Greetings. Welcome to the Medexus Pharmaceuticals third quarter 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, Investor Relations with Medexus. You may begin.
Thank you. Good morning, everyone. Welcome to the Medexus Pharmaceuticals third fiscal quarter 2023 earnings call. On the call this morning are Ken d'Entremont, Chief Executive Officer, and Marcel Konrad, 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, the 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 of 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, is available on the company's website at www.medexus.com and on SEDAR at www.sedar.com. As a reminder, Medexus reports on March 31st fiscal year basis for the quarter ended December 31st, 2022 was the company's fiscal Q3 2023. Medexus reports financial results in US dollars. 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 are proud to announce another record quarter for Medexus. As one key indicator, we achieved revenue of $28.7 million for fiscal Q3 2023. We saw growth across all of our leading prescription products this quarter, which was further complemented by the addition of Gleolan net sales in the U.S. Our third quarter revenue of $28.7 million compares favorably to $21.3 million for the same period last year or 35% growth year-over-year. The $7.4 million increase is mainly due to an increase in net sales across our portfolio and the contribution from Gleolan in the U.S. Third quarter adjusted EBITDA increased to $5.2 million, compared to $1.9 million for the same period last year.
The $3.3 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 like to highlight this is our fifth consecutive quarter of positive adjusted EBITDA, demonstrating strength and stability in our product portfolio as we close out fiscal 2023 and look ahead to fiscal 2024. We produced a net loss of $1.5 million for Q3 compared to a net loss of $1.2 million for the same period last year. Our adjusted net loss, which adjusts for unrealized losses or gains related to our convertible debentures that are included in net loss, was $0.9 million compared to $3.4 million for the same period last year.
As at December 31st, 2022, we had $9.3 million in cash and cash equivalents, with $10.1 million in total available liquidity. We are actively evaluating options regarding our capital structure. We, including as it relates to our debt financing arrangements with a view to preparing for planned future growth. I will let Marcel comment on this project later in this call. 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. IXINITY saw strong unit demand in the U.S. during the trailing 12 months ended December 31st, 2022. This reflects new patient conversions on top of stable existing base of patients following the resumption of in-person selling earlier in the year.
We continue to improve the IXINITY manufacturing process, which has had a positive impact on IXINITY manufacturing costs. Rupall continued to see strong unit demand, achieving 25% growth for the trailing 12 months ended December 31st, 2022. This continues Rupall'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 five years since launch. Turning to Rasuvo, unit demand remained strong for the trailing 12 months ended December 31st, 2022, maintaining the product's leading position in the moderately growing U.S. branded methotrexate market with a limited sales force allocation. Increasing competition in the U.S. branded methotrexate market continues to negatively affect Rasuvo product level revenue. On Metoject saw unit demand increase in the trailing 12 months ended December 31st, 2022.
This was despite the ongoing impacts from a generic entry into the Canadian methotrexate market in calendar 2020. Although product revenue was negatively impacted due to a decrease in effective unit level prices. The trial for the patent litigation we launched against the generic competitor in 2020 completed in January 2023. We anticipate that the federal court, which is the court overseeing this trial, will issue its decision later in calendar year 2023. In March of 2022, we acquired the exclusive right to commercialize Gleolan in the U.S. As I mentioned, September 2022 was the first full month, and December 31st, 2022 was the first full fiscal quarter where we recognized 100% of Gleolan net sales. Sales have continued to be in line with expectations.
This reflects our successful execution of a seamless transition to full US commercial responsibility and puts us in a position to continue executing on our commercial plan. We also actively pursue opportunities to build our product portfolio by licensing and acquiring new products and by exploring additional indications within our current product portfolio. The advancement of any one of these pipeline opportunities would provide significant step up in our growth profile. We are also pleased to welcome Harmony Garges, Chief Medical Officer for ViiV Healthcare, and Menassie Taddese, previously a Senior Executive Advisor in Viatris, to the Medexus board of directors. Harmony's significant experience leading medical affairs and medical regulatory matters, and Menassie's strong management experience and expertise in corporate finance will undoubtedly be assets as we grow our business.
