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.
spk12: Greetings. Welcome to the Intel GenX first quarter 2023 financial results conference call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Stephen Kilmer. You may begin.
spk07: Good afternoon, and thank you for joining us on today's call. With me on the line are Dr. Horst Zerbe, Intelligent X's chairman and former CEO, Dwight Gorham, Intelligent X's newly appointed CEO, Andre Godin, our president and CFO, Dr. David Kadeko, the company's head of corporate development and strategic alliances, Dr. Frank Piatrantonio, our director of clinical research, and Tommy Kemi, our senior vice president and general counsel. Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars unless otherwise mentioned, and today's call may contain forward-looking information that represents our expectations as of today and accordingly are subject to change. We do not undertake any obligation to update any forward-looking statements except as may be required by U.S. and Canadian securities laws. A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks and results may differ materially. Details on these risks and assumptions can be found in our filings with the U.S. and Canadian Securities Commissions. I would now like to turn the call over to Dr. Zervais. Of course.
spk13: Thank you, Steve. Good afternoon, everyone, and thank you for joining us for the Intertenix first quarter 2023 conference call. On today's call, I will provide a corporate update and discuss the progress we have made on our key pipeline projects. Then André will review our financial results. Following that, we will open up the line for your questions. Before launching into an update, I would like to take this opportunity to welcome our newly appointed CEO, Dwight Gorham, to our team and to his inaugural Intergenics Index call. About a year ago, I informed the Board of Directors of my intent to retire as CEO of the company. The board subsequently appointed a succession committee chaired by Bernard Boudreau, which, after thorough search that was conducted with the help of the Montreal-based executive search firm Heidrich & Struggles, recommended that the board appoint Dwight Gorham as the new CEO of the company. On March 13th, the board accepted my resignation and unanimously appointed Dwight Warren as the new CEO, effective upon my resignation. I will continue to serve on the board and remain available to help the new CEO during the transition. Dwight is exceptionally well qualified to lead intergenics through and beyond its transformation from an R&D company to a successful commercial manufacturing operation. Dwight is an engineer by training. Most recently, Dwight served as president and CEO of Pillar 5 Pharma, a pharmaceutical contract manufacturing organization with a specialty in sterile ophthalmic products. Before joining Pillar 5 in 2015, he served as senior vice president and general manager of global operations of Pharma Science. Prior to that, he held a variety of senior roles, including President and CEO at AccuCaps Industries, a leading North American supplier of soft gelatin capsules, a variety of management assignments at the Borough's Welcome Facility in Montreal, President of GlaxoPharma, a Montreal-based CMO and supplier of parenteral and lyophilization products, General Manager of Baker Cummings and Director of Operations, at the Canadian arm of Glaxo, which is now GSK. During each of these assignments, he managed to significantly improve the financial performance of the company or the unit he was responsible for. While he's still just getting up to speed, Dwight has agreed to join us today on the call, and he will be available to participate in the Q&A session following our introductory remarks.
spk02: With that, I will now update on our key programs.
spk13: First on Akai, a phase one PK and dose escalation, PK meaning pharmacokinetics and dose escalation study using DMT buccal film is ongoing. Activities have also commenced to proceed with the next phase of the development which is a phase two step. Moving on to ResaPort, last month, the FDA approved our 505B2 NDA for Resafilm, the U.S. market name for ResaPort. Importantly, this followed a successful pre-approval inspection by the agency of our Montreal manufacturing facility in March of this year. This was a major milestone achievement for Intergenix as it was our first FDA approval for a film product that is based on our proprietary Versafilm technology and that was fully developed in-house. We certainly view this as an important validation of our Versafilm technology and will communicate this accordingly to our partners and investors. According to the American Migraine Foundation, 39 million, or 12% of Americans, suffer from migraine, which is the second leading cause of disability nationwide. Our partner for RezaFilm in the U.S., Jansco Pharma, is targeting the manufacturing of elevation batches, which would be the first available product for later in the year, and then full commercialization in early 2024. I should also mention that the FDA approval came with a request to develop and submit within two years to FDA for review and approval of five milligram pediatric version of the film. Recently, we met with Exceltis, our partner for Resupport in Spain. They reported great feedback from Custardly doctors and patients that have been struggling with significant product substitution at the pharmacy level. They are now working on a strategy to overcome the loss in sales, and Excelsis is waiting for regulatory approval to implement that new strategy. In