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Synopsys Inc. Message Board

lakers_w 234 posts  |  Last Activity: 13 hours ago Member since: Jun 13, 2000
  • I'll start with what Matt wrote about production. This was not hypothetical, but a straight answer. Matt expects three fill/finish lines to be ready (& CMC qualified) on time. The two new lines are faster than the first line, and are being tested as we speak. At his last conference (Morgan Stanley) Matt specifically mentioned CMC in connection with milestone payments. I asked him about that and he replied "Good catch. I was trying to hint that many milestones may be happening quickly."

    Regarding expansion, Matt replied that further expansion would come as the result of EU launch.
    I'll write more later, some of which will be my analysis or my "reading between the lines", especially regarding how the EU launch and FDA approval of Toujeo fits into Sanofi's strategy and what I believe to be the reason for the "controlled launch". You may be delighted to learn that is is NOT because of concerns over production capacity.

    By mnholdem, 10/2

    Obamayoumama on 10/2 said:
    1. Yes there are hurdles that MNKD can achieve without SNY, Matt in one of the conference calls talked about getting the equipment certified. SNY didn't go into this agreement not to make sales. There are many mutually agreed terms regarding the efforts SNY will make towards sales.
    2. Yes there are commitments we heard that on a previous conference call.
    3. We spoke about the loan and the size of the loan. Matt made it clear that the $175 million was much more than they will ever need. He didn't mention an exact number but said that if you knew him, you would know that the $175 million was much more tha projected to need.

  • Reported via Event Date Name Ticker Shares * Change % of Portfolio

    13F 2013-12-31 MannKind Corp MNKD 8,000 0 0.00
    13F 2014-03-31 MannKind Corp MNKD 1,989,630 1,981,630 0.12
    13F 2014-06-30 MannKind Corp MNKD 2,006,236 16,606 0.29
    13F 2014-09-30 MannKind Corp MNKD 2,009,230 2,994 0.14

  • Reply to

    9/30 Top holders' Shedule 13F filings:

    by lakers_w Oct 12, 2014 12:58 PM
    lakers_w lakers_w Oct 12, 2014 1:28 PM Flag

    whalewisdomDOTcom/stock/mnkd
    whalewisdomDOTcom/filer/stock_history/integral-derivatives-llc/mnkd/

    Integral Derivatives
    Reported via Event Date Name Ticker Shares * Change % of Portfolio
    13F 2013-12-31 MannKind Corp MNKD (PUT) 45,000 New 0.00
    13F 2013-12-31 MannKind Corp MNKD (CALL) 78,600 33,600 0.01
    13F 2014-03-31 MannKind Corp MNKD 13,058 -65,542 0.00
    13F 2014-03-31 MannKind Corp MNKD (CALL) 58,600 45,542 0.00
    13F 2014-03-31 MannKind Corp MNKD (PUT) 110,600 52,000 0.01
    13F 2014-06-30 MannKind Corp MNKD (CALL) 33,500 -77,100 0.01
    13F 2014-06-30 MannKind Corp MNKD (PUT) 50,100 16,600 0.01
    13F 2014-09-30 MannKind Corp MNKD (PUT) 65,400 15,300 0.01
    13F 2014-09-30 MannKind Corp MNKD (CALL) 46,500 -18,900 0.00

  • Reply to

    9/30 Top holders' Shedule 13F filings:

    by lakers_w Oct 12, 2014 12:58 PM
    lakers_w lakers_w Oct 12, 2014 1:08 PM Flag

    Creative Planning
    Reported via Event Date Name Ticker Shares * Change % of Portfolio

    13F 2013-12-31 MannKind Corp MNKD 8,000 0 0.00
    13F 2014-03-31 MannKind Corp MNKD 1,989,630 1,981,630 0.12
    13F 2014-06-30 MannKind Corp MNKD 2,006,236 16,606 0.29
    13F 2014-09-30 MannKind Corp MNKD 2,009,230 2,994 0.14

    whalewisdomDOTcom/filer/stock_history/creative-planning/mnkd/

  • Reply to

    9/30 Top holders' Shedule 13F filings:

    by lakers_w Oct 12, 2014 12:58 PM
    lakers_w lakers_w Oct 12, 2014 1:03 PM Flag

