Q2 2020 Jaguar Health Inc Earnings Call
Good day and welcome to the check your health Investor call Today's conference is being recorded.
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 coaxed prospects for the company.
Uncertainties regarding market acceptance of products, the impact of competitive products and pricing industry trends I'm product and technology is initiatives, including products in the developing stage, which may not have chief scientific objectives, well meet stringent regulatory requirements.
Forward looking statements are subject to risks and uncertainties that could cause actual results could differ materially from those concentration in such forward looking statements.
Statements are based on currently available information and managements current assumptions expectations I'm projections about future events.
Why management believes that its assumptions expectations on projections a reasonable in view of currently available information you are cautioned not to place undue reliance on these forward looking statements.
The Companys actual results may differ materially from those discussed in this call for a variety of reasons.
You didn't dose described in the forward looking statements on risk factor section of the company's form 10-K for the year ending December 31st 2019, which was filed on April Craig's 2020.
Other filings with the FCC, which always available on the Investor Relations section of Jack Yours website.
Except as required by law check your help 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 fix and condensed consolidated financial statements presented on a GAAP basis by providing gross sales non-GAAP EBITDA a non-GAAP for current EBITDA.
Accurate believes that the disclosure actions copies 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 not be viewed in isolation or just substitutes for GAAP net sales I've got that lost or not substitute for or superior to measures of financial performance in conformity with GAAP.
At this time it it's my pleasure to turn the call over a piece of container Joris helps president and Chief Executive Officer, Lisa floor is yours.
Thank you and thank you all who are on the phone very much they're doing or call today.
My name is we've got me I am the founder and CEO I'm Jaguar health and our wholly owned subsidiary Nacco Pharmaceuticals, I made use Jaguar and Napa interchangeably.
I wanted to start today's call by giving my heartfelt. Thanks to our dedicated team many of whom I've been working with meaning over the last 30 via some now persevering would shelter at home with one goal in mind Bonnie responsibly in 16, we harvested Lucy prescription medicines to people in need around the world.
I'm going to start the key financial results in second quarter, 2000, 20 million filled with gratitude inside.
The Jaguar Nacco team has adapted rise during the modified working environment and get it with for example, civil tools and techniques.
We've adopted to support educate you an expanded access to my kids eat well our dedicated sales reps work for the most parts sheltered at home.
My kids being net product revenue during the second quarter 2020.
Approximately $3.2 million compared with net sales during the first quarter 2020 of approximately $830000 net sales for the second quarter of 2020, Ricky This is 378% of the first quarter of 2000.
24, an increase of 2.3 million quarter over quarter.
My Tennessee roads product revenue. This is non-GAAP number during the second quarter of 2020.
Approximately 6.3 million compared with gross sales during the first quarter 2020, which was approximately 1.3 million.
Gross sales for the second quarter 2020 represented 482% of that first quarter of 2020 points increase of approximately 5 million quarter over quarter.
In the second quarter 2020 weeks old 3030 bottle of my testing.
The second quarter 2020, we sold 1950 Bucks.
Q2, 2020 figure that amounts to more than 155%.
Well, the Q1 2020 bottle quantity.
As I've mentioned before we're striving to enhance access to my kids eat all people in United States movie KBB struggling chronic diarrhea, who rely on this drug Mckenzie is an important part she knew regimen.
And to bring my testing to a sustainable commercial business as the company continues to supports its passive.
I can I see the for it's only natural fair trade <unk> Big School drug approved under FDA dependable garden.
Board members libertine begin searching for new drug candidates in 19 Nolan.
Moving to begin to loosen reinforced areas around the world.
In the hands on between traditional village talk a research team about a diversity of plants used to treat the number of diseases and today, we have an extensive library of plants 2300.
First hand, it's not the status investigation with additional crossings and its report includes proton what's the retreat sports caliber.
Active ingredients season like testing.
The key mission of the company.
To advance couldn't so were really did pipeline development efforts.
