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Post by matt on Apr 25, 2016 15:57:35 GMT -5
The "host" is the person the conference call company coordinates all the administrative details with; it is not the main speaker on the call. The host maintains a second open phone line to the conference call company and directs which analysts or shareholders waiting in the queue get to ask questions and in which order. Most quarterly conference calls are 100% scripted and orchestrated from word go; this MNKD update might be different.
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Post by matt on Apr 25, 2016 8:30:22 GMT -5
Attempts to reverse T2D are focused on making the body more insulin sensitive. Type 1 diabetics have a problem because their bodies fail to produce enough insulin (pancreatic beta islet cells die or become incompetent for various reasons), but Type II diabetics often produce plenty of insulin but their bodies do not respond normally to the insulin that is produced. This is often referred to as a lack of "insulin sensitivity". Over time the Type II body produces more and more insulin in an attempt to offset the lack of sensitivity, but that can in turn exhaust the islet cells and at that point the patient may need supplemental insulin.
The principal causes of Type II are genetic and life-style related. Obviously you cannot change your genetic composition, but you can change your diet and exercise regimen and, if you do, your sensitivity to insulin will change accordingly. The question of whether an new versus old Type II can be reversed depends on a host of factors including the residual level of insulin production and, most importantly, the motivation of the patient to change their diet and level of exercise. It is not reversible for everyone, but many can reverse the disease or at least lessen the severity. Given the complexity of diabetes, advice on whether a particular patient can mitigate existing disease is a topic more suitable to discuss with a physician following a comprehensive work up rather than a message board discussion.
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Post by matt on Apr 23, 2016 10:31:39 GMT -5
According to NASDAQ rules a market maker may choose to participate in the after hours market or pre-market trading sessions, but they don't have to. However, if they do then they must quote a bid-ask spread for securities they cover and must buy or sell at the quoted price. A lot of market makers will actively participate in the after hours session for a short time but then, if there is no activity, they shut down and go home for the day.
However, to minimize any exposure to surprise announcements, they quote numbers far removed from the last traded price (remember the exchange requires them to fill orders at the prices they quote). So these are not "real" quotes but a way to signal that the particular market maker is closed for business. The quotes return to a normal range as the opening bell approaches on Monday morning. If you want a realistic view of the price, wait until Sunday and see where the company trades on TASE and do the foreign currency calculations. There is usually minimal difference between TASE and NASDAQ when both markets are open.
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Post by matt on Apr 22, 2016 7:16:37 GMT -5
While I think a label change would certainly help, I don't think I can agree with a change "sooner rather than later". This was an extremely small study, just 34 patients across four different arms, so an average of just 8.5 subjects per arm. That makes for some very weak statistical power and as a matter of pure mathematics the study cannot meet the FDA's criteria for a label change; that will take a much larger study. Note that the study was originally designed in 2008 and just terminated (for undisclosed reasons) in 2016. Nothing happens fast in pharma, especially when rolling back a safety measure is concerned.
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Post by matt on Apr 20, 2016 9:04:27 GMT -5
The interesting question is whether all the states legalizing marijuana will destroy the market for a legitimate drug. There is no question that cannabinoids have a favorable effect in many diseases, but getting a natural or synthetic molecule into TS or any other delivery system will require the developer to run the gauntlet of FDA approval with the associated delays and costs. Will that still be an interesting market to invest in if your friendly neighborhood pot dealer can hook you up without a prescription? Certainly physicians will be happier prescribing an approved drug, but will the informal market kill the pricing such that bringing a legitimate drug to market is economically infeasible.
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Post by matt on Apr 19, 2016 7:36:50 GMT -5
This is great news! Does anyone know the kind of bite these guys take? All of these contract marketing companies work the same way, and it is an ala carte relationship. In some cases they just provide a few warm bodies and in other cases they provide a full-service sales and marketing organization. Obviously the more services they provide the more it costs, and some contracts have performance-based bonuses included. Without knowing the details of the contract, it is hard to say how much MNKD will have to pay.
One wild card is whether the sales force will be Publicis hires or MNKD hires as that affects compensation and who has to pay for expansion or termination costs. Contractors are not well-paid relative to pharma company reps, but it would be surprising if MNKD could hire this kind of sales force for less than $5 million (that assumes roughly $85K salary, bonus, car allowance, etc.). MNKD marketing expenses would be on top of that.
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Post by matt on Apr 18, 2016 15:10:02 GMT -5
The item on outstanding shares is obviously what the lawyers refer to as a "scrivener's error". The number of shares outstanding is printed on the first page of every 10-Q and 10-K the last of which read:
"As of February 22, 2016, there were 428,850,858 shares of the registrant’s Common Stock outstanding."
Either the MNKD staff is working too hard and somebody made a silly mistake, or else the outside law firm has an associate unfamiliar with the client that is about to get a butt chewing. Drafting errors happen; that is why you can amend any SEC document after filing.