    Vanguard 14.02M $154.09M June 30, 2014
    BlackRock Fund Advisors 9.62M $105.49M June 30, 2014
    BlackRock Institutional Trust Company, N.A. 6.09M $66.75M June 30, 2014
    STATE STREET CORPORATION 4.85M $53.26M June 30, 2014
    Bank of America Corporation 4.50M $49.30M June 30, 2014
    BlackRock Advisors 2.14M $23.49M June 30, 2014
    AYM Capital 2.06M $22.57M June 30, 2014
    Renaissance Technologies 1.77M $19.40M June 30, 2014
    HIGHBRIDGE CAPITAL MANAGEMENT 1.37M $15.07M June 30, 2014
    Geode Capital Management 1.32M $14.50M June 30, 2014
    BOLTON 1.28M $14.07M June 30, 2014
    TIAA-CREF Investment Management 1.27M $13.94M June 30, 2014
    HAP Trading 1.07M $2.76M June 30, 2014
    Deutsche Bank Aktiengesellschaft 1.01M $0 June 30, 2014
    National Asset Management 879942 $9679 June 30, 2014
    Spot Trading L.L.C 800033 $8.78M June 30, 2014

    SUSQUEHANNA INTERNATIONAL 13.13M $52.78M March 31, 2014
    FMR 9.96M $40.04M March 31, 2014
    Barclays 8.02M $32.07M March 31, 2014
    Greywolf Capital Management 4.78M $19.21M March 31, 2014
    NORTHERN TRUST 2.05M $8.26M March 31, 2014
    Millennium Management 1.80M $7.26M March 31, 2014
    Tang Capital Management 1.80M $7.24M March 31, 2014
    GOLDMAN SACHS 1.46M $5.89M March 31, 2014
    ARISTEIA CAPITAL 1.20M $4.82M March 31, 2014
    Dr. Jeffrey R. Jay, M.D. 1.07M $4.32M March 31, 2014
    Jefferies 1.07M $4.30M March 31, 2014
    Deerfield Management Company 1000000 $4.02M March 31, 2014
    Guggenheim Capital, LLC Managers 831549 $3.34M March 31, 2014
    Tenor Capital Management 814676 $3.27M March 31, 2014
    Oxford Asset Management 1.12M $2.76M March 31, 2012

  • Fund Name Number of Shares Share Valuation As Of
    Creative Planning 2.01M $11.87M Sept. 30, 2014
    CR Intrinsic Investors 1.30M $7.41M Sept. 30, 2013
    Sabby Management 934021 $5323 Sept. 30, 2013
    UBS AG 823819 $4.70M Sept. 30, 2013

  • lakers_w lakers_w Oct 12, 2014 2:18 AM Flag

    All this tells you there are a lot of people and hedge funds holding short positions in MNKD. With no bad news on the horizon and low trading volume, the best way for these shorts to get out of their positions is to spread doubt in the media. This strategy has certainly been evident on CNBC. For example, Jim Cramer, who has always been unceasingly negative on MNKD stock, was asked about MNKD by a caller on last Monday's Mad Money. In response, he resorted to muttering that he'd heard negative things about the stock from people who knew, though not a word was said illuminating what these negative things might have been.

    But the shorts can't hold on forever, and the critical thing to keep in mind is that 63,995,678 MNKD shares were held short on March 29, 2014, just before the ADCOM meeting where Afrezza received the near unanimous expert recommendations that led to its approval. That tells us a lot about the prices at which most of these shares were shorted.

    That's because, at the time of the ADCOM when those roughly 64 million share were held short, MNKD stock had not traded over $6/share since 2010 except for three months in the summer of 2013. During much of this time it traded under $3. Over the months right before the ADCOM, the price mostly traded in the $5 range.

    So while shorts who bought in during the brief periods in the past when the stock surged over $7/share may have closed out their positions with a profit, it's likely there are a lot of shorts left who will need the price to drop considerably lower than its current level to be able to close their positions without taking a loss.

    The last hope of these shorts is that Afrezza will fail to sell when it finally hits the market this winter. If it doesn't, there are going to be a lot of shorts all heading for the exits at once and, once again, this drama queen of a stock could get very interesting indeed.

  • A huge amount of MNKD stock was shorted back when it was trading in the range between $5 and $6.25 before the ADCOM. So its likely most shorts need the price to drop below $5.50 to make any money.

    But the lack of the expected short squeeze is making a lot of people dump the stock right now, which may be getting a lot of shorts out of their positions with a controlled loss.

    Or not. Perhaps people who bought in at $2 are taking their profits and those who bought in late expecting to become overnight millionaires are cutting their losses, by selling to funds and individuals who were waiting for the partnership to buy in.

