This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk05: Good day, ladies and gentlemen, and welcome to the Orgenesis First Quarter 2021 Business Update Conference Call. At this time, all participants have been placed on listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, David Wallman of Investor Relations. Sir, the floor is yours.
spk00: Thank you. Good morning, everyone, and welcome to the Orgenesis First Quarter 2021 Business Update Conference Call. On the call with us this morning are Verit Kaplan, Chief Executive Officer, and Neil Reitinger, Chief Financial Officer. If you have any questions after the call or would like any additional information about the company, please contact Crescendo Communications at 212-671-1020. This conference call contains forward-looking statements which are made pursuant to the Safe Harbor provisions of Section 27A of the Securities Act of 1933 as amended, and Section 21E of the Securities and Exchange Act of 1934 as amended. These forward-looking statements involve substantial uncertainties and risks and are based upon current expectations, estimates, and projections and reflect our beliefs and assumptions based upon information available to us as of the date of this conference call. We caution listeners that forward-looking statements are predictions based on our current expectations about future events. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties, and assumptions that are difficult to predict. Our actual results, performance, or achievements could differ materially from those expressed or implied by the forward-looking statements as a result of a number of factors, including but not limited to the risks and uncertainties discussed under the heading Risk Factors in Item 1A of our annual report on Form 10-K for the fiscal year ended December 31, 2020, and our other filings with the Securities and Exchange Commission. We undertake no obligation to revise or update any forward-looking statement for any reason. I'd now like to turn the call over to Ms. Varad Kaplan. Please go ahead, Varad.
spk01: Thank you, David, and thanks to everyone for joining us on our call today. I am pleased to report we achieved 400% growth in revenue for the first quarter of 2021, which reflects the early success of our poor care strategy. I'll talk more about this in a moment. At the same time, we achieved positive operating income and maintained a solid balance sheet with $41.8 million of cash as of March 31, 2021. Let me take a minute to recap on our ProCare strategy. As discussed last quarter, following the sale of MasterCell, we have been hard at work implementing our ProCare platform, which we believe is the key to unlocking the full potential of the cell and gene therapy industry. Currently, cells are manufactured using centralized production, which is standard across the industry. However, this strategy has resulted in high costs for cell and gene therapies, such as the CAR-T therapies, which can range in the hundreds of thousands of dollars per patient. Our goal is to dramatically lower these costs through on-site processing of our therapies, which will support payer uptake and make these therapies more broadly available to patients. We believe this is a crucial step that is necessary for cell therapies to become widely available. Towards this end, our business is built around three key pillars, therapies, technologies, and networking. These pillars align the interests of the therapy developers, the hospitals, and patients in a way that has not been done before. Our method of operation is based on out-licensing of therapies from leading research centers and hospitals, adapting the lab-based processes to customized automation solutions, and integrating the combined process in our arm pools, which is short for Ogenesis Mobile Production Units and Labs. We have developed this approach based on a decade of experience in process development of such therapies and working closely with researchers from leading academic institutes as well as from biotech companies active in this space. To accelerate achieving our goal, we are setting up joint venture partnerships in order to rapidly deploy our point-of-care systems and capabilities around the world. In the U.S., we are working directly with the hospitals. Each one of these partners brings strong technical, regulatory, and local market expertise. Additionally, each of these partners have tremendous skin in the game as they are investing heavily in their side in personnel, regulatory, and clinical expenses, as well as infrastructure in the respective territories. Our reported revenues reflect just the first phase of our relationships with these local joint venture partners. based on long-term contracts we put in place to support the local clinical and regulatory goals. One might think of it as similar to a franchise model. In order to gain access to a particular territory, the partner commits to investing the required efforts to receive marketing authorizations and partners with us for the setup of the point-of-care operations. We provide them with a roadmap to therapies, R&D support, tech transfer, regulatory and clinical services, training, and access to our arm pools. All of the above are prerequisites