This conference call transcript was computer generated and almost certianly contains errors. This transcript is provided for information purposes only.EarningsCall, LLC makes no representation about the accuracy of the aforementioned transcript, and you are cautioned not to place undue reliance on the information provided by the transcript.
spk09: 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.
spk00: 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.
spk05: 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?
spk08: Thank you. Thanks, Ken. Total revenue for the fiscal second quarter ended September 30, 2022 was 27.7 million, an increase of 9.8 million compared to revenue of 17.9 million for the three months period ended September 30, 2021, and a 4.7 million increase versus prior quarter. The year-over-year increase of 9.8 million was primarily attributable to an increase in net sales of Xfinity Andrew Paul, and the recognition of 100% of net sales of ClearLand sold in the US starting September 2022. Even without that additional ClearLand revenue, the base business demonstrated a very strong performance this quarter. ClearLand sales have been in line with expectations to date and our December 2022 fiscal quarter will be the first full quarter in which we recognize 100% of ClearLand revenues. Gross profit was 16.1 million for the three-month period ended September 30, 2022, compared to gross profit of 9.4 million for the same period last year. The gross margin was 68.1% for the three-month period ended September 30, 2022, compared to 52.4% for the three-month period ended September 30, 2021. The increase in gross margin is a result of increased net sales, product mix, and initial promising results from our investments in operational efficiencies in the Xfinity manufacturing process. Selling and administrative expenses were $12.9 million for the three-month period ended September 30, 2022, compared to $11.7 million for the three-month period ended September 30, 2021. Research and development spend was $0.9 million for the three-month period ended September 30, 2022. This compares to $1.8 million for the three-month period ended September 30, 2021. The decrease was primarily attributable to reductions in investment in the Ximity Phase 4 clinical trial as it approaches its analysis and clinical study report stage. We continue to invest a moderate amount of additional capital in the Ximity manufacturing process improvement initiative. As a result, adjusted EBITDA for the three-month period ended September 30, 2022 was positive 4.2 million compared to negative 2 million for the three months period ended September 30, 2021. This is an all-time high quarterly adjusted EBITDA and the fourth sequential quarter of positive EBITDA, which we view as a significant achievement for our company. The net loss for the three months period ended September 30, 2022 was 2.7 million compared to a net profit of 10.1 million for the same period last year, which was primarily driven by an unrealized gain on the change in Ferravaglia embedded derivatives in Medex's convertible debentures of 16.3 million last year. The embedded derivatives in our convertible debentures are sensitive to, amongst others, fluctuations in our share price. We believe that adjusted net income or loss provides a better representation of performance of our operations because it excludes that non-cash federal value adjustment on liabilities, which may be settled for shares. Our adjusted net loss for the three-month period ended September 30, 2022 was 2.8 million compared to 6.1 million for the three-month period ended September 30, 2021. Cash and cash equivalents was $9.6 million at September 30, 2022, reflecting an increase of $2.3 million during the quarter. Our available liquidity was $10.1 million at September 30, 2022, which consisted of $9.6 million in cash and cash equivalents and an on-ground credit of $0.5 million available under our ABL facility, which we upsized by $5 million in September 2022. During the second quarter, we saw an increase in our cash position versus the prior quarter, despite the increase in working capital as we prepare for continued growth. We anticipate seeing the benefits in our cash flow in the coming quarters. At the same time, we are evaluating strategies to clean up our balance sheet and have hired third party advisors to help us with that endeavor. We've been consistent in executing our plan quarter after quarter. with sequential revenue growth and improving profitability. This is the fourth consecutive quarter demonstrating positive adjusted EBITDA, and we are looking forward to building that momentum in quarters to come.
spk00: Operator, we will now open the call to questions.
spk09: Thank you very much. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on a speakerphone to provide optimum sound quality. Please hold whilst we poll for questions. Thank you. Your first question is coming from Andre Dean of Research Capital. Andre, your line is live.
