Morningstar | Momenta's Earnings Should Improve on Eventual Product Launches
Momenta uses proprietary methods to characterize the unique structural attributes and manufacturing requirements of complex drugs. The company has primarily shifted its focus toward early-stage novel products after having previously focused on characterizing complex generics and biosimilar drugs. We think the company's demonstrated expertise in complex molecules makes it a viable industry player and possible takeover target.Complex molecules face higher development, manufacturing, and regulatory hurdles, which reduces competition and pricing pressure typically seen in generic drug markets. Momenta currently only has two approved products. Its first product approved in July 2010 was a generic version of Sanofi’s Lovenox, which it launched through a partnership with Novartis. Until Amphastar (through a partnership with Actavis) and other generic Lovenox contenders entered the market, Momenta and Sandoz recorded more than $1 billion in generic Lovenox sales with an approximate 60% operating margin during its first year as the only approved generic version on the market at the time. Also partnered with Sandoz, Momenta received another U.S. Food and Drug Administration approval in early 2015 for its generic version of Teva's Copaxone, a multiple sclerosis injectable with nearly $4 billion in global sales, and launched the product in June 2015. However, Teva's conversion of Copaxone patients to a newer and less frequently injected formulation reduced Momenta's market share gains. Momenta's launch on this new formulation in early 2018 took longer than we originally expected, and allowed Mylan to enter the market with its own version of this difficult-to-manufacture drug.Management also has partnerships with Mylan for biosimilar Eylea. We view the Mylan partnership as a positive, but Mylan's lack of biologic manufacturing and clinical marketing capabilities may stall their market penetration. Momenta does not currently have a partner for its biosimilar Humira, which has completed clinical trials and is secured for a November 2023 launch date.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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