Good day and welcome to the Jaguar Health Conference Call. Today's conference is being recorded. At this time, I'd like to turn the conference over to Steve Silver from KCSA Strategic Communications. Please go ahead sir..

Thank you. 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, industry trends and product and technology initiatives.

These statements are based on currently available information and management's current assumptions, expectations and projections about future events.

While management believes that assumptions, 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 in Risk Factor sections of the company's form 10K and its other filings with the SEC which are available on Jaguar's Investor Relations website 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..

Thank you, very much and thank you everybody who has called in and I apologize for this slight delay here. We are so pleased to be hosting our first financial update post the merger of Jaguar and Napo to now the combined company Jaguar Health.

This a transformative time for us with the commercial forward integration into the revenue stream from sales of Mytesi, our first in class FDA-approved anti-secretory, antidiarrheal agent with a specific indication for the symptomatic relief of noninfectious diarrhea in adult patients with HIV/AIDS on antiretroviral therapy.

By definition, this is a unique call, since there will only be one first post-merger update, therefore I want to address three distinct pieces of information with respect to commercial activity of Mytesi on this call.

The first is that our 10-Q, which will be filed in the next days, will represent commercial activity for Mytesi just from August and September of this year since the merger closed on July 31 of this year and the quarter end September 30.

However, on the call we will put that in perspective and indicate the sales of Mytesi up for your October 31 just two weeks ago. Second, we analyze our operations based on growth sales, growth sales are defined as an order placed from the wholesaler and product that moves out of our warehouse.

This is also the activity upon which we receive cash, which is important event. Growth sales are distinct from GAAP accounting net sales that we report in our 10-Q, which is the movement of product from the whole the wholesaler to retail include trade discounts, rebates etcetera.

So, for clarity, our warehouse 2 for example Cardinal that is growth sales, are aware for example that is growth cells that's where we get our cash. Cardinal 2 for example Walgreen that is where we record sales according to GAAP.

And finally Mytesi was able to benefit from meaningful spend on marketing, advertising, medical education, promotional activity after the merger and the direct sales force of seven reporting to a national sales director for just the last four weeks, since the second week of October of this year.

We want to be able to inform you on the benefit we're seeing already on Mytesi sales, which we believe is in part because our sales force has collectively over 40 years experience directly with HIV caregivers and they were able to have meaningful sessions with healthcare providers, the gatekeepers to writing a Mytesi prescription from their first day in the field with Mytesi, truly the definition of hitting the ground running.

In fact, this experience has been so impactful, we just decided to hire three more sales reps with the same HIV experience. They are in our office training today. They were here yesterday they will be out in the field next week. I would like to take a moment to share one anecdote related to me just yesterday by this new sales team.

They told me how refreshing it is to be representing our first-in-class agent, the only product currently approved by noninfectious diarrhea in adult HIV patients instead of the struggle to pitch healthcare providers on a competing antiretroviral therapy.

Diarrhea is a neglected comorbidity and a chronic problem in this patient population and for this reason, we're very fortunate that we have chronic safety data in place for Mytesi and an opportunity for monthly refill. Here are the two important numbers; the important takeaway for today.

Total Mytesi sales for 2017 through October 30, are $2.8 million and average monthly sales of Mytesi have increased 50% from August through October 30 of this year versus the first seven months of the year January through July.

Again, let me underscore, we just put a meaningful sales and marketing effort in plate post-merger in August and our direct sales reps just in place for three weeks in October and we're seeing that impact. With this momentum, I will pass the communication now to our National Sales Director, Pete Riojas and let his enthusiasm carry this call forward.

He will be followed by comments from our Cohead of Marketing, [Katie McFarland], the Chair of our Scientific Advisory Board and the Developer of Mytesi, Dr. Pravin Chaturvedi, who talk about the development of follow-on indications for Mytesi and we'll conclude with our CFO, Karen Wright, who will speak to the financials in the 10-Q we will file.

Thanks, and let me turn it over to Pete with great enthusiasm..

Thank you, Lisa and good afternoon, everyone. My name is Pete Riojas and I'm excited to be here. I bring 30 years of industry experience not only in sales, but marketing, operations and senior management.

I have a pharmacy background and really am excited to bring value to this organization and more specifically to this patient base in selling this quality product Mytesi.

Joining Napo Pharmaceuticals Jaguar Health on August 21 was truly exciting for me, bringing the 30 years of industry experience along with building a sales team I will provide value to Napo and Jaguar Health.

I was given the task to hire a team within a month, achieve that and how we've had seven reps in the field since the second week of October, I hired the five team members.

Three of them as was mentioned by Lisa have over 40 years of combined experience in the HIV arena as well as those three team members, the balance two, have a combined 17 years of experience in gastroenterology.

