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Post by rrtzmd on Nov 3, 2015 11:37:44 GMT -5
18M+ shares are in calls below $3.00 strike, according to last night's OI. Where are the shares for delivery ? It depends on whether they are "covered" or "naked." If "covered," whoever sold them just delivers the stock from their account. If "naked" then they have to be bought on the market. The vast majority are most likely "covered." |
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Post by rrtzmd on Nov 1, 2015 22:43:22 GMT -5
The reporter misspelled his name, but reported Matt Pfeffer's comments. He hopes that MannKind's products will be in Israeli hospitals soon:
Matthew Pepper, Vice president and CFO of MannKind, who took the stage and rang the TASE opening bell added, "I am proud and excited to be in Israel to list Mannkind for trade on the TASE. This is the first step of the company in Israel which reflects our intention to maintain a long term relationship with the Israeli capital market and the local biomedical industry. MannKind managed to promote a product throughout all stages of development to marketing approval and to market. Our ability to deliver insulin through an inhaler involves a revolutionary technology and I hope that our collaboration with Sanofi will help the inhaler also enter the Israeli hospitals soon. We are going to continue to develop the unique technology also for additional medical indications."
www.mondovisione.com/media-and-resources/news/tel-aviv-stock-exchange-opening-bell-ceremony-with-mannkind-corporation/
I would like to see Matt and Hakan banish the word "hope" from their vocabulary. It would sound so much better if they said, "we believe". This is good news however. For all intents and purposes, it might be best simply to ban Matt and Hakan from saying anything, period. |
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Post by rrtzmd on Oct 31, 2015 22:55:13 GMT -5
Sanofi says they'll be sharing their latest "roadmap" on November 6: roadmap announcement coming up"Despite headwinds in our diabetes business, we are confident in Sanofi's long-term prospects and we look forward to sharing our roadmap for the Group on November 6, 2015." I noticed they were aggressive about pushing praluent: "In September, the European Commission (EC) granted marketing authorization for Praluent® (alirocumab, collaboration with Regeneron) for the treatment in certain adult patients of hypercholesterolemia characterized by high level of low-density lipoprotein (LDL) cholesterol. This approval follows the FDA approval received on July 24th. In August, Praluent® was also submitted to Japanese health authorities." But I still can't find anything regarding efforts to gain foreign approval for afrezza. This will change in 1Q16 as a result of 9/22 JAC. Multiple new fronts will be opened simultaneously in the Diabetes War when the Allies fight back in EU and ME. Olivier was fed up. He will declare war on Nov 6. 'Nuff is 'Nuff. The 3rd, 4th indicator might be autoimmune disease TS drugs Rheumatoid arthritis (RA) is an autoimmune disease that causes chronic inflammation of the joints. Autoimmune diseases are illnesses that occur when the body's tissues are mistakenly attacked by their own immune system. AbbVie's Humira and Amgen's Enbrel together hold more than 80% of the inflammatory condition market share. Enbrel is currently on pace for $5 billion in sales, whereas Humira could be on pace for a record year of more than $13 billion. With little in the way of established competition, these two titans can raise their prices on an almost as-needed basis. Something worth watching here is the imminent loss of patent exclusivity on Humira at the end of 2016 and the eventual introduction of non-branded competition. It's possible that the inflammatory condition class could see cost cuts in the near future with Humira's dominance ending, but we're still a little more than a year away from that happening. Can we say AbbVie's inhaled Humira? Multiple sclerosis (MS) is a potentially disabling disease of the brain and spinal cord (central nervous system). In MS, the immune system attacks the protective sheath (myelin) that covers nerve fibers and causes communication problems between your brain and the rest of your body. There are a number of big players in MS, such as Teva Pharmaceutical (NYSE:TEVA) with its new longer-acting version of Copaxone. It'll be interesting to see how successful Teva is in transitioning patients over to the new extended formulation considering the prior-generation formulation is now