And we were pleased to report our progress on our lead target follow on indication for my testing the profile occupancy in Cincinnati, we have cancer therapy related diarrhea referred to with the team.
In adult patients with solid tumors, receiving targeted cancer therapy with or without standard chemotherapy.
As we were excited to report last week, our investigational new drug application referred to as not easy.
My NAPCO, we'd be happy with the study is good sound really seem TTB cancer indication is now active.
Activation of this I mean, he is a key milestones we NAPCO to initiate the single pivotal trial with my testing to supporting seek approval in labeling for CTP, which would allow NAPCO. Two then educate them can vote or this education.
We had three speakers for the company for today's call. In addition to me.
Following my comments Carol like that Jaguars, Senior Vice President Finance, and Chief Accounting Officer will provide a brief recap of Q2 2020 financials.
Falling Carol well hear from our vice President of commercial strategy, even when who'll provide updates regarding or recently initiated enhanced market access programs warm I can't see Gordon approved indication.
Symptomatic relief of Don's actually gardea in adult patients with HIV and on Integra therapy.
And just doesn't purging can accumulate because he feels trends related to this new program.
Finally, our chief Scientific officer, Dr., because instead of ready, we'll talk about pipeline activity regarding fulfilling their andacollo testing.
Before we dive in I'd like to an all of you participating today no that we're conducting the call.
I would say listen on the event, which means we won't be taking questions. Whoever we believe today's call will be in answering questions.
I will now turn the call over to care lives there to recap Q2 results Carol Yu online.
Yes.
Thank you Lisa and thank you all for joining our call today.
The key financial highlights for the quarter ended June 30, 2020 odd Stalin.
Net sales during the second quarter of 2020.
Approximately $3.2 million.
And $1.7 million into second quarter of 29 team.
This second quarter.
2020 result.
Represents 186%.
The same period in 29 team.
Or an increase of 1.5 million quarter over quarter.
Total my testing bottled sold for the second quarter of 2020 represented 104% of the bottled sold in the same period in 2019.
The total operating expense for the second quarter 2020.
It was approximately 11.6 million, that's compared to 12.3 million for the same period last year.
A 6% or $700000.
Decrease quarter over quarter.
The decrease in total operating expenses.
Was viewed to a $4 million impairment charge in the second quarter of 2019 and on the same period this year.
And approximately 1 million decrease in Costco product revenues research and development and sales and marketing expenses.
Offset by a warrant inducement expense.
3.7 million.
And then increases in general and administrative expense of $600000.
The net loss for the second quarter of 2020 was 9.2 million compared to a net loss of 16.7 million in the second quarter 29 team.
A 45% or approximately.
7.5 million decrease quarter over quarter.
The decrease in net loss was due to the increase of by took seamless price.
A decrease in operating loss of 2.2 million.
An interest expense was lower by 3.2 million.
A 2.7 million losses extinguishment of debt was recorded.
During the three months ended June 32019, and on the same period this year.
That concludes my recap of high level financials.
The second quarter 2020.
I'll now hand, the discussion they'll work towards that speaker anyone.
Good morning at all.
Second quarter marked significant commercial treatments in financial terms I described were killed.
One of the most successful initiatives to acquire new patients and to increase probably won't be working with the launch of the guy who cares patient support program.
The Jaguar and novel.
We committed expanding our customer activity to all patients in need gold ensuring that no patients with regard to actually was too much of the due to cost.
Applecare initiative, hopefully doctors barriers for patients regardless of the income were hoping sherlyn status.
Okay, that's proven critical.
Cobra offset part out of pocket called simple impose blend true.
Provide free drug uninsured, because all the board electricity and advocate on behalf of patients with insurers required prior authorizations card painful patients.
In particular, the improvements that were made to the coping program showed significant increases the number of months commercially insured patients based on my closing.
Warrants your commercial imperative increase increasing patient persistency.
He services could not have been implemented.
