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Well, I just had a pretty innocuous post deleted on this same subject so I'll try and hope that this one passes the Pravda squad. If you truly believe that the FDA is so easily corrupted, and, further, that Momenta is not able to effectively counter this pressure, you should sell all of your shares on Monday, point blank. Momenta has no serious novel drug program, so everything they do in the future is going to involve this block-to-block street fighting in the courts and with the regulatory agency. If Momenta can't handle the relative weakling Amphastar, how are they going to handle Pfizer or Amgen?
'Not likely to get any cheaper'
Not even if:
Sanofi launches an AG.
Teva gets approval.
Generic Copaxone gets rejected by the FDA *or*
Momenta loses at the patent trial.
The judge refuses to give a PI to Momenta regarding Amphastar's generic.
There continues to be no progress on the FoB front.
Momenta decides to burn all of their cash on M118.
The FDA takes forever to develop the biologic generic pathway.
The new oral anticoagulants continue to chip away at Lovenox.
Not to mention the usual unknown unknowns (what happens in case of another heparin scare?)
Frankly, there's a lot more than can go wrong then can go right with this company. Given how cheap blue chip stocks are right now, there's frankly little reason to bother with this name. I'm almost out of my position in this disaster, at a pretty big loss. In retrospect, the time to get out was this summer when it became clear that Momenta's preferred pathway of fully substitutable biogenerics was not going to happen with the FDA until late this decade and, additionally, that they were having no luck interesting Sandoz or anybody else in their generic biologics program in any case.
Now, I don't think this is a horrible company or anything, but there's lots of downside risk and upside reward that is entirely dependent on capricious and unknowable rulings by courts and regulatory agencies.
Yes, MNTA must have game-planned for this event and should have a response (both to Amphastar and for shareholders) by tomorrow at the latest. Craig Wheeler has been AWOL lately, now it's time to earn that 140% bonus. I don't see any downside to suing Amphastar, if they lose, so what? It will still be the same outcome as we have right now.
I believe fair value is around $11 or $12, derived using my NPV model. I am going to sell some of my position today, but hold on to the majority of my shares to see what happens with the lawsuit I imagine MNTA is going to file against Amphastar. I think the Copaxone trial is a coin flip at best so it seems like a long dearth of good news for Craig Wheeler and friends.
Caisse du Quebec and other Canadian pension funds have a dual mandate of investor returns and economic development of their funding province.
Does Massachusetts have pension-run private funds like Caisse du Quebec and Ontario Teachers? It would make sense at this point to have said entity buy up Momenta to obtain not only the lucrative cash stream but also keep the corporate tax revenues and jobs that Momenta provides in-state.
Given that the company is retreating from its previous stance of insisting that a partner pursue a multiple-drug development path as part of an agreement, it's pretty clear that MNTA is the one who is having to modify its negotiating position.
They said they have more heparin-based drugs they want to advance out of the clinic. M118 and the alleged M402 program haven't been rousing successes to date, but the verbiage in the job posts indicates they may be staffing up these new programs.
I have the FoB program given next-to-zero value in my MNTA model. They tout, on one hand, an unique ability to characterize and develop complex biogenerics, but then keep mentioning a need to improve their ability with cell line generation, develop a pilot bioreactor and generally develop or improve many aspects of biologic drug development. The message does not add up, and the lack of a partnership to this point tells me I`m not the only one who thinks so.
Momenta also has identified full substitutability as a key facet of their approach, but has admitted that the FDA likely won`t be prepared to designate any FoB`s that way until 2014 - 2015 or later. That gives a pretty low NPV on Momenta`s efforts, even if you think they have something special to offer in this space and will be able to execute their strategy.
Despite my misgivings, I do think Momenta clearly has some valuable skills to offer FoB developers, but unless they can show fairly soon that somebody is interested in their full-lifecycle abilities I believe they would be better off offering their analytic abilities to multiple parties for a small royalty or similar.
