Good morning, everyone, and welcome to the Medexus Pharmaceuticals Second Quarter 2026 Conference Call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions following the presentation. If anyone should require operator assistance during this conference, please press star zero on your phone keypad. Please note this conference is being recorded. I will now turn the conference over to your host, Victoria Rutherford, Investor Relations. Victoria, the floor is yours.
Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals Second Fiscal Quarter 2026 Earnings Call. On the call this morning are Ken d'Entremont , Chief Executive Officer, and Brendon 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 Canadian securities laws that is based on certain assumptions that Medexus believes to be reasonable in the circumstances but is subject to risk 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, which do not have any standardized meaning under the 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's website at www.medexus.com and on SEDAR Plus 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 to 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 are now over eight months into the commercial launch of Graphopex. We are extremely pleased with the progress achieved thus far, and product performance to date has exceeded our pre-launch expectations, with October 2025 representing the strongest month of patient demand we have seen since launch. The $6 million we have invested in Graphopex launch to date through September 30 is already having a significant impact. As of today, we have engaged with 83% of all 180 U.S. transplant centers. 29% of U.S. transplant centers have already ordered Graphopex for procedures in their institutions, and 69% of those 52 institutions have reordered. For the six-month period ending September 30, we recognize product-level net revenue from Graphopex of $6.2 million.
We still expect that Graphopex will begin contributing positively to quarterly operating cash flows by fourth calendar quarter 2025, which is our fiscal Q3 2026, reinforcing its potential as a meaningful driver of long-term value. The initial adoption by major commercial payers and leading healthcare institutions has been highly encouraging, and early indicators of patient-level demand continue to validate the value proposition Graphopex delivers. To that end, product-level net revenue from Graphopex in fiscal Q2 2026 totaled $3.1 million relative to $3 million of Graphopex personnel and infrastructure investments. In fiscal Q3 2026, we expect that the underlying patient demand of Graphopex will be approximately $3 million-$4 million. This compares to $2.2 million in fiscal Q1 2026 and $2.1 million in fiscal Q2.
Considering the estimated one to two months of inventory on hand at our wholesaler at September 30, we anticipate patient demand in fiscal Q3 2026 will result in product-level net revenue of Graphopex of between $2.5 million and $3.5 million. Starting October 1, 2025, eligible procedures under Medicare involving the use of Graphopex are eligible for additional reimbursement through the NTAP program or new technology add-on payment. As I have mentioned previously, this program is designed to provide temporary supplemental reimbursement to institutions that use designated new higher-cost medical technologies, making it easier for hospitals to adopt products such as Graphopex and thereby improving Medicare patient access to cutting-edge care. We believe that the NTAP program's objectives are being met here, and we expect that NTAP eligibility for Graphopex has and will continue to drive adoption and utilization in our fiscal Q3 2026.
Overall, our fiscal Q2 2026 results remain solid, with positive operating income, adjusted EBITDA, and operating cash flows. Our results reflect a continuation of portfolio dynamics we have discussed in the past quarters, coupled with continued growth momentum of Graphopex, which we view as a continuing testament to our portfolio approach. Our fiscal Q2 2026 net revenue was $24.7 million, a decrease compared to $26.3 million for the same period last year. Our fiscal Q226 adjusted EBITDA was $4.4 million, a decrease compared to $6 million for the same period last year, but our second consecutive fiscal quarter of adjusted EBITDA growth since the approval and launch of Graphopex in fiscal Q4 2025.
We produced a modest net loss of $0.3 million for the quarter, a decrease compared to + $0.1 million for the same period last year, but we still produced positive operating income of $1.4 million in fiscal Q2 2026, a decrease compared to $1.6 million for the same period last year, but again, our second consecutive fiscal quarter of operating income growth since the approval and launch of Graphopex. Turning to a few notes on our other products, in Canada, unit demand for Trecondyv grew by 69% over the trailing 12-month period ending September 30th. In September 2025, Health Canada issued a notice of compliance in respect of generic version of Treosulfan for injection in Canada. We intend to monitor for and evaluate the potential effects of this development for any future commercial launch of the now-approved generic product.
