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Post by compound26 on Sept 23, 2016 11:22:19 GMT -5
Trodisc: I'm sorry you feel so bad about your lost investment, that you feel compelled to trash MNKD and use borderline profanity in personal attacks against posters. Now that you're out, I can only wish you the best in your future investments. If there was an ignore button on this site, you'd be on it with me. Good luck to you wherever life leads. Aloha. ilovekauai, yes, you can block any of the members whose posts you don't want to see.
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Post by compound26 on Sept 21, 2016 14:45:49 GMT -5
Yes, this was discussed before. See below. And I believe Matt/Mike has referred to this article in their recent presentations.
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Post by compound26 on Sept 18, 2016 16:11:40 GMT -5
Please share the articles if you can. As others in this board have pointed out, these articles are easily among the best that have ever been written by the medical world regarding Afrezza. They are a big step forward compared with the typical medical journal articles regarding Afrezza that we have seen in the past.
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Post by compound26 on Sept 16, 2016 16:43:43 GMT -5
Indeed. Can somebody please help me understand why the author would write such an article, given his board position with NN? Could it be that someone still has a sense of fair play no matter who they work for? That's an uplifting thought. He has retired from his teaching job after 45 years teaching there. He has lived as type 1 for 67 years. I think at this point of life he cares more about speaking the truth and spreading the information to help the diabetics. Author Information: The author retired from the Washington State University College of Pharmacy in 2013 after 45 years and remains a distinguished professor emeritus of pharmacotherapy. He has lived with type 1 diabetes for 67 years and has used an insulin pump for 37 years, 9 months. - See more at: www.ajmc.com/journals/evidence-based-diabetes-management/2016/september-2016/afrezza-treating-diabetes-in-a-physiologic-manner#sthash.4QWZ35U8.dpuf
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Post by compound26 on Sept 1, 2016 15:48:47 GMT -5
In California there are so many prescribers yet so few prescriptions.... I do like that PWD can find a prescriber easily on the website. Per Mike, there are over 3,000 doctors who wrote one or more prescriptions. With our cumulative prescription at around 30,000 (per Symphony). On average, each prescriber wrote about 10 prescriptions. Excluding some top prescribers, most of the prescribers on average probably have wrote 5 or less prescriptions.
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Post by compound26 on Sept 1, 2016 14:26:30 GMT -5
I just checked again. It works this time. Great! One more promise delivered by Mike and his team.
Counting what Mike and his team has done in the last 90 days, you wonder what work has Sanofi has actually done while they were marketing Afrezza and yet they "claimed" they have spent $200 million on the marketing of Afrezza (based on the fact Mann's loan facility with Sanofi has an outstanding obligation of around $70 million).
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Post by compound26 on Sept 1, 2016 14:06:21 GMT -5
Looks like there have been updates to the website. www.afrezza.comI like the "find a doctor" portal. Should really be called "find a prescriber", but that's fine. The site for health care providers isn't up at the moment, probably a short-term problem. Afrezzapro.com seems to be migrating to afrezza.com/hcp or hcp.afrezza.com Hopefully the videos were made and purchased during the Sanofi period. I would still like to see more technical information on the site. Or at least some mention of the difference between monomeric human insulin and insulin analogs. I know they are super bound by FDA rules, but that seems like important information to me. cathode, I clicked on the "find a doctor" link and it does not work.
