Good day and welcome to the Jaguar Health Company Updates Conference Call. Today's conference is being recorded. At this time, I'd like to turn the conference over to [indiscernible]. Please go ahead, sir.

Thank you, Simon. 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 products, the impacts 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 subjects 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 current assumptions, expectations and projections about future events. While management believes that it’s a function of expectations and projections are reasonable in view of currently available information, you are cautioned not to place undue reliance on these forward-looking statements. The company's actual results may differ materially from those discussed in this call for a variety of reasons including those described in the forward-looking statements and Risk Factors sections of the company's Form 10-K for the year ending December 31, 2017, which was filed April 9, 2018 and its other filings with the SEC which are available on the Investor relations section of Jaguar's website. Except as required by law, Jaguar Health undertakes no obligation to update or revise any forward-looking statements contained in this presentation to reflect new information, future events or otherwise. After the prepared remarks, we will be opening the call to a question-and-answer period. On the call today, we have Lisa Conte, President and Chief Executive Officer; Karen Wright, Chief Financial Officer and Treasurer; Dr. Steven King, Executive Vice President, Sustainable Supply, Ethnobotanical Research and Intellectual Property; Dr. Pravin Chaturvedi, Chief Scientific Officer and Chair of Napo Scientific Advisory Board and Robert Griffing, Chief Commercialization Officer. At this time, it's my pleasure to turn the call over to Lisa Conte, President and Chief Executive Officer of Jaguar Health. Lisa, the floor is yours.

Thanks a lot, [indiscernible]. Thank you all for joining us. I appreciate this opportunity to update the Jaguar Health Napo Pharmaceuticals community today. To clarify, Napo is a wholly-owned subsidiary of Jaguar and I therefore may use the terms Jaguar, Napo and the company interchangeably during my comments on this call. We had the extraordinary opportunity to be commercializing and when I say commercializing, I mean Napo reps directly marketing and selling. Our first in class FDA approved anti-secretory, anti-diarrheal agent, crofelemer, trade name Mytesi for a specialty market in people living with HIV AIDS. Our near term focus is to become a stable cash flow positive business, supported primarily by growth in Mytesi sales for its current approved indications. Longer term, we have a remarkable risk mitigated product crofelemer is our pipeline within a product. Crofelemer is the source of multiple novel important potential follow-on indications for an FDA approved drug, Mytesi, approved for chronic indications and therefore supported by a chronic safety package, with GMP commercial manufacturing in place and proof of concept clinical data for most of the follow-on indications. The depths of the pipeline provide supportive care solutions for large patient populations across multiple disease indications, it will fuel long-term value creation for investors and it provides non-dilutive funding opportunities for partner collaborations around the globe. In addition to informing you this morning about our financial and operational progress, a key goal of today's call is to share with you what makes Mytesi a unique treatment option. Dr. Pravin Chaturvedi, our Chief Scientific Officer and the Chair of Napo Scientific Advisory Board who designed the successful pivotal program that resulted in Mytesi’s FDA approval will shortly provide more background on Mytesi’s novel mechanism of action and broad application across multiple conditions. Moving on to review our…

Thank you, Lisa. Good morning, everybody. I'm Pravin Chaturvedi. I’ll talk about mechanism of action for crofelemer. So crofelemer is a novel and first in class, which means first in kind drug approved by the FDA to provide symptomatic relief of non-infectious diarrhea in people living with HIV and AIDS that receive anti-retroviral therapy. It is actually the first anti-diarrheal drug that was approved by the FDA, because it is not a constipating agent and it does not alter any normal gut habits. Just so you know, the other drugs from the past that have been grandfathered for the treatment of diarrhea are from the opiate family and they cause constipation. Examples that you would be familiar with are Imodium, over-the-counter drug, which has a generic name Loperamide [indiscernible] which are available by prescription only. These agents are actually referred to as anti-motility agents, because they reduce gut motility and resulting constipation and that's how they produce a reduction in bowel movement, but they do not affect diarrhea itself. Furthermore, these drugs, these anti-motility agents are approved for acute use, which is less than 3 days and are not indicated for chronic diarrhea and they pose various clinical risks for the patients with chronic usage. The anti-motility drugs do not address the physiological cause of diarrhea, the physiological cause, the loss of electrolytes and fluids and by not ameliorating diarrhea, they simply reduce the bowel movements and cause constipation. The consequences of constipation include abdominal pain, distension and bloating and many patients get rebound diarrhea from the breakthrough to gut motility changes. For explanation, diarrhea of the clinical condition, which is defined as the passage of unformed watery bowel movements. Even the passage of one watery bowel movement constitutes diarrhea and there is risk for significant electrolyte and fluid loss…

At this point, we will open up to Q&A. [indiscernible], can I turn it over to you to monitor that please?

Sure. Thank you very much, Lisa and Pravin. So Simon, please queue for questions and answer.

[Operator Instructions] We’ll now take our first question from Jason Kolbert from H.C. Wainwright.

