Pharmala Biotech Holdings Inc. (MDMA) Earnings Call Transcript & Summary

Welcome on this Thursday, February 6, to what we hope will be a regular occurrence, which is we're going to be talking about our earnings and our financials. I'm going to start doing this on a regular basis. So hi, I'm Nick. I'm the CEO of Pharmala. Joining me today is our new CFO, who you probably haven't had a chance to hear from, at least not live like this yet. This is Will Avery, everyone. Will retired from MNP LLP in 2023, where he was a partner, spending the majority of his time over a 20-year career there, servicing public companies like ourselves. Will is based in Toronto, where he lives with his wife and 2 young kids. And he joined us back in September, Will? August, September, something like that.

Yes. September, officially in October.

In September, yes, yes. So, Will has been helping us with all kinds of stuff and really professionalizing the organization. So glad to have the investors have a chance to speak to him and hear from him today.

Yes. Happy to be here, too. Thank you, Nick, for that intro. I'm absolutely so happy to be a part of such an awesome team here and I look forward to what we're going to be able to do in the years to come. Before we get underway here, I would like to take this opportunity to refer to the cautionary wording about forward-looking statements, as well as the risk factors included in our MD&A as filed on SEDAR+ on January 29, 2025. Those statements about cautionary wording and risk factors apply to the information discussed in this webinar as of the date of this webinar being February 6, 2025. However, this webinar is intended to be a discussion of the interim results for the period ended November 30, 2024, and is not intended to be an update of the information therein to the present date. With that, I'd like to start with an overview of the key aspects of our recent financial results. During fiscal 2024, the company realized revenue of over $1 million, representing growth of approximately 95% year-over-year. This was led by growth in MDMA product sales of $723,000 or a 73% increase year-over-year. In fiscal '24, the company also increased customer deposits to $208,000. In Q1, we've continued this growth, which has resulted in a $70,000 increase, bringing the total customer deposits to $283,000. Just to give a little background on that, generally, we require deposits that account for up to 50% of the total contract value. And while not universal to all of our contracts, many of these deposits are nonrefundable or refundable only in the event that customers failure to secure a clinical trial permit is based on our underlying chemistry, manufacturing and control information, which we provide to these customers. The related customer deposits can be recognized with -- along with the remaining revenue when the underlying product is delivered to the customer. Based on our experience, it is uncommon for clinical trials not to move forward. However, in fiscal 2024, we did have one such instance. And as a result, the nonrefundable deposit was taken into revenue. While we would have loved to see the growth in deposits turned into revenues in Q1, our sales cycle is such that many of these customers require the issuance of their clinical trial and/or import permits from the relevant regulatory bodies before we can ship the related material. Adding to that, on October 21, 2024, we terminated the supply agreement with CCrest Labs and initiated a program to secure new distributors in both the U.S. and Canadian markets. We have successfully partnered with Merhavim Pharmaceuticals, who are already a manufacturer and research partner of the company, and we've recommenced distribution subsequent to November 30. In the U.S., while we continue to seek a permanent distribution partner, we are currently moving forward on individual exports for U.S. clinical trials and have applied for the necessary Health Canada Export Permit to enable us to do so. Due to the highly regulated nature of our operations, all of these initiatives have taken time to accomplish. And as a result, during Q1, we didn't fulfill any shipments of MDMA product to patients under the SAP or to clinical trial customers, and our revenue was limited to the Cortexa license fees. As mentioned, having partnered with Merhavim, we've recommenced distribution. And on upon securing the necessary permits, we expect to ship the related products and recognize the revenue in future quarters. Another item, I'd like to highlight from our Q1 relates to our cost profile. So there were some new found efficiencies allowed total expenditures, excluding stock-based compensation, depreciation and amortization, and a loss on debt settlement, to remain relatively consistent quarter-after-quarter despite bringing strategic team members on board. While these team members carried incremental costs resulting in overall increase in expenses, we believe we are stronger and better set up for the future with our addition. Further, some of those incremental costs were offset by cost reductions elsewhere, primarily in office and general expenses. The final item, I'd like to highlight for you all today pertains to our financing position. During the period ended November 30, 2024 and subsequent, we've secured funding reflective of our team's commitment and belief in the future of the company. Firstly, we entered into a share for debt settlement with our legal counsel, taking 100,000 accounts payable off the books without using any cash. Secondly, our Director group stepped up and exercised some of their outstanding options, resulting in a further $42,500 on top of the $70,000 received in fiscal 2024 from the CEO. We believe that this shows a commitment of Management and Directors to the company's future. And lastly, and most importantly, on December 13, 2024 we secured funding from the sale of units consisting of one common share and a half warrant, which is exercisable at $0.27 for 3 years for gross proceeds of just over $1.5 million. We are pleased to announce that Matthew Azrieli participated as a lead investor in this private placement and as announced today, has subsequently agreed to become an adviser to the company. These inflows have strengthened our cash position for the future and combined with the conversion of our customer deposits into revenue and our partnership with Merhavim, we're well positioned for our future growth. Nick, I'll turn it back to you.

