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spk03: over to your host, Craig McPhail. Please proceed.
spk01: Thank you, operator. Good afternoon, everyone, and thank you for joining us for our fiscal first quarter 2024 results conference call. Discussing Numinous' performance today are Peyton Nyquist, founder and CEO, and Nikhil Henda, chief financial officer. Joining them for analyst questions at the end of our formal remarks are Reid Robinson, Chief Clinical Officer, and Paul Fieldking, Chief Science Officer. The following discussion may include forward-looking statements that are based on current expectations and are subject to a number of risks and uncertainties. The risks and uncertainties that could cause our actual financial and operating results to differ significantly from our forward-looking statements are detailed in our MD&A for the quarter ended November 30th, 2023. and in our other Canadian securities filings available on CDAR. Numinance does not undertake to update or revise any forward-looking statements to reflect new events or circumstances, except as required by law. Our first quarter results were made available earlier this afternoon. We encourage you to review our earnings release, MD&A, and financial statements available on our website and CDAR. As a reminder, all figures discussed on today's call are in Canadian dollars. I'll now turn the call over to Peyton Nyquist, Chief Executive Officer.
spk04: Thanks, Craig, and good afternoon, everyone. I'd like to start by extending our utmost gratitude that our work is conducted on the unceded homelands of the Musqueam, Squamish, and Tsleil-Waututh peoples and on other sovereign indigenous lands and territories across Turtle Island. We are committed to a path towards reconciliation through continuous learning, reciprocity, and humility. We're looking forward to the opportunities available to us in 2024. This will be a pivotal year for psychedelics as more drugs are advanced to commercialization and regulatory approval. This past December, MAPS submitted a new drug application to the FDA for the treatment of PTSD with MDMA. This follows a successful phase three trial, which indicated that over 70% of participants no longer met the criteria for having PTSD after receiving three dosing sessions together with therapy. As MDMA has been designated as breakthrough therapy, the FDA has 60 days to accept the application for review and decide whether MDMA will receive a priority review of six months. This development was very well received by the psychedelic therapy community as it puts us significantly closer to providing transformational care for millions of Americans afflicted with PTSD. The markets also reacted well with the MAPS news. Now rebranding as Lycos Therapeutics has raised $100 million with an oversubscribed private placement. It's important to note that this application for the treatment of PTSD with MDMA is just one of several psychedelic therapies under development. According to the news service Psychedelic Alpha, There are over 30 psychedelic compounds in the Phase II or Phase III clinical trial stage, with most addressing conditions for which there is no effective treatment, and Numinous is well-positioned to benefit from that. The advanced stages of drug development drive the demand for efficient and clarifying clinical research. Once approved, these drugs will be required to be administered and monitored in treatment clinics using FDA-approved methodology. Considering the expected strong demand once these drugs are approved, there will be a high demand for trained psychedelic therapy practitioners. On all three fronts, Numinous is well positioned with the most comprehensive offering in behavioral health care. Let's start to look at the details of the quarter with our wellness clinics. We conducted almost 20,000 clinical appointments in the first quarter, slightly declining from our 21,000 in the fourth quarter of 2023, Year over year, appointments were up about 3%. The quarter over quarter sequential decline in appointments was mainly due to the reduced appointments in our Canadian clinics as we scaled back services that were not focused on our core of mental wellness and also with an increased focus on higher margin service lines. The year over year increase resulted from improved clinic utilization across the clinics as a result of an operational focus on expanding appointments for ketamine services. New clients made up about 7% of the appointments in Q1, and about 22% were ketamine-spravato-related. In our Canadian clinics, we are also treating patients with MDMA and psilocybin-assisted therapy under Health Canada's Special Access Program. Delivering excellent patient care and experience continues to be a priority at all our clinics. And in the past quarter, we put in place several initiatives to elevate service across the clinics. One was an eight-week in-house education program for all clinical staff to establish consistent best practices across the network. This covered all aspects of our clinic operations, including service standards, patient care, and operational systems. We take pride in delivering excellent patient care and a great patient experience. And programs like this will ensure that every patient benefits from a consistent, high-quality, numinous experience at all our clinics. We also took important steps to removing the obstacles preventing patients from seeking help. This included improving our digital presence with a refreshed website, a unified numinous digital presence on search engines, and an enhanced patient booking process. We also expanded our hours of operation in our transformative care center, including opening earlier and staying open later, along with seven-day-a-week access. Together with expert care, these initiatives will drive appointment growth, clinic utilization, and ultimately strong financial performance. Next, I'll talk about our practitioner certification training program which we see as a strategic growth channel and an important source of high margin revenue. Over 700 learners have enrolled in Numinous training programs, and we expect that number to increase with the recent launch of our