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Yes, of course you’re right CN. How silly of me to overlook the qualifying terms of those multiple previous statements. By the way, I hear Cryoport is hiring. With your astute wordsmithing skills, you have great potential to fit right in.
In all fairness to Cryoport, this is probably the best way for them to have a stock offering. I’m just not sure why they couldn’t come out and say that this is what they were looking at when they met with Jefferies in April. They had to give that ridiculous song and dance about the rumors not being true and don’t anticipate them coming true. But guess what? Then they actually do come true. . . hmmmm, and only a few months later. Rather dubious in my opinion.
And hey, look at that, they're also diluting . . . and they sure seemed to time this incredibly well with the positive news out today . . . almost as if they had advanced notice or something.
Of course, please disregard Shelton's previous statements regarding this subject since this management has NO credibility in my opinion. As a reminder:
Q4 conference call in March: (enough cash for the year)
Nathan Cusick
Okay, cool and then with the current my fleet expansion do you guys in both European convergence and East Coast center do you expect your cash on hand to be sufficient for this are you looking for possibly like debt markets are possible secondary offerings to deal with this construction and further build-out.
Jerrell Shelton
Well, we will approach the financing as we go along. We have enough cash now to fulfill our plan for this year. So that's not on the table and we'll look at things as we move along, but we have nothing planned at this time.
Q1 conference call in May: (comfortable with cash position . . . no plans for capital raise)
Jason Seidl (Cowen)
Okay, perfect. And I think, you sort of alluded to it before, but it seems like at least on a balance sheet perspective, you guys are pretty comfortable with your cash position. No need to raise from your fund. I just want to know, if you wanted to comment on that because there had been at times your stocks moved around and we heard rumors in the market because people talking [indiscernible] cash, so I am just curious of your official statement on your balance sheet is.
Jerrell Shelton
I mean, I think, some of those rumors in the market came as a result of what I mentioned and at the end of my comments where we do – we are in the market building out our relationships in the marketplace with institutional investors and others because a lot of folks simply haven’t heard of us and we run into them every day. We are not a large company. We haven’t been around all that long and a lot of people haven’t heard of us. So we do spend time. So there is rumors got started, they were, obviously they didn’t come true and we don’t anticipate them coming true. We are at comfortable cash position right now fortunately and so we don’t have any plans immediately to raise capital on any basis right now other than there will be some warrants that will come in over this year because they will expire and so we will get some money from that. But some investment from that but we don’t have any plans for today for a capital raise.
UNBELIEVABLE!
SOS reiterating his buy recommendation
https://smithonstocks.com/antares-investment-story-has-shifted-from-pipeline-promise-to-commercial-potential-atrs-3-74-buy/
But CB, then you'd have to change your name! Hindsight is 20/20, but I think it’s far too early to give up on CYRX. Slow and steady growth is not a bad thing, plus diversification is usually wise.
I though ATRS might not break out until next month but the news flow has been quite positive lately, and the volume indicates accumulation, so $4 is easily possible by the PDUFA date, and likely higher if it receives approval. I would expect a pullback and some volatility until the new revenues stabilize at some point though.
Hi all. Hmmm, I see some familiar names here. Big news today after a very long wait. Looks like this one is under accumulation. Unfortunately, I only had about half of the position I wanted before the Pfizer announcement. I didn’t want to chase it, but now I have FOMO as I think it may keep funning into the PDUFA.
I think Larry Smith read your post “Most if not all analysts have called for 20 million” and decided to raise his projections!
I thought this would be a year of solid growth with revenues ramping toward the end of the year with BP outsourcing, and a number of new approvals to increase the ramp into 2019, but my expectations have been lowered considerably. A year ago, I invested more heavily into CYRX than BLFS because I think it has greater upside potential. At this point though, the potential may be a little further out, and it’s always been more difficult to quantify Cryoport’s software angle with the information management provides. I believe even at the current price, CYRX is still trading at a premium due to the take-out possibility, and new institutional support. I expected a drop after the Q2 earnings report and think we may drift a bit further by the end of the quarter window dressing unless some good news occurs.
