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Post by mnkdmorelong on Jan 5, 2016 11:26:09 GMT -5
I sense that there are many on this Board who are not connected to reality. The shock of SNY's termination has caused many to vent rather than think.
MNKD is now in a more dire situation. No energy should be put to suing SNY for various misdeeds. This leads to nothing.
Some have voiced an opinion that SNY cancelled the contract so they can buy MNKD. Does this make any sense at all?
In six months, the cost to maintain Afrezza will rise dramatically. Who is going to pay for the ongoing safety study. How about EU certification. So on and so forth. Focus on solving these problems is best for the company. Suing companies just waste critical resources.
If anything I think Desisto's hire is a positive. If it were a wind down scenario, he would never have signed on. I look forward to the 4:30 meeting.
Our ace in the hole is Al Mann. He will not want a failed Afrezza to be a black mark on his distinguished career.
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Post by mnkdmorelong on Jan 5, 2016 10:58:22 GMT -5
El Wrongo! The cancellation was big time negative! If Afrezza had any value in the insulin market, SNY would never have cancelled. Tim Tebow, the Heisman winning QB from Florida was found to have inferior NFL QB skills. He no longer plays. Same with Afrezza; it failed as an every day prandial. El Wrongo? Ask anyone using the drug. It reduces A1c dramatically. It decreases the amount of the basal insulin that T1s need. T1s were getting off of their pumps. It will cut into the basal market when it reaches its potential. Another drug company will have quietly noticed. My guess is that there has been a plan in place for quite a while. You must understand the difference between Afrezza the product and Afrezza the business. The Afrezza product is excellent. But not enough diabetics made the switch to make Afrezza the business viable. The cancellation of the contract at the earliest possible date tells me that SNY sees no hope for Afrezza the business. Moreover, they think that none of their competitors can pick up Afrezza and do better.
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Post by mnkdmorelong on Jan 5, 2016 10:43:46 GMT -5
I'm just speculating but SNY's termination of the deal might be hardball tactic of getting Mannkind to sell Afrezza for cheap to them. SNY knew Al wouldn't sell for a lower price so what does SNY have to lose by terminating the deal and putting the screws to a financially strapped Mannkind to sell Afrezza for a much lower price than what Al wants? They'd never do this. By terminating the partnership, Sanofi now has NO rights to Afrezza, freeing up Al and the board to agree to a buyout with literally anyone else. Sanofi is bye-bye. They have no chance of ever retaining any rights to Afrezza or any TS application now. I still think SNY wanted to buy it, but they wanted it cheap, far cheaper than Al was willing to sell for, so they starved the launch intentionally in the hopes that MNKD would go bankrupt and they could but it in liquidation. They never made an attempt at commercialization. Something tells me that with a new CEO slated to take over on the day that the partnership was terminated, that there is some plan in the works. People have speculated that there may be another partner waiting in the wings, but I'm not sure. I do think we'll find one but I'm not sure there's one now. This is most assuredly NOT a negative development. SNY was doing nothing to make Afrezza a success and was not providing liquidity to ensure MNKD's operations. We just cut A LOT of dead weight. New CEO, new partner, new future. Today is a good day. El Wrongo! The cancellation was big time negative! If Afrezza had any value in the insulin market, SNY would never have cancelled. Tim Tebow, the Heisman winning QB from Florida was found to have inferior NFL QB skills. He no longer plays. Same with Afrezza; it failed as an every day prandial.
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Post by mnkdmorelong on Jan 5, 2016 10:07:08 GMT -5
Al mentioned long ago he was approached by a Chinese pharma to partner. IIRC he was tempted but declined. He also mentioned there were smaller regional pharmas interested in Afrezza. Let's see if this path is taken. It might be time for Mannkind to attack other countries than the United States to sell Afrezza. China, Saudi Arabia, Israel or any country on that list I posted a few weeks ago. I have to believe the Afrezza suitors from two years ago are gone. Why be the second company to throw money into a hole? We must accept the verdict of the jury (the entire insulin market) who is saying Afrezza will be a niche market. MNKD must be right-sized to work under these market conditions. I can see VRX coming in. The Danbury facility must shrink. Why have corporate headquarters 2000 miles away? So on and so forth.
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Post by mnkdmorelong on Jan 5, 2016 9:45:52 GMT -5
Holy cow! Sanofi pulled the plug. I have to believe that Desisto's start day of today was factored in.
The clear message from SNY is that they believe Afrezza cannot be commercialized. Most likely the other companies in this space have the same opinion.
TS's coattails are long so I think TS as an excipient for other API's is stalled for now.
