SAN DIEGO, Aug. 8, 2017 /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 second
quarter ended June 30.
"A clear highlight of the second quarter was approval of
Genentech's RITUXAN HYCELATM in the U.S., and the
resulting strong interest from new potential partners who seek to
coformulate with our ENHANZE® technology," said Dr.
Helen Torley, president and chief
executive officer. "We have strong momentum in the
ENHANZE® business with continued growth in royalties and
a number of catalysts in the second half of 2017, including Lilly's
recent start of their Phase 1 study, Janssen's upcoming start of
their Phase 3 study of subcutaneous daratumumab and our expectation
for a new collaboration agreement.
"At the same time, we are executing well in our HALO-301 study
of PEGPH20 with screening and enrollment tracking to our
expectations and investigator enthusiasm continuing to be strong. I
also remain encouraged by recent progress screening and enrolling
patients in the dose expansion portion of our Phase 1b study of
PEGPH20 in combination with KEYTRUDA® and the recent
initiation of Genentech's study of PEGPH20 with
TECENTRIQ®.
"With strategic and operational progress across both pillars, we
look forward to the potential for additional value inflecting
events in the coming months."
Second Quarter 2017 and Recent Highlights include:
- Approval of Genentech's RITUXAN
HYCELA™ by the Food and Drug
Administration (FDA). The combination of rituximab and
Halozyme's hyaluronidase human ENHANZE® technology has
been approved for patients with follicular lymphoma, diffuse large
B-cell lymphoma and chronic lymphocytic leukemia and is now
available to patients in more than 60 countries worldwide.
- Eli Lilly initiating a Phase 1 study of an
investigational new therapy in combination with Halozyme's
ENHANZE® technology as part of the companies' 2015
Global Collaboration and Licensing agreement.
- Johnson and Johnson highlighting progress with the
subcutaneous formulation of DARZALEX® (daratumumab)
during their 2017 Pharmaceutical Business Review. The formulation,
which uses Halozyme's ENHANZE® technology to enable a
5-minute infusion, is currently being studied in a Phase 1b
clinical trial and planned to begin a Phase 3 study later this
year.
- Progress 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). Screening and enrollment in the study
continues to track in line with expectations and investigator
enthusiasm remains strong.
- Initiation of a Genentech-funded Phase 1b/2 multi-arm
clinical trial evaluating PEGPH20 with
TECENTRIQ® (atezolizumab) in patients
with previously treated metastatic pancreatic ductal
adenocarcinoma. The study is part of a clinical collaboration
agreement announced in 2016 to evaluate PEGPH20 and atezolizumab in
up to eight tumor types.
- Progress in the dose expansion phase of the ongoing
Phase 1b clinical study evaluating PEGPH20 in combination with
KEYTRUDA® (pembrolizumab) in non-small cell lung and
gastric cancer patients. Halozyme may report initial response rate
data by the end of the year, depending on the pace of enrollment
and time to response.
- Oral presentations of Halozyme's Phase 2 randomized
HALO-202 study data at the European Society for Medical
Oncology's World Congress on Gastrointestinal Cancer and American
Society of Clinical Oncology annual meeting. The presentations
expanded on the topline results shared in January with additional
data from the study as of December
2016.
Second Quarter 2017 Financial Highlights
- Revenue for the second quarter was $33.8
million compared to $33.3
million for the second quarter of 2016. The year-over-year
increase was driven by growth in royalties from partner sales of
Herceptin® SC, MabThera® SC and
HYQVIA®, offset by a decrease in research and
development reimbursements and license payments from
ENHANZE® partners. Revenue for the second quarter
included $14.7 million in royalties,
an increase of 20 percent from the prior-year period, $8.9 million in sales of bulk rHuPH20 primarily
for use in manufacturing collaboration products and $3.9 million in HYLENEX® recombinant
(hyaluronidase human injection) product sales.
- Research and development expenses for the second quarter were
$38.3 million, compared to
$35.5 million for the second quarter
of 2016. The increase was primarily due to a ramp in spending
associated with the HALO-301 study.
- Selling, general and administrative expenses for the second
quarter were $13.1 million, compared
to $11.2 million for the second
quarter of 2016. The increase was primarily due to personnel
expenses, including stock compensation, for the period.
- Net loss for the second quarter was $30.8 million, or $0.23 per share, compared to net loss in the
second quarter of 2016 of $26.9
million, or $0.21 per
share.
- Cash, cash equivalents and marketable securities were
$297.5 million at June 30, 2017, compared to $179 million at March 31, 2017.
Financial Outlook for 2017
Halozyme increased year-end cash guidance and reiterated all
other components of its financial guidance, now expecting:
- Net revenue of $115 million to $130
million;
- Operating expenses of $240 million to
$250 million;
- Operating cash burn of $75 million to
$85 million; and
- Year-end cash balance of $245 million to
$260 million, an increase from its prior range of
$110 million to $125 million to
reflect net proceeds of $135 million
from a previously announced public offering of 11.5 million shares
of common stock.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for
the second quarter of 2017 today, Tuesday,
August 8 at 4:30 p.m.
ET/1:30 p.m. PT. Dr.