Yes. Look, guys, if I can distill down some of the stuff that Will talked about. Number one, I think, look, long-time investors and shareholders of the company will know to look for the line item of customer deposits in our financial statements. New investors and shareholders may not know it, but it is sort of critical to the business, right? We've never had a situation where our documentation is the cause for someone not to get their clinical trial approved. And that's really the triggering factor for a refund. So if we continue to do our jobs properly, of course, those deposits continue to fuel the growth of the company. We utilize that cash for ongoing operations and it does get converted into revenue for accounting purposes when we actually ship the goods. We don't control entirely when those goods are shipped. It depends on a range of factors, regulatory operations, just physical operations, getting the goods to their destination. And we are always looking to improve our operational efficiency. So we'll be talking in some of the questions -- question-and-answer period about what we're going to do around the United States, about positioning inventory. Certainly, lots of questions have come up in the last little while around tariffs and what those do to us. But we're always looking for better ways to be more efficient and get our customer -- get our goods closer to customer, which is part of the reason why we started Cortexa and why we began to do manufacturing in Australia for the Australian customer, right? The closer we can get to that end user -- I think the better off the company is in the long run. And frankly, I think it also improves our cost base, both cost of goods and of course, just our operational costs. Canada is not a low-cost jurisdiction, unfortunately. So despite all being from Canada and being strong boosters of Canada, not always the best place to do your manufacturing. And certainly, shipping everything from Canada is not always the best sort of operational decision. So with that, maybe I'll ask Conway to start reading through some of the questions that we received in advance of the webinar. We'll try to field all of these questions. Now, there's at least one person, I know who may have some questions Conway, can you just text Robert, and let him know that he's welcome to ask any questions that he has. Robert is actually a Professional Analyst. So I'm not playing favorites here. It's a professional courtesy. But if he has any questions for us, he is more than welcome to ask them. Other than that, for the investors, we have received your questions in advance, and we'll feed them one at a time. Okay.

All right. I'll dive right in. When will we be moving forward with our Phase 2 trials?

So Will, you can take that one?

Yes, I can take that one. Look, as you know, clinical trials, they're expensive. We went into last year with the stated goal of finding a non-dilutive partner to cover at least part of those costs. That process is still ongoing. And although, we have had some progress, we don't have anything specific to report at this time. There have also been some changes reported by the Australian tax office that's delayed our progress. We hope that we'll be able to make an announcement by the end of this quarter, but I want to just make it clear for everyone that, that time line may shift. But we're doing our best to keep moving all of this forward and find that funding partner.

Yes. I will just add. It is really about finding efficient ways to fund the trial at this point, the protocol. I think like, again, this is, I think, all well known, but the protocol is done, our trial partner is sort of in place. It's really a question of making sure that we finance this in an efficient way, both from a tax perspective and from just not just selling shares, but also maybe finding a non-dilutive partner who could help us with it.

Nice. With the increasing momentum around MDMA in the industry, how does Pharmala plan to leverage this trend to its advantage while also balancing its other projects in its pipeline?

