Q2 2022 Jaguar Health Inc Earnings Call
Ladies and gentlemen, please standby.
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 impact of competitive product and pricing.
Industry trends and product initiatives, including products in the development stage, which may not achieve scientific objective 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 current available information, which management's current assumptions expectations and projections about future events, while management believes its assumptions expectations and projections are reasonable in the view of the current available information you're cautioned not to place undue reliance on these.
Forward looking statements.
The company's actual results may differ materially from those discussed during this webcast for a variety of reasons, including those described in the forward looking statements and risk factors section of the company's Form 10-K for the year 2021, which was filed March 11th 2022.
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 undertakes no obligation to update or revise any forward looking statements.
Entailed in this presentation to reflect new information future events or otherwise. Additionally, please note that the company's supplements its condensed consolidated financial statements presented on a GAAP basis.
By providing gross sales non-GAAP EBITDA and non-GAAP recurring EBITDA Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information that reflects the basis upon which the company's management assesses and operates the business. These non-GAAP financial measures not to.
Viewed in isolation or as a substitute for GAAP net sales and GAAP net loss and are not subject or substitutes for or superior to measure.
Our financial performance in conformity with GAAP.
Today's conference is being recorded at this time. It is my pleasure to turn the call over to Lisa Conte Jaguar Health founder President and Chief Executive Officer.
Floor is yours Lisa.
Thank you that's quite a mouthful.
Welcome all.
Lease accounting.
And I am the founder President and CEO of Jaguar Health.
And our wholly owned subsidiary in the United States Nappo Pharmaceuticals, I'm also chairman of the Board of novel Therapeutics Corporation, We established in Iran, Italy last year for which we granted an exclusive license to <unk> polymer in Europe , and I'll be speaking about that more later, but I'm going to begin today with it.
Top line results for the second quarter of 2022 prescription product net revenue of $2.9 million, representing an approximate 12% increase over Q1 2022, a quarter over quarter your calculation.
Nick.
44% increase over Q2 last year 2021.
Year over year calculation.
Is the fourth consecutive quarter of growth in my testing that revenue and we are quite pleased with the growth trajectory of our current prescription drug business and as you'll hear quite excited about the late stage pipeline opportunity that we feel will be transformative in the value creation and value.
Question for all our stakeholders, including patients and shareholders.
I'll continue with a few brief update and then Carol lives that Jaguar Chief Financial Officer will provide a recap of the.
<unk> financial results for the second quarter of 2022 after Carl.
When Jack Welch Chief commercial officer.
Well update on latest D related commercial initiatives to continue to educate and HIV.
The activities that will serve future pipeline indications cofounder.
And about ongoing commercial efforts underway for can we see a one our prescription drug for the treatment of chemotherapy induced diarrhea, which I'll refer to a CAGR chemotherapy induced diarrhea.
Dog that has been conditionally approved by the FDA and became commercially available veterinarians in the United States to provide comfort and relief to their canine patients.
The end of April 2022. This is the first quarter that we are recording sales for candidly with day, one which is very exciting and important for those patients.
As a reminder.
Our commercialized drug product.
My test engineer.
The generic name is cross selling.
It is a first in class anti Secretary agent approved initially quite a specialty indication of the symptomatic relief of non infectious diary of adult patients with HIV AIDS on anti retroviral therapy.
The term specialty implies this is a relatively small.
Portland, the relatively small market.
This indication with fast track by the FDA and that's why it's the first approved indications for cross selling.
It's really powerful about cofounder is that this is a pipeline within a product and what I'm going to focus on today are the two late stage clinical milestones, we have but we feel our potentially transformative initiatives for the company to take cross selling there from a pipeline opportunity to tangible revenue.
Radio patient benefiting product indications.
Interestingly you can leave your SD Wan is conditionally approved by the censors veterinary medicine of the FDA for chemotherapy induced diarrhea, and Doug. The two women follow on indications we are focused on our cancer therapy related diarrhea, and the U S.
And through that those therapeutics, which I'll refer to as nalco barreled through macro there is where does the business model.
Or indication of short bowel syndrome in Europe .
Each of these indications have been major clinical events claimed to take place within the next approximate six to 12 months.
So first what exactly are these indications.
Talk about skin cancer therapy related diarrhea.
