Medexus Pharmaceuticals Inc.

Greetings. Welcome to the Medexus Pharmaceuticals first quarter 2027 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, Victoria Rutherford, Investor Relations, you may begin.

Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals first fiscal quarter 2027 earnings call. On the call this morning are Ken d'Entremont, Chief Executive Officer, and Brendon Buschman, 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 Canadian securities laws that is based on certain assumptions that Medexis believes to be reasonable in the circumstances but is subject to risks and uncertainties. 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 EBITDA adjusted EBITDA margin and adjusted gross margin and net debt, 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 forward-looking information and non-GAAP measures, including reconciliations, please refer to the company's MDNA, which, along with the financial statements, is available on the company website at www.medexus.com and on CDARplus at www.cdarplus.ca. As a reminder, Medexus reports on a March 31st fiscal year basis. Medexus reports financial results in U.S. dollars and all references are in U.S. dollars unless otherwise specified. I would now like to turn the call over to Ken d'Entremont.

Thank you, Victoria, and thank you everyone for joining us on this call today. We're pleased with our first quarter results which reinforce our confidence in the growth trajectory of Grapepex and the strength of our business. Grapepex delivered its strongest quarter to date with product level performance of Grapepex, net of working capital changes accretive to quarterly operating cash flows in fiscal Q127. The product continues to perform in line with our expectations that product level net revenue from Graphopex will be $30 to $32 million for fiscal year 2027, making it an increasingly important driver of Medex's operating and financial performance. For the three months ending June 30th, we recognized product-level net revenue from Graphapex of $4.9 million compared to approximately $3.2 million of product-level personnel and infrastructure investments over the same period. Commercial adoption also continues to progress well. Wholesaler data as of June 30th, 26th shows that 75 individual health care institutions have already ordered graphopex for procedures in their institutions and 54 of those institutions have placed repeat orders. ordering by healthcare institutions and payer coverage and access trends have been highly encouraging and the early indicators of patient-level demand continue to reinforce the value proposition Graphapex brings to patients, providers, and payers. Based on the continued commercial traction we are seeing, we continue to expect Graphopex to achieve annual product level net revenue of approximately $100 to $175 million within five years after commercial launch. Beyond the continued success of Graphopex, we remain excited about the broader opportunities we see in the Aloe HSCT space and are continuing to invest strategically to strengthen our leadership in this space. In June, we signed agreements for the exclusive Canadian rights to commercialize UM171 cell therapy. As we discussed on our last call, this is a proprietary advanced clinical stage investigational drug product that recently received conditional marketing authorization in Europe from the European Commission as ZemCell Pro. If approved in Canada, UM171 Cell Therapy would be an excellent strategic fit with Triosulfan, which we commercialize in Canada as Tricondyph. Turning to our overall financial performance, net revenue for fiscal Q127 increased to $28.6 million from $24.6 million in the prior year. while adjusted EBITDA increased to $4.7 million from $3.4 million. We also generated net income of $0.5 million consistent with prior year period and operating income improved to $2.1 million from $0.9 million. We otherwise remain focused on delivering strong overall performance across our portfolio of products in both the US and Canada. Supported by our resilient portfolio of established products, the continued growth of Graphopex, an exciting new product opportunity in UM 171 Cell Therapy in Canada, and strong fiscal foundation, we remain focused on discipline execution, generating cash, investing in business opportunities that create long-term value. I will now turn the call over to Brendon, who will discuss financial results in more detail. Thank you, Ken.

