- MNTA (click for stock research page) presented 10/21 at the BioCentury Newsmakers Conference (find webcast link and complete biotech webcast calendar on Upcoming Events page)
- Continue reading for my extensive notes from the presentation by Rick Shea, Momenta CFO
- Cash balance end of 3q will be over $300m, year-end 2011 vicinity of $350m
- sole generic status changed as of 9/19/2011. WPI announced intention to launch 4q2011 in retail channel...because of the significant change in economics that this triggers, and to seek to protect our investment in the program, we sued Watson and Amphastar
- Shea worded very carefully so didn't for sure say whether contractual change has oocured [Note - it is now clear that no contractual change was triggered by Amphastar laucnh yet, but SNY has launched an authorized generic version of Lovenox sometime in October, triggering a change to hybrid economics]
- believe we have cash to continue programs thru approval of generic copaxone
- it is substantially in our benefit to prevent the launch of this product (Amphastar/Watson enoxaparin)
- m-enoxaparin passed $1b cumulative sales in July 2011. We get 45% split of profit, which about 70% of sales [so note that a change to royalty model vs profit share model lowers the % of net sales going to MNTA from ~32% to 10-12%...a significant change, but not as drastic as it first seems]
- Sandoz currently has approximately 50% market share (split with branded Lovenox from SNY)
- those economics do change upon launch/marketing of competing product
- in case of authorized generic- hybrid system- we get royalty for a period, then revert to profit share [a slightly new description which sent me back to the original license agreement for details- see my more detailed post on this over at Investors Hub]
- FDA agreed with SNY citizen's petition that the "1,6 anhyrdro structure" was a signature marker for lovenox
- We are looking for a preliminary injection (PI) to keep amphastar off the market until patent litigation is complete
- we reported to the court yesterday that, based on discovery, we believe they are infringing the 1,6 anhydro patent. With regards to the second patent with another method - based on our review of Amphastar's ANDA, we told court that we don't believe they are infringing that patent
- Legal standard- the judge has to conclude that MNTA is likely to win lawsuit and would suffer irreparable harm if Amphastar product is allowed to enter the market...getting this type of injunction is infrequent, is a high hurdle
- Whether we get the PI or not, we still believe that we have a strong case in the underlying patent litigation which will contunue
- We did sue Teva also even though they are not yet approved - because they had made commercial inventory and said they expected approval. That litigation is proceeding.
- We are expecting court ruling today because TRO expires. Judge could either rule on PI or extend TRO, or could not rule and allow TRO to lapse [note that the judge extended the TRO for one week, through 10/28/2011]
- copaxone program - mnta pays development costs, sandoz commerical and legal. 50/50 profit split in all competitive situations
- copaxone litigation - consolidated with Mylan and the trial was completed in September. briefing is scheduled, final briefs to be submitted. Judge's ruling could be 6-12 months or more...2q-3q2012 time frame.
- FOB. We are taking the same approach as took with lovenox, and applying our technology to glycosylated proteins and antibodies
- we are not willing to front the cost of m118 phase 3 study
- M402 clinical trial 2012
- q&a in breakout session
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