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| HUMAN GENOME SCIENCES ANNOUNCES FOURTH-QUARTER AND FULL-YEAR 2009 FINANCIAL RESULTS AND KEY DEVELOPMENTS | |
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- Positive results for BENLYSTA™ pivotal Phase 3 trials announced in July and November 2009; marketing applications in United States and Europe expected second quarter 2010 - - Marketing applications for ZALBIN™ submitted in U.S. and Europe in fourth quarter 2009; BLA in U.S. accepted as filed by FDA with PDUFA date of October 4, 2010 - - 2009 revenue exceeded $275 million; included $180 million from deliveries of raxibacumab to U.S. Strategic National Stockpile - - HGS ended 2009 with $1.2 billion in cash and investments, including net proceeds from successful public offerings of HGSI common stock completed in August and December 2009 - ROCKVILLE, Maryland – March 2, 2010 – Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced financial results for the quarter and full year ended December 31, 2009, and provided highlights of recent key developments. “2009 was an outstanding year of progress for HGS on all fronts,” said H. Thomas Watkins, President and Chief Executive Officer. “We and GlaxoSmithKline reported positive results from both Phase 3 trials of BENLYSTA in systemic lupus, and we plan to submit marketing applications in the U.S. and Europe in the second quarter of 2010. We reported positive results from our second Phase 3 trial of ZALBIN in chronic hepatitis C, and we and Novartis submitted marketing applications in the U.S. and Europe in the fourth quarter of last year. We also generated our first product sales in 2009 and recognized $180 million in revenues from deliveries of raxibacumab. In the GSK clinical pipeline, darapladib for cardiovascular disease and Syncria® for type 2 diabetes are both moving through Phase 3 trials. We greatly strengthened our cash position with two successful public offerings of common stock and ended 2009 with $1.2 billion in cash and investments. Both BENLYSTA and ZALBIN have the potential to receive approval in the U.S. late in 2010, and we are well positioned to work with our partners to launch them successfully.” FINANCIAL RESULTSHGS reported increased revenues of $275.7 million for the year ended December 31, 2009, compared with revenues of $48.4 million for 2008. Revenues for 2009 included $180.2 million recognized from sales and deliveries to the U.S. Strategic National Stockpile under the raxibacumab contract with the U.S. Government, $54.2 million recognized from the ZALBIN agreement with Novartis, $24.4 million recognized from manufacturing and development services other than raxibacumab, and $4.7 million recognized from the BENLYSTA agreement with GSK. The Company reported net income for 2009 of $5.7 million ($0.04 per share), compared with a net loss of $268.9 million ($1.99 per share) for 2008. The improvement in net income for 2009 was due primarily to increased revenues, lower research and development and general and administrative expenses, and a gain on extinguishment of debt. Cash increased by $818.7 million during 2009 primarily as a result of the successful public offerings of HGSI common stock completed in August and December 2009. As of December 31, 2009, cash and investments totaled $1.2 billion, of which $1.1 billion was unrestricted and available for operations. This compares with cash and investments totaling $372.9 million as of December 31, 2008, of which $303.6 million was unrestricted and available for operations. Net cash flow for 2009 totaled $29.7 million, compared with net cash burn of $244.8 million for 2008; this does not include the effect of the public offerings of HGSI common stock and the repurchase of $106.2 million principal amount of outstanding long-term debt. The improvement primarily reflected increased revenues and lower research and development and general and administrative expenses. (For information on the calculation of this non-GAAP financial measure, visit www.hgsi.com/images/Q42009results/netcashburn.pdf.) For the fourth quarter ended December 31, 2009, HGS reported revenues of $53.0 million, compared with revenues of $12.9 million for the same period in 2008. Fourth quarter 2009 revenues included $27.6 million recognized from the ZALBIN agreement with Novartis, $17.7 million recognized from sales and deliveries of raxibacumab to the U.S. Strategic National Stockpile, $5.3 million recognized from manufacturing and development services other than raxibacumab, and $1.0 million recognized from the BENLYSTA agreement with GSK. The Company’s net loss for the quarter ended December 31, 2009 decreased to $9.7 million ($0.06 per share), compared with a net loss of $61.9 million ($0.46 per share) for the fourth quarter of 2008. The decrease in net loss was due primarily to higher revenues and lower research and development and general and administrative expenses. “The HGS financial position was significantly strengthened during 2009,” said Tim Barabe, Senior Vice President and Chief Financial Officer. “With the proceeds from two successful public offerings of HGSI common stock, our cash position is more than sufficient to take us through the filing of marketing applications and the launch of our late-stage products, while also continuing to enable investment in our earlier-stage pipeline. Excluding $813 million in new funding, we realized net cash flow of nearly $30 million in 2009.” HIGHLIGHTS OF RECENT PROGRESS BENLYSTA™:On Track for Second Quarter 2010 Submission of U.S. and European Marketing Applications; Potential U.S. Approval Fourth Quarter 2010
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| HUMAN GENOME SCIENCES, INC. |
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| Three months ended December 31, |
Twelve months ended December 31, |
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| 2009 |
2008(a) |
2009 |
2008(a) |
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| (dollars in thousands, except share and per share amounts) |
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| Revenue: |
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| Product sales......................................................... |
$ 17,693 |
$ - |
$ 154,074 |
$ - |
||||
| Manufacturing and development services............ |
5,360 |
- |
50,653 |
- |
||||
| Research and development collaborative agreements........................................................ |
