-----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, G6LfzqsAoNb5TGa91KZFjDFpEtOsRlP/z7snDNMHQPPxBqOIb7pY2hD7pi6msTcJ cDk/+LIMlk0UhEDBvXEk5g== 0000950137-04-009868.txt : 20041112 0000950137-04-009868.hdr.sgml : 20041111 20041112143501 ACCESSION NUMBER: 0000950137-04-009868 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041112 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041112 DATE AS OF CHANGE: 20041112 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: 041138381 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 a03367e8vk.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 12, 2004

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
  92121

 
 
 
(Address of principal executive offices)
  (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


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Item 2.02 Results of Operations and Financial Condition.

     On November 12, 2004, Halozyme Therapeutics, Inc. issued a press release to report its financial results for the three months ended September 30, 2004. 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 12, 2004.

 


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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 12, 2004  By:   /s/ David A. Ramsay    
    David A. Ramsay   
    Secretary and Chief Financial Officer   
 

 

EX-99.1 2 a03367exv99w1.txt EXHIBIT 99.1 [HALOZYME THERAPEUTICS LOGO] HALOZYME CONTACT INVESTOR RELATIONS CONTACTS David A. Ramsay Ina McGuinness / Bruce Voss Chief Financial Officer Lippert/Heilshorn & Associates (858) 794-8889 (310) 691-7100 dramsay@halozyme.com imcguinness@lhai.com HALOZYME THERAPEUTICS REPORTS THIRD QUARTER 2004 FINANCIAL RESULTS SAN DIEGO, NOVEMBER 12, 2004 - Halozyme Therapeutics, Inc. (AMEX: HTI), a development stage biopharmaceutical company developing and commercializing recombinant human enzymes, today reported progress and financial results for the three months ended September 30, 2004. THIRD QUARTER 2004 AND SUBSEQUENT HIGHLIGHTS - The signing of an exclusive sales and marketing agreement with Baxter Healthcare Corporation for commercialization of Halozyme's investigational therapeutic, Enhanze SC(TM): Baxter will market, distribute and sell Enhanze SC, Halozyme's recombinant human PH20 hyaluronidase enzyme (rHuPH20), for certain indications in the United States and Puerto Rico upon approval of the therapeutic by the U.S. Food and Drug Administration (FDA). Upon approval, Baxter and Halozyme will be equal partners in the commercialization of the product. - The filing of a 510(k) application for Cumulase(TM) with the FDA, which will evaluate Cumulase for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures: Cumulase is an ex vivo formulation of rHuPH20 designed to replace bovine and ovine enzymes currently used for the preparation of oocytes prior to IVF during the process of intracytoplasmic sperm injection (ICSI), in which the enzyme is an essential component. The total Cumulase market consists of an estimated 500,000 ICSI cycles worldwide in 2004. Halozyme has signed agreements with Cook Ob/Gyn Incorporated, MediCult A/S and MidAtlantic Diagnostics, Inc. to distribute Cumulase worldwide. - The receipt of ISO 13485:2003 certification: ISO 13485:2003 addresses the establishment of a quality system focused on medical devices, and is the first step in obtaining the CE (European Conformity) Mark authorizing distribution to the 25 European Union (EU) and three European Free Trade Association (EFTA) member states. With this registration, Halozyme is well positioned to move forward with its Cumulase medical device. - more - - The reporting of Cumulase study results at the Technology Pavilion of the American Society of Reproductive Medicine (ASRM) 2004 Annual Meeting in Philadelphia: Studies from Stanford University revealed that after extended exposure to Cumulase, murine oocytes (eggs) demonstrated fertilization rates similar to natural IVF, whereas in the same time period, oocytes exposed to bovine hyaluronidase experienced approximately a 50 percent decrease in viability relative to natural IVF or Cumulase treated oocytes. - The completion of a $13.9 million private placement: The Company issued an aggregate of approximately 7.9 million shares of common stock at $1.75 per share and warrants to purchase up to 2.4 million additional shares of common stock at an exercise price of $2.25 per share. The transaction closed on October 13, 2004. - The listing of Halozyme's common stock on the American Stock Exchange(R) (Amex(R)): Halozyme's common stock commenced trading on the Amex under the symbol "HTI" on Monday, November 1, 2004. THIRD QUARTER 2004 