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Post by bill on Jan 11, 2016 17:05:05 GMT -5
There could be a couple of reasons: 1. The Dexcom / Google partnership would be alive and well with Afrezza in the mix. In fact, support from Google may be what it particularly attractive for Dexcom to reach out to MNKD, if they did. 2. Dexcom's CGM might be a device that would become popular for T2s so they could fine-tune their dosing; either as a purchase or a rent/lease. 3. Even if Afrezza reduces the amount of basal insulin needed by T1s, it doesn't eliminate it so it wouldn't cut into sales for that reason; only if patients switched from pumps to injections and CGMs for their basal dosing would it have an adverse affect on pumps. 4. The biggest upside is if Afrezza goes mega-blockbuster and drags CGMs along with them because of Afrezza and the Google instrumentation. The potential huge upside in CGM sales could dwarf the reduction in pumps. The combination of Google, CGMs, and Afrezza could secure a significant market share across all T1s and T2s world-wide over the next ten years. Lots of money to be made if this is done correctly. How can Afrezza increase the use of CGM? I can't see T2s doing it. Is there a halo effect from Afrezza being in the lineup? Maybe if it ever delivered blockbuster sales. If it didn't, the CGM company would have burnt 8 figures of dollars. Not worth it. T2s might find a CGM attractive if they could rent one for a few months so they could calibrate how Afrezza affects their blood sugar during a variety of meal situations. Even better if the readings are all uploaded to Google for real-time analysis so they could get recommendations on when to take Afrezza and how much to take. After a few months, many T2s would have figured out the dosing and would no longer need the CGM / Google feedback to get things right. Alternatively, if CGMs get really popular the price might drop to the point where they become very affordable to even T2s. If you were a T2 and "knew" that using the CGM and Afrezza would keep your blood sugar in the non-diabetic range wouldn't you at least consider using it if it was affordable, assuming you couldn't control your blood sugar without the CGM?
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Post by bill on Jan 11, 2016 17:12:49 GMT -5
Here's some crazy inferential logic for you to consider... Duane DeSisto's hiring announcement said that MNKD was prepared to defend him if Insulet pressed an NDA suit, but his hiring was withdrawn for just that reason. It seems unlikely that MNKD was kidding, or that they didn't analyze his NDA agreement correctly, or that Insulet filed a cease-and-desist that surprised MNKD. It also seems unlikely that Duane wanted to back out, and he and MNKD decided the best way to avoid losing face was to blame it on Insulet. Instead, perhaps circumstances changed post the SNY announcement, and DeSisto suddenly acquired an actual NDA conflict of interest. A buy out wouldn't do it since that would reduce his NDA exposure. But a new partnership could be a reason for increased NDA exposure. A new TS partnership wouldn't have been a surprise, but a new Afrezza partnership could have been a surprise. Therefore, perhaps we will hear some better news when/if that partnership is announcement. I'm thinking that a Medtronic Afrezza partnership would be the type of event that would cause this type of reaction by DeSisto and MNKD, but that's purely speculative on my part. As I said at the beginning "crazy inferential logic." Many on this Board have hinted that SNY did not like the way Afrezza reduced the sale of basal (Lantus) insulin usage. Maybe so. Why then would an insulin infusion company want to buy a company whose products reduce the infusion of insulin? mnkdmorelong My subsequent replies assumed you were correct that Dexcom also provided pumps in addition to their CGM. However, when I reviewed their web site I didn't see anything about infusers or pumps. Did I miss something? Just checking... Thanks!
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Post by agedhippie on Jan 11, 2016 17:13:37 GMT -5
Everyone is talking about CGMs like they are free. These are the facts around CGMs. - A lot of insurers only partially cover them for Type 1 diabetics and almost no Type 2 diabetics are covered.
- The out of pocket costs for a CGM are thousands of dollars per year if you self fund.
- Dexcom has licensing agreements with pump manufacturers that they would not want to damage.
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Post by bill on Jan 11, 2016 17:18:13 GMT -5
Everyone is talking about CGMs like they are free. These are the facts around CGMs. - A lot of insurers only partially cover them for Type 1 diabetics and almost no Type 2 diabetics are covered.
- The out of pocket costs for a CGM are thousands of dollars per year if you self fund.
- Dexcom has licensing agreements with pump manufacturers that they would not want to damage.
All great points. I didn't intend to imply that it was an uncontested layup for CGMs, either for Afrezza or for T2s however it seems as though Dexcom might be imaginative enough to see a future where Afrezza is recognized as a best in class diabetes treatment where the biggest challenge becomes dose timing and size. If that were the case, CGMs (and perhaps Google analytics) can come to the rescue. If the CGM market grows significantly then insurance coverage and price may both improve to the benefit of affordability. The use of Afrezza with CGMs won't have that much of an adverse affect on pump manufacturers because Afrezza is a mealtime insulin and T1s will always need some form of basal insulin.