January, we entered into an exclusive supply agreement where we support with R1 Pharmaceuticals Industries, Lebanon, SAL, and various countries in the MENA region. Moving on to Tadalafil, as we reported last quarter, there was a slight delay as our partner, Equestiv, had encountered some API-related issues for Tadalafil. However, the R&D teams from both companies worked diligently and formed a task force to address the issue. We believe that we have now solved the API issue and are preparing for manufacturing of the clinical batch. As for cannabis, The arbitration process involving till rate is currently in progress. As arbitration proceedings are confidential, we are unable to provide further details regarding this dispute at this time. We will promptly update our investors as soon as a resolution has been reached. Two words on Montelukast. We were able to add five more sites to this study And as a result, we've seen an increase in patient enrollment, especially in the last two months. We're targeting to end enrollment by July, possibly even earlier if the rate of enrollment has been as active as in the past two months. While enrollment in the ongoing Phase II Buena clinical trial in patients with mild to moderate Alzheimer's disease, or AD, is continuing. We are also now expanding the Montelukas repurposing program to include another major neurodegenerative disorder, Parkinson's disease, or PD. We believe that Montelukas versafilm has the potential to be disease-modifying in both AD and PD. In February, we announced the research collaboration with Dr. Pierre Svenningsen of the Karolinska Institute and plan to conduct a multicenter randomized, double-blind, placebo-controlled medical study to investigate the use of Monteluca's MRSA film for the treatment of bleeding. Dr. Svenningsen will serve as the lead principal investigator for the planned study and will sponsor it through a grant awarded by the Swedish Research Council in the amount of $2 million. Intergenics will supply Dr. Svenningson with both active and placebo films to be used in the 18-month treatment regimen for study participants. Upon completion of the study, Intergenics will retain the intellectual property rights and use the findings to further develop this program for PD treatment. We currently expect the study to commence in QC 2023, and we'll provide more details on its design at that time. Moving on to Xaromet, in April, we announced that ChemoResearch, who is agent and affiliate to Xaromet, received a complete response letter from the FDA regarding the submitted, abbreviated new drug application of buprenorphine buprenorphine. Euprenorphine buccal film is a generic version of Pelbuca, an opioid that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments are inadequate. Pelbuca was approved by the FDA in 2015 and is applied to the oral or buccal mucosa every 12 hours. Euprenorphine buccal film incorporates our Versafilm technologies in a novel formulation and is designed to be a bioequivalent lower-cost alternative for patients. Pyramid CRL response is expected in the current quarter. Lastly, animal health. In the fourth quarter, we entered into a new vetafilm feasibility and development agreement with an undisclosed animal health company for a vetafilm-based oral formulation containing CBD for use in companion animals. The results from the CBD study are expected in the current quarter. As the newly appointed head of corporate development and strategic alliances, Dr. David K. Deckel is also engaged in discussions with potential major animal health partners. And with that, I would now like to turn the call over to Andre for a review of our financial results. Andre?
spk02: Thank you, Urs.
spk04: Good afternoon, everyone. As Urs just mentioned, it's a few minutes to discuss the company's financial performance for the first quarter ended March 31st, 2023. On the revenue front, total revenue for 2023 first quarter amounted to $162,000 compared to $237,000 in the same period last year. The change is mainly attributable to decreases in R&D revenues of $63,000 and royalty on product sales of $12,000. Operating costs and expenses were $2.8 million for Q1 2023 versus $2.5 million for the corresponding three-month period of 2022. For Q1 2023, the company had an operating loss of $2.6 million compared to $2.3 million in Q1 of 2022. Adjusted EBITDA was negative $2.4 million for Q1 2023 compared to negative $2.1 million in Q1 2022. Our net comprehensive loss was $2.9 million, or $0.02 on a basic and diluted per share basis for Q1 2023, down slightly from a net comprehensive loss of $3 million, or $0.02 per share for the comparable period of 2022. As of March 31, 2023, the company's cash and short-term investment totaled $3.8 million. I will now turn the call back to Dr. Zerbe. Horst?
spk02: Thanks, Andre.
spk13: In closing, I'd like to once again recognize our team for executing on our long-term strategy. With that, I will now turn the call over for questions. I'd like to remind you that our forward-looking statements apply to both our prepared remarks and the following QA. Thank you.
spk12: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate that your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star key. One moment, please, while we poll for questions. We have a first question in the queue from David Nguyen, a private investigator or a private investor.
spk14: ...and see revenue.
spk03: Have we gone to the PBMs? Have we gone to... the wholesalers. I just want to understand the marketing plan or the commercialization plan for this product moving forward.