I think this question from Sean Hannan with Needham gets to the heart of the issue . . . when are the damn revenues you promised us finally coming?
Sean Hannan
. . . can you give us an update here that might be a little more specific in terms of how you are modifying your expectations of timeline, say, for Gilead or Novartis with those specific therapies to hit those targeted $8 million to $10 million in revenues . . .?
Jerrell Shelton
Yeah. Sean, I'm going to make a few comments and I'm going to turn it over to Mark Sawicki to give you a more detailed answer to your questions. But I'm going to start off saying first of all, we are dealing with revolutionary therapies. These therapies had never before been done and these companies are taking great care to make sure that those points of care are qualified and that the inoculation takes place and that the therapies are exactly right. They don't want any setbacks. They don't want any problems and they are being very responsible. So we are highly respective of that. Is the ramp a little bit off where we expected? Yes, it is, but that's to be expected. This is biology that we are working with and it's data-driven and data is being collected and care is being taken and a responsible approach is being taken as well. So with that, I'll turn it to Mark for more finite answer.
Mark Sawicki
Thanks, Jerry. So as we take a look at this and we look at the activity ongoing within our two commercial clients, they continue to take a very, very aggressive stance in the marketplace and I think publicly they disclosed enhanced manufacturing competencies. Jerry talked about the Kite facility in Amsterdam and Novartis has announced additional manufacturing capacity coming online in Europe as well. Very aggressive expansion plans, both of them have publicly acknowledged their launch profiles in Europe. And so I don't think that we are going to see a material difference in that ramp. It's just going to - I would still feel very confident that that top line in is an appropriate number. It's just - as these things come online, we are going to see that ramp just aggressively modify maybe geographically more so than anything on a significant delay or anything along those lines, so.
(So enough dancing around guys . . . how long will we have to wait? )
Sean Hannan
Okay. Well, let me ask totally different way because I just feel I need a little bit more information, because we are a few quarters into the experience and I think yes, it's a new one and it's a new process for everybody . . . So at this point are we talking about the ability that we should be able to get into the range in concept in year 2020 or 2021 or is it possible that's a little further out than that?
Jerrell Shelton
Yeah, I think that, first of all, there is a lot of data available on both the Kite and the Gilead Kite website and through their calls, as well as through Novartis. As for our planning, we feel that our planning is on target. We didn't build facilities for them to be vacant or hire people for them to be idle and there is some orchestration to take place and there is load to place on these facilities and ramp up times and so forth as I mentioned earlier. But we feel that we are on schedule and we are coordinated with the manufactures and we talk - we have dedicated program managers and we have fluid conversation lines going all of the time. So we feel confident that we are on the right pathway and we made the right decisions in terms of building out our capacity and our planning. Mark, would you like to add anything to that?
Mark Sawicki
No, I think that's accurate. Well, we can't provide specific guidance on what the ramp schedules look like, because its proprietary in nature. What Jerry had mentioned is true. I mean we are working very, very closely with both parties ensuring that we have the right assets in place at the right time and we haven't gone through an aggressive build out of two new facilities with the expectation that that volume is distant in timeframe.
And they still didn't even answer the question.
“Cryoport and its stock are coiled like a spring” SOS is still recommending it @14 . . .and he raised his ’18 revenue projection from $18.5M to $19.3M
https://smithonstocks.com/cryoport-reiterating-my-buy-recommendation-cyrx-buy-14-20/
I agree on World Courier, and thought of them as the closest competitor with the most capabilities and resources, so yes, that partnership announcement speaks volumes. Now we discover that they have been working together for several years? It’s clear that there’s a lot more is going on behind the curtain with Cryoport than they choose to share with their investors. This latest partnership suggests to me that Cryoport is also collaborating to use their Cryoportal software on a certain project that Amerisourcebergen and McKesson are working on, and Cardinal Health may also join. This is why I posted many months ago that it will be interesting to see if Cryoport also announces a partnership with Cardinal Health. Cryoport hasn’t said a word about this either, but I think this is why Cryoport has now signed partnerships with 2 of the 3 major pharmaceutical distributors in the U.S.. One thing to keep in mind . . .many acquisitions begin first as partnerships.
