Earnings Call Transcript - INM Q4 2021

Operator, Operator

Thank you for standing by and welcome to the InMed Pharmaceuticals Inc. Fourth Quarter Fiscal 2021 Financial Results and Business Update. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. As a reminder, today's program may be recorded. I would now like to introduce your host for today's program, Bruce Colwill, Chief Financial Officer. Please go ahead, sir.

Colin Clancy, Senior Director of Investor Relations

Thank you, Jonathan, and good day, ladies and gentlemen. My name is Colin Clancy, InMed's Senior Director of Investor Relations. Welcome to InMed’s fourth quarter and full year fiscal 2021 financial results and business update conference call. Please note our speakers are joining us today from remote locations, so we appreciate your patience if we encounter any unexpected technical challenges. Before we begin, we would like to go over our disclosure statements, followed by a review of our recent announcement to acquire BayMedica together with a progress update on our cannabinoid manufacturing and therapeutic development programs, which will be led by our President and CEO, Eric Adams. Mr. Bruce Colwill, our Chief Financial Officer will then review the financial results of operations. Following that, we will be available for a question-and-answer session. Also joining us today to address your questions will be Eric Hsu, Senior Vice President of Preclinical Research and Development; Alexandra Mancini, Senior Vice President, Clinical and Regulatory Affairs; and Michael Woudenberg, Vice President of Chemistry, Manufacturing and Control. Please be advised that certain statements in the following conference call regarding expectations for InMed’s business operations, clinical development, key personnel, contractual arrangements, regulatory approvals, revenue opportunities, financing and cash runway, all constitute forward-looking statements. Such statements are not historical facts, but rather predictions about the future, which inherently involve assumptions, risks, and uncertainties. Actual results may differ materially from those contained in the forward-looking statements. A description of these risks can be found in our latest disclosure documents and our recent press releases. InMed does not undertake any obligation to update any forward-looking statements during this call. I would like to now turn it over to InMed’s President and CEO, Eric Adams. Eric?

