IntelGenx Technologies Corp.
Q4 2021 Earnings Call Transcript

Published: 24 Mar 2022

[Operator:]

Good afternoon, ladies and gentlemen, and welcome to the IntelGenx Fourth Quarter and Full Year 2021 Financial Results Conference Call. At this time, all participants have been placed in a listen-only mode. We will open the floor for your questions and comments after the presentation. It is now my pleasure to turn the floor over to your host. Steve Kilmer. Sir, the floor is yours.

[Stephen Kilmer:]

Thank you. Good afternoon, everyone. And thank you for joining us on today's call. With me on the line or Dr. Horst Zerbe, IntelGenx CEO, Andre Goden, our President and CFO, Tommy Kenny, our General Counsel and Dr. Dana Madson, the Company's Vice President of the Business and Corporate Development. Before we begin, I would like to remind you that all amounts mentioned today are in US 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 US 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 the risks and assumptions can be found in our filings with the US and Canadian securities commissions. I'd like now to turn the call over to Dr. Zerbe. Horst?

[Horst Zerbe:]

Thank you, Steve. Good afternoon, everyone and -- fourth quarter and full year 2021 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 today we'll review our Q4 and full year 2021 financial results. Following that, we will open up the line for your questions. First on our atai partnership in March of last year, we announced our strategic partnership with a atai Life Sciences, which has positioned us as a leading developer and manufacturer in the psychedelic therapeutic space while also providing the financial capacity to continue progressing our pharmaceutical film product candidates towards commercialization. In connection with this partnership, atai acquired approximately 25% of IntelGenx for approximately $12.3 million and granted us an initial secured loan in the amount of $2 million. atai subsequently granted us a second secured loan in the amount of $500,000. In May we entered into a second feasibility agreement with atai for the development of novel formulations of Salvinorin A, a naturally occurring psychedelic compound based on IntelGenx's primary film technologies. In September, we entered into an amended and restated secured loan agreement with atai, which committed $6 million in future financial support to IntelGenx. This loan was required for us to meet certain requirements in conjunction with our uplifting up-listing to the TSX big board. Our stock began tradinge on Canada's most senior exchange on October 7. Our graduation to the TSX marks an important milestone for IntelGenx and should support the development of a stronger profile in the investment community. Last month, we received a third term loan from atai in the amount of $3 million. We look forward to continuing to work with ATAI, to develop more efficacious treatments for patients with treatment resistant depression and other mental health indications. Moving on to RIZAPORT, in September, we were pleased to announce that Exeltis our RIZAPORT commercialization partner in 27 European Union countries launched RIZAPORT in Spain. This was the first versa film based product to launch in the global pharmaceutical market and was a major milestone for IntelGenx. With the European migraine drug market expected to approach $1.5 million by 2024, we are looking forward to working with Exeltis to launch re supportRIZAPORT* in additional European countries in the future. Two Few words on Tadalafil, in September, we announced that Aquestive Therapeutics our co-development and commercialization partner for Tadalafil oral films entered into a definitive license and supply agreement with an undisclosed leading men's health company. This is an important development in our collaboration with Aquestive that will help make Tadalafil oral films available to men's suffering from erectly erectile* dysfunction and benign prosthetic hyperplasia or BPH. On cannabis films, in February of last year, the United States patent and trademark office granted a notice of allowance for our US patent application covering novel disintegrating oral film formulations designed for the transmucosal absorption of drug, especially Tetrahydrocannabinol or THC. This patent is intended to protect our DisinteQ* products, which enable THC absorption via the oral cavity, thus minimizing the amount of THC that becomes subjected to unwanted oral first pass metabolism. In August, we transitioned from a development to commercial stage company by completing our initial shipment of CBD Filmstrips in support of Heritage Cannabis launch of the CB4 four control brand in Canada. We're looking forward to continuing to work with Heritage on oral thin film cannabis products. On Montelukast, in January, we were finally able to resume patient enrolment and dosing in our Phase II BUENA clinical trial in patients with mild to moderate Alzheimers disease. This proof of concept study is proceeding under the (ph) protocol with a higher daily dose that was previously cleared by Health Canada. We're looking forward to collecting value of the data on Montelukast versa film safety, feasibility, tolerability and efficacy for the treatment of mild to moderate Alzheimer's disease. In addition, we expect to explore the products candidates efficacy in a couple of other major indications. We hope to announce those details soon. Now, a few words on animal health., In February of last year, IntelGenx filed a new provisional patent application at the US PTO that covers the incorporation of high concentrations of active ingredients in products based on our better filmVetaFilm* proprietary veterinary oral* film technology. This higher loading capability enables a formulation with the ratio of active to polymer of one to one. So this new patent will allow us to incorporate high amounts of drug into our film while still keeping it small enough to administer easily to companion animals. Back in early 2020, we entered into a feasibility study agreement with an undisclosed partner with for an undisclosed molecule for undisclosed molecule for buckle buccal* absorption using IntelGenx proprietary beta VetaFilm* platform. This feasibility study was successful and in October of 2021, we entered into an additional R&D agreement with this undisclosed company to further optimize the buckle Buccal* film and to manufacture films for clinical study. And with that, I would now like to turn the call over to Andre for a review of our financial results. Andre?

