Medexus Pharmaceuticals Inc.

Greetings. Welcome to the Medexis First Fiscal Quarter 2025 Earnings 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 call over to your host, Victoria Rutherford. Ma'am, you may begin.

Thank you and good morning everyone. Welcome to the Medexus Pharmaceuticals first fiscal quarter 2025 earnings call. On the call this morning are Ken D'Entremont, Chief Executive Officer, and Brendan Bushman, Chief Financial Officer. If you have any questions after the conference call or would like further information about the company, please contact Adelaide Capital at 480-625-5772. I would like to remind everyone that this discussion will include forward-looking information as defined in securities laws. Actual results may differ materially from historical results or results anticipated by the forward-looking information. In addition, this discussion will also include non-GAAP measures such as adjusted net income and loss and adjusted EBITDA, which do not have any standardized meaning under IFRS and therefore may not be comparable to similar measures presented by other companies. For more information about the company's forward-looking information and non-GAAP measures, including reconciliations to net income and loss, please refer to the company's MD&A, which, along with the financial statements, is available on the company's website at www.medexus.com and on CDARplus at www.cdarplus.ca. As a reminder, Medexus reports on March 31st fiscal year basis, and Medexus reports financial results in U.S. dollars. I would now like to turn the call over to Ken D'Entremont.

Good morning, and thank you for joining us on the call today. We are pleased with our fiscal Q125 results, particularly our positive net income and strong adjusted EBITDA, which allowed us to comfortably play down principal under our credit facility. Our fiscal Q125 revenue was $27.3 million, a decrease compared to a record $31.6 million for the same period last year. Rupal's outperformance during the allergy season was a notable contributor to revenue, combined with resilience from the rest of our product portfolio. We are proud of our fiscal Q125 adjusted EBITDA of $6.1 million, a decrease compared to a record $6.6 million for the same period last year. We are also very proud to have produced solid net income of $2 million for the quarter, an improvement of $1.3 million over the same period last year, and positive operating income of $4 million, a decrease of $0.8 million compared to a record $4.8 million for the same period last year. These important metrics for fiscal Q125 were all positively impacted by the financial discipline initiatives we have been working on, such as the January 24 cost reduction initiative we have discussed in the past. They have had a positive impact on operating costs and cost structure. Turning to our specific products, Xfinity unit demand for the United States decreased by 6% over the trailing 12-month period ending June 30, 24. We will continue seeking to maintain existing demand noting that our current view is that the trends we have mentioned in recent quarters have now stabilized and are now fully reflected in product level revenue. Again, our investments in our Xfinity Manufacturing Process Improvement Initiative have had a positive impact on batch yield and manufacturing costs, extending into fiscal Q125. And we view this as a great accomplishment following a lot of hard work from our dedicated team. Rupal unit demand in Canada increased by 17% over the trailing 12-month period ending June 30th, 24. As I mentioned, Rupal was a notable contributor to revenue for fiscal Q125, reflecting both our successful execution of the product's typical seasonality, particularly in this past quarter. We continue to see tropical Turbinafine which has been under regulatory review with Health Canada since December as a strategic fit with Rupel. If and when approved, this product will enter a market that we estimate to be $88 million Canadian dollars on an annual basis. Resuvo unit demand in the United States remains strong during fiscal Q125. We are continually evaluating our pricing strategies for Resuvo in light of evolving market dynamics. As part of our execution of these pricing strategies, we did reduce discounts offered to large customers in fiscal Q125, which contributed to a dip in Resuvo net sales for the quarter. This may have a moderate near-term effect on product-level revenue. MetalJet unit demand was likewise strong, increasing 11% in the trailing 12-month period ending June 30, 2024. in spite of direct generic competition. Given overall market dynamics, we have been implementing unit-level pricing strategies for Metalject as well, with a view to defending the product's strong market position. I will end this discussion of our leading products with a brief word on Glioland. In late July, we initiated discussions to unwind our business relationship for Glioland in the United States. While we have successfully grown the product, performance has remained lower than we originally expected, based on our experience commercializing glialand in Canada. Unit demand in the United States did grow over the trailing 12 months ended June 30th, 24, as our commercialization efforts continue to result in new customers adopting the product, but it is not expected to be a significant driver of growth in the future. Given our revolving U.S. product portfolio and the growth opportunities we see ahead, we began discussions to return the product to our partner. As you can imagine, the substance of those discussions is sensitive. What I can tell you is that our conversations with our partner are going well, and we are confident the parties will come to a plan that works for all. We look forward to continuing to work with our partners on our successful business relationship, commercializing Glialand in Canada. Finally, on Triosulfan, we continue to eagerly await a decision from the FDA on Med-Act's April 2024 resubmission of the NDA for Triosulfan, which we still expect no later than October 30th, 24. We continue to believe that Triosulfan would make a substantial contribution to this therapeutic space, as it has in Europe and Canada, and the FDA's commitment to review the Triosulfan NDA brings us a step closer to making the product a viable treatment option in the United States. Our plan remains to target a commercial launch in the first half of calendar year 25. We have begun making judicious investments in personnel to prepare for a potential positive FDA decision in October. As we have said before, we think Triosulfan would have a material positive impact on our total revenue. We currently believe that annual product-level revenue in the United States has the potential to exceed $100 million within five years after commercial launch. We would not expect to begin recognizing significant revenue from Trilosulfan until early fiscal year 26, meaning second quarter 25 at the earliest. Under the terms of our agreement with MEDAC, We and our counterparts at MEDAC are currently discussing the terms of a further amendment to our agreement with respect to any adjustments to the value of unpaid milestone payments. We are highly focused on quickly achieving clarity on the remaining contractual milestones under our agreement, and we are confident that the parties will ultimately arrive at a fair and commercially reasonable outcome. In sum, We continue to focus on maintaining stability in our base business and generating cash from operations as we prepare for the revenue opportunities presented by our product pipeline. I will now turn the call over to Brendan, who will discuss our financial results in more detail. Brendan?

