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IGXT Q2 2020 Earnings Call Transcript

Operator: Ladies and gentlemen, thank you for standing by, and welcome to IntelGenx Reports Second Quarter 2020 Financial Results. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to Stephen Kilmer, Investor Relations. Thank you. Please go ahead.

Stephen Kilmer: Thank you. Good afternoon, everyone, and thank you for joining us on today's call. With me on the line are Dr. Horst Zerbe, IntelGenx's CEO; and André Godin, our President and CFO. Before we begin, I would like to remind you that all amounts mentioned today are in U.S. dollars, unless otherwise mentioned, 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 as may be required by U.S. and Canadian Securities 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 U.S. and Canadian Securities Commissions. I would like to now turn the call over to Dr. Zerbe. Horst?

Horst Zerbe: Thank you, Steve. Good afternoon, everyone, and thank you for joining us for the IntelGenx second quarter 2020 conference call. On today's call, I will provide a corporate update and discuss the progress we've made on our key pipeline projects. Following that, Andre will review our Q2 2020 financial results. Then we will open up the line for your questions. Let me start with RIZAPORT. On June 10, we attended a Type A meeting with the FDA, during which we obtained clarity on the chemistry, manufacturing, and controls inflammation. They are required for the resubmission of our RIZAPORT NDA. The meeting was very productive, and we were pleased with the outcome. We are now looking forward to completing the work required to resubmit our NDA, and remain committed to making this innovative new oral film product available to people who suffer [Technical Difficulty]. With respect to our plans for organization outside of the U.S., in order to accelerate the launch in Spain, we have agreed with Exeltis Healthcare to continue commercial production at the originally listed contract manufacturing organization in Germany, rather than at our manufacturing facility in Canada, which would require a time-consuming site change on the German side to our manufacturing site in Montreal. While manufacturing for the U.S. and certain other markets will continue to be performed at our Montreal production facility, keeping commercial production in Europe will result in an earlier product launch in Spain, and potentially other European countries. Our partner, Exeltis, has a strong interest in commercialization rights for all European countries. The parties have been in negotiation for some time, and expect to be in a position to announce an agreement shortly. Moving on now to Tadalafil. On April 30, Aquestive received feedback from the FDA regarding the protocol design of the irritation study that FDA had requested in the CRO. This study will be jointly conducted by Aquestive and IntelGenx. We'll now discuss the FDA's recommendations. We are comfortable to [Technical Difficulty] not major and will not have any significant impact on the study design. We will be updating the protocol, evaluate some of the requested changes with the CRO, and revise the protocol. Once the protocol is finalized by both IntelGenx and Aquestive, we will be sending the protocol to the FDA for final approval, which should take about four to six weeks, and because of this, at this moment, we do not have a concrete timeline as to when we will start to study. The CRO, however, is ready to go, and will start the study as soon as we have the green light from FDA. In addition, both companies are evaluating several term sheets that we received for licensing Tadalafil for the U.S. and other territories. Now, moving on to cannabis-infused films. In June, we achieved a significant milestone with the receipt of a cannabis micro-processing license from Health Canada, which allows for commercial production of cannabis-infused films at our Montreal, Quebec facility. Subsequent to quarter end, we amended the exclusivity terms of our license development and supply agreement with Tilray to allow us to co-develop and commercialize CBD products with additional partners. While we continue to work with Tilray to align on the timing of a potential commercial launch of our first co-developed cannabis-infused film product, we are now in active discussions with other potential partners to commercialize CBD [Technical Difficulty]. Now Montelukast, the BUENA study remains on a temporary recruitment hold, as the target study population is considered to be a high-risk group for severe illness from COVID-19. We are closely monitoring the situation and will resume enrollment under our amended protocol as soon as practical. In the meantime, we will continue to evaluate the trial's expansion to the United States via a potential IND filing with the FDA when it is appropriate. Moving on to animal health. During the first quarter, we entered the animal health space by signing a feasibility study agreement with a leading animal health industry player. The formulation development and are in the process of manufacturing a clinical batch for a clinical study in dogs, which is expected to commence in Q3. And now, a few words on the performance improvement program that we introduced on the previous call. [Technical Difficulty] of our team's dedication and perseverance, which resulted in the identification of two short-term revenue generating opportunities this quarter. The first is the use of our manufacturing facility's excess capacity to produce hand sanitizer products to help combat COVID-19 infections. In early June, Health Canada authorized the sale of our hand sanitizer product, both in liquid and gel formulations, assigning natural product numbers that permit product distribution to healthcare and commercial settings across Canada. I'm happy to report that we've just released the first commercial batch of gel hand sanitizers to the market. We have set up a transactional website that will allow consumers to directly order the product from us, and we have one sales person reaching out to customers and handling orders. We are preparing to begin product shipments in the third quarter of this year. Subsequent to quarter end, we entered into a feasibility agreement with Cybin for the developing film [ph] for the delivery of pharmaceutical grade psilocybin. This agreement is a testament to both the versatility and clinical analysis of our VersaFilm platform. In addition to offering a convenient method of administration, the technology offers superior drug bioavailability, which decreases both the amount of active pharmaceutical ingredients required for dose, as well as time to onset of action. We are looking forward to working with Cybin to realize these potential benefits for patients suffering with mental health disorders. We will continue to pursue creating opportunities, targeting products that do not require regulatory approval. In addition, we will continue to focus on partnering our current product pipeline, which includes 10 pharmaceutical or film product candidates, as well as pursuing additional oral thin film manufacturing opportunities. With that, I would now like to turn the call over to our President and CFO, André Godin, who will review our financial results. Andre?

