-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, D5oM2rED+SFqFAPTIYibong/R8y4HPxeNe7KMqGvutZ7RvMo1x/olaDyskafvMIE 01ucs2/WB4v9OQd/vVeUmg== 0000950123-10-096667.txt : 20101027 0000950123-10-096667.hdr.sgml : 20101027 20101027163036 ACCESSION NUMBER: 0000950123-10-096667 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20101027 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20101027 DATE AS OF CHANGE: 20101027 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HUMAN GENOME SCIENCES INC CENTRAL INDEX KEY: 0000901219 STANDARD INDUSTRIAL CLASSIFICATION: IN VITRO & IN VIVO DIAGNOSTIC SUBSTANCES [2835] IRS NUMBER: 223178468 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-14169 FILM NUMBER: 101145217 BUSINESS ADDRESS: STREET 1: 14200 SHADY GROVE ROAD CITY: ROCKVILLE STATE: MD ZIP: 20850-3338 BUSINESS PHONE: 3013098504 MAIL ADDRESS: STREET 1: 14200 SHADY GROVE ROAD CITY: ROCKVILLE STATE: MD ZIP: 20850 8-K 1 c07236e8vk.htm FORM 8-K Form 8-K
 
 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 8-K

CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 27, 2010

HUMAN GENOME SCIENCES, INC.
(Exact name of registrant as specified in its charter)
         
Delaware   001-14169   22-3178468
(State or other Jurisdiction of Incorporation)   (Commission File Number)   (IRS Employer Identification No.)
     
14200 Shady Grove Road, Rockville, Maryland
  20850-7464
(Address of Principal Executive Offices)   (Zip Code)

Registrant’s telephone number, including area code: (301) 309-8504
 
 
(Former name or former address if changed since last report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 
 

 

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Item 2.02. Results of Operations and Financial Condition.

On October 27, 2010, Human Genome Sciences, Inc. issued a press release announcing its financial results for the quarter ended September 30, 2010. The company also provided updated guidance regarding expected cash and investments at year-end 2010. A copy of the release is furnished as Exhibit 99 to this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits.

99       Press Release, dated October 27, 2010.

 

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

     
HUMAN GENOME SCIENCES, INC.

      By: /s/ James H. Davis, Ph.D.
        Name: James H. Davis, Ph.D.
        Title: Executive Vice President, General
Counsel and Secretary

Date: October 27, 2010

 

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INDEX TO EXHIBITS

     
Exhibit No.   Description
99
  Press Release, dated October 27, 2010.

 

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EX-99 2 c07236exv99.htm EXHIBIT 99 Exhibit 99
EXHIBIT 99
(HUMAN GENOME SCIENCES, INC. LOGO)
     
Media Contact:
  Investor Contacts:
Jerry Parrott
  Claudine Prowse, Ph.D.
Vice President, Corporate Communications
  Executive Director, Investor Relations
301-315-2777
  301-315-1785
 
  Peter Vozzo
 
  Senior Director, Investor Relations
301-251-6003
HUMAN GENOME SCIENCES ANNOUNCES THIRD QUARTER 2010
FINANCIAL RESULTS AND KEY DEVELOPMENTS
- BENLYSTA® granted priority review by FDA, with PDUFA target date of December 9, 2010 -
ROCKVILLE, Maryland — October 27, 2010 — Human Genome Sciences, Inc. (Nasdaq: HGSI) today announced financial results for the quarter ended September 30, 2010, and provided highlights of recent key developments.
“BENLYSTA has continued to make excellent progress in the third quarter and we look forward to the upcoming FDA advisory committee meeting,” said H. Thomas Watkins, President and Chief Executive Officer. “We have completed the hiring of our BENLYSTA sales force and sales management team for the United States. Their training is now underway, and we are currently building an organization to work alongside GlaxoSmithKline in Europe. Regulatory applications have been submitted in Europe, Australia, Canada and Switzerland, and we anticipate regulatory submissions in a number of additional countries in the coming months. We continue to believe that BENLYSTA could become the first new approved drug for lupus in more than 50 years.”
FINANCIAL RESULTS
HGS reported revenues for the quarter ended September 30, 2010 of $50.8 million, compared with revenues of $18.8 million for the same period in 2009. Revenues primarily included $36.1 million recognized from payments previously received under the ZALBIN™ agreement with Novartis, $7.3 million recognized from sales and deliveries of raxibacumab to the U.S. Strategic National Stockpile, and $5.1 million from manufacturing and development services other than raxibacumab.

