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Post by matt on Apr 2, 2018 7:34:36 GMT -5
Even without sales kicking in right away . . . I don't think you can start a serious discussion with that qualification. Investors take a look at an opportunity and estimate what a product will do in the market and, based on that analysis, assign a value they are willing to pay. The numbers are always bigger in the minds of some investors before the reality of the market sets in; this is why a lot of players invest in developmental stage biotechs and then exit immediately upon approval. In the case of Afrezza, there have been at least two launches (one with Sanofi and one or more with MNKD managed resources depending on how you look at things) with disappointing results relative to the estimates that drove post-approval valuation. You can analyze the reasons to death, but the fact is that the drug has been on the market for several years without results coming anywhere close to the perceived potential. Sales do have to kick in to change the established perception.
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Post by matt on Mar 29, 2018 10:57:51 GMT -5
We better hit higher than that. The pps continues to completely dissappoint. 2.20??? at this point is complete BS Is the runway/funding still expected to last until end of Q2? If so, then a cash infusion is very imminent and there is a great possibility that dilution will be necessary. I suspect this is being priced into SP at this time. I think that is a fair assessment. Mike has promised a number of things since arriving at MNKD, some of which he delivered on and some he has not. A hard core fundamental investor would say that he has hit on some of the softer commitments and missed on the harder to achieve financial metrics. He claims he has two term sheets in process and that he hopes to get some big upfront dollars, but the market is showing its disbelief. That is not to say that Mike is deliberately misleading, but the market wants to see executed definitive agreements and the cash in the bank before they will credit his statements. Compounding that perception is presentation at the H.C. Wainwright conference in a few weeks; nobody presents at the Wainwright conferences unless they are looking to do a raise, and the financial terms on Wainwright deals are almost never attractive. When the words and the music don't go together, the market gets nervous.
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Post by matt on Mar 27, 2018 10:27:58 GMT -5
Finding a partner requires MNKD to have something the partner is truly interested in having. In the past 5-10 years most pharmas have exited or halted development on drugs to treat metabolic diseases in favor of neurology (Alzheimer's, Parkinson's), oncology, or pain management where the margins are better. You can't, for example, partner an insulin product with a company primarily focused on oncology drugs for example. That narrows the playing field very substantially, and with two strong players in the insulin sector (Lilly and Novo) and one weaker one (Sanofi) most companies can find more interesting opportunities where they are not starting out in fourth position doing battle with portfolios of well-established products.
TS meanwhile is a drug delivery technology; it is not a drug. Pharmas have a huge array of drug delivery technologies that they can license in when they need one, and most pharma companies (J&J being the notable exception) do not have separate drug delivery divisions. If a pharma partner decides that inhalation is the best way to get a drug into the patient they will gladly do a deal on TS, but the drug is the dog that wags the drug delivery tail. The tail does not wag the dog.
Remember that when looking at partnerships, the partner gets to vote too. It is not enough that Afrezza might be an interesting partnership opportunity, it has to be one of the best out of all opportunities available to the potential partner or else they will pick something else to invest in.
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Post by matt on Mar 26, 2018 9:46:30 GMT -5
Life style, diet, infections (both bacterial and viral), gut microbiota and more cause epigenetic changes, and those changes tend to persist for at least a generation or two. The range of epigenetic changes is just starting to be understood and you will be reading a lot more on this topic in the coming years. Epigenetic changes affect how a cell functions by changing the methylation, acetylation, or phosphorylation of DNA during the transcription phase, thus altering the expression of proteins without changing the underlying DNA. Such changes can have profound effects on the endocrine responses in the human body.
