Q4 2019 Earnings Call
Good day and welcome to the Jaguar 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 growth prospects for the company uncertainties regarding market acceptance of products.
Competitive products and pricing industries industry trends and product and technology initiatives, including products.
Elements stage, which may not have chief scientific objectives or meet stringent regulatory requirements.
These 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 managements current assumptions expectations projections about future events, well management believes that its assumptions expectations and projections are reasonable.
Currently available information you are cautioned not to place undue reliance on these forward looking statements.
Actual results may differ materially from does discussed and that's called for a variety of reasons, including those described in the forward looking statements and risk factor section of the company's form 10-K for the year ending December 31, 2019, which was filed April 3rd 2020, and its other filings with the FCC, which are available on the Investor Relations section.
But site, except as required by law Jaguar 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, it's going to condensed consolidated financial statements presented on a GAAP basis by providing gross sales non-GAAP EBITDA and non-GAAP rent recurring EBITDA Jaguar believes that the disclosure items at these non-GAAP measures provide investors with additional information that reflects the basis upon which company management and stuff.
This is an operates the business. These non-GAAP financial measures should not be viewed in isolation, whereas substitutes for GAAP net sales and GAAP net loss and are not substitutes for or superior to measures of financial performance in conformity with gap.
At this time, it's my pleasure to turn the call over to Lisa Conti, Jack White House, President and Chief Executive Officer, Lisa the floor is yours.
Thank you. Thank you very much and thank you all who are on the so very much for joining our call today.
My name that leads to compete.
Founder and CEO of Jaguar Hill, and our wholly owned subsidiary no pharmaceuticals are they use the names nacco and Jaguar interchangeably throughout this call.
First I of course, when it's in my warmest wishes to everyone has we all navigator. These unprecedented online me feel grateful to report that everyone, a jaktwo Jaguar and now so we're fine.
Well sheltered at home doing this cold remotely and as such we would not be taking to anything today.
Third as a company has been together over 10 to 25 years three lines have been working together for over 30 years.
That's trusted familiarity and continuity allow us to work well together, even one working remotely now we literally finished each others do sentences.
30 years ago, we were in the middle of another can't get Nick HIV and pronounced though you run the mission to find actually source plant based medicine to meet urgent global health needs.
We successfully brought my tessie from the tree immune responses, we harvest for me Amazon resource to the first and only oral Nancy prescription medicine crude under botanical gardens by the FDA.
Today, we find ourselves in the middle of the calls at 19 and Dennis.
Looking the Dfc to determine if my Tennessee they'd be appropriate for emergency use authorization for symptomatic relief of diarrhea in patients with Cobiz 19.
[noise] nearly 38 million people live with HIV globally in nearly 25 billion people use anti retroviral therapy based on data from you and things at the end of June 2019.
As a reminder, my Tennessee, the first in class parents, they speak with reagent currently ft crew for the indication is symptomatic relief noninfectious diarrhea in adult patients with HIV being on anti retroviral therapy.
We have an essential partner with my testing were essential business.
And we've anticipated stocked up in taking steps to ensure that patients living with HIV, who rely on like testing has interrupted access to this first of its current world class B prescription medicine.
I can't see as we've said before the product in the pipeline, we're actively developing multiple potential follow on pipeline indication focus on T.I. indication.
Most of dance being cancer therapies, evaded diarrhea, which we refer to lets see TV.
Oh, the potential GE, all indications are food irritable bowel syndrome.
Glover toward bowel disease encroachment supportive care functional diarrhea.
In pediatric where gastrointestinal disease indications.
There are five primary topics will be covering for today's call was blocked participating speakers from the company to think speakers.
I'll begin with its got his update regarding our ongoing business development efforts and provide an update on Kohl's is 19 related activities.
Next I'll turn the discussion over to our senior VP of finance and Chief Accounting Officer, Carol like that.
I will recap financials for 2019 them because lot of comparisons to 2018.
After Carol will introduce schemes and our vice president of commercial strategy, Ian will discuss the multiple facets of Napcos enhanced market access strategy for my Testy currently approved indication of HIV would be the death diarrhea.
Which is an initiative we're quite excited about does occur in real time.
Dr. Stephen King Archie So that no botanical science and also the project leader of our Colorado Development program will provide information regarding recently approved funding support from the National Institute of allergy and infectious diseases.
In support of the color program moving forward.
He will also discuss the world and traditional medicine has played and potentially currently playing.
The fight against global pathogenic scourges.
