jst ...............Al is pushing 90 years old, how much time do you think he has. God willing he lives to be 100, but I think he will take his $billions from Mannkind today and apply them to work being done by his foundation, charitable organizations and his new start-up Medallion Therapuetic Inc.
Someone doesn't want the 2015 note converted or have Bank of America return 9 million shares they borrowed from Mannkind next Thursday :)
Mannkind broke and closed about $10.20 on June 4th & 30th consecutive trading days from the 4th is next Wednesday July 16th. Through yesterday, Mannkind stock has closed at or above $10.20 seventeen trading days leaving the stock needing to close at or above $10.30 three out of the four next trading days beginning today to allow Mannkind to Terminate the Note next Thursday July 17th. Let's see if this something MM are working towards for Mannkind.
Al owns close to 40% of this company totaling about 160 million shares. This is his company as evident by the name of the company and he will do what he wants and what's in his best interest.
mike I agree with you 100%. I think all the talk about caring to get this product approved quickly for the benefit of diabetes patients seems disingenuous. They don't seem to have any urgency to actually get Afrezza in the hands of diabetes patients quickly following approval. Bottom line this is all about money and it's the driving force behind the delay. Alfred Mann and his financial planners are driving the process towards his end goal.
I would not completely eliminate that possibility. I find not having a partnership deal in place to coincide with FDA approval after all these years a little strange. What's even more strange is the company not hosting a conference call to discuss their biggest achievement ever FDA approval. Not wanting to hold a conference call to discuss FDA approval because they feared they would be asked questions about Partnership is absolutely ridiculous. FDA approval is here and there are still a ton of unanswered questions. Once again I will say while Mannkind is a publicly traded company, Alfred Mann is running it more like its privately held.
Read my entire message. I am suggesting a quick announcement will result because big pharma wants to get the deal done asap and meet Al's demands. Then again the longer we don't get news there needs to be a reason why it's not happening. It good be good news that multiple company's are aggressively trying to partner up with Mannkind, multiple company's are looking to buyout Mannkind or it could be bad news that Mannkind is not getting the deal they want. Unfortunately silence leaves the door open for a lot of speculation.
FDA approval and clean label should motivate big pharma to pull the trigger quickly to sign a final contract, however, the longer we go without an announcement then we need to question why is it taking so long. An extended delay can only mean one of two things, Mannkind has multiple offers on the table or they are getting #$%$ offers they don't want. I hope we get a quick partnership announcement which will validate big pharma's belief about the huge commercial opportunity they are signing up to get control of.
Marketing and Sales
-A promotion and advertising plan has been developed.
-Advertising copy has been developed and media contracts and arrangements have been made.
-Promotional materials and sales literature have been developed, ordered, and are ready to distribute.
-Sales and distribution channels have been identified and established.
-Sales personnel have been hired & trained.
-Sales personnel have the needed sales literature, sales support material and product samples.
-Product pricing has been established and approved.
-The sales forecast has been updated based on the latest forecast of market demand.
-The website has been updated.
-Press releases have been prepared and are ready to distribute.
-Industry analysts or other influential personnel have been briefed as planned.
-A product release and/or general availability has been announced.
I will have to wait for the agreement to be announced to see how it compares to say the Amylin/Lilly deal that was signed during Phase III testing. Amylin got a 50/50 split for U.S. revenues & an 80/20 splite for outside the United States. The deal got Amylin $80 million upfront money and another $300 million in future milestone payment. Lilly also worked and supported Amylin to build out a commercial sales team to co-promote Byetta in the U.S. Overall the deal wasn't bad, but Amylin lost sight of one important factor trustworthiness and Lilly failed that test in a big way when they under cut the collaboration agreement with Amylin by developing their own once weekly GLP-1 drug Dulaglutide that eventually complete with Bydureon. Once Mannkind's announces the agreement, we can see for ourselves if the wait was worth it.
dued...first off I used Byetta as an example to compare drug launch for newly approved innovative drugs. Also, Byetta is not an insulin, it's a GLP-1 drug and it's not long acting but injected twice daily. Bydureon is the long acting version of Byetta. Bottom-line the commercial opportunity for Afrezza is significantly greater than Byetta/Bydureon and the sales numbers I quoted for Byetta were as of 2005 & 2006 and as you state the diabetes market is much bigger today and that will only help Afrezza generate better sales results in 2014 & 2015 compared to Byetta 's 2005 & 2006 sales numbers.
I wonder where is the Sec investigation looking into the highly usual press release issued by the FDA just one hour before the market closed that allowed significant manipulation to occur. Here is today's Sec announcement.