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Post by compound26 on Aug 30, 2016 17:23:48 GMT -5
I believe Matt P''s exact words were, as I recall, mnkd will have enough money to take us into 1st Q 17. I do not remember him being more specific such as end of the Q. I agree. That is also what I recall. But I believe, based on the available and expected cash, they should have enough cash to last towards the end of 1st quarter, while still have enough cash and ATM available at that point for them to secure further financing in the next quarter or so. See my projection in another post (link below). However, to say "we have enough cash to last us into first quarter of 2017" will not be a conflict with any financing that Mannking may seek before first quarter 2017 (such as anytime this year), as any financing they seek will then further extend their runway into the future. Also, as for RLS milestone, even though the contract has a total possible milestone payments of $100 million plus, I will be satisfied to get $10 milestone payment for this year. I don't think we will get a milestone this year of $25 million or anything like that. mnkd.proboards.com/post/77661/thread
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Post by compound26 on Aug 30, 2016 15:03:36 GMT -5
Here is my cash projection for Mannkind. It appears we do have sufficient cash to last through March 2017, assuming: (a) Matt and Mike tries everything to keep the cash burn flat (10 million per month), which I believe they do intend to; (b) Mannkind gets another 10 million under insulin put (while still maintaining the 10 million cash burn, i.e., with increase expenditure on insulin purchase) in the third and fourth quarters combined; and (c) Mannkind gets a 10 million milestone from RLS by year end of 2016. Month | TRx | Cash | Available under Mann Loan Facility | Available under ATM | Comment | June | N/A | 63.7 | 30 | 50 |
| July | 250 | 53.7 | 30 | 50 |
| August | 350 | 43.7 | 30 | 50 |
| September | 450 | 38.7 | 30 | 50 | 5 from insulin put | October | 550 | 33.7 | 30 | 50 | 5 from insulin put | November | 650 | 33.7 | 20 | 50 | 10 draw under Mann credit line. | December | 750 | 33.7 | 20 | 50 | 10 from RLS | January | 850 | 33.7 | 10 | 50 | 10 draw under Mann credit line. | February | 950 | 33.7 | 0 | 50 | 10 draw under Mann credit line. | March | 1050 | 28.7 | 0 | 50 | 5 from Afrezza sales since August 2016. |
Based on the above projection, Mannkind will have 28.7 million cash and 50 million under ATM at the end of March 2017, with an expected TRx around 1,000. If during any time from now and through March 2017, SP goes above 2, I would think Mannkind will probably use some of the ATM and therefore preserve some of its cash. Based on such progress, I think each of the following events will be likely to occur within a few months (i.e., second quarter of 2017), which will further extend Mannkind's runway much longer: 1. Settlement payment from Sanofi (even if just forgiveness of existing debt + release of Sanofi's lien on the Mannkind headquarter building, which is worth 20 million+ if sold, will be helpful); 2. an international deal with some upfront fee; 3. a label change (beneficial for SP and further increase of TRx); 4. a partnership for epinephrine; 5. Use of ATM on better SP (with a renewal of ATM registration for future use).
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Post by compound26 on Aug 28, 2016 22:53:07 GMT -5
Very safe to say that script would have increased again this week if Medicare/Medicaid lapse didn't occur. I'd venture to guess we would have seen New 150-160 and Total in the 260-270 range.. Of course a guess. . but either way we are seeing a pattern of increasing or steady.. Also think that we will probably see some .70's throughout the week. It's a long race... not a spring.. GL Wondering if Medicare/Medicaid is really 30%.... Not sure whether 30% of Afrezza users are actually covered by Medicare and Medicaid (for which Mike C. must have the data ), however, if someone has asked me to give a blind guess, that will be the number I will give. Per this wikipedia article: "The percentage and number of people covered by Medicaid in 2012 were not statistically different from 2011, at 16.4 percent and 50.9 million. The percentage and number of people covered by Medicare increased in 2012 to 15.7 percent and 48.9 million, from 15.2 percent and 46.9 million in 2011. Since 2009, Medicaid has covered more people than Medicare." The above numbers add up to about 30% and 100 million people.
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Post by compound26 on Aug 25, 2016 17:03:54 GMT -5
6,000/7,000 weekly TRx to break even sounds right. Looking at the IMS chart, we had around 20,000 (21,279 TRx per IMS chart) for the first year of launch). Mike C. has mentioned that we had a $7 million first year sales. To get to an annual sales around $120 million (the current annual cash burn of Mannkind), we will need to increase the annual TRx of 20,000 by 17/18 fold (120/7=17.15), and then you divide it by 52 and you will get a 6,000/7,000 weekly TRx. 6,000/7,000 weekly TRx translates into around 30,000 monthly TRx. Mike c. mentions about a 1.5 million insulin TRx monthly. That means we need to get to 2% of the total monthly insulin (basal + bolus) prescriptions to break even. (However, this only considers the US market and Afrezza alone. If Afrezza gains traction, we will have revenues of Afrezza and other TS products in and out US. So if Afrezza gains traction, I would think if we get to 1% of the total monthly insulin (basal + bolus) prescriptions, we will be very close to break even as we will surely have Afrezza sales outside US to come in later. Looking at the situation from that angle, then if we hit 3,000 TRx weekly, we will be well under our way to break even.) 3,000 TRx weekly is completely feasible, if we recall that, Exubera was at around 2,000 TRx weekly before it was pulled off from the market. Sure Pfizer put a lot of sales efforts into marketing Exubera, but Afrezza is much better product. Plus, we now have CGMs, social media and other tail winds for Afrezza. One word: Awareness
There is some very interesting testimony coming out of the shareholder class action lawsuit trial that was dismissed by a federal judge this week. A former Sanofi sales rep testified that Sanofi did not provide either enough reps or enough marketing material for the Sanofi reps to successfully market Afrezza to physicians. With MannKind now driving this bus, events will unfold quite a bit differently. Focus on getting the low-cost spirometry equipment into the hands of the endos, get them up to speed on the proper method for titrating new Afrezza patients, make it easy to deal with insurance carriers and then...
