |
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291,853 |
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Income (loss) from operations .................................. |
(90,911) |
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(65,145) |
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(256,095) |
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(266,098) |
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Net investment income (expense) ............................. |
(1,982) |
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(1,799) |
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(6,353) |
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166 |
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Gain on sale of investment ....................................... |
– |
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– |
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– |
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14,759 |
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Income (loss) before taxes ...................................... |
(92,893) |
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(66,944) |
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(262,448) |
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(251,173) |
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Provision for income taxes ....................................... |
– |
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– |
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– |
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– |
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Net income (loss) ................................................................ |
$ (92,893) |
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$ (66,944) |
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$(262,448) |
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$(251,173) |
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Net income (loss) per share, basic and diluted ............. |
$(0.69) |
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$(0.50) |
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$(1.95) |
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$(1.91) |
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Weighted average shares outstanding, basic & diluted.. |
134,669,590 |
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132,953,759 |
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134,333,418 |
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131,815,414 |
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(a) Includes stock-based compensation expense of $3,454 ($0.03 per share) and $3,856 ($0.03 per share) for the three months ended December 31, 2007 and 2006, respectively. Includes stock-based compensation expense of $13,278 ($0.10 per share) and $16,337 ($0.13 per share) for the twelve months ended December 31, 2007 and 2006, respectively. Includes expenses of $16,852 ($0.13 per share) for the three and twelve months ended December 31, 2007 related to the licensing and collaboration agreement entered into with Aegera Therapeutics.
(b) Includes stock-based compensation expense of $1,807 ($0.02 per share) and $2,683 ($0.02 per share) for the three months ended December 31, 2007 and 2006, respectively. Includes stock-based compensation expense of $8,413 ($0.07 per share) and $10,270 ($0.08 per share) for the twelve months ended December 31, 2007 and 2006, respectively.
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CONSOLIDATED BALANCE SHEET DATA: |
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As of December 31, 2007 |
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As of December 31, 2006 |
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(dollars in thousands) |
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Cash, cash equivalents and investments (c) ........................................... |
$603,840 |
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$ 763,084 |
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Total assets (c) ................................................................................... |
949,105 |
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1,149,668 |
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Total debt, less current portion .............................................................. |
754,099 |
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751,526 |
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Total stockholders’ equity (deficit) ......................................................... |
(11,902) |
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213,923 |
(c) Includes $70,931 and $61,165 in restricted investments at December 31, 2007 and December 31, 2006 , respectively.
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CONTACT:
Jerry Parrott
Vice President, Corporate Communications
301/315-2777
Kate de Santis
Director, Investor Relations
301/251-6003



