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Post by jpg on Aug 17, 2014 12:47:17 GMT -5
Yes Liane you are correct:
I think anyone modeling near or long term sales of Afrezza using current prandial insulin sales as a benchmark should be questioned or discounted.
If Sanofi gets this right and introduces Afrezza wisely they will reset standards using labeled (needle phobia being in the label) indication for Afrezza while combining it with ADA guidelines stating the next step after Metformin should be to consider the use of insulin. I am certain they will be a bit more elegant in the way they do this then my one liner but that is the way to be on label and go after the bottom of the iceberg.
I also trust they will do this smartly without pushing this hard to ramp up sales and please our more impatient shareholders who just want quarter over quarter sale growth results now. In my crashed post (my iPod is so ridiculously old I should sell a few shares of Mannkind and buy a new one) I gave a brief sketch of how I presume they will target early MD adopters and thought leaders with smart educational workshops etc.
JPG
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Post by dreamboatcruise on Aug 17, 2014 13:06:09 GMT -5
Yes Liane you are correct: I think anyone modeling near or long term sales of Afrezza using current prandial insulin sales as a benchmark should be questioned or discounted. If Sanofi gets this right and introduces Afrezza wisely they will reset standards using labeled (needle phobia being in the label) indication for Afrezza while combining it with ADA guidelines stating the next step after Metformin should be to consider the use of insulin. I am certain they will be a bit more elegant in the way they do this then my one liner but that is the way to be on label and go after the bottom of the iceberg. I also trust they will do this smartly without pushing this hard to ramp up sales and please our more impatient shareholders who just want quarter over quarter sale growth results now. In my crashed post (my iPod is so ridiculously old I should sell a few shares of Mannkind and buy a new one) I gave a brief sketch of how I presume they will target early MD adopters and thought leaders with smart educational workshops etc. JPG Please correct me if I am mistaken, but I thought the ADA guideline about next steps beyond Metformin is basal insulin not prandial. Many Afrezza knowledgeable folks here believe that Afrezza may indeed be proven to be the right choice as a second line or perhaps even first line treatment, but I don't think there is anyone beyond the company that has endorsed this. If there are 3rd party medical sources that start getting behind the idea of early prandial use, I'd love to see a dedicated thread with pinned to the top of board that collects these statements, papers, studies, etc. |
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Post by jpg on Aug 17, 2014 13:06:51 GMT -5
To me this defines the essence of why I think anyone modeling near or long term sales of Afrezza using prandial insulin sales as a benchmark should be questioned or discounted. The model inputs are wrong. Those analysts are assuming 'spherical cows'. Given that just above your post I was doing exactly what you say should be discounted, I would make the counter argument that modeling the current baseline is an important part of the near term analysis of this. The discussion of this thread was in the context of 1st year sales and whether $1B is possible/likely. Many investors, including myself, believe Afrezza can be a game changer and expand the market for prandial insulin. Not to mention that Technosphere will be used well beyond the diabetes segment. But, a paradigm shift in diabetes treatment isn't something most would probably assume will occur within the first year to any meaningful extent. There might be some doctors to start trying early prandial use, but most will likely wait for published results from the early adopters. I'm going to be curious to see whether Sanofi announces clinical trials to try to prove Afrezza as a superior first line intervention. Do you feel they will? Does that not threaten the Lantus franchise? I'm hoping that part of full agreement, which we see in 3 months, will show that this was part of the negotiation and Sanofi is committed to pushing for this game changing aspect of Afrezza. It seems hard to imagine it happening if Sanofi is not behind it... no? Hi Mr. Lizard, My comment had nothing to do with your post specifically and I highly respect your insights and opinions.yUpu are by far alone in using the current prandial sales line of reasoning as a baseline.. I am the outlier on this I think. The way I interpret Sanofi's thinking on this topic I think I am in good company though! Again I don't think current prandial sales are that relevant in all this anymore then prandial sales are relevant when a new class of oral agent comes along. As Sanofi repeatedly said during the CC: there are no needles... How analysts can consistently compare something that needs to be injected 3 -4 times a day to something which doesn't need any injection should obviously be questioned but the paradigms of analysts and Wall Street need to live on till proven to be wrong I guess. I would venture to say the paradigm shift that MDs will have to make will be less intense then the paradigm shifts that those stuck with the current prandial model as a baseline for sales has to shift... I agree there is always a risk Sanofi drags it's feet but with 65% of profits they certainly would be properly incentivized to sell. Will it hurt their basal business? Not if their new and improved insulin works as promised (1/3 then injected volume: hopefully not painful to inject) and really flat (what could go better with Afrezza then that? Now listen to comments about bringing down cost if insulin for less affluent countries. I have one concern about Sanofi and their new insulin vs Afrezza but need to do a bit more digging on that one before commenting 'publicly' (I still have a day job!). JPG |