for enabling supply of therapies at the point of care. They will continue to require this initial support, and though they may find local providers to assist them with all of the above, they benefit from receiving these services from us since we have developed so much internal expertise specifically in the cell and gene therapy field. The second phase of our revenues comes as a therapeutic pipeline advances. And the hospitals working with our local partners require production of cell therapies. As the products are sold to the hospitals and our partnerships are profitable, we will be getting royalty both on the sale of the products and on processing service. Once the initial validation stage is finalized, we expect our partners to expand their activities to additional sites and hospitals. Currently, each of our partners has several validation centers So revenues are limited to our joint activities in those sites, but we believe the incoming revenue is still sustainable. The second stage is the one which we expect rapid acceleration of our revenues, both from services as well as royalties to our genesis. We believe this is a highly scalable model, and rather than investing all the capital ourselves without local market expertise, we believe we have substantially de-risked our model by leveraging outside support from our regional partners. At the heart of our business model, our goal is to provide life-changing treatments to a large number of patients at reduced cost within the point-of-care setting. Initially, we are focusing on autologous cell-based immunotherapies, therapeutics, as well as therapies for metabolic disease, antiviral disease, and tissue regeneration. We have built a robust therapeutic pipeline, which includes more than 30 cell and gene therapies, and we continue to evaluate new therapies. Unlike a traditional biotech with a handful of therapies in the pipeline, we have access to many therapies and technologies, all at different stages of development through our growing partnerships with researchers, commercial entities, and hospitals. As an example, in March we entered into a second phase of collaboration with Hospital Infantil Nino Jesus in Madrid, with exclusive license to commercialize a cellular solid tumor therapy. The benefit we bring to therapy development through our ProCare network is highly valued by hospitals and biotech companies. We are a strategic partner that can enable the clinical development and support processing needs, while at the same time providing access to our entire ProCare distribution networks. We are also investing in new point-of-care technologies that can be integrated into our ampoules. These systems enable us to produce autologous cell and gene therapies along with viral processing capabilities directly at the point of care in a consistent and standardized manner in all locations. There are a number of advantages to these systems, such as a short setup time, they have a small footprint, and they lower the cost of production through automated operation and parallel processing. In addition, we designed them in a scalable and modular format so we can add capacity as the needs of the hospital and our local partners expand. The response from the industry has been very encouraging, especially at the hospital, where these samples allow medical institutions to overcome the historical challenge that have made it difficult to provide these therapies to patients in a timely and efficient manner. We can now do this without the logistical nightmares of dealing with a centralized production facility or the difficulty of building clean rooms in hospitals. We believe the AMPLs are an important step to quickly expand our capacity, and we look forward to increasing both the quantity and locations of our systems. In the meantime, we continue to grow our ProCare network, which now includes partnerships in various countries across North America, Europe, Asia, Latin America, Middle East, and Australia. As an example, we recently began a collaboration with the Bambino Jesu Children's Hospital in Rome to establish a point-of-care self-therapy center at the hospital. On one final note, I'm pleased to report that as announced yesterday, we received an investigational device exemption, or what's known as an IDE approval by the U.S. FDA to conduct the first in human feasibility study of the tissue genesis isolator 2 to treat acute respiratory distress syndrome resulting from COVID-19 infection. This is just one of the great assets we have benefited from the Collegor acquisition. In addition to systems and therapies, the Collegor team itself is a wonderful addition to our existing team, bringing in expertise and know-how that we highly value for many of our therapies. We look forward to providing further updates on the progress of this clinical trial. So to wrap up, I remain as encouraged as ever by the outlook for the business and proud to report we achieved a four-fold increase in revenue over the same period last year. I truly believe this revenue growth, combined with our healthy margins, improved cash flow, and solid balance sheet, all bode extremely well for the future. On that note, I'll now turn the call over to Neil Isinger, our Chief Financial Officer.
