8/8/2024

speaker
Conference Operator

Greetings. Welcome to the Medexis First Fiscal Quarter 2025 Earnings 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 call over to your host, Victoria Rutherford. Ma'am, you may begin.

speaker
Victoria Rutherford
Director of Investor Relations

Thank you and good morning everyone. Welcome to the Medexus Pharmaceuticals first fiscal 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 net income and loss and adjusted EBITDA, 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 the company's 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, is available on the company's website at www.medexus.com and on CDARplus at www.cdarplus.ca. As a reminder, Medexus reports on March 31st fiscal year basis, and Medexus reports financial results in U.S. dollars. I would now like to turn the call over to Ken D'Entremont.

speaker
Ken D'Entremont
Chief Executive Officer

Good morning, and thank you for joining us on the call today. We are pleased with our fiscal Q125 results, particularly our positive net income and strong adjusted EBITDA, which allowed us to comfortably play down principal under our credit facility. Our fiscal Q125 revenue was $27.3 million, a decrease compared to a record $31.6 million for the same period last year. Rupal's outperformance during the allergy season was a notable contributor to revenue, combined with resilience from the rest of our product portfolio. We are proud of our fiscal Q125 adjusted EBITDA of $6.1 million, a decrease compared to a record $6.6 million for the same period last year. We are also very proud to have produced solid net income of $2 million for the quarter, an improvement of $1.3 million over the same period last year, and positive operating income of $4 million, a decrease of $0.8 million compared to a record $4.8 million for the same period last year. These important metrics for fiscal Q125 were all positively impacted by the financial discipline initiatives we have been working on, such as the January 24 cost reduction initiative we have discussed in the past. They have had a positive impact on operating costs and cost structure. Turning to our specific products, Xfinity unit demand for the United States decreased by 6% over the trailing 12-month period ending June 30, 24. We will continue seeking to maintain existing demand noting that our current view is that the trends we have mentioned in recent quarters have now stabilized and are now fully reflected in product level revenue. Again, our investments in our Xfinity Manufacturing Process Improvement Initiative have had a positive impact on batch yield and manufacturing costs, extending into fiscal Q125. And we view this as a great accomplishment following a lot of hard work from our dedicated team. Rupal unit demand in Canada increased by 17% over the trailing 12-month period ending June 30th, 24. As I mentioned, Rupal was a notable contributor to revenue for fiscal Q125, reflecting both our successful execution of the product's typical seasonality, particularly in this past quarter. We continue to see tropical Turbinafine which has been under regulatory review with Health Canada since December as a strategic fit with Rupel. If and when approved, this product will enter a market that we estimate to be $88 million Canadian dollars on an annual basis. Resuvo unit demand in the United States remains strong during fiscal Q125. We are continually evaluating our pricing strategies for Resuvo in light of evolving market dynamics. As part of our execution of these pricing strategies, we did reduce discounts offered to large customers in fiscal Q125, which contributed to a dip in Resuvo net sales for the quarter. This may have a moderate near-term effect on product-level revenue. MetalJet unit demand was likewise strong, increasing 11% in the trailing 12-month period ending June 30, 2024. in spite of direct generic competition. Given overall market dynamics, we have been implementing unit-level pricing strategies for Metalject as well, with a view to defending the product's strong market position. I will end this discussion of our leading products with a brief word on Glioland. In late July, we initiated discussions to unwind our business relationship for Glioland in the United States. While we have successfully grown the product, performance has remained lower than we originally expected, based on our experience commercializing glialand in Canada. Unit demand in the United States did grow over the trailing 12 months ended June 30th, 24, as our commercialization efforts continue to result in new customers adopting the product, but it is not expected to be a significant driver of growth in the future. Given our revolving U.S. product portfolio and the growth opportunities we see ahead, we began discussions to return the product to our partner. As you can imagine, the substance of those discussions is sensitive. What I can tell you is that our conversations with our partner are going well, and we are confident the parties will come to a plan that works for all. We look forward to continuing to work with our partners on our successful business relationship, commercializing Glialand in Canada. Finally, on Triosulfan, we continue to eagerly await a decision from the FDA on Med-Act's April 2024 resubmission of the NDA for Triosulfan, which we still expect no later than October 30th, 24. We continue to believe that Triosulfan would make a substantial contribution to this therapeutic space, as it has in Europe and Canada, and the FDA's commitment to review the Triosulfan NDA brings us a step closer to making the product a viable treatment option in the United States. Our plan remains to target a commercial launch in the first half of calendar year 25. We have begun making judicious investments in personnel to prepare for a potential positive FDA decision in October. As we have said before, we think Triosulfan would have a material positive impact on our total revenue. We currently believe that annual product-level revenue in the United States has the potential to exceed $100 million within five years after commercial launch. We would not expect to begin recognizing significant revenue from Trilosulfan until early fiscal year 26, meaning second quarter 25 at the earliest. Under the terms of our agreement with MEDAC, We and our counterparts at MEDAC are currently discussing the terms of a further amendment to our agreement with respect to any adjustments to the value of unpaid milestone payments. We are highly focused on quickly achieving clarity on the remaining contractual milestones under our agreement, and we are confident that the parties will ultimately arrive at a fair and commercially reasonable outcome. In sum, We continue to focus on maintaining stability in our base business and generating cash from operations as we prepare for the revenue opportunities presented by our product pipeline. I will now turn the call over to Brendan, who will discuss our financial results in more detail. Brendan?

Disclaimer

This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.

-

-