In particular, I would like to highlight Harmony's medical leadership for over a dozen new drug applications and new product launches, and Menassie's 26 years of experience leading large commercial and cross-functional organizations. I will now turn the call over to Marcel, who will discuss our financial results in more detail. Marcel?
Thank you. Thank you, Ken. Total revenue for the three-month period ended December 31st, 2022 was $28.7 million, an increase of $7.4 million compared to revenue of $21.3 million for the three-month period ended December 31st, 2021, and a $1 million increase versus prior quarter. The year-over-year increase of $7.4 million was mainly due to an increase in net sales across our portfolio and the contribution from Gleolan. As a reminder, the three-month period ended December 31st, 2022 is the first full fiscal quarter in which we recognized 100% of Gleolan revenues. Gross profit was $15.9 million for the three-month period ended December 31st, 2022, compared to gross profit of $11.5 million for the same period last year.
The gross margin was 55.4% for the three-month period ended December 31st, 2022, compared to 54.1% for the three-month period ended 31st, 2021. The increase in gross margin is a result of product mix and ongoing improvements to the IXINITY manufacturing process, which has had a positive impact on IXINITY manufacturing costs. Selling and administrative expenses were $11.9 million for the three-month period ended December 31st, 2022, compared to $10.7 million for the three-month period ended December 31st, 2021. Research and development was $0.7 million for the three-month period ended December 31st, 2022. This compares to $1 million for the three-month period ended December 31st, 2021. The decrease was primarily due to reductions in investment in the IXINITY phase IV clinical trial as it approaches its analysis and clinical study report stage.
Adjusted EBITDA for the three-month period ended December 31st, 2022 was positive $5.2 million, compared to $1.9 million for the three-month period ended December 31st, 2021. This is another all-time high quarterly adjusted EBITDA and the fifth sequential quarter of positive EBITDA, which we view as a significant achievement for our company, demonstrating the durability of our operations. The net loss for the three-month period ended December 31st, 2022 was $1.5 million, compared to a net loss of $1.2 million for the same period last year. We believe that adjusted net income or loss provides a better representation of performance of our operations because it excludes non-cash fair value adjustments on liabilities which may be settled for shares.
Our adjusted net loss for the three-month period ended December 31st, 2022 was $0.9 million, compared to $3.4 million for the three-month period ended December 31st, 2021. Cash and cash equivalents was $9.3 million at December 31st, 2022 versus $9.6 million at September 30, 2022. Our available liquidity hasn't changed versus prior quarter and was $10.1 million at December 31st, 2022, which consisted of $9.3 million in cash and cash equivalents and an undrawn credit of $0.8 million available under our ABL facility. We saw an increase of our accounts receivable and inventory positions versus prior quarter and at the beginning of the fiscal year. We anticipate seeing the benefit in our cash flow in the coming quarters.
We're also actively continuing to evaluate options with respect to our capital structure. We're making very good progress on securing options to manage our near-term liabilities and are in advanced stages of a competitive process that has involved a number of highly interested capital providers. We've been consistent in executing our plan quarter after quarter with sequential revenue growth and improving profitability. Again, this is the fifth consecutive quarter demonstrating positive adjusted EBITDA, and we're looking forward to continuing to build that momentum in quarters to come.
Operator, we will now open the call to questions.
Thank you. At this time, we'll be conducting a question-and-answer session. If you would like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment please, while we poll for questions. The first question today is coming from Andre Uddin from Research Capital. Andre, your line is live.
Thank you. Hi, Ken and Marcel. Just, looking at your IXINITY pediatric trial, when should that approximately read out, if we could have a bit of color on that? If that data is positive, when would you expect to file a supplementary BLA? Thanks.
Hi, Andre, and thanks for the question. The IXINITY trial, we would expect to file it first half of calendar 2023, and that would hopefully end up with a decision latter end of the year.
When should we expect that data around? Is that this quarter or next quarter?
We haven't decided what to do in terms of releasing the data. We do believe it is sufficient to support an application. We haven't really contemplated putting the data out.
Okay. Okay. Thanks, Ken. That's it. That's my only question. Thank you.
Thanks, Andre.
