Q4 2023 Jaguar Health Inc Earnings Call
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 products and pricing industry trends and productive initiatives.
Including products in the development stage, which may not achieve scientific objectives 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 currently available information and management's current assumptions expectations and projections about future events.
While management believes 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 the worst this webcast for a variety of reasons, including those described in the forward looking statements and risk factors sections of the company's Form 10-K for the year 2023 which was filed on April 1st 2024.
And its other filings with the SEC, which are available on the Investor Relations section of Jaguar's website.
Yeah.
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 the company supplements its condensed consolidated financial statements presented 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 that reflects the basis upon which company management assesses and operates the business.
These non-GAAP financial measures should be viewed in isolation or as substitutes for GAAP net sales and 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.
At this time, it's my pleasure to turn the call over to Lisa Conte Jaguar Health founder President and Chief Executive Officer, Lisa the floor is yours.
Lisa A. Conte: Testing 123.
Lisa Conte: Okay.
Lisa Conte: No.
Lisa A. Conte: Thank you for joining our investor webcast for the fourth quarter of 2023, Hello. My name is Lisa Conte I'm, the founder President and CEO Jaguar Health and our wholly owned subsidiary Napo Pharmaceuticals as usual I may be using the words Jaguar Napa interchangeably to refer to our company on it. Thank you.
<unk> for joining this webcast.
Lisa A. Conte: Let me start with the burning question I hear from shareholders. The timing of release of results from the on target trial.
Lisa A. Conte: On targets as a reminder, is our pivotal phase III trial of <unk>, which is our novel plant based prescription drugs.
Lisa A. Conte: For the prophylaxis of cancer therapy related diarrhea in patients with all solid tumors on targeted therapy.
Lisa A. Conte: With or without cytotoxic chemotherapy.
We completed the in life treatment phase of approximately 280 patients in the fourth quarter of last year 2023.
And let me describe a bit of that study.
Lisa A. Conte: It's a first of its kind patient reported outcome study and what does that mean the clinical endpoints are based on real time patient reported outcomes recorded in a digital App reported daily in a digital app.
Lisa A. Conte: Was conducted in six different countries.
Lisa A. Conte: The database is locked and what does that mean.
Lisa A. Conte: Patient reported outcome data the primary endpoint data is secure and we are fully confident in the integrity and the security of the data and I'm going to repeat that several times, we are fully confident in the integrity and security of the data.
Lisa A. Conte: So why are there still no results reported from the on target trial.
Lisa A. Conte: As with many small companies and to tell you the truth, even large pharmaceutical companies involved with expansive global pivotal trials.
Lisa A. Conte: We use several third party contractors for example for complex highly complex statistical programming algorithms and who all must adhere and do adhere to G. C. P. Good clinical practice compliance good clinical practice.
Lisa A. Conte: Holiday measures required by the FDA for human clinical trials.
Lisa A. Conte: These activities are integral components of what we referred to as the statistical analysis plan for on target.
Lisa A. Conte: Alright, and November 2023, well, we the company were still blinded to the results and what does that mean that means nobody in the company knows what patients are on placebo or consumer.
We became aware of an error in the programming from one of our statistical analysis contractors.
That would be applied the algorithm that would be applied to the data of the trial.
Lisa A. Conte: Again, this does not touch on the integrity of the data collection the algorithm that would be applied to that data.
Lisa A. Conte: Since we remain blinded candidly it took us some time to process what to do.
Lisa A. Conte: Could there be more.
Lisa A. Conte: We are aware, we are a small company with high expectations for timing of a key milestone key milestone being the relief of the on target data a milestone for our phase three trial for a potential supplemental indications for a product that's already proved that this could be transformative.
Lisa A. Conte: With respect to both the company valuation and.
Lisa A. Conte: The patient community and need.
So in order to address the complexity of statistical programming needs.
Lisa A. Conte: Remember, there's around 10 different solid tumor types 24 different targeted therapy six different countries daily patient reported outcomes.
Lisa A. Conte: Anywhere from 90 to 180 days multiple intraday centuries of day.
Lisa A. Conte: We have retained a clinically savvy and a very experienced bio statistics and programming expert and we did this back in 2023 to review and to lead and oversee the statistical programming N V implementation of the analysis plan.
Lisa A. Conte: He is leading this effort with informed expertise and what does that mean.
Lisa A. Conte: This expert Biostatistician also led the analysis of the successful pivotal phase III advent trial, which led to the approval of cross sell them or for the current indication for HIV related diarrhea. The my chest you trade name product.
