Medexus Pharmaceuticals Inc.

Medexus Pharmaceuticals Inc.

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Medexus Pharmaceuticals Inc.US flagOther OTC
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Q4 FY2026 · Earnings Call TranscriptJune 26, 2026

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Operator

Greetings. Welcome to the Medexus Pharmaceuticals fiscal fourth quarter and year-end 2026 conference call.

I will now like to turn the conference over to your host, Victoria Rutherford, Investor Relations of Medexus.

Operator

Victoria Rutherford

Thank you. Good morning, everyone.

Welcome to the Medexus Pharmaceuticals fiscal fourth quarter and year-end 2026 earnings call. On the call this morning are Ken d'Entremont, Chief Executive Officer, and Brendon Buschman, Chief Financial Officer.

I would like to remind everyone that this discussion will include forward-looking information as defined in Canadian securities laws. This discussion will also include non-GAAP measures such as adjusted EBITDA, adjusted EBITDA margin, adjusted gross margin, and net debt.

For more information, please refer to the company's MD&A, which along with the financial statements, is available at www.medexus.com and on SEDAR+ at www.sedarplus.ca. Medexus reports on a March 31st fiscal year basis and reports financial results in US dollars.

I would now like to turn the call over to Ken d'Entremont.

Victoria Rutherford

Ken d'Entremont

Thank you, Victoria. Thanks everyone for joining us on the call today.

We're proud to report that product level revenue performance for GRAFAPEX, net of working capital changes, was accretive to quarterly operating cash flows in fiscal Q4 2026, representing a significant milestone in the commercialization of the product. We're encouraged by GRAFAPEX's strong progress to date, with product level performance continuing to demonstrate strong momentum, and we continue to expect annual product level net revenue to exceed $100 million within five years of launch.

For the 12-month period ending March 31st, 2026, we recognized product level net revenue from GRAFAPEX of $11.6 million, exceeding the $11.2 million we invested in the GRAFAPEX launch over the same period. Building on this momentum, we expect GRAFAPEX to generate product level net revenue between $30 million and $32 million for fiscal year 2027 and to drive our growth in operating cash flows moving forward.

As of today, 74 of all 180 U.S. transplant centers have already ordered GRAFAPEX for procedures in their institutions, and 54 of those institutions have reordered.

Overall, our fiscal Q4 2026 results remain strong, delivering positive operating income, adjusted EBITDA, and operating cash flow. These results reflect the portfolio evolution we have discussed in past quarters as we build on the continued growth momentum from GRAFAPEX.

The continued momentum of GRAFAPEX and our ongoing business development initiatives focused on Allo-HSCT will build on that foundation and position Medexus for sustainable long-term growth. Our fiscal Q4 2026 net revenue was $24.7 million, a decrease compared to $24.8 million for the same period last year.

Our fiscal Q4 2026 adjusted EBITDA was $4.3 million, an increase compared to $2.3 million for the same period last year. Our net loss of $2.7 million for fiscal Q4 2026 is a decrease from the net loss of $0.6 million for the same period last year, and positive operating income of $1.2 million is an increase of $2.4 million compared to the operating loss of $1.2 million for the same period last year.

Our fiscal year 2026 net revenue was $99.3 million, which compares to $108.3 million for fiscal year 2025. The $9 million year-over-year decrease in net revenue primarily reflects the lower product level net revenue from Gleolan in the United States following the March 2025 termination of our U.S.

Gleolan agreement, and from Rupall in Canada due to generic competition. The decrease was partially offset by contributions from GRAFAPEX and the strength in Rasuvo.

We reported adjusted EBITDA of $16.5 million for fiscal year 2026, which compares to $20.2 million for fiscal year 2025. We reported net loss of $2.4 million for fiscal year 2026 compared to net income of $2.2 million for fiscal year 2025.