off patent. For now, Copaxone maintains a commanding lead with nearly 30% market share, but expect this share to shift when Express Scripts updates the data next year. Inhaled Copaxone by Teva? Per the license agreement: SNY/MNKD license agreement"JAC Decision-Making. All decisions within the authority of the JAC shall be made by unanimous vote or written consent, with the MannKind members of the JAC collectively having one vote and the Sanofi members of the JAC collectively having one vote in all decisions of the JAC. The members of the JAC shall use reasonable efforts to reach agreement on all matters. If, despite such efforts, agreement on a particular matter cannot be reached by the JAC within 15 days after the JAC first considers such matter (or such shorter or longer time as may be agreed by the Parties), then either Party may, by written notice to the other Party, have such matter referred to, on behalf of MannKind, the President of MannKind and, on behalf of Sanofi, the Senior Vice President – Global Diabetes of Sanofi. Such executives shall use reasonable efforts to resolve the matter referred to them within 10 days after such referral. If, despite such efforts, such executives are unable to resolve such matter within 10 days after such referral (or such shorter or longer time as may be agreed by the Parties), then the Sanofi co-chair on the JAC shall have the right to make the final decision with regard to the disputed matter following good faith consideration of MannKind’s comments, subject to Section 3.4 and provided that the Sanofi co-chair on the JAC shall not have power to resolve a dispute: (i) in a manner that would require MannKind to perform activities (A) for which Sanofi will not reimburse MannKind’s costs (except as expressly set forth in this Agreement or the Supply Agreement) or (B) which MannKind has not agreed to perform as set forth in this Agreement or otherwise in writing; (ii) in a manner that would conflict with the terms of this Agreement or the Supply Agreement, including all Exhibits and Schedules hereto and thereto; (iii) by unilaterally determining that it has fulfilled any diligence obligations hereunder; (iv) in a manner that would modify or increase MannKind’s responsibilities under the Development Plan; or (v) regarding changes to any Budget, except as may be required to reflect activities required by a Regulatory Authority or Applicable Laws. For all purposes under this Agreement, any decision made pursuant to this Section 3.1(f) shall be deemed to be the decision of the JAC." In other words, while MNKD can "plead" its case, the SNY "co-chair" is the final judge and jury. Now, the recent Sanofi earnings report and conference call obviously didn't suggest much in the way of enthusiasm about afrezza and didn't offer any info about the latest JAC meeting or info about any "new fronts" in the "diabetes wars." Given SNY's "oligarchy," I don't see any reason to expect the "kingdom" to change management strategy from the one it has been following. Perhaps SNY's November 6 presentation will offer further insight, but about the only thing the CEO could announce significant for afrezza would be a trial demonstrating that's it's more than "non-inferior." |
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Post by rrtzmd on Oct 31, 2015 20:37:35 GMT -5
I won't go and find it for you, but there is an announced road map for approval in Europe and Japan, and we are not there yet. Therefore your statements seems clearly premature and somewhat malicious, or if you prefer simply wrong Sanofi says they'll be sharing their latest "roadmap" on November 6: roadmap announcement coming up"Despite headwinds in our diabetes business, we are confident in Sanofi's long-term prospects and we look forward to sharing our roadmap for the Group on November 6, 2015." I noticed they were aggressive about pushing praluent: "In September, the European Commission (EC) granted marketing authorization for Praluent® (alirocumab, collaboration with Regeneron) for the treatment in certain adult patients of hypercholesterolemia characterized by high level of low-density lipoprotein (LDL) cholesterol. This approval follows the FDA approval received on July 24th. In August, Praluent® was also submitted to Japanese health authorities." But I still can't find anything regarding efforts to gain foreign approval for afrezza. |
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Post by rrtzmd on Oct 31, 2015 14:39:20 GMT -5
