MEDXF (MEDXF) Q1 2027 Earnings Report, Transcript and Summary

Greetings. Welcome to the Medexus Pharmaceuticals First Quarter 2027 Conference Call. [Operator Instructions] 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 Medexus 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 MD&A which, along with the financial statements, is available on the company website at www.medexus.com and on SEDAR+ at www.sedarplus.ca. As a reminder, Medexus reports on a March 31 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 GRAFAPEX and the strength of our business. GRAFAPEX delivered its strongest quarter to date with product level performance of GRAFAPEX, net of working capital changes, accretive to quarterly operating cash flows in fiscal Q1 '27. The product continues to perform in line with our expectations that product level net revenue from GRAFAPEX will be $30 million to $32 million for fiscal year 2027, making it an increasingly important driver of Medexus' operating and financial performance. For the 3 months ending June 30, we recognized product level net revenue from GRAFAPEX 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 30, '26, shows that 75 individual health care institutions have already ordered GRAFAPEX for procedures in their institutions and 54 of those institutions have placed repeat orders. Ordering by health care 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 GRAFAPEX brings to patients, providers and payers. Based on the continued commercial traction we are seeing, we continue to expect GRAFAPEX to achieve annual product level net revenue of approximately $100 million to $175 million within 5 years after commercial launch. Beyond the continued success of GRAFAPEX, we remain excited about the broader opportunities we see in the allo-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 Zemcelpro. If approved in Canada, UM171 cell therapy would be an excellent strategic fit with Treosulfan, which we commercialize in Canada as Trecondyv. Turning to our overall financial performance. Net revenue for fiscal Q1 '27 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 U.S. and Canada. Supported by our resilient portfolio of established products, the continued growth of GRAFAPEX and exciting new product opportunity in UM171 cell therapy in Canada and strong fiscal foundation, we remain focused on disciplined execution, generating cash, investing in business opportunities that create long-term value. I will now turn the call over to Brendon, who will discuss our financial results in more detail.

Thank you, Ken. Our strong results for fiscal Q1 '27 demonstrate both the growth trajectory of GRAFAPEX and the durability of our portfolio of established products. As Ken mentioned, we generated $4.9 million of product level net revenue from GRAFAPEX in fiscal Q1 '27 and product level performance of GRAFAPEX, 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 GRAFAPEX and IXINITY. Gross profit was $15.9 million for fiscal Q1 '27 compared to $13.8 million for the same period last year. Gross margin was 55.6% for fiscal Q1 '27 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 GRAFAPEX. Selling, general and administrative expenses were $13 million for fiscal Q1 '27 compared to $12.2 million for the same period last year. Adjusted EBITDA was $4.7 million for fiscal Q1 '27, 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 GRAFAPEX for fiscal Q1 '27, exceeding the $3.2 million of GRAFAPEX personnel and infrastructure investments in the same period, along with the year-over-year increase in product level net revenue from IXINITY, partially offset by the onetime positive impact of royalty revenue in the comparative quarter. Net 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 30, '26, our net debt was $20.9 million, an increase of $5.2 million compared to $15.7 million as at March 31, '26. Net debt to adjusted EBITDA was 1.18x as of June 30, '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 GRAFAPEX 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.

[Operator Instructions] Your first question for today is from Andre Uddin with Research Capital.

You reported nice GRAFAPEX 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 2 quarters?

Thanks, Andre. I don't have the exact percentage, Brendon, unless you have it. But I can 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 peak GRAFAPEX sales estimate of $100 million to $175 million, based on your model in terms of what you're seeing, what has changed, would you say the most positively since you initially established that range? Is it the number of centers, the procedures per center, the market share pricing? Or is it something else?

Yes, all good questions. There's a lot in there. Pricing has been excellent. We've received our price universally. And we're -- 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 indicator of future revenue is the degree to which hospitals are adopting this as standard of care. Obviously, that is a goal of ours, and we've described that the $100 million to $175 million represents a 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?

Yes. Clearly, we're focused in HSCT or stem cell transplantation and adjacent areas. So building on the platform that GRAFAPEX provides for us. UM171 is a clear indication of that, that's a cell source that would be used following a conditioning agent like GRAFAPEX. And so strategically right in line with where we want to be. So I would expect that we would continue to do business development in that same area.

Your next question is from Scott Henry with AGP.

Starting on the big picture with GRAFAPEX. Obviously, very strong quarter in first quarter of $4.9 million, close to $5 million. But your $30 million to $32 million for the year is still a pretty big number relative to $5 million. 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?