I actually think this overlaps and relates to another area that I’ve also been interested to know about. I had a hunch that AmerisourceBergen/World Courier was also involved in qualifying for the outsourced handling of Big Pharma’s biologics and other therapies last year. The Drug Supply Chain Security Act (DSCSA) is a big concern for Big Pharma, and although it was postponed for a year, it should take effect by this November. Cryoport has stated that the Bristol Myers agreement relates to the handling of “a multi-billion dollar monoclonal antibody” (Yervoy or Opdivo) and it will generate revenue from management fees as well as on a per-shipment basis. Also, on the Q3 ’17 conference call, management mentioned that they now have agreements with Sanofi and J&J, and indicated that it relates to the support of one or more of their biologic therapies. Once these initial tests were validated, it could lead to much greater expansion with these companies and many others. Cryoport said that they expected more agreements in the coming quarters, and there haven't been. This is a huge revenue opportunity that should be near-term, not years down the road like the cryo opportunity. Why hasn’t there been any updates? Has Cryoport focused on the software opportunity instead of the logistics opportunity?
BTW - I would keep my expectations for European revenues tempered for at least the first year ($2M?) and congrats on the anniversary (I guess?).
Haven't read the transcript yet but this is conference call hghlights from my notes:
How many times have we heard this phrase?
“we anticipate this trend to accelerate in the coming months”
5 new patents pending for new products to be introduced later this year
446k commercial revenue from kymriah and yescarta (45% growth)
added 22 net new trials
34 phase 3 trials in Q2 vs 31 Q1
Industry has 5 bla’s filed so far and 4 more bla or ema rest of year
Novartis 16m Q2 vs 12m Q1 - applied for approvals in japan australia and canada
Gilead 68m Q2 vs 40m Q1 now 60 centers open and expects 20 centers in eu in 2018
bluebirdbird bio’s lentiglobin has accelerated status in US and EU and expects to file in EU in 2018
Revenues: Biopharma 3.849 Reproductive 499k Animal Health 279 - total 4.627 (nailed it!)
animal health - expect revenue to increase in coming quarters
Have lost 5.2 million first 6 months
Six month operating expense - 8.9m
Six month stock-based compensation expense - 2.5m
Margins 54% - may decline as new logistics centers come online
Cash increased from 15m to 20m due to warrants
Attending Cowen and Janney investor conferences in Q3
World Courier has been a partner for several years? huh?
chain of compliance name is trademarked
24m-28m is breakeven revenues
Will provide forecasts in the future - huh?
It was an impressive recovery, but I sure won’t be adding at these levels. I think some were waiting to see if there is any guidance or clues about future commercializations, but it seems Shelton is getting more vague and lowering expectations with each call this year. On the Q4 call in March he said 5-7 expected filings by their customers, then on the Q1 call in May he said 5 or 6 filings by their customers. Now he is only saying that the industry has had 5 filing and expects 4 more by the end of the year. Hmmm. There have actually been more filings than that so far, but some were filed by Big Pharma and maybe he doesn't include those? BTW - does anyone know if Immunomedics, Novimmune, or Medimmune are customers? (they've all filed)
When I listen to these canned calls reading from a script, and see pics of their “state of the art” logistics facilities, I’m reminded that this is a very small company that has big ambitions. It will likely achieve them, but it will take longer than many here would like. When rob said it’s not ready to be held in drawer yet, I doubt he realizes that most of you have already held this in the drawer so long that it has layers of dust!
