Morningstar | Momenta Reports Solid Novel Drug Progress During Fiscal 2018 Update
Momenta reported solid progress on its novel drug programs during its fiscal 2018 fourth-quarter update. We may adjust our fair value estimate as we incorporate new assumptions, and we are leaving our no-moat rating intact. While we still think Momenta's focus on novel drug candidates holds promise, we continue to view the area as largely unproven territory for the company. Separately, the company reported a year-end cash balance of roughly $449 million, thanks in part to its $230 million equity financing in December. Although management does not expect any further capital dilution before 2020, we would not be surprised to see the company again turn to the equity capital markets if needed.Momenta's M281 FcRN program continues to move through various studies, with several indication targets. The company's phase 2 trial in generalized myasthenia gravis is currently enrolling patients. Additionally, Momenta has begun its first fetal-maternal trial and plans to enroll approximately 15 patients, in order to target hemolytic disease of the fetus and newborn. The company intends to add a third M281 trial during the second half of 2019 to an additional specialty disease area. Lastly, despite Momenta's efforts to explore M281's gene therapy applications, we are skeptical that gene therapy will become a significant focus for the company.
There were no major updates regarding the company's biosimilar and complex generics activities. Momenta continues to hold discussions with potential partners for its M923 biosimilar Humira, but we still think biosimilar competition for the drug will prove to be a formidable challenge by the time of its November 2023 U.S. launch date. Separately, Momenta's Glatopa product revenue fell roughly 18% versus the year-ago period, primarily due to continued competitive pressure. We expect this trend to persist as the company continues its shift away from the complex generic category.
Momenta Pharmaceuticals is a biotechnology company focused on the discovery and development of biologic therapies for the treatment of rare immune-mediated diseases. The company's programs include: M281, which is a fully-human anti-neonatal Fc receptor (FcRn), aglycosylated immunoglobulin G (IgG1), monoclonal antibody, designed to reduce circulating human immunoglobulin G (IgG) antibodies by completely blocking endogenous IgG recycling via FcRn; M230, which is a recombinant trivalent human IgG1 Fc multimer; and M254, which is a hyper-sialylated immunoglobulin designed as a high potency alternative to IVIg, a therapeutic drug product that contains pooled, IgG antibodies purified from blood plasma.
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