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.
11/8/2024
Good morning everyone and welcome to the MedXS Pharmaceuticals second quarter 2025 conference call. At this time all participants are in a listen only mode and we will open for questions following the 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. Victoria, the floor is yours.
Thank you and good morning everyone. Welcome to the MedXS Pharmaceuticals second fiscal quarter 2025 earnings call. On the call this morning are Ken Dantremont, Chief Executive Officer and Brendan Bushman, Chief Financial Officer. If you have any questions after the call or would like further information about the company, please contact Adelaide Capital at -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, the 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 forward looking information and non-GAAP measures including reconciliation to net income and loss, please refer to the company's MDNA which along with the financial statements is available on the company's website at .medxs.com and on Cedar Plus at .cedarplus.ca. As a reminder, MedXS reports on a March 31st fiscal year basis. MedXS reports financial results in US dollars. I would now like to turn the call over to Ken Dantremont.
Thank you Victoria and thank you everyone for joining this call today. We're pleased with our fiscal Q2-25 results, particularly our stable revenue, positive net income and strong adjusted EBITDA which allowed us to begin preparations for potential approval of triosulfan by the end of January 2025 and comfortably pay down $4.1 million in principle under our credit facility during the quarter. Our fiscal Q2-25 revenue was $26.3 million, a decrease compared to $30.3 million for the same period last year. We are proud of our fiscal Q2 adjusted EBITDA of $6 million, an increase compared to $5.3 million for the same period last year. We continue to produce positive net income of $0.1 million for the quarter, an improvement of $1.2 million over the same period last year and positive operating income of $1.6 million, a decrease of $1.9 million compared to $3.6 million for the same period last year. These important metrics for fiscal Q2-25 continue to be positively impacted by the financial discipline initiatives we have been working on which continue to have a positive effect on operating costs and cost structure. Turning to our specific products, Exxonity unit demand in the United States decreased by 4% over the trailing 12-month period ending September 30th. We will continue seeking to maintain existing demand and to improve management of product supply to the market. Our investments in our Exxonity manufacturing process improvement initiative have had a positive impact on batch yield and manufacturing costs, now extending into fiscal Q2-25. Rupal unit demand in Canada increased by 17% over the trailing 12-month period ending September 30th. Rupal was a notable contributor to revenue for fiscal Q2-25. We continue to see tropical atopical tribunafine which has been under regulatory review with Health Canada since last December as a strategic fit with Rupal. If and when approved, this product will enter a market we estimate to be $88 million Canadian dollars on an annual basis. Resuvo unit demand in the United States remained strong during fiscal Q2-25 although the factors we have discussed in the past continue to affect product level revenue and we may continue to have a moderate near-term effect on product level revenue. Metalject unit demand was likewise strong, increasing 10% in the trailing 12-month period ending September 30th 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 strong market position. GLIOLAND unit demand in the United States grew 7% over the trailing 12-month period ending September 30th, 2024 as our commercialization efforts continue to result in new customers adopting the product. We continue to discuss the future of our involvement in the commercializing of GLIOLAND in the United States with our licensing partner and we will provide an update if and when warranted. On tropical turbinaphene, a pipeline product for us, our December 2023 new drug submission for turbinaphene hydrochloride nail lacquer to treat fungal nail infections remains under ongoing review by Health Canada. We currently expect Health Canada will complete its review of the NDS and issue a decision in fiscal Q4-25. This is consistent with our plan to target a commercial launch in the first half of calendar year 2025. As part of this process, we are monitoring potential regulatory changes in Ontario regarding expanded prescribing authority for pharmacists for common ailments including fungal nail infections and also head lice. If adopted, these regulatory changes could enhance availability and accessibility of tropical turbinaphene if and when approved and also NIDA, a treatment for head lice, which could increase unit demand for these products in the important Ontario market. We also remain excited about triosulfate, which we hold commercialization rights to in both the Canadian and U.S. markets. In Canada, where we commercialize the product under the brand name Trikonda, unit demand grew an impressive 49% over the trailing 12-month period ending September 30th, 2024. In addition, we recently completed a collaborative negotiation process with the PCPA, an independent organization that negotiates framework terms for public access to pharmaceutical products on behalf of government organizations. This is a critical step in bringing Trikonda closer to public access, and the next step will now be for participating government organizations to make their respective final decisions on public reimbursement for the regions. We are committed to continuing to work with participating jurisdictions to make Trikonda available as soon as possible through public duck plans for eligible patients needed. We see the positive experience we have had in Canada with triosulfate as an important indicator of triosulfate's prospects and potential in both the Canadian and U.S. markets. In the U.S., we continue to eagerly await a decision from the FDA on Med-Acts April 2024 resubmission of the NDA for triosulfate, which we now expect no later than January 30th, 2025. We continue to believe triosulfate would make a substantial contribution to this therapeutic space as it has in Europe and Canada, and the FDA's commitment to continue reviewing the triosulfate NDA brings 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 2025. We have therefore begun making investments in personnel and infrastructure to prepare for potential positive FDA decisions. If approved by the FDA, we expect triosulfate to have a material positive impact on our total revenue among other key financial performance indicators. Based on internal estimates and research, we believe that annual product level revenue in the United States has the potential to exceed $100 million within five years after commercial launch. Under the terms of our U.S. agreement with Med-Acts, we and our counterparts at Med-Acts continue to discuss the terms of a further amendment to our agreement with respect to any adjustments to the value of unpaid milestone payments. We remain 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 pipeline products. I will now turn the call over to Brendan who will discuss our financial results in more detail. Brendan.
You're reading a preview of the MDP Q2 2025 earnings call.
Free account.