spk01: Hi, Ken. I'm Marcel. Nice quarter. Just actually had a bit of a tough question for you. Maybe you could just share a little bit market intelligence that you may have on CSL's hemophilia B gene therapy product. I was looking. ICER appears to be on site for about $2 million pricing, something like that, which seems quite high. So just wondering what percentage of patients do you think would actually opt in for that, and do you think that would actually have any impact on Xenity? Any color there would be great. Thanks.
spk05: Yeah, thanks, Andre. Thanks for the question. We've been watching it very closely, obviously. It's in the market where we participate. We have close contact with physicians as well as patients, especially pharmacies that deliver drugs. So we get a lot of feedback on what the potential might be. You pointed out that the price of the drug is extremely high. and so it would therefore be reserved for only the most severe patients. I think there's a lot of patients and physicians who will wait and see. Only someone who's not being controlled might be considered a candidate initially until more experience is generated with the drug, which is typical of drugs in this space where there's a lot of caution because of historical factors issues with the products used in the space. It's often no one wants to be the first one on.
spk01: Okay, that's great. Thanks, Ken.
spk09: Thank you very much. Your next question is coming from Justin Keywood of Stiefel. Justin, your line is live.
spk04: Hi, good morning. Thank you for taking my call. Do you have any updates as far as timing for triosulfan? And has there been any change since the last quarter as far as your confidence in the resubmission process? Thank you.
spk05: Hey, Justin. Thanks for the question. I'll deal with the second part first. No, no change in our confidence with respect to the provability of the drug. It's been approved everywhere else in the world, including Canada, where we managed the submission. So the drug is a needed advancement, you know, in this therapeutic area. So, you know, we still believe that it very much will be approved eventually. In terms of the timing, we don't know yet. And so we are in discussions with both the partner who's responsible and is the sponsor of the drug with the FDA and with the agency themselves to make sure that what we do put in will be sufficient for them to make a decision on the file.
spk04: Understood. And then obviously the profitability of the business inflected in the quarter, was there any seasonal impact where we should expect some normalization for Q4?
spk05: As you know, there is some seasonality with respect to our revenue in Rupal and somewhat with NIDA, although NIDA is a small contributor. So, some seasonality in the revenue, but that's somewhat offset now by the addition of Glioland, which is coming on 100% in this quarter that we're working on. So, I would think that we'll continue to have very strong revenue going forward. And the EBITDA number, as Marcel had said, we have consistently improved on our EBITDA number. and now we're at a new level that we're pleased with and may have some growth opportunities there.
spk04: And what is the peak sales target for Glialand in both Canada and the U.S.?
spk05: Yeah, we haven't given any guidance on peak revenue, but I can say that current revenue is in the $12 million to $16 million range U.S., and it's at the top end of that range now that we've had it for some time. And we think that we can significantly grow that. The use of fluorescence-guided resection for glioblastoma is about 50%, we think, in the U.S. relative to other developed markets. So we do believe there are some growth opportunities with respect to the product. We've significantly increased both the sales and marketing initiatives on the product
spk04: And so we'll be eager to see the drug respond to those efforts. Great. Thank you for taking my questions. Pleasure.
spk09: Thank you very much. Your next question is coming from Raul Sarraguesa from Raymond James. Raul, your line is live.
spk03: Morning, Ken Marcel. Congratulations on the quarter, and thanks for taking our questions. Um, so quickly first, uh, recognizing that Cleo land was a hundred cents, uh, recognized this quarter. Um, and as you mentioned, Ken, that, uh, Cleo's close to it, you know, the $16 million that you've talked about in terms of revenue, you know, can you talk about how we should be thinking about now future growth, right? Because this, this is what drove the growth this quarter. And as we move forward, you know, where should we be looking for exponential growth? You know, outside of CREO, of course.
