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Post by compound26 on Dec 29, 2017 12:28:35 GMT -5
Sorry to be a nerd, but this isn't a surprise at all. It's a common forecasting technique to average a number of independent estimates when predicting the future. That tends to be more accurate than any one source. The key word here is independent - it doesn't help if people bias one another, which doesn't seem to have been the case here. :-) OK then. Perhaps we should start another: When will we hit $10 per share? Just throwing the numbers out: $10 August 10, 2018. $20 November 10, 2018.
$40 November 10, 2019.
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Post by compound26 on Dec 28, 2017 12:42:54 GMT -5
TRx 508 (Nrx 268; refills 240); Total Sales $600,000
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Post by compound26 on Dec 18, 2017 9:57:49 GMT -5
"Perhaps someone that interacts with Michael Kovoacy can point him to this piece. Readers and investors are not well served when analysts are in a banter such as this. With this, I want to set some of the record straight and hopefully get to a point where readers are better served. Michael Kovacocy and I look at this company in different ways. That is fine. It is healthy. It gives readers various perspectives." seekingalpha.com/instablog/175233-spencer-osborne/5087294-mannkind-michael-kovacocy-spencer-osborne Michael K has strong opinions, as he does about all his stocks. Spencer is very emotionally involved, enough so that he blocks myself, Nate, and many other people that give info about how Afrezza works. That’s my take on it:-) Yes, S.O. is very opinionated. He has many problems. My issues with S.O. are: 1. He basically only sees the bearish side of the Mannkind story (he is very biased to the short side, yet he acts like he is always balanced);
2. His timing on trading often times is terrible, yet he acts like he knows everything and does not admit any mistakes in his predictions.
Here is what he wrote on his article published on SA on April 25, 2017, when Mannkind shares were trading at $0.9: “ I have stated this many times. MannKind is losing leverage every day. That means that long term shareholders are losing leverage every day. If you find yourself stretching any situation to find a positive light, you will likely be left in the dark.” seekingalpha.com/article/4065089-mannkind-may-go-bankruptWe all know what happened next: Mike took over as the new CEOin May, we did a label update in Sept. and raised money at $6 in October.
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Post by compound26 on Dec 14, 2017 12:14:37 GMT -5
Really silly for MNKD to even be considering doing any acquisitions...Any money they have should be going into selling Afrezza , funding pediatric and trep t trials. Those shares should be used to generate funding and get partnerships. I still don't understand whether they really believe they can go at this alone in the long run. I think it all depends on what the acquisition is and whether the acquisition is value-creating to the Mannkind shareholders. Let's suppose Mannkind acquires One Drop for certain number of Mannkind shares. If One Drop is actually cash flow positive right now and is expected to grow its cash flow further in the future and if Mannkind paid a good price (from the perspective of the Mannkind shareholders), I would not object to such an acquisition.
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Post by compound26 on Dec 8, 2017 20:05:20 GMT -5
Thanks Sportsrancho for posting that. We're ironing out some kinks with the website, and creating a more robust platform by which to promote what we're doing. We've been busy and there's been very good feedback on the basic business and treatment model. vdexdiabetes Come here often and keep us posted. We really want you guys to be immensely successful!
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Post by compound26 on Nov 29, 2017 18:22:44 GMT -5
Agree with the posts above that the Deerfield option of converting $10 million debt at around $3.25 is not a major (or not as major as some at this board believe) factor in where the PPS is right now.
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Post by compound26 on Nov 29, 2017 11:30:43 GMT -5
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Post by compound26 on Nov 28, 2017 17:37:40 GMT -5
By the way, in the following statement of Mike "So it's really a matter of are we going to be $50 million, $100 million, or $500 million", he was really referring to the annual sales of Afrezza (rather than the market cap of Mannnind). I would like to point this out in case someone here would read that comment as referring to market cap of Mannkind.
