SAN DIEGO, Feb. 20, 2018
/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO), a
biotechnology company developing novel oncology and drug-delivery
therapies, today reported financial results and recent highlights
for the fourth quarter and full-year ended December 31, 2017.
"Building on a truly transformative year in 2017, we begin 2018
executing against a strong portfolio of new ENHANZE
collaborations," said Dr. Helen
Torley, president and chief executive officer. "With Janssen
now studying Darzalex® SC in four Phase 3 trials, Roche
recently initiating a Phase 1 study with ENHANZE and multiple
targets projected to enter the clinic in the coming quarters, we
have good line of sight to our goal of having six targets in
clinical development by year-end, doubling the number of targets in
the clinic from 2017.
"In our oncology pillar, we continue to project achieving the
target number of progression-free survival events in HALO-301 late
in the fourth quarter of 2018. In addition, we are making good
progress in our exploration of the pan-tumor potential of PEGPH20
and look forward to sharing response-rate data from our combination
studies with Halaven® and potentially with
Keytruda® in the second half of the year. We begin 2018
in a strong position with multiple value-generating opportunities
ahead for patients, the company and for shareholders."
Fourth Quarter 2017 and Recent Highlights include:
- Janssen expanding its development program for the
subcutaneous formulation of DARZALEX (daratumumab) with six
planned and ongoing clinical studies. Halozyme's ENHANZE technology
has the potential to enable a 15-ml injection to be delivered in
five minutes or less. The ongoing or planned trials in patients
with Amyloidosis, Smoldering Myeloma and Multiple Myeloma include
four Phase 3 studies, one Phase 2 study and one Phase 1 study.
- Roche initiating a Phase 1 study of an undisclosed
target with Halozyme's ENHANZE drug-delivery technology.
- Alexion announcing plans to initiate a Phase 1 trial in
2018 to study a next-generation subcutaneous formulation of
ALXN1210 (ALXN1210 SC) with ENHANZE.
- Baxalta and Roche achieving commercial milestones for
products using ENHANZE triggering $5
million and $7 million in
respective milestone payments.
- Continued progress screening and enrolling patients in the
HALO-301 study of PEGPH20 in combination with
ABRAXANE® (nab-paclitaxel) and gemcitabine in first-line
metastatic pancreas cancer patients with high levels of tumor
hyaluronan (HA-High). An interim analysis will be conducted for the
first primary endpoint of progression-free survival when the target
number of events has been reached, which the company continues to
project will be in late Q4.
Fourth Quarter 2017 Financial Highlights
- Revenue for the fourth quarter was $189.6 million compared to $39 million for the fourth quarter of 2016. The
year-over-year increase was driven by $101.4
million recognized upon the effective date of the BMS
collaboration, a $15 million
milestone payment from Janssen, a $40
million upfront payment from Alexion and growth in royalties
from partner sales of Herceptin® (trastuzumab) SC,
MabThera® (rituximab) SC and HYQVIA® (Immune
Globulin Infusion 10% (Human) with Recombinant Human
Hyaluronidase), offset by a decrease in research and development
reimbursements. Revenue for the fourth quarter included
$17.7 million in royalties, an
increase of 24 percent from the prior-year period, $8.4 million in sales of bulk rHuPH20 primarily
for use in manufacturing collaboration products and $4.2 million in HYLENEX® recombinant
(hyaluronidase human injection) product sales.
Revenue for the full year was $316.6
million, compared to $146.7
million in 2016.
- Research and development expenses for the fourth quarter were
$41.4 million, compared to
$41.3 million for the fourth quarter
of 2016.
Research and development expenses for the full year were
$150.6 million, compared to
$150.8 million in 2016.
- Selling, general and administrative expenses for the fourth
quarter were $14.8 million, compared
to $12.2 million for the fourth
quarter of 2016. The increase was primarily due to personnel
expenses, including stock compensation, for the period.
Selling, general and administrative expenses for 2017 were
$53.8 million, compared to
$45.9 million in 2016.
- Net income for the fourth quarter was $123.9 million, or $0.85 per share, compared to net loss in the
fourth quarter of 2016 of $27.4
million, or $0.21 per
share.
Net income for the full year was $63
million, or $0.45 per share,
compared to a net loss of $103
million in 2016, or $0.81 per
share.
- Cash, cash equivalents and marketable securities were
$469.2 million at December 31, 2017, compared to $316.9 million at September 30, 2017.
Financial Outlook for 2018
Halozyme reiterated its financial guidance of:
- Net revenue of $115 million to
$125 million, including 25% to 30%
royalty growth;
- Operating expenses of $230
million to $240 million;
- Operating cash burn of $75
million to $85 million;
and
- Year-end cash balance of $305
million to $315 million.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for
the fourth quarter of 2017 today, Tuesday,
February 20 at 4:30 p.m.
ET/1:30 p.m. PT. Dr. Torley
will lead the call, which will be webcast live through the
"Investors" section of Halozyme's corporate website and a recording
made available following the close of the call. To access the
webcast and additional documents related to the call, please visit
halozyme.com approximately fifteen minutes prior to the call to
register, download and install any necessary audio software. The
call may also be accessed by dialing (877) 410-5657 (domestic
callers) or (334) 323-7224 (international callers) using passcode
769890. A telephone replay will be available after the call by
dialing (877) 919-4059 (domestic callers) or (334) 323-0140
(international callers) using replay ID number 95494046.
