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Craig was hopeful that he could announce a partnership before years end for the FoB program.
M118 gets more interesting. Please refer to the ReadMeFirst for more details on what that gets dicey.
I speculate* that there is something else going on. But I won't go into the details on my thinking for fear that i will be seen as a conspiracy theorist. (As many of you know, I am a firm believer that short-term activity of individual equities is easily manipulated, but not so easy in the long-term). (i.e. hold tight, if you still believe, but i fear we may meander down here in the short-term)
* I know that speculating is not looked upon fondly on this board, but I have a hard time controlling myself.
I don't believe MNTA has ever asserted, explicitly or implicitly, that they will be the sole Lovenox generic "for years to come." In fact, I've been impressed with the restraint they've shown in this regard. I do think that restraint is warranted, since MNTA does not know the specifics of (1) TEVA's mL application, (2) TEVA's progress with their characterization platform/technology, (3) TEVA's discussion with the FDA or (4) TEVA's ability to exploit corrupt public officials (okay, okay, i'm being cynical on the last one :)
That being said, MNTA has been unequivocal that their characterization platform provides a quantitative and qualitative edge over competitors, and that it will be hard for the competitors to "catch up" (i.e. characterize at the granular level that MNTA is able to achieve) in the near future.
To an outsider, MNTA looks like a great short candidate. Why? :
(1) A lot of "hardcore" longs, (2) threat of mL competition from a real powerhouse (TEVA), (2) legal hurdles (with Copaxone), (4) profit dilution as a result of a partnership agreement, (5) an asymptotic PPS rise after approval, etc...
The question in my mind... what catalyst will be "the one" that moves MNTA significantly (higher or lower) from here. I put my money on (1) partnership for FoB or M118. I am not convinced that the impending NVS Quarterly CC will suddenly "wake up" the market to MNTA. Folks already see the uptake, the script numbers, and have a general sense that mL is, for the time being, bring in the doh to MNTA. I think a partnership on M118 or FoB with a major player will further validate MNTA's platform and may finally convince the naysayers that they have something unique in their technology.
Zipjet, i think your assessment is dead on the money. I suspect your approach will be vindicated in the near term. Suffice it to say that MNTA is (1) printing money, (2) has a great pipeline, (3) a variety of strong partnership opportunities, and (4) continues to be the sole generic 2+ months after approval, without any substantive evidence that supports a TEVA approval in the near term.*
* = TEVA previously indicated that the delay was due to the 1 month lag in providing immunogencity data to the FDA (i.e. TEVA provided immunogenecity data 1 month after MNTA so they expect a 1 month "natural" delay in their approval). Now that the excuse has elapsed, they've decided to be mum on the subject. (At the last conference call Bill M. stated that he had nothing new to add to their previous assertion that they expect to be approved soon) We are 2+ months into the post approval paradigm. I've long suspected, that if TEVA was close to approval, the FDA would have timed the approvals to take place simultaneously. (seems to make the most sense logistically)
Wow. They keep shorting about ~800k-1 million shares every 2 weeks. That is pretty darn significant. Volume has been anemic lately, yet they are still shorting. interesting.....
I added a substantial amount to my holdings today. I have transferred additional funds from other accounts, and hope that the price continues to meander until that money is available for use. This is incredible and insane at the same time ... makes me wonder.
From the Q2 Teva Conference Call (July 27th, 2010)
Bill Marth
Good morning, Ken and thanks for the question. With respect to our Lovenox file, we are continuing to dialogue with the agency. I would say to you that we feel that we're on track. We're progressing ahead. We did file slightly later, about a month later than Momenta on the response the immunogenicity, which is very likely why we haven't received our notification yet.
It's almost October ... the 1 month "timing" excuse is over due by a month. Interesting....
No analyst has come out to opine on the disparity between price targets and the market price. It is a little odd. Could the $15 PPS be really a reflection of expectation that TEVA may get approved? I would think that there would be some premium built into the stock in light of approval (notwithstanding possible TEVA approval), but there is absolutely none. Several analysts have already come out and spoken about the potential that MNTA would be acquired, yet the stock continues to drift below pre-approval levels. Hmmmm .....
