HALOZYME THERAPEUTICS, INC. SAN DIEGO, Nov. 9, 2015 /PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company developing novel oncology and drug-delivery therapies, today reported financial results for the third quarter ended September 30, 2015. Revenue for the quarter of $20.8 million and a net loss of $24.5 million, or $0.19 per share, compared to revenue of $14.6 million and a net loss of $20.3 million, or $0.16 per share, for the third quarter of 2014. Financial results for the quarter were in line with company expectations and its annual financial guidance, which the company reiterated today.
"With more than 100 patients now enrolled in Stage 2 of our Phase 2 study in pancreatic cancer patients, we are on track to close enrollment by the end of the year and achieve a major milestone toward our goal of ultimately commercializing PEGPH20," said Dr. Helen Torley, president and CEO. "Strong progress was made towards our goal of evaluating the pan tumor potential of PEGH20 by dosing the first patient in our immuno-oncology clinical trial in combination with Merck's KEYTRUDA(®) and by executing well on our broader clinical trial roadmap, including planning for initiation of our Phase 3 study in pancreatic cancer at the end of the first quarter of 2016.
"At the same time, our ENHANZE(TM) technology platform continued to deliver a growing royalty revenue stream from collaboration and licensing agreements with Roche and Baxalta, and we achieved important milestones toward potential future royalties with Pfizer, Janssen and AbbVie. Further progress was demonstrated by Pfizer and Janssen who initiated dosing in separate Phase 1 clinical trials with ENHANZE, while AbbVie announced plans to work with Halozyme on HUMIRA(®) (adalimumab) with the goal to help reduce the number of induction injections and deliver additional performance benefits."
Third Quarter 2015 Highlights and Subsequent Events include:
-- Enrolling more than 100 patients to date in Stage 2 of Halozyme Study
202 of investigational new drug PEGPH20 in metastatic pancreatic ductal
adenocarcinoma patients. Halozyme plans to complete its target
enrollment of 114 patients by the end of 2015 and present results of the
study in the second half of 2016.
-- Submitting Study 301 protocol to the FDA and European Regulatory
Authorities. This Phase 3 study of PEGPH20 in previously untreated
metastatic pancreatic cancer patients is planned for initiation by the
end of first quarter 2016. Halozyme also made progress during the
quarter with its partner Ventana toward completing a companion
diagnostic test that will be used to prospectively screen patients for
high levels of hyaluronan (HA). HA is a glycosaminoglycan, or chain of
natural sugars in the body that accumulate around certain tumors.
PEGPH20 is designed to temporarily degrade HA, improving the access of
co-administered therapies.
-- Dosing the first patient in Halozyme's Phase 1b study of PEGPH20 plus
KEYTRUDA(®) (pembrolizumab). The company is studying patients with
relapsed/refractory Stage IIIB/IV non-small cell lung cancer and
recurrent locally advanced or metastatic gastric adenocarcinoma. This
trial is Halozyme-sponsored and is being conducted at a number of
leading oncology centers with KEYTRUDA experience.
-- Progressing into a second dosing cohort in the Halozyme Phase 1b/2
PRIMAL study of PEGPH20 plus docetaxel in non-small cell lung cancer
patients. Actions initiated during the quarter have resulted in an
increase in the number of patients screened for the study. Once a
maximum tolerated dose is determined, the company plans to expand the
study with additional sites outside the U.S. and screen patients
prospectively for trial eligibility based on high levels of HA.
-- Advancing Halozyme's clinical collaboration with Eisai toward initiation
of its Phase 1b/2 study in the first quarter of 2016. Halozyme and Eisai
will co-fund the clinical trial to explore whether HALAVEN(®)
(eribulin) in combination with PEGPH20 can improve overall response
rate, as compared with HALAVEN alone as a therapy for advanced
HER2-negative high-HA metastatic breast cancer patients.
-- Achieving partner clinical milestones with the Halozyme ENHANZE(TM)
technology platform, including Pfizer's first dosing of healthy subjects
with rivipansel and ENHANZE in a Phase 1 clinical trial; Janssen's first
dosing of the anti-CD38 daratumumab with ENHANZE in a Phase 1b clinical
trial in multiple myeloma patients; and AbbVie announcing plans for
HUMIRA(®) a (adalimumab) under a collaboration and licensing agreement
formed with Halozyme in June of 2015, with a goal to help reduce the
number of induction injections at higher doses and deliver additional
performance benefits.
Third Quarter 2015 Financial Highlights
-- Revenue for the third quarter was $20.8 million, compared to $14.6
million for the third quarter of 2014, driven primarily by an increase
in royalties from partner sales of Herceptin SC, MabThera SC and HyQvia.