Estimated that up to 80% with chemotherapy patients experience diarrhea.
Managing diarrhea has the potential to impact at all.
Unlike cancer therapy is approximately 40% of patients go Oh, they're lifesaving cancer therapy or move to or even start with a sub therapeutic dose of their chemotherapy due to diarrhea.
This is in addition to the impact on patient comfort.
Maybe.
The cost to the health care system from events dehydration, and a potential infection point quite important for health care reimbursement.
Enrollment is continuing for the target study, our pivotal phase III trial of cross selling there for cancer therapy related diarrhea in humans for.
We're aiming to complete enrollment with a total of 256 patients by the first half of 2023.
This is a prophylaxis study, which tells you a lot about how important it is to get in front of the impact of diarrhea during cancer treatment.
PPD is not in your garden variety diarrhea. This is diarrhea that with patients in the hospital not only for the hydration.
So electrolyte imbalance that can have cardiovascular effects and can cause Oregon shut down.
Even resulted in deaths in some patients who have been in cancer agent manufacturers clinical trials.
With the new targeted cancer therapies that are used chronically both in metastatic and I'm curious, Kansas situations therapies are used for months or years until the patient passes on sometimes the incidents of diarrhea is as high as 100%.
Recent reports show the diarrhea approved 50% to 100% of the time with different targeted agents.
Project, the potential market opportunity for CTD.
Since scrip element is the first drug candidate that's being evaluated to be approved for this indication. We're looking at an analogous market chemotherapy induced nausea, and vomiting referred to as C. I N V.
This market is projected to be close to a 3 billion dollar global market. This year. According to a report published by Allied market research.
The agents are typically only used for the first three days and traditional cytotoxic chemotherapy with CTD cancer therapy related diarrhea.
Talking about diarrhea that can persist on a chronic basis for months.
For years.
The successful completion of our on target pivotal trial will result in a supplemental new drug application filings for the same formulation is currently commercialized cofounded by testing.
<unk> is of course already approved for a chronic use.
And people living with HIV AIDS and has a full FDA compliant supply chain in place from the rain bars.
Essentially every one of our specialty pharmacy distribution network across the United States.
As a reminder, safety and manufacturing are the two most common reasons that new drug applications fail.
Activities are completed for my testing from a regulatory perspective.
We spent much care and engaged in extensive communication with GSK in the design and implementation of the final clinical and regulatory steps to support bringing cross sell them or to cancer patients suffering with diarrhea.
I'll now discuss our second prioritized pipeline indication for copolymer short bowel syndrome referred to as Sps.
Sps is a catastrophic situation for patients. It is a classic rare disease affecting an estimated 40000 people around the world.
So normal guys.
Is 20 to 25 feet in length.
Yes, the patient Scott could be less than five feet for congenital reasons or as a result of surgery due to cancer inflammation or an accident.
As you can imagine with a very shortcuts.
Sid.
Whatever goes in comes right out.
The bottom line is there not enough intestinal real estate Theres nothing Thats circled area.
The Sps patients to absorb what I'll call the nutrients supplied carbohydrates proteins vitamins and minerals.
So what happens is these patients often end up on parental nutrition, the intriguing intravenous feeding of liquid nutrients for up to 20 hours a day seven days a week.
Obviously, a significant negative impact on the patient's quality of life.
And there are multiple negative health effects infections, and complications associated with parental nutrition.
Rental nutrition is also expensive costing hundreds of thousands to $1 million a year to manage an individual patient, including the myriad of complications with high morbidity and mortality.
The global <unk> market is projected to reach $5 billion by 2027. According to reports from vision Research reports.
Although printer nutrition is is considered the standard of care. There is a good product approved for Sps called to do good time, which is the <unk> analogs.
It is essentially a growth hormone intended to grow the real estate that we've got.
Lately, so that there is a little bit more time for absorption of the nutrients to life.
It's administered as an injection and is estimated to be utilized in less than 10% less than 10% for the Sps patient population to do good tide has a range of side effects and cannot be used chronically.
It has been shown to increase cardiovascular cardiovascular risks.
Especially the risk of developing congestive heart failure and the teams have been shown to increase absorption and metabolism of concomitant medications.
The primary endpoint in the trial for the approval of the decline is the reduction in the time required to be on parental nutrition.