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Post by compound26 on Nov 28, 2017 16:47:51 GMT -5
Read Mike's interview a couple of times. It is full of information and hints! Here are a few bits for your thoughts. Speights: How long do you think it will take for you to know if the TV campaign is really working effectively? Castagna: I think in terms of turning into prescriptions, it will take about two months to start to see a meaningful lift. We'll measure every week, but in general, you think about a patient has a visit six to eight weeks out, maybe 12 weeks out, so you've got to see the TV [commercial] probably three to five times, and then they're reminded for the next doctor's appointment. We can tell you in the first week of the TV ad, Google search AdWords are up, website hits are up fourfold, copay downloads are up. So we can tell you all the early metrics that would indicate it's working are up, but the real metric to me is going to be prescriptions and people taking the drug. And that will just take some time, but the early metrics are positive so far. Speights: The Motley Fool is a site geared toward investors. What would you say to either existing shareholders who have held on to MannKind stock for quite a long time or to new investors who are taking a look at MannKind? Why should they keep their MannKind stock or invest in MannKind? Castagna: So if you have a three-month view of the world, this might not be the right stock. It may be up or down, who knows? I think if you've got a six- to 12- to 18-month view of the world, then you can see the trends continue to head in the right direction, and you'll get clarity on the forecast of revenue, as well as the breakeven of the company and the pipeline. I think it's a good value today. If I could buy more, I would. I just think, looking for a publicly traded biotech who's got a phase 3 asset, full label approval, worldwide rights, and an integrated manufacturing plant for a $350 million market cap, go find me one -- with a drug like this for as big a need as this. If it was a bad drug, I would be worried. I wouldn't even be here. This is a fantastic drug. We've got the wind at our back, and the sails moving in the right direction. We're not at full speed right now, but the wind's turning, the tide's turning. Everything's going in the right direction right now. With the financing we got, it gave us extra breathing room to turn on TV and make some bigger decisions as we go forward. But at this point, it's purely an investment of scale-up discussion. This isn't about will the drug succeed or not, will the company be in bankruptcy or not. I don't see those things happening at this point. The drug will succeed. The company is not heading for bankruptcy. So it's really a matter of are we going to be $50 million, $100 million, or $500 million. And I think those trends over the next six months will really start to show people what can happen. Future sales for Afrezza Speights: What do you think a realistic view of Afrezza sales over the next three years or five years? Castagna: We haven't given guidance yet, so I can't give you much guidance on that. But I will say, it was supposed to originally be a $2 billion-plus product, and it's still capable of being very successful. I think the unmet need is there in the marketplace. For 20 years, we've not moved A1Cs for people that are on insulin. I don't think we've improved people's outcomes on insulin. Despite the adoption of 500,000 people taking pumps, 200,000 people on Dexcom, we're not seeing a difference in the A1C outcomes. So we can keep doing the same thing of injecting insulin all day long, or we can try something different.
Maybe it still won't change. I don't know the answer. But when I see 70% of the people aren't at goal, then we might as well not have a goal. So we strive to get more people to goal. And the reason people don't get to goal is they're afraid of hypoglycemia, afraid of pushing the doses of insulin because of the way it works. It's great that you can measure sugar all day long, but if you don't have a tool in your bag that can adjust that sugar quickly, what's the purpose in measuring it? As these technologies get adopted, people are going to see they have a problem. I do believe we're the only tool in that toolbox that can adjust as quickly as we do. I think over time, as we do the studies we're doing and people see the results, they're going to jump on board.
Speights: What about the rest of the pipeline?
Castagna: With Trepostinil -- we went to the FDA in June and we got phenomenal feedback on a very clear development pathway. So that's not that expensive and it's relatively straightforward. And what that means is that we'll be submitting our IND in January, and in the first six months of next year we'll be testing that. It will be our second drug ever put in patients. And sometime next year we'll know whether or not we have another molecule going forward into a larger phase 3 program. And that could be phenomenal. It's a huge category in need of dosing that we can believe we can dose higher levels in a more convenient administration method, so this will be another unmet need we're working on. So that's just something to watch out for.
One Drop partnership
Castagna: We look to One Drop -- they've done a phenomenal job of building a patient-focused platform around self-directed care. So one of the things they have is an unlimited test strip membership model for $30 a month. And so we're looking to bolt on to their platform an insulin membership model. There's around $300 million in cash sales in this country where people are paying three to five hundred dollars a month for insulin. And so we look at that as a significant opportunity to help some of the people offset some of the high costs of insulin.