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Post by matt on Mar 26, 2018 6:53:32 GMT -5
Española? Why did they pick that location? Anyone have any insights? It's 30 mins north of Santa Fe and Los Alamos (relatively close) and 90 mins from Albuquerque. As a total guess two Native American pueblo tribes border the town: Santa Clara Pueblo on the south and Ohkay Owingeh on the north. I have seen numbers as high as 35% having T2. Maybe they got a grant. If they did and are using afrezza that would be awesome news if they have great success. That is a very good guess. The Pima tribe of Native Americans ranged from central Arizona and New Mexico south 200 across the Mexican border. They were a desert people living off a high fiber, low fat diet of cactus, woody plants, corn, brown rice, and wild game / fish. Prior to WWII, metabolic disease was practically unheard of on either side of the border, and historically the people of the tribe could wander north and south without regard to political borders. The Pima are one of the only homogenous, genetically identical people separated by an artificial border. After WWII the border started to be enforced and the disease rates diverged. American Pima north of the border adopted a typical urban profile with a US diet and the Mexican Pima to the south maintained the traditional life style and diet. The US Pima have the highest recorded rate of metabolic disease for any ethnic group on the planet with prevalence of diabetes at 34% for adult age males and 41% for adult age females; those rates increase to 70% of both sexes by age 55. In comparison, the Mexican Pima have rates of 6% for adult males, 9% for adult females. Since the Pima are genetically identical any differences that begin at the border are attributable to life style and diet choice. This provides an interesting laboratory to study health innovations, and for this reason the Pima are the most studied ethnic population on earth. Just do a Google search on "Pima diabetes" and you will find numerous studies.
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Post by matt on Mar 23, 2018 13:53:56 GMT -5
Quote; endos know that so these graphs do not particularly impress them. Reply: aged, what does impress the endo's ? (besides testosterone cream) To get results with Afrezza, or any other drug but especially Afrezza, it has to be used as described on the label. Most physicians simply accept that the vast majority of their patients will fail to follow instructions so if a drug is not forgiving on excursions from therapy then graphs like the ones above will simply not be believed. I have written clinical trial protocols requiring diabetics to have an HbA1c at or below 7 and was told by my investigators that enrollment would be extremely slow to non-existent at that hospital (a very large and well-respected university research center). We finally settled on an inclusion criterion of HbA1c <=8, but I still got a lot of push-back. Regardless, physician know that studies based on a small number of patients that are closely monitored under clinical trial conditions are not representative of results to be expected from large populations of patients that are not part of a study. Twenty years of experience as a physician treating patients that don't adhere to their prescribed treatment / exercise / diet regimen is always going to outweigh a salesmen waving the results of a new study. So what does impress endos? Frankly not much.
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Post by matt on Mar 22, 2018 13:56:06 GMT -5
All the major drug distributors have value-added call center services to insure that patients get their meds. Usually the meds are far more expensive than Afrezza, usually this kind of service is provided for the $40K per year medications, but it is not unheard of.
It is a highly customized service and it is not cheap, at least for the really good programs. The vendor can also take responsibility for physician office authorization and for getting insurance to preauthorize (they have secret express phone numbers to reach the right folks at all the major insurance companies). January, when everybody switches insurance, is a zoo getting all the patients reauthorized in time for their first script of the year. The programs work well, but I doubt MNKD can afford it long-term.
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Post by matt on Mar 20, 2018 11:34:25 GMT -5
Most investment conferences I have been to (and that is a lot of them) have had overlapping sessions, with some having as many as six companies presenting at once. The company is allocated 25 minutes to give their presentation and 5 minutes is allowed to switch rooms if necessary before the next session starts. The presentation slot generally does not leave time for any questions. The presentation session is followed by a 25 minute break-out session in a smaller room where interested parties can ask the presenter questions in a one-on-one format. If there is additional interest at the end of the breakout session other arrangements can be made to continue the discussion in private. The amount of activity in the break-out session is usually indicative of the amount of interest in the company; a full break-out room is a good thing.