Eric Adams, President and CEO

Thank you, Colin, and thank you all for being here today. Since our last update for investors, InMed has made significant strides, announcing key corporate developments and progress across our therapeutic and manufacturing programs. In June, we shared that we entered a non-binding letter of intent to acquire BayMedica, a private U.S. company focused on manufacturing and commercializing rare cannabinoids. Once the merger is complete, InMed will be well-positioned as a leader in the rare cannabinoids space, especially in clinical development, manufacturing, and commercialization within the health and wellness sector. Additionally, we concluded a private placement with an institutional investor at the end of the fiscal year, which closed on July 2nd, and added $11 million to our balance sheet. In the fourth quarter, we reached important milestones in our manufacturing program for our proprietary IntegraSyn process, and we continue to advance in our therapeutic programs, establishing ourselves as a global leader in CBN or cannabinol clinical development. Regarding the BayMedica acquisition, we confirmed the non-binding letter of intent on June 29th, and they are already our research collaborators in the U.S., specializing in rare cannabinoids and cannabinoid analogs. Last week, on September 13th, we announced the signing of a definitive agreement to proceed with the acquisition, which is awaiting standard closing conditions and should be completed in the coming weeks. We believe this acquisition will be transformative, positioning InMed as a leader in the manufacturing and development of rare cannabinoids. Collaborating with BayMedica combines unique expertise that enhances our capabilities like never before. We've worked closely with BayMedica since November 2019, and through our Research Collaboration Agreement, we've seen how effectively our teams collaborate and the potential synergies in our technologies and rare cannabinoid knowledge. BayMedica's team has vast experience across various fields, including synthetic biology and pharmaceutical drug design, and their pioneering work in synthetic biology over the years will strengthen our position in the market. This acquisition gives InMed greater flexibility in manufacturing, enabling us to choose the most suitable and cost-effective production methods for each cannabinoid targeted for commercialization. We will be able to produce a variety of rare cannabinoid products for pharmaceutical development and consumer health markets. BayMedica focuses primarily on B2B wholesale sales of rare cannabinoids for health and wellness products, including cosmetics and nutraceuticals. They currently excel in large-scale production of their non-intoxicating rare cannabinoid, CBC, with batch sizes exceeding 200 kilograms, and they are prepared to scale up to metric tons as demand rises. Sales of their initial product, Prodiol CBC, have exceeded $2.5 million since launching in December 2019, achieving an average growth of 35% quarter-on-quarter for the year ending June 30, 2021. Given that they began operations just before a global pandemic, this growth is commendable given their limited resources. Upon completing the merger, we plan to accelerate our commercial activities and expect revenue growth in the short to medium term. Beyond CBC, BayMedica is developing several high-value rare cannabinoids, such as CBDV and THCV, for health and wellness markets. Their strategy emphasizes high-demand, high-margin products, rather than easily commoditized ones like CBD. Another significant aspect of acquiring BayMedica is their library of novel cannabinoid analogs, some of which InMed plans to evaluate for future therapeutic use. The advantage of these analogs is that they have been patented as new chemical entities, unlike naturally occurring cannabinoids that are not patentable. This provides added intellectual property protection and opens up future partnering opportunities. Overall, BayMedica contributes immediate revenue potential while balancing our long-term pharmaceutical goals and providing comprehensive manufacturing capabilities for the entire rare cannabinoid market. It enriches our scientific and management expertise and grants us access to laboratory facilities for developing our pharmaceutical R&D programs. Everyone at both InMed and BayMedica is looking forward to closing this agreement soon, integrating our teams, and collaborating to become a leader in this growing sector. Next, I want to discuss IntegraSyn. IntegraSyn is InMed's integrated method for producing pharmaceutical-grade bioidentical cannabinoids efficiently. Earlier this year, the program achieved a critical milestone with a cannabinoid output of 2 grams per liter, indicating commercial viability, and supporting a transition to large-scale production. After ongoing optimization, we have improved the yield to 5 grams per liter, significantly higher than current industry standards. Achieving better yields reduces production costs due to increased cannabinoid yield per batch. Our team is now focused on scaling up to larger batches ahead of commercial production. However, we have encountered a global supply chain issue concerning a specific starting material that may affect our planned production of a 1-kilogram batch this year. We are waiting for more details from our contract manufacturer, Almac, regarding the potential impact on timing and costs. Meanwhile, we aim to produce a pilot batch to validate the process, which, post integration with BayMedica, could also be used for scaling up other cannabinoids. One of the key benefits of IntegraSyn is its ability to use the initial cannabinoid produced as a basis for creating differentiated cannabinoids. Our team is also preparing the manufacturing process to meet GMP standards for pharmaceutical production. Our goal is to efficiently, flexibly, and economically produce cannabinoids that mirror those found in nature. Recent advancements reaffirm our belief that we are on the right path toward establishing IntegraSyn as a commercially viable GMP solution for large-scale production of rare cannabinoids. Now, let's discuss our therapeutic programs, starting with INM-755 for epidermolysis bullosa (EB). INM-755 cannabinol cream is a topical treatment for this severe genetic skin disorder. On April 28, 2021, we submitted Clinical Trial Applications to initiate a Phase 2 clinical trial across multiple countries, and we are on track to begin this trial soon. Applications have been submitted to authorities and ethics committees in several European countries and Israel. While we await approval, we are optimistic about starting enrollment for the Phase 2 trial shortly. This trial will involve up to 20 patients over a 28-day treatment period and will assess the safety and preliminary efficacy of INM-755 in treating symptoms and promoting wound healing. Importantly, this will be the first Phase 2 clinical trial for CBN. Moving on to INM-088, which is a topical eyedrop formulation for glaucoma, also containing cannabinol. Current glaucoma treatments focus on reducing intraocular pressure, but preclinical studies suggest that INM-088 may offer neuroprotection and lower intraocular pressure. We recently presented preclinical data at the H.C. Wainwright Ophthalmology Conference, showcasing the effectiveness of cannabinol in protecting retinal ganglion cells, which indicates its potential for preserving vision in glaucoma and similar conditions. Over the past quarter, we have been setting up a larger manufacturing process for upcoming GLP studies, completing necessary dose-ranging studies to support these trials. Key data from the 088 program has been submitted for publication in a peer-reviewed journal, and we anticipate filing applications by the second half of 2022 to start human clinical trials. In summary, we have made significant progress across all our programs over the last fiscal year, announcing several positive corporate initiatives that will have a transformative impact. In the coming months, shareholders can expect the following catalysts: the closing of the BayMedica acquisition, allowing us to integrate teams and boost commercial activities; the start of our Phase 2 clinical trial, which will be the first time CBN is studied at this phase; the publication of glaucoma data in a peer-reviewed journal, which will enhance the credibility of our therapeutic programs; and scaling IntegraSyn to larger batches ahead of commercial production. I also want to briefly address the recent decline in our share price. We are surprised and disappointed by this trend, particularly given our strengthening fundamentals, including the BayMedica acquisition announcement. While it's challenging to pinpoint the exact causes, we recognize that as a biotech company considered cannabis-adjacent, our stock price is affected by the overall market performance of cannabis stocks, which have seen significant declines recently. We are closely monitoring the situation and are allocating more resources to Investor Relations to enhance our outreach and clarify our value proposition to investors. With several key catalysts on the horizon, we expect to positively impact the company's fundamentals. Now, I'll turn the call over to our CFO, Bruce Colwill, for details on our capital plans and a review of our year-end financials. Bruce?

