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): May 7, 2012

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 May 7, 2012, Halozyme Therapeutics, Inc., (the “Company”) issued a press release to report its financial results for the first quarter ended March 31, 2012. 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 5.07 Submission of Matters to a Vote of Security Holders.

The Company’s Annual Meeting of Stockholders was held on May 3, 2012. At the Annual Meeting, the total number of shares represented in person or by proxy was 90,330,732. The Company’s stockholders voted on the following three proposals:

Proposal No. 1

To elect two Class II directors to hold office for a three-year term and until their respective successors are elected and qualified. The voting results were as follows:

Nominees	Votes For		Votes Against		Broker Non-Votes
Randal J. Kirk		68,078,163		4,291,772		17,960,797
John S. Patton, Ph.D.		70,960,235		1,409,700		17,960,797

Both nominees were elected to the board of directors.

Proposal No. 2

To approve, by advisory vote, the Company’s executive compensation. The voting results were as follows:

For	Against		Abstain		Broker Non-Votes
71,347,379		1,006,062		16,494		17,960,797

The foregoing proposal was approved.

Proposal No. 3

To ratify the selection of Ernst & Young LLP as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2012. The voting results were as follows:

For	Against		Abstain
90,287,793		34,990		7,949

The foregoing proposal was approved.

Item 9.01 Financial Statements and Exhibits.

Exhibit No.		Description
	99.1	Press Release, dated May 7, 2012

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.
May 7, 2012	By:	Jean Liu
		Name: Jean Liu
		Title: Vice President, General Counsel & Secretary

Exhibit Index

Exhibit No.	Description
99.1	Press release, dated May 7, 2012

EX-99.1

Exhibit 99.1

Media/Investor Contact:

Anne Erickson

Executive Director
Halozyme Therapeutics

858-704-8264

aerickson@halozyme.com

HALOZYME REPORTS FIRST QUARTER 2012 FINANCIAL RESULTS

SAN DIEGO, May 7, 2012 – Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the quarter ended March 31, 2012.

“We achieved a significant milestone in the first quarter with the European regulatory filing of the subcutaneous Herceptin program by our partner Roche,” said Gregory I. Frost, Ph.D., President and Chief Executive Officer, Halozyme. “Despite the HyQ regulatory delay from our Baxter collaboration, our pipeline has continued to make tangible progress on all fronts, as well as across diverse therapeutic areas and geographies.”

First Quarter Highlights
Highlights of Halozyme’s first quarter activities and recent events include:

• Notification from the European Patent Office (EPO) that a hearing scheduled in opposition of the European patent for Halozyme’s recombinant human hyaluronidase enzyme (rHuPH20) was cancelled and the EPO acknowledged the patentability of the claims. The Company anticipates the EPO to issue a final written decision to this effect.

• Announced with our collaborator, Baxter, that the U.S. Food and Drug Administration (FDA) requested additional information to complete its review of the HyQ Biologics License Application (BLA).The Companies will work together to develop studies to provide additional data to address the concerns raised by the agency.

• In addition to filing a Line Extension Application for subcutaneous (SC) Herceptin^® (trastuzumab) with the European Medicines Agency (EMA), Roche presented Phase 3 registration data from the HannaH trial at the Early Breast Cancer Conference in Vienna. The study met its co-primary endpoints of pharmacokinetics and efficacy. Herceptin SC, using rHuPH20, may provide greater convenience to patients versus the traditional IV method due to its less invasive administration route and quicker administration time (5 minutes versus 30 – 90 minutes).

• Roche reiterated their intent to file the Line Extension Application of subcutaneous MabThera^® (rituxumab with rHuPH20) to the EMA this year for the treatment of Non-Hodgkin’s Lymphoma, Chronic Lymphocytic Leukemia and Follicular Lymphoma.

• Announced positive data with ViroPharma regarding a Phase 2 SC trial of Cinryze^® (C1 esterase inhibitor [human]) in combination with rHuPH20, in patients with hereditary angioedema. Presented at the American Academy of Allergy Asthma & Immunology, the study demonstrated that SC co-administration of Cinryze with rHuPH20 was well tolerated and resulted in sustained physiologically relevant C1 INH functional concentrations.

• Updated the Hylenex^® recombinant (hyaluronidase human injection) label to include instructions for pre-administration of the enzyme in advance of other injected or subcutaneously infused drugs, and information from non-clinical studies that provide further data on the safety profile of Hylenex.

First Quarter 2012 Financial Results
The net loss for the first quarter of 2012 was $15.1 million, or $0.14 per share, compared with a net loss for the first quarter of 2011 of $9.6 million, or $0.10 per share.

• Revenues for the first quarter of 2012 were $7.4 million, compared to $7.5 million for the first quarter of 2011. Revenues in the first quarter of 2012 primarily consisted of a milestone payment from Roche of $4 million and research and development reimbursements from partners.

• Research and development expenses for the first quarter of 2012 were $15.9 million, compared with $13.8 million for the first quarter of 2011, primarily due to an increase in manufacturing activities and compensation costs, partially offset by a decrease in clinical trial activities.