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Post by matt on Mar 20, 2018 7:21:50 GMT -5
ok, the gist, expect journals to be a bit pay to play as well. correct me if I am miss interpreting. please. oh and thank you. I have started to like you more. I would not say that journals are pay to play. Most journals will allow articles to be viewed for free if the author pays a fee, usually about $3,000, and open access is now required for any article that results from US government sponsored research which is why you see more articles available from PubMed links. The author still has to get the article accepted and as I mentioned that is often a blinded process to keep it fair. That said, the journals that are subscription based have more financial resources to hire editors, proof-readers, have better graphics departments, and are just generally better staffed. Larger organizations can simply turn around a project faster because they have all the necessary tools in house. The garage mechanic on the corner of your street can probably fix your car given a few days, but a large dealership can likely do it faster because they will have special tools for that model and all the necessary parts in stock. Publishing is not that different.
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Post by matt on Mar 19, 2018 8:22:42 GMT -5
Quote; The fastest journals rarely take more than six weeks between acceptance for publication and the final version while the slowest ones take up to a year. Reply:, by that metric, what is the fastest possible publishing data that can be calculated? please.? Admittedly that is a subjective opinion, but one based on a lot of experience. I normally read ten to fifteen journal articles most weeks, and some publish the dates on their Internet site. Here is the detail from one article randomly selected from my Endnote library: Received 8 February 2016; Revised 2 May 2016; Accepted 22 May 2016, Published June 15, 2016So that paper took about four months to publish and five months to make it to paper, but the "early edition" was available on-line May 22. There is no hard metric you can calculate, but if you read the same journals every month like I do then you get a feel for which ones are fast and which ones are slow. You can also tell the speed by comparing the PubMed record, which shows the actual publication date, with the date a paper was downloaded. Endnote is a software that archives all my publications (about 5,500 at last count) and it keeps track of the date I first acquired a paper and the date the PubMed record was last updated. The big commercial publishers (John Wiley for example) often go to print within a few weeks of the on-line edition, while many of the free Internet only journals can take a long time. Some Wiley articles are processed fast enough that you never see a separate on-line version' they first appear in their final form with both print and electronic versions published simultaneously. My perception, right or wrong, is that if a lot of libraries are paying several thousand dollars a year for a subscription to a journal, then the publisher has the financial resources to produce a quality publication promptly, while the free Internet only journals are staffed more by volunteers who can only devote a portion of their time to the journal. The corollary is that because those journals are charging a lot of money it is much harder to get published unless the content is of high interest, truly breaks new ground, or is the final report on an exceedingly large multi-center study. For that reason I would expect to see the STAT study appear in a specialty publication devoted to treatment of diabetes or metabolic disease in general, but not in a major journal like JAMA or Lancet.
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Post by matt on Mar 19, 2018 7:33:20 GMT -5
There seems to be a lot of confusion about conferences and peer review. The author submits an abstract to the conference organizers. If accepted, the material is presented at the conference and the abstract or extended (more detailed) abstract is published in the conference proceedings. That is not peer reviewed, but can be cited in scientific papers. After the conference (or even before in some cases, not sure with ADA), the author is free to submit a full manuscript to any journal, where it will be reviewed first by an editor to be sure it fits the scope of the journal, and then sent for outside review. Many journals have a difficult time finding enough people to review papers, so those of us in academia get bombarded with requests to review papers within our area of expertise. If we accept, we join one or two other reviewers and provide our recommendations to the author(s) and editor. If the paper is not rejected, then generally the authors are asked to make minor or major revisions, after which the paper may be accepted for publication. I have seen the entire process take anywhere from a few weeks to more than 10 months, depending on the journal and how busy the reviewers and authors are. That is a good summary of what really happens with peer review. To that I would add that some journals go out of their way to redact certain information (author name(s), study name, and anything that could identify the institution) to make sure that the review is not influenced by prior relationships. Obviously reviewers tend to be well-informed about events happening in their field of expertise and can still make a pretty good guess where the paper comes from, but still the process is as fair as it can be. I would also point out that just because there is a long delay getting into print does not mean the information is unavailable. Virtually all journals will make papers available on the Internet the moment they are accepted for publication. While the paper is subject to change, normally to incorporate minor comments and to allow the journal to produce publication quality graphics, the essence of the paper is there for all to see (at least those who have a subscription). The fastest journals rarely take more than six weeks between acceptance for publication and the final version while the slowest ones take up to a year. With academics, the timing can have a lot to do with what else is going on at the university (exams, graduation, vacation periods, etc.).