Usually by about 20%.
What we're looking to do with cofounder is to reduce the timeline printing nutrition is the primary endpoint as well.
And provide better stool formation and a quality of life measurements with fulfilling a strong safety profile, we expect patients to be able to tolerate and benefit from cross sell them are chronically.
SCE is development of cofounder is being pursued through the company we established in.
In Europe last year called <unk> Therapeutics Nacco Sara.
Which holds an exclusive license to fulfill them or for Europe from Jaguar, It's a classic license agreements incorporating upfront payments milestones and royalties. The reason for facing this new company in Europe is because the EMA the European Medicines agency, which is the FDA of Europe hasn't early.
Access program for orphan indications like Sps because of the impact on patients with published proof of concept data patient and specific major markets in Europe can get access to our products through an early access program will full approval is being pursued and for those patients the product <unk>.
First and this is not a program that exists in the United States.
We have approved the planned investigator initiated proof of concept trial profiling there for SBS.
And the third party investigator is targeting the presentation of results from this study in December of this year 2022 at a global Gi conference, which will take place in Dubai.
With the publication of the results of this proof of concept study Napoli Sarah is aiming to implement the early access program for patient treatment and revenue generation.
Timing of this happened to coincide with when we expect to complete our pivotal phase III trials for pharma for cancer therapy related diarrhea.
Again, a key advantage of the Napa Sarah efforts to Jaguar is that Napa, Sarah is well over majority owned by Jaguar, providing potential equity accretion value to Jaguar shareholders and stakeholders value that we believe is unrecognized at this time.
<unk> also received the value of any clinical data generated by net vocera for SBS and we typically <unk> received the value and the ability to utilize the CTD cancer phase III data Jaguar is developing.
The parallel complementary and geographically focused development efforts of fulfilling her for each of these two core pipeline mutations <unk> D in SBS.
Pressing simultaneously.
Celebrity collaboratively each with their own dedicated focused and extremely.
Experienced and talented team.
So to recap in approximately 12 months, we expect to have completion of enrollment in our phase III trial of cancer therapy related diarrhea called the on target trial in.
And expect to have published proof of concept data in support of an early access program in Europe for SBS, which could bring in meaningful revenues to expected transformative events that are on the near term horizon.
An additional key milestones for 2022 on the human front is the filing of an investigational new drug IND application.
Application with the FDA in the third quarter.
This year were symptomatic relief of diarrhea from cholera.
For our N. P 300 drug candidate also referred to as luck Wimmer Lucky.
<unk> is a different chemical collection of pro Anthos antigens extracted from Crow tons luxury tree, which was the same tree from which we get a cold summer.
Which we believe define Guadalajara as distinct product from copolymer Thunder FCA botanical guidance the guidance upon which <unk> is approved.
<unk> works by the same novel anti <unk> mechanism of action is fulfillment yet has the lower manufacturing cost.
In support of this R&D, we received comprehensive animal toxicity preclinical services supported by the National Institute of allergy and infectious diseases for preclinical studies.
We plan to pursue a tropical disease priority review voucher could work under the Fda's financial incentive programs to develop drugs with tropical diseases, such as cholera priority vouchers are transferable and in past transactions by other companies had sulfur prices ranging from 67 to 350.
And which provides for potential immediate return on investment upon approval of the product for the symptomatic disease diarrhea from Colorado.
Moving along to the animal health side of our business as I mentioned cross selling there is also the active ingredient and Kevin <unk>, our product for chemotherapy induced diarrhea dogs.
For which commercial launch activities are ongoing now.
The whole cancer situations is remarkably analogous to the human situation.
As with human cancer patients doubtful off their disease, modifying chemotherapy or move to a sub therapeutic dose.
Approximately 40% of the time due to diarrhea, meaning these dogs cannot complete their therapeutic dose of chemotherapy because of the diarrhea.
The country is the dog is one of the most important if not the most important consideration of the dog owner, when deciding whether or not to put their dogs get cancer treatment. Because of course, you can't talk to the dog and let them know, it's going to be terrible for three months Youll feel awful hanging there.
You have the whole dynamic of the quality of life of the households, with the dogs that may have lost control on the rug or the bed in the household.
There are a couple of really important factors in the dog market.