Our strong results for fiscal Q127 demonstrate both the growth trajectory of Graphapex and the durability of our portfolio of established products. As Ken mentioned, we generated $4.9 million of product level net revenue from Graphapex in fiscal Q127 and product level performance of Graphapex net of working capital changes continues to be accretive to quarterly operating cash flows. Underlying patient demand was $4.8 million for fiscal Q1-27, representing growth of 23% compared to $3.9 million for fiscal Q4-26 and 118% compared to $2.2 million for fiscal Q1-26. Turning to the full quarterly results, total net revenue for fiscal Q1-27 was $28.6 million. This represents an increase of $4 million compared to $24.6 million for the same period last year. The $4 million year-over-year net revenue increase was primarily due to an increase in product-level net revenue from Graphopex and Xenity. Gross profit was $15.9 million for fiscal Q127 compared to $13.8 million for the same period last year. Gross margin was 55.6% for fiscal Q127 compared to a gross margin of 56.0% for the same period last year. Adjusted gross margin was 63.8% compared to 65.5% for the same period last year. The gross margin and adjusted gross margin decreases are due to the prior year one-time positive impact of royalty revenue on gross margin and adjusted gross margin in fiscal Q1 26, without which gross margin and adjusted gross margin would have increased in fiscal Q1 27 compared to fiscal Q1 26 due to changes in the relative contribution of product level net revenue. in particular, an increasing level of net sales of Graphopex. Selling, general, and administrative expenses were $13 million for fiscal Q127 compared to $12.2 million for the same period last year. Adjusted EBITDA was $4.7 million for fiscal Q127, an increase of $1.3 million compared to $3.4 million for the same period last year. The $1.3 million year-over-year adjusted EBITDA increase was primarily due to the $4.9 million of product-level net revenue from Graphopex for fiscal Q1-27, exceeding the $3.2 million of Graphopex personnel and infrastructure investments in the same period, along with the year-over-year increase in product-level net revenue from Xenity, partially offset by the one-time positive impact of royalty revenue in the comparative. Debt income was $0.5 million for fiscal Q1 27, which is consistent with fiscal Q1 26. Cash used by operating activities was $0.7 million for Q1 27, a decrease of $4.6 million compared to $3.9 million in cash provided by operating activities for the same period last year. primarily due to the settlement of year-end payables and the associated timing of working capital items. As of June 30th, 26, our net debt was $20.9 million, an increase of 5.2 million compared to 15.7 million as at March 31st, 26. Net debt to adjusted EBITDA was 1.18 times as of June 30th, 26. We are entering the remainder of fiscal year 2027 from a position of financial strength. We expect to generate meaningful operating cash flow in fiscal year 2027 as Graphapex continues to scale and our portfolio of established products continues to demonstrate its resilience. As always, there can be variability in quarter to quarter results. and the operating environment also remains variable. But we are encouraged by the strength of our business and remain well positioned to continue building the company and expanding its portfolios in the coming quarters and beyond. Operator, I will now open the call to analyst 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 your question 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.

Thanks, Operator. Hi, Ken and Brendon. You reported a nice graph of sales this quarter. Can you tell us approximately what percentage of that revenue is now coming from repeat ordering versus first-time orders, and how has that mix changed over, let's say, the last two quarters?

Thanks, Andre. I don't know the exact percentage, Brendon, unless you have it, but I can't tell you directionally. Most of the revenue is coming from repeat orders of hospitals that are starting to adopt it more broadly. I think the leading indicator is that first order, but that then tends to develop into much broader use once they have the first experience, and that really is a driver behind our revenue.

Okay, that's fine. And then just looking at your your peak graphic sales estimate of 100 to 175 million, you know, based on your model, in terms of what you're seeing, what has changed, would you say the most positively since you initially established our range? Is it the number of centers, the procedures per center, the market share pricing, or is it something else? Thanks.

Yeah, all good questions. There's a lot in there. Pricing's been excellent. We've received our price universally, and as you can tell from our numbers, we're not discounting anything, almost. So we're really pleased with price and we've got very broad adoption acceptance commercially as well as within the institution. So price is strong. I think our best, you know, indicator of future revenue is the degree to which hospitals are adopting this as standard of care. You know, obviously that is a goal of ours and we've described that the 100 to 175 million represents 29 to 42% market share. And we're seeing hospitals, many hospitals that have already achieved that. So I think that's our most encouraging metric that reinforces the support and our belief that we'll achieve the guidance.

Okay, that's great. And just one more question. Can you provide more detail ideally on where you envision Your business development going over the next year?

Yeah, clearly we're focused in HSCTs or stem cell transplantation and adjacent areas. So building on the platform that Grafapex provides for us, UM7-1 is a clear indication of that. That's a cell source that would be used following a conditioning agent like Grafapex. And so strategically, you know, right in line with where we want to be. So I would expect that they you know, we would continue to do business development in that same area Okay, that's great.

Thanks.

Thanks, Ken Your next question is from Scott Henry with AGP Thank you and good morning Starting on the the big picture with Graphopex obviously very strong quarter in first quarter of 4.9 million, close to five. But your 30 to 32 million for the year is still a pretty big number relative to five. So can you talk a little bit about how we should think about the trajectory to get to where we are in Q1 to where you expect to be in the full year? Thank you.

