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Thank you sir for your guidance. Much appreciated.
Confidential Treatment Order (ct Order)
Date : 02/07/2017 @ 11:17AM
Source : Edgar (US Regulatory)
Stock : Momenta Pharmaceuticals, Inc. (MM) (MNTA)
ANy clue what this may be about?
TIA
Good afternoon marthambles. Fun exercise indeed and offer my following guesses:
1. MNTA receives sole approval for 40mg Copaxone,
2. MNTA shares approval with Mylan.
My guess: In the event of number 1, MNTA increases 40-60%. If 2, MNTA closes UP 10-25%.
Personally it is my belief that MNTA will be solely approved. Mylan delay in obtaining the 20 mg dose suggest to me they are 12-24 months behind MNTA .
So you are proposing that MNTA approval for thrice weekly (40 mg dose) is being held up by the FDA until MYL's own 40 mg dose is approved by the FDA? Is that even legal?? Just perplexed I have to admit. Thank you.
I've noticed the same these last 5 trading days, specifically the lower volumes. Perhaps it's just the quiet before the storm. As Dew articulated in a post this last week, MNTA may be difficult for some to follow given the complexity. This next 2 months should be interesting to say the least. By April 1st, I expect things to be "jumping".
Momenta Pharmaceuticals Announces Worldwide Collaboration With Mylan to Jointly Develop and Commercialize Six Biosimilar Products
CAMBRIDGE, Mass., Jan. 08, 2016 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (MNTA) today announced that it has entered into an exclusive global collaboration agreement with Mylan N.V. (MYL), (MYL) to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including Momenta’s biosimilar candidate ORENCIA® (abatacept).
“We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. Our two companies have a common focus on building an industry leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “By combining Momenta’s proven capabilities in complex product development and Mylan’s world class global R&D, supply chain and commercial infrastructure, we are well positioned to become a strong competitor in this developing field. Our joint vision is to bring high quality, cost effective biosimilar products to markets worldwide and we believe our success will deliver a strong return to our companies’ stakeholders.”
Mylan CEO Heather Bresch commented, “This exciting collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan in this area of significant future growth, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar development experience, operational excellence and expansive global commercial footprint. Through this collaboration, as well as other partnerships and the strong internal capabilities we have cultivated, Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world.”
Under the agreement, Mylan will make an upfront cash payment of $45 million and up to $200 million in contingent milestone payments to Momenta, with each company sharing equally in the costs and profits with respect to the products. The companies will be jointly responsible for product development and Mylan will lead worldwide commercialization efforts, with Momenta having an option to co-commercialize in a supporting commercial role, any approved products in the United States.
Momenta Pharmaceuticals Announces Worldwide Collaboration With Mylan to Jointly Develop and Commercialize Six Biosimilar Products
Momenta to Host a Conference Call for Investors Today at 10 AM ET
CAMBRIDGE, Mass., Jan. 08, 2016 (GLOBE NEWSWIRE) -- Momenta Pharmaceuticals, Inc. (MNTA) today announced that it has entered into an exclusive global collaboration agreement with Mylan N.V. (MYL), (MYL) to develop, manufacture and commercialize six of Momenta’s current biosimilar candidates, including Momenta’s biosimilar candidate ORENCIA® (abatacept).
“We are thrilled to welcome Mylan as our new collaboration partner for biosimilars. Our two companies have a common focus on building an industry leading biosimilar portfolio that offers safe, effective and affordable products to the patients that need them,” said Craig A. Wheeler, President and Chief Executive Officer of Momenta Pharmaceuticals. “By combining Momenta’s proven capabilities in complex product development and Mylan’s world class global R&D, supply chain and commercial infrastructure, we are well positioned to become a strong competitor in this developing field. Our joint vision is to bring high quality, cost effective biosimilar products to markets worldwide and we believe our success will deliver a strong return to our companies’ stakeholders.”