www.investorvillage.com/smbd.asp?mb=1492&mn=8031&pt=msg&mid=14102357%C2%A0online Russian Jewish news - Afrezza karman.zahav.ru/Articles/6714/sanofiInhaled insulin AFREZZA may soon appear in IsraelInhaled insulin AFREZZA may soon appear in Israel08/14/2014 10:44 Pharmaceutical company Sanofi and American biopharmaceutical corporation MannKind, engaged in research of cancer and diabetes, as well as the development of therapeutic drugs against these diseases, have signed an agreement for the distribution of the first of its kind inhaled insulin AFREZZA. A new form of insulin for the treatment of type 1 and type 2, has received considerable support from the FDA (FDA Office of the Food and Drug Administration in the United States), for now, the use of insulin by diabetic patients of the first and the second type is much easier and painless . AFREZZA is a revolutionary innovation: human insulin analog, equal in potency of human insulin and charged into the cartridge (inhaler) for inhalation. AFREZZA - a rapid-acting insulin, which, like their counterparts (eg, insulin Apidra), simulates the response of the body to increase blood sugar levels after a meal, soaked in parallel with the highest food. Such insulin necessarily used in addition to basal insulin (for example, Lantus). The use of rapid-acting insulin as a food insulin has the following advantages: * Rapid onset of action allows you to inject insulin just before eating, when we already know the amount of food that will be eaten now, * In some cases when it is difficult to determine in advance the amount of food, including young children, the injection can be made after a meal by the dose depending on the amount of food, * Due to the fact that the duration of ultrashort insulin roughly corresponds to the time increase in blood sugar after a meal, you can not snack between meals. However, one disadvantage of using such are part of the daily insulin injections. Roni Birinboym, CEO of Sanofi in Israel: "Inhaled insulin AFREZZA save diabetics from having to do injections and greatly facilitate their lives. This is a real revolution in the world of pharmacology. Our company will do everything necessary to deliver as soon as possible this insulin in Israel. " AFREZZA go on sale in America in early 2015. Of course, the problem is that Sanofi is responsible for international approval, sales, and distribution. So far they haven't expressed much interest in attempting approval in other countries. |
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Post by rrtzmd on Oct 31, 2015 14:35:03 GMT -5
One could argue that the theory I put forth here was an attempt to make myself feel better about Sanofi. Trust me, I want to believe that there is a bigger game plan. Could that cloud my judgement? Perhaps. That said, something just doesn't add up with what we can see versus what must actually be happening behind the scenes. Sanofi knew long before they partnered with Mannkind that Lantus was going to lose massive market share. It is why they developed its replacement. Sanofi stated that the launch of Afrezza would be gradual. So they knew that sales would not ramp up quickly. I'm sure they could not predict exactly how sales would turn out, but they had an idea. So in the most recent quarterly report they state that Lantus is losing market share more quickly and gee everything else is bad too in their whole diabetes unit. The way the CEO talked about their whole diabetes program made it appear like they did not have any plan. That's what I am not buying. You would need to believe that Sanofi is incompetent. That is a theory that many bashers are floating right now. I have an attorney friend who told me once that one of the best court room strategies he used was to feign that he was fearful of the opposing council. He laughed when he told me how as he showed fear and incompetence, how overconfident the other side would get. He won most of his cases. Could I be wrong, absolutely. I just don't buy that Sanofi is just going to lay down and let their diabetes program along with Afrezza just die a slow death. I believe they have a plan. "I believe they have a plan." The only "plan" afrezza needs from Sanofi is a one to do a trial to attempt to demonstrate something better than "non-inferiority." Without something analogous to the "real life" toujeo trial for afrezza, I can imagine no other plan that could make a significant difference. |
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Post by rrtzmd on Oct 31, 2015 14:24:40 GMT -5
