SAN DIEGO, Aug. 10, 2015 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO), a biotechnology company
developing novel oncology and drug-delivery therapies, today
reported financial results for the second quarter ended
June 30, 2015. Financial highlights
include revenues of $43.4 million and
net income of $3.0 million, or
$0.02 per share, compared to revenues
of $18.4 million and a net loss of
$16.3 million, or $0.13 per share, for the second quarter of 2014.
"Our performance in the quarter continued to demonstrate the
strength of our two-pillar strategy," said Dr. Helen Torley, president and CEO. "In the ENHANZE
pillar, we signed our largest licensing agreement in company
history with AbbVie, which has the potential to generate new
royalty revenue and approximately $130
million for each of up to nine targets.
"In our oncology pillar, we continued to make good progress
toward the planned initiation of our phase 3 trial in metastatic
pancreatic cancer patients, and expanded our efforts to explore and
demonstrate the pan-tumor potential of our investigational new
drug, PEGPH20, through our first oncology clinical collaboration
agreement. This agreement with Eisai will broaden the PEGPH20
development plan into breast cancer, building on our ongoing work
in pancreatic and non-small cell lung cancer, exploring
combinations with chemotherapies and immunotherapies."
Second Quarter 2015 Highlights and Subsequent Events
- Global clinical collaboration with Eisai Co., Ltd. to
investigate HALAVEN® (eribulin) and PEGPH20 in
metastatic breast cancer: Halozyme entered into a worldwide
clinical collaboration with Eisai Co. Ltd. to evaluate HALAVEN in
combination with PEGPH20 in first line HER2-negative metastatic
breast cancer patients. The companies will co-fund a phase 1b/2
clinical trial to explore whether HALAVEN in combination with
PEGPH20 can improve overall response rate, as compared with HALAVEN
alone.
- Received feedback from the European Medicines Agency (EMA)
on the Phase 3 Study 301 design. During the quarter, the
company received scientific advice from the EMA for its planned
Phase 3 registration study in metastatic pancreatic cancer patients
with high-HA tumors. Based on feedback received to date from the
U.S. Food and Drug Administration (FDA) and the EMA, the company
plans to proceed with the trial design previously discussed with
the FDA and continues to target the end of first quarter 2016 to
initiate the study.
- Global collaboration with AbbVie to develop and
commercialize products using ENHANZE™ technology: Halozyme
entered into a worldwide collaboration and license agreement with
AbbVie for the purpose of developing and commercializing products
combining proprietary AbbVie compounds with Halozyme's ENHANZE
technology. Halozyme received an initial payment of $23 million in June
2015. The agreement provides for milestone payments totaling
approximately $130 million for each of up to nine
collaboration targets, in addition to tiered royalty payments based
on net sales of products using ENHANZE technology.
- Interim results from Study 202 evaluating PEGPH20 with
gemcitabine and ABRAXANE® (nab-paclitaxel) in metastatic
pancreatic cancer patients were presented at the annual meeting of
the American Society of Clinical Oncology (ASCO): In a
retrospectively defined sub-population of patients, the data showed
a doubling in median progression free survival in metastatic
pancreatic cancer patients with high levels of hyaluronan (HA) who
were treated with PEGPH20 combined with ABRAXANE and gemcitabine
(9.2 months vs. 4.3 months in patients treated with ABRAXANE and
gemcitabine alone). Additional reported results included:
- A more than doubling of overall response rate of 52 percent
versus 24 percent (p-value of 0.038) and a duration of response of
8.1 months compared to 3.7 months in high HA patients treated with
PEGPH20 combined with ABRAXANE and gemcitabine (PAG) versus
ABRAXANE and gemcitabine (AG);
- A trend toward improvement in median overall survival of 12
months compared to 9 months in high HA patients treated with PAG
versus AG (hazard ratio of 0.62) despite discontinuation of PEGPH20
in more than half of the PAG-treated patients at the time of the
clinical hold in April 2014.
- A thromboembolic event (TE) event rate of 13 percent in 38
patients treated with PAG versus 18 percent in 17 patients
receiving AG.