Ixinity unit demand in the United States decreased by 3% over the trailing 12-month period ending September 30, 2025. We continue to invest judiciously in our Ixinity manufacturing process improvement initiative, which has been ongoing for some years now. This initiative has resulted in a 30% decrease in product-level cost of goods, comparing fiscal Q2 2026 to fiscal Q1 2021, being the first fiscal quarter following our acquisition of the product in February of 2020. This informs our choice to make modest further investments in this process, approximately $1.2 million of which we expect to pay in fiscal year 2026. Rasuvo unit demand in the United States has decreased by 2%, and Metoject unit demand in Canada decreased by 9% over the trailing 12-month period ending September 30, 2025.
Regarding Rasuvo, during the last quarter, we learned that another product in the branded methotrexate auto-injector market had been withdrawn by its distributor. We expect increased unit demand for Rasuvo over time as inventory of the withdrawn product sells down and patients and healthcare professionals look for alternatives. Rupall continues to face generic competition in Canada following the loss of its regulatory exclusivity period in January 2025, and as a result, unit demand over the three- and six-month period ending September 30th decreased by 58% and 55% compared to the corresponding prior year periods. While the impact of generic erosion on product-level net revenue appears to have slowed in fiscal Q1 2026, generic competition will continue to have an adverse impact on product-level performance. We view this pattern as still typical of products in this later stage of product lifecycle.
In summary, we remain focused on delivering strong overall performance across our portfolio of products in both the U.S. and Canada, advancing Graphopex in the U.S., and strategically positioning the company to capitalize on future revenue opportunities. I'll now turn the call over to Brendon, who will discuss our financial results in more detail.
Thank you, Ken. Our results for fiscal Q226 were solid and continue to reflect the natural transitional changes of our evolving product portfolio. We are very pleased with the early performance of Graphopex, which, as Ken mentioned, generated $3.1 million of product-level net revenue in our fiscal Q2 2026, and is, net of working capital changes, expected to begin contributing positively to operating cash flows in the fourth calendar quarter of 2025, which is our fiscal Q3 2026. Turning to the full quarterly results, total net revenue for fiscal Q2 2026 was $24.7 million. This represents a decrease of $1.6 million compared to $26.3 million for the same period last year. The $1.6 million year-over-year net revenue decrease was attributable in part to reduced net sales of Rupall in Canada and the March 2025 return of Gleolan in the United States to the licensor.
This was partially offset by product-level net revenue from Graphopex, among other factors. Gross profit was $13.8 million for fiscal Q2 2026 compared to $14.1 million for the same period last year. Gross margin was 55.7% for fiscal Q2 2026, which is an improvement on the 53.7% we achieved in the same period last year. We expect increasing product-level net revenue from Graphopex, together with the absence of product-level net revenue from Gleolan post-March 2025, to have a positive effect on the company-level gross margin. These resulting changes to gross margin are expected to continue to emerge over fiscal year 2026. Selling general and administrative expenses were $11.9 million for fiscal Q2 2026 compared to $9.7 million for the same period last year. The $2.2 million year-over-year increase in selling general and administrative expenses was primarily due to the $3 million of Graphopex personnel and infrastructure investments we incurred in fiscal Q2 2026.
We expect these investments to stabilize at approximately $3 million-$4 million per quarter, although individual future quarters could deviate from this estimate. Adjusted EBITDA was $4.4 million for fiscal Q2 2026, a decrease of $1.6 million compared to $6 million for the same period last year. The decrease was primarily due to the effects of generic competition on product-level net revenue of Rupall. Net loss was $0.3 million for fiscal Q2 2026, a decrease of $0.4 million compared to net income of $0.1 million for the same period last year. We continue to generate cash from our operating activities, with quarterly operating cash flow of $3.3 million compared to $6.9 million for fiscal Q2 2025. Cash on hand of $9.4 million at September 30, 2025, compares to $24 million at March 31, 2025.
The primary factor in this net decrease in cash is the company's aggregate payments of $16.6 million under our senior secured credit agreement, substantially reducing our outstanding principal amount. As of September 30, 2025, our net debt was $11.7 million, a decrease of $1.5 million compared to $13.2 million as of March 31, 2025. We are in the advanced stages of a process to refinance our credit agreement and have a high degree of confidence that we will be able to announce a long-term agreement well in advance of the current facility's maturity in March 2026. As always, there can be variability in quarter-to-quarter results, and the operating environment also remains variable, 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 analyst questions.
Thank you very much. We are now conducting our question and answer session. If you would like to ask a question, please press star one on your phone keypad now. A confirmation tone will indicate that your line is in the queue. You may press star two if you would like to remove your question from the queue. For anyone using speaker equipment, it might be necessary to pick up your handset before you press the keys. Please wait a moment whilst we poll for questions. Thank you. Our first question is coming from Andre Uddin of Research Capital. Andre, your line is live.