 

 


 

The Company reported a reduced net loss for the third quarter of 2010 of $40.9 million ($0.22 per share), compared with a net loss of $49.0 million ($0.32 per share) for the third quarter of 2009.
For the first nine months of 2010, HGS reported revenues of $136.1 million, compared with revenues of $222.8 million for the same period of the previous year. Revenues primarily included $82.8 million recognized from the ZALBIN agreement with Novartis, $34.0 million recognized from the sale and delivery of raxibacumab to the U.S. Strategic National Stockpile, and $13.7 million from manufacturing and development services other than raxibacumab. The reduction in revenues for the current nine months, compared with the same period last year, primarily reflected the higher level of raxibacumab revenue recognized in 2009, $162.7 million, partially offset by increased recognition of revenue from the ZALBIN agreement in 2010.
The Company reported a net loss of $145.6 million ($0.78 per share) for the nine months ended September 30, 2010, compared with net income of $15.4 million ($0.11 per share) for the same period of the previous year. The net loss for the current nine months, compared with the same period last year, primarily reflected the difference described above in raxibacumab and ZALBIN revenue recognized in 2010 versus the same period in 2009, in addition to a gain in 2009 of $38.9 million on the extinguishment of debt.
As of September 30, 2010, cash and investments totaled $1.0 billion, of which $938.6 million was unrestricted and available for operations. This compares with cash and investments totaling $1.2 billion as of December 31, 2009, of which $1.1 billion was unrestricted and available for operations. HGS expects cash and investments at year-end 2010 to total approximately $900-950 million.
“HGS has continued to invest in building the commercial infrastructure and expertise required to support a world-class launch of BENLYSTA,” said David P. Southwell, Executive Vice President and Chief Financial Officer. “With approximately $1 billion of cash and equivalents, HGS is well-positioned financially to support the launch and growth of BENLYSTA and to fund our research and development program.”
HIGHLIGHTS OF RECENT PROGRESS
BENLYSTA®: Granted Priority Review by FDA; Assigned December 9, 2010 PDUFA Target Date
In August 2010, the FDA granted a priority review designation to BENLYSTA (belimumab) as a potential treatment for autoantibody-positive patients with clinically active systemic lupus erythematosus (SLE). A priority review designation is granted to drugs that, if approved, offer major advances in treatment or provide a treatment where no adequate therapy exists. The FDA has assigned belimumab a PDUFA target date of December 9, 2010, and an FDA Advisory Committee meeting to consider the belimumab Biologics License Application (BLA) is scheduled to take place on November 16, 2010. No new drug for lupus has been approved by regulatory authorities in more than 50 years.

 

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In July 2010, HGS and Lonza announced an agreement for future commercial supply of BENLYSTA. Although HGS believes that its large-scale manufacturing facility has sufficient capacity to provide worldwide supply of BENLYSTA following approval and for the first two to three years following launch, it is likely that additional capacity will eventually be required. Lonza production is expected to be available for supply of the U.S. market in the first half of 2012. BENLYSTA is being developed by HGS and GSK under a co-development and commercialization agreement entered into in 2006.
Raxibacumab: $34.0 Million in Revenue Recognized from Deliveries to the U.S. Strategic National Stockpile in First Nine Months of 2010
In the third quarter and first nine months of 2010, HGS recognized $7.3 million and $34.0 million in revenue, respectively, from the delivery of raxibacumab to the U.S. Strategic National Stockpile. The delivery was made under a purchase order received from the U.S. Government in July 2009 for 45,000 doses of raxibacumab to be delivered over a three-year period. HGS expects to receive approximately $142 million from this award as deliveries are completed, including $51.7 million recognized to date. 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).
ZALBIN™: Complete Response Letter Received from the FDA; HGS and Novartis Will Not Continue Development of ZALBIN
On October 4, 2010, as expected, HGS received a complete response letter from the FDA, regarding the Company’s BLA for 900-mcg ZALBIN (albinterferon alfa-2b, known in Europe as JOULFERON®) dosed every two weeks for the treatment of chronic hepatitis C. HGS and Novartis have decided not to develop ZALBIN further. Based on this decision, in September 2010, HGS recognized all remaining deferred revenue relating to payments previously received under the ZALBIN agreement with Novartis. There will, however, be certain additional research and development costs incurred by both parties in the near future as activities are concluded.
About Human Genome Sciences
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs.
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 e-mail to medinfo@hgsi.com or by calling HGS at (877) 822-8472.
HGS, Human Genome Sciences, BENLYSTA, and ZALBIN are trademarks of Human Genome Sciences, Inc. Other trademarks referenced are the property of their respective owners.

