-----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, EtYTJPMPNfAtpVvtw14lROCgBKjpKG2aEZFOSeOXf32tR8VgJDLrPPIBHQRZtMP+ MnQzNMgCc0zHPn9q7uFj0w== 0001299933-09-004444.txt : 20091106 0001299933-09-004444.hdr.sgml : 20091106 20091106103319 ACCESSION NUMBER: 0001299933-09-004444 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20091106 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20091106 DATE AS OF CHANGE: 20091106 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: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32335 FILM NUMBER: 091163156 BUSINESS ADDRESS: STREET 1: 11388 SORRENTO VALLEY ROAD CITY: SAN DIEGO STATE: CA ZIP: 92121-1345 BUSINESS PHONE: (858) 794-8889 MAIL ADDRESS: STREET 1: 11388 SORRENTO VALLEY ROAD CITY: SAN DIEGO STATE: CA ZIP: 92121-1345 FORMER COMPANY: FORMER CONFORMED NAME: GLOBAL YACHT SERVICES INC DATE OF NAME CHANGE: 20010912 8-K 1 htm_35037.htm LIVE FILING HALOZYME THERAPEUTICS, INC. (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):   November 6, 2009

HALOZYME THERAPEUTICS, INC.
__________________________________________
(Exact name of registrant as specified in its charter)

     
Delaware 001-32335 88-0488686
_____________________
(State or other jurisdiction 		_____________
(Commission 		______________
(I.R.S. Employer
of incorporation) File Number) Identification No.)
      
11388 Sorrento Valley Road, 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:

[  ]  Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
[  ]  Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
[  ]  Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
[  ]  Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02 Results of Operations and Financial Condition.

On November 6, 2009, Halozyme Therapeutics, Inc. issued a press release to report its financial results for the three and nine months ended September 30, 2009. 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.

Exhibit No. Description
99.1 Press release, dated November 6, 2009





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 6, 2009   By:   Kurt A. Gustafson
       
        Name: Kurt A. Gustafson
        Title: Vice President, CFO

Exhibit Index


     
Exhibit No.   Description
 
99.1
  Press release, dated November 6, 2009
EX-99.1 2 exhibit1.htm EX-99.1 EX-99.1

Halozyme Contact
Robert H. Uhl
Senior Director, Investor Relations
(858) 704-8264
ruhl@halozyme.com

Halozyme Therapeutics Reports Third Quarter 2009 Financial Results

SAN DIEGO, November 6, 2009 – Halozyme Therapeutics, Inc. (Nasdaq: HALO), a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets, today reported financial results for the three and nine months ended September 30, 2009.

“Our alliances have continued to achieve strong progress with Roche’s initiation of the Phase 3 registration trial for subcutaneous Herceptin, and Baxter’s completion of patient enrollment in the Phase 3 GAMMAGARD with PH20 pivotal study and the launch of Hylenex in pediatric hydration,” said Jonathan Lim, M.D., president and CEO. “Our balanced business strategy consisting of partnered development programs and proprietary pipeline product candidates made noteworthy advances through another quarter.”

Third Quarter 2009 and Recent Corporate Developments and Scientific Achievements

  •   Roche initiated a Phase 3 clinical trial with subcutaneous Herceptin formulated with Halozyme’s recombinant PH20 enzyme. This represents the first Roche product to enter a Phase 3 registration trial as part of the Halozyme-Roche collaboration, and initiation of this clinical trial triggered a milestone payment of $5 million to Halozyme. Roche intends to enroll 552 patients with HER2-positive breast cancer in the study.

  •   Roche also initiated a Phase 1 pharmacokinetic clinical trial with a subcutaneous formulation of a Roche biologic using Halozyme’s recombinant PH20 hyaluronidase enzyme. This biologic represents the third Roche proprietary compound directed to an exclusive target to enter the clinic as part of the Halozyme-Roche collaboration. Initiation of the study triggered a milestone payment to Halozyme for an undisclosed amount.

