Jaguar Health, Inc.
Q1 2021 Earnings Call Transcript

Published: 17 May 2021

[Operator:]

Good day and welcome to the Jaguar Health Investor Webcast. Today's conference is being recorded. Before I turn the call over to management, I'd like to remind you that management may make forward-looking statements relating to such matters as continued growth prospects for the company, uncertainties regarding market acceptance of product, the impact of competitive products and pricing, industry trends and product and technology initiatives including products in the development stage, which may not achieve scientific objectives or meet stringent regulatory requirements. Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those contemplated in such forward-looking statements. These statements are based on currently available information and management's current assumptions, expectations and projections about future events. While management believes that its assumptions, expectations and projections are reasonable in view of current available information, you are cautioned not to place undue reliance on these forward-looking statements.

[Lisa Conte:]

Thank you. Thank you for that, for those statements. And thank you all for joining our webcast today. My name is Lisa Conte and I'm the founder and the CEO of Jaguar Health and our wholly owned subsidiary in the United States Napo Pharmaceuticals and I'm so pleased to add I am also a director of our new Italian subsidiary, Napo EU. Today we will update stakeholders on progress of Napo EU's proposed business combination with Dragon SPAC, the progress of our ongoing Phase III trial in cancer therapy related diarrhea and of course the financial performance of the commercialization of Mytesi in the quarter of 2021 specifically in comparison to last year, the first quarter of 2020. We're going to start with the key financial results for the first quarter of 2021 which will be provided by Carol Lizak, Jaguar's Chief Financial Officer. Before we jump in, I'd like to let all of you participating today know that we will have a brief Q&A segment at the end of the webcast to address questions if any submitted in writing. Questions can be submitted via the webcast link for today's event that appears on the events and presentations page in the Investor Relations section of Jaguar's website. The URL for Jaguar's website is jaguar.health. Okay, we’ll now move along and start with the key financial results for the first quarter of 2021. And I'm going to turn it over to Carol Lizak. You're on Carol.

[Carol Lizak:]

Well, thank you, Lisa. And thank you all for joining our webcast today. Key financial highlights for the quarter ended March 31, 2021 are as follows. Mytesi net sales during the first quarter of 2021 were approximately $1.2 million and $0.9 million in the first quarter of 2020. This first quarter 2021 results represents an increase of approximately 43% of the same period in 2020 or an increase of $0.3 million quarter-over-quarter. Mytesi gross sales during the quarter, the first quarter of 2021 were approximately $4.6 million and $1.3 million in the first quarter of 2020. This first quarter of 2021 results represents an increase of approximately 250% of the same period in 2020 or an increase of $3.3 million quarter-over-quarter. Total Mytesi unit sales volume increased by approximately 6% in the first quarter of 2021 over the first quarter of 2020. U.S. prescriptions for Mytesi decreased slightly by 2% in the first quarter of 2021 as compared to the first quarter of 2020. Prescription volume is the best estimate of patient demand while unit sales volume may reflect varying buying patterns among wholesalers as they manage their inventory levels. This can result in differences between these two metrics. The company believes the COVID-19 pandemic played a role in the slight decline in prescription volume with the pandemic resulting in fewer patient visits to their healthcare providers and subsequently fewer opportunities to diagnose new Mytesi patients. This is consistent with overall pharmaceutical industry performance that showed a negative growth in total U.S. prescriptions for all drugs and decreases in new to brand prescriptions. Additionally, pandemic necessitated travel restrictions negatively impacted the ability of the company's sales personnel to promote Mytesi to physicians in the first quarter of 2021. For the first quarter of 2021. The loss from operations was $8.8 million, compared to a loss of $7.7 million in the first quarter of 2020, a loss increase of 15% or $1.1 million quarter-over-quarter. The net loss for the first quarter of 2021 was $12 million, compared to a net loss of $7.9 million in the first quarter of 2020 a 51.3% or approximately $4.1 million increase quarter-over-quarter. In addition to the loss from operations, interest expense increased by $1.7 million from $199,000 in the three months ended March 31, 2020 to $1.9 million for the same period in 2021 primarily due to interest expense incurred on royalty interest agreements and exchange note two.

[Lisa Conte:]

Thanks Carol. Okay, I'm now going to move to Napo EU which is the name target of Dragon SPAC and I'm happy to announce that Dragon SPAC like Jaguar subsidiary Napo EU has recently been successfully incorporated in Italy and has brought on two remarkable board members. The process of incorporating Dragon SPAC to Dragon SPAC's founding sponsor Josh Mailman a little longer than hoped a lot longer than hoped due to factors such as pandemic necessitated administrative and government office closures and delays. The same issues we faced in the timing to get Napo EU incorporated in Italy. Josh has indicated that he expects the financing of Dragon SPAC with Napo EU as the name target for merger to be completed by the end of June, 2021. We too are confident of that timing. We are both being advised by global and Italian banks and expect to hold another joint communication this month introducing the board members, drug development updates and of course the key business activities. I know this feels long. I received the investor messages. So let me say that again. Josh has indicated that he expects the financing of Dragon SPAC with Napo EU as the target for merger to be completed by the end of June 2021 this year and we too are confident of that timing. In the meantime, the crofelemer drug development for the European marketplace for COVID related diarrhea is moving with deliberate speed being funded now by the parent corporation and targeting an accelerated regulatory pathway, conditional marketing authorization by the EMA, the European Medicines Agency, which is the European FDA for COVID related diarrhea. The early life provides an interesting analogy. I'm sure you've all heard of the 17 year emergence of the cicadas, it made me think what was Napo pharmaceuticals doing 17 years ago. It looked back and at that time we were creating the manufacturing process and transferring that technology, the manufacturing process for Crofelemer to India. That is currently part of the approval for Mytesi. That's quite interesting. Most people don't realize that the two most common reasons that new drug applications fail are because of safety in manufacturing issues.