spk08: Thank you, Vered. Our revenues for the three months ended March 31st, 2021, were $9.4 million compared to $1.9 million for the three months ended March 31st, 2020, reflecting an increase in point-of-care development service revenue due to increased activity under our master service agreements with existing and new joint venture partners. Cost of services and other research and development expenses for the three months ended March 31st, 2021 were 6.1 million, compared to 4.9 million for the three months ended March 31st, 2020, representing an increase of 25%. The increase is mainly attributable to the continued expansion of our pipeline of licensed CGTs, the expansion of our POC, point of care capacity globally, further investments in automated processing units and processes, further development of owned and licensed advanced therapies to enable commercial production and additional work with partners to enable efficient closed processing system technologies addressing PO care needs. Selling, general, and administrative expenses for the three months ended March 31st, 2021 were $3 million compared to $3.5 million for the three months ended March 31st, 2020, representing a decrease of 16%. The decrease in selling General administrative expenses is primarily attributable to a decrease in accounting and legal fees as a result of decreased corporate investment activities in 2021 compared to 2020. In terms of liquidity, we ended at the first quarter of 2021 with cash and cash equivalents of approximately $41.8 million and had no long-term debt. Operator, we'll now open the call to questions. Thank you.
spk05: Certainly. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star one on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. And the first question is coming from Bruce Jackson. Bruce, your line is live. Please announce your affiliation and pose your question.
spk07: Hi, Bruce Jackson, the Benchmark Company. Congratulations on the strong quarter. At this run rate, if you were to continue this, you'd hit like $37 million or more for an annual revenue number. I know that with this business, it tends to be lumpy sometimes, for lack of a better term. So maybe you could just give us a rough idea of how the revenue might unfold for the rest of this year.
spk01: So, Bruce, thanks for the question. And so, you know, I always say this to shareholders and people. This is a business that should not be judged quarter by quarter. It's cell processing, cell development, cell and gene therapies. I would say more of a long-run process. But, you know, just looking at the work we have ahead of us for the next year, I would say it's going to be pretty persistent in terms of the support we need to give to our cell and gene therapies. I can't, of course, give a forecast on the numbers because we have not made any such forecast public. But I will say that I think for the next year and even more, we have our work kind of cut out for us. And we know what we need to do to support our partners. And these are long-term contracts, usually for a year or two. sometimes even more. So we're expecting to continue our activities and perhaps manage to grow them. But as, again, I explained before, we are focusing on our validation centers and really want to make sure our model is validated before expanding to the full capacity we think we can and hope to do so in the future. I hope that kind of summarizes the answer.
spk07: Oh yeah, I understand it's difficult to forecast, so just trying to get a rough idea of what's going on. And speaking of the validation centers, maybe you could tell us how many ampoules are out there right now and whether or not you have a target for how many ampoules might be out there, say, by the end of the year.
spk01: So we do have our internal targets, but again, this is not public information. Our aim is to have around 30 validation centers. How many arm pulls will be in each center is difficult to say at the moment. Some centers can begin work, by the way, without the arm pulls because they've got smaller systems of hours incorporated in the clean rooms, but others are waiting in line for those that have not received them. So we're trying to be as efficient as possible and make sure we spread out as quickly as possible. I think we will be able to answer all the supply needs we have this year. And as we kind of expand and get into more clinical work, we may need additional arm pulls at each site. But for now, I think we have our targets set, and I think we can provide the capacity needed.
spk06: Okay, thank you for taking my questions. I'll hop back in queue.
spk01: Thank you.
spk05: Thank you. And the next question is coming from Calvin Seto. Calvin, your line is live. Please announce your affiliation and pose your question.
spk04: Hi, Verit. Thanks for the great results. So when OJJC does well, I know it's a win for your partners and more importantly, the patients that you are serving. So I'm thrilled to be on this journey as your shareholder. So could you talk a little bit more about the overall progress for your CD19 and autologous insulin-producing cells in terms of the clinical trials? Are they progressing smoothly according to your timeline?
