So much speculation. Did some fairy hit greatday with a pixie roofie? I wont live long enough to see an $80 stock and neither will greatday. One thing we do agree on now is that I too believe we can see profitability by the end of 2017. Unless CERS mucks up the works with a total messed up roll out of the platelet/ffp market in the USA I don't see how they could not. Note that the funding is for a very long time so don't go crazy thinking CERS will have a red cell product ready for USA market before 2019.Buy under $6 until we get some guidance about second half 2016 revenue.
Over the long term this is fantastic news! This removes a major financial burden that would have had to be financed with equity sales and removes financial risk while letting CERS time to modify/tweak the red cell product.......................an opportunity they no longer have with the potential CE mark submission, that data is in. I have a suspicion that product development was hampered by lack of development funds, This is a Major development over the next few years.
Well hardly anyone uses whole blood anymore since it more efficient and patient effective to split the WB into red cells and plasma. While plasma is transfused per units don't forget platelets are drawn by apheresis in the USA and come in 5-10 unit equivalent doses. So your 1.6M platelets translate into 320-160 thousand platelet transfusion sets for CERS.
Gamma irradiation only prevents white cell engraftment does nothing with pathogen reduction/inactivation so Intercept is the superior product in relation to CMV and other viral/bacterial risks. Gamma irradiation reduces shelf life time while Intercept does not.
Interstate has nothing to do with PI, screened/tested units are already transported nation wide. PI treated platelets are only licensed for 5 days but CERS has applied (I believe) for a 7 day outdate which is a nice plus.
No patient regardless of platelet need should be subjected to transfusion transmitted sepsis or disease transmission. If you need platelets they should be PI.
If you believe CERS can not "break-even" with 100% of the USA platelet market I don't understand your analysis? If you are basing your investment on RBC approval alone.......... you are in a very, very risky gamble. I don't gamble...... I invest. Buy below $6.
No one really gets excited anymore about those "future" revenue possibilities. CERS has never been able to penetrate 25% in any market worldwide, EU wide, or USA wide yet. Even though it seems highly likely they should be able to penetrate at least 100% of the USA platelet market I'm hoping they should be able to get 25% by mid 2017. There is no positive movement in the EU with platelets but we could at least see an approval in Canada which might be positive to the 2017 bottom line. Extremely slow implementation is a CERS trademark so don't expect to see a big revenue jump in late 2016. As far as RBCs go its only a pipe dream at this point so I would not even go there with the revenue picture. Accumulate now under $6 for a possible double by late 2017
Transfusion transmitted sepsis is deadly..................................yes that is a fact and accurately stated. A fact no one's child or loved one should be at risk for. The solution is simple, cost effective , and well the right thing to do.
It is amazing to me that the USA has been so negligent in regards to platelet transmitted sepsis for so long. The technology with Intercept and other methods of PI has been out there for years but the FDA has kowtowed to the "testing is sufficient" segment of the blood industry. Money still is the major factor when it comes to healthcare.
Your facts are edited with bias. I'm so very long CERS but when you do this you sound a little like the guy here telling people that Intercept is killing people! You don't have to bend the truth to know CERS will become a 600 pound gorilla in the platelet/plasma market and when/if they can get a RBC product that does not cause an antibody response they will DOMINATE a world wide RBC market. BUT........ to your headline. CERS does not have 100% penetration in the French platelet/plasma market not even close, and the "no longer testing" only applies to that minority market FOR ONLY platelets/plasma not RBCs. True we have the USA contracts but we can only hope implementation will take no longer than 4th QTR 2016 so we can see some revenue by 2017. Just go back to your Switzerland and take a look at how exceeding long it took from contract to implementation............ CERS is not a can do company, they will succeed but it will take much longer than reasonable expectations. They are pretty slow in implementation but this is only partially their fault, blood centers are not models of efficiency and they tend to be very cautious (rightly so) when they change long established procedures/protocols. If things are so great in EU why did CERS dump their general manager in the EU? The RBC triple dose is not a sure thing, will not be submitted for approval until late 2016, will not be possibly approved until late 2017, will not be implemented until who knows when? Could a major pandemic change all of this.....................yes. You don't invest on remote possibilities you invest on highest probabilities. Buy below $6 with a 2018 horizon. IMHO
You fail to mention that they have $20M debt outstanding, so its not 100, it is 80. Second you don't sell stock when you have only 2 quarters of operating funds, or the market is in the tank. Its smart and prudent to float stock when you have at least a year of operating cash.
