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):	 	February 28, 2017	
________________________
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 February 28, 2017 , Halozyme Therapeutics, Inc. issued a press release to report its financial results for the fourth quarter and the full year ended December 31, 2016 . 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	February 28, 2017	

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.	
  	 	 	 	 	
February 28, 2017	 	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	February 28, 2017	

Exhibit 99.1

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

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

HALOZYME REPORTS FOURTH QUARTER AND FULL YEAR 2016 FINANCIAL RESULTS

- Strong progress in global HALO 301 clinical trial following positive randomized Phase 2 HALO- 202 results -

- Supportive partner data presented at ASH in two key ENHANZE ™ platform programs -

- 2016 Royalty Revenue of $51 million increased 65 percent from prior year -

SAN DIEGO, February 28, 2017 - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results and recent highlights for the fourth quarter and full year ended December 31, 2016.

“We exited 2016 in a strong position through the benefit of our differentiated business model and having made substantial progress across both of our value-creating pillars,” said Dr. Helen Torley, president and chief executive officer. “The positive Phase 2 data we reported last month affirms our conviction in PEGPH20, our lead investigational oncology drug, and supports our ongoing Phase 3 study in pancreas cancer patients. We have made strong progress initiating global sites in the Phase 3 study and see momentum building in the number of patients we are screening.

“Our ENHANZE™ platform remains an important value driver as royalty revenue demonstrated yet another quarter of robust growth, and exceeded $50 million for the year. With positive data presented by Genentech and Janssen at the American Society of Hematology annual meeting for their ENHANZE-partnered programs and a recent BLA filing in the U.S. by Genentech, we remain very encouraged by the royalty growth potential from current and new products over the long term.”

Fourth Quarter 2016 and Recent Highlights include:
		
•	Reporting a statistically significant improvement in the primary endpoint of progression-free survival (PFS) of all evaluable patients, and in the secondary endpoint of PFS in patients with high levels of hyaluronan (HA), as of a December 2016 data cut in the Phase 2 randomized HALO-202 study of PEGPH20 in combination with ABRAXANE ® (nab-paclitaxel) and gemcitabine in advanced pancreas cancer patients. The primary safety endpoint to evaluate and demonstrate a reduction in the rate of thromboembolic events in the PEGPH20 arm was also achieved .	

In the population that closely mirrors the HALO-301 Phase 3 study, a 91 percent improvement was achieved in median PFS for HA-High patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in the control arm. A 50 percent improvement was also reported in median overall survival (OS) for HA-High patients in the PEGPH20 arm, 11.7 months compared to 7.8 months in the control arm.

•	Screening patients at nearly 200 global sites and receiving approval in all 22 participating countries for HALO-301, the company’s Phase 3 study of pancreas cancer patients.	

•	Entering the dose expansion phase of the ongoing Phase 1b clinical study evaluating PEGPH20 in combination with KEYTRUDA ® (pembrolizumab) in relapsed non-small cell lung and gastric cancer patients. The company expects to enroll approximately 50 patients with high levels of HA at 30 U.S. sites.	

•	Announcing a broad clinical collaboration agreement with Genentech to evaluate PEGPH20 and TECENTRIQ ® (atezolizumab) in up to 8 tumor types. Halozyme plans to initiate a Phase 1b trial to evaluate the combination in gallbladder cancer and cholangiocarcinoma, and Roche plans to initiate multiple Phase 1b/2 trials within their novel immunotherapy MORPHEUS clinical trial platform to evaluate the combination in pancreas and gastric cancers in the second half of 2017.	

•	Presenting supportive clinical data by ENHANZE™ partners at the American Society of Hematology annual meeting in November. Genentech presented data from the SABRINA Phase 3 study indicating comparable response rates and time-to-event data for subcutaneous rituximab compared to IV administration. The data presentation followed acceptance by the Food and Drug Administration (FDA) of a Biologics License Application for a subcutaneous formulation of Rituximab using Halozyme’s ENHANZE™ technology. Roche has indicated it is seeking approval in chronic lymphocytic leukemia and non-Hodgkin’s lymphoma, with an action date in June.	

