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Cytosorbents Corporation (CTSO)

Q4 2013 Earnings Call· Mon, Mar 31, 2014

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Transcript

Executives

Management

Phillip P. Chan – President and Chief Executive Officer Kathleen Bloch – Chief Financial Officer Christian Steiner – Vice President-Sales and Marketing Vincent Capponi – Chief Operating Officer Christopher Cramer – Vice President-Business Development

Operator

Operator

Good day, ladies and gentlemen, and thank you for standing by. Welcome to the Cytosorbents’ 2013 Shareholder Update Conference Call. During today’s presentation, all parties will be in listen-only mode. This conference is being recorded March 31, 2014. I would now like to turn the conference over to our moderator, Donna Maricnas [ph].

Unidentified Company Representative

Operator

Thank you, operator and good afternoon. Welcome to Cytosorbent’s 2013 operating and financial results conference call. With us today are, Dr. Phillip Chan, Chief Executive Officer and President, Vincent Capponi, Chief Operating Officer, Kathleen Bloch, Chief Financial Officer, Dr. Christian Steiner, VP of Sales and Marketing from Germany and Chris Kramer, VP of Business Development. Before I turn the call over to Dr. Chan, I’d like to remind listeners that during the call management’s prepared remarks may contain forward-looking statements which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to question today. Therefore the company claims protection under Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today and therefore we reproduce some more detailed discussions of these risks and uncertainties in the company’s filing for the SEC. Any projections as to the company’s future performance represented by management include estimates today as of March 31, 2014. And the company assumes no obligation to update these projections in the future as market conditions change. During today’s conference call, we will first have an overview presentation covering the financial and operating highlights for the quarter by Dr. Chan and Ms. Bloch. We again, have done our best to take everyone submit the question that we’ll do our best to address them in the presentation, but also at the Q&A session with management follow-up. Thanks everyone again for participating. If we do not ask your question, we would ask you to contact the company directly after the call time. At this time, I would like to turn the call over to Dr. Phillip Chan. Please go ahead, Dr. Chan.

Phillip P. Chan

Analyst

Thanks very much Donna. And welcome everyone to our 2013 operating and financial results conference call. Thank you very much for taking the time to join the call today. Since our last earnings report there have been a lot of developments and we definitely have new shareholders online today and what I’d like to do is actually go over a brief summary of the company for the benefit of those new shareholders as well as for those who need an update of our story. Following that Kathy will give a brief overview of our financial and operating progress for the quarter as well as for 2013, and I will come back on the line with an overview of the catalysts for 2014 that will help us drive growth for this year. So, Cytosorbents is an emerging leader in critical care immunotherapy. We are leading the prevention or treatment of life-threatening inflammation in the intensive care unit. When we talk about immunotherapy, broadly taken it is the ability to manipulate the immune response to help fight disease. Now this is $100 billion in revenue market. This is not a total addressable market. This is not a potential theoretical market. This is actually a market that has $100 billion in revenues for blockbuster products focused on manipulating the immune system. Now we all know that’s the immune response in order to function normally has to be not too high and not too low, when the immune system is not functioning well, people are at high risk of developing infection, cancer, as well as poor healing . And on the other end of the spectrum, when the immune system is too high, patients are at high likelihood of developing things like allergy, asthma, anaphylaxis, autoimmune diseases, severe inflammation such as sepsis or SIRS…

Kathleen Bloch

Analyst

Thank you Phil and good afternoon everyone. And today we’re going to – right now we’re going to cover some of the company’s key financial results. And of course we encourage everyone listening to refer to our press release and our annual report on Form 10-K for a more detailed information regarding our operating results. The first, look at revenue our total revenues for 2013 were approximately $2.4 million. 2013 was our first full year of product commercialization and our product sales we’re pleased to report we’re approximately $822,000 which is a dramatic increase over 2012 products revenues of approximately $152,000. We also know that brand revenue for 2013 was approximately $1.6 million as compared to approximately $1.2 million for 2012. Next, we’ll look at the quarter-over-quarter sales results. This chart highlights the product sales of CytoSorb for each of the last six quarters since we began the commercialization of the product. First of all, note that product sales for the fourth quarter of 2013 touch the blue border [ph] of the far right are approximately $317,000, and this represent at the highest quarterly sales achieved by the company thus far. They are in fact approximately 54% higher than product sales for the third quarter ended September 30, 2013. We actually completed orders worth and invoiced approximately $351,000 in the fourth quarter of 2014. That of this amount, approximately $37,000 could be not be recognized as revenue until 2014 due to common carrier delays in picking up the products which is where we sell slightly short of our guidance for the fourth quarter of 2013. And now, our guidance for the first quarter of 2014. We’re expecting product sales of approximately $530,000, $570,000 which is an increase of approximately 75% over the fourth quarter of 2013. This is the new…