- Global agreement with Ventana Medical Systems to
collaboratively develop a companion diagnostic for cancer
treatment: Entered into a global agreement with Ventana to
develop and commercialize a companion diagnostic assay for use with
PEGPH20. Under the agreement, Ventana will develop the in vitro
diagnostic, with the intent of submitting it for regulatory
approval in the United States,
Europe and other countries.
Second Quarter 2015 Financial Highlights
- Revenues for the second quarter of 2015 were $43.4 million, compared to $18.4 million for the second quarter of 2014,
driven by a $23 million payment for
initiation of a global collaboration agreement with AbbVie.
Revenues in the second quarter included $6.4
million in royalty revenue from sales of products under
collaboration agreements, $7.7
million in product sales of bulk rHuPH20 for use in
manufacturing collaboration products for Roche and Baxalta,
$4.2 million in
Hylenex® recombinant (hyaluronidase human
injection) product sales, and $24.7
million in collaboration revenues, which includes the
$23 million payment from AbbVie.
Royalty revenues represent January to March
2015 partnered product sales as a result of the one quarter
lag in royalty reports.
- Research and development expenses for the second quarter of
2015 were $21.2 million, compared to
$18.6 million for the second quarter
of 2014. The increase was primarily due to an increase in expenses
related to preclinical and clinical activities for PEGPH20, off-set
by a planned decrease in expenses associated with discontinued
development programs.
- Selling, general and administrative expenses for the second
quarter of 2015 were $9.8 million,
compared to $8.8 million for the
second quarter of 2014. The increase was primarily due to an
increase in personnel expenses, including stock compensation, for
the period.
- Net income for the second quarter of 2015 was $3.0 million, or $0.02 per share, compared to a net loss for the
second quarter of 2014 of $16.3
million, or $0.13 per
share.
- Cash, cash equivalents and marketable securities were
$140.7 million at June 30, 2015, compared to $128.5 million at March
31, 2015. Net cash increase in the second quarter of 2015
was approximately $12.2 million.
Financial Outlook for 2015
For the full year 2015, the company revised its previously
disclosed guidance to the following:
- Net revenues to be in the range of $110
million to $115 million, from a prior range of $85 million to $95 million.
- Operating expenses to be in the range of $160 million to $170 million, from a prior range
of $145 million to $155 million.
- Net cash burn to be between $20 million
to $30 million, from a prior range of $35 to $45 million, with year-end cash balance
expected to be $105 million to $115
million.
The company raised its revenue projection due to payment
received from the AbbVie agreement. Operating expenses are expected
to increase primarily due to acceleration of a bulk PH20
manufacturing campaign to fulfill current and future orders, and
the building of capabilities related to an expansion of the PEGPH20
clinical program from 2 to 5 trials, including assuring readiness
for the global phase 3 study at the end of Q1 2016. Cash burn is
expected to decrease due to the inflow of new revenue, partially
offset by the increase in planned expenses.
Webcast and Conference Call
Halozyme will webcast its quarterly update conference call today,
August 10, 2015 at 4:30 p.m. ET/1:30 p.m.
PT. During the call, management will discuss financial
results and provide a business update. To listen to the live
webcast and view additional documents related to the call, please
visit the "Investors" section of Halozyme's corporate website at
www.halozyme.com. A webcast replay will be available shortly after
the call at the same address. To participate by phone, please dial
(866) 710-0179 (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 53958140.
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. PEGPH20 is currently in development for metastatic
pancreatic cancer, non-small cell lung 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 and AbbVie for its drug
delivery platform, ENHANZE™, which enables biologics and small
molecule compounds that are currently administered intravenously to
be delivered subcutaneously. 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 2015, the development and commercialization
of product candidates and the potential benefits and attributes of
such product candidates and expected financial outlook for 2015)
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 from collaborators, unexpected
results or delays in development 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 10, 2015.