Tim Anderson from Sanford Bernstein is in cahoots with the dark matter. We likely have the opposite of irrational exuberance ... irrational pessimism.
ITMN has overtaken MNTA in market capitalization. Now its time for SQNM, with their "theoretical" (fraudulent) Down's syndrome test, to overtake MNTA. (SQNM mkt cap @ 525 million today, MNTA mkt cap @ $668 million)
It doesn't matter that MNTA has the only approved version of generic lovenox, is printing money hand over fist, a partnership with Novartis, a phenomenal pipeline, and a proven molecular characterization platform. What matters is the flavor of the week on wall street. An efficient market is just around the corner ... perhaps next week will be our week!
Have a great weekend....
This rumor is clearly limited to iHubbers. If this rumor had been disseminated to theflyonthewall, MNTA would be spiking to $50. :P
Yes. Like a swarm of mosquitoes attracted towards a warm lantern, the PPS is attracted to the pre-eminent strike-price on expiration day.
It is in TEVA's interest to assert their generic lovenox application is close to approval. (see http://investorshub.advfn.com/boards/read_msg.aspx?message_id=53488805)
Why?
By stating that they are close to approval, TEVA is asserting that they have characterization technology as advanced (practically speaking) as MNTA's. This sends a positive message to the market about TEVA's capabilities. Do they have equivalent technology? I think you can make a strong inference from the TEVA PR immediately following announcement of MNTA's mL approval, that they do not have the same level of sophistication, but are trying to get their application approved nonetheless.
Additionally ...
(*) MNTA had been asserting that they were close to approval several years before it actually happened. What would be the benefit of TEVA coming out and saying they are way behind and have several challenges before obtaining approval.
(**) If TEVA does manage to obtain approval, I think it likely that it will be as a non-substitutable branded generic. (see readmefirst on this possibility)
Agree on all counts. I opined about this in post #103342 (http://investorshub.advfn.com/boards/read_msg.aspx?message_id=54014381)
If the FDA continues to hold off on TEVA's application through late October, i think buyers will start to recognize that its not a "bureaucratic" delay and that there are likely deeper issues with TEVA's mL application.
I suspect buyers will step in at that time, and we could start to see MNTA's PPS rise back to low-mid twenty levels. Thus, IMHO, this is an excellent buying opportunity.
That being said, I have been very mistaken in my prognostication with respect to MNTA PPS. That being said, at these levels, it may be an excellent take out target. It's so darn cheap....
The Short thesis is simple.
1) TEVA will get mL approval in the near future, 2) MNTA will not get FDA approval for generic Copaxone, 3) MNTA will not partner M118 in a meaningful way, 4) MNTA will not be acquired anytime soon, 5) Uptake of mL will be less than stellar.
I vehemently disagree with all the aforementioned assertions, and #5 has already been smashed (just look at the script numbers)
Market gets it wrong plenty of times. SQNM market cap > 500 million $'s as of this email. It approached ~2 billion $'s several months ago based on "faulty" data.
I think MNTA will reverse aggressively back to the mid-twenties at some point in the near future.
It's official ... as of this email, ITMN has a market cap exceeding that of MNTA. Very sad, very bizarre.
ITMN = 11.98 = 672 million $ market cap
MNTA = 14.77 = 668 million $ market cap
ITMN vs. MNTA Market Cap....
We are getting very close to my prediction that ITMN will overtake MNTA in market capitalization. (As of this note, ITMN market cap = 666 million, MNTA = 676 million) SQNM is approaching ~$500 million in market capitalization today. A truly interesting, bizarre and irrational situation.
Dew, i think some TA discussion would be useful. Clearly, MNTA is not responding solely to the fundamentals (at least not at this point). I will post to the MNTA forum and will post a link here, as I have been following the TA for some time.
Would be nice to see a squeeze.
It's about time.
MNTA longs ....
this could be our turn-around week. Hold on tight. Back to $20's soon?
We have to be patient. Short-term price action can be irrational. I hope this turns around aggressively, but I suspect it may require some major announcement around m118 or markman. The only other catalyst is runnup to NVS Oct earnings CC, or divine intervention.
Best of luck to the longs.