More important God help support patients ability, but usually store and stay on very picky. Once it has been for scored by the provider.
I hope you'll team has been delivering failed cold educational programs and customer support works really well.
Well, we look forward, we're totally blogs or actions, we have effectively leveraged technology would be conducted with customers and drybulk commercial okay.
We've also been interesting that there should be realized with small team with barden reps. If we can now we get customers across many stage disease.
I read the part will drive each of these goals.
As a result of these upwards or commercial payer patients has now increased from 44% between 30% to 55% <unk> second quarter 2020, the very important metric to understand the spring my because you bring in a significantly supported their children Hills.
That includes my comment sort of doing I will now turn the discussion over to Dr., Trevor Baby disgust Goldberg development activities.
Thanks.
Good morning to real cool.
As Lisa mentioned, we now have an active R&D for evaluation My Trophy, which is going from a 125 milligram delayed release tablets for the person like systems symptomatic relief from diarrhea in adult patients with solid tumors, receiving targeted therapy with or without standard chemotherapy.
An important milestone for my testing.
It goes study will evaluate.
Currently are from formulation on my testing at the same dosing regimen.
Logic for these non inspection diarrhea deleverage Ivy its patients.
Hello.
Given the same formulation I don't think we wouldn't be able to continue.
For years, the country established infrastructure for manufacturing testing that really so from accessory.
Oh Tomorrow, we'll be able to cross reference our existing data.
Clinical pharmacology and sort of Nonclinical studies will be approved indication HIV.
He is a significant constantine benefit for the development of like that people gases.
Yes.
The youngest medical need for an interesting dog on cancer patients receiving therapy I mean, hi, currently no physiological reacting entered I don't know drugs.
For kind of sort of into later time yet.
According to the center for disease control intervention CBC, approximately 650000 cancer patients in the U.S. received chemotherapy and outpatient oncology clinic each year.
That is a common adverse event seem to chemotherapy agents typically used in breast and colon cancers.
Particularly in the more recently introduced therapeutic classes. So if it doesn't go to factors such a wonderful an antibody for easier for investors.
That was in kinase inhibitors, OTI carriers, which are often houston onto ventral metastatic setting for the management of cancer as chronic therapy.
For instance, diarrhea has been reported its one of the most common side effects would you care to get tighter hasn't reported screen up to 81% of the patients such a continent recently approved to selective teekay and for the irreversible Antarctica and are not an important living which has reported in this incident that guy ranging between 86% to 95%.
And published studies.
Got it has also been reported to the commentary except for some of the seem to get four six initiatives, which are also use or not you interpret static settings.
Inability of new therapies with entirely on cancer patients receiving targeted scandal chemotherapeutic agents will likely result in improved tolerability of the cancer therapy regimen.
Dosing levels and potentially dangerous dose reductions truck holidays.
Instances in which patients cancer therapies to be discontinued potentially leading to improved considerably adherence and outcomes.
Unmitigated I've gotten cancer patients receiving therapy also has the potential to close mild to moderate.
Ratio increased susceptibility to infections and on non interest.
Yes.
And all of physiological reacting.
My Trophy holds promise for treating secret sorted out again conservation and provides an opportunity to support compliance with the appropriate cancer therapy dosing regimens.
We have demonstrated some of these benefits in the recent dog study.
Which is an appropriate animal model for human diarrhea experience.
15, Apple presented themselves for preclinical study in dogs.
I never done the effects of the Felmer into writing symptomatic relief that are associated with that I turn it over things at the American Association of cancer research, but you're not going to meeting in June 20 to 20. This study was conducted by not book in collaboration with poor biotechnology.
Makes it a broadband technology to guidance approved for an extended out you've been treatment for adult patients with early stage her two positive breast cancer.
And for the metastatic hertwo positive breast cancer.
In addition to not that was planned pivotal.
Clinical study in cancer therapeutic area, that's an ongoing investigator initiated trials.
