-----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, QSggmHXGKumfErEU6rE3+8PwBkte/+09SkNJ5aaTyuppCIGHXwCo73xi3YuFa0eV UMDwEy8qqE+pRz/0Nq9fvA== 0001299933-10-002983.txt : 20100806 0001299933-10-002983.hdr.sgml : 20100806 20100806100047 ACCESSION NUMBER: 0001299933-10-002983 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20100806 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20100806 DATE AS OF CHANGE: 20100806 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: 10996602 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_38630.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):   August 6, 2010

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 August 6, 2010, Halozyme Therapeutics, Inc. issued a press release to report its financial results for the second quarter ended June 30, 2010. 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 August 6, 2010






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 6, 2010   By:   James E. Cartoni
       
        Name: James E. Cartoni
        Title: Secretary and Vice President, Legal


Exhibit Index


     
Exhibit No.   Description

 
99.1
  Press release, dated August 6, 2010
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 Second Quarter 2010 Financial Results

SAN DIEGO, August 6, 2010 – 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 second quarter ended June 30, 2010.

“Halozyme continued to make good progress across multiple development programs in the second quarter, including Ultrafast Insulin, PEGPH20, and our alliance programs with Roche and Baxter,” said Jonathan Lim, M.D., Halozyme’s president and CEO. “The exciting clinical results that we presented at the ADA provided additional evidence that the fast-in, fast-out profile for Halozyme’s Ultrafast Insulin leads to better glycemic control for patients with diabetes. Two additional treatment studies will be underway soon, which we believe will provide further support for this hypothesis.”

Second Quarter 2010 and Recent Business Highlights

    Halozyme presented the results from three of its Ultrafast Insulin studies at this year’s American Diabetes Association (ADA) 70th Scientific Sessions – June 25-29, 2010 in Orlando:

  1)   A Phase 1 study of three mealtime insulin analogs with and without rHuPH20 (recombinant human hyaluronidase, PH20) demonstrated that the coinjection of PH20 with lispro (Humalog®), aspart (NovoLog®) and glulisine (Apidra®) results in a more physiologic fast-in, fast-out profile and enhances the glucodynamic performance for each analog.

  2)   A Phase 2 mealtime study demonstrated that subcutaneous coadministration of rHuPH20 with lispro significantly improved postprandial hyperglycemia, reduced hypoglycemia, and accelerated the absorption of mealtime insulin in patients with type 2 diabetes.

  3)   A poster presentation described the effects in a preclinical pharmacokinetic study on several insulins formulated with and without rHuPh20 in three animal models and determined that the Yucatan minipig was most comparable to humans.

    Halozyme initiated a voluntary recall of HYLENEX in May due to the presence of particles in a small number of vials of the product. No related medical events have been reported. Halozyme is working to identify and resolve the cause of the problem with the goal of returning HYLENEX to the marketplace as quickly as possible.

    The PEGPH20 cancer program recently expanded with the initiation of a second Phase 1 clinical trial. Patients with advanced cancer enrolled in the study will receive intravenous PEGPH20 plus oral dexamethasone. Animal models support the use of dexamethasone to achieve higher and more intensive dosing regimens of PEGPH20. The two parallel Phase 1 trials are designed to identify recommended Phase 2 doses of PEGPH20 with and without concomitant dexamethasone administration. Halozyme plans to report interim results from the ongoing Phase 1 studies during the fourth quarter of 2010 at a regional scientific oncology meeting. Additional information about these PEGPH20 trials can be found at clinicaltrials.gov using the identifiers NCT00834704 and NCT01170897.

Second Quarter 2010 Financial Results

The net loss for the second quarter of 2010 was $12.2 million, or $0.13 per share, compared with a net loss for the second quarter of 2009 of $17.1 million, or $0.21 per share.

    Revenue for the second quarter of 2010 was $3.2 million, compared to $1.4 million for the second quarter of 2009. Revenues under collaborative agreements for the second quarter of 2010 were $3.0 million, compared to $1.2 million for the second quarter of 2009. Revenues under collaborative agreements in the second quarter 2010 primarily consisted of the amortization of upfront fees received from Baxter and Roche of $804,000 and research and development reimbursements from Baxter and Roche of $2.1 million.

    Research and development expenses for the second quarter of 2010 were $11.9 million, compared with $14.6 million for the second quarter of 2009, primarily due to lower manufacturing costs associated with clinical trial material and a decrease in clinical trial expenses.

    Selling, general and administrative expenses for the second quarter of 2010 were $3.4 million, compared to $3.9 million for the second quarter of 2009, reflecting lower salary and bonus accruals.