Yes. 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 million to $32 million 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. So as we go through the year, so this quarter that we're working on now will probably be the most challenging quarter because it's the summer months. And 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. So even though I think we described June as being our strongest month ever with 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 that gives us a lot of confidence that now moving into August, September, which tend to be strong months, we're going to see continued acceleration of our revenue growth, and that leads into further quarters where we expect to continue to see growth. So we're on a really good trajectory and the leading indicators 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?

Yes, 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 30, 2025. And that related to Gleolan in the U.S., which was a product we gave back to the licensor in March of 2025. But as term of giving that product back, we received royalty revenue through until June 30. 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.

But is it -- so it is not also in Q1 '27 fiscal?

No, it's not.

Okay. Then digging into that just briefly, but first, sequentially, the Canadian sales improved up $1 million basically from fourth quarter fiscal '26, which I assume was Rupall. Should we expect that strength to continue? Or is this just a strong first quarter?

If you're comparing sort of quarter over previous quarter, that strength in Rupall is mostly just the seasonality of the allergy season, which was a little bit stronger this year as a result of some of the forest fires. 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 to be reasonably similar for fiscal '27 here.

Okay. Great. And then just a final question on UM171, what should we think about as the next steps in terms of gauging how the time line on that is progressing? I know there's a couple of options. Just want to get an idea of what to focus on there.

Yes. 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.

And in a situation like that, do you have to request a meeting? Have you requested a meeting? Is there a time line when we think that may happen? Just any color along the specific next steps around that in front of Health Canada.

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.

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

Congratulations on these strong results. I'm going to start on GRAFAPEX. I recall you discussing that adult utilization is the key driver of this drug and then 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.

Yes. Thanks, Michael. It's a good question. So yes, 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 color. Now on -- still on GRAFAPEX, I wonder if you could just discuss what you're seeing as inventory levels among wholesalers and if we're -- and we saw like 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. Yes, I can speak to that. Yes, we -- I know it's in our MD&A, and our inventory levels at the end of June were about one time -- one month 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 2-plus months of inventory on hand. And then over the course of the year, that kind of reduced to about 1x. So that was the case at March 31. It was the case at June 30, 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. Maybe one last one on some other aspects of your portfolio. I wonder if you could comment on the status of Rupall sales post genericization. You mentioned some stability there, but I wonder if you could go a bit deeper. And then also touch on how IXINITY is trending.

I'll let Brendon take those too.

Perfect. Yes. So Rupall, we -- I'm trying to remember a couple of quarters ago, we had sort of spoken about how it had lost about 60% to about 2/3 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 IXINITY, we are seeing kind of continued durable product as we've talked about in -- over the last couple of years at this point. What we did see this quarter, one of the reasons for the year-over-year improvement in revenue and EBITDA is IXINITY did have a strong quarter. And part of that, we believe, is timing, but timing of patient orders, not wholesaler orders. So it's -- 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.

Your next question is from David Martin with Bloom Burton.

This is Gireesh on for David. Congrats on the quarter. Just starting with GRAFAPEX. Are you seeing any sort of off-label use for other indications such as CASGEVY?

Yes. Good question. So 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 2 largest forms of leukemia that undergo allo transplant at 10 grams, which is the label 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. And 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?

Yes, I can speak to that. So our messaging on tariffs has been pretty consistent over the last few quarters. Our expectation remains on Rasuvo, which is brought in from Germany, that the 15% U.S. negotiated tariff will apply. With GRAFAPEX 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 we still sort of believe our base case or worst case, I guess, in that case is the 15% -- the same 15% applying to GRAFAPEX. So the impact on our overall margins is not material. We don't anticipate any tariff-specific price changes.

Okay. And just following up on Rasuvo. You did mention there was an ANDA filer this quarter. Is the 30-month stay in effect? And does this litigation change how you're thinking about the durability of Rasuvo demand given that tailwind that happened when the competitor had exited?

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

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

So another question on GRAFAPEX 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?

Yes. Thanks, Chris, for the question. So yes, the NTAP has been confirmed to continue for another year, which you're right, it would -- 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. So the trailing leverage ratio is about 1.2x. Do you have perhaps a target leverage ratio before you're going to be diverting more capital towards debt paydown versus other types of capital deployment?

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 3x range. And I think given the durability of our sort of established portfolio and our level of conviction on GRAFAPEX, we would be kind of comfortable getting back to that range.

[Operator Instructions] 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 GRAFAPEX, combined with our expanding presence in the allo-HSCT space, reinforces our confidence in Medexus' 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.