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If you need more color on this check out "Naked short selling controversy" via https://en.wikipedia.org/wiki/Overstock.com
Big surprise who was ready to pay big "compensations".
On a more positive note: I had enough time to a) buy shares at idiotic price levels and b) I have enough time to let the revenue increases and gross margins do their job.
Meanwhile I stick with Warren B.: "the more shorts the better." -
Quiz: what is the percentage of companies with 2 breakthrough designations which have been taken over by big pharma?
Hint: the answer has three digits.
Check out: https://seekingalpha.com/article/4314267-real-value-of-breakthrough-therapy-designation
("Takeover offers for a company with 2 breakthrough therapy designations increase significantly and quickly...
All the companies with 2 or more BTDs were gobbled up by big pharma. This list essentially represents low hanging fruit for a Big Pharma acquisition. Any company with 2 or more BTDs would be in the hot zone for acquisition.")
Everyone: please check out https://nakedshortreport.com/how-to-detect-short-trades and do not hurt yourselves nodding.
$CTSO Prof. Ince on CYCOV-study / Dr. Supady: "Comparing apples to peanuts. Really poor study. Unbelieveable it got accepted. If you don't understand what's going on with your patient you're doing witch doctor medicine... you should be trying something else..." :)
The show starts at 29:40 -
10-K says:
"ExThera Medical Corporation is a privately held company that has developed its Seraph™ (Selective Removal by Apheresis) platform that consists of heparin coated, solid polyurethane beads. Heparin has the ability to bind some, but not all viruses, bacteria, toxins and cytokines. In in vitro studies using 1 mL of human septic blood, there was no statistically different change in IL-6 or Interferon-gamma compared to control, but effected a ~50% reduction in TNF-alpha. This inability to remove a broad range of cytokines will likely limit its efficacy as a treatment in sepsis. It has repositioned Seraph™ as a pathogen removal technology, and has completed a 15 patient CE Mark registration trial in Germany evaluating the safety and efficacy of bacterial removal from blood. It received EU CE-Mark approval in July 2019, and established distribution in Germany, Italy and Benelux. In addition, in 2013, it partnered with BioBridge Global to apply its technology to pathogen reduction in transfused blood products. In 2020, Seraph received FDA Emergency Use Authorization for use in adult critically ill COVID-19 patients to reduce pathogens and inflammatory mediators from the bloodstream. Seraph was recently designated by FDA for inclusion into the Expedited Access Pathway (EAP) Program for the specific application of removing drug resistant pathogens from whole blood.
We believe our CytoSorb cartridge has significant competitive, technological, and/or economic advantages over systems by these other companies."
Two quotes from this study:
1.
"Statistical Analysis
To investigate the impact of HA on the outcome, we used inverse probability of treatment weighting (IPTW) in order to achieve balanced distributions of baseline characteristics
in both treatment groups, and to minimize confounding by indication."
2.
"The duration of hospital stay was significantly
longer in the HA group than in the control group (HA vs. control: 15.2 (11.8 to 19.6) vs. 9.0 (7.1 to 11.3) days"
Sorry, but to claim that HA was the reason that patients had to stay 6.2 days longer in the hospital in comparison to a balance Non-HA patient group is at best a bad joke.
They cleary messed up the IPTW.
Maybe some other remarks:
1.
I noticed that Renal Disease metrics for the HA-Group was significantly higher than in the Control-Group (32.5 % vs 14.4 %) – especially in context of the postoperative renal failure comparison (HA 13.2 % vs 20.0 % in Control) – this seems quite noticeable – do you agree?
2.
Concerning: „Markedly, more patients in the HA group required norepinephrine (HA vs. Control: 88.4 vs. 52.8 %; p = 0.001" – for me we have a highly unbalanced comparison here - way off to be normalized or balanced.
Just my 2 cents.
Maybe you should check the dilution of CTSO. From 2015 to today we are talking about ca. 61 %. Without this dilution the current price would be at around 14,50 USD.
I guess you should look at the bright side realizing that CTSO is debt free with 71 Mio USD cash at hand, ready to pay a new production line and all studies they need - unfortunately this was no "free lunch".
Keeping my fingers crossed and looking closely that the dilution will now come to a stop or at least return to very modest levels.
Most important clinic in Europe in matters of heart transplantations: "We consider Cytosorb as ultima ratio for severe sepsis."
That was me. Poor guy from Germany collecting some more shares. Unfortunately with no insider news.
If you read carefully you should realize that Cytosorb is way more effective than Tocilizumab:
https://literature.cytosorb-therapy.com/infoitem/extracorporeal-cytokine-removal-in-severe-car-t-cell-associated-cytokine-release-syndrome-2?lang=en
Willing to bet 5 USD that this patient would be still alive if they had used the adsorber instead of Tocilizumab early on.
Not so sure about the "short sellers are a necessary ingredient in the stock market" part.
1. Over the years CTSO has received around 30 million USD in grants - as I assume mostly tax payers money.
2. Hence, we assume CTSO is grants-worthy - working for a good cause, changing medicine and saving many, many lives.
3. Stock prices should be as fair as possible - and in my opinion it is fully sufficient to have the option to be either long or flat to derive absolutely fair prices.