I am absolutely stunned!
For those who thought SNY was sandbagging or intentionally slow playing the game or intentionally soft launched the product now have your clear answer. They tried and failed and gave up after only one year. They spent many million of $$$ and walked away with no fear that a competitor such as NVO would jump in. Amazing!
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Post by mnkdmorelong on Jan 4, 2016 22:43:11 GMT -5
What does SNY have to do to get label improved? What kind of study needs to be done? How long would it take? Could they actually be working on this without us knowing about it? A lot depends on what they are trying to get on the label. FDA trials are public, so no, nothing in secret. The already finished clamp studies might be used to change the label with regard to ketoacidosis, though that seems minor improvement. To get A1c improvement claim would require new trials not yet announced... the type would be a trial with proper protocols for Afrezza with a comparator group on traditional SQ RAA to show Afrezza can lead to lower A1c. Some have speculated that it would take minimum of 2 years for trial and label change. In my opinion trials could be done quicker but I don't have much insight into how long FDA review for a label change might take. It was bought out at the AdCom meeting that Afrezza does not do as good a job as Novolog in HbA1c. If it were not for the statistical "head start" given to Afrezza, the clinical trials would have failed. But this is using Afrezza as you would Novolog. To highlight the real benefit of Afrezza, it must be used differently. The early adopters such as Sam Finta have figured it out and their HbA1c are dropping. Putting this on the label would be beneficial but time consuming as you say. Another route to go is for SNY to sponsor studies by thought leaders using an improved protocol. The better results can be published and that serves as a marketing piece. These clinical trials are not as rigorous as FDA style as there is no monitoring. I had hope that social media would have done some heavy lifting and cause diabetics to demand Afrezza. Sadly, this has not happened in a meaningful way.
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Post by mnkdmorelong on Jan 3, 2016 12:24:08 GMT -5
I think that it's relevant that Duane mentioned improving shareholder value in his very first public statement after being hired. When I do my DD on other biotech/pharmaceutical development companies, they're issuing press releases that highlight positive test results from even preclinical studies. MannKind does none of that, so how are they suppose to attract BP or investors? Hopefully, Duane DeSisto will see to it that the public gets a look at much more than blithe statements like, "we have a plethora of riches". Years ago, MannKind published test results for multiple API and Alfred Mann, and other leaders from within the company, openly talked about the various API they want to develop. But for the past several years, MannKind has gone silent. It may have an over reaction by Mann to the shareholder lawsuit, but the time has come for MannKind Corporation to become more vocal about their technology and potential. I hope DeSisto puts an immediate end to all the silence. We must not expect much from Duane as will be on the job for only a few days. At this stage of the game, nothing can be worse for MNKD than a cheerleading CEO. We live in a swamp of plaintiff's lawyers whose primary prey are companies that can be snared using securities laws. These same lawyers will pass on biopharmas press releasing positive data for the promise of future value was created by the investors buying up the shares. My style of investing draws information from what companies say or do not say. It would be good to hear a reaffirmation from SNY. It would be very good if we hear about TS being ported to a new API. If we do not hear anything, it means the TS/API market has stalled. There is good reason to believe this since Afrezza has not been the American Pharaoh we all expected.
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Post by mnkdmorelong on Jan 3, 2016 8:01:24 GMT -5
There have been many "tells' that forewarned of problems with Mankind. You cited Hakam's solicitation for candidate APIs for TS. This means the TS deals they were working on at that timer were shaky. How about the DTC (consumer magazines) during this summer? No change in NRx! This to me is amazing. All those dollars yielded nothing. And how about Matt's attempt to roll the 2016 convertible debt forward? Most of the bondholders wanted cash. They wanted out. And I think the SNY deal was a tell. MNKD only receive 35% of the profits net of shared expenses. The share price sold off from $10 to $6. Was this the best deal MNKD could get? Another tell that most people did not see was at the AdCom in April 2014. One of the committee members who represented the industry was a chap from NVO. He did not say one word during the entire meeting. Nothing positive, nothing negative. It seemed to me that if NVO had an interest in Afrezza, he would have talked it up. As it turned out, NVO did not license Afrezza. Is this the best you can do? Point out spelling errors? There are others on this Board who have similar spelling errors; they get a pass as they should. But when a poster with insightful comments based on facts, you call it FUD. The FUD is in your mind. You fear loss of your entire investment in MNKD. I am in a similar situation. But I do not dunk my head in a hole in the ground to resist hearing the truth. I thought this Pro Board was a step up from the YMB. What I find are Afrezza Luddites denying the existence of the tragedy that is now unfolding. Another phenomenon underway on this Board is a variant of the Stockholm Syndrome. We have people on this Board believing SNY and MNKD intended to uber soft launch Afrezza. This is why first year sales are only $10 mln. This is nuts! Another wrote that 35% share of the pie is generous. It was probably the best deal MNKD could get. But it is factually true that the market did not like it based on the stock's sell off from $10 to $6. The deal was not generous and was a "tell" that the insulin industry did not place a huge value on the Afrezza opportunity.
