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2/10/2022
Good day, ladies and gentlemen, and welcome to the Medexis Pharmaceuticals Third Quarter 2022 Earnings Call. At this time, all participants have been placed on the 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, Victoria Rutherford. Ma'am, the floor is yours.
Thank you, and good morning, everyone. Welcome to the Medexus Pharmaceuticals third quarter fiscal 2022 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 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 references to certain non-IFRS financial 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-IFRS financial 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.medexis.com and the company's corporate filings on CDAR at www.cdar.com. I would now like to turn the call over to Ken D'Entremont.
Thank you, Victoria. Good morning, everyone. Thanks for joining us on the call today. We've got some prepared statements that we'll read and then be happy to take questions at the end. In the third quarter of fiscal 2022, we achieved revenue of $21.3 million compared to $17.9 million in the second quarter of fiscal 2022 and $24.3 million in the quarter ending December 31st, 2020 or the previous year. Revenues during Q3 were positively impacted by stronger Xfinity sales quarter over quarter. as we began to see the results of the channel correction we initiated a few quarters ago. This improvement was partially moderated by the typical seasonality we have in our portfolio, specifically with the repel sales, which reflected a severe allergy season in Canada, and then, as expected, returned to normal levels in the fall. Adjusted EBITDA was positive at 1.9 million, compared to negative $2 million in Q2 and compares to $3.9 million for Q3 last year. This improvement from Q2 also reflects the improvements we have seen in Xfinity, in particular in the manufacturing process, which we will touch on later in the call, as well as the reduction of expenses in Q3. Our net loss of $1.2 million compared to a net loss of $12.8 million for the same period last year. Our Q3 figure included a non-cash unrealized gain of $2.2 million on the fair value of the embedded derivatives in our convertible debentures, which was driven by a change in our share price at the end of the applicable periods. Our adjusted net loss, which adjusts for these unrealized losses or gains, was 3.4 million compared to 0.4 million for the same period last year. Our net cash flow was 1.4 million in the period compared to a use of 2.9 million for the same period last year. And at December 31st, 2021, we had 9.6 million in cash and cash equivalents with 10.1 million of total available liquidity. Turning to our specific product lines, we saw a sequential quarter-over-quarter improvement overall in our core business and are excited about the new and potential additions to our product portfolio, which we believe will generate growth momentum over the coming years. During the quarter, we saw a recovery in Xfinity sales that validates our recent initiatives to reset the supply chain and selling process over the last few quarters. And our unit market demand figures suggest a moderate level of patient conversions on top of a stable existing base of patients. We're also continuing to invest in a phase four pediatric study that, if successful, will expand the Xfinity product label to include the pediatric population of patients under 12 years of age with hemophilia B. During Q3, we completed enrollment in our trial. and the trial is expected to be completed by June of 2022 this year. Once completed, a successful study could support an expansion of the indicated patient population for Xfinity, and we are exploring approaches to address this potentially expanded market. Rupal saw strong and continued unit demand growth of 30% for the trailing 12 months ended December 31st, 2021. 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 physicians increasingly switching patients to Rupal from either the generic prescription antihistamines or over-the-counter products. Turning to Resubo, a once-weekly, subcutaneous, single-dose autoinjector of methotrexate indicated for the treatment of rheumatoid arthritis, psoriasis, and juvenile idiopathic arthritis. On a unit-sold basis, Resuvo continued to maintain and, in fact, slightly increased its market share in the United States, and the trailing 12 months ended December 31, 2021. However, product revenue was negatively impacted by a decrease in the effective unit-level prices we implemented during this period to defend our strong market share in light of increased competition in the branded methotrexate market. Medoject is a pre-filled syringe of methotrexate, which is indicated for the treatment of rheumatoid arthritis and psoriasis. Even with a generic entry into the Canadian market in 2020, Medoject had a unit demand increase of 8% in the trailing 12 months ended December 31st, 2021. Again, product revenue was negatively impacted by a similarly motivated decrease in effective unit-level prices. As we have discussed in the past, we continue to be excited about triosulfan. We expect that it will become a leading agent for use in conditioning regimens as part of allogeneic hematopoietic stem cell transplantation protocols, or thankfully abbreviated, alloHSCT. This is a therapeutic area of great strategic interest for us. In June of 2021, we received notice of compliance from Health Canada to commercialize Triosulfan, which we currently market in Canada under the trade name Precondiff. We have entered into an exclusive license with MedAct GmbH to commercialize Triosulfan in Canada and now have fully launched in the Canadian market. We also entered into an exclusive license with MedAct in February 2021 to commercialize Triosulfan in the United States. As we have previously discussed, on August 2, 2021, we were notified by MedAct of a complete response letter from the U.S. Food and Drug Administration relating to the new drug application for the use of Triosulfan in the United States. We participated in MedAct's Type A meeting with the FDA on November 23, 2021, to review MED Act resubmission plan. Following that meeting and based on our discussions with MED Act, our view is that there is a path towards approval that does not involve completing an additional phase three study, provided that MED Act delivers to the FDA materials that address the FDA's outstanding issues set out in the CRL. The MDA resubmission is currently expected to occur in the second quarter of 2022. with a final FDA decision expected two to six months after the NDA resubmission, timing that is substantially consistent with our previous estimates. We continue to believe that Triosulfan could eventually overtake the current market leading product in the U.S., Busulfan, which realized 126 million in the U.S. sales prior to genericization. In the meantime, We do not expect to make additional milestone payments to MedAct until we have received FDA approval. In addition to our current product portfolio, we also have a right of first refusal on current products from MedAct, the previous owner of MedExis US. We believe that several of these products represent a promising commercial opportunity in North America, and we are in the process of assessing the licensing of these products. We are also in discussion with several partners regarding other licensing opportunities that we believe have the potential to material contribute to the revenue over the next few years. A key component of our growth strategy will be to continue to leverage our infrastructure through new product acquisitions and partnerships. We are exploring a number of opportunities, including a portion of the deal pipeline in the negotiation phase in both the US and Canada. 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. We aim to continue to grow revenue, leverage our North American sales force across products, realize synergies from our predecessor companies, and maintain strict financial discipline. In summary, we believe we have built a highly scalable business model which should provide significant incremental earnings potential. I'll now turn the call over to Marcel, who will discuss our financial results in more detail. Marcel?
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