SAN DIEGO, Nov. 7, 2016
/PRNewswire/ -- Halozyme Therapeutics, Inc. (NASDAQ: HALO) today
reported financial results and recent highlights for the third
quarter ended September 30.
"The third quarter was highlighted by Genentech's BLA filing for
rituximab in a subcutaneous formulation using Halozyme's ENHANZE
platform in multiple blood cancers, a development that adds to the
potential for our royalty revenue and highlights the benefits of
our business model," said Dr. Helen
Torley, president and chief executive officer. "In our
oncology pillar, we continued initiation of our global sites in our
phase 3 study of PEGPH20 and are making progress toward dose
expansion in our study with Keytruda, all as we anticipate
reporting topline results from stage 2 of our HALO-202 study once
the data is mature."
Halozyme was recently informed by the independent statistician
for the data monitoring committee of its HALO-202 study that
progression-free survival data are not yet mature for analysis. As
a result, the company now expects the reporting of data may move
into 2017, depending on when it is mature for analysis.
Third Quarter 2016 and Recent Highlights include:
- The inclusion of PEGPH20 in the Pancreatic Cancer Action
Network's Precision Promise initiative, a broad industry and
pancreatic cancer community coalition established to study
pancreatic cancer therapies in patients based on the molecular
profile of their tumors. The clinical trial plans to enroll
patients at 12 consortium sites in the U.S. beginning in spring
2017.
- Continuing to initiate sites in the HALO-301 | Pancreatic
study toward the goal of having approximately 90 percent of
centers ready to screen patients by the end of 2016.
- Progressing in dose escalation 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 continues to project
that the study will move to the dose expansion phase by the end of
2016.
- U.S. Food and Drug Administration (FDA) filing a Biologics
License Application (BLA) to support approval for the subcutaneous
formulation of Rituximab in multiple blood cancer indications.
Including all approved indications, Roche reported total 2015 sales
of rituximab in the United States
of 3.76 billion CHF.
- Pfizer announcing discontinuation of the global clinical
development program for bococizumab, its investigational PCSK9
inhibitor. The development of a subcutaneous version on the
Halozyme ENHANZE platform has also been discontinued. Pfizer also
made a portfolio decision to discontinue development of rivipansel
with the ENHANZE platform even though the technology performed as
intended. Pfizer continues to develop an additional program with
the ENHANZE platform for an undisclosed target.
Third Quarter 2016 Financial Highlights
- Revenue for the third quarter was $31.9
million compared to $20.8
million for the third quarter of 2015, driven primarily by
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 third quarter included $13
million in royalties, an increase of 58 percent from the
prior-year period, $9.6 million in
sales of bulk rHuPH20 primarily for use in manufacturing
collaboration products and $3.7
million in HYLENEX® recombinant (hyaluronidase
human injection) product sales.
- Research and development expenses for the third quarter were
$33.9 million, compared to
$27.6 million for the third 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 third
quarter were $11.6 million, compared
to $10.2 million for the third
quarter of 2015. The increase was primarily due to personnel
expenses, including stock compensation, for the period.
- Net loss for the third quarter was $28.9
million, or $0.23 per share,
compared to a net loss in the third quarter of 2015 of $24.5 million, or $0.19 per share.
- Cash, cash equivalents and marketable securities were
$221.1 million at September 30 compared to $230 million at June 30,
2016.
Financial Outlook for 2016
For the full year 2016, the company updated and narrowed its
financial guidance, now expecting:
- Net revenue of $145 million to $150
million, raising the lower end of its prior $140 million to $150 million range;
- Operating expenses of $240 million to
$245 million, from the prior $245
million to $260 million range;
- Cash flow of $75 million to $85
million, from the prior range of $65
million to $85 million;
- Year-end cash balance of $180 million to
$190 million, raising the lower end of its prior
$170 million to $190 million
range.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for
the third quarter 2016 today, Monday,
November 7 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 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) (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
22039188.
