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 10, 2018	
________________________
HALOZYME THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
________________________

				
Delaware	001-32335	 	88-0488686	
(State or other jurisdiction
of incorporation)	(Commission
File Number)	 	(IRS Employer
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:
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))

	

Item 2.02 Results of Operations and Financial Condition.
On May 10, 2018 , Halozyme Therapeutics, Inc. issued a press release to report its financial results for the first quarter March 31, 2018 . A copy of 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, as amended, (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	May 10, 2018	

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 10, 2018	 	By:	 	/s/ Harry J. Leonhardt, Esq.	
 	 	 	 	 	
 	 	Name:	 	Harry J. Leonhardt, Esq.	
 	 	Title:	 	Senior Vice President, General Counsel, Chief Compliance Officer and Corporate Secretary	

Exhibit Index

	

Exhibit No.	 	Description	 	
 	 	 	 	
99.1	 	Press release dated	May 10, 2018	

Exhibit 99.1

Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com

Chris Burton
858-704-8352
ir@halozyme.com

HALOZYME REPORTS FIRST QUARTER 2018 RESULTS

-- Revenue of $30.9 Million Includes a 50 Percent Increase in Royalty Revenue on a Reported Basis --

-- Eight ENHANZE ® -Partnered Products Expected in Clinical Studies in 2018, Two More than Forecasted in January --

-- Target Number of Progression-Free Survival Events in HALO-301 Study Now Projected to be Achieved Between December 2018 and February 2019; Enrollment on Track to Reach Approximately 500 Patients by Year-End --

SAN DIEGO, May 10, 2018 - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results and recent highlights for the first quarter ended March 31.

"Reflecting the enthusiasm and opportunity for competitive differentiation that ENHANZE may provide, in the first quarter we supported our partners in planning for initiation of an unprecedented number of clinical study starts in 2018, including two additional Phase 1 studies that were not included in our forecast at the beginning of the year,” said Dr. Helen Torley, president and chief executive officer. “The momentum we have with ENHANZE reinforces our conviction for the approximately $1 billion royalty revenue potential we outlined in January.

"For PEGPH20, we currently project we will achieve the target number of Progression-Free Survival (PFS) events in HALO-301 between December 2018 and February 2019. Upon achieving the target number of PFS events, final data collection and the steps required for database lock prior to the interim analysis will be initiated. With enrollment at the end of April on track with more than 350 patients, we continue to project approximately 500 patients will have been enrolled by year-end."
  
First Quarter 2018 and Recent Highlights include:

•	Two new ENHANZE Phase 1 clinical studies now planned for initiation in 2018 by collaboration partners, a result of momentum generated through new agreements in 2017. The eight ENHANZE-partnered products expected to be in a clinical study in 2018 is an increase from the company’s forecast in January of six.	

•	Collaboration partner Bristol-Myers Squibb planning to initiate two Phase 1 studies in 2018 , including a new study of an undisclosed target with Halozyme’s ENHANZE technology planned for Q2 and a study of nivolumab with ENHANZE planned for Q3.	

•	Among the products in clinical study, Janssen continues in multiple ongoing trials of a subcutaneous formulation of DARZALEX ® (daratumumab) in support of plans for commercialization . Halozyme’s ENHANZE technology has the potential to enable a 15-ml injection to be delivered in five minutes or less. The ongoing or planned trials in patients with Multiple Myeloma, Amyloidosis and Smoldering Myeloma include four Phase 3 studies and two earlier stage studies.	

•	Continued progress screening and enrolling patients in the HALO-301 study of PEGPH20 in combination with ABRAXANE ® (nab-paclitaxel) and gemcitabine in first-line metastatic pancreas cancer patients with high levels of tumor hyaluronan (HA-High). An interim analysis will be conducted for the first primary endpoint of PFS when the target number of events has been reached, which the company currently projects will occur between December 2018 and February 2019. Upon achieving the target number of PFS events, final data collection and the steps required for database lock prior to the interim analysis will be initiated .	

•	Acceptance of an abstract for poster presentation at the 2018 American Society of Clinical Oncology Annual Meeting examining Extracellular Matrix Circulating Peptide Biomarkers as Potential Predictors of Survival in Patients with Untreated Metastatic Pancreatic Ductal Adenocarcinoma Receiving Pegvorhyaluronidase Alfa (PEGPH20), nab-Paclitaxel and Gemcitabine.	

First Quarter 2018 Financial Highlights

•	Revenue for the first quarter was $30.9 million compared to $29.6 million for the first quarter of 2017 . The year-over-year increase was driven by 50 percent growth in royalties on a reported basis from partner sales of Herceptin ® (trastuzumab) SC, MabThera ® (rituximab) SC, RITUXAN HYCELA TM and HYQVIA ® (Immune Globulin Infusion 10% (Human) with Recombinant Human Hyaluronidase), offset by the expected decrease in bulk rHuPH20 sales to partners and research and development reimbursements. Revenue for the first quarter included $20.9 million in royalties, $3.4 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $3.4 million in HYLENEX ® recombinant (hyaluronidase human injection) product sales.	
		
•	Research and development expenses for the first quarter were $38 million , compared to $36.9 million for the first quarter of 2017 .	
		
•	Selling, general and administrative expenses for the first quarter were $13.6 million , compared to $12.6 million for the first quarter of 2017 . The increase was primarily due to personnel expenses, including stock compensation, for the period.	
		
