Momenta Pharmaceuticals Inc. MNTA reported first-quarter 2015 loss of 40 cents per share, narrower than the Zacks Consensus Estimate of a loss of 48 cents and the year-ago loss of 53 cents per share.
However, revenues tumbled 20.6% to $8.6 million from the year-ago quarter, missing the Zacks Consensus Estimate of $11 million. Total revenue comprised product revenues ($2.7 million), and research and development revenues ($5.8 million).
The Quarter in Detail
Research and development expenses were $22.7 million, down 14.8% from the year-ago quarter. The decrease was primarily due to the reversal of stock compensation expense associated with performance-based stock awards.
Pipeline Update
Momenta’s three-times-a-week generic version of Teva Pharmaceutical’s TEVA Copaxone is currently under FDA review. The company believes that this formulation can be commercially launched as early as the first quarter of 2017.
Meanwhile, Momenta and partner Sandoz (a Novartis NVS company) informed the Court of Appeals for the Federal Circuit about the FDA approval of Glatopa (generic version of Copaxone 20 mg/mL) and sent a request for an expedited decision regarding the validity of the patents covering Copaxone daily including the one slated to expire on Sep 1, 2015. Momenta expects the Court to issue its decision shortly.
Under collaboration with Baxter International Inc. BAX, Momenta started a randomized, double-blind, single-dose study in healthy volunteers to compare the pharmacokinetics, safety, tolerability and immunogenicity of the biosimilar version of Humira (M923) with Humira. Data should be out by the fourth quarter of 2015 and the first regulatory submission for the candidate is expected in 2017.
Additionally, Momenta is enrolling patients in a phase II study to evaluate the anti-tumor activity of necuparanib in combination with Abraxane and Gemzar, versus Abraxane/gemcitabine combination. Data from this study should be out by the end of 2016 or in the first half of 2017.
2015 Guidance
Momenta expects its net cash usage (excluding revenues from the approval and potential launch of Glatopa as well as revenues from any potential new collaboration) in the range of $28 million – $32 million per quarter for the rest of 2015. However, the projected cash burn for the second quarter will be offset by a $10 million milestone payment received for the approval of Glatopa under its collaboration with Sandoz.
Momenta added that it will earn an additional $10 million milestone from Sandoz when Glatopa is launched. Additionally, the company expects revenues from Enoxaparin sales to decline further this year under competitive pressure.
Our Take
Momenta carries a Zacks Rank #1 (Strong Buy). The approval of Glatopa is a major positive for Momenta. Being the first and only “AP-rated” substitutable generic version of daily Copaxone 20 mg/mL, Momenta and Sandoz will be able to grab the first opportunity of providing a much-needed and affordable treatment option for multiple sclerosis.
Meanwhile, we are pleased with Momenta’s progress on developing its novel candidate, necuparanib. With fast track status in the U.S., we expect necuparanib’s development process to expedite.
Another well-ranked stock in the health care sector include Horizon Pharma plc HZNP, carrying the same Zacks Rank as Momenta.
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