[Carol Lizak:]

140 million additional shares.

[Lisa Conte:]

140 million. Thank you. So we currently have 150 million shares that are authorized, almost all those are utilized on a fully diluted basis. So 140 million which is not an indication that we're using that number, it's just to have it done. And so we don't have to come back and do this in any foreseeable future. As I said, shares are important as a commercial organization with one product. Of course, we're always on the outlook for business development activities. And there are some business development activities, for example, that are it's more valuable, in our opinion for the shareholders to utilize shares rather than to use cash, for example. So the company really needs to have additional shares to operate and the number as I said it's just so that we don't have to be coming back and doing this in the next five years or so. Okay. Do we have any additional pharmaceuticals in the pipeline? So our philosophy for drug development is risk mitigation. So drug development in pharmaceutical industries is risk based pharmaceutical development is exactly what it says it's risky. And as I mentioned, for Mytesi for Crofelemer, we already have two of the most important issues, two of the most risky issues when you file a new drug application addressed, which is safety and in particular chronic safety and commercial manufacturing. And so what we do with our six or seven, follow on indications is take as much risk out of the pipeline as possible. How do we do that? What's left is to achieve pivotal trial results that shows that the product works to the statistical satisfaction of the FDA. So we meet with the FDA and spend the time. This is not a rapid process and spend the time to gain their agreement on patient enrollment criteria on trial design on endpoint definition on the statistics that will be used for the endpoint definition. We have well over a dozen studies published studies with Crofelemer. So we understand what is the endpoint, what is the powering that is necessary, that shows that the product works into the satisfaction of the FDA. And we don't want to compromise on that experience and that knowledge in our trial design. So for example, for cancer therapy related diarrhea, we spent close to two years working with the FDA to come up with a design and a common vision of design and endpoint definition of statistics that we feel A, mirrors the successful design that we had in our pivotal trial for the HIV the approved indication. And B, will in fact be successful. And C, will in fact, allow not only for enrollment for the trials. So you don't want to have criteria that limits the enrollment of the trial because it's so strict but also therefore will support the label that will allow for broad utilization by as many patients as possible that can benefit. So for example, the cancer study well we expect to have final results that's a long study it’s about 240 something patients by the end of second half of 2022. And that's taking into account a bit of a slow up that has occurred during the pandemic when there were certain sites that were managing COVID and we’re not able to open up and sign on for clinical trials which is changing right now. Okay. Another question. How is the employment of Napo EU managed? Napo EU is currently searching for three key positions, Managing Director essentially a business head president, head of Napo EU, a Chief Medical Officer and head of regulatory. So we'll be there in Europe will be there in Italy employed there. At this time, there is a signed management service agreement with key personnel from Napo pharmaceuticals. So Napo EU is progressing or I should say the COVID indication, as I indicated in my comments is progressing. It is not slowed up in any way based on support from Napo pharmaceuticals Jaguar Health a parent corporation here in the United States and that's adding value to Napo EU. So Napo EU is continuing to gain in value as it is the name target of Dragons SPAC. Okay, is there any update on the NEOMED? So the NEOMED is the nominating advisor is basically the investment -- sort of between an investment bank and a governance body, when you list publicly on the aim exchange in Italy. And so we will, as I said we expect to have a joint, especially in a joint announcement as we did in the past with Josh Mailman and at that point, we expect to be naming the organizations that we're working with. So there are details of engagement letters, etc that need to be worked out. And then we'll be naming the banks that we're working with. What is the status of emergency authorization with Long-Hauler? And is it granted only upon Nepo EU IPO? So the drug development process with the EMA, which is the equivalent of in Europe, of the, in the European Union of the FDA here in the United States is unrelated in, it's unrelated to the Napo EU IPO. So that, as I said is progressing, we have met with an European regulatory agency. We have agreement on a COVID related patient populations, more the acute infected that qualifies for conditional approval. And we've been asked to provide a protocol synopsis which we have provided and waiting for response on that. And in the meantime, preparing to initiate the clinical trial. In Europe, we've already identified the CRO, the Clinical Research Organization that we will be working with and that is moving forward. So there is nothing that is slowed up. And as I said, this is a pathway, drug development pathway that is unrelated to the IPO or this fact financing or the merger with Napo EU. And my other message was a congratulations on the financial metrics. That's nice. And I think those are all the questions. So Peter, did I miss any?

[Peter Hodge:]

I wish I believe all the questions that we can address have been addressed.

[Lisa Conte:]

Okay. Well, thank you everyone who listened in. Thank you everyone who participated. Thank you for your support of Jaguar Napo Pharmaceuticals and Napo EU in Europe. We are energized. So I'm glad we did this early. We have a full day ahead of us. So best to all of you be healthy, be safe. And we'll talk. We'll have another session in the next couple of weeks as I mentioned. Thank you.

[Carol Lizak:]

Thank you.

[Operator:]