Cynk Tech shares halted by Finra
Reuters 1 hour ago
(Reuters) - Cynk Technology (CYNK.PK) shares have been halted by the Financial Industry Regulation Authority on Friday, under the "Extraordinary Event Halt" code.
Cynk, a development-stage company that "intends to develop a social network business," has seen its shares surge 24,000 percent in the last month.
On Finra's website, it was indicated that the shares were halted under a category labeled "U3-Extraordinary Event Halt."
Finra defines a U3 halt as one occurring "because FINRA has determined that an extraordinary event has occurred or is ongoing that has had a material effect on the market for the OTC Equity Security or the security underlying an OTC ADR or has caused or has the potential to cause major disruption to the marketplace or significant uncertainty in the settlement and clearance process."
Byetta was FDA approved on April 29, 2005 and was launched in the U.S. on June 1, 2005. Seven month sales in 2005 were $75 million & full year sales in 2006 were $430 million. Had Mannkind been prepared to launch Affrezza with a marketing partner 30 days from approval or July 27, 2014, I honestly believe that Afrezza's 2014 six month & 2015 full year sales results would have exceeded those seen by Byetta. I expect if Afrezza was available to be sold on July 27, 2014, sales for the six months in 2014 could have come in close to $150 million and 2015 full years results could have been between $750 million to $1 billion. Instead Afrezza is not scheduled to be launched in the U.S. until some undisclosed timeline in 2015 and that will mean a lot of lost revenues. Get a deal done and start selling this mega blockbuster.
I fully understand they are working, but now having an approved mega blockbuster drug sitting around waiting for someone to sell is costing money and continues to inconvenience diabetics especially those that are staring insulin for the first time everyday and still don't have Afrezza available to them. I am a late investor to Mannkind so the long delay between 2009 & 2013 gave me an opportunity to buy shares a lot cheaper than the original longs who got in at much higher prices. If I were one of the original longs in Mannkind who bought shares above today's stock price, I would have preferred to have seen the company establish a development/commercial partnership much earlier that would have avoided the huge shareholder dilution that has occurred mostly to the benefit of Alfred Mann who exchanged warrants to pay down debt for cheap shares in the low $2's.
The $500 million in lost revenues during Afrezza's first year accounts for the six month delay that no revenues are being earned and for the delayed ramp up in sales during the 1st year because of the delay.
While Mannkind & Al are haggling to get a someone approved and ready to sell Afrezza in the United States, the possible six month or longer delay in a U.S. launch is going to cost the company much needed money, shareholder value and most important its keeping the drug unnecessarily out of the hands of diabetics. I expect the impact on Afrezza's first year sales based on a six month U.S. launch delay could be lost revenues of upwards to $500 million and they will have all those Type II patients who were ready to start or switch over to insulin during the six month delay having to start insulin treatment using a competitive injected rapid acting insulin instead of Afrezza. Who knows how many potential patients Mannkind will lose during the six month delay because Afrezza is simply not available to them and they start treatment using a competitors insulin ? Once these patients start insulin treatment using a competing insulin drug, it will take sometime to eventually get them to switch onto Afrezza. A six month delay and 1Q 2015 U.S. launch will cost a lot in lost revenues and seeing a lot of new patients starting on Afrezza and then you have the global delay caused by a delayed regulatory filings outside the United States that delays commercial launches outside the U.S. and results in lost revues and lost patients. I just hope the delay in getting a partnership deal done will be financially worth the negative impact it is now having on sales and diabetes patients who want to start using the drug.
May 6, 2014, 2:57pm PDT
Theravance eyes June 2 split into drug, royalties companies
Theravance CEO Rick Winningham: Drug development and royalty management companies are "well positioned for 2014 and beyond."
Theravance Inc. will split into two companies — one sucking up the royalties from its partnership with GlaxoSmithKline, the other focused on drug development — on June 2, the company said Tuesday.
Both companies will be well financed, Theravance (NASDAQ: THRX) CEO Rick Winningham said on a conference call with analysts, with the royalty wing offering a 25-cents-per-share quarterly dividend to shareholders.
South San Francisco-based Theravance last month raised $450 million secured by 40 percent of the royalties from the sale of GlaxoSmithKline's respiratory diseases drugs Relvar, Breo and Anoro. Much of that cash is destined for the royalty company.
Meanwhile, the biopharmaceutical wing of Theravance will be funded with $400 million as it pursues small-molecule treatments for bacterial infections, central nervous system and pain, respiratory disease and gastrointestinal motility dysfunction.
Theravance previously said it hoped to fund the drug-development company with about $300 million.
The drug development and royalty management companies are "well positioned for 2014 and beyond," Winningham said.
Chris I would go back even further and say April 1st successful ADCOM was the game changer. After the vote was announced, I expect Mannkind's & Greenhill's phones started ringing off the hook.