SAN DIEGO, Feb. 28, 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 fourth quarter and full year ended December 31, 2016.
"We exited 2016 in a strong position through the benefit of our
differentiated business model and having made substantial progress
across both of our value-creating pillars," said Dr. Helen Torley, president and chief executive
officer. "The positive Phase 2 data we reported last month affirms
our conviction in PEGPH20, our lead investigational oncology drug,
and supports our ongoing Phase 3 study in pancreas cancer patients.
We have made strong progress initiating global sites in the Phase 3
study and see momentum building in the number of patients we are
screening.
"Our ENHANZE™ platform remains an important value driver as
royalty revenue demonstrated yet another quarter of robust growth,
and exceeded $50 million for the
year. With positive data presented by Genentech and Janssen at the
American Society of Hematology annual meeting for their
ENHANZE-partnered programs and a recent BLA filing in the U.S. by
Genentech, we remain very encouraged by the royalty growth
potential from current and new products over the long term."
Fourth Quarter 2016 and Recent Highlights include:
- Reporting a statistically significant improvement in the
primary endpoint of progression-free survival (PFS) of all
evaluable patients, and in the secondary endpoint of PFS in
patients with high levels of hyaluronan (HA), as of a December 2016 data cut in the Phase 2 randomized
HALO-202 study of PEGPH20 in combination with ABRAXANE®
(nab-paclitaxel) and gemcitabine in advanced pancreas cancer
patients. The primary safety endpoint to evaluate and demonstrate a
reduction in the rate of thromboembolic events in the PEGPH20 arm
was also achieved.
In the population that closely mirrors the HALO-301 Phase 3 study,
a 91 percent improvement was achieved in median PFS for HA-High
patients in the PEGPH20 arm, 8.6 months compared to 4.5 months in
the control arm. A 50 percent improvement was also reported in
median overall survival (OS) for HA-High patients in the PEGPH20
arm, 11.7 months compared to 7.8 months in the control arm.
- Screening patients at nearly 200 global sites and
receiving approval in all 22 participating countries for HALO-301,
the company's Phase 3 study of pancreas cancer patients.
- Entering the dose expansion phase of the ongoing Phase
1b clinical study evaluating PEGPH20 in combination with
KEYTRUDA® (pembrolizumab) in relapsed non-small cell
lung and gastric cancer patients. The company expects to enroll
approximately 50 patients with high levels of HA at 30 U.S.
sites.
- Announcing a broad clinical collaboration agreement with
Genentech to evaluate PEGPH20 and TECENTRIQ®
(atezolizumab) in up to 8 tumor types. Halozyme plans to initiate a
Phase 1b trial to evaluate the combination in gallbladder cancer
and cholangiocarcinoma, and Roche plans to initiate multiple Phase
1b/2 trials within their novel immunotherapy MORPHEUS clinical
trial platform to evaluate the combination in pancreas and gastric
cancers in the second half of 2017.
- Presenting supportive clinical data by ENHANZE™ partners
at the American Society of Hematology annual meeting in November.
Genentech presented data from the SABRINA Phase 3 study indicating
comparable response rates and time-to-event data for subcutaneous
rituximab compared to IV administration. The data presentation
followed acceptance by the Food and Drug Administration (FDA) of a
Biologics License Application for a subcutaneous formulation of
rituximab using Halozyme's ENHANZE™ technology. Roche has indicated
it is seeking approval in chronic lymphocytic leukemia and
non-Hodgkin's lymphoma, with an action date in June.
In addition, Janssen presented data indicating its subcutaneous
formulation of daratumumab on the ENHANZE™ platform was well
tolerated and had an efficacy and pharmacokinetic profile
consistent with the IV formulation, demonstrating the feasibility
of a 30-minute, 90 mL dose and supporting further study in a Phase
3 clinical trial.
Fourth Quarter and Full Year 2016 Financial
Highlights
- Revenue for the fourth quarter was $39
million compared to $52.2
million for the fourth quarter of 2015. The year-over-year
decrease was driven by $25 million
received upon signing the Lilly collaboration agreement in 2015,
offset by increases in royalties from partner sales of
Herceptin® SC, MabThera® SC and
HYQVIA®, API sales to partners, and manufacturing and
clinical supply reimbursements from ENHANZE™ partners. Revenue for
the fourth quarter included $14.3
million in royalties, an increase of 50 percent from the
prior-year period, $9 million in
sales of bulk rHuPH20 primarily for use in manufacturing
collaboration products and $4.4
million in HYLENEX® recombinant (hyaluronidase
human injection) product sales.
Revenue for 2016 totaled $146.7
million, an increase of 9 percent from 2015, including
royalty revenue of $51 million, an
increase of 65 percent from 2015.
- Research and development expenses for the fourth quarter were
$41.3 million, compared to
$27.7 million for the fourth quarter
of 2015. The planned increases were primarily due to a ramp in
spending associated with the HALO-301 study, personnel expenses,
and manufacturing and clinical supply expenses that are reimbursed
by ENHANZE™ partners.
- Selling, general and administrative expenses for the fourth
quarter were $12.2 million, compared
to $10.6 million for the fourth
quarter of 2015. The increase was primarily due to personnel
expenses, including stock compensation, for the period.
- Operating expenses for 2016 totaled $229.9 million, an increase of 41 percent from
2015.
- Net loss for the fourth quarter was $27.4 million, or $0.21 per share, compared to net income in the
fourth quarter of 2015 of $4.3
million, or $0.03 per share.
Net loss for 2016 totaled $103
million, or $0.81 per
share.
- Cash, cash equivalents and marketable securities were
$205 million at December 31, 2016, compared to $221.1 million at September 30, 2016.
