Q2 2023 Jaguar Health Inc Earnings Call

Jaguar as if you know the company is a commercial stage pharmaceutical company focusing on developing novel proprietary prescription medicines sustainably derived from plants from rainforest areas for people primarily in animals with Gi distress.

Physically overactive bowel, which is fresh lexicon introducing today.

There's a range of interpretations when we use the word diarrhea with the terminology overactive bowel. We include symptoms such as chronic debilitating loose watery stools or someone referred to diarrhea.

Also Gi urgency and unpredictability in G I incontinence.

All disrupting and disturbing to the patient their quality of life and their health.

I'll now review also the relationship of the Jaguar family companies.

<unk> pharmaceuticals wholly owned by Jaguar focuses on developing and commercially for commercializing the human prescription pharmaceuticals, we developed.

Napa Pharmaceuticals, propelling our drug product candidate is the subject of the on target study our ongoing pivotal phase three clinical trial for preventative treatment of chemotherapy induced overactive Bell B I O B and that is the acronym that we're all going to start to get used to CIO.

<unk>.

In adults with cancer on targeted therapy.

Jaguar family Company Nap, both therapeutics as opposed to an Apple Pharmaceuticals, Nappo Therapeutics is an Italian Corporation Jaguar established in Milan, Italy in 2021 focused on expanding profiling or access in Europe .

Lee for rare diseases.

Jaguar health doing business as analog Jaguar animal health focus is on developing and commercializing animal prescription pharmaceuticals, and nonprescription products, a small portion of our business.

And then Magdalena Biosciences is a joint venture recently formed by Jaguar and the women's health and his focus on earlier stage developing novel prescription medicines derived from plants for mental health indications non crop element related.

As a reminder, our commercialized human prescription drug product.

Polymer is brand named my testing the generic name is correct. All of them are brand name My testing. It's a first in class anti secrets are required ion channel modulators approved initially in the U S for the specialty indication of symptomatic relief of non infectious diarrhea in adult patients with HIV.

AIDS on anti retroviral therapy that has the label.

As the term specialty market imply this is a relatively small market in the United States.

Indication was fast tracked by the FDA and that's primarily the reason why it's the first FDA approved indication for <unk>.

For Palmar My Tessie is plant based it's organic it's natural it's sustainably harvested it's fair trade and it is the only oral prescription drug approved by the FDA under per technical guidance. There is no practical pathway to bring a generic.

Asian of cross selling or to the market under botanical guidance.

So in addition to all the patents we filed just like any other pharmaceutical company doesn't hold the expense associated with that.

We essentially have an exclusivity position forever.

And that's a very powerful factor when we're in discussions for example, corporate partnerships and we're talking about terminal value and net present value and potential license fees non dilutive funds to come into the company.

We have global unencumbered rights to cross element. So there are always business development activities and discussions going on and you never know when these are actually going to occur.

And come to the public consciousness.

Well the market for small cap biotech is.

Is undeniably and a horrible state that presence.

We are Jaguar are fortunate.

This year that we have two major and what we feel are transformative clinical events coming up in the next couple of months literally around the corner that.

It takes pipeline opportunities to major blockbuster opportunities and this is the most important takeaway message from today and I'll say it again, two major late stage clinical events, which we feel will be transformative for our company value recognition and patient.

Assistance.

First and foremost these late stage clinical events are major opportunities to help address neglected medical needs for patients and what follows from a focus on patients.

The benefits to all the stakeholders in the company financial and otherwise.

As I frequently say, what's really powerful about cross selling or is that it is a pipeline within our products fulfill them or has the potential to be expanded to multiple follow on indications beyond the HIV indication.

Can't focus on all potential indications at the same time. So the ones that we are prioritizing are focusing on now are.

Chemotherapy induced overactive Bell Ci Ob and happened in which we're going to get used to see I O b.

Which previously we have been referring to as cancer therapy related diarrhea. So.

Let me make that link for a long term followers CTD cancer therapy related diarrhea, now referred to as a more inclusive C. I O b.

And.

Two rare disease indications short bowel syndrome, and micro needless inclusion disease N V I D with intestinal failure.

S. P. S. Your bowel syndrome in N V I V with intestinal failure.

Catastrophic medical situations for patients, where they end up on total parental nutrition for up to 20 hours a day seven days a week.

There are currently no approved drug treatments for N V I D as.

As we were thrilled to announce last week the S. T. A activated our investigational new drug application for cross selling or <unk> for the treatment of N B I D.