Helen Torley, president and chief
executive officer, will lead the call. The call will be webcast
live through the "Investors" section of Halozyme's corporate
website and a recording will be made available following the close
of the call. To access the webcast and additional documents related
to the call, please visit http://www.halozyme.com approximately
fifteen minutes prior to the call to register, download and install
any necessary audio software. The call may also be accessed at
(877) 410-5657 (domestic callers) (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 33950544.
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 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 and
Lilly 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 2017, 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 2017)
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 Quarterly Report on Form 10-Q filed with the
Securities and Exchange Commission on August 8, 2017.
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
(In thousands,
except per share amounts)
|
|
|
|
Three Months
Ended
|
|
Six Months
Ended
|
|
|
June
30,
|
|
June
30,
|
|
|
2017
|
|
2016
|
|
2017
|
|
2016
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
|
$
|
12,780
|
|
|
$
|
13,699
|
|
|
$
|
24,214
|
|
|
$
|
26,639
|
|
Royalties
|
|
14,738
|
|
|
12,272
|
|
|
28,720
|
|
|
23,659
|
|
Revenues under
collaborative
agreements
|
|
6,232
|
|
|
7,365
|
|
|
10,384
|
|
|
25,537
|
|
Total
revenues
|
|
33,750
|
|
|
33,336
|
|
|
63,318
|
|
|
75,835
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
7,788
|
|
|
8,308
|
|
|
15,332
|
|
|
16,070
|
|
Research and
development
|
|
38,339
|
|
|
35,530
|
|
|
75,274
|
|
|
75,630
|
|
Selling, general and
administrative
|
|
13,101
|
|
|
11,221
|
|
|
25,716
|
|
|
22,027
|
|
Total operating
expenses
|
|
59,228
|
|
|
55,059
|
|
|
116,322
|
|
|
113,727
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(25,478)
|
|
|
(21,723)
|
|
|
(53,004)
|
|
|
(37,892)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Investment and other
income,
net
|
|
435
|
|
|
397
|
|
|
722
|
|
|
626
|
|
Interest
expense
|
|
(5,540)
|
|
|
(5,249)
|
|
|
(10,988)
|
|
|
(9,125)
|
|
Net loss before
income taxes
|
|
(30,583)
|
|
|
(26,575)
|
|
|
(63,270)
|
|
|
(46,391)
|
|
Income tax
expense
|
|
180
|
|
|
300
|
|
|
390
|
|
|
300
|
|
Net
loss
|
|
$
|
(30,763)
|
|
|
$
|
(26,875)
|
|
|
$
|
(63,660)
|
|
|
$
|
(46,691)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.23)
|
|
|
$
|
(0.21)
|
|
|
$
|
(0.48)
|
|
|
$
|
(0.37)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss per share:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
134,013
|
|
|
127,958
|
|
|
131,300
|
|
|
127,787
|
|
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
|
|
June 30,
2017
|
|
December 31,
2016
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
114,745
|
|
|
$
|
66,764
|
|
Marketable
securities, available-for-sale
|
|
182,788
|
|
|
138,217
|
|
Accounts receivable,
net
|
|
14,473
|
|
|
15,680
|
|
Inventories
|
|
15,172
|
|
|
14,623
|
|
Prepaid expenses and
other assets
|
|
13,656
|
|
|
21,248
|
|
Total current
assets
|
|
340,834
|
|
|
256,532
|
|
Property and
equipment, net
|
|
3,330
|
|
|
4,264
|
|
Prepaid expenses and
other assets
|
|
122
|
|
|
219
|
|
Restricted
cash
|
|
500
|
|
|
500
|
|
Total
assets
|
|
$
|
344,786
|
|
|
$
|
261,515
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY (DEFICIT)
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
5,650
|
|
|
$
|
3,578
|
|
Accrued
expenses
|
|
26,934
|
|
|
28,821
|
|
Deferred revenue,
current portion
|
|
4,516
|
|
|
4,793
|
|
Current portion of
long-term debt, net
|
|
45,515
|
|
|
17,393
|
|
Total current
liabilities
|
|
82,615
|
|
|
54,585
|
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
|
37,779
|
|
|
39,825
|
|
Long-term debt,
net
|
|
165,517
|
|
|
199,228
|
|
Other long-term
liabilities
|
|
710
|
|
|
358
|
|
|
|
|
|
|
Stockholders' equity
(deficit):
|
|
|
|
|
Common
stock
|
|
142
|
|
|
130
|
|
Additional paid-in
capital
|
|
707,086
|
|
|
552,737
|
|
Accumulated other
comprehensive loss
|
|
(61)
|
|
|
(6)
|
|
Accumulated
deficit
|
|
(649,002)
|
|
|
(585,342)
|
|
Total stockholders'
equity (deficit)
|
|
58,165
|
|
|
(32,481)
|
|
Total liabilities and
stockholders' equity (deficit)
|
|
$
|
344,786
|
|
|
$
|
261,515
|
|
Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
View original content with
multimedia:http://www.prnewswire.com/news-releases/halozyme-reports-second-quarter-2017-results-300500763.html
SOURCE Halozyme Therapeutics, Inc.