SAN DIEGO, Feb. 23, 2021 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today reported financial results
for the fourth quarter and full year ended December 31, 2020
and provided an update on its recent corporate activities and
outlook.
"The fourth quarter capped an extraordinary year for Halozyme
during which we transitioned to a profitable, high-growth company
with strong prospects for continued growth over the long-term,"
said Dr. Helen Torley, president and
chief executive officer. "Our strong growth prospects are
fueled by recent product approvals for subcutaneous
DARZALEX® (daratumumab) and
Phesgo® (pertuzumab, trastuzumab and hyaluronidase)
utilizing our ENHANZE® technology. Building
on our portfolio of 5 commercialized partner products, we project
the expansion of our development pipeline, including 4 products
being evaluated in 7 phase 3 studies utilizing our
ENHANZE® technology. We believe this
advancing pipeline of products utilizing our
ENHANZE® technology is setting the potential for
multiple waves of future product launches that will deliver
long-term growth in revenues, profitability and cash flow."
Fourth Quarter 2020 and Recent Highlights Include:
- In February 2021, argenx
announced a "go" decision for its ADHERE trial evaluating
subcutaneous (SC) efgartigimod with ENHANZE® technology
in chronic inflammatory demyelinating polyneuropathy (CIDP). argenx
plans to continue enrollment to include approximately 130 patients
to support potential registration of SC efgartigimod for the
treatment of CIDP.
- In January 2021,
ENHANZE® partner Janssen Biotech, Inc. (Janssen)
received U.S. Food and Drug Administration (FDA) accelerated
approval of DARZALEX FASPRO® (daratumumab and
hyaluronidase-fihj) in combination with bortezomib,
cyclophosphamide and dexamethasone (D-VCd) for the treatment of
adult patients with newly diagnosed light chain (AL) amyloidosis.
AL amyloidosis is a rare and potentially fatal disease that
develops when plasma cells in the bone marrow generate abnormal
light chains, which form amyloid deposits in vital organs and lead
to organ deterioration. There were previously no approved therapies
for the disease.
- In January 2021, argenx initiated
a Phase 3 study of ARGX-113 with ENHANZE® technology in
pemphigus vulgaris and pemphigus foliaceus, rare autoimmune
diseases that cause painful blisters on the skin and mucous
membranes.
- In December 2020, argenx
initiated a Phase 3 study of ARGX-113 with ENHANZE®
technology for patients with immune thrombocytopenia (ITP), an
immune disorder in which the blood does not clot normally,
resulting in a $15 million payment to
Halozyme.
- In December 2020, Roche initiated
a Phase 3 study in patients with non-small cell lung cancer for
Tecentriq® (atezolizumab) with ENHANZE®
technology, resulting in a $17
million payment to Halozyme.
- In December 2020, the Company
announced that the European Commission approved Roche's
Phesgo®, a fixed-dose combination of Perjeta®
(pertuzumab) and Herceptin® (trastuzumab) with
ENHANZE® technology, administered by SC injection for
the treatment of patients with early and metastatic HER2-positive
breast cancer. This was the first time the European Commission
approved a product combining two monoclonal antibodies that can be
administered by a single SC injection utilizing
ENHANZE® technology.
- In November 2020, the Company
announced a global collaboration and license agreement that
provides Horizon Therapeutics plc exclusive access to
ENHANZE® technology for SC formulation of medicines
targeting IGF-1R for which the Company received an upfront payment
of $30 million. Horizon intends to
use ENHANZE® technology to develop a SC formulation of
TEPEZZA® (teprotumumab-trbw), indicated for the
treatment of Thyroid Eye Disease, a serious, progressive and
vision-threatening rare autoimmune disease, potentially shortening
drug administration time, reducing healthcare practitioner time and
offering additional flexibility and convenience for patients.
- In November 2020, Janssen
initiated a Phase 1 study of amivantamab utilizing
ENHANZE® technology in advanced solid tumors.
- In November 2020, the Company
announced that Janssen submitted regulatory applications to the FDA
and European Medicines Agency (EMA) seeking approval of DARZALEX
FASPRO® in the U.S. and as DARZALEX® SC in
the European Union (EU) utilizing ENHANZE® technology in
combination with pomalidomide and dexamethasone (D-Pd) for the
treatment of patients with relapsed or refractory multiple myeloma
who have received at least one prior line of therapy.
- In November 2020, Janssen
submitted a Type II variation application to the EMA seeking
European approval for DARZALEX® SC utilizing
ENHANZE® technology to be used in the treatment of
patients with AL amyloidosis.
