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.
spk02: Thank you, JL. Good afternoon, everyone, and thank you for joining us for our fiscal second quarter 2024 results conference call. Discussing Numinous' performance today are Peyton Nyquist, founder and CEO, and Melanie Ballou, interim chief financial officer. The following discussion may include forward-looking statements that are based on certain 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 February 29, 2024, and in our other security filings available on CDAR. Numen does not undertake to update or revise any forward-looking statements to reflect new events or circumstances, except as required by law. Our second quarter results were released 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 today 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 the work that our work is conducted on the unceded homelands of the Musqueam, Squamish, and Tsleil-Waututh peoples and on other sovereign indigenous lands across and territories across Turtle Isles. We are committed to a path towards reconciliation through continuous learning, reciprocity, and humility. In the second quarter of fiscal 2024, we continue to focus on preparing numinous to capture the growth opportunities across the spectrum of psychedelic assisted therapy. As the sector's only fully integrated behavioral healthcare provider, we are well positioned to benefit. This strategy is bolstered by the continued advancement of drug candidates towards FDA approval. As mentioned last quarter, Lycos Therapeutics MDMA treatment is now with the FDA as a new drug application. With MDMA designated as a breakthrough therapy, the FDA has 60 days to accept the application for review and decide whether MDMA will receive priority review in the review of six months. This March, MindMed's LSD-based MM120 program for the treatment of generalized anxiety disorder also received breakthrough status after the results of its Phase IIb clinical trials were released. The study showed that four weeks after, a single 100-microgram dose of M120, 48% of participants achieved remission, no longer showed clinically significant anxiety, and 65% showed clinically meaningful improvement. This joins the breakthrough therapy designation granted earlier to USONA Institute psilocybin treatment for major depressive disorders. The Phase II study of psilocybin showed in a six-week trial but a 25-milligram dose of psilocybin administered with psychological support was associated with a rapid and sustained antidepressant effect. In addition to providing the highest enrolling sites for the MM120 clinical trial, Numenous CEDAR clinical research provided sites for USONA's Phase II trial and will again be a research partner for the Phase III trial. According to the news, the new service psychedelic alpha there are over 35 psychedelic compounds in the phase two or phase three trial stage with most addressing conditions for which there's no effective treatment this momentum indicates the progress that psychedelic treatments are making to become accepted as treatments for serious mental health conditions and available to the general public this provides opportunities for continued growth across the three areas of our business 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 patient demand once drugs are approved, there will be a high demand for trained psychedelic therapy practitioners. Since the third quarter of fiscal 2023, we have focused the company on taking advantage of these opportunities. This includes optimizing our operations and implementing cost-containing measures. As part of these initiatives, we announced this morning that we will focus on growth opportunities in the United States while shifting to a resource-efficient capital light model to continue to support Canadian organizations and the therapists and healthcare professionals practicing in this mental health treatment sphere. This decision was made with careful consideration and foresight and resulted from our previously announced strategic review. This reorganization is a strategic shift for Numinous and will allow it to focus on its clinical operations in the United States. Numinous has entered into a non-binding letter of intent with Canadian Center for Psychedelic Healing with respect to a component of of the Canadian reorganization and is actively working to settle definitive terms. Going forward, our focus will be on the significant opportunities available in the United States. With MDMA at the new drug application stage with the FDA and several novel drug therapies at late clinical trial stages, we expect the U.S. to be the first to introduce breakthrough therapies in patient care. We believe this decision also aligns strongly with our goal of profitability from our existing operations. It's important to note that our U.S. operations generated 88% of our revenue in fiscal 2023, with our U.S. wellness clinics having an optimized business model with full-time practitioners and near-term profitable evidence. To continue to support healthcare professionals and reinforce its commitment to advancing novel psychedelic-assisted therapies in Canada, Numinous is introducing a pilot membership program under its Numinous Network Initiative. Through the program, Canadian therapists and healthcare professionals will retain access to the latest therapeutic protocols, including ketamine and psychedelic assistance therapies. Participants will benefit from ongoing support, including supervisory and mentorship engagements with Numinous medical and clinical leaders and certified training programs. This pilot will lay the foundation for a future subscription-based model. Looking at the details of the quarter, we'll begin with our wellness clinics. We conducted almost 18,000 clinical appointments in the second quarter, compared to about 20,000 in the first quarter of 24. The decline in appointment count is due to seasonality, the continued focus in Canada on higher margin service lines, and the closing of our Phoenix clinic. Year over year, appointments at our Utah clinics grew by over 3%. This growth, despite a more extended wellness break in December for our therapists, demonstrates Utah's growth potential. New clients made up about 6% of appointments in Q2 and about 18% were ketamine and cervato-related. We have focused on visibility and excellent patient care to drive continued clinic growth. Our transformative care center has been operating seven days a week, for the past two quarters to increase client accessibility. We have also introduced complimentary information calls. We have completed a comprehensive revamp of our digital infrastructure, including optimized online listings and website, enhancing accessibility and user experience for existing and prospective clients. Bookings are now integrated into our Google listings along with chat functionality. smart reminder systems, and enhanced scheduling capabilities. This has streamlined the client acquisition processes and helped existing clients easily navigate their care. As a result of our efforts to focus on accessibility and excellent care, we have received over 400 five-star Google reviews and are constantly consistently high ratings across all clinics. 