Lisa A. Conte: And therefore.
Lisa A. Conte: He understands the endpoints in the context of Cofounders paradigm shifting mechanism of action for normalizing Gi function in a chronic situation of a first of its kind clinical trial.
Lisa A. Conte: For the supportive care indications in cancer patients.
Our charter to him.
Lisa A. Conte: It should go where he needs to go working under G. P's.
Lisa A. Conte: And work with urgency.
Lisa A. Conte: We could not and did not put a specific time constraints for a process that was unfolding and that is why we have not been able to reliably issue a precise timeline for the completion of data analysis.
And results disclosure for the on target trial.
Lisa A. Conte: Of course, we have been updated the results are forthcoming.
Lisa A. Conte: I recognize on causing frustration and that I cannot reliably provide a specific date I can reliably assure all of you that the integrity of the process of the data analysis as well as the data itself leading to the clinical trial results disclosure.
Lisa A. Conte: As our first and foremost priority.
Lisa A. Conte: Okay.
Lisa A. Conte: I'd like to speak to our strategic focus are important strategic focus and the fortitude of our commitment to cancer supportive care.
Lisa A. Conte: A prominent cancer patient advocate.
Lisa A. Conte: A person living with metastatic cancer for 15 years.
Lisa A. Conte: Speaks to 21 different five six distinct side effects of cancer treatment that she has managed throughout her continuing battle with cancer.
Lisa A. Conte: Obviously.
Lisa A. Conte: There is an abundance of unmet medical need in cancer supportive care to our mission.
Lisa A. Conte: What's more important and patient quality of life.
Lisa A. Conte: D comfort choice.
Lisa A. Conte: Choice.
Lisa A. Conte: N.
The opportunity to be able to maintain adherence to lifesaving cancer therapy.
Lisa A. Conte: What we're all about.
It's estimated.
Lisa A. Conte: Approximately 80 plus percent of cancer survivors have unmet supportive care needs and many many many patients go off or reduced their lifesaving cancer therapy.
Lisa A. Conte: Specifically because of these adverse side effects.
Lisa A. Conte: And as an example patients with cancer therapy related diarrhea C. T D topic near and Dear to my Hearts have been shown more than 40% of the time to discontinue their chemotherapy or their targeted therapy, they're lifesaving cancer therapy.
Lisa A. Conte: Cost of diarrhea, 40% more likely than patients without.
Lisa A. Conte: C T D.
Lisa A. Conte: We at Jaguar Nappo are evaluating additional commercial opportunities in cancer supportive care to supplement our efforts and C. T D and.
Lisa A. Conte: And by the way see TD as an indication we also referred to as chemotherapy induced overactive Bell.
Lisa A. Conte: So do stay tuned to our first further efforts here.
Lisa A. Conte: Our participation in elevating patient voice in cancer care is a key initiative in this pursuit. We have established and are just launching digital channels multiple digital channels devoted to creating.
Lisa A. Conte: Community.
Lisa A. Conte: Conversation exchange and education jointly with cancer patients. These.
Lisa A. Conte: These will be launched in conjunction with our participation at the oncology Nursing Society Congress Congress, which takes place in April April 24 through 'twenty in Washington D. C. This year.
Lisa A. Conte: And the American Society of clinical oncology <unk> annual meeting, which takes place at the beginning of June in Chicago This year.
Lisa A. Conte: Nurses nurse practitioners are key partners in navigating patients supportive care journey journey.
Lisa A. Conte: Our digital channels, providing opportunity for patients to share their stories.
Lisa A. Conte: And we will also include a video blog that I host.
None: As I too became a person living with a cancer diagnosis this past year.
None: It happens.
None: And it's happening way too frequently.
None: At the end of this call will be sharing with video highlighting the company's passion for supportive care X as expressed by key personnel from Jaguar.
None: Way too many people are living with cancer or have a loved one living with cancer diagnosis.
None: Key word is living.
None: Our mission is to help passions live with cancer not just.
None: Exist.
None: One additional recent event very exciting recent events solidifying our patient focus is the recent out license deal. We just completed with Gen. Iraq, a company called <unk> I will refer to them as Jen.
None: Jen is a public Turkish specialty pharmaceutical company with a business model centered on partnering with global innovator pharmaceutical companies like Jaguar.
None: To bring therapies to their territories to serve significant unmet medical needs.