And finally, dr. 'cause instead of city, our Chief Scientific officer will speak to the regulatory developments related to customer for the potential P.T.D. indication as potential pediatric rare disease indications for congenital die real disorder in short bowel syndrome.
Let's jump right in looking forward. We believe 2020 has the potential to be a transformative year for Jaguar example, our core goals for 2020 include initiating the pivotal trial and the second half of this year for my Chesty for CTG cancer therapy everybody.
Diarrhea in completing the rollout of our enhanced market access strategy game, which is part of the company's larger strategies to support the health of HIV patients, especially during this time of global crisis.
The majority people living with HIV AIDS in the United States are older.
As Tim Anderson, the founder of the nonprofit organization, let's take care a survivor syndrome.
Pointed out to me recently, not our first pandemic week so.
The community is resilient as is now, though and we believe or enhance patient access plan will help expand my testing axis.
HIV patients.
You'll hear more about from here.
He do our business model this sustainable de conversion business peppers supports the company's strategy to become a stable cash flow causes business supported primarily by growth in my TFC failed.
Simultaneously and as I stated before we are confident that by mid 2020, well for regional X U.S. business development deal, possibly more than one.
Bringing dawn to beat of dollars to support the pivotal trial initiation indoor key clinical development activities for pipeline follow one indication with my 10th Street.
I'm Entre and NAPCO is pipeline pipeline pipeline jurors by business development business development business development for that pipeline mobilization.
We have a remarkable risk mitigated product pipeline pipelines have been in product I can't say that enough.
Which contains multiple novel in important one indication for like testing.
I remind you a jump product that is already approved by the FDA for chronic indication and therefore supported by chronic safety package GNP commercial manufacturing is in place where my testing and several of the follow on indications for my testing are backed by strong phase two.
Endorsed proof of concept data.
The depth of our pipelines provides potential supportive care solutions for large patient populations across multiple disease indications around the globe.
And we believe this pipeline just fewer long term value creation for investors and provide non dilutive funding opportunities for park the collaboration around the world.
I really like a cancer therapy continues to be the core focus of our pipeline development efforts a significant portion of the patients undergoing cancer treatment experienced diarrhea.
Novel targeted cancer therapy agents, such as their Liberals Dr. receptor antibody Herceptin for example, and tyrosine kinase inhibitors receptors.
I'm, sorry, I'm getting retired thing playing these inhibitors with or without standard chemotherapy agent.
They activate natural chloride secretion pathways in the gastrointestinal Q mucosa.
Potentially leading to the secret Troy diarrhea.
According to data appearing in treatment guidelines for the I'd, which stands for chemotherapy induced diarrhea owning a P.T.D. and this was in the table 2004, it's true of Gastroenterology and Endoscopy news.
I mean, the most common adverse events reported in chemotherapy patients.
So I read it in this patient population has the potential to cause dehydration.
Okay see anti motility agent.
Just the opioid movie in the low pair my close constipation and left the Gi.
And many cancer patients with only require drug holidays for dose reductions in real life saving cancer therapy.
Better management of diarrhea allows for better or potentially allows for better compliance with the therapeutic dosing of targeted treatments for cancer.
And as we've shown in relevant animal model potentially leading to better clinical outcomes for cancer patients and in particular for cancer patients a long term as had been therapy.
You continue I wasn't mentioned our efforts to make my kids be available for supportive care was weighted to cope with 19.
We submitted an emergency use authorization request on March 21st 2020.
The request was based on in accompanied by a letters endorsement submitted to Dr. Janet Woodcock director of the FDA Center for drug evaluation of research MCC to F.D.A. Commissioner Dr. Stephen coupon.
From a world leader in the field of infectious diseases and epidemiology.
The letters endorsement is based on information in publications is key opinion leaders has been reviewing real time.
Which indicate that there is adequate information to document diarrhea, and other gastrointestinal symptom or early thinking at the school that 19 prior to the pulmonary symptoms.
His review of data also supports dependent but the virus can be shipped from the guts and it does potentially transmittable via this people.
Decreasing sequel volumes by changing the stool consistency from watery deformed school.
He to the mechanism of action and the result of my testing with not only support patient care.
But could does all could reduce the contagion with which to health care providers.
As we've heard from D.F.D.A., they expect to get backed with indeed with respect to this potential off label use of by testing.
So pleased to have the if these attention for request to provide possible supports it could be thinking patients and potentially reduce contagion among patients and healthcare workers.
