SAN DIEGO, Aug. 6, 2019 /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, 2019 and provided an update on recent corporate
activities.
"We are very pleased with the strong progress in both pillars of
our business in 2019," said Dr. Helen
Torley, president and chief executive officer.
"ENHANZE® progress included Janssen recently submitting
regulatory applications to the U.S. Food and Drug Administration
and the European Medicines Agency, and our most recently announced
partner, argenx, initiating its first phase 1 study utilizing the
ENHANZE® drug delivery technology. In addition, we
remain focused on PEGPH20, where our HALO-301 pivotal phase 3 trial
in metastatic front-line pancreas cancer is on track for the
announcement of topline results by December
2019."
Second Quarter 2019 and Recent Highlights Include:
- In July 2019, ENHANZE®
collaborator Janssen Biotech, Inc. (Janssen) submitted a Biologics
License Application to the U.S. Food and Drug Administration and an
extension application to the European Medicines Agency for the
subcutaneous delivery of DARZALEX® (daratumumab) for
patients with multiple myeloma. Janssen's regulatory submissions
followed the announcement and subsequent presentation of positive
results from its phase 3 COLUMBA study at the American Society of
Clinical Oncology Annual Meeting in June
2019. The COLUMBA study investigated subcutaneously
administered DARZALEX® in comparison to intravenous
DARZALEX® in patients with relapsed or refractory
multiple myeloma.
- In July 2019, argenx dosed the
first subject in a phase 1 clinical trial evaluating the safety,
pharmacokinetics and pharmacodynamics of efgartigimod (ARGX-113),
using Halozyme's proprietary ENHANZE® drug delivery
technology, triggering a $5 million
payment to Halozyme. Additionally, in May
2019, argenx nominated a second target to be studied using
ENHANZE® technology, a human complement factor C2
associated with the product candidate ARGX-117, which is being
developed to treat severe autoimmune diseases, triggering a
$10 million payment to Halozyme.
- In June 2019, the target number
of 330 overall survival events in the HALO-301 clinical trial was
reached. The company plans to conduct the final overall survival
analysis upon data maturity which will occur when all patients
enrolled in the study have been followed for at least 8.5 months.
Accordingly, data maturity is projected to be achieved in
mid-September 2019. Based on this
timing of data maturity, the company expects to announce topline
results for the HALO-301 clinical trial by December 2019.
- In June 2019, a Cooperative
Research and Development Agreement (CRADA) was announced with the
National Institute of Allergy and Infectious Diseases' Vaccine
Research Center (VRC), part of the National Institute of Health,
enabling the VRC's use of ENHANZE® technology to develop
subcutaneous formulations of broadly neutralizing antibodies
(bnAbs) against HIV for HIV treatment.
Second Quarter 2019 Financial Highlights
- Revenue for the second quarter was $39.1
million compared to $35.2
million for the second quarter of 2018. The year-over-year
increase was primarily driven by higher ENHANZE® license
payments. Revenue for the quarter included $18.1 million in royalties and $5.8 million in product sales, which compared to
$20.0 million and $4.5 million, respectively, in the prior year
period. The decrease in royalties was mainly driven by lower sales
of Herceptin® SC by Roche, partially offset by higher
sales of RITUXAN HYCELA™ in the U.S. by Roche and higher sales of
HyQvia by Takeda.
- Research and development expenses for the second quarter were
$33.9 million, compared to
$40.1 million for the second quarter
of 2018. The decline in expenses was driven by reduced clinical
trial activity due to the completion of enrollment in
HALO-301.
- Selling, general and administrative expenses for the second
quarter were $17.3 million, compared
to $14.4 million for the second
quarter of 2018. The increase is related to an increase in
personnel expenses as well as preparations for the potential
commercial launch of PEGPH20.
- Net loss for the second quarter was $14.6 million, or $0.10 per share, compared to a net loss in the
second quarter of 2018 of $22.9
million, or $0.16 per
share.
- Cash, cash equivalents and marketable securities were
$287.5 million at June 30, 2019, compared to $354.5 million at December
31, 2018.
Financial Outlook for 2019
Halozyme is updating its 2019 financial guidance ranges:
- Total revenues unchanged from prior guidance of $205 million to $215
million, including revenue from royalties of $72 million to $74
million;
- Operating expenses of $255
million to $265 million, down
from prior guidance of $265 million
to $275 million, or operating
expenses excluding cost of goods sold $215
million to $225 million, down
from prior guidance of $225 million
to $235 million;
- Operating cash burn of $40
million to $50 million, down
from prior guidance of $45 million to
$55 million;
- Debt repayment of approximately $90
million; the company now expects to pay off the remainder of
the royalty-backed debt by the end of the second quarter of
2020;
- Year-end cash, cash equivalents and marketable securities
balance of $220 million to
$230 million, up from prior guidance
of $210 million to $220 million.
This guidance continues to exclude revenue from any potential,
new ENHANZE® global collaboration and licensing
agreements.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for
the second quarter of 2019 today, Tuesday, August 6, 2019 at
4:30 p.m. ET/1:30 p.m. PT. Dr. Torley will lead the call,
which will be webcast live through the "Investors" section of
Halozyme's corporate website and a replay will be available
following the close of the call. To access the webcast and
additional documents related to the call, please visit halozyme.com
approximately fifteen minutes prior to the call to register,
download and install any necessary audio software. The call may
also be accessed by dialing (877) 824-0907 (domestic callers) or
(647) 689-5655 (international callers). A telephone replay will be
available after the call by dialing (800) 585-8367 (domestic
callers) or (416) 621-4642 (international callers) using replay ID
number 5549627.