[Andre Godin:]

Thank you Horst. Good afternoon, everyone. As Horst mentioned, I'd like to take a few minutes to discuss the company's financial performance for the fourth quarter, as well as the full fiscal year ended December 31, 2021. For the fourth quarter of 2021, the total revenue amounted to $494,000 compared to $790,000 in the same period last year. The change is mainly attributable to a $425,000 decrease in revenue from licensing agreement receiveding in 2020 and that was partially offset by increases in R&D revenues of $94,000 and product revenues of $35,000. Operating costs and expenses were $3 million for the Q4 2021 versus $1.8 million for the corresponding three month period of 2020. For Q4 2021, the company had an operating loss of $2.5 million compared to an op operating loss of $1 million for the comparable period is of 2020. Adjusted EBITDA with was negative $2.3 million for Q4 2021 compared to $0.8 million for the same period last year. The net comprehensive loss was $2.9 million or $0.02 on a basic and delete diluted* per share basis for Q4 2021, compared to net comprehensive loss of $1.2 million or one share -- $0.01 sorry, per share for the comparable period of 2020. Now let's look at the full year end of 2021. Total revenues for the year end, December 31, 2021 amounted to $1.5 million. And this is consistent with the year end and the December 31, 2020. Operating costs and expenses were $9.5 million for the 12 month period ended December 31, 2021 versus $7.8 million for the corresponding period of 2020. For the full year of 2021, the company and an operating loss of $8 million compared to an operating loss of $6.2 million for the comparable period of 2020. Our net comprehensive loss for the year was $9.9 million or $0.07 per basic and diluted shares for the 12 months of 2021 compared to net comprehensive loss of $7.1 million or also $0.07, sorry, per share for the comparable period of 2020. As at December 31, 2021, the company's cash and short term investment totalled $9.9 million, which did not include the $3 million sicker secured* loan rented granted* to IntelGenx by atai in February of 2022. I would like to point out that a lot of the increase in the expenses is attributable to the fact that we received several Canadian government support programs related to COVID covering among other things, employee salary during 2020. On that, I will now turn the call back to Dr. Zerbe. Horst?

[Horst Zerbe:]

Thanks Andre. In closing, I'd like to once again recognize our team for executing on our long term strategy. And with that, I will now turn the call over for questions. I would like to remind you that our forward-looking statements apply to both our prepared remarks and to following Q&A. Thank you.

[Operator:]

Thank you, ladies and gentlemen, the floor is open for questions. The first question is coming from Anthony Cantone with CRI. Your line is live.,

[Anthony Cantone:]

Dr. Zerbe and Andre, I wanted to ask about this, Tilray arbitration. Can you give us a little, information about the progress? Do you see this settling soon?

[Horst Zerbe:]

Hi, Anthony it's Horst here, and thanks for the question. We sure can., I will turn over to Tommy Kenny, our General Counsel, and he will comment on that.

[Tommy Kenny:]

Hi Anthony, thank you for your question. As you may know, the proceeding for the arbitration is confidential. What you can reiterate is that we're very confident that the other alleged* breach of the agreement by Tilray will be proven in arbitration, but right now we're continuing the proceeding as with was announced to shareholder. We will be able to give you some more information when we have a closing of the proceeding when it's adjudicated or if there is a settlement between, but for now, there is not much we can say about the proceedings.

[Anthony Cantone:]

Okay. I have another question if I may.,

[Horst Zerbe:]

Yeah, go ahead.

[Anthony Cantone:]

So Alzheimers, I know that we restarted the high dosage Alzheimers study. How long do you anticipate that it'll take to recruit and when do you believe we'll get results of this Alzheimers trial?