spk13: David, we missed the first part of the question. Could you please repeat the question?
spk03: Basically, I'm sorry. Thank you again for allowing this. Risenport's been approved. I just want to understand the commercialization plan of IGXT for this product because it's pretty significant to gain an FDA approval, even though it's a 505 drug. I'm just trying to understand, has the company contacted PBMs, you know, wholesalers? How are we going to distribute this product? How are we going to make it aware that it's on the market compared to the oral option that's out there?
spk13: David, do you want to respond to that?
spk10: Yeah, happy to. Hi, David. Thanks for the question. David Kudeko here, SVP, head of corporate development and strategic alliances. So we do have a commercial partner in the US that we've had for quite some time. That commercial partner is Gensco. So we are in active discussions as we have been since the inception or the execution of the contract. to a finalized commercialization plan. So all planning for this is well underway for the launch of the product in the U.S.
spk03: Are there any details you can give to how they're going to get this out to the wholesalers and make also like physician awareness channels which they're going to market this product?
spk10: I think it'll be more traditional type of sales and marketing efforts here. We're unable to really give more final details at this point in time with Gensco, and mainly because we're still finalizing the commercialization plans for the product.
spk13: David, I should probably add, because it's relevant for the timing of the launch, that we still have to conduct the process validation so we have to manufacture three batches and undergo a full process validation exercise with those that's a requirement by the agency and during that time we will finalize with our partner gensco in detail the launch and marketing activities.
spk03: So a final question I raised before, could we expect a 2023 launch?
spk10: David, do you want to respond? Yeah, I would say it's highly unlikely that we'll see a 2023 launch. It is possible, but just given all the planning that's involved to launch a product, you know, once approved by the FDA. I would say we're looking at sometime in 2024. Okay. Thank you for that.
spk03: In regards to Montelukas, Dr. Zirk, you've talked about the enrollment speed. It sounds very favorable. Say that you stop enrollment in July, when can we have the first set of data?
spk13: Frank, do you want to respond to that? Frank is our clinical director or director of clinical research.
spk14: Frank, you have to unmute yourself. Frank, can you unmute yourself?
spk04: Can anyone speak to the data? Yeah, I guess. Do you want to do it or do you want me to do it?
spk02: No, go ahead.
spk04: Yeah, so basically if enrollment is finalized by June, July, since it's a six-month treatment, then we're expecting the trial to be over by year end or early Q1. So data should be available late Q1 or early Q2 of next year.
spk03: All right. Thank you so much.
spk12: I don't have any more questions.
spk04: Thank you.
spk12: Our next questioner comes from Abraham Shapiro.
spk08: Yeah. Hi. Good afternoon, Andre and Horst. I like the news of the product development, uh, the past quarter. So congratulations on FDA approval. My, my concern is, uh, cash on hand, you know, uh, what can we expect, uh, for a raise? That's, uh, Andre.
spk04: Yeah. I hate, uh, thanks for your question. Um, I think, you know, we're, we're very cautious and patient because, uh, you know, the stock price, obviously, but we have multiple options. We're looking at multiple options. We will have to raise money at some point. Right now, you know, we're managing the cash very carefully. But, you know, I wouldn't worry. We always find ways and we'll find ways again. But, you know, we're expecting some good catalysts to come in the near future. So, hopefully that can give some momentum to the stock and we can raise money at a higher level because as you can see, the stock price is pretty depressed right now. I mean, the entire market, but especially small cap. So, you know, we're being cautious, but, you know, we have a plan and we have multiple options.
spk08: Okay, because I saw, you know, your partner requested It's stock has risen nicely the past quarter. I'm looking forward to that happening until Gen X. I have a couple other questions. Gensco, your partner, are they going to make some sort of announcement, some sort of public relations announcement, put something on their website?
spk10: That's a good question. I mean, Jensco is a private company, so there's likely no press release issued. As far as products available on their website, I mean, yeah, I mean, that's not a bad idea either.
spk08: Because if you go on there, there's no mention of, you know, of Intelligenix at all.
spk10: Yeah, I mean, you know, to their defense, however, I mean, the product was just approved, you know, two to three weeks ago, so... We'll let them breathe a bit. But we have regular communications with them, and I think that's a good idea. Thank you.
spk08: That would be good. That's a welcome to Intel GenX. Best of luck. Dr. Zerbe, enjoy your extra time. That's all I got for now. Thank you.