I also want to touch on a new business development opportunity we secured in the HSCT space. Earlier this month, we signed agreements for the exclusive Canadian rights to commercialize UM171 Cell Therapy.

This is a proprietary advanced clinical stage investigational drug that recently received conditional marketing authorization in Europe from the European Commission as ZEMCELPRO. Given its current stage of development in Canada, we do not expect to begin commercialization of the product before calendar year 2028, with the exact timing depending on a number of factors including our ongoing evaluation of available regulatory pathways.

The product candidate is an excellent strategic fit with treosulfan, our existing hemato-oncology product, which we commercialize in Canada as Trecondyv. Our organization is already well acquainted with the Allo-HSCT field, and we see this product candidate as an important potential contribution to the Canadian market and to our medium-term product pipeline.

I'd now like to turn the call over to Brendon.

Ken d'Entremont

Brendon Buschman

Thank you, Ken. Fiscal year 2026 was an important transitional year for Medexus, being the first fiscal year reflecting product level performance of GRAFAPEX.

Net revenue for fiscal Q4 2026 was $24.7 million, a decrease of $0.1 million compared to $24.8 million for the same period last year. Net revenue for the full year was $99.3 million, reflecting a $9 million decrease compared to $108.3 million in the prior year.

These decreases were primarily due to reduced product level net revenue resulting from the return of Gleolan in the United States and the genericization of Rupall in Canada. In all, Medexus generated approximately $87.7 million of net revenue from our established portfolio and $11.6 million of net revenue from GRAFAPEX in fiscal year 2026.

Gross profit was $13.3 million and $54.4 million for the three and 12-month periods ended March 31, 2026, compared to $12.4 million and $56.6 million for the same periods in the previous year. Gross margin was 53.8% and 54.8% for the three and 12-month periods ending March 31, 2026, an improvement compared to 50.2% and 52.2% for the same periods in the previous year.

The increase in gross margin was driven by the change in the relative contribution of product level net revenue, in particular an increasing level of net sales of GRAFAPEX and the absence of sales of Gleolan in the U.S. Selling, general and administrative expenses were $10.6 million and $45.9 million for the three and 12-month periods ended March 31, 2026, compared to $12.2 million and $43.2 million for the same periods in the previous year.

Adjusted EBITDA for the three and 12-month periods ended March 31, 2026, was $4.3 million and $16.5 million, compared to $2.3 million and $20.2 million for the same periods in the previous year. The $2 million increase in adjusted EBITDA for fiscal Q4 2026 benefited from GRAFAPEX product level net revenue of $3.4 million exceeding the $2.7 million of GRAFAPEX personnel and infrastructure investments in the same period.

Net loss for the three and 12-month periods ended March 31, 2026, was $2.7 million and $2.4 million compared to net loss of $0.6 million and net income of $2.2 million for the same periods last year. Operating cash flow was $3.8 million and $18.9 million for the three and 12-month periods ending March 31st, 2026, compared to $2.3 million and $24 million for the same periods in the prior year.

Even while continuing to invest in the launch of GRAFAPEX, we have generated an average of $4.2 million of cash from operating activities per quarter in the five quarters since launch. Cash on hand was $6.5 million at March 31st, 2026 compared to $24 million at March 31st, 2025.

The notable factor in these changes was our payment in full of the $15 million regulatory milestone under our GRAFAPEX agreement over the course of fiscal year 2026. We've meaningfully strengthened our balance sheet with our new credit agreement with National Bank of Canada, which includes significantly lower quarterly principal repayments.

With net debt to adjusted EBITDA of 0.95 for the trailing four fiscal quarters ended March 31st, 2026, our financial strength has enabled us to repurchase over $1.2 million common shares to date under our NCIB. As of March 31st, 2026, we had $22.4 million of debt outstanding under our two National Bank credit facilities, consisting of $2.5 million drawn under our revolving credit facility and the remainder under our term loan facility.

Operator, we will now open the call to analyst questions.

