Momenta Pharmaceuticals (NASDAQ: MNTA) reported fourth-quarter earnings on Tuesday, but analysts weren't discussing the numbers. Instead, most of their questions focused on the company's disclosure on Friday that the three-times-weekly version of Glatopa wouldn't likely be approved this quarter.
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Momenta Pharmaceuticals results: The raw numbers
Data source: Momenta Pharmaceuticals.
Image source: Getty Images.
What happened with Momenta Pharmaceuticals this quarter?
- Revenue was up only because of an increase in research and development revenue from its partners. Product revenue was down year over year due to Momenta's $3.6 million reimbursement to partner Novartis (NYSE: NVS) for its share of legal expenses.
- Investors shouldn't get too excited about the profit this quarter -- it was entirely due to the termination of the agreement with Shireto market M923, Momenta's biosimilar of Humira, which accelerated the booking of the income from the deal.
- In November, the company announced positive results from a phase 3 trial testing M923 in patients with moderate-to-severe plaque psoriasis.
- Momenta and partner Mylan (NASDAQ: MYL) started a phase 1 trial for M834, their biosimilar of Orencia, which should read out in the second half of this year.
- In January, the company announced an agreement with CSL for the development of M230 and the other next-generation Fc multimer programs.
- Momenta ended the year with $353 million in the bank, but that doesn't include payments from Shire and CSL, which will be booked in the current quarter.
What management had to say
Craig Wheeler, Momenta's president and CEO, gave an update on the M923 program now that it's back in Momenta's hands: "We have received multiple inquiries about the program from potential collaboration partners, and we are evaluating all of our options, including keeping the program for ourselves in the U.S."
On the potential to switch to a different contract manufacturer for the filling of Glatopa syringes, Wheeler wasn't sure if that would be any faster than waiting for Pfizerto resolve its FDA issues at the McPherson plant, which is likely required for Momenta and Novartis to gain approval of the three-times-weekly version. He said, "It's really hard to speculate how long it will take to transfer to a second site, because it really depends on availability of a second site and being able to move something in. I think at this point in time, we remain pretty confident that we will be able to resolve whatever issues are existing in the McPherson plant."
While waiting for approval and launch of the three-times-weekly version of Glatopa, investors can look forward to the first submission of a marketing application for M923 in the middle of this year and the aforementioned phase 1 data for M834 in the second half of the year.
Beyond M834, the biosimilar partnership with Mylan is progressing with the second drug from the partnership, M710, expected to enter the clinic in late 2017 or early 2018. The companies haven't disclosed what branded drug M710 is a biosimilar of, presumably for competitive reasons, but they'll have to disclose it eventually -- and certainly before the first clinical trial begins.
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