And the FDA approved a physician I N D for an SBS patients with or distressful in severe diarrhea situation.

We are so grateful that Corona has an opportunity to benefit these patients who are not only managing really difficult health situations. So also the dramatic impact on their quality of life.

Our Paramount near term completion of our clinical activity for a phase III pivotal on target trial of my testing. This is literally the same formulation as my testy currently on the market.

For the follow on indications of the preventative treatment of chemotherapy induced overactive Bell.

We've completed.

Patient enrollment foreign target an important milestone on our journey to making copolymer available to treat the neglect of comorbidity of C. I O B and topline results from this pivotal trial are expected in late October of this year 2023 again, one of the most important takeaway messages.

This call topline results in late October of this year to potentially expand the indication my testing.

The C I O b.

In support of our goal of obtaining FDA approval for a paradigm shifting first oral drug for the preventative treatment and management of suite C. I O b.

<unk> is the first trial of its kind of.

The trial includes participation of adult cancer patients with a diversity of solid tumor types, we call that a basket trial.

It is the first clinical trial to include multiple targeted therapies that have greater than 50% all grade diarrhea on their label and which by the way he decided because typically works in a real world setting situation than the label.

Includes targeted therapy.

With or without standard cytotoxic chemotherapy being administered to the patient.

And it is the first trial for prophylactic use the preventative treatment.

Which with targeted therapy is a situation where you're treating the patient.

Potentially for months and years, often essentially for the rest of their lives and both the curative and metastatic situation.

We compare this to for example, the established chemotherapy induced nausea and vomiting.

Protocols and by the way that is referred to as C. I N V.

Treatment typically occurs for the first three days with C. I N V in a limited cytotoxic chemotherapy treatment protocol.

So.

See I Obi chemotherapy induced overactive bell.

Is a dramatically different situation from the nausea C. I N V in terms of the length of treatment.

There's an estimated $1 9 million new cancer cases projected in the U S for this year 2023.

The global market for the comparable C. I N V. Prophylactic indication is projected to reach a value of approximately $3 9 billion.

2029, and that's according to market research from an outside firm eye health care analyst.

Those products are taken for approximately three days for the six months or so of the duration of cytotoxic chemo. The on target study design is studying preventative treatment of C. I O b.

Chronically administered targeted therapy, essentially every day for months and years and sometimes from the rest of the patients hopefully extended in quality of life.

Another important similarity is the preventative treatment to address and assist the opportunity for the patient to stay.

And with their anti cancer therapy, potentially affecting the outcome of the patient's cancer care in a positive way.

I'm going to refer back to the lexicon shifted C. I O b, which as you've heard is similar to the terminology for C. I N V.

So C I N T chemotherapy induced neuropathic pain.

Preventative labeling benefits the patient who could be dealing with severe watery stools daily essentially changing the patient to their home as.

As well as the patient who deals with the unsettling unpredictable and disrupting surprise diarrhea, which might happen once a week once a month, but unpredictable.

Both circumstances can be isolating embarrassing and impact the dignity and well being of the person with the cancer diagnosis as well as the health and compliance to other therapy in locations the anti cancer therapies.

As you know analogy think a preventative treatment for epilepsy, you don't want to wait until the seizure occurs to treat you want therapy onboard to prevent and mitigate the impact of a seizure. That's how we think about the preventative treatment of the full range of episodes of C. I O b.

The cancer treatment landscape has wonderfully radically changed where in the age of targeted therapies youre seeing our ties them for new targeted therapies wherever pharmaceutical companies advertise direct to consumers.

Dozens of approved targeted therapies, most if not all of which cause diarrhea by the exact secret Tory mechanism that CRO Felonry normalizes fulfillment was a novel first in class anti Sikh retort gastrointestinal chloride channel modulator.

It is the disruption to.

<unk> is caused by oversee accretion of fluids into the intestines. Following the active secretion of chloride ions into got so the utmost as that occurs from the actress accretion of X. This card items into the gut and the water. Therefore that follows and then the watery diarrhea that occurs.

By normalizing I am whoa fulfill them as unique mechanism of action it normalizes the flow of fluids in into the intestine.

Normalized intestinal behavior.

Fulfillment is taken orally in it.

Locally in the gut, meaning it goes into the intestine and it normalizes that over activation as I just described it doesn't block it up or clogged up.

Normalizes that over activation.

Which normalizes the flow of water in the intestines and billing brings a fluid situation back to normalcy.

