SAN DIEGO, Aug. 10, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported financial results
for the second quarter ended June 30, 2020 and provided an
update on its recent corporate activities and outlook.
"The second quarter marked the achievement of multiple key
milestones for Halozyme including two FDA approvals and one EMA
approval for partnered drugs bringing the total number of
FDA-approved products utilizing our ENHANZE® drug
delivery technology to five," said Dr. Helen Torley, president and chief executive
officer. "In addition, we are delighted to report that in the
second quarter we delivered our first profitable quarter of
expected sustainable profitability with earnings per share of
$0.19. We see this as an important
first step in our transformation to a high growth, high margin
business delivering sustainable revenue growth and profitability
over the long term. The events of the quarter were highlighted by
our partner Janssen receiving approvals in both the U.S. and the EU
for the subcutaneous form of DARZALEX® utilizing
ENHANZE®, which is branded as DARZALEX
FASPROTM in the U.S. We earned $25 million in total milestone payments from
Janssen during the quarter, upon the first commercial sales in both
markets. In late June, our partner Roche received FDA approval for
Phesgo™, a fixed-dose combination of two monoclonal antibodies,
Perjeta® and Herceptin®, utilizing our
ENHANZE® technology for the treatment of patients with
HER2-positive breast cancer. In addition to providing important new
treatment options for patients, each of these newly-approved drugs
represents the subcutaneous form of a growing, blockbuster
franchise, and we expect their adoption to be an important driver
of our growth and profitability in the coming years."
"I want to again express my gratitude to the Halozyme team, our
partners and suppliers for their tireless work as we all navigate
challenges posed by the COVID-19 pandemic," continued Dr. Torley.
"Based on the latest information from our partners, I am pleased to
report that we are maintaining our financial outlook for the full
year 2020. It is possible that our partners' timelines may
change as a result of future changes related to COVID-19. We will
continue to monitor this closely and provide updates as
appropriate."
Second Quarter 2020 and Recent Highlights Include:
- On June 29, the Company announced
that Roche received FDA approval for Phesgo™ (pertuzumab,
trastuzumab, and hyaluronidase-zzxf), a fixed-dose combination of
Perjeta® and Herceptin® for subcutaneous
injection utilizing ENHANZE® technology for the
treatment of patients with HER2-positive breast cancer. Phesgo™ can
be administered in approximately eight minutes for the initial
loading dose and approximately five minutes for each subsequent
maintenance dose. This is compared to approximately 150 minutes for
a sequential infusion of a loading dose of Perjeta® and
Herceptin® using the standard intravenous (IV)
formulations, and between 60-150 minutes for subsequent maintenance
infusions of the two medicines. Phesgo™ can be administered by a
healthcare professional in a treatment center or at a patient's
home.
- On June 13, the Company announced
that findings from Janssen's phase 3 ANDROMEDA (AMY3001) study
evaluating subcutaneous daratumumab utilizing
ENHANZE® in light-chain Amyloidosis were
presented at the European Hematology Association 25th Annual
Congress. Janssen reported that the study met the primary endpoint
of percentage of patients with hematologic complete response.
- On June 4, the Company announced
that Janssen received European marketing authorization for the
subcutaneous formulation of DARZALEX® (daratumumab)
utilizing ENHANZE® for the treatment of
adult patients with multiple myeloma in all currently approved
DARZALEX® intravenous (IV) formulation indications in
frontline and relapsed / refractory settings. Subsequent launch of
the product and first commercial sale in Europe resulted in a $10 million milestone payment in the
quarter.
- In June 2020, Bristol Myers
Squibb initiated a Phase 1/2 study of ipilimumab in combination
with nivolumab in multiple tumor types utilizing
ENHANZE® technology.
- On May 1, the Company announced
that Janssen received U.S. FDA approval of DARZALEX
FASPROTM (daratumumab hyaluronidase human- fihj)
in four regimens across five indications in multiple myeloma
patients, including newly diagnosed, transplant-ineligible patients
as well as relapsed or refractory patients. As a fixed-dose
formulation, DARZALEX FASPROTM can be
administered subcutaneously over three to five minutes,
significantly less time than IV DARZALEX®, which
requires multi-hour infusions. Subsequent launch of the product and
first commercial sale resulted in a $15
million milestone in the quarter.
Second Quarter 2020 Financial Highlights
- Revenue for the second quarter was $55.2
million compared to $39.1
million for the second quarter of 2019. The year-over-year
increase was primarily driven by $32.3
million in collaboration payments from Janssen and Bristol Myers Squibb in the current
period. Revenue for the quarter included $15.8 million in royalties, which compared to
$18.1 million in the prior year
period.