You would be effects of profoundly interesting functional or chronic idiopathic diarrhea.
They also include I'd be aspirations for diarrhea at the University of Texas in Houston.
Study was recently initiated and patients are being screened and enrolled on the trial has been affected by restrictions due to covert 19.
In other exploratory trial in functional data is being initiated it because of any kind of medical center Harvard Medical School institution in Boston. This study will have before being double blind treatment target filled up there. Another four weeks of up on different treatment, what eligible patients with functional area.
This study is expected to initiate enrollment during Q4 2020.
In addition to be function I missed anything investigator initiated trials in metastatic hertwo positive breast cancer patients at Georgetown University Medical Center is nearing completion efforts enrollment.
NAPCO is also developing a new liquid formulation that allow the initiation of clinical studies in pediatric patients that have congenital target the sodas and acquire feeding tubes, and all total parenteral nutrition support.
That's always going to stay active discussions with clinicians and regulatory exports about this more fun and rare disease patient population.
And is developing the appropriate clinical data from time to support the goal of expediting availability of course summer, but this patient population to addressing your diarrhea.
In summary, the novel R&D team continues to support the development of profoundly cancer therapy to later diarrhea in a dose on it to my patients.
On a couple of million pilot studies for functional and get your pocket diarrhea Anatels on the team is engaged in development of an appropriate pediatric liquid formulation to support stays in pediatric patients congenital down into sodas.
I'll turn the discussion back over to lease the country Lisa.
Thank you for them they he and thank you Carol.
I'm looking ahead to the small I'm excited to announce the Jaguar is planning to host of virtual CPB cancer therapy, diarrhea focused disease education event for investors and business development contest that we're calling diarrhea dialogues with me virtual meeting key opinion leader oncologists pace.
And the kids and supportive care experts will address the importance of supportive care for people experiencing honest lower GE on track to stress.
Typically with regard to build hitting diarrhea.
Variance as a result of cancer therapy.
We hope all investors and business development contacts taking part in today's call to join for this event and will be each week further details regarding event along with information about how to register to participate as we get closer to be October Twentyth date to save the basically.
Yeah I was wondering now though.
We remain committed to our dual strategy.
14 regional ex U.S. business development deals to bring in Nondilutive dollars to fund upwards to keep attention like you see pipeline indications to clinical trial to support our goal of expanding who don't want access to all patients in need throughout the world well, we simultaneously work to become stable.
Cash flow positive business supported primarily by growth you might have seen sales it's approved indication.
Well the pandemic can travel restrictions have elongated those business discussion, there's no doubt needs when my kids globally, and we remain confident that collaborations movies sports.
It's interesting over to the legacy outside of Jaguars business for a moment I'd like to comment regarding our efforts to gain if he could go to market can alenia.
Oh plant based prescription drug candidate for the treatment of cancer induced diarrhea referred to it see I'd in dogs.
As we announced last month Jaguar has submitted to the 58 cents to prevent nearing minutes and just called senior in the.
The second to last required technical section of our application to support conditional approval of candidly via four I see I'd cancer, it's chemotherapy and just diarrhea in dogs under what's called them mining use my new species animal health after 2004, which is similar to orphan drug designation.
The human drug products.
We expect to submit the last section of our application for can't really the of course, the I'd in dogs by the end of this month.
According to current estimates more than 230000 dogs in the United States and see chemotherapy treatment the very cancers, each year roughly one for more than 50000 dogs are estimated to experience diarrhea and to sign effect of the treatment.
There are currently no excuse proved and twice weekly Tory prescription products to management type it debilitating diarrhea in dogs.
Which is not only oh and comfort issued for the dog. The patients. It's also obviously important for the dog owners peace of mind, where their homes and they're living environment.
Since our July 2000, 17000 merger with now though as previously noted.
Definitely human portfolio has been in continues to be our core focus.