spk01: Thanks for the question and thanks for the support. So I think we are progressing according to timelines. And I'll begin with the autologous kind of insulin-producing cells because what we did as our strategy, our first strategy, is to expand the Coligo product, KyloCell, because we believe that's a very good base for our program. Once we have that expanded, we can add in additional cells to that. Because if you may remember, we have orphan indication for patients that have undergone a complete pancreatectomy. So this product is a first stage. This is already being sold in the U.S. and we are trying to expand the capacity of supplying this product through ampullizing this product and in parallel working on adding in additional cell types such as our API cells and other cell types to make this a more robust products for those patients who unfortunately don't have enough islets. So that's, I think, going according to plan, and so are our programs in Europe. We have had some difficulties in collecting all the biopsies of the liver cells because of COVID-19, but I think we're now ramping it up and coming back to our initial program, so that's going well as well. On the CD19 product, I think we have not announced which, so I can't say, but I will say that I think we have at least one major research center in each continent involved in this, and we're very much hoping to see this start getting into the clinical phase, and we're very excited about this, seeing if we can make these cells at a at a substantial decrease in cost as a validation of our platform, of our strategy.
spk04: All right. Thank you, Verit. I just have one more question as well. Given that KLSL is one of our commercialized products, could you share with us any developments on automating KLSL and expanding to more centers? And also, we'd like to find out When will CSL be available to more hospitals across America? Thank you.
spk01: So, thanks. So, we're still working on the automation and optimization of this product. We actually have a center who's already kind of chosen to be our validation center with us. We will have to do, of course, some comparability testing in order to approved this for use in the US and in parallel we're working on expanding and trying to get an approval for these products in other regions such as Europe or Asia which will take a bit longer because again this is a cell therapy utilizing islets and we have to go through a process but of course we have accumulated a lot of data from the US so I'm hoping that if we finish this process by this year by the end of this year we will be able to to expand. And I'm talking about the automation process, not the legislation in other countries. So I'm hoping if we finish the automation by the end of this year, we will have the ability to expand that capacity.
spk04: Alright, sounds really exciting. I just thought of one question because I was visiting your website today and I noticed that we hired this lady, this very experienced lady called Aisha. I think she's performing the role of a General Counsel and Compliance Officer. So could you share with us more about her focus at Orgenesis and also shed some light on the surrounding factors that prompted you to hire a general counsel? Is it because there's more negotiations now, especially in the areas of royalties and working with hospitals too?
spk01: Well, actually, Orgenesis is a wonderful lady and we're very happy to have her on the team. We did this move for making sure we're compliant with all our obligations and that we can have a very close kind of, I would say, control over all our activities with all our partners. And also to make sure in terms of different legislation issues that we are following all the regulations we should in each country, in each location. And also is doing a great job in kind of compiling all of this into a systematic approach, which will allow us to control our activities with each partner in each region.
spk04: All right, thank you. I just want to end off by saying that your team is always doing a great job creating affordable healthcare that's accessible to everyone. So once again, thank you, Verit.
spk01: Thank you. Thanks very much for the questions.
spk05: Thank you. Ladies and gentlemen, don't forget if you wish to enter the queue to ask a question, please press star one on your phone at any time. And the next question is coming from Megan Han. Megan, your line is live. Please announce your affiliation and pose your question.
spk02: Hey, Barrett. First off, I would like to congratulate you for such amazing first quarter results. And as your shareholder, I feel really happy to see how our genesis is going to impact lives all over the world. And I'm really glad to be able to speak with you today. So I would like to ask, how do you go about choosing which hospitals to place your OMPROs at, and how you expect the deployment and validation of your OMPROs to be in the coming year or so?