spk12: Thank you. Thank you. We now hear from Hugh Kiley. A reminder, if you would like to pose a question, please press star one.
spk11: Just to follow up, good afternoon, everyone, and welcome to the new members that join the Intelligenix family. Excited to have you on board. Just a couple of follow-up questions, and I'll go back in the queue, is regarding the Gensco rollout and with the comment that David made as the normal sales process. Any idea of the number of sales people that they have in that organization? I know it's private, so the information is limited in scope. Just wondering how they're going to tackle the major U.S.
spk10: Yeah, no, thanks for the question. I mean, it is a fairly smaller organization. I'm not sure the number of employees that work there that wouldn't be considered public information, but I would say it's not necessarily even the number of salespeople they or any organization would have in commercialization. It's where is the product going to be positioned as far as effort allocation is concerned. And this will become one of their top priorities as an organization. So we're very much looking forward to working with Gensco at this point. But as far as, again, I don't know if I would be focus so much on solely at least the number of salespeople. Just, you know, back to effort allocation.
spk11: Okay. The follow-up to that one is the other countries that have partnered with Intelligenix, the RISPOR, any update on South Korea or the ANWR territories?
spk02: Yeah, the R1. I'm sorry. Go ahead, Taylor.
spk10: I was just going to say there's no real update to R1. All I can say is that there are ongoing negotiations and discussions with all of the above that you just mentioned. Okay.
spk11: And consistent with the Visipor, any details of the product substitution and packaging that there are? excelsis experience in spain and we have an estimated time frame where that would uh everyone was pretty excited with the rollout and you know 18 months ago just do they see a light at the end of the tunnel on that david i'll horse they'll leave that one with you yeah um what excelsis um has done there is um
spk13: change the packaging format in such a way that it would prevent substitution at the pharmacy level. They submitted that a few months ago to the Spanish regulatory authority and they're waiting currently as we speak for approval. When the approval will be issued. Obviously, I can't tell you, but I know it's pending. Excelsis is waiting for a response from the authority, and then immediately after that, they will transfer that into the market.
spk11: With that issue that was in Spain, Dr. Zebi, would that be a challenge in the other countries that Excelsis has the the way to commercialize in Europe?
spk13: I would think so. We don't have any specific knowledge about that, but I would certainly think so. I mean, Exceltis has been around for some years, so I think that they will learn from past experience and not commit similar mistakes in other jurisdictions. But that is... Speculation on my part, we haven't discussed that specifically with them.
spk11: Okay. Thank you for that response. And then follow-up on the fourth quarter call was any update on the discussion with a company that would be potentially replacing PAR for Suboxone?
spk13: That discussion, and I know what you're talking about, I don't want to, actually I can't disclose that potential partner. That discussion is currently on hold because bankruptcy proceedings have still not been completed and so we have to wait until that process has come to a closure in full because only then will the asset become available. We have in the meantime and our potential partner for that has in the meantime confirmed with PAR that the asset would be available. So I assume that once the process has come to a conclusion, that those negotiations will resume.
spk11: Okay. It'll be hard to put a timeframe on that, I imagine. Same as the ENDO project that we discussed on the last fourth quarter, the undisclosed ENDO, is that still terminated or tabled or ended?
spk13: That was the second program that we had with endo slash par. That program unfortunately at this point is on hold. We have not at this point anyways found an alternative partner to continue that program.
spk11: Is it still a potential product that would be attractive to somebody? Do you believe? Or is that may be shelved?
spk13: It depends on how the sales of the reference product develop. Until a few months ago, the sales of the reference product, the brand, were lagging behind expectations And I haven't checked recently as to whether there has been any, at least say, significant improvement. So that's really all I can say on the comment on that one.
spk11: Okay. Two more, then I'll go back in the queue. The transdermal patches, discussion still going on in that unique product?
spk13: Yes, that is still going on and it is the likelihood that that negotiation will come to fruition has increased. We have received a provisional informal notice of acceptance by our partner. So there I'm very confident that this will come to a positive result. David, if you want to comment further, that would be the extent of my comment.
spk11: Thank you, Dr. Zerbe, as always.
spk13: Thank you.
spk11: Did you have no comment, David?
spk10: Yeah, yeah, no, I thought we were moving on. Yeah, I did want to make a comment that that is something from a business development side. That is something we're pitching to potential clients. And I know that there is interest just in, you know, in my short time that I've been here, it's come up several times with potential partners. So the transdermal technology is definitely a positive asset that we have within our tool bag at Intelligenix for future potential partners.
