is waiting for the inflection point
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Nice. My DD has been focused on the technology and trial. Looks like I need to branch out a bit. I didn't see anything mentioned about it in the Q1 call. Is there a good summary of the situation somewhere online?
That will require a team of lawyers which means a boatload of money. I don't see much happening with that until they get some cash from a partnership or at least sales ramp up. But again, I am new here, so if you have any info on them already taking action please share.
I am personally not expecting much. It has been pretty apparent that all their resources have been focused on getting through the interim analysis. In their Q1 call they pretty much stated that their product is superior to what is available in the EU, but without strong clinical study data to support it, it doesn't sound like they ere expecting to gain much traction. Data and FDA approval would be the traction to expand in those markets.
"I have been asked several times about our business in Europe and the Middle East and why our Neutrolin sales are insignificant. Let me answer this question. The European, Middle East markets are different from the U.S. market. There are several alternatives for catheter lock solutions on the Europe, Middle East markets, the majority of which are citrate-based with a variety of concentrations and sold at very low prices.
The citrate concentrations that are used in this market in our opinion do not have the anti-microbial firepower to significantly prevent CRBSI. There seems to be little to no robust data that is randomized, double blind control trials that show the efficacy and safety of these citrate catheter solutions.
In order to penetrate this market, we will need to thrive competitively and have compelling clinical data for Neutrolin."
I guess my point is that this was never a case of a multi dollar stock that drifted to penny land. Instead it is a story of a penny stock that experienced slow and steady growth and only did a reverse split to uplist to Nasdaq.
Well, At one point it briefly traded around 50 cents. Most longs, like myself would be averaged in the 16- 20 cent range and even investors as recent as a year ago are looking at close to a 200% increase.
Now listed on the Russell 2000 and 3000 index, expanding production capacity, etc.
It is still a smoldering fire. However, there are many potential catalist to turn it to a conflagration. CAR T, liver disease treatment with bilirubin removal, rhabdo treatment and removal of plasma free hemoglobin in cardiac surgery.
Re: Meeting Tuesday. Last week I spoke with Dan at CRMD's IR company. Pretty much every question I asked spun back to the fact the data had not been unblinded yet so that the company really cannot choose a direction to go until they get the details of the results. However he did reiterate a number of times that I should listen to the call on Tuesday. With so many unknowns at this point, why so much encouragement to listen to the call unless there IS some new good news going to be released, right?
BTW, unlike what I have read about this company CTSO has been more financially conservative. A few other things to note. They have partnered with Fresenius, Dr Carl June, pioneer of CAR T Cell therapy, is on their medical advisory board and from the start of the company Dr Richard Bartlett, pioneer of ECMO, has been their CMO.
I will admit that I am a recent CRMD investor and don't know much about the CELG JUNO merger, but the talk of CELG acquisitions here has me thinking about my much larger biotech investment. One of the biggest issues companies with CAR T-Cell treatment, like JUNO, is CRS, Cytokine Release Syndrome. It is similar to sepsis where the body's own immune system goes into overdrive and ends up attacking it's own organs. With CRS it can be countered with steroid, but that can actually kill the effectiveness of the cancer therapy, something that you don't want with a treatment that may cost North of $500K. CTSO has an EU approved Cytokine filter that has been used safely in over 47,000 human treatments. At $1000 a treatment it seems like a no brainer as a rescue therapy for CRS from CAR T. I don't think CTSO is looking to sell until their pipeline matures, but they also look like a good target for CELG. Or they could become a company the size of CELG 5-10 years down the road.
I actually learned of CRMD from the CTSO board.
To the admins, if you run a strict board about talking about other companies, feel free to delete my post. I am just trying to share because CRMD would never have been on my radar without the post on the CTSO board. Up over 100% in 5 months is a great thing!
I don't think the meeting Tuesday will reveal too much significant new info, but I too am locked and loaded. 30k shares for now.
When I spoke to IR yesterday afternoon I asked questions on each of these items. He did not have any info on the CRO and on the other items he simply said there are a lot of unknowns and the company needs to see the unblinded data before making decisions and moving foward.
Go ahead and give Dan a call if you want to confirm. He said he has been fielding tons of calls on CorMedix.
What type of substantial info are you expecting? I think the company is going to have to see the data before they can decide the next steps.