Revenue for the quarter included $8.3 million in royalties, $6.3 million
in sales of bulk rHuPH20 for use in manufacturing collaboration
products, $3.9 million in HYLENEX(®) recombinant (hyaluronidase human
injection) product sales, and $2.2 million in collaboration revenue.
-- Research and development expenses for the third quarter were $27.6
million, compared to $19.9 million for the third quarter of 2014. The
planned increase was primarily due to expenses for preclinical and
clinical support of PEGPH20.
-- Selling, general and administrative expenses for the third quarter were
$10.2 million, compared to $8.6 million for the third quarter of 2014.
The increase was primarily due to an increase in personnel expenses,
including stock compensation, for the period.
-- Net loss for the third quarter was $24.5 million, or $0.19 per share,
compared to a net loss in the third quarter of 2014 of $20.3 million, or
$0.16 per share.
-- Cash, cash equivalents and marketable securities were $123.7 million at
Sept. 30, compared to $140.7 million at June 30, 2015.
Financial Outlook
For the full year 2015, the company maintains its previously announced guidance of:
-- Net revenues to be in the range of $110 million to $115 million;
-- Operating expenses to be in the range of $160 million to $170 million;
and
-- Net cash burn to be between $20 million to $30 million.
Webcast and Conference Call
Halozyme will webcast its quarterly update conference call today, November 9, 2015 at 4:30 p.m. ET/1:30 p.m. PT. During the call, management will discuss financial results and provide a business update. To listen to the live webcast and view additional documents related to the call, 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 by phone, please dial (877) 410-5657 (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 passcode 75162222.
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. 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 and AbbVie for its drug delivery platform, ENHANZE(TM), which enables biologics and small molecule compounds that are currently administered intravenously to be delivered subcutaneously. 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 2015, the development and commercialization of product candidates and the potential benefits and attributes of such product candidates and expected financial outlook for 2015) 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 of product candidates 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 November 9, 2015.
Contact:
Jim Mazzola
Halozyme Therapeutics
858-704-8122
ir@halozyme.com
Halozyme Therapeutics, Inc.
Condensed Consolidated Statements of Operations
(Unaudited)
(In thousands, except per share amounts)
Three Months Ended Nine Months Ended
September 30, September 30,
2015 2014 2015 2014
---- ---- ---- ----
Revenues:
Product sales,
net $10,301 $9,617 $32,503 $27,679
Royalties 8,274 2,895 21,431 5,382
Revenues under
collaborative
agreements 2,205 2,094 28,896 11,896
Total revenues 20,780 14,606 82,830 44,957
------ ------ ------ ------
Operating Expenses:
Cost of
product sales 6,180 5,141 20,818 16,585
Research and
development 27,611 19,904 65,490 59,968
Selling,
general and
administrative 10,226 8,587 29,439 27,589
------------
Total operating expenses 44,017 33,632 115,747 104,142
------ ------ ------- -------
Operating loss (23,237) (19,026) (32,917) (59,185)
Other income (expense):
Investment and other income,
net 78 122 267 287
Interest expense (1,301) (1,376) (3,899) (4,203)
------ ------ ------ ------
Net loss $(24,460) $(20,280) $(36,549) $(63,101)
======== ======== ======== ========
Basic and diluted net loss
per share $(0.19) $(0.16) $(0.29) $(0.52)
Shares used in computing basic and
diluted net loss per share
126,921 124,041 126,127 122,157
Halozyme Therapeutics, Inc.
Condensed Consolidated Balance Sheets
(Unaudited)
(In thousands)
September 30, December 31,
2015 2014
---- ----
ASSETS
Current assets:
Cash and cash
equivalents $71,514 $61,389
Marketable
securities,
available-for-
sale 52,204 74,234
Accounts
receivable, net 8,392 9,149
Inventories 11,101 6,406
Prepaid expenses
and other assets 9,879 10,143
-----------------
Total current assets 153,090 161,321
Property and equipment, net 2,686 2,951
Prepaid expenses and other assets 2,458 1,205
Restricted cash 500 500
Total assets $158,734 $165,977
======== ========
LIABILITIES AND STOCKHOLDERS' EQUITY
Current liabilities:
Accounts payable $4,437 $3,003
Accrued expenses 18,926 13,961
Deferred revenue,
current portion 5,789 7,367
Current portion
of long-term
debt, net 15,699 -
----------------
Total current liabilities 44,851 24,331
Deferred revenue, net of current
portion 44,244 47,267
Long-term debt, net 34,094 49,860
Other long-term liabilities 3,746 3,167
Stockholders' equity:
Common stock 128 126
Additional paid-
in capital 518,647 491,694
Accumulated other
comprehensive
loss - (41)
Accumulated
deficit (486,976) (450,427)
------------
Total stockholders' equity 31,799 41,352
------ ------
Total liabilities and
stockholders' equity $158,734 $165,977
======== ========
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SOURCE Halozyme Therapeutics, Inc.