The team initially started calling on infectious disease physicians as well as family practitioners and general practitioner physicians seeing these HIV patients. The team has now expanded into gastroenterology to the impact the HIV community patient.

What was identified in gastroenterology along with these patients suffering from a condition that Mytesi, based on this immediate beneficial impact, we saw and I wanted to build the momentum that was requested by these three more team members, but more importantly having the ability to increase our sales force we were granted the ability to increase our team members by three.

That request was granted as well as effective as November 27 we will have 10 full-time territory managers in key markets to act, access impact our business effectively. The key markets we've identified are New York, Miami, Atlanta, St. Louis/Chicago, Houston, New Orleans, Philadelphia/Washington DC, Los Angeles and obviously here in San Francisco.

The mission statement of our sales force is, "working as a team, we strive to change people's lives by selling to healthcare professionals or HCP, the efficacy and safety of Mytesi". The primary goal is to meet and exceed our sales-goal outlined by our President and CEO.

In the deployment, we as a team have identified that customers, HCP have not been constantly or consistently called on by sales professionals about the safety and efficacy of Mytesi. We as a team are committed to bring value in delivering a quality selling message.

Applying our innovation through communication, by sharing best practices will allow our customers the ability to impact patient through value. Through our weekly conference call as a team, we discussed ways to access and deliver our selling message.

We continue to make tough decisions, which is necessary to impact patient lives by calling on the right physician with the right message frequently to impact our patient with confidence. Mytesi has never had a team with a true marketing message as well as the resources to sell this product.

Our campaign of enough is enough and the HIV-positive patient is what will make a difference. The team has also been provided with samples for trial by physicians to patient.

Last the team will also provide physician education programs to bring value and allow providers the ability to interact with other colleagues and discuss the safety and efficacy of Mytesi.

I'm really excited the passes over to Katie McFarland who discuss remarkable and effective supporting marketing and medical education activities that we and sales are able to access and collaborate with. Thank you for your time..

Thanks Steve. Okay Katie, off to you..

Okay. Thank you very much and like Pete, my name is Katie McFarland and like Pete I also am a pharmacist and we've now been working with Napo and Jaguar for little over a year since the reacquisition of Crofelemer by Napo.

My background, I have been in the pharmaceutical industry for over 25 years, 20 of that has been spent in marketing, primarily responsible for preapproval marketing as well as product launch and so I've been involved some very large product launches such as Lipitor and Celexa as well and specialty launches of Lectern 24 and we're very pleased now to be taking Mytesi through really what is the official Napo launch of the product for the treatment at HIV-related diarrhea.

So, I am pleased to share an overview of the marketing activity for Mytesi. This marketing activity is designed to raise awareness and usage of Mytesi through three major tactical plans.

Number one is to support our sales representatives and Pete's team with controlling materials that they can use when they're calling on kitty targets in their territories.

Two we're informing HIV specialists and other healthcare petitioners who see HIV patients in uncovered geography through nonpersonal promotion and three, identifying and activating people living with HIV, the patient who suffer from diarrhea to ask their patient for treatment of Mytesi.

So, in order to make all this come about and to develop the controlling materials for Mytesi, we've done extensive work to compile data to best communicate the effectiveness of Mytesi as well as the need for this product amongst HIV patients. We performed an analysis of the long-term data from the Advent trial.

This was submitted by the investigators as an abstract and presented this past July at the International Aids Society Meeting in Paris.

Among the highlights of the data presented, is the fact on Mytesi therapy, over 75% of patients had at least a 50% reduction in their diarrhea episodes and over 50% of patients had complete resolution of their diarrhea. This data has become the backbone of our Mytesi promotion.

In our market research, we've consistently identified gaps that exist in the perception of the problem of diarrhea and HIV. The clinicians basically split into two camps.

Those who say diarrhea isn't a problem in HIV anymore and the exact opposite, which are those who tell us if doctors tell you there is no more diarrhea, they're not answering their patients.

In contrast to the doctor we have significant numbers of patients who report having a problem with diarrhea and many tell us stories of having brought this up with their physician throughout the years and either being told while you shouldn’t diarrhea or diarrhea in just the fact of life with HIV.

Over time many patients have just given up asking their doctor because they presume there is nothing they can offer them. So, it's these gaps that we're striving to close with our promotion of Mytesi. The data are compelling.

Recent publications from major HIV clinics around the country and this in the United States report a prevalence of diarrhea between 19% and 24% in HIV patients.

Of these patients, who experienced diarrhea, three quarters of them report that it is bothersome or very bothersome and additionally, HIV patients sometimes stop taking their antiretroviral therapy without telling their doctor and diarrhea is the number one reason they state for doing so.

So, the comprehensive marketing program we've launched, post the merger of Napo with Jaguar is intended to address the fact that we've uncovered since Napo regained the rights to Crofelemer.

