2/6/2025

speaker
Operator
Conference Operator

Good morning, everyone. Welcome to the Medexus Pharmaceuticals third quarter 2025 conference call. At this time, all participants have been placed on a listen-only mode. 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 of Medexus. Over to you.

speaker
Victoria Rutherford
Investor Relations

Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals Third Quarter 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 securities laws. 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 and adjusted EBITDA 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.medexus.com and on CEDARplus at www.cedarplus.ca. As a reminder, Medexus reports on March 31st 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.

speaker
Ken D'Entremont
Chief Executive Officer

Thank you, Victoria, and thank you, everyone, for joining us on this call today. We've had a busy and exciting month post-quarter. We saw the successful completion of the FDA review process for Grafipex, and we completed a $30 million Canadian dollar public offering of common shares just last week. Between the strong fiscal Q3 and the net proceeds of the offering, we believe we are in a great position as we prepare for the launch of Graphopex in the United States. I will speak more to these developments in a few moments, but I want to quickly hit on our financial highlights from the quarter. We're pleased with the fiscal Q3 25 results, particularly our stable revenue, positive net income, and strong adjusted EBITDA. which have allowed us to continue preparing for the launch of Graphapex in the first half of calendar year 25, meaning that we expect product to be commercially available by April 25. Our fiscal Q3 25 revenue was $30 million, an increase compared to $25.2 million for the same period last year. Our fiscal Q325 adjusted EBITDA was $5.8 million, an increase compared to $3.2 million for the same period last year. We continue to produce positive net income of $0.7 million for the quarter, an improvement of $1.2 million over the same period last year, and positive operating income of $3.8 million, an increase of $2.8 million compared to $1.6 million for the same period last year. These important metrics for fiscal Q3 continue to reflect the financial discipline initiatives we implemented last year in our operating cost and cost structure. They also reflect around $1.9 million of fiscal Q3 2025 operating expenses in support of Graphapex, which is a change from fiscal Q3 last year. Turning to our specific products, I would first like to talk about Graphapex, as this product will provide a substantial uptake to our growth profile over the coming years. On January 22nd, we learned that the FDA had approved Grafapex, which is our branded name for Triosulfan for injection in the US. Grafapex holds orphan drug designation under the Orphan Drug Act, meaning that the product will benefit from at least seven years of regulatory exclusivity in the FDA approved indication. We hold exclusive commercial rights to Grafipex in the United States under a February 2021 exclusive license agreement with our strategic partner, Medac. We are targeting a commercial launch in the first half of calendar year 2025 with product expected to be commercially available by April. We believe that annual product level revenue for Grafipex has the potential to exceed $100 million within five years after commercial launch. Given the FDA approval, we do now owe a regulatory milestone payment to our partners at MEDAC. The amount payable to MEDAC is based on the language of the product label approved by the FDA. We have determined that MEDAC has earned a $15 million regulatory milestone amount And we are working with med act to confirm that amount in light of the terms of our agreement. The milestone amount is payable in installments. So for a $15 million milestone, we would pay 2.5 million by June 30th, 2025 5 million by October 1st and 7.5 million by January 1st, 26. Although we have the right to temporarily defer some of these amounts in Canada, Unit demand for Tricondo grew by 55% over the trailing 12-month period ending December 31, 2024. This strong performance does not yet include the effects of our successful November 24 completion of negotiation process with the Penn Canadian Pharmaceutical Alliance and subsequent decisions by participating government organizations on public reimbursement of Tricondo. To date, BC and Ontario have executed listing agreements to reimburse to conduct in those provinces. Accinity unit demand in the United States decreased by 1% over the trailing 12 month period ending December 31st, 2024. We expect that unit demand will remain stable over the remainder of fiscal 25. This performance reflects the success of our efforts to maintain existing demand despite a reduction in allocated Salesforce resources to Xfinity since January 24. Our investments in Xfinity manufacturing process improvement initiatives have greatly had a positive impact on batch yield and manufacturing costs, now extending into fiscal year 2025. Glean-O-Land unit demand in the United States grew by more than 8% over the 12-month period period ending December 31st, 2024, as our commercialization efforts continue to result in new customers adopting the product. We continue to discuss the future of our involvement in commercializing glialand in the United States with our licensing partner, and we'll provide an update if and when warranted. Propel unit demand in Canada increased by 18% over the trailing 12-month period ending December 31st, 2024. RuPaul's market exclusivity, granted by Health Canada, expired in January 2025. We expect that RuPaul will now begin to face generic competition in Canada, and we have initiated a strategy to support the product in this context. The SUBO unit demand in the United States and MetalJet unit demand in Canada both remained strong during fiscal Q3 2025. although the factors we have discussed in the past have continued to affect product level revenue. On trabenafine hydrochloride, a nail lacquer to treat nail fungus infections, we recently received a notice of deficiency from Health Canada regarding our new drug submission for the product. The notice identified concerns and uncertainties associated with the design of the phase three trial submitted to support the requested indication and the interpretation of the efficacy results. We remain focused on building our North American allergy and dermatology franchise, but in the meantime, we have redeployed resources to support other portfolio products in this therapeutic area, including Lupal and NIDA. In sum, we continue to focus on maintaining stability in our base business and generating cash from operations as we prepare for the launch of Grafitex in the United States, and other potential revenue opportunities in the future. I will now turn the call over to Brendan, who will discuss our financial results in more detail. Brendan?

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