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SUPN continues to be a big winner. Just look at the prescription growth in the last three years. With this indication now added on label, continued growth is ahead. SUPN customers require long term drug therapy. Investors can't ask for a better situation. The pipeline continues to look good, too.
Andy, interesting development with latest case report -- from Russia -- Noted that "Use of CytoSorb in complex therapy of generalized meningococcal infection, septic shock and MOF in a pediatric patient" case report came from Russia. And, the patient was a young child. Very encouraging that Russian docs are beginning to discover CytoSorb. Plus, the influence and reach of Fresenius is obvious throughout the report. It makes me wonder if ICU docs consult with Fresenius during critical situations and if Fresenius makes the recommendation to introduce CytoSorb. This would suggest that Fresenius has an incredibly high level of confidence in CytoSorb. Also makes me wonder if they put up the $10MM in an eye blink last week?? Thanks for posting these case reports. Very revealing...
Great Conference Call and Another Big Growth Year in 2016 -- The FDA approval of the migraine indication is about to happen. This company has a solid ongoing revenue stream that will expand significantly in 2017 and likely again for the next several years. The reason is simple. SUPN has "customers for life." The nonsense in Washington has little effect as these customers require constant daily medication. SUPN's epilepsy franchise is strong with Oxtellar XR, an extended-release oxcarbazepine; and Trokendi XR, an extended-release topiramate. Epilepsy patients and their docs appreciate the minimize side effects that this mandatory medicine has. The ADHD drug pipeline holds significant potential, too. This is a very important need, too. Prescriptions for Oxtellar and Trokendi continue to grow nicely, with patent protection exclusivity until 2023. There is a long clear runway to ramp up revenues ahead for SUPN when you look at the facts...not news blubs. With a forward P/E under 16 and quarterly revenue growth of 40+%, SUPN continues to be an investment gem, despite the day traders playing with the price around quarterly report time. SUPN is going higher.
Superb growth without US sales...DebitsAndCredits, interesting 5 pillars. But the one bugaboo that reluctant investors point to is FDA approval yet to come. I think it is a mistake to make this a central focus of an investment thesis in CTSO. The US is only 330 million people. CTSO already serves populations over 2 billion. None of them care about the FDA's slow and stodgy approach to accept data from non-US studies. Gosh, the main purpose of the FDA Cardiac Surgery Pilot study was "safety." Duh! There had been 10,000 safe human treatments with CytoSorb before the pilot study began. Today, there are 20,000 safe human uses. When the FDA finally wakes up, it will be icing on the cake for us investors. Think about this. CTSO will likely have 2017 revenues of $20 million or more, with doubling again in 2018 to $40 million or more. Just one hospital in Germany is now ordering $1 million a year in CytoSorb units. None of this growth relies on FDA. Plus, Chan is in China today. Not one of the 3 billion people living in China cares about the FDA either. All these folks care about how CytoSorb saves lives, shortens ICU stays, and helps them get well again. And, as Germany has shown, insurance companies want docs using it because it saves medical payouts. Your fifth pillar should be the expansion of third-party payers throughout the world. This will significantly accelerate sales.
What's clear is the "beads" performed for this 9-month-old cardiac surgery post-op case. CytoSorb assisted in the recovery and provided another treatment option. The reason for the low flow rate is not discussed. Perhaps it is typical of this kind of very young patient in this very weak condition. More learning is needed with pediatric cardiac surgery patients and Dr. Chan and team are likely examining this topic. Pears, always good to see you writing and thinking about CytoSorb. "Keeping all of us on our toes," as you like to say. This case history is further evidence that CytoSorb continues on a steady path of market expansion, indications expansion and patient population expansion. As an investor in CTSO, this is one more thing to like. You can nod your head YES! now.
Oh, there's data, but FDA doesn't speak German. European studies provide plenty of solid evidence, as do the 17,000 safe uses of CytoSorb worldwide (x-USA of course). Countless lives pulled back from the edge of death in ICUs elsewhere beyond all other known treatments. Fresenius and Terumo wouldn't put their sterling brands behind CytoSorb if these statements weren't true. But, alas, the FDA says "Do it all again, Chan, HERE!" As if humans were different if they were born on the other side of an ocean. Remember MRI imaging FDA approval, Pears? Ten years helping docs outside of the USA before the FDA said "yeah, sure, okay. You feriners were right." Geez!