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
November 7, 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
|
|
Nine Months
Ended
|
|
|
September
30,
|
|
September
30,
|
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
|
Revenues:
|
|
|
|
|
|
|
|
|
|
Product sales,
net
|
|
$
|
13,331
|
|
|
$
|
10,301
|
|
|
$
|
39,970
|
|
|
$
|
32,503
|
|
|
Royalties
|
|
13,036
|
|
|
8,274
|
|
|
36,695
|
|
|
21,431
|
|
|
Revenues under
collaborative agreements
|
|
5,486
|
|
|
2,205
|
|
|
31,023
|
|
|
28,896
|
|
|
Total
revenues
|
|
31,853
|
|
|
20,780
|
|
|
107,688
|
|
|
82,830
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
9,134
|
|
|
6,180
|
|
|
25,204
|
|
|
20,818
|
|
|
Research and
development
|
|
33,863
|
|
|
27,611
|
|
|
109,493
|
|
|
65,490
|
|
|
Selling, general and
administrative
|
|
11,599
|
|
|
10,226
|
|
|
33,626
|
|
|
29,439
|
|
|
Total operating
expenses
|
|
54,596
|
|
|
44,017
|
|
|
168,323
|
|
|
115,747
|
|
|
|
|
|
|
|
|
|
|
|
Operating
loss
|
|
(22,743)
|
|
|
(23,237)
|
|
|
(60,635)
|
|
|
(32,917)
|
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
|
Interest and other
income, net
|
|
334
|
|
|
78
|
|
|
960
|
|
|
267
|
|
|
Interest
expense
|
|
(5,253)
|
|
|
(1,301)
|
|
|
(14,378)
|
|
|
(3,899)
|
|
|
Net loss before
income taxes
|
|
(27,662)
|
|
|
(24,460)
|
|
|
(74,053)
|
|
|
(36,549)
|
|
|
Income tax
expense
|
|
1,284
|
|
|
—
|
|
|
1,584
|
|
|
—
|
|
|
Net loss
|
|
$
|
(28,946)
|
|
|
$
|
(24,460)
|
|
|
$
|
(75,637)
|
|
|
$
|
(36,549)
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.23)
|
|
|
$
|
(0.19)
|
|
|
$
|
(0.59)
|
|
|
$
|
(0.29)
|
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss per share:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
128,154
|
|
|
126,921
|
|
|
127,886
|
|
|
126,127
|
|
|
Halozyme
Therapeutics, Inc.
Condensed Consolidated Balance
Sheets
(Unaudited)
(In
thousands)
|
|
|
|
|
|
|
|
September 30,
2016
|
|
December 31,
2015
|
|
ASSETS
|
|
|
|
|
|
Current
assets:
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
61,207
|
|
|
$
|
43,292
|
|
|
Marketable
securities, available-for-sale
|
|
159,845
|
|
|
65,047
|
|
|
Accounts receivable,
net
|
|
17,679
|
|
|
32,410
|
|
|
Inventories
|
|
12,852
|
|
|
9,489
|
|
|
Prepaid manufacturing
costs
|
|
14,960
|
|
|
16,155
|
|
|
Prepaid expenses and
other assets
|
|
6,062
|
|
|
5,379
|
|
|
Total current
assets
|
|
272,605
|
|
|
171,772
|
|
|
Property and
equipment, net
|
|
4,407
|
|
|
3,943
|
|
|
Prepaid expenses and
other assets
|
|
4,986
|
|
|
5,574
|
|
|
Restricted
cash
|
|
500
|
|
|
500
|
|
|
Total
assets
|
|
$
|
282,498
|
|
|
$
|
181,789
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' (DEFICIT) EQUITY
|
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
|
Accounts
payable
|
|
$
|
4,641
|
|
|
$
|
4,499
|
|
|
Accrued
expenses
|
|
25,733
|
|
|
26,792
|
|
|
Deferred revenue,
current portion
|
|
9,892
|
|
|
9,304
|
|
|
Current portion of
long-term debt
|
|
12,394
|
|
|
21,862
|
|
|
Total current
liabilities
|
|
52,660
|
|
|
62,457
|
|
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
|
40,849
|
|
|
43,919
|
|
|
Long-term debt,
net
|
|
199,803
|
|
|
27,971
|
|
|
Other long-term
liability
|
|
1,178
|
|
|
4,443
|
|
|
|
|
|
|
|
Stockholders'
(deficit) equity:
|
|
|
|
|
|
Common
stock
|
|
129
|
|
|
128
|
|
|
Additional paid-in
capital
|
|
545,751
|
|
|
525,628
|
|
|
Accumulated other
comprehensive income
|
|
83
|
|
|
(99)
|
|
|
Accumulated
deficit
|
|
(557,955)
|
|
|
(482,658)
|
|
|
Total stockholders'
(deficit) equity
|
|
(11,992)
|
|
|
42,999
|
|
|
Total liabilities and
stockholders' (deficit) equity
|
|
$
|
282,498
|
|
|
$
|
181,789
|
|
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SOURCE Halozyme Therapeutics, Inc.