spk11: And the other one that's in your tool bag, David, is Loxapine. The last call, there was potential discussions going on with an interested partner. Is that still active?
spk10: I'll put this one back to Horst again.
spk13: Yeah. On Loxapine, there's no progress to report. uh, since last quarter. Um, we, we will reach out, but quite frankly, um, because of obvious reasons, you know, for, for the, for the past couple of months and the, the focus has really, um, more been on, um, on, on the Zahramit activity on, uh, on, uh, on, on resupport and, and related aspects. Um, Loxapine has not been pushed to the side, but it has not received much attention over the past quarter. It continues to be an important and, as we think, very valuable asset. And as soon as BD finds the time, they will proactively continue to reach out.
spk11: All right, and one last one, then I'll go into the queue. The Bell Booker with the CRL and then with the challenges with the other company, I follow that pretty closely with the legal issues. Is there still four indications with your partner that would be developed for the marketplace for doses, or has it changed?
spk13: No, that hasn't changed at this point. That's still the case. I mean, eventually, the partner plans to commercialize all strengths, but for the moment, the focus is on those four strengths. But, I mean, the reality is the sales volume of those two strengths that we are not actively pursuing at this point is in the 10% range, so it really wouldn't make much of a difference. Those two low strengths are mostly used in the initial phase to titrate patients up to their final maintenance level. And so that's why they don't play any significant role sales-wise.
spk11: All right. And then last, I'll go in the queue on the VETA film. Is it three companies that we're in partnership with or just two with multiple programs?
spk13: Yeah, David, I'll pass that on to you.
spk11: I'm sorry. Can you repeat the question? On the Vetafilm partnership, David, is it three companies or just two companies with multiple programs?
spk10: All right. Well, there's multiple programs ongoing right now. We do have, there's a couple of them that we're deep in discussions with and hope to have an update for you once they do, if they become public over the next little while.
spk11: Okay, but is it still two companies or more than two that are under a partnership or a contract for trials? Yes.
spk10: Yeah, we have the University of PEI, Prince Edward Island in Canada. And I believe there's another one, and I'm not sure if that's been made public, and that would be for CBD in dogs.
spk13: So there are two. I can confirm that it's forced to confirm what David said. We're actively talking to two companies, and then in addition to that, we are... a study with University of Prince Edward Island.
spk11: Okay. Okay, I'll go back in a queue. Thank you for your responses and taking my questions.
spk13: You're welcome.
spk12: We now hear from Brett Geeky.
spk05: Yes, I was wondering, I think Andre had mentioned some catalysts coming up that he thought would boost the share price. I mean, If an FDA approval wasn't a catalyst to boost the share price, I mean, what do you all have coming up that you think is going to do some good to the share price?
spk13: I mean, we have significant catalysts coming up. I can only confirm what Andre said, but for obvious reasons, we cannot provide any details. So I'm I apologize for that.
spk05: And these are in 2023? Oh, yeah, in the near term.
spk02: Okay, one more question.
spk05: Go ahead. Have you guys entertained at all a reverse split or anything to try to get the share price up to maybe attract... Investors, I'm sure, at a barely over 10% share price, there's a lot of investors that are not attracted to that.
spk13: Not seriously. I mean, the stock is being... Andrei, you're welcome to comment further, but we think the share price is right now massively manipulated. And so we're not contemplating a reverse split at this point. Andre, feel free to add to that.
spk04: Yeah, I don't think that the reverse split would be an answer. If we were to at some point uplift the NASDAQ, that could be helpful. But at this level, I think that what we need to do is really execute on our front Like I said earlier, there's some catalysts coming. Work with our group and orphan program to get it approved. Launch product on the market. And I think that will definitely make the stock appreciate. And since there's a lot of short on the stock right now, we basically need to squeeze the short. And the only way to squeeze the short is by executing properly and announcing very tangible news. And that's what we're working on right now.
spk13: And increase volume with that.
spk14: Yeah.
spk05: Right. Okay. I guess I just would have expected the RIS announcement to have done that a little more than, obviously it didn't do it at all as we've gone backwards, but I appreciate you guys' information. Thank you.
spk12: Our next questioner is Badi Zenedai.
spk05: Hi, good afternoon, gentlemen. My first question is in regards to the CRL that was received by chemo. Per your press release, you said that chemo received the CRL, so is it fair to assume that the CRL has nothing to do with the actual film and stability and more of like a packaging technicality on the partner's end? And if you can shed some light on the CRL.