Yeah, thanks, Scott. Great question. I'm sure that's on a lot of people's minds. So the reason we have confidence in the 30 to 32 is because of the leading indicators, which are obviously formulary listings, commercial support from the payers, and then finally, first use from the hospitals. And so we're seeing all those leading indicators very much support what we've given as the guidance. As we go through the year, this quarter that we're working on now will probably be the most challenging quarter because it's the summer months. You'll remember last year we had a significant dip in July, and this year we haven't seen that to nearly the same degree. Even though I think we described June as being our strongest month ever, a significant uptake, and I think the Bloomberg data supported that, the uptake we're seeing in the summer months has been really strong. And the uptake in July, which historically last year was a very soft month for us, this year it was our second best month ever. and so, you know, that gives us a lot of confidence that now moving into August, September, which tend to be strong months, you know, we're going to see continued acceleration of our revenue growth and that leads into, you know, further quarters where we expect to continue to see growth. So we're on a really good trajectory in the leading indicators, you know, support what we've guided to.

Okay, great. It's certainly an impressive target for the product. Shifting gears, I guess for clarity, it looks like there was about $1.3 million in GTA royalty revenue. I assume that shows up in the U.S. revenue line, is that correct?

Yeah, I can speak to that. So that's in the comparative quarter. So that's revenue we received in Q1 of 26, so the quarter ending June 30th, 2025. And that related to Glioland in the US, which was a product we gave back to the licensor in March of 2025. But as a term of giving that product back, we received royalty revenue through till June 30th. So that's what that $1.3 million relates to. It's in the comparative quarter. It's a one-time royalty revenue, and it's just creating a little bit of noise when you kind of compare the quarter over quarter.

So it is not also in Q127 fiscal?

No, it's not.

Okay. Then digging into that just briefly, but first sequentially – The Canadian sales improved up a million basically from fourth quarter fiscal 26, which I assume was RuPaul. Should we expect that strength to continue or is this just a strong first quarter?

If you're comparing quarter over quarter, Thank you for joining us. But if you're just looking at it kind of compared to the comparative quarter being Q1 of last year, it's going to be a little bit more consistent. So if you remember, the product was genericized and I believe it was January of 2025. And so we saw a pretty quick erosion and then it's kind of stabilized. So I would just sort of look at last year's quarterly phasing for the Canadian portfolio and expect it for fiscal 27 here.

Okay, great. And then just a final question. On UM 171, what should we think about as the next steps in terms of gauging how the timeline on that is progressing? I know there's a couple options. I just want to get an idea of what to focus on there.

Yeah, the next step is to get in front of Health Canada and discuss the regulatory path forward. Being a Canadian development where there's a large unmet medical need, we're optimistic that we'll be able to find an expedited path, but there's no guarantee on that until we negotiate that with the agency.

In a situation like that, do you have to request a meeting? Have you requested a meeting? Is there a timeline when we think that may happen? Just any color along the specific next steps around that?

Yes. Yes, so we have to request the meeting. I believe that has been done. I'm not sure that it's been set yet, but we would expect it to happen in the fall.

Okay, that's great. Thank you. and thank you for taking the questions.

Your next question for today is from Michael Freeman with Raymond James.

Hey, good morning, Tim, Brendon, and congratulations on these strong results. I'm going to start on Grafipex. I recall you discussing that adult utilization is the key driver of this drug and the reimbursement was very supportive of that. I wonder if you could describe penetration into the adult population and what you're seeing among docs for that adult population.

Yeah, thanks, Michael. That's a good question. So, yeah, the growth that we're experiencing is largely coming from the adult population. I mean, we had real strong uptake in pediatrics initially right out of the gate last year. and now this growth is happening from adult institutions and with adult patients. And as you probably know or remind you that 85% of the market is adult patients. So clearly getting strong uptake in that segment is really important to us and that's where we're seeing the growth coming from. That's great. I appreciate that, Keller.

Now, still on graph effects, I wonder if you could just discuss what you're seeing as inventory levels among wholesalers. And we saw a pretty close alignment between underlying demand and product level revenue this quarter. I wonder if you could discuss that relationship and how you're seeing inventory levels now.

I'll let Brendon take that one.

Perfect, yeah, I can speak to that.

Yeah, I know it's in our MD&A and our inventory levels at the end of June were about one time, one month's worth of inventory, a little bit less depending on which month you use. But what we really saw is a strong, if you go back to the initial launch, wholesalers looking to hold two plus months of inventory on hand. And then over the course of the year, that kind of reduced to about one times. That was the case at March 31st. It was the case at June 30th, which is why you sort of see that consistency between the demand sales and the ex-factory sales. We hope that that consistency continues, but we don't have any control over wholesaler ordering patterns.