    There is no way of knowing right now how likely is it that the short squeeze has been merely postponed, rather than avoided. The only people who know what prices are critical here are the remaining shorts, and they aren't saying.

    We don't know how many there are, nor what price point they originally sold at. All we know is that they are doing what they can to spread the fear and doubt that will get people dumping their positions.

  • lakers_w lakers_w Oct 11, 2014 6:01 PM Flag

    Under the terms of the agreement, MannKind Corporation will receive an upfront payment of $150 million and potential milestone payments of up to $775 million. The milestone payments are dependent upon specific regulatory and development targets, as well as sales thresholds. Sanofi and MannKind will share profits and losses on a global basis, with Sanofi retaining 65% and MannKind receiving 35%. Sanofi has agreed to advance to MannKind its share of the collaboration’s expenses up to a limit of $175 million.

    Sny will reimburse $175M loan for its share of expense.
    Mnkd will get $1.1B from Afrezza GM after COGS for its prior R&D cost, front loading.
    35% profit is equiv to 25% royalty which is historically good.
    Mnkd also gets $925M milestone.

    Did u read my post "Dissecting Sny deal"?

    I asked Pfeffer to issue a press release to clarify the deal.

    Many shorts and trader pretend ignorance to drive pps down. Are u one of them?

  • lakers_w lakers_w Oct 11, 2014 3:06 PM Flag

    Hedge funds short Mnkd down knowing that the next catalyst is at least a mo away, then LBO at cheap price. SNY, Lilly, Novodisk are accumulating shrs too, check Level 2 large buy at day end every day. May the best win.

  • lakers_w lakers_w Oct 11, 2014 2:16 PM Flag

    Inhaled insulin question
    Question: I’m a diabetic and have to test my blood sugar several times a day. I then have to inject myself with insulin. My arms, abdomen and legs get sore and it’s not easy to do discretely at a restaurant. Is there an alternative?

  • You could wait a year to see how Afrezza performs in the open market, or you can gauge the partnership.
    MannKind has made no secret about it seeking a partner to market Afrezza. So far there have been no takers, or at least anything that has resulted in a partnership. Therefore, if MannKind fails to find a partner, then it’s a good sign that big pharma is not confident in the product or its competitive advantage. If MannKind sells a large stake in future sales of Afrezza for $100 million, then it’s a good sign that management doesn’t have faith in Afrezza. However, if MannKind gets a Pharmacyclics-like deal, one with $1 billion in cash and half of future revenue, then it’s a good indication to get long MannKind.
    By wallstcheatsheetDOTcom/business/mannkind-corp-will-afrezzas-fda-approval-shake-up-big-pharma.html/?a=viewall#ixzz3FoiHXs00

    Mnkd get reimbursed for prior R&D $1.1B plus milestone payment of 925 M plus 35% profit for Afrezza life. Time to cover, shorties!

  • daytondailynewsDOTcom/videos/news/fast-acting-inhaled-insulin-afrezza-approved-by/vCghK5/?nmredir=true&__federated=1

    The U.S. Food and Drug Administration has approved a fast-acting, inhalable insulin drug called Afrezza.

    "Afrezza Dissolves rapidly upon inhalation to the deep lung...
    Peak I Zulu levels are achieved within 12 to 15 mins of administration."

  • validate the Afrezza mention.
    A picture of the page here: dropboxDOTcom/s/d91smxmnxwyb221/Oct13.png?dl=0
    Announcement in WOMAN'S WORLD MAGAZINE PG 15 OCOTBER ISSUE

    In the large yellow oval, the Ads said:
    "Health Update
    New needle-free insulin

    The FDA has just approved Afrezza, a fast-acting inhalable form of insulin to treat diabetes.
    ASK YOUR DOCTOR IF the new drug IS RIGHT FOR YOU."

    AT ALL SUPERMARKET CHECKOUTS - why am i reading woman's world..... ladies in the house....circulation of this is huge - cat is out of the bag and only the beginning!!!!!!

    Woman's World is a free American supermarket weekly magazine with a circulation of 1.6 million readers.

  • Company Symbol 9/30/14 9/15/14 Chg % Chg % Float Days to
    cover Avg daily
    volume

    10 MannKind Corporation MNKD 78,579,323 74,292,867 4,286,456 5.8 31.6 15 5,418,887

  • 4. Production of Afrezza should begin in November.

    Sanofi is expecting a robust launch in the first quarter of 2015. This is why, as part of the deal, SNY demanded that MNKD contract to buy a lot more insulin so that there will be sufficient insulin on hand to meet these expectations.

