-----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, LIn3yC0fpHP6vJwwqRW9/zbkJcGuZCE0tARbne2xYHv/eqoWSU7s/HhX598pny/j wCt9OmPQRx2g7fX+Jeiipg== 0000936392-05-000397.txt : 20051116 0000936392-05-000397.hdr.sgml : 20051116 20051116152847 ACCESSION NUMBER: 0000936392-05-000397 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20051111 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20051116 DATE AS OF CHANGE: 20051116 FILER: COMPANY DATA: COMPANY CONFORMED NAME: HALOZYME THERAPEUTICS INC CENTRAL INDEX KEY: 0001159036 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 880488686 STATE OF INCORPORATION: NV FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32335 FILM NUMBER: 051209733 BUSINESS ADDRESS: STREET 1: 11588 SORRENTO VALLEY ROAD STREET 2: SUITE 17 CITY: SAN DIEGO STATE: CA ZIP: 92121 BUSINESS PHONE: (858) 794-8889 FORMER COMPANY: FORMER CONFORMED NAME: GLOBAL YACHT SERVICES INC DATE OF NAME CHANGE: 20010912 8-K 1 a14674e8vk.htm FORM 8-K e8vk
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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
November 11, 2005
 
HALOZYME THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
         
Nevada   000-49616   88-0488686
 
(State or other jurisdiction
of incorporation)
  (Commission
File Number)
  (IRS Employer
Identification No.)
     
11588 Sorrento Valley Road, Suite 17, San Diego, California
(Address of principal executive offices)
  92121
(Zip Code)
Registrant’s telephone number, including area code: (858) 794-8889
Not Applicable
 
(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 (see General Instruction A.2. below):
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))
 
 

 


TABLE OF CONTENTS

Item 2.02 Results of Operations and Financial Condition.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
EXHIBIT 99.1


Table of Contents

Item 2.02 Results of Operations and Financial Condition.
     On November 11, 2005, Halozyme Therapeutics, Inc. issued a press release to report its financial results for the three months ended September 30, 2005. The press release is attached as Exhibit 99.1, which is furnished under Item 2.02 of this report and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such filing.
Item 9.01 Financial Statements and Exhibits.
  (c)   Exhibits.
             
Exhibit No.   Description        
99.1
  Press Release dated November 11, 2005.

 


Table of Contents

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  Halozyme Therapeutics, Inc.
 
 
November 11, 2005  By:   /s/ David A. Ramsay    
    David A. Ramsay   
    Secretary and Chief Financial Officer   
 

 

EX-99.1 2 a14674exv99w1.htm EXHIBIT 99.1 exv99w1
 

(HALOZYME COMPANY LOGO)
     
Halozyme Contact
  Investor Relations Contacts
David A. Ramsay
  Don Markley / Zachary Bryant
Chief Financial Officer
  Lippert/Heilshorn & Associates
(858) 794-8889
  (310) 691-7100
dramsay@halozyme.com
  dmarkley@lhai.com
HALOZYME THERAPEUTICS REPORTS THIRD QUARTER 2005
FINANCIAL RESULTS
— Conference Call and Webcast Today at 8:00 a.m. PDT —
SAN DIEGO, November 11, 2005 – Halozyme Therapeutics, Inc. (AMEX: HTI), a biopharmaceutical company focused on the development and commercialization of recombinant human enzymes, today reported progress and financial results for the three months ended September 30, 2005.
“We continue to make solid progress on all fronts and are meeting our milestones, including the initiation of our ChemophaseÔ Phase I clinical trial, as targeted,” stated Jonathan Lim, MD, Halozyme’s Chairman and CEO. “We are extremely pleased with the advancement of our oncology drug candidate, Chemophase, into the clinic. Chemophase is designed to enhance the delivery of chemotherapeutic agents to tumor tissue, which may renew response to chemotherapy regimens and potentially increase patient survival.”
Third Quarter 2005 and Subsequent Week’s Highlights
    The initiation of patient enrollment for the Chemophase Phase I clinical trial and the dosing of two patients. Chemophase is a novel recombinant therapeutic being developed to enhance the delivery of chemotherapy. The initial clinical protocol for Chemophase is designed to evaluate a single intravesical (into the bladder) administration of Chemophase with the widely used anticancer drug mitomycin in patients with superficial bladder cancer. The Phase I study will enroll at least five evaluable patients with superficial bladder cancer. The objectives of the study are to determine the safety, tolerability and pharmacokinetics of Chemophase administered intravesically with mitomycin. The study is being conducted at BCG Oncology in Phoenix, Arizona under the supervision of Donald L. Lamm, MD, the principal investigator.
    The presentation of new pharmacokinetic and efficacy data with a novel, chemically modified form of a recombinant human hyaluronidase enzyme in animal ischemic stroke models. The data were presented at the 2005 American Neurological Association annual meeting in San Diego. The enzyme, called rHuPH20, when conjugated to polyethylene glycol (PEG), demonstrated a dramatically longer serum half life (approximately 100-fold) compared with the unmodified form, thereby preventing it from being rapidly cleared from circulation. Both rHuPH20 and PEG-rHuPH20 demonstrated increased survival in stroke models.