Bruce Colwill, Chief Financial Officer

Thank you, Eric, and thank you everyone for being on the call today. As a reminder, our fiscal year concludes on June 30th, so we will be discussing our year-end results. Our 10-K is available on our website and sec.gov. First, I'd like to mention our financing from this summer. As Eric mentioned earlier, we completed a private placement on July 2nd with an institutional investor, raising approximately $12 million. Under this placement, we issued around 4 million common shares or common share equivalents in the form of pre-funded warrants and warrants to purchase approximately 4 million common shares. After fees and expenses, we received net proceeds of about $11 million. This funding will enable us to continue advancing our current programs and anticipate closing the BayMedica transaction, which will help accelerate BayMedica's commercial initiatives, including the expected launches of several valuable rare cannabinoid products. For the year ending June 30, 2021, we reported a net loss of approximately $10 million, or $1.52 per share, compared to a net loss of about $9 million, or $1.71 per share, for the year ending June 30, 2020. Research and development expenses for the year totaled around $5.3 million, a slight decrease from the approximately $5.8 million from the prior year, primarily due to lower purchases of the active pharmaceutical ingredient for the INM-755 cream used in our trial. Clinical trial supplies were acquired well ahead of the planned 201 study. Additionally, share-based payments were about $300,000 lower in the recent fiscal year, while expenditures related to our contract research organization for the 201 study increased by roughly $200,000 compared to the previous year. Moving on to general and administrative expenses, G&A expenses were approximately $4.5 million for fiscal year 2021, up from about $3.2 million the previous year. This increase was mainly driven by higher insurance costs linked to our NASDAQ listing, along with increased personnel expenses, though these were partially offset by reduced share-based payments and lower Investor Relations expenses. Our non-cash share-based payments related to stock option grants for the latest year were about $600,000, compared to around $1 million the previous year. These amounts are included in our research and development and general and administrative expenses. Looking at our balance sheet, at the end of the year on June 30th, our cash and cash equivalents were roughly $7.4 million, compared to about $5.8 million at the end of the previous fiscal year. The increase in cash was mainly due to the November 2020 public offering and the February 2021 private placement, mostly offset by cash outflows from operating activities. As of June 30, 2021, the total number of issued and outstanding shares was approximately 8 million. It's worth noting the impact of our July 2021 private placement on our issued and outstanding shares; we issued about 4 million common shares or equivalents in the form of pre-funded warrants. For these pre-funded warrants, the investor paid nearly the full price for the common shares, meaning we received almost all of the $12 million, except for a slight fraction. The shares related to the pre-funded warrants are not counted as issued until they're exercised, so our issued and outstanding shares won’t reflect the 4 million common shares, and our market cap won’t account for any unexercised pre-funded warrants. Briefly addressing cash, our guidance stated that with cash and equivalents of approximately $7.4 million and about $11 million from the July 2021 private placement, we expect to have enough funding to support our operations into the second quarter of fiscal 2023, which corresponds to the last quarter of calendar 2022. After closing and integrating activities with BayMedica, as Eric mentioned earlier, we expect to further refine our cash runway. I would like to turn the call back over to Jonathan for a Q&A session. Please remember that Alex Mancini, Eric Hsu, and Michael Woudenberg are also here for questions.