So it's very different business model and taking a little bit longer to get off the ground, because no one's ever done this in the pharmaceutical industry for a prescription-based product. So a lot more lawyers and pharmacy things we have to work through, but we're coming very close to getting that together and that'll be exciting to see. But that collaboration remains strong, and the people there are great. And so we'll continue to see how we integrate technology into coaching as well as getting better customer service to your doorstep on your prescription drugs.
International plans
Castagna: We filed in Brazil. We will file by ourselves in some markets like Canada. And we'll evaluate Europe and Australia. And then we'll partner in markets like China, the Middle East, and India and Japan. And so as you look out, those are some of the ways we continue to expect to bring in revenue and royalties in the future that will create more value for our shareholders.
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Post by compound26 on Nov 27, 2017 13:45:09 GMT -5
IMO, the trending lower over the last couple of weeks is just short noise. The volumes are low so I think we are seeing a lot of churning. So over the last several weeks, I don't think we have seen a large net change one way or the other. I don't think the short interest has grown much or dropped much. It will be interesting to see what happens to the short philosophy if scripts continue to show solid growth over the remainder of the 4th quarter. Note that based on the last weeks' Afrezza sales of $571K, Apidra's $2.2M sales is only 3.85 times of that of Afrezza. At the beginning of this year, when Afrezza's sales was around $160K, that ratio was 13.75 times. Let's see where we stand by the end of the fourth quarter.
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Post by compound26 on Nov 27, 2017 12:22:59 GMT -5
Here is an old post i made about the refills problem. IMO the problems with refill rate can be broken down into 3 categories: 1. People who do not titrate correctly, and therefore afrezza does not work for them. 2. People who like afrezza but cannot continue using it due to insurance problems and cannot afford out of pocket costs. 3. People who use afrezza sparingly ONLY for as needed corrections, they would not need refills for many months. All three categories are very popular in user testimonials i've seen on online message boards so let's break them down and how Mannkind is solving all three since Mike Castagna joined the team. Number 1. One of the first things Mike did was create the titration pack, a combination pack of units designed to let patients experiment with what works best for them. Diabetes is not a one size fits all disease and therefore a one size fits all dosing doesn't always work for patients. The titration pack worked but patients still are struggling with changing their old school mindset that decades of injectables insulin usage has created. If you follow the comments you will see patients commonly calling it out that when they first try Afrezza they sometimes think it does not work for them. This is due to not taking enough units most of the time, something that is quite common and will be fixed with the new label and additional prescriber education. The other big issue is that what works for the first few weeks of Afrezza may not continue to work within those first few months which is likely why Mike expanded the titration pack to be an up to 90 day prescription. Titration is a key period but so is getting HELP along the way. When patients are getting support from Afrezza advocates with experience, they almost always get it right and i've seen how powerful that is. I think that is one of the cornerstones of the One Drop collaboration and the reason they are doing this new study, there is going to be some really good refill results for patients who titrate with help from a one drop expert. 2. Pretty common issue that comes up is insurance problems, and not just getting the first fill but especially when refilling a prescription. Not only that but this even happens for the patients who have been on afrezza for years now, who all of a sudden get declined and must go through the appeals process year after year. One of the big wins with the label change is the idea that it will help Mannkind renegotiate it's contracts with these insurance companies. Getting afrezza out of tier 3 and into tier 2, no prior authorization across the board will be a huge boost to refill rate. This was a big focus for Mannkind and one that i expect improves significantly for next year. We've also all also heard "Uber of Diabetes", Mike's ideas about cutting out the middle man and going direct to consumer, while it's a novel idea i don't see it impacting us in the short term but potentially could be a revolutionary idea for long term Afrezza sales. 