4. Short sellers tend to put enormous pressure on cashflow negative companies such as CTSO - who in the crucial and forming years have practically no other choice than to invest heavily in R & D.
5. In the context of a grants-tax-payer-money worthy company like CTSO in my opinion it would make perfect sense to politically not allow or ban short selling immediately.
Murph, let me quote Dr. Geidel and his Powerpoint-Presentation from last week shown during the Webinar:
"The adsorber method has become our standard procedure in pts. loaded with Ticagrelor or Rivaroxaban."
Should I ever meet this guy and his colleagues who had the idea to use Cytosorb in the blood thinner context I will not know how to thank them adequately.
It feels like everybody is off the point here. If I may... in my view this is the context and the bigger picture:
1. WHY THE ADSORBER IS A GIFT FOR PATIENTS, SURGEONS AND CLINICS?
The guys from the Asklepios clinics in Germany LOVE the adsorber because of two reasons:
1. it DRASTICALLY improves patient safety
2. it substantially improves the overall throughput times of patients
Throughput times are critical in Europe in terms of profit numbers.
Background: each indication / treatment is reimbursed with a fixed amount called "Fallpauschale" in Germany (flat rate or lump compensation). If you are interested in profits, and Asklepios is quite "famous" for that and aim for ROIs of 12 - 15 %, it is crucial for them to get rid off the patients asap and not lose any time with complications.
I do not know about the US but to my knowledge this should apply to more or less all clinics in Europe: you only make serious money if you keep complications to a minimum and improve throughput times as much as you can.
2. WHY ARE THESE BLOOD THINNERS ABSOLUTE BLOCKBUSTERS FOR ASTRAZENECA AND BAYER?
By far most people around the world tend to mess up their arteries by just eating meat and consuming dairy products (please check out the documentary Game Changers -
Advice to shorties:
1. Check out the Ticagrelor webinar of today.
2. Find out that the adsorber works just as well for Xarelto.
3. Find out that Xarelto is revenuewise huge for BAYER.
4. Realize that cardiac surgeons will LOVE the adsorber.
5. Realize that the adsorber will become SOC in no time.
6. Realize that the revenue in the blood-thinner context alone can easily amount to 500 mio USD per year in a rather short time frame.
7. Realize that just this one indication would justify a CTSO stock price of 100 USD.
8. Run and cover your ass.
Okay. Let's have a look at the direct sales in Germany.
2017 - 7.9 Mio USD
2018 - 11.8 Mio USD (plus 49 % vs 2017)
2019 - 14.4 Mio USD (plus 22 % vs 2018)
I guess 1 mio can historically be attributed to Bad Oeyenhausen (early and heavy cardiac surgery "user clinic").
At the current stage without black swan treatments a clinic with a proper ICU should typically have a demand of 200 - 400 k per year - let's say on average 300k p.a.
2017 - 6.9 / 0.3 = 23 hospitals
2018 - 10.8 / 0.3 = 36 hospitals
2019 - 13.4 / 0.3 = 45 hospitals
Although this is just speculation or let's say an educated guess: most of these hospitals should be university clinics - my guess here 30 out of 45 hospitals in 2019. In my humble opinion the next logical step (due to the constraints mentioned in context with the purchasing-groups) was to approach clinic chains such as Helios. And there is some evidence out there that they got the Helios account in Q3/Q4 2019.
As already stated: besides clinic chains, special clinics (Bad Oeyenhausen etc) and universitary clinics it is and will not be easy to even get listed for the more common and smaller hospitals unless the adsorber is considered as "Standard of Care".
Nevermind: all the people I am in contact with personally already consider the adsorber as SOC. :)
Would love to see that happen asap.
From an ethical point of view I guess this should be the time now to consider a take-over, flood the company with cash and immediately build new production facilities.
However and just in case this does not happen: I am fine with smaller steps as well. Maybe because I do not know of any other company that has the potential to grow by 50 % for period of 10 - 15 years at gross margins of 80 %.
Nothing on Corona so far, sorry. And, you're right, it has been a tough ride for all of us especially since August 2018.
I am afraid I got some goose bumps reading Dr. Chans shareholder letter earlier this year. And, yes, I am afraid I am also one of the too many sending funny emails to him now and then. :)
Thanks. I guess we are all here to not miss any of Techxens amazing posts. :)
I was told that the reimbursements are the same everywhere in Germany.
The issue here is that for all non universitary clinics purchases are a lot more bureaucratic and time consuming.
Smaller hospitals will likely not make any purchases on their own. Almost all of them are organized in something like purchasing-groups, which bundles orders. These groups will likely sit down only once a year and can only purchase what is listed in the current product/devices lists. It can take years to get listed there.
My latest news in this context is ca. 1.5 years old. Back then Cytosorb was far from being listed for regular/smaller hospitals.
Until Cytosorb is considered as Standard of Care chances are that in many place they are still not listed.
According to my sources since ca. one year it was raised to 1.200 Euro. Sorry that I can not provide a link.