The most likely reason that an HIV clinician has never used Crofelemer or Mytesi is because they’ve never heard of the product and as Pete mentioned, this product has never really had the promotional push behind it that we are now implementing.

So, I don't want to bore you with lot of details, but I am going to share just a few highlights of the activities that we launched for Mytesi.

We have conducted and continue to conduct Advisory Boards with HIV specialist, gastroenterologists, managed care payers, nurses and patients and patient advocacy groups, all of which are helping inform us that the best way is to get the word out and what to communicate about Mytesi to these important groups.

Secondly, compelling materials and detail aids for the sales force to use in their discussion with clinicians as well as patient education materials and the samples that Pete mentioned to start patient on Mytesi.

A Mytesi Speaker Bureau with HIV specialists, gastroenterologists, nurses, patients and case managers who will help us educate clinician and patients at events around the country. Support programs for patients, including a co-pay coupon and patient assistance program.

In addition, we have many nonpersonal promotional efforts including a large advertising campaign, which was launched in late September. The campaign is called, "Enough is Enough".

It is currently running in print and online digital advertising in nine HIV and gastroenterology medical journals and their websites, five national HIV magazines including Pause and HIV-Positive and Plus magazines along with their digital version and then 23 regional LGBT magazines and newspapers and their digital outlets, which run across 16 major metropolitan areas in the United States.

We also have tele sales coverage to what we call white space. These are geographies where we do not have a live Mytesi rep and the tele sales rep can deliver product messages as well as sample. We have a few websites, most notably, Mytesi.com and enoughdiarrhea.com, which are linked to all of our digital promotional activity.

We've been doing public relations, which has resulted in over 25 stories about HIV-related diarrhea and Mytesi and relevant HIV media outlets. And lastly, we have just kicked off and unbranded educational campaign called, "Keep Your Pants on Unless You Don't Want To", which is a bit of a cheeky way.

This was developed with the input of both HIV patients and advocates looking for a lighthearted way to address HIV-related diarrhea. This has been launched through social media on Facebook and Twitter and in events such as the AIDS Walk LA and Gay Pride.

This campaign is designed to be a more lighthearted way to raise awareness about diarrhea and encourage patients to ask their doctor for treatment. So, I hope I've given you a good taste of the efforts and promotion behind Mytesi. We're very proud of the campaigns and the materials we've created, but really the patients are our driver.

In all of the interviews and discussions we've had with people living with HIV who experienced diarrhea, they’ve implored us to help them break the silence and dispel the miss around HIV-related diarrhea to make sure that patients and their doctors know about Mytesi. Thank you very much and I am going to pass it now to I believe Pravin..

Good morning, Katie. And yeah, let me just underscore incredibly rewarding it is to work in this particular community and have such direct access to the patients who are so motivated and Mytesi as in my secretory agent is basic normalizing mechanism of action that gives it an opportunity for any follow-on indications in the gastrointestinal area.

So, Dr.

Pravin Chaturvedi, Pravin, are you on the phone right now? Are you on the phone?.

I am at the airport and I am in a noisy zone. So, thank you, I'll talk..

And Pravin who has developed many, many drugs and how many people in the pharmaceutical industry can say that is the developer of Mytesi. He negotiated the spa for the pivotal trial, the Advent trial that got Mytesi approved this first indication. So, Pravin I'll let you talk about this pipeline and the product..

Thank you, Lisa and good afternoon, everyone. My name is Pravin Chaturvedi.

I am the Chair of the Scientific Advisory Board and by training I have degrees in pharmacy as well as neuropharmacology and I've been in the industry for nearly 30 years and been associated with the development of drug Crofelemer is one of my latest drugs and it's so important to have this drug made available to HIV patient, because the patients now are ageing and have several comorbidities that actually affect the general ageing population as well and with the use of antiretroviral therapy, we've had good control of viral loads and have improved T-cell account status but the comorbidities continue to exists and these are particularly affecting gastrointestinal tract and cardiac, liver, metabolic disorders such as diabetes and CNS.

And in fact, gastrointestinal adverse events as Katie mentioned like diarrhea are actually the single highest factor for this drug configuration and patient in the patient population.

When we did the pivotal trial with crofelemer, that at least are referred to, we did it in HIV patients for receiving antiretroviral therapy as well as some of those patients had diarrhea from unrelated issues to the therapeutic regimen and we now understand that that has to do with HIV enteropathy and that is a condition that affects HIV patients.

And these patients have HIV enteropathy is and when they are undetectable and they are viral loads are completely suppressed.

The patient survey report also indicate that about 25% of the patients have chronic diarrhea, some of which maybe atrophic enteropathy and so [crofelemer] is important to all these HIV patients that have diarrhea as there are no other approved treatment for chronic diarrhea and the patient have usually exhausted their limited options such as OTC blood and Lomotil, which is a prescription drug.

