Market has been up huge the last month or so including today and we just go down. Unreal. No one seems to see any value in the stock even at $13. Orwin needs to go. He's run this one into the ground in less than six months. Company needs to be sold or a major partnership regardless of what happens to AZN in May.
Orbimed stands to lose almost 150 mil if this one goes under .Someone competent needs to take the reins and fast! Nice end to the quarter.
That sounds like it is basically almost unworkable. That and apparently the lack of direct communication with the sales rep and the physicians office?
Good hearing from you AK....The shelf life issue is apparently discussed below. I think the paperwork issue is a valid one. I think the specialty vs regular pharmacy issue is a valid one. Insurance should take care of itself over time.
The bigger issue I think could well be Nephs not wanting to prescribe either Velt or ZS9 as they view HK
as an issue that they will take care of when or if the need arises,( ie, some acute traumatic event), and not something they want to treat on a daily basis via medications. I'm very surprised frankly at the slow up take thus far of Velt given that Nephs were crying for something to address the issue for the first time in 50 years as a chronic "unmet" need in all their journals, etc. Oh well. We'll see over time I guess.
I think most are giving RLYP a pass for awhile on script numbers and especially paid script numbers,
but the ramp must show incremental improvement on all fronts. I mean the potential market in the US alone is estimated at 3 million patients. If docs are slow to get on board we need to find out why. Is payment an issue?
Are the logistics of delivery of product too cumbersome? Is the paper work required too bothersome? Is the drug working well with the patients or are there any issues? Etc.
Could be Nephs are slow to buy the need for chronic care of HK? Maybe they simply feel all is ok unless you end up in the ER. Cards are the ones who need to get on board. That is where the real benefit could be.
Probably 70% of their patients are elderly with CHF.
Will be interesting to hear the feedback from Orwin after a few more months....
ihat...Yes...I really think unfortunately you're going to be right. I think the panel has probably been on junkets with these folks courtesy in part by sponsors like AZN. Been at dinners or partying at conventions with them;
golf...the whole enchilada. And from their perspective what's the harm? Two drugs vs one brings about more competition and prices come down. Isn't that the objective now by politicians?
So getting up in AZN's face in the public light is going to take some guts and not sure the panel members will be motivated in that direction. Hope they do the right thing but frankly I'm not confident they will.
Mike.... I do not believe either that we should discount the weight that AZN pulls with the FDA and the physician and hospital community in general. The FDA knows they basically need them (big pharma) while
RLYP was expendable in their eyes. I too am fearful that the game is
rigged and they cut a wide berth for AZN in this approval hearing.
Craig....Taking on an incremental drug to market will most certainly lead to significant incremental costs.
Cost of goods sold will be one of the smallest variables. AZN will still have the same advertising and marketing costs that we do or possibly even more. They will still have on-going studies. They will still
have management and sales force expenses attributable to development and marketing of ZS9.
Legal costs, patent costs, regulatory costs, etc.
Just because they are now owned by a large pharma like AZN doesn't mean these expenses are not
fully accounted for into gross and net margin calculations for reporting net profits. Basic accounting.
The launch of ZS9 if they get that far will have very similar if not even higher expenses then we're
seeing now with Velt.
AZN will not get a CRL for ZS9. They WILL however likely get a warning label re use of ZS9 for those on sodium restricted diets or have advanced chronic heart or kidney disease, edema, or high blood pressure. They will also be required to do human DDI studies.
Oh I see....AZN averages 15.8% in net margins with all of the drugs they own, but with this little sodium bomb they acquired for 2.7 billion, they're going to have 80% net margins?. I mean you're either trying to be funny or you're dumb as dirt. Possibly both?
You are absolutely dreaming about the 80% NET margins? They average 15.8% NET margins on all of their current drug sales. What do you not understand? It's 4th grade math.
Look it up on 25.7bil in sales for 2015. You don't think they would take the 22% net profit margins for RLYP in their royalty rights agreement for the EU in a nano second?
Thanks AK for not rubbing it in as you sure the heck earned the right to given ZSPH v RLYP. I had the chance to make 70% on my money in RLYP last Dec but didn't sell because of taxes...lol...Dumb. Thought if I put it off until Jan I'd be in a new tax year.
I really like TRVN. Could be a homerun if current trials continue on like the others. Brand new treatment to replace morphine eventually and the heart drug sounds very interesting as well although pretty early stage.
GL to us and nice to see you again Silver as we've been around the horn on alot of these huh?!
The problem with "John" is apparently he has a pretty big ego...Is out to prove what happened with AFFY was simply a fluke and he really is a great "CEO". That he has little personal wealth at stake in the company via shares he bought at the market with his own money.He has laid out a plan to capture the market in utmost urgency without adequately assessing the current and near term future size of that market. He is basically imune from dilution as his share options and exercise prices will simply be adjusted. We have no such luxury..
Orwin is at the helm if the Titanic and won't reduce speed. Iceberg dead ahead and he's standing in the buffet line totally clueless. We need a mutiny. Someone who will reduce expesnes substantially and right now .A Board that will shop the company for sale starting now. If ZS9 by a slim chance gets a clean label, we're screwed regardless.
Orbimed can't be that cavalier with their client's money. Company needs to be sold, and now. $28 is a done deal.
Agree they do not need to run additional trials on these very collateral issues like food intake etc.
Total waste of money and focus. Orwin must go. His idea of a launch is to spend as much money as possible and it will work. Doesn't work in a marriage and doesn't work here. You have a product with no competition
for at least six to nine months, and an SNY and in house over 200 man sales force, so if you cannot launch the product with the 300 mil in the bank...,punt.
Management et al has no problem with funding via stock cause they'll simply issue more option, grants, or stock to themselves, so it's not an issue from their perspective. The company, after May, needs to be sold.
We need someone at the helm that will get that done. Maybe Orbimed will wake up some day and decide they didn't like losing 147 million dollars during the last three months, and get someone at the helm who can get us sold before it is too late.
So they ran a 750 plus patient year long study just for the heck of it? LOL....
The FDA didn't "ask" RLYP for a year long study either. You either have the common sense to do that
if you're going after a chronic indication or you don't. Just think about it. You're going before the FDA to ask
permission for your drug to be given to patients over a long period of time..Perhaps even for many years.
So the FDA is supposed to approve that request based on your 28 day study? Does that make sense?