Johnny_C
7 years ago
Lawsuit was filed against Cemp today. Temporary CEO gave himself 1.8 million dollar golden parachute if deal goes through.
8 mil penalty if deal doesnβt go through, unheard of with a private company merge like this.
Add the 8 mil and they could have wasted 12 million plus if this gets torpedoed, which it should
Assuming the Soli is worthless, which it is not, this should be worth 7 dollars just on cash, tax loss and being a public entity.
If they have a funding source for Soli that makes this even more bizarre.
Johnny_C
7 years ago
It is never a smart strategy for a small biotech to market their own products, the upfront losses are staggering.
This deal is so bad it is trading under cash. They say MS shopped this to 90 companies and this was the best they could do.
Will be interesting to read the full disclosure by MS because they could also be liable in lawsuits.
IF Soli is as easy to approve as you say it is they should cut staff to bare minimum and spend the 70 mil. If it is a success it will be a blockbuster and large pharma will swallow them up.
The cash, tax loss, patents, Japan trials, and all the 600 mil in RD and data are currently worth less than the net cash on hand...
agamemnus
7 years ago
Absence of evidence isn't evidence of absence, but it's hard to tell just how much lying is going on. They DID submit a 2K patient safety study and it was turned down by the FDA. If you see BARDA fund a part of the safety study, the stock should explode.
I really cannot trust Cempra's analysis one way or the other. According to Japan's public clinicaltrials site, there are three soli trials, but Cempra keeps saying one CABP and doesn't mention the others. And how many patients will it enroll? No one (at least investors) know. Half of those patients can be added to the safety study. Maybe even you could add patients from the non-CABP studies because after all the FDA did count people from different studies to the current overall database.
Let's say there are in total 1.2K patients being treated in all 3 studies. So that reduces the sum by 20%. Assuming you trust the 75m figure, then that is 60m. And BARDA already committed more than this on the pediatric program -- $68.2m. I don't know if they'll foot the bill 100%, but maybe half-way. Then get Menarini to pay the other half for a contract. They are already paying for half of the CABP Baxdela trial, which maybe costs something like $20-$25m.
It's totally do-able.
About the salespeople: https://www.sec.gov/Archives/edgar/data/1461993/000119312517281202/g438060ex99_1s11g1.jpg -- sales force to expand based on adoption. A smart build-out strategy.
agamemnus
7 years ago
To answer your questions/complaints:
"Have you read the 800 plus pages of crap, just when I had someone spend half a day printing that garbage they updated it so one has to play hide and seek finding the changes."
I don't know where/when they updated it. There is only one preliminary proxy SEC filing. Not sure what you are seeing here.
"If this is so hot why is CEMP getting very little in return, Cemp has the cash, Cemp is on NASDAQ, CEMP also has a valuable tax benefit to a profitable company, CEMP has valuable patents."
I agree they do, but Baxdela is also very valuable.
"They should have had a persuasive 30-to 40 page powerpoint presentation highlighting the benefits."
They'll have a presentation that probably just regurgitates some parts of the proxy. At the risk of sounding like a know-it-all, I don't think the presentation will be any better than my article. But maybe when the company says it, it might make more people aware of it. Or it might not. My latest article has been read by
"The modeling I read does not have Soli hitting the market until 2022.. If it only costs 75 mil to get oral completed in less than a year why dont they just do that. They will have a blockbuster drug at that point. Not to mention get in and hire some big hitters to sue the FDA. There is a plan."
Dr. Z said it would take 2-3 years and 75 million and the proxy says 2021 (not 2022), but I have no reason to believe any of these numbers are correct.
If they do not do some sort of merger, Cempra management does not get golden parachutes, which is hundreds of thousands of dollars for each top dog. There is also a nominal decrease in risk of solithromycin not getting approval even after the 6,000 patient trial is run, which is part of their merger rationale, but I don't believe that the risk is there.
Other than that, there is the synergy in the merger in several respects:
* Combined SG&A will be reduced compared to separate SG&A.
* The combined company will have more freedom to really be able to fully market Baxdela. 90m from Oberland Capital is a lot, but possibly not ideal.