When you think of anti Diarrheal historically, you think of products, such as Imodium and loperamide, which were taken typically typically after a diarrhea episode occurs then.

These products are opioids and they essentially work by the mechanism of constipation.

And obviously you can't stay concentrated chronically.

Well that one is not an opioid and therefore does not have that risk of constipation, because fulfilling her was acting locally in the gut. It doesn't have any no known known drug drug interactions.

Fulfillment doesn't have secondary metabolites, causing problems later on you don't have a first pass effect in the liver and its not an antibiotic. So you don't have the resistance that antibiotics can generate and the safety profile is part of why we focused on complicated patient situations, where you don't want to interfere.

With her lifesaving therapies, and you do want to address the quality of life and the health care health benefit implications that can come from managing C. I O b.

Yeah.

The two most common reasons, why new drug applications fail or safety and manufacturing my Tennessee is already on the market for an improved chronic indication. So we've already completed for example, two year carcinogenicity safety is a huge hallmark of the product we have never seen a side effect profile different then.

Placebo and we have no series adverse events that have been reported for a product that's been in the market for many years now and then thousands of patients living with HIV AIDS on label.

So in October when we release top line data, it's a matter of what is the statistical significance.

On the primary endpoint for the on target trial in people undergoing cancer treatment. That's the key transformative event for the cancer indications C. I O b.

Again top line data last week of October and then the rest of the data it is so.

Theres, a beautiful collection of secondary endpoints in a rich database that will come from the completion of this trial. The rest of that data will come out in conferences and presentations that will make throughout the next year.

As we prepare for the potential approval of my Tessie product that's already in full supply chain from the rainforest essentially any specialty pharmacy in the United States for this important new indication for this much larger neglected market opportunity with a much larger number of patients.

Actually benefiting.

Yeah.

[laughter] Rina.

We believe the on target trial will successfully demonstrate the normalization copolymer provides to the over activation.

<unk> targeted cancer therapies and that cofounder shouldn't be taken as a companion drug every single day.

And should be part of the standard targeted therapy protocols.

Well patients are remaining on their targeted cancer therapy again, either you know curative situation or to maintain cancer as a chronic situation that patients can live with.

And the key word here is live with not just exist.

But.

Live life fully addressing the quality of life.

<unk> undergoing cancer treatment focusing on control and Disney.

In a common voice in the choice of how to live.

This is the power of patient voice.

Which importantly is infused throughout our development and educational planning.

And there are potential important health benefits to highlight as well, which is very important not only for the patients and of course, the health care providers prescribing providers also for payers.

Publications show that about 40% of the time people living with cancer on targeted therapies will go to a sub therapeutic dose or go off their life saving targeted therapy because of the side effect of diarrhea loose watery stools overactive Bell.

So preventing.

This type of diarrhea, otherwise known as chemotherapy induced overactive ballas, we're introducing today can support better adherence to cancer treatment for patients and better treatment outcomes and it's been shown that it costs about three times as much to take care of people living with cancer and targeted therapies when <unk>.

I suffer from loose water stools diarrhea as well.

I'll now discuss Jaguar is to prioritize rare disease investigative indications for a novel profile them or how.

Powder and highly concentrated oral formulations, so copolymer, yet a different product than my tessie.

N V. I D is a life threatening an ultra rare autosomal recessive disease estimated to effect a couple of hundred newborns and children globally, leading to intestinal failure.

Significant morbidity and even death from severe secrets diarrhea.

Well there are currently no approved therapeutic treatments for M. B I D total parental nutrition delivery of nutrition of life.

And I V.

Which is the standard of care for the management is N V I D.

Cost around $150000, a year or multiples of that with complications.

MDI patients suffering from severe Colorado liked the diarrhea daily daily.

Daily and symptomatic management of diarrhea in N V. I D may reduce their dependence on parental nutrition.

We plan to host an investor facing webinar in the near future with leading pediatric Gastroenterologist further elaborate the value of managing diarrhea, and N V. I D patients with intestinal failure and bring a greater understanding to this ultra rare disease.

<unk> has been granted orphan drug designation by the FDA and the European Medicines Agency EMA for N V. I D N prevail and Theres also been granted orphan drug designation by the FDA and the EMA for short bowel syndrome, which is referred to as SBS.

S P. A L S.

S. P S patients with intestinal failure are also treated with parental nutrition.

Jaguar.

