I would not have thought J&J would make a play for ampe until I realized they own DePuy (manufacturers of replacement knees which is a huge market). Now I get it, if ampion is showing signs of cartilage regrowth then the reduced need for knee replacement would almost immediately cut into the sales of DePuy and over a period of time may reduce the need for knee replacements by 70-80% so if J&J should be the high bidder for ampion then they hedge their bet. I'm hearing the marketing rights after the BLA is filed for ampion could be as high as 1 billion with a 15-20% royalty worldwide. There are other big Pharmas interested as well so let us hope a bidding war begins after the BLA is filed. Comments please.
So many way deals can go:
1) Acquisition of the company
2) Acquisition of Ampion
3) License Ampion
4) Marketing Agreement.
I am thinking if they don't get the right deal, they could go with something like option 4. They have the manufacturing capability (smart move). They have a big pharma powerhouse marketer; sell. This way they can have a "test drive" of sorts to demonstrate just what the drug will do in the market place. It offsets potentially some of the "assumptions/discounting" of standard valuation methodologies. A year or two into it they sell. In this scenario, they are "proving" the value and have leverage then to drive the right price.
Although I have no insight on possible J&J interest, Mr. M did recently reconfirm that the BLA filing will be the time when he entertains possible bids for Ampion participation. He has done a lot of work on past deal structures and valuations and believes maximum shareholder value can be achieved upon filing - not before unless an unusually attractive deal is put on the table. While he is still open to talking with new potential partners, he is not eager to go through more due diligence meetings with potential tire kickers for two reasons: First, without putting a number on it, he feels he has a sufficient cohort of interested parties who have done their work, and absent an unusual opportunity, has pretty much closed the door to new potential partners because (second) this due diligence process takes up about a month-and-a-half of the company's personnel's time. As a for instance, the visitors generally want to go through the company's patents word-by-word - very time consuming. Once we get the trial data, hopefully within the next 4 [?] weeks, next step will be to get the plant cleared by the FDA that involves two critical steps: First, are automated procedures in place to ensure no "bad" product gets produced (something like assurance that this would be no more than a 1 in 100,000 occurrence) and that "substantial" quantities can be produced in good order. No specific timing on getting GMP for the plant, but expectation remains that all the pieces should be in place by year end. What I like about this management is they always have their foot on the accelerator pedal and push hard to get things done as fast as possible - in contrast to most bio startups I've been involved with that proceeded at a more regal pace, burning a lot of cash in the process. Mr. M mentioned cash is around $72 million and most of the heavy duty costs for the year - trials, new plant - are behind them.
good detective work. We need more of it. As most know, I believe the evidence for *significant* cartilage regeneration is weak. There was an "suggestion" and "indication" of local stem cell recruitment at 20 wks but no measurable improvement. This is why they are trying multiple dosing and higher resolution MRI as well as recording the biomarkers in the current study. If there is any means of increasing the potency to equal that of a single SC therapy, that could be interesting, but it is speculative at this stage. It is most certainly not going to reduce knee replacements anytime in the next 5 years even if it did work. The cartilage damage is too far gone at this point for those that will need surgery in that timeframe.
"as high as" is a number used for marketing. Like most biotech deals, the PR number is a maximum to generate as much fervor as possible. The real number might be half. Citi and Jefferies are consultants for buyouts and their respective near term valuations are much less. Also, the current market conditions, fueled in part by government statements against biotech valuations and pricing serve to reduce the value of any deal.
Appreciate your thoughts but I do strongly disagree with your take on the 5 year effect on knee replacements. I had a total kr in 2009 on right knee and in late 2013 total kr on my left knee and I can tell you I had waited and hoped for stem cell regen for cartilage even before I had to have the tkr in 2009. If OA 3-4 patients saw just a glimmer of hope with ampion injections they would wait as my friend, a total knee replacement and the rehab is a horrible 3-4 month experience. Then the BIG IF comes if ampion does in fact regen cartilage then J & J would drive the marketing rights of ampion to unbelievable heights. All of this will play out within the next 12 months as I understand the multiple injections of ampion for stem cell activation and cartilage regen begins almost immediately. Very excited about the prospects as this would be HUGE and would also apply to other medical conditions. HUGE HUGE and the price of ampe goes ballistic !!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!!
Mr. Glass Half Full, per conversations with AMPE, they state that the analysts price targets are by design conservative(especially in regards to market penetration), and are likely to be upgraded as more clinical data becomes available. They also feel strongly that some kind of healing is going on, as some patients are experiencing pain relief beyond 20 weeks from a single injection.
Synvic is always used as a multiple injection regimen, so the question you could ask, is why the SPRING OR STEP trials didn't involve multiple injections.