Halozyme Therapeutics, Inc.
) reported a fourth quarter loss of 19 cents per share, much
wider than the year-ago loss of 4 cents per share and the Zacks
Consensus Estimate of a loss of 17 cents per share. Lower
revenues and higher costs led to the year-over-year increase in
Fourth quarter revenues were $12.5 million, down 42.6% from
the year-ago quarter. Revenues lagged the Zacks Consensus
Estimate of $16 million.
In 2013, the company reported a loss of 74 cents per share,
wider than the year-ago loss of 48 cents per share and the Zacks
Consensus Estimate of a loss of 72 cents per share.
Revenues increased 29.5% to $54.8 million in 2013. Revenues,
however, lagged the Zacks Consensus Estimate of $57 million.
Hylenex generated net sales of $4.0 million in the reported
quarter (including a one-time adjustment of $1.1 million).
R&D expenses increased 12.7% year over year to $20.9
million. This increase was primarily driven by increase in
clinical studies, partially offset by lower manufacturing
SG&A expenses increased 34.1% year over year to $9.4
million. The increase was primarily attributable to increased
Halozyme has a number of partnered programs. Halozyme's
Baxter International Inc.
) submitted an amended biologics license application (BLA) for
HyQvia and pre-clinical data (for the treatment of primary
immunodeficiency (PI)) in response to the Complete Response
Letter (CRL) issued by the U.S. Food and Drug Administration
(FDA) in 2012. Halozyme expects the FDA to give a response in six
) MabThera SC (subcutaneous formulation of MabThera), developed
using Halozyme's rHuPH20, received a positive opinion from the
European Committee for Medicinal Products for Human Use (CHMP) in
Jan 2014 for the treatment of non-Hodgkin's lymphoma (NHL). A
final response regarding approval should be out shortly.
Meanwhile, the company is enrolling patients for its phase II
study on PEGPH20 for pancreatic cancer. The primary endpoint of
this study is progression-free-survival. Patient enrolment is
expected to be completed in the second half of 2014. Halozyme
intends to start another study on PEGPH20 in late 2014 in a solid
Top-line results from two studies should be out later this
quarter − the CONSISTENT 1 study evaluating Hylenex recombinant
as an adjunct in the treatment of type I diabetes patients
using insulin pumps and from a phase I/II proof-of-concept study
on HTI-501 for the treatment of cellulite.
Additionally, Halozyme said that it is in discussions with the
FDA regarding a label update for Hylenex so as to include
important safety and efficacy data.
Halozyme expects net cash burn in the range of $45 million -
$55 million in 2014.
Halozyme carries a Zacks Rank #2 (Buy). A better-ranked stock
in the biopharmaceutical sector is
Biogen Idec Inc.
) carrying a Zacks Rank #1 (Strong Buy).
BAXTER INTL (BAX): Free Stock Analysis Report
BIOGEN IDEC INC (BIIB): Free Stock Analysis
HALOZYME THERA (HALO): Free Stock Analysis
ROCHE HLDG LTD (RHHBY): Free Stock Analysis
To read this article on Zacks.com click here.