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 pegvorhyaluronidase alfa (PEGPH20), applies a
unique approach to targeting solid tumors, allowing increased
access of co-administered cancer drug therapies to the tumor in
animal models. 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, AbbVie, Lilly,
Bristol-Myers Squibb and Alexion for its ENHANZE® drug
delivery technology. 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 2018, entering into new collaboration
agreements, the development and commercialization of product
candidates, including timing of clinical trial results
announcements and future development and commercial activities of
our collaboration partners, the potential benefits and attributes
of such product candidates and expected financial outlook for 2018)
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, including revenues from
collaborators, unexpected delays in entering into new collaboration
agreements, unexpected results or delays in development of product
candidates, including delays in clinical trial patient enrollment
and development activities of our collaboration partners, 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 February 20, 2018.
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
(In thousands,
except per share amounts)
|
|
|
|
Three Months
Ended
|
|
Twelve Months
Ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
|
$
|
12,593
|
|
|
$
|
13,422
|
|
|
$
|
50,396
|
|
|
$
|
53,392
|
|
Royalties
|
|
17,668
|
|
|
14,289
|
|
|
63,507
|
|
|
50,984
|
|
Revenues under
collaborative agreements
|
|
159,303
|
|
|
11,292
|
|
|
202,710
|
|
|
42,315
|
|
Total
revenues
|
|
189,564
|
|
|
39,003
|
|
|
316,613
|
|
|
146,691
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
7,488
|
|
|
8,002
|
|
|
31,152
|
|
|
33,206
|
|
Research and
development
|
|
41,376
|
|
|
41,349
|
|
|
150,643
|
|
|
150,842
|
|
Selling, general and
administrative
|
|
14,771
|
|
|
12,227
|
|
|
53,816
|
|
|
45,853
|
|
Total operating
expenses
|
|
63,635
|
|
|
61,578
|
|
|
235,611
|
|
|
229,901
|
|
|
|
|
|
|
|
|
|
|
Operating income
(loss)
|
|
125,929
|
|
|
(22,575)
|
|
|
81,002
|
|
|
(83,210)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Investment and other
income, net
|
|
1,080
|
|
|
366
|
|
|
2,592
|
|
|
1,326
|
|
Interest
expense
|
|
(5,458)
|
|
|
(5,599)
|
|
|
(21,984)
|
|
|
(19,977)
|
|
Income (loss) before
income taxes
|
|
121,551
|
|
|
(27,808)
|
|
|
61,610
|
|
|
(101,861)
|
|
Income tax (benefit)
expense
|
|
(2,331)
|
|
|
(422)
|
|
|
(1,361)
|
|
|
1,162
|
|
Net income
(loss)
|
|
$
|
123,882
|
|
|
$
|
(27,386)
|
|
|
$
|
62,971
|
|
|
$
|
(103,023)
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.87
|
|
|
$
|
(0.21)
|
|
|
$
|
0.46
|
|
|
$
|
(0.81)
|
|
Diluted
|
|
$
|
0.85
|
|
|
$
|
(0.21)
|
|
|
$
|
0.45
|
|
|
$
|
(0.81)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
141,718
|
|
|
128,185
|
|
|
136,419
|
|
|
127,964
|
|
Diluted
|
|
145,633
|
|
|
128,185
|
|
|
139,068
|
|
|
127,964
|
|
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
|
|
December
31, 2017
|
|
December
31, 2016
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
168,740
|
|
|
$
|
66,764
|
|
Marketable
securities, available-for-sale
|
|
300,474
|
|
|
138,217
|
|
Accounts receivable,
net
|
|
22,133
|
|
|
15,680
|
|
Inventories
|
|
5,146
|
|
|
14,623
|
|
Prepaid expenses and
other assets
|
|
13,879
|
|
|
21,248
|
|
Total current
assets
|
|
510,372
|
|
|
256,532
|
|
Property and
equipment, net
|
|
3,520
|
|
|
4,264
|
|
Prepaid expenses and
other assets
|
|
5,553
|
|
|
219
|
|
Restricted
cash
|
|
500
|
|
|
500
|
|
Total
assets
|
|
$
519,945
|
|
|
$
|
261,515
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
7,948
|
|
|
$
|
3,578
|
|
Accrued
expenses
|
|
39,601
|
|
|
28,821
|
|
Deferred revenue,
current portion
|
|
6,568
|
|
|
4,793
|
|
Current portion of
long-term debt, net
|
|
77,211
|
|
|
17,393
|
|
Total current
liabilities
|
|
131,328
|
|
|
54,585
|
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
|
54,297
|
|
|
39,825
|
|
Long-term debt,
net
|
|
125,140
|
|
|
199,228
|
|
Other long-term
liabilities
|
|
814
|
|
|
358
|
|
|
|
|
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
Common
stock
|
|
143
|
|
|
130
|
|
Additional paid-in
capital
|
|
731,044
|
|
|
552,737
|
|
Accumulated other
comprehensive loss
|
|
(450)
|
|
|
(6)
|
|
Accumulated
deficit
|
|
(522,371)
|
|
|
(585,342)
|
|
Total stockholders'
equity (deficit)
|
|
208,366
|
|
|
(32,481)
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
|
519,945
|
|
|
$
|
261,515
|
|
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.