I would agree with this. However, I rarely see biotech trade at cash because future burn will be taken into consideration. The problem is that the cash isn't stable cash that will hold..it's going to dwindle. However, the good thing with Targacept is that they are lean in terms of employees and they don't have any major cash burning programs. I think 3.00 to 3.50 is about right.
I don't believe they'll bring in a new program as Targacept is a beautiful candidate for a reverse merger. You have a shell...really good cash...a potential management team (though these teams are often replaced) and the AZ asset + the gastroparesis candidate (though very early and without value at this stage..it's still a liability). I would see off the nicotinic platform if possible and load the balance sheet with cash. I actually went through this when I owned Neotherapeutics way way back when and SPPI reversed into them. I held for a number of years and actually ended up making money. TRGT is probably a good bet at these levels, but I'm not playing it. I do have one concern..not sure how others feel. I'm paraphrasing but Hill said that the trial was scheduled to readout around 6/30 and that we should give or take a month. He then briefly mentioned that these trials don't tend to read out early. I was thinking we would see data around the end of June. We should hear next week, but I'm intrigued that it has taken the full amount of time for the results. I'm not sure if that's a good sign or a bad sign! Impossible to read into it but it's something to ponder anyway!
I of course was not holding TRGT, but I am troubled by the execution of this urinary incontinence trial. This isn't to point fingers or slam any employee. I just wonder why they didn't take this program through a small well-controlled Phase 2a proof of concept before wasting so much time/money on a huge Phase 2.
It will be interesting to see where the price goes.
It's definitely a valid thought and one that I have also considered. Botox can be used for dystonia and spasticity relating to a number of CNS conditions. However, this isn't their specialty of course.
Having said this, Allergan was caught off-guard by Valeant and doesn't have a lot of time to mount a counterattack. What I read was that they were eyeing two M&A deals. The first has been discussed which is Salix. Salix makes sense for Allergan since they are both specialty pharma focused on highly selective areas. The second company hasn't been announced, but the way to get rid of Valeant is to make the deal more expensive and to use some of the cash on the balance sheet.
I don't think the fit is obvious, but they've had a long term relationship (which always helps) and I don't think any group would be considered stupid for bringing Pimavanserin into the pipeline. Allergan could even spin-off a separate entity focused on CNS with Botox as the anchor and Pimavanserin as the future.
This is all wild speculation, but I have to admit to considering the same exact possibility.
There may be NDA related news that could significantly increase the price target. For instance, the FDA could grant Acadia "Priority Review" status which would cut the timeline to approval considerably (6 months). The FDA will typically inform the company of a Priority Review designation within 60 days of receiving the NDA. Incidentally, the first 60 days is the filing review period and this is when the FDA will decide things like priority review. The official approval clock starts ticking at the end of this first 60 days. We could be talking about approval next summer if they get a priority review.
I would just again reference my above post since I personally believe a Priority Review is also quite likely. This would happen within 60 days of the actual NDA filing.
Start adding together terminology like "Bolt on Acquisition" from Cramer, reality like "Breakthrough Therapy Designation" and maybe even "Priority Review" (which is coming in my opinion within 60 days of NDA filing) and the shorts have so much to worry about. Not only is Acadia performing on all levels, but outside acquisition forces and FDA actions can rocket this quickly. Shorts are more than worried.
I honestly have no issue with shorts making money where they can. I have my long term capital gains locked in here and I'm not budging from my position. Having said this, deals (M&A and licensing) will be heating up for all biopharma groups in the coming months. Summer months slow all discussions, but things tend to come together in the autumn. I'm still not convinced that an offer won't appear. The Breakthrough Therapy Designation will make an acquirer that much more confident that approval will happen. Priority Review is also likely IMO. Of course, if we get a six month review (likely in my opinion) we could be talking about approval in the summer 2015. Once the NDA is filed there will be a long line of catalysts to look at. It's going to be a really exciting 2015 if Acadia can stay single that long. We'll see. They're looking gorgeous and everyone knows it.
In other words, priority review is highly likely. I remember when risperidone was approved in 1994....20 years later a newer generation antipsychotic is finally ready to face the FDA. We all know how much revenue the atypicals generated as a class...it's around $14 billion for those who don't know. There is only one Nuplazid...no other class members to share this market with. Yes, we will only be approved for PDP at first, but Nuplazid will of course be looked at for ADP, schizophrenia and bipolar. Off-label and expanded label in CNS is almost a given because so few new drugs are approved. I have been waiting a long time for the next generation to appear. As an investor, Acadia is dreamy.
Thanks. Yes, I've been around and am always watching Acadia closely. We're starting to see things line up now. I'm looking forward to the actual NDA filing and then a Priority Review designation. It's not guaranteed but I believe that it's highly likely and the Breakthrough Therapy Designation today increases my confidence. A clock is now ticking and we haven't really had that with Acadia before. In the next four months the NDA will be filed and we may see additional clinical trial launches in areas such as schizophrenia and perhaps something in the sleep/wake area for Parkinson's patients since Pimavanserin clearly has a very positive impact here. Early 2015 will likely bring news regarding Priority Review which should set the stage for a lot of excitement going into the approval decision which I believe will be before the end of summer 2015. I don't have a price target, but it's certainly far north of where we are today. If we become a so-called bolt on the terms should be excellent with contingency rights should ADP, schizophrenia and other indications pan out. Exciting times for sure.
Haha, well maybe I have too much time also! I actually sat here and calculated your shares and profit. You made that into a fun math problem so I had no choice! So you have 28,000 shares and you made $73,641.28 today. Well done!!
I don't think it's possible due to all the other variable. For instance, how many of those breakthrough therapies had a second Phase 3 waved off because the data was so compelling that the FDA said one Phase 3 is enough? I know this hasn't happened in CNS before so this case is almost without precedent.
