|
|
Post by compound26 on Oct 27, 2015 10:29:40 GMT -5
This study is another piece of evidence of Sanofi's commitment to Afrezza. The study won't complete until Feb. 2017. If, as some shorts (e.g., AF and his friends) have claimed, Sanofi will dump Afrezza as soon as possible (AF and his friends have mentioned early 2016), why would Sanofi choose to use Afrezza in this study? Think about it, if Afrezza becomes unavailable in the middle of the study, what will happen to the study? And by the way, according this article, on average, Phase 3 Clinical Trial Costs Exceed $26,000 per Patient. "Estimated Enrollment: 500 Study Start Date: October 2015 Estimated Study Completion Date: February 2017 Estimated Primary Completion Date: February 2017 (Final data collection date for primary outcome measure)" |
|
|
|
6.1
Oct 26, 2015 9:57:38 GMT -5
Post by compound26 on Oct 26, 2015 9:57:38 GMT -5
My husband's first 90 day Afrezza blood test is in. Unlike many of our conscientious "testers", he is not so vigilant about ever testing his blood sugar. Here are the facts. Type 2 diabetic for 7 years Previously "maintained" at 7.9 and climbing, despite excellent diet, skinny, mega dose of Metformin and onglyza Begged Dr for Afrezza from Feb to July Went for pulmonary tests Other clearances Kaiser doesn't cover this, so we have to pay more than $400 monthly (after coupon) Started Afrezza three months ago He had some trouble adjusting in the beginning and used the "Coach" program After about a week, he started inhaling 10-15 minutes after starting meal (or snack) About a week after that, he stopped checking his bg starting it had regularly been under 150 with no hypos No bg tests between then and now. (I know, not the best role model) A1C results from Thursday's blood test showed 6.1 I'd like it under 6, but right now, I'm ecstatic! suebeeee1, can you also share your husband's wonderful results on Twitter? If you already have, can you share a link to your tweet? |
|
|
|
Post by compound26 on Oct 16, 2015 14:37:16 GMT -5
Share on facebook, 3.6K. Those ladies at Cleveland Clinic do know how to write popular articles.  Share on facebook, 3.6K Share on twitter, 292 Share on linkedin, 18 Share on pinterest_share, 6 |
|
|
|
Post by compound26 on Oct 15, 2015 15:43:19 GMT -5
So basically MNKD would be in a position where one year after FDA approval, they got $200 million free and clear from SNY and some basic marketing and education of the market. They are then free to choose a new partner with some of the pieces already in place to continue the marketing and sales of the product and unencumbered by the 35/65 split that everyone was griping about incessantly. If I had a way to make $200 million a year with no obligations, I'd be all over that personally. I think they'd still owe the loan from Sanofi (175M max) for their share of the "losses"....but otherwise agreed. Agree. If Sanofi elects to walk away as of January 2016 (which I think is very very unlikely), many other big pharma will be interested in partnering with Mannkind. For example, Matt has wrote: Afrezza w/ Tresiba: A perfect Match? Assuming what Matt claimed in his article and video is acute and other type ones can replicate his results, if Sanofi walks away from Afrezza, Sanofi will face a HUGE risk of losing a significant market share in the basal market. That risk will grow substantially if there comes a bundle of Afrezza + Tresiba down the road. |
|
|
|
Post by compound26 on Oct 14, 2015 14:26:15 GMT -5
harryx1, thanks! The first link got the correct photo of Afrezza! The second still has an incorrect one. |
|
|
|
Post by compound26 on Oct 13, 2015 17:56:49 GMT -5
James, I agree with your analysis in the last two posts. Additionally, I will not be surprised that either or both of the Sanofi and Mann Group facilities be expanded/upsized at some point.
Given that Mannkind set a $4.6 floor for the recent debt and equity swap settlement, I think at this point Mannkind will elect to not use its ATM facility unless share price are at least around $4.6 or higher.
At least with respect to the Mann Group facility, I believe Matt hinted in a few occasions that, if necessary, Al may expand that facility. At $10M per quarter's operational cash burn rate, if Al expands that facility by $30M to $50M, that will bridge for another 3-5 additional quarters.