Contacts:
Schond Greenway
Halozyme Therapeutics
858-704-8352
ir@halozyme.com
Jim Mazzola
Halozyme Therapeutics
858-704-8122
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,
|
|
|
|
2015
|
|
2014
|
|
2015
|
|
2014
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
$ 12,342
|
|
$ 9,494
|
|
$ 22,202
|
|
$ 18,062
|
|
Royalties
|
6,382
|
|
1,688
|
|
13,157
|
|
2,487
|
|
Revenues under
collaborative agreements
|
24,660
|
|
7,203
|
|
26,691
|
|
9,802
|
|
|
Total
revenues
|
43,384
|
|
18,385
|
|
62,050
|
|
30,351
|
Operating
Expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
8,144
|
|
5,924
|
|
14,638
|
|
11,444
|
|
Research and
development
|
21,195
|
|
18,649
|
|
37,879
|
|
40,064
|
|
Selling, general and
administrative
|
9,814
|
|
8,752
|
|
19,213
|
|
19,002
|
|
|
Total operating
expenses
|
39,153
|
|
33,325
|
|
71,730
|
|
70,510
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
4,231
|
|
(14,940)
|
|
(9,680)
|
|
(40,159)
|
Other income
(expense):
|
|
|
|
|
|
|
|
Investment and other
income, net
|
87
|
|
118
|
|
189
|
|
165
|
Interest
expense
|
(1,299)
|
|
(1,451)
|
|
(2,598)
|
|
(2,827)
|
Net income (loss)
|
$ 3,019
|
|
$ (16,273)
|
|
$ (12,089)
|
|
$ (42,821)
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share
|
|
|
|
|
|
|
|
|
Basic
|
$ 0.02
|
|
$ (0.13)
|
|
$ (0.10)
|
|
$ (0.35)
|
|
Diluted
|
$ 0.02
|
|
$ (0.13)
|
|
$ (0.10)
|
|
$ (0.35)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per share
|
|
|
|
|
|
|
|
|
Basic
|
126,144
|
|
123,710
|
|
125,723
|
|
121,200
|
|
Diluted
|
134,507
|
|
123,710
|
|
125,723
|
|
121,200
|
Halozyme
Therapeutics, Inc
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
|
|
|
|
|
|
|
|
June
30,
|
|
December
31,
|
|
|
|
2015
|
|
2014
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
$ 67,769
|
|
$ 61,389
|
|
Marketable
securities, available-for-sale
|
72,946
|
|
74,234
|
|
Accounts receivable,
net
|
9,738
|
|
9,149
|
|
Inventories
|
7,723
|
|
6,406
|
|
Prepaid expenses and
other assets
|
10,266
|
|
10,143
|
|
|
Total current
assets
|
168,442
|
|
161,321
|
Property and
equipment, net
|
2,594
|
|
2,951
|
Prepaid expenses and
other assets
|
2,511
|
|
1,205
|
Restricted
cash
|
500
|
|
500
|
|
|
Total
assets
|
$ 174,047
|
|
$ 165,977
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
$ 4,138
|
|
$ 3,003
|
|
Accrued
expenses
|
14,821
|
|
13,961
|
|
Deferred revenue,
current portion
|
6,424
|
|
7,367
|
|
Current portion of
long-term debt, net
|
9,656
|
|
-
|
|
|
Total current
liabilities
|
35,039
|
|
24,331
|
Deferred revenue, net
of current portion
|
45,252
|
|
47,267
|
Long-term debt,
net
|
40,098
|
|
49,860
|
Other long-term
liabilities
|
3,429
|
|
3,167
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
128
|
|
126
|
|
Additional paid-in
capital
|
512,657
|
|
491,694
|
|
Accumulated other
comprehensive loss
|
(40)
|
|
(41)
|
|
Accumulated
deficit
|
(462,516)
|
|
(450,427)
|
|
|
Total stockholders'
equity
|
50,229
|
|
41,352
|
|
|
Total liabilities and
stockholders' equity
|
$ 174,047
|
|
$ 165,977
|
Logo -
http://photos.prnewswire.com/prnh/20100302/LA63139LOGO
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/halozyme-reports-second-quarter-2015-financial-results-300126275.html
SOURCE Halozyme Therapeutics, Inc.