UCBJF UCB NPV (PK)

Momenta Pharmaceuticals Inc. (MNTA) reported first quarter 2013 net loss per share of 48 cents, wider than the Zacks Consensus Estimate of a loss of 43 cents and the year-ago loss of 10 cents.

First quarter revenues of $7.6 million were down 218.4% year over year. Revenues missed the Zacks Consensus Estimate of $9 million. The downtrend was due to competitive pressure resulting from the entry of other generic versions of Sanofi’s (SNY) Lovenox.

We note that Momenta and Sandoz had inked a deal in Nov 2003 to jointly develop and commercialize a generic version of Lovenox. Following the launch of a competitor’s generic version of Lovenox in Jan 2012, there was a change in the basis of revenue that Momenta received from Sandoz. The change was from a hybrid profit share to a straight royalty structure.

Sandoz reported first quarter 2013 generic Lovenox net sales of $47 million, down 73.3% year over year. Sales were hit by the loss of exclusivity on generic Lovenox.

Research and development expenses were $22.3 million, compared with $18.6 million in the year-ago quarter. The increase was attributable to Momenta’s efforts to develop its pipeline. General and administrative expenses declined to $9.7 million from $11 million in the year-ago quarter mainly due to lower legal fees.

2013 Guidance 

Momenta confirmed its 2013 guidance with total operating expenses, excluding stock-based compensation and net of collaborative revenues, expected to be about $30 million per quarter. Momenta expects average net cash usage in the range of $20 million to $24 million per quarter for a total operating cash usage of roughly $80 million to $90 million.

Pipeline

Apart from reporting first quarter earnings, Momenta provided an update on its pipeline. Momenta stated that the abbreviated new drug application (ANDA) for M356, its generic version of Teva Pharmaceutical Industries Ltd.’s (TEVA) Copaxone, is under active review by the US Food and Drug Administration (FDA). An appellate decision in the patent infringement lawsuit initiated by Teva is expected in the second half of 2013.

Three biosimilar products are currently under development, namely, M923 and M834 for the treatment of autoimmune and other inflammatory indications, and M511 for the treatment of cancers. Momenta intends to submit an Investigational New Drug (IND) application for M923 in 2014. In addition, Momenta is working towards the achievement of development criteria for milestone payments in 2014 for M511 and M834.

Momenta's first quarter results were disappointing with shares declining 6.9%. Momenta carries a Zacks Rank #3 (Hold). Right now, UCB (UCBJF) looks attractive with a Zacks Rank #1 (Strong Buy).

 
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