- In October 2020, the Company
announced that argenx expanded its existing global collaboration
and license agreement that was signed in February 2019. Under the expansion, argenx gained
the ability to exclusively access Halozyme's ENHANZE®
drug delivery technology for three additional targets upon
nomination for a total of up to six targets. To date, argenx has
nominated two targets including the human neonatal Fc receptor
FcRn, which is blocked by efgartigimod, and complement component
C2.
- During the fourth quarter, the Company repurchased
approximately 1.1 million shares of common stock for $37.6 million at an average price per share of
$34.36, bringing the total 2020
repurchases to $150.0 million at an
average price of $23.05.
Fourth Quarter and Full Year 2020 Financial
Highlights
- Revenue for the fourth quarter was $121.7 million compared to $53.7 million for the fourth quarter of 2019. The
year-over-year increase was primarily driven by a $30.0 million upfront payment from Horizon, a
$15.0 million sales milestone from
Janssen, an increase in royalty revenue following the strong
DARZALEX FASPRO® launch during the second quarter
and an increase in product sales. Revenue for the quarter
included $32.0 million in
royalties, an increase of 86% compared to $17.2 million in the prior year period.
Total revenues for the full year were $267.6
million, compared with $196.0
million in 2019, representing growth of 37% year over
year.
- Research and development expenses for the fourth quarter were
$7.4 million, compared to
$45.1 million for the fourth 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 beginning in November 2019 and one-time restructuring charges
of $17.2 million in the prior year
related to the shift in strategic focus to the Company's
ENHANZE® technology.
Research and development expenses for the full year were
$34.2 million, compared with
$140.8 million in 2019.
- Selling, general and administrative expenses for the fourth
quarter were $10.4 million, compared
to $23.9 million for the fourth
quarter of 2019. The decrease was due to lower compensation and
commercial-related expenses related to the corporate restructuring
announced in November 2019 and a
one-time restructuring charge of $11.2
million in the prior year.
Selling, general and administrative expenses for the full year were
$45.7 million, compared with
$77.3 million in 2019.
- Operating income for the fourth quarter was $77.6 million, compared to an operating loss of
$32.1 million in the fourth quarter
of 2019.
Operating income for the full year was $144.3 million, compared to an operating loss of
$67.6 million in 2019.
- Net income for the fourth quarter was $73.2 million, or $0.50 per share, compared to a net loss in the
fourth quarter of 2019 of $34.4
million, or loss of $0.24 per
share.
Net income for the full year was $129.1
million or $0.91 per share,
compared to a net loss of $72.2
million or loss of $0.50 per
share in 2019.
- Cash, cash equivalents and marketable securities were
$368.0 million at December 31,
2020, compared to $421.3 million at
December 31, 2019.
- During 2020, the Company repurchased 6.5 million shares of
common stock for $150 million at an
average price of $23.05, bringing the
total for share repurchases since the announcement of the Company's
three-year share repurchase program to $350.0 million at an average price of
$19.88.
Financial Outlook for 2021
Based on the latest information from collaboration partners and
planned expenditures for the year, the Company expects:
- Revenues of $375 million to
$395 million, representing
year-over-year growth of 40%-48%, with revenues from royalties
projected to approximately double versus 2020;
- Operating Income of $215 million
to $235 million, representing
year-over-year growth of 49%-63%;
- Earnings per share on a GAAP basis of $1.40 to $1.55,
representing year-over-year growth of 54%-70%.
The Company plans to repurchase up to $125 million in common stock during 2021 as part
of the $550 million three-year share
repurchase plan authorized by Halozyme's board of directors in
2019. The amount and timing of shares to be repurchased in 2021
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 fourth quarter of 2020 today, Tuesday, February 23, 2021
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/7096809. After
registering, you will receive an email confirmation that includes
dial in details and unique conference call codes for entry.
Registration is open through the live call. However, to ensure you
are connected for the full call, we suggest registering a day in
advance or at minimum 10 minutes before the start of the call.