One analyst said his average last year was ~$100k per trial, but that is likely based over the entire length of the trial, which is different for each phase. The mix of trials has also changed over the past year; Phase III trials have grown from 17 in Q1 last year to 31 in Q1 this year. My model is likely much simpler.
In Q1, Biopharma revenue was $3.3M ($3M from 214 clinical trials and $300k commercial) Reproductive Medicine was $500k, and Animal Health was $240k. They added 22 trials during Q1, but I don’t believe the trials contribute until the following quarter. My average is $14k per trial, ($3M divided by 214) so I added $300k for the 22 trials that were added during Q1 to the Q2 estimate (understanding the trial mix is likely different). I also guesstimated a 50% growth rate this quarter in commercial revenue, so my model shows: Biopharma revenue of 3.81M ($3.3M clinical trials and $500k commercial) Reproductive Medicine $540k, and Animal Health $260k, so total $4.61M.
Cryoport met with both Roth Capital and Needham last month so it appears that they may have been assisting with numbers on the World Courier deal, and then they both came out with upgrades and their price targets nearly doubled, so the potential for this deal is significant. I’m not sure how to model this revenue for Q3 and beyond. When is the revenue recognized? I think most of it is up-front, but term-based licenses are somewhat complicated since there are multiple components and usually some post contract support. I'll be interested to hear the few details they provide during the conference call. BTW - where is Rev3lation? I thought he was the numbers guy.
Six tenths of one percent.
Combined Q1 revenue for Kymriah ($12M) and Yescarta ($40M) were $52M which produced $318k in revenues for Cryoport. (about $2k per patient)
Hi cold, thanks for popping in. I don’t think Bristol Myers is just another customer. They represent potential cold-chain outsourcing revenue from Big Pharma that could be magnitudes higher than cryo. Now whether that is higher than potential software licensing, I’m not sure, but I do look at it as another significant and growing potential revenue stream that shouldn’t be discounted.
Funny you should mention BLFS, I just unloaded quite a bit today (for a 10 bagger). While they are both going much higher longer term, valuations are getting pretty stretched. I completely agree that CYRX and BLFS are uniquely positioned in an industry that is only in the first inning, but the new FDA guidelines, https://tinyurl.com/y8nvefz6 while significantly positive long term, may actually prove to be a headwind in the near term. If you listened to the Novartis call, they indicated some manufacturing issues with Kymriah and were working with the FDA, and many of these smaller companies may encounter difficulties as well.
Anyone have thoughts on the new partnership with World Courier/AmerisourceBergen? I’m reminded of coldasice’s software model, and I was somewhat skeptical at the time. I thought that Cryoport would rather differentiate themselves and could win more business by offering the best solution. Perhaps their thinking is that they are already embedded in trials with so many key companies and think they already have their business, and they are looking to expand in other ways. I’ll be curious how they answer questions for the rationale on the Q2 conference call. It is interesting that Cryoport has posted a couple articles about M & A in the pharma industry. Subtle hints?
Bristol Myers update? Haha that’s a good one CB.
If you’re following Cryoport’s end markets, then you probably know that Novartis reported Q2 earnings yesterday, In case you’re not, they reported that Kymriah had sales of $16M. (up from $12M in Q1). That’s not real encouraging, but I expect Gilead to report better numbers for Yescarta next week.
If you’re following Cryoport’s Twitter feed, then you probably know what Zacks is predicting for Q2. In case you’re not, they are predicting $4.32M. Other analysts have estimates ranging from $4.20M to $4.52M. FWIW - At the beginning of the year, I had 4.31M for Q2 (absolute coincidence with Zacks) but after the Q1 beat, I tweaked the model a little and it now shows 4.63M.
Uh oh. rob’s back and checking in on what the dumb money thinks. Anyway, nice post rob - sometimes you’re not so bad.
