SAN DIEGO, Feb. 29, 2016 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported financial results
for the fourth quarter and full year ended December 31, 2015, which included a fourth
quarter increase in royalty revenue of 136 percent from the prior
year period and net income of $4.3
million, or $0.03 per share,
compared to a net loss in the fourth quarter of 2014 of
$5.3 million, or $0.04 per share. For the full year, total
revenue increased 79 percent to $135.1
million compared to $75.3
million in the prior year.
"We closed 2015 with record progress across both pillars of our
strategy and enter 2016 with strong momentum," said Dr.
Helen Torley, president and chief
executive officer. "In our oncology pillar, an investigational
device exemption was submitted to the FDA earlier this month by our
partner Ventana for the PEGPH20 companion diagnostic test. We
remain on track to dose the first patient in March in our Phase 3
study in pancreatic cancer patients. We are also continuing to
evaluate the dose of PEGPH20 in our lung and gastric cancer trials
and are preparing for the initiation of the breast cancer trial
with our clinical partner Eisai.
"At the same time, our ENHANZE™ platform continues to generate
more value than any other time in company history. With royalty
revenue growth in the fourth quarter, a newly signed licensing and
collaboration agreement with Eli Lilly and four co-formulated
products in the clinic, our ENHANZE platform remains a clear
differentiator in any market environment."
Fourth Quarter 2015 Highlights and Subsequent Events
include:
- Submitting an investigational device exemption to the
FDA for the companion diagnostic test developed with Ventana
to prospectively identify patients with high levels of hyaluronan,
or HA.
- Remaining on track to dose first patient in HALO-301 |
Pancreatic study in March 2016, a
Phase 3 study to explore PEGPH20 with gemcitabine and
ABRAXANE® (nab-paclitaxel) in metastatic pancreatic
cancer patients at approximately 200 sites in 20 countries located
in North America, Europe, South
America and Asia
Pacific.
- Closing enrollment in HALO-202 | Pancreatic study with 133
patients in Stage 2 (total 279 patients enrolled), the company
remains blinded to the efficacy results and continues to project
mature progression-free survival data and overall response rate
data in the fourth quarter of 2016.
- Continuing to explore the pan-tumor potential of
PEGPH20, the company made progress towards identifying the
maximum tolerated dose of PEGPH20 in its phase 1b/2 PRIMAL study of
PEGPH20 plus docetaxel in lung cancer patients, and Phase 1b study
of PEGPH20 plus KEYTRUDA® (pembrolizumab) in lung and
gastric cancer patients. In addition, Halozyme expects to initiate
the study of PEGPH20 plus eribulin in HER2 negative breast cancer
patients through a clinical collaboration with Eisai in the second
quarter of 2016.
- Signing the company's sixth collaboration and licensing
agreement for Halozyme's proprietary ENHANZE™ technology
platform with Eli Lilly for up to five targets, each with
potential milestone payments of $160
million. The agreement resulted in a $25 million upfront license fee to Halozyme that
was recorded in the fourth quarter.
- Earlier this month, dosing the first subject in Pfizer's
Phase 1 clinical trial evaluating the safety, tolerability and
pharmacokinetics of bococizumab, an investigational PCSK9
inhibitor developed by Pfizer, Inc. using Halozyme's
ENHANZE™ platform. The initiation of the clinical trial
triggered a $1 million milestone
payment to Halozyme under the collaboration and license agreement
between Halozyme and Pfizer entered into in 2012.
- In January, dosing the first subject in AbbVie's Phase 1
clinical trial evaluating the safety and pharmacokinetics of
adalimumab (HUMIRA®) with Halozyme's
ENHANZE™ platform, resulting in a $5 million milestone payment under the
collaboration and license agreement between Halozyme and AbbVie
entered into in June of 2015.
- In the fourth quarter, dosing the first subjects in Pfizer's
Phase 1 clinical trial of rivipansel and Janssen's Phase 1b
clinical trial of daratumumab with Halozyme's ENHANZE™
platform.
Fourth Quarter and Full Year 2015 Financial
Highlights
- Revenue for the fourth quarter was $52.2
million, compared to $30.4
million for the fourth quarter of 2014, driven primarily by
the upfront license fee from Eli Lilly and royalties from partner
sales of Herceptin® SC, MabThera® SC and
HyQvia®. Revenue for the quarter included
$9.5 million in royalties,
$9.3 million in sales of bulk rHuPH20
for use in manufacturing collaboration products and $4.3 million in HYLENEX® recombinant
(hyaluronidase human injection) product sales. Revenue for
the full year was $135.1 million
compared to $75.3 million in the
previous year.
- Research and development expenses for the fourth quarter were
$27.7 million, compared to
$19.7 million for the fourth quarter
of 2014. The planned increases were primarily due to expenses for
preclinical and clinical support of PEGPH20.
- Selling, general and administrative expenses for the fourth
quarter were $10.6 million, compared
to $8.4 million for the fourth
quarter of 2014. The increase was primarily due to an increase in
personnel expenses, including stock compensation, for the
period.
- Net income for the fourth quarter was $4.3 million, or $0.03 per share, compared to a net loss in the
fourth quarter of 2014 of $5.3
million, or $0.04 per share.
