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 11, 2014
________________________
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 August 11, 2014, Halozyme Therapeutics, Inc. issued a press release to announce its financial results for the second quarter ended June 30, 2014. 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 11, 2014
 
 





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 11, 2014
 
By:
 
/s/ Jean Liu
 
 
 
 
 
 
 
Name:
 
Jean Liu
 
 
Title:
 
Vice President, General Counsel & Secretary




Exhibit Index

 
 
 
Exhibit No.
 
Description
 
 
 
99.1
 
Press release dated August 11, 2014


EX99.1 2Q2014


Exhibit 99.1

Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com

Media Contact:
Susan Neath Francis
212-301-7182
sfrancis@wcgworld.com
    


HALOZYME REPORTS SECOND QUARTER 2014
FINANCIAL RESULTS

- Patient dosing and enrollment resumed for PEGPH20 Phase 2 clinical trial -

- Commercial launch of MabThera SC triggered $5 million milestone payment -


SAN DIEGO, August 11, 2014 -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today reported financial results for the second quarter ended June 30, 2014. Financial highlights for the second quarter include revenues of $18.4 million and a net loss of $16.3 million, or $0.13 per share. This compares to revenues of $14.5 million and a net loss of $22.9 million, or $0.20 per share, for the second quarter of 2013.

“This was a quarter of strong progress across our proprietary and partner programs,” stated Dr. Helen Torley, President and Chief Executive Officer. “We are pleased to have resolved the clinical hold and to resume patient enrollment and dosing in our Phase 2 clinical trial for PEGPH20 in patients with pancreatic cancer. The launch of MabThera® SC, the continued sales ramp of Herceptin® SC in Europe, and the recent vote by the Blood Products Advisory Committee (BPAC) of the U.S. Food and Drug Administration (FDA) that Baxter’s HyQvia has a favorable benefit to risk profile, continue to validate our proprietary Enhanze™ platform.”

Second Quarter Highlights

•
Patient dosing and enrollment resumed for PEGPH20 clinical program in pancreatic cancer: In June, the U.S. FDA removed the clinical hold on patient enrollment and dosing of PEGPH20 in the ongoing Phase 2 trial (Study 202) evaluating PEGPH20 in patients with pancreatic cancer permitting the study to resume under a revised protocol. Modifications to the Study 202 protocol include the added use of low-molecular weight heparin as a prophylaxis and the modification of the inclusion/exclusion criteria to exclude patients who may be at higher risk of thromboembolic events. In addition to the over 100 patients already enrolled in the trial, Halozyme plans to enroll a similar number of additional patients. Approximately 75% of the anticipated clinical sites have received independent review board approvals and the Company anticipates continued IRB approvals in the coming weeks.





•
CONSISTENT 1 trial results in type 1 diabetes patients presented in late-breaker poster at ADA: The CONSISTENT 1 trial is evaluating Hylenex® recombinant and a new formulation of Hylenex currently under FDA review when used as pretreatment of the insulin infusion site in patients with type 1 diabetes receiving continuous subcutaneous insulin infusion in comparison to no pre-treatment. Data reported in a poster presentation at the 74th Scientific Sessions of the American Diabetes Association in San Francisco showed that the study achieved its primary endpoint of non-inferiority for A1C at six months between the use of Hylenex and the new formulation of Hylenex in comparison to no pre-treatment. The poster also presented data indicating that there was a potential reduction in the rate of hypoglycemic events associated with the use of the Hylenex formulations in comparison to no pre-treatment.

•
MabThera® SC launched by Roche in first EU market: In June 2014, Roche initiated the European launch of its new subcutaneous (SC) formulation of MabThera (rituximab) that uses Halozyme's recombinant human hyaluronidase (rHuPH20) for the treatment of patients with follicular lymphoma and diffuse large B-cell lymphoma. The previously approved formulation of MabThera is delivered by an intravenous infusion which takes approximately 2.5 hours. The new MabThera SC formulation can be administered subcutaneously in approximately 5 minutes and comes as a ready-to-use, fixed dose, 1,400 mg solution, which shortens pharmacy preparation time and reduces the overall impact on hospital resources. The first commercial launch in the EU has triggered a $5 million milestone payment to Halozyme.

Second Quarter and Six Months 2014 Financial Highlights

•
Revenues for the second quarter of 2014 were $18.4 million, compared to $14.5 million for the second quarter of 2013. Revenues in the second quarter included $6.0 million in product sales of bulk rHuPH20 for use in manufacturing Roche products, $7.2 million in collaboration revenues, $3.0 million in Hylenex® product sales, and $1.7 million in royalty revenue from sales of products under our collaborations. Revenues for the six months were $30.4 million compared to $26.3 million in the corresponding period of 2013.

•
Research and development expenses for the second quarter of 2014 were $18.6 million, compared with $28.0 million for the second quarter of 2013. The decrease was primarily driven by lower manufacturing costs, which are now included in cost of product sales.

•
Selling, general and administrative expenses for the second quarter of 2014 were $8.8 million, compared to $7.3 million for the second quarter of 2013. The increase was mainly due to an increase in compensation costs and patent and professional fees.