None: And I just returned from Turkey. This week kicking off the collaboration with Johns founder and CEO.
None: His long experience 34 years in the Turkish market and neighboring countries and his house.
None: <unk> for cancer patient support of care.
None: Drove this important caproate collaboration at this time.
None: Prior to the availability of on target results.
None: He also recognizes the value opportunity in jaguars upcoming potentially transformative value event.
None: As Jen has invested $2 million and a 70% premium.
To where the stock is trading.
None: Jen is also a market leader in rare disease indications as part of the recent license agreement. Gen. Also has licensed rights to cross sell them or for the rare disease orphan indications of intestinal failure with short bowel syndrome, Sps and micro viewers inclusion.
None: <unk> disease and V I D.
None: They have Jen has.
None: This decatur manufacturing capabilities, and we'll we'll be working with them on our novel highly concentrated liquid formulation of <unk> for these orphan indications, which is a distinct product from my tessie, which is a pill formulation of <unk>.
None: Jaguar is currently supporting five different clinical efforts in intestinal failure across three different continents intestinal failure with Sps and M. B I D.
None: With strong leadership and participation coming from our Italian subsidiary Nappo Therapeutics.
None: Let me tell you about Napa Therapeutics Doctor Masimo Ridell eat as a board member of Napa era, as well as I am and I'm very pleased to announce that we have appointed masimo to the role of president of Jaguar International.
None: Masimo is the European pharmaceutical industry leader.
None: This Takeda leader and entrepreneur.
None: With more than 35 years experience in the sector and in particular in the innovation of therapies developed to treat rare and orphan diseases.
None: He holds a ph D in clinical pharmacology. He's remarkable he was just with me on this recent trip and other trips to Turkey to make the Gen deal happened.
None: He lives and breathes the pharma industry his relationships at the key leadership of many pharmaceutical companies.
None: For example was instrumental in bringing about the introduction to and the recent agreement with Jim.
None: His focus will center on supporting and driving our efforts to further develop and expand Jaguars business outside of United States.
None: A few minutes will play a short video for Masimo in which he discusses why he has decided to expand his role in Jaguar the value that he sees and participating with Jaguar and we are so thrilled and grateful he is doing so.
None: So in summary, the cancer treatment landscape has radically changed for the better.
None: In the age of targeted therapies targeted therapies are allowing people to live longer and are often taken chronically for years in some cases decades.
None: However.
None: The advent of targeted therapies has also led to a rise in treatment related side effects and unmet supportive care needs.
None: As a company with a deep dedication to patient supportive care, we are increasing our focus on cancer supportive care.
None: Through the process of bringing fulfill them here from a tree in the rainforest too.
None: Pharmacies are product in pharmacies across the United States for supportive care indication for people living with HIV AIDS.
Sure GOR has gained a great deal of experience about educating.
None: Health care professionals and patients and payers.
None: About a paradigm shifting mechanism of action.
None: Well, the HIV market supportive care, maybe a stagnating market and in some ways thankfully due to the innovations in HIV treatment.
None: Important care needs in cancer are increasing.
None: We acknowledge the rigors of both short term.
None: And perpetual treatment and do.
None: Do not believe any cancer therapy related side effects, whether it's extreme fatigue debilitating diarrhea.
None: Here loss chronic neuropathy chronic pain.
None: Or any of the other 21 side effects should ever be viewed as acceptable or tolerable. There are no tolerable toxicities.
None: And now we will hear from Masimo for Delhi, and then from our CFO Carol Liza regarding the financial highlights from the fourth quarter of 2023.
None: And then I will be back thank you.
None: Today is Eddie Ambling day for me.
None: He reminds me of my through yesterday in the pharmaceutical industry.
None: Manny is a little more than 35 years ago.
None: Like many of you there.
None: Joyce <unk> to come to work.
None: And I can meet or beat.
None: Because I believe in <unk> and <unk>.
None: Where the best opportunities for me.
None: I am sure we are doing things without lot of Zurich.
None: Our programs our product.
None: Our values and our experience to ultimately make the award at a better place quote our patients before they families.
None: A new Tolkien with our Chief Executive Officer, Lisa there.
None: There was no bad debt company to join <unk>.
Lisa A. Conte: I wanted to make a difference for the quality of life.
Lisa A. Conte: All of our patients.
Lisa A. Conte: The same is mutation.
Lisa A. Conte: <unk> continues to drive me today.
