Q3 2023 Jaguar Health Inc Earnings Call and Business Update
Before I turn the call over to the 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 products and pricing industry trends and product initiative, including products in the development stage, which may not achieve scientific objectives or meet stringent regulatory requirements.
Forward looking statements are not 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.
<unk> patients and projections about future events.
While management believes that its 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.
During this webcast for a variety of reasons.
Those described in the forward looking statements and risk factor sections of the company's Form 10-K for the year 2022.
Which was filed March 'twenty four 'twenty to 'twenty three.
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 contained in this presentation to reflect new information future events or otherwise.
Additionally, please note that the company supplements its condensed consolidated financial statements.
Centered on a GAAP basis by providing non-GAAP EBITDA.
And non-GAAP recurring EBITDA Jaguar believes that the disclosure items of these non-GAAP measures provide investors with additional information.
Flex the basis upon which company management assesses and operates the business.
These non-GAAP financial measures should not be viewed in isolation or as substitutes for GAAP net sales.
GAAP net loss and are not substitute for or superior to measures of financial performance in conformity with GAAP.
Today's conference is being recorded.
This time, it's my pleasure to turn the call over to Lisa Conte Jaguar Health's founder President.
They've officer, Lisa the floor is yours.
Thank you very much I'm glad we didn't miss that opportunity to hear the very important forward looking statements. Thank you all for joining my name is Lisa Conte and following my comments. This morning, Caroline <unk>, our Chief Financial Officer will provide a detailed recap of the key financial results for the third quarter of 2012.
Three although I will tell you I'm careful to say that we're pleased to report that net revenue increased 5% in the third quarter of 2023 versus the second quarter of 2023.
However, this is <unk>.
A momentous time for Jaguar and and hopefully our momentum time, the most important takeaway from todays webcast is regarding the potential opportunity to expand the current indication of our FDA approved product profile over under the trade name My Tessie.
From the parent specialty indication of nine infectious diarrhea in adults living with HIV AIDS on anti retroviral therapy specialty is a very important indication. It was fast track priority review by the FDA. So it's a relatively small indication in the United States.
And we're looking to potentially expand into the much more profound frankly, much larger neglected need.
For the preventative treatment of <unk>.
Diarrhea in adult cancer patients with solid tumors, receiving targeted therapy with or without standard chemotherapy topline results from our pivotal phase III trial referred to as the on target trial, which is investigating safety and efficacy for this indication of cross sell there are expected to be.
Before Thanksgiving Thanksgiving 2023, so literally around the corner.
This trial is studying an indication we also referred to as preventative treatment of chemotherapy induced overactive down if you've ever heard us the terms chemotherapy induced nausea, and vomiting in chemotherapy induced pain in neuropathy chemotherapy induced overactive bell which includes symptoms.
Such as unpredictable indoor chronic debilitating diarrhea loose a watery stools and urgency.
We believe cofounder represents a paradigm king approach and mechanism of action and new way of treating and potentially preventing treatment limiting diarrhea cancer treatment limiting diarrhea associated with cancer therapy in these patients.
And that's very in terms of the potential patient benefit.
For patients comfort patient dignity potentially patient quality of life.
And the opportunity to expand dramatically the number of people that can access and benefit from cross sell them or.
I recently been conducting a listening tour of patient advocacy groups, particularly the metastatic cancer patient population.
The metastatic patient voice is becoming more and more prominent theyre living longer 510, 20 years with the amazing breakthroughs in targeted therapies.
So as I'm hearing and learning at what cost to quality of life with side effects from cancer therapies targeted therapies that will be on for the rest of their life.
I had the founder of a cancer patient advocacy organization told me yesterday that she has no doubt.
Most of her patient members would prefer to have a shorter survival time with less severe side effects.
Is that a patient and caregiver survey that was published this past August in the journal J C. O oncology practice indicated that quality of life was the number one topic of importance to patients.
Quality of life ranked higher than survival ranked higher than access to care ranked higher than cost of care.
What are some of these side effects.
More than 80 targeted cancer therapies are FDA approved many of which caused diarrhea in 50% to 100% of patients.
In addition cancer patients suffer from pain neuropathy muscle cramping, nausea, fatigue, alopecia rashes itching and more.
Patients want to live not just exist and at the same time recognizing that their lives are likely to be different.
As an example, one patient I spoke with has unpredictable diarrhea.
And continents.
She almost didn't know if it should be called diarrhea, because it doesn't happen to her everyday not even every week, which is another issue trying to.
Gain a common understanding of the definition of diarrhea.
Anyway, the unpredictability causes her to wear a diaper when she leaves home.
She also mentioned when she thought how long zoom call anyway, when she leaves home she feels particularly vulnerable when she's walking for exercise, which used to be a daily activity of hers along with her her friend hiking tried.
