SAN DIEGO, Aug. 9, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported financial results
and recent highlights for the second quarter ended June 30.
"I am very pleased with the strong momentum in our ENHANZE™
platform leading to today's increase in our 2016 revenue guidance,
driven by continued royalty revenue growth and expansion of the
addressable patient population through the approval of two new
indications," said Dr. Helen Torley,
president and chief executive officer. "With a range of new targets
being tested in phase 1 trials, ENHANZE remains a growing value
driver for the company.
"We also continue to see strong, ongoing interest and support
from investigators for PEGPH20 as we initiated sites in our phase 3
study in pancreatic cancer, dosed the first metastatic breast
cancer patient in our clinical trial with Eisai and resumed our
trial in combination with KEYTRUDA® (pembrolizumab) in
lung and gastric cancer patients."
Second Quarter 2016 and Recent Highlights include:
- Presenting key efficacy and safety data from stage 1 of its
phase 2 clinical study in metastatic pancreatic cancer patients
treated with PEGPH20 at the 2016 American Society of Clinical
Oncology Annual Conference. The results continued to show
clinically meaningful efficacy for HA-high patients treated with
PEGPH20 plus gemcitabine and ABRAXANE®
(nab-paclitaxel) versus gemcitabine and ABRAXANE alone, including
median progression free survival of 9.2 months versus 6.0 months.
Safety data presented from stage 2 of the study continued to show a
reduction in the rate of thromboembolic events in both treatment
arms as compared to stage 1.
- The company expects to report mature response rate and
progression free survival data from stage 2 of the study in the
fourth quarter.
- Progressing with site initiations in the HALO-301 |
Pancreatic study towards the goal of approximately 90 percent
of centers ready to screen patients by the end of 2016.
- After assessing recruitment and the enrollment of
increasingly later line patients, Halozyme has decided to
discontinue the PRIMAL study of PEGPH20 with docetaxel in
non-small cell lung cancer patients and focus on immuno-oncology
therapy in its ongoing phase 1b study of PEGPH20 in combination
with KEYTRUDA®.
- Resuming patient enrollment and dosing in its ongoing phase
1b clinical study evaluating PEGPH20 in combination with
KEYTRUDA® (pembrolizumab) in relapsed lung and
gastric cancer patients under a revised clinical protocol. The
revised protocol has been submitted to all institutional review
boards (IRB) and is pending feedback from the FDA. The majority of
IRBs have approved the amended protocol allowing the study to
resume. The company continues to project that the study will move
into the dose expansion phase by the end of 2016, pending feedback
from the FDA.
- Dosing of first patient in its phase 1b/2 clinical
collaboration with Eisai evaluating eribulin in combination
with PEGPH20 in women with advanced or metastatic, HER2-negative,
HA-high breast cancer.
- Shire launching the pediatric indication of
HYQVIA® in eight European countries to treat primary
and certain secondary immunodeficiencies, following a marketing
authorization granted by the European Commission in May. HYQVIA is
co-administered with Halozyme's ENHANZE™ technology.
- Pfizer completing a phase 1 study of rivipansel with
rHuPH20, demonstrating the feasibility of large volume
subcutaneous administration in combination with Halozyme's ENHANZE™
technology.
- Roche receiving approval by the European Medicines
Agency for an indication of Mabthera® SC to
treat patients with chronic lymphocytic leukemia.
- Refinancing existing debt, increasing expected cash
balances by $22 million in 2016
and 2017, with the option to borrow an additional $15 million in 2017.
Second Quarter 2016 Financial Highlights
- Revenue for the second quarter was $33.3
million compared to $43.4
million for the second quarter of 2015. Revenue in the prior
year period included $23 million for
the initiation of the company's partnership with AbbVie. Excluding
the $23 million payment, revenue grew
64 percent year-on-year. Revenue for the second quarter included
$12.3 million in royalties,
$9.5 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.
- Research and development expenses for the second quarter were
$35.5 million, compared to
$21.2 million for the second quarter
of 2015. The planned increases were primarily due to a ramp in
spending associated with PEGPH20 study HALO-301, the investment in
studies to explore the pan-tumor potential of PEGPH20 and
manufacturing and clinical supply expenses that are reimbursed by
ENHANZE™ partners.
- Selling, general and administrative expenses for the second
quarter were $11.2 million, compared
to $9.8 million for the second
quarter of 2015. The increase was primarily due to personnel
expenses, including stock compensation, for the period.
- Net loss for the second quarter was $26.9 million, or $0.21 per share, compared to net income in the
second quarter of 2015 of $3 million,
or $0.02 per share.
- Cash, cash equivalents and marketable securities were
$230 million at June 30 compared to $238.6
million at March 31,
2016.
