SAN DIEGO, March 2, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported financial
results for the fourth quarter and full year ended December 31, 2014. Financial highlights for the
fourth quarter include revenues of $30.4
million and a net loss of $5.3
million, or $0.04 per share.
This compares to revenues of $12.5
million and a net loss of $22.0
million, or $0.19 per share,
for the fourth quarter of 2013. Financial highlights for the full
year 2014 include revenues of $75.3
million and a net loss of $68.4
million, or $0.56 per share.
This compares to revenues of $54.8
million and a net loss of $83.5
million, or $0.74 per share,
in the prior year.
"This has been a remarkable year of growth and progress for
Halozyme. We achieved record revenues for the quarter and year,
received the first U.S. approval and launch of a Biologics License
Application utilizing our ENHANZE™ technology with the approval of
Baxter's HYQVIA, and announced the
launch of our third partnered product,
MabThera® SC in Europe," said Dr. Helen Torley, President and Chief Executive
Officer. "With continued projected growth in our royalty revenues,
multiple near-term milestones for our investigational new drug
PEGPH20, and a strong financial position, we believe we are
well-positioned to grow shareholder value in 2015 and beyond."
Fourth Quarter 2014 Highlights and Subsequent Events
- Announced interim results of Study 202
evaluating investigational PEGPH20 with gemcitabine and
ABRAXANE® (nab-paclitaxel) in Stage IV
pancreatic cancer patients: In January
2015, Halozyme announced interim data from Study 202. Data
reported included data from 146 patients enrolled in Stage 1 of the
Phase 2 trial (Study 202), the population enrolled prior to the
April 2014 clinical hold and included
data on progression-free survival and overall response rate. In a
retrospectively defined sub-population of patients with tumors that
accumulated high levels of hyaluronan (HA), there was a
statistically significant improvement in the median
progression-free survival (HR=0.38; p=0.031) in patients treated
with PEGPH20, ABRAXANE®
(nab-paclitaxel) and gemcitabine (PAG) (9.2 months) vs. treatment
with ABRAXANE® (nab-paclitaxel) and
gemcitabine (AG) alone (4.3 months). The overall response rate was
also statistically significant at 71% vs. 29% for high HA patients
treatment with PAG compared to AG (p=0.016). Evaluating the most
frequently reported treatment-emergent adverse events, the overall
incidence was similar between treatment arms with the exception of
a higher incidence of peripheral edema, muscle spasms and
neutropenia in patients treated with PAG. In addition, the rate of
thromboembolic events was 41.9% compared to 24.6% in the PAG vs. AG
arm with the majority being Grade 2 or 3. In Q1 2015, the Company
plans to discuss these data and the benefit:risk of PEGPH20 and its
plans to initiate a registration trial with the FDA.
- Initiated Phase 1b/2 clinical trial of
PEGPH20 in non-small cell lung cancer (NSCLC): In January 2015, the Company began patient screening
in an international Phase 1b/2 randomized clinical trial (PRIMAL)
of our investigational new drug PEGPH20 as a second-line therapy
for patients with locally advanced and metastatic NSCLC.
- Record quarterly revenues of $30.4 million, including royalty revenues of
$4.0 million representing
approximately 40% growth from third quarter: Reported
$30.4 million in revenues in the
fourth quarter, which reflects record quarterly revenues for the
Company. Royalty revenues of $4.0
million represent July to September
2014 sales as a result of the one quarter lag in royalty
reports. The Company anticipates first quarter 2015 royalty
revenues to be in the range of $6 million to
$7 million, which represents October to December 2014 sales.
- Global collaboration with Janssen to
develop and commercialize subcutaneous products using ENHANZE™
technology: Halozyme entered into a worldwide collaboration and
license agreement with Janssen Biotech, Inc. (Janssen) for the
purpose of developing and commercializing products combining
proprietary Janssen compounds with Halozyme's ENHANZE technology.
Halozyme received an initial payment of $15
million in December 2014. The
agreement provides for milestone payments totaling up to
$566 million, in addition to royalty
payments based on net sales of products using ENHANZE
technology.
- Baxter
launched HYQVIA in the U.S. for adult patients with primary
immunodeficiency: In October, Baxter and Halozyme announced the launch and
first shipments of HYQVIA [Immune Globulin Infusion 10% (Human)
with Recombinant Human Hyaluronidase], for adult patients with
primary immunodeficiency, in the United
States.
- PEGPH20 granted Orphan Drug Designation for pancreatic
cancer: In October, the FDA granted Orphan Drug designation for
PEGPH20 for the treatment of pancreatic cancer. In December, the
European Commission, acting on the recommendation from the
Committee for Orphan Medicinal Products of the European Medicines
Agency, also designated PEGPH20 an orphan medicinal product for the
treatment of pancreatic cancer.
- U.S. patent issued for companion
diagnostic for PEGPH20: In October, U.S. Patent No. 8,846,034
issued claiming methods for selecting a subject for treatment of a
hyaluronan-associated disease with an anti-hyaluronan agent, such
as PEGPH20, as well as diagnostic agents for the detection and
quantification of hyaluronan in a biological sample in
patients.
Fourth Quarter and Full Year 2014 Financial
Highlights
- Revenues for the fourth quarter of 2014 were $30.4 million, compared to $12.5 million for the fourth quarter of 2013.