Phillip P. Chan

Analyst

Thanks very much Candy. The financing that we just did, that added almost $10 million to our balance sheet, I will go a long way in terms of catalyzing our growth for 2014. Instead of doing what we need to do, we now have the capital of resources to do what we want to do and what is right for the business in order to build shareholder value, as well as grow our business more rapidly. As we talked about in the first conference call, our earnings call, third quarter earnings call last year, one of the places where we are looking to spend new capital is to stimulate CytoSorb sales. Kathleen mentioned that we now have more than a 100 key opinion leaders in Germany and Austria, and our goal for this year is to leverage those key opinion leader contacts in order to be able to try usage deep within your department amongst the junior and senior physicians in those departments. So rather than having key opinion leaders use the therapy once or twice a month, our goal is to actually have the permissions these clinicians, these junior and senior physicians utilize and think about the therapy on a daily basis when they admit patients with the variety of illnesses such as sepsis, burn injury, trauma, pancreatitis, and many other illnesses. In addition because of all the opportunity that we have, our goal is to really increase our sales team as well, as well as our clinical and distributor support material I will cover on the next slide. In addition, what we are seeing right now is that not only our we have one intensive care unit in the hospital and many of our reference hospitals that we are working with today. We’ve expanded from one key opinion…

Unidentified Company Representative

Operator

Thank you Dr. Ken. Over the past several week, we’ve been receiving a number of questions from investors. I think one of the most common questions relates to sale of CytoSorb. Christian , , sales seem to be trending upward, can you comment on your progress with direct sales?

Christian Steiner

Analyst

Yes, thank you Donna and good evening to everybody. So, first of all, because of the high level of interest that we have seen in cardiac surgery for the past 12 months, we have intentionally modified our sales efforts to dedicate more resources towards this [clean] (ph) application. Cardiac surgery has a number of very attractive characteristics as it relates to CytoSorb therapy. In addition to what Phil mentioned in his presentation, relatively to critically ill patients, cardiac surgery patients are much more homogenous, and are needing currently more predictable and repeated outcomes. Doctors know exactly what in going to happen and when it happens. We have also seen the clinical data can be generated much faster and are more predictive compared to data generated in [critical] (ph) premises. Furthermore, the group of current customers is relatively small and they are defined including approximately 100 cardiac surgery centers in the German speaking countries. In addition, the events of cardiovascular diseases and related surgery in public is much higher compared to sepsis. Given that cardiac surgery generates significant profits for hospitals, allocation of resources and purchases by the hospitals also (inaudible). There are approximately 0.5 million cardiac surgeries performed in the European Union per year. Based on statistics from the German Society of Thoracic and Cardiovascular Surgery, in 2012 there were approximately 100,000 cardiac surgeries in Germany alone. This represents the German market opportunity of about 100 million, and CystoSorb became standard of care. In addition to being a very profitable modest cost, it will help to build a bridge to many other possible indications of our technology. Our existing sales staff will spend a significant amount of sales time on this in the near term. Just to give you an example, in 2013 we had eight to 10 cardiac surgery…

Unidentified Company Representative

Operator

That’s very helpful, Christian. As Kathy mentioned, distributors in international expansion are another major source of revenue growth. How are distributors contributing to sales results and what is your overall outlook for 2014?

Christian Steiner

Analyst

Yes, thank you. The growth of our international business outside Germany is going to be a major topic for this year. As Kathy mentioned, CE Mark approval is (inaudible) to be sold in all 28 countries of the European Union and we’ll also have to expand our distribution way beyond Europe. We have been pleased with the reception of the technology in general, but particularly in many countries outside of Western Europe. Physicians in these other countries are very progressive and eager to use new technologies, particularly blood purification. The challenges in these markets are similar everywhere; product registration, adoption, and reimbursement. It is one of the reasons we will be adding a specific distributor support person this year. In 2013, the majority of players that come on direct to us (inaudible) especially Germany and Austria. However, as we sign more distributors and existing distributors gain product illustrations in the countries, I expect that distributor revenue will become a very significant proportion of overall revenues in the future. In terms of outlook for 2014, we just had another strong quarter of revenue growth benefiting from strong market demand. We will of course continue to work to expand usage and adoption in all direct and distributor territories. Back to you, Donna.