Lisa A. Conte: This is an incredible honor for me to say that this company and to devote really mindful mycological it and the clinical experience.
Lisa A. Conte: Additional time to the company.
Lisa A. Conte: Focusing on new debt a <unk> solution.
Lisa A. Conte: Granted the orphan drugs.
Lisa A. Conte: Products and innovative specialty pharma products and technology.
Lisa A. Conte: And the.
Lisa A. Conte: Together with them with my inclination that medical national experience to <unk>.
Spanned the geographic today says over Jaguar.
Lisa A. Conte: Around the world.
Lisa A. Conte: We must be angry to do more always.
Lisa A. Conte: <unk> always.
Lisa A. Conte: Very angry to do more.
Lisa A. Conte: I learned in my longest theory is that the pharma and biotech companies.
Lisa A. Conte: Do not respect could edition.
Lisa A. Conte: The Companys Daddy spec only innovation.
Lisa A. Conte: In innovation.
Lisa A. Conte: Well no.
Lisa A. Conte: Excuse me, we'll now hear from Pat. Thank you Masimo phrases amazing statements in amazing contribution again, we're so grateful to have him involved already making.
Pat: Very very important difference in.
Pat: Getting products to patients with I have an echo there.
Pat: And fulfilling the mission of Jaguar and CRO Fellinger Karel I'll now turn it over to you to talk about the financial highlights from the fourth quarter and in association with our K filing today.
Karel: Well, thank you Lisa and thank you all for joining our webcast today.
Karel: I'll begin my review of our financials for the fourth quarter of 2023.
Karel: Prescription product net revenue was approximately $9 $7 million in the year 2023.
Karel: Representing a decrease of approximately 18% over the combined prescription product net revenue in the year in 'twenty, 'twenty, two which totaled approximately $11 $9 million.
Karel: The combined prescription net revenue was approximately $2.3 million.
Karel: In the fourth quarter of 2023.
Karel: Representing a decrease of 18% over the combined prescription net revenue in the third quarter of 2023.
Karel: Which totaled approximately 2.8 million and a decrease of approximately 30% over the combined prescription net revenue in the fourth quarter of 2022.
Karel: Which totaled approximately $3.3 million.
Karel: My tests in total prescription volume tico.
Karel: Decreased by about 4% in the year 2023 over 2022.
Mike Kathy Oh prescription volume increased slightly by approximately 1% in the fourth quarter of 2023.
Karel: Compared to the.
Karel: Third quarter of 2023.
And decreased by approximately 4% in the fourth quarter of 2023 over the fourth quarter of 'twenty two.
Karel: Chris Decryption volume differs from invoice sales volume, which reflects among other factors varying buying patterns among specialty pharmacies in the coal network as they manage their inventory levels.
Karel: Loss from operations decreased by $100000 from $34 4 million in 2022.
Karel: With $34 3 million in 2023.
Karel: Which included an impairment loss on intangible assets.
About $400000.
Karel: non-GAAP recurring EBITDA for 2023, and 2022 were a net loss of 34, and a half million dollars and 27.4 million respectively.
Karel: Net loss attributable to common shareholders decreased by approximately $6 $2 million in 2023.
Karel: From 47, and a half million in 'twenty two.
Karel: To 41 3 million in 2023.
None: That concludes.
Please my recap of high level financials for the fourth quarter of 2023.
None: I will now have the discussion back to Lisa Conte.
Thank you Carol.
Alright, I would like to bring this call to a conclusion, let just again reiterating.
Lisa A. Conte: Jaguar the family of companies Nappo, we are highly energized about our important and near term initiatives. Thank you all for joining thank you for support of our mission to support the quality of life the dignity.
Lisa A. Conte: The treatment outcomes of people in need around the world and in particular, our focus right now on cancer therapy.
Lisa A. Conte: Associated side effects.
Lisa A. Conte: We're going to end our webcast at this time and we have one less video that we're going to play a few video of the Jaguar team members speaking about what cancer supportive care means to them.
Lisa A. Conte: And again it will be a launch of multiple digital channels and we look forward to having an interactive conversation with those.
Lisa A. Conte: Dealing with this topic. Thank you all very much.
Lisa A. Conte: Hi, There my name is Lisa Conte I'm, the founder President and CEO of Jaguar health in our wholly owned subsidiary Napa Pharmaceuticals.
Lisa A. Conte: Our our natural product prescription pharmaceutical company.
Lisa A. Conte: Our mission is to do something important something lasting.
