6/26/2025

speaker
Operator
Conference Operator

Greetings. Welcome to the Medexis Pharmaceuticals fourth quarter and fiscal year-end 2025 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 of Medexis. You may begin.

speaker
Victoria Rutherford
Investor Relations, Medexis Pharmaceuticals

Thank you, and good morning, everyone. Welcome to the Medexis Pharmaceuticals fourth quarter and fiscal year 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 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, the 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 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 to net income and loss, please refer to the company's MD&A, which, along with the financial statements, are available on the company's website at www.medexis.com and on Cedar Plus at www.cedarplus.ca. As a reminder, Medexis reports on March 31st fiscal year basis. Medexis 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.

speaker
Ken D'Entremont
Chief Executive Officer

Thank you, Victoria, and thank you, everyone, for joining us on the call today. The last few months have been an exciting and dynamic time at Medex's as we have begun the commercialization efforts for Graphapex, the brand name for triosulfan in the United States. I'm pleased to report that Medex has achieved 0.6 million of product level revenue for Graphapex in fiscal Q4 25 after becoming commercially available late in February. Relative to 2.7 million of Graphapex personnel and infrastructure investments in the quarter, and our preliminary estimates indicate that we have already generated over 2.5 million of product level revenue in fiscal Q1 26. We continue to expect that Graphapex will be accretive to quarterly operating cash flows by fiscal Q4 26, that's calendar Q1 26. Although we continue to assess the strong market response and performance of key indicators for any updates to this expectation. We continue to expect that the annual product level adjusted gross margin of Graphapex will ultimately be approximately 80%, although as a preliminary estimate, product level adjusted gross margin will be slightly higher in the initial months after commercial launch, primarily due to the evolving reimbursement dynamics for the product. Our fiscal Q4 net revenue was 24.8 million, a decrease compared to 26 million for the same period last year. Our fiscal Q4-25 adjusted EBITDA was $2.3 million, a decrease compared to $4.4 million for the same period last year. This decrease was primarily due to $2.7 million of Grafitex personnel and infrastructure investments over the quarter to support our commercialization efforts for the product. Our net income of negative $0.6 million for the quarter increased is a decrease from the positive 0.8 million for the same period last year. And negative operating income of 1.2 million is a decrease of 2 million compared to positive 0.8 million for the same period last year. Again, the decreases in these metrics are primarily due to the investment we are making in Graphapex commercialization efforts at this time. We're also proud of the financial results we're reporting for our fiscal year 25. We achieved record adjusted EBITDA and record net income in fiscal year 25, both primarily due to effects of our ongoing financial discipline efforts and further supporting the stability of our base business-based portfolio. Our fiscal year 25 net revenue was 108.3 million, which compares to 113.1 million in fiscal 24. We reported adjusted EBITDA of 20.2 million for fiscal year 25, which compares to 19.5 million in fiscal year 24. We also produced a net income of 2.2 million compared to negative 0.2 million in the fiscal year 24. Turning to our specific products, the key business update for this quarter is the commercialization of Graphapex. We initiated the execution of a commercial launch of Grafitex in the first half of calendar year 25, with product commercially available in the United States in February. The launch, which was originally expected to occur in April of 25, followed swiftly on the FDA's approval of the product in January, allowing us to begin generating product-level revenue earlier than originally planned. We have seen a positive market response to Grafitex to date with the progress consistent with our expectations. Four large commercial players together covering an approximate 34 million patient lives and 12 individual healthcare institutions representing 7% of the 180 transplant centers in the United States have made positive formulary inclusion determinations. This is a promising indicator of the product's commercial potential. An additional 15 payers have added Graphopex on their prior authorization list. Wholesaler data shows that 34 of the 180 transplant centers have already ordered Graphopex for procedures in their institutions. We are very happy with Graphopex product performance to date. The response from the market and the attention of Triosulfan from the medical and scientific community has been excellent. In Canada, unit demand for Tricondo, the brand name for Triosulfan in Canada, grew by 70% over the trailing 12-month period ending March 31, 2025. To date, British Columbia, Ontario, and Quebec have executed listing agreements to reimburse Tricondo in those provinces following a positive PCPA decision in November of 24. Xfinity unit demand in the United States increased by 1% over the trailing 12-month period ending March 31st, 25. We expect that the unit demand will remain relatively stable, with only slight continued decreases in the near term. RuPaul unit demand in Canada increased by 14% over the trailing 12-month period ending March 31st, 25. Rupal's market exclusivity, granted by Health Canada, expired in January 25. Rupal has now begun to face generic competition in Canada, and we have initiated a strategy to support the product in this context. Presuvo unit demand in the United States and Mediject unit demand in Canada both remain strong during fiscal Q4-25, although the factors we have discussed in the past continue to affect product-level revenue. I will now turn the call over to Brendan, who will discuss our financial results in more detail.

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