Medexus Pharmaceuticals Inc.

Greetings and welcome to the Medexis Fiscal Second Quarter 2024 Earnings Call. At this time, all participants are on a listen-only mode and 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 conference over to your host, Magda Gardner of Investor Relations. Magda, you may begin.

Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals second fiscal quarter 2024 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 more information about the company, please contact Adelaide Capital at 416-206-8869. I would like to remind everyone that this discussion will include forward-looking information as defined in securities law. 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 debt 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 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 CDAR Plus at www.cdarplus.ca. As a reminder, Medexus reports on a March 31st fiscal year basis. Medexus reports financial results in U.S. dollars. I would now like to turn the call over to Ken Dantramont.

Thank you very much and welcome everyone to the call today. We're very pleased to report another great quarter with solid performance in our product portfolio, in particular continued strong demand growth for Rupal. This is translated into a positive operating profit for the quarter and meant that we met our targeted quarter end cash position ahead of the October 16th maturity date for our convertible debentures, which we repaid fully in cash. Our fiscal Q2-24 revenue of $30.3 million compares favorably to $27.7 million for the same period last year, or 9.4% growth year-over-year. The $2.6 million increase is mainly due to recognizing 100% of Glioland net sales in total revenue and continuing strong Rupel demand growth. Adjusted EBITDA increased to $5.3 million for the quarter compared to $4.2 million for the same period last year. The $1.1 million year-over-year increase is mainly due to increases in revenue and a reduction in operating expenses. We produced a net loss of $1.1 million for the quarter, an improvement compared to a net loss of $2.7 million for the same period last year. Overall, we are pleased to be reporting this quarter of financial results with positive key metrics and year-over-year revenue growth. I'll let Marcel comment on the details later in this call, but I also want to highlight our success in securing the accordion feature of our credit agreement with BMO, which we applied towards the convertible to ventures, and our success in completing our October 2023 bought deal public offerings, which we intend to use for working capital and general corporate purposes, including our ongoing business development activities and initiatives. I also want to highlight our success in executing the Third Amendment of our U.S. Triosulfan Agreement, which we think responds well to the current status of the FDA regulatory review process by, one, further extending the agreed outside date for FDA approval, and two, outlining a process for potentially agreeing to adjust the value of unpaid milestone payments in light of future circumstances around Triosulfate's prospects in the U.S. market. Turning to our specific products, Xfinity unit demand in the United States decreased during the quarter and over the trailing 12-month period ending September 30, 2023. Demand continues to reflect the effects of lower observed average quantities of product consumed by an increasing number of newer patients. We intend to continue monitoring these trends and assessing their potential impact on product level revenue. We are optimistic about the prospects for a favorable FDA decision on the supplemental BLA for the treatment of pediatric patients, which the FDA accepted for review in June 2023. If approved, we think the new pediatric indication would, in addition to expanding the current market potential for the product, provide us with an opportunity to reinforce brand awareness and messaging for Xfinity in relevant markets. Our optimism here is partially due to our familiarity with the data presented at the National Hemophilia Foundation Bleeding Disorders Conference earlier this year in National Harbor, Maryland, where we Researchers reported that prophylaxis with Xfinity was associated with low annualized bleeding rates, effective control of bleeding episodes, consistent pH, and a consistent safety profile. On Resuvo, we maintain a market-leading position during the quarter as unit demand remains strong in the moderately growing U.S.-branded methotrexate market. We continue to deploy a highly efficient allocation of sales field resources and our position remains strong despite sustained competition in the market. Repel unit demand in Canada remains strong during the quarter, which is reflected in the unit demand growth of 22% over the trailing 12-month period ended September 30, 2023. This strong performance reflects successful execution of our sales and marketing initiatives, as well as the timing of certain orders during the quarter relative to planned price increases. This was partially offset by the effects of increased competition on relatively smaller unit demand in the pediatric segment. We see Tropical Turbinafine, which we licensed in March, as a strategic fit with Rupel, and we expect that, if and when approved by Health Canada, that new product will both contribute to our Canadian revenues and engage our in-place commercial infrastructure currently supporting Rupel. On GLEOLAND in the United States, we continue to execute our post-transition commercial plan, including new sales and marketing initiatives. This has included continued application of existing Salesforce resources to expand and deepen market coverage, improved distribution of relevant product information content in relevant forms, and increasing application of our broad range of commercial expertise to the relevant market. We expect to continue developing insights regarding market dynamics and the potential through these initiatives to inform our continued commercialization efforts as we seek to maximize product-level revenue. Metalject unit demand in Canada increased by 14% in the trailing 12-month period ended September 30, 2023, in spite of direct generic competition. Product level performance continues to experience disruption from the launch of a generic product in the Canadian methotrexate market in the calendar 2020. We continue to seek to defend the product's strong market position as we await the federal court's decision following the January 2023 trial in the patent litigation we initiated against Metalject's generic competitor in 2020. We continue to remain optimistic about Triosulfan an agent for the use in conditioning regimens as part of allogeneic hematopoietic stem cell transplantation protocols, or ALLO-HFCT. We have fully launched the product in the Canadian market under the trade name Tricondyph. In the US, Triosulfan remains under an ongoing regulatory review process with the FDA. Medac, our licensor and the party responsible for the regulatory matters, continues to work towards responding to the FDA. As most of you are aware, the process for obtaining FDA approval has been delayed beyond the outside date for FDA approval previously agreed to with MED-AC. As such, as I mentioned earlier, in September, we entered into a third amendment to our U.S. triosulfan agreement with MED-AC to address this ongoing delay. We continue to expect that it we'll take MED Act a period extending into the first half of calendar year 2024 to collect and submit the information requested by the FDA and obtain FDA acceptance of MED Act's Triasulfan NDA resubmission. We in MED Act will then have a specific negotiation period to agree to a further amendment on any adjustments to unpaid milestone payments. We have no obligation to make any milestone payments before the effective date of the further amendment, if any. We expect that the commercial experience we are gaining in Canada and the positive data regarding the product will serve us well if and when the FDA approves Triosulfan in the United States, where Triosulfan is an important pipeline product for us. If and when approved in the US, we expect that Triosulfan will become a leading agent for the use in condition regimens as part of ALOHSCT and continue to benefit from the orphan drug exclusivity period that would begin to run from the FDA approval. While we continue to focus on maintaining stability of our base business and generating cash from operations, we also look for near-term transaction opportunities to augment our product portfolio increase the scale of our operations, and deliver long-term growth. A key component of our growth strategy will be to continue to lever our infrastructure through business development by executing new product acquisitions and partnerships. In the meantime, we continue working to increase revenue, develop and leverage our commercial infrastructure across existing 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?