In addition, Janssen presented data indicating its subcutaneous formulation of daratumumab on the ENHANZE™ platform was well tolerated and had an efficacy and pharmacokinetic profile consistent with the IV formulation, demonstrating the feasibility of a 30-minute, 90 mL dose and supporting further study in a Phase 3 clinical trial.

Fourth Quarter and Full Year 2016 Financial Highlights
		
•	Revenue for the fourth quarter was $39 million compared to $52.2 million for the fourth quarter of 2015. The year-over-year decrease was driven by $25 million received upon signing the Lilly collaboration agreement in 2015, offset by increases in royalties from partner sales of Herceptin ® SC, MabThera ® SC and HYQVIA ® , API sales to partners, and manufacturing and clinical supply reimbursements from ENHANZE™ partners. Revenue for the fourth quarter included $14.3 million in royalties, an increase of 50 percent from the prior-year period, $9 million in sales of bulk rHuPH20 primarily for use in manufacturing collaboration products and $4.4 million in HYLENEX ® recombinant (hyaluronidase human injection) product sales.	
Revenue for 2016 totaled $146.7 million , an increase of 9 percent from 2015, including royalty revenue of $51 million , an increase of 65 percent from 2015.
		
•	Research and development expenses for the fourth quarter were $41.3 million , compared to $27.7 million for the fourth quarter of 2015. The planned increases were primarily due to a ramp in spending associated with the HALO-301 study, personnel expenses, and manufacturing and clinical supply expenses that are reimbursed by ENHANZE™ partners.	
		
•	Selling, general and administrative expenses for the fourth quarter were $12.2 million , compared to $10.6 million for the fourth quarter of 2015. The increase was primarily due to personnel expenses, including stock compensation, for the period.	
		
•	Operating expenses for 2016 totaled $229.9 million , an increase of 41 percent from 2015.	
		
•	Net loss for the fourth quarter was $27.4 million , or $0.21 per share, compared to net income in the fourth quarter of 2015 of $4.3 million , or $0.03 per share. Net loss for 2016 totaled $103 million , or $0.81 per share.	
		
•	Cash, cash equivalents and marketable securities were $205 million at December 31, 2016, compared to $221.1 million at September 30, 2016.	

Financial Outlook for 2017
For 2017, the company reiterated and updated the cash portions of its financial guidance, now expecting:
		
•	Net revenue of $115 million to $130 million, excluding any new ENHANZE collaboration agreements;	
		
•	Operating expenses of $240 million to $250 million;	
		
•	Operating cash burn of $75 million to $85 million; and	
		
•	Year-end cash balance of $110 million to $125 million, an increase from its prior range of $100 million to $110 million.	

Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for the fourth quarter and full year 2016 today, Tuesday, February 28 at 4:30 p.m. ET/1:30 p.m. PT. Dr. Helen Torley, president and chief executive officer, will lead the call. The call will be webcast live through the "Investors" section of Halozyme's corporate website and a recording will be made available following the close of the call. To access the webcast and additional documents related to the call, please visit http://www.halozyme.com approximately fifteen minutes prior to the call to register, download and install any necessary audio software. The call may also be accessed at (877) 410-5657 (domestic callers) (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 15609911.
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 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 and Lilly for its ENHANZE™ drug delivery platform. 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 2017, the development and commercialization of product candidates, including clinical trial patient enrollment projections and future development activities of our collaboration partners, the potential benefits and attributes of such product candidates and expected financial outlook for 2017) 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 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 Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2017 .

