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spk00: Good morning, ladies and gentlemen, and welcome to the Intel Jenks third quarter 2022 financial results call. At this time, all participants have been placed on a listen-only mode, and the floor will be open for questions and comments after the presentation. It is now my pleasure to turn the floor over to your host, Stephen Kilmer, Investor Relations. Sir, the floor is yours.
spk02: Thank you. Good morning, everyone, and thank you for joining us on today's call. With me on the line are Dr. Horst Hervé, Intelligent Access CEO, André Godin, our President and CFO, Dr. Dana Madsen, the company's Vice President of Business and Corporate Development, Dr. Frank Pietrantonio, our Director of Clinical Research, and Tommy Kenney, our VP, Legal Affairs and Intellectual Property and General Counsel. Before we begin, I would like to remind you that all amounts mentioned today are U.S. unless otherwise indicated, and today's call may contain forward-looking information that represents our expectations as of today and accordingly are subject to change. We do not undertake any obligation to update any forward-looking statements except that it may be required by U.S. and Canadian security laws. A number of assumptions were made by us in preparing these forward-looking statements, which are subject to risks and results may differ materially. Details on these risks and assumptions can be found in our filings with the U.S. and Canadian security commissions. I would now like to turn over the call to Dr. Gervais. Horst?
spk01: Thank you, Steve. Good morning, everyone, and thank you for joining us for the Intergenics third quarter 2022 conference call. On today's call, I will provide a corporate update and discuss the progress we've made on our key pipeline projects. Then André will review our third quarter 2022 financial results. Following that, we will open up the line for your questions. However, before I start with the update, I would like to again take the opportunity and apologize for the mishap that happened yesterday with our scheduled call. Apparently, there was a mix-up with numbers or whatever happened there, so the call couldn't happen. Again, management apologizes for that. So having said that, let me now move on to the projects. I start with Atai. In September, we shipped a clinical trial batch of our previously undisclosed candidate, buccal DLS-01 to Atai. DLS-01 is a pharmaceutical-grade psychedelic buccal film containing a synthetic form of NN-dimethyltryptamine or DMT. Atai is developing the product as a novel therapy for treatment-resistant depression in combination with its digital therapeutic design to provide contextual mindset and setting support to patients prior to dosing. With an estimated 100 million people living with treatment-resistant depression globally, DLS-01's potential is significant. Last month, Atai announced that it had dosed the first subject in its phase one clinical trial of buccal DLS-01 with top line results expected in the first half of 2023. Now this is the first ever in human clinical study evaluating an oral thin film psychedelic drug candidate. We're thrilled to have achieved this milestone in partnership with Atai. and look forward to the results of the phase one trial, as well as other programs that could potentially arise from this partnership. Subsequent to quarter end, we responded to the complete response letter for our 505 P2 NEA for resafilm, formerly known as resaport versafilm, received from the FDA in March 2020. Based on the feedback from a previous type A meeting, we conducted additional product testing and are confident that this response provides all of the additional chemistry, manufacturing, and controls information that the FDA requires. We're now looking forward to their response as we continue to work to make Rusafilm available to acute migraine patients. Recently, we met with Exceltis, our partner for Resupport in Spain. They reported great feedback from prescribing doctors and patients, but have been struggling with significant product substitution at the pharmacy level. They are now working on a strategy to overcome the loss in sales, and I'm sure Dana can comment on that in the Q&A section. In addition, the BD team is working on finalizing another distribution agreement for resupport for additional regions. Comment on Tadalafil. As we reported last quarter, there was a slight delay as our partner, Equestiv, had encountered some API-related issues for Tadalafil. However, the R&D teams from both companies were diligently informed to task force to address the issue. We believe that we have now solved the formulation issue and are waiting for some contractual amendments to be put in place before we can move forward with the project. On cannabis, last week we filed a new provisional US patent application that covers a newly developed platform that enables the incorporation of lipophilic active ingredients and cannabinoids such as THC in buccal and sublingual oil film formulations of cannabis-infused products while optimizing onset of action. The technology may also be used when more than one ingredient, such as THC and CBD, is applied in a single-film product. This filing reflects our continued progress in developing noncombustible product alternatives for both medical and recreational use cannabis markets, and we intend to file applications in additional international jurisdictions to further strengthen our patent portfolio. We're also making progress on the commercial side. Our partner, Heritage, received an additional order in September and is selling the product through the medical as well as through the recreational channels. Here, Heritage received listing on the CB4 control strips at Shopper's, one of the largest Canadian retail pharmacy chains. Now a few words on oral film technology. Subsequent to Quarant, our patent portfolio was further strengthened with the issuance of a U.S. patent covering our claims for an oral film dosage form designed for modulating drug absorption of sublingually administered pharmaceuticals, including some cannabinoids. This is the