Introduction to Psychedelics program. This free course will introduce learners to the Numinous and encourage them to continue into full practitioner training. In January, the entire training program was mitigated to a new learning management, migrated, sorry, to a new learning management system platform, which ensures we continue to provide a leading training program that improves learners' engagement, satisfaction, navigation, and community experience. What drives success in Numinous' practitioner training is that our differentiated offering combines highly experienced instructors with real-life experience administering psychedelic-assisted therapy in our clinics and clinical research expertise that informs our training. Soon, we will add experiential learning opportunities so learners get first-hand experience with these medicines. This is delivered in a blended learning format that optimizes adult learning. After completing the course, Accreditation is available through major regulatory bodies in both Canada and the United States. Currently, we are working with the Oregon Health Authority to receive formal approval under their guidelines. This enhances the credibility of our certification pathway and increases the program's visibility when it is included on authority's list of approved training programs. The progress we are making with Numinous Learning Pathway positions us to be the essential training provider to meet the high demand for therapists in psychedelic assisted therapy. The third essential component of our business is CDER Clinical Research. CCR is the research partner of choice for leading drug development companies, including traditional pharmaceutical companies, research organizations, and the leading psychedelic drug development companies. CCR also provides Numinous with frontline experience in administering breakthrough psychedelic therapies and knowledge of patient care and clinical practice that informs the rest of our business. In fact, both Paul and Reed have helped design training and are the faculty of Numinous certification pathway. The first quarter of 2024, CCR managed 22 clinical trial sites, including 456 patient appointments. One of these was for the Ketamine Research Foundation, with CCR providing one of five research sites investigating the potential of CAT in improving the quality of life for individuals facing end-of-life challenges. In December, CCR was chosen as one of multiple sites for Beckley SciTech's cutting-edge Phase 2B clinical trial for treatment-resistant depression. The study aims to evaluate the efficacy and safety of different doses of Beckley's proprietary intranasal formulation of the short-acting psychedelic compound 5-MeO-DMT. With the continued increase in psychedelic drugs under investigation and CCR's expanding expertise, we expect steady growth in our clinical research division. Based with the significant opportunities ahead for us, To benefit fully, we continue to maintain financial discipline. Increasing revenue and gross margin while optimizing our overhead will continue to be the focus for 2024. As we said on our last call, we are seeing the positive impact of our cost containment measures and, starting in October, have reduced our annualized cash expenses such that our cash burn is now under $1 million a month. As a result, our operating expenses declined by 19.9% in Q1 of 24 compared to Q4 of 23. We see further opportunities to optimize operations and are now focused on achieving positive EBITDA on a consolidated basis with our current operations. With that, I'll now turn the call over to Nikhil to discuss our quarterly results in more detail. Nikhil?
spk00: Thanks, Peyton, and good evening, everyone. This quarter, driven by the ramp up of our services in the United States and Canada, revenue grew 4.9% to $5.9 million compared to the same quarter last year. Revenue from our wellness clinic network was $4.9 million, declining by 1.2% compared to the same period last year and decreasing by 0.7% compared to Q4 2023. Revenue from CCR rose 49.5%. to $1 million from $700,000 in the same period last year, but fell 12.9% from $1.2 million in Q4 2023. Revenues from our wellness clinics comprised 83% of total revenue during the first quarter, up from 80% in the prior quarter, but down from 88% in Q1 2023, highlighting a more diversified revenue mix year over year. U.S. operations comprised 84% of total revenues this quarter compared to 87% last quarter. First quarter gross margins were 36.1%, up from 29.5% the previous quarter and down from 41.9% the same quarter last year. We again decreased operating expenses through our cost optimization initiatives as we continue to focus operating expenses on how to best support revenue-generating activities. This quarter, operating expenses were $6.3 million, falling from $7.9 million last quarter, once you exclude the one-time cost in the last quarter, and down from $9.1 million in Q1 2023. As a result of our expense optimization efforts, we narrowed our net loss substantially this quarter to $4.4 million, or two cents per share. compared to $9.3 million in the prior quarter and $6.1 million in the same period last year. Total net cash outflow during the quarter was $3.8 million, a decrease of $0.6 million compared to the previous quarter. We ended the quarter with $4.7 million of cash on hand and $4.6 million of working capital. Our monthly cash outflow has remained under $1 million due to our cost containment measures. In Q1 2024, we implemented an at-the-market equity program that allows us to issue and sell up to $10 million in common shares. In the quarter, we issued 620,500 common shares for net proceeds of $74,779. Subsequent to the quarter, we issued an additional 3,468,000 common shares for net proceeds of $394,920. The combination of our focus on driving high margin revenue, optimizing our operating expenses, and further industry catalysts, such as the expected MDMA assisted therapy approval in the US, puts us in a solid roadmap to achieving strong revenue growth and positive EBITDA on a consolidated basis. And with that overview of our financial results, I'll turn the call back to Peyton for some closing remarks.