spk01: So thank you, first of all, for your cool words. Much appreciated. And as for your question. You know, that's part of the reason we have regional partners, because they really understand the region where they're working, and so they know which hospitals are the leading centers. I would say kind of the voices of authority in this space, that once our systems are, I would say, validated in this hospital, it really does serve as a kind of sign of excellence. So you can see this by activity also in the U.S. with JHU and UC Davis. We're really trying to choose the best hospitals that are also research centers because then we can work with existing researchers that have, in many cases, grants that do not allow them to cover actually the expense of making these products by working with an external CDMO. So by going there, we're actually solving more than one problem, right? We're also supplying our therapies but also helping them with their therapies, which is very important in order to push this sector forward. So we've really tried to choose in each region, I would say, the leading kind of hospitals in the cell and gene therapy space that want to expand and understand these therapies and also have the clinical teams that can implement these therapies in the clinical settings. That is not always trivial. As we go about the validation, as we are able to show that these units, our mobile units, as well as our therapies, are available at reduced price, and as we go through different clinical stages or through hospital exemption, no matter what the regulatory framework, once we have those in a more validated fashion, And validation doesn't mean the therapy needs to be approved. It means that we are continuously manufacturing, processing, supplying these therapies through our automated units. At that stage, then we can start expanding. Now, not for every hospital do we need to have clinical trials. Not for every hospital do we need to run through full regulatory process. Our goal is to do this through the validation centers and then just expand supply capabilities to other hospitals. So it will be, I hope, a much simpler process in entering and expanding. And as stated in our documents and our filings, we really want to focus on validation for the next year or two. We want to make sure we... kind of optimize our model. We are also in learning stage as we kind of set up this model. And I think once we do that, it will be much easier to just expand in the existing centers as well as open up new centers for us directly and for our regional partners.
spk03: All right. Thank you.
spk02: That's a really thoughtful business strategy, and it makes a lot of sense. I have another question. So for this quarter, we recorded a slight profit on a good level. So do we expect similar profitability going forward? Or is there scope for any improvement in your margin?
spk01: So during this validation process, our model is really based on a cost plus model. Remember, our goal here is not to squeeze out Distributors are partners as much as possible. Our goal is to actually support them in their regulatory filings and their achievements. So for any work we are doing to support them, we will continue using our costless model. And for work that is coming in from external sources that work with our partners or work done for the hospitals, I think we can slowly build up higher margins. But again, our focus as a geneticist is not just to make as much money as we can on each therapy. It's to make as many therapies as possible. So we're really focusing on expansion. Because even in the existing hospitals, perhaps we can charge much more. But our goal is to keep a sustainable model, so to allow for quick and healthy expansion. We would rather... make less money on many more patients than a lot of money on each patient. So I hope to sustain our model. We will continue in our validation model. And hopefully, our margins will improve. But our goal at this point is really the validation. The fact that even in this validation model, we can build a sustainable model is what lets us really I would say, optimize our system, our platforms, and our relationship to the hospitals as we advance towards market approval of these products.
spk08: And Megan, also just to, on top of that, for SG&A, just as far as that line item goes, we don't expect material changes in that either. Just like Barrett said, we actually expect that to be sustainable as well. So, except for Any other corporate transactions that caused that to fluctuate from last year, legal and accounting, we expect the same on SG&A. Okay.
spk02: All right. Thank you both for that answer. Also, building on what Kelvin asked earlier, apart from Kaiser Cell, may I ask what other therapies are there that we are likely to opulize in the pipeline over the next two years?
spk01: So we're working on MSC products, which are orthopedic indications. We're working on kidney disease. We're working on, of course, different wound healing, dermatology products. We're working on antiviral therapies. So we're really trying to amplifies everything we can get our hands on. Some will take longer. Some will be quicker. It really depends on how complex the therapy is. But we are focusing. This is a big focus for us in incorporating automation, incorporating different technologies into the ampoules. I think for the moment on clinical side, we're very kind of focused on, of course, the pancreatic project, on the immuno-oncology and dermatology, orthopedics. This is kind of our main focus at the moment. But in parallel, we're working on many other things that should be incorporated. Now, not every time do we need to begin all of the work again. Many of these therapies build on expertise built on existing therapies. So as we advance to more and more therapies, actually the amount of work we need to invest in ompulism goes down, so it's not as though we have to begin from scratch every time.
spk03: Thanks a lot, Vera. I just want to say that you are really doing a noble cause here, and you really have my full support. Thank you so much.
spk01: Thank you for these kind words. I very much appreciate it.
spk05: Thank you. And the next question is a follow-up from Bruce Jackson. Bruce, your line is live.