[Horst Zerbe:]

Yeah. Okay. Thanks for the question, Anthony. So I think I mentioned, previously that enrolment has resumed after we had to put the study on hold you due* to the COVID situation. We expect, the enrolment to be completed, let me see, in December of -- I'm sorry, in August of this year and then the last patient needs to be dozed for six months that will take us to approximately February of 2023. Then comes the data crunching. So we expect final results from that study to be available by mid 2023 May, June.

[Anthony Cantone:]

Okay. Could you give us a little bit more information regarding your animal healthcare initiatives? I know that the VersaFilm VetaFilm* was exciting news that, you had some good clinical results and have we made any progress on moving forward with the commercialization?

[Horst Zerbe:]

We sure have. Dana can, can comment on that because Dana has been maintaining the contract with the partner there. Dana, can you please comment?

[Dana Matzen:]

Of course. Hi Anthony. So as you're correct, we're moving forward on our one contract with a US company on our beta VetaFilm* platform. As you know this is a prescription program. So we're manufacturing for another clinical trial some film. And after this, we will follow the regulatory proceedings. So this is not something that's going to be launched tomorrow. It will take some time. We need to do some additional trials. It's just a normal regulatory pathway but on the general animal health strategy right now, we did hire external help in end of Q4 last year. We presented our VetaFilm platform to many animal health companies and three companies are at this moment actively evaluating our platform to see how it would fit within their pipeline and compounds to use our platform going forward.

[Anthony Cantone:]

Okay. So this is still, far in the distance as far as getting it on the market. So more than like two, three years. Okay.

[Dana Matzen:]

Yes, that's correct. Yes.

[Anthony Cantone:]

And, tell us about the psychedelics. So we were excited about the atai relationship and I know that atai has a couple of two or three compounds for psychedelics and, can you give us any progress on that?

[Horst Zerbe:]

Yeah. Dana you want to comment? You're sure knows those clinical….

[Dana Matzen:]

Sure. Yeah, of course I can. My pleasure. So for the psychedelics program, so one of them we're manufacturing right now, the GMP product for the clinical supply. There is the clinical program is going to be head overseas. So there has to be some, permits being exchanged at this moment, but everything is on track to run the clinical trial and on our end, our obligation is to submit those samples or the film support of firms for the clinical spacesite. So we're almost done with one project, at least for that stage. And for the other one, we're for it we're starting right now on the formulation optimization so that we also can manufacture then and a clinically trial sample for a clinical trial. And in addition, we are in discussion on other programs on this with our partner.

[Anthony Cantone:]

In the psychedelic space or some other space?

[Dana Matzen:]

No, in the psychedelic space.

[Anthony Cantone:]

Okay. Tell us about Tadalafil. Are we getting close to a product that's gonnagoing to be commercialized?

[Horst Zerbe:]

So you broke off Anthony. Can you please repeat?

[Anthony Cantone:]

Okay. So to Tadalafil, are we getting closer to commercialization of the thin film version of Tadalafil?

[Dana Matzen:]

Yes. So, I can answer that as well. So as you know, this is a partner program with Aquestive where both companies are responsible for preparing the answers for the CRA that the product has received. There is, we're preparing right now, some studies to answer the CRA. It's all underway. We're where within the timeline that we are toalso communicated to our commercial partner and we're expecting that the product, will be submitted to the FDA for review later this year. And then, hopefully soon, early next year we were going to see the product being approved and then launch preparation to happen.

[Anthony Cantone:]

Early in 2023. Okay.

[Dana Matzen:]

Yes.

[Anthony Cantone:]

Okay. And, tell me, so this is really for Andre. I see that we have some debt maturing this year in 2022. Are we, how do we handle the maturities?

[Andre Godin:]

Well, Some of, about 25%, 30% has already been converted, of this debenture maturing in June and obviously we're hoping that, some more can be converted, but based on the share price right now, the conversion is about $0.40. So if we don't get converted, we have two options to reimburse it in cash or in share. So, the option at that moment would probably be to pay it in cash, but the decision hasn’t been final yet.

[Anthony Cantone:]

Okay. That's all I have.

[Operator:]

Okay. The next question is coming from Jeremy Latin. , private investor. Your line is live.

[Unidentified Analyst:]

Yes. Good afternoon. Thanks for taking my question. It's Latin, by the way. That's okay though. Your previous person also answer asked a couple of my questions, but one question I did have was, could you give us some information about how things are going with the migraine sales in Europe because we haven't heard anything and a little bit of news, if it's good would help?