Thank you for the very comprehensive update. I'd like to start with a couple of financial questions. So maybe Karen can help out. Can you, Karen, can you just let me know for housekeeping purposes, what is the current share count, what's the fully diluted share count, what's the cash balance remaining at the company today?

The total common and preferred stock outstanding is 30,279,809. Of that, we have common stock voting shares 24,278,104. We have non-convertible non-voting common stock of 2,686,749 and preferred stock as converted 3,314,956.

Okay. And the cash balance, Karen?

Our cash balance is, as will be reported in the Q, I can't give that out yet. We have not issued that. But I can tell you it’s approximately -- that we raised the 9 million October 4 and our net proceeds of that were 7.2 million.

And I see that the Q was delayed. When can we expect the Q to file?

The Q has been approved by our auditors. They were doing a final national review of a debt extinguishment analysis that we did that was fairly complicated. So that should be filed within the next day or two.

Okay. Let me just go through a few other things. Lisa, can you talk a little bit about how we should be dealing with the gross Mytesi sales versus net and you did talk a little bit about what some of the adjustments are. On a going forward basis, how should we be looking at those adjustments? And I know it's early to talk about guidance, but do you have any kind of thoughts about what the guidance would look like in HIV for 2019? And can you talk a little bit about what the contribution was from RedHill in terms of the percent of revenues that are recorded?

Thanks for being on the call. I'll answer the questions I can here. So, we're not giving out guidance for 2019 at this time, but I can say we are getting more confidence in the track record in there for predicting the future with more certainty, since we have had a full commercialization on board now for a little over six months or about six months. So, look at the growth that we’ve had quarter-on-quarter, look at the growth that we’ll continue to have based on what we've seen in October and you can start to connect dots where we think we'll end up in 2019. RedHill, it’s very early because you get your data about a month late. So we have two months of data on RedHill, but they couldn't be more enthusiastic and encouraged and there is growth. So again since I'm not giving out guidance, I can't say where I think they’ll contribute, but it is meaningful enough that we would fully expect to continue with them in 2019. As far as the mix, I may have vowed here a comment. As we get on more ADAP formularies, which is very important because it's a large number of the HIV patients, insurance of last resort. ADAP 340B, we get hit with pretty high discounts from gross to net, yet, we're increasing our prescriptions, we're increasing the noise, the awareness, the utilization in the patient population. So our gross to net OCR -- our net to gross has been decreasing. We think that the right way – we’re having more discounts, has to go forward.

Yes. As we add additional ADAP and meet the needs of the HIV patients, we are increasing our charge docs and discounts, meeting the population needs.

Rob, do you want to comment on mix that you see going forward?

Sure. I think you've addressed it nicely. Jason, nice to meet you over the phone here. What we currently see and this comes from decision resource group and there hasn't been much change in the mix, but as Lisa mentioned, as we see additional states come on board, some of the bigger ones that were mentioned like New York and hopefully Florida in the coming weeks, there will be -- we expect a little bit of a shift, but right now, it's been about 38% of our business is commercially insured and 60% are your government programs, such as Medicaid, Medicare, ADAP and we do expect that to stay fairly consistent, some minor tweaks going forward, as I said, because of the additional states that are putting it on formulary for ADAP.

And Lisa, can you talk a little bit in terms of your experience with the docs, how many -- what percentage of those revenues represent new doctors, first time prescriptions versus repeat or refills business? Are you seeing refill starting to pick up?

I'm going to pass that one over to Bob as well, because he’s data at his fingertips.

Yeah. So really good question. We are seeing additional doctors prescribe. In fact, one of the metrics we look at is the breadth and depth of prescribing, not only month over month, but quarter over quarter and we are seeing very strong growth in those that are prescribing two or more prescriptions, but we're also -- so that's your depth of prescribing. We're also seeing the breadth in terms of just those first time prescribe that have prescribed one prescription. So we're very encouraged, which tells us that our representatives are in fact being affected and one of the new metrics that we just started to receive data on is the Nuta [ph] brand and Jason, I'm not sure how familiar you are with the Nuta brand versus new RX, but Nuta where IQVIA breaks it out are those patients that are actually first time prescribed your brand as opposed to a new RX which could be a patient who receives a prescription, they may take a drug holiday or once they're 3 or 4 refills, whatever the number is expires they have to get a new piece of paper and that's counted as a new RX, but it isn't necessarily a new patient. So looking at Nuta brand share, we're actually seeing the ratio of NBRX to TRX, about 21%. And that's twice the rate of what IQVIA expects for a chronic brand like Mytesi. They see an average of 10%. So we're coming in around 21%, which is a really nice positive that physicians are better identifying patients within their practice that are continuing to suffer with diarrhea.

And Lisa, last, can we talk a little bit about catalysts and I'd like to talk about the CTD investigator driven studies, the HALT-D study and the UCSF study and can you tell me a little bit about when I might see data coming from those events and/or the start of the second trial?

