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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
August 8, 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))	

 

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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 August 8, 2005, Halozyme Therapeutics, Inc. issued a press release to report its financial results for the three months ended June 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 August 8, 2005.		

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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.
 	 	
August 8, 2005 	By:  	/s/ David A. Ramsay  	 	
 	 	David A. Ramsay  	 	
 	 	Secretary and Chief Financial Officer  	 	

  

Exhibit 99.1

Halozyme Contact	 	Investor Relations Contacts	
David A. Ramsay	 	Zack Bryant / Bruce Voss	
Chief Financial Officer	 	Lippert/Heilshorn & Associates	
(858) 794-8889	 	(310) 691-7100	
dramsay@halozyme.com	 	zbryant@lhai.com	
HALOZYME THERAPEUTICS REPORTS SECOND QUARTER 2005
FINANCIAL RESULTS
— Conference Call and Webcast Today at 8:00 a.m. PDT —
SAN DIEGO, August 8, 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 June 30, 2005.
Second Quarter 2005 and Subsequent Week’s Highlights

 	•	 	The submission of an Investigational New Drug (IND) application for Chemophase TM to the U.S. Food and Drug Administration (FDA). Chemophase is a formulation of recombinant human hyaluronidase being developed as a chemoadjuvant for the treatment of cancer. This IND was submitted to enable the initiation of the first clinical trial with Chemophase, administered intravesically (i.e., in the bladder) with the chemotherapeutic agent mitomycin to patients with bladder cancer.	

 	•	 	The acceptance by the FDA and the granting of Priority Review status for Halozyme’s New Drug Application (NDA) for Hylenex™. Hylenex, the first product in Halozyme’s Enhanze Ô Technology portfolio, is for potential use as a “spreading agent” to enhance the drug delivery of local anesthesia, contrast agents and for subcutaneous fluid replacement, or hypodermoclysis.	

 	•	 	The launch of Cumulase Ô for the treatment of oocytes to facilitate certain in vitro fertilization (IVF) procedures. The active pharmaceutical ingredient in Cumulase is the first and only recombinant human hyaluronidase approved in the United States and in the European Union (EU) for cumulus removal in the IVF process. Halozyme received 510(k) clearance from the FDA in April 2005 and CE Mark approval in December 2004.	

 	•	 	The presentation of results from new preclinical studies investigating the use of Halozyme’s rHuPH20 hyaluronidase enzyme in conjunction with chemotherapy at the American Association for Cancer Research in Anaheim, California. Studies conducted in	

 

 	 	 	collaboration with the University of Trondheim, Norway, showed rHuPH20 reduced both tumor interstitial fluid pressure in animal models and the resistance of cultured human bladder carcinoma aggregates to a commonly used chemotherapy agent. The company also announced its selection of bladder cancer as its first therapeutic target for Chemophase in oncology.	

 	•	 	The presentation of new preclinical study results of Halozyme’s rHuPH20 hyaluronidase enzyme at the 2005 Association for Research in Vision and Ophthalmology annual meeting in Fort Lauderdale, Florida. These preclinical safety and pharmacology animal studies showed that when viscoelastic agents commonly used in cataract surgery were left in the eyes of animals, injection of Halozyme’s rHuPH20 enzyme into the front of the eye significantly reduced the incidence and severity of intraocular pressure rises.	

 	•	 	The bolstering of Halozyme’s management team with the addition of Richard C. Yocum, MD, and its Board with the addition of Steve Thornton. Dr. Yocum joined Halozyme as its new Vice President of Clinical Development and Medical Affairs and brings to Halozyme more than 23 years of experience in clinical drug development, project team management, clinical research trial design and implementation and patient care. Mr. Thornton brings to the Board more than 27 years of strategic and operational experience within large and small pharmaceutical companies in the fields of branded and generic drugs, medical devices and drug delivery technologies.	
Second Quarter 2005 Financial Results

 	•	 	Net loss for the second quarter of 2005 was $2.9 million, or $0.06 per share, compared with a net loss for the second quarter of 2004 of $2.1 million, or $0.05 per share. Net loss for the six months ended June 30, 2005 was $6.1 million, or $0.12 per share compared with a net loss for the six months ended June 30, 2005 of $3.4 million, or $0.12 per share.	

 	•	 	Research and development expenses for the second quarter of 2005 were $2.2 million, compared with $1.5 million for the second quarter of 2004, reflecting increased research, development and manufacturing expenses associated with the Company’s Cumulase and Hylenex product candidates.	

 	•	 	Selling, general and administrative expenses for the second quarter of 2005 were $0.8 million, compared with $0.6 million for the second quarter of 2004, reflecting increased personnel costs and the costs of being a public company, including accounting and legal expenses.	

 	•	 	Cash and cash equivalents were $10.1 million as of June 30, 2005 compared with $13.1 million at March 31, 2005 and $5.9 million as of June 30, 2004.	
“We continue to make solid progress on all fronts and are meeting our milestones, including launch of our first product Cumulase, as targeted,” stated Jonathan Lim, MD, Halozyme’s Chairman and CEO. “We are extremely pleased with our progress toward bringing our oncology

 

drug candidate, Chemophase, into the clinic later this year. 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. Our goal is to initiate clinical trials in bladder cancer in the fourth quarter of 2005.”
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 8211578. 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 and regulatory strategy and the regulatory filing and potential clinical study 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.
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HALOZYME THERAPEUTICS, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS — UNAUDITED
FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2005 AND 2004

 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
 	 	Three Months Ended	 	 	Six Months Ended	 	
 	 	June 30,	 	 	June 30,	 	
 	 	2005	 	 	2004	 	 	2005	 	 	2004	 	
REVENUES:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Product Sales	 	$	45,703	 	 	$	—	 	 	$	45,703	 	 	$	—	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
EXPENSES:	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Cost of sales	 	 	21,024	 	 	 	—	 	 	 	21,024	 	 	 	—	 	
Research and development	 	 	2,172,949	 	 	 	1,521,576	 	 	 	4,635,239	 	 	 	2,218,157	 	
Selling, general and administrative	 	 	797,388	 	 	 	567,550	 	 	 	1,606,009	 	 	 	1,078,521	 	

Total Expenses	 	 	2,991,361	 	 	 	2,089,126	 	 	 	6,262,272	 	 	 	3,296,678	 	

LOSS FROM OPERATIONS	 	 	(2,945,658	)	 	 	(2,089,126	)	 	 	(6,216,569	)	 	 	(3,296,678	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Other income (expense), net	 	 	77,324	 	 	 	14,429	 	 	 	155,159	 	 	 	(62,441	)	

LOSS BEFORE INCOME TAXES	 	 	(2,868,334	)	 	 	(2,074,697	)	 	 	(6,061,410	)	 	 	(3,359,119	)	
 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	 	
Income Tax Expense	 	 	—	 	 	 	—	 	 	 	—	 	 	 	—	 	

NET LOSS	 	$	(2,868,334	)	 	$	(2,074,697	)	 	$	(6,061,410	)	 	$	(3,359,119	)	

Net loss per share, basic and diluted	 	$	(0.06	)	 	$	(0.05	)	 	$	(0.12	)	 	$	(0.12	)	

Shares used in computing net loss per share, basic and diluted	 	 	49,945,467	 	 	 	39,432,904	 	 	 	49,761,501	 	 	 	27,437,074	 	
 	 	 	 	 	 	 	 	 	 	 	 	 	
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