Unidentified Company Representative

Operator

Christian, during the week of March 19, CytoSorb participated in the 34th International Symposium on Intensive Care and Emergency Medicine Congress at Brussels and hosted a scientific symposium entitled SIRS and SEPSIS – New Therapy with CytoSorb. Please tell us about that.

Christian Steiner

Analyst

Thank you, Donna. So Phil mentioned this already. The CytoSorbents scientific deposing at the Brussels ISICEM Conference, the biggest in terms of Care Medicine Congress in the world was really great success, especially the lineup of all speakers was remarkable. Professor Herwig Gerlach is the President of the Germany Sepsis Society and member of the International Surviving Sepsis Guideline Committee. Professor John Kellum is the one of the top five few intensive gynecologists in the world and has done most of the preclinical up to this time up. Professor Michael Quintel one of the leading in terms with Germany, he is the past President of DV, the German anti-disciplinary society for intensive care and emerging medicine and leads the department of anesthesiology and intensive care medicine of the University of Cuttington [ph] which has the most experience of using final [indiscernible] in patients suffering from septic shock. And last but not least, Professor Karl Träger is one of the most experienced user of CytoSorb in cardiac surgery patients. Not many companies can easily have such excellent speaker to present. This ICA reflects our excellent materials and also the belief this will be hardly seven or product and now, the presentation covered the wide range of material from the basis of the new response and fitness to pre-clinical and clinical data and then to different application in sepsis and cardiac surgery. And yet approximately 100 people at this symposium and obtained a lot of feedback. We are currently working on the summary of these tasks for the new future.

Unidentified Company Representative

Operator

Okay Christian, can you bring us up to-date regarding the investor initiative studies underway.

Christian Steiner

Analyst

Yes, of course. I only can repeat myself by saying that a talent body of clinical and published evidence is essential for the next phases of commercialization of all CytoSorb therapy, they still outline in this presentation additional funding that we have received, we will continue to be focused on five key levels to generate the necessary data that we need to make CytoSorb done at out of KN hospital. Number one is published cases and case reports and case serious. Number two, international CytoSorb. Number three, the more than 30 of investigated and initiative clinical project and trial, and number four, which is in the trials including pivotal studies. And additionally, of course, studies to investigate an important high topics such as ill children, antibiotic removal and other studies are planned. These levels are not necessarily sequential but will be brought on unparalleled. Case reports are low level grade of evidence but helped tremendously because they are real world examples of how this helped people used successfully by others, along as the parameters of treatment. They removed inertia and encouraged others to try the therapy in similar situations. Along these lines, there will be two datasets published on theory and post operative styles of applications and cardiac surgery, patient later in the year. The cause is expected in April. The next evident layer, the international time observatory should be online by the end of the Q2 of this year. We took massive effort to set up the high quality medical registry, which also fulfills FDA requirements and is led by the world renowned sepsis researcher Professor Brunkhorst and his study sent at the University of Jena, Germany. This will give us the opportunity to quickly – very quickly collect data from nearly all treated patients on an international base.…

Unidentified Company Representative

Operator

Thanks very much Chris, and another topic on many people’s mind is the Air Force rhabdomyolysis trial and various programs such as DARPA. Dr. Chan discussed it briefly but Vinc could you please elaborate a little more regarding the progress of these programs.

Vincent Capponi

Analyst

Thanks Donna. As Phillip mentioned the Air Force Rhabdomyolysis trial has begun. We were approved last year July but we experienced delays in the clinic as a result of the sequestration that occurred in 2013, with these governmental delays behind us we are up and running. In addition, we decided to add a second site to increase the rate of enrollment and we are in the process of doing this now. We will bring this site on in the coming months as soon as the contract requirements and the IRB approvals have been completed. Regarding grants, I’m happy to say we’ve recently returned from the annul DARPA principal investigator meeting where we represented on our progress for year two. We’ve made good progress against our milestones taking down nearly $1.1 billion in DARPA grant funding and approximately $0.5 billion in other grant funding for 2013. Our progress in the program continues and we have supplied a small quantity of devices for testing by Battelle Memorial Institute, a systems integrator. We are encouraged by DARPAs continued interest in the CytoSorb technology and we looked forward to providing second and third generation bead technology to address toxins in addition to cytokines. Beyond DARPA, we’ve completed the Phase I SBIR for burn and trauma and received an additional Phase I grant from NHLBI or the HemoDefend inline filter and beads in the back. We continue to look toward new brand opportunities as a way of securing non-dilutive funding to advance research for Cytosorbents platform. Donna?