 


 

    The indication by Baxter of its desire to market, sell, and distribute Hylenex™ in the European Union, on an exclusive basis. Hylenex is a local formulation of recombinant human hyaluronidase under development for use as a “spreading agent” to enhance the delivery of local anesthesia, contrast agents, and for subcutaneous fluid replacement (also called hypodermoclysis). The parties are currently negotiating the definitive agreement. If the parties are unable to reach mutual agreement on terms, Baxter’s option will expire. Halozyme filed a New Drug Application in the United States for Hylenex on March 23, 2005 and is awaiting a response to the application by the FDA.
Third Quarter 2005 Financial Results
    Net loss for the third quarter of 2005 was $3.7 million, or $0.07 per share, compared with a net loss for the third quarter of 2004 of $3.3 million, or $0.08 per share. Net loss for the nine months ended September 30, 2005 was $9.8 million, or $0.20 per share compared with a net loss for the nine months ended September 30, 2004 of $6.6 million, or $0.21 per share.
    Research and development expenses for the third quarter of 2005 were $3.2 million, compared with $2.6 million for the third quarter of 2004, reflecting increased research, development and manufacturing expenses associated with the Company’s Cumulase, Hylenex and Chemophase product candidates.
    Selling, general and administrative expenses for the third quarter of 2005 were $0.6 million, compared with $0.7 million for the third quarter of 2004, reflecting a decrease in legal expenses during the current quarter.
    Cash and cash equivalents were $6.6 million as of September 30, 2005, compared with $10.1 million at June 30, 2005, and $3.5 million as of September 30, 2004.
Conference Call
Halozyme management will host an investment community conference call today to discuss these topics beginning at 8:00 a.m. PT (11:00 a.m. ET). To participate via telephone, please call 888-463-4487 for domestic callers, or 706-679-5355 for international callers. A telephone replay will be available for 48 hours by dialing 800-642-1687 from the U.S., or 706-645-9291 for international callers, and entering reservation number 2048481. The conference call will be broadcast live over the Internet at www.halozyme.com and will be available for 30 days.
About Halozyme Therapeutics, Inc.
Halozyme is a biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility, ophthalmology, and oncology communities. The company’s portfolio of products under development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme’s recombinant human enzymes may replace current animal slaughterhouse-derived enzymes that carry potential risks of animal pathogen transmission and immunogenicity. The versatility of the first enzyme, rHuPH20, enables Halozyme to develop the product as a medical device, drug enhancement agent, and therapeutic biologic.

 


 

Safe Harbor Statement
In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the Company’s products under development, product development plans, milestones, regulatory strategy, regulatory filings and clinical studies) that involve risk and uncertainties that could cause actual results to differ materially from those in the forward-looking statements. The forward-looking statements are also identified through use of the words “believe,” “enable,” “may,” “will,” “could,” “intends,” “estimate,” “anticipate,” “plan,” “predict,” “probable,” “potential,” “possible,” “should,” “continue,” and other words of similar meaning. Actual results could differ materially from the expectations contained in forward-looking statements as a result of several factors, including regulatory approval requirements and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the company’s reports on Forms 10-KSB, 10-QSB and other filings with the Securities and Exchange Commission.
[Table to Follow]

 


 

HALOZYME THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS — UNAUDITED
FOR THE THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2005 AND 2004
 
                                 
    Three Months Ended     Nine Months Ended  
    September 30,     September 30,  
    2005     2004     2005     2004  
REVENUES:
                               
Product Sales
  $ 25,644     $     $ 71,347     $  
 
                               
EXPENSES:
                               
Cost of sales
    10,091             31,115        
Research and development
    3,173,261       2,598,335       7,808,500       4,816,492  
Selling, general and administrative
    608,090       664,896       2,214,098       1,743,417  
 
                       
 
                               
Total Expenses
    3,791,442       3,263,231       10,053,713       6,559,909  
 
                       
 
                               
LOSS FROM OPERATIONS
    (3,765,798 )     (3,263,231 )     (9,982,366 )     (6,559,909 )
 
                               
Other income (expense), net
    65,322       10,086       220,480       (52,355 )
 
                       
 
                               
LOSS BEFORE INCOME TAXES
    (3,700,476 )     (3,253,145 )     (9,761,886 )     (6,612,264 )
 
                               
Income Tax Expense
                       
 
                       
 
                               
NET LOSS
  $ (3,700,476 )   $ (3,253,145 )   $ (9,761,886 )   $ (6,612,264 )
 
                       
 
                               
Net loss per share, basic and diluted
  $ (0.07 )   $ (0.08 )   $ (0.20 )   $ (0.21 )
 
                       
 
                               
Shares used in computing net loss per share, basic and diluted
    49,978,696       39,573,312       49,834,695       31,512,015  
 
                       
###

 

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