On the first point I would agree if taken by itself, but after a 100% move without significant news or cause, it seems ancillary. I’ll take your word for the index flow number, but I thought it was a little higher. I may have underestimated the durability of the non-index flow, but will see after Q2 numbers. With regard to end markets, so far, Kymriah revenues have been disappointing, and the latest news isn’t encouraging:
https://www.fiercepharma.com/pharma/cms-cancels-value-based-pricing-plan-novartis-kymriah-report
Good auxiliary advice, but I’m just guessing, that taking a gamble on a hunch is not something you’re real familiar with. Sure, understanding the why is ideal, but a win is a win, and being right in the end despite lacking full knowledge or wrong assumptions, makes the win all the sweeter. Things don’t always happen the way you plan or think it will. Understanding the rules of the game and preparation are key. Sometimes, simply being in the right place at the right time is all it takes, like studying the tides and knowing that a rising tide is coming to lift your boat.
Well I guess I was wrong too if I agreed with you. There were a couple reasons I thought it could go higher after your call, and both occurred; analysts raised their targets, and a new commercial customer was announced. I thought it was curious that all the analysts were silent when the price surpassed their targets. The price has gotten way ahead of earnings, and at some point it will either fall back in line, or earnings will have to increase tremendously to catch up. (or I guess it could become a cult stock like Tesla) My guess is the former. In 2018 . . . I estimate revenues ~$23M. Based on this, my target price next year is mid to high teens.
BTW - remember this post?
hyperopia Tuesday, 09/19/17 08:05:21 AM
Re: CYRXorbust post# 10703
I didn’t see any upcoming Roth investor conferences, but who knows. I had a potential theory that the fly was being used as a sell signal since the rumors only seem to happen when the stock is up, but that theory was soundly debunked over the last of couple weeks! But I agree, and that was the point of one of my posts a couple months ago when they filed to increase the share count. If they do a raise at a an optimal time while the stock is riding high, they don’t need to issue that many shares. If management can’t figure this out, I would hope some of these investment bankers they meet so often with will advise them. Anyway, Happy Independence Day to any Americans.
Cryoport management to meet with Roth Capital Meetings to be held in the Midwest June 12-13 hosted by Roth Capital.
https://thefly.com/landingPageNews.php?id=2742222&headline=CYRX-Cryoport-management-to-meet-with-Roth-Capital
Wonder if this had anything to do with the Richard Baldry’s raised price target? He noted that the EMA recommendation roughly doubles the market for Yescarta and Kymriah, and potential further upside in 2019. Is there anyone who didn’t think this was likely or priced in?
laser, maybe you were just being facetious, but there are far more than the 3 or 4 of us who believe DCVax will be successful. There are company insiders who have recently loaded up with options, venture capitalists who provided funding, 69 doctors who co-authored a medical journal article and have personally worked with the treatment (including two of the top neurosurgeons in the world), and of course hundreds of patients (who were on death’s doorstep) and their families who have experienced first hand, how the treatment extended their lives. And I’m certain there are many more. I liken it to the Muller investigation where one side quietly goes about their business and continues to work, while the other side makes a lot of noise and tries to obfuscate.
I also don’t believe that the current price is indicative of the probability of success. The company trades on the OTC where SEC regulations are lax to put it mildly, and I think this is why the current price is where it is, and I will leave it at that. Those in power tend to prefer the status quo.
But on this we do agree . . . the risk/reward is very favorable.
CN, Short answer: (no pun intended haha) I’m still long the shares I bought in November, but I sold a lot last week and Monday that I bought a little over a year ago. (a 5 bagger)
Everyone has different financial and tax situations and buy and sell for a number of reasons, so don’t read too much into it. I do take note when the insiders buy however. They may sell for a number of reasons, but they only buy for one.
I know almost everyone on these message boards has an agenda and I know you were only asking, but my agenda is to learn and share information and it is not my intention to influence anyone or let my personal investment decisions influence the information I share.