Thank you, Ken. We are pleased to report our ninth consecutive quarter of positive operating income and 11th consecutive quarter of positive adjusted EBITDA. which speaks to the continued strength of our product portfolio and commercial execution. We are particularly pleased with our $2 million of positive net income for fiscal Q1 2025 and our $6.1 million adjusted EBITDA from $27.3 million of revenue. These results are due to a strong overall quarterly performance, successful execution of our targeted reductions in operating expenses, and a streamlined capital structure. We also continue to generate cash from our operating activities with a record quarterly operating cash flow of $8.2 million, driving our positive cash flow in fiscal Q1 2025. Turning to the full quarterly results, total revenue for fiscal Q1 2025 was $27.3 million. This represents a decrease of $4.3 million compared to $31.6 million for Q1 2024. As Ken mentioned, fiscal Q1 last year was a record quarter for us. The $4.3 million year-over-year revenue decrease was primarily attributable to reduced net sales of Resuvo, declines in net sales of Infinity when compared to Q1 2024. These trends have impacted our year-over-year results since fiscal Q3 2024, and as Ken mentioned, have largely stabilized. The decrease was partially offset by continuing growth in repal net sales, which were also meaningfully affected by the product's typical seasonality in both periods, and a slight year-over-year increase in glial land net sales. Gross profit was $14.8 million for Q1 2025, compared to $17.2 million for the same period last year. Gross margin was 54.4% for Q1 2025, which is comparable to the 54.6% we achieved in the same period last year. Our gross margin for the first quarter of fiscal year 2025 has improved versus the last quarter of fiscal 2024, which was 51.2%. This improvement is driven by reduced exempted unit costs, as well as the treatment of GLHLAM cost of sales per IFRS accounting standards. We expect this improved gross margin to persist for the near term. Selling and administrative expenses were $10.3 million for Q1 2025 compared to $11.9 million for the same period last year. The $1.6 million year-over-year decrease in this line item was primarily attributable to targeted reductions in operating expenses. I want to pause on this point to note that we have now achieved the positive effects on our operating costs and cost structure that were the target of our previously discussed cost reduction initiatives. So we do expect that selling and administrative expenses have largely stabilized for the near term, pending the investments for triosulfan that Ken mentioned. Adjusted EBITDA was $6.1 million for Q1 2025. a decrease of $0.5 million compared to our quarterly record of $6.6 million for the same period last year. The decrease in adjusted EBITDA was primarily attributable to the year-over-year decrease in revenue in fiscal Q1 2025, offset by reductions in operating expenses extending into fiscal Q1 2025, and improvements in Xfinity cost of sales attributable to our Xfinity Manufacturing Process Improvement Initiative. Net income of $2 million for Q1 2025 reflects a $1.3 million increase compared to net income of $0.7 million for the same period last year. As Ken mentioned, we view this as a significant achievement and look forward to striving for positive net income in the quarters to come. Likewise, our cash position was a highlight of this past quarter with $8.5 million cash on hand at June 30th, 2024. compared to $5.3 million at March 31st, 2024, an increase of $3.2 million. We continue to generate cash from our operating activities with record quarterly operating cash flow of $8.2 million compared to $4.2 million for fiscal Q1 2024. As of June 30th, 2024, we had a combined $48.3 million outstanding under our two BMO credit facilities consisting of $3.5 million drawn under our revolving credit facility and the remainder outstanding under our near-term loan facility. Both facilities mature in March 2026, and we will continue to pay down principal over the remaining term. As always, there can be variability in quarter to quarter results, but we look forward to continuing to build the company and its portfolio in the coming quarters and beyond. Operator, we will now open the call to questions.

