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, 2019	
HALOZYME THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
________________________
Commission File Number 001-32335

			
Delaware	 	88-0488686	
(State or other jurisdiction of incorporation or organization)	 	(I.R.S. Employer Identification No.)	
 	 	
11388 Sorrento Valley Road	 	92121	
San Diego	 	(Zip Code)	
California	 	 	
(Address of principal executive offices)	 	 	
( 858 ) 794-8889
(Registrant’s telephone number, including area code)
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))

Securities registered pursuant to Section 12(b) of the Act:

			
Title of each class	Trading Symbol(s)	Name of each exchange on which registered	
Common Stock, $0.001 par value	HALO	The Nasdaq Stock Market LLC	
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 ( §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 ( §240.12b-2 of this chapter).         
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

	

Item 2.02 Results of Operations and Financial Condition.
On August 6, 2019 , Halozyme Therapeutics, Inc. issued a press release to report its financial results for the second quarter end June 30, 2019 . 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	August 6, 2019	

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, 2019	 	By:	 	/s/ Harry J. Leonhardt, Esq.	
 	 	 	 	 	
 	 	Name:	 	Harry J. Leonhardt, Esq.	
 	 	Title:	 	Senior Vice President, General Counsel and Corporate Secretary	

Exhibit 99.1

HALOZYME REPORTS SECOND QUARTER 2019 RESULTS

- Total Revenues Increase 11% to $39.1 million Compared to $35.2 million in Prior-year Period -

- ENHANZE ® Partner Janssen Submits Regulatory Applications for Subcutaneous Formulation of DARZALEX ® in the U.S. and EU -

- Pivotal Phase 3 Trial Results from HALO-301 Evaluating PEGPH20 in Metastatic Pancreas Cancer Expected by December 2019 -

SAN DIEGO, August 6, 2019 - Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results for the second quarter ended June 30, 2019 and provided an update on recent corporate activities.

“We are very pleased with the strong progress in both pillars of our business in 2019,” said Dr. Helen Torley, president and chief executive officer. “ENHANZE ® progress included Janssen recently submitting regulatory applications to the U.S. Food and Drug Administration and the European Medicines Agency, and our most recently announced partner, argenx, initiating its first phase 1 study utilizing the ENHANZE ® drug delivery technology. In addition, we remain focused on PEGPH20, where our HALO-301 pivotal phase 3 trial in metastatic front-line pancreas cancer is on track for the announcement of topline results by December 2019.”

Second Quarter 2019 and Recent Highlights Include:

•	In July 2019, ENHANZE ® collaborator Janssen Biotech, Inc. (Janssen) submitted a Biologics License Application to the U.S. Food and Drug Administration and an extension application to the European Medicines Agency for the subcutaneous delivery of DARZALEX ® (daratumumab) for patients with multiple myeloma. Janssen’s regulatory submissions followed the announcement and subsequent presentation of positive results from its phase 3 COLUMBA study at the American Society of Clinical Oncology Annual Meeting in June 2019. The COLUMBA study investigated subcutaneously administered DARZALEX ® in comparison to intravenous DARZALEX ® in patients with relapsed or refractory multiple myeloma.	

•	In July 2019, argenx dosed the first subject in a phase 1 clinical trial evaluating the safety, pharmacokinetics and pharmacodynamics of efgartigimod (ARGX-113), using Halozyme's proprietary ENHANZE ® drug delivery technology, triggering a $5 million payment to Halozyme . Additionally, in May 2019, argenx nominated a second target to be studied using ENHANZE ®  technology, a human complement factor C2 associated with the product	

candidate ARGX-117, which is being developed to treat severe autoimmune diseases, triggering a $10 million payment to Halozyme.

•	In June 2019, the target number of 330 overall survival events in the HALO-301 clinical trial was reached. The company plans to conduct the final overall survival analysis upon data maturity which will occur when all patients enrolled in the study have been followed for at least 8.5 months. Accordingly, data maturity is projected to be achieved in mid-September 2019. Based on this timing of data maturity, the company expects to announce topline results for the HALO-301 clinical trial by December 2019.	

•	In June 2019, a Cooperative Research and Development Agreement (CRADA) was announced with the National Institute of Allergy and Infectious Diseases’ Vaccine Research Center (VRC), part of the National Institute of Health, enabling the VRC’s use of ENHANZE ® technology to develop subcutaneous formulations of broadly neutralizing antibodies (bnAbs) against HIV for HIV treatment.	

Second Quarter 2019 Financial Highlights

•	Revenue for the second quarter was $39.1 million compared to $35.2 million for the second quarter of 2018. The year-over-year increase was primarily driven by higher ENHANZE ®  license payments. Revenue for the quarter included $18.1 million in royalties and $5.8 million in product sales, which compared to $20.0 million and $4.5 million , respectively, in the prior year period. The decrease in royalties was mainly driven by lower sales of Herceptin ® SC by Roche, partially offset by higher sales of RITUXAN HYCELA™ in the U.S. by Roche and higher sales of HyQvia by Takeda.	

•	Research and development expenses for the second quarter were $33.9 million , compared to $40.1 million for the second quarter of 2018. The decline in expenses was driven by reduced clinical trial activity due to the completion of enrollment in HALO-301.	

•	Selling, general and administrative expenses for the second quarter were $17.3 million , compared to $14.4 million for the second quarter of 2018. The increase is related to an increase in personnel expenses as well as preparations for the potential commercial launch of PEGPH20.	

•	Net loss for the second quarter was $14.6 million , or $0.10 per share, compared to a net loss in the second quarter of 2018 of $22.9 million , or $0.16 per share.	