 

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Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements are based on Human Genome Sciences’ current intent, belief and expectations. These statements are not guarantees of future performance and are subject to certain risks and uncertainties that are difficult to predict. Actual results may differ materially from these forward-looking statements because of Human Genome Sciences’ unproven business model, its dependence on new technologies, the uncertainty and timing of clinical trials and regulatory approvals, Human Genome Sciences’ ability to develop and commercialize products, its dependence on collaborators for services and revenue, its substantial indebtedness and lease obligations, its changing requirements and costs associated with facilities, intense competition, the uncertainty of patent and intellectual property protection, Human Genome Sciences’ dependence on key management and key suppliers, the uncertainty of regulation of products, the impact of future alliances or transactions and other risks described in the Company’s filings with the SEC. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of today’s date. Human Genome Sciences undertakes no obligation to update or revise the information contained in this announcement whether as a result of new information, future events or circumstances or otherwise.

 

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HUMAN GENOME SCIENCES, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS
                                 
    Three months ended September 30,     Nine months ended September 30,  
    2010     2009     2010     2009  
    (in thousands, except share and per share amounts)  
 
                               
Revenue:
                               
Product sales
  $ 7,295     $     $ 33,963     $ 136,381  
Manufacturing and development services
    5,677       8,668       15,177       45,294  
Research and development collaborative agreements
    37,810       10,166       86,948       41,117  
 
                       
Total revenue
    50,782       18,834       136,088       222,792  
 
                       
Costs and expenses:
                               
Cost of product sales
    8,434             23,529       14,569  
Cost of manufacturing and development services
    3,338       7,331       7,364       17,239  
Research and development expenses
    42,471       34,794       151,331       131,379  
General and administrative expenses
    26,365       14,673       68,456       41,754  
Facility-related exit costs
                      11,434  
 
                       
Total costs and expenses (a)
    80,608       56,798       250,680       216,375  
 
                       
Income (loss) from operations
    (29,826 )     (37,964 )     (114,592 )     6,417  
Investment income
    3,794       3,137       13,497       10,354  
Interest expense
    (14,949 )     (14,409 )     (44,409 )     (43,958 )
Gain on extinguishment of debt
                      38,873  
Gain on sale of long-term equity investment
                      5,259  
Charge for impaired investments
                      (1,250 )
Other income (expense)
    122       233       (95 )     (295 )
 
                       
Income (loss) before taxes
    (40,859 )     (49,003 )     (145,599 )     15,400  
Provision for income taxes
                       
 
                       
Net income (loss)
  $ (40,859 )   $ (49,003 )   $ (145,599 )   $ 15,400  
 
                       
Basic net income (loss) per share
  $ (0.22 )   $ (0.32 )   $ (0.78 )   $ 0.11  
 
                       
Diluted net income (loss) per share
  $ (0.22 )   $ (0.32 )   $ (0.78 )   $ 0.11  
 
                       
Weighted average shares outstanding, basic
    188,420,580       154,513,251       187,418,995       142,104,996  
 
                       
Weighted average shares outstanding, diluted
    188,420,580       154,513,251       187,418,995       145,537,847  
 
                       
     
(a)   Includes stock-based compensation expense of $6,984 ($0.04 basic and diluted share) and $3,226 ($0.02 per basic and diluted share) for the three months ended September 30, 2010 and 2009, respectively. Includes stock-based compensation expense of $17,803 ($0.09 basic and diluted share) and $9,547 ($0.07 per basic and diluted share) for the nine months ended September 2010 and 2009, respectively.

 

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CONSOLIDATED BALANCE SHEET DATA:
                 
    As of     As of  
    September 30, 2010     December 31, 2009  
    (in thousands)  
Cash, cash equivalents and investments (b)
  $ 1,018,120     $ 1,191,660  
Total assets (b)
    1,370,625       1,530,630  
Convertible subordinated debt (c)
    366,899       349,807  
Lease financing
    250,076       248,628  
Total stockholders’ equity
    666,757       755,415  
     
(b)   Includes $79,480 and $88,437 in restricted investments at September 30, 2010 and December 31, 2009, respectively.
 
(c)   Convertible subordinated debt is net of unamortized debt discount of $36,942 and $54,043 as of September 30, 2010 and December 31, 2009, respectively. Convertible subordinated debt at face value is $403,840 and $403,850 as of September 30, 2010 and December 31, 2009, respectively.
# # #

 

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-----END PRIVACY-ENHANCED MESSAGE-----