CYRX has doubled in 2 months, but has Cryoport announced any new support contracts or anything to justify this? No, I think it’s mainly because index funds were required to buy CYRX whether they wanted to or not. There was a lot of accumulation in the past month, but how much of that volume is going to be held? The huge increase in short interest indicates that some people think it won’t be held that long.
4 or 5 more commercializations? Just to be perfectly clear, there is a difference between filings and commercializations. Once a company files, it can take the regulatory authority 6 months or longer to reach a decision. Then, a commercialization will only happen IF the filing is approved, and even then, it will take a few more months to prepare and ramp. At this point, even if a filing happens today, Cryoport will not see commercial revenues for almost a year.
And to keep management honest, during the Q4 conference call on March 6th, this is a direct quote from the CEO Jerrell Shelton: “As a result of the anticipated number of accelerated United States Biologic License Applications and European Medicine Agency filings from our current clients, and based on public reports, we are increasing our projected number of combined BLA and EMA filings. Previously, we anticipated supporting two to four additional therapies during 2018; we now think that number is five to seven therapies.”
Then, during the Q1 conference call on May 3rd, Jerrell Shelton said “we anticipate supporting a further 5 or 6 additional BLA or EMA filings in 2018 based on internal information and a forecast from the alliance of regenerative medicine in addition to Kymriah’s second indication approval which I mentioned earlier."
But to answer your question, yes the year is half over and Cryoport clients have filed exactly 0 times so far this year, so yeah it would good to have at least 1 filed by now. They did actually hype the expectation of one (BLUE EMA filing) on Twitter yesterday.
It’s actually a good thing management doesn’t provide earnings guidance. They continue to over promise and under deliver.
I have to agree. There is a reason short interest is up. Over 400M market cap? For what? More losses on ~5M revenue this quarter? I think a 300M market cap is pushing it, unless there is a huge earnings beat and guidance for more of the same going forward. What are the chances of that?
You guys do know about dark pools, right? They are lightly-regulated private trading venues set up by the large investment banks to bypass the major exchanges to lower their trading costs, and allow institutional investors to match large buy and sell orders without displaying the quote to the public, discretely masking their activities (and theoretically lowering volatility). The volume continues to grow, and now I would guess almost half of all trading is done this way, and often in pre/after market hours.
Not sure about others but Charles Schwab’s, StreetSmartEdge platform has a “block trade indicator”, and TD Ameritrade’s ThinkOrSwim platform has “trade flash”, where some large trades can be monitored real time.
Further reading:
http://www.finra.org/investors/can-you-swim-dark-pool
http://www.traderplanet.com/articles/view/167551-track-the-dark-pools-with-the-balance-of-power-bop-indicator/
This board has been so quiet I thought everyone sold. This index inclusion is one of the very few “free lunches” for the average investor. The index funds are benchmarked against the closing price today and many will trade toward the close to minimize their tracking error. Some hedge funds that have taken positions based on the well-known Russell Effect often unwind their positions on or soon after the actual reconstitution date. We may see some volatility and selling pressure in CYRX.
It doesn't look like it, but it did finally hit my number today. If you ever wanted to know what algorithmic trading looks like, just take a look at CYRX's chart.
Congrats gigi!
I think this news was baked in and the air is beginning to feel pretty thin up here . . .
Hi gigi21 - your goal is within reach, but It appears that this statement:
I think the only way we reach $14 a share, my personal goal, is to be bought out.
Speaking of FedEx and UPS . . .Did you know that they are already using blockchain? Is Cryoport?
5 companies using blockchain to drive their supply chain
Businesses are using the ledger technology behind Bitcoin to track their supply more efficiently.
By Olivia Krauth | February 9, 2018, 8:37 AM PST
https://www.techrepublic.com/article/5-companies-using-blockchain-to-drive-their-supply-chain/
1. Walmart
Using blockchain, Walmart employees can track some products back to their roots—literally. After scanning mangoes or a couple dozen other products with the store's app, employees can see which farm the fruit came from and where it's stored in the backroom, according to the Wall Street Journal. The technology could help customers understand where their food comes from and could streamline the restocking process.