Lisa A. Conte: <unk> sustainable for the patients that we serve.
Lisa A. Conte: In that vein, we are fully committed to the field of cancer supportive care.
Lisa A. Conte: It's more important and quality of life patient dignity patient advocacy patient choices patient comfort.
Lisa A. Conte: So I've asked each of my senior team members to talk about what supportive care means to them.
Lisa A. Conte: And I would like to ask in the past year.
None: I too became a person living with a cancer diagnosis it happens.
None: The key to me is.
None: Living with a cancer diagnosis and not just existing.
None: And that's the core of our mission as well.
None: You very much for this opportunity to introduce you to Jaguar Nappo, while cancer treatment was revolutionized.
None: As an oncologist I took care of many patients.
None: We're not by traditional option to me supportive care mean innovating new option to meet those needs. So patients can focus on their quality of life.
None: So go to Paris.
None: One's wellbeing.
None: <unk> pricing contract.
None: Anna tripled per tougher Christine.
None: Hi.
None: All patients.
None: When colleges supportive care to me.
None: Is that small cloud on a scorching summer day that blocks the sun offering the hope of reprieve.
None: It's the compassionate belief that alleviating a patient suffering we're restoring their degree.
None: Major send the message.
None: That inspires patients the key findings.
None: It's the wisdom to realize that saving a patient's life and <unk>.
None: Real life worth living are not mutually exclusive that we can have both.
None: This is a partnership that gives each patient.
None: Voice and their own oncology care.
None: Our not only the actual business director here at NAPCO.
None: But I am a loving husband over creators cancer survivor.
None: Who's in her third year remission.
None: Yes.
None: To me supportive care means management of the S for side effects, such as diarrhea vomiting.
Assessing unmet supportive care needs.
Having a chronic pain team behind them.
None: Psychological support.
None: Organized groups and having good quality of rehabilitation.
And being able to continue with their cancer treatment.
Having integrated care teams and protecting utter vital organs and functions and most significantly empathy empathizing with a patient and being sensitive to their needs.
None: Cancer supportive care is really important and central to our mission as a company and what it means to compete with.
None: We get to help patients through one of the most difficult experiences of their lives.
None: I sum it up in Emily one sentence and that's actually not my words, it's the words of a leukemia survivor and she said, it's not just comparable to survive, but to thrive and I think that's the most important thing that we can do for patients.
None: What are you supportive care to me.
None: To me supportive care is cancer care that puts the patient experience first.
None: Providing support of care to a patient with cancer involves not only addressing their physical needs such as the cancer, but also addressing and caring for their psychological their spiritual and emotional needs and my role I've seen firsthand how sn.
None: Support of care is to oncology patients it's.
None: It's not just about the treatments redevelop but about ensuring a quality of life for patients and their families.
None: Supportive care means acknowledging the person behind the diagnosis and dedicating ourselves to their comfort dignity and hope.
None: Since our company's core belief that every single patient deserves compassion and support on their journey through cancer treatments.
None: To me cancer supportive care means addressing cancer therapy side effects, so that a patient has a better chance to stay on therapy longer.
None: Proving their survival odds, while at the same time, improving their quality of life supportive care to me means dignity. It means life just focusing on the patient is being treated and not just what they are being treated.
None: This report you can consider as a fundamental component of the modern oncology visa both my personal point of view.
None: The advent of a new concept therapies in particular alongside aspect of the growth and the aging of the population better survival rates for the treatment of oncology patients.
None: So see the cost of care is uncovering a fundamental lever that must be clearly define it to be integrated the supportive care services.
None: Across the global spectrum of the disease or the oncology supportive care can be defined in two simple yet powerful words.
None: Passion.
None: And love.
None: To me supportive care means relief from unnecessary pain.
None: Ability to live life more fully.
None: And the ability to live with dignity, which everyone deserves.
Curt: My name is Curt <unk> I'm, the Chief scientific officer of macro Pharmaceuticals, and Jaguar health.
Curt: I am also a cancer survivor.
Curt: As a cancer patients from the time of diagnosis of cancer.
Curt: Through the treatment and subsequent survivorship.
Curt: For all of them affect your activities of daily living.
Really three things eating bathing and mobility.
Curt: To me, Kansas supportive care supports all of those three fundamental and essential activities.
None: And that's fine.
None: We are happy to be a part of this journey.
None: Supportive care to me means DVD quality of life compassion kindness as part of the healing process.
None: Yes.