When the Flint study was stopped in January due to early achievement of the primary endpoint, it caused this stock to jump to the moon. Yesterday, we received additional data from post trial testing. The jewel presented last night was that OCA reversed fibrosis in NASH patients. This is akin to a liver transplant in a pill. The news spawned the typical short covering but not the fireworks I expected.
There are still price estimates in the $400-500 range. ICPT has a potential blockbuster drug. Sanity will return soon to the market.
I have held MNKD for several years now and have a nice gain. But I expected much more today from the Sanofi deal. There was constant selling today meaning investors were getting out. There is no catalyst for a bump in price until next year. I see this as dead money until then.
ICPT has done much better for me in the short run.
I read it briefly. My key take away is that the improvement due to OCA goes away after the drug is stopped.
Not much on the lipid problem.
First off, Kevin needs to be talked off the ledge he is on somewhere.
The market's reaction to the Sanofi deal is lukewarm at best. The shorts can cover at their leisure so there will be no thunderous short squeeze. Sanofi is the large pharma MNKD needs to market Afrezza. But there are several aspects of the deal that are less than glowing.
The partnership is structured as a JV where both members share the cost and profits 65/35. Afrezza is transferred to Sanofi at COGS which means a lot of MNKD's current costs are placed on the product. This is good. The up front cost to market Afrezza means there will be no profits to MNKD for several quarters. They will have to survive on the up front $150 mln and progress payments.
AF, bless his wretched soul pointed out that ARNA's deal is better since they get 35% royalties up front on sales.
On the webcast, PIerre of Sanofi highlighted the injection adverse market as key. He did not mention the ultra rapid acting nature of Afrezza. Al did so at the end of the webcast.
In sum, we have a deal. Not a great deal but one that will prove out if Afrezza can garner large volumes of sales.
Some confusion this morning. There is a webcast at 830 am EST to discuss the Sanofi deal. Some newswire said there is one at 2:00 pm EST; this seems wrong. As per Friday, there is an ER webcast at 5:00 pm EST.
Be on the one at 8:30 am EST.
You must first understand the bifurcation of tasks that the ensuing partnership will entail MNKD will manufacture Afrezza along with RA and R&D. The partner will be strictly sales and marketing. Purchase agreements for raw materials are always tied to manufacturing. Any payment to the insulin supplier will be next year after MNKD is flush with cash.
The new insulin supply agreement does not really tell the entire story. MNKD has a large supply of lyophilized insulin purchased in 2011. It has been on ice for the last 3 years and will be used to make product subject to FDA approval. Since Amphastar does not start until next year, I surmise that the iced insulin is good and they are making product now for product launch. For the beancounters out there, the iced insulin has already been written off so it is essentially free. A few years ago, MNKD said it had enough iced insulin to make $1 bln product.
It seems there will be a product launch. Who will be our partner?
GALT's NASH drug is based on apple pectin, a naturally occurring fruit and consumed widely without adverse events. It was the second cohort in Phase 1 that they flopped. Leave it to AF to frame the failure in an odious fashion. They will go on to the third cohort at higher dosage to observe Phase 1 endpoints (safety) and if the appearance of biomarkers that tell if the drug is working. Absent the latter, GALT needs to punt.
ICPT is much further along. The FDA may accept OCA for NASH notwithstanding the cholesterol issue given that people will die from lack of treatment.
The best part of the ICPT story is the low stock float. Many biopharmas must dilute and dilute to get over the finish line.
One other point:
Hedge fund managers are not gods with awe inspiring power. Last week Bill Ackman tried his best to take down HLF by presenting incontrovertible evidence that HLF is a scam. How well did he do? HLF's stock started to go up as he started his presentation. By the end of the day it was up 25%.