Data has not been unblinded so the company doesn't even know the detailed result yet.
I think they have to draw down some additional funds from Bridge Bank before we have to worry about another success fee and it will be calculated based on the share price at the time they get the additional funds, if the ever do. Check the filings on Edgars for the details.
Fantastic! We have not heard much mention of tender orders recently, but coincidentally I happened to include it yesterday in my list of events that will move the company forward within the next 5 years.
Sorry about a 6/7 duplicate. Had to get the meowing cat out of my 5 year olds room so he would not wake him up and lost my train of thought.
Ok, so what should be different about the company in 5 years from now? Here are a few things that come to mind, but I am probably still missing some things.
1. RECESS 2 study complete and likely successful because of the experience from RECESS 1, IIT in the EU and Cytosorb Registry data collected prior to trial start.
2. Germany Endocarditis study complete.
3. Hemodefend study complete and hopefully a partner with licensing agreement in place and the partner has commercialized the product.
4. US sepsis trial in full swing and likely close to fully populated.
5. International Cytosorb Registry fully enrolled with 3000 cases for treatment of many different issues and data available to clinicians.
6. Advancement of the Potassium filter in the pipeline.
7. Advancement of potassium filter.
8. 5 years of partners ramping up marketing in sales. Remember
Dr. Chan has stated that Germany is about 3 years ahead of the other countries as far as marketing and sales, so where should these other 50+ countries be in 5 years.
9. Tender orders?
10. Sales in Canada and other countries that use the FDA clearance for their standard for approval.
11. 50+ investigator initiated trial, most of which should be completed within 5 years.
12. Likely start, if not completion of an addition US study for Bilirubin removal.
13. Likely start, if not completion of an additional US study for Myoglobin removal.
900M Market cap in 5 years? Yes, I would not be happy with that. It is less than a triple from here. 900M in annual sales, yes, that would work for me. Yet it doesn't sound like they believe production capacity needs to be near that level in this timeframe, so perhaps your expectations are more realistic. If that is where we are in 5 years, which I doubt, I am not taking it to the bank, I am holding out. Of course I will pick up some new trading shares along the way for my side bets and may dabble with the options market a bit.
I thought we made our peace eskay. Where is the love? LOL.
Not Bertha, but in my opinion an FDA approval obviously would greatly increase the value of the company, so why would they even consider letting another company buy them out early on the cheap? BTW, they do have a poison pill provision to thwart a hostile take over from a deep pocket Pharma.
My concern is that if they are only doing 80M is sales 3-5 years from now they will not be able to get nearly what those products are worth. All three areas will be multi-Billion dollar markets eventually, in my opinion. So selling out for each area should not be for less than multiple billions. If the combined sales for all three are south of 100M at the time, I don't think they could get close to that valuation.
Don't get me wrong, I am still a Cytosorb beleiver. I did sell my trading shares recently, but I will not sell a single long share until we hit a multi billion market cap or get bought out. When I hear inflection point I don't think a steady 18% quarterly growth for 5 years. I am patient, but I am growing weary. To put things in perspective, I was pushing my 2 year old son in a stroller on the St Petersburg pier when news of the CE approval hit my phone. This Friday he starts 4th grade. Frustrating!
900M in 5 years would make you happy? Meanwhile drug companies hemeraging cash are valued in the multi billions. What am I missing? Is the paradigm shift from a device being used instead of a drug just not clicking with the investment world or are there big bios/pharmas working to keep this company down? Everything I hear is positive, so why no love? Is there something toxic keeping the institutional investors out. I just don't get it.
Another stock that was talked about here and on the CTSO Yahoo board a few years ago is SRPT. I have not followed them in a few years, but I just checked them out. I'm not sure about their pipeline, but if I recall correctly their FDA approved product is for a smallish MD patient population. I was shocked to see their market cap over 7 BILLION. EPS? -0.86. Everything I hear on the CTSO Q calls is positive. What are they doing wrong to still be valued where they are?
Tech, as always, great detailed info. I agree it is a great Q report, like all the others before, excluding the sales force reorganization one. I think most retail investors have been expecting a big partner to ramp up at some time and see Q sales increase larger than 15-20%. That has not happened yet. I get that we have no large scale studies for the sales forces can point to, so we are hoping FDA approval will get us that exponential sales increase. So that is supposed to be about 2.5 years out.