FINANCIAL RESULTS - Net loss for the third quarter of 2004 was $3.3 million, or $0.08 per share, compared to a net loss for the third quarter of 2003 of $0.4 million, or $0.05 per share. - Research and development expenses for the third quarter of 2004 were $2.6 million, compared to $0.3 million for the third quarter of 2003, reflecting increased research and development expenses associated with the development and manufacturing of the Company's Cumulase and Enhanze SC product candidates. - General and administrative expenses for the third quarter of 2004 were $0.7 million, compared to $0.2 million for the third quarter of 2003, reflecting increased personnel costs and the costs of being a public company. - Cash and cash equivalents were $3.5 million at September 30, 2004 compared to $5.9 million at June 30, 2004. Halozyme's lead product candidates are Cumulase, which is designed as an aid in the in vitro fertilization process and Enhanze SC, which is designed as a spreading agent for local anesthesia in cataract surgery. Both product candidates target established markets, are based on a common, proprietary technology platform and offer significant competitive safety and potency advantages compared to current alternatives. - more - "Our accomplishments this quarter, and year to date, highlight the tremendous therapeutic potential of Halozyme's recombinant human hyaluronidase in all of its forms," said Jonathan Lim, MD, Halozyme's Chairman and CEO. "The execution of key licensing deals, the filing of our 510(k) application for Cumulase(TM) in the third quarter of 2004, and our planned filing of a New Drug Application for Enhanze SC(TM) in the first quarter of 2005 keep us on track to achieve our stated commercialization goals for Cumulase and Enhanze SC, our first two product candidates." CONFERENCE CALL Jonathan Lim, MD, Chairman and Chief Executive Officer, Gregory Frost, Vice President and Chief Scientific Officer, and David Ramsay, Vice President and Chief Financial Officer, will host an investment community conference call today beginning at 8:00 a.m. PT (11:00 a.m. ET) to discuss the results and provide a business update. Individuals interested in participating in the conference call may do so by dialing 888-463-4487 for domestic callers, or 706-679-5355 for international callers. Those interested in listening to the conference call live via the Internet may do so by visiting the Investor Relations section of the Company's website at www.halozyme.com. A replay will be available on Halozyme's website for 30 days. 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 1694457. ABOUT HALOZYME THERAPEUTICS, INC. Halozyme Therapeutics, Inc. is a development stage biopharmaceutical company dedicated to developing and commercializing recombinant human enzymes for the infertility (Cumulase), ophthalmology (Enhanze SC), and oncology (Chemophase(TM)) markets. The company's portfolio of products in development is based on intellectual property covering the family of human enzymes known as hyaluronidases. Halozyme is developing the first recombinant human hyaluronidase (rHuPH20) as a medical device (Cumulase), drug enhancement agent (Enhanze SC) and therapeutic biologic (Chemophase). 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 and regulatory strategy and the regulatory filing and potential launch dates assuming regulatory approval) 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. (FINANCIAL TABLE FOLLOWS) HALOZYME THERAPEUTICS, INC. A DEVELOPMENT STAGE COMPANY CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)
THREE MONTHS ENDED NINE MONTHS ENDED SEPTEMBER 30, SEPTEMBER 30, ------------- ------------- 2004 2003 2004 2003 ---- ---- ---- ---- EXPENSES: Research and development $ 2,598,335 $ 254,903 $ 4,816,492 $ 764,007 General and administrative 664,896 153,327 1,743,417 268,489 ------------ ------------ ------------ ------------ Total Expenses 3,263,231 408,230 6,559,909 1,032,496 Other income (expense), net 10,086 (30,784) (52,355) (80,985) ------------ ------------ ------------ ------------ LOSS BEFORE INCOME TAXES (3,253,145) (439,014) (6,612,264) (1,113,481) Income Tax Expense -- -- -- -- ------------ ------------ ------------ ------------ NET LOSS $ (3,253,145) $ (439,014) $ (6,612,264) $ (1,113,481) ============ ============ ============ ============ Net loss per share, basic and diluted $ (0.08) $ (0.05) $ (0.21) $ (0.14) ============ ============ ============ ============ Shares used in computing net loss per share, basic and diluted 39,573,312 8,196,362 31,512,015 8,196,362 ============ ============ ============ ============
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