The incidence of cancer in dogs is reported to be followers tons. What we've seen in humans, an estimated 9 million dogs were required by U S households, during the pandemic. According to the American Pet products Association, bringing the total number of dogs in the United States to about $108 million, which is roughly one dog for Ed.
Every three unions in the country and unfortunately about 50% of dogs over the age of 10 are going to be diagnosed with cancer at some point.
When you are sitting here market operates in a pay out of pocket model from a financial perspective. This dynamic allows us to have great predictability between gross revenue and net revenue and a higher overall gross to net ratio, which is a much different situation than we have on the human side of the business in the United States.
Education and promotion about the devastating impact of cancer therapy related diarrhea builds awareness about the importance of managing diarrhea. So that the practitioners can take the best care of the patients.
Whether the patient is a human or a dog.
We launched the first ever canine cancer registry.
In the United States in May in New York believe it or not the Red Sea did not previously exist in the United States for canine cancer.
It was an event the launch of this with great fanfare, a great PR event, a great Investor relations event and a great educational event. This.
This project is called the Jaguar health canine cancer take charge initiative that snap and then our goal in establishing the first U S National canine cancer registry and cancer care index is to assess the prevalence and incidence of cancer in dogs and most importantly, how you can keep the dog.
And the entire family situations comfortable during what is often a very siloed and tragic event for our families and help create a community support with the information that comes from our registry.
On August 10th Gala, believing national polling organization published an article providing their analysis.
It's from take charge keen on cancer.
Ever nationally representative survey of U S dog owners experience with the disease. The data from the survey indicate that of the 67% of Americans, 67%, who have had at least one dog in the past 10 years nearly one in five which is about 30 million people.
That at least one of their dogs experienced cancer.
In addition to CIB and dogs Profounder is expected to be conditionally approved for the treatment of exercise induced diarrhea and dogs in the next six months.
With the take charge initiative underway the commercial launch of <unk>, one continuing the potential additional dog indications where consumer this is jaguars near of the dog.
In the next 12 months there is the potential for a lot of other used on both the canine and human fronts, we have global rights to vulnerable all indications on the business development front in June as announced we entered an exclusive license and services agreement with Ontario.
Canada base Cineworld technologies corporations in the world for the treatment of diary and dogs in the China market with cannot leave you.
The agreement is structured to bring license fees of $5 million and up to $5 million in unregistered equity infusion to Jaguar over the next approximately 24 months as.
As additional consideration for the license Jaguar is entitled to receive 60% of any products from sales of the product in China and is Jaguar reimburses cineworld for the direct expense of obtaining regulatory approval in China. The profit sharing will be 80% and 20, respectively for Jaguar.
In <unk> World.
We also entered an agreement at the end of the first quarter of 2022. This year with quadrant from pharma that grants quandary exclusive promotional commercialization and distribution rights were specified human indications of fulfillment in Bahrain, Kuwait, Qatar, Saudi Arabia, and the UAE.
<unk> and Oman.
This is a revenue sharing relationship for HIV related diarrhea, and the agreement terms provide jaguar with an increase in the revenue sharing percentage for sales in these countries of newly approved indications, which will apply to the CTD and potentially inflammatory bowel disease indications for fulfill them are of course upon.
Marketing approval.
And in June .
2022, this year Jaguar XE Women's health signed a letter of intent to enter collaboration agreement to develop botanical prescription drugs.
Terrific psychoactive target indications in the United States.
The goal of the collaboration is to extend the botanical drug development skill sets of both companies in order to develop pharmaceutical grade plant based standardized drug candidates and then partner with potential future licensees regarding their responsibility.
The more expensive development and commercialization of these novel drugs.
Jaguars in new Gen Therapeutics initiatives ATI aimed to discover and develop groundbreaking novel natural medicines derived and psychedelic psychoactive plants for the treatment and potential cure of mood disorders, neuro degenerative diseases addiction, and mental health disorders.
On the current agents being pursued by multiple third parties, including psilocybin MDMA means and for others.
What we're focusing on the next generation of <unk>.
These compounds.
This effort has mobilized Jaguar asset library of 'twenty 300 plants and 30 clubs in your plant extracts that was generated over three decades.
I believe you can expect to see additional business development deals because we are committed it is our cause to bring cross selling there and all our potential products to all patient populations in need and geographies around the world.