Operator, Operator

Our first question comes from Scott Henry from ROTH Capital. Please go ahead with your question.

Scott Henry, Analyst

Thank you, and good morning. Just a couple of questions. First, with regards to the BayMedica acquisition, how should we think about revenues for fiscal year 2022? I don't know if you can give us kind of a pro forma 2021 number. Just trying to get a sense of the magnitude we should expect in the upcoming year?

Bruce Colwill, Chief Financial Officer

Yes, let me grab that one. So, good to hear from you, Scott. No, a good question. So, what we have disclosed is that BayMedica, they've launched their first product that Eric talked about CBC and they launched that very, very late in 2019. And they launched it basically just as the pandemic was taking off. But despite that, they saw some pretty good growth, actually. And we announced that in 12 months, up to June 30, 2021 being our fiscal year, they did an average of 35% quarter-on-quarter growth in sales of that product, which is great. And we do see a number of product launches coming out of the pipe as well over the coming year here as well. So, with respect to your specific question, though, Scott with respect to what is our current guidance on revenue in 2022, it's just a little bit early for that. We haven't actually closed the transaction yet. So, one of the first things we need to do as a group as far as integration plans is really sit down and look at that funnel. Look at the prioritization of that. Look at the prioritization of that relative to our own programs and portfolio. And then we'll be in a position shortly after that to give a little bit more guidance with respect to the sales growth. But suffice it to say, we do expect the numbers to grow from what I articulated a few minutes ago on the historical given that, that product has just been launched and the revenues have been growing pretty healthily quarter-on-quarter.

Scott Henry, Analyst

And then with IntegraSyn, as you're starting to make these bigger batches, do you get a sense of how we should expect that business model to play out whether you use those quantities internally, whether you license them, B2B? How do you expect that business model to play out over the coming years?

Eric Adams, President and CEO

Thanks, Scott. Good to hear from you. It's going to be one piece of this machine as we start to integrate the two teams and look across the spectrum at the different technologies that we have available to us. I've been saying for some time that there's no one size fits all approach to cannabinoid manufacturing. There are the biosynthetic approaches, there are the chemical synthesis approaches, and there's IntegraSyn, which is kind of a hybrid approach. And depending on which specific cannabinoid you want to make and its structure, depending on how much of the cannabinoid you want to make, are you trying to make 1 kilogram, are you trying to make 1 ton, and what quality you need to make off that, is it food grade top quality for consumer health and wellness or is it pharmaceutical grade? That all plays a part in determining which pathway is best to take. The plant itself only uses biosynthesis for about a handful of cannabinoids; three or four primary cannabinoids are made via this enzymatic biosynthesis approach inside the plant. All the rest are made with some form of chemical synthesis. So just out of the gate, you can see that even the plant utilizes a number of different processes to do these things efficiently. And we suspect that that's probably from a cost perspective, the way to approach this and the way to look at it. So, we're going to sit down and kind of bring all the big brains together on the manufacturing side and the science side, and kind of develop a game plan for where best to utilize these different technologies to commercialize different cannabinoids. So there's not like a one specific game plan for IntegraSyn versus one specific for chemical synthesis, it’s really a suite of opportunities that we have to figure out how to optimize and where best to apply each of those inside the rare cannabinoid market.

