SAN DIEGO, May 9, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported financial results
for the first quarter ended March 31,
which included an increase in revenue of 128 percent from the
prior-year period and a net loss of $19.8
million, or $0.16 per share,
compared to a net loss in the first quarter of 2015 of $15.1 million, or $0.12 per share.
"During the first quarter, we continued to execute against our
two-pillar strategy with ongoing clinical studies of PEGPH20 and
through growing the value of our ENHANZE™ platform," said
Dr. Helen Torley, president and
chief executive officer. "We made good progress toward our goal of
initiating greater than 90 percent of HALO-301 sites by the end of
the year and in evaluating the recommended dose to take into the
expansion phase of our lung and gastric cancer studies.
"With our ENHANZE platform, we continued to see strong growth in
royalty revenue combined with progress from our partners' programs.
During the quarter, Lilly nominated its third target triggering an
$8 million milestone and Pfizer
nominated an additional target triggering a $1.5 million milestone. These developments
highlight the great potential associated with our ENHANZE
technology franchise."
First Quarter 2016 and Recent Highlights include:
- Dosing of first patient in HALO-301 | Pancreatic study in
March, a phase 3 study to explore PEGPH20 with gemcitabine and
ABRAXANE® (nab-paclitaxel) in metastatic pancreatic
cancer patients. The company plans to initiate sites outside
the United States beginning in the
second quarter and to reach its target of greater than 90 percent
of centers ready to start screening patients by the end of the
year.
- Approval by the Food and Drug Administration (FDA) of an
investigational device exemption for the companion diagnostic
test developed with Ventana to prospectively identify patients with
high levels of hyaluronan, or HA, in the company's phase 3
study.
- Progressing towards dose expansion in its phase 1b/2 PRIMAL
study of PEGPH20 plus docetaxel in non-small cell lung cancer
patients. The company is now evaluating patients at a dose of 2.2
µg/kg and remains on track to move into the dose expansion phase of
the study in the second half of 2016.
- Advancing into the second dosing cohort and recently
submitting a protocol amendment in its phase 1b study of PEGPH20
plus KEYTRUDA® (pembrolizumab) in lung and gastric
cancer patients. The company submitted the protocol amendment to
the FDA based on bleeding events observed in heavily pretreated
relapsed gastric cancer patients. These events were not classified
as dose limiting toxicities or determined by investigators to be
related to PEGPH20. Halozyme is awaiting feedback from the FDA and
plans to resume enrollment in the second dosing cohort following
approval of the amendment.
- Eli Lilly nominating their third target to be studied with
Halozyme's ENHANZE™ platform, triggering an $8 million milestone payment to Halozyme which
will be received in the second quarter.
- Pfizer nominating an additional target to be studied with
Halozyme's ENHANZE™ platform, triggering a $1.5 million milestone to Halozyme.
- Baxalta receiving a positive opinion for
HYQVIA® from the Committee for Medicinal Products
for Human Use for a pediatric indication in Europe. In addition, Baxalta initiated a phase
3 trial in patients with chronic inflammatory demyelinating
polyneuropathy.
- Expansion of oncology pipeline and demonstration of
expertise in the tumor microenvironment with two new
preclinical programs, an immune checkpoint inhibitor targeting
adenosine and a novel antibody-drug conjugate targeting epidermal
growth factor receptor. Preclinical data for the discovery and
early development of these potential drug candidates were shared
during the 2016 American Association for Cancer Research annual
conference.
First Quarter 2016 Financial Highlights
- Revenue for the first quarter was $42.5
million, compared to $18.7
million for the first quarter of 2015, driven primarily by
milestone payments from Lilly and AbbVie, as well as royalties from
partner sales of Herceptin® SC, MabThera® SC
and HYQVIA®. Revenue for the quarter included
$11.4 million in royalties,
$9.0 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 first quarter were
$40.1 million, compared to
$16.7 million for the first quarter
of 2015. The planned increases were primarily due to expenses for
preclinical and clinical support of PEGPH20 and clinical API supply
to ENHANZE™ partners.
- Selling, general and administrative expenses for the first
quarter were $10.8 million, compared
to $9.4 million for the first quarter
of 2015. The increase was primarily due to an increase in personnel
expenses, including stock compensation, for the period.
- Net loss for the first quarter was $19.8
million, or $0.16 per share,
compared to a net loss in the first quarter of 2015 of $15.1 million, or $0.12 per share.