3. This group is interesting, I've read about many who keep Afrezza as a tool in the toolkit but don't use it daily only once in a while for serious highs or a cheat meal. Hospitals too which keep Afrezza stocked but may not need consistent orders. I'm actually hoping Mannkind has some ideas to get more of these types of use cases as they could make Afrezza the must have tool out there - One thing i have seen is the "Monopack" language being trademarked and i'm hoping this will be a new packaging available for these types of one off use cases. Keep in mind these users are already Afrezza approved and although they use it sparingly now they are much likelier to become full time users then somebody who still has to go through the education process. -M --- Now a quick update to that post. As you can see the refill problem is very complex BUT i want to comment on what happens when patients DON't have trouble getting their RX via their insurance, and have proper expert guidance in titrating afrezza. Here is an excerpt from a recent VDEX PR: "Vdex is concerned that, regardless of the positive developments about the labeling, if a physician does not have time to properly instruct the patient in its use, Afrezza will continue to be an under-utilized product. Further, there is still a high drop-out rate among patients, suggesting that patients are not seeing the benefits of the product. Estimates put the retention rate generally at less than 50%. In contrast, Vdex’ retention rate is above 90%." “We at Vdex believe the high drop rate is directly related to the amount of time physicians are spending with patients. It takes time to get patients using Afrezza properly, but when a patient gets proper instruction, the results are excellent. We’ve seen that exact thing with our patients,” added McCullough. “That’s why we created this program.” 90% retention rate! Excellent summary on the refills issues. Mannkind also discussed this issue on the last CC. Here is what Pat said regarding this: seekingalpha.com/article/4122005-mannkinds-mnkd-ceo-michael-castagna-q3-2017-results-earnings-call-transcript?part=singleAnother thing I wanted to talk about if you look at the gray colored line on the slide, that is the refill line and we do get questions on refills. So I wanted to take a moment to walk through some of the things, some of the thoughts and insights around that. This is something as I said we do watch on a regular basis but first and foremost whenever you're growing a brand it is essential and very critical to have the NRx line exceed the refill rate to accelerate your growth. That's exactly what's happening and we expect to see this continue in the future. Now in July we also made a committed effort to shift from the old SKUs to the new SKUs, a proportion of our Afrezza business. We removed one SKU with the label update and plan to phase out two more SKUs in the next three to six months. This is an effort to streamline and simplify our NDC portfolio for both patients as well as providers. And next we know that not every prescription is for a 30 day supply of insulin. For example some patients use Afrezza in addition to their comp, others use mail order that may have larger quantities, and some patients simply are not compliant and don't follow the suggested dosing regimen. And we know that these do have some impact to the refill rates. So let's take a little closer look at the trending of some of the newer versus older SKUs that I referenced before. And what you can see in the graph is a representation of these two groups of SKUs, the ones that were phasing out as well as the new ones over the time period of May to September of 2017. So let's first look at the SKUs that we're facing now, and those are represented by the blue bar and you can see from May through September there's been about a 31% reduction in TRx volume. Over that same period the group of new Afrezza SKUs which is represented by the grey bars have experienced significant growth in TRx volume. Once again when you have a transition like this going on we do believe that it has some impact on the refill rate.
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Post by compound26 on Nov 20, 2017 15:06:10 GMT -5
This is may be a little boring. So anyone who is not interested in accounting probably can skip this thread. Note what Mannkind management stated in the last CC: seekingalpha.com/article/4122005-mannkinds-mnkd-ceo-michael-castagna-q3-2017-results-earnings-call-transcript?part=singleI thought it would be prudent to spend a little bit of time describing our revenue recognition model as it is different from most other pharma companies at this time. We are on a sell through model which means that we recognize revenue for most of ourselves when the patient buys Afrezza from a pharmacy not when we ship to wholesalers. Before the patient buys Afrezza there is a right of return that exists for the wholesale and retail channels. Once the patient gets a prescription filled, the right of return ceases to exist. Current GAAP says that if we can't reliably estimate expected returns at the time shipment we must defer revenue until such time as that rate ceases to exist. So if you're following along the slide, MannKind sells Afrezza to wholesalers who sell on to retailers