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

																	
 	 	Three Months Ended	 	For the Year Ended	
 	 	December 31,	 	December 31,	
 	 	2016	 	2015	 	2016	 	2015	
Revenues:	 	 	 	 	 	 	 	 	
Product sales, net	 	$	13,422		 	$	13,579		 	$	53,392		 	$	46,082		
Royalties	 	14,289		 	9,544		 	50,984		 	30,975		
Revenues under collaborative agreements	 	11,292		 	29,104		 	42,315		 	58,000		
Total revenues	 	39,003		 	52,227		 	146,691		 	135,057		
 	 	 	 	 	 	 	 	 	
Operating expenses:	 	 	 	 	 	 	 	 	
Cost of product sales	 	8,002		 	8,427		 	33,206		 	29,245		
Research and development	 	41,349		 	27,746		 	150,842		 	93,236		
Selling, general and administrative	 	12,227		 	10,589		 	45,853		 	40,028		
Total operating expenses	 	61,578		 	46,762		 	229,901		 	162,509		
 	 	 	 	 	 	 	 	 	
Operating (loss) income	 	(22,575	)	 	5,465		 	(83,210	)	 	(27,452	)	
Other income (expense):	 	 	 	 	 	 	 	 	
Investment and other income, net	 	366		 	155		 	1,326		 	422		
Interest expense	 	(5,599	)	 	(1,302	)	 	(19,977	)	 	(5,201	)	
Net (loss) income before income taxes	 	(27,808	)	 	4,318		 	(101,861	)	 	(32,231	)	
Income tax expense (benefit)	 	(422	)	 	—		 	1,162		 	—		
Net loss	 	$	(27,386	)	 	$	4,318		 	$	(103,023	)	 	$	(32,231	)	
 	 	 	 	 	 	 	 	 	
Net loss per share:	 	 	 	 	 	 	 	 	
Basic	 	$	(0.21	)	 	$	0.03		 	$	(0.81	)	 	$	(0.25	)	
Diluted	 	$	(0.21	)	 	$	0.03		 	$	(0.81	)	 	$	(0.25	)	
 	 	 	 	 	 	 	 	 	
Shares used in computing net loss per share:	 	 	 	 	 	 	 	 	
Basic	 	128,185		 	127,197		 	127,964		 	126,704		
Diluted	 	128,185		 	129,248		 	127,964		 	126,704		

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

									
 	 	December 31,
2016	 	December 31,
2015	
ASSETS	 	 	 	 	
Current assets:	 	 	 	 	
Cash and cash equivalents	 	$	66,764		 	$	43,292		
Marketable securities, available-for-sale	 	138,217		 	65,047		
Accounts receivable, net	 	15,680		 	32,410		
Inventories	 	14,623		 	9,489		
Prepaid expenses and other assets	 	21,248		 	21,534		
Total current assets	 	256,532		 	171,772		
Property and equipment, net	 	4,264		 	3,943		
Prepaid expenses and other assets	 	219		 	5,574		
Restricted cash	 	500		 	500		
Total assets	 	$	261,515		 	$	181,789		
 	 	 	 	 	
LIABILITIES AND STOCKHOLDERS’ (DEFICIT) EQUITY	 	 	 	 	
Current liabilities:	 	 	 	 	
Accounts payable	 	$	3,578		 	$	4,499		
Accrued expenses	 	28,821		 	26,792		
Deferred revenue, current portion	 	4,793		 	9,304		
Current portion of long-term debt	 	17,393		 	21,862		
Total current liabilities	 	54,585		 	62,457		
 	 			 			
Deferred revenue, net of current portion	 	39,825		 	43,919		
Long-term debt, net	 	199,228		 	27,971		
Other long-term liabilities	 	358		 	4,443		
 	 	 	 	 	
Stockholders’ (deficit) equity:	 	 	 	 	
Common stock	 	130		 	128		
Additional paid-in capital	 	552,737		 	525,628		
Accumulated other comprehensive loss	 	(6	)	 	(99	)	
Accumulated deficit	 	(585,342	)	 	(482,658	)	
Total stockholders’ (deficit) equity	 	(32,481	)	 	42,999		
Total liabilities and stockholders’ (deficit) equity	 	$	261,515		 	$	181,789		

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