- Research and development expenses for the second quarter were
$9.0 million, compared to
$33.9 million for the second quarter
of 2019. The decrease in expenses was due to a decrease in clinical
trial activities-related costs as a result of the Company halting
its oncology drug development efforts in November 2019.
- Selling, general and administrative expenses for the second
quarter were $11.0 million, compared
to $17.3 million for the second
quarter of 2019. The decrease was due to lower compensation and
commercial-related expenses related to the corporate restructuring
announced in November 2019.
- The Company reported the first quarter of what it expects will
be sustainable profitability. Net income for the second quarter was
$25.8 million, or $0.19 per share, compared to a net loss in the
second quarter of 2019 of $14.6
million, or $0.10 per
share.
- Cash, cash equivalents and marketable securities were
$385.4 million at June 30, 2020, compared to $421.3 million at December
31, 2019.
Financial Outlook for 2020
The Company continues to monitor the impact of the COVID-19
pandemic on its business and receives updates from its partners and
suppliers on how their businesses are affected. Based on this
information and Halozyme's planned expenditures for the year, the
Company's 2020 financial guidance remains unchanged. For 2020
Halozyme continues to expect:
- Revenues of $230 million to
$245 million, representing growth of
17% to 25%;
- Earnings per share on a GAAP basis of $0.60 to $0.75.
The Company remains committed to capital return and plans to
repurchase an additional number of shares, up to an additional
$96 million worth, during the
remainder of 2020. The amount and timing of shares repurchased
during 2020 will be subject to a variety of factors including
market conditions, other business considerations and applicable
legal requirements.
Webcast and Conference Call
Halozyme will webcast its Quarterly Update Conference Call for
the second quarter of 2020 today, Monday, August 10, 2020 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 register for this conference
call, please use this link:
http://www.directeventreg.com/registration/event/6277618. 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. A
telephone replay will be available for two weeks after the call by
dialing (800) 585-8367 (domestic callers) or (416) 621-4642
(international callers) using replay ID number 6277618.
About Halozyme
Halozyme is a biopharmaceutical company bringing disruptive
solutions to significantly improve patient experiences and outcomes
for emerging and established therapies. Halozyme advises and
supports its biopharmaceutical partners in key aspects of new drug
development with the goal of improving patients' lives while
helping its partners achieve global commercial success. As the
innovators of the ENHANZE® technology, which can reduce
hours-long treatments to a matter of minutes, Halozyme's
commercially-validated solution has positively impacted more than
400,000 patient lives via five commercialized products across more
than 100 global markets. Halozyme and its world-class partners are
currently advancing multiple therapeutic programs intended to
deliver innovative therapies, with the potential to improve the
lives of patients around the globe. Halozyme's proprietary enzyme
rHuPH20 forms the basis of the ENHANZE® technology and
is used to facilitate the delivery of injected drugs and fluids,
potentially reducing the treatment burden of other drugs to
patients. Halozyme has licensed its ENHANZE® technology
to leading pharmaceutical and biotechnology companies including
Roche, Baxalta, Pfizer, Janssen, AbbVie, Lilly, Bristol-Myers
Squibb, Alexion and argenx. Halozyme derives revenues from these
collaborations in the form of milestones and royalties as the
Company's partners make progress developing and commercializing
their products being developed with ENHANZE®. 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
in this press release include forward-looking statements including,
without limitation, statements concerning the Company's expected
future financial performance (including the Company's financial
outlook for 2020) and expectations for future growth,
profitability, revenue, margins, expenses and earnings-per-share
and the Company's plans to continue its share repurchase
program. Forward-looking statements regarding the Company's
ENHANZE® drug delivery technology may include the
possible activity, benefits and attributes of ENHANZE®,
the possible method of action of ENHANZE®, its potential
application to aid in the dispersion and absorption of other
injected therapeutic drugs and facilitating more rapid delivery of
injectable medications through subcutaneous delivery.
Forward-looking statements regarding the Company's
ENHANZE® business may include potential growth
driven by our partners' development and commercialization efforts,
the size and growth prospects of our partners' drug franchises,
potential new ENHANZE® collaborations and collaborative
targets and regulatory review and potential approvals of new
ENHANZE® products. These 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 and involve risk and uncertainties that could cause actual
results to differ materially from those in the forward-looking
statements. Actual results could differ materially from the
expectations contained in these forward-looking statements as a
result of several factors, including unexpected levels of revenues,
expenditures and costs, inability to sustain profitability,
unexpected delays in the execution of the Company's share
repurchase program, unexpected results or delays in the growth of
the Company's ENHANZE® business, or in the development,
regulatory review or commercialization of ENHANZE®
products, including any potential delays caused by the current
COVID-19 global pandemic, regulatory approval requirements,
unexpected adverse events or patient outcomes and competitive
conditions. These and other factors that may result in differences
are discussed in greater detail in the Company's most recently
filed Annual Report on Form 10-K filed with the Securities and
Exchange Commission.