Brendon Buschman

Operator

Your first question for today is from Scott Henry with Alliance Global Partners.

Operator

Scott Henry

GRAFAPEX guidance is $30 million to $32 million for fiscal 2027, which is a pretty tight and impressive range. Can you talk a little about the cadence to reach those numbers and where the inflection point would come?

Scott Henry

Ken d'Entremont

The 50% growth sequentially quarter-over-quarter is very meaningful. We expect the increase in revenue for GRAFAPEX to come from two sources — one, hospitals who have already ordered will increase the volume of their orders, and two, new hospitals coming on board.

We expect to see quarter-over-quarter progression to get us to that $30 million to $32 million for the full year.

Ken d'Entremont

Scott Henry

Is there any seasonality we should factor in? Q4 would have to be a double-digit million quarter to reach these numbers.

How should we expect that progression?

Scott Henry

Ken d'Entremont

The seasonality we observed last year was that in the summer months there are fewer procedures, particularly for non-malignant disease, so July and August ought to be a little bit slower. It tends to accelerate through the fall months.

December with the holiday season also probably sees fewer procedures. The seasonality is more related to the numbers of procedures and the availability of transplanters than anything else.

We're only starting year two now, so we don't know the exact magnitude of change, but we do expect to see some seasonality.

Ken d'Entremont

Scott Henry

With regards to Canada, should we think of the quarterly run rate as flattish for now, or do you expect some rebound?

Scott Henry

Brendon Buschman

For Canadian revenues and really all of our established portfolio, which is everything but GRAFAPEX, the noise that came through the return of Gleolan to the licensor in the U.S. and the genericization of Rupall has now largely been erased.

If you're considering that to be durable on both sides of the border, that would be the right way to look at it.

Brendon Buschman

Scott Henry

How should we think about the revenue growth rates for Rasuvo and IXINITY in the U.S. in fiscal 2027?

Scott Henry

Brendon Buschman

The same answer — think of it as durable. I wouldn't model in any sort of meaningful growth, nor would I model in any sort of meaningful erosion in both of those products.

Brendon Buschman

Operator

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

Operator

Michael Freeman

On GRAFAPEX, I see that 74 of 180 transplant institutions have ordered as of the date of the press release. Can you confirm that's a first quarter number, and how many of these institutions have GRAFAPEX on formulary today?

Michael Freeman

Ken d'Entremont

The number of institutions ordering is as of the most recent information before the press release, a few days ago. In terms of how many have it on formulary — most of them.

There is no standard answer here. Typically, having something on formulary creates access to the drug, but that is not always the case.

There are some hospitals, many pediatric hospitals, where it does not need to be on formulary and they still have full access. The important thing is whether they can use it without restrictions, and we are reporting very good uptake in terms of formulary listings.

It is very much on track for where we expect to be.

Ken d'Entremont

Michael Freeman

On commercial health plans, you cited some impressive total covered lives figures, but also that 42 health plans have established coverage pathways for GRAFAPEX — a number that stepped down from Q3. What would explain the difference?

Michael Freeman

Ken d'Entremont

There is always change in the commercial payer landscape — plans consolidating, et cetera. The important number is how many lives covered, which is over 200 million.

We have most of the lives covered, and I would add that we've had no issues in terms of getting product for people commercially. There is very broad access to the drug at the price we have set, and on the reimbursement side we see it as quite positive.

Ken d'Entremont

Michael Freeman

Can you dive in further on the UM171 business development deal? What are the most likely regulatory pathways you see with Health Canada, and does this reframe your business development focus?

Do you see more opportunity to pick up assets in the Allo-HSCT space?

Michael Freeman

Ken d'Entremont

In recent quarters we've been describing a transition away from a diversified specialty pharma company operating three therapeutic areas to a rare disease orphan drug company operating in one therapeutic area, specifically HSCT and adjacent areas. That transition has largely happened.