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Post by bill on Jan 11, 2016 17:24:21 GMT -5
Duane jumped off the titanic..... They can spin it all they want! If that were true then MNKD outright lied in their press release since they said that MNKD withdrew the offer because of Insulet. I doubt that they would create that cover story knowing the lie might become a liability in the event of future lawsuits. I think it much more likely that something happened post his hiring that created a real conflict of interest with regards to DeSisto's NDA with Insulet. As a result, MNKD could not defend what was not defensible and the offer had to be withdrawn. That's an explanation that would be both truthful and defensible.
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Post by agedhippie on Jan 11, 2016 18:36:41 GMT -5
Everyone is talking about CGMs like they are free. These are the facts around CGMs. - A lot of insurers only partially cover them for Type 1 diabetics and almost no Type 2 diabetics are covered.
- The out of pocket costs for a CGM are thousands of dollars per year if you self fund.
- Dexcom has licensing agreements with pump manufacturers that they would not want to damage.
All great points. I didn't intend to imply that it was an uncontested layup for CGMs, either for Afrezza or for T2s however it seems as though Dexcom might be imaginative enough to see a future where Afrezza is recognized as a best in class diabetes treatment where the biggest challenge becomes dose timing and size. If that were the case, CGMs (and perhaps Google analytics) can come to the rescue. If the CGM market grows significantly then insurance coverage and price may both improve to the benefit of affordability. The use of Afrezza with CGMs won't have that much of an adverse affect on pump manufacturers because Afrezza is a mealtime insulin and T1s will always need some form of basal insulin. It was a huge battle to get CGMs covered at all and even now they are not covered by Medicare. The run costs on a Dexcom are $5,500 per year plus the cost of the receiver and insurers do not like the look of that. The number of Type 2 diabetics makes them expensive hence even blood test strips are heavily restricted for them. A low cost CGM would be wonderful, but there is nothing on the horizon even in Europe who are usually ahead of the US. There are other CGMs out there, Medtronics and Abbotts spring to mind, but the costs on them all are comparable.
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Post by Deleted on Jan 11, 2016 18:38:58 GMT -5
this thread is running on the 9th page. Looking forward for the next sensation thread
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Post by ricguy on Jan 11, 2016 18:42:23 GMT -5
this thread is running on the 9th page. Looking forward for the next sensation thread "Afrezza Users Should be Hired to Negotiate a Buyout!"
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Post by kbrion77 on Jan 11, 2016 18:48:47 GMT -5
I'm not a non-compete agreement expert but the below language is from Insulet's 10K. How is Mannkind not a competitor of Insulet with what the language below states? Are we dealing with idiots here or am I completely missing something? Did MNKD and Duane just think this wouldn't come up? I just can't for the life of me believe he backed out because Sanofi terminated the agreement unless his job was contingent on that partnership. You really can't make this bizarre story up anymore.
10K:
Technological breakthroughs in diabetes monitoring, treatment or prevention could render the OmniPod System obsolete. In addition, our own new product development initiatives may prove to be ineffective or not commercially successful.
The diabetes treatment market is subject to rapid technological change and product innovation. The OmniPod System is based on our proprietary technology, but a number of companies, medical researchers and existing pharmaceutical companies are pursuing new delivery devices, delivery technologies, sensing technologies, procedures, drugs and other therapeutics for the monitoring, treatment and/or prevention of insulin-dependent diabetes. For example, FDA approval of a commercially viable “closed-loop” system that combines continuous “real-time” glucose sensing or monitoring and automatic continuous subcutaneous insulin infusion in a manner that delivers appropriate amounts of insulin on a timely basis without patient direction could have a material adverse effect on our revenue and future profitability. Medtronic has developed an FDA- approved product combining continuous glucose sensing and CSII therapy and if we fail to do so or are delayed in doing so, we may be at a competitive disadvantage, which could negatively impact our business. In addition, the National Institutes of Health and other supporters of diabetes research are continually seeking ways to prevent, cure or improve the treatment of diabetes. Also, Mannkind Corporation is seeking to develop an inhaled insulin product for the treatment of diabetes. Any technological breakthroughs in diabetes monitoring, treatment or prevention could render the OmniPod System obsolete, which may have a material adverse effect on our business, financial condition and results of operations.
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Post by compound26 on Jan 11, 2016 18:59:40 GMT -5
MannKind Names Financial Chief Pfeffer as CEO www.wsj.com/articles/mannkind-names-financial-chief-pfeffer-as-ceo-1452525589Matthew Pfeffer to continue as chief financial officer and take a vacant board seat By ANNE STEELE Jan. 11, 2016 10:19 a.m. ET MannKind Corp. on Monday said it appointed Chief Financial Officer Matthew Pfeffer chief executive, replacing founder Alfred Mann, and said it has withdrawn its offer to Duane DeSisto because of objections by his former company that his employment would violate its non-compete agreement. Insulet Corp. said Mr. DeSisto’s non-competition agreement remains in effect until Sept. 17.