And what? Lose all your money that’s what….I posted for the first time a couple weeks ago here and got lynched. Asked some basic questions on this board like……. Does the current management team at MNKD have the track record to turn this around (someone suggested I find that answer on Edgars LOL) and why didn’t Matt just come out and tell the whole story about the debt pay off…..I found it Interesting that he could tell part of the story at the Aegis presentation but couldn’t divulge all using the quiet period as an excuse. That’s shifty…… When I started investing the investment firms would deliver the stock (paper) and we clipped coupons (bearer bonds). Admittedly I am not familiar with some of the current terms used in public forums i.e. FUD, or valuation methods (Uber) but I do have enough experience to know investing in proven leadership is a key component to a successful long term outcome with any type of investment. I own the stock and the call options (Leaps). I went long the positions because I hate needles and believe in the product. My concern now is the management and their ability to get this done before the lights go out. I guess we will all learn more on the next earnings call - when is that? The next earnings call? As far as I can tell - I don't remember attempting to "lynch" you or anyone else on this board, whether or not your views are contrarian to mine, unless you go by a different name and we have corresponded in the past. I like to see rational and reasoned arguments and discussions about MNKD to help my own investment thesis. What I grow tired of is people "worried" about me losing all my money. There sure are a lot of people concerned about me on this message board and around the internet that I have never met, nor likely ever will meet. While I appreciate your genuine concern about my welfare, quite frankly none of you knows my exact situation in life, my risk tolerance, nor my long term goals. Without that why are you the least bit concerned with how I invest MY money? Everyone must have their own investment portfolio, timeline, and appetite for risk, and then balance it against the public information they have about the companies they invest in. I can't say that I have been investing nearly as long as you have so I can't say I have ever seen a paper stock certificate (well except for a 10 shares of the Pittsburg and Lake Erie Railroad @ $50 that was sold in 1957 that I have hanging on the wall of my office for winning a train board game tournament  I am in my early 30s and I have a long timeline ahead of me of investments I will be making, companies I will be starting, and places I'll be traveling. MNKD is one of my many investments that include a portfolio of many public companies large and small, some real estate, my own software company that I founded, a stake in some professional poker player's winnings, part ownership of a professional video game player league, an investment in a climbing gym, a stake in a puzzle escape room, some money put into an organic farm, and probably some other random investments I have forgotten about. Do I pay attention to all of them? To some degree - sure. But I don't let worries about their short term valuations ruin the wonderful life that I am living and if they ever did, that's when I would know it was time to sell. And just for the record, the "money" that I have in MNKD I have already committed to as a donation to my alma mater. It would sadden me to see the investment tank because then my school would receive substantially less, but the odds are good that my investment will be great and be worth millions if not hundreds of millions (okay that might be a stretch), by the time I turn it over to my school - tax free, might I add which is why you will never see me daytrading and eating the 39.6% automatic hit on my investment. So given that and my knowledge that I have the inherent intelligence, initiative, skills, knowledge, and work ethic to make many times over the money I have invested in MNKD, you can understand why I do not worry about minor non events and non news with regards to MNKD. If something material does change either positive or negative, then I will re-evaluate my investment. Until then my analysis when I bought the stock is no different than it is now. lmj implied that management better get their act together or else. I on the other hand feel that management can only do so much within the constraints they have. I am of the school of thought that Warren Buffet subscribes to - make sure you have a foolproof product that will sell despite fools running the company because eventually they will. The lights will not go out at MNKD. They hold too much intellectual property and value not to be gobbled up should the worst case scenario happen. Life goes on either way. Stop agonizing over the day to day and only invest what you are willing to lose. You will sleep better and live a better life as a result. "I on the other hand feel that management can only do so much within the constraints they have." That's an important part of the problem. MNKD's management can effectively do nothing but appeal to Sanofi to "get on the ball." Beyond that they are totally powerless. Worse yet, MNKD also appears to be in difficult financial straits, so doing anything other than sending appeals to Sanofi is probably out of the question. |
