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8/10/2023
Greetings and welcome to the Medexus Pharmaceuticals Inc. first fiscal quarter 2024 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, Magda Gardner, Investor Relations. Magda, you may begin.
Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals first 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 further information about the company, please contact Adelaide Capital at 416 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 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.medexin.com and on CEDAR Plus at www.federplus.ca. As a reminder, Medexis reports on a March 31st fiscal year basis. Medexis reports financial results in U.S. dollars. I would now like to turn the call over to Ken John-Tremont.
Thank you, Magda, and thank you everyone for joining us on this call today. We're very pleased to report another great quarter with continued strength and stability across the company's base business and notably strong repel performance driving the order's record revenues. These results demonstrate the robustness of our product portfolio and our ability to generate revenue growth and positive operating profit, net income, and adjusted EBITDA. Our fiscal Q1-24 revenue of $31.6 million compares favorably to $23 million for the same period last year, or 37% growth year-over-year. The $8.5 million increase is mainly due to continued strong sales of Xinity, strong Rupel demand growth that also benefited from timing of orders, solid Resuvo Metaljet performance, and the inclusion of U.S. Cleoland net sales and total revenue. Adjusted EBITDA increased to $6.6 million for the quarter compared to $1.9 million for the same period last year. The $4.7 million year-over-year increase is mainly due to increases in revenue that I mentioned and a small reduction in operating expenses. We produced net income of $0.7 million for the quarter compared to a net loss of $1.4 million for the same period last year. Overall, we are thrilled to be reporting this strong quarter of financial results. I will let Marcel comment further on our financial results later in the call. Now, turning to our specific product lines, our core business remains strong and stable, and we continue to work on potential additions to our product portfolio to generate additional growth momentum. Xfinity unit demand in the United States remained strong during the quarter, experienced a slight decrease over the trailing 12-month period ended June 30th. This reflects the effects of lower observed average quantities of product consumed by newer patients, following the particularly strong quarter for new patient conversions in fiscal Q4 23. We have also continued to invest moderately in our manufacturing process improvement initiative, which has had a positive impact on batch yield and manufacturing costs. We will continue to monitor these benefits against expected increases in direct costs of our third party contract manufacturing agreements. On Resuvo, we maintain a market-leading position during the quarter as unit demand for Resuvo remains strong in the moderately growing U.S.-branded methotrexate market. We continue to deploy a highly efficient allocation of Salesforce resources, and our position remains strong despite sustained competition in the U.S.-branded methotrexate market. Rupal unit demand in Canada remains strong during the quarter, which is reflected in the unit demand growth of 26% over the trailing 12-month period ended June 30th. This performance reflects successful execution of our sales and marketing initiatives, as well as the timing of certain orders during the quarter. We see Tropical Turbinephine, which we licensed in March, as a strategic fit with Rupal, 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 Rupal. On GLEON, we continue to execute our post-transition commercial plan in the U.S., including new sales and marketing initiatives. As well, in May, we presented data at ISPOR 2023 demonstrating a 33% cost savings with Glioland compared to conventional white light surgery in U.S. patients with high-grade glioma. Based on the publication, we found that although Glioland is additive to the cost of surgery, its use results in lower costs per imaging complete resection and therefore is a more efficient use of resources in the surgical resection of high-grade glioma. Metal jack unit demand in Canada increased by 12% in the trailing 12-month period ended June 30th in spite of direct generic competition. In the quarter, metal jack unit demand benefited from unanticipated shortages of product inventory of the competing product. We continue to seek to defend and grow the product's strong market position as we await a court decision following the January 2023 trial for patent litigation we initiated against Metal Jack's generic competitor in 2020. We remain optimistic about Triosulfan, an agent for use in conditioning regimens as part of allogeneic hematopoietic stem cell transportation protocols, or LOHSCT. In May 2023, we learned that researchers at Toronto's Princess Margaret Hospital presented positive new data on Triosulfan at MDS 2023. The retrospective analysis of patient outcomes found improved one-year overall survival for certain patients treated with Triosulfan, among other positive findings. The study further supports our optimism regarding Triosulfan's potential positive impact in both Canada where we have commercially launched Triosulfan under the brand name Tricondyph and in the United States. In the U.S., Triosulfan remains under an ongoing regulatory review process with the FDA. MEDAC, as the party responsible for regulatory matters under our license agreement for Triosulfan, continues to work on responding to the FDA's request regarding the Triosulfan NDA. We still expect it will take MEDAC until the first half calendar year 2024 to collect and submit the information requested by the FDA. As set out in our license agreement, we are discussing with MEDAC what, if any, adjustments to our license agreement may be needed to reflect this extended FDA process, which has now continued beyond the agreed outside date for FDA approval in our license agreement. A key component of our growth strategy will continue to be to leverage our infrastructure through new product acquisitions and partnerships. We therefore continue to explore new product opportunities in both current and planned therapeutic areas in both the United States and Canada. 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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