spk04: Thanks, Nikhil. To reiterate, we see 2024 as a pivotal year for the adoption and expansion of psychedelic treatment to address the significant behavioral health crisis. And Numinous's diverse business operations provide the crucial infrastructure to make these advances a reality for many patients in need. We look forward to updating you as our progress in the upcoming quarters with our focus on leveraging our operational focus into positive cash flow and profitability. Before we open the call for live questions, we will take some questions that were sent to us by investors.
spk01: Hi, Peyton. Hi, Peyton. I have two questions sent to us from investors by email. Here's the first one. There's been positive news from Numinous and the industry in general on the advances in psychedelic treatment. However, the share price remains disturbingly low. What are you doing about that?
spk04: Yeah, that's a great question. With management among the largest shareholders of Numinous, we're well aware of the share price activity. To me, it seems like the market does not fully understand the value of our business. As you may have seen from the earnings released today, the board is reviewing some strategic alternatives available to us to unlocking shareholder value. The focus of this is how we unlock some of the value that we believe is not properly reflected in our share price and ensure that we have a strong capital position. This could take various forms, whether that be a partnership or other means to bolster our capital base and also to support shareholder value creation over the medium term. Shareholders will be informed should the board decide on a course of action.
spk01: Thank you. Now, here's the second one. What is the expected pace of growth in demand for your certification pathway? and do you have the personnel and facilities to keep up with the demand?
spk04: Based on the large population of potential patients needing psychedelic-assisted therapy, we expect that demand will be high, particularly once MDMA is approved, and the bottleneck in providing care will be a shortage of trained therapists. We have designed the certification pathway to be scalable. This comes from the learning management system we have implemented, and the faculty available. Many that come from our experienced and highly qualified care providers, many come from our experienced and highly qualified care providers at our clinics. We can easily increase the cohort in our programs with a minimal cost increase. As training scales, we expect it to provide strong support in the delivery of MDMA-assisted therapy and also strong financial contributions to Numinus. With that, we'll open the call to questions from analysts and institutional investors. Operator?
spk03: We do have a question from the line of Michael Akunowich with Maxim Group. Please go ahead.
spk02: Hey there. Thank you for taking the question and congratulations on the progress this quarter.
spk03: Thanks, Michael.
spk02: So I guess to kick things off, I'd like to see if you could just highlight where some of that improvement that you saw, in particular the gross margins, came from, since revenues did go down slightly, but overall your gross profit increased fairly significantly. Is this a result of a reduction in unprofitable services? Could you just give a bit more color on that, please?
spk04: Yeah, I can maybe start, and then I'd hand it over to Nikhil. As we mentioned on the call, really looking to shift some of the services, obviously, as more and more people get interested in ketamine-assisted therapy, which is a longer form of therapy, but with higher margins associated with it, and offering other opportunities for accessibility, whether through our virtual platform, which helps increase the margins as well. But Nikhil maybe can talk a little bit more about that.