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Post by rrtzmd on Oct 30, 2015 0:00:07 GMT -5
It sounds odd to say it but I am relieved to hear Sanofi setting expectations for Afrezza low. This is actually not bad from a long-term standpoint. Too many times unrealistic expectations have been set and taken advantage of when they are not met. Hopefully their models for Afrezza sales over the next 3 years predict much lower than expected sales, so when Afrezza does start to take a foothold it will be seen as a triumph and not be downplayed. The problem is how long MNKD, given its financial condition, can tolerate SNY's low "expectations." |
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Post by rrtzmd on Oct 29, 2015 14:38:27 GMT -5
Novo is down over 6% and Sanofi over 3%. The diabetic space is getting hurt. Mannkind down 12%. Whatever and does it really matter? It's all trading noise. Diabetes isn't going away! Well, I don't think the whole 12% 16% 18% was sector specific. Although, I agree with you, at this point in time, it does not matter, I too am starting to wonder when it will start mattering. I have my own game plan and time projections, and I want to see it played out, so for the time being I am not going anywhere. However, I can not in good faith say I am not annoyed about how the whole game is being played, and, in days like today, equally annoyed about the lack of empathy towards MNKD investors from both SNY and MNKD management, which, in theory, must have known exactly what SNY would say, and do little, at least in appearance, to soften the blow. Of course there is the argument to be made of whether they could actually say something to soften the blow, or anything they say would have made it worst. Based on recent history one could easily argue the latter would be more likely. "Of course there is the argument to be made of whether they could actually say something to soften the blow..." I suspect that was the purpose of the press releases about the 9 million shares being returned and the Tel Aviv listing. The timing seems just a little too "good" -- 23rd, 26th, 29th. The question remains about the other "shoe" that drops in a few more days. |
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Post by rrtzmd on Oct 29, 2015 14:12:45 GMT -5
Many biotech stocks in my portfolio or on my watchlist are in the red today:
ISIS -0.7% INO -0.9% NWBO -0.9% CARA -1.8% ZIOP -1.76% HALO -3.02% NVAX -3.27% XON -4.5% NLNK -4.78% MNKD -5.69% EXAS -7.85%
ACAD is +0.08% SGMO is +11.83% following CEO Edward Lanphier comments at yesterday's Q3 2015 earnings call.
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Obviously, our partner's earnings call didn't result in stellar results for Afrezza, but I wish folks would calm down a bit. Sanofi's treatment of Afrezza is not the primary reason why the share price is down today.
Down 16.4% at 3:10 and that is one ugly chart. Looks like it just jumped off a cliff at 2:30. |
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Post by rrtzmd on Oct 29, 2015 11:52:49 GMT -5
I think it's beyond serious question that Afrezza works magnificently. What is causing me pause is definitely not the product itself which is clearly wonderful. I'm not personally even losing patience. I can wait for blockbuster status, but I'm not so sure how long Mannkind's balance sheet will allow the company to wait. My concern relates to whether Mannkind can reach positive cash flow on its current financing. SNY's comments today would seem to shed a negative light on those prospects because they tend to indicate that SNY's already not very high short term expectations for Afrezza may not be met in reality. SNY is in the best position to know what is likely to happen to Afrezza's sales over the next few quarters and if they are walking back their already not so impressive expectations, what does that say about MNKD's likely need for more cash before it reaches profitability?