latest in a series of patents recently granted to Intergenix and is expected to remain in force at least until 2038, not including any potential patent term extensions. This patent specifically covers an oral film dosage form designed for modulating absorption profile of sublingually administered actives and will enable the development of a wide variety of protective products designed for improved drug delivery. A few comments on Montelukast. During the quarter, the Buena Studies enrollment reached the halfway point, and we launched a Facebook awareness campaign to attract more study participants and accelerate enrollment. I'm pleased to report that this campaign has been successful, and as of today, we have six sites activated, a total of 38 patients randomized, and 22 patients have completed treatment. Another seven patients will have completed treatment by year end. Assuming enrollment continues at the current rate, we believe we will complete enrollment by the end of 2022. Finally, a comment on chemo. Subsequent to Quarant, we announced that our previously undisclosed development candidate, buprenorphine buccal film, received a GDUFA date of April 28, 2023. We partnered with chemo, part of the Institute Pharma Group, on the development of buprenorphine buccal film in September 2016. and we co-developed the candidate's ANDA that was filed through Zaromet and is currently under review by the FDA. Buprenorphine buccal film is a generic version of Pelbuca, an opioid that is used to manage pain severe enough to require daily, around-the-clock, long-term treatment with an opioid when other pain treatments are inadequate. Pelbuca was approved by the FDA in 2015 and is applied to the oral or buccal mucosa every 12 hours. Lupinorphine buccal film incorporates our Versafilm technology in a novel formulation and is designed to be a bioequivalent lower-cost alternative for patients. According to IMS Health, global annual sales of Pelbuca were 315 million as of July 2022. We're looking forward to FDA's decision and assuming positive decision by the FDA. We're looking forward to the commercialization of buprenorphine buccal film as soon as possible. Two words on animal health. As you may have seen earlier this week, we announced a new VETA film feasibility and development agreement with an undisclosed animal health company for a VETA film-based oral film formulation containing CBD for use in companion animals. This marks yet another milestone in advancing our unique drug deliver technology into the animal health space. In addition, we shipped additional better film buckle films for another undisclosed animal health company for an upcoming clinical trial in companion animals in the US. Further, ED is in discussions with academic institutions to collaborate on the Betafilm platform and drive innovation forward. And with that, I'd like to turn over the call to André for a review of our financial results. André?
spk03: Thank you, Urs. Good afternoon, everyone. As Urs mentioned, I'll take a few minutes to discuss companies' financial performance for the third quarter ended September 30th First of all, I'd like to make a slight correction on Monte Lucas. There might have been maybe a typo or something, but the enrollment that was initially supposed to be completed by the end of the year might be extended to 2023. We will keep you updated on that. on any further development, but I don't think that end of 2022 is achievable for multiple reasons, which we can explain at the Q&A. On the third quarter, the total revenue for 2022 amounted to $142,000, down 76% from $593,000 in the same period last year. The change is mainly attributable to decreases in sales milestone revenue of 320,000 and R&D revenue of 141,000. Operating costs and expenses were 2.5 million for Q3 2022 versus 2.2 million for the corresponding three-month period of 2021. For Q3 2022, the company had an operating loss of 2.4 million compared to an operating loss of 1.6 million for the comparable period of 2021. Adjusted EBITDA was negative 2.2 million for Q3 2022 compared to 1.4 million for the same period last year. Our net comprehensive loss was 3 million or 2 cents on a basic and diluted per share basis for Q3 2022 compared to a net comprehensive loss of 2.2 million or one cent per share for comparable period of 2021. It is also important to note that during Q3 2022, operating expenses, operating loss, as well as EBITDA loss have been impacted by a non-cash expense related to the high devaluation of the Canadian dollar versus the U.S. currency. Without this extraordinary expense, the operating expense would have been approximately $200,000 less than Q3 of 2021. I will now turn the call back to Dr. Zerbe. Thanks, Anthony.
spk01: In closing, I'd like to once again recognize our team for executing on our long-term strategy. And with that, I will now turn the call over for questions. I'd like to remind you that our forward-looking statements apply to both our prepared remarks and the following QA. Thank you.
spk00: Thank you. Ladies and gentlemen, the floor is now open for questions. If you have any questions or comments, please press star 1 on your phone at this time. We ask that while posing your question, you please pick up your handset if listening on speakerphone to provide optimum sound quality. Please hold while we poll for questions. Once again, if you have any questions, please press star 1 on your phone at this time. As there appear to be no questions in the queue, I will hand it back to management for any closing comments they may have.
spk01: Thanks, operator. So this concludes our Q3 2022 investor update call. I would once again like to thank the entire intergenics team for its hard work and dedication, our board of directors for the continued support of the management team, and finally, our investors for continuing to believe in and supporting us. Thank you and goodbye.
spk00: Thank you, ladies and gentlemen. This does conclude today's conference call. You may disconnect your lines at this time and have a wonderful day, and we thank you for your participation.
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