Mr. Pfeffer, whose appointment became effective Sunday, will continue as chief financial officer and will take a vacant board seat. Mr. Mann had been serving as interim chief executive since November when former chief executive Hakan Edstrom resigned after less than a year at the helm. The shake-up comes amid a steep drop in the company’s stock, fueled by flagging sales of MannKind’s key diabetes drug Afrezza. Shares have plunged 89% over the past 12 months, and the stock has erased more than half its value this month alone. Last week, MannKind announced the termination of its licensing pact with Sanofi-Aventis in the U.S. for the development and sale of Afrezza and signaled that it might look to sell the drug. On Monday, Kent Kresa, lead director of MannKind, said Mr. Pfeffer “understands the strategic and financial challenges that we face at this very important time for our company and has already begun to pursue a number of solutions.” Write to Anne Steele at Anne.Steele@wsj.com
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Post by humann on Jan 11, 2016 19:13:24 GMT -5
I'm not a non-compete agreement expert but the below language is from Insulet's 10K. How is Mannkind not a competitor of Insulet with what the language below states? Are we dealing with idiots here or am I completely missing something? Did MNKD and Duane just think this wouldn't come up? I just can't for the life of me believe he backed out because Sanofi terminated the agreement unless his job was contingent on that partnership. You really can't make this bizarre story up anymore. 10K: Technological breakthroughs in diabetes monitoring, treatment or prevention could render the OmniPod System obsolete. In addition, our own new product development initiatives may prove to be ineffective or not commercially successful.
Also, Mannkind Corporation is seeking to develop an inhaled insulin product for the treatment of diabetes. Any technological breakthroughs in diabetes monitoring, treatment or prevention could render the OmniPod System obsolete, which may have a material adverse effect on our business, financial condition and results of operations.huh.... seems pretty clear to me. Threatening obsolescence of OmniPod would constitute competition in my book. Thanks for pointing this out. What on earth were they doing hiring him?
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Post by slapshot on Jan 11, 2016 19:32:37 GMT -5
All great points. I didn't intend to imply that it was an uncontested layup for CGMs, either for Afrezza or for T2s however it seems as though Dexcom might be imaginative enough to see a future where Afrezza is recognized as a best in class diabetes treatment where the biggest challenge becomes dose timing and size. If that were the case, CGMs (and perhaps Google analytics) can come to the rescue. If the CGM market grows significantly then insurance coverage and price may both improve to the benefit of affordability. The use of Afrezza with CGMs won't have that much of an adverse affect on pump manufacturers because Afrezza is a mealtime insulin and T1s will always need some form of basal insulin. It was a huge battle to get CGMs covered at all and even now they are not covered by Medicare. The run costs on a Dexcom are $5,500 per year plus the cost of the receiver and insurers do not like the look of that. The number of Type 2 diabetics makes them expensive hence even blood test strips are heavily restricted for them. A low cost CGM would be wonderful, but there is nothing on the horizon even in Europe who are usually ahead of the US. There are other CGMs out there, Medtronics and Abbotts spring to mind, but the costs on them all are comparable. Im beginning to think that Afrezza needs the use of CGMs to appeal to diabetics in general and T2s particularly. I think maybe the reason why Afrezza has appealed to T1s it that they have CGMs and could see the real time needs and benefits and therefore were able to dynamically adjust their dosages and timing to maximize their results. The T1s willing to adjust their habits and dosage protocols (with real time feedback from the CGM) have gotten incredible results, while perhaps those less willing or able could take or leave it (Afrezza) as their results are mixed or relatively similar to other products. T2s (or those without a CGM) are taking Afrezza in the dark as they cant see the real time feedback and thus cant optimize the dosage or timing and therefore aren't necessarily getting good results. On top of that, the label and perhaps instructions from doctors may not offer the best timing / dosage information to begin with. Just my 2 cents based on what i have read here.