Thank you. Once again, ladies and gentlemen, you can press star one if you wish to enter the Q&A queue at this time. The next question is coming from Rahul Sarugaser from Raymond James. Rahul, your line is live.
Good morning, Ken, Marcel. Thanks so much for taking our questions, and congratulations on the revenue this quarter. In your pre-announced, in your pre-announced earnings, you talked about Trispan, you know, the timelines around Trio, which sort of push it out, you know, minimum about a year. You had talked previously about, you know, the cost structure associated with, you know, with that sales force, which is, you know, obviously applicable to different parts of the business. We see that the SG&A did come down by $1 million, which, you know, netted out as a positive contribution to EBITDA, which is great. How should we be thinking about your SG&A going forward, and sort of a right sizing of that cost structure?
I think a good question, Rahul. Thanks for that. The IXINITY expenses are all completely allocated elsewhere now. There is no spending associated with treosulfan. Excuse me, I may have said IXINITY. There's no Trio spending. Everything's allocated. The restructure that we did in October took out anything that was applied to Trio, and the rest of the infrastructure got applied to the new Gleolan product. Obviously, it's the same institutional sell. Going forward, we would expect the SG&A to be basically what you saw this quarter.
Great. That's, that's very helpful. Just sort of a housekeeping question. You noted that the improving gross margins on IXINITY is helping with the bottom line. However, you know, we did see sort of a net increase in cost of goods. You know, can you give us a little more color on that and how should we be thinking about, you know, cost of goods going forward and total gross margin?
Yeah, I'll make a bit of a comment and then turn it over to Marcel for a more detailed answer. It's really got to do with product mix. Remember we brought Gleolan in without really deploying any capital, in exchange for that, we, you know, gave a higher royalty than we might normally. That's part of it. It's mainly product mix. I'll turn it over to Marcel to give a little more detail.
Yeah, that's, that's really what, again, that's what's mainly driving. We've, we've got multiple sort of forces that are coming through COGS and go through COGS. One of the upside forces is the IXINITY continuous improvement project that we talked about a few quarters ago, which we had in new inventory. Now we see the benefit in COGS, for example, this quarter. This is counterbalanced by the IXINITY acquisition, so to speak, from the license perspective, where we said this product is a, as a, as a reminder, we very low upfront, but we're having about a 50%, 60% hit into COGS for this product. A bit of a counter effect there.
Bottom line, very accretive very quickly as an investment. And then there is other elements in COGS that usually flow there where we monitor ups and downs. On the margin side, this is gonna continue be driven by these forces. Again, going forward, mainly on the product mix, we'll keep an eye on that, and we'll see these ups and downs there.
Perfect. That's really helpful. Just one quick last question. You made very specific mention about, you know, continuously looking for new products and expanding, you know, the product portfolio and as a result, you know, the top line. Could you give us a sense for your pipeline? You know, how should we be looking at your new product acquisitions, you know, in this year?
Yeah, great question. The way we're looking at it, we have two things. We do have a pipeline of products, you know, already built, including treosulfan, IXINITY pediatric, Gleolan meningioma, and Triamcinolone hexacetonide U.S. We do have a pipeline. Then we're looking to build that, obviously. You know, licensing options are always good options, when we don't have a ton of capital to deploy. That's primarily what we're looking at. There's good opportunities there. We're very active, we hope we've got, you know, something to announce soon.
Great. Thanks. Thanks again for taking our questions. We'll get back in the queue.
Thank you. The next question is coming from Prasath Pandurangan from Bloom Burton. Prasath, your line is live.
Hi. Good morning, Ken and Marcel. Thanks for taking my question. I have just the one. In terms of the options for capital providers that you're looking at, you know, given those, how do you look at interest costs going forward?
Hi, Prasath. Yeah, good question. I'll start to answer that question and turn it over to Marcel, see if he's got anything more to add. I think you need to start with the background. You know, clearly, MidCap's been a fantastic debt provider for us. They were there to support the acquisition of IXINITY. In 2020, they expanded that facility by $5 million. I guess that was September 2022. They've been a great partner. Our debenture holders are, you know, many of the big blocks are, you know, long-term Medexus investors, so, you know, we know them well. Those two groups have been great support for us growing our business.