Certainly. 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 your line is in the question queue. You may press star 2 if you would like to remove yourself from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment while we poll for questions. Your first question for today is from Andre Uden with Research Capital.

Hi, Ken and Brendan. Thanks for the questions. Just wanted to get a bit of clarity in terms of what you're planning to do with Glioland. Is it to return the product back to Medic or find a new marketing partner? Can you just talk a little bit about that?

Yeah. Hi, Andre, and thanks for the question. Yeah, we're in discussions with the licensor and only the licensor. And so it'll be their decision as to what to do with the product. We don't see any immediate effect and probably nothing in the near term. And so obviously these discussions have just been initiated. They are sensitive. So I really don't have anything to say beyond that.

Okay. And can you just remind us, I don't know if this was disclosed before, but how much did you pay to get the marketing rights to Cleoland?

I don't recall what was disclosed before, but it was a very small sum up front with various time-based milestones over the life of the agreement. So it was a very small amount up front.

Okay. Okay, that's great. Thanks. And then just given some of the corporate changes you've made, could you just please discuss also which products your sales force is most focused on promoting to sort of strategically stabilize your sales?

Yeah, that's a great question. So, you know, obviously they're focused on the largest products and make the biggest contribution. So that would be Xfinity, Resuvo, Glioland, Rupal, and then in Canada, also the specialty products, which include Trisulfan, Metal Jack, Glioland. I think that's it. That's great. Thanks, Ken.

Your next question is coming from Raul Saragazar with Raymond James.

Morning, Ken. Morning, Brandon. Thanks so much for taking our questions. So fully recognizing that the real-time discussions are quite sensitive. Perhaps maybe you can give us a sense of the timeline around it and when you think you might have some clarity on it.

Hi, Gabriel. Thanks for the question. I think, as I said in my earlier comment, they've just been initiated. And As they are sensitive, clearly both parties want to come to some commercially reasonable resolution, and they will continue to be our partners on real land in Canada. So I can't really speak to the timeline, but clearly both partners will want to see a resolution as quickly as possible, and we'll put that information out at the appropriate time.

Okay, that's fair and helpful. And now, pivoting to TRIO, you talked a little bit about it and your confidence, and I'm still mostly looking at the FDA review concluding before the end of October. Perhaps you could sort of reiterate what is different in this review and application that provides for that confidence relative to the previous attempts?

Yeah, great question. And so I think some clarity on this is important. Following the CRL, there were two attempts at a resubmission and each attempt was refused by the FDA. So this one is different in that the FDA did the screening and accepted the resubmission. And so it, once again, is an active review. So I think that's a big difference than what has previously happened and in what bodes our confidence.

Okay, perfect. That's helpful. I'm certainly looking forward to that. That's all from us today. I will get back to you. Thank you so much.

Your next question for today is from Stefan Queenville with Ventum Capital Markets.

Hi, guys. Sorry to belabor the point here on Glioland, but I just want to understand this a bit better. You know, obviously the product has sort of, I mean, maybe in the U.S., maybe not in Canada, underperformed expectations. The dynamic here really has to do with you guys reorienting yourself around trio cell phone and the opportunity there. Is that what this is primarily about? Or is there, there's something else going on with the product in terms of its overall profitability to the firm or, you know, maybe upcoming milestones in the trade-off for profitability in those milestones.