    Cash and cash equivalents were $41.3 million as of June 30, 2010, compared with $67.5 million as of December 31, 2009 and $89.2 million as of June 30, 2009. Net cash burn for the second quarter of 2010 was approximately $13.9 million.

Upcoming Corporate Presentations

Halozyme representatives are scheduled to present at the following investor conferences:

    Collins Stewart, LLC Health Care Event to be held in New York, August 11, 2010

    UBS Global Life Sciences Conference to be held in New York, September 20-22, 2010

    The Fifth Annual JMP Securities Healthcare Conference to be held in New York, September 27-28, 2010.

Conference Call

Halozyme management will host a conference call and webcast on August 6 to discuss these topics beginning at 8:00 a.m. PDT (11:00 a.m. EDT). To participate via telephone, please call 877.407.8037 for domestic callers or 201.689.8037 for international callers. A telephone replay will be available beginning approximately two hours after the call by dialing 877.660.6853 from the U.S. or 201.612.7415 for international callers and using account # 367 and replay ID # 354763. 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

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 product portfolio is primarily 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 absorption and dispersion of biologics. The company has key partnerships with Roche to apply Enhanze technology to Roche’s biological therapeutics, including Herceptin® and MabThera®, for up to 13 targets, and with Baxter BioScience to apply Enhanze technology to GAMMAGARD Liquid®. Halozyme’s Ultrafast Insulin program combines its rHuPH20 enzyme with mealtime insulins, which may produce more rapid absorption, faster action, and improved glycemic control. The product candidates in Halozyme’s 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, and expected activities under our collaborative partnerships) 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

                                 
    Quarters Ended   Six Months Ended
    June 30,   June 30,
    2010   2009   2010   2009
    (unaudited)   (unaudited)   (unaudited)   (unaudited)
REVENUES:
                               
Product sales
  $ 199,530     $ 179,951     $ 597,340     $ 258,158  
Revenues under collaborative agreements
    3,013,823       1,246,205       6,057,744       3,940,369  
 
                               
Total revenues
    3,213,353       1,426,156       6,655,084       4,198,527  
 
                               
OPERATING EXPENSES:
                               
Cost of product sales
    83,539       45,097       89,199       49,301  
Research and development
    11,924,406       14,561,137       23,391,610       28,601,224  
Selling, general and administrative
    3,357,486       3,903,642       7,114,499       7,390,464  
 
                               
Total operating expenses
    15,365,431       18,509,876       30,595,308       36,040,989  
 
                               
OPERATING LOSS
    (12,152,078 )     (17,083,720 )     (23,940,224 )     (31,842,462 )
Interest and other income, net
    1,155       23,695       1,824       57,073  
 
                               
NET LOSS
  $ (12,150,923 )   $ (17,060,025 )   $ (23,938,400 )   $ (31,785,389 )
 
                               
Basic and diluted net loss per share
  $ (0.13 )   $ (0.21 )   $ (0.26 )   $ (0.38 )
 
                               
Shares used in computing basic and diluted net loss per share
    91,766,799       82,990,107       91,689,909       82,807,253  
 
                               

Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets

                 
    June 30,   December 31,
    2010   2009
    (unaudited)        
ASSETS
               
Current assets:
               
Cash and cash equivalents
  $ 41,312,426     $ 67,464,506  
Accounts receivable
    2,253,771       4,243,909  
Inventory
    1,081,876       1,159,551  
Prepaid expenses and other assets
    4,676,229       1,573,777  
 
               
Total current assets
    49,324,302       74,441,743  
Property and equipment, net
    2,161,549       2,708,016  
 
               
Total Assets
  $ 51,485,851     $ 77,149,759  
 
               
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY
               
Current liabilities:
               
Accounts payable
  $ 2,101,349     $ 2,820,491  
Accrued expenses
    4,134,661       6,083,854  
Deferred revenue
    4,825,735       5,492,604  
 
               
Total current liabilities
    11,061,745       14,396,949  
Deferred revenue, net of current portion
    53,857,056       54,989,588  
Deferred rent, net of current portion
    684,315       859,833  
Stockholders’ (deficit) equity:
               
Common stock
    92,010       91,682  
Additional paid-in capital
    181,739,270       178,821,852  
Accumulated deficit
    (195,948,545 )     (172,010,145 )
 
               
Total stockholders’ (deficit) equity
    (14,117,265 )     6,903,389  
 
               
Total Liabilities and Stockholders’ (Deficit) Equity
  $ 51,485,851     $ 77,149,759  
 
               

###

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