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Post by mnkdmorelong on Jan 6, 2016 7:27:24 GMT -5
You make many assumptions. First what is the jurisdiction? If France, MNKD's lawyers will need to hire French lawyers to decipher French laws (Napoleonic Code). Will the judge allow testimony from another case? Probably not. Most of the cause of low Afrezza sales is tied to its high price. Per the contract, SNY has sole rights to set prices. The parties probably talked about the price before the contract. How is MNKD going to prove damages based on a too high Afrezza price? SNY suffered just as much as MNKD. It takes a lot of gumption to file a lawsuit. Mostly because of the huge cost involved. Don't think for a minute that anybody who has been wronged can sue the wrongor. There is no law firm in this world that will take this case on as a contingency. Why would they commit legal resources when they can make money elsewhere. I know, the payday at the end. As an investor, you were looking for the MNKD payday. Has it arrived yet? 14.4 Governing Law. This Agreement, and all questions regarding the existence, validity, interpretation, breach or performance of this Agreement, shall be governed by, and construed and enforced in accordance with, the laws of the State of New York, United States, without reference to its conflicts of law principles with the exception of sections 5-1401 and 5-1402 of New York General Obligations Law. The United Nations Conventions on Contracts for the International Sale of Goods shall not be applicable to this Agreement. Thanks for the link. NY State laws will be used. But what is the jurisdiction? One can sue in France using NY State laws. This may sound perverse but an Order from a NY court may not enforceable in France. Look for another part of the contract that speaks about this.
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Post by mnkdmorelong on Jan 6, 2016 6:57:12 GMT -5
I posted this in another thread so I apologize for the duplication but it seems more appropriate here. If MNKD decides to pursue ligitation, they have an excellent case, just as strong as Genzyme does against SNY if not stronger. Let me explain why they'd likely win. (i) Take a look at Sanofi's partnership with Regeneron for the drug Praluent. It's a cholesterol fighting drug that Sanofi signed for. FDA approval to preferred coverage with insurance coverage took four (4) months. It costs in excess of $14,000 per year. Now compare what they did for Afrezza. Poor doctor education, worsening formulary coverage, little to no advertising expenditures...... Comparing the two makes it clear they neglected Afrezza. Compare the commercially reasonable efforts of the two, and throw in poor doctor education, no efforts to improve insurance coverage and a few patient testimonials about how they had to do all the work to get the drug on their own, and you paint a stark picture of Sanofi's failure contractually. As others have said, you could also compare it to the launch to their other insulin products and I wager you'd find Afrezza launch lacking in comparison. (ii) The U.S. legal system and especially jury trials, love to stick to the big business when they can. Juries typically result in LARGE punitive damages for companies they find liable. You make the case that a large FOREIGN company like Sanofi swoops in and does a small AMERICAN biopharma dirty and Sanofi could be looking at hundreds of millions if not billions in damages. Appeal to a juror's emotions and more often than not, they'll vote guilty for no other reason other than sympathy for the plaintiff if you make a decent case. Sanofi would likely settle out of court and I expect that to occur with Genzyme as well. It could drag on for a while, but a decent law firm would likely accept the case for nothing up front if they small a big payday with settlement money when it's all over. They did MNKD dirty. It's plain to see and a jury would too. After all, the burden of proof is much lower in a civil trial as opposed to a criminal one but I don't think this would ever see a courtroom. Sanofi wouldn't want it to. You make many assumptions. First what is the jurisdiction? If France, MNKD's lawyers will need to hire French lawyers to decipher French laws (Napoleonic Code). Will the judge allow testimony from another case? Probably not. Most of the cause of low Afrezza sales is tied to its high price. Per the contract, SNY has sole rights to set prices. The parties probably talked about the price before the contract. How is MNKD going to prove damages based on a too high Afrezza price? SNY suffered just as much as MNKD. It takes a lot of gumption to file a lawsuit. Mostly because of the huge cost involved. Don't think for a minute that anybody who has been wronged can sue the wrongor. There is no law firm in this world that will take this case on as a contingency. Why would they commit legal resources when they can make money elsewhere. I know, the payday at the end. As an investor, you were looking for the MNKD payday. Has it arrived yet?
