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Post by centralcoastinvestor on Feb 14, 2016 18:56:29 GMT -5
I completely agree that sales will improve dramatically with an e-marketing campaign and pricing on par with RAA insulins. Cost and awareness will do wonders for Afrezza. I remain optimistic and underwater. Are you thinking that patients themselves will be willing/able to pay out of pocket with a cost reduction to parity with SQ RAA? I don't think there are large numbers of people that can and would pay a significant premium for Afrezza if they could get Novolog or Humalog at the preferred co-pay tier. I'm not expecting dramatic growth in scripts as I believe it will depend on better formulary coverage and increased acceptance within the medical community, and I'm skeptical there is a quick fix for either of those. I remain optimistic that Afrezza will be successful, but fearful of what will need to be done to get us there and what it will mean for my MNKD shares. I may be seeing the script issue differently from many here. Sanofi so successfully killed Afrezza sales that most in the market believe Mannkind and Afrezza are dead. As crazy as this sounds, that provides Mannkind a unique opportunity. If Mannkind can show even small week over week script growth in the first several months, a couple of things will happen. First, it wil show that Sanofi was sandbagging Afrezza, which many in the market already believe. The market just doesn't believe Mannkind will survive the sandbagging perpetrated by Sanofi. Second, it will show growth in Afrezza which I believe will draw interest. There just aren't that many growth stories out in the general market now and a growing script count however small will be intriguing to some investors. We need just a little positive momentum. |
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Post by prvs on Feb 15, 2016 6:44:21 GMT -5
There was a question on FB about getting Afrezza to veterans. Matt said it would be a top priority (paraphrasing). Is the insurance formulary acceptance easier to get if it's for the VA rather than for an HMO?
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Post by LosingMyBullishness on Feb 15, 2016 7:25:53 GMT -5
kc,
I understand that it is your favorite concept that MNKD should be sold. You trust that this company will develop Afrezza and not shelf it.
Now MNKD had been advertising a partnership in the past and the best one, the one with really deep pockets and a CEO Al Mann trusted that he would really develop Afrezza was actually SNY. Al Mann made it always very clear that his upmost interest is to bring Afrezza to as many diabetics (and pre-diabetics) as possible.
So after the disaster with SNY sandbagging MNKD - and you can see this clearly both in scripts [nice steady growth till July 2015 and then growth slowed down] and google searches - what company do you think would provide such confidence to Al Mann?
And are you yourself sure that they would not shelf it?
I actually do not trust any incumbent in the Diabetes area. They are well established, know each other well and live together side-by-side. Afrezza is an unknown, a disturbance and such companies love their forecasts and hade disturbances.
And another big Pharma player without prior Diabetes experience? That is risky. A lot of hurdles, new sales reps, a lot of Endos to massage. It is easier to acquire a company in your area of sales.
Not convincing for me.
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Post by kc on Feb 15, 2016 9:21:07 GMT -5
Intrinsic my only comment is they need cash to run the company. I do not want to see the stock further diluted as that will only hurt us as shareholders. To successfully market Afrezza you need to have a lot of capital to invest. We are close to bankruptcy. A Band-Aid such as selling more shares does nothing to help us long term except more dilution.
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Post by prvs on Feb 15, 2016 9:31:03 GMT -5
Has anyone read the risks section of the 10-Q? Is it known that SNY has a first priority mortgage on the Valencia CA facility and will probably get the lion's share of the sale price? This must be why Matt says MNKD will get "a little" money from the sale of the CA building. He's not being modest or downplaying it.
Sorry for throwing cold water on the people who think the CA facility sale is going to solve most of MNKDs cash problems. SNY may prefer to wipe out the debt with this sale.
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Post by cretin11 on Feb 15, 2016 10:57:48 GMT -5
I haven't seen anybody suggest the sale of that property would solve most of the cash problems.
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Post by LosingMyBullishness on Feb 15, 2016 11:13:47 GMT -5
kc,
I agree that they need cash. My assumption is that selling is the last resort. They plan to partner and create awareness and lower price. Then they hope that price reduction, early adopter testimonies, higher awareness and good study result at ADA will convince insurances and endos.
It is going to be a tight match, but, hey, what a ride.
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Post by kc on Feb 15, 2016 11:54:10 GMT -5
Somebody buying the entire company will be committed to selling Afrezza. Partnership didn't work with Sanofi.