As we go forward, you know, Marcel mentioned that we've had five quarters of strong revenue growth, strong positive EBITDA. That opens the door to other debt providers. you know, we're in discussions with a tier one institutional lender that we think will help us with our growth plans into the future.
Thank you. That's very helpful.
Thank you. There were no other questions in queue at this time. I would now like to hand the call back to Ken d'Entremont for some closing remarks. Ken, actually, we did get a couple more questions. Are you okay to take a few more?
Yeah, absolutely. Go ahead.
The next question is coming from Tania Armstrong-Whitworth from Canaccord Genuity. Tania, your line is live.
Thank you. Good morning, gentlemen. firstly, I'm wondering if you can speak to the investment in working capital this quarter. for instance, receivables were up pretty meaningfully. What exactly does that like, why is this the investment that you've chosen, and what is it doing for your free cash flow in future quarters?
Hi, Tania. I'll turn that over to Marcel.
Yeah, yeah. Hi, Tania. Can take that. As we've said in previous quarter, as we've grown the business, now this particular quarter, we've seen our cash position relatively stable quarter-over-quarter. Because we're growing revenue, obviously our accounts receivable has grown with it. We've invested, so to speak, in the inventory side, specifically in our two lead products. You've also seen that some of our payables came down quarter-over-quarter and since the beginning of the year. We're one of the effects of bringing a new product on board is obviously that we're collecting these receivables.
It is a bit of an administrative process to collect those, but we are monitoring our receivables very closely. We've had a very good quarter for Gleolan, for example. We're monitoring our cash position going forward as we always do, but expect some of the benefits, as I said in my prepared remarks in the future quarters as we collect these receivables, for example.
Okay. Excellent. If I'm not mistaken, I believe Gleolan loses orphan exclusivity in 2024. Could you just remind me what kind of IP protection you have for that asset and how long that's gonna provide protection for?
You're correct. The IP runs out in that time frame you described. There are no generic competitors worldwide. The LA API is managed tightly by our partner. You know, so we don't really expect a generic competitor. There are actions, you know, on foot that will provide, we hope, some additional protection, but I can't talk about those right now.
Okay. Excellent. Then lastly here, if for any reason the outcome of the Metoject litigation is not in your favor, do you have any plans for that product different than current? For example, would you perhaps reduce your sales force allocation to it?
Yeah, we've already done that. So, you know, it's getting a pretty minor allocation at this stage. You know, we've got Gleolan and treosulfan in Canada, so that's where the allocation's gone. In spite of that, the, you know, the unit volume of Metoject continues to grow even with the generic direct competitor in the market. You know, we're really pleased with the performance of the product. Should we lose, we wouldn't change anything. Should we win, you know, we would be in line for pretty substantial recovery of losses, and we probably would put some sales force allocation back on the product
Okay. Excellent. Thank you. That's all for me.
Thank you. The next question is coming from Julian Hung from Stifel. Julian, your line is live.
Hi. Thanks for taking my question. This is Julian speaking on behalf of Justin today. I was wondering if you could provide an update on the milestone payments regarding treosulfan, whether there's any discussions on extending or perhaps adjusting these adjustments, and what's the most likely outcome?
Hi, Julian. Good question. There are none due, we owe nothing, unless it gets approved or until it gets approved. There is a contractual obligation to renegotiate the financial terms of the agreement in April of this year, should the product not be approved by that point in time, and we obviously don't think it will be approved by that point in time. Those discussions are ongoing. Can't really comment on the outcome.
All right. Thank you so much for taking my question.
Thank you. There were no other questions in queue. I'd like to turn the call back to Ken d'Entremont for closing remarks.
Thank you everyone for joining the call today. This was an excellent quarter for Medexus, demonstrating both the strength and stability of our product portfolio and our ability to generate consistent revenue growth and positive adjusted EBITDA. We remain excited about all the opportunities within our product pipeline, and we'll continue to work in advancing these projects. We look forward to a strong full fiscal 2023 and continue our momentum into fiscal 2024. Thanks for your time.
Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.