6/22/2023

speaker
Operator
Conference Operator

Greetings. Welcome to the Medexis Pharmaceuticals fourth quarter and fiscal year 2023 earnings call. At this time, all participants are in a listen-only mode. 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, Victoria Rutherford. You may begin.

speaker
Victoria Rutherford
Host, Investor Relations

Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals' fourth fiscal quarter and fiscal year 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 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 reconciliations to net income and loss, please refer to the company's MD&A, which, along with the financial statements, are available on the company's website at www.medexus.com and on CDAR at www.cdar.com. As a reminder, Medexus reports on the March 31st fiscal year basis. Medexus reports financial results in U.S. dollars. I would now like to turn the call over to Ken D'Entremont.

speaker
Ken D'Entremont
Chief Executive Officer

Thank you, Victoria, and thanks everyone for joining us on this call today. We are extremely proud of the financial results we're reporting for our fiscal 2023. We attained both record revenue and record adjusted EBITDA for the fiscal year 2023, plus announced our overall strongest fourth quarter to date. This accomplishment was driven by strong performance across all our leading prescription products and the addition of Gleoland net sales in the U.S., We're also proud to note that this has translated into positive net income for fiscal year 23. Our fourth quarter revenue was $28.6 million. That compares favorably to $20.3 million for the same period last year, or 41% growth year over year. The $8.3 million increase is mainly due to an increase in net sales across our portfolio and a contribution from Glialand. Fourth quarter adjusted EBITDA increased to 4.8 million compared to 1.1 million for the same period last year. The 3.7 million year-over-year increase is mainly due to the increase in net sales I mentioned and a reduction in research and development costs. I would also like to highlight this is our sixth consecutive quarter of positive adjusted EBITDA demonstrating the strength and stability of our product portfolio. as we close out fiscal year 23 and look ahead to fiscal 24. We produced net income of $6.9 million for Q4 compared to a net loss of $5.3 million for the same period last year. Our adjusted net income, which adjusts for unrealized losses or gains related to our convertible debentures that are included in net income, was 6.0 million compared to a net loss of 4.6 million for the same period last year. At March 31st, 2023, we had total available liquidity of 13.1 million in cash and cash equivalents. We were pleased to announce a non-dilutive debt financing in March of 23, which contributed to our cash position and demonstrated our access to capital on competitive terms. I will let Marcel comment further on this topic later in the call. Overall, we are thrilled to have achieved a record $108.1 million revenue for the year, which compares to $76.7 million for fiscal 2022, or 41% growth year over year. Adjusted EBITDA for the year was $16.1 million in 2023, representing another record for Medexis. and comparing favorably to negative 3.9 million overall in fiscal year 2022. Turning to our specific product lines, our core business is still growing, and we continue to work on potential additions to our product portfolio to generate additional growth momentum. Unit demand for Xfinity in the U.S. remained strong during the trailing 12 months ended March 31, 2023, with the fourth quarter reflecting the best quarter of fiscal year 23 for new patient conversions on top of a stable existing base of patients. The strength was also attributed to the resumption of in-person selling earlier in the year. We continue to improve the Xfinity manufacturing process, which has had a positive impact on Xfinity manufacturing costs. Rupel continued to see strong unit demand growth, achieving 25% growth for the trailing 12 months ended March 31st, 2023. This continues Rupel's trend as one of the fastest growing antihistamines in the Canadian prescription market. This strong performance reflects successful execution of our sales and marketing initiatives over the six years since launch. Turning to Resuvo, Unit demand remained strong for the trailing 12 months ended March 31, 23, maintaining the product's leading position in the moderately growing U.S. branded methotrexate market with a highly efficient allocation of Salesforce resources. However, increased competition in the U.S. branded methotrexate market continued to impact Resuvo product level revenue. On MetalJect, We saw unit demand increase in the trailing 12 months ended March 31st, 2023. This was despite the ongoing impact of a generic entry into the Canadian methotrexate market in calendar 2020. Although product revenue was negatively impacted by a decrease in effective unit level prices. The trial for the patent litigation we launched against a generic competitor in 2020 completed this past January 23. We anticipate that the federal court, which is the court overseeing the trial, will issue its decision later in calendar 23. On GLEOLAND, unit demand in the United States continues to be in line with expectations, with the fourth fiscal quarter 23 having included the best month of U.S. unit sales of the fiscal year 23. The strong performance reflects successful execution of our commercial plans. We also actively pursue opportunities to build our portfolio by licensing and acquiring new products and by exploring additional indications within our current product portfolio. The advancement of any one of our product opportunities would provide a significant step up in our growth profile. As we have discussed in the past, we remain optimistic about Triosulfan, an agent used 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 brand name Tricondo. Recent data from a retrospective analysis out of Toronto's Princess Margaret Hospital found a 30% improvement in one year overall survival for patients treated with Triosulfan, which we find extremely encouraging and relevant to the US population as well. We expect that the commercial experience we are gaining in Canada and the growing body of positive information about the product, like this PMH study, will serve us well if and when the FDA approves Triosulfan in the United States, where Triosulfan is an important pipeline product for us. On that topic, MED Act, the licensor of our commercial rights to Triosulfan and the party responsible for the regulatory matters under our license agreement, continues to work towards resubmission of the NDA for Triosulfan. We expect that it will take MED Act up to a year to collect and submit the information requested by the FDA. On another business development front, in March 2023, we secured the exclusive Canadian rights to commercialize terbinafine hydrochloride nail lacquer, which has been widely used in other markets to treat nail fungus infections. This deal represents a positive addition to our allergy and dermatology franchise in Canada. The product fits strategically with Rupel, and we expect that it will both contribute to our Canadian revenues and engage the commercial infrastructure we have in place to support Rupal. We will submit for Health Canada approval later in calendar 23. Xcinity, already one of our leading products, presents another pipeline opportunity for us. The FDA recently accepted for review our Xcinity Supplemental Biological License application for pediatric patients. A successful BLA 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. In another opportunity within the MED-AXIS pipeline, the licensor of our commercialization rights to glialand continues to pursue research and development activities for a meningioma indication for glialand. Our commercial rights include this additional indication. We also continue to explore new product opportunities in both current and planned therapeutic areas in both the United States and Canada as we evaluate transaction opportunities against our strategic plan. A key component of our growth strategy will be to continue to lever our infrastructure through new product acquisitions and partnerships. We will continue to look at optimizing our product 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 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?

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