spk07: Hi. Thank you for taking the follow-up question. So yesterday you put out a press release about the IDE for the isolator 2, and I just wanted to clarify, is this like a new version of the isolator that you're working with, and what are the improvements that you've made to it?
spk01: So yes, there are improvements in usability and efficiency and safety in all aspects. It's just a better product. It's a closed system for making SCF. And this is the first time it's been approved for intravenous use for COVID patients. So I think that's a big step, just taking into account that to go through this IDE process The team has had to face a lot of scrutiny from the regulatory authorities. So I'm very proud of the work on this. And I think this opens up also a window to additional therapies that can be deployed by this system. We also have some other clinical trials ongoing and in preparation for the cells provided by this system. So I think it's a great milestone for us.
spk06: Okay, great.
spk07: And then last question is on the metabolically optimized T-cell program. Any update on that?
spk01: So in parallel to CD19, and we are working very hard on this and setting up sites that can treat patients with this, that can be involved in a clinical trial to validate the system. And we're still working with agencies, with regulatory agencies, which indications would be optimal and where we want to start our work there. Though we are hoping we will be approved at least in the clinical stage for multiple indications. So, yes, we're working on that. And I think hopefully it will follow quickly after the CAR-T product.
spk06: Okay. Great. That's it for me. Thank you very much.
spk01: Thank you.
spk05: Thank you. And we also have a follow-up coming from Calvin Sito. Calvin, your line is live.
spk04: All right. Hey, Nell. This is Calvin here. So I'm just looking at the cost of services and other research and development expenses for this quarter, comparing with the previous year, the same quarter, quarter one. So I did notice that our professional fees and consulting fees have actually gone up from 400K to about 2 million, whereas our other research and development expenses have fell from 2.8 million to about 800K. So could you speak about the nature of such expenses? Are both typically reoccurring or some of it could be like a one-off, especially for the other research and development expenses because it kind of dropped by quite a fair bit? Thank you.
spk08: Well, there's a combination of costs associated with all those expenses, right? Could be there's personnel, there's labor, So in some quarters that will go up, some quarters that will go down. You have development and clinical. You have license and royalties. There's various regulatory fees. There's consumables in there. So yes, from quarter to quarter, those may vary depending on the types of development services and tech transfer we do to support our partners, okay? So the correlation between those won't necessarily be linear. it will vary because the need that they have for our support varies. The difference here for this year is that obviously as we're generating more and more revenue, the need for what we do to support those services increases and so on, and the variability will increase as well.
spk04: All right, thanks. Just one more to squeeze in. In terms of the revenue that we are earning from our partners for providing the tech transfer, In terms of credit days, do we extend credit days to them? And if so, could you share with us, is it 30 days, 45 days, or 60 days? Thank you.
spk08: Yes, we do extend credit. And in most of the situations we extend credit, it's 150 days. Okay.
spk04: Is there any reason why it's so long? Because in terms of cash flow, maybe cash flow could be negative for quite some time because, you know, we have not, you know, if they don't pay within like 60 days or so, then, you know, we have to draw on our current cash in order to fund our operations. Thank you.
spk08: That is true. Just like any. Go ahead.
spk01: No, go ahead. Go ahead. Go ahead.
spk08: Yeah, that is true just like any customer that we have to monitor that carefully, whether it be a 30-day or a 60- or a 90-day customer. This has been traditionally our approach even since last year in terms of when we were generating revenue and which has proven out to be and so far in our trends has been those receivables being collectible. So our sales we had last year, 150 days into the period were collected. We collected receivables in this period that were from the previous periods on that 150 days. So we so far see the same trend going into second quarter and third quarter on those receivables, all right? But that's the way the MSA and way the relationships are structured, especially to as they develop as their partners in this sort of pioneering effort they have, okay? That may change in the future. We expect that potentially to change. But at this point, we don't see any sort of, you know, there certainly is cash flow risk on that with any company with any length of time they extend their receivables, but we haven't seen that thus far, okay? Sorry, Barrett, if you want to continue on that.
