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6/23/2022
Good morning, ladies and gentlemen, and welcome to the Medexus Pharmaceuticals fourth quarter 2022 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, Ms. Victoria Rutherford. Victoria, the floor is yours.
Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals fourth quarter and fiscal year 2022 earnings call. On the call this morning are Ken Ventremont, 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 that is based on certain material factors or assumptions and is subject to risks and uncertainties that could cause actual results to differ materially from historical results or results anticipated by the forward-looking information. In addition, during the course of this call, there may also be reference to certain non-IFRS financial measures or non-GAAP measures, including references to 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 both 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 the company's corporate filings on CDAR at www.cdar.com. I would now like to turn the call over to Ken Ventremont.
Thank you, Victoria, and thanks, everyone, for joining us on the call today. We continue to make progress on our growth objectives and are achieving several exciting initiatives that we believe will have a meaningful impact on our business going forward. During the fiscal fourth quarter that ended March 31st, 22, we achieved revenue of $20.3 million compared to $17.6 million for the same period last year, or 15% growth year over year. I am pleased to report that this represents the strongest fourth quarter at Medexus to date. The $2.6 million increase is primarily attributable to an increase in the net sales of Xfinity during the quarter as pharmacy and wholesale customers return to buying patterns better aligned with patient unit demand. Rupel and Resubo also had solid sales during the quarter. Fourth quarter adjusted EBITDA increased to $1.1 million compared to negative $1.6 million for the same period last year. The $2.7 million increase is primarily attributable to the increase in net sales of Xfinity in the fourth quarter of 2022 and a $0.9 million expense related to a one-time destruction of Xfinity inventory in the fourth quarter of 2021. We produced a net loss of $5.3 million for Q4 compared to a net loss of $10.5 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 $4.6 million compared to negative $5.2 million for the same period last year. As at March 31, 2022, we had $10 million in cash and cash equivalents with $11.2 million in total available liquidity. Overall, we are pleased to have achieved $76.7 million in revenue for the year, which compares to $79.7 million for fiscal 2021. The adjusted EBITDA for the year was negative $3.9 million in 2022 compared to positive $8.2 million last year. Turning to our specific product lines, our core business remains strong. We are excited about new and potential additions to our product portfolio, which we believe will generate growth momentum over the coming years. Unit demand for Xfinity continues to grow. During the fourth quarter of 22, we saw sales normalize as pharmacy and wholesale customers have now worked through much of the recruit inventory and returned to buying patterns better aligned with patient unit demand. We continue to invest in the manufacturing improvement initiatives, and we expect the resulting operational efficiencies to ultimately improve the gross margins for Xcidity over the coming quarters. We're also continuing to invest in a phase four pediatric study that, if successful, will expand the Xcinity product label to include the pediatric population of patients under 12 years of age with hemophilia B. Medexis expects the analysis and clinical study report to be completed in the first quarter of 23. Once completed, a successful study could support a significant expansion of the indicated patient population for Xcinity and we are exploring approaches to address this potentially expanded market. Rupel continued to see strong unit demand growth, achieving 31% growth for the trailing 12 months ended March 31, 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 a successful sustained execution of our sales and marketing initiatives as physicians continue switching patients to Repel from either generic prescription antihistamines or over-the-counter products. Turning to Resuvo, on a unit sold basis, Resuvo continues to maintain its strong market position and, in fact, increased its market share in the United States and the trailing 12 months ended March 31, 2022. However, increasing competition in the U.S. branded methotrexate market continued to negatively affect receivable product-level revenue. We implemented an effective unit-level price reduction to defend the product's market-leading position. On MetalJet, even with a generic entry in the Canadian methotrexate market in calendar 2020, Metal Jack saw unit demand increase in the trailing 12 months ended March 31st, 22. Again, product revenue was negatively impacted by a similarly motivated decrease in effective unit level prices. We continue to work towards conclusion of the litigation against the generic competitor and a trial date has been set for calendar Q1, 23. We will continue to update shareholders on the material developments in this matter. These existing products have primarily driven our performance to date. We also actively pursue opportunities to complement our existing portfolio by licensing and acquiring new products. For example, we recently acquired the exclusive rights to commercialize Glioland in the United States and Canada. Glioland is currently used as an optical imaging agent indicated in patients with glioma as an adjunct for the visualization of malignant tissue during surgery. We estimate Glialand's annualized revenue to be between $12 and $16 million. We expect to complete the transition of full responsibility for commercialization of Glialand in the United States from our partners at NXDC and begin recognizing full product revenue in fiscal Q2 23. Our U.S. relaunch of Glialand will complement our existing commercialization rights to Glialand in Canada. where we executed a full commercialization, a full commercial launch of Gliolan in February of 21. As we have discussed in the past, we continue to be excited about Triosulfan. We expect that it will become a leading agent for the use of conditioning regimens as part of allogeneic, hemopoietic stem cell transplantation protocols, or thankfully, AlloHSCT. This is a therapeutic area of strong strategic interest for us. We recently shared the results and analysis of the pivotal phase three clinical trial triosulfan conducted by our partner, MedAct. We were very encouraged by these results and would like to point everyone to a presentation made by Dr. Filippo Milano, who reviewed the results of the pivotal study. Dr. Milano is a physician scientist whose research is focused in the area of stem cell transplantation to treat blood cancers. You can view Dr. Milano's presentation on our investor relations section of our website. In June of 2021, we received a notice of compliance from Health Canada to commercialize Triosulfan, which we currently market in Canada under the trade name Tricondyph. We have now fully launched in the Canadian market and expect that the commercial experience we're gaining in Canada will serve us well if and when the FDA approves Triosulfan in the United States. Our partners at MedAct continue to collect data requested by the FDA in May of 22 to complete MedAct's resubmission of their new drug application for Triosulfan. The data collection process is progressing well, and MedAct continues to expect to respond to the FDA's information request in July of 22, which would be well within the 12-month timeline required by the FDA's complete response letter. A final FDA decision is expected two to six months after the FDA considers MedAct NDA resubmission to be complete. If the FDA approves Triosulfan, we'll then be obliged to pay certain milestone payments to MedAct that would range anywhere between $15 and $45 million, depending on the terms of the FDA's approval. We continue to believe Triosulfan could eventually overtake the current market-leading product in the U.S., Busulfan, which realized 126 million in annual U.S. sales prior to genericization. In the meantime, we do not expect to make any additional milestone payments to MEDAC until we have received FDA approval, and we are evaluating options to finance any milestones that may come due with a number of interested capital partners. We also continue to regularly explore additional complementary product opportunities in both current and planned therapeutic areas in both the United States and Canada, and regularly evaluate various other transaction opportunities based on our strategic plan. A key component of our growth strategy will 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 to work 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. Marcel?
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