So I think a more likely situation will be that Mannkind will first use the loans available under the Mann Group facility (compared with the ATM facility) and see where they are with respect to the milestone payments. If the cash balance dips below a certain amount, say $30M, they will probably ask Al to expand the Mann Group facility by anywhere from $20M (two quarters' operational cash burn) to $50M (five quarters' operational cash burn).
|
|
|
|
Post by compound26 on Oct 13, 2015 16:23:08 GMT -5
Here is my take. Please feel free to correct me:
radiohet, this is Compound26, I am using your table template.
Here is my take for the third quarter:
| Cash end 2nd qtr | 107M |
| | Debt settled cash | -50M |
| | 3rd qtr cash burn | -13M |
| | cash (end 3rd qtr) | $44M | $69M if $25M milestone booked for 3rd qtr | | Loan available under Mann Facility | $30M |
| | Loan available under Sanofi Facility | $132M | $147M available as of end of 2nd qtr, so I added $15M balance for the last qtr | | Available under ATM Facility | $50M |
|
Based on the above, the Sanofi facility at $132M available and $15M per qtr burn rate (for Afrezza commercialization related expenses), can last another 8.8 qtr (over 2 years) after the 3rd qtr. The 69M cash (including the $25M milestone that we expect Mannk will receive in the near future), plus 30M loan available from Al Mann, and $50M available under ATM, at a $13M per qtr burn rate (for Mannkind's operation related expenses), can last another 11.5 qtr (about 3 years) after the 3rd qtr. If Mannkind reduces its future qtr cash burn to $10M per qtr, this can last another 14.9 qtr (about 4 years) after the 3rd qtr. |
|
|
|
Post by compound26 on Oct 13, 2015 14:17:51 GMT -5
hey! i resemble that remark! lol and probably more logical too to slice and dice something Personally, I think this concentration of prescribing doctors in Florida and California probably may have resulted from the fact that more clinical trials of Afrezza in the past were carried out in sites located in these two states. Therefore, there are more readily accessible markets in terms of both doctors and patients who have a better awareness of Afrezza than those in other states. Of course, the above is just my hypothesis. |
|
|
|
Post by compound26 on Oct 13, 2015 13:37:01 GMT -5
In looking over afrezzausers list of prescribing docs currently numbering 87, a full 1/3 are in 1 state...California. Very populous state but not 1/3 of US diabetic population i would imagine. Also only about 1/2 the states accounted for and many big cities missing (Houston, Phoenix to name 2) Yes, the same feeling here. See my comment regarding this about one month ago: Looking at the Afrezza-prescribing physician list maintained by Sam, one will notice that California and Florida physicians now constitute around 50% of all the physicians listed there. Assuming Sam's list catches a good percentage of all the prescribing physicians (which I believe is the case as the total number in Sam's list is around 60-70 already), do the doctors or residents of California and Florida have an out-sized interest in Afrezza compared with doctors or residents of the other states? I do not think so. So I think, naturally, and, over time, the penetration rate of Afrezza in the other states will improve to catch up with that of California and Florida. If that occurs tomorrow (hypothetically) and everything else remains unchanged, by a rough estimate, with just that simple improvement in penetration rate, the TRx would be around 2.5 times that of the status quo. That will translate to a weekly TRx of 1,500 and an annual sales of $40 million. |
|
|
|
Post by compound26 on Oct 13, 2015 8:26:34 GMT -5
I'll bring up another analyst--this one consistently trashes MNKD: Looking for Diogenes. In his SA piece today he focused on cash burn, saying: " IF MannKind paid out $50 million in order to address this debt issue, that could be the final nail in this bloated valuation for MNKD. They had $107 million in cash at the end of the last Q. If they paid out $50 million that leaves $57 million, now less the same burn rate of last Q being $28 million that leaves $28 million--but then there is a loan convenient that requires MNKD to have on hand at all times $25 million that leaves a whopping $3 million dollars that isn't encumbered. So basically now that we are two weeks into the four Q, MannKind is out of operating cash." Do folks here, think the situation is that dire? If that's what Looking for Diogenes wrote, then he either is deliberately lying or did not do his due diligence. Per Mann's second quarter conference call transcript, Mannkind's cash burn is $13 million for the last quarter. "Cash and cash equivalents were $107.2 million at June 30, 2015, compared to $120.8 million in the first quarter of 2015." See last quarter's conference call transcript. Even AF admits that in his article: MannKind Silent on Debt Conversion, Suggesting Costly Cash Settlement, where he says: "in the second quarter, MannKind used $13 million in cash to fund operations." Additionally, MannKind's still have $30.1 million available to borrow under the amended loan agreement with The Mann Group. See last quarter's conference call