spk05: Yeah, so thanks, Raoul. Good question. So let's start with GLEOLAB. You know, we started to recognize the revenue in this past quarter, but only for one month. That was September. This quarter we're working on, we'll have all three months at 100% revenue. Historically, prior to booking the revenue ourselves, we were only booking about half of it. So, you know, Glinoline obviously will grow significantly in terms of what we book for the drug in the US. Plus, you know, the growth from the newly executed sales and marketing plan that will, you know, take time to really get traction, but should start to bear some fruit soon. Xfinity clearly is a significant growth driver. We've shown, you know, the substantial improvement year over year following us correcting the channel, which was the right thing to do. And so we do expect that drug to continue to grow strongly. Rupel has been growing strongly for many years, continues at a 25% clip even five years after launch. So, you know, I think the existing portfolio still has growth potential within it. And then we turn to our product pipeline. You know, clearly triosulfans, you know, it's a hundred plus million dollar drug if it went approved. Glutal MN and geoma is a significant step up in terms of the patient population that would be eligible for the drug. And the activity pediatric population is a significant step up. If you think that, you know, obviously hemophilia B is diagnosed in childhood. We generated all the revenue that we have today from product switches. We don't get any new product starts. So clearly with the pediatric indication, we'll be seeking new product starts, which will create an even stronger base of patients for that drug.
spk03: Terrific. That's very helpful. Thanks again. So my follow-up is, given your optimism around TRIO notwithstanding, given that you had ratcheted up your sales team in anticipation of TRIO. Now that has been deferred somewhat. Is there a way that you guys are looking at in terms of, in the intermediate term, managing the cost profile we've seen SG&A escalate? Of course, some of that has come with GLIO. How should we be thinking about SG&A in the coming quarters, particularly as there's some measure of uncertainty around TRIO?
spk05: Yeah, it's a great question. So, you know, we've done two things. One, as you pointed out, we licensed Glioland and applied a lot of the infrastructure that we had built for Tril-Sulfan has been applied to Glioland. The second thing we did, as we mentioned in the script, is that we did cut some of the costs related to Tril-Sulfan. There's a further delay, obviously. And therefore, we made the election that we would focus entirely on existing products as Triloxan works its way through the regulatory process. You should think about the improvement or reduction in costs in the order of a million to a million and a half per year.
spk03: Terrific. That's very, very helpful. Thanks, Ken. Thanks, Marcel. And we'll get back in the queue.
spk09: Thank you very much. Your next question is coming from Scott Henry of Roth Capital Partners. Scott, your line is live.
spk02: Thank you, and good morning. A couple questions. First, looking at the strength in the quarter, it appears that it was largely in the U.S. part of the business, and your comments suggest that it was, at least the main part of it was, Xenity shares. First, do you think that's a correct statement? And second, how should we think about Xenity going forward sequentially? Was this a blowout quarter? Should it come down off this number or should it go up off this number? Just trying to get a sense of how we should relay this quarter going forward. Thank you.
spk05: Yeah. Thanks, Todd. Good question. First, the The growth is not just Xcinity and Glioland, so it's not just U.S., it's also Rupel. So Rupel continues to perform extremely well and makes a significant contribution. Rupel is one of our top four drugs in the entire company, so it's partially Rupel. Secondly, the way you should think about Xcinity is, you know, we've talked a lot about patient demand. It was tough to talk about it when we were doing the channel reset, but our patient demand, even during that reset, continued to be extremely strong. Demand has always been there and is steadily increasing. Unfortunately, it wasn't reflected in revenue for a few quarters, but now it is. There's nothing unusual about the Xfinity revenue this quarter. This is just reflecting normal demand in the market.
spk02: Okay. Then would you care to make any comments on what we should expect for the second half of the year? This $27.7 million revenue is a blowout number currently. do you expect the second half of the year to be stronger or, or weaker or flat with the first half of the year?
spk05: Yeah. So we we've guided that. We certainly expect to be over a hundred million in revenue for the full year. Uh, the 27, seven, we did this quarter, uh, had some seasonality with respect to repel, uh, but that's offset now by a glial land coming online, uh, and strong, uh, Xfinity and the sumo revenue. So, uh, we would expect that we'll continue to show sequential progress quarter to quarter through to the end of the year.