From reading the transcript of the latest call, I got the sense that Craig (can I call you that, buddy?) is backing away from his insistence that a partner commit wholly to Momenta's FoB program and is now open to partnering the development compounds individually. Given that he is also now talking about developing the FoB programs further before partnering, it is clear that there has not been much interest in Momenta's FoB capabilities to this point.
Well, come on, it's only fair that if some are going to crow about how Teva's Lovenox has not been approved yet, then it's only fair that some outrageously incorrect predictions of the post-approval Momenta share price are brought up as well (are those still in the RMF?). As for generic Lovenox, the overhang of a generic will never go away because Sanofi can launch one at any time for any reason.
SKW.v/SKWEF.pk
SKW isn't overpriced, their 2P NAV is around .51 cents. The big issue is if after their disastrous 1Q results they have to go back to the market to continue to drill. The most common rumour is that Bellatrix is the acquirer.
Great post.
Where is the proof that Momenta is creating long-term shareholder value by pursuing the FoB programs? Just because the company says it doesn't make it so. Just a year ago, Craig Wheeler would emphasize that Momenta was a company dedicated to original compounds and just using the generics business as a funding source. As M118 floundered, the story was changed to emphasize the FoB business.
Now, we know everyone and their dog is entering the FoB market (Samsung?) and no partner as yet has thought that Momenta has anything vital in this space, despite the large cash burn the company is spending trying to build out its biologic capabilities. Of more worry is that Sandoz has not expressed any interest in Momenta's technology, despite knowing the company the best, and that the FDA is at least half-a-decade away from approving the pathway that Momenta claims to need to differentiate their approach.
Now, this doesn't mean that Craig Wheeler is a bad CEO, but there is certainly room for criticism of his performance. M118 has been a bit of a debacle, with the money spent on it by Momenta only for the program to flounder due to lack of partner interest. M402 has had problems getting to the clinic and a FoB partnership does not seem imminent. If Copaxone is approved by the FDA or a lucrative FoB partnership is signed in the next six months then all of this discussion is moot, but right now it's not.
2016 is when Wheeler sees FoB's being allowed to be fully substitutable, not when Momenta will release their FoB. I agree their touted value proposition (deeper analytic/characterization capabilities) seems pretty inconsequential given that timeline. Five years is a lot of time for the other players in the FoB space to develop similar abilities to Momenta, that is, if you believe Momenta has any special capabilities in this field in the first place.
There was some discussion on the main board about what Craig Wheeler recently said about U.S. biogenerics, namely that he doesn't expect the FDA to allow full substitutability until 2016, and he is an optimist about that date compared to industry expectation. This calls into question Momenta's value proposition in this space. I would sure like to see some movement in the non-Novartis pipeline.
ELN may be a good play in the runup to the results. It would be gutsy to hold through them, though.
What they have said about FoB's has been all over the map, from being close to a deal to 'finally having the resources to develop the programs the way we would like'. I also retain a healthy degree of skepticism over their FoB program until we see some concrete news. The elephant in the room, of course, is that Sandoz has chosen not to sign any further partnerships with Momenta despite knowing their technology the best.
jbog, allow me to answer in the spirit to which we have become accustomed.
What, don't you believe in MNTA!! I bet you don't even own any shares!! Go back to Yahoo!!
I don't believe they were guiding for a FoB deal this year until now.
For what it is worth, LinkedIn reports 18% YoY job growth at Momenta.
I will be hugely surprised if the M402 trial starts recruiting before the halfway point of the year and would not be shocked to see the start pushed into 2012. As I live nowhere near NYC, I can only offer you a signature bet rather than a meal if you are in the mood to wager on the matter.
I think the financing was necessary. Momenta clearly believed that Teva approval was a distinct possibility by year end (as we now know, this was a common belief amongst both investment banks and hospital buying groups). They decided to raise enough money to feel comfortable for the next couple of years without excessive dilution. It was a prudent, if ugly, move.
That being said, I would like to see either a one-time dividend or a stock buyback as penance for the move if we see two or three more quarters of juicy Lovenox revenue.
They have been pushing back the guided IND filing date for M402 over the last year. For reference, see your earlier post mentioning their guidance for an early 2011 filing.
