There's potential for a lot to happen for Momenta Pharmaceuticals (MNTA +0.00%) this year, but at this point the biotech is waiting on quite a few outside forces: potential partner(s), the FDA, and the court system.
While that would normally make for a rather boring earnings conference call, there was news on Momenta's fourth quarter call about its collaboration with Baxter (BAX +1.40%). As part of the 2011 partnership, Baxter had the option of licensing up to six biosimilar drugs, but following a decision to reorganize and focus on late-stage drugs, Baxter let the option expire and returned rights to its second pick, M834, to Momenta.
Losing a partner is a big deal, but this definitely appears to be one of those it's-not-you-it's-me kind of breakups. Baxter isn't even saying that biosimilars are a bad investment since the company is still retaining rights to the first biosimilar selected as part of the partnership, M923, a knockoff of AbbVie's (ABBV 0.60%) Humira. Baxter is running a 300 person clinical trial comparing M923 to the branded version, which should read out in the fourth quarter, putting it on track for regulatory approval in 2017.
Now that Momenta has regained rights to M834, which the biotech disclosed is a biosimilar version of Bristol-Myers Squibb's (BMY 0.40%) Orencia, it's free to license the drug to another company. Hopefully that'll happen before the drug moves into the clinic next year, as the clinical trials aren't cheap. Momenta has six more biosimilars further behind in development, which the company can package with M834 if it wants to do a deal with a similar structure to the one with Baxter.
While the biosimilar program is years away from generating income, Momenta could get revenue from its generic version of Teva Pharmaceuticals' (TEVA 0.01%) Copaxone this year. Momenta and partner Novartis (NVS +1.77%) are still waiting on an approval from the FDA for the generic.
If the approval comes in before September 1, Novartis will have to decide whether it wants to make an at-risk launch, as Teva has one patent that doesn't expire until then. A Court of Appeals for the Federal Circuit found the patent invalid, but last month the Supreme Court sent the case back to the appeals court. It appears unlikely -- although not impossible -- that the appeals court will make a decision before the patent expires on September 1.
Momenta and Novartis are also waiting on the court system to make a decision in their patent lawsuit against Amphastar and Teva, which launched a generic version of Sanofi's (SNY +1.13%) Lovenox to compete with Momenta and Novartis' copycat. Momenta claims that their manufacturing method infringes on one of Momenta's patents. If the court agrees -- the next decision could come this year -- Momenta and Novartis could eventually be awarded damages.
The award -- or potentially a settlement -- could mean hundreds of millions for Momenta. The company received just $4.7 million off sales of the drug in the fourth quarter, compared to the more than $80 million per quarter it was getting back in 2011 before Amphastar and Teva launched their competing generic.
With all this waiting and uncertain timing, Momenta has to be careful with its cash situation. The company ended last year with $191.5 million, including $18.3 million that it raised by selling stock through an "at the market" program. With a $30 million burn expected for the first quarter, the company has a year and half of cash, but has the option to extend that runway by selling more shares through its at the market program or by licensing the drugs in its pipeline, which could bring in upfront cash and/or lower expenses that would be picked up by the partner.