Lastly, I'd like to let all of you participating today know that we'll have a brief Q&A segment as we always do at the end of this webcast to address questions. If there are any.
Please submit in writing questions can be submitted via the webcast link for today's event that appears on the events and presentations page of the Investor Relations section of Jaguar's website. The Urls to Jaguar's website is Jaguar Dot Hills.
Well now move along to key financial results for the first quarter of 2022 parallel I'll turn it over to you. Please.
Thank you Lisa and thank you all for joining our webcast today.
I'll begin my review of our financials for the second quarter of 2022.
My checking net revenues during the second quarter of 2022 was approximately $2 8 million.
And about $2 6 million in the first quarter of 2022.
An increase of approximately $200000 or 10% quarter over quarter.
And the increase of 644% over Mike chassis net revenues in the second quarter of 2021.
Which totaled 400 about 400000.
My chest E prescription volume.
The metric the company believes to be the best indicator of growth in patient demand.
Increased eight 2% in the second quarter of 2022.
Or would the second the first quarter of 2022.
Prescription volume difference from Invoiced sales volume.
Which reflect among other factors.
Very in buying patterns among specialty pharmacies in the coast network of zinc.
Managed their inventory levels.
Mike Chucky gross revenue.
non-GAAP measure.
Was approximately $3 7 million in the second quarter of 2022 and.
And $3 4 million in the first quarter of 2022.
Representing an increase of approximately $300000.
Four 9% quarter over quarter.
And a decrease of approximately 24% over my test gross revenue in the second quarter of 2021, which totaled approximately $4 9 million.
As Lisa mentioned candidly your CA, one became commercially available to veterinarians across the U S. A D end of April 2022.
Kendall <unk> CA, one net and gross revenue during the second quarter of 2022.
We're $87400.
non-GAAP EBITDA.
For the second quarter of 2022, and the second quarter of 2021 was a net loss of five $4 million.
And $10 8 million respectively.
For the second quarter of 2022, the loss from operations was $6 $3 million.
Compared to a loss of $11 6 million in the second quarter of 2021.
A decrease of $5 3 million quarter over quarter.
For the second quarter of 2022, the net loss attributable to common shareholders was approximately $9 4 million compared to a net loss of $14 1 million in the second quarter of 2021.
A decrease of approximately $4 7 million quarter.
Quarter over quarter.
And in addition to the loss from operations.
<unk> expense increased by $500000.
$2 million in the three months ended June 32021.
Two 5 million for the same period in 2022, that's primarily due to the interest from the royalty in those agreements.
And change in fair value of <unk>.
Financial instruments and hybrid instruments designated at fair value options.
<unk> increased $1 2 million from.
From a loss of 500000 in the three months ended June 32021.
Two a gain of $700000 for the same period in 2022.
Other expense increased by $1 1 million.
From 200000 industry months ended June 32021.
The $1 1 million for the same period in 2022 due to the foreign currency transactions.
That concludes my recap of high level financials.
Second quarter of 2022.
I will now hand, the discussion over to Ian <unk>, our Chief commercial officer.
Thank you Carol and good morning Joel.
As Carl stated my test a total prescription volume metric, we believe to be the best indicator of patient demand.
Creased eight 2% in the second quarter of 2022 over the first quarter of 2022.
As previously announced the transition we completed this past January to a closed network of specialty pharmacies resulted in a meaningful reduction in my test your distribution costs as well as a higher average net price.
I am very pleased to report that we significantly outperformed the industry gross to net average in the second quarter of 2022 as we did in both of the two previous quarters.
For sales of our human prescription product.
This improvement in our GTS was largely as a result of the efficiencies realized by the transition to a closed network of specialty pharmacies.
And as we mentioned Q2 2022 is the fourth consecutive quarter of growth in my testing revenue, which we're also very pleased about.
A key component of the company's market access strategy, our initiative to transition to a closed network of specialty pharmacies is intended to help remove access barriers for patients prescribed <unk> and.
That includes services, such as a higher level of support for prior authorizations, and appeals adherence counseling and home delivery options.
Patients often visit retail pharmacies for short term or uncomplicated medical needs specialty pharmacies focused primarily on serving patients with complex and chronic medical conditions like HIV.