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Post by agedhippie on Feb 15, 2016 12:51:11 GMT -5
kc, I agree that they need cash. My assumption is that selling is the last resort. They plan to partner and create awareness and lower price. Then they hope that price reduction, early adopter testimonies, higher awareness and good study result at ADA will convince insurances and endos. It is going to be a tight match, but, hey, what a ride. Right now Mannkind has a limited life without extra cash and the vendor management team at an insurer is not going to approve a supplier who may well not be there in a few months. Dropping the price is only part of the equation, they also want stability. A solid partner would fix that issue so that is the obvious priority. Raising awareness also costs money, you are not going to reach the audience required with social media. This sort of coverage takes real money which is in short supply. Even then unless you convince the doctors the patient will have the doctor selling against Afrezza and the doctor will likely win unless the case is compelling which currently it is not to the general public (non-inferior, black box warning, lung risk, etc.) Reaching the doctors is key to success. The study results will not achieve much. The best we will get out of that is the removal of the ketoacidosis risk which is worth having but only brings Afrezza into line with RAA. Basically the studies fix some of the inferior positions. The pediatric study will not be completed in time, and the lung study has not even got an approved protocol yet (although it should by the time of the ADA). Of the proposed solutions awareness and price reductions reduce the length of time Mannkind can survive since they are reducing the available cash. It also will reduce the price someone will pay for Mannkind as desperation sets in. Right now I do not see any way other than new cash to fix the position. It can come from Al or dilution, my bet is dilution and if that is case case then the sooner the better. |
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Post by dreamboatcruise on Feb 15, 2016 13:21:52 GMT -5
The study results will not achieve much. The best we will get out of that is the removal of the ketoacidosis risk which is worth having but only brings Afrezza into line with RAA. Basically the studies fix some of the inferior positions. The pediatric study will not be completed in time, and the lung study has not even got an approved protocol yet (although it should by the time of the ADA). Why did Afrezza get the warning for keto and what about these new clamp studies vs the old ones would prompt its removal? |
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Post by mnholdem on Feb 15, 2016 14:19:51 GMT -5
Label: AFREZZA- insulin human powder, metered
AFREZZA- insulin human
DRUG LABEL INFORMATION
...
5 WARNINGS AND PRECAUTIONS
...
5.6 Diabetic Ketoacidosis
In clinical trials enrolling subjects with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in subjects receiving AFREZZA (0.43%; n=13) than in subjects receiving comparators (0.14%; n=3). In patients at risk for DKA, such as those with an acute illness or infection, increase the frequency of glucose monitoring and consider delivery of insulin using an alternate route of administration if indicated [see LIMITATIONS OF USE(1)].
Source: dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76fb46f1-82db-40da-ba19-b3a7b0bd78ff#S5.6
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Post by dreamboatcruise on Feb 15, 2016 14:33:58 GMT -5
mnholdem... I don't understand the connection of how the clamp study would produce results relevant to risk of DKA. I was hoping someone with more physiology/medical background might be able to explain.
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Post by sweedee79 on Feb 15, 2016 14:44:00 GMT -5
Label: AFREZZA- insulin human powder, metered
AFREZZA- insulin human
DRUG LABEL INFORMATION
...
5 WARNINGS AND PRECAUTIONS
...
5.6 Diabetic Ketoacidosis
In clinical trials enrolling subjects with type 1 diabetes, diabetic ketoacidosis (DKA) was more common in subjects receiving AFREZZA (0.43%; n=13) than in subjects receiving comparators (0.14%; n=3). In patients at risk for DKA, such as those with an acute illness or infection, increase the frequency of glucose monitoring and consider delivery of insulin using an alternate route of administration if indicated [see LIMITATIONS OF USE(1)].
Source: dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=76fb46f1-82db-40da-ba19-b3a7b0bd78ff#S5.6
This is absolutely true. It happened to my dad. His blood sugar got away from him while we were on vacation. Even much higher doses of Afrezza were not able to bring his blood sugar down in a timely manner. He suffered thru it. We believed he would have had to go back on injectable for a time until his blood sugar came back down. However, had the docs prescribed him the right dose of Afrezza in the first place his blood sugar wouldn't have gotten away from him at all.
A big problem we have is that Afrezza is so different. Dosing needed is often higher than injectable even tho the label says they are the same dose for dose, again label changes are needed. These issues alone could account for some of the slow uptake if patients and docs have a bad experience simply because they don't understand the drug. I believe its harder to get a correct dose for T1 diabetes than for T2.
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Post by agedhippie on Feb 15, 2016 15:30:39 GMT -5
High blood are awkward for several reason and not just for Afrezza. Everyone has a correction factor which is the number of points one unit of insulin will reduce your glucose levels by. As you numbers get higher that ratio shifts and your insulin resistance increases so you need more insulin than before.
Sweedee79 has the issue perfect. I suspect you run into a problem of breathlessness making it hard to inhale properly and of the quantity needed. Everyone talks about hypos, but it's DKA in Type 1 and it's partner HHNS in Type 2 that are the real killers, the mortality rate are 2-5% for DKA and 15% for HSS respectively.
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Post by mnholdem on Feb 15, 2016 17:31:32 GMT -5
mnholdem ... I don't understand the connection of how the clamp study would produce results relevant to risk of DKA. I was hoping someone with more physiology/medical background might be able to explain. Sure. I posted why Afrezza got the DKA, and am also hoping somebody with the expertise can explain. I do remember a long time ago that somebody wrote that it was because Afrezza had not proven in the FDA to be dose proportionate when administered at higher units. |
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