However, a common story here is that friends without cancer can't face the reality of their now metastatic friend and often find excuses to not be there.
So this woman had a bit of a happy story for animal lovers. She got a job site with Herman.
We know dogs don't mind Stinky things. So she is comfortable with the unpredictability when she's with Herman.
This is patient reality.
Diapers in dogs when.
When clinical studies referred to manageable toxicities patients as manageable for whom.
You can hear more of my patient quality of life stories from the video podcast series I initiated in which you can view on Jaguar social media channels.
Okay.
The corvette on Earth battery cofounder is the active ingredient and my Tessie.
Our prescription drug product that is already commercially available FDA approved and the on target trial is evaluating the same formulation the same dose of cross selling or that comprises my tessie.
All patients enrolled in the on target study, our solid tumor patients on targeted therapies and focusing enrollment criteria on targeted therapies that cause diarrhea in more than 50% of patients with or without cytotoxic chemotherapy.
And that number of targeted agents is 24 24 of the more than 80 approved targeted therapies. This is what's referred to as a basket trial designed to bring benefit to as much of the patient population as possible.
My Tennessee is already in Commerce, we plan to file a supplemental new drug application or my testing My test. He is approved under a new drug application for its HIV indication, we plan to file a supplemental new drug application for the prevention of cancer therapy related diarrhea based on the on target result.
<unk>, well, most new drug applications fail or get delayed because of a safety issue or manufacturing issue.
My chest. He was already approved for its HIV indication, which is a chronic indication and therefore chronic safety testing has already been completed and the drug of course is available from our network of specialty pharmacies throughout the United States.
So what we're focused on.
With the top line results before the end of <unk> before Thanksgiving. So what we're focused on with these top line results of the on target trial is statistical significance of the primary efficacy endpoint to support a potential expanded label and expensive expanded education.
And promotional activities.
This brings me to the second key takeaway for todays webcast second key clinical takeaway Jaguar supporting investigator initiated an investigator I N D proof of concept studies of a different formulation of profiling or the powder formulation of cross selling there for them in demonstration as liquid oral solution, which.
As a distinct product it's distinct from my testing.
And it's for the rare disease indications of micro V live inclusion of disease I'm going to refer to that as in my D, which is a congenital diarrheal disorder.
In short bowel syndrome, I'm going to refer to that as SBS.
With intestinal failure.
We're supporting these trials on three different continents U S Europe, and the Middle East North Africa regions.
Well sell them or has been granted orphan drug designation by both the FDA and the European Medicines agency, which is called the N a.
N V I D N S. B S with intestinal failure and we expect to have proof of concept data coming from six different third party proof of concept studies on three different continents between the ended the year at the beginning of 2024 again just around the corner.
In accordance with the guidelines of specific European countries published data from such clinical investigations could support reimbursed early patient access to cross sell them or.
For SBS <unk> N V I D for these catastrophic and orphan lifelong conditions.
And we're looking to we're targeting by late 2024.
This is the program the early patient access program to reimburse early patient access program that does not exist in the United States by forming Napoli Therapeutics in 2021 in Italy, we put our commercial footprint in Europe to be able to take advantage of this opportunity well the product is going through a full global.
<unk> program and.
And the ideas of severe it's actually an ultra rare infant disease characterized by intestinal failure.
Yeah, no absorption asset base instability bottomed.
Bottom line, requiring intensive parenteral support for nutritional and fluid management every single day.
There are currently no approved drug treatments or any other therapeutic agents in development that we're aware of for N V I D.
Personal failure is a catastrophic health situations, but often afflicts patients with short bowel syndrome as well.
And the short bowel syndrome patients a typical gun is about 2025 feet for a normal person assure bell might be five feet or less it could be due to congenital reasons. It could be do surgery could be due to an accident in this situation, there's not enough intestinal surface area to absorb the nutrients of light proteins.
Cards, vitamins and minerals et cetera.
These patients typically end up on parental nutrition seven days, a week 20 hours a day.
And absolutely catastrophic situation as I mentioned and a significant opportunity also for infections and complications this need for daily IV injury intervention has high.
<unk>, Unfortunately high mortality and high expense it can cost from a half a million dollars or $2 million a year to take care of these patients and the resulting complications.
There is a product approved for short bowel syndrome, which is called to due to new nucleotide. It's not the standard of care and it's utilizing a small percentage of patients. It's basically a growth hormone and everything in the pipeline that we've been able to find in this category is.
In the category of a growth hormone, where you're attempting to grow that got a bit. So the parental nutrition can be reduced by about 15% to 20% and now you have an accepted regulatory endpoint.
But we're looking to do with cross selling or is to decrease the secretions, where novel anti secret Tory agent to hit that regulatory endpoint of decreasing the need for parental nutrition by about 15 or 20% as well as benefits dual formation as you can imagine with a short cut its like a set of what goes incomes.