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 pegvorhyaluronidase alfa (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 the
treatment of several cancers and has the potential to be used 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, Lilly,
Bristol-Myers Squibb, Alexion and argenx for its
ENHANZE® drug delivery technology. 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 future growth, revenue and milestone and other
potential payments from collaboration partners, the development and
commercialization of product candidates, including timing of
clinical trial results announcements and future development and
commercial activities of our collaboration partners, the potential
benefits and attributes of such product candidates and expected
financial outlook for 2019) 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 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 Quarterly Report
on Form 10-Q filed with the Securities and Exchange Commission on
August 6, 2019.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
Halozyme
Therapeutics, Inc.
Condensed
Consolidated Statements of Operations
(Unaudited)
(In thousands,
except per share amounts)
|
|
|
|
Three Months
Ended
June 30,
|
|
Six Months
Ended
June 30,
|
|
|
2019
|
|
2018
|
|
2019
|
|
2018
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
18,107
|
|
|
$
|
19,989
|
|
|
$
|
36,060
|
|
|
$
|
40,933
|
|
Product sales,
net
|
|
5,760
|
|
|
4,483
|
|
|
14,150
|
|
|
11,284
|
|
Revenues under
collaborative agreements
|
|
15,281
|
|
|
10,730
|
|
|
45,887
|
|
|
13,857
|
|
Total
revenues
|
|
39,148
|
|
|
35,202
|
|
|
96,097
|
|
|
66,074
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
1,877
|
|
|
836
|
|
|
6,526
|
|
|
3,888
|
|
Research and
development
|
|
33,910
|
|
|
40,086
|
|
|
65,238
|
|
|
78,062
|
|
Selling, general and
administrative
|
|
17,338
|
|
|
14,353
|
|
|
35,344
|
|
|
27,909
|
|
Total operating
expenses
|
|
53,125
|
|
|
55,275
|
|
|
107,108
|
|
|
109,859
|
|
Operating
loss
|
|
(13,977)
|
|
|
(20,073)
|
|
|
(11,011)
|
|
|
(43,785)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Investment and other
income, net
|
|
1,983
|
|
|
1,983
|
|
|
4,040
|
|
|
3,651
|
|
Interest
expense
|
|
(2,613)
|
|
|
(4,770)
|
|
|
(5,818)
|
|
|
(10,000)
|
|
Net loss before
income taxes
|
|
(14,607)
|
|
|
(22,860)
|
|
|
(12,789)
|
|
|
(50,134)
|
|
Income tax
expense
|
|
17
|
|
|
33
|
|
|
39
|
|
|
220
|
|
Net loss
|
|
$
|
(14,624)
|
|
|
$
|
(22,893)
|
|
|
$
|
(12,828)
|
|
|
$
|
(50,354)
|
|
|
|
|
|
|
|
|
|
|
Net loss per
share:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.10)
|
|
|
$
|
(0.16)
|
|
|
$
|
(0.09)
|
|
|
$
|
(0.35)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net loss per share:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
145,411
|
|
|
143,568
|
|
|
145,051
|
|
|
143,114
|
|
Halozyme
Therapeutics, Inc.
Condensed
Consolidated Balance Sheets
(Unaudited)
(In
thousands)
|
|
|
|
June 30,
2019
|
|
December 31,
2018
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
67,041
|
|
|
$
|
57,936
|
|
Marketable
securities, available-for-sale
|
|
220,424
|
|
|
296,590
|
|
Accounts receivable,
net and other contract assets
|
|
32,219
|
|
|
30,005
|
|
Inventories
|
|
43,900
|
|
|
22,625
|
|
Prepaid expenses and
other assets
|
|
28,122
|
|
|
20,693
|
|
Total current
assets
|
|
391,706
|
|
|
427,849
|
|
Property and
equipment, net
|
|
15,079
|
|
|
7,465
|
|
Prepaid expenses and
other assets
|
|
10,545
|
|
|
4,434
|
|
Restricted
cash
|
|
500
|
|
|
500
|
|
Total
assets
|
|
$
|
417,830
|
|
|
$
|
440,248
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
12,467
|
|
|
$
|
4,079
|
|
Accrued
expenses
|
|
45,561
|
|
|
49,529
|
|
Deferred revenue,
current portion
|
|
6,511
|
|
|
4,247
|
|
Current portion of
long-term debt, net
|
|
70,878
|
|
|
91,506
|
|
Total current
liabilities
|
|
135,417
|
|
|
149,361
|
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
|
1,746
|
|
|
5,008
|
|
Long-term debt,
net
|
|
14,083
|
|
|
34,874
|
|
Other long-term
liabilities
|
|
6,532
|
|
|
2,118
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
|
146
|
|
|
145
|
|
Additional paid-in
capital
|
|
803,782
|
|
|
780,457
|
|
Accumulated other
comprehensive income (loss)
|
|
390
|
|
|
(277)
|
|
Accumulated
deficit
|
|
(544,266)
|
|
|
(531,438)
|
|
Total stockholders'
equity
|
|
260,052
|
|
|
248,887
|
|
Total liabilities and
stockholders' equity
|
|
$
|
417,830
|
|
|
$
|
440,248
|
|
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SOURCE Halozyme Therapeutics, Inc.