Momenta Pharmaceuticals (MNTA - Free Report) reported mixed results for fourth-quarter 2019, as the company reported a wider loss on higher expenses, while sales beat estimates.
The company reported a loss of 85 cents per share in the quarter, much wider than the Zacks Consensus Estimate of a loss of 57 cents and the year-ago quarter’s loss of 10 cents.
Revenues in the quarter came in at $8.1 million, significantly down from the year-ago quarter’s $42.8 million. The figure, however, beat the Zacks Consensus Estimate of $5 million.
Quarter in Detail
Momenta’s top line comprises product revenues of $7.9 million from Sandoz’s sales of Glatopa, a generic version of Teva’s (TEVA - Free Report) Copaxone (20 mg), which decreased from $10.8 million in the year-ago quarter due to rising competition from Mylan’s (MYL - Free Report) entry into the Copaxone market.
Research and development revenues came in at $0.3 million compared with the year-ago quarter’s $32 million.
Research and development expenses came in at $38.3 million, flaring up from the $28.7 million incurred in the year-ago quarter, due to a rise in manufacturing and clinical trial costs for nipocalimab and M254.
General and administrative expenses more than doubled to $58.9 million due to a $35-million expense related to a settlement agreement with Nashville General Hospital related to Enoxaparin Sodium Injection.
Momenta’s novel auto-immune portfolio includes M230, a Selective Immunomodulator of Fc receptors (SIF3); Nipocalimab (M281), an anti-FcRn monoclonal antibody; and M254, a hypersialylated immunoglobulin designed as a high potency alternative for intravenous immunoglobulin (IVIg).
This January, Momenta announced interim results, featuring early favorable responses to M254. Based on these data, Momenta is expanding Part B to include at least one additional lower dose cohort and augment the number of patients in existing cohorts. Enrollment for the study is ongoing.
The company also plans to launch a phase II study of M254 in chronic inflammatory demyelinating polyneuropathy (CIDP) in the fourth quarter this year.
Target enrollment has been achieved in Vivacity-MG, the phase II study of nipocalimab in generalized myasthenia gravis (gMG). Momenta expects to report top-line data in the third quarter of 2020.
Unity, the phase II study of nipocalimab in hemolytic disease of the fetus and newborn (HDFN), is enrolling patients. Top-line data is expected in 2021.
Energy Study, the phase II/III clinical study of nipocalimab in warm autoimmune hemolytic anemia (wAIHA) is enrolling patients.
In January 2020, Momenta nominated M267, a SIFbody candidate targeting CD38, for clinical development.
Meanwhile, M710, which is a proposed biosimilar to Regeneron’s (REGN - Free Report) Eylea, is being developed in collaboration with Mylan, which is conducting its study in patients with diabetic macular edema to compare safety, efficacy and immunogenicity of M710 with Eylea. Mylan expects to target U.S. submission in 2021.
Momenta’s business has been adversely impacted by competition. Consequently, Momenta has decided to focus on the discovery and development of novel drugs to treat rare, immune-mediated disorders. We expect investors to focus on further updates from the drug candidates in development as the year progress.
Momenta’s stock has gained 55.7% in the year so far, as against the industry’s decline of 1.%.
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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