So other patient population has started to give their knowledge and social approval and have stated develop [it] and we have been starting to assemble key opinion leaders and Scientific Advisory Board members to start developing thoughtful protocols and campaigns for the development of the drug.

So because this is the only drug approved for symptomatic relief of non-infectious treatment of HIV patients, patients such as those who have cancer, who have saved chemotherapy agent and/or patients that have Crone's disease for instance post operatively and suffering from chronic watery diarrhea for a long time and we have started to use this from infectious disease, oncologists as well as gastroenterologists and starting to develop proper Clinical Advisory Board and key opinion leaders and SME members to get guidance on what is appropriate management of their watery diarrhea under such condition and this is a standard part of the process of developing any drug with a better and redeveloped associated diarrhea.

So, the feedback from all these SAP and discussion has started to provide us with some outline for potential clinical investigation to evaluate the safety and effectiveness of the crofelemer in additional indication.

For instant a cancer patient receive starter in kinase inhibitors along with other chemotherapeutic agent in various cancer types of non-emerging assay, trilogy clinical opportunity for crofelemer to provide symptomatic relief of watery diarrhea as well as patient.

And similarly, in inflammatory bowel diseases, and postoperative Crone's patient appear to be also another patient population that is drug.

For pediatric patients, we've actually received feedback from pediatric gastroenterologists who are saving numbers to start to think about appropriate opportunity for using crofelemer and potentially orphan indication such as short bowel syndrome, where we have received an orphan drug designation from the FDA which is a heterogeneous condition in children that have chronic watery diarrhea.

So, we started developing that and we also have previously conducted a couple of Phase 2 studies in DIBF diarrhea predominant IBS study and analyze that data using the [indiscernible] Foundation Criteria of 2010 and shown that crofelemer produces a significant benefit to those of 125 BID in women in the primary endpoint of abdominal pain showing consistency.

So, we have published one set of results from the old criteria and now we also are looking to submit the additional analysis of publication in the future.

So, as you can see, crofelemer is a very important medicine and it has provided significant benefit in HIV patients and presents tremendous opportunities in additional indication where there is an unmet or underserved need. So, I will stop here and turn it over to Lisa Conte and thank you..

Thanks Pravin and thanks for accommodating while you were in the airport. And now I am going to turn it over to Karen Wright and Karen is going to talk about the financial GAAP reporting..

Yes, I would like to review the GAAP revenue results as distinct from the operational gross sales Lisa discussed earlier, which the company uses to analyze for commercial activity and goal achievement. So, I will be discussing the third quarter 2017 and for the nine months ended September 30, 2017.

As Lisa stated, the third quarter of 2017 was the first month Jaguar Health Inc. reported consolidated human and animal revenue in their financial results.

Since the merger between Jaguar Animal Health and Napo Pharmaceuticals was effective July 31, 2017, there are only two of human revenue results being included in the third quarter 2017 and the nine months hereto date financial statement.

The company's human product revenue is for Mytesi and the company's animal product revenue is [indiscernible] and has collaboration revenue included.

GAAP revenue results for the third quarter ended September 30, total net revenue for the third quarter of 2017 was $1.1 million comprised of $346,000 Mytesi dollars and Mytesi product revenue, in $82,000 of Neonorm product revenue and $655,000 of collaboration income.

Total net revenues for the third quarter of 2016 was $50,000 comprised solely of Neonorm product. Quarter-over-quarter total 2017 revenue was $1 million higher than 2016.

Total net revenue for the nine months ending September 30, 2017 was $2.8 million comprised of $346,000 in Mytesi product revenue $236,000 of Neonorm product revenue and $2.2 million of collaboration revenue.

Total net revenue from the nine months ended 2016 was $13,000 consisting only of Neonorm revenue, which was $123,000 lower than the same period in 2017. Total revenue for the nine months ending September 30, 2017 was $2.7 million higher than the same period in 2016 due to additional Mytesi revenue and collaboration revenue.

I'd like to return it back over to Lisa now..

Thank you, Karen and just some terminology Crofelemer which you heard then referred to as the generic name of Mytesi, the pharmaceutical agreement ingredient in Mytesi and I want to thank you for listening and accommodating. We are thrilled to be commercializing Mytesi. It's the result of many, many years of labor.

Many, many years of risk based pharmaceutical development and it's really wonderful to be talking about a commercial activity and helping patients directly.

To recap, I'd like to repeat the two important numbers from today, the two takeaway, total Mytesi growth sales for 2017 through October 30, 2017 are $2.8 million and average monthly sales of Mytesi has increased 50% from August through October 30 of this year versus the first seven months of the year January through July, coincident with the marketing and sales activity that we were able to put on marketing for the past three months, sales just for three weeks in October.

Thank you very much for listening and we're looking forward to having calls like this on a quarterly basis. Good night..

That does conclude our conference for today. Thank you for your participation..