Revenues in the fourth quarter included $5.9
million in product sales of bulk rHuPH20 for use in
manufacturing Roche's collaboration products, $4.1 million in Hylenex® recombinant (hyaluronidase human injection)
product sales, $4.0 million in
royalty revenue from sales of products under our collaborations and
a $15 million licensing fee from
Janssen. Revenues for the full year were $75.3 million compared to $54.8 million in the previous year.
- Research and development expenses for the fourth quarter of
2014 were $19.7 million, compared to
$20.9 million for the fourth quarter
of 2013. The decrease was primarily due to a decrease in clinical
trial expenses related to our diabetes program.
- Selling, general and administrative expenses for the fourth
quarter of 2014 were $8.4 million,
compared to $9.4 million for the
fourth quarter of 2013. The decrease was primarily due to a
decrease in expenses related to our diabetes program.
- The net loss for the fourth quarter of 2014 was $5.3 million, or $0.04 per share, compared to a net loss for the
fourth quarter of 2013 of $22.0
million, or $0.19 per share.
The net loss for the full year 2014 totaled $68.4 million or $0.56 per share compared to a net loss of
$83.5 million or $0.74 per share for the full year 2013.
- Cash, cash equivalents and marketable securities were
$135.6 million at December 31, 2014, compared to $134.5 million at September 30, 2014. Excluding the net proceeds of
$107.7 million from the February 2014 financing, net cash used during
2014 was approximately $43.6
million.
Financial Outlook for 2015
For the full year 2015, the Company expects:
- 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,
March 2, 2015 at 4:30 p.m. ET/1:30 p.m.
PT. During the call, management will discuss the financial
results for the fourth 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 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
32695691.
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, 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 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 Annual Report on
Form 10-K filed with the Securities and Exchange Commission on
March 2, 2015.
Investor Contact:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Media Contact:
Susan Neath Francis
212-301-7182
sfrancis@w2ogroup.com
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
(in thousands,
except per share data)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
2014
|
|
2013
|
|
2014
|
|
2013
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
$ 10,144
|
|
$ 9,805
|
|
$ 37,823
|
|
$ 24,439
|
|
Revenues under
collaborative agreements
|
16,190
|
|
2,660
|
|
28,086
|
|
30,327
|
|
Royalties
|
4,043
|
|
33
|
|
9,425
|
|
33
|
|
|
Total
revenues
|
30,377
|
|
12,498
|
|
75,334
|
|
54,799
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
6,147
|
|
3,540
|
|
22,732
|
|
6,246
|
|
Research and
development
|
19,728
|
|
20,926
|
|
79,696
|
|
96,640
|
|
Selling, general and
administrative
|
8,353
|
|
9,356
|
|
35,942
|
|
32,347
|
|
|
Total operating
expenses
|
34,228
|
|
33,822
|
|
138,370
|
|
135,233
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
(3,851)
|
|
(21,324)
|
|
(63,036)
|
|
(80,434)
|
|
|
|
|
|
|
|
|
|
|
Investment and other
(expense) income, net
|
(45)
|
|
64
|
|
242
|
|
229
|
Interest
expense
|
(1,378)
|
|
(727)
|
|
(5,581)
|
|
(3,274)
|
Net loss
|
$ (5,274)
|
|
$ (21,987)
|
|
$ (68,375)
|
|
$ (83,479)
|
|
|
|
|
|
|
|
|
|
|
Basic and diluted net
loss per share
|
$ (0.04)
|
|
$ (0.19)
|
|
$ (0.56)
|
|
$ (0.74)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing basic and diluted net
loss per share
|
|
|
|
|
|
|
|
124,272
|
|
113,550
|
|
122,690
|
|
112,805
|
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(in
thousands)
|
|
|
|
|
|
|
|
|
|
December
31,
|
|
December
31,
|
|
|
|
2014
|
|
2013
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$
61,389
|
|
$
27,357
|
|
Marketable
securities, available-for-sale
|
74,234
|
|
44,146
|
|
Accounts receivable,
net
|
9,149
|
|
9,097
|
|
Inventories
|
6,406
|
|
6,170
|
|
Prepaid expenses and
other assets
|
10,143
|
|
8,425
|
|
|
Total current
assets
|
161,321
|
|
95,195
|
Property and
equipment, net
|
2,951
|
|
3,422
|
Prepaid expenses and
other assets
|
1,205
|
|
2,676
|
Restricted
cash
|
500
|
|
500
|
|
|
Total
assets
|
$
165,977
|
|
$
101,793
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$
3,003
|
|
$
3,135
|
|
Accrued
expenses
|
13,961
|
|
14,369
|
|
Deferred revenue,
current portion
|
7,367
|
|
7,398
|
|
|
Total current
liabilities
|
24,331
|
|
24,902
|
Deferred revenue, net
of current portion
|
47,267
|
|
45,745
|
Long-term debt,
net
|
49,860
|
|
49,772
|
Other long-term
liabilities
|
3,167
|
|
1,364
|
|
|
|
|
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
Common
stock
|
126
|
|
115
|
|
Additional paid-in
capital
|
491,694
|
|
361,930
|
|
Accumulated other
comprehensive (loss) income
|
(41)
|
|
17
|
|
Accumulated
deficit
|
(450,427)
|
|
(382,052)
|
|
|
Total stockholders'
equity (deficit)
|
41,352
|
|
(19,990)
|
|
|
Total liabilities and
stockholders' equity (deficit)
|
$
165,977
|
|
$
101,793
|
|
|
|
|
|
|
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SOURCE Halozyme Therapeutics, Inc.