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Post by matt on Mar 15, 2018 18:03:40 GMT -5
Dilution will depress the price and allow shorts to cover at a lower price. Given the vote to authorize more shares, and the daily trading volume, bankruptcy is off the table for a few years at least. So long as a public company can issue more shares, and has enough trading volume to attract investors, bankruptcy is not something to worry about.
If the company runs out of shares and can't get authorization for more, or trading volume dries up so that new shares cannot be sold, or the company is unable to refinance or defer a large maturing debt then that is another matter, but none of those are likely in the near term.
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Post by matt on Mar 15, 2018 9:59:08 GMT -5
MNKD would need to tool their campaign to average a 1-2K for incremental new RX's. Event will more funding, MNKD needs to recoup TV campaign expenses within a year, more likely a positive spend ROI which would be around $500 per incremental new RX. eg, a $5,000,000 campaign to be ROI spend positive would need to generate 10K new prescriptions. If those sorts of returns were possible, I expect that MNKD would be spending the money already. $5 million is small money to generate 10K in NRx and while that might cause some near term dilution, I doubt many shareholders would complain if the script results were there. The fact that MNKD is not carpet bombing the networks with advertising suggests that the results from the test markets were not that strong. I suspect the company is still looking for a combination of promotional tools that are both affordable and which result in enough near term sales growth to move the needle in a measurable way. That is not an easy task is a crowded space with strong competitors.
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Post by matt on Mar 13, 2018 14:37:05 GMT -5
Straightly, Sorry to burst your bubble, Deerfield has historically taken the stock in lieu of payment and then sold it on the open market. Their last 13g shows that they sold their 5% poisition they had back in May. As for Al Mann group, their mission is to help MNKD where possible, but they received a really sweet deal getting an option at 4.00 in the future for waiting. They either will cash in big, or loose what is left. I have to agree with the comment above. Deerfield is structured as a bond fund that first and foremost is there to protect the capital of their investors. If they wanted to be fully exposed to biotech risk they would be structured as a biotech fund, but instead they prefer to make loans that have some form of equity sweetener on the back end. Historically they have not held onto any shares they received in exchange for debt repayments, and it should not shock anybody if they were short before making this deal, either by shorting MNKD in the market or being synthetically short via put options. As for the Mann Group, nobody knows what their motivations are at this point. With the passing of Mr. Mann, some of the investment is controlled by trustees who have legal obligations to the ultimate beneficiaries of the trusts, and they must follow the intension of the grantor as specified in the trust document. Those are private instruments so what those specific instructions are is pure guesswork. While Mr. Mann was the ultimate friendly shareholder, he might also have wanted to endow education trusts, donate to museums, provide for his grandchildren, and fund other worthwhile causes after his death. The trust document should have laid out those priorities and the trust has to be managed in accordance with those wishes as filed. If the trust wants or needs more cash to fulfill its mandates, this transaction gives them that opportunity, but it is far from certain that they do. Nobody will know what is happening until the ownership tables are updated in the DEF14A and the Mann Group holdings are compared with the previous disclosure.
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Post by matt on Mar 13, 2018 14:20:40 GMT -5
I can not wait for the peer reviews. Dr Kendall has to know some peers? That is not how peer review works. There are peer-review panels for each publication and the ones looking at any given article, normally three reviewers, are chosen at random from that panel. The peer-reviewers are blinded to the extent possible with the trade names of the drug blacked out, the name of the study blacked out, and the author(s) of the study not revealed. A well-informed reviewer might be able to make an intelligent guess as to which study and which product, but that is far from a certainty. In any case, the company does not interact with the reviewers at any point so who Dr. Kendall may or may not know doesn't factor into the process.
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