before dispensing to patients. Revenue is deferred until patient buys Afrezza. We recognize revenue based on simply prescription data which is an estimate of prescriptions filled in the marketplace. We enhance this data by trying to understand how much Afrezza is sitting in the wholesale and retail channels which is what should be deferred. Please note that we don't have complete visibility into the retail channel at this time. In addition there are other factors which impact the revenue recognized for shipments to the wholesale and retail channels such as price increases and vouchers for free product. Once we determine the gross revenue to recognize and defer, we adjust the revenue and deferred revenue for our gross to net which represents fees, discounts, and rebates such as wholesaler fees, patient co-pays, and managed care and government rebates. So as you can see this is extremely complicated and subject to estimates and showed us what estimates and actual don't match. I hope that we have laid this out in sufficient detail for you to understand our revenue recognition model that will be used through quarter four of 2017. How the New Revenue Recognition Guidelines Will Affect Life Sciences Companiesby Scott Ehrlich, Founder and Managing Director, Mind the GAAP, and Trevor Gillespie, Partner, Life Sciences Practice 7/2014 www.mossadams.com/articles/2014/july/new-revenue-recognition-rules-for-life-scienceswww.mossadams.com/getmedia/a69e39f0-34d4-41ca-a09d-ea4def21e460/17-TEC-1427-TIF-Life-Sciences-Rebrand_RGBAfter years of debate the Financial Accounting Standards Board (FASB) has issued final new guidelines on revenue recognition. The rules, which total 700 pages and represent a fundamentally new model for recognizing revenue, become effective in 2017 for public companies and the following year for nonpublic entities. The new revenue rules may effectively eliminate the sell-through method. This may concern some life sciences companies that currently prefer this approach. These companies might be able to continue recognizing revenue in this manner by changing the nature of their business arrangements with customers. For example, they could seek to amend customer contracts to make them more akin to a consignment arrangement. In most consignment arrangements, control over a product isn’t transferred to the customer until it’s sold through to the end user. Therefore, revenue wouldn’t be recognized until the “second sale” occurs, similar to the accounting outcome under today’s sell-through model. Also read the following for an in-depth discussion of sell-through vs sell-to by KPMG: home.kpmg.com/content/dam/kpmg/pdf/2016/05/IFRS-practice-issues-revenue.pdf
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Post by compound26 on Nov 15, 2017 18:09:01 GMT -5
mnholdem, Prior to starting Afrezza, Spiro's had been struggling with elxtremely elevated liver enzymes ( ALT, AST and ALK ) High Triglycerides and High . Cholesterol. for over 19 years or so. My first lab work after being on Afrezza for only 3 month's showed that virtually all of my liver enzymes and cholesterol levels were in the normal range for the first time in over 10 years. They have all remained mostly normal since starting Afrezza. uvula My 7.1 A1c indicated an average daily Blood Glucose of 157, that is not OK. I was starting to have episodes of small fiber neuropathy in my hands and feet. That is not fun. BTW, the small fiber neuropathy disappeared soon after starting Afrezza. Spiro here, facts are facts, Afrezza works great, if used properly. spiro Please be gentle and subtle. Or my bank accounts will suffer once against as I will be tempted to add more Mannkind shares.
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Post by compound26 on Nov 14, 2017 12:15:25 GMT -5
Not sure if this has already been posted elsewhere. It appears the completion date has been updated. Study Comparing Prandial Insulin Aspart vs. Technosphere Insulin in Patients With Type 1 Diabetes on Multiple Daily Injections: Investigator-Initiated A Real-life Pilot Study—STAT Study (STAT) This study is ongoing, but not recruiting participants. Sponsor: University of Colorado Denver School of Medicine Barbara Davis Center ClinicalTrials.gov Identifier: NCT03143816 First Posted: May 8, 2017 Last Update Posted: November 9, 2017
Estimated Enrollment: 60 Actual Study Start Date: September 30, 2017
Estimated Study Completion Date: December 31, 2017
Estimated Primary Completion Date: December 15, 2017 (Final data collection date for primary outcome measure) clinicaltrials.gov/ct2/show/NCT03143816
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Post by compound26 on Nov 13, 2017 18:42:43 GMT -5
Not sure how to make it. Deerfield sold 2.7 million shares, but its principal James Flynn increased Mannkind holding by 5.2 million shares based on this same report. f Deerfield sold during the move up to $6 + in October, they have made good profit. And they get to buy up to 4 million shares at $3.25 soon. whalewisdom.com/stock/mnkd
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