Hey Pears! I've always enjoyed your thoughts. CTSO is getting close to liftoff. Free hemoglobin numbers in the Cardiac Surgery Pilot Study will be released soon. Chan is holding them back due to protocol. He wants docs to see them first. I don't know the schedule for cardiac surgeon conferences, but expect one might be on tap in next month or two. Do you know when? Plus, Q4 is about to end, and Terumo took its first order and Fresenius is pumping CytoSorb. Loved the German insurance reimbursement approval, too. It all means more mo', mo' money. One issue might be currency adjustment due to Euro/Dollar, but overall, sales will likely increase nicely again, providing further proof of constantly strengthening growth trend. Excellent buy sub $5, if you can get it.
Before we know the cardiac surgery data, Dr. Chan has said he will follow protocol by presenting it first to FDA, then next to a formal cardiac doc conference. He doesn't want to step on the FDA's toes or slight medical professionals. However, on the last conference call, he described the data as "promising" -- perhaps a euphemism for "positively lowering free hemoglobin and lowering inflammation post cardiac surgery for better patient outcomes" -- but he couldn't say those words publicly yet. He also said CTSO expected to start a pivotal FDA trial in the next few months, with possible FDA approval coming in 2018. All very good signals to investors.
Before we know the cardiac surgery data, Dr. Chan has said he will follow protocol by presenting it first to FDA, then next to a formal cardiac doc conference. He doesn't want to step on the FDA's toes or slight medical professionals. However, on the last conference call, he described the data as "promising" -- perhaps a euphemism for "positively lowering free hemoglobin and lowering inflammation post cardiac surgery for better patient outcomes" -- but he couldn't say those words publicly yet. He also said CTSO expected to start a pivotal FDA trial in the next few months, with possible FDA approval coming in 2018. All very good signals to investors.
Another positive indication - Grant from Cystic Fibrosis Foundation MTNB has received a research contract award from Cystic Fibrosis Foundation Therapeutics Inc. (CFFT), the non-profit drug discovery and development affiliate of the Cystic Fibrosis Foundation, to study its lead antibiotic product candidate MAT2501, for the treatment of pre-clinical nontuberculous mycobacterium infection (NTM) in models of cystic fibrosis (CF). The award provided by CFFT will support a collaborative research program between Matinas BioPharma and Colorado State University (CSU) to study the efficacy of MAT2501 in the treatment of NTM infection by a range of mycobacterium species, including mycobacterium abscessus, in a CF lung infection model developed by CSU.
2 products now in FDA approval process. Safety profile looking good. Early efficacy numbers should come in about six months from now. FDA fast track designation adds promise to this company. If MTNB's drug platform Phase I and II data start to provide the alternative answer to outdated antibiotics, we should see this stock surge. Possibly a hot takeover target in a matter of months. Big pharma would want to control this promising drug platform. Worth it to wait and see.
Snow, maybe you should move on. CTSO's chart is on a solid, long term upward path with bumps here and there. Someday, CTSO will be a good dividend stock because of future cash flows -- or an acquisition target for the same reason. Another one like this is CERS, a blood filtering company that removes viruses and toxins from stored blood...American Red Cross is a big customer and ramping up all of its blood collection centers due to Zeka. These kinds of companies provide future big volume, repeat order, as their products are required daily. CTSO and CERS products take time to catch hold. If you are willing to own an investment for a long time, buy these kinds of consumable products. Otherwise, get into something you can day trade that constantly bounces up and down with news stories, rather than depending on company fundamentals to drive stock price. Nothing wrong with trading companies with rapid price changes. That's just not for me. I'm a long investor. Good luck no matter what you decide. It's a big world and opportunities for all of us to succeed.
