Momenta Pharmaceuticals, Inc. Continues Its Wait for Higher Sales

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Momenta Pharmaceuticals (MNTA) released third-quarter earnings on Wednesday. The drug company is producing solid sales for what it has to work with, but next year and beyond offer larger opportunities for investors to look forward to.

Momenta Pharmaceuticals' results: The raw numbers

YOY = year over year. Data source: Company press release.

What happened with Momenta Pharmaceuticals this quarter?

• Momenta recorded $23.3 million in product revenues from its partner Novartis' (NVS -0.55%) sale of Glatopa, their generic version of Teva Pharmaceuticals' (TEVA -3.04%) once-daily multiple sclerosis drug Copaxone. That's an increase of over $2 million compared to the second quarter, and Novartis estimates it's taken 40% of the once-daily market from Teva Pharmaceuticals.
• Of course, that once-daily market has shrunk as Teva has moved patients on to its higher dose three-times weekly version that 78% of Copaxone patients now take. A patent lawsuit over the three-times weekly version of Copaxone was completed in October; Momenta and Novartis expect a decision to be issued in the first quarter of next year.
• In September, Momenta regained the rights to M923, its biosimilar of Humira from Shire, who got it through its acquisition of Baxalta. Under the terms of the collaboration, Shire is required to pay for the program for an additional year, at which point it will be handed back to Momenta. Top-line data for the phase 3 trial is expected later this year, putting it on track to submit a marketing application in the middle of next year.
• Momenta and its biosimilar partner, Mylan (MYL), announced the initiation of a phase 1 trial for their lead candidate, M834, a biosimilar version of the rheumatoid arthritis drug Orencia, which earned Momenta a $25 million milestone payment.

What management had to say

Craig Wheeler, Momenta's president and CEO, talked a little bit about the potential to license out M923 again, but hinted that investors shouldn't expect a deal anytime soon. "We will be evaluating all of our options for this program in the coming months, including potentially securing a new commercial partner. We have received multiple inquiries about the program, but our top priority right now is to work closely with Baxalta to ensure a smooth transition of all the ongoing work streams in order to keep the M923 program on track," he said.

Recently, Teva sent a letter to the Food and Drug Administration recommending that the agency take a closer look at the analytic tests used to compare complex generics to the branded product, but Wheeler didn't sound worried. According to him, "I would have to put that in the category of absolutely no surprise to me. They have been very good and very consistent at putting new things in front of the agency and in front of anybody who will listen since we started this program probably 10 years ago."

Looking forward

Momenta looks like it can grow substantially in the coming years with the three-times weekly version of Copaxone hopefully launching in the beginning of next year, assuming Momenta gains FDA approval and the patent lawsuit goes its way.

Beyond next year, the biosimilar program is progressing with potential sales of M923 in 2018 and M834 in 2020.