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Post by matt on Apr 18, 2016 7:57:09 GMT -5
I don't understand the part where it says they have 429M shares authorizes but uninssued. Then it says the offering is for 550M? A registration statement is for a stated amount of money while authorized shares are for a stated number of shares. The maximum size of the offering, practically speaking, is the share price multiplied by the remaining unissued shares. The fact that a company registers a $500 million offering does not mean that they can legally sell that much if they don't have enough unissued shares to sell. For example, if the share price is $1 and the unissued shares are 100 million, the company can only complete a $100 million offering despite what the registration statement says.
If the registration goes through at $500 million and the company later increases the authorized shares (as MNKD has requested) or if the price per share increases, then the full amount of the registration can be used. It all comes down to the market values on the day the deal is done; either the price per share, authorized shares, or face value of the registration statement will limit the size of the offering but you can't know which of those is the binding constraint until it actually happens.
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Post by matt on Apr 18, 2016 6:03:00 GMT -5
A shelf registration is a preliminary step before any shares can be sold. Almost every public company qualified by the rules to file an S-3 has filed an S-3 because it allows them to move quickly if the financial markets become favorable.
Dilution can happen if three things are true:
A. If the company has freely issuable authorized shares,
B. An effective registration statement, AND
C. The board has elected to issue new shares
Most every public company goes through the motions of steps A and B "just in case" because there isn't much cost to doing so. Companies that need cash pull the trigger on step C, and that can be in whole or in part (i.e. if there are 100 million shares authorized but unissued, the company can issue the full 100 million or some lesser amount, say 20 million). Also be aware that the price shown in shelf registration is not the price the shares will sell for; it is just a hypothetical price used to compute the registration fee. The actual price is whatever the market says on the days the shares are sold, which could be significantly higher or lower.
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Post by matt on Apr 17, 2016 13:47:12 GMT -5
I don't believe that's an accurate conclusion. Do you have any proof? Liane is correct, this point is specifically covered in the original license contract. Mannkind had the option to repurchase the inventory from Sanofi at a negotiated price or, if they chose not to repurchase the inventory, Sanofi has 180 days from April 4 to dispose of any product still within the permissible shelf life period. It would appear clear from the circumstances that either Mannkind elected to conserve its cash and did not repurchase the product, or else the parties could not agree on a price.
It is common in the industry for the surviving distributor to take over any inventory at historical cost (i.e. reimbursing the previous distributor for what they paid, but no profit). That is the normal practice because it is the nice and polite way to do business (karma counts for something), and because the outgoing distributor will always elect to fire sale the remaining inventory to the big distributors (Cardinal, Amerisource Bergen, or McKesson) rather than take a loss on excess inventory. Since manufacturers want to control prices in the market, it is not desirable to have a bunch of deeply discounted product floating around the distribution system that was dumped by a previous partner.
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Post by matt on Apr 16, 2016 16:54:33 GMT -5
I think you have to be realistic on what will be discussed. If there was a material event Matt would have been required to disclose it within four days per SEC regulations. The fact that the conference call was scheduled more than four days ahead tells you what you need to know.
This is sort of a no win for Matt. Some shareholders have been screaming that they are not kept informed, yet when a conference call is scheduled to update the situation many are not happy unless there is big news. You can't have it both ways. I think that Matt is doing his best under the circumstances and he can't just snap his fingers and make financing deals or distribution deals materialize out of thin air. Give him a bit of slack . . . or sell your shares.
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Post by matt on Apr 14, 2016 17:40:15 GMT -5
So long as Matt has a script that is believable this will be OK for a while. Ultimately, he has to deliver sales but he still has a few quarters to achieve that, but if his strategy is deemed BS by the market (such as too much emphasis on social media marketing) then the message will not be well-received and the price on the 20th will be a blood bath. If he announces a partnership of some sort, it will be the opposite story and the price will spike.
This is a great time for an option straddle. The price is unlikely to stay flat following the announcement, so buy some puts and buy some calls. Regardless of how the price moves, one option will finish out of the money for a 100% loss, but the other will more than offset the loss in profits.
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Post by matt on Apr 14, 2016 12:57:31 GMT -5
In a word, no. Actions such as those discussed in the SA article you linked are designed to garner shareholder support, but as a legal matter they will go nowhere. The Supreme Court has held, repeatedly, that shareholders have ONE AND ONLY ONE cause of action under federal securities law, and that is the right to sue the issuer for making materially false or misleading statements in connection with the sale of a security in violation of Section 10(b) of the Securities Act of 1934. That is why when a company restates earnings or makes a surprisingly bad announcement, the vulture lawyers swoop in and start looking for clients; it is their only chance to bring a lawsuit. All other remedies under the securities law are reserved exclusively to the SEC so that is agency you have to petition if you have a grievance.