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Post by dreamboatcruise on Aug 17, 2014 13:46:11 GMT -5
I think Al might say that what would be better would be very early intervention with a ultra-fast acting prandial (Afrezza) without a basal, which may slow the progression of the disease that normally occurs through the cycle of insulin resistance and beta cell burn out. Basal insulins contribute to insulin resistance and as insulin resistance sets in the beta cells are stressed to react to the spike in sugar after meals. If you are modeling that basal insulins like Lantus will still be used in prescribing regimens, then I don't think it is a sea change in the overall market for prandial (Afrezza is a prandial, even if it is novel for a couple of important reasons... it isn't used other than mealtime). If you assume that Afrezza is in conjunction with Lantus then the fact that it is inhaled rather than injected is likely to expand the overall use of prandial only by a limited amount because almost everyone that progresses to Lantus is already ending up using prandial at some point (I believe that true, but interested if anyone knows real stats)... the non-needle Afrezza would likely get some patients to agree to prandial earlier than they otherwise would. But having patients start on prandial a couple/few years earlier because of Afrezza doesn't take a 1x prandial market and turn it into 2x? So I guess the question is what change you see happening in prescribing in the near term and what does that mean for overall doses of prandial vs current prandial dosing? |
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Post by mnkdd on Aug 17, 2014 14:26:39 GMT -5
I think Al might say that what would be better would be very early intervention with a ultra-fast acting prandial (Afrezza) without a basal, which may slow the progression of the disease that normally occurs through the cycle of insulin resistance and beta cell burn out. Basal insulins contribute to insulin resistance and as insulin resistance sets in the beta cells are stressed to react to the spike in sugar after meals. If you are modeling that basal insulins like Lantus will still be used in prescribing regimens, then I don't think it is a sea change in the overall market for prandial (Afrezza is a prandial, even if it is novel for a couple of important reasons... it isn't used other than mealtime). If you assume that Afrezza is in conjunction with Lantus then the fact that it is inhaled rather than injected is likely to expand the overall use of prandial only by a limited amount because almost everyone that progresses to Lantus is already ending up using prandial at some point (I believe that true, but interested if anyone knows real stats)... the non-needle Afrezza would likely get some patients to agree to prandial earlier than they otherwise would. But having patients start on prandial a couple/few years earlier because of Afrezza doesn't take a 1x prandial market and turn it into 2x? So I guess the question is what change you see happening in prescribing in the near term and what does that mean for overall doses of prandial vs current prandial dosing? I think what JPG is saying is that Afrezza will reach Type 2's (who are using oral meds) and expand/take over THAT market. I think that is where the big revenue will come in. |
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Post by dreamboatcruise on Aug 17, 2014 15:08:30 GMT -5
I think what JPG is saying is that Afrezza will reach Type 2's (who are using oral meds) and expand/take over THAT market. I think that is where the big revenue will come in. So you're predicting it would become second line treatment after Metformin... before or in conjunction with basal insulin? Or a first line instead of Metformin? Or? The details would seem to matter in trying to make projections... and then adjusting those projections if what does happen is different than what the projections are based on. I'm all ears and would find it very exciting. I'd be very interested in thoughtful analysis of what this could mean for sales over the roll out of Afrezza. When do you think we'll start seeing doctors, ADA, etc. advocating for such changes in treatment? How long before that meaningfully changes size of potential Afrezza user population? Will Sanofi actively advocate for Afrezza to be used as first or second line treatment... which would mean before Lantus? I guess I would just like seeing sales projections over a range of assumptions about changes in prescribing practices... with a conservative assumption being that this change will come slowly and more aggressive projections assuming faster change. |
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Post by mnkdd on Aug 17, 2014 16:01:28 GMT -5
I think what JPG is saying is that Afrezza will reach Type 2's (who are using oral meds) and expand/take over THAT market. I think that is where the big revenue will come in. So you're predicting it would become second line treatment after Metformin... before or in conjunction with basal insulin? Or a first line instead of Metformin? Or? The details would seem to matter in trying to make projections... and then adjusting those projections if what does happen is different than what the projections are based on. I'm all ears and would find it very exciting. I'd be very interested in thoughtful analysis of what this could mean for sales over the roll out of Afrezza. When do you think we'll start seeing doctors, ADA, etc. advocating for such changes in treatment? How long before that meaningfully changes size of potential Afrezza user population? Will Sanofi actively advocate for Afrezza to be used as first or second line treatment... which would mean before Lantus? I guess I would just like seeing sales projections over a range of assumptions about changes in prescribing practices... with a conservative assumption being that this change will come slowly and more aggressive projections assuming faster change. I think Afrezza will be used first line instead of Metformin-- have you read the side effects of that drug? As for your other demands for sales projects/timetables... well, shoot, nobody knows this yet. Why don't we wait to hear more info from both companies. Or, we'll just have to wait for the sales figures to come in. Why are you so worried over things you can't control? |