UM171 is an example of that. Our business development effort is focused exclusively in HSCT and adjacent areas — that's where our strength is and that's where we have a product portfolio.

UM171 is a perfect strategic fit aligned with GRAFAPEX: GRAFAPEX is the first step in a transplant where they condition the bone marrow, UM171 is a potential cell source. It's an absolute perfect strategic fit.

On the regulatory pathway — we see two potential pathways. One, like Europe, where this could serve patients who can't find donors as a cell source, which would likely be a faster regulatory pathway due to unmet medical need.

The second is to complete clinical development through a phase III study and then register based on that clinical work. Of course, we have to sit down with the regulator to confirm they see it the same way and take their advice.

Ken d'Entremont

Michael Freeman

What should we expect for SG&A as revenue scales through this year?

Michael Freeman

Brendon Buschman

We've guided to $3 million to $4 million in SG&A specific to GRAFAPEX. We do expect a modest increase in overall SG&A over the course of 2027 compared to 2026.

We would also expect an increase in R&D spending specific to investigator-initiated trials in GRAFAPEX, as well as augmented spend to continue to improve the IXINITY process. So a modest increase in SG&A and a little more meaningful increase in R&D in fiscal 2027.

Brendon Buschman

Operator

Your next question is from David Martin with Bloom Burton.

Operator

David Martin

You talked about potentially an expedited path or completing clinical development for UM171 in Canada. What would the timeline for approval be in both those scenarios?

David Martin

Ken d'Entremont

That matches up with what we put in the press release — 2028 for the expedited path versus approximately 2031 for the clinical development route.

Ken d'Entremont

David Martin

You talk about HSCT and adjacent areas. What are the adjacent areas?

David Martin

Ken d'Entremont

Bringing patients into a transplant — there's a lot of different disease states where chemotherapy is needed to prepare them for a potential transplant. AML, MDS, and other blood-borne cancers we would be interested in.

Anything within the transplant space specifically. We now have at least two products in transplant in Canada, and it'd be nice to add something for GvHD prophylaxis and other areas within transplant.

Adjacent areas including patients coming into transplant are targets where we have infrastructure and experience.

Ken d'Entremont

David Martin

Last quarter you mentioned wholesaler inventory was down to one and a half to two months, and it looks like it was drawn down further this quarter — patient level use of $3.9 million versus revenues of $3.4 million. Are wholesalers starting to stock back up, and should we expect a surge in the current quarter?

David Martin

Brendon Buschman

I certainly wouldn't guide to a surge. The amount that the wholesaler will hold can be anywhere from one to two months at any given time, and where it is at quarter end can be anywhere in between.

I would guide towards expecting that it'll probably stay somewhere in the one to one and a half months of inventory on hand going forward.

Brendon Buschman

Ken d'Entremont

The only thing I would add is that as our monthly volume grows, the amount of inventory they're going to hold will grow appropriately.

Ken d'Entremont

David Martin

On Rasuvo — you mentioned the increase due to the withdrawal of a competitor, but finished with a note subject to future changes in competitive market dynamics. Are you anticipating the competitor will come back on the market, or is this just a general statement?

David Martin

Ken d'Entremont

More or less a general statement. There's always the potential that the competitor could come back — there's work that would be needed to be done in order to come back.

There aren't any other competitors that could leave; we are currently the only auto-injector of methotrexate. It's possible that there could be shortages in other forms of methotrexate, which has happened in the past.

All those dynamics could happen. It's more of a cautionary statement than anything.

Ken d'Entremont

Operator

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

Operator

Ken d'Entremont

Thank you. I just want to thank everyone for joining us on the call today.

We look to continue to build and advance on GRAFAPEX in the coming months and quarters, and it's driven strong performance. We look forward to reporting on the rest of fiscal 2027.

Thank you very much. This concludes today's conference, and you may disconnect your lines at this time.

Thank you for your participation.