- Cash, cash equivalents and marketable securities were
$238.6 million at Mar. 31, 2016 compared to $108.3 million at Dec. 31,
2015.
Financial Outlook for 2016
For the full year 2016, the company is updating its previously
announced guidance. Halozyme now expects:
- Net revenues to be in the range of $130
million to $145 million, an increase from the prior range of
$110 million to $125 million, driven
by unplanned ENHANZE™ milestones and an increase in bulk product
sales to ENHANZE™ partners;
- Operating expenses to be in the range of $245 million to $260 million, a narrowing of the
bottom end of the prior range of $240
million to $260 million as a result of the increase in
product sales to ENHANZE™ partners;
- Cash flow to be in the range of $45
million to $65 million, an increase from the prior range of
$35 million to $55 million; and
- Year-end cash balance to be in the range of $150 million to $170 million, an increase from
the prior range of $140 million to $160
million.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for
the first quarter 2016 today, Monday, May
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 11528439.
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 Annual Report on Form
10-K filed with the Securities and Exchange Commission on
February 29, 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
|
|
March
31,
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
Product sales,
net
|
$ 12,940
|
|
$ 9,860
|
Royalties
|
11,387
|
|
6,775
|
Revenues under
collaborative agreements
|
18,172
|
|
2,031
|
Total
revenues
|
42,499
|
|
18,666
|
|
|
|
|
Operating
expenses:
|
|
|
|
Cost of product
sales
|
7,762
|
|
6,494
|
Research and
development
|
40,100
|
|
16,684
|
Selling, general and
administrative
|
10,806
|
|
9,399
|
Total operating
expenses
|
58,668
|
|
32,577
|
|
|
|
|
Operating
loss
|
(16,169)
|
|
(13,911)
|
|
|
|
|
Other income
(expense):
|
|
|
|
Investment and other
income, net
|
229
|
|
102
|
Interest
expense
|
(3,876)
|
|
(1,299)
|
|
|
|
|
Net loss
|
$(19,816)
|
|
$(15,108)
|
|
|
|
|
Basic and diluted net
loss per share
|
$ (0.16)
|
|
$ (0.12)
|
|
|
|
|
Shares used in
computing basic and diluted net loss per share:
|
127,615
|
|
125,299
|
Halozyme
Therapeutics, Inc.
Condensed
Consolidated Balance Sheets
(Unaudited)
(In
thousands)
|
|
|
|
|
|
|
|
|
|
March
31,
|
|
December
31,
|
|
2016
|
|
2015
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
Cash and cash
equivalents
|
$ 69,093
|
|
$
43,292
|
Marketable
securities, available-for-sale
|
169,545
|
|
65,047
|
Accounts receivable,
net
|
25,543
|
|
32,410
|
Inventories
|
10,345
|
|
9,489
|
Prepaid expenses and
other assets
|
22,509
|
|
21,534
|
Total current
assets
|
297,035
|
|
171,772
|
|
|
|
|
Property and
equipment, net
|
4,440
|
|
3,943
|
Prepaid expenses and
other assets
|
7,121
|
|
5,574
|
Restricted
cash
|
500
|
|
500
|
|
|
|
|
Total
Assets
|
$309,096
|
|
$ 181,789
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
Accounts
payable
|
$ 6,211
|
|
$
4,499
|
Accrued
expenses
|
21,791
|
|
26,792
|
Deferred revenue,
current portion
|
8,804
|
|
9,304
|
Current portion of
long-term debt, net
|
27,417
|
|
21,862
|
Total current
liabilities
|
64,223
|
|
62,457
|
|
|
|
|
Deferred revenue, net
of current portion
|
42,895
|
|
43,919
|
Long-term debt,
net
|
168,600
|
|
27,971
|
Other long-term
liabilities
|
3,906
|
|
4,443
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
Common
stock
|
129
|
|
128
|
Additional paid-in
capital
|
531,390
|
|
525,628
|
Accumulated other
comprehensive loss
|
88
|
|
(99)
|
Accumulated
deficit
|
(502,135)
|
|
(482,658)
|
Total Stockholders'
Equity
|
29,472
|
|
42,999
|
|
|
|
|
Total Liabilities and
Stockholders' Equity
|
$309,096
|
|
$ 181,789
|
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SOURCE Halozyme Therapeutics, Inc.