29,904 |
12,906 |
71,022 |
48,422 |
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| Total revenue...................................................... |
52,957 |
12,906 |
275,749 |
48,422 |
||||
| Cost of product sales............................................ |
1,236 |
- |
15,805 |
- |
||||
| Cost of manufacturing and development services................................................................................... |
976 |
- |
18,215 |
- |
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| Research and development expenses.................... |
42,330 |
48,652 |
173,709 |
243,257 |
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| General and administrative expenses................... |
19,319 |
14,860 |
61,073 |
60,865 |
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| Facility-related exit charges (credits) (b)............. |
(10,675) |
– |
759 |
– |
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| Total costs and expenses (c).............................. |
53,186 |
63,512 |
269,561 |
304,122 |
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| Income (loss) from operations................................. |
(229) |
(50,606) |
6,188 |
(255,700) |
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| Investment income.................................................... |
3,623 |
4,903 |
12,727 |
23,487 |
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| Interest expense........................................................ |
(14,465) |
(15,946) |
(58,424) |
(62,912) |
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| Gain on extinguishment of debt............................... |
- |
- |
38,873 |
- |
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| Gain on sale of long-term equity investment........... |
- |
- |
5,259 |
32,518 |
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| Other income (expense)............................................ |
56 |
(235) |
(238) |
(6,284) |
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| Income (loss) before taxes ....................................... |
(11,015) |
(61,884) |
4,385 |
(268,891) |
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| Income tax benefit.................................................... |
1,274 |
- |
1,274 |
- |
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| Net income (loss)...................................................... |
$(9,741) |
$ (61,884) |
$ 5,659 |
$ (268,891) |
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| Basic net income (loss) per share............................. |
$(0.06) |
$(0.46) |
$0.04 |
$(1.99) |
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| Diluted net income (loss) per share......................... |
$(0.06) |
$(0.46) |
$0.04 |
$(1.99) |
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| Weighted average shares outstanding, basic......... |
170,700,803 |
135,518,032 |
149,334,426 |
135,406,642 |
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| Weighted average shares outstanding, diluted..... |
170,700,803 |
135,518,032 |
155,053,473 |
135,406,642 |
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(a) HGS adopted new guidance related to accounting for convertible debt instruments effective January 1, 2009, which required restatement of prior periods, as applicable. Research and development expenses, interest expense, net loss and net loss per share as previously reported for the three months ended December 31, 2008 were $48,516, $9,894, $55,696 and $0.41 per basic and diluted share, respectively. Research and development expenses, interest expense, net loss and net loss per share as previously reported for the year ended December 31, 2008 were $242,710, $39,483, $244,915 and $1.81 per basic and diluted share, respectively.
(b) Facility-related exit credits during the three months ended December 31, 2009 relate to the reversal of substantially all of an exit charge recorded during the three months ended June 30, 2009. HGS has decided to resume production in certain previously-vacant space in order to support upcoming manufacturing activities.
(c) Includes stock-based compensation expense of $2,977 ($0.02 per basic and diluted share) and $4,645 ($0.03 per basic and diluted share) for the three months ended December 31, 2009 and 2008, respectively. Includes stock-based compensation expense of $12,524 ($0.08 per basic and diluted share) and $18,593 ($0.14 per basic and diluted share) for the year ended December 31, 2009 and 2008, respectively.
| CONSOLIDATED BALANCE SHEET |
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| As of |
As of |
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| (dollars in thousands) |
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| Cash, cash equivalents and investments (e)............................................ |
$ 1,191,660 | $ 372,939 |
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| Total assets (e).......................................................................................... |
1,530,630 |
686,832 |
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| Convertible subordinated debt (f)............................................................ |
349,807 |
417,597 |
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| Lease financing......................................................................................... |
248,628 |
246,477 |
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| Total stockholders’ equity (deficit).......................................................... |
755,415 |
(136,304) |
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(d)As noted in footnote (a), the adoption of new accounting guidance required restatement of prior periods. Total assets, convertible subordinated debt, and total stockholders’ deficit as previously reported were $674,164, $510,000, and $(241,375) as of December 31, 2008.
(e) Includes $88,437 and $69,360 in restricted investments at December 31, 2009 and December 31, 2008, respectively.
(f) Convertible subordinated debt is net of unamortized debt discount of $54,043 and $92,403 as of December 31, 2009 and December 31, 2008, respectively. Convertible subordinated debt at face value is $403,850 and $510,000 as of December 31, 2009 and December 31, 2008, respectively.
# # #
Media Contact:
Jerry Parrott
Vice President, Corporate Communications
301-315-2777
Investor Contact:
Peter Vozzo
Senior Director, Investor Relations
301-251-6003