Mylan CEO Heather Bresch commented, “This exciting collaboration with Momenta is focused on the next wave of biosimilar products and represents an important next step for Mylan in this area of significant future growth, leveraging Momenta’s unique technology capabilities and Mylan’s strong science, biosimilar development experience, operational excellence and expansive global commercial footprint. Through this collaboration, as well as other partnerships and the strong internal capabilities we have cultivated, Mylan is further expanding what is already one of the industry’s most robust and diverse biosimilar portfolios and helping to ensure we can deliver enhanced access to these critical products to patients around the world.”
Under the agreement, Mylan will make an upfront cash payment of $45 million and up to $200 million in contingent milestone payments to Momenta, with each company sharing equally in the costs and profits with respect to the products. The companies will be jointly responsible for product development and Mylan will lead worldwide commercialization efforts, with Momenta having an option to co-commercialize in a supporting commercial role, any approved products in the United States.
Silly question, please excuse me. Why would you expect a "pop" given how MNTA has behaved in the past apropos partnerships? Personally I don't expect much at all. May I ask what your thoughts are on timing? Given the end of the year and holidays, I don't see this happening at the earliest until late Q1-2016. Thank you in advance for your comments/thoguths.
Rich
Thanks Tony for your insight. Appreciate your time.
ARRY
Would anyone care to comment on ARRY of late and if the current valuation is worthy of a modest investment?
TIA
Rich
Amen to that. Given the market over reaction dynamics, I'd estimate a max of $18 then a free fall as many divest....all FWIW and my lame opinion.
Amazing to me that the FDA still has anxiety about approving mCopax after such a lengthy review process. All good news for Teva.
The contracts are worth $0 until Gevo can economically produce isobutanol at commercial scale on corn mash.....that my friends is critical, not dextrose. Until then it remains HIGHLY speculative investment. Period. Did you listen to the last cc? How much actually isobutanaol was produced and sold to their clients? When is the next dilution round coming? Just keeping this "real".
I agree with your sentiment given the dynamics the market is faced with this week. Thanks for your message the other day. I'll get back to you shortly.
Thank you in kind for your reply. I do appreciate a spirited exchange. While I agree that retail investors may take an interest in ATOS this October with the focus on "Breast Health", I still feel that the investment community (Wall Street) won't take much of an interest until such time that ATOS shows significant growth and a projected timeline when they break even. When this happens, I too think this company will really take off. If ATOS gets 1% of the 38 Million mammograms to convert to the ForeCYTE Breast Health Test™, that would represent an impressive $220 Million in sales revenue (minus commissions paid to account managers & or distributors....I am estimating 45% in my mathematical models for now). If and when ForeCYTE Breast Health Test™ becomes the standard care for breast health monitoring, the numbers are staggering. Please feel free to question my thought process......TIA
I envision this lingering between $4.90 - $5.50 until they report next quarters earnings. Just because a deal was signed with McKesson Medical-Surgical, it doesn't mean ATOS will fly high anytime soon. Sales reps need to be trained and supplied with materials to go out and sell. On the supply side of the equation, the CMO producing the MASCT devices, collection kits, and all the downstream logistics need to be in place. What is important now is simply executing.
I would like to see some type of forward guidance from ATOS on sales estimates for 2014 and margins so we can look at appropriate valuations predicated on meaningful information, not hype.
Please don't get me wrong, I personally would enjoy seeing this valuation much higher a month from now. I'm just working to keep my expectations in check. GLTA
"possible slowdown of FDA processes"....could the FDA get slower as it relates to mC review? It's been some time and surely I for one thought they (FDA) would have publicly weighed in by now.
Certainly if MNTA dips back to the $10-$11 range, I will add more. Today I felt it was a "buy" for me personally.
Added today at $14.36. Still believe long term this will be a great company.
Thank you for the information. I'll be calling tomorrow (Monday) and express my concerns. I bought a bunch this week at $1.50 and felt it continues to be oversold compared to Gevo's piers. Time will tell how this all plays out. Perhaps I should have held off buying until the end of the month......