Scott Henry, Analyst

Final question, just with INM-755, how long should we expect from completion of enrollment to data release? I know it’s a 28-day treatment period. But how long is the follow-up at the end of the treatment period? Just so we can get a sense of when perhaps that data will be out?

Eric Adams, President and CEO

Sure. Alex, maybe you could take that one?

Alexandra Mancini, Senior Vice President, Clinical and Regulatory Affairs

Yes, certainly. The study design consists of a 28-day treatment period for each patient, followed by an additional week of safety follow-up after treatment ends. However, the enrollment period will last several months, potentially up to 12 months, once we start. To clarify, the 28-day treatment is specific to each patient. After the last patient completes their treatment, it will take several months to make the data available. This includes time for database locking, consolidation, and analysis, which will take at least a month or more. Overall, I would estimate that it will be about three to four months, or potentially longer, following the completion of the last patient.

Operator, Operator

Your next question comes from the line of Max Jacobs from Edison Group.

Max Jacobs, Analyst

So just on the BayMedica acquisition, I mean, I'm also wondering if you could provide any color on the rollout of the additional cannabinoids, which one do you think will be rolled out first and what can you say about timing?

Eric Adams, President and CEO

Thank you, Max. We are not ready to provide any guidance until we have the opportunity to dig into the specifics of what BayMedica is currently managing. They have some strategies in mind regarding how to move forward and when. However, they have been operating with very limited financial and human resources. Therefore, as part of the integration, we aim to find ways to speed up the ramp-up and commercialization of these cannabinoids. It is still too early to give precise timing on this. We expect there will be additional cannabinoid launches over the next few quarters, but we need to collaborate closely with them to prioritize effectively and ensure that we are funding the right initiatives. We plan to provide more guidance in the coming months, especially through the next year, and we hope to share some revenue projections. It’s challenging to estimate revenue in this emerging market segment without being actively selling products and understanding demand. These will be the first large-scale introductions of these cannabinoids. While some are currently selling small batches, we are aiming to produce hundreds of kilograms or even tons of product. As a result, the price point should significantly decrease; some cannabinoids are currently priced at $80,000 to $90,000 per kilogram due to high production costs of $70,000 to $75,000 per kilogram. There are many variables involved, and we need to clarify our approach, but we do believe there is strong demand for these new rare cannabinoids, and it will be a highly profitable business for us. We will be happy to offer more guidance as we finalize our plans.

Max Jacobs, Analyst

Great. That was very helpful. And then just on the current product, the CBC product. Maybe what can you tell us about the types of customers for it, like who is buying it?

Eric Adams, President and CEO

Currently, BayMedica operates solely in the B2B space and does not have consumer-branded products available. Their business model focuses on selling to wholesale distributors looking to provide a range of cannabinoids to their customers, or directly to manufacturers who incorporate the product into their creams, lotions, tablets, and other formulations for sale in the market. This cannabinoid is relatively new, having been brought to market at a commercial scale in December 2019, but the pandemic has slowed its rollout. At present, less than 50% of sales are to wholesalers, while the remainder goes to smaller manufacturers specializing in cannabinoid-based health and wellness products. These manufacturers are experimenting with formulations and testing market interest, resulting in a gradual increase in sales. BayMedica likely has fewer than 100 customers currently, many of whom order repeatedly, and they are expanding their customer base as they increase production in response to growing demand. Although it’s still in the early stages, the prospects are promising, and BayMedica appears set to become a leading manufacturer of CBC.

Max Jacobs, Analyst

Wonderful. That was very helpful. And then just last question, just on INM-088. I mean, what do you think will be the timing for an IND for that?

Eric Adams, President and CEO

Yes, I mentioned that we are considering filing in the latter half of next year. There are several steps we need to complete that will influence the timing of an IND. We have multiple IND-enabling toxicology studies that must be conducted. Additionally, we plan to have a pre-IND meeting with the FDA to discuss our development strategy and ensure alignment with their expectations. We have finalized the formulation and have conducted several studies on it, including aspects like dosing regimens and amounts. However, we still need to continue these toxicology studies in preparation, which will take up a significant portion of the next year. As we make progress and start obtaining results, we will be in a better position to provide a more specific timeline for filing the IND. For now, we are targeting the latter half of next calendar year.