spk00: Yeah, thanks, Peyton, and thanks, Mike, for the question. Good to hear from you. So I think there's a couple of things here. So first of all, as part of our just review generally of support, so another way of saying expenses for revenue-generating activities, that that's primarily focused on operating expenditures, but some of it is on the cost of goods sold as well. So you'll see that refocus that we've had, or I should say enhanced focus on this, was primarily on operating expenditures, but there was some on gross margins, the cost of goods sold, how can we be more efficient with our resources and the services we deliver, while at the same time enhancing the client experience. So ensuring we're delivering the highest quality of care, but also with a high client experience. So there's that generally that we saw really benefits across the clinics in both Canada, the US, and in training. And as Ping was saying, it's part of its mix as well. As you can appreciate in the U.S. clinic network in specific, we offer more traditional services such as med management and psychotherapy, and then more innovative services like ketamine-assisted therapy, Spravato, and ketamine from a medicine-only perspective. And all of those have different margin profiles. And so we saw, as Payton was saying, a mixed change over the past quarter. And if you look at the gross margin compared to last year in the comparable period, you'll see it's actually down. So this gross margin, we hope to see a trend higher, but there likely may be some volatility in coming quarters as we look to bring on new clients, but also just ensuring that they are all receiving the best treatment plans possible. We have to really be mindful of the best treatment plan for them may actually be lower margin products. And so just making sure we offer the full suite. And each of those suites really focused on what is the best client outcome, and within that, the best client experience. But obviously, for every service we're doing, also looking at the margin profile. So this quarter specifically, to sum it up, there was some efficiencies on cost of goods sold, and also a change of mix in the services that we provided clients.
spk02: All right. Thank you for that, Nikhil. As a follow-up, I'd like to just do some general housekeeping questions, see if you can give an update on a transition to full-time employees, especially in Canada, as well as the Numinous Network, and if you've seen an uptick in interest since MAPS filed.
spk04: I can maybe touch on the Numinous Network, and Nikhil can take the other part of your question. You've definitely seen a huge increase for not just Numinous Network, but I think now with MAPS financed and in the application process, I think the question on everybody's mind for 2024 is really integration and implementation of these services. And we've seen a huge amount of people very interested in the Numinous Network, but also our training, because not only have we been the clinical trial sites for a number of these different studies, but we've also actually offered these treatments in a real world setting with the special access program up in Canada. So I think everybody, especially in the early days, is really looking towards who has some experience and expertise to lean on where now the big question is, it's looking like approval is going to happen. you know, how are we actually going to do this in clinical practice and how do we provide scale, knowing that there is a huge demand of people looking for these services, but limited access to it, especially in the early going. Mikhail, do you want to take the other part of that question?
spk00: Yes. Thank you, Peyton. Just on the full-time versus part-time, I think, you know, that the main focus for us, Mike, is what's the best way to provide great patient care and a wonderful client experience? And so we believe full-time employees, which is how we largely operate in the US, provide not only a more fulfilling opportunity for the actual health practitioners, but greater engagement, greater focus on the clients that are in our clinics as they're full-time. So we have seen some changes in Canada with a certain greater emphasis on full-time employees. But that being said, the part-time practitioners that we have who have clients with us in our clinics in Canada and also clients elsewhere are still a crucial part to our business and likely will be for quite some time. So I think for us it's really a balance of what do we want to commit to from a full-time perspective to ensure that we have high patient care and great employee engagement at the same time respecting some of the flexibility that some of our practitioners wish from a part-time perspective that also frankly provides us a certain amount of financial flexibility. So we'll see that slowly evolve over time, but really the focus is what are we hearing from the practitioners in terms of engagement, their desire, and really importantly, what are the patients actually providing in terms of feedback? You know, we just launched a Net Promoter Score program, which is a really wonderful way for us to get direct feedback in addition to the other avenues we have for communication. So we'll continue to enhance that. And as Peyton mentioned on the call, there's been a real focus this past quarter for us on just going back to some of the basics So what we call the philosophy of care and transformative care. And so our operational team, along with all the practitioners in the different clinics, really we're focusing on what are some of the fundamentals we should do from a patient care perspective, but also more broadly, just a client experience in terms of when the client comes into the clinic, how they're treated, how we want them to go through the client journey to ensure that it's not just the clinical component that's obviously of a very high caliber, but also some of the other components aspects of the client experience. So back to your initial question, we have seen a migration towards more