My best speculation for this deep drop is that CERS is in the process of an equity financing. Every time CERS does a stock sale it is done at a deep discount to market, so from the pps weeks prior to the CC I would not be terribly surprised to see that done in the low $5 range. This would explain the present drop, otherwise this could be more ominous. CERS history is one of unexpected delays, regulatory non approvals, and poor market penetrations. All these negatives do not diminish a very bright future............we will just need to push back the future a little longer. Buy under $6.
Agree on it being oversold but I fail to find anything that would move up until the next CC. Look at this as an opportunity to buy more.
I guess you don't believe the last CC? The comments about the RBC submission? Patience grasshopper. CERS has had a CE Mark for platelets since 2002. This is perfect storm time for CERS............even a broken clock gets the time right twice a day...............they cant screw this up. They have the FDA approval, the contracts, and Aedes aegypti. Think late 2017-early 2018. Buy below $6.
BLA submissions/ approvals for the blood suppliers will severely constrain US revenue so don't look for any dramatic revenue upside this year, for instance ARC has told CERS it will slowly roll out its BLAs for each of its centers during the 2nd half of 2016. So as I said in an earlier post we should keep our panties from bunching until 1st QTR 2017.
Interesting to note that the FDA is being its usual jackass self and making CERS get approval for not only each platelet type (in plasma, in solution, etc) but for each platform by which those platelets are drawn!!!!!!
Did not realize that only the AMICUS platform has been FDA approved in USA and I cant remember the percentage that translates to in US but it might only be 50% of the platelet pheresis!!!!! This will also depress potential revenue.
EU sales are flat to softening and CERS sees this for all of 2016. WHY???? This is not just a currency issue but an actual stall or slip. I do not know what is going on there. Any one know? CERS management gave not one reason and basically avoided the question by saying they are focusing all their energies in US rollout. This is troublesome.
EMA red cell submission being thought over carefully and hope to submit in 2nd half 2016. This is code for 4th QTR 2016.With at least a 6 month minimum review process it would be late 2017 approval and a possible 2018 rollout. Using history as guide it will take CERS into 2019 to get any meaningful revenue.
Again I predict a pps double in late 2017 and a triple in 2018 even with 20-30M more shares. Patience is a virtue. Like I said before these management clowns (all except the science guys) will succeed despite themselves.
(Thus they were taking a longer term view. I suggest that the rest of us do the same.)
Well if you read any of my posts you know I've been saying this for many years. I've followed CERS longer than anyone here and have learned that it will take CERS longer to implement single ply toilet tissue in the executive restroom, twice as long as any normal corporation. The thing you need to have is a long horizon from here, think mid 2017 before any major shift in revenue. Realistically we should see a double in earnings by 1st QTR 2018. Remember bottom line these guys will succeed despite themselves..... the product is needed to make the blood supply safe and they have a few years lead over the competition. Yes there is another company out there with a plasma/platelet PI system with CE Mark approval.
Prepare your selves for a little sticker shock because with only $90M minus $20M in outstanding debt burning around $20M per QTR CERS is going to sell stock this year......maybe by June is my guess but before the OCT-DEC period. If history is any guide that stock sale will come at a 25% discount to the pps at the time of sale. I think you are still safe buying below $6 but don't be surprised to wake up one morning to find that CERS has sold 20M shares for $5.50.