    The ultimate plan is to use SNY's insulin as the raw material, which will reduce costs and increase margin. But because any insulin used to manufacture Afrezza must go through an FDA approval process MNKD ensured it has adequate supplies for the next several years of the one insulin that the FDA has already approved.

    It has not been decided whether the aging Pfizer insulin (already expensed) will be submitted for approval. With Sanofi being a manufacturer of insulin, that old insulin may well end up a sunk cost.

    1. MNKD believes that the 65/35 profit sharing deal with Sanofi will yield them the equivalent of a 25% royalty, but with several advantages.

    One is that the deal is for the life of Afrezza as a product, not just the life of the patent. This is important, because the history of other patented insulins like Humalog and Novolog shows that they typically continue to be sold as premium prices long after the patents were due to expire. The other advantage is that the terms of the agreement mean that Sanofi (NYSE:SNY) will be fronting MNKD's development costs going forward into the launch, which means that MNKD will not need to issue more shares. This is good news for shareholders.

  • 2. The tests are done for the 12 unit cartridge and management expects to submit it for approval shortly.

    The hope is to have these large cartridges available at the time of the product launch. This is very significant, because most people with type 2 diabetes will be using doses that will range from 12-36 units per meal. The larger the cartridges, the fewer needed to fill a prescription. As Matthew Pfeffer, MNKD's CFO points out, the factory measures production in cartridges, not units of insulin, so being able to produce the larger cartridges means that more patients can be served with the same production capacity.

    3. There is the possibility that MNKD will also produce cartridges with smaller doses than are currently available.

    I see this as almost certain. That's because the FDA has asked for a post approval pediatric study involving children as young as age four. Children of that age who have diabetes almost all have type 1 diabetes and they use much smaller doses than adults, often doses in the range of 1/2 to 1 unit. The current smallest Afrezza cartridge is 4 units, which is far too much insulin for very small children. The availability of a smaller dose cartridge would also expand the number of people with Type 1 who could use Afrezza, as many of those who strive for tight control also use doses in the 1-2 unit range.

  • 6. More details emerge about the marketing strategy.

    While existing users of fast-acting insulin are an important market, and one that SNY is extremely well positioned to access, given its established relationships with both endocrinologists and general practitioners who prescribe Lantus, the much more enticing market is people with type 2 diabetes who are not currently using any insulin. It sounds like SNY will be aggressively pursuing this market, as we should hope they will, not only for the sake of profits, but because so many of these patients need to lower their blood sugar more aggressively if they are to avoid diabetic complications. Using Afrezza should make this possible and avoid the concerns that are developing around the safety of the incretin drugs.

    7. SNY is going to be aggressively pursuing approval in other countries.

    Most of the testing has already been done that is required for submission to European markets. And the value of the SNY/MNKD deal becomes evident when you realize that Sanofi has already gotten Lantus approved in 120 countries. That means it already has the expertise needed to negotiate the requirements needed to get Afrezza approved in the world market.

  • 5. There are plans to apply the Technosphere technology to other drugs, but given the limits on manufacturing capacity the challenge is to determine which drug candidates would be the most profitable and hence worth producing.

    The most interesting comment made on this topic was the suggestion that the use of the Technosphere technology to administer pain medications has the advantage that, since pain drugs are not administered on a daily basis the way insulin or some GLP-1 drugs are, getting approval for their use with the Technosphere technology may be much easier. This would be because the fear of damaging the lung is much less with only occasional use. This makes a lot of sense, and gives me the impression that the migraine drug is probably the next one to be developed as a Technosphere offering.

    Though the GLP-1 drug is also discussed as a candidate, and SNY has the right as part of the partnership deal to first refusal for the application of the Technosphere technology to a GLP-1 drug, their drug is not currently approved for use in the U.S.. In addition, given the grave concerns that have been raised about the side effects of this class of drugs, the road to approval for a Technosphere GLP-1 drug could involve long and costly safety studies. Pain drugs are probably a much better choice.

    Another comment that stood out in this presentation was Pfeffer's comment that there are quite a few important drugs that might be candidates for using the Technosphere delivery system because they have safety problems when delivered into the digestive system, because they are toxic to the liver, but which might be safe if administered in a way that skipped digestion. This makes me suspect that there may be a specific drug under consideration that would fit this description.

  • lakers_w lakers_w Oct 10, 2014 3:19 PM Flag

    Blue Light Special sale. ER on 11/3. Technosphere licensing announced soon...

SNPS
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