Importantly, this transition allowed us to begin utilizing sales in prescription data.
Directly provided by our network of specialty pharmacies to more accurately track prescription volume and the patient journey, rather than relying on a third party provider of estimate data for these important performance metrics.
This also assists in the preparation of our U S commercial distribution network for potential future indication expansion.
Hello merge other populations of patients with complex medical needs, such as CTD inflammatory bowel disease and SBS.
I'm also pleased to report that our innovative recently launched programs that further support patients connecting to care and medication extra services are continuing as planned. The first program is our telehealth initiatives, which went live in May.
That enables patients seeking help with their HIV related diarrhea to be linked immediately to a provider for assistance with their medical needs. This new capability prevents patients from having to wait until their next scheduled doctor visit.
With what is an urgent problem.
Our second recently launched program delivers digital my test and disease state education directly into providers EHR electronic health record system. So that they learn about my testing at the moment. They are seeing their HIV patients. This technology allows us to intelligently deliver ads to a provider based on the profile of the patient they are seeing.
In their exam room and this is strictly one way communication you did not receive any protected health information.
Both of these programs are designed to drive incremental brand awareness among prescribers, who have not written might chassis.
Previously and among patients who have not been able to receive immediate care for their HIV related diarrhea.
Turning to the animal health side of our business. We're thrilled as Lisa mentioned, we cannot leave you see one or FDA conditionally approved treatment for chemotherapy induced diarrhea, or CIP and dogs became commercially available to veterinarians across the United States at the end of April 2022.
Since that time, we have succeeded in pushing <unk> into broad distribution with the leading veterinary distribution centers.
See new clinics ordering and cannot leave UC one each week and then have multiple clinics that have.
Placed repeat orders.
A great indicator that <unk> are seeing the clinical benefits of our product among their patients.
Generally you see a one is an important prescription drug introduction for the veterinary community and the thousands of dogs experiencing CIB.
As we have commented dogs as with humans may discontinue their chemotherapy treatment approximately 40% of the time due to diarrhea.
Leave your Q1 can help support the comfort and quality of life of dogs, while being treated with chemotherapy, which we help them remain compliant with their life saving treatments.
The reception of cannot leave you see one among general practice Thats in veterinary oncologist, who have learned about the product has been extremely positive.
Commercial launch activities for <unk>, one remain underway the product was the focus of Jaguar animal health exhibit booth at the April Veterinary Cancer Society Midyear conference in regards to Mexico.
We also held a well attended dinner event for veterinary oncologists about CIB in dogs at this conference we exhibited at the 2022 American College of Veterinary internal Medicine <unk>.
Forum in Austin in June and we will be exhibiting at the upcoming international veterinary emergency in critical care Symposium.
San Antonio Texas to September .
And at the Veterinary Cancer Society annual conference in Norfolk, Virginia.
October we're also developing a CIB educational content that will be eligible for continuing education credits for veterinarians to help increase awareness of this important issue.
As announced we expect can leave you could additionally receive FDA conditional approval under the name can leave you see a two to the <unk>.
Treatment of exercise induced diarrhea or I'd.
And dogs in the first quarter of 2023.
That includes my comments. Thank you all for your time today and I'll pass the conversation back to Lisa.
Thanks, Ian Thanks Carol.
We at Jaguar, Nappo and Napa <unk>.
It was about all of our important initiatives underway in 2022 and beyond I would also like you mentioned that as we announced this past Friday Jaguar received formal notice on August 18 separate listing qualifications staff of the NASDAQ stock market has granted the company an additional 180 day Grace period.
Through February 13, 2023 to regain compliance with the $1 bid price requirement for continued listing on the NASDAQ capital market.
Police have obtained additional time from NASDAQ to evidence compliance with the bid price requirement and as we seek to regain compliance with this rule. We are laser focused on our two late stage clinical events in the next approximately six to 12 months that we expect to be transformational in terms of.
Value creation in recognition for the company, we did file a preliminary proxy on Friday August 19th for a special meeting of the shareholders of Jaguar as noted in the proxy resolution we are not seeking a reverse split of the Jaguar shares well.
Well now open the floor for a written questions that have come in and I will move to those now and repeat the question there aren't a lot, but there is a couple here.
One of them was is during the past slide presentation.
You mentioned that there would be color voucher filing in the first half of the second.