IMHO: It is in TEVA's best interest to assert (1) that they will receive mL approval and (2) that a Copaxone generic will not be approved by the FDA. This strategy will persist well into next year (they will continually assert that they are expecting approval soon)... TEVA has no incentive to admit otherwise.
Over time, the market will realize TEVA's approach and will also realize that an explicit FDA denial of the other outstanding mL applications will not be forthcoming... those applications could be in perpetual bureaucratic purgatory.
MNTA is not unique in having "bearish" rumors surround it. In fact, the rumors are not even being aggressively disseminated. One analyst (Bernstein) said TEVA is likely to receive mL approval by the end of the year. The other half-dozen analysts said they don't see TEVA getting approval in the forseeable future. Doesn't seem so bearish to me.
Something else is going on here. Companies like Sequenom have a market cap approaching 500 million $'s, they have no meaningful products, revenue or near-term approvals. In fact, the only have controversy.
IMHO, MNTA trading below its pre-approval levels is bordering on the insane, the cynical side in me considers "conspiracy theories", the practical side buys more when i can muster up the dry powder.
Update on ITMN / MNTA market capitalization.
I previously predicted that ITMN's market cap would soon exceed MNTA's. As of this post, ITMN market cap is ~633 Million. MNTA market cap is $655 million. Early next week, we could see ITMN market cap overtake MNTA.
Market is nuts.
MNTA: Trading @ 14$ ... pretty phenomenal. makes me sick to my stomach and excited at the same time. SQNM, ITMN, IDIX and many other biotechs may soon overtake MNTA.
MNTA down 7% on 500k shares. Okay.....
Dew,
In a post a few weeks ago, Zipjet did an excellent job articulating the game-theory analysis likely to drive the decision making process for SNY around a Lovenox AG.
I would have been surprised to see a large pharma make a decision out of "spite"*, one which could adversely affect the bottom-line without any tangible benefit. (unless you consider "giving MNTA and Sandoz the middle finger" a tangible benefit)
* I didn't rule it out as impossible, but a AG at this point was in my opinion highly improbable.
I was referring specifically to NVS acquiring the majority stake from Nestle.
http://online.wsj.com/article/SB10001424052748703959704575452851119998716.html?ru=yahoo&mod=yahoo_hs
With the NVS-Alcon deal consummated, the likelihood of a short-term buyout has improved. (I would rate it at 20% chance over the next 3-6 months). The long-term likelihood of a buyout by NVS stands at 40%. The likelihood of a buyout by a third-party over the next ~5 years stands at 70%, IMHO.
Even if one subscribes to the belief that TEVA is close to obtaining mL approval (which IMHO is not likely), there is a strong argument to be made that the FDA will refrain from acting on the other outstanding applications (TEVA/Amphastar mL applications), until the Sanofi v. FDA case winds down. (i.e. Goes to trial and appeals are exhausted) That could take several months.
MNTA Opinion on PI
First a point of clarification, for the confused.
FDA SEC. "505" = "21 USC 355".
Mouton, I agree with you that the Judge cited 355(j)(2)(A)(vi) as justification. However, I respectfully disagree with your assertion that the holding was not justified under the bioequivalence clause 355(j)(2)(a)(iv). The thrust of the courts opinion is that clauses (355)(j)(2)(A)(i)-(viii) are "sufficiently broad" and "provide the FDA with ample discretion to evaluate an ANDA."
Please note the following on page 15-16 of the opinion....
"Sanofi argues that this case should be resolved under Chevron step one because § 355(j)(2)(A) “unambiguously prohibits FDA from requiring an ANDA applicant to conduct basic safety testing such as immunogenicity testing.” Pl.’s Reply Br. at 5. While it is undoubtedly true that the FDA may not require an ANDA applicant to submit information beyond what is specified in § 355(j)(2)(A)(i)-(viii), the FDA persuasively counters that “the categories of required information are set forth in broad, general terms that provide FDA with ample discretion to determine what information it may assess to evaluate an ANDA.” Fed. Defs.’ Surreply at 4; see also Serono, 158 F.3d at 1324 (“[T]he clauses [in § 355(j)(2)(A)(i)-(viii)] simply describe what the ‘information’ in an application must ‘show.’ They do not specify the kinds of studies that can or cannot be used to satisfy the requirement[s].”). This Court agrees."