Insider Purchases
CEO, Patrick Gruber purchases 13,300 shares at $3.72 on the open market this morning. $49,476
http://www.insider-monitor.com/insider_stock_purchases.html
Clearly we all understand your frustration. If you have the fortitude, perhaps picking up a few shares will help your psyché through this period of time. The pps of Gevo is suffering do to several factors that they (Gevo executives) can’t control. Summer doldrums of Wall Street, the entire Biofuel sector appears to be out of favor with investors, the uneducated retail investors that are reacting to sentiment about Gevo’s litigation with Butamax. On the emotional (human) side we have folks that invested with the hope of a bounce off the $4.95 level that now have given up and are selling or have already sold at a loss. My only lame suggestion sir is to keep the faith and trust your instincts and reasons for investing in Gevo in the first place. Other than that sir I don’t have much else to offer you.
Gevo Told By Judge Not To Ship Fuel Product Pending Appeal
http://www.bloomberg.com/news/2012-07-06/gevo-told-by-judge-not-to-ship-fuel-product-pending-appeal-1-.html?cmpid=yhoo
A U.S. judge who told Gevo Inc. (GEVO) last month it didn’t infringe a patent held by Butamax Advanced Biofuels LLC, a joint venture of DuPont Co. (DD) and BP Plc (BP/), today ordered it not to distribute its renewable-fuel products pending an appeal.
Butamax sued Gevo, backed by the oil refiner Total SA (FP) and specialty-chemicals maker Lanxess AG (LXS), in 2011 alleging misuse of technology for genetically engineered microorganisms used to produce biofuels. U.S. District Judge Sue Robinson in mid-June denied Butamax’s bid to block Gevo’s fuel sales.
“While the court concluded” that Butamax “doesn’t hold a valid patent” and Gevo doesn’t infringe, “the court readily acknowledges that the U.S. Court of Appeals for the Federal Circuit could disagree,” Robinson wrote in an order today staying her earlier ruling and asking for an expedited appeal.
She said Gevo “shall not deliver, provide, distribute, ship, release or transfer in any way” its yeast product until the Washington court makes its decision.
Brett Lund, Gevo’s general counsel, didn’t immediately return a voice-mail message seeking comment on the ruling. Pam Schools, a Butamax spokeswoman, didn’t immediately return an e- mailed message seeking comment.
Gevo, based in Englewood, Colorado, is involved in several patent lawsuits with Wilmington-based Butamax. Gevo built a biofuels plant in Luverne, Minnesota, to produce renewable additives for refiners that make diesel and jet fuel.
Gevo fell 8 cents to $4.44 today in Nasdaq Stock Market trading. DuPont fell 71 cents to $48.90 in New York Stock Exchange composite trading.
The case is Butamax Advanced Biofuels LLC v. Gevo Inc., 11- cv-54, U.S. District Court, District of Delaware (Wilmington).
To contact the reporter on this story: Phil Milford in Wilmington, Delaware, at pmilford@bloomberg.net
IMHO, this sector is very much out of favor. For example, when you look at other companies like Solazyme (SZYM), Amyris (AMRS), Codexis, (CDXS) and KiOR (KIOR), these all appear to have had a major pull back when looking at the 52 week high for each. In some cases like AMRS, the pull has been brutal. Regardless I am comfortable with Gevo and feel they are headed in the right direction and have many good partnerships that will help them succeed.
I personally do not believe that “something is fishy” going on with management. They clearly communicated earlier this year they needed to raise capital and smartly did so while the opportunity to do so was good for them. The SEC I can’t imagine would investigate anything in my point of view as “GEVO management” hasn’t done anything to warrant it, again from my perspective.
In short, I view Gevo’s chances as “above average” compared to other companies in the same market sector. I believe they have the best chances of succeeding and thus I remain patient and confident.
Thank you
"Don't you think it will make her look bad if she reverses it so soon after the ruling, won't it look like she judged hastily just less than 2 weeks ago?"
Honestly, I’m not sure what to think. Clearly she (judge) is bothered by GEVO’s inconsistencies thus opening the door to a change in opinion. I have to say this really is unfortunately that GEVO has flexed their muscles so soon before the court hears the patent(s) litigation next April 2013. Over confidence breeds arrogance and in this case I sincerely hope it doesn’t cost GEVO any near term opportunities.