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Post by liane on Aug 17, 2014 16:43:40 GMT -5
Afrezza is indicated to improve glycemic control in adult. It is administered at the beginning of a meal. This is about as specific as the label gets. At present, it is the AACE algorithm that provides a flowchart for managing the treatment of diabetes: www.aace.com/files/aace_algorithm.pdfThis is just a guideline developed by the endos; it provides a starting point for care. Physicians have a lot of leeway based on individual patient needs and tolerances. Nonetheless, prandial insulin currently is way down the list. There is nothing in the label that prevents Afrezza being used earlier. That will be between a physician and their patient. Sanofi will market it as a prandial insulin, but for now, they cannot make statements about using Afrezza earlier in the treatment plan. That will be for physicians to figure out on their own. This will take time; my guess - within 2 years we see it moving up the protocol. |
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Post by hopetoretire on Aug 17, 2014 16:48:50 GMT -5
I guess I would just like seeing sales projections over a range of assumptions about changes in prescribing practices... with a conservative assumption being that this change will come slowly and more aggressive projections assuming faster change. The only sales projections and range of assumptions that matter are Sanofi's and they aint talkin. The rest is pure speculation for the fun of speculating. No one should base their investments on such baseless guessing and limited facts. Our prospects are better than they were before the potential deal-breakers: adcom; FDA approval; and partnership. We now have a decade of speculation on multiple message boards, but we don't really know any more about sales than we did on the day of the IPO in 2004. The enthusiasts are (overly?) enthusiastic about sales and the doubters are still (overly?) doubtful about sales....time will tell. IF and when Sanofi speaks about sales projections, then analysts can analyze. Until then it's speculation not analysis. (I wish I could break my addiction to reading the boards everyday and do something more productive with the time!) |
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Post by mnkdd on Aug 17, 2014 16:50:19 GMT -5
Afrezza is indicated to improve glycemic control in adult. It is administered at the beginning of a meal. This is about as specific as the label gets. At present, it is the AACE algorithm that provides a flowchart for managing the treatment of diabetes: www.aace.com/files/aace_algorithm.pdfThis is just a guideline developed by the endos; it provides a starting point for care. Physicians have a lot of leeway based on individual patient needs and tolerances. Nonetheless, prandial insulin currently is way down the list. There is nothing in the label that prevents Afrezza being used earlier. That will be between a physician and their patient. Sanofi will market it as a prandial insulin, but for now, they cannot make statements about using Afrezza earlier in the treatment plan. That will be for physicians to figure out on their own. This will take time; my guess - within 2 years we see it moving up the protocol. Very helpful chart-- great post! What I find interesting is the side effects of all the drugs mentioned... given the choice, I'd go for Afrezza. |
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Post by dreamboatcruise on Aug 17, 2014 17:41:49 GMT -5
I guess I would just like seeing sales projections over a range of assumptions about changes in prescribing practices... with a conservative assumption being that this change will come slowly and more aggressive projections assuming faster change. The only sales projections and range of assumptions that matter are Sanofi's and they aint talkin. The rest is pure speculation for the fun of speculating. No one should base their investments on such baseless guessing and limited facts. Our prospects are better than they were before the potential deal-breakers: adcom; FDA approval; and partnership. We now have a decade of speculation on multiple message boards, but we don't really know any more about sales than we did on the day of the IPO in 2004. The enthusiasts are (overly?) enthusiastic about sales and the doubters are still (overly?) doubtful about sales....time will tell. IF and when Sanofi speaks about sales projections, then analysts can analyze. Until then it's speculation not analysis. (I wish I could break my addiction to reading the boards everyday and do something more productive with the time!) People often make money in stocks by educating themselves about markets and doing this type of early "speculative" analysis. If you can come up the range of possible outcomes based on the known information and find that the downside risk at the low end of the likely range is outweighed by the upside possibility at high or even median points of the likely range, it can make a good speculative investment. If you wait for a bunch of analysts to have hard numbers and come to the same results with non-speculative analysis (i.e. simple math from known data) then you likely miss a lot of profits. Even once Sanofi comes out with projections, if they ever do that, it is still good to have done independent analysis. Companies do sometimes release projections that are not realistic. |
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Post by babaoriley on Aug 17, 2014 17:59:52 GMT -5
"(I wish I could break my addiction to reading the boards everyday and do something more productive with the time!)"