•	Net loss for the first quarter was $27.5 million , or $0.19 per share, compared to net loss in the first quarter of 2017 of $32.9 million , or $0.26 per share.	
		
•	Cash, cash equivalents and marketable securities were $433.7 million at March 31, 2018 , compared to $469.2 million at December 31, 2017.	

Financial Outlook for 2018

Halozyme reiterated its financial guidance of:

•	Net revenue of $115 million to $125 million, including 25 to 30 percent royalty growth;	

•	Operating expenses of $230 million to $240 million;	

•	Operating cash burn of $75 million to $85 million; and	

•	Year-end cash balance of $305 million to $315 million .	

Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the first quarter of 2018 today, Thursday, May 10 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call, which will be webcast live through the "Investors" section of Halozyme's corporate website and a recording made available following the close of the call. To access the webcast and additional documents related to the call, please visit halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed by dialing (877) 410-5657 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 68917761.

About Halozyme

Halozyme Therapeutics is a biotechnology company focused on developing and commercializing novel oncology therapies that target the tumor microenvironment. Halozyme’s lead proprietary program, investigational drug pegvorhyaluronidase alfa (PEGPH20), applies a unique approach to targeting solid tumors, allowing increased access of co-administered cancer drug therapies to the tumor in animal models. PEGPH20 is currently in development for metastatic pancreatic cancer, non-small cell lung cancer, gastric cancer, metastatic breast cancer and has potential across additional cancers in combination with different types of cancer therapies. In addition to its proprietary product portfolio, Halozyme has established value-driving partnerships with leading pharmaceutical companies including Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers Squibb and Alexion for its ENHANZE ® drug delivery technology. Halozyme is headquartered in San Diego. 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 Company's future expectations and plans for growth in 2018, entering into new collaboration agreements, the development and commercialization of product candidates, including timing of clinical trial results announcements and future development and commercial activities of our collaboration partners, the potential benefits and attributes of such product candidates and expected financial outlook for 2018) 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 typically, but not always, 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 and costs, unexpected fluctuations or changes in revenues, including revenues from collaborators, unexpected delays in entering into new collaboration agreements, unexpected results or delays in development of product candidates, including delays in clinical trial patient enrollment and development activities of our collaboration partners, and regulatory review, regulatory approval requirements, unexpected adverse events and competitive conditions. These and other factors that may result in differences are discussed in greater detail in the Company's Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on May 10, 2018 .

Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)

									
 	 	Three Months Ended	
 	 	March 31,	
 	 	2018	 	2017	
Revenues:	 	 	 	 	
Royalties	 	$	20,944		 	$	13,982		
Product sales, net	 	6,801		 	11,434		
Revenues under collaborative agreements	 	3,127		 	4,152		
Total revenues	 	30,872		 	29,568		
 	 	 	 	 	
Operating expenses:	 	 	 	 	
Cost of product sales	 	3,052		 	7,544		
Research and development	 	37,976		 	36,935		
Selling, general and administrative	 	13,556		 	12,615		
Total operating expenses	 	54,584		 	57,094		
 	 	 	 	 	
Operating loss	 	(23,712	)	 	(27,526	)	
Other income (expense):	 			 			
Investment and other income, net	 	1,668		 	287		
Interest expense	 	(5,230	)	 	(5,448	)	
Net loss before income taxes	 	(27,274	)	 	(32,687	)	
Income tax expense	 	187		 	210		
Net loss	 	$	(27,461	)	 	$	(32,897	)	
 	 	 	 	 	
Net loss per share:	 	 	 	 	
Basic and diluted	 	$	(0.19	)	 	$	(0.26	)	
 	 		 		
Shares used in computing net loss per share:	 		 		
Basic and diluted	 	142,656		 	128,615		

Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)

									
 	 	March 31,
2018	 	December 31,
2017	
ASSETS	 	 	 	 	
Current assets:	 	 	 	 	
Cash and cash equivalents	 	$	98,012		 	$	168,740		
Marketable securities, available-for-sale	 	335,682		 	300,474		
Accounts receivable, net	 	26,574		 	22,133		
Inventories	 	4,393		 	5,146		
Prepaid expenses and other assets	 	19,809		 	13,879		
Total current assets	 	484,470		 	510,372		
Property and equipment, net	 	4,937		 	3,520		
Prepaid expenses and other assets	 	5,562		 	5,553		
Restricted cash	 	500		 	500		
Total assets	 	$	495,469		 	$	519,945		
 	 	 	 	 	
LIABILITIES AND STOCKHOLDERS’ EQUITY	 	 	 	 	
Current liabilities:	 	 	 	 	
Accounts payable	 	$	3,628		 	$	7,948		
Accrued expenses	 	31,889		 	39,601		
Deferred revenue, current portion	 	1,247		 	6,568		
Current portion of long-term debt, net	 	82,460		 	77,211		
Total current liabilities	 	119,224		 	131,328		
 	 	 	 	 	
Deferred revenue, net of current portion	 	6,006		 	54,297		
Long-term debt, net	 	102,696		 	125,140		
Other long-term liabilities	 	2,479		 	814		
 	 	 	 	 	
Stockholders’ equity:	 	 	 	 	
Common stock	 	144		 	143		
Additional paid-in capital	 	744,359		 	731,044		
Accumulated other comprehensive loss	 	(870	)	 	(450	)	
Accumulated deficit	 	(478,569	)	 	(522,371	)	
Total stockholders’ equity	 	265,064		 	208,366		
Total liabilities and stockholders’ equity	 	$	495,469		 	$	519,945		

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