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No idea where bottom is, and I really can't see MNTA being anything but dead money until something happens, and the PPS is being treated as such and I imagine will continue to be.
Thanks DD.
Just curious, do you any predictions for what kind of trials MNTA will ultimately have to do?
I would say it has been the most promising biotech of this millennia with no fulfillment.
I thought MNTA had an 11% royalty now? The above computes to 7.65%.
MNTA briefs from copax appeal: Does anyone have access to these or know where to find them? TIA
MNTA's management compensation is extremely high and generous with the current state of the company/stock. If they still had enox, I would be fine with it.
Momenta expects to submit the first IND (Investigational New Drug) application in 2014 for its lead biosimilar, M923
What a yawner of a conference
there is those 11s :P
MNTA expecting IND submission in 2014 for first compound in Baxter collab.
Also, doesn't look like baxter milestones are going to help that much (not until 2014) as MNTA burns up to $90m a year now...
Nothing wrong with a little wishful thinking! :)
It looks like analysts haven't updated their models to reflect the enox revenue, so I imagine the pretty high miss, although completely expected will drop this stock significantly tomorrow (unless something else comes out).
LOL!!!
TEVA: Bill Marth is stepping down immediately and will stay on as an advisor through 2013 until he officially retires.
I don't see what MNTAs legal team has to do with anything. Like I've said previously, if MNTA had the same panel as the Classen case, the PI never would have been lifted.
Your point is not lost and it will be interesting how management responds over the next few months all considering, although I really don't put a lot of blame on them for what has transpired with enox.
My sense is the market sees no point in owning the stock now. I think referring to MNTA as "dead money" at this juncture is not unfair. I'm still holding all my shares including my recent purchases in the 14s. 2015 or bust!
To be honest, the move makes sense with all the facts at hand. MNTA is now burning cash at a pretty significant rate. That $412m is gonna go relatively quickly. everything else (m-copax, enox, fob program) is an uncertainty. At least the form 4s have been far and few between lately :P
Iwfal,
you actually agreed with DD ie the switch to trade secrets before :P :)
Right now much of their substitutible business model is hanging on one legal thread (I.e. if the recent ruling on safe harbor gets upheld it kills >50% of their NPV.
Any other disturbing quotes?
FWIW I think MNTA has a fair shot at overturning the 2015 patent, but very little chance of the 2014s... CWs confidence in that was a bit strange, especially when they still haven't been approved.
The length of time it's taken m-copax is also a bit disturbing at this point to be perfectly honest
Why not? What do you really know about it?
They are the facts according to this board. I think when you have the legal decision of the courts, overturning those facts, you should be accepting.
TEVA will.
MNTA has been frustrating
Perhaps, but MNTA has historically been very prudent/conservative. Regardless, many things can happen b/t now and then to change all that.
On another note, will the milestones be material in that they'll be PRd, or will they just show up every Q?
So it will certainly help some, but nothing to degree that MNTA is now a pretty high cash burning entity like it used to be. M-copax or en banc couldn't come soon enough!
Roger on final. I do think MNTA/Sandoz/MYL have a solid shot of defeating that 2015 patent in appeals though, but that's another story.
With regards to Mylan's powerhouse status, I'll again refer to TEVA whom has yet (and probably never will) to get t-enox (also a knock-off, like Mylan's) approved so it's not that simple.
And I still contend that if MNTA gets m-copax approved (as I imagine it will be done in similar way to m-enox, where MNTA pretty much made the rules), it will be a telling statement from the FDA on how they'll respond to MNTAs FOB program (Which I know you attribute 0 value).
I see no reason that approvals will come before or at patent expiration, 2015.
Will they be significant enough to off-set to some degree what will be a pretty high burn rate going forward?
Well, what is your opinion on the approvability of copax as well as timing?
MNTA cash going forward if ampha wins the enox case, and appeals don't work for copax patents:
Okay so MNTA has $412m. After this Q it will be around $387. I imagine MNTA will be burning 20-25m from here on out (I think 34m enox sales is low for previous reasons stated on this board. I would expect at least $50m enox sales per q).
There are 12 more quarters before the absolute latest for a copax launch. That's another 300m burned leaving MNTA with 87m before copax launch. That cuts things pretty close... I wonder if another financing is in the cards.
Gotcha. 3 years of lost rev would be around $3b. I agree that is very unlikely if the case ever got to the damages part...
I'm still not getting it I guess. The majority opinion was based on a borderline absurd reading of safe-harbor, not MNTAs actual patents. Why would Amphastar not be on the hook if the courts eventually find in MNTAs favor? Is there precedents for this kind of thing?
Very insightful.
which, I suggest, would largely indemnify them.
I speak frequently with an analyst who covers WPI and that is what management has told her. They say Ampha calls the shots and was their decision to launch. They also say Ampha will be solely responsible for any damages. Obviously, Paul Bisaro is highly influential and I imagine if he really didn't want WPI to launch it he could have, but who knows.
It was completely Amphastar's call to launch.
Gonna be nasty for MNTA this Q. Here's a hint on what happened from WPI 2nd Q call
So the LOVENOX market, so we have grown from about 2% market share in the beginning of the quarter to about 10% market share now. As you know, we are only operating in the retail space. We now have a good supply and steady supplies from Amphastar. And then -- so the market has been growing. The price erosion has been significantly more than we expected. There has been a very hectic competition in that market with the AG and also from Sandoz. B
However, if the preliminary PI is reinstated, MNTA still has to negotiate a settlement with NVS that restores the old Lovenox economic arrangement in part
Hypothetically, if en banc is granted, and then the majority opinion is overturned, does that reinstate the PI?
Classen's full response is here:
#151175
Pretty strong statement from them as well:
"the loss of tens of billions of dollars that are annually invested in developing new methods and devices for ensuring the safety of drugs and medical devices which regularly save and improve the lives of countless people. In the short term, a few pharmaceutical companies will avoid paying some licensing fees, in the long term, an entire area of medical research will be shut down."
I like MNTAs chances for en banc....
Also for reference, the full Classen brief is here: http://www.hpm.com/pdf/blog/Enoxaparin%20-%20Momenta-Amphastar%20Safe%20Harbor%20-%20Classen%20Amicus%20on%20Rehearing%20Petition.pdf