The main thrust of the original post I referenced was: "The Sanofi suit alleges that FDC Act § 505(j)(2)(A)“specifically precludes FDA from requiring the submission of such [safety and effectiveness] information." This is NOT true. "
The opinion is consistent with what I stated above.... reliance on (j)(2)(A)(iv) vs. (j)(2)(A)(vi) is IMHO immaterial.
(My original post is at http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52744625)
Good ruling. I just read the opinion. I posted a few messages over the last few days analyzing SNY's PI motion and why I thought it was "bunk". (see my posts below) The court agreed on both counts! Yea for MNTA longs!
See
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=52744625
&
http://investorshub.advfn.com/boards/read_msg.aspx?message_id=53393560
WASHINGTON, Aug 25 (Reuters) - A U.S. judge on Wednesday refused to block sale of a generic version of Sanofi-Aventis SA's <SASY.PA> blood thinner marketed by Novartis AG's <NOVN.VX> Sandoz unit and Momenta Inc. <MNTA.O>
U.S. District Judge Emmet Sullivan refused to issue a preliminary injunction after a request by Sanofi to block the generic version of its Lovenox drug that Sandoz is already selling.
The U.S. Food and Drug Administration approved the generic blood thinner in July despite concerns by Sanofi that the agency failed to follow its procedures or ensure the generic drug had the same active ingredient as Lovenox.
The FDA approval was the first time the agency had approved a generic for that kind of complex medicine, which some experts have said could signal that the door is opening to clearing other generics that involve complex compounds.
After the generic Lovenox was approved, Sanofi warned that its earnings would drop as much as 4 percent this year. Last year, Sanofi's second-biggest drug had worldwide sales of $4billion, 60 percent in the United States.
Teva Pharmaceutical Industries Ltd <TEVA.O> and a partnership involving Watson Pharmaceuticals Inc <WPI.N> and Amphastar Pharmaceuticals are also awaiting FDA action on their own applications to sell a generic version of the blood thinner. (Reporting by Jeremy Pelofsky; Editing by Gary Hill) ((jeremy.pelofsky@thomsonreuters.com; +1 202 898 8396; jeremy.pelofsky.reuters.com@reuters.net)) Keywords: NOVARTIS/SANOFI
MNTA trying really hard to go green ...
MNTA LONGS:
Hold tight, don't despair. :)
Someone on this board will soon claim to have bought at the very bottom of this sell-off.
"I tripled my position yesterday at the lows just before it headed back to the 20's. Had been waiting a long time for that moment and I knew it was just the time."
To people that find themselves deeply underwater as a result of reading this board and buying into the MNTA hype, I ask you, do you feel misled? If you don't, how do you explain the plunge to 15 from 25?
This board provides a platform to discuss/critique/refine various valuation scenarios. Most posters who were willing to step out and provide potential post-approval PPS predictions, provided a framework to justify their valuation.
All board members have been free and have been encouraged to review various scenarios based on the wealth of facts that have been captured and memorialized in the Readmefirst. Individuals should always draw their own conclusions.
MNTA's price action in the short-term has been perplexing to many long-time board-members ... does it mean that the MNTA bulls were wrong and that MNTA will never meet the price targets you "cite"... absolutely not. Do any of us know how MNTA's PPS would respond in the short-term to a ruling by the court for/against the SNY PI... probably not? I certainly don't. It could go back to 26, to 20, or may not even get above 17. One thing is for sure, assuming MNTA continues to bring home the cash, and can deliver on some of their other pipelines in the way they delivered on generic lovenox, their PPS/valuation will more accurately reflect the fundamentals of the company. Whether that happens in 1 month, 3 months, 6 months or 2 years, is anybody's guess.
I continue to be bullish on MNTA in the short, intermediate and long-term. Does that mean i am obvlious to the risk of investing in the stock-market... absolutely not. I have been vehemently against short-term trading, because of instances like the MNTA approval, which defy my "common-sense".
ITMN / MNTA:
At the current rate, ITMN's market capitalization will soon exceed MNTA's. They are actually within a stone throws from each-other. Pretty remarkable in light of MNTA's FDA approval of mL and ITMN's story. Crazy stock market.