Unidentified Company Representative

Operator

Have the increases in sales impacted production and do we have sufficient capacity for the near future at our existing facility?

Vincent Capponi

Analyst

Okay, great question. Our quarter-over-quarter growth continues to gain momentum and with an average increase in excess of 50%, but this increased growth comes in need to increase production to assure product availability for our customers. As such we are adding additional production staff to increase our output to address the growing demand for CytoSorb. Regarding plant capacity, we believe we have sufficient capacity to meet our needs into 2015, however from a manufacturing perspective our need to consider new facility is not far off given the lead time to bring on a new plant online. We have begun engineering layouts to model various plant capacities and cost scenarios to better prepare for future growth, the question that often comes up is why not outsource? This is a good question, and simply it revolves around the need to maximize production flexibility, control quality and know-how. Regarding flexibility by controlling production we control the schedule, if we outsource we are at the mercy of lead times and production scheduling associated with the contract manufacturer. In other words, we are not the only customers that contract manufacturer has, we have to get into queue. Product quality is critical to our success, production in our direct control allows us to focus on quality and ensure the expectations of our customers are already being met. Know-how in a highly technique business such as this is a critical part of our success. If we begin outsourcing our products, we must also outsource our know-how making it difficult to control trade secrets, for these reasons we have decided to keep manufacturing in CytoSorb in-house but we will continue to consider outsourcing as an option to meet additional capacity requirement as the business grows.

Unidentified Company Representative

Operator

Has the company made any progress in advancing the development of the HemoDefend product?

Vincent Capponi

Analyst

Hey, HemoDefend will fit nicely with; we will fit nicely in additional product line to be sold by our direct sales force in the ICU along the CytoSorb. Chris will speak to the partnering opportunities in a moment, but I believe likely, we will likely see the strategic partner for larger rollout of this product outside of Germany. Regarding development efforts for EBIT event, we’ve included resources for development in our 2014 budget and began more rigorous engineering efforts. Our intend is to develop a first generation western class three hemoglobin both are produced with high risk patient required in blood transfusion. At this point, we have develop prototypes and I’ve shown proof-of-concept with the technology. We can’t predicate to final end date and having an improved product, but we have made good progress and identifying to keep project milestones for critical path items for us to begin refining our development timeline. Donna.

Unidentified Company Representative

Operator

Thank you very much Vince. Let’s move to business development, Chris on the last call you talk about the Biocon product partnership and described how it will work? With the partnership now up and running, can you describe how things are going so far and what we might expect for the remainder of 2014?

Christopher Cramer

Analyst

Thanks Donna. Our partnership with Biocon is going very well, in fact many of our investors have noticed the positive remarks issued in the recent quarterly report. Early in the year, Phil and I met with Kiran Shaw, Biocon’s Chairman and Managing Director. After speaking with her, it’s clear to us that Biocon understand the CytoSorb value proposition and it’s putting the necessary resources into making our partnership successful. While Biocon is still in the beginning stages launching CytoSorb market demand has been favorable. Initial field marketing and sales efforts have commenced several major cities through the surviving assisted with campaign, Biocon has been able to highlight the team of prevention of sepsis and saving patients lives. Interest levels continue arise among the key opinion leader physicians and the success story so far have been instrumental for other insensitive to initiate treatment. More recently user meanings it helps per usage of the device and have raised interest levels to create a protocol in sepsis management and the roll of CytoSorb. In addition for reasons of proactively reaching out to Biocon telling more about CytoSorb and many of expressed interest and trying it in their hospital. As a result I am pleased to report the Biocon’s already excited it’s first sales projections within the first six months. The remainder of 2014 is shaping up to be very busy with several Biocon let’s formal targeted marketing and outreach programs and the developing key opinion leader support for CytoSorb, increasing product awareness, collecting usage in case study data and driving physician adoption. Biocon have announced they will create a separate dedicated sales and marketing team to ensure adequate attention is given to creating awareness of CytoSorb and educating physicians on the usage of CytoSorb. In addition, Biocon is developing a patient registry and evaluating different case studies for developing manuscripts. We will continue to swap Biocon by sharing data from our various studies in conducting fresher training throughout the year. Overall, we are very pleased with the Biocon partnership and look forward to continued success. We believe this partnership as potentially to change for treatment of critical care illnesses such as Sepsis and are confident that our work related ground work with expanded partnership in the future.

