Q4 2021 Jaguar Health Inc Earnings Call
Please standby we're about to begin.
Before I turn the call over to management I would like to remind you that management may make forward looking statements relating to such matters as continued growth prospects for the company uncertainties regarding market acceptance of products, the impact of competitive products and pricing industry trends and product and technology.
Initiatives, including product development stage, which may not achieve scientific objective or meet stringent regulatory requirements forward looking statements are subject to risks and uncertainties that would cause actual results to differ materially from those contemplated from 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 that its assumptions expectations and projections are reasonable in view of currently available information you are cautioned not to place undue risk.
Clients on those forward looking statements.
The company's actual results may differ materially from those discussed in the column for variety of reasons, including those described in forward looking statements and risk factors sections of the company's Form 10-K for the year ending December 31st 2021, which was filed on March 11th.
2022 .
And its other filings with the SEC, which are available on the Investor Relations section of Jaguar's website.
Okay.
I'm sorry.
Excuse me.
Except as required by law Jaguar health undertakes no obligations to us.
Dave or revise any forward looking statements continued in this presentation to reflect on new information future events or otherwise. Additionally, please note that today's.
Is that the company's supplement its convince consolidated financial statements presented on a GAAP basis by providing gross sales non-GAAP EBITDA and non-GAAP recurring EBITDA Jaguar believes that the disclosure of these non-GAAP measures provide investors with additional information.
Yeah.
So based upon the company's manager, Matt management actresses and.
Operates and operates the business.
These non-GAAP financial measures should not be viewed in isolation or as.
Substitution for GAAP net sales and GAAP net loss.
And are not substitute for or superior to measures of financial performance.
Maybe with the gap at this time it is my pleasure to turn the call to Lisa Conte Jaguar Health Thunder.
Sandra.
Didn't and Chief Executive Officer, Lisa the floor is yours.
Well. Thank you alley that was quite thorough and I understand a mouthful.
Thank you all and welcome.
As you just heard my name is Lisa Conte I am the founder President and CEO of Jaguar Health and our wholly owned subsidiary in the United States Nappo Pharmaceuticals.
I'm also chairman of the board of Napa Therapeutics Corporation, we established in Milan, Italy last year that focuses on expanding profile of our access in Europe specifically.
Specifically in that both Sarah is initially pursuing our rare disease business model based on the orphan designation of cross selling or <unk> for short bowel syndrome, known as Sps, you'll hear me refer to it as SBS throughout this presentation, you'll hear more about that in a moment.
Also of note Jaguar is the majority shareholder of an Apple thera, providing equity