transcript. Finally, Mannkind still has $147 million available under its loan facility with Sanofi. See last quarter's conference call transcript. Going forward, it appears Mannkind's cash burn rate probably will be less than $13 million per quarter as a result of all the cost-reducing efforts that Mannkind has been implementing recently. It would not surprise me if they manage to reduce their cash burn rate to around $10 million per quarter. If that's the case, Mannkind's $30.1 million available to borrow under the amended loan agreement with The Mann Group will be able to bridge Mannkind for three quarters. And the expected $25 million manufacturing milestone will extend that time period for another 2.5 quarters. (See this article on this manufacturing milestone.) Even though Matt in his latest presentation said Mannkind have not received this milestone payment yet, he did confirm that he would expect this milestone payment to be received at some point in the future. And there is sloppiness all over the place in the short paragraph quoted above. First, the author got the facts wrong about the cash burn rate as pointed above. Second, you will notice that in the author's calculation, 57-28=28.  Third, he says there is a "loan convenient" (apparently a typo for "loan covenant"). Where are SA's editors? And the scary thing is that this author now has 28 articled published in SA! |
|
|
|
Post by compound26 on Oct 13, 2015 8:12:21 GMT -5
In the past month ( 7th month after launch ):
Formulary Status (Afrezza) | Sept 12, 2015 | Oct 12, 2015 | +/- Change | | Total Plans | 6,950 | 6,963 | +13 | | Preferred | 90 | 95 | + 5 | | Covered | 2,242 | 2,261 | +19 | | Restricted | 1,412 | 1,446 | +34 | | Not Covered | 3,206 | 3,161 | - 45 |
Of the 45 plans that picked up coverage of Afrezza in September, Restricted coverage outnumbered Preferred+Covered placement in formularies.
It seems like a trickle right now but, according to Hakan, we should started seeing increasing coverage throughout months 7-12 post launch.
Source: FormularyLookup.com
Overnight, two plans moved Afrezza from Restricted (now @ 1,444 plans) to Preferred (now @ 97 plans). I thought this site was updated weekly, but apparently there are daily updates. I'm considering starting a table, similar to what Liane does with script counts, only this one would track Formulary Status from the free site FormularyLookup.
What does everyone think of that idea? Board members would able to track changes in formulary coverage for Afrezza (I'm thinking of updating by week).
mnholdem, that's a great idea! |
|
|
|
Post by compound26 on Oct 12, 2015 22:50:40 GMT -5
I'll bring up another analyst--this one consistently trashes MNKD: Looking for Diogenes. In his SA piece today he focused on cash burn, saying: " IF MannKind paid out $50 million in order to address this debt issue, that could be the final nail in this bloated valuation for MNKD. They had $107 million in cash at the end of the last Q. If they paid out $50 million that leaves $57 million, now less the same burn rate of last Q being $28 million that leaves $28 million--but then there is a loan convenient that requires MNKD to have on hand at all times $25 million that leaves a whopping $3 million dollars that isn't encumbered. So basically now that we are two weeks into the four Q, MannKind is out of operating cash." Do folks here, think the situation is that dire? If that's what Looking for Diogenes wrote, then he either is deliberately lying or did not do his due diligence. Per Mann's second quarter conference call transcript, Mannkind's cash burn is $13 million for the last quarter. "Cash and cash equivalents were $107.2 million at June 30, 2015, compared to $120.8 million in the first quarter of 2015." See last quarter's conference call transcript. Even AF admits that in his article: MannKind Silent on Debt Conversion, Suggesting Costly Cash Settlement, where he says: "in the second quarter, MannKind used $13 million in cash to fund operations." Additionally, MannKind's still have $30.1 million available to borrow under the amended loan agreement with The Mann Group. See last quarter's conference call transcript. Finally, Mannkind still has $147 million available under its loan facility with Sanofi. See last quarter's conference call transcript. Going forward, it appears Mannkind's cash burn rate probably will be less than $13 million per quarter as a result of all the cost-reducing efforts that Mannkind has been implementing recently. It would not surprise me if they manage to reduce their cash burn rate to around $10 million per quarter. If that's the case, Mannkind's $30.1 million available to borrow under the amended loan agreement with The Mann Group will be able to bridge Mannkind for three quarters. And the expected $25 million manufacturing milestone will extend that time period for another 2.5 quarters. (See this article on this manufacturing milestone.) Even though Matt in his latest presentation said Mannkind have not received this milestone payment yet, he did confirm that he would expect this milestone payment to be received at some point in the future. |
|
|
|
Post by compound26 on Oct 12, 2015 17:40:49 GMT -5
Pretty nice Monday with a FBG of 102.