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Post by bill on Jan 11, 2016 20:10:42 GMT -5
It was a huge battle to get CGMs covered at all and even now they are not covered by Medicare. The run costs on a Dexcom are $5,500 per year plus the cost of the receiver and insurers do not like the look of that. The number of Type 2 diabetics makes them expensive hence even blood test strips are heavily restricted for them. A low cost CGM would be wonderful, but there is nothing on the horizon even in Europe who are usually ahead of the US. There are other CGMs out there, Medtronics and Abbotts spring to mind, but the costs on them all are comparable. Im beginning to think that Afrezza needs the use of CGMs to appeal to diabetics in general and T2s particularly. I think maybe the reason why Afrezza has appealed to T1s it that they have CGMs and could see the real time needs and benefits and therefore were able to dynamically adjust their dosages and timing to maximize their results. The T1s willing to adjust their habits and dosage protocols (with real time feedback from the CGM) have gotten incredible results, while perhaps those less willing or able could take or leave it (Afrezza) as their results are mixed or relatively similar to other products. T2s (or those without a CGM) are taking Afrezza in the dark as they cant see the real time feedback and thus cant optimize the dosage or timing and therefore aren't necessarily getting good results. On top of that, the label and perhaps instructions from doctors may not offer the best timing / dosage information to begin with. Just my 2 cents based on what i have read here. Maybe what you've said is part of the reason Google is working with Dexcom to create a non-invasive CGM device. Ideally, such a device would include a wireless transmitter and be much less expensive than the current technology. Marry something like that up with Afrezza and you're good to go on many fronts. The question in my mind is whether the "imagineers" for such technologies can overcome all the bureaucratic inertia that either stalls or kills such ideas. At least there seems to be some uncertainty again in the minds of the shorts since they didn't drop the share price this AM. Guess they're waiting with bated breath for Matt's presentation this week as well. Unfortunately, Matt may not be at liberty to be completely transparent, just yet.
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Post by Deleted on Jan 11, 2016 21:25:52 GMT -5
MannKind Names Financial Chief Pfeffer as CEO www.wsj.com/articles/mannkind-names-financial-chief-pfeffer-as-ceo-1452525589Matthew Pfeffer to continue as chief financial officer and take a vacant board seat By ANNE STEELE Jan. 11, 2016 10:19 a.m. ET MannKind Corp. on Monday said it appointed Chief Financial Officer Matthew Pfeffer chief executive, replacing founder Alfred Mann, and said it has withdrawn its offer to Duane DeSisto because of objections by his former company that his employment would violate its non-compete agreement. Insulet Corp. said Mr. DeSisto’s non-competition agreement remains in effect until Sept. 17.
Mr. Pfeffer, whose appointment became effective Sunday, will continue as chief financial officer and will take a vacant board seat. Mr. Mann had been serving as interim chief executive since November when former chief executive Hakan Edstrom resigned after less than a year at the helm. The shake-up comes amid a steep drop in the company’s stock, fueled by flagging sales of MannKind’s key diabetes drug Afrezza. Shares have plunged 89% over the past 12 months, and the stock has erased more than half its value this month alone. Last week, MannKind announced the termination of its licensing pact with Sanofi-Aventis in the U.S. for the development and sale of Afrezza and signaled that it might look to sell the drug. On Monday, Kent Kresa, lead director of MannKind, said Mr. Pfeffer “understands the strategic and financial challenges that we face at this very important time for our company and has already begun to pursue a number of solutions.” Write to Anne Steele at Anne.Steele@wsj.com can we confirm is the agreement is valid until sept 2016 or sept 2017. I thought it was sept 2016 investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=949755MannKind Provides Update on Senior Management PDF Add to Briefcase VALENCIA, Calif., Jan. 11, 2016 (GLOBE NEWSWIRE) -- MannKind Corporation (NASDAQ:MNKD) (TASE:MNKD) today announced that MannKind has withdrawn its offer to employ Duane M. DeSisto as its President and Chief Executive Officer as a consequence of objections raised by Insulet Corporation, the former employer of Mr. DeSisto, that the employment of Mr. DeSisto by MannKind would violate Insulet's non-competition agreement with Mr. DeSisto, which is in effect until September 17, 2016. As a result, Mr. DeSisto will not join MannKind as an officer and director, as previously announced. - See more at: investors.mannkindcorp.com/releasedetail.cfm?ReleaseID=949755#sthash.Uk4G71Wa.dpuf
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Post by lorcan458 on Jan 11, 2016 23:37:18 GMT -5
I hope he doesn't have time to read it as he is finalizing a game-changing presentation, but I wrote him a letter that I hope he agrees with.
Matt,
Congratulations on your new role as CEO. You already heard from us who are down over 90%, our hopes, fears, frustration and often stunned disbelief at both the actions of our enemies and the silence and lack of effective response from Mannkind. The days of silent ineffectiveness and, honestly, complacent incompetence, must be behind us forever.
I look forward to your presentation on Wednesday. I know you will come out with a complete, coherent, clear, confident plan, with multiple positive updates as to what Mannkind has been working on these many months.
I hope Al sees this as a personal fight and he will use all his influence to gain allies who will help us fight. You’re going to be in MBA textbooks, like it or not. You can be the CEO that defeated big pharma, the HFT / Dark Pool / Short Sellers cabal and made the lives of millions of diabetics far better than it would have been if you had not taken over as CEO. Make history. Save Mannkind.
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