full-time practitioners. Part-time will still be, though, a core part for us, especially in Canada, but we will look specifically as to what's the best mix in relation to providing wonderful patient care and also great client experience. And if I could just add on to what Peyton was saying regarding the newness network, I think, you know, when you look at what's happening with MDMA-assisted therapies, coming up for approval likely mid this calendar year. As Peyton was mentioning, there's a few aspects really to be implemented prior to delivering actually MDMA-assisted therapy in a clinic. So one of them, and the first one we see, is really training. So how can practitioners feel confident in the safety and efficacy of delivering this novel therapy, and how can the regulators and others, and so we think that our training pathway is a premium product, one that's not only innovative, but really provides the best learning experience and also the best confidence to practitioners going forward. And we think we will first see the greatest uptake in that. So I think for us, from a mission perspective, it's crucial because we think that will help support safety and efficacy from an MDMA-assisted therapy perspective. There is also financial gain to that, but I think more importantly will help trained practitioners for the upcoming clinical setting. Second is, once you have those practitioners trained, some of them who wish potentially to start their own clinic or are in a clinical setting that is not equipped for the delivery of MDMA acid therapy will need some assistance, as Peyton was mentioning, on SLPs, protocols, set and setting, and that's where a numinous network would come in. And then eventually we'll see it in the clinics as well, both in our clinics in the U.S. when it's permissible, and other clinics outside of our clinic network. So I think there's a few steps there, but really prior to the numinous network really taking off, I think you'll see the leading indicator will be our training pathway taking off and seeing some of the results there, and we're already seeing some early traction. So I just wanted to add that on. Thank you for your question.
spk02: Yeah, thank you. I really appreciate the additional insight. And then one more for me, and I'll hop back in the queue. I'd like you to Take a little bit of a longer-term look, and especially in the context of the recent news we saw from Compass and Green Book, as well as with the Comp 360 Phase 3 data coming up in pretty short order. Is there anything in particular that you're doing on the silo front for something like Comp 360 to make sure that you're prepared to launch that down the line? Or is the focus more on MDMA in the near term, given that that's likely to have a much quicker path right now to revenue generation?
spk04: Yeah, I can touch on that. I think it's a bit of both. Obviously, with our training pathways, we offer opportunities for people to deepen their learning on MDMA-assisted therapy, but also psilocybin-assisted therapy and ketamine-assisted therapy. And to kind of continue with that, we've also had the opportunity now up in Canada to treat a number of people with psilocybin-assisted therapy through the special access program. So, you know, it continues to be something that we engage with. And I think Compass, you know, has initiated or signaled that they're starting to really look at, you know, what does commercialization look like, which I think is very smart on their part, you know, knowing how long it takes to get things set up and making sure that they're ahead of that. But, you know, we've also been the clinical trial sites for for Compass and others who are using psilocybin to treat different indications. And so that's really given us the opportunity to deepen those relationships with those drug developers like Compass, but also run their protocols in our clinics, which is also clinics where we treat people. So we've been able to sort of implement this in as close to a real world setting as possible. So I think there's a natural opportunity to be prepared and be kind of some of the first sites prepared for it once approved. And I think that's probably, you know, where you see a lot of the opportunities with MDMA is I think there's a lot of headway we can make focusing on MDMA and commercializing or helping commercialize that therapy that is infrastructure that will be very valuable to other drug developers once approved being that there's a forged pathway there already. We see lots of opportunity this year to deepen those relationships, but also get into practice, hopefully, with approval of MDMA in the second half of this year.
spk05: All right.
spk00: Thank you very much. If I could just add to that, I think the key word that Peyton used there was infrastructure. I think, Mike, it's not binary as to is it MDMA-assisted therapy or is it focused on compasses medicine. It's more... we have an infrastructure in place straight from clinical trials to the clinics, the training, really for a variety of medicines. And as we obviously have an expertise in psychedelics, as you'll see with our clinical trials with CCR, it's for everything. So we think that there's really a platform here. While MDMA-assisted therapy will likely be the one that's approved first, we don't see that they're mutually exclusive. As Peyton's saying, they're actually reinforcing the experiences that we have with all of them will reinforce one another as they all go towards commercialization with the infrastructure that we have.
spk03: All right. Thank you for that additional insight. Thanks for the questions, Michael. Appreciate it. I would now like to turn the call over to Peyton Nightvest for closing remarks.
spk04: Thanks, Operator, and thanks, everybody, for joining us today for the conference call. We look forward to speaking with you in April when we'll report our fiscal second quarter 2024 results.
spk03: This concludes today's call. You may now disconnect.
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