spk02: Okay, great. And then final question, just when I look at the balance sheet, I think you got the current portion of the long-term debt is around $30 million. Could you just talk about that, what exactly is due and how we should think about that liability? Okay.
spk05: Yeah, I'll turn that one over to Marcel.
spk08: Yeah, hi, Scott. Yeah, I can take that. Yeah, this is a good question on the shift from long-term to short-term. That is mainly due to our facility. We have in place the 10 million term and the 2025 million on the ABL side, which is coming to you now within the 12 months in July. So we know that calendar year 2023 is going to be pivotal for us to look at the balance sheet, to look at the liability side of the house. That is the first one which is coming due in September, in July, the facility, and then in October, our adventures will be due next year.
spk02: Okay, so that $30 million is due in July and October?
spk08: That $30 million is due in July. That's purely related to the TurboLoan and AVL facility that is now classified as a short-term liability.
spk02: Okay. Thank you for taking the questions.
spk09: Thank you very much. Your next question is from Pranath Panbarangan from Bloom Burton. Pranath, your line is live.
spk06: Hi, good morning. Congrats on the good quarter. First, could you talk about how we should think about the gross margin once the product mix kind of stabilizes and after adjusting for these malty?
spk05: Yeah, I'll make a quick comment and turn that one over to Marcel as well. So gross margin, obviously, we've been very focused on extended gross margin, which when we took it, had a lower gross margin than the rest of the portfolio. So we have been working towards improving that, and we are certainly seeing the benefit of that. It's somewhat offset by GLEOLAND, and I'll let Marcel speak to that.
spk08: Yeah, if you look at our gross margin year over year, you see, obviously on the year-to-date, significant improvement versus last year. Even on a quarterly basis, now you see what I mentioned, a six-percentage point improvement quarter over quarter. A lot of that is driven by by increased sales, you know, product mixes is one of them. We now see Glialand coming into the mix that will affect the gross margin, but I would say overall the exceeded improvement process will positively contribute to our gross margins going forward. So it will be always a bit of a mix of product sales, increase in the sales level itself, And then as we go forward and talk about product improvement initiatives, we will be talking more closely in the coming quarters about that.
spk06: Great. Thank you. And then secondly, can you talk a little bit more about the balance sheet optimization strategies that you're exploring?
spk05: Again, I'll make a quick comment and turn it over to Marcel. Obviously, we're looking at those debentures. As you know, we have the option of paying them either in cash or shares at the company's discretion. Given where the markets are today, we want to have the ability to pay them in cash. And so we're working towards that end. I'll turn it over to Marcel to give you a little more color.
spk08: Yeah, Prasad, as I mentioned before, to Scott's question on the facility now, in the short term, calendar year 2023 will be pivotal for us to look at the balance sheet side, the liability side of the house. As I mentioned in the script that we've hired third party advisors to help us through this pivotal period, I think we have a very good value proposition. We've come to an attractive profile. We've delivered four quarters of sequential positive EBITDA. We showed good fundamentals, so we're very excited about the next few quarters. And obviously today, there's nothing to say about any material updates we will provide in the coming quarters.
spk07: Great. Thank you very much.
spk09: Thank you very much. Ladies and gentlemen, if there are any remaining questions, please press star 1 on your phone handset. Okay, we appear to have no further questions in the queue. I will now hand back over to Ken for any closing remarks.
spk05: Well, great. Thank you very much. Thank you for joining us on the call today, and thank you for the great questions. You know, our base business has demonstrated incredible strength, which we will believe will continue over the coming quarters. We are thrilled that Glioland is now generating revenue in the U.S., which will continue to grow in the next quarter, with December being that first full quarter that we recognize 100% of net sales as we continue to execute that commercial plan. We remain excited about all our opportunities within our product pipeline, and we continue to work towards advancing each of those. So we look forward to future strong quarters. Thank you for your participation.
spk09: Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your phone lines at this time and have a wonderful day. Thank you for your participation.
Disclaimer