Is supporting investigator initiated proof of concept studies of cross selling or for S. P. S. N V. I D with intestinal failure in the EU and Mena regions with the goal of reducing dependence on parental nutrition by about 15% to 20%.

Known and accepted regulatory endpoint.

We're also providing product for an FDA approved physician I N D. Four in SBS patients here in the United States.

We'll be looking at improved stool volume.

N stool formation and other metabolic measures.

In accordance with the guidelines of specific EU countries published data from such clinical investigations could support reimbursed reimbursed early patient access to cross sell them or for short bowel syndrome or N V. I D are both potentially in 2024th for these <unk>.

Hitting conditions in early access programs, which do not exist in the United States, providing opportunity for reimbursement will impacting the morbidity and high cost of care for these chronic neglected needs and it was a major catalysts, an impetus for us establishing nappo therapeutics in.

In Europe to be able to have feet on the ground to be able to access.

These early patient access opportunities for both patients and the benefit for all our stakeholders and again that is the second major what we feel is a transformative clinical event late stage clinical event in 2023 around the corner.

For these rare diseases to effect the opportunity for.

Patients to access these products in 2024.

An estimated 40004 thousand patients around the world. So it's a typical rare disease business model S. P. S patients have high morbidity and mortality I expense.

Active patient advocacy group.

And the patients require very expensive and toxic in some cases very toxic parental nutrition essentially every single day 20 hours a day for the rest of their lives.

The goal the global SBS market is projected again. These are rare disease business models, it's projected to grow to by third parties to $4 $6 billion. In 2027. This is a market research firm vision research reports other studies put the growth to approximately two.

<unk> billion dollars.

And the standard of care at this time for the population of SPF patients is in fact parenteral nutrition.

So to recap here, we expect to have top line results from our phase III trial for <unk> for the prophylaxis of chemotherapy induced overactive Bell C. I O b.

In the last week of October this year.

And we expect initial proof of concept evidence before the end of the year for patients with either S. P. S. <unk> N V I D with intestinal failure and supportive early patient access participation in certain European countries. So both potentially.

<unk> revenue generations in 2024 based on these late stage clinical results and 2023.

Before I hand, the discussion over to our CFO Carol.

I'd like to let all of you participating today know that we will have a brief Q&A segment at the end of the webcast to address any questions.

Submitted in writing and they 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 in the U R. L. For our website is Jaguar got health.

And we'll now move along to the key financial results for the second quarter of 2023, Carol I'll turn it over to you.

Well, 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 2023.

Prescription product net revenue was approximately $2.7 million in the second quarter of 2023.

Representing an increase of 36% compared to prescription product net revenue in the first quarter of 2023, which totaled approximately $2 million.

And a decrease of approximately 8% over prescription product that's revenue in the second quarter of 2022.

Which totaled approximately $2 $9 million.

Yeah.

My Tuffy prescription volume.

Increased approximately 4% in the second quarter of 2023.

Compared to the first quarter of 2023.

<unk> decreased approximately 4.5% ended the second quarter of 'twenty three.

<unk> to the second quarter of 2022.

Prescription volume differs from Invoiced sales volume.

Which reflects among other factors.

Or are you buying patterns among specialty pharmacies in the closed that work.

They manage their inventory levels.

Loss from operations increased by $1.6 million from $6 5 million.

In the quarter ended June 32022 to.

Two $8.1 million during the same period in 2023.

Largely from increased research and development expenses.

Weighted to the clinical trials for C. I O b.

Other indications.

non-GAAP recurring EBITDA for the second quarter of 2023 in the second quarter of 2022 were a net loss of seven $8 million and $5 $3 million respectively.

Net loss attributable to common shareholders.

Increased by approximately $2 8 million from $9 $4 million in the quarter ended.

June 30, 2022 to.

The $12 2 million in the.

The same period in 2023.

That concludes my recap of high level financials for the second quarter of 2023.

And I will now hand, the discussion back to Liza countries.

Thank you tear them, we are Jaguar and our family of companies are highly highly energized about all of our important initiatives underway in 2023 and the culmination of these late stage clinical events and what this can mean for patients and all that follows from that.

We have no questions that have come in unless I have.

Screwed up my access to them, but I believe we have no questions. So with that we'll conclude our call for today. Thank you all who have listened and participated in support Jaguar.

Have a good day.

Thank you. This will conclude today's conference you may disconnect at this time and thank you for your participation.

Yeah.

Okay.

Yes.

[music].

Oh.

Yeah.

[music].

Yeah.

[music].

Yeah.

[music].

Okay.