Halozyme Therapeutics, Inc.
) reported second quarter 2013 loss of 20 cents per share, much
wider than the Zacks Consensus Estimate of a loss of 14 cents per
share and the year-ago loss of 13 cents per share. The wider loss
was due to higher operating expenses.
The company's net product revenue for the second quarter of 2013
shot up 86.3% to $14.5 million. Revenues were boosted by research
and development (R&D) reimbursements from partners. The Zacks
Consensus Estimate stood at $12 million for the second quarter of
In the second quarter of 2013, R&D expenses were $28 million,
up 74.1% year over year. R&D expenses were driven by costs
associated with product launches and clinical trials. Selling,
general and administrative expenses increased 30.8% to $7.3
million, reflecting an increase in commercial activities.
Halozyme made significant progress with respect to its pipeline
in the second quarter of 2013. Halozyme's partner,
Baxter International Inc.
) received approval from the European Commission for HyQvia as
replacement therapy for adults suffering from primary and
secondary immunodeficiencies. HyQvia was launched the EU in Jul
2013, which triggered a $4 million milestone payment to Halozyme.
In Jun 2013, the Committee for Medicinal Products for Human Use
granted Halozyme's partner,
) a positive opinion on the subcutaneous (SC) formulation of
Herceptin. Roche is looking for Herceptin's label expansion and
get the drug approved for treating patients suffering from human
epidermal growth factor receptor 2 (HER2)-positive breast cancer
in the EU. Roche expects to launch the drug in the EU and the
U.S. by the end of this year, subject to regulatory approval.
Apart from Herceptin SC, another drug, MabThera SC, developed in
collaboration with Roche is under regulatory review in the EU.
However, Halozyme received a major setback when partner
) announced that it is discontinuing its phase II study on a SC
version of Cinryze in combination with rHuPH20. The study was
discontinued as a number of patients developed non-neutralizing
Halozyme carries a Zacks Rank #2 (Buy).
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