SAN DIEGO, May 11, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported financial results
for the first quarter ended March 31, 2020 and provided an
update on its recent corporate activities and outlook.
"This has been a very exciting start to the year for Halozyme as
we have achieved multiple value-creating events in our
ENHANZE® business, including U.S. FDA approval for
DARZALEX FASPROTM with a broad set of label
indications, and the receipt of a positive CHMP opinion in the EU,
also recommending a broad set of label indications. The positive
CHMP opinion is typically a precursor to marketing
clearance," said Dr. Helen
Torley, president and chief executive officer. "As we look
ahead, we are excited about the launches of subcutaneous
DARZALEX® in the U.S. and E.U. as well as the potential
FDA approval of the subcutaneous fixed-dose combination of
Perjeta® and Herceptin® later this year, and
what they may mean for patients."
"I want to express my gratitude to the Halozyme team, our
partners and suppliers for our continued progress in spite of the
challenges posed by COVID-19," continued Dr. Torley. "In light of
these challenges, it is obviously difficult to predict how the
pandemic recovery will unfold in the coming quarters. However,
based on the latest information from our partners and suppliers,
and our team's commitment to maintaining a lean operating
structure, we feel confident maintaining our 2020 financial
guidance at this time."
First Quarter 2020 and Recent Highlights Include:
- On May 1, the Company announced
that The Janssen Pharmaceutical Companies of Johnson and Johnson
received U.S. FDA approval of DARZALEX FASPROTM
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.
- On April 30, the Company
announced that Janssen-Cilag International NV (Janssen) received a
Committee for Medicinal Products for Human Use (CHMP) Positive
Opinion from the European Medicines Agency (EMA) recommending
approval of a DARZALEX® (daratumumab) subcutaneous (SC)
formulation for the treatment of adult patients with multiple
myeloma in frontline and relapsed/refractory settings. The CHMP's
Positive Opinion for daratumumab SC formulation applies to multiple
current daratumumab indications including newly diagnosed and
transplant-ineligible patients, as well as relapsed or refractory
patients.
- In April, the Company announced the submission of a New Drug
Application (NDA) to Japan's
Ministry of Health, Labour and Welfare (MHLW) by Janssen
Pharmaceutical K.K. (Janssen) seeking approval of a new
subcutaneous (SC) formulation of daratumumab, an intravenous (IV)
treatment approved for patients with multiple myeloma.
- During the first quarter, the Company repurchased 3.2 million
shares of its common stock at a weighted average price of
$16.15 per share. These repurchased
shares were in addition to shares repurchased as part of an
Accelerated Share Repurchase plan that was completed in
mid-February. To date the Company has repurchased over $250 million in shares as part of its three-year
share repurchase authorization of up to $550
million approved by the Board in November 2019.
- In February, the Company announced that the FDA has accepted a
Biologics License Application (BLA) from Genentech, a member of the
Roche Group, for the fixed-dose combination of pertuzumab
(Perjeta®) and trastuzumab (Herceptin® ) for
subcutaneous administration using ENHANZE® technology in
combination with IV chemotherapy for the treatment of eligible
patients with HER2-positive breast cancer, with an action date of
October 18, 2020.
First Quarter 2020 Financial Highlights
- Revenue for the first quarter was $25.4
million compared to $56.9
million for the first quarter of 2019. The year-over-year
decrease was primarily driven by a $30
million upfront payment from argenx in the prior year
period. Revenue for the quarter included $16.8 million in royalties, which compared to
$18.0 million in the prior year
period.
- Research and development expenses for the first quarter were
$10.2 million, compared to
$31.3 million for the first 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 and related restructuring as
announced in November 2019.
- Selling, general and administrative expenses for the first
quarter were $12.6 million, compared
to $18.0 million for the first
quarter of 2019. The decrease was due to lower compensation and
commercial-related expenses related to the corporate restructuring
announced in November 2019.
- Net loss for the first quarter was $6.1
million, or $0.04 per share,
compared to a net income in the first quarter of 2019 of
$1.8 million, or $0.01 per share.
- Cash, cash equivalents and marketable securities were
$368.2 million at March 31, 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 receive 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 from that first
provided on January 14, 2020. 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 with
the first quarter of sustainable profitability beginning in Q2
2020.