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=47769823
Now, missing a timeline to move a pre-clinical drug into P1 by a few months is not a capital offense but they have not met their stated timelines on this program.
They are just staring to hire someone to design and run the M402 trials now, yikes. We might be looking at next year for trial start.
Took the opportunity to lighten up a little bit at this level. I believe that MNTA is approaching its fair value, especially until we get some more progress on the rest of the pipeline, including the magical disappearing M118 and M402.
10nisman, this is a board for all MNTA discussion, not only MNTA cheerleading. Quit telling people to stop posting.
Elan stock has really shot up the last few days. Another runup before the alzheimer results, I would guess.
Take it for what you paid for it, but a friend of mine was working on a Cisco contract a couple of months ago and was told that the company consists 'entirely of project managers now'. I hate tech companies that have outsourced all of the actual value-added design and manufacturing aspects of their business, and Cisco seems to be a prime example of a hollowed out company that will be facing newly-empowered contractors-cum-competitors in the very near future.
This is a discussion board about MNTA, not a cheerleading forum for management. If you don't like what jbog, or anybody else, is saying, don't read it.
I called IR and asked for all Momenta executives to stay at 'The Elk' until the share price goes over $18 again.
http://www.scoutingny.com/?p=3348
Does anybody have a link to a mp3 or similar of the conference call? No browser I have will play that call link on the Momenta site.
Teva would have to divest generic Copaxone if they buy Momenta, otherwise I don't see the regulatory issues in a merger.
In the same vein, I'm sure I'm not the only one looking forward to the NY Times expose and congressional hearings into CRO business and clinical practices in five to seven years. Well, Ian Read will be long gone, counting his option and bonus money, before those chickens come home to roost.
The fact of the matter is that MNTA has to show it has legitimate interests beyond generic Lovenox. In presentation after presentation, Craig Wheeler has proclaimed the generics business a sideline to allow Momenta to develop its new drug candidates. However, M118 is looking less viable by the day and there is nothing else in the pipeline besides a pre-clinical cancer drug that has been repeatedly delayed.
There is also significant downside risk here, on the legal fronts from Sanofi, Teva and Amphastar, on the clinical front from generic Copaxone and the other generic Lovenox's and not to mention any black swan events like a problem with Momenta's generic Lovenox.
I have a fair value of around $18 at this point, but there can be wild swings to the upside and downside given developments in the future. If I was new to the stock, I would wait for some positive momentum before opening a position here.
Didn't know about those other ones given my quick research, that was a good post on the other board. I guess we'll see how it shakes out. I wonder if Amphastar will hear something about their application soon as well. Momenta'a ace-in-the-hole is their lawsuit against Teva. Even if Teva is approved this year, I imagine Momenta will ask for an injunction regarding the shipping of any product from Teva.
In any case, it's time for Momenta to show some real progress in their M118 and biosimilar programs. There needs to be some good news soon that shows this company has something beyond generic Lovenox.
As someone on the other board mentioned, the other Google-able mention of a minor deficiency letter to an ANDA was to SangStat for their generic version of CycloSporine. The letter was received on Feb. 12, 1998 and they got approval on Nov. 3, 1998, about eight months later. It seems reasonable, then, to model full approval of T-Enox before the end of the year.
I think this also safely settles the question of whether Teva's submission was Lupenox or not.
1) transition gave up an equity stake in ELND-005 and a $30M milestone upon P3 initiation for a royalty and smaller initiation milestone. the only economic benefit they get from the deal is that a paltry $9M is guaranteed now as a signing bonus. Given that they could have cancelled the partnership and signed a new deal with another company, this indicates very little confidence in the future of ELND-005 and a desperate need for immediate cash on the part of transition.
2) Given that the future of ELND-005 is dubious at best, that becomes the third lead compound that transition has failed to advance to a late stage trial. I don't think transition is a Repros-style scam, but at some point the board of directors has to question the utility of this company. I certainly don't think investors should give much credence to any aspect of their development program.
After Thelin, I think the FDA deserves some benefit of the doubt when it comes to their judgement on marginal drugs.