  •   Halozyme’s ultrafast insulin program moved forward during the third quarter. A Phase 1 clinical study began in September that will assess the effects of three approved prandial (mealtime) insulin analogs administered with PH20 compared to each of the analogs alone. This randomized, six-way cross-over design, euglycemic clamp study will compare the pharmacokinetics (PK) and glucodynamics (GD) of three insulin analogs. Previous studies conducted by Halozyme have demonstrated that the combination of insulin lispro (Humalog®) with PH20 yielded faster systemic insulin absorption, increased peak insulin concentrations, and improved glycemic control when compared to insulin lispro alone. The study is expected to enroll 18 healthy subjects and the results should be available by 2Q10. Our goal is to develop a best in class insulin product in comparison to the current gold standard analog products on the market today.

  •   Baxter, Halozyme’s licensee, launched Hylenex (hyaluronidase human injection) in early October at the scientific assembly of the American College of Emergency Physicians (ACEP) for use in pediatric rehydration. Hylenex allows fluids to be administered subcutaneously rather than through a vein, which can help lead to successful rehydration more quickly. Clinical data presented at the ACEP meeting showed that subcutaneous treatment facilitated by Hylenex successfully rehydrated 94% of pediatric patients, that 90% of catheters were successfully inserted on the first attempt, and 96% of clinicians rated the procedure easy to perform. Hylenex rehydration was preferred by parents as nine out of 10 surveyed were satisfied or very satisfied with the procedure.

Third Quarter 2009 Financial Results

The net loss for the third quarter of 2009 was $13.9 million, or $0.16 per share, compared with a net loss for the third quarter of 2008 of $10.9 million, or $0.14 per share. Net loss for the nine months ended September 30, 2009 was $45.7 million, or $0.54 per share, compared with a net loss of $31.8 million, or $0.40 per share for the comparable period last year.

  •   Revenue for the third quarter of 2009 was $3.0 million, compared to $2.5 million for the third quarter of 2008. Revenues under collaborative agreements for the third quarter of 2009 were $2.6 million, compared to $2.2 million for the third quarter of 2008. Revenues under collaborative agreements in the third quarter of 2009 primarily consisted of the amortization of license fees and a milestone payment received from Baxter and Roche of $1.8 million and research and development reimbursements from Baxter and Roche of $0.8 million.

  •   Research and development expenses for the third quarter of 2009 were $13.2 million, compared to $10.1 million for the third quarter of 2008, primarily due to an increase in clinical trial expenses as a result of higher spending on the ultrafast insulin program, and an increase in research and development headcount.

  •   Selling, general and administrative expenses for the third quarter of 2009 were $3.7 million, compared to $3.5 million for the third quarter of 2008.

  •   Cash and cash equivalents totaled $77.6 million as of September 30, 2009, compared with $63.7 million as of December 31, 2008 and $72.5 million as of September 30, 2008. During the third quarter of 2009 the company received cash of $2.8 million related to warrant exercises. Net cash burn for the third quarter of 2009 was $11.6 million.

Upcoming Corporate and Scientific Presentations

Halozyme management will be presenting at the Lazard Capital Markets 6th Annual Healthcare Conference to be held in New York City on November 18, 2009 at 11:30 a.m. To listen to the event live or to hear the replay please visit the Halozyme corporate Web site. The company will also be presenting results from an intra-patient variability clinical study at the Diabetes Technology Society in San Francisco on November 6, 2009.

Conference Call

Halozyme management will host a conference call and webcast on November 6, 2009 to discuss these topics beginning at 8:00 a.m. PST (11:00 a.m. EST). To participate via telephone, please call 888-256-9044 for domestic callers or 706-643-5585 for international callers. The conference ID # is 37881291. A telephone replay will be available beginning approximately two hours after the call by dialing 800-642-1687 for domestic callers or 706-645-9291 for international callers. The conference call will be broadcast live over the Internet at www.halozyme.com and the replay will be available on the company’s Web site for seven days.