I am in regular contact with a couple of people who see the adsorber in action on a regular or even daily basis. All of them tell me the adsorber is working and personally would not enter a hospital not having/using the adsorber anymore.
The biggest issue and only concern about the adsorber for actual users: if you use it too late you will rescue people who would be better off dead. So it is key to use it really early - ideally in a stand alone approach, e.g. as soon the blood pressure declines.
Furthermore: 30+ out of 38 university clinics in Germany already use the adsorber. If you dig really deep, you will find that clinic chains such as Helios (owner: Fresenius) are meanwhile using the adsorber. Two weeks ago a cardiac surgeon from a rather well-known cardiac clinic told me that they finally are getting trained on using the adsorber.
Black swans aside: things are progressing here in Germany but apparently it takes time. And while the cash burn rates remain in high regions (1.9 mio USD per month in Q4) shorties will continue to have their fun. Which is by the way fine with me to buy wagonloads of shares. I sort of represent a couple of investors holding well above 400k of shares. :)
One last thing and fun fact: whenever I get in discussions with people demanding RCTs on Cytosorb I ask them if there are any RCTs on the usage of catecholamines because there are not any. The same thing will happen with the adsorber: forget about RCTs - we are at a stage in which ethically you can not longer justify to not use the adsorber in critically ill patients.
To my knowledge the reimbursement per adsorber is 1.200 Euro in Germany.
I am in contact with adsorber users, who are seeing the adsorber in action almost on a daily basis. Apparently you are not.
Watch out: there is some ass slapping ahead, slappie.
Being short can easily turn out to be suicidal here. The latest cash burn rates with only 16 mio USD left in cash might look tempting in going short. But this is a very shortsighted idea.
In case CTSO struggles to organize new loans and does not really want to sell stocks at these prices, there is a good chance that they find a proper partner or agree to some sort of takeover.
With or without RCTs - the adsorber does miracles in context of reducing the need for catecholamines. Everyone should check out the side effects of heavy catecholamine usage. In contrast the adsorber has no negative side effects at all and if used at an early stage might help to completely avoid the usage of these very common drugs.
Fun fact: it is 100% clear that catecholmines save millions of lives every year. No one will really argue about that, however: today and to date there is no RCT on the usage of catecholamines.
The moment CTSO announces that they are in negotiations with any of the big players (Novartis, Fresenius), the stock price should easily jump up to old highs within less than 3 minutes.
Even rumors about a potential takeover would do the trick.
With a sequential sales growth (Q2 -> Q3) of minus 2.1 % and a YOY growth of only 12.3 % - you might argue if CTSO can still be considered a growth story or growth play.
As we all know CTSO is currently reorganizing its sales structure and approach - especially in countries outside of Germany.
So maybe it makes sense to have a closer look at how the sales growth actually turned out in its most mature market: Germany.
2018-Q3: 2.766.922 USD
2019-Q3: 3.445.632 USD
That's a YOY sales growth of 24.5 % and if you exclude the currency impact CTSO has a growth rate of 29.1 % there.
Personally everything above 20 % in sales growth will do to keep me patient and rather happy waiting for the potentially game changing study outcomes.
I guess CTSO is not to blame for the declining Euro. Hence, it makes sense to keep in mind that the sales revenues would have been well above 6 Mio (6.2) - which would have been an even more decent result.
https://www.sciencedirect.com/science/article/pii/S000349751930102X?dgcid=rss_sd_all#
"Conclusions
The intra-operative use of Cytosorb adsorption of Ticagrelor and Rivaroxaban in emergency open-heart operations is reported for the first time. The data show that the strategy is safe and an effective method to reduce bleeding complications. We recommend the use for safety in patients with Ticagrelor or Rivaroxaban undergoing emergency cardiac surgery."
Sorry. Duplicated post.
1. Revenue levels were WAY lower back then
2. "Our" CEO expects operational profitability this year
3. Just check out the last case of the week where a very high IL-6 level of 1.578 ng/l (SEVERE sepsis) was reduced to 58 ng/l within 32 hours by using just one filter
4. First indication and interim results on the REMOVE study look promising according to
First of all I wonder if the new study is actually the old study from 2016 described in here: https://ccforum.biomedcentral.com/articles/10.1186/s13054-016-1270-0
However, some remarks:
1. The filter was only in use during the surgery (in average for a time of ca. 3 hours)
2. The IL-6 levels before the CPB were 0 for both CTSO- and control group
3. Reminder: the filter was only used during CPB
4. Measuring IL-6 levels 24, 48 or 120 hours AFTER the actual filter usage in patients with overall rather lower IL-6 levels does not make too much sense to me overall.
A proper study in my view would have been: select patients after CPB with IL-6 levels indicating more than smaller local infections (typically > 150 ng/l) apply filter usage, react properly on filter clotting if necessary and change filters after max 24h and continue treatment until IL-6 levels are well below let's say 50 ng/l. Measure outcomes each 12 hours and compare them to a non filter control group.
FYI: I am not the expert here - just a private investor. As always it is a good idea to do your own DD.