Momenta Pharmaceuticals (NASDAQ: MNTA) continued to tread water in the second quarter, waiting for approval by the U.S. Food and Drug Administration of its copycat of the three-times weekly version of Copaxone, Teva Pharmaceutical's (NYSE: TEVA) drug for multiple sclerosis. Fortunately the biotech ended the quarter with $457 million in the bank, giving it plenty of time to become cash flow positive.
Momenta Pharmaceuticals results: The raw numbers
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What happened with Momenta Pharmaceuticals this quarter?
- Revenue from Novartis (NYSE: NVS) for sales of Glatopa, a daily version of Copaxone, were down slightly to $19.1 million this year, compared to $20.7 million in the year-ago quarter. Some of the decline, however, came from $0.6 million that Momenta had to reimburse to Novartis for legal expenses. The drug has 40% of the market for the daily version of Copaxone, but the larger opportunity is in the three-times-weekly version.
- The rest of the decline in revenue came from the collaboration with Baxalta, which ended at the end of last year.
- After the quarter closed, on July 1, Momenta got a $10 million milestone payment from Novartis, for having Glatopa on the market for a second year as the only FDA-approved generic version of Copaxone.
- Later in July, a jury ruled that Amphastar's generic version of Lovenox infringed on Momenta's patents covering the method for manufacturing the drug, but ruled Momenta's patents invalid and unenforceable. Momenta is considering appealing the decision.
- Momenta and Novartis continue to wait for FDA approval of the three-times-weekly version of Glatopa. They disclosed earlier this year that Novartis' contractor responsible for filling the syringes with the drug got a warning letter from the FDA, which will likely have to be resolved before the drug can be approved. Momenta thinks it's possible that an approval from the FDA could come this year.
What management had to say
While Momenta is hopeful that the FDA warning letter can be resolved, president and CEO Craig Wheeler said the company is also working on a backup plan with Sandoz, Novartis' generic-drug unit:
Nearly a year ago Shire, which bought Baxalta, backed out of the deal for M923, a biosimilar of Humira. Momenta is still looking for a partner for the drug, but Wheeler hinted that talks are progressing well:
While investors are naturally focused on the potential near-term approval of the three-times-weekly version of Glatopa, Momenta has plenty of other irons in the fire:
- The company plans to submit its marketing application for M923 in the fourth quarter, although a launch isn't expected until 2020, as it waits for patents on Humira to expire or be invalidated.
- Top-line data for a phase 1 trial testing Momenta's second biosimilar, M834, a copycat of Orencia, is expected in the second half of this year. Because it's a biosimilar, Momenta and partner Mylan should be able to advance straight to phase 3 development.
- One of Momenta's novel compounds, M281, which targets the neonatal Fc receptor, will read out phase 1 data in healthy volunteers in the second half of this year. If a safe dose is found, the company can move on to testing the drug in patients with autoantibody-driven diseases.
- Another novel drug, M230, which is partnered with CSL, should enter the clinic this year.
Momenta might not have much momentum at the moment, but there's potential for things to accelerate rather quickly.
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