The net loss for the full year totaled $32.2
million, or $0.25 per share,
compared to a net loss of $68.4
million, or $0.56 per share,
for 2014.
- Cash, cash equivalents and marketable securities were
$108.3 million at Dec. 31, compared to $123.7 million at Sept.
30, 2015. Net cash burn during 2015 was approximately
$27.3 million.
Financial Outlook for 2016
For the full year 2016, the
company maintains its previously announced guidance of:
- Net revenues to be in the range of $110
million to $125 million;
- Operating expenses to be in the range of $240 million to $260 million;
- Cash Flow to be in the range of $35
million to $55 million; and
- Year-end cash balance of $140 million to
$160 million.
Webcast and Conference Call
Halozyme will webcast its
Quarterly Update Conference Call for the fourth quarter and full
year 2015 today, Monday, February 29
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
|
|
Year
Ended
|
|
December
31,
|
|
December
31,
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Revenues:
|
|
|
|
|
|
|
|
Product sales,
net
|
$13,579
|
|
$10,144
|
|
$ 46,082
|
|
$ 37,823
|
Revenues under
collaborative agreements
|
29,104
|
|
16,190
|
|
58,000
|
|
28,086
|
Royalties
|
9,544
|
|
4,043
|
|
30,975
|
|
9,425
|
Total
revenues
|
52,227
|
|
30,377
|
|
135,057
|
|
75,334
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product
sales
|
8,427
|
|
6,147
|
|
29,245
|
|
22,732
|
Research and
development
|
27,746
|
|
19,728
|
|
93,236
|
|
79,696
|
Selling, general and
administrative
|
10,589
|
|
8,353
|
|
40,028
|
|
35,942
|
Total operating
expenses
|
46,762
|
|
34,228
|
|
162,509
|
|
138,370
|
|
|
|
|
|
|
|
|
Operating income
(loss)
|
5,465
|
|
(3,851)
|
|
(27,452)
|
|
(63,036)
|
|
|
|
|
|
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Investment and other
income, net
|
155
|
|
(45)
|
|
422
|
|
242
|
Interest
expense
|
(1,302)
|
|
(1,378)
|
|
(5,201)
|
|
(5,581)
|
|
|
|
|
|
|
|
|
Net income
(loss)
|
$ 4,318
|
|
$ (5,274)
|
|
$(32,231)
|
|
$(68,375)
|
|
|
|
|
|
|
|
|
Basic net income
(loss) per share
|
$ 0.03
|
|
$ (0.04)
|
|
$ (0.25)
|
|
$ (0.56)
|
Diluted net income
(loss) per share
|
$ 0.03
|
|
$ (0.04)
|
|
$ (0.25)
|
|
$ (0.56)
|
|
|
|
|
|
|
|
|
Shares used in
computing basic net income (loss) per share:
|
127,197
|
|
124,272
|
|
126,704
|
|
122,690
|
Shares used in
computing diluted net income (loss) per share:
|
129,248
|
|
124,272
|
|
126,704
|
|
122,690
|
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
December
31,
|
|
2015
|
|
2014
|
|
|
|
|
ASSETS
|
|
|
|
|
|
|
|
CURRENT
ASSETS:
|
|
|
|
Cash and cash
equivalents
|
$ 43,292
|
|
$ 61,389
|
Marketable
securities, available-for-sale
|
65,047
|
|
74,234
|
Accounts receivable,
net
|
32,410
|
|
9,149
|
Inventories
|
9,489
|
|
6,406
|
Prepaid expenses and
other assets
|
21,534
|
|
10,143
|
Total current
assets
|
171,772
|
|
161,321
|
|
|
|
|
Property and
equipment, net
|
3,943
|
|
2,951
|
Prepaid expenses and
other assets
|
5,574
|
|
1,205
|
Restricted
cash
|
500
|
|
500
|
|
|
|
|
Total
Assets
|
$181,789
|
|
$165,977
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
CURRENT
LIABILITIES:
|
|
|
|
Accounts
payable
|
$ 4,499
|
|
$ 3,003
|
Accrued
expenses
|
26,792
|
|
13,961
|
Deferred revenue,
current portion
|
9,304
|
|
7,367
|
Current portion of
long-term debt, net
|
21,862
|
|
-
|
Total current
liabilities
|
62,457
|
|
24,331
|
|
|
|
|
Deferred revenue, net
of current portion
|
43,919
|
|
47,267
|
Long-term debt,
net
|
27,971
|
|
49,860
|
Other long-term
liabilities
|
4,443
|
|
3,167
|
|
|
|
|
STOCKHOLDERS'
EQUITY:
|
|
|
|
Common
stock
|
128
|
|
126
|
Additional paid-in
capital
|
525,628
|
|
491,694
|
Accumulated other
comprehensive loss
|
(99)
|
|
(41)
|
Accumulated
deficit
|
(482,658)
|
|
(450,427)
|
Total Stockholders'
Equity
|
42,999
|
|
41,352
|
|
|
|
|
Total Liabilities and
Stockholders' Equity
|
$181,789
|
|
$165,977
|
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SOURCE Halozyme Therapeutics, Inc.