11/8/2022

speaker
Operator
Conference Call Operator

Good morning, ladies and gentlemen, and welcome to the Medexus Pharmaceuticals second 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, Ms. Victoria Rutherford, Investor Relations. Victoria, the floor is yours.

speaker
Victoria Rutherford
Investor Relations

Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals second 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 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.

speaker
Ken D'Entremont
Chief Executive Officer

Thank you, Victoria. Good morning, everyone, and thanks for joining us on the call today. We're proud to announce the strongest quarter in Medex's history, achieving revenue of $27.7 million for our fiscal second quarter ended September 30th, 2022. We saw organic growth across all our leading prescription products this quarter, which was further complemented by the recognition of 100% of Glioland net sales in the U.S. in our revenues starting from September. Our second quarter revenue of $27.7 million compares favorably to $17.9 million. for the same period last year, or a 55% growth year-over-year. The $9.8 million increase is primarily attributable to an increase in the net sales of Xfinity and RuPaul, as well as the recognition of revenue from Glioland sales in the United States, as I mentioned. Second quarter adjusted EBITDA increased to $4.2 million compared to negative $2 million for the same period last year. The $6.2 million increase is primarily attributable to the increase in sales revenue, including GLEOLAB sales in the United States, a reduction in research and development costs, and an increase in gross margins. We produced a net loss of $2.7 million for fiscal Q2 compared to net profit of $10.1 million for the same period last year. The profit last year was primarily due to an unrealized gain on the change in fair value of the embedded derivatives in Medex's convertible debentures. Our adjusted net loss, which adjusts for these unrealized losses or gains related to our convertible debentures that are included in net loss, was negative 2.8 million compared to negative 6.1 million for the same period last year. At September 30th, 22, we had 9.6 million in cash and cash equivalents with 10.1 million of total available liquidity. During the quarter, we invested in our networking capital as we prepared for continued growth and to take on new business, especially as it relates to GLEOLAB. We anticipate seeing the benefit of this investment in our cash flow in the coming quarters. We are also actively evaluating strategies to optimize our balance sheet and capital structure to support this growth and have engaged third-party advisors to help us in this initiative. Turning to our specific product lines, our core business is growing, and we are excited about new and potential additions to our product portfolio, which we believe will generate growth momentum over the coming years. Xfinity saw strong unit demand in the United States during the 12 months ending September 30th, 22, reflecting new patient conversions on top of a stable existing base of patients following resumption of in-person selling earlier in the year. We continue to invest in an ongoing initiative to improve the Xfinity manufacturing process. Preliminary results have indicated meaningfully improved yields, and we have started to see moderate improvements in gross margin for the product. Rappel continued to see strong unit demand growth, achieving 25% growth for the trailing 12 months ended September 30th, 22. Continuing its trend is one of the fastest growing antihistamines in the Canadian prescription market. This growth reflects the peak of Canada's allergy season during the quarter, together with continued successful execution of our sales and marketing initiatives. Turning to Resuvo, unit demand remained strong in the 12 months ended September 30th, maintaining the product's leading position in the moderately growing U.S. branded methotrexate market with limited sales force allocation. However, increased competition in the U.S. branded methotrexate market continues to negatively affect Resuvo product level revenue. On Metaljet, Even with a generic entry into the Canadian methotrexate market in calendar 2020, MediJet's unit demand increase in the trailing 12 months ended September 30th, although product revenue was negatively impacted by a 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 Q1 23. We look to continue updating shareholders on any material developments in this matter. In March of 22, we acquired the exclusive rights to commercialize GLEOLAND in the United States. As I previously mentioned, September 22 was the first full month we began recognizing 100% of GLEOLAND net sales, and December 31, 22, will be the first full quarter in which we recognize 100% of glialand net sales. Since we acquired the exclusive rights to commercialize glialand, sales have continued to be in line with expectations. This reflects our successful execution of a seamless transition to full U.S. commercial responsibility and puts Medexis in a position to successfully execute on our commercial plan which includes additional sales and marketing initiatives. These 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, as well as exploring additional indications within our current product portfolio. The advancement of any one of these product pipeline opportunities would provide a significant step up in our growth profile. As we have discussed in the past, we continue to be excited about Triosulfan, an agent for use in conditioning regimens as part of allogeneic hematopoietic stem cell transplantation protocols, or AlloHSCT. We have fully launched the product in the Canadian market under the trade name Tricondyph, and we 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, where Triosulfan is an important pipeline product for us. If and when approved in the U.S., we expect that Triosulfan will become a leading agent for use in conditioning regimens as part of Allo HSCT. In September of 22, Our partners at MEDAC informed us that the FDA had delivered them a second notice of incomplete response regarding MEDAC's July 22 new drug application resubmission for Triosulfam. This notice requested further supporting information from MEDAC to complete MEDAC's NDA resubmission, but did not require submission of new clinical data. We will provide an update to shareholders and other stakeholders once we know whether the resubmission has been accepted and are better able to assess the impact of this delay. We have applied much of the infrastructure added in anticipation of the Triosulfan launch to support Glioland, gaining experience in many of the same institutions that are expected to use Triosulfan if and when it is approved. We also implemented a restructuring plan in October of 22 in order to focus our resources on existing products. Xfinity, already one of our leading products, presents another pipeline opportunity for us. The clinical phase of our phase four pediatric study for Xfinity is complete and we are now preparing the analysis and clinical study report. We currently expect to submit this study to the FDA in the first half of calendar 23. 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 potentially expanded market. Another opportunity within the Medexis pipeline is a meningioma indication for Glioland. The licensor of our commercial rights to Glioland continues to pursue research and development activities for a meningioma indication for Glioland. Our exclusive commercialization rights include this additional indication. 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 our 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 commercial 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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