Halozyme Therapeutics, Inc.
) shares gained 3.39% following the announcement of the second
quarter 2014 results. Shares have declined marginally since
The company's second quarter 2014 loss came in at 13 cents per
share, narrower than the year-ago loss of 20 cents per share and
the Zacks Consensus Estimate of a loss of 18 cents per share.
Halozyme Therapeutics, Inc - Earnings Surprise
Second quarter revenues increased 27.2% to $18.4 million,
surpassing the Zacks Consensus Estimate of $14.2 million.
The Quarter in Detail
The company generated revenues of $6 million and $3 million from
the sale of rHuPH20 and Hylenex, respectively. The company earned
$1.7 million from royalties and $7.2 million from
R&D expenses decreased 33.4% to $18.6 million. This decrease
was primarily driven by lower manufacturing costs.
SG&A expenses increased 19.9% to $8.8 million. This increase
was essentially due to higher compensation costs and patent
Halozyme announced that the FDA has removed the clinical hold
from a phase II study (Study 202) evaluating PEGPH20 as a
first-line therapy in patients suffering from stage IV metastatic
pancreatic cancer. Following the removal of the clinical hold, the
company has resumed patient enrollment and dosing of PEGPH20.
Halozyme has a number of partnered programs. The subcutaneous
formulation of Roche's (
) MabThera developed using Halozyme's rHuPH20 for the treatment of
common forms of non-Hodgkin's lymphoma (NHL), which includes
follicular lymphoma and diffuse large B cell lymphoma was launched
in the EU. The launch triggered a milestone payment of $5 million
Apart from Roche, Halozyme also has an agreement with Baxter
International Inc. (
). Halozyme announced that Baxter's HyQvia (for the treatment of
primary immunodeficiency) received a positive recommendation from
the Blood Products Advisory Committee (BPAC) of the FDA.
Based on the pre-clinical and clinical data, the Advisory
Committee voted (15 to 1) that HyQvia has a favourable risk-benefit
profile. HyQvia is a combination of immunoglobin and rHuPH20.
The FDA will examine the recommendation from the BPAC in its
review of Baxter's amendment to the Biologics License Application
(BLA) submitted in Dec 2013. The company expects the FDA to come up
with its response by Sep 30, 2014.
Additionally, Halozyme is in discussion with the FDA regarding a
label update for Hylenex.
We expect investor focus to remain on pipeline updates.
Halozyme carries a Zacks Rank #2 (Buy). A better-ranked stock in
the health care sector is Actelion Ltd. (
) carrying a Zacks Rank #1 (Strong Buy).
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