In addition, I'm betting that a fair number of the breakthrough designations were for orphan indications.
You're not going to find many potential mega-blockbusters with a second Phase 3 waved off that were given this status. Acadia is a rare bird and she will fly high. IMHO!
I think that depends on the form the offer takes. In other words, if an actual term sheet is presented (representing a formal offer) it will go to the BOD and then I believe there is a legal requirement. However, I'm not sure an informal offer or "discussion purposes" offer is viewed the same way. I think there is some latitude here. Most of these talks sit in the "discussion" stage for a long time before anything formal is put on paper.
Baker Bros was a big investor in a public company called Neurogen. It was a small company with Stephen Davis as CEO and a pipeline of several interesting mid and early stage candidates. This is the same Stephen Davis who is now our CFO. Neurogen was a troubled company so has very little in common with Acadia other than a major investor being Baker Brothers and Stephen Davis as the CEO. It's obvious that Baker Brothers likes the talent of Mr. Davis or they wouldn't have recruited him to Acadia. That brings me to Neurogen's M&A deal with Ligand that was executed while Stephen Davis was captain of the ship and while Baker Brothers was the largest (or one of the largest investors). The deal occurred in 2009.
I don't reference the deal for size because Neurogen never reached its true potential. I reference this deal because of its style and because of the players involved (Stephen Davis and Baker Bros). The deal called for a certain upfront and then a lot of contingency value rights once various milestones or events were triggered. Neurogen also retained the rights to sell some other assets before the deal closed. That part likely won't pertain to the Acadia situation if M&A does indeed take place here.
With Acadia, I think you're talking about a very nice upfront amount with a lot of back loaded items as well. For instance, approval for the PDP indication would trigger x payment, positive phase 2 results in ADP would trigger X payment, positive schizophrenia results would trigger X payment, etc. The problem with this style is that it doesn't really have a way of honoring longer term events such as the ADP indication getting formal approval or schizophrenia getting formal approval. Because of this, a partner is going to be required to either pay a great deal upfront to take out Acadia so that all shareholders are OK letting go today or there will have to be contingency rights so good ADP results reward shareholders. All my opinion.
Interesting thoughts. I agree about CVR deals, but it's something that must be considered since the Neurogen/Ligand deal was built around the CVR's and Baker brought in Stephen Davis. I probably wouldn't be willing to hold most CVR deals until closure (and haven't held them in the past), but I would be willing to hold for ADP since there is so much potential value there.
There was the line of thinking that a company wouldn't buy a group post-NDA filing and before formal FDA approval, but Roche just killed this concept with the Intermune deal. Having said this, pirfenidone was already approved in the EU and Canada. Still, FDA approval hasn't yet occurred. I think the NDA filing is essential before a deal is done and I think a Priority Review designation will help a great deal. Any potential deal without CVR's would have to give close to full value to PDP and then a big bonus for ADP, schiz and all of the other potential indications. The struggle for Acadia is that the value will blast through the $50 mark really quickly if this works well in ADP. We already know there are signs of efficacy in schizophrenia and I have little doubt that it will capture significant market share there. Some analysts think schizophrenia is tapped out, but current meds are less than ideal and most doctors and patients would prefer a combo of Pimavanserin and risperidone (or another atypical) if it could offer equal/improved efficacy at a much lower dose (to avoid the nasty side effects of atypicals).
Could $50 get it done today? That's just shy of $5 billion. Intermune just got $8.3B and Acadia's Pimavanserin has way more potential than perfinidone. But that's just it...potential. We have the PDP market locked up most likely....if we lock up ADP the value will blast through $50 quickly. I could see $50 happening with a CVR for ADP. ADP is just too large to not get some reward for it.
I'm very happy to see Cramer finally touting ACAD...it's about time. The pronunciation was classic...I think it just proves that the upside is simply tremendous. Most groups still don't even know the name of Pimavanserin and the stock is going to continue way up as that changes.
My guess is that he will be on the show at some point. Uli is pretty low profile, but he does tell the pimavanserin story extremely well. Frankly, no one ever believed in Pimavanserin as much as Uli (at least outwardly). He has done one heck of a great job.
Six months ago Acadia completed an offering at the $28.50 level and raised a bit over $180 million. What has changed since then? First, we're much closer to the NDA filing and no red flags have emerged. Second, the Alzheimer's study has continued to evolve. Third, we now have a breakthrough therapy designation which exponentially increases the odds that we will also get a priority review within 60 days of the NDA filing. That's a lot of added value and we still have the opportunity to buy at the price institutions paid six months ago.
The next big milestones are definitely the NDA filing, NDA acceptance and Priority Review Designation. I won't speculate beyond that, but it's my opinion that approval for PDP is highly likely and maybe much quicker than we originally speculated due to the breakthrough therapy designation. I don't know where the share price will be, but it should be much higher than today and the Alzheimer's data knocking on the door will bring excitement/speculation to a new high. The funny thing is that Pimavanserin doesn't really get the love it deserves as an off-label drug that psychiatrists and neurologists will try for many other conditions. It reminds me when drugs like gabapentin and provigil were approved for narrow indications, but had absolute booms in sales due to off-label indications. Maybe with time Acadia will expand the label to many indications, but it's just a fact that CNS rarely sees new medications. The indication that gets very little attention is schizophrenia, but if Pima can really be given alongside a very low dose of risperidone with equal efficacy to normal dose risperidone it's a huge breakthrough for patients. The side effects of atypicals can really be terrible. Very exciting asset for sure.
Finally, we never give love to the pipeline but Acadia will likely have another winner at some point.
All my opinion so please do your own DD. Looking good here fellow longs. Btw, I added.