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Post by mnkdmorelong on Jan 6, 2016 5:27:35 GMT -5
What about the clinical trials? The longer term safety isn't due until 2023, but runs 5 years, that means MNKD will need to to start recruiting 2017. 1) What are the estimates on costs for the rest of the near term trials? 2) Can we ask for a delay in the longer term trial? Ah, it is costly to have total control of Afrezza. SNY bailed before Safety Study costs started. MNKD is working on the Plan. We should know more next week.
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Post by mnkdmorelong on Jan 6, 2016 4:58:47 GMT -5
Pursuant to the Web conference today: MMNKD is going to be just fine as Sanofi will market and sell until July 4 and MNKD can also begin selling alongside Sanofi until July 4th when they will retain all sales and marketing rights. These rights get more valuable each day as there are more customers each day. With 60 million in cash and uncle Al Mann who has provided another $30 million if needed as a loan the company will do just fine and hopefully will be profitable by year end. This will propel the stock skyward so now is the best time the lowest price to buy this great stock. I love to recommend stocks that are on sale now with unlimited up side. What say you all... is tomorrow a good time to buy or are you going to let me make all the profits? Everything is not all right with MNKD. Afrezza sales are only $10 mln/yr (growing). This business does not spin off enough cash to support itself (now) and pay MNKD's corporate bills. Financing will be needed.
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Post by mnkdmorelong on Jan 5, 2016 22:50:35 GMT -5
As of yesterday, SNY no longer has exclusive rights to market Afrezza. MNKD could fill purchase orders now.
Whatever SNY sells its 65/35. If MNKD, its 100%.
The reality is that MNKD does not have the organization to market Afrezza. There will be chaos until a new sales/marketing structure is put in place.
I can see MNKD getting aggressive and appointing a company like CVS or Walgreens Boots to be the exclusive vendor for Afrezza. This gets the locations and insurance payment system. In other words, script fulfillment is done. Now they have to figure out how to sell to docs and patients. It will not be easy.
When MNKD does come up with their plan, they still need money to make it work.
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Post by mnkdmorelong on Jan 5, 2016 22:30:11 GMT -5
But at what cost ? Does funding a lawsuit shorten the clock on operations if a TS deal is not found soon ? For a highly winnable case, law firms normally charges nothing to plaintiffs in exchange for a percentage. If Sny settles or ruled to pay $1B, the law firm may take 20-30% cut. This case would cost Mnkd nothing for as long as the court takes. A law suit should unlock SH value. The Breaching Party is clearly Sny. Once the suit filed, Sny may initially offer to pay what left in the milestone payments 925-200 = $725M at min. I'd use it as a low bar. Mnkd may ask much more than that using Lantus lifetime sale as the benchmark. Whoa, slow down. Lawyer's fees for these types of lawsuits are paid for by the parties. Discovery and Depositions will run millions. Then there is the trial (if at all). It will take at least 3 years depending on the court to get to trial. MNKD must prove that SNY did not perform as per the contract. How are they going to do this? Pfizer's Exubera also failed. This will be SNY's defense. How is a jury going to sort through all this and decide? SNY has much more money than MNKD. They will not offer to pay for anything. In fact, they may extend Discovery and be aggressive with motion practice to make it more costly for MNKD.
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Post by mnkdmorelong on Jan 5, 2016 21:44:53 GMT -5
S&P Futures are down big time. The market did not like what Matt said this afternoon.
Only kidding.
But not kidding is that the North Koreans may have tested a nuclear weapon. If so, this is what the futures are responding to.