And we're grateful to I'm proud of the Minneapolis stakeholders that have taken the initiatives and perseverance in the time of chaos to play a meaningful will and speaking to aggressively during this pent demand.
Back to a major core business.
We'll now move along through the 2019 financial results.
The company filed into 2019 10-K on Friday book Thered be a SIFI. The 10-K kind of course be viewed on the Fccs website.
On the Investor Relations section of the Jaguar website.
I'll now turn the call over to characterize that Jaguar Senior Vice President and Chief Accounting Officer to read New topline financial results for the year ended December 31st 2019.
Carol.
Thank you Lisa and thank you all for joining our call today.
Keith financial highlights for the year ended December 31, 2019 are as follows.
2019, like Catsix net sales were approximately 5.7 million.
An increase of 36%.
And year over year.
And my TFC.
Total prescription volume increased 62%.
2019 and over the year 2018.
The total operating expenses 40 year.
2019 was 34.7 million.
Compared to 35.2 million for the year 2018.
A 1% or 500000 decrease year over year.
The decrease in total operating expenses.
Was primarily due to the write off of goodwill.
I'd point 2 million, India 2018.
Offset by an impairment of long lived intangible assets for 4 million.
600 mill thousands in the settlement of the royalty license agreement.
That concludes my recap of high level to play that shows for 29 team.
I'll now hand, the discussion the works to our next speaker he and win.
Good morning, all Oh, we succeeded in her opening comments and then the company announced last week.
Hello is expanding that whole carriers or patient support program for my cousin.
The company that's good news.
<unk> prescription drugs indicated for the symptomatic relief of Noninfectious diarrhea in adult patients living with each I'd be on any merger of oral therapies.
The changes to the Nacco cares program aren't going to increase my 20 patient access.
Take and persistent can.
We try to interact with the which is chronic diarrhea due to the direct or indirect effects of each already on the GR truck is a problem for many HIV positive patients. Unlike certain anytime real products are only approved for acute use because he is a non opioid right because it's a very low risk, causing constipation.
He was approved for contribution its unique mechanism of action helps ensure the diarrhea does not have to become the normal for adult patients living with I'm trying to be on individual therapy.
Our field teams efforts remain focused primarily on positions were already like he might cause he prescriptions on a leading access issues for each locations.
And on increasing the duration my cousin therapy maturity pensions is clinically appropriate also reducing my treasury related cost burden in non government supported beer channels.
Expansion should not who cares program reasons income limits on patients eligible for unopposed uninsured free drug program significantly increases coping support commercially insured patients when allows the coke amount to remain the same whether a patient fills a 30 day, we're going to do prescription of Partovi <unk>.
He became effective on people first.
The key components of the medical care as market access program involves offerings significantly expanded support for Errol eligible patients to reduce out of pocket cost as a barrier to obtaining markedly in the U.S. Yoo income women for the patient assistance program, which offers free drug uninsured patients increased from two times.
The federal poverty limit the five times, the federal probably one.
150% increase and then I couldn't be coakley benefit for commercially insured patients.
Increase rumor from an annual maximum $1200, the $6000, which was a four or 400% improves.
Most eligible patients will now pay no more than $25 for them I can be prescription. Additionally, patients can now use their copay cards or to refill Mckinsey prescriptions earlier and every 30 days.
Fast start prescriptions will soon be available to provide immediate access to my pleasure for patients who she reimbursement challenges in a bridge drip program will soon be available for patients who have a lapse insurance coverage.
To support providers patient.
Patients with access services from reimbursement in prior authorization support.
Two appeals and patient assistance dispensing for my cousin Napcos working with Florida based was just Rx designed and implemented a comprehensive BP support services program. The Starbucks has extensive experience supporting each of you you shouldn't trends developing industry, leading technology platform called <unk>.
Streamline therapy in the fusion.
Our new market access strategy is also designed to significantly increase the number of specialty pharmacies involved in back have you distribution specialty pharmacies offering high touch patient engagement model to help ensure appropriate using drugs like because the an optimal patient outcomes.
Like that or expanded patient support program is launching dream covert Nike endemic to especially benefit Mckenzie patients and we have lost jobs or health insurance during the crisis.
We're removing barriers for patients to access might cause he and the changes we've instituted should help ensure patients standpoint goods social business, you've got cousins whetstone treating them at occasion diary as a chronic life altering condition and each of these patients on the yorkie and it's our goal to remove like have you actually channels for all patients who need regardless of their income.
Level as well, it's wonderful orders, especially during this national crisis.