[Horst Zerbe:]

That would again be di Dana.

[Dana Matzen:]

Yeah, my pleasure. So our commercial partner Exeltis in Spain, sees a very good trend of the product. We had a sales meeting at the end of the year and the product is certainly getting traction. Thethey're launching a great campaign to really push the marketing and going out with a really nice promotion. At this moment we're waiting for, it's still early days there. They're launch in September and the beginning you usually wait for a little bit, but so far the traction is great. They, really get a nice percentage of the market and, it's all very hopeful. So that's as much as much as I can say.

[Unidentified Analyst:]

Okay. So you can't provide any kind of numbers or what it added to your revenue or anything like any detail?

[Dana Matzen:]

No, it's too early. We are receiving royalty of the product. So, and royalties, it will take a bit, but…

[Unidentified Analyst:]

Okay. Early Any progress on moving into other countries? I know there are things going on in Europe right now, but have there been any discussions about expanding your market?

[Dana Matzen:]

Yes, we are in fact a scheduled to discuss the global reach and to other markets within Europe. So I do have a card set up that they're global head of business development to really discuss the strategies and which markets they're going to go next. Certainly there is going to be a regulatory strategy behind because the product is approved in Spain and there are different ways to get it approved in the additional markets. But yes, that's certainly the goal.

[Unidentified Analyst:]

Okay. Very good. So there's progress there in other words, and thank you. That's good news. The other question I had, regarding CBD strips, again, we haven't heard anything since the summer. So six months ago, or more than six months ago now, since you made your last shipment. Any more business happening there or is that kind of quiet?

[Dana Matzen:]

Horst, do you want me to answer that question?

[Horst Zerbe:]

Yeah, yeah, you should.

[Dana Matzen:]

Okay. so for the cannabis franchise, we are really exploring now, additional markets. As you know, Canada has a very unique regulatory framework to yes, that allows company to market and launch cannabis film, which is not the same in, let's say Europe. So we were working with regulatory experts to see how we can export into other markets and what it would take to make our product fit into these categories. But, there is a strong interest for example, Germany where, cannabis is allowed to import our product there and we're working on this very actively. So there will be some progress coming.

[Unidentified Analyst:]

So that's good. Thank you. That's good news as well, but nothing imminent here in Canada or there's nothing sort of coming quickly. It's just it you're working on it. Is that where you're at?

[Dana Matzen:]

That's correct. Yes.

[Unidentified Analyst:]

Okay. Very good. If I could just make comment and to everybody, and I don't know how you're going to react to this. There's been a lot of silence from management to the market since, well, really over the last six months we haven't heard much of anything from you. Would it be possible to keep your shareholders and the market's up to date a little bit more effectively. Your Investor Relations person doesn't do anything. No offense. If he's on the call. We don't hear anything. There's just, -- there's no news and yours, a very news driven stock. Let's not get repeat ourselves. Would it be possible to improve the flow of information because it sounds like you have a lot to say.

[Horst Zerbe:]

We have weekly meetings to discuss shareholder communication. We take that very seriously. We don't want to, get on a path that just in order to be heard. Wwe come out with irrelevant or a nonsense information like and some companies apparently prefer to do. That is not really our style. So we try to publish information that is really material and of value for investors to be heard. That's our general policy. So there are at times stretches where while we are extremely active in our business development activities and here in the lab, that there is just not that the information has not just advanced to the point that we can come out with meaningful information. So that's why, we see at times stretches where we, have to remain silent for the reasons that as I explained before, but that doesn't mean that things are not happening. Things are happening. We just wait for the trigger moments and events, but we hear you loudly and clearly, and we will certainly make every effort to keep investors informed to the best of our ability.

[Operator:]

Okay. The next question is coming from let's see here, Tom McGlynn, private investor. Your line 'is live.

[Unidentified Analyst:]

Yes. Thank you for taking my call. My first question is regarding the migraine following with the FDA filing, I'm sorry, with the FDA. I believe it was supposed to be complete first quarter 2022. Where are you with this? And has there been problems, whether while there's a delay?

