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™ 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™ 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™, 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.