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
|
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues:
|
|
|
|
|
|
|
|
|
Royalties
|
|
$
|
15,846
|
|
|
$
|
18,107
|
|
|
$
|
32,668
|
|
|
$
|
36,060
|
|
Product sales,
net
|
|
6,337
|
|
|
5,760
|
|
|
14,484
|
|
|
14,150
|
|
Revenues under
collaborative agreements
|
|
33,038
|
|
|
15,281
|
|
|
33,423
|
|
|
45,887
|
|
Total
revenues
|
|
55,221
|
|
|
39,148
|
|
|
80,575
|
|
|
96,097
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
Cost of product
sales
|
|
5,740
|
|
|
1,877
|
|
|
11,527
|
|
|
6,526
|
|
Research and
development
|
|
8,951
|
|
|
33,910
|
|
|
19,109
|
|
|
65,238
|
|
Selling, general and
administrative
|
|
10,975
|
|
|
17,338
|
|
|
23,607
|
|
|
35,344
|
|
Total operating
expenses
|
|
25,666
|
|
|
53,125
|
|
|
54,243
|
|
|
107,108
|
|
Operating income
(loss)
|
|
29,555
|
|
|
(13,977)
|
|
|
26,332
|
|
|
(11,011)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
|
Investment and other
income, net
|
|
1,324
|
|
|
1,983
|
|
|
3,803
|
|
|
4,040
|
|
Interest
expense
|
|
(5,004)
|
|
|
(2,613)
|
|
|
(10,352)
|
|
|
(5,818)
|
|
Net income (loss)
before income taxes
|
|
25,875
|
|
|
(14,607)
|
|
|
19,783
|
|
|
(12,789)
|
|
Income tax
expense
|
|
58
|
|
|
17
|
|
|
69
|
|
|
39
|
|
Net income
(loss)
|
|
$
|
25,817
|
|
|
$
|
(14,624)
|
|
|
$
|
19,714
|
|
|
$
|
(12,828)
|
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
0.19
|
|
|
$
|
(0.10)
|
|
|
$
|
0.14
|
|
|
$
|
(0.09)
|
|
Diluted
|
|
$
|
0.19
|
|
|
$
|
(0.10)
|
|
|
$
|
0.14
|
|
|
$
|
(0.09)
|
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per share:
|
|
|
|
|
|
|
|
|
Basic
|
|
135,935
|
|
|
145,411
|
|
|
136,572
|
|
|
145,051
|
|
Diluted
|
|
138,084
|
|
|
145,411
|
|
|
138,837
|
|
|
145,051
|
|
Halozyme
Therapeutics, Inc.
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
|
|
June
30, 2020
|
|
December
31, 2019
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
133,606
|
|
|
$
|
120,179
|
|
Marketable
securities, available-for-sale
|
|
251,840
|
|
|
301,083
|
|
Accounts receivable,
net
|
|
37,401
|
|
|
59,442
|
|
Inventories
|
|
48,271
|
|
|
29,359
|
|
Prepaid expenses and
other assets
|
|
29,240
|
|
|
33,373
|
|
Total current
assets
|
|
500,358
|
|
|
543,436
|
|
Property and
equipment, net
|
|
11,169
|
|
|
10,855
|
|
Prepaid expenses and
other assets
|
|
14,970
|
|
|
11,083
|
|
Restricted
cash
|
|
500
|
|
|
500
|
|
Total
assets
|
|
$
|
526,997
|
|
|
$
|
565,874
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
4,067
|
|
|
$
|
6,434
|
|
Accrued
expenses
|
|
21,258
|
|
|
55,649
|
|
Deferred revenue,
current portion
|
|
748
|
|
|
4,012
|
|
Current portion of
long-term debt, net
|
|
—
|
|
|
19,542
|
|
Total current
liabilities
|
|
26,073
|
|
|
85,637
|
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
|
641
|
|
|
1,247
|
|
Long-term debt,
net
|
|
390,079
|
|
|
383,045
|
|
Other long-term
liabilities
|
|
4,627
|
|
|
4,180
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
|
137
|
|
|
137
|
|
Additional paid-in
capital
|
|
688,318
|
|
|
695,066
|
|
Accumulated other
comprehensive income (loss)
|
|
1,086
|
|
|
240
|
|
Accumulated
deficit
|
|
(583,964)
|
|
|
(603,678)
|
|
Total stockholders'
equity
|
|
105,577
|
|
|
91,765
|
|
Total liabilities and
stockholders' equity
|
|
$
|
526,997
|
|
|
$
|
565,874
|
|
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SOURCE Halozyme Therapeutics, Inc.