[Horst Zerbe:]

We manufactured three full scale batches as required by FDA to respond to the complete response letter. These three batches are currently in stability testing. We plan to contact FDA by midyear for to apply for meeting, to then discuss details of the response. So, you're right. Quite some time ago, we were under the impression that we could respond earlier this year. Unfortunately the, manufacturing of these batches, have stretched out a little more mostly because we were in conflicts in our manufacturing operation with BELBUCA manufacturing, which was quite time consuming. So there has been, we have to admit that there has been a slight delay, but the batch is happy manufactured, they look good, stability testing so far gives us a very promising results. So we are moving forward there.

[Unidentified Analyst:]

So you're thinking submission would occur second half of this year and then take another six months. So we'd be looking at the earliest approval being January 2023.

[Horst Zerbe:]

I think January 2023 would be challenging. It would be 2023, but I think more towards, midyear. Dana, do you recall the more specific dates?

[Dana Matzen:]

Yeah, so right now I think the plan is that we're going to have a six month review and that would bring us into early 2023 kind of mid to early 2023 somewhere there. Summer 2023 I think that's the most we can say at this moment there. We still have to meet with the FTDA. There are a couple of unknown items, which we don't know how to impact the timeline. And based on that our current prediction is that we will have an approved product by the summer next year.

[Unidentified Analyst:]

I'm sure we all agree. It's about time that this thing gets moving. The cash was very disturbing last year. Do we see that becoming -- do we see that minimizing and from this call, it doesn't seem like there's much revenue going to be affecting this year on the horizon. Andre, can you give us some insight into how you see the cash burn increasing, decreasing stabilizing, and what kind of revenue might we expect this year because I'm not hearing very much.

[Andre Godin:]

Yeah, we try to control our spending. Obviously the last year we add a lot of support from the Kenyan Canadian Government, like I said, which obviously was reduced our cash burn. But, we're trying to stay very tight and, minimize spending. But, as we mentioned, we are looking to launch, a couple of products next year. So we need to be commercial ready. So which means we need to hire, few people in the back in the manufacturing, because we might be, maybe not around the clock, but depending on the volume, we could be very busy in the back. So, apart from that, I don't see any substantial expenditure on our end because we like I said, we keep everything very tight. In terms of revenue, we're hoping that for 2022, we'll have R&D revenue obviously, and hopefully cannabis and RIZAPORT, we haven't disclosed yet, or because we haven't received a report from our commercial partner in Spain, but we will be disclosing some royalty in the next quarter and from that, it should continue every, every quarter. The launch app as mentioned -- as Dana mentioned in September. So, by year end, there's about 90 days before we get our royalty payment. So it will be in Q2 and then we'll get recurrent revenue coming from RIZAPORT in Spain, but we're working very hard trying to obviously increase revenue, near term revenue and, like I said earlier, 2023, hopefully we'll have revenue increase.

[Operator:]

Okay. The next question is coming from David a Private Investor. David, your line is live,

[Unidentified Analyst:]

Good afternoon, everyone. Thank you for allowing me to speak here today, but I have two questions in regards to the BUENA trial, I know there was a re commencement. My specific question is that how many total patients are enrolled at the moment and how many have been enrolled since the recommencements recommitment of this trial.

[Horst Zerbe:]

In total, I believe we're right now at around 35 or 36 in that neighborhood. And since we raised enrolment one patient has been -- has, has commenced treatment and two are now nearing the end of the evaluation and then should go on treatment.

[Unidentified Analyst:]

Okay. Not part of -- Oh, I'm sorry.

[Horst Zerbe:]

Right now to give you a broader picture that with the sites that we have and the commitment that we will enrol one patient per month per site that the full enrol enrolment will have completed by August.

[Unidentified Analyst:]

Okay. A follow up to that is what do the numbers nbers need to treat to achieve any sort of clinical significance?

[Horst Zerbe:]

I'm sorry. I did. I missed that acoustically. Can you please repeat? Yeah.

[Unidentified Analyst:]

What is the number needed to treat, to achieve some sort of clinical significance?

[Horst Zerbe:]

The study has been populated, so that based on the pretrial stats that we were running we can assume that we will have sufficient power to make a statement regarding efficacy.

[Unidentified Analyst:]

And, just to…

[Horst Zerbe:]

Clarify with this with the 70 patients; we believe the study has been sufficiently powered.

[Unidentified Analyst:]

Thank you for that.

[Operator:]

Okay. The next question is coming from Hugh Kylie , a Private Investor. Hugh, your line is live.

[Unidentified Analyst:]

Yes. Good afternoon, everyone. And thank you for taking my call. Some of my questions have been answered, but I'd like to start with the VISPO you'll h ave to say the are you allowed to say when the end date will be done on the facility? Excuse me, stability testing. I know the batches were manufactured, but may have been a hiccup, but any idea when the six months will end?