Okay. All right. Thank you, Brendon. One last one on some other aspects of your portfolio. I wonder if you could comment on the status of RuPaul sales post-genericization. You mentioned some stability there, but I wonder if you could go a bit deeper and then also touch on how Xfinity is trending.

I'll let Brendon take those two.

Perfect. Yeah, so RuPaul, I'm trying to remember a couple of quarters ago, we had sort of spoken about how it had lost about 60% to about two thirds of its unit volume. That has stayed stable. So we have seen over the last couple of quarters that sort of market share It is still slowly declining, but the rate of decline has slowed meaningfully. On Xenity, we are seeing kind of continued durable products as we've talked about over the last couple of years at this point. What we did see this quarter, one of the reasons for the and many, many, many more. and part of that we believe is timing, but timing of patient orders, not wholesaler orders. So we did see, I think we called out in the MD&A a 12% increase in demand quarter over comparative quarter, but it's still a little bit of wait and see how much of that is durable and how much of that is just due to say people filling prescriptions before going on vacation, for example.

Got it. Okay. That's all rational. Thank you very much. I'll pass it on.

Your next question is from David Martin with Bloom Burton.

Good morning, Kenneth and Brendon. This is Garish on for David. Correct on the quarter. Just starting with graph of PEX, are you seeing any sort of off-label use for other indications such as Cas-Jevi?

Yeah. Good question. I think when we described the pediatric uptake, we did call out that in the pediatric area there tends to be a high degree of off-label use. What we're seeing with the adult population, which is driving most of the volume now, is largely on-label, so the initial uses tend to be very much on-label, so AML, MDS, which are the two largest forms of leukemia, that undergo allotransplant. At 10 grams, which is the labeled dose, that tends to be where they start. And then as they get comfort, it may move off label. But it's our belief that most of the use we've gotten so far has been very much on label.

Okay, thanks. Could you quantify the expected impact of tariffs on your margins and do you expect any further impact or will any sort of cost be passed down?

Yeah, I can speak to that. So our messaging on tariffs has been pretty consistent over the last few quarters. Our expectation remains on RESUVO, which is brought in from Germany, that the 15% EU-US negotiated tariff will apply. with Grafopex that could still apply, but there is a potential for an orphan drug carve out. So we're still we're waiting to sort of see how that pans out. But, you know, we still sort of believe our our base case or worst case, I guess, in that in that case is the 15 percent, the same 15 percent applying to Graphitex. So the impact on our overall margins is not material. We don't anticipate any tariff specific price changes.

OK, thanks. And just following up on Resuvo. You did mention there was an end of fallout this quarter. Is the 30-month stay in effect? And does this litigation change how you're thinking about the durability of receivable demand given that tailwind that happened when the competitor had exited?

Yeah, so we do expect a 30-month stay to apply here. It's been filed. So, you know, we think that the drug will just continue to perform along the demand that, you know, trend that has been established. So we got the one-time kind of bump. It's been stable since then, and we would expect that to continue.

Okay.

Thank you.

That's it from us.

Your next question for today is from Chris Pugh with Canaccord.

Good morning. Thanks for taking my question. So another question on Graphitex regarding the NTAP. It looks like fiscal year for Medicare ends at the end of September. I'm wondering if you're having any discussions with Medicare ahead of this first year of the program and can we assume that it's going to continue?

Yeah, thanks, Chris, for the question. So, yes, the NTAP has been confirmed to continue for another year, which you're right. The second term for the NTAP for Grafapex would be initiated in October.

Okay, that's great. And perhaps a question on the balance sheet. The trade leverage ratio is about 1.2 times. Do you have perhaps a target leverage ratio before you're going to be diverting more capital towards that pay down versus other types of capital deployments?

It's a good question. It's something we're obviously constantly looking at as we balance our leverage versus paying for some of the BD opportunities that we're looking at. I will say, historically, we had kind of gotten up into the three times range. And I think given the durability of our sort of Okay, great. That's for me. Once again, if you would like to ask a question, please press star 1.

We have reached the end of the question and answer session and I will now turn the call over to Ken for closing remarks.

Thank you everyone for joining us on the call today. We are encouraged by the strong start to fiscal 27 and the progress we continue to make across the business. The commercial success of Grafitex combined with our expanding presence in the aloe HFCT space reinforces our confidence that Medexis' long-term growth strategy We appreciate your continued interest and support and thank you for joining us.

This concludes today's conference and you may disconnect your lines at this time. Thank you for your participation.