Right out.
Let me go back to the growth hormone approach.
They also have no benefit in a situation where the good is fully intact, but not functioning which is the case in several different congenital diarrheal disorders like N V. I E. The good is fully intact, but there is intestinal failure. So theres nothing to grow Theres no benefit of a Brooklyn alone approach.
That'd be limitations with the growth hormone approach for example.
And patient has cancer or risk of cancer or some abnormal hyper proliferative disease, you don't want to be giving a growth hormone.
Patients recovering from surgery, which is the case for many of these patients typically need 15 to 18 months for bowel adaptation, where they can't be.
Administered a growth hormone the preliminary should not have any of these limitations were looking to have fulfill them to become the standard of care in the treatment of intestinal familiar broadly whether it's due to short bowel syndrome or involves a fully intact got which.
It seems to be about 50% of the market.
Now if we go back to cancer and are on target with trial.
When we talk about prophylaxis for cancer therapy related diarrhea, it's important to note that cancer is our number one side effects associated with cancer therapy.
We think about an analogous situation as I had mentioned chemotherapy induced nausea, and vomiting, where there are agents approved.
Agents are typically used prophylactic Lee for just the first three days in the cytotoxic chemotherapy as opposed to a chronic diarrhea that we're talking about with these targeted therapies that patients are on often for the rest of their life.
To go back to.
Chemotherapy induced nausea, and vomiting the market.
<unk> is expected to be down about $4 billion in 2029, and this is according to third party market research I health care analyst and easily half of that market is priced and valued as it as a generic they're originary products available.
When we're talking about prophylaxis for cancer therapy related diarrhea, with targeted therapies that are taking long term and clinically often for the rest of the patient's life in a metastatic situation.
We're talking about a much more profound situations for number of patients and how long they can benefit.
The standard of care for.
For cancer therapy related diarrhea.
Is believe it or not to take the patient off their cancer therapy.
Or to go to a sub therapeutic dose or to start at a sub therapeutic dose.
We think about promoting and loperamide agents that you can get at the pharmacy. These are opioids.
And opioid based and you can't use in opioid based such as Imodium or paranoid on a chronic basis. They havent, specifically been tested or approved for cancer therapy related diarrhea.
And.
When we think about it.
Ah patient being taken off their cancer therapy now, we're talking about an impact on the outcome of the cancer care.
And in some cases once you go off of therapy. You then have to move on to another one so you start to run out of options.
One of the reasons why we designed the on target trial as a prophylactic trial is to address the problem before it happens. So the patient does not have to adjust their cancer therapy regimens regimen lifesaving cancer regimen.
Close to diarrhea.
With me on target trial, there are different aspects of the study that I think resonate with different audiences different benefits.
First there's the goal of supporting the comfort and dignity of patients to supportive care aspect of preventing diarrhea. In these patients that are on targeted therapy.
And what could be more important than patient quality of life. That's what it's all about in the pharmaceutical industry.
Next though there is a third party study in fact, often by Dr. Pablo <unk>, who is also the national principal investigator for our on target study and his study indicates that patients with cancer therapy related diarrhea are 40% more likely to discontinue their chemotherapy or targeted therapy.
Then patients without cancer therapy related diarrhea.
And that may be something that resonates loudly with the oncologists as we mentioned the opportunity for patients to stay on their cancer therapy and have an impact on the outcome of their cancer treatment.
And then thirdly, there's also an independent third party studies authored by Dr. Eric Rolling a member of Napa Scientific Advisory Board.
It shows that it costs about three times as much to take care of a cancer patient with diarrhea compared to a patient without diarrhea.
Given the need for a diary related visits to the hospital for Rehydration office visits prescriptions certainly of interest to reimbursement organizations. So these different aspects these different potential benefits patient quality of life, keeping the patient on their cancer therapy.
Cost are all important they may they may have different levels of priority in recognition of importance with different audiences.
The cancer treatment landscape has radically changed where in the age of targeted therapies and essentially most targeted cancer therapies work by mechanism that induces the type of chloride ion channel diarrhea that is specifically addressed by cross selling them or <unk>.
<unk> is normal it's a first in class anti secrets, Laurie gastrointestinal chloride channel modulator normalizer.
So polymer normalizes gut function, there's no aging that's been specifically tested for this type of diarrhea.
I think normalizes got function.
If a patient is in a normal situation in taste profile of mirror nothing happens, so it's active and normalizing and providing its benefit in.
And abnormally active.
Secretly situation, which occurs often.
In cancer patients on targeted therapy.
When we get to the rare disease and orphan indications of intestinal failure associated with short bowel syndrome with congenital diarrheal diseases, such as N V. I D that I described.
You also have an agent here cross sell them or that has demonstrated safety in order to be used on a chronic basis. The global short bowel syndrome market is projected to reach a value of 4.6 billion.