Thanks. And great question. You know, recall that, you know, we, we licensed glial land after the CRL on trio and, as an opportunity to gain experience in the institutions and promote a product that was similar to where we were going in institutional sales. So that was great. The problem was we brought on a product that was mature. I think both parties believed that with additional resources it would grow. And it did to some degree, but not to a degree that either party is satisfied with. So when we look at it, we say, okay, given our product portfolio and where we're going in the future, given what we expect from Glialand, it just made better sense to invest our efforts in our product portfolio than continuing to try to support Glialand. Remember, the margin on Glialand was not as strong as the rest of our portfolio. And we made the true up payment last year. So it, it, it doesn't deliver, you know, what we would want. And so, you know, I think it makes sense for us to negotiate this unwinding with our partner. And we're certainly going to keep you informed, you know, once we have something to announce.

Okay. And so, you know, I think that the key focus now is preparation for the TRIO launch. Obviously, you've made some comments. You know, you don't expect to have, you know, material revenue to Q2 of 25. So it sounds like you're being cautious in terms of hiring ahead of that to some degree. Although this sounds like what you're doing is just shifting resources within the company to prepare for the launch is what I'm hearing.

um can you talk about uh what you're doing to prepare for the trio launch so you hit the ground running and you make the most of the asset once it uh gets approved yeah great question again um two two key things um one is you know prepare the clinicians uh for the eventual uh approval we hope um so adding the MSL that we talked about last quarter is really important. So we have people who are sharing the clinical information, the most recent clinical information with the clinicians who are going to be using the product. So that effort is ongoing. And then secondly, preparing for the reimbursement of the product in the institutions, which is critically important. So obviously, enabling access to a drug that we think the clinicians will want. So those two efforts have been initiated, and we are judiciously adding people to support those efforts. Great. That's all from me. Thanks.

Your next question is from Justin Keywood with Stiefel.

Good morning. Nice to see the profitability on the lower revenue. And there was mention of some cost reduction initiatives, and there does seem to be some moving parts in preparing for TRIO. My question is, how should we look at the profitability and cash profile for the remainder of the year and going into next?

Thanks, Justin. I think that's an appropriate question for Brandon.

Yeah, the way I would look at it is our margins at the gross margin level, at the EBITDA margin level that we're kind of seeing this quarter, we anticipate are repeatable. And so that our EBITDA or adjusted EBITDA, I should say, has historically quite closely tracked our cash flow from operations on a sort of average basis. And I would anticipate that to continue as well. Our financing costs, primarily interest on our BMO debt, are stable. In prior years, there was a lot of variability as a result of the convertible ventures. So those financing costs are a lot more predictable going forward than they have been. So it should be much easier to kind of estimate net income and free cash flow than it historically has been. I will also mention on on our BMO debt. We are, I think we've disclosed this, we are paying quarterly payments of $3.3 million of principal from now until maturity in March of 2026.

Thanks for the additional color. And then for RuPaul, I believe there was a bit of a delay in the allergy season this year, but there still seem to be pretty good results. Should we anticipate some stronger results in the next quarter for that product? And then also looking into 2025, as far as the potential generic entry, how are we looking at that revenue stream? Is it still expected to be relatively stable or is there a drop-off anticipated?

Yeah, great question. So, yes, the allergy season, you know, had a bit of a different cadence this year, but was, again, very strong, as evidenced by, you know, the good performance of RuPaul last quarter. So we would expect that, you know, last quarter was the peak quarter, but we would expect this quarter will be a good quarter for RuPaul. And then obviously, typical seasonality kicks in in the next couple of quarters. It declines a little bit. So for next year, lots of exclusivity. Remember that we only have private reimbursement. We don't have public reimbursement. So there is no forced substitution. So our efforts will be on maintaining exclusivity. the product through, you know, various programs. But we would expect it to be, you know, it'll kind of peak and then start to decline. We don't see a sharp decline like you would in a forced substitution kind of scenario, but we would expect a decline. And that's why terbinafine is important to us. You know, we see the a probable approval of terbinafine around the same time, and then a possible launch if that decision is positive, which would keep the sales force occupied on a new product launch while continuing to maintain Rupel.

Great. Thanks for that, Collar. And then just finally on the additional products, there was some mention of the ability for pharmacists to prescribe additional products in Ontario and that could potentially have an impact? Are you able to quantify that at all?

Yeah, it's a great question. Thanks for bringing that up. No, we can't quantify it yet, although NIDA is a product you're referring to. A similar situation has existed in Quebec for several years. And NIDA is the leading product in Quebec with a very strong market share. Ontario, obviously, is the largest market for these products, and we don't have nearly as strong a market share in Ontario as we do in Quebec. So we think that that change in legislation, which we believe is coming soon, will benefit NIDA. Clearly, we will put programs in place to take advantage of that.

Interesting, thanks for taking my call This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation