- Here are my notes from the Momenta Pharma $MNTA webcast at the Bank of American Merrill Lynch Healthcare conference on 5/10/2011:
- This event format involved only a brief overview of company, mirrored recent comments at 1q2011 conference call
- NVS/MNTA is supply constrained, can't ship more units that did in 1q11, but sales will fluctuate q to q
- Copaxone (M356) has been under FDA review for about 2.5 yrs already. Confortable that they have the necessary info in the package for approval as interchangeable generic
- FDA "analytics important in review for FOB"..degree of knowledge/characterization will dictate how much preclinical and clinical work needed
- MNTA has two novel heparin based products
- M402 file IND and enter clinic in 2011 (this phrasing could be a slight slip on IND timeline)
- q&a session:
- Lovenox market is split hospital (70%) and retail (30%). Generic takes 80% of retail market, smaller share in hospital to get to 45-50% total. Retail is heavier on high dose form (higher unit selling price and higher margin)...so NVS/Sandoz/MNTA dollar share of mkt higher than unit share...came into mkt w/ modest discount, SNY responded w/ light discounting...mkt is pretty stable where it is...
- Won't be signing more customers because of supply constaint
- Question: In FDA response to SNY CP, they said "a sponsor" had sufficient tech to characerize lovenox. shoiuld we read into status of teva product? MNTA speaker didn't take the bait.
- Teva entry would cause price decline and could trigger SNY authorized generic launch. analyst report from $75m per qtr to royalty of $10-20m per qtr
- Lawsuit filed against teva would help prevent this potential transition as well
- Would be complicated to add capacity. Risk that it would take them offline for a time
- Any theoretical settlement discusson w/ teva would have to involve both NVS and MNTA
- no significant recent changes in margin on lovenox. Added some hosptial accts recently, would cause slight decrease in margins due to product mix differences
- $50m more milestone possible from NVS, have not disclosed structure/triggers.
- royalty to MIT is based on MNTA revs, so would decrease if 3rd entrant to market
- Characterization of copaxone vs lovenox: which is harder? Some aspects easier, some harder. No need to worry about heparin supply/contamination. Copaxone is made from amino acids- straightforward staring material and chemical manufacturing process. Cutting and recombination polyermization makes copaxone more heterogeneous (10^29 combinations according to teva CP).
- Copaxone litigation includes 7 orange book (OB) patents and 2 non-OB patents. Trial starts 9/7/2011
- Enoxaparin trial- didn't get accelerated process. Maybe because judge didn't think approval was imminent. So got normal schedule leading to trial in 2013. Judge does have access to info about teva ANDA -could accelerate process/injunction if approval immenient
- copaxone- don't beleive FDA will require safety and efficacy studies. For lovenox, MNTA did preclinical immunogeicty studies and small PK/PD study. that sort of study is always possible
- Does MNTA have independent commercial aspirations? That would be very long term. no plans related to any of current products, maybe consider for novel products
- No plans for lovenox trials for EU mkt. Heard recently that EMEA is backing off this requirement. Margins not good for lovenox in the EU. So this would be on a country by country basis (and currently have supply issue anyway)
- Lovenox deal is US and EU only. Copaxone is worldwide deal
- How important is staying profitable long-term, vs investing in near term dilutive oppportunities. Don't think they are in the world of earnings multiples. Have said that teva entry would return MNTA to a cash burning company.
- Copaxone 180 day exclusivity has expired because 30 month period has expired. An exception can be granted anyway at discretion of FDA. "We are counting more on the fact that copaxone is so complex, will have greater than 180 day lead on mylan or any other competitors"