Okay. And Conway, I see Robert does have his hand up. So, maybe if you can text with him and just find out what his question is. Okay. So number one, look, I agree. I will say, we are seeing very significant increased sales as a result of the acceleration of government funding for MDMA research, especially in the U.S. We are also seeing increased clinical trials in Canada, although future clinical trial demand for MDMA from Australia has slowed down a bit. I think this is somewhat logical because now there's an actual access pathway in Australia, right? At this time, we do see progress made in our sales pipeline as synergistic with the rest of our business. So if we have a profitable year, we can reinvest in R&D, we can develop new drugs, et cetera. We are also clearly monetizing our MDMA development in another way. As you would have seen a little while ago, we announced our first drug for data deal for LaNeo MDMA. And that can help us a lot. I mean it can help us with reimbursement. It can help us with product registration in certain markets. So I would expect that we are going to do more deals like that in the future. But of course, the primary responsibility for the company is just to drive sales and drive revenue.

Should we give Robert a chance to speak right now as he has his hand up?

Sure. I think he just asked a question. Go ahead.

Robert, whenever you're ready.

Yes. I just wanted to know -- you announced several contracts, I think, around 5 since -- over the last 3 or 4 months. Are you able to disclose, how much those contracts in aggregate are worth to you in terms of revenue going forward?

So I think what we can do is based on our current financials, so these would be -- this would include all of the deposits made to date. I think we were at about -- Will, correct me if I'm wrong, $280,000 in deposits.

Correct. Yes, $280,000 in customer deposits.

Okay. So that would translate to a 50% deposit, that would translate to just under $600,000 in potential revenue out of those contracts. Now, I will say that does not include all of the contracts that we have announced, because at the time when we closed the financials in November, we hadn't received the deposits for all of those customers. So it's more than 600,000, assuming all of those go through, of course. But that's what it would have been at the time of the last financials, and I shouldn't front run the financials.

And do you actually -- when you deliver them, you deliver them in batches in separate batches at different times to the same -- to the particular client? Or is it one off batch to each client?

Yes. Okay. So sometimes, when our client -- look, we're in the customer service business. So, if our clients really want multiple shipments, we will deliver multiple shipments, and we'll recognize the revenue partially rather than all at the same time. Due to the regulatory environment that we live in, we don't love to do that just because like it's import permits all over again, and it's painful. It also costs our customers quite a bit of money. I mean, a controlled substance shipment just from Canada to the U.S. can be like $3,000. But that said, if the customer wants to pay it and they really don't want to hold the material or they're worried that they're -- if they have a long-term trial and they want fresh batches of drug product along the way, yes, look, I mean, the answer is yes, we will do that sometimes, but it's not our preference.

Just a couple of more questions. It seems like Lykos is preparing to -- and it's been in discussions with the FDA, preparing to -- for a third study of its Phase III MDMA-assisted therapy. Are you actually -- since they've cut out their production capacity, are you going to be supplying them?

So we have no contract with Lykos at this time. That said, we do have a very warm relationship. It's been reported in the press that they've sent a number of clinical trials our way. I can confirm that, that is accurate. So look, if they need material, if they need support, we are happy to provide it. And we'll just stay close to them and be of service wherever we can.

And my final question is basically, can you give us the latest on your own drug development projects?

Yes, absolutely. So we talked a little bit about the Phase II trial for ALA-002 already. That's where that is. In a similar fashion for APA, which is our sort of Tier 2 molecule, we're looking at ways to do the preclinical for that molecule, and it does require preclinical because it is a net new molecule. For that one, we're trying to find, again, non-dilutive partners who could help us finance that. Preclinical, there's sort of 2 elements to it, right? There's the chemistry manufacturing and control, the manufacture of the new molecule, and there's the actual rodent testing. Most of the rodent testing that we do at the University of Arkansas for Medical Sciences at Bill Fentagrossi's lab, that's non-GLP rodent testing. So it's what we call proof of concept. it is not acceptable for the kind of toxicological dossier that we would need to develop. And so we're -- again, we're looking for a nondilutive partner. We think we found one, like we think we're close. But until the deal is done, nothing is there. So again, hope in the next 3 months to be able to announce both the nondilutive funding for the ALA trial and some nondilutive funding for the development of APA through preclinical. But until it's done, it's not done.

Very informative.

Okay. Conway, where are we at with the questions?

We got a couple more. Is Pharmala supplying the VA for their trials?

So the answer is yes. Our contracts are not with the VA directly. That's not how this works. So the VA funds trial sites, and we are contracted to supply a number of VA sites. We're also looking forward to more grant funding flowing this year, like this year being 2025 for groups such as the Defense Health Agency in the U.S., which had a very large public call, that's $10 million for MDMA PTSD research. Hope to be able to hear and announce which researchers are going to be getting that grant funding as well.