About Halozyme Therapeutics, Inc.

Halozyme is a biopharmaceutical company developing and commercializing products targeting the extracellular matrix for the endocrinology, oncology, dermatology and drug delivery markets. The company’s portfolio of products and product candidates is based on intellectual property covering the family of human enzymes known as hyaluronidases and additional enzymes that affect the extracellular matrix. Halozyme’s EnhanzeÔ technology is a novel drug delivery platform designed to increase the dispersion and absorption of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche’s biological therapeutics for up to 13 targets and with Baxter BioScience to apply Enhanze technology to Baxter’s biological therapeutic compound, GAMMAGARD® Liquid. The product candidates in Halozyme’s research pipeline target multiple areas of significant unmet medical need. For more information visit www.halozyme.com.

Safe Harbor Statement

In addition to historical information, the statements set forth above include forward-looking statements (including, without limitation, statements concerning the timing and scope of our clinical trials as well as clinical trials performed by our partners) 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-K, 10-Q, and other filings with the Securities and Exchange Commission.

###

1

Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations

                                 
    Three Months Ended   Nine Months Ended
    September 30,   September 30,
    2009   2008   2009   2008
    (unaudited)   (unaudited)   (unaudited)   (unaudited)
REVENUES:
                                
Revenues under collaboration agreements
   $ 2,617,776     $ 2,194,325     $ 6,558,145     $ 5,209,897  
Product sales
     411,109       267,901       669,267       492,066  
 
                                
Total revenues
     3,028,885       2,462,226       7,227,412       5,701,963  
 
                                
OPERATING EXPENSES:
                                
Cost of product sales
     102,638       130,720       151,939       205,036  
Research and development
     13,162,748       10,080,775       41,763,972       27,450,454  
Selling, general and administrative
     3,703,099       3,450,450       11,093,563       11,454,228  
 
                                
Total operating expenses
     16,968,485       13,661,945       53,009,474       39,109,718  
 
                                
OPERATING LOSS
     (13,939,600 )     (11,199,719 )     (45,782,062 )     (33,407,755 )
Interest income
     29,318       327,561       86,391       1,579,210  
 
                                
NET LOSS
   $ (13,910,282 )   $ (10,872,158 )   $ (45,695,671 )   $ (31,828,545 )
 
                                
Basic and diluted net loss per share
   $ (0.16 )   $ (0.14 )   $ (0.54 )   $ (0.40 )
 
                                
Shares used in computing basic and diluted net loss per share
     89,570,540       80,293,800       85,086,456       79,383,614  
 
                                

Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets

                 
    September 30,   December 31,
    2009   2008
    (unaudited)        
ASSETS
                
Current assets:
                
Cash and cash equivalents
   $ 77,635,792     $ 63,715,906  
Accounts receivable
     1,589,750       7,264,410  
Inventory
     1,238,254       441,323  
Prepaid expenses and other assets
     2,942,015       2,591,149  
 
                
Total current assets
     83,405,811       74,012,788  
Property and equipment, net
     2,703,592       2,549,925  
 
                
Total Assets
   $ 86,109,403     $ 76,562,713  
 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY
                
Current liabilities:
                
Accounts payable
   $ 5,121,914     $ 6,668,791  
Accrued expenses
     5,749,610       3,995,897  
Deferred revenue
     4,941,580       3,553,730  
 
                
Total current liabilities
     15,813,104       14,218,418  
Deferred revenue, net of current portion
     52,747,933       45,894,726  
Deferred rent, net of current portion
     947,881       1,069,573  
Stockholders’ Equity:
                
Common stock
     91,095       81,554  
Additional paid-in capital
     175,854,683       128,948,064  
Accumulated deficit
     (159,345,293 )     (113,649,622 )
 
                
Total stockholders’ equity
     16,600,485       15,379,996  
 
                
Total Liabilities and Stockholders’ Equity
   $ 86,109,403     $ 76,562,713  
 
                

###

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