SAN DIEGO, Jan. 14, 2020 /PRNewswire/ -- Halozyme
Therapeutics, Inc. (NASDAQ: HALO) today provided an update on its
outlook for 2020, including financial guidance.
"We have made tremendous progress repositioning the company to
focus solely on driving the growth and profitability of our
ENHANZE® business," said Dr. Helen Torley, president and chief executive
officer. "Looking ahead, we anticipate a number of value-creating
financial and ENHANZE-related milestones will be achieved during
2020."
Anticipated 2020 ENHANZE® Key Events
- U.S. Food and Drug Administration (FDA) decision on the
approval of the Biologics License Application submitted by
ENHANZE® collaboration partner Janssen Biotech, Inc.
(Janssen) in July 2019 for
Daratumumab SC.
- European Medicines Agency (EMA) decision on the approval of the
extension application submitted by Janssen-Cilag International NV
(Janssen) in July 2019 for
Daratumumab SC.
- Completion in Q1 2020 of regulatory submissions to the FDA and
EMA by Roche seeking approval for the fixed-dose combination of
Perjeta® and Herceptin® utilizing
ENHANZE® in combination with intravenous
chemotherapy.
- At least 3 new Phase 3 and 1 Phase 2 clinical trial initiations
by ENHANZE® collaboration partners.
- Initiation of at least five new Phase 1 clinical trials with
partner products utilizing the ENHANZE® drug delivery
technology.
Update on Capital Return Program
On November 4, 2019 the Company
announced its Board of Directors approved a plan to repurchase up
to $350 million in stock over the
next three years. Subsequently, on November
12, 2019 the Company announced the Board further approved
the repurchase of an additional $200
million worth of shares in conjunction with an offering of
convertible senior notes, due 2024, resulting in a total three-year
share repurchase authorization of up to $550
million.
As of December 31, 2019, the
Company had repurchased 8.5 million shares of Halozyme stock under
this program. In addition, 2.1 million shares had been delivered to
the Company as part of a $50 million
Accelerated Share Repurchase (ASR), which is expected to be
completed in the first quarter of 2020. Following completion of the
ASR, the Company will have repurchased a total of $200 million worth of shares. As of December 31 2019, the Company had 136.7 million
shares outstanding.
The Company plans to repurchase an additional number of shares,
up to $150 million worth, during
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.
2020 Financial Guidance
For 2020, Halozyme expects revenues of $230 million to $245
million, representing growth of 18% to 26% over the 2019
expected revenue of approximately $195
million.
The Company expects sustainable profitability beginning in the
second quarter of 2020. Also, the Company continues to project
annualized operating expenses, excluding cost of goods sold, of
between $65 million and $75 million will be achieved by the fourth
quarter of 2020.
Table 1. 2020 Financial Guidance
|
Guidance
Range
|
Net
Revenue
|
$230 million to $245
million
|
Earnings Per Share
(GAAP)
|
$0.60 to
$0.75
|
The Company plans to report fourth quarter and full year 2019
financial results on February 24,
2020.
About Halozyme
Halozyme Therapeutics is a
biotechnology company focused on novel biological and drug delivery
approaches. Halozyme's proprietary enzyme rHuPH20 is used to
facilitate the delivery of injected drugs and fluids and
potentially reduce the treatment burden of other drugs to patients.
Halozyme has licensed its rHuPH20 technology, called ENHANZE®, 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 presentation include
forward-looking statements including, without limitation,
statements concerning the Company's expected future financial
performance 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 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, 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 most recently filed Annual Report on Form 10-K and
Quarterly Reports on Form 10-Q filed with the Securities and
Exchange Commission.
Contact:
Al Kildani
Vice President, Investor Relations and Corporate Communications
858-704-8122
ir@halozyme.com
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SOURCE Halozyme Therapeutics, Inc.