Dr. Chan said "I think that the new facility at full capacity is expected to be able to produce roughly $80 million in sales, product sales. And so I think that we fully expect to get there in the next several years, I think, next three to five years."
Enter 5.2 x 1.18 in your calculator. You have to hit equals 16 time to get close to 80. 15 quarters, 4 years. So they are expecting around 18% quarter over quarter sales increase even with a possible FDA approval around 2.5 years down the road? It would make sense if they could not sell anything until FDA approval, but 2.5 years down the road they should have a large established sales infrastructure in 50+ other countries already.
Yes, after a decade following the company, that statement and number frustrates me.
Plus, after the the success fee was triggered, did the price hover around the $8 level? Nope, it went up almost 50%. Hmmm. Seems fishy to me.
You don't think management ever suppressed the share price? There was a wall at $8 for a long long time. There was also a success fee triggered at the $8 level. Hmm, what was the average sale price of the most recently report ATM sales. I'm pretty sure it was $7.97. If it walks like a duck and quacks like a duck, it probably isn't a chicken.
We have had hope's of that exponential increase in sales, but 80M in 3-5 years is a steady 20% Q over Q growth.
20% is good. However, I said this 4-5 years ago, but I think Fresenius may be the manipulator. They tried to develop a Cytokine filter and failed. They have deep pockets, transitioning or not, but how many years have we supposedly been partners, 4 years? Where are the sales? Brushing it off as their merger distraction is BS. They are setting up for a buyout on first FDA approval, IMHO..
I'm pretty sure that Trump thing came up as a question at the Q1 call. Look up the transcript. This rollercoaster is really frustrating, to say the least. There is no doubt in my mind that Cytosorb will be successful, but the company seeming to not care about the share price is maddening. The lower share price means higher dilution when a capital raise comes... I said it many times before and I still think the company kept the price under $8 deliberately by using the ATM. We are still up 50% from that level at least.
The thing that bothers me the most is the manufacturing capacity. Correct me if I am wrong, but did I hear that 80M capacity should cover them 3-5 years? I hope I heard that wrong, because that works out to 20% Q over Q growth, which would be great for most companies, but if you are seriously expecting an FDA approval in 2 years, that makes no sense.
Come on guys, conservative optimism is one thing, but but if you really believe you have a paradigm shifting medical treatment, which I think they do, the WORLD needs to know.
Now 12.22 after hours at least.
Frustrating! : (
Expand age limitations and to include other types of cardiac surgery with extended time on the bypass pump or requiring excessive suction leading to higher levels of hemolysis.
But that is just my guess based on following the company for a decade, using my ability to listen to conference calls, reading clinical trials dot gov, reading case studies and having some basic deductive reasoning skills
Someone with a higher IQ might have a better idea what is going on though.
Trade at 14.20!
Is that a total of 29 sites expected for refresh 2? Isn't that a lot more than previously planned?
After hours action in the mid 13's.
5.2 is sales
Wish it was that easy. Germany probably has sales in 1000's of units and I am pretty sure $1000 is the current list price. The new countries and even some older ones, the sales might be 0-100 units.
I may not have a big IQ like some on this board, but if I was in a stock that went up 120% in 3 trading days I might take some profit. Heck, I might even sell half my shares taking back my initial investment, realizing a smaller profit, but still have what are essentially free shares in the penny stock. I'm sure someone with a higher IQ would have a much better plan though.
All your eggs in one basket?
Have a great weekend.
The shelf registration was housekeeping.
The reason I brought up the other company on this board is that I was hoping the person who mentioned it here back in February might speak up. Anyway, at least a few on here got to take advantage of the good news. If Mike cashed out today he made a solid $7500 in 24 hours on an $18,000 investment. Now that is a good day!
This stock has been a roller coaster for years. You can't sweat the short term fluctuations that are based on no new material information. We are at a new base, up 50% from the $8 level we were stuck at for a long time. Barring a surprise downturn in Q2 sales, which I think is very unlikely, we are in very good shape. Hopefully, reaching profitability and having funds for the cardiac trial will move us up to the next level soon. I still don't know that I would mess with buying call options right now though.