2. Maersk
The world's largest shipping company completed its first test of blockchain technology in March 2017, looking at how it could help manage its cargo. In the test, Maersk, Dutch customs, and US Homeland Security were all able to remotely access data about the cargo, suggesting the technology may streamline and secure international shipping.
3. British Airways
The airline tested using blockchain to manage data about flights between London, Geneva, and Miami in 2017, the Wall Street Journal said. Using one unchangeable history source, the airline hoped to reduce conflicting flight information coming from gate monitors, flight apps, and the airline's website.
4. UPS
The shipping company UPS joined the Blockchain in Trucking Alliance (BiTA) in November, hoping to push for increased transparency among all groups involved in the supply chain. The group is working to develop blockchain standards for the freight industry.
"In the future, blockchain standards and intercompany collaboration will support the logistics strategies that enable UPS customers to participate in global trade and finance," UPS said in a press release.
Currently, UPS is looking at how blockchain can be used in its customs brokerage business.
5. FedEx
FedEx, another shipping giant, joined BiTA in February and has already launched a blockchain-powered pilot program to help solve customer disputes. The company hopes the program will clarify what data should be stored on blockchain to best remedy customer issues. FedEx also hopes to use the technology to store records.
further reading . . .
Blockchain will be the killer app for supply chain management in 2018
The distributed ledger technology that underpins cryptocurrencies is now poised to disrupt supply chain management – especially in the global shipping industry.
By Lucas Mearian
Senior Reporter, Computerworld | MAY 8, 2018 2:55 PM PT
https://www.computerworld.com/article/3249252/emerging-technology/blockchain-will-be-the-killer-app-for-supply-chain-management-in-2018.html
Gottlieb at BIO 2018: 40 Gene Therapy Approvals by 2022
Published: Jun 07, 2018 By Mark Terry
As the 2018 BIO International Convention wraps up in Boston today, it kicked off with a fireside chat with Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration (FDA). Gottlieb was interviewed by Jim Greenwood, president and chief executive officer of BIO.
In a wide-ranging discussion, Gottlieb said he expects the FDA to approve 40 gene therapies by 2022 and might see cures for diseases like sickle cell anemia within 10 years. He also noted that there are complexities in gene therapy that are related to product issues as compared to clinical issues, which is requiring the agency to approach approvals differently. Gottlieb indicated that agency will publish six guidance documents regarding gene therapies soon. . .
Gottlieb also said the agency may be willing to accept more uncertainty for certain gene and cell therapies, particularly with those earning the new Regenerative Medicine Advanced Therapy (RMAT) designation. He noted that as of the end of April, there had been 62 RMAT designation submissions since the inception of the program in December 2016, and 19 designations have been granted. Of these 19 products, 14 also have orphan designation.
Here is a list of companies/products that have received FDA regenerative medicine advanced therapy designation or RMAT. Many of these are Cryoport clients . . .
Abeona Therapeutics (EB-101 Gene Therapy in Epidermolysis Bullosa)
Abeona Therapeutics (ABO-102 Gene Therapy in MPS IIIA)
Asterias (AST-OPC1, spinal cord injury)
Athersys (MultiStem)
BlueBird Bio (Lentiglobin in SCID)
Capricor (CAP1002, Duchenne Muscular Dystrophy)
Enzyvant (DiGeorge syndrome)
Fortress Biotech (Cellvation’s CEVA101, traumatic brain injury)
Humacyte (Vascular Access for Hemodialysis)
jCyte (Retinitis Pigmentosa)
Juno (JCAR017; CAR-T)
Kiadis Pharma (ATIR101, blood disorders)
Mallinckrodt/Stratatech’s Stratagraft
Mesoblast (Heart Failure, mesenchymal precursor cell therapy)
MiMedx Group (AmnioFix for osteoarthritis)
Vericel Ixmyelocel-T
CN, if you’re talking about the Form S-8 filed on Friday, then yes Cryoport registered 5 million shares for the 2018 Omnibus Equity Incentive Plan. It’s a very sore subject that I’ve been trying to get over. Thanks for picking the scab!