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. Numinous Training has made significant strides in the past four months towards its mission of providing comprehensive training programs in psychedelic-assisted therapy and building a system of care for clients accessing these services. Since its inception, nearly 1,500 learners have enrolled in Numinous' training programs, joining from over 15 countries. This compares to 700 learners reported last quarter. Cohorts have increased at all program levels, including our higher-level molecular foundations courses. Last quarter, we launched our Introduction to Psychedelics program. This free course has proven to be an effective way to introduce the entire training program and 30 learners from the introduction course have already signed up for paid numinous program. Next quarter, we will launch a community platform allowing practitioners to access ongoing mentorship support and networking opportunities with other psychedelic providers worldwide. The platform will also provide exclusive continuing education opportunities, webinars, and operational advice for establishing and growing their practice. We are also in the early stages of an initiative to provide training directly to psychedelic drug development companies for practitioners working with participants in clinical trials. This would leverage our clinical research experience and expertise for our trainers. Considering the growth in clinical trials globally, we see this as an attractive growth opportunity. We are pleased with the momentum we are seeing with our training program. We are establishing the gold standard of psychedelic therapy practitioner training, which will attract even more learners as treatments advance through FDA approvals. Looking at CDER clinical research, in Q2, we managed 15 clinical trial sites, including 260 patient appointments compared to 22 trials and 325 appointments in Q1. This decline from the previous quarter was as we completed several high-value clinical trials in the past quarter and wound down the Phoenix Research Center. Currently, CCR is working on two clinical trials, including a Phase III of psilocybin to treat major depressive order at our Murray and Draper, Utah locations. Four further trials are on deck to commence in Q3. With a continued increase of psychedelic drugs moving into phase two and phase three trials, along with CCR's expanding expertise and extensive relationship to drug developers, we expect steady growth in our clinical research division. Based with significant opportunities in our business segments, our focus remains on financial discipline. A key initiative is cost containment. Since Q2 2023, we have reduced our headcount by 60%. This has meant eliminating non-revenue generating roles and aligning all remaining employees on growth-oriented initiatives and activities. We have also trimmed through the organization, including renegotiating or terminating vendor and agency agreements. The psychedelic therapy treatments expected to be approved in the U.S. before other jurisdictions will focus our resources on building profitable U.S. operations to capture this attractive opportunity. To date, we have closed our numinous bioscience business and our unprofitable clinic in Phoenix, Arizona. With the consolidation of operations, numinous is optimizing its patient experience and care model, improving efficiencies and establishing best practices for future expansion. At this point, I'd like to welcome Melanie Valloux, who joined us last month as interim CFO. Melanie is a seasoned financial professional who brings U.S. corporate finance and capital markets experience to Numinous, which aligns with our plans to increase our presence with U.S.-based patients and investors. Melanie will now provide a financial overview for the quarter.
spk00: Thanks, Peyton, and good afternoon, everyone. This quarter's revenue was $5 million compared to $5.9 million in Q1 2024 and $5.4 million in the same quarter last year. The decline reflects the changes Peyton mentioned that were made in the past three quarters to optimize operations and the seasonal impact of fewer clinic appointments in December and January. Revenue from our wellness clinic network was $4.3 million, declining 9.5% compared to the same period last year and decreasing by 13% compared to Q1 2024. Revenue from CCR rose 21% to $0.7 million from $0.6 million in the same period last year and fell 27.1% from $1 million in Q1 2024. As the timing of the clinical trials creates variability in CCR's quarterly revenue, A more illustrative way to look at CCR's revenue is on a trailing 12-month basis. CCR generated $4 million for the 12 months ended February 29, 2024, compared to $2 million for the 12 months ended February 28, 2023. Looking at the revenue mix, wellness clinics comprised 85% of total revenue during the second quarter up from 83% in the prior quarter, but down from 88% in quarter two 2023. This highlights a more diversified revenue mix year over year. U.S. operations comprised 87% of total revenue this quarter compared to 84% last quarter. Gross margins in the second quarter were 33%, down from 36.1% the previous quarter and 39.3% in the same quarter last year. Operating expenditures in Q2 were 6.4 million compared to 6.3 million in Q1, a 1.5% increase after excluding a one-time non-cash charge of 0.3 million to recognize deferred financing costs from the ATM program. Also including Q2 were operating expenditures of $0.5 million in non-recurring consulting fees related to our cost containment measures. Reflecting the success of our cost containment measures, operating expenses decreased 27 percent compared to Q2 2023. Our net loss this quarter was $6 million, or two cents per share, compared to $4.4 million in the prior quarter. The increase in net loss for the quarter is due to increases in legal, consulting, and marketing expenditures, 0.5 million of which are non-recurring cost-cutting initiatives, and 0.7 million loss on the sale of the company's investment in Alto Neuroscience. Total net cash inflow during the quarter was 1.9 million, an increase of 5.8 million compared to a cash outflow of 3.9 million in the previous quarter. We ended the quarter with $6.6 million of cash on hand and $6.4 million of working capital. In Q2 2024, we announced the closing of our prospectus offering for net proceeds of $5.5 million. This quarter, we raised an additional $0.3 million through our previously announced at the market equity offering program. 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 U.S. put us on 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, Melanie. Over the past several quarters, Numinous has taken important measures to capitalize on the growth potential of the psychedelic health sector. Going forward, Numinous will be a leaner and more efficient organization that will benefit from the advances in drug development, the mainstreaming of psychedelic assisted therapy, and the demand for trained practitioners. A stronger team also supports us. Last month, Donna Wilson and Donna Wong were added to the board of directors. They bring important experience in strategy, corporate finance, corporate governance, and people management. Also in February, Rick Doblin, the founder and president of MAPS, joined as an unpaid, non-exclusive strategic advisor. Before we open the call to live questions, we will take some questions sent to us by investors.