Our groundbreaking work to develop treatments the dog suffering from chronic diarrhea devices, hopefully model for the Union medical need it's important to note that most cancer treatment ages provided to dogs are human drug or how to see mechanism of action as human cancer drugs in these agents and mechanisms.
Bashing, often have meaningful ways of diarrhea.
We're seeing in humans in the dogs as well.
We need it absolutely does that mean, we absorb systemically does not alter gastrointestinal motility like no significant effect when normally function is.
Functioning intestinal ion channels, where the transportable after lunch with food and there's no sign of six different from placebo.
The teachers are further augmented by the lack of north Texas cannot leave here on the absorption mineral metabolism of co administered chemotherapy drugs.
Poorly whereby other routes of administration.
In addition to pursuing an indication of 'cause owner for T.I.D. in dogs. Jasper is also seeking to the snow to go to market kind of lead you exercise synergies during the dog.
That's been candidly the it could be available under conditional approval for both see ageing and you know maybe in the first half of next year 2021.
So that two comments on our core Union business.
We look forward to continuing and extending the NAPCO cares program as part of our enhanced market access strategy has worked towards becoming a stable cash flow positive business supported primarily by growth in my Kids seems hills.
Our Montana, not Bovie means pipeline pipeline pipeline driven by business development is as they did.
The focus from being responsible stewards completely every day.
As I frequently state, we have a remarkable risk mitigated pipeline.
That includes multiple novel and important potential follow on indications for my testing and hotel owner in the pediatric formulation.
Which we consider to be a pipeline in eight products and they tend to be the like going into the product.
In Pete commercial manufacturing, obviously is in place for the commercial vacancy in several of our targeted Chris element in like has he probably one indication are backed by strong phase two indoor proof of concept data.
As an addition reminder, because my sense is approved under Ft is botanical gardens.
The only oral product designation, there's no pathway by which the generic version can be developed.
The best work pipeline provides potential supportive care solutions for large patient populations across multiple disease indications around the globe.
We believe its pipeline with fewer long term value creation for investors can provide non dilutive funding opportunities for apartments collaboration.
Beyond the cancer indications TTB pipeline exploration liquids television, including the potential indications such as congenital giant religious movie, which is a rare disease indications with infants and children.
Total chaos for inflammatory bowel disease.
You didn't build bowel syndrome.
In idiopathic functional diarrhea.
Natural pipeline expirations are also underway for a second generation anti Cdtwenty agent left from her.
It's also comes from coupons, absolutely quote potential indication in Colorado, we made a done deal.
Certainly supported by the Nic I'd.
We continue to be concerned about the impact of cobot honor reinforce partners the local in indigenous communities in the previous Amazon.
Part isn't having many areas been impacted like coal, but they are showing resilience in our managing their family farms in communities with great care.
The collection of Wensberg Sakhalin quotes on let's move to the latex material from which might have to is extracted im terrified.
Continuing with only money delays as is essential reforestation with various regions you rely very strongly and our relationships with indigenous in local communities in Peru and on the agent and powerful knowledge. These traditional people have about plan ecosystem and natural healing compounds.
Ongoing sources as and when can do you need to be critical in these regions of through leaving me as those fully committed to supporting our local and indigenous partners as we continue to operate in accordance with relevant regional and National government cool with guidelines in safety measures.
I'm also happy to report that the employee head Count goes Jaguar NAPCO has remained stable throughout the course of the global crisis and Napcos National team a highly experienced HIV sales professionals, we mean fully in place.
We believe 2020 has lived up to our vision, but it would be a transformative year for Jaguar NAPCO I'm extremely pleased with Overachievement. Thus far this year and continued to be grateful for the ongoing support and dedication of our employing our stockholders our local in vision.
As partners and crew and all our stakeholders as we continue efforts to grow sales and progress multiple possible follow on indications. So many tests.
And of course are important important focus on the patients in.
That concludes my call from today. Thank you all once again for joining <unk> they can be well. Thank you.
This concludes today's conference call. Thank you all for your participation you may now disconnect.
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