Order of 2022 when is the filing of the voucher recall are going to happen.
That is a bit of a misunderstanding so.
The voucher for the caller program the tropical disease priority review voucher is something that is granted by the FDA upon FDA approval for the tropical disease. So another case could be approval of <unk> for Colorado, which has never been planned for 2022 with Hudson.
<unk> planned and what will happen is the filing of the IMD, which.
Will occur in the third quarter. So that's just around the corner of this year. When the clinical program is completed successfully is when you potentially can keep the voucher and then the voucher is transferable and it could be sold at that time.
As a reminder, Colorado.
Care to be indications approved and being pursued from co hellinger, Colorado is an acute indications. So the clinical trials are and that we have done in the past for Colorado with cross selling there with the same mechanism of action of our published.
Three days of treatment.
What are the earnings from Napa, specifically, so in case again, I know, sometimes it can be confusing with the name Napa Pharmaceuticals is wholly owned by Jaguar health. So essentially they are interchangeable when we say Jaguar dabo.
<unk> therapeutics not macro pharmaceuticals novel Therapeutics is the private Italian Corporation that was established in Italy under an exclusive license to Chris Allen from Jaguar.
<unk> pharmaceuticals.
And it is.
As I mentioned well over a majority owned also by Jaguar and therefore, we have the equity benefit in a corporation as well as the license benefit.
And.
Let's see can you remind us of the primary endpoint and the on target study.
And what is the expectation going into data read out in the near term with constitutes a positive readout from the study. So the study is the label being targeted for.
Prophylaxis.
Cancer therapy related diarrhea basket approval for.
All solid tumors in patients.
On targeted therapy visa tyrosine kinase inhibitors epidermal growth factor receptor antibodies with or without cytotoxic chemotherapy prophylaxis and this was.
A suggestion and.
It's been an assistance from the FDA, which is really a <unk>.
Wonderful opportunity for patients to never have to experience the diarrhea and also.
Quite beneficial from a commercial perspective.
The three primary endpoint is after three months.
And it's an area under the curve calculation of the improvement in stool formation or essentially the reduction in diarrhea compared to the placebo. So its 256 patients my testing literally my testing the same dose same formulation.
One to one compared to placebo patient enrollment will be is targeted to be completed in the first half of 2023 three months as I mentioned for the primary endpoint sales in the second half of 2023 is when we would expect to have the readout what constitutes the positive results.
In the pharmaceutical industry is really remarkable in that it's a single point. It is the P value on the primary endpoint and that would allow us theyre going to expand the indicate labeled indication for my testing and we are already preparing for inventory production.
Or towards the end of 2022 beginning of 2024.
Yeah.
Okay.
Will we pay a dividend.
There is no plans to pay any dividend at this point when we're profitable organization.
And as we have our pipeline indications approved.
That is something that can be considered.
Okay.
Are you in negotiations with other strategic partners absolutely as I mentioned, you can expect to see business development deals going forward in particular again as I've mentioned, we have discussions going on with the <unk> therapeutics initiatives.
<unk> is.
In effort to mobilize and find value from an asset that we created over three decades. So 23 in Japan 3500 plant extracts looking at those that could provide potential second generation psychoactive psychedelic.
Products that we will partner with a and we are seeking partnerships with one of the many well financed companies that are focused on psychoactive and psychedelics as again as I mentioned suicide than in D&A ketamine, they're all chasing about the same seven compounds what are the next generation.
Whether the new mechanisms of action, we can bring to the table with what we do so well, which is the library the Aetna botanical firsthand information the guidance on how to proceed with a product under botanical guidance the supply and count on the partner that is focused on regulatory clinical development.
Commercialization in these areas as our internal efforts are focused clinically on fulfillment and gastrointestinal indication.
And or is that a compliment here. Thank you.
And that is all the questions at the that's.
All the questions.
Thank you I know this was a long call there's a lot of news.
And we appreciate your interest in consideration that concludes our webcast for today. Thanks. Once again all of you for joining and your interest in Jaguar <unk> Napa natural therapeutics, and we are going to get back to work, but there's a lot to do.
Thank you.
Once again, ladies and gentlemen, this does conclude your webcast for today. Thank you for your participation and you may now disconnect.
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Okay.
Yes.
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