spk02: Hi, Peyton. I have two questions sent to us by investors via email. Here's the first one. Given the 26 to 38-week training period for MDMA-assisted therapy, what incentives exist for therapists to undertake this training before FDA approval?
spk04: Thanks, Craig. We have seen a strong interest in the training program with learners enrolling from several countries and diverse backgrounds. As we reported this quarter, enrollment has doubled to almost 1,500 compared to Q1. I think what makes The course attractive is that it provides comprehensive training from the fundamentals of psychedelics to specific training on ketamine, psilocybin, and MDMA therapy. It also appeals to those who are considering entering the field of psychedelic-assisted therapy, as well as experienced traditional therapists to understand how it can help their patients or better work with patient self-administering. Once MDMA is approved, we expect demand may increase and our scalable offering will be able to meet it.
spk02: Thanks, Payton. Here's the second one. With your increasing focus on U.S. operations, when can we expect Numinous to be listed on a U.S. exchange?
spk04: To increase our exposure to the U.S. investors and capital markets, we are always considering the optimal way to achieve that. When the markets and the timing are right, we'll do what's best for Numinous and our shareholders. If those are the only questions, we'll open the call up to questions from analysts and institutional investors.
spk01: Thank you. Your first question comes from the line of Michael Okunowich of Maxim. Your line is open.
spk05: Hey, Peyton. Thank you so much for taking my questions today. I guess, first off, I'd just like to see if you could
spk03: provide a little bit more granularity on how your decisions regarding the Canadian clinics could potentially impact your expense profile and your path to profitability?
spk05: Sure.
spk04: Without getting into too much detail as we're still waiting to define or to sign the definitive agreement, the Canadian businesses have been a challenge to get to profitability with overhead also being a consideration into that. And with the potential opportunity that we're seeing with the clinics in Canada to be able to transition them to the numinous network model provides us ongoing exposure to Canada with a much reduced overhead cost and continue to provide scale as well.
spk05: All right.
spk03: Thank you. And then I'd like to see if you could provide just a bit more color on how your plans to focus on U.S. operations could manifest. Would you look towards bringing on board additional clinics directly through the network, organic opening? And is that something in the near-term focus, or is the near-term really just to prepare your existing clinics for MDMA-assisted therapy, and then down the road look towards more expansion in the U.S.? ?
spk04: Yeah, good question. We continue to see operation or opportunities to grow within our existing business and improve as we continue to make the path towards profitability. And so I think there's lots of opportunity to expand within the owned infrastructure that we've got, but are continuing to evaluate opportunities out there in the marketplace and certainly continuing to develop the numinous network
spk03: uh particularly as as we look towards the approval or potential approval of of mdma in august um and making sure that that product is is ready to go uh on approval all right thank you and then just one last one for me and i'll hop back into the queue i'd like to see if you could provide just a little bit of color on your and your thoughts on what the recent decision in utah regarding um opening psychedelic medicine. Sorry, I lost my train of thought. The recent legislative action supporting psychedelic medicine in Utah, what that might mean for your clinics.
spk04: Yeah, I think, to me, the most sort of exciting part of that is when we think about rescheduling these drugs once the FDA is approved. more broadly you know i think what utah has demonstrated is a is a willingness and keen interest in supporting these therapies uh and i think you know also if you think about insurance coverage um you know to to have that be highlighted and already being considered within the healthcare system in utah uh i think presents lots of opportunities for utah to be you know one of the states to be at the forefront of uh of any regulation changes in regards to different psychedelic therapies, but obviously most paying attention to MDMA-assisted therapy.
spk03: All right. Thank you very much for taking my questions today. Thanks, Michael.
spk01: With no further questions, this concludes our Q&A session. I'll now turn the conference back over to Peyton Nykvest for closing remarks.
spk04: Thanks, Operator, and thank you, everyone, for joining our conference call today. I look forward to speaking with you in July when we will report our fiscal third quarter 2024 results.
spk01: This concludes today's conference call. You may now disconnect.
Disclaimer