[Horst Zerbe:]

The six months will end around mid-year for, let's say for the last batch. For the first batch, the six months will end around April and then, second batch a little later. And, and third batch around June, if I recall correctly. Yeah.

[Unidentified Analyst:]

Okay. That's a good time frame. And then may that maybe you start op making inroad for the next meeting with the FDA? From the end, the stability you, you reach out to see if you can have a sit down session?

[Horst Zerbe:]

Yes. From the end, the stability you reach out to see if you can have sit down session?We're, Once we have sufficient data, that will be actually couple months before we completed the six months data for the third batch, we'll reach out to FDA to apply for a meeting to discuss filing strategy.

[Unidentified Analyst:]

Okay. That's Thank you for that one. And Tadafill data flow on the irritation study is end date of that. I know you said it was eight; it takes about eight months for that's the irritation study with that end by the end of June?

[Horst Zerbe:]

Dana, do you want to comment you, you are in your dialogue with requested Aquestive?

[Dana Matzen:]

Yeah, absolutely. So at this moment the irritation study hasn't started because we had to make sure that we have the right people and that we're following the protocol that we discussed with the FDA. The plan is to start in April. There at had to be new batch manufacturers. So we had to be conscious about that and getting the time of the CRO to have patients ready. So the, the current plan is to start the study in April.

[Unidentified Analyst:]

So, in April eight months from there, we'll hopefully get an update. All right. And regarding to Tadafill that to Dallas, or I know you you've entered agreement with the US commercialization partner, any discussions going on for other countries worldwide,

[Dana Matzen:]

Their capabilities are really for the US market and, and that's what we partnered with them for.

[Unidentified Analyst:]

Is there any discussions with anyone else they were out any other of the interested parties?

[Dana Matzen:]

Of course, yes. Actually in fact Horst horse and I just came back from a partnering conference where I had nervous discussions about European rights for this product. So we're going to do our follow up and then see if, if those partners have the commercial capabilities to really support what our program.

[Unidentified Analyst:]

Okay. Thank you for that, Dana. And just Dana, one of the questions I my connection was little weak, but right now we have agreements for with two animal healthcare companies. First one, January 20 and another one this year, this past year. Is that accurate?

[Dana Matzen:]

That is accurate. Yes.

[Unidentified Analyst:]

And, and did I hear and correct me if I didn't hear it properly, youyou're in discussion with a host more of other veterinarian companies?

[Dana Matzen:]

Yes. Yes, we are. We sent out our sample to evaluating, it is a new technology. So the concept is different than giving a tablet. So a lot of companies have an interest in seeing how certainly the firm would work in an animate setting. They want to see it for themselves, so they they're testing it and we would see what comes out of it and which programs would fit onto that platform. But yes, we are oin the discussions with several companies.

[Unidentified Analyst:]

Okay. And last question is on the, the big Heritage Georgia that was talked about in the third quarter call, qu is was that progressing order? Is that so on storage?

[Dana Matzen:]

Everything has been shipped.

[Unidentified Analyst:]

Everything has been shipped. All right. And, I think that completes my questions. I'll go back into queue.

[Operator:]

Okay. The next question is coming from Adam Adam Tubero from Psychedelic Invest.com. Your line 'is live.

[Adam Tubero:]

Hey, how are you guys doing today? Thank you so much for taking my question. or question So the one I want to leave with was about Heritage. So if all the Heritage orders had shipped, shouldn't that have reflected more significantly on the book? The small order was about $75,000 K in revenue? and you guys said that you shipped had out aa, a much larger order. Can you guys give any clarity on that?

[Horst Zerbe:]

Dana, can you comment?

[Dana Matzen:]

You, I think it's more financial statement problem. I think the orders were shipped. I think when the invoices get paid, I, I would refer to Andre, but we, we shipped everything out and there's certainly are some royalties art, sob varieties due, which are royalty variety report is in the progress right now. AgainAndre, we explained already that a lot of those contracts, there's a certain period after the quarter closes where the company's prepared the Royal reports and then pay. So this is all in the progress, but yes, you would see something reflected soon.

[Adam Tubero:]

Okay, awesome. I appreciate that. Also, alright, so my next question is going to be specifically about the me .-- all right. So did you guys, I was, when I was listening earlier, did you mention Sabin or was I hearing things?