•
The net loss for the second quarter of 2014 was $16.3 million, or $0.13 per share, compared with a net loss for the second quarter of 2013 of $22.9 million, or $0.20 per share. The net loss for the six months to date totaled $42.8 million or $0.35 per share compared to a net loss of $42.2 million or $0.38 per share for the first six months of 2013.

•
Cash, cash equivalents and marketable securities were $147.6 million at June 30, 2014, compared with $164.5 million at March 31, 2014. Net cash used in the second quarter of 2014 was approximately $16.9 million.

Webcast and Conference Call
Halozyme will webcast its quarterly update conference call today, August 11, 2014 at 4:30 p.m. EDT/1:30 p.m. PDT. During the call, management will discuss the financial results for the second quarter of 2014 and provide a business update. To listen to the live webcast please visit the "Investors" section of Halozyme's corporate website at www.halozyme.com. A webcast replay will be available shortly after the call at the same address. To participate, dial (866) 710-0179 (domestic callers) or (334) 323-7224 (international callers) using passcode 769890. A telephone replay will be available shortly after the call by dialing (877) 919-4059 (domestic callers) or (334) 323-0140 (international callers) using replay ID number 71625396.









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, which increase the dispersion and absorption of biologics, drugs and fluids. Halozyme's pipeline addresses therapeutic areas, including oncology, diabetes and dermatology that have significant unmet medical need today. The Company markets Hylenex® recombinant (hyaluronidase human injection) and has partnerships with Roche, Pfizer and Baxter. 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 Company's future expectations and plans for enrollment of patients in Study 202 for PEGPH20, the development and commercialization of product candidates and the potential benefits and attributes of such product candidates) 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 from collaborators, unexpected results or delays in development 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 11, 2014.





Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(in thousands, except per share data)
 
Three Months Ended
 
Six Months Ended
 
June 30,
 
June 30,
 
2014
 
2013
 
2014
 
2013
Revenues:
 
 
 
 
 
 
 
Product sales, net
$
9,494

 
$
3,100

 
$
18,062

 
$
4,608

Royalties
1,688

 
—

 
2,487

 
—

Revenues under collaborative agreements
7,203

 
11,354

 
9,802

 
21,679

Total revenues
18,385

 
14,454

 
30,351

 
26,287

 
 
 
 
 
 
 
 
Operating expenses:
 
 
 
 
 
 
 
Cost of product sales
5,924

 
1,284

 
11,444

 
2,023

Research and development
18,649

 
27,991

 
40,064

 
50,025

Selling, general and administrative
8,752

 
7,300

 
19,002

 
14,856

Total operating expenses
33,325

 
36,575

 
70,510

 
66,904

 
 
 
 
 
 
 
 
Operating loss
(14,940
)
 
(22,121
)
 
(40,159
)
 
(40,617
)
 
 
 
 
 
 
 
 
Investment and other income
118

 
58

 
165

 
113

Interest expense
(1,451
)
 
(849
)
 
(2,827
)
 
(1,696
)
Net Loss
$
(16,273
)
 
$
(22,912
)
 
$
(42,821
)
 
$
(42,200
)
 
 
 
 
 
 
 
 
Basic and diluted net loss per share
$
(0.13
)
 
$
(0.20
)
 
$
(0.35
)
 
$
(0.38
)
 
 
 
 
 
 
 
 
Shares used in computing basic and diluted
     net loss per share
123,710

 
112,486

 
121,200

 
112,452






Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(in thousands)
 
June 30,
2014
 
December 31,
2013
ASSETS
 
 
 
Current assets:
 
 
 
Cash and cash equivalents
$
56,135

 
$
27,357

Marketable securities, available-for-sale
91,513

 
44,146

Accounts receivable, net
12,895

 
9,097

Inventories
7,114

 
6,170

Prepaid expenses and other assets
7,966

 
8,425

Total current assets
175,623

 
95,195

Property and equipment, net
3,343

 
3,422

Prepaid expenses and other assets
2,586

 
2,676

Restricted cash
500

 
500

Total Assets
$
182,052

 
$
101,793

 
 
 
 
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)
 
 
 
Current liabilities:
 
 
 
Accounts payable
$
3,910

 
$
3,135

Accrued expenses
16,455

 
14,369

Deferred revenue, current portion
5,153

 
7,398

Current portion of long-term debt, net
6,203

 
—

Total current liabilities
31,721

 
24,902

Deferred revenue, net of current portion
48,565

 
45,745

Long-term debt, net
43,613

 
49,772

Other long-term liabilities
2,854

 
1,364

 
 
 
 
Stockholders’ equity (deficit):
 
 
 
Common stock
125

 
115

Additional paid-in capital
480,044

 
361,930

Accumulated other comprehensive income
3

 
17

Accumulated deficit
(424,873
)
 
(382,052
)
Total stockholders’ equity (deficit)
55,299

 
(19,990
)
Total Liabilities and Stockholders’ Equity (Deficit)
$
182,052

 
$
101,793



###