Operator, Operator

Thank you. I'd now like to hand the program back to Colin Clancy.

Colin Clancy, Senior Director of Investor Relations

Thanks, Jonathan. So, we've had a couple of questions submitted prior to the call by email from shareholders primarily focused on BayMedica. Question one, Shane, has mentioned on the previous webinar about the 200 kg batches of CBC, can you explain what that really means to the market, whether they can do the same quantities for other cannabinoids?

Eric Adams, President and CEO

Sure. Many companies are currently manufacturing 1 kilogram batches using chemical synthesis or other processes that don't scale up well for commercial production. While it’s possible to conduct various experiments on a small scale, transitioning these methods to an industrial setting often proves challenging. Several companies are undertaking benchtop production runs of substances like CBC and other cannabinoids, but the high costs involved make it tough to sustain at a larger market scale. For instance, although producing these cannabinoids might cost around $70,000 per kilogram, the ability to sell them for $90,000 can mitigate some of the financial strain. However, this model isn't viable for widespread industrial application. BayMedica, leveraging its expertise in organic chemistry and synthetic biology, focuses on creating industrial-scale production methods that are both large-scale and cost-effective. They began with CBC, successfully developing a process to produce it at a significant scale of 200 kilograms. Having proven this capability, they can now scale up to ton quantities using a similar approach, potentially achieving cost reductions through economies of scale. They've successfully established a method for industrial-scale CBC production and are now applying these techniques to other rare cannabinoids. Their ongoing work includes both proprietary methods and collaborations to identify effective industrial scale processes. They aim to replicate the same successful scaling for these other cannabinoids, moving towards hundreds of kilograms and eventually ton quantities as demand grows. There's a significant difference between small-scale benchtop production and large-scale industrial manufacturing.

Colin Clancy, Senior Director of Investor Relations

Thanks, Eric. And one final question. As a pharmaceutical company, how important are BayMedica's new analogs and patents?

Eric Adams, President and CEO

Yes, that's a great question. The combined company will have 12 patent families, with 7 related to manufacturing and 5 related to products. One of the key patents that BayMedica brings is a patent application covering a broad range of cannabinoid analogs. An analog is created by taking a natural structure, like CBN, and attaching a different chemical group to enhance its therapeutic potential, safety profile, absorption rate, or other pharmacokinetic qualities. This new entity is patentable because it has been modified in a way that is not obvious and hasn’t been done before. However, the CBN molecule itself cannot be patented since it occurs in nature. This is highly valuable to us. We will take these novel analogs and screen them in our models to explore their therapeutic potential for treating various diseases, which is central to our work at InMed. Now, we have in-house access to a wealth of cannabinoids and need to sift through them to identify the most promising candidates. This work is already underway as part of our collaboration, and we will be able to accelerate it. The program will be led by Eric Hsu and his preclinical group to identify potential hits and progress them through development.

Colin Clancy, Senior Director of Investor Relations

Thanks, Eric. That was the final pre-submitted question. I would like to hand it back to Jonathan.

Operator, Operator

Thank you. And this does conclude the question-and-answer session of today's program. I'd like to hand the program back to Eric Adams, President and CEO for any further remarks.

Eric Adams, President and CEO

Okay, thank you. So just in closing, I would like to thank everyone for their continued support over the last year. We have recently made significant advancements, and we are confident these will create considerable shareholder value in the short, mid and long-term. Looking ahead, we are excited for what the next few months will bring and the immense opportunities that lie ahead for InMed. We truly believe that this will be a transformative year for the company and its shareholders and look forward to updating everyone on our continued progress and milestones over the coming months. Thanks again for participating today.

Operator, Operator

Thank you, ladies and gentlemen, for your participation in today's conference. This does conclude the program. You may now disconnect. Good day.