Sure. So for cancer related diarrhea, what you just mentioned to everybody else on the phone, HALT is the investigator initiated trial that is being funded by Genentech Roche. They are just about at interim number of patients enrolled, so they have to be treated for a couple of months. So we’re quite confident that that interim results will be read out in the first half of 2019. So we're just around the corner from that. The UCSF study has just started enrolling, so I don't even know if they have their first patient in yet. There are potentially going to be some modifications to that protocol, which will be even more important for crofelemer treatment and that is the study that is being funded by Puma with neratinib and adjuvant therapy. Neither of those trials, let’s make it clear, neither of those trials is going to be a pivotal trial that will give us the indication in cancer related diarrhea, but it does give us experience in this patient population and awareness in the physician, in the treating community, in the cancer community. So the pivotal trial that we're targeting is the basis of the discussion with the FDA literally now. Within the next month or two, we'll have that discussion. We've already filed for that. Actually starting that trial will require at this point pulling in funding from a non-dilutive source. So, as you know, we have been working on corporate partnering activities. We did pull off first one before the end of the year. That's not sufficient funding for us to be able to start the cancer trial. So once we have that funding in place, we'll be able to start that trial, but we are moving -- we're not moving any time here, because to have the greatest probability of success of a clinical trial, particularly, a pivotal program, you want to have met with KOLs, you want to be realistic and practical about enrollment criteria endpoint definition. Put that in front of the FDA to the extent that it's necessary or useful to get a spot agreement, we want to do that. So get as much regulatory risk out of the way, those early implementations out of the way, so when that funding comes in, we’re immediately hitting the ground to start the clinical trials. And we're not only doing any cancer related diabetes, but we're moving down the pipeline one by one, getting ready to go into clinical the trials when we have something to do so.

[Operator Instructions] We'll now take our next question from Jon Glaser from JMP Capital.

A question, you referred to the month of October briefly, can you just tell us about the trends in the last time or relative to the same trajectory as in the months before? And then with regard to RedHill, if you were to sort of guestimate 6 to 9 months from now, what percentage of your sales might be coming from RedHill’s sales force versus your own?

So the first question and you were just low for a little bit. I didn't quite hear the first question. I'm sorry.

I'm sorry. You’ve briefly mentioned the month of October. Can you confirm that the trends in October are basically on the same trajectory as you saw in the months before?

I definitely can confirm that and you can plot out the numbers that we gave you. So, yeah, we are highly encouraged with the growth in October, the growth we're continuing to see. And as far as RedHill, I don't want to put any numbers or expectations out there for RedHill. It's early. As I said, we only have two months of data for them. So we know how long it took us to feel confident in our own forecasting and projections from our sales force. And part of that is because, they're, for the most part, in a different medical discipline. So we're dealing with, for the most part, with the infectious disease docs to high decile, the high prescribing anti-retroviral diarrheal docs. So their patient population is HIV patients and our challenge is start talking about diarrhea and I think you've heard me say, it can be 6, 7, 8 details before you get the physician to start talking about diarrhea in their patient population and then the floodgates do open. So there, right now, we have two months experience with them in a GI office where there is a meaningful population of HIV. So it's on label to target them, but that by no means is the majority of their patients. So we have to learn what it’s taking to get the prescriptions to happen there, before we have confidence about projecting and forecasting what they may be able to do. And that's the primary reason for holding back on this point. But I can tell you, they -- in two months, it went up. They grew.

We’ll now take our next question from Ed Jeffrey [ph] from Aegis Capital.

I think you just touched on this, but I just wanted to clarify, so I have an understanding of your funding going forward. You have a lot going on, how are your funding partnerships, cash on hand, all your activities going forward.

Our clinical activities for the pipeline, going into clinical trials, we would expect to fund from non-dilutive sources from corporate partnering. So that is to come in, as an example, we've said, our Knight partnership, that's about 3% of the global marketplace in Canada and Israel and we saw how meaningful that was. So as we get to larger populations of the global partnership, in the corporate partnerships that we are pursuing, we would expect to have sufficient non-dilutive dollars to pursue some of these clinical trials. We take a small portion of the funds that we just raised in the financing in October, about $1.5 million max, that is being devoted to the pipeline to get ready for this clinical trial. So as I discussed, all the preparatory activities with KOLs, protocol, regulatory activities, you have to do that anyway, so we're getting that, we have time now. We're getting those activities done and that mitigates the risk even further for a drug that's already approved now, taken as much as the regulatory and planning risk out of the way as possible. For Mytesi, the goal -- selling Mytesi right now for the chronic indication, the goal is to have a solid financial foundation. So we're selling and receiving revenue within our means. We're not sure if the current funding is going to allow us to get there and we are always looking at the same way we’ve funded ourselves historically. There's always an equity opportunity and equity line of credit now, because we do have revenue stream. We still have royalty opportunities. None of that is currently planned. What is planned is to get ourselves to a breakeven position from Mytesi and we do feel confident that we can project sales to plan for that purpose.

[Operator Instructions] It appears there are no further questions on the telephone at this time. I would like to turn the conference back over to our host for any additional or closing remarks.

Thank you all for the time this morning. We appreciate it and we're going to get back to work here. Our mantra here is Mytesi, Mytesi, Mytesi. So that's where we're going to march. I appreciate your interest in the story and the company.

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