Thanks, Operator. Hi, Ken and Brendon. Just looking at Rasuvo. Just wondering which branded methotrexate auto injector was withdrawn from the market and what market share did that product have?
Yeah, thanks, Andre. So it was Otrexup. If you recall, there were just the two of us in the market. We had an 80% share and they had the rest.
Okay. In terms of looking at NTAP, can you discuss what, in terms of influencing NTAP Graphopex sales, like since October 1, about what percentage of patients have been treated under this program, do you think?
Yeah, that's a great question. We estimate that the Medicare/Medicaid portion of this market is someplace between 20% and 30% of total market. Obviously, the NTAP designation has a significant impact on access for those patients because it basically closes the gap between us and the generic competitive product. It gives them early access to cutting-edge technology. We would expect that uptake will accelerate for that group of patients.
Okay. Just one last question. In terms of your BD pipeline, how does it look at this point in time, and are you considering bringing in another product? Thanks.
Yeah, great question. Obviously, we're laser-focused on executing on Graphopex. That is the future of the company. That's where we're putting the majority of our effort. We're always scouting for additional business development opportunities in the therapeutic areas where we participate so that we can leverage the infrastructure that we have. We're always looking. Obviously, when we find something attractive, we'll share that with shareholders.
Okay. That's great. Thanks, Ken.
Thank you very much. Our next question is coming from Michael Freeman of Raymond James. Michael, your line is live.
Hey, good morning, Ken and Brendon. Congrats on the quarter. A few questions here. I wonder if you could give us an update on Graphopex's formulary inclusion, insurance coverage dynamics, and any feedback you're getting on the doctor and patient experience using Graphopex so far.
Yeah, thanks, Michael. Great questions. First, on the reimbursement front, I think we've described that we're ahead of expectations with the launch of the product. I mean, we're reporting on six months in. We're now eight months in. The reimbursement situation has been very positive, both from the institutional level where P&T committees are including the product on their formularies, which gives the physicians access within the institution, and then commercial payers are putting positive recommendations in their plans where necessary to reimburse it. We have not run into any significant issue with respect to getting access to the product. Obviously, it just takes time for institutions to go through the process of adding it to their formulary. That's kind of what we're experiencing right now. We're very pleased with where we are today.
Oh, that's with respect to the second part of your question, which was feedback from clinicians. We've always known that this is a very important addition to their options for conditioning of patients undergoing transplant. Clinically, the evidence is very strong. We are seeing adoption in the places where we expected it. Again, positive feedback, which emboldens our confidence that the drug is going to be a major part of transplant and will achieve that target we've set, which is 100+ by five years.
All right. Great. Thanks, Ken. Now, on IXINITY, it looks like sales have been holding in quite well despite competition. I wonder what you would attribute the durability of this product to.
Yeah, thanks for that. It's been a part of people's treatment for many years now. We have a strong group of patients who are very comfortable and satisfied with the product, and they consistently use the product. We have a group of sales and marketing people in the field who are doing a great job at making sure those patients remain satisfied with the product. I think it's a combination of both. Partially, it's the drug, and it works really well. We have people who support it who do a really good job.
Okay. Thanks very much. I'll pass the line.
Thank you very much. Just a reminder there, if there are any remaining questions, you can still join the queue by pressing star one on your phone keypad. Our next question is coming from Scott Henry of A.G.P. Scott, your line is live.
Thank you and good morning. Ken, for starters, I didn't quite hear, you had given some guidance for fiscal Q3 Graphopex. Could you just repeat that? It chopped up a little on my end.
Revenue fiscal Q3? I think we said $2.5 million-$3.5 million. Brendon, do you have the number?
Yeah. So we're also guiding to demand sales. So we've guided to $3.4 million in demand sales, and that compares to $2.1 million, I believe, for fiscal Q2. And in X Factory, so that'd be wholesaler sales, we're guiding to $2.5 million-$3.5 million, which compares to $3.1 million in Q2.
The demand should be greater than the reported sales. Why would that be? I mean, typically, when a product's growing, the opposite is true. Could you give any color on that?
Yeah.
I can speak to that.
Sorry, no. Go ahead. Yeah, go ahead, Brendon.