...bring on the marketing.
So few have even heard the name Afrezza, let alone what it can do for patients. Build physician and patient awareness and 3k+ weekly script is feasible indeed.
mnholdem Totally agree. Mike C has stated that despite Sanofi's one year marketing efforts, 90% of the PWDs is not aware of Afrezza. But as Mike said, that's a positive right now. Sanofi reached 627 TRx weekly with "little or no efforts", with 90% of the PWDs not aware of Afrezza. So what happens when 90% of the PWDs is made aware of Afrezza?
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Post by compound26 on Aug 25, 2016 15:41:20 GMT -5
6,000/7,000 weekly TRx to break even sounds right.
Looking at the IMS chart, we had around 20,000 (21,279 TRx per IMS chart) for the first year of launch). Mike C. has mentioned that we had a $7 million first year sales. To get to an annual sales around $120 million (the current annual cash burn of Mannkind), we will need to increase the annual TRx of 20,000 by 17/18 fold (120/7=17.15), and then you divide it by 52 and you will get a 6,000/7,000 weekly TRx.
6,000/7,000 weekly TRx translates into around 30,000 monthly TRx. Mike c. mentions about a 1.5 million insulin TRx monthly. That means we need to get to 2% of the total monthly insulin (basal + bolus) prescriptions to break even.
(However, this only considers the US market and Afrezza alone. If Afrezza gains traction, we will have revenues of Afrezza and other TS products in and out US. So if Afrezza gains traction, I would think if we get to 1% of the total monthly insulin (basal + bolus) prescriptions, we will be very close to break even as we will surely have Afrezza sales outside US to come in later. Looking at the situation from that angle, then if we hit 3,000 TRx weekly, we will be well under our way to break even.)
3,000 TRx weekly is completely feasible, if we recall that, Exubera was at around 2,000 TRx weekly before it was pulled off from the market. Sure Pfizer put a lot of sales efforts into marketing Exubera, but Afrezza is much better product. Plus, we now have CGMs, social media and other tail winds for Afrezza.
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Post by compound26 on Aug 17, 2016 12:32:57 GMT -5
The titration and insurance issues are kind of a chicken and egg problem. Did patients stop using Afrezza because they couldn't titrate with limited packs and then discover insurance wouldn't cover Afrezza anyway? Or did they try Afrezza knowing they would have to fight for coverage and then find out they couldn't titrate and just gave up? I'll bet both scenarios played out multiple times. Maybe what Mike and the team are trying to overcome is just plain frustration. Regarding agedhippie's post (earlier in this thread) about Sanofi probably having stats as to why people stopped using and your post, MNKD at the CC's made it clear that it was a combination of factors including those who used sample packs and didnt go any farther. As I recall factors involved were titration/initial dosing problems (including but not limited to running out), coverage(insurance), preauthorization hurdles, and pricing and a combination thereof. prvs michaelcastagna yes, apparently, it is a combination of factors. However, for Mannkind to succeed, it needs to address each of these issues. Since Sanofi drops its efforts in marketing Afrezza, the Afrezza NRx and TRx has steadily declined since Sept./Oct. 2015. To me, that is not surprising or a big concern. However, the weekly refills has also declined from 250/300 level reached at the start of 2016 to around 160/170 level right now. That is a bigger concern to me. Yes, insurance and reimbursement is an issue. However, since for those users who are already on Afrezza, these should be less an issue. Plus, even though NRx are relatively low in the first half of 2016 and retention rate is not satisfactory, a part of the NRx is nevertheless being turned into refills each and every week, therefore, ideally, our total refills should still steadily increase despite these factors. To me, the steadily dropping of weekly refills suggest that some users are dropping out after one or two refills and that the numbers dropping out of the refills exceeds the numbers being added via NRx. That is worrisome. To me, most likely, those who drop out of the refills did not titrate Afrezza well to give them the good control they wanted. To me, a steady rise of refills is even more important than a steady rise of NRx. As long as we can retain a great majority of the existing users, refills will keep rising, no matter how small the NRx is. On the other hand, even if the NRx is high, if we keep loosing users (even after one or two refills), our TRx will not rise significantly. I would think it is important from now on that Mannkind makes every effort to make sure that each new user is followed up in the initial 7-10 days. Do not know whether it is doable or not. But perhaps Mannkind gets the patient's contact information through their enrollment of the Afrezza co-pay card? Maybe some of the nurse educators can follow up on these new users and to the extent a new patient has any titration issue refer the patient to a titration specialist/doctor engaged by Mannkind?