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Post by mnkdmorelong on Jan 2, 2016 21:07:51 GMT -5
my premise for getting into this stock was that Afrezza would be a blockbuster. I have since come to the realization that it will be a niche drug. I also failed to take into account the dilution that this company has and will have to have in the future in order to survive. At 5 bucks, the market cap will be about 2.5 billion and if it gets to that point, I could see another secondary. As for TS applications, I have lost all hope that any deal of significance is forthcoming. When the CEO begs for potential partner to call him during a cc, it's not really a good sign. There have been many "tells' that forewarned of problems with Mankind. You cited Hakam's solicitation for candidate APIs for TS. This means the TS deals they were working on at that timer were shaky. How about the DTC (consumer magazines) during this summer? No change in NRx! This to me is amazing. All those dollars yielded nothing. And how about Matt's attempt to roll the 2016 convertible debt forward? Most of the bondholders wanted cash. They wanted out. And I think the SNY deal was a tell. MNKD only receive 35% of the profits net of shared expenses. The share price sold off from $10 to $6. Was this the best deal MNKD could get? Another tell that most people did not see was at the AdCom in April 2014. One of the committee members who represented the industry was a chap from NVO. He did not say one word during the entire meeting. Nothing positive, nothing negative. It seemed to me that if NVO had an interest in Afrezza, he would have talked it up. As it turned out, NVO did not license Afrezza.
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Post by mnkdmorelong on Jan 1, 2016 8:03:47 GMT -5
YMB and this board had extensive threads on Hakam's revenue projections back in 2014 which suggested that Afrezza sales would top $250 million in 2015. According to Symphony reports, 2015 revenue will be just over $10 million or about four percent of that projection. I think many invested on that projection and many sold or went short based on the delta between the projection and the actual results. But we now realize that the diabetic community will take much more time to embrace Afrezza (doctors and patients). So here is my serious question: Symphony reports that current weekly sales are around $370,000 per week. Hakam's projection of $250 million in sales would equate to $4.8 million per week or about thirteen times current sales. And no this isn't a soft-bash. I am long with more shares than I care to admit and I have a family member who is "ALL-IN" on this stock at much higher levels. Like all of us, I'm trying to get my head around whether sales have any realistic potential to catapult from current levels to thirteen times more than current sales. And 2015 was Hakam's "conservative" projection, with much higher sales in 2016 and 2017. Longs periods of comm silence from a company are never a good sign. But hopefully the transition in leadership will lead to some positive comm and better transparency going forward. Does anyone see a thirteen fold increase in sales as a conservative goal for 2016? Is it possible that sales will be more brisk in another country where the hurdles and customer costs might be negligible by comparison? Are other countries looking and US sales and having second thoughts because of the very slow launch? Serious responses only please. Thank-you You bring up Hakam's forecast of $250 mln in 2015. Although this is reality (you can't change the past), it puts you at odds with many on this Board. They believe that MNKD and SNY planned a very soft launch. The actual sales of $10 mln in 2015 bears out this thesis. No, there will not be a large increase in sales for 2016. The forces that reduced a $250 mln forecast to $10 mln actual are still in place. The best investors can hope for is stability in the financial structure of Mannkind. I think the very bad results in the US has put a pause in worldwide launches. I'm not saying it's stopped; but committing money after you've lost a boatload in the US is worrisome.
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Post by mnkdmorelong on Dec 27, 2015 16:18:27 GMT -5
It is not the variable cost of production that is the problem. The Danbury facility is very large. They gave us a tour at the last Shareholders meeting in May and the problem was obvious. The production line is run in batch mode since demand is so low. Since then, MNKD has added two more filling lines that are not needed now. To support the marketing of Technosphere as an excipient, a large technical staff is needed. And of course there are the bonds that need to be serviced.
MNKD just had another round of layoffs which will help the cash burn rate. Not good enough; more cash is needed to tide the company through until Afrezza sales throw off cash.
You are into disruptive technology with Afrezza. It will one day be the every day prandial insulin for T1s. The key question is, will the current capital structure survive until that date.
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Post by mnkdmorelong on Dec 27, 2015 9:53:32 GMT -5
My comment on demand refers to TS as an API excipient.
