Holding onto every single share here. SO many possibilities: we have QIDP pending with a decision coming in less than 2 weeks, IP hearing next Friday with possibly a decision in February, partnering, US pivotal study starting, hopefully more revenue coming online from the Middle East. Neutrolin will eventually become the worldwide standard for catheter care. People don't realize the significance of this...it's not just a hemodialysis product.
Sentiment: Strong Buy
My guess is it's a combination of the filing, imminent FDA decisions, and Rob, but probably 80% Rob. People who take Rob's advice are all in ZIOP which is having a big day today, so many of them may be taking profits in ZIOP and rolling it into CRMD.
north of 80% with a cost average of around $0.80-0.90. I think CRMD has probably the most appealing risk/reward ratio of any stock I've ever owned.
Go to clinicaltrials.gov and type in "macrogenics." Look how many failed drugs are listed there: MGAWN1, RAV12, I would also put teplizumab in that category. These guys are well respected for some reason but they've never accomplished anything, all they do is sign deals and collect milestones. Drug fails, move on, sign more deals, collect more milestones. It's like a biotech pyramid scheme.
The collaborations that MGNX has set up are the only thing to like here, but even their collaborators are flying blind. The recent Takeda agreement did not specify targets. Takeda is just interested in exploring the platform further.
Bispecifics are not exactly new. Micromet has been working on this since at least the early 2000s according to their publication record. Has anyone out there seen any data showing that bispecifics can do anything but deplete CD19+ cells? Nope.
Furthermore, while MGNX management brags that they have cash to 2017, look at the completion date for most of their phase 1 studies. 2017. So in 2 years, this company will be out of cash and ready for phase 2...if any of their molecules show activity at all.
Don't be fooled by the string of deals Macrogenics has put together. People are interested in the DART platform, but their interest will soon fade when they start seeing phase 1 safety data.
Sentiment: Strong Sell
I'd say it's easy money. Market overall is at all time highs, MGNX business development guy is willing to let A LOT of shares go at $23-25/share. Any molecules that have a chance of working are phase 1 or pre-clinical. What is going to happen to move the stock up? Nothing, at least not in the next few weeks.
A few questions/comments:
1) QIDP status comes with automatic fast track. So why would you bother applying for fast track and then applying for QIDP separately? Why not just apply for QIDP and then get both from 1 application? There must be a reason, but I don't understand it at this point. Anyone else know?
2) The Neutrolin monitoring program - this is a great idea and I'm glad the data are looking extremely favorable. There's just one problem. Neutrolin is not selling in the EU and it's NOT because people don't believe it works. It's because TauroLock with Heparin is well established, probably around the same price or maybe cheaper, and people have no compelling reason to switch.
3) I plotted cost of sales and net revenue for the last 3 quarters. The lines are at least headed in the right direction. We started with $12k in rev and COS over $81k. Now rev has gone up 4X and COS has dropped to $37k. So while all these numbers are quite small, at least the trend is favorable.
4) 2 analysts on the call from Dawson James and Maxim. As far as I know neither one currently covers the stock. It would be nice to get more coverage as the CRMD story matures.
There have to be companies at least considering buying CRMD at this point. For maybe $100-150M, you get a product which has beyond a shadow of a doubt, been proven to be safe and effective, you have the US market which is completely untapped (no competition) with an easy 1 and done study for approval, then you throw in the wild-card of the EU litigation and a possible $50M in revenue annually if their lawsuit is successful (and additional potential sales in other countries which accept the CE Mark), and it seems like a tremendous deal and a no brainer acquisition.
When there is little doubt that the phase 3 study will be successful, that's when you acquire instead of partner. Why partner at this stage? No risk of failure and you'll just end up paying more post-phase 3.
Let's just hope they deliver their fast track/QIDP Christmas present. I"m not really sure why they bothered to file a separate application for fast track because QIDP comes with automatic fast track status. I must be missing something...
If you want an EPS story, buy Apple or something. Yes, rev sucks but there is a clear reason. It starts with T and ends with Pharm. Lawsuit has been filed.
Anyone mentioning a buyout is nuts. First of all their business development guy just sold over $500k in stock. He would be the one orchestrating the buyout if there was one. Secondly, their only late stage drug is margetuximab which is an undifferentiated asset which has yet to prove itself in the clinic and there are already approved drugs out there that are likely equivalent or possibly superior to margetuximab. No one is going to buy the copmany for margetuximab. Beyond that they have only very early stage stuff. Big pharma does not pay premiums for completely unproven molecules. No one is going to buy an oncology company pre-phase 2. I'm short from $25. These guys are 5 years from even having a mature phase 2 data set from a molecule that is commercially viable. If the market corrects this could easily be a $10 stock.
I'm not so sure now. The guidance says fast track can be applied for at time of IND filing or after. No idea if QIDP follows those same rules. One would think they would want to file for QIDP as soon as possible, but who knows.
Call just scheduled for 9 am EST on Friday 11/14 with numbers after close 11/13.
that was sarcasm in case it wasn't obvious. I'm actually hoping they are waiting to hear from FDA regarding QIDP, and hopefully we get a joint QIDP/Q3 earnings call. QIDP/fast track would be big news worthy of a conference call, even if it's just a dog and pony show
no I think they've having a special Saturday call in order to enhance analyst participation. Their usual "announce the call 48 hrs in advance and schedule it at 6 am for half the country" just isn't cutting it.
CRMD definitely filed paperwork for QIDP or maybe breakthrough when they filed the IND, that's just how it's done. We will hear by 11/21, I suspect much sooner.