spk13: There is... Let me just think how to properly respond to that. There is one tox-related question that our partner, however, thinks to be able to respond to within an acceptable period of time.
spk02: And then there was
spk13: another comment that we quite frankly don't understand because we believe that we provided the information to the agency and that's you know the main reason as to why our partner has filed a request for reconsideration okay so it's like just
spk05: To sum it up, the CRL had nothing to do with, for example, the stability of the film or anything to do with the manufacturing part of it. Is that safe to say?
spk13: It has got nothing to do with the manufacturing and or the stability. That is correct.
spk05: Okay. The next question that I have is in regards to heritage and your CBD films. Any update on that with like new orders from Heritage? How is that whole process going, like from sales and so forth?
spk13: Yeah, David, I would prefer if you responded to that. You met with them just a few days ago, so please.
spk10: Yeah, so the Heritage agreement is still proceeding. The purchase orders, we hope and expect, will come in short order. I mean, if you follow the Canadian market at all, where the deal is for at this time, the Canadian markets in general within cannabis is just not produced to the level of expectations that a lot of investors and analysts had initially predicted. So moving forward, while we're optimistic that Heritage will continue to place additional orders, It's not, we don't necessarily hold the same level of grandiose expectations for the Canadian cannabis market as potentially historically some of my predecessors did.
spk05: Okay. All right. And the next question that I have is in regards to the Rizoport Versafilm approval that you recently got. Was Intel GenX expecting any sort of royalty payment upon FDA approval from Gensco? Was that in the contract?
spk13: There's a payment due upon shipping first commercial batch, if I remember correctly. Is that correct, David?
spk10: There's actually a payment due from the time of FDA approval. And yes, that's contractual.
spk05: Okay.
spk04: And my last... Right now, but yeah, exactly.
spk05: And this will be reflected in Q2? Yeah. Okay. Is there any way that you can shed light on roughly like, is it like a six-figure, seven-figure royalty payment?
spk04: It's six figures.
spk05: Okay. My last question is in regards to the R1 pharmaceuticals and that whole contract that you have with them. Since the RIS report just got FDA approval, are you going to be supplying the RIS report to those nations directly from your manufacturing facility in Canada?
spk10: Horst, I'll give this to you, but my understanding is that we're currently assessing different parts of the agreement, but if you have other information, Horst, please feel free to chime in.
spk02: Yeah. The deal was negotiated on the basis of the European approval, so
spk13: For the most part, the product would be manufactured by our manufacturing partner in Europe, and we would receive royalties. However, we do have under the guarantee option of manufacturing the product ourselves.
spk05: Okay. All right. I just wanted to touch base on one thing that was mentioned by a previous caller and what Andre was saying in regards to possibly considering a reverse SPIT. I just want to say that I think Intelligenics has come a long way on its own, and I highly, highly don't entertain the idea of a reverse SPIT. the results and the execution of this company will speak for itself and it will eventually get the company to the fair valuation where it needs to be because it's highly undervalued right now. And I think the company, what you guys are doing, focusing on execution and not just manipulating the stock price just to make the company look appealing. I think what you're doing is an amazing job. And we've been supporting you for all these years. I've been with Intel Jones for like 11 plus years. And I believe in the company. And I think, you know, we're at the finish line.
spk13: First of all, I really appreciate the comment. Thank you so much. But then what I really want to stress, we're fully on board with your assessment. I mean, we have discussed a reverse split several times and we have every single time come to the same conclusion. This is nothing that we would seriously entertain, and going forward, I cannot see that to be changing at all. André, if you want to add to that, please go ahead, but my position on this is very clear.
spk04: Yeah, I mean, if I may add, I already commented on that, and I think that We're fully aligned with your comment here. And the only way that we would contemplate that is if the stock was much higher and it would be to migrate to NASDAQ. But right now, it's totally out of the question to contemplate any reverse split. I got you.
spk05: I got you. And congratulations to you guys on the Resupport approval. And welcome to Dwight, to the company. And we are supporting you, and we are fully behind you, and we believe in the vision that Intelligenix has.
spk12: Thank you very much for your support.
spk05: You got it.
spk12: Thank you. We have Hugh Kiley back on the line.
spk11: Dr. Gerby, first of all, my apologies for not recognizing you and the company and the successful success FDA approval of Vizipor. I dropped the ball on that one. So congratulations to you and all your team members on the continued long focus on that successful journey. A couple questions I have. A couple of follow-up questions on the cannabis film with the... market acceptance of the film of the slowing down and that does the Intent still to focus on the the adult use or the medical cannabis. Where do you see the biggest market opportunity?