From the article you posted....
Butamax asked U.S. District Court Judge Sue Robinson to maintain the status of her June 12 order limiting Gevo's sales of isobutanol produced at a startup plant in Luverne, Minn., to a subsidiary of South Africa-based energy and chemicals company Sasol for chemical applications, and to the U.S. Air Force for jet fuel testing applications.
Robinson said she would issue her ruling no earlier than Friday.
While saying Butamax has a heavy burden in proving that she should maintain the status quo, the judge also expressed concern about apparent contradictions between what Gevo has told the public and what is has told the court.
Robinson noted that Gevo was arguing that it would suffer irreparable harm if she maintains restrictions on its entry into the fuels markets, despite the company's previous indications to the court and in public statements that its business plan was primarily focused on the chemical industry.
"There's been so much inconsistency between public and litigation statements," she told Gevo attorney James Brogan.
Robinson also seemed to dismiss Brogan's arguments that preventing Gevo from moving forward in trying to develop fuel industry partnerships until the patent dispute is finally resolved will scare away investors and make it difficult for the company to raise much-need capital.
"You're asking me to base a decision on a market that is not predictable," the judge said, suggesting that investors are "fickle" and that those who might decide to turn away or sit on the fence now could quickly swing Gevo's way if it wins the patent fight.
"It's hard for me to believe that anything on Wall Street is written in stone," she said. "It's hard for me to believe that there are lost investors who can't be made up."
What concerns me in the statement made by the Court yesterday is apparently GEVO has now given the Judge more reason(s) to consider Butamax's side apropos the potential damages incurred pertaining to the fuel industry. If in fact the court reverses her decision issued on June 20th (Denied the Motion for Preliminary Injunction sought by Butamax™), Gevo will take a significant hit until such time the trial for April 2013 is played out. This is critical as any potential partnerships "could" be on hold until the litigation is all sorted out. JMHO
Possible news flow
The presiding judge, Honorable Judge Sue L. Robinson’s has a scheduled hearing today, July 3, 2012 on Butamax motions for an appeal for the preliminary injunction against Gevo. Wonder if we will hear anything later today......
"Do you think there might be a rally today?"
Possible, but I wouldn't expect too much today. I would look for the next significant move to be next Tuesday, July 3rd. From the most recent 8-K:
"In connection with their appeal, Butamax has also filed related motions with the United States District Court for the District of Delaware seeking to overturn or change the decision of the court with respect to the preliminary injunction. When the presiding judge has scheduled a hearing on these motions for July 3, 2012"
If the Honorable Judge Sue L. Robinson’s judicial opinion remains the same as she ruled earlier this month, “that plaintiff (Butamax) does not hold a valid patent, nor would the defendant (Gevo) infringe if it did.”, then I think we could see a move up in PPS as confidence increases again in Gevo's technology.
JMHO
This is a nice buying opportunity for those that have been on the sidelines.
Biopearl,
Just my 2 cents, but I would not sell your shares tomorrow. If the market over reacts, it may be a good time to add a few shares. We (MNTA share holders) have been down this road several times this last 18 months and I have no doubt it will bounce back. As previously expressed, it may take some time, but overall the company is in great financial shape and has many “irons in the fire”. You can always sell your shares later this year as we close another calendar year for taxes purposes, but selling this next week I think would be a mistake. JMHO
Linhdtu....very well said, thank you. You concisely captured the essence of what I was thinking.
Best Regards
"That may be true; however, the case just decided by the District Court was about Teva’s IP, not MNTA’s."
You are correct sir, my mistake. I should have been much more specific. My opinionated statement was a general comment as to what I personally view in hindsight. Given all I have read, reviewed and understood, I specifically had come to the conclusion that the IP estate surrounding MNTA’s m-Lovenox was so superior, that companies like Amphastar had very little if any chance of FDA approval let alone market the product successfully. Today I know this was a gross mistake and assumption on my part and in no way am criticizing MNTA science or legal skills.