Financial Outlook for 2017
For 2017, the company reiterated and updated the cash portions
of its financial guidance, now expecting:
- Net revenue of $115 million to $130
million, excluding any new ENHANZE™ collaboration
agreements;
- Operating expenses of $240 million to
$250 million;
- Operating cash burn of $75 million to
$85 million; and
- Year-end cash balance of $110 million to
$125 million, an increase from its prior range of
$100 million to $110 million.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for
the fourth quarter and full year 2016 today, Tuesday, February 28 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 15609911.
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 2017, the development and commercialization
of product candidates, including clinical trial patient enrollment
projections and future development 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 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 Annual Report on Form 10-K filed
with the Securities and Exchange Commission on February 28, 2017.
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Statements of Operations
|
(Unaudited)
|
(In thousands,
except per share amounts)
|
|
|
|
Three Months
Ended
|
|
For the Year
Ended
|
|
|
December
31,
|
|
December
31,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
Revenues:
|
|
|
|
|
|
|
|
|
Product sales,
net
|
|
$
|
13,422
|
|
|
$
|
13,579
|
|
|
$
|
53,392
|
|
|
$
|
46,082
|
|
Royalties
|
|
14,289
|
|
|
9,544
|
|
|
50,984
|
|
|
30,975
|
|
Revenues under
collaborative agreements
|
|
11,292
|
|
|
29,104
|
|
|
42,315
|
|
|
58,000
|
|
Total
revenues
|
|
39,003
|
|
|
52,227
|
|
|
146,691
|
|
|
135,057
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
8,002
|
|
|
8,427
|
|
|
33,206
|
|
|
29,245
|
|
Research and
development
|
|
41,349
|
|
|
27,746
|
|
|
150,842
|
|
|
93,236
|
|
Selling, general and
administrative
|
|
12,227
|
|
|
10,589
|
|
|
45,853
|
|
|
40,028
|
|
Total operating
expenses
|
|
61,578
|
|
|
46,762
|
|
|
229,901
|
|
|
162,509
|
|
|
|
|
|
|
|
|
|
|
Operating (loss)
income
|
|
(22,575)
|
|
|
5,465
|
|
|
(83,210)
|
|
|
(27,452)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Investment and other
income, net
|
|
366
|
|
|
155
|
|
|
1,326
|
|
|
422
|
|
Interest
expense
|
|
(5,599)
|
|
|
(1,302)
|
|
|
(19,977)
|
|
|
(5,201)
|
|
Net (loss) income
before income taxes
|
|
(27,808)
|
|
|
4,318
|
|
|
(101,861)
|
|
|
(32,231)
|
|
Income tax expense
(benefit)
|
|
(422)
|
|
|
—
|
|
|
1,162
|
|
|
—
|
|
Net loss
|
|
$
|
(27,386)
|
|
|
$
|
4,318
|
|
|
$
|
(103,023)
|
|
|
$
|
(32,231)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.21)
|
|
|
$
|
0.03
|
|
|
$
|
(0.81)
|
|
|
$
|
(0.25)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted
|
|
$
|
(0.21)
|
|
|
$
|
0.03
|
|
|
$
|
(0.81)
|
|
|
$
|
(0.25)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
128,185
|
|
|
127,197
|
|
|
127,964
|
|
|
126,704
|
|
Diluted
|
|
128,185
|
|
|
129,248
|
|
|
127,964
|
|
|
126,704
|
|
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
|
|
December 31,
2016
|
|
December 31,
2015
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
66,764
|
|
|
$
|
43,292
|
|
Marketable
securities, available-for-sale
|
|
138,217
|
|
|
65,047
|
|
Accounts receivable,
net
|
|
15,680
|
|
|
32,410
|
|
Inventories
|
|
14,623
|
|
|
9,489
|
|
Prepaid expenses and
other assets
|
|
21,248
|
|
|
21,534
|
|
Total current
assets
|
|
256,532
|
|
|
171,772
|
|
Property and
equipment, net
|
|
4,264
|
|
|
3,943
|
|
Prepaid expenses and
other assets
|
|
219
|
|
|
5,574
|
|
Restricted
cash
|
|
500
|
|
|
500
|
|
Total
assets
|
|
$
|
261,515
|
|
|
$
|
181,789
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
3,578
|
|
|
$
|
4,499
|
|
Accrued
expenses
|
|
28,821
|
|
|
26,792
|
|
Deferred revenue,
current portion
|
|
4,793
|
|
|
9,304
|
|
Current portion of
long-term debt
|
|
17,393
|
|
|
21,862
|
|
Total current
liabilities
|
|
54,585
|
|
|
62,457
|
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
|
39,825
|
|
|
43,919
|
|
Long-term debt,
net
|
|
199,228
|
|
|
27,971
|
|
Other long-term
liabilities
|
|
358
|
|
|
4,443
|
|
|
|
|
|
|
Stockholders'
(deficit) equity:
|
|
|
|
|
Common
stock
|
|
130
|
|
|
128
|
|
Additional paid-in
capital
|
|
552,737
|
|
|
525,628
|
|
Accumulated other
comprehensive loss
|
|
(6)
|
|
|
(99)
|
|
Accumulated
deficit
|
|
(585,342)
|
|
|
(482,658)
|
|
Total stockholders'
(deficit) equity
|
|
(32,481)
|
|
|
42,999
|
|
Total liabilities and
stockholders' (deficit) equity
|
|
$
|
261,515
|
|
|
$
|
181,789
|
|
Contacts:
Jim
Mazzola
858-704-8122
ir@halozyme.com
Chris Burton
858-704-8352
ir@halozyme.com
To view the original version on PR Newswire,
visit:http://www.prnewswire.com/news-releases/halozyme-reports-fourth-quarter-and-full-year-2016-financial-results-300415248.html
SOURCE Halozyme Therapeutics, Inc.