• Selling, general and administrative (SG&A) expenses for the first quarter of 2012 were $6.6 million, compared to $3.4 million for the first quarter of 2011. The increase for SG&A was due to higher compensation costs and higher marketing and market research expenses during the quarter.

• Cash and cash equivalents were $116.6 million as of March 31, 2012, compared with $73.8 million as of March 31, 2011. Excluding the net proceeds of $81.5 million from the financing in February 2012, net cash used in the first quarter of 2012 was approximately $17.7 million.

Due to the HyQ regulatory delay, we anticipate 2012 cash burn to be $55-$60 million, instead of $50-$55 million as previously forecasted.

Conference Call
Halozyme will webcast its Quarterly Update Conference Call today at 4:30 p.m. ET/1:30 p.m. PT. Gregory I. Frost, Ph.D., Halozyme’s President and Chief Executive Officer, will lead the call. During the call, the Company plans to provide further details underlying its first quarter 2012 financial results. To access the webcast, please log on to www.halozyme.com approximately fifteen minutes prior to the call to register, download, and install any necessary audio software. For those without access to the Internet, the live call may be accessed by phone by calling (877) 407-8037 (domestic callers) or (201) 689-8037 (international callers). A telephone replay will be available shortly after the call by dialing (877) 660-6853 (domestic callers) or (201) 612-7415 (international callers) using account number 367 and replay ID number 393124.

Upcoming Corporate Presentations
Halozyme is scheduled to present at the upcoming investor conference.

• Bank of America Merrill Lynch 2012 Healthcare Conference in Las Vegas on May 16, 2012 at 1:00 p.m. ET/10:00 a.m. PT. Gregory I. Frost, Ph.D., President and Chief Executive Officer of Halozyme Therapeutics, will provide a corporate overview.

The presentation will be webcast through the “Investors” section of Halozyme’s corporate website at www.halozyme.com, and a recording will be made available for 90 days following the event. To access the live webcast, please log on to Halozyme’s website approximately fifteen minutes prior to the presentation to register and download any necessary audio software.

About Halozyme
Halozyme Therapeutics is a biopharmaceutical company dedicated to developing and commercializing innovative products that advance patient care. With a diversified portfolio of enzymes that target the extracellular matrix, the Company’s research focuses primarily on a family of human enzymes, known as hyaluronidases, that increase the absorption and dispersion of biologics. Halozyme’s pipeline addresses therapeutic areas, such as diabetes, oncology and dermatology that have significant unmet medical need. The Company markets Hylenex^® recombinant (hyaluronidase human injection) and has partnerships with Roche, Baxter, ViroPharma and Intrexon. Halozyme is headquartered in San Diego, CA. For more information on how we are innovating, please visit our corporate website at 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 EPO’s anticipated issuance of a final written decision regarding our European patent for rHuPH20, Roche’s anticipated filing of the Line Extension Application of subcutaneous MabThera^® (rituxumab with rHuPH20) to the European Medicines Agency this year, our anticipated cash burn for 2012 and potential benefits and attributes of our product candidates. These statements 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 unexpected expenditures, clinical trial results, delays in development and regulatory review, 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.

Halozyme Therapeutics, Inc.
Unaudited Condensed Consolidated Statements of Operations

	Three Months Ended March 31,
	2012			2011
REVENUES:
Product sales, net	$	187,411		$	165,449
Revenues under collaborative agreements		7,252,768			7,378,445
Total revenues		7,440,179			7,543,894
OPERATING EXPENSES:
Cost of product sales		70,761			11,717
Research and development		15,891,109			13,785,797
Selling, general and administrative		6,618,707			3,405,966
Total operating expenses		22,580,577			17,203,480
OPERATING LOSS		(15,140,398	)		(9,659,586	)
Interest and other income, net		21,217			23,869
NET LOSS	$	(15,119,181	)	$	(9,635,717	)
Basic and diluted net loss per share	$	(0.14	)	$	(0.10	)
Shares used in computing basic and diluted net loss per share		107,589,514			100,927,402

Halozyme Therapeutics, Inc.
Unaudited Condensed Consolidated Balance Sheets

	March 31,			December 31,
	2012			2011
ASSETS
Current assets:
Cash and cash equivalents	$	116,608,304		$	52,825,527
Accounts receivable, net		5,550,830			2,262,465
Inventory		1,496,783			567,263
Prepaid expenses and other assets		8,910,059			8,332,242
Total current assets		132,565,976			63,987,497
Property and equipment, net		2,152,934			1,771,048
Total Assets	$	134,718,910		$	65,758,545
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	3,011,181		$	7,556,859
Accrued expenses		7,184,794			5,615,574
Deferred revenue, current portion		6,484,800			4,129,407
Total current liabilities		16,680,775			17,301,840
Deferred revenue, net of current portion		36,130,767			36,754,583
Deferred rent, net of current portion		846,957			802,006
Stockholders’ Equity:
Common stock		112,411			103,990
Additional paid-in capital		341,088,827			255,817,772
Accumulated deficit		(260,140,827	)		(245,021,646	)
Total stockholders’ equity		81,060,411			10,900,116
Total Liabilities and Stockholders’ Equity	$	134,718,910		$	65,758,545

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