[Horst Zerbe:]

No, we didn't I didn't mention Cybin Sabin in the in my introductory remarks.

[Adam Tubero:]

No. Okay. Sorry about that. Okay. No problem. So that brings me into my that next question. So you explain how that you were going to work on more psychedelic formulations, who I'm assuming assist with Ataiis with a tie. So we know right now the two things you're working on, or we don't know we're speculating is DMT and Cybin related. Could you give us any insight on what other psychedelic medicines you might be working on and can you and it's going to be with Atai. a, Can you give a yes or no about that?

[Horst Zerbe:]

We currently have two active programs. You mentioned the, the compounds and we are in discussions for a third one. And I think commencement of that program is more or less imminent. And so with that, we would then have three programs in active development. What comes afterwards? we don't know yet. There will be more, I mean, we have a very long list of candidates from them. Several doesn’t, comment bit, which one will be next. We can say. They Today, they haven't discussed that yet with us.

[Adam Tubero:]

Very welcome, man. I appreciate you guys very much in closing what I say also that if you guys are or Dana or any, one of you would ever want to do a Q&A, I would love to do one with you guys, and it would be an easy way for you guys to get some more exposure if you that's what you want to do. Because I heard a caller mentions that earlier. I just want to throw that out there. So thank you for very much and I appreciate you guys.

[Operator:]

Okay. The next question is coming from Grant Gatey, private investor. Grant; your line 'is live,

[Unidentified Analyst:]

Good afternoon, everyone. I, I think I heard earlier, you said that part of the delay in manufacturing, RIZAPORT batch is, was because you were I guess manufacturing, Belbucabeca is that, is that accurate?

[Horst Zerbe:]

That is correct. Yeah.

[Unidentified Analyst:]

So would you expect any revenue from that or what?

[Horst Zerbe:]

We, we can't comment on that. I'm sorry. So I get strict instructions from legal that we are obligated to remain silent on the status of, of that program.

[Unidentified Analyst:]

Okay. And then back to the heritage, I think last caller mentioned on the, the revenues and, and you all had said that I guess the sales reports or , or quarterly reports weren't in or whatever, but wouldn't you, when you receive the manufacturing portion of that revenue soon after it's delivered,

[Andre Godin:]

Are we talking about CBD now?

[Unidentified Analyst:]

Yes. Heritage.

[Andre Godin:]

Yeah. They all didn't didn accounted for, . So they all didn't accounted for in our financial statement. So I think that we recorded some in Q4 and some in Q1 for a total of roughly about a hundred thousand$100,000.

[Unidentified Analyst:]

So even the large order has been accounted for in the 2021 financials?

[Andre Godin:]

I don't know what, what you mean by large order, but…

[Unidentified Analyst:]

You all had a small order. And then you said you You all had a smaller order. And then you said you had a, a follow up with a larger order that was in storage and it's now been shipped. So are you saying that that's been accounted for?

[Andre Godin:]

Yeah, that's been accounted for, yeah.

[Unidentified Analyst:]

Okay.

[Andre Godin:]

But we haven't received the royalty yet, but the manufacturing revenue has been accounted for.

[Unidentified Analyst:]

Okay. And one last question. So back to what another call was saying, it seems like there's probably, it doesn't appear that there's a lot of, of revenue in line for 2022, except possibly I guess, RIZAPORT, which we don't know how much that is. Do you, do you foresee, you've got enough capital to get you through mid-2023 when some of the programs mature and start generating revenue?

[Andre Godin:]

Yes. This is what the intent is. So we're basically, okay. For the, for at least another 12 to 15 months at which point we will be generating revenue. So we, we don't see the necessity of raising money unless it would be for specific opportunity, but for the burn rate, we're fine.

[Unidentified Analyst:]

Okay, good. I guess from what I'm hearing RIZAPORT, Tadalafil, Tadalafil won't be even if they're approved mid-2023, I mean, we're really not going to start seeing much revenue till wider part of 2023. Is that accurate?

[Andre Godin:]

Yes, we we're expecting, like I said earlier to launch two new pro projects and programs in 2023 and Tadalafil Al might be a, the third one depending on the outcome of the irritation study and the time line of the irritation study,.

[Unidentified Analyst:]

What are the, excuse me, what are the other two besides Tadalafil co lot people, maybe I'm missing one or?

[Andre Godin:]

RIZAPORT For US and the other one we cannot disclose.