Additionally, I unfortunately assumed that given the tremendous amount of money invested by MNTA/NVA on developing IP for mCopaxone and a production strategy, that they (MNTA) had surely developed and patented IP that would lead to successful production without even coming close to infringing on TEVA’s IP.
I understand the landscape could change for MNTA over the next 1-2 years and they could prevail on these open unresolved legal cases. I am just expressing my “surprise” and disappointment if you will as to the events of the last 12 months and how I and perhaps other investors “may” not view MNTA proprietary technology as “superior” as I had at one time. As with all things, time will tell.
Hi Gary,
I agree in that the market will once again express it's unhappiness come Monday, but I personally don't see the pps going down to the $12's. Unfortunately I have a feeling it will take much longer this time to recover from this piece of news.
I get the sense investors including myself are tiring of more bad news every time we seem to get a little momentum going. It appears that MNTA IP isn't as strong as I had thought. Amazing how the tables have turned from 12 months ago. I continue to hold out for better days.
Rich (invested and haven't sold one share since late 2010)
Teva Announces Favorable Court Ruling in COPAXONE® Patent Infringement Litigation
http://finance.yahoo.com/news/teva-announces-favorable-court-ruling-062800629.html
JERUSALEM--(BUSINESS WIRE)--
Teva Pharmaceutical Industries Ltd. (TEVA) announced today the U.S. District Court for the Southern District of New York has found in favor of Teva in the Company’s patent infringement lawsuit against Momenta Pharmaceuticals, Inc./Sandoz Inc. and Mylan Laboratories Inc./Natco Pharmaceuticals regarding Teva’s relapsing-remitting multiple sclerosis (RRMS) product, COPAXONE®. Teva filed suit against Momenta/Sandoz and Mylan/Natco for infringement of multiple patents covering the chemical composition of COPAXONE®, methods of using the product and processes for manufacturing the product. This decision covers several patents, the last of which expires on September 1, 2015.
The judge rejected Momenta/Sandoz and Mylan/Natco’s claims that the COPAXONE® patents are invalid and unenforceable and found that the purported generic versions of COPAXONE® for which Momenta/Sandoz and Mylan/Natco seek Food and Drug Administration (FDA) approval infringe those patents. This ruling should prevent the FDA from approving, and the defendants from selling their purported generic versions of COPAXONE® in the U.S. until the Orange Book patents expire on May 24, 2014. As a result of this ruling, Teva also believes that the defendants will be enjoined from selling their products until the process patent expires on September 1, 2015. Furthermore, any purported generic version of COPAXONE® would need to obtain FDA approval prior to being made available to the public. At this point, it is unclear what the requirements would be for approval of a purported generic synthetic peptide.
Dr. Jeremy Levin, Teva’s President and Chief Executive Officer stated, “Teva is confident COPAXONE® will remain a proprietary, global market leading product for the reduction of relapses in patients with RRMS over the product’s lifecycle given the strength of its intellectual property (IP) rights.”
Not so fast....I don't believe the FDA takes into consideration legal issues when considering approval of a drug. Or am I again completely out to lunch????? Comments please....
MCC,
Good morning to you. FWIW, I thought the questions posed by Indigokid were good ones and frankly have been on my mind as well. All the uncertainty surrounding the legal aspects of mL and aL are still an important component IMHO for MNTA.
Thank you kindly sire for your notes on the AM. Sounds positive.
"Wouldn't be surprised to see 12s or even lower...."
What a depressing thought. 21 months later and I'm surprised to admit I am underwater. Life in the big city.....
On another note.....THANK YOU to all the service men and women out there in every branch of our armed forces. YOU are all a blessing to us. Happy Memorial Day.
Thanks ghmm....I listened. Nothing new here. Maybe 2013 will be our year...LOL.
Advancement of Copaxone—regulatory. . . 10% 70% 7.0%
Advancement of Copaxone—development . . 10% 70% 7.0%
I find this "assessment" somewhat bothering in that they are not all that bullish on their own efforts on m-Copaxone and where things stand today. Anyone else draw the same inference?
Congrats....one week later and I'm sure you are all smiles. Nice call.