André Godin: Thanks, Horst. So for the second quarter, total revenue amounted to $42,000, compared to $197,000 in the same period last year. The decrease was mainly attributable to a decrease in R&D revenue, $455,000. Operating costs and expenses were $1.8 million for Q2 2020 versus $2.5 million for the corresponding three-month period of 2019. The decrease is mainly attributable to $580,000 decrease in R&D expenses and $165,000 decrease in selling, general, and administration expenses compared to the same period last year. For Q2 2020, the Company had an operating loss of $1.8 million, compared to an operating loss of $2.3 million for the comparable period of 2019. Adjusted EBITDA was negative $1.5 million for Q2 2020, compared to negative $2.1 million for the same period of last year. Net comprehensive loss was $1.3 million or $0.01 on a basic and diluted per share basis for Q2 2020, compared to a net comprehensive loss of $2.5 million or $0.03 per share for the comparable period of 2019. As at June 30, 2020, the Company's cash and short-term investment totaled $3.1 million, compared to $4.4 million as at March 31, 2020. Finally, following approval at the June 2020 meeting of the debenture holder, the maturity date of our CAD7.6 million convertible unsecured subordinated debenture was extended from June 30, 2020 to June 30, 2022. The conversion price was reduced from CAD1.35 to CAD0.50, and the coupon remained at 8% for the [indiscernible]. I will now turn the call back to Dr. Zerbe to conclude our remarks.

Horst Zerbe: Thanks, Andre. In closing, we've made important progress since introducing our performance improvement program last quarter, and I'm pleased by our teams to basically to execute on this new strategy, particularly with their identification of two short-term revenue generating opportunities this quarter. As we continue to execute on our performance improvement program, we believe that the recent receipt of our Health Canada cannabis micro-processing license well positions IntelGenx to pursue additional commercial partners for our CBD-containing film products. I will now turn the call over for questions. I would like to remind you that our forward-looking statements apply to both our prepared remarks and the following Q&A. Thank you.

Operator: [Operator Instructions] Our first question comes from the line of Eric Hurst [ph]. Your line is open.

Unidentified Analyst: Hello, thank you very much. Hello, Dr. Zerbe. I'm a private shareholder, and you didn't mention anything about the Tilray progress. I mean, by your comments, it sounds like there is a lack of alignment on how to move forward. But I was wondering if you could shed some more light on that. You provided the last call, a very short timeline after receiving the micro-processing license, so I'd love to hear about that.

Horst Zerbe: Yes. And that's a perfectly understandable question, and thank you for that question. I have to admit we were very surprised by Tilray's decision and response immediately after we received the micro-processing license, that they had decided not to [Technical Difficulty] with the launch of the product, which had been fully developed and was really ready for launch. We were, as I said before, completely surprised by that. So following that, we entered into quite intense negotiations with Tilray because we didn't quite accept that in a product like the CBD film, the first CBD film on the Canadian market, would be delayed or withheld. So we negotiated with Tilray an arrangement, under which their exclusivity was converted into a non-exclusivity, which enabled us and allowed us to enter into discussions with additional cannabis companies. Without being able, hopefully understandably, to disclose any details. But I can say that discussions are very well underway. We have identified product opportunities with at least two companies. We are discussing well contractual arrangements, and the expectation is that product launch could happen probably in late Q4. But I do not want to commit to that because I'm not fully in control of that. What I can say qualitatively is that discussions with potential alternative partners are progressing very well. I hope that answers your question.