spk10: Y'all take this one I think I mean without question the bigger opportunity is within adult use in Canada as opposed to medical that said there's a much higher price point in medical too, so I We're opportunistic as to which market to target. But to be honest with you, Hugh, this isn't so much around what Intelligenix is going to be focused on. It's more a matter of what Heritage is going to be focused on, our commercialization partner. And they deal in both sectors within the Canadian cannabis market, both medical and health use.
spk11: Okay. And then the... Expansion, I know we've been in Australia and Canada. Is there any other countries with heritage on the horizon and or other partners? Just taking the same five countries outlined on the investor presentation?
spk10: I don't know which countries or when that investor presentation was compiled. But like I said, as I just started a month or two ago, I'm in the process of reevaluating a lot of previous business opportunities and where we're going to invest business development's time and effort. And cannabis is certainly one of those areas that I'm keeping a close eye on. That said, keep in mind, we do have the potential arrangement with Tilray subject to the outcome of our dealings with them. So as far as additional countries, you know, the U.S., uh, right now is likely not going to happen just because of the legality, uh, there. And then Australia is still relatively small markets, certainly maybe parts of Europe. Um, but Canada is, is really the focus at least, uh, for right now.
spk11: Okay. Thank you for that one, uh, David. And just on the, uh, the, the old cannabis or film, there's a handful of other companies out there. Any of them that you see is, uh, a strong competitor to Intelligenix product?
spk10: To be honest, I haven't seen any oral film strips in cannabis. So I would have to do some more due diligence if others exist. But yeah, to my knowledge, I don't know of any others, at least not in Canada. In other areas of the world, that could be a different story. So yeah, I'll leave it at that for now.
spk11: That was a very good answer. Pardon my humor. Dr. Zuby, any interest in partnership with anybody with your major repurposing effort, Monte Lucas?
spk13: We're waiting until we have initial results actually from both studies. I mean, the Buena study is... nearing its end so early next year second quarter first second quarter we will know the outcome and will then in earnest start our outreach we had in the past discussions with alum with a number of companies big pharma certainly amongst them and with no exception the message that we received was we're interested, but show us the data. So with that in mind, we haven't seriously entertained any outreach activities, you know, while the Buena study is still ongoing. I suspect that with the Parkinson's study, It has not even begun. It will be similar. However, the situation is different in so far as Professor Swenningsen, the lead investigator of that study, already conducted an efficacy study with Montelukast in 40 patients and found significant level of efficacy which prompted him to design this much larger study and if I recall correctly in 170 patients so there we have very good evidence that the molecules is in fact effective in Parkinson patients so there The outreach might start sooner.
spk11: That's very good news. That would be very good. Last question, Andre, is regarding some of the prior questions on the catalyst in the air. The catalyst you were indicating over and above Rizepor and Belbuca, or is there something else maybe in the horizon?
spk04: Yeah, it's something else. I mean, obviously, we're working on multiple fronts. BD is very active. So, I mean, you know, of course, we want this Ripper North film to be approved and launched. That's a priority because it represents, you know, great volume, great revenue for us. But, you know, the focus is also on other things. As you can see on the corporate presentation, And hopefully we can have some catalyst there as well in the near term. Okay.
spk02: That's all for me. Thank you all. Thank you. You're welcome.
spk03: David Wynn. Yeah, thank you. Just one more quick question. You know, it's great that we have a new management team in place. Is it safe to assume for the next earnings call, that they will be up to speed on all the company's operations. And I know, Mr. Kardeckel, you mentioned that you're going to look at past programs. Will it be an update on future programs based on what you will be seeing in the past and maybe some of what Andre said, what other programs you're looking at in terms of business development? I just want to make sure that when we come to this next call, it's clear cut. It's not a lot of going back and forth. and we have our new CEO speaking to the investors.
spk13: Yeah, that one I can confirm. The new CEO will be actively running the next investor call. That I can say. I would have mentioned that in my concluding comments, but since you asked me that, that I can confirm.
spk02: Thank you.
spk12: Abraham Shapiro.
spk08: Yeah, just one last thing. I just want to mention that I'm really happy of the results this past quarter and congratulations. And certainly the share price is way undervalued in my opinion. You know, I went in as I nibbled for some more at this price. But I'm 110% behind not doing reverse split. I think a reverse split plays into the hands of the shorts. And I'm with you 110%. Please do not do a reverse split. Best of luck to all. Thank you.