Nonsense, hopetoretire, reading this board is excellent training for when your hope becomes reality!! At that point, you'll have all kinds of other hours to be productive!
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Post by jpg on Aug 17, 2014 20:40:24 GMT -5
Hi Dream, Find below a few answers (and questions) to your above multiple responses to me and other posters. Unless stated otherwise I am thinking only of type 2 patients. My impressions are based on many years of observation of patterns of practice by physicians and patient preferences in drug usage. One of my 'hobbies' is medical anthropology. This is by definition 'soft and subjective' information. Regardless of this 'softness' my projections are very significantly not aligned to what most financial pundits are saying. Either I or they are dramatically wrong. Time will tell. You state that: 'If you assume that Afrezza is in conjunction with Lantus then the fact that it is inhaled rather than injected is likely to expand the overall use of prandial only by a limited amount because almost everyone that progresses to Lantus is already ending up using prandial at some point (I believe that true, but interested if anyone knows real stats)... ' JPG: I would strongly disagree that everyone who progresses to Lantus ends up on pradials. A low percentage of overall patients with advanced disease actually end up on basal and prandial in real life. This is obviously a very big difference in baseline assumptions and has major implications to any model. I will go one step further: You also stated (in a previous post): Please correct me if I am mistaken, but I thought the ADA guideline about next steps beyond Metformin is basal insulin not prandial. JPG: Find below a link to an ADA guideline: www.ndei.org/ADA-2014-guidelines-type-2-diabetes-medications-.aspxYou will see they say insulin. Most would probably correctly assume this refers to basal though. Read the rest of the info. There is a lot of room for clinical judgement and 'plasticity or flexibility' in decision making. Liane sent a reference which gives a complex (and confusing to me anyway) decision tree but the preamble states simplicity should be favored... Notice the 2 guidelines are not exactly the same (I am being polite...). All this prescription for diabetics is a lot less 'hard' then most non MDs think it is... Question for you: If the next step after Metformin should be a basal why are there so many other pills out there that are prescribed by MDs before insulin is ever considered (seemingly against ADA advice to introduce insulin early)? Could there be something to this needle phobia thing? Hmmm... I will also state that a very significant majority of advanced diabetics don't even end up on a basal insulin (so forget about the prandial 3-4 times a day injection stuff!). Imagine if we could figure out a way to give patients insulin without injections? Would that be seen as a way to avoid giving a lot of those maybe not so hot pills? This was the pot of gold not so many years ago. Maybe it won't be such a stretch for MDs to go with inhaled insulin instead of pills (they clearly aren't prescribing that much injected stuff for some reason) in 'needle phobics'. What happens as disease progresses and they need a bit more then Afrezza? Introduce a pill or get them onto a once daily, low volume daily basal? Hmmm. Who sells that again? I would have a ton more to say about this (sorry  ) but I have to do some real work! JPG |
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Post by dreamboatcruise on Aug 17, 2014 21:12:05 GMT -5
Why are you so worried over things you can't control? Not worried... just hoping to profit from figuring things out before they become general knowledge. |
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Post by seanismorris on Aug 18, 2014 14:34:40 GMT -5
More than 9,600 calls changed hands on MannKind Corporation during the first hour of today's session, representing 1.14 times the expected intraday volume. The most active option is the weekly 8/22 7-strike call, where 2,421 contracts have crossed the tape. With only 778 contracts in open interest at this short-term option, it's safe to assume new calls are being opened here today. Plus, 77% of the volume has traded at the ask price, and implied volatility rose as some of the day's big block trades changed hands -- so it looks as though speculative players are initiating new bullish bets on MNKD today. Based on the option's volume-weighted average price (VWAP) of $0.21, breakeven at this Friday's close will be $7.21 (strike price plus VWAP). At last check, MNKD is up 2.6% to trade at $7.04, so today's short-term option bulls are betting on the shares to gain more than 2.4% by week's end. Last week brought some major fundamental developments for MNKD, including a deal with Sanofi SA (ADR) (NYSE:SNY) that could be worth up to $925 million. That news helped to overshadow a wider-than-forecast second-quarter loss for MNKD. On the charts, MannKind Corporation (NASDAQ:MNKD) is in the process of bouncing from its 200-day moving average. The stock could now be establishing support atop the $7 level, which previously served as resistance back in April. www.schaeffersresearch.com/marketcenters/optionscenter/content/most+active+options+update+mannkind+corporation+mnkd/default.aspx?ID=122301 |
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) but I have to do some real work!