Q316 growth outstanding! Revenue was $2.4 million, a single quarter record. The bulk came from $2.1 million in Q3 CytoSorb product sales, also a record quarter. On the conference call, CFO pointed out that annual revenue growth rate is at +120%. Total 2015 annual revenues were about $4 million, and that number has been easily exceeded in the first three quarters of 2016. Current company projection for 2016 revenues is $7.9 million -- but could be higher. CFO said that the company expects to reach $20 million in sales in two years or less. $20 million is the breakeven point, after which she indicated every dollar of revenue will provide roughly 50 cents in profit. "At that point, CTSO will be a very good investment for its shareholders," she said. In addition, color on Fresenius relationship indicated that it is still in the early stages of developing new accounts. As accounts take hold, they will likely follow the same reorder patterns of existing customers. The number of indications for which CytoSorb is being used is about two dozen or more, and for some indications, like sepsis, some hospitals have already made CytoSorb the de facto standard of care, meaning every case is treated with CytoSorb. It's the go to product for severe inflammation. The cardiac surgery pilot study results for reducing Free Hemoglobin were termed promising, but data was withheld from the conference call because it has not yet been presented to the FDA. (EU studies already indicate Free Hemoglobin reductions in cardiac surgery.) After FDA review, the data will be presented to a professional cardiac surgeon conference, then comes PR. Company sounded confident in call that the next (and possibly pivotal) FDA study could go forward in early 2017, getting it ever closer to FDA approval for severe cardiac surgery. No other method is known to reduce free hemoglobin, a inflammatory mediator. Currently CytoSorb is being sold in 42 countries, with rapid sales acceleration expected to continue, driving revenues for the next several years even without US approval in place. Everything still looks good. If you want facts, listen to conference calls, IMO.
What did he say? What Sirius station? Sorry, but I won't click any links for security reasons.
No reason for SUPN to sell off. FDA approval for migraine indication is only four months away. This should add significant sales. Also, existing prescription sales continue to grow. Plus all active FDA trials continue to look good. Can't find any negatives to SUPN's fundamentals. Puzzling dip in price.
All healthcare has been hit. CTSO relative strength has remained high vs NBI-X. This is a possible sign CTSO will recover faster than others in the healthcare sector. Very confused market right now -- dominated by fear from political risks. This phase will pass.
Wondering if traders realize there is no US political risk in CTSO stock and if the sell off with US healthcare is in error? Sure, US biotech and healthcare are getting hit due to current political risks here. But there's no connection to CTSO. While it is a New Jersey company, all CTSO sales come from 42 foreign countries. CytoSorb is not sold in the US yet. Paulness, thanks for your prediction of $3 million in revenues for Q316. We'll know next week. I'm guessing $2.8 million. Anything over $3 million would be a blockbuster, considered total sales were about $4 million last year. Looks like CTSO is on track to easily double 2015 revenues. The acceleration in growth is just beginning with partners like Terumo and Fresenius still in the very early stages of their marketing programs for the CytoSorb brand. Biocon (India) is a wild card, as is Russia and the Middle East. Penetration is just beginning in South America, too. Maybe Canada is next? Also, interesting note in the release this week about two additional markets coming on board -- the story mentioned the strong gross margins (60%+) continue to be in place. This could be a real cash cow. The case history report also indicated CytoSorb is becoming the Standard of Care for sepsis cases. All the parts and pieces continue to fit together -- all good signs for continued revenue growth. US politics won't affect any of CTSO's fundamental growth drivers. Fear alone can't hold CTSO down too long.
Keynes said "when the facts change, I change. What do you do?" My analysis is based on the changing marketing conditions for CytoSorb. I've been watching these patterns develop for three years. Today docs and hospitals who use it don't want to give it up. They are increasing their uses for different medical indications. Strong, persistent reorder patterns are evident. CytoSorb is now spreading to more countries each quarter. Large research and teaching hospitals were the first to use it. Now satellite hospitals around them are also ordering, based only on professional referrals from nearby colleagues -- no marketing effort required. The product is taking on a life of its own. Fresenius and Terumo have trained their own sales forces to market the product. These two companies would never stain their reputations by selling something that wasn't fully vetted. All this data is hard to ignore, unless you don't what to see what is happening in the current quarters. My advice is to listen to the next conference call, probably coming up in November. Evaluate Q316 product revenue gains YoY and QoQ. Read the analysts comments. Look at the partnerships. Read the case histories. Read the summaries from investigator studies in EU. Look at the data generated by the cardiac surgery study with over 300 patients in Europe. Immerse yourself in what is happening with CTSO. Or, you can choose to look at one data point and make your decision. It's okay with me whatever you decide. I only respond because false impressions are being conveyed based on what I believe are very narrow viewpoints. GL
Snow, rapid revenue acceleration is just beginning for CTSO. If you are a chartist or invest solely on past performance, it easy to see a cautious approach. But, understanding the company's product, the growth of reorders, the expansion of distributors, the expansion of countries in which the product can be sold (now 40), and realizing that the gross margin on CytoSorb is exceptional at above 60%, a growth investor begins to realize how quickly this micro cap will become very profitable. What's more, remember when IBM PCs adopted the Windows operating system? IBM validated Windows, drew huge attention to it, and provided enormous cash flow for MSFT. It's okay to think of Fresenius in a similar way as a giant in the medical world. Starting in Q116, Fresenius starting featuring CytoSorb in its latest, most advanced machines. Two weeks ago, Terumo, a giant in cardiac surgery, is doing something similar. Remember, CytoSorb is a high-end disposable product. A new one is inserted into the machine for each use. CTSO already had a growing customer base prior to these partnership deals. My advice is to dig into the business from the ground up, the marketing organization, distributor partnerships, new customer growth, reorder growth, the expansion of medical indications for which the product is being used, and dozens of other relative points about the safety and efficacy of this product -- now with over 14,000 safe human uses and thousands of lives saved. It's also moving steadily toward FDA approval so it can be sold in the US, perhaps in 2018. This is a dynamic situation that deserves greater insight by investors than looking at one metric, IMO. Take a deeper look at CTSO.