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Post by mnkdmorelong on Jan 5, 2016 19:30:13 GMT -5
Matt gave the essential facts: Afrezza is the best meal time insulin. Without Sanofi, MannKind can price Afrezza competitively and achieve blockbuster status in a shorter time frame than Sanofi projected.I could be wrong, but I don't think he ever said that. You are not wrong. Matt said Mannkind can price Afrezza lower as they now have marketing rights. Everything else Kastanes wrote was not uttered by Matt.
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Post by mnkdmorelong on Jan 5, 2016 18:39:41 GMT -5
I have listened to Matt over the years and today he sounded determined, not flustered at all. Obviously, they do not have a Plan B ready to go. Central to any plan will be a lower price for Afrezza. They need to descend into Tier 2 everywhere. He spoke about the cash; they have $60 mln on hand and $30 credit available from Al. They will stretch this into 2017.
Matt did say this is not the end of Afrezza or Mannkind. But eight months ago he also said the 2015 debt refinance was not going to be dilutive.
Where do we go from here? It would be a shock to me if MNKD was blindsided by SNY and had to gin up a plan B now.
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Post by mnkdmorelong on Jan 5, 2016 13:31:20 GMT -5
The theater of interest is now the 4:30 pm teleconference. Something rational and positive must come from the meeting. Otherwise the stock does the drip drip drip lower.
On the assumption MNKD knew well in advance, we will hear the best possible news that planning can create.
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Post by mnkdmorelong on Jan 5, 2016 12:50:13 GMT -5
He is no longer CEO. What words do you use to describe his leaving the post?
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Post by mnkdmorelong on Jan 5, 2016 12:46:54 GMT -5
Many drug companies with new products often go it alone. They have better control over the sales force and messaging. But this comes at a considerable cost.
Afrezza is an insulin so it make sense to comarket it with other insulins. This is the SNY deal.
To gin up a reasonable sales force will cost millions and will not be as effective as SNY's. Why? SNY's sales force is trained, have the relationships and can live off of other sales while Afrezza develops. A totally new sales force must live off of Afrezza.
In sum, MNKD can go it alone if it had big bucks.
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Post by mnkdmorelong on Jan 5, 2016 12:29:37 GMT -5
Before or after Hakan resigned?
Before or after New CEO hiring?
Does new CEO know this news before he accepted this position?
Please tell us your thoughts? If one day your spouse tells you (s)he wants a divorce, is it a surprise? MNKD knew, Desisto knew. I think Hakan got fired for his pleading "we need to talk" statement. It showed desperation.
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Post by mnkdmorelong on Jan 5, 2016 12:10:58 GMT -5
I am trying to think out loud. Others please chime in- Why would MNKD agree to JPM conference? 1) Is it possible they did not know SNY was dropping them 2) Lets spin this as a positive, but I dont see that going well. All questions asked will be negative and how far out they are from BK 3) Will they have something positive to say that day? If MNKD did not know this was coming, their antennas need to be calibrated. BK occurs when bonds cannot be paid due to low cash. In the case of MNKD, I can see Al Mann footing the bond payments until better days happen. We are aligned with Al; the Afressza IP and FDA approval is tied to MNKD stock. We want to keep this intact. I am positive for today's meeting. Many on this Board want pablum; say anything to sooth the injured soul. This is bad. We need a real new direction; that is the reason for Desisto. If I am wrong, then MNKD management is inept.
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Post by mnkdmorelong on Jan 5, 2016 11:45:26 GMT -5
It was a terrible marriage that simply had to end. Sure MNKD took a hit, but what matters more is the future potential which Sanofi was surely holding back. You can't promote a drug you don't believe in, and Sanofi never believed in Afrezza. Many on this Board had the impression that SNY sandbagged the roll out of Afrezza. I think the truth is that SNY put in a lot of effort early on. But sales were way too slow for their efforts. So they cut back in recent months just waiting for the first day to cancel. Any other insulin company would have suffered the same fate.
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