Medexus Pharmaceuticals Inc.

Good day, ladies and gentlemen, and welcome to the Medexus Pharmaceuticals first quarter 2023 earnings call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Victoria Rutherford, Investor Relations at Medexus Pharmaceuticals. Ma'am, the floor is yours.

Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals first fiscal quarter 2023 earnings call. On the call this morning are Ken D'Entremont, Chief Executive Officer, and Marcel Conrad, 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 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 a reconciliation of each of adjusted net loss and adjusted EBITDA to net loss, please refer to the company's management discussion and analysis, which, along with the financial statements, are available on the company's website at www.medexas.com and on CDAR at www.cdar.com. I would now like to turn the call over to Ken D'Entremont.

Thank you, Victoria, and thanks, everybody, for joining us on the call this morning. We are proud to announce a regular first quarter for Medexus. Our base business continues to perform strongly and was complemented by recognition of a portion of revenue from glialand sales in the United States following our recent acquisition of glialand commercialization rights. During the first quarter, ended June 30th, 2022, We achieved revenue of $23 million compared to $17.3 million in the same period last year, or 33% growth year over year. The $5.7 million increase is primarily attributable to an increase in the net sales of Xfinity and recognition of a portion of revenue from Glenoland sales in the United States, plus a 22% growth in RuPaul year over year. First quarter adjusted EBITDA increased to $1.9 million compared to negative $4.9 million for the same period last year. The $6.8 million increase was primarily attributable to the increase in sales as well as an expected reduction in research and development costs. We are pleased to achieve this adjusted EBITDA while continuing to maintain appropriate investments in our preparations for the U.S. commercial launch of Triosulfate. We produced a net loss of $1.4 million for Q1 compared to a net loss of $6.6 million for the same period last year. Our adjusted net loss, which adjusts for unrealized losses or gains related to our convertible debentures included in net loss, was negative 3.6 million compared to negative 9.8 million for the same period last year. At June 30th, 2022, we had 7.3 million in cash and cash equivalents with 8.7 million of total available liquidity. Turning to our specific product lines, our core business is performing well, and we are excited about new and potential additions to our product portfolio, which we believe will generate growth momentum over the coming years. We are pleased to say that we have corrected the affinity channel. Pharmacy and wholesale customers have now returned to normal buying patterns that are better aligned with patient unit demand. We are continuing to invest in our manufacturing improvement initiative, and we expect the resulting operational efficiencies to improve the gross margins for Xfinity over the coming quarters. The clinical phase of our phase four pediatric study for Xfinity is now complete, and we are now preparing the analysis and clinical study report, which we expect to be completed in the first quarter of calendar 2023. A successful study could support a significant expansion of the indicated patient population for Xfinity to hemophilia B patients under 12 years of age, and we are exploring approaches to address this potential expanded market. Rappel continued to see strong unit demand growth, achieving 22% growth for the trailing 12 months into June 30, 2022, continuing its trend as one of the fastest-growing antihistamines in the Canadian prescription market. Again, this growth reflects a severe allergy season across Canada and successful sustained execution of our sales and marketing initiatives as physicians continue switching patients to Rupal from either generic prescription antihistamines or over-the-counter products. Turning to Resuvo, on a unit sold basis, Resuvo continued to maintain its strong market position and in fact increased its market share in the United States in the trailing 12 months ended June 30th, 2022. However, increasing competition in the US branded methotrexate market continued to negatively affect receivable product level revenue. We implemented effective unit level pricey reductions to defend our product strong market position. On metal deck, Even with a generic entry to the Canadian methotrexate market in calendar 2020, MedArchJet saw unit demand increase in the trailing 12-month period ending June 30, 2022. Again, product revenue was negatively impacted by a similarly motivated decrease in effective unit-level prices. We continue to work towards conclusion of litigation against the generic competitor, and a trial date has been set for calendar Q1 2023. We will continue to update shareholders on material developments in this matter. These existing products have primarily driven our performance to date. We also actively pursue opportunities to complement our existing product portfolio by licensing and acquiring new products. For example, in March of 2022, MEDEXIS acquired the exclusive right to commercialize glialand in the United States. As I mentioned, we recognize some Glialand revenue this past quarter, representing a portion of the quarter's product net, portion of the product's net sales, as per terms of the license agreement. We anticipate completing our agreed transition process in full within the current quarter. This will result in Medexis having full responsibility for commercialization of Glialand in the United States, which will allow us to begin fully recognizing product revenue within the three-month period ending September 30, 2022. Our U.S. relaunch of Glioland will complement our existing commercialization rights to Glioland in Canada, where we executed a full commercial launch of Glioland in February of 2021. As we have discussed in the past, we continue to be excited about Triosulfan, We expect that it will become a leading agent for use in conditioning regimens as part of allogeneic hematopoietic stem cell transplantation protocols, or alloHSCT, which is a therapeutic area of interest for Med-Axis. In June 2021, we received a notice of compliance from Health Canada to commercialize Triosulfan, which we currently market in Canada under the trade name Tricondin. We have now fully launched in the Canadian market and expect that the commercial experience we are gaining in Canada will serve us well if and when the FDA approves Triosulfan in the United States. Our partners at Medec recently resubmitted updates to data files and supporting information to the FDA to complete the resubmission of their new drug application for Triosulfan. The review clock for the FDA's review of the NDA resubmission will then start if and when the response is considered complete by the FDA, with final FDA decision expected two to six months thereafter. An FDA approval would allow for commercial launch of Triosulfan in the United States in the first half of calendar 2023. If the FDA approves Triosulfan, we will then be obliged to pay a milestone payment to MED Act that would range anywhere between $15 and $45 million. depending on the terms of the FDA's approval. Last week, we signed an amendment to our license agreement with MED Act. The amendment extended the date by which we would be obliged to pay this milestone amount to October 2023. This means that at the time of FDA approval, we would only need to pay immediately 2.5 million credit against our milestones that MEDAC had provided us in September of 2021. This will allow us to launch and begin commercialization well before these license payments must be paid. During the extended registration period, we have continued to work diligently with MEDAC to prepare for the launch. If approved by the FDA, we expect that commercialization of triosulfan would have a material positive impact on the company's total revenue as we estimate that the current market leading product in the United States generated $126 million at peak annual revenue before genericization. We also continue to regularly explore additional complementary product opportunities in both current and planned therapeutic areas and in both the United States and Canada, and regularly evaluate various other transaction opportunities based on our strategic plan. A key component of this growth strategy will be to continue to leverage our infrastructure through new product acquisitions and partnerships. We will continue to look at optimizing our portfolio and leveraging our resources with the goal of executing near-term accretive transactions to achieve our sales growth targets over the coming years. In the meantime, we continue working to increase revenue develop and leverage our commercialization infrastructure across products, and maintain strict financial discipline. I will now turn the call over to Marcel, who will discuss our financial results in more detail.