Shares of Momenta Pharmaceuticals Inc. (MNTA - Free Report) gained 8.6% after the company reported better-than-expected results for the fourth quarter.
The company reported loss per share of 7 cents in the quarter (excluding restructuring charges), narrower than the Zacks Consensus Estimate of 46 cents and the year-ago loss of 18 cents.
Revenues in the quarter came in at $42.8 million, which declined from $64.6 million in the year-ago quarter but beat the Zacks Consensus Estimate of $21.1 million.
Quarter in Detail
Momenta’s top line comprises product revenues of $10.8 million earned from Sandoz’s sales of Glatopa, a generic version of Copaxone (20 mg), compared with $13.4 million in the year-ago quarter due to increasing competition from Mylan’s (MYL - Free Report) entry into the Copaxone market.
Research and development revenues came in at $32.1 million compared with $51.2 million in the year-ago quarter.
Research and development expenses decreased to $28.7 million from $36.1 million in the year-ago quarter, due to decrease in spending on biosimilars program. As a result of its strategic review (results announced in October 2018), Momenta concluded to advance two late-stage biosimilar assets — M923, which is its wholly-owned proposed biosimilar to AbbVie’s (ABBV - Free Report) Humira, and M710, which is a proposed biosimilar to Regeneron’s Eylea being developed in collaboration with Mylan. The company decided to exit participation in the development of its five other biosimilar programs, including M834, a proposed biosimilar to Orencia.
General and administrative expenses were $21.5 million, up 36.1% year over year due to increased legal costs and depreciation.
Momenta entered into a settlement agreement with AbbVie in November 2018, providing worldwide rights to launch M923. Under the terms of the agreements and subject to approval by health regulatory authorities, Momenta may launch M923 worldwide based on agreed-to launch dates, including in the United States in November 2023. In August 2018, Mylan initiated a clinical trial in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with Eylea.
Momenta’s novel auto-immune portfolio includes M230, a Selective Immunomodulator of Fc receptors (SIF3); M281, an anti-FcRn monoclonal antibody; and M254.
Momenta initiated two phase II proof of concept clinical trials on M281, one in generalized myasthenia gravis (gMG) and the other in hemolytic disease of the fetus and newborn (HDFN), with top-line results anticipated in 2020 and 2021, respectively. Momenta also plans to initiate a third study of M281 in an additional autoimmune indication in 2019.
In January 2019, Momenta announced that the first subject was dosed in the phase I/II clinical trial of M254 in immune thrombocytopenia (ITP). The multi-part study will first enroll healthy volunteers, and includes single and multiple dose studies, and a randomized cross-over study comparing M254 to IVIg. Preliminary clinical data is expected in 2020.
The phase I trial on M230 in healthy volunteers to evaluate the safety and tolerability is ongoing. Momenta’s partner, CSL expects to complete the phase I study by the end of 2019.
Momenta generated revenues of $75.6 million in 2018, significantly down from $138.8 million in 2017.
Momenta expects 2019 expenses to be $45-$55 million. The company completed a $230-million equity financing in December and ended the year with a cash balance of $449 million.
Momenta’s fourth-quarter results were better than expected. Last year was a transformational year for Momenta as it undertook a strategic review with the goal to transform the company from its dual focus on novel drugs in biosimilars to a company primarily focused on the discovery and development of novel drugs to treat rare, immune-mediated disorders. The company has narrowed its focus on its biosimilars portfolio.
Earlier, the FDA approval of Glatopa 40 mg relieved Momenta, but competition was stiff as Mylan had already won the FDA’s approval for a generic version of Teva Pharmaceuticals’ (TEVA - Free Report) Copaxone 40 mg, thereby limiting gains.
Hence, Momenta is now focussing on its novel drugs portfolio. We expect investors to focus on further updates from the drug candidates in development as the year progress.
Momenta currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
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