Momenta Pharmaceuticals (NASDAQ:MNTA) missed being profitable by just $2.2 million in the second quarter. Not bad for having launched Glatopa, its generic version of Teva Pharmaceuticals' Copaxone, on June 18, just 12 days before the end of the quarter.
Of course, the $20 million milestone payment from partner Novartis for getting Glatopa approved and launched certainly helped, as did the $19 million Momenta booked on revenue from Glatopa sales. Some of the sales came from socking, but management wasn't willing to break it out for investors on the conference call.
The $19 million is pure profit as it's Momenta's portion of the 50/50 profit-sharing agreement with Novartis. Momenta's share was actually $28 million, but the biotech had to repay $9 million in pre-launch legal expenses to Novartis.
Sales of enoxaparin, Momenta's generic version of Sanofi's Lovenox, were headed in the other direction after the launch of an generic by Teva in the first quarter. The additional competition resulted in even lower prices and volume. Combine that with a switch from royalties to a 50% profit share with Novartis and revenue from enoxaparin dropped to just $0.1 million from $5.7 million in the year-ago quarter.
There's potential for sales of enoxaparin to rebound if Momenta and Novartis can successfully appeal a lower court's decision that Momenta's patents on manufacturing enoxaparin aren't enforceable under Hatch Waxman's "safe harbor." The trial was in May and last month the U.S. solicitor general filed a brief that supported Momenta's interpretation of the "safe harbor" provision. A decision from the appellate court is expected this year.
More products coming
Glatopa is the daily version of Copaxone, but Momenta also has a copycat of the higher-strength version of Copaxone that can be dosed three times per week. If the patents on that version are invalidated, Momenta and Novartis could launch in 2017 if its generic version is approved by the FDA, which seems likely since it's the same drug substance as Glatopa.
On the biosimilar front, Momenta is expecting data for its first biosimilar, a copycat of AbbVie's Humira, in the fourth quarter and expects to start a larger patient study this year. If all goes well, Momenta and partner Baxalta will be able to gain approval in 2017 and launch in 2018.
Next in line is M834, a biosimilar of Bristol-Myers Squibb's Orencia, which Momenta expects to advance into the clinic next year with a potential launch in 2019 if patents can be invalidated.
With seven more biosimilars behind M834, management said it's looking to establish a broad collaboration deal this year. It might be difficult to license all seven un-partnered programs to one company since there's likely to be some overlap with potential partners' internal programs, but it might be possible to break it up into a couple of partnerships. If not, Momenta will seek to partner them individually, although that obviously isn't ideal.
After raising $150 million in a secondary offering in May, Momenta is sitting on a nice nest egg of $377 million, which should help in the negotiations with partners for its biosimilars programs. Just as we've seen with enoxoparin, sales of Glatopa could dry up as quickly as they started if another generic comes on the market, so the cash in the bank shows potential partners that Momenta can carry its share of the cost of development.
The cash can also be used to pay for its internal branded drugs, including necuparanib, which is in a phase 2 trial in pancreatic cancer that's scheduled to read out in the first half of 2017. Momenta can get more from a potential partner if it can get drugs through proof-of-concept phase 2 studies before partnering them, but that's obviously only possible if the biotech has cash to spend on clinical trials.