One 6 billion by 2027 and that's according to a third party report vision research reports.
And it's because of the significant morbidity mortality expensive interventions complications necessary to maintain these patients typically on parental nutrition seven days, a week 20 hours a day.
And as I mentioned, you know with with that administration comes those complications. So our goal is to introduce a completely new approach in standard of care to the management of intestinal failure and the reducing the chronic need for parental nutrition.
In this patient population.
Other upcoming catalysts at this momentous time for Jaguar.
Include the very prestigious San Antonio Breast cancer Conference, which is early in December where the results of our pivotal on target trial have been accepted for poster presentation.
Because this is a basket trial, where Roland includes all solid tumors will be able to put out that topline data. This month and have the scientific presentation December focused on the breast cancer participants.
And then also be able to present results at upcoming cancer conferences in 2020 for focusing on for example, the lung cancer patients with liver patients ultimately ASKO, which is typically in may which is the the the Grand annual cancer Conference.
We expect to simultaneously be pursuing the regulatory track.
With positive data, we would plan to file a supplemental NDA for the current approved my Tennessee to expand the indication to prophylaxis of cancer therapy related diarrhea, with the goal of achieving approval and having the product available to cancer patients in 2024.
Certainly manufacturing to that goal right now.
So again I can't say it enough in November we'll have topline data from the on target trial released and there'll be a continual flow of data and news.
From this very rich trial thereafter.
I've indicated the most important clinical events that we feel are momentum drivers in beacon can be transformative for the value recognition of Jaguar the very very tough time in the biotech industry. We don't know any other company our size our valuation that has.
This type of late stage clinical data.
On a product that is already approved.
To really bring some recognition to the pipeline and the strength and the neglected need and the opportunity for all our stakeholders, including the shareholders in the company. We have a lot of news coming up we're very high volume traded stock, we don't have any structured deals and our capitalization currently we do.
Have any warrants that anybody's trading around.
So we feel like we're in a good position to not only have value for the patients which is what it's all about their quality of life.
You had also the coincident benefits that comes to as I mentioned, all the stakeholders in the company as well.
Before I hand, the discussion over to our.
So Carol I think I'd like to tell all of you participating today that I know with important.
Pivotal data around the corner we.
We will not be hosting a Q&A segment at the end of this webcast. We do expect to have another webcast with the on target pivotal data release as I mentioned around the corner well.
Well now move to the financial results for the third quarter Carol you there.
Okay.
Okay. Good yeah.
Yes.
Can you hear me.
Yep Yep.
Very well I'll begin my review of our financials for the third quarter 'twenty to 'twenty three.
The combined prescription net revenue for my Tessie and casually easier CA, one was $2 $8 million in the third quarter of 2023 reps.
Representing an increase of 5% compared to the combined net revenue in the second quarter. So in each one of these suites.
Which totaled approximately $2 $7 million.
And a decrease of approximately 11% over the combined net revenue in the third quarter of 22, which totaled approximately $3 $1 million.
My taxi prescription volume.
Main unchanged in the third quarter of 2023.
Compared to the second quarter of 2023.
<unk> decreased approximately seven anyhow for cents in the third quarter of 2023 compared to the third quarter of 2022.
Prescription volume differs from Invoiced sales volume.
Which reflects among other factors varying buying patterns among specialty pharmacies in there close to that work.
They manage their inventory levels.
Loss from operation.
Decreased by $1 $1 million.
From $9 $9 million in the quarter ended September 32022.
Two $8.8 million during the same period in 2023.
non-GAAP recurring EBITDA for.
For the third quarter of 2023.
Third quarter of 2022.
Or a net loss of 6.2 million and eight and a half million dollars respectively.
Net loss attributable to common shareholders decreased by approximately $4.7 million from $12 6 million in the third quarter ended September 30, 2022.
The 7.8 million in the same period in 2023.
That concludes my recap of high level financials for the third quarter of 2023.
I'll now hand, it back to Lisa.
Yeah.
Thank you Carol and as you can see in our Q filing our current cash position is over $6 million to recap will the market for small cap biotech sits in a horrible state at present.
Jaguar fortunate that we have two major and what we feel are transformative clinical events coming up shortly literally around the corner with the potential to take pipeline opportunities to major blockbuster opportunities and these are clinical efforts that started many years ago. So as I mentioned unfortunate that they are concluding.
This year.
These are two major opportunities to help address.
Important significant neglected medical needs for patients what follows from a focus on patients.
Are the benefits to all the stakeholders in the company.
We at Jaguar, and our family of companies, including Nappo Pharmaceuticals, So you often hear Napa and Jaguar used interchangeably.
Our highly energized about these important near term initiatives. Thank you for attention and interest and we expect to have another webinar. Shortly this year.
<unk>.
The conference has now concluded. Thank you for attending today's presentation you may now disconnect.
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