[Unidentified Analyst:]

Okay. So there's an undisclosed project that you feel is going to launch in early 2020

[Andre Godin:]

Potentially launch in 2023. Yes.

[Unidentified Analyst:]

Okay. Thank you all.

[Andre Godin:]

You're welcome.

[Operator:]

Okay. The next question is coming from Joe Val, private investor, Joe, your line's live

[Unidentified Analyst:]

Hello and good afternoon. I have kind of a blast in the past item to ask about it may its cash cap flow. So hopefully, I don't know, there's something there, but I doubt. Back when you guys told the Forfivo XLForfivoXL royalty stream, as I understood it, there was a potentially significant milestone possibility something like $23 million or something like that of potential milestones of which IntelGenx would have the rights to 65%. Can you, it, it doesn't seem like that's happening or has ever will, will happen. I'm just wondering if you can clarify for us whatever happened with those four, both milestones? Thank you.

[Andre Godin:]

Yeah. Or I can answer that. Yes. I mean, There was several milestones that were that were possible for us to receive after we monetize the asset. But unfortunately those milestones were based on achieving certain level of sales and those lever levels were, were not met. So unfortunately, even though we were entitled to receive them, if those level of sales would've been met, it, it never did. So that's why we didn't get any of those milestones.

[Unidentified Analyst:]

Okay. Is that something you're still tracking or is it considered dead at this point?

[Andre Godin:]

No, it is dead because it was per year and the levels of those sales cells needed to be met let's say the year after we monetized and the following year. So there was two potential milestones that we could receive two years after we monetized the assets. But after that, there was no longer any milestone that could, we could receive. So it's, gone.

[Unidentified Analyst:]

Okay. Well, it's -- it seems that the timing of the monetization was Sweden. -- thank you very much. That was my only question.

[Andre Godin:]

Thank you.

[Operator:]

Okay. The next question is coming from Hugh Kylie, private investor. Your line is live.

[Unidentified Analyst:]

Thanks is again, I'll be short and sweet,. Dana a couple quarters ago., I inquired about the VevaDerm very Durham you were in the potential discussions with interested partners, any progress on that product?

[Dana Matzen:]

Yeah. Thank you for that question. So yeah, absolutely correct. We were in discussions at with a large company and that company had some reorganization. The project was put on hold for a while and received recently approved. So we are again get moving forward with discussions, but at that point we had to be on hold for quite a while because of some reorganization at that company.

[Unidentified Analyst:]

Okay. Thank you. And then I guess this goes a time to Tommy with the THC platform of part, that form of products that you have, is that still are you prevented from discussing with other partners, whether this y this to a , legal issue is being resolved?

[Tommy Kenny:]

It depends on the technology. Some technologies, we cannot approach the partner because they were exclusively given to Tilray. Some other technologies are not partnered with Tilray and could be open, but at this, at this point, we're trying to get clarity on the Tilray situation, through arbitration, and then make sure that we have -- we're clear to go and able to be in the market because it's a strategic opportunity for us to be in this field. So we hope that the arbitration will be, shorter than the court proceedings. So normally arbitration could be quite expedient. So that's what we're hoping for. And we will make sure that this is dealt with as soon as possible. But in the meantime, we could still be discussing some opportunities with Cannabis Company, whether it's CBD or THC.

[Unidentified Analyst:]

Okay, thank you for that. And, and the just do you expect a long drawn out trial with, against bio delivery down in Delaware? I know it's scheduled for April. Do you expect that to be?

[Tommy Kenny:]

It is still scheduled for April. We're expected that the trial will go ahead as of today. you never know before trial, there could be a settlement, but right now we're, we're expecting to trial late April.

[Unidentified Analyst:]

Okay. And that's all the questions I have. Thank you.

[Operator:]

Okay. The next question is coming from, let's see here. Just one moment, bro. Garcia , and oh, just one moment. Okay. I'd like to turn the floor back to Dr. Zerbe doctor for closing remarks.

[Horst Zerbe:]

Okay. the line was a little distorted, but I understand we're done with the question. So this would then conclude our Q4 and, and year-end 2021 investor update call. And I would, once again like to thank the entire team for its hard work and dedication, our board of directors for their continued support of the management team, and finally our investors for continuing to believe in and supporting us. Thank you and goodbye.

[Operator:]

Thank you, ladies and gentlemen, . This does conclude today's conference call. You may disconnect your four lines at this time and have a wonderful day. Thank you for your participation.