SAN DIEGO, May 11, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
reported financial results for the first quarter ended March 31, 2015. Financial highlights include
revenues of $18.7 million and a net
loss of $15.1 million, or
$0.12 per share, compared to revenues
of $12.0 million and a net loss of
$26.5 million, or $0.22 per share, for the first quarter of
2014.
"We continued to execute well in the first quarter against a
focused strategy in oncology, ramping investments in our core
program and achieving significant milestones toward the initiation
of a Phase 3 study in pancreatic cancer patients early next year,"
said Dr. Helen Torley, president and
chief executive officer. "In addition to this strategic progress,
we exited the quarter in a much stronger financial position than
last year due to a steady increase in royalty revenues from our
rHuPH20 platform."
First Quarter 2015 Highlights and Subsequent Events
- Announced plans to initiate a Phase 3 clinical study (Study
301) in metastatic pancreatic cancer patients with high-hyaluronan
(HA) tumors: Based on feedback following a Type B meeting
with the FDA, the company intends to initiate a Phase 3 study that
will allow for a potential marketing application based on either
progression free survival (PFS) or overall survival. Use of
PFS as the basis for marketing approval will be subject to the
overall benefit and risk associated with Halozyme's investigational
new drug, PEGPH20, combined with nab-paclitaxel
(ABRAXANE®) and gemcitabine therapy, including
the:
- Magnitude of the PFS treatment effect observed;
- Toxicity profile; and
- Interim overall survival.
The company plans to use a companion diagnostic test to
prospectively identify and select patients with high levels of HA
for its Phase 3 trial. The FDA provided feedback supporting the
selection of high-HA patients and confirmed that an Investigational
Device Exemption – or IDE – will be required prior to initiating
the Phase 3 study. An IDE is a regulatory application that
summarizes the methodology, validation and proposed cut-point for
patient selection. The company plans to submit the IDE to support
the late Q1 2016 Study 301 start.
- Presented in January the interim results of Study 202
evaluating PEGPH20 with gemcitabine and ABRAXANE (nab-paclitaxel)
in metastatic pancreatic cancer patients: In a retrospectively
defined sub-population of patients, the data showed a statistically
significant doubling in median PFS in metastatic pancreatic cancer
patients with high levels of HA who were treated with PEGPH20
combined with nab-paclitaxel (ABRAXANE) and gemcitabine (9.2 months
vs. 4.3 months in patients treated with nab-paclitaxel ABRAXANE and
gemcitabine alone). The potential risk profile, including rate of
thromboembolic events, was also evaluated.
In April, the company also announced plans to present the interim
results of the study during an oral presentation by Dr.
Sunil Hingorani, a principal
investigator, at the annual meeting of the American Society of
Clinical Oncology (ASCO).
- Initiated enrollment in a Phase 1b/2 clinical trial of
investigational PEGPH20 in non-small cell lung cancer (NSCLC):
The company began enrollment in the Phase 1b/2 randomized clinical
trial (PRIMAL) of PEGPH20 in combination with docetaxel as a
second-line therapy for patients with locally advanced and
metastatic NSCLC.
- Published preclinical study results of PEGPH20 in
Molecular Cancer Therapeutics (Singha et al., February 2015 14:523-532): Data highlights
the use and potential of PEGPH20 to enhance the anti-cancer
activity of the accompanying immunotherapy (trastuzumab and immune
cells) in high-HA breast and ovarian cancer preclinical models. The
paper expands on previously reported data in a poster presentation
at the ASCO 2015 Gastrointestinal Cancers Symposium in San Francisco. The manuscript was written and
funded by Halozyme.
- Daratumumab selected as the first product candidate under
Janssen collaboration: In March, Genmab A/S announced plans for
a Phase 1 clinical trial of a subcutaneous formulation of the
anti-CD38 antibody daratumumab using the ENHANZE™ technology.
Daratumumab is being developed under a collaboration between
Janssen and Genmab A/S since August
2012 when Genmab granted Janssen an exclusive worldwide
license to develop, manufacture, and commercialize daratumumab.
Daratumumab, a human monoclonal antibody that targets CD38, is in
clinical development as a single agent and in combination with
standard of care therapies in several settings of multiple
myeloma.
First Quarter 2015 Financial Highlights
- Revenues for the first quarter of 2015 were $18.7 million, compared to $12.0 million for the first quarter of 2014.
Revenues in the first quarter included $6.8
million in royalty revenue from sales of products under
collaboration agreements, $6.1
million in product sales of bulk rHuPH20 for use in
manufacturing collaboration products for Roche, $3.8 million in Hylenex®
recombinant (hyaluronidase human injection) product sales,
and $2.0 million in collaboration
revenues. Royalty revenues represent October to December 2014 sales as a result of the one
quarter lag in royalty reports.