For the last two quarters, we have seen that be the case as the wholesaler has just held on to inventory on hand. They are sitting at between one and a half to two months of inventory right now, which is very consistent with industry norms. We cannot really control how much inventory they will have on hand at any time. That is kind of why we are—and just as a side—because we have a single wholesaler model, we do not necessarily have the gives and takes that we would have for some of our other products. That is why we are really focused on guiding towards demand sales as well and then trying to bridge that to that X Factory sales.
Okay. You mentioned October was the largest month. Can you comment on the demand run rate in October? If you annualized October, what sort of level we would be at?
Yeah, we're not really giving granularity down to that level. Clearly, with October coming in so strong, maybe partially due to reimbursement improvement, which started in the month, we don't know for sure. We will find out later. Yeah, we're well on track to kind of what we've been guiding to and expecting on Graphopex. Brendon, can you give a little more color, maybe?
Yeah. I mean, as far as the actual demand, what we can say is it's very much in line with supporting the $3 million-$4 million that we have guided to. As Ken mentioned, it is the strongest month of demand that we've had yet.
Okay. Great. Yeah, the launch has been very strong, in my opinion. One of the things—I mean, I've seen a lot of launches over the last 20 years. Every launch has its own curve. With a product like this, how would you think about, based on the early information you have, what kind of launch curve this would be? Obviously, it went way up in the beginning, but now would you expect gradual growth, or do you think you might hit an inflection point and accelerating growth as reimbursement comes together? My question is, based on what you've seen, how do you think we should think about this launch trajectory going forward based on the dynamics of this market?
Yeah, that's a great question. This is a very unique situation because, as we've discussed previously, this is a drug that there's a lot of information out there about it. It's been launched in many other territories before it hits the U.S., which is not usually the case. What we have observed is, as expected, in the early going, the first few months, we got a lot of pediatric use. There's a very strong need for it in pediatrics. Now we're starting to get access to the adults, which will really drive that revenue growth going forward. It's almost like this two-phase sort of a launch where real quick uptake in the very beginning plateaus. Now, as we're seeing reimbursement come in place for adults, it starts to accelerate again. That's kind of what we expect.
As you know well, Scott, the first year typically is a year spent on trying to get reimbursement. We have seen strong uptake even while that effort has been ongoing. We feel good about it accelerating into next year.
Okay. Final question. Just on the Canadian sales, they were at a very high level in the first half of fiscal 2025. You had some competitive issues there, which brought it down to a new level. Where we are right now, do you see this as kind of a base for growth going forward, or just trying to get a sense if the Canadian business has kind of bottomed out and we should start to think about sequential growth going forward?
There's a lot in that one. Obviously, we had a broad portfolio in Canada. This was lots of ups and downs. Rupall being the major driver of that, we said in the comments that we see that erosion starting to slow. We would hope that that's the case. We expect some continued erosion on Rupall, but at a declining rate. I guess that gets to your point about is it starting to trough. That's possible. We've got other headwinds on Metoject, which showed some continued erosion, but again, at kind of a declining rate. All these ups and downs, I think the Canadian business is flat to declining, continue for a few quarters, and then trough.
Okay. Great. Thank you for the color. Thank you for taking the questions.
Thank you very much. Our next question is coming from [Gary] of Bloom Burton & Co. David, your line is live.
Good morning, Ken and Brendon. This is [Gary Shaunford], for Dave. Can you provide a bit more color on the ongoing Rasuvo sales dynamics? Have you seen any early signs of market share gain with the competitor leaving? Have prices sort of stabilized in terms of gross and net adjustment? Thanks.
Yeah, great questions. Yes and yes. We did see—we are seeing increased unit volume uptake as a result of the competitor announcing they were withdrawing and inventory starting to work down. That is happening. Yes, obviously, price had kind of troughed. We do not see any further declines.
Do you expect price to either increase going forward, or would it be stable?
Most of this business is under contract. You wouldn't expect to see anything happen in the short term. As contracts expire and then get renegotiated, that would be the point at which we'd start to see some movement.
Okay. Thanks. That's it from us.
Thank you very much. We appear to have reached the end of our question and answer session. I will now hand back over to the management team for any closing comments.
I just want to thank everybody for joining us on the call today. We remain pleased with the business performance in this past quarter, which continues to underscore the strength and strategic value of our portfolio approach. This solid foundation positions Medexus well as we enter the next phase of growth driven by continuing rollout of Graphopex. We look forward to the opportunities that lie ahead in fiscal 2026 and beyond. Thank everybody for joining the call today.
Thank you very much. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. We thank you for your participation.