The SEC probably should bring more enforcement actions, but you cannot do the simple math you have done and conclude that 50% of all trades resulted in a FTD. The way the Depository Trust handles shares and transfers between brokerages and shares going between certificates and street name is mind numbingly complex if you are trying to figure out what is really going on. The DTC always get it right, in total, and the shares outstanding always balance with what the company has authorized and issued but there are a lot of moving pieces with the possibility of double counts, triple counts, and quadruple counts on given transactions. Without reconciling all the underlying data you can't know what is going on and nobody has access to all the data except the SEC. The NASDAQ doesn't know all the numbers, the transfer agent doesn't know, and MNKD doesn't know and, to make matters more interesting, none of those entities can get their hands on the data even if they wanted to unravel the knot.
Is somebody doing something illegal? Maybe so, but as a shareholder you can neither prove it nor disprove it. |
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Post by matt on Apr 14, 2016 7:50:14 GMT -5
Correct me if I am wrong. APRIL 30TH ISH we find out about institutional Holdings? Let's say we either stay at 26% or move higher,how much of a influence will this have on the stock price? I think it would be huge! Thank you in advance for your thoughts! Most funds are required to report their portfolio holdings as of the end of the 1st and 3rd quarters, and the report is not due until 60 days after quarter end, which means the next reports are not due until end of May. Funds that are 13F filers have a different set rules for 13F designated securities so the requirements get a little complicated.
Most funds have not updated their reports since the end of November when they reported what their holdings were as of September 30. Since the end of Q3 the company has listed on TASE, there have been two changes in the CEO slot, Sanofi terminated the distribution agreement, the sales and financial results for Q3 and Q4 have been disclosed, and the company has booked a big write-off. Relying on stale institutional information from September to make investment decisions in May probably not the best idea.
Those that understand the institutional filing rules know that all of these reports are due long after the information is no longer relevant. You shouldn't expect much price action just because the paperwork catches up to the trades.
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Post by matt on Apr 12, 2016 17:48:43 GMT -5
Interesting it says the field is Neurology, Inflammation I wonder if the neurology has anything to do with Alzheimer's ? IMO, as I stated in my other thread, it has Amgen written all over it... and here is the Amgen's current pipeline in those two areas... Just saying... Therapeutic Area NeuroscienceAMG 581 Therapeutic Area Neuroscience - Modality Small Molecule AMG 581 is a small molecule being investigated for the treatment of schizophrenia. AMG 301Therapeutic Area Neuroscience - Modality Monoclonal Antibody AMG 301 is a monoclonal antibody being investigated for the treatment of migraine. AMG 520Therapeutic Area Neuroscience - Modality Small Molecule. AMG 520 (CNP520) is a small molecule inhibitor of BACE. It is being investigated for the prevention of Alzheimer’s Disease, with Phase 2 studies ongoing. AMG 334Therapeutic Area Neuroscience - Modality Monoclonal Antibody. AMG 334 is a human monoclonal antibody that inhibits the receptor for calcitonin gene-related peptide. It is being investigated for the prophylaxis of migraine. Phase 3 studies in episodic migraine, and a Phase 2 study in chronic migraine, are ongoing. Therapeutic Area InflammationAMG 592Therapeutic Area Inflammation - Modality Fusion Protein AMG 592 is an IL-2 mutein Fc fusion protein. It is being investigated as a treatment for inflammatory diseases. AMG 357Therapeutic Area Inflammation - Modality Small Molecule AMG 357 is a small molecule. It is being investigated as a treatment for autoimmune diseases. AMG 557Therapeutic Area Inflammation - Modality Monoclonal Antibody AMG 557 is a human monoclonal antibody that inhibits the action of B7 related protein (B7RP-1). It is being investigated as a treatment for systemic lupus erythematosus. AMG 157Therapeutic Area Inflammation - Modality Monoclonal Antibody AMG 157 is a human monoclonal antibody that inhibits the action of TSLP. It is being investigated as a treatment for asthma and atopic dermatitis, with Phase 2 studies ongoing. AMG 181Therapeutic Area Inflammation - Modality Monoclonal Antibody AMG 181 is a human monoclonal antibody that inhibits the action of alpha4/beta7. It is being investigated as a treatment for ulcerative colitis and Crohn's disease, with Phase 2 studies ongoing. Enbrel® (etanercept) Therapeutic Area Inflammation - Modality Fusion Protein ENBREL is a fusion protein that inhibits tumor necrosis factor. A Phase 3 study to evaluate ENBREL as a monotherapy for psoriatic arthritis treatment is ongoing. A Phase 3 study to evaluate ENBREL as a monotherapy in maintaining remission in rheumatoid arthritis is ongoing. Not saying you are wrong about that, but pretty much every big pharma is going after these indications. You can substitute Pfizer, Novartis, Glaxo, or Merck into the equation and not have a significantly different answer. Anti-infectives were hot in the 1970's and 1980;s, metabolic drugs were hot in the 1990's and early 2000's, but not so much any more due to the explosion of generics as patents expired on the early ACE inhibitors, ARBs, statins and so forth. Most pharmas moved on to monoclonals, neuro drugs, and cancer where pricing is still attractive, but it will be something totally different in ten years.
It is just the product life cycle at work - station wagons gave way to minivans which gave way to SUVs. I never even got my station wagon with the imitation wood panels on the side.
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