That concludes my comments for today, Steve I'll now turn the discussion over to you.
Thank you you can sense for those of you on the phone lead time to join US. This morning, and then Steve King I'm, the chief sustainable supplies, a couple times the surgeon intellectual property officer for Jaguar novel.
Well again I'm happy to report that metabolism formed last week on people first.
Received additional preclinical services from the National Institute of allergy and infectious diseases.
To put the development of luck summer novel drug product candidate pool, they called it indication.
And I like each sweet crude clinical services and it'd be pointed contract with will conduct toxicology testing for 28 day Rat study.
I know you'd be part of the National Institutes would help.
As previously announced wonder and ideally I'd be sweep preclinical services. These NIH funded contract was conducted plots called be tough and of course, some big dogs.
Hello, This is an acute.
I was caused blood infection and tested the vectoring reveal.
According to the centers for disease control prevention of U.S. Department of Health services.
And that's to me that we the 5 million call of acute and more than 100000 called related deaths occur each year round the world.
Due to be hydration not to call it took protection so.
Typically occurs as opposed to 18 hours after inception.
Let them or which we also will prove to be 300 has the same mechanism was asking us for polymer and looking to be less costly to produce.
Previously presented stage to date on football them or for the treatment of the devastating diarrhea and call where patients from that are now International Center.
We will do for you for search stock up on the Dutch.
Funding permitted decline followed soon how do you find collect summer followed that same political.
Same principle investigator and using the same kind of the 12 plates in Bangladesh for the development.
Additionally, we believe this drug candidate makes court afterwards to see priority would be bolger.
Theory for called it indicates.
Fairly review vultures aggressive baidu that due to drug developers as an incentive developed treatment.
That's good diseases and rare pediatric.
But many of you are no doubt, we're not mission dating back to the company spots company founded.
We discovered and developed marbled cookie plant big prescription medicine that can be spots and be harvest proved to be perjured globally.
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Felmer acumen union in by testing over a few crude non opioid prescription growth.
Indicated symptomatically de mob back to Saudi Arabia, and adult patients with HIV.
She's a promote therapies is extracted purified 'cause an amazon reinforced feet bocom likewise.
So that they put quotes on like for like treat other rich history.
Please bring business people so miserable.
At present.
So to cope with my team and then.
There was a great deal of information in the global media related to another plant based medicine, one to change the world a long time ago, the medicine I'm, referring to quinine, which was discovered forgive me, but that's what people Ecuador, Libya <unk>.
It's about the Amazonian seats control not this from house to Transceivers inflammation and pain.
Well you explore consultant medical Duncan wind on this call properties, the beginning with the 17th century.
Whatnot remains an important and from a little girls almost 400 years. After its effectiveness was first documents.
Why not going quite a dime are still at the approved drugs used car yet so there's just too problems and mud systems.
Well I hung ching the world and loyalty, but a lot of European nations to develop.
It's floor talks to region, but have been devastated by on control Board.
Uh huh.
Oh.
The derivatives of corn has to be and Portland, we developed between back to 31, and I think pretty poor to prevent and treat malaria before and after World War two.
Well, if one and the mother of synthetic deliberative hydroxy cooler corn well also use today to treat as opposed to play doesn't lupus.
No medical the switch focusing on the potential to use these two synthetic derivatives quinine to combat who didn't like team.
It's not clear drugs will prove to be safe and or if that's good for golden Monkey.
I believe it's looking remembering.
Medical classes and discovery of mute Therapeutics has roots connected to the medical knowledge and didn't peoples and attract phase of used for centuries part of your traditional mode.
In fact, the interesting historical footnote contractual reportedly once said that the genotypes. They werent can you just move wasn't mine and all the doctors and manpower so called upon to new business, given kind of what's going on.
I'm very proud of the fact that my testing also has its roots in traditional medicine and I'm proud that my test we are the pipeline in the product the Trump employed by Lisa being developed for multiple possible fall wants indications that novels during commitment to develop and commercialize me traditional condensate medicines.
We expect that it won't be another manager for the wouldn't you get made aware of the wisdom of conserving and leveraging traditional medical mileage.
Mhm.
On to you.
Thank you Steve Good morning, everybody thanks for joining.
And my name is for much of anything on the channels.
Gold.
So so it's your scientific officer Pharmaceuticals on Georgia.
At least I mentioned earlier Annapolis.
Sure enough to be clinical trials for from a second half of Twentytwenty.
Pivotal trials for indication prevention and treatment of cancer.