The guidance on earnings per share does not reflect any
potential impact from the Company's plans to repurchase any
additional number of shares, up to an additional $98 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 first quarter of 2020 today, Monday, May 11, 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 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 (833) 968-2181 (domestic callers) or
(825) 312-2108 (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 3199114.
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 three 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 profitability, revenue,
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,
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, 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 March 31,
|
|
|
2020
|
|
2019
|
Revenues:
|
|
|
|
|
Royalties
|
|
$
|
16,822
|
|
|
$
|
17,953
|
|
Product sales,
net
|
|
8,147
|
|
|
8,390
|
|
Revenues under
collaborative agreements
|
|
385
|
|
|
30,606
|
|
Total
revenues
|
|
25,354
|
|
|
56,949
|
|
Operating
expenses:
|
|
|
|
|
Cost of product
sales
|
|
5,787
|
|
|
4,649
|
|
Research and
development
|
|
10,158
|
|
|
31,328
|
|
Selling, general and
administrative
|
|
12,632
|
|
|
18,006
|
|
Total operating
expenses
|
|
28,577
|
|
|
53,983
|
|
Operating (loss)
income
|
|
(3,223)
|
|
|
2,966
|
|
Other income
(expense):
|
|
|
|
|
Investment and other
income, net
|
|
2,479
|
|
|
2,057
|
|
Interest
expense
|
|
(5,348)
|
|
|
(3,205)
|
|
Net (loss) income
before income taxes
|
|
(6,092)
|
|
|
1,818
|
|
Income tax
expense
|
|
11
|
|
|
22
|
|
Net (loss)
income
|
|
$
|
(6,103)
|
|
|
$
|
1,796
|
|
|
|
|
|
|
Net (loss) income per
share:
|
|
|
|
|
Basic
|
|
$
|
(0.04)
|
|
|
$
|
0.01
|
|
Diluted
|
|
$
|
(0.04)
|
|
|
$
|
0.01
|
|
|
|
|
|
|
Shares used in
computing net (loss) income per share:
|
|
|
|
|
Basic
|
|
137,186
|
|
|
144,743
|
|
Diluted
|
|
137,186
|
|
|
147,474
|
|
Halozyme
Therapeutics, Inc
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
|
|
March 31,
2020
|
|
December 31,
2019
|
ASSETS
|
|
|
|
|
Current
assets:
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
104,820
|
|
|
$
|
120,179
|
|
Marketable
securities, available-for-sale
|
|
263,363
|
|
|
301,083
|
|
Accounts receivable,
net
|
|
29,749
|
|
|
59,442
|
|
Inventories
|
|
41,452
|
|
|
29,359
|
|
Prepaid expenses and
other assets
|
|
28,587
|
|
|
33,373
|
|
Total current
assets
|
|
467,971
|
|
|
543,436
|
|
Property and
equipment, net
|
|
11,752
|
|
|
10,855
|
|
Prepaid expenses and
other assets
|
|
12,130
|
|
|
11,083
|
|
Restricted
cash
|
|
500
|
|
|
500
|
|
Total
assets
|
|
$
|
492,353
|
|
|
$
|
565,874
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
|
Current
liabilities:
|
|
|
|
|
Accounts
payable
|
|
$
|
8,320
|
|
|
$
|
6,434
|
|
Accrued
expenses
|
|
26,811
|
|
|
55,649
|
|
Deferred revenue,
current portion
|
|
4,012
|
|
|
4,012
|
|
Current portion of
long-term debt, net
|
|
2,859
|
|
|
19,542
|
|
Total current
liabilities
|
|
42,002
|
|
|
85,637
|
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
|
641
|
|
|
1,247
|
|
Long-term debt,
net
|
|
386,571
|
|
|
383,045
|
|
Other long-term
liabilities
|
|
5,097
|
|
|
4,180
|
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
|
Common
stock
|
|
135
|
|
|
137
|
|
Additional paid-in
capital
|
|
667,677
|
|
|
695,066
|
|
Accumulated other
comprehensive income (loss)
|
|
11
|
|
|
240
|
|
Accumulated
deficit
|
|
(609,781)
|
|
|
(603,678)
|
|
Total stockholders'
equity
|
|
58,042
|
|
|
91,765
|
|
Total liabilities and
stockholders' equity
|
|
$
|
492,353
|
|
|
$
|
565,874
|
|
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SOURCE Halozyme Therapeutics, Inc.