•	Cash, cash equivalents and marketable securities were $287.5 million at June 30, 2019 , compared to $354.5 million at December 31, 2018.	

Financial Outlook for 2019

Halozyme is updating its 2019 financial guidance ranges:

•	Total revenues unchanged from prior guidance of $205 million to $215 million, including revenue from royalties of $72 million to $74 million;	

•	Operating expenses of $255 million to $265 million, down from prior guidance of $265 million to $275 million, or operating expenses excluding cost of goods sold $215 million to $225;	

million, down from prior guidance of $225 million to $235 million

•	Operating cash burn of $40 million to $50 million, down from prior guidance of $45 million to $55 million;	

•	Debt repayment of approximately $90 million; the company now expects to pay off the remainder of the royalty-backed debt by the end of the second quarter of 2020;	

•	Year-end cash, cash equivalents and marketable securities balance of $220 million to $230 million, up from prior guidance of $210 million to $220 million.	

This guidance continues to exclude revenue from any potential, new ENHANZE ® global collaboration and licensing agreements.

Webcast and Conference Call

Halozyme will webcast its Quarterly Update Conference Call for the second quarter of 2019 today, Tuesday, August 6, 2019 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 replay will be 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) 824-0907 (domestic callers) or (647) 689-5655 (international callers). A telephone replay will be available after the call by dialing (800) 585-8367 (domestic callers) or (416) 621-4642 (international callers) using replay ID number 5549627.

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 the treatment of several cancers and has the potential to be used 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, Alexion and argenx 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 future growth, revenue and milestone and other potential payments from collaboration partners, 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 2019) 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 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 August 6, 2019 .

Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com

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

																	
 	 	Three Months Ended
June 30,	 	Six Months Ended
June 30,	
 	 	2019	 	2018	 	2019	 	2018	
Revenues:	 	 	 	 	 	 	 	 	
Royalties	 	$	18,107		 	$	19,989		 	$	36,060		 	$	40,933		
Product sales, net	 	5,760		 	4,483		 	14,150		 	11,284		
Revenues under collaborative agreements	 	15,281		 	10,730		 	45,887		 	13,857		
Total revenues	 	39,148		 	35,202		 	96,097		 	66,074		
Operating expenses:	 	 	 	 	 	 	 	 	
Cost of product sales	 	1,877		 	836		 	6,526		 	3,888		
Research and development	 	33,910		 	40,086		 	65,238		 	78,062		
Selling, general and administrative	 	17,338		 	14,353		 	35,344		 	27,909		
Total operating expenses	 	53,125		 	55,275		 	107,108		 	109,859		
Operating loss	 	(13,977	)	 	(20,073	)	 	(11,011	)	 	(43,785	)	
Other income (expense):	 	 	 	 	 	 	 	 	
Investment and other income, net	 	1,983		 	1,983		 	4,040		 	3,651		
Interest expense	 	(2,613	)	 	(4,770	)	 	(5,818	)	 	(10,000	)	
Net loss before income taxes	 	(14,607	)	 	(22,860	)	 	(12,789	)	 	(50,134	)	
Income tax expense	 	17		 	33		 	39		 	220		
Net loss	 	$	(14,624	)	 	$	(22,893	)	 	$	(12,828	)	 	$	(50,354	)	
 	 	 	 	 	 	 	 	 	
Net loss per share:	 	 	 	 	 	 	 	 	
Basic and diluted	 	$	(0.10	)	 	$	(0.16	)	 	$	(0.09	)	 	$	(0.35	)	
 	 	 	 	 	 	 	 	 	
Shares used in computing net loss per share:	 	 	 	 	 	 	 	 	
Basic and diluted	 	145,411		 	143,568		 	145,051		 	143,114		

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

									
 	 	June 30,
2019	 	December 31,
2018	
ASSETS	 	 	 	 	
Current assets:	 	 	 	 	
Cash and cash equivalents	 	$	67,041		 	$	57,936		
Marketable securities, available-for-sale	 	220,424		 	296,590		
Accounts receivable, net and other contract assets	 	32,219		 	30,005		
Inventories	 	43,900		 	22,625		
Prepaid expenses and other assets	 	28,122		 	20,693		
Total current assets	 	391,706		 	427,849		
Property and equipment, net	 	15,079		 	7,465		
Prepaid expenses and other assets	 	10,545		 	4,434		
Restricted cash	 	500		 	500		
Total assets	 	$	417,830		 	$	440,248		
 	 	 	 	 	
LIABILITIES AND STOCKHOLDERS’ EQUITY	 	 	 	 	
Current liabilities:	 	 	 	 	
Accounts payable	 	$	12,467		 	$	4,079		
Accrued expenses	 	45,561		 	49,529		
Deferred revenue, current portion	 	6,511		 	4,247		
Current portion of long-term debt, net	 	70,878		 	91,506		
Total current liabilities	 	135,417		 	149,361		
 	 	 	 	 	
Deferred revenue, net of current portion	 	1,746		 	5,008		
Long-term debt, net	 	14,083		 	34,874		
Other long-term liabilities	 	6,532		 	2,118		
 	 	 	 	 	
Stockholders’ equity:	 	 	 	 	
Common stock	 	146		 	145		
Additional paid-in capital	 	803,782		 	780,457		
Accumulated other comprehensive income (loss)	 	390		 	(277	)	
Accumulated deficit	 	(544,266	)	 	(531,438	)	
Total stockholders’ equity	 	260,052		 	248,887		
Total liabilities and stockholders’ equity	 	$	417,830		 	$	440,248		

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