Needless to say that Afrezza demand has also not been great. SNY did execute some DTC advertising in August of this year. Did you notice the bump in NRx during this period? This is a trick rhetorical question for there was no market response! What should have happened did not happen. This tells us something. What specifically, I don't know.
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Post by mnkdmorelong on Dec 27, 2015 9:47:06 GMT -5
Perhaps mindless cheerleading is too extreme; maybe “group think” is more appropriate. I sense that this ProBoards has a hidden agenda cloaked in the acronym “FUD.” It’s almost like an ostrich with its head in the sand. You don’t want to hear anything negative, as it will amplify the fear already in your mind. Is this your role as admin? Is it to protect the children from hearing naughty words? My “good” comment is actually very good. It’s like having a put against your MNKD holdings. Companies similarly situated, as MNKD would have thrown in the towel just to reduce the interest expense so they can press on. We can thank the presence of Al Mann for many things; but just being the largest shareholder affords us some protection as shareholders. A significant portion of my trading strategy is inferences drawn from what does or does not happen. It has been over a year since FDA approval for Afrezza. Not one API has been ported over to Technosphere since then. It may happen soon but the large delay tells me that demand is not great. I agree that MNKD will receive a technology fee but it will not put a dent into the cash flow. I suggest that this Board is for the free flow of opinions, positive or negative that may be of interest to others. Personal attacks such as seen on YMB are out. The reader can filter out unsupported negative opinions. If you censure those with differing opinions, then you should rename this board “ The feel good MNKD Board.” Not one to disagree but, infering that demand isnt great is like also stating there is a buyout in the works. MNKD has and continues to be the WORST in communicating with investors. Not a peep from management, and often questions are deflected to Sanofi. So until any decent news comes out we sit and wait. Unless you have a crystal ball. If so what does the future hold? My comment on "demand" refers to Technosphere as a delivery system and it is not as expected. Consider this analogy: New run movies are rated from the first weekend's gross sales. By similarity I would have expected a large rush of interested parties to port their API over to Technosphere. This did not happen. It is reasonable to say "demand is not great." Why would it be any different? Would you buy a car after seeing the same model rated poorly by Consumer's Report? The lukewarm launch of Afrezza hurt TS marketing. An interested drug company must weigh the $100 mlns in investment to get a TS label. There may be APIs that can only be inhaled: So far we have not heard of it. Lack of communications is a sign of an organization under stress and cannot do anything about it. Look at VRX: A company under stress but has done something. They have communicated well (even the bad news.
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Post by mnkdmorelong on Dec 27, 2015 8:28:18 GMT -5
MNKD's stock price is telling us that unless something happens, we are on the runway to running out of cash. I think that Desisto is an unknown notwithstanding his diabetes experience. He will have to be a better salesperson than Hakan.
What will make a difference for MNKD and its investors is if the shorts go away. If they cover, the price goes up making a secondary palatable, not suicidal as it is now. I don't know how this will happen. I think Afrezza is now tier 3 and the other prandials tier 2 (insurance wise). If SNY's insulin gets approved the cost structure will change. Perhaps then we can negotiate with insurance companies to gain tier 2. This may put fear in the minds of the shorts.
Otherwise, I am like all other under water longs. Just waiting for something to happen and slipping deeper under the waves every day.
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Post by mnkdmorelong on Dec 27, 2015 8:13:14 GMT -5
Perhaps mindless cheerleading is too extreme; maybe “group think” is more appropriate.
I sense that this ProBoards has a hidden agenda cloaked in the acronym “FUD.” It’s almost like an ostrich with its head in the sand. You don’t want to hear anything negative, as it will amplify the fear already in your mind. Is this your role as admin? Is it to protect the children from hearing naughty words?
My “good” comment is actually very good. It’s like having a put against your MNKD holdings. Companies similarly situated, as MNKD would have thrown in the towel just to reduce the interest expense so they can press on. We can thank the presence of Al Mann for many things; but just being the largest shareholder affords us some protection as shareholders.
A significant portion of my trading strategy is inferences drawn from what does or does not happen. It has been over a year since FDA approval for Afrezza. Not one API has been ported over to Technosphere since then. It may happen soon but the large delay tells me that demand is not great. I agree that MNKD will receive a technology fee but it will not put a dent into the cash flow.
I suggest that this Board is for the free flow of opinions, positive or negative that may be of interest to others. Personal attacks such as seen on YMB are out. The reader can filter out unsupported negative opinions. If you censure those with differing opinions, then you should rename this board “The feel good MNKD Board.”
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