spk13: No worries, Abe. No worries. Thank you, Aiden. Yeah. Dustin Foster.
spk01: Hi, gentlemen. A quick question and quick comment. The question is about the arbitration with Tilray, and I understand you can't say anything in terms of substance content. Can you give any color on timing, either what would be agreed to going in when a decision would come, or anything else without violating your oaths, to give us a little idea on progress or timing?
spk06: I mean, the only thing I can tell you is that the most likely decision would come in the fall. As far as we can go, this is highly confidential, and that's the reason why companies decide arbitration instead of court processes. If we were in court, I could give you the full picture, but now I just don't want to hamper our position.
spk01: Of course, and that's fine. That is helpful, and thank you. Finally, I was a shareholder many a year ago and have just recently joined you guys again. And at that time, several years ago, I think a reverse split, you actually had authority for it from the shareholders and decided not to do it. And I think that was one of the boldest and wisest things you gentlemen did, because most small cap money losing companies think that that's the answer. And, of course, as we know, the original share price after reverse split goes right back down within eight months or ten months to where it was. The market cap is one-tenth of what it was. And even being part of the NASDAQ is overrated because the dark pool trading, off-exchange trading, is there, too. So I just want to congratulate you on that decision years ago. and affirm that your ongoing decision not to entertain it or even contemplate it is smart and wise and, at that time, bold. And thank you again. I look forward to good things this time, although I lost a little money with you guys years ago. So thank you again. Thank you.
spk02: Thank you. Doug Bistler.
spk09: Hello. I just want to thank... course for being accessible and and congratulating on his retirement and leadership and vision over the years and welcome to the new management team I have a question what what product or products in the pipeline has the most potential to generate the revenue that's needed to place the company in a break-even position the quickest David
spk13: I think that's one for you.
spk10: Yeah, I was going to take that. So that's a good question, and that's part of our exercise in defining which of the business segments we should be targeting with a priority basis. What I can tell you is that Risa, with launch into the U.S., is likely not going to be the highest potential revenue-generating opportunities. That's not to say it's still a major priority for the company. One of our top priorities is But as far as drugs that are approved, you know, if and when we address the CRL with our partner with Zyromed, between that and Reza, those are going to be two of the most important products to the company. But then you look at other potential products as well that we have within our pipeline to Dalafil being a very important product used for ED. And then another area, when you look at and when you talk about profitability, it's one thing to talk about revenue, but it's another thing to talk about margin. And that's something that we have to be very shrewd and careful with in defining what are the highest margin types of segments and businesses we target. And one of those areas is our CDMO opportunity. And that's a pivot that was undertaken several months ago. where we hired another business development member as part of my team. He's really mostly focused on CDMO outreach and generating new business from that avenue. Moving forward, I expect you'll be hearing more and more about that on the next and subsequent conference calls.
spk09: Thank you. One other question you may or may not be able to answer, but With regard to legal expenses on the litigation regarding Tillery, have those expenses been high, and does the company have the ability to recapture any legal expenses should they be successful in the arbitration settlement?
spk06: Maybe I can answer that. Arbitration, contrary to court, is a process where you can normally recoup legal expenses. That means at the end, the arbitrator will rule on legal fees as much as the substance of the case.
spk09: Thank you.
spk02: That's all I have. Thank you, Kylie.
spk11: A quick question for Tommy regarding your comment with Tori. you know, somewhere potentially in the fall. Is there potential that could be sooner that, Tommy, if an agreement is worked out or settled?
spk06: We always hope that something can happen sooner, but to answer the question, we don't have anything that would give us any indication other than sometime in the fall.
spk11: Okay. Okay. That's it for me.
spk12: We have reached the end of the question and answer session, and I will now turn the call over to Horst Dessert for closing remarks.
spk13: Thank you. And this concludes our first quarter 2023 investor update call. I would once again like to thank the entire Intergenix team for its hard work and dedication, all of the directors for their continued support of the management team, and finally, our investors for continuing to believe in and supporting us. And on a personal note, I would like to reiterate what a pleasure it has been steering this company to this pivotal stage, and I look forward to continuing to contribute to its success as chairman. Naturally, going forward and in future course, as I previously mentioned, Dwight will lead these calls instead of me. And as my last comment, there is really no doubt in my mind that I'm passing the torch into the right habits.
spk02: Thanks to everybody and goodbye. This concludes today's conference and you may disconnect your lines at this time.
spk12: Thank you for your participation.
Disclaimer