Yeah.
Yeah.
Cancer patients.
Target indications.
I see today as I said.
After studies.
Forfeiting gastritis soda, such a short bowel syndrome.
Yes.
<unk>.
I don't see TV study.
Discussions.
With key opinion leaders and we have received.
Hi, I'm Statistical analysis plan.
We are revising the clinical protocol to accommodate their inputs.
Presenting that occurs at documents and doing the statistical analysis plan.
And then other requirements.
The pivotal don't seem to do.
Okay.
The principal investigator for.
A major institution major cancer institution sticks.
Our goal is to ensure that the protocol consistency unmet medical need for the treatment of seem to be combined with the practicalities operation.
Hi.
We're also ensuring that statisticians from book.
Yes.
Right.
Relevant to perform as unique physiological mechanism of action.
Okay. So do you foresee today's analogous.
Okay.
Mike This is going to pitch I indication.
And as a bottom fraud risk mitigation strategy, we intend to use the same formulation and dosing that's going to commercialize legacy.
In addition to working with key opinion leaders on clinical strategy on trial designs have been coordinating with the multi National Association of supported cancer care.
Yes.
We are supporting their efforts to set some guidelines for the treatment and management of diving in cancer patients.
On a going level to sponsor for the last conference, which was to be held in Spain in June this year.
Plus one for obvious reasons stock.
We will continue to work with the leadership team of mask and provide support.
Why.
China.
I'm doing.
What a pediatric clinical study in the orphan indication.
We prepared a dose.
To support.
Discussion with you.
That weve submitted it and we expect 50 Angelo Gordon.
Approximately 30 days.
Yeah.
The package.
Pretty R&D briefing document from Apple outline.
Okay clinical trial, and shut downs syndrome, and potentially kind of congenital adrenal disorders.
I was going after like the rationale for addressing type.
For sort of climates in children, but it does shortfalls and travel content.
So what does.
Sps on city.
Syndrome and content.
Well I'm much more prevalent in regions, such as the Middle East North Africa region.
Region.
They're not upon sanguine, that's marriages and we're pleased to actually have to support a secure opinion leader in that region Dr. mob mentality.
On the shape coming from a nickel sentiment I would hobbies, providing us with the guidance to conduct appropriate clinical studies in the Mena region.
As mentioned earlier reduction of central or but I'm sort of interesting to climb into these children.
Yes.
So those would improve the quality of their lives as one of them for the on Sofia survival.
That's fair planning for potentially doing two pediatric clinical studies that will provide evidence of safety of my Duffy.
I guess is handled seem to be patients.
And I'll pass the microphone back onto Lisa for her.
Closing comments, thank you Lisa.
Thanks prevent thank you to all the speakers.
And then he told the listeners.
In closing I'm proud to announce this past February nonprofit American detailed councils has given the 2019 Barrow each hardware commercial investment inside of additional research Award.
In recognition of Napcos ongoing commitment to the sustainable development that production of natural therapeutic preparation, we had it wouldn't Miss that award ceremony for obvious reasons as well.
Typically this award acknowledges the successful development and approval of customer, which is derived as Steve said send them a bit snow press on less brightree and the Amazon Green bar.
The development of cooked allover has been the King mission of Napoli core team members for more than 13 years, and we remain fully committed to expanding developer asked us to all patients in need throughout the world.
Previous recipients of this would include our partner Italian based in Dayno, one of the world's largest produces a clinically tested botanical and stuff for the pharmaceutical markets.
As a reminder, like at the is the first and only all plant based subscription Desi drugs approved under Ft aid botanical gardens, and there's no passing by which engineered product can be developed for drugs approved under mechanical guide.
I'm extremely pleased with all our achievements in 2019 and continued to be grateful for the ongoing support and dedication of our employees stock holders and all of our stakeholders as we continue efforts in 2010 20 gross sales.
Bringing on more partners congrats multiple possible follow on indication my testing and drive this company to a breakeven cash flow positive situation.
I'm also very proud to be working with a team that such high integrity values, which have been displayed probably during this time of global crisis.
I'll repeat the words because anderson.
This is not our first pandemic Lisa.
We are grateful to be working together to make a difference in the lives of people living with chronic life altering Gee I conditions.
They said earlier, we believe 2020 has the potential to be is transforming its near the Jaguar and math, though.
With that we concluded our common.
Thank you all once again for joining todays call, they say well and stay home.
Thank you.
And that does conclude today's conference again, thank you for your participation.
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