The latest report shows 71.7 mln shares MNKD stock shorted. This is an increase of 4 mln shares since the last report. Short interest was abnormally high for the last 6 months. Why would it increase after FDA approved Afrezza? If money is on the line, only the clearest logic backing the investment thesis prevails. In my mind’s eye, it is illogical to hold a short knowing that a catalytic event (partnership announcement) is looming and the odds on bet is positive. Like a child, I rationalized the dissonance by assuming the shorts were hedged.
But Jason Carp’s article shattered my fantasy. The poorly written article’s intentions were to induce a bear run which offers cover for the shorts. I have changed my mind and I think the majority of the shorts are unhedged. They are waiting for a bad partnership or no partnership to be announced. If the shorts are right, they will cover at a nice profit, but not at $1. If the longs are right, there will be a tremendous short squeeze.
I am long the stock and short the puts. We will all find out soon who wins.
The value of MNKD will depend on the quality of the partnership. If it is comprised of Hong Kong Pharma to do the far east, Moldova Meds to do Europe, and Walmart for the US, the price will be low. However if AstraZeneca is the exclusive WW partner, the price will be much higher. Analysts cannot guess at the partnership makeup and will wait until the announcement. It will not be long.
Everyone knows MNKD management is in discussion with potential partners. Many here have cried for a conference call. Why. What would be the purpose? Certainly Al cannot say he is talking to ABC and DEF company. These negotiations are very delicate and profoundly affect the value of the stock . Let them do their work. Warren Buffet said the stock market transfers wealth from the patient to those who want quick action. Don't be a loser long who sells too quickly.
The quiet period pertains to earnings announcement. I think it starts two weeks before the date. Surprisingly, its not an SEC rule: just common practice. MNKD will announce earnings (ha!) in early August. They are not in any quiet period now. Insofar as they have not announced when earnings will be announced, the quiet perioid clock has not started yet. They may delay earnings announcement pending an important development: I wonder what that could be?
Otherwise known as Afrezzauser.
He is a T1 participant in the 171 trial and is a strong advocate of Afrezza at AdCom and on this board. One would have thought he would have posted upon FDA approval. He wants to (and will do a good job) to work for MNKD in a sales role. Perhaps MNKD thinks this is a good idea but he was warned not to continue posting. I can understand this. Anyway, congrats Sam, you will soon have the prandial insulin that will simplify your life. And if you get a job with MNKD, good luck.
At the AdCom meeting, the consumer panel member Diana Hallare said: "It's not all about HbA1c in referring to Afrezza's higher numbers. Diabetics do their best to control their long term blood sugar (HbA1c) but can die from a hypoglycemic event in doing so. Fast acting insulin as exemplified by Novolog stay in the blood way too long and is the cause of dead-in-bed syndrome. Diabetics will have with Afrezza the ability to better control their instantaneous sugar level. Docs will learn with Afrezza, they can target their patients to lower HbA1c and not fear a deadly hypo. Due to its quick in and quick out action, Afrezza will usher in a new way for diabetics to control their lives. Using old metrics (HbA1c) doesn't describe the benefits of this new therapy.
I think the number grew slightly to 69 mln shares. A very big number.
Part of the answer is in the 5.25% convertible debt due 2015. As part of this offering, MNKD lent 9 mln shares to the lenders for the purpose of shorting. When converted, these bonds yield 16 mln shares of new stock. I think the lenders borrowed another 7 mln shares and shorted these also. In a few days, the lenders will exercise their conversion rights and be issued 16 mln shares of MNKD for repayment of the debt ($110 mln). These shares will be used to repay MNKD's 9 mln borrowed shares and close out the 7 mln shares in other borrowings.
Even with this, the short interest is still large. Shorts should have been all over AH trading on Friday. But they were not. Mostly retail traders in
Pfeiffer at the Wells Fargo event said it could be days or months. The deal team (brokers) is incentivized to do the deal faster than later. Insofar as the label contained no surprises, there will be no new ground broken by the parties in concluding their negotiations. Pharma deals have been rich this year; I expect longs should be happy.