spk01: Yeah, and also I want to add that many of our regional partners, they generate their support from grants, from the clinicians, from the hospitals, and they need the time to generate their revenue. So in order, and this is a new model, a new business, and we do not want to put too much pressure on them. So we want to give them a chance to actually profit from the work we're supplying to them. And in many cases, grant authorities, you know, they'll take 90 days or even more, 120, just to see the expenses and then pay back cash and stuff like that. So we want to be sensitive to that.
spk04: All right, thank you. Now, Barrett, thanks so much for spending the effort to explain, and thanks for the answer.
spk01: Welcome.
spk05: Thank you. And the next question is coming from Anthony Marchese. Anthony, your line is live.
spk09: Hey, Barrett. Congratulations. Fantastic quarter, and you've put a lot of time and effort into this, and I will say in the time that I've known you, everything you've said has always been come true pretty much on time and exactly what you say. So again, congratulations. Two questions. One, can you discuss your activities or your backlog, if you will, with on tools in the United States? I don't know if you ever discussed that.
spk01: Well, I don't think we've discussed that, but I'm happy to discuss it now. So certainly the hospital we are working with are waiting for the ampules. Again, we have to kind of bring them overseas, so they have to travel. And I think they're very excited about the prospect of incorporating them. And, of course, we're working on the ampulization of the chylus cell project, which will go into additional centers. So that's kind of the focus of our activity. It's not that we intend to spread 100 of these over the U.S. in the next few months. We really want to focus on the centers we're working with. I don't think we've announced all the centers, just the two major ones. But again, our goal is to have validation centers and to make sure these ampoules are well located and I personally think it's better to expand more on pools in one site before expanding to additional sites. It's just, you know, in terms of overhead and achieving our goals, I think that's better. So that will be our focus.
spk09: Got it. Okay. And you do correct me if I'm wrong, but I believe in the last call, you guys said that you do have a share buyback in place. And if you do, have you made any purchases or plan to make any purchases under the plan?
spk08: We do have a share buyback in place, and we are continuing to make purchases because the threshold floor on that is roughly $4.50. You'll see in each filing, you'll see a disclosure that relates to how much we purchase each quarter. So far, in this first quarter, there was There was a one purchase. We've had a couple purchases whenever you see that level level that will take place. So whenever you see the stock activity in that area, most likely that plan kicks into place. Okay, so you can track that from last year's level. And then, of course, each quarterly as it occurs. Okay. Great.
spk09: And just final question. Are you seeing any more. I mean, given these results, I would hope that you would have more potential analyst following? Are you seeing any further interest, uh, in terms of, and I realize you don't need cash and so that's always an issue, but are you seeing any more interest from, uh, analysts at this point?
spk01: Yeah, go ahead. Go ahead.
spk08: Um, it's percolating. Yes, we did. We're seeing that we're, we've had, we've had discussions with, um, different institutions that are looking and asking more questions, which I think is probably an inflection point for us in terms of the exposure level we can get with those institutions and understanding our business, yes. Can I say, as far as analyst coverage, no. I mean, I don't think there's anything meaningful that has occurred that we can say that we can point to because we have certain analysts that are covering the stock. But as far as a larger base of investor and then institutional investment, we're starting to see that percolate. I don't know that it's coming at a like I said, meaningful level yet, but hopefully that is a trend that will continue. Okay. You might agree that that's going to be an important next step to have us resonate within the investment community. Okay.
spk09: No, I think given, given that your cashflow positive, I think that's a tremendous inflection point. And I think that, you know, you know, the fact that you're not burning any more cash, I think absolutely should be a catalyst for people to get involved in any case. Congratulations and keep up the great work.
spk05: Thank you.
spk01: Thank you.
spk05: Thank you. There were no other questions from the lines at this time. I'd now like to hand the call back to the Orogenesis Management Team for any closing remarks.
spk01: So I'd like to thank everyone for participating in our first quarter of 2021 Business Update Conference Call. We're very excited about the outlook for the business and appreciate the strong support of our shareholders. We look forward to providing further updates in our progress in the weeks and months ahead. Thank you. Thank you, everyone.
spk05: Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.
Disclaimer