* Once solithromycin is approved, they already have a sales force to sell it, for many of the same indications, but in complementary areas and similar advantages in those areas. For example,
++ Solithromycin is supposed to replace two drugs.
++ Baxdela is supposed to replace two or more drugs.
++ They are both mutation-resistant. They have some potentially complementary contra-indications.
++ Safety will be touted for both.
++ Baxdela will start in mostly hospital use for serious skin infections (i.e.: ABSSSI) and very serious CABP, while solithromycin is really intended as a replacement for azithromycin.
"Why did the idiot board go along with prabda and most likely hundreds of millions of dollars hiring a salesforce for a product that wasn't even approved?"
You might have seen my post on SA. It was simply foolishness by Prabha combined with monetary incentives to waste money in this way. They got bonuses for prepping a sales force before approval! See page 202 to the top of page 212.
"Didn't she say after the manufacturing issue that the delay was fine because the product would have been best launched 6 months later when doctors would be more receptive because of flu season."
It was 100% spin, what can I say. If they had approval in December and a sales force in place, they would have caught the most critical part of the 2016-2017 CABP season via sample packs, which (like the flu season) peaks between December and February. But she is no longer CEO.
"Your big pharma is big in Italy and some of EU but they don't have a big presence here. 70 reps is a start but more than likely double that will be needed. And the big question is how much risk they take rolling this out."
I've spoken with a few people who think 70 reps is just fine to start with. I'm sure they will increase that over time. All those reps need training, and they don't even have a CEO yet.
"Why isn't a big US pharma on this, those reps would have multiple products to showcase. Right now, your big pharma is not impressive at all"
Menarini has almost 17,000 employees. A lot of those work in the area of manufacturing. Definitely not a Pfizer though. But guess what.... Pfizer was partially responsible for the Cempra CRL as their manufacturing plant wasn't up to snuff for the FDA!
As for the US, can you give me an example of a big pharma selling someone else's antibiotic successfully? The fluoroquinolones that are being used by the dozens of millions in prescriptions every year are almost all generic, so it doesn't look great initially. Big pharma doesn't like the risk. What usually happens is a buyout, not a partnership (Cubist eating Optimer, Merck eating Cubist, Pfizer buying Astrazeneca antibiotics last year, etc.), because half-measures make no sense here.
So Melinta wasn't bought out. But you have no way of knowing if that wasn't a possibility.
"I hope I am wrong but these Cemp people are idiots as far as I can see. Why would they agree to pay 8 mil if the deal doesn't go through, that is bullshit."
I thought it was 5, but anyway, that is customary to account for potential lost opportunities. Melinta would potentially be out of other deals due to this merger... like a buyout by a big pharma!!!
"And to think that this is trading underwater if liquidation value is crazy. They might have to reverse split the stock just to meet Nasdaq requirements."
I do believe the stock is substantially undervalued. That is based on what the potential is based on my analysis of the science and competitive advantages of Baxdela and solithromycin, not what the stock market or even some big shots from big pharma think it is worth. Eventually, with good management execution, the market will catch up.
Johnny_C
7 years ago
They are not that big in the US. Plus it is yet to be seen what risk they are assuming the first few years to market this.
Why did the idiot board go along with prabda and most likely hundreds of millions of dollars hiring a salesforce for a product that wasn't even approved?
Salary, car, computers, insurance and severance for what, nothing. The lawyers suing Cemp should drill down on that.
Didn't she say after the manufacturing issue that the delay was fine because the product would have been best launched 6 months later when doctors would be more receptive because of flu season.
Your big pharma is big in Italy and some of EU but they don't have a big presence here. 70 reps is a start but more than likely double that will be needed. And the big question is how much risk they take rolling this out.
Why isn't a big US pharma on this, those reps would have multiple products to showcase. Right now, your big pharma is not impressive at all
I hope I am wrong but these Cemp people are idiots as far as I can see. Why would they agree to pay 8 mil if the deal doesn't go through, that is bullshit.
And to think that this is trading underwater if liquidation value is crazy. They might have to reverse split the stock just to meet Nasdaq requirements