- Research and development expenses for the first quarter of 2015
were $16.7 million, compared to
$21.4 million for the first quarter
of 2014. The decrease was primarily due to a planned decrease in
expenses associated with the diabetes program.
- Selling, general and administrative expenses for the first
quarter of 2015 were $9.4 million,
compared to $10.3 million for the
first quarter of 2014. The decrease was primarily due to a decrease
in compensation expenses.
- The net loss for the first quarter of 2015 was $15.1 million, or $0.12 per share, compared to a net loss for the
first quarter of 2014 of $26.5
million, or $0.22 per
share.
- Cash, cash equivalents and marketable securities were
$128.5 million at March 31, 2015, compared to $135.6 million at December
31, 2014. Net cash used in the first quarter of 2015 was
approximately $7.1 million.
Financial Outlook for 2015
For the full year 2015, the company reiterated its previously
disclosed guidance of:
- Net revenues to be in the range of $85
million to $95 million.
- Operating expenses to be in the range of $145 million to $155 million.
- Net cash burn to be between $35 million
to $45 million.
Webcast and Conference Call
Halozyme will webcast its quarterly update conference call
today, May 11, 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
(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 passcode 48722220.
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,
our 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 and
non-small cell lung 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, Pfizer, Janssen and Baxter 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
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 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
May 11, 2015.
Contacts:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Jim Mazzola
Halozyme Therapeutics
858-704-8122
ir@halozyme.com
Halozyme
Therapeutics, Inc
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
(in thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
|
|
March
31,
|
|
|
|
2015
|
|
2014
|
Revenues:
|
|
|
|
|
Product sales,
net
|
$ 9,860
|
|
$ 8,568
|
|
Royalties
|
6,775
|
|
799
|
|
Revenues under
collaborative agreements
|
2,031
|
|
2,599
|
|
|
Total
revenues
|
18,666
|
|
11,966
|
Operating
Expenses:
|
|
|
|
|
Cost of product
sales
|
6,494
|
|
5,520
|
|
Research and
development
|
16,684
|
|
21,415
|
|
Selling, general and
administrative
|
9,399
|
|
10,250
|
|
|
Total operating
expenses
|
32,577
|
|
37,185
|
|
|
|
|
|
|
Operating
loss
|
(13,911)
|
|
(25,219)
|
Other income
(expense):
|
|
|
|
Investment and other
income, net
|
102
|
|
47
|
Interest
expense
|
(1,299)
|
|
(1,376)
|
Net loss
|
$ (15,108)
|
|
$ (26,548)
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$ (0.12)
|
|
$ (0.22)
|
|
|
|
|
|
|
Shares used in
computing basic and diluted
|
|
|
|
|
net loss per
share
|
125,299
|
|
118,943
|
Halozyme
Therapeutics, Inc
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
|
|
2015
|
|
2014
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$ 44,287
|
|
$
61,389
|
|
Marketable
securities, available-for-sale
|
84,212
|
|
74,234
|
|
Accounts receivable,
net
|
7,725
|
|
9,149
|
|
Inventories
|
7,482
|
|
6,406
|
|
Prepaid expenses and
other assets
|
9,623
|
|
10,143
|
|
|
Total current
assets
|
153,329
|
|
161,321
|
Property and
equipment, net
|
2,732
|
|
2,951
|
Prepaid expenses and
other assets
|
2,564
|
|
1,205
|
Restricted
cash
|
500
|
|
500
|
|
|
Total
assets
|
$ 159,125
|
|
$
165,977
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$ 3,299
|
|
$
3,003
|
|
Accrued
expenses
|
12,813
|
|
13,961
|
|
Deferred revenue,
current portion
|
6,367
|
|
7,367
|
|
Current portion of
long-term debt, net
|
3,730
|
|
-
|
|
|
Total current
liabilities
|
26,209
|
|
24,331
|
Deferred revenue, net
of current portion
|
46,259
|
|
47,267
|
Long-term debt,
net
|
45,985
|
|
49,860
|
Other long-term
liabilities
|
3,127
|
|
3,167
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
127
|
|
126
|
|
Additional paid-in
capital
|
502,980
|
|
491,694
|
|
Accumulated other
comprehensive loss
|
(27)
|
|
(41)
|
|
Accumulated
deficit
|
(465,535)
|
|
(450,427)
|
|
|
Total stockholders'
equity
|
37,545
|
|
41,352
|
|
|
Total liabilities and
stockholders' equity
|
$ 159,125
|
|
$
165,977
|
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SOURCE Halozyme Therapeutics, Inc.