I'd appreciate any insights on this issue from the board. Thanks. Indeed, my own rough calculations suggest that by January MNKD will have about 180 million in debt -- figuring about 50 million on the Sanofi loan. Of course, they still have the 20-25 million a year obligation to buy insulin from Amphastar. Not counting those expenses, there's still the "burn" of 15-20 give or take million a quarter. Although milestones might be on the way, I posted in the "thoughts sanofis right terminate agreement" why those may be a long way away. Based on the recent debt settlement problems, neither Al nor anyone else seems willing to step in and lend a hand and/or money. So in the meantime, what's MNKD to do to pay the bills? At this point the long term success of afrezza seems irrelevant to Mannkind's current problems. |
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Post by rrtzmd on Oct 29, 2015 11:29:20 GMT -5
Afrezza sales has nothing to do with their declining sales as mnholdem said it's net new so it's not like Afrezza is losing sales. It is climbing (slower than we would like) but it is going in the right direction. I would think with the declining sales in the diabetes market this would be an opportune time to use the Ace in the hole (Afrezza) to regain market share and sales. I understand that the label is less than ideal currently and assume they are working to fix that but the perception in absence of info is they are just sulking in their sorrows of declining sales instead of doing something about it. The press release says: "Accounting for recent market trends, Sanofi now projects global diabetes sales over the period of 2015-2018 to decline at an average annualized rate of between 4% and 8% at CER. Approximately half of this revision is linked to insulin glargine and the other half is related to reduced expectations for Afrezza®, Lyxumia® and BGM (Blood Glucose Monitoring)." That sounds to me like they are not blaming afrezza for declining sales per se, but are blaming afrezza and the other two for half of the REVISION in sales estimates. In other words, in the original estimates they accorded afrezza turned out significantly higher than actual revenues. |
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Post by rrtzmd on Oct 29, 2015 11:11:30 GMT -5
Thanks for the links. The first thing that stood out to me was slide 8 showing the graph of the first 25 weeks of toujeo sales with the accompanying note of "additional launches in Q3 in Japan, Canada, U.K, and other EU countries." Then slide 13 claims tier 2 status for praluent and that "launches in first EU countries underway." One would think that it would be more cost efficient to co-launch afrezza with toujeo and praluent or at least try. |
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Post by rrtzmd on Oct 29, 2015 10:54:45 GMT -5
This is what bothers me. Why is Praluent Sanofi's golden child ? Jérôme Contamine: As you know, Praluent® received U.S. approval in late July and EU approval in late September. The product was launched in the U.S. within days and is gaining market access and developing awareness in the broader medical community. It will become available in some major European countries by year end. Our comprehensive patient and prescriber support hub, called “MyPraluent”, has already served as an effective platform for over 4,000 prescribers. We recently secured branded preferred Tier 2 commercial formulary position with Express Scripts. In addition to gaining greater U.S. market access, near-term expansion opportunities are focused on driving product awareness and adoption. We are also pleased to report that launches in the first European countries are underway. So overall, launch progress is consistent with our expectations of a gradual uptake in the market. Profit margin for one, and I suspect they expect toujeo and praluent to be gain third party payor support more easily than afrezza, based upon the new clinical trials they have initiated with those two drugs. |
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Post by rrtzmd on Oct 28, 2015 0:28:21 GMT -5
New ticker symbol: מנקד Can someone post a link to a real time MNKD quote on the TASE? I want to start getting up at 2am to check quotes instead of waiting until 0930 every day Just posted this on ST also. If you bring it up (in English) for BTX now, and then switch the security/company/symbol selection to MNKD when it starts, you'll get real time data, historical charts, etc etc. Its not up yet to select. Here is a direct link to the BTX page: www.tase.co.il/Eng/General/Company/Pages/companyMainData.aspx?ShareID=01136365&CompanyID=001651&subDataType=0&Just been taking the platform for a little test drive. Useful stuff there! Curious to see though, if the real time data will be posted in $US or not ... This is the MNKD page: MNKD trading |
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I am in my early 30s and I have a long timeline ahead of me of investments I will be making, companies I will be starting, and places I'll be traveling. MNKD is one of my many investments that include a portfolio of many public companies large and small, some real estate, my own software company that I founded, a stake in some professional poker player's winnings, part ownership of a professional video game player league, an investment in a climbing gym, a stake in a puzzle escape room, some money put into an organic farm, and probably some other random investments I have forgotten about. Do I pay attention to all of them? To some degree - sure. But I don't let worries about their short term valuations ruin the wonderful life that I am living and if they ever did, that's when I would know it was time to sell. 