In terms man power, since we are probably talking about 1,000 new patients every month at most at this moment, that will be 250 per week or 50 per day. I would think Mannkind does have the resource to follow up with these new patients. However, I do not know whether the current medical practices allow them to do so. Also, is it possible for Mannkind to create some type of Afrezza community site like the Amazon Q&A service? In Amazon, for every popular product, there is a section called "Customer Questions & Answers". Where a user can post any question and other users can answer the question. All the questions and answers are archived and searchable. A user can get lots of useful information about a product by looking through these Q&As. The keys is that all the questions are answers by Amazon's customers and no Amazon representative is involved. Additionally, based on my experience, if you post a question, someone will very timely answer the question. This an excellent example of cloud sourcing. Based on how well Afrezza has worked for some of the early adopters, perhaps a similar Afrezza Q&A community can be supported and monitored (but without actual involvement by any Mannkind employee) by Mannkind? Any Afrezza user will share their experience solely as a share of their personal experience (not as a medical advice). I think in such a site, initially, we can probably have 20-30 successful Afrezza early adopters to volunteer to each write a few paragraphs about their best tips on Afrezza titration, with several themes, like their typical dosage, timing, how many follow-up doses they will need, how many units and boxes they use every week and month, improvement in their quality of life (weight loss, sleep quality, less diabetic complications (neuropathy, Cholesterol level, etc.), freedom in dining out and exercise, etc.), how to dose for fatty and slow digesting foods (pizza, etc.), how to address dry cough issue (if any), their experience deal with prior authorization and insurance, which insurance they are using, etc. Those information will then get categorized (like dosage related, gender, age, type 1 and type 2, different food type, etc.), archived and made searchable. This will serve as a good starting point for an Afrezza community.Above are some of my random thoughts that I throw out for your consideration. They may not be practical, but just in case any of them is helpful in stimulating your creative discussions.
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Post by compound26 on Aug 15, 2016 22:26:22 GMT -5
esstan2001 Agree with your wording. It will be great if the label can be worded like this. To me, the more specific the better. People generally just follow directions when take a medicine. Since Afrezza is no new (and so different from the RAAs), a specific instruction (with the optimal timing of the dose) will probably bring out the best results with most new users upon their initial trials. I will probably add a little bit: .. .recommended dosing within 15 minutes after the start of the meal ( which timing may be fine tuned as necessary ......). then something to the effect of ... Supplemental doses to cover [verbage describing slow to metabolize foods] as required
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Post by compound26 on Aug 15, 2016 22:12:28 GMT -5
In the label change that Mannkind is planning to submit to FDA in Sept./Oct., I wonder if they can get both of the following reclassification and clarification:
1. Ultra-rapid classification.
Whether Afrezza can be classified as ultra-rapid insulin (a class by itself) as compared with within the same class with RAAs;
2. Dosing time clarification.
Whether the instruction can clarify that Afrezza is to be taken "after the start of" the meal instead of "at the beginning of” each meal.
"At the beginning of” each meal implies that you first take the Afrezza and then you eat.
"After the start of" the meal will be much clear. You first eat (and start the meal) and then you take the Afrezza.
While there may only be 10-15 minutes difference of timing between these two dosage time, this difference can be crucial for users to get the best results with Afrezza.
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