Unidentified Company Representative

Operator

Can you please comment on the progress towards establishing new strategic partnership for CytoSorb and describe where things stand relative to the partnership discussion you described on our last earnings call?

Christopher Cramer

Analyst

Sure. As I mentioned on our last earnings call, we’ve identified a key group of potential industry partners where we believe CytoSorb is a strong step from both the commercial and strategic perspectives. These partners have been prioritized for their ability to globally develop the market and maximize the potential opportunity for CytoSorb. Over the last quarter and throughout the remainder of the year, our BD efforts have and was focused on developing relationships with these key players. In short, we continued to see strong interest in CytoSorb from major strategic players. Conferences such as the German Cardiovascular Surgery Society, European Association with Cardiothoracic surgery, International Symposium on Intensive Care and Emergency Medicine, The JPMorgan Healthcare Conference and others have given us an opportunity to showcase CytoSorb and meet with virtually all of our target partners. I’m pleased to report that we continue to make good progress in establishing relationships with senior business leaders and advancing partnership discussions in both critical care and cardiac surgery organizations. While deals with large corporate partners can take some time to develop for many reasons, some outside of our control it’s most important that they recognized is the value proportion of our products and potential role in their future strategy, I’m pleased to say that partners are indeed responding very favorably to our message and our partnership discussions are definitely moving in the right direction. I'm encouraged by our progress to-date and I remain confident about the strategic partnership potential for CytoSorb and to other products. The business development team will be very active throughout the reminder 2014 and participating in industry conferences and advancing our strategic partnership objectives we hope to more positive news to discuss on future earnings calls.

Unidentified Company Representative

Operator

How about progress on strategic partnerships for Cytosorbents’ development program like HemoDefend?

Phillip P. Chan

Analyst

Turned on to everyone HemoDefend is our advanced development program for improving the safety and quality of transfused blood. As Phil mentioned earlier, HemoDefend has the potential to reduce a broad range of transfusion reactions by moving various substances such as free hemoglobin, bioactive lipids, antibodies and other contaminants commonly found in stored blood. HemoDefend is a multi-faceted platform technology with multiple potential opportunities in purifying blood components such as packed red blood cells, platelets and plasma in various clinical studies including blood collection, processing, storage and point of care transfusion settings. The first generation HemoDefend inline filter will target hospital-based customers for using high risk transfusion patients. Our goal with HemoDefend is to identify our partner to help fund and commercialize the platform. To that end we’ve been very activate in conferences like the American Association for Blood Banking, International Society of Blood Transfusions and many others, much like CytoSorb the value proportion for HemoDefend has been very positively received by potential strategic partners in the blood management space. In addition to BD efforts, we are taking steps to de-risk HemoDefend as Vincent talked about thereby making it easier and more attractive for a large partner to potentially enter into an agreement. For example, we made strides in advancing the product design based on expert user input, we continue to expand the data on a removable capabilities to research collaborations with groups such as NHLBI and we’ve confirmed the likely regulatory path for the first generation HemoDefend inline filter in both U.S. and EU. All these are significant accomplishments which further helped to increase the value of the HemoDefend platform and improve our ability to establish the strategic partnership. Finally, as Phil had mentioned in his presentation, we’re monitoring several important clinical studies which we believe to provide an additional positive tailwind to our partnering efforts. Most notably the RECESS and ABLE trials that Donna talked about, those studies are exploring the hypothesis that old blood is bad blood if they’re positive we could accelerate the need for blood verification solution such as HemoDefend. In summary, we continue to make good progress on developing and de-risking HemoDefend while investments like this take time, we’re confident that they will ultimately help increase the value of the platform and advanced discussions with strategic, potential strategic partners. Overall I’m very optimistic. Overall, I’m very optimistic about the opportunities that lie ahead for us for HemoDefend.

Unidentified Company Representative

Operator

Thank you, Chris. Well, we seem to cover what were the major questions, Dr. Chan any closing remarks.

Phillip P. Chan

Analyst

:

Operator

Operator

Ladies and gentlemen, this concludes Cytosorbents’ 2013 shareholder update conference call. If you would like to listen to a replay of today’s conference call, please dial 877-870-5176 and international dialers can call 858-384-5517. thank you for your participation. You may know disconnect.