Financial Outlook for 2016
For the full year 2016, the company updated its prior guidance
and now expects:
- Net revenues to be in the range of $140
million to $150 million, an increase from the prior range of
$130 million to $145 million;
- Operating expenses to continue to be in the range of
$245 million to $260 million;
- Cash flow to be in the range of $65
million to $85 million, an increase from the prior range of
$45 million to $65 million; and
- Year-end cash balance to be in the range of $170 million to $190 million from the prior range
of $150 million to $170 million,
which was increased on June 8 when
the company announced a debt refinancing agreement.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for
the second quarter 2016 today, Tuesday,
August 9 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. For those without access to the
Internet, the live call may be accessed by phone by calling (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 79675248.
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 platform. 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 2016, the development and commercialization
of product candidates and the potential benefits and attributes of
such product candidates and expected financial outlook for 2016)
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 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
August 9, 2016.
Contacts:
Jim Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
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,
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$
13,699
|
|
$
12,342
|
|
$
26,639
|
|
$
22,202
|
Royalties
|
12,272
|
|
6,382
|
|
23,659
|
|
13,157
|
Revenues under
collaborative agreements
|
7,365
|
|
24,660
|
|
25,537
|
|
26,691
|
Total
revenues
|
33,336
|
|
43,384
|
|
75,835
|
|
62,050
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product
sales
|
8,308
|
|
8,144
|
|
16,070
|
|
14,638
|
Research and
development
|
35,530
|
|
21,195
|
|
75,630
|
|
37,879
|
Selling, general and
administrative
|
11,221
|
|
9,814
|
|
22,027
|
|
19,213
|
Total operating
expenses
|
55,059
|
|
39,153
|
|
113,727
|
|
71,730
|
|
|
|
|
|
|
|
|
Operating (loss)
income
|
(21,723)
|
|
4,231
|
|
(37,892)
|
|
(9,680)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Investment and other
income, net
|
397
|
|
87
|
|
626
|
|
189
|
Interest
expense
|
(5,249)
|
|
(1,299)
|
|
(9,125)
|
|
(2,598)
|
|
|
|
|
|
|
|
|
Net (loss) income
before income taxes
|
(26,575)
|
|
3,019
|
|
(46,391)
|
|
(12,089)
|
|
|
|
|
|
|
|
|
Income tax
expense
|
300
|
|
—
|
|
300
|
|
—
|
|
|
|
|
|
|
|
|
Net (loss)
income
|
$ (26,875)
|
|
$
3,019
|
|
$ (46,691)
|
|
$ (12,089)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per
share
|
|
|
|
|
|
|
|
Basic
|
$
(0.21)
|
|
$
0.02
|
|
$
(0.37)
|
|
$
(0.10)
|
Diluted
|
$
(0.21)
|
|
$
0.02
|
|
$
(0.37)
|
|
$
(0.10)
|
|
|
|
|
|
|
|
|
Shares used in
computing net (loss) income per share:
|
|
|
|
|
|
|
|
Basic
|
127,958
|
|
126,144
|
|
127,787
|
|
125,723
|
Diluted
|
127,958
|
|
134,507
|
|
127,787
|
|
125,723
|
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
61,233
|
|
$
43,292
|
Marketable
securities, available-for-sale
|
|
168,757
|
|
65,047
|
Accounts receivable,
net
|
|
23,227
|
|
32,410
|
Inventories
|
|
10,755
|
|
9,489
|
Prepaid manufacturing
costs
|
|
16,740
|
|
16,155
|
Prepaid expenses and
other assets
|
|
3,632
|
|
5,379
|
Total current
assets
|
|
284,344
|
|
171,772
|
|
|
|
|
|
Property and
equipment, net
|
|
4,682
|
|
3,943
|
Prepaid expenses and
other assets
|
|
6,601
|
|
5,574
|
Restricted
cash
|
|
500
|
|
500
|
|
|
|
|
|
Total
Assets
|
|
$
296,127
|
|
$
181,789
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
|
Accounts
payable
|
|
$
3,650
|
|
$
4,499
|
Accrued
expenses
|
|
23,851
|
|
26,792
|
Deferred revenue,
current portion
|
|
8,096
|
|
9,304
|
Current portion of
long-term debt
|
|
3,288
|
|
21,862
|
Total current
liabilities
|
|
38,885
|
|
62,457
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
|
41,872
|
|
43,919
|
Long-term debt,
net
|
|
204,850
|
|
27,971
|
Other long-term
liabilities
|
|
600
|
|
4,443
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
|
Common
stock
|
|
129
|
|
128
|
Additional paid-in
capital
|
|
538,585
|
|
525,628
|
Accumulated other
comprehensive income (loss)
|
|
216
|
|
(99)
|
Accumulated
deficit
|
|
(529,010)
|
|
(482,658)
|
Total stockholders'
equity
|
|
9,920
|
|
42,999
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
296,127
|
|
$
181,789
|
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SOURCE Halozyme Therapeutics, Inc.