My advice for what its worth is do not count any of the RBC potential revenues into your projections, No one really knows how this will play out at this time, what restrictions will be placed on potential approval, what the acceptance of a restricted indication product will be, or how the presence of the Zika virus will shift the medical risk reward equilibrium with blood products. I still see a stock that could double or triple from here by 2018 on platelets/FFP.
Another positive news release, how many is that in a row? Amazing. Canada and UK, come on get off your A###s and approve! Again if it drops below 6 buy. We are the King Kong of PI platelet and ffp. lol
Just read the CFR - Code of Federal Regulations Title 21 or 7342.001 - Inspection of Licensed and Unlicensed Blood Banks, Brokers, Reference Laboratories, and Contractors. I have personally spoken with FDA inspectors over the years, attended seminars of the AABB, etc, where the FDA has presented. "broad label" does not exist. The one valid point you have is the EMA and the FDA do not always see things the same way. I'm not very familiar with the EMA regulations and am assuming they are close to the FDA ones in respect to blood products.
(Have you ever heard of "broad label" usage?)
Why then is there a chronic transfusion clinical trial being conducted at all? Don't forget those antibodies encountered in the first Intercept RBC P3 were only in patients receiving repeated transfusions over a period of time. Blood is a life sustaining biologic and not a drug and "broad label" doesn't fly. That's why platelets in plasma was a really big deal........you can't take a platelet in solution and call it a platelet in plasma. There is no "broad label" with blood products. I know this for a fact! The FDA told me so.
( First of all, Cerus' Chief Medical Officer Richard Benjamin, MD PhD is one of the world's foremost experts on blood safety, so I am highly confident in Cerus' medical leadership!)
We are in agreement here, he is a definite upgrade to present and past CERS management.
(Based on my research too, it appears that a very high percentage of Red Blood Cell units are transfused in acute (short-term) settings like surgery! Confirmed with a couple doc friends of mine (it's a high number folks), etc.)
Well elective cardiac surgeries use very little blood and for very short periods with little follow up use after surgery and CERS picked this class for a reason. Little antigen exposure and short time antigen presentation.
The only highly transfused acute surgeries usual require long term transfusion support, you don't go from the ER to the OR to the SCU and stop bleeding post op. Trauma patients easily fall into the chronic group and it will be interesting and very important how the CE Mark is worded if the submission is accepted at all without chronic transfusion data. This is my opinion.
How is the thesis flawed? 100% inaccurate? Really? You know for a fact? Well give me some facts and I will gladly thank you for the enlightenment.
“While Cerus certainly faced some early challenges in the development of its RBC system, the company has made meaningful progress in recent years with both a U.S. Phase 2 recovery and lifespan study and a European Phase 3 clinical trial for acute anemia patients hitting their respective primary endpoints,” she added.
The important part is " Phase 3 clinical trial for acute anemia patients hitting their respective primary endpoints". The stress on the acute and not the chronic part. The acute part is not the $2B market you mention. Together the chronic and acute market together maybe $2B, but the acute market is very small and I don't think hospitals will stock Acute PI RBCs because the C/T ratios will lead to a huge outdate problem. A better question to ask would be when will CERS release the chronic anemia data? The USA P2 results are meaningless.........they have already proved similar results in multiple other studies. PI Intercept RBCs need the chronic approval to become the SOC. Again let me say I find CERS to be a buy anywhere under $6 because the PLT/FFP market should be worth $10-$20 alone in a few years.
One win after another.................a truly impressive string! So why are we still at $6 and not $10? That's because only Benjamin is a winner................ the rest of CERS management is more like clown circus................they will succeed (I believe) but it will take longer and be more tortured then we expect. Wall Street knows this, the analysts know better than to jump in until the money is in the bank, and the major owners here are covered with their shorts and can play the game short term and long term. I will still buy more anytime the stock falls below $6. I am keeping everything crossed for a positive CC and not more of " we are projecting revenues in line with last year". I only got so many years left and I would like to purchase my first Mercedes with cash.