I read Matt's piece on "Timing is Everything" and decided to give it a try. The basic idea is instead of taking Afrezza at the beginning of the meal you'll get better results by waiting 10 minutes into your meal. OK I'll bite....how can I go wrong on a trial.
For my test I picked a Taco Bell Taco Salad. Taco Salad has 74 carbs with the shell. Gusty move you say. Pre meal my BG was 89....took my basic 8 units....one hour later my BG was 92. Amazing
blindhog1. That's a great experiment! Way to go! This proves that Matt's observation and comment in his video and article are accurate. And both your and Matt's experience support Al Mann's claim that "the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat." And note that Matt's observation and comment in his video and article regarding the timing and dosage of follow-up doses also support Al Mann's statements below. [Matt gave an example where he was having a five-course Japanese banquet, he took a green dose (8-Unit) Afrezza every forty-five minutes or so and his BG level remained perfect throughout the dinner. And the same approach worked for him at a dinner party, where he even drank sugary cocktails]. Al made his above comment in this interview: An Exclusive Interview with Al Mann, Founder and CEO, Mannkind Corp."SF: Was that when you changed to the new device? AM: No, I think that a problem during the trials was that some patients took their dose of Afrezza even before starting to eat. The trial protocols called for Afrezza to be dosed “at the beginning of the meal,” but sometimes it was taken even before. We need to do additional trials to gain more experience with optimized dosing times. Actual ingestion of food in most meals in the United States except in restaurants takes only about 30 minutes, so I believe that the first Afrezza dose really ought to be taken ten or fifteen minutes after starting to eat.
For a longer meal, which is not very common, a second dose might be taken fifty or sixty minutes after starting to eat.
For a long feast that lasts for an hour and a half or more, I suggest a third dose be taken at maybe one and a half hours after start.
Interestingly I believe the size of all those doses should probably be the same for most patients.
Unfortunately the trial protocols called for dosing at the beginning of the meal so we will need to do more trials to be able to gain FDA label approval of optimized dosing." |
|
|
|
Post by compound26 on Oct 12, 2015 16:43:57 GMT -5
Some interesting comments from this article: Selecting the Most Effective Advertising MediaOutdoor advertising/billboards: These reach more people for a dollar than any other media, but are limited to a picture and no more than eight words. Radio: Reaches the second most people for a dollar, but cannot be targeted geographically and can only be loosely demographically targeted. But if people will drive significant distances to buy your product, or if you're selling a "we come to you" service, this is likely your best bet. Cable television: Offers the impact of moving images as well as spoken words. Can easily be geographically targeted. But your ad will likely look homemade. Broadcast television: Big prestige. Big bucks. But able to target psychographic profiles. Buy specific shows; never buy a rotator.Newspapers: Reach customers who are in the market to buy today. Unfortunately, people not currently in the market for your product or service are less likely to notice your ad than if it had appeared in another media. Magazines: Expensive, but high-impact with tight targeting. Little waste. Weakness is infrequency of repetition. Direct mail: Highly targeted, all the way down to the level of the individual. But shockingly expensive to do right.Yellow Pages: Essentially a service directory for the customer who has not yet made up his or her mind. Very foolish for retail businesses. |
|
|
|
Post by compound26 on Oct 12, 2015 16:16:32 GMT -5
mssciguy, interesting, where did you get that "twenty views (average) is now required for a single sale" data? I would like to take a look at that study/survey. It's from a local SmartUps emarketing talk (SmartUps is the Meetup for local startups). I am not sure that you really need a study or survey to convince yourself-- look at TV ads, radio ads, internet ad, it's all repetition. From my own experiments in emarketing, I can tell you for sure that in the absence of deep discounts, 10-20 page views gets one sale (although what I had was unique). Maybe Afrezza is unique enough to get sold without all that repetition. But then, maybe it will take more. Too early to tell, and Pfizer poisoned the well in some ways with their product. No, I don't need a study or survey to convince myself. Just interested to see if there is something else interesting in such a study. |
|