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, argenx and Horizon Therapeutics. 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 2021) and expectations for future growth,
profitability, revenue, operating income, cash flow, 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
December
31,
|
|
Twelve Months
Ended
December
31,
|
|
2020
|
|
2019
|
|
2020
|
|
2019
|
Revenues:
|
|
|
|
|
|
|
|
Royalties
|
$
|
31,997
|
|
|
$
|
17,230
|
|
|
$
|
88,596
|
|
|
$
|
69,899
|
|
Product sales,
net
|
32,455
|
|
|
22,693
|
|
|
55,987
|
|
|
66,048
|
|
Revenues under
collaborative agreements
|
57,251
|
|
|
13,742
|
|
|
123,011
|
|
|
60,045
|
|
Total
revenues
|
121,703
|
|
|
53,665
|
|
|
267,594
|
|
|
195,992
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
Cost of product
sales
|
26,272
|
|
|
16,687
|
|
|
43,367
|
|
|
45,546
|
|
Research and
development
|
7,380
|
|
|
45,111
|
|
|
34,236
|
|
|
140,804
|
|
Selling, general and
administrative
|
10,427
|
|
|
23,929
|
|
|
45,736
|
|
|
77,252
|
|
Total operating
expenses
|
44,079
|
|
|
85,727
|
|
|
123,339
|
|
|
263,602
|
|
Operating income
(loss)
|
77,624
|
|
|
(32,062)
|
|
|
144,255
|
|
|
(67,610)
|
|
Other income
(expense):
|
|
|
|
|
|
|
|
Investment and other
income, net
|
661
|
|
|
1,333
|
|
|
5,425
|
|
|
6,986
|
|
Interest
expense
|
(5,036)
|
|
|
(3,731)
|
|
|
(20,378)
|
|
|
(11,627)
|
|
Net income (loss)
before income taxes
|
73,249
|
|
|
(34,460)
|
|
|
129,302
|
|
|
(72,251)
|
|
Income tax
expense
|
85
|
|
|
(63)
|
|
|
217
|
|
|
(11)
|
|
Net income
(loss)
|
$
|
73,164
|
|
|
$
|
(34,397)
|
|
|
$
|
129,085
|
|
|
$
|
(72,240)
|
|
|
|
|
|
|
|
|
|
Net income (loss) per
share:
|
|
|
|
|
|
|
|
Basic
|
$
|
0.54
|
|
|
$
|
(0.24)
|
|
|
$
|
0.95
|
|
|
$
|
(0.50)
|
|
Diluted
|
$
|
0.50
|
|
|
$
|
(0.24)
|
|
|
$
|
0.91
|
|
|
$
|
(0.50)
|
|
|
|
|
|
|
|
|
|
Shares used in
computing net income (loss) per share:
|
|
|
|
|
|
|
|
Basic
|
135,107
|
|
|
141,046
|
|
|
136,206
|
|
|
144,329
|
|
Diluted
|
145,122
|
|
|
141,046
|
|
|
141,463
|
|
|
144,329
|
|
|
|
|
Halozyme
Therapeutics, Inc
|
Condensed
Consolidated Balance Sheets
|
(Unaudited)
|
(In
thousands)
|
|
|
December
31,
2020
|
|
December
31,
2019
|
ASSETS
|
|
|
|
Current
assets:
|
|
|
|
Cash and cash
equivalents
|
$
|
147,703
|
|
|
$
|
120,179
|
|
Marketable securities,
available-for-sale
|
220,310
|
|
|
301,083
|
|
Accounts receivable,
net and other contract assets
|
97,730
|
|
|
59,442
|
|
Inventories
|
60,747
|
|
|
29,359
|
|
Prepaid expenses and
other assets
|
28,274
|
|
|
33,373
|
|
Total current
assets
|
554,764
|
|
|
543,436
|
|
Property and
equipment, net
|
10,593
|
|
|
10,855
|
|
Prepaid expenses and
other assets
|
14,067
|
|
|
11,083
|
|
Restricted
cash
|
500
|
|
|
500
|
|
Total
assets
|
$
|
579,924
|
|
|
$
|
565,874
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY
|
|
|
|
Current
liabilities:
|
|
|
|
Accounts
payable
|
$
|
1,928
|
|
|
$
|
6,434
|
|
Accrued
expenses
|
20,483
|
|
|
55,649
|
|
Deferred revenue,
current portion
|
1,746
|
|
|
4,012
|
|
Current portion of
long-term debt, net
|
397,228
|
|
|
19,542
|
|
Total current
liabilities
|
421,385
|
|
|
85,637
|
|
|
|
|
|
Deferred revenue, net
of current portion
|
4,026
|
|
|
1,247
|
|
Long-term debt,
net
|
—
|
|
|
383,045
|
|
Other long-term
liabilities
|
3,466
|
|
|
4,180
|
|
|
|
|
|
Stockholders'
equity:
|
|
|
|
Common
stock
|
135
|
|
|
137
|
|
Additional paid-in
capital
|
625,483
|
|
|
695,066
|
|
Accumulated other
comprehensive income (loss)
|
22
|
|
|
240
|
|
Accumulated
deficit
|
(474,593)
|
|
|
(603,678)
|
|
Total stockholders'
equity
|
151,047
|
|
|
91,765
|
|
Total liabilities and
stockholders' equity
|
$
|
579,924
|
|
|
$
|
565,874
|
|
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SOURCE Halozyme Therapeutics, Inc.