Unidentified Analyst: Thank you very much. One follow-up question. The hand sanitizer business. Are you able to shed any light on how close that business could come to covering the fixed costs?

Horst Zerbe: I think Andre is better prepared to respond to that. He oversees that program.

André Godin: Yes. So it is more like a test program that we've started, that we've initiated. We're happy to report that we will be shipping our first orders next week, and it will depend on the demand. Obviously, it is difficult to say at this time because we have a few orders coming from small businesses. And we will have our transactional website up and running next week. So it will depend on to demand. So if the demand is there, we expect this product to generate some revenues. But in order to cover burn rate, I think that we have a long way to go. I mean, it is something that we would like this product to contribute to reducing burn rate, but time will tell how much of that product can help cover them.

Unidentified Analyst: Thank you very much. I'm hanging in there and looking forward to seeing the results as they come in the coming months.

Horst Zerbe: Thank you for the call.

Operator: [Operator Instructions] Your next question comes from Stephen Silman, Investor. Your line is open.

Stephen Silman: Hi. Can you hear me? I'm speaking on a cell phone from the U.K.

Horst Zerbe: Yes, yes, we can hear you.

Stephen Silman: My question to you - well, I have two questions. The first is a follow-up on question I raised last time, which has to do with corporate governance. I suggested to you that the time has come for the positions of Chairman and CEO to be separated. I think you said that is something that is under consideration, but there were no imminent plans. I really do feel that it's quite inappropriate for Dr. Zerbe to be both Chairman and Chief Executive. The impression I get is that we have this Company Board is that really is quite super that doesn't do anything. You must remember that the function-- the Chief Executive is accountable to the Board and the Board is accountable to the shareholders, and we get nothing from the Board We get no sense that the Board is as disturbed by the failure of this Company to generate revenues year, after year, after year and [indiscernible] an absolutely classic example of the problem. You're throwing around the balls in the air. We've got animals. We've got a hand sanitizer. We seem to have no strategy. Just desperate tactics to try and raise revenue, and you're spread far too thin. It doesn't sound as though any of your projects are liable to make the Company cash flow positive before we run out of cash. And I am deeply, deeply concerned by the performance of both the executive and the Board, and I think something needs to be done about it, and I would welcome your comments.

Horst Zerbe: I mean, that's directed to me. It's Zerbe speaking. You are certainly entitled to your opinion as far as your corporate governance comments are concerned. The restructure, first of all, is not all that uncommon. Secondly, it's captured in our bylaws. It's all - there's support, legal support. And finally, with respect to your comment about the Board doing nothing I don't want to comment a lot on that, but the Board is in fact very active and certainly meeting its fiduciary responsibility with this [Technical Difficulty]. In terms of what you perceive as an apparent conflict, whenever a potential conflict comes up, I step down, and the Vice Chair steps up, and so we are fully within our - we're fully legal. And it's, like I said, supported by our bylaws. With respect to your comments on product and project progress, let me put it this way. I'm not claiming that we're doing everything right. We have made mistakes. We admit to that. What I can tell you is that we realize that we are in a serious situation. We have identified the areas of weakness, and we are working extremely hard. When I say we, I mean management with support of the Board. We're working extremely hard on eliminating or rectifying those. And as far as project progress, we are making progress, as I just reported. For example on RIZAPORT, the launch in Spain is imminent. I haven't mentioned that we just finished, successfully completed the manufacturing of submission batches for a first to file opportunity for our partner to handle [ph] in the interest of saving time. So like I said, you are entitled to the opportunity. But I think a few comments were necessary to state our position relative to these opinions.

Operator: Ladies and gentlemen, this does conclude the Q&A period, and I'll turn it back over to you, Dr. Zerbe, for any closing remarks.

Horst Zerbe: Thank you, and thanks again to everybody staying loyal and supportive with IntelGenx. And last but certainly not least, I'd like to thank our staff here and our Board for continued support. So thank you, everybody.

Operator: Ladies and gentlemen, this concludes today's conference call. Thank you for your participation, and you may now disconnect.