Awesome. Any upcoming news from Cortexa?

So guys, we get this all the time. We don't front-run the news. We do not announce news before it's announced. So please don't ask this question in the future. The news comes out when the news comes out. Go ahead, Conway?

Implications for MDMA with RK's confirmation and subsequent FDA approval over the next 3 months for a long-term investor.

Okay. So look, I have -- just personally, on a personal note, I've been absolutely blown away by how the issue of MDMA-assisted therapy and psychedelics more broadly have changed in the U.S. over the last few years. So when we started Pharmala, I would still say this was considered in the U.S. like a leftwing coated issue. And I think now, especially in the U.S., more than anywhere else, it is either a bipartisan issue or even like maybe a soft Republican coated issue. However, despite all that, I do want to temper expectations on what will happen in the U.S. as a result of cabinet plan. So regardless of whether RFK Jr. Gets confirmed or not, I really don't have any way of knowing what the legislative and regulatory priorities are for either the Trump administration or for him. So I can say, there's a number of folks around the cabinet table who are supportive. In December, I met with the new national security adviser, Mike Waltz. There have been public comments by the new Defense Secretary, Pete Hegseth, who've been -- they've all been quite vocal. They're all veterans. They've all been quite vocal about their support for psychedelic-assisted therapy, specifically for veterans and especially for MDMA-assisted therapy. But that doesn't necessarily translate to like rapid action. So I don't want people to assume that one appointment to cabinet is going to be a complete game changer. It might be, but that's not -- like, we don't run our business that way. That's not how we plan. So we will keep working with our partners in the U.S. We do consider that a growth market for us. Certainly, that's where we've seen a lot of growth in the last 6 months or so. And we will try to capitalize on all of the opportunities that we see there.

Awesome. Good. So I go into the next question. In connection with information included in our previous news release, is Pharmala still considering setting up in the U.S. either for a sales office or to produce directly there to supply all of our American contracts?

I'll take this one, Nick. I kind of touched on that in my section. We are still looking for a U.S.-based distributor. So we anticipate doing a material amount of business in the U.S. over the next 24 months and expect that a U.S. distributor will not only lower our cross-border trade risk, but also just simply make our operations there more straightforward.

Awesome. What do you think about the recently announced international collaboration announced between the U.K., Canadian and U.S. psychedelic industry leaders? Do you think it will bring significant positive change to the industry?

Okay. So this is a PsyCan initiative. Obviously, I am the Board Chair at PsyCan, but this is not an initiative that I was personally heavily involved in. I basically -- you've heard about it when it was a done deal. It was done by our Executive Director at PsyCan. I'm going to limit my comments to the following. Number one, PsyCan is a trade association. They do influence things over the long term, but they have a mandate to work on behalf of the entire industry, not on behalf of any specific company. So I like doing work with PsyCan. I think a rising tide lifts all ships. I think it's important. But I don't think that any initiative at PsyCan will have a specific measurable impact on like our financial performance in the short term. In the long term, absolutely. In the short term, not so much. The other thing I will say is, this specific thing, which is basically a collaboration between trade groups and lobbying entities in 3 different countries, in the U.K., in Canada and in the U.S. is largely about exporting best practices. But I think personally, if I had to pick a jurisdiction with the best practices right now, it's actually Australia. So a lot of it is trying to take the Australian model and shove it into government ears in Canada, and the U.K. and in the U.S. And we will see what the results are. But again, I don't anticipate it will bring massive sea change in the short-term.

That's all we have for submitted questions.

Okay. Okay. Well, listen, thank you very much for joining, everyone. Nice to the point, a 25-minute webinar. In the future, we're always happy to field questions, but we do need time to review for something like this, we need time to review them. So I know I see some questions sent into the chat. As per our instructions, unless you are a professional working in the -- as an Analyst, you do need to register in advance and you need to send in your questions in advance, and we'll be more than happy to field them. I will try to do some more AMAs on the forums, but really, we are quite busy in trying to get some actual work done for the company. So that remains our #1 priority. So once again, thank you very much for joining. Will, thanks for the recap and look forward to speaking to all of you soon.

Yes. Great time today, folks. Hopefully, you all found it useful.