Snow, your numbers are two quarters behind. The acceleration in product sales in the Q116 and Q216 are the result of multiple factors, including the expansion of countries where CytoSorb is sold, the distributorship agreement with Fresenius, the largest dialysis company in the world, and the expansion of indications for which CytoSorb has been proved to be effective in lowering inflammation. The cardiac surgery indication, given the aging population, is very significant. CytoSorb is not just sold for sepsis cases. Perhaps you ought to look at recent QoQ growth? Based on the first two qrts/16 sales alone, CTSO has already matched 2015 annual sales. At the current rate of increase, 2016 revenues will more than double 2015 annual revenue, to about $9 to $10 million. If this rate of increase holds firm in 2017, sales will be over $20 million...with a 60%+ gross margin. What people don't seem to recognize about CytoSorb is it is a high-end medical disposable product. Reorders require no marketing cost. Reorder rates are high and existing customers expand their CytoSorb uses according to past management calls. Fresenius and Terumo (just signed on) agreements indicate continuous increases in new customers, creating steadily increasing reorders. CTSO will become a cash cow...and this is without having approval yet in the US.
You're right. 140% increase in product sales revenues in Q216 vs a year earlier isn't very good. The 60%+ gross margin stinks also. Probably not very important also that the largest dialysis company in the world started marketing and selling the product last quarter either. Or that one of the big 3 global companies in cardiac surgery just started selling CytoSorb this quarter. I see your point. There must be something else out there with better numbers, that include: CytoSorb® product sales for Q2 2016 were a record $1.9 million. This represents an increase of approximately 140% over Q2 2015 product sales of $0.8 million, as a result of strong increases in both direct and distributor sales
Second quarter 2016 annualized product sales run rate was approximately $7.4 million, as compared to an annualized product sales run rate of approximately $3.1 million in the second quarter of 2015
Total revenue for the second quarter of 2016 was $2.2 million, which includes both product sales and grant revenue
Overall gross margins rose to approximately $1.3 million in Q2 2016, representing an increase of approximately $0.8 million as compared to approximately $0.5 million in Q2 2015
Product gross margins for Q2 2016 increased to 68% compared to approximately 63% for Q2 2015. Maybe I should check back in 2017 when annual sales more than double again, and perhaps again.
BOGUS EMAIL CIRCULATING -- NOT RELATED TO CYTOSORB - After the close today, as a CTSO investor, I received a bogus email about a law suit involving tiny blood filters inserted into the body. CytoSorb is an excorporal blood filter, used inside a machine. It is considered to be an "inline" filter, meaning that is included in the line which carries the flow of blood to a dialysis machine or a blood pump. Whoever mailed this email manipulating the CTSO stock price which dropped 12% today. I've made the company aware that this has happened and advised them to contact the SEC.
Shorts are running away. Tight stops have been hit. There is more positive news coming when quarterly sales numbers are announced and they again exceed expectations. 2016 revenues will likely be between $9 and $10 million, more than double 2015's $3.9 million. Shorts are getting out.
Solid post. It is great to see an American journalist writing about CytoSorb. It's a wonder that the FDA is so dense that it can ignore this technology for years. 14,000 safe human treatments in the rest of the world, thousands of lives saved, countless patients who lived to go home after all other treatments were exhausted. Perhaps America will finally catch up to the fact that CytoSorb works to quell severe inflammation so docs regain control of their patients and patients recover. CytoSorb works to help the immune system recover and work properly. Thanks for posting this, Andy.