ViroPharma Posts Q2 Profit; To Discontinue Phase 2 Study Of Subcutaneous Cinryze

(RTTNews) - ViroPharma Inc. (VPHM) reported that its second-quarter of 2013 GAAP net income was $0.6 million compared to a GAAP net loss of $6 million in the second quarter of 2012. GAAP earnings per share was $0.01 compared to GAAP loss per share of $0.08 last year.

Non-GAAP adjusted net income for the quarter was $11 million, compared to $5 million for the same period in 2012. Non-GAAP adjusted net earnings per share was $0.15 for the second quarter of 2013 compared to $0.07 for the same period in 2012.

Net sales for the second quarter were $104 million up from $95 million in the comparative period of 2012. The increase in net sales quarter over quarter was driven by the commercial product growth of both Cinryze in the U.S. and higher European product sales.

Analysts polled by Thomson Reuters expected the company to report earnings of $0.01 per share and revenues of $105.06 million for the quarter. Analysts' estimates typically exclude special items.

For the year 2013, the company reiterated Worldwide net product sales, North American Cinryze sales guidance. Worldwide net product sales are expected to be $440 to $465 million. Net North American Cinryze sales are expected to be $390 to $400 million; and Research and development (R&D) and selling, general and administrative (SG&A) expenses are expected to be $240 to $260 million.

In a separate press release, ViroPharma announced that,following discussion with the Center for Biologics Evaluation and Research or CBER division of the U.S. Food and Drug Administration, the company is going to discontinue this Phase 2 study, which evaluates Subcutaneous Cinryze (C1 Esterase Inhibitor [Human]) With Recombinant Human Hyaluronidase or rHuPH20.

The discontinuation of the study is a precaution related to the emergence of an unexpected incidence and titer of non-neutralizing anti-rHuPH20 antibodies in a number of patients with the formulation being used in this study. These antibodies have not been associated with any adverse clinical effects and are of unknown clinical significance, the company said.

The study was fully enrolled and 41 patients completed at least one dosing arm of study drug with a total of 20 patients having completed both dosing arms. These data will be informative for design of future subcutaneous administration studies.

In parallel with the conduct of this Phase 2 study, the company has developed an optimized, low-volume subcutaneous formulation of Cinryze. As a result, the company said it expects to conduct a Phase 3 subcutaneous registration study with this alternative formulation in the same time frame that had been anticipated previously for the combination product.