Oh c’mon CB, let’s have a political debate. Actually, I think a while back a few of us weighed in on this subject. If there is a recession and market sell-off, there will be a flight to quality and safety in both the bond and equity markets. High yield fixed instruments will become out of favor (for treasuries), as will previously hot stocks. In the equity markets, investors will flee from small cap high-flying biotech to large-cap consumer staples, utilities, and companies with stable earnings, And yes, there are some solid names in healthcare that will still do well in a recession, but If you’re asking if Cryoport is a company investors will flock to in this event (or even stay in), the answer is definitely not.
Cryoport is enjoying a very nice run lately and I think this is likely due to the Russell Effect and not the company’s fundamentals. This next week should be interesting, starting with ASCO this weekend and the preliminary index list next Friday.
I saw that headline earlier and it sounded like Cryoport rallied because Palynziq just received FDA approval, but it was just click bait. Unfortunately, Cryoport doesn’t support this treatment. Dr. Tran was recapping a number of stocks that BioSci Capital Partners covers but had nothing new on Cryoport, and was just promoting his subscription service which has an in-depth report on Cryoport. Did you see the comment Larry Smith made on the article? (I’ll give him a deserving plug)
Smith On Stocks, Contributor
Cryoport has been and remains one of my strongest recommendations. It may be the best way to invest in regnerative medicine that is based on living cells, arguably the most exciting new technology in biopharma. For an in-depth report on the company, see my initiation report written on April 12, 2017. The stock has quintupled since my intial recommendation. The link is smithonstocks.com/...
I look forward to the next quintuple although it is likely to take more than one year. My latest update on the company was on May 16, 2018. The link is smithonstocks.com/...
Ha ha. Yeah Larry it was a great pick, but I agree that it may take longer than a year to quintuple again. (but I hope it doesn’t)
Well CB, part of your wish was granted - price pushed well north of $11 on good volume. Do you think there was some short covering or some front running index inclusion as others have speculated, or something else? I don’t think I’ve seen a million share day in the year I’ve been in CYRX, and now two in a row? That got my attention. Where do you think a new floor will be established? Any other technicians have a guess?
Anyway, It will be interesting to watch what some of the analysts do with their ratings now that their price targets were reached.
Yes laser, a great day, but better days are ahead! Encouraging events are happening, and hopefully it won’t be too much longer.
Close but no cigar. It appears that some are speculating that the RTT legislation will be good for the experimental therapies in development and therefore good for Cryoport. It's also a good day for terminally ill patients.
Still waiting for the filing. . . does anyone know how the vote went? Or if there was even a quorum? Bad news is best dispensed on Fridays, but maybe they will wait until next week. Hoping at least these went this way:
Proposal 1: WITHHOLD all the nominees to the Board
Proposal 3: AGAINST the approval of the Cryoport, Inc. 2018 Omnibus Equity Incentive Plan.
Proposal 4: AGAINST the approval of the Authorized Shares Proposal.
Proposal 5: AGAINST the approval of the compensation of the named executive officers.
Somehow, I doubt it though
New SOS update https://smithonstocks.com/cryoport-updated-sales-and-earnings-model-cyrx-buy-9-69/
I thought that analysts would appreciate Croyoport providing some commercial sales data so they can make better projections. Mr. Smith is still conservative, and his 2020 projections are closer to my 2019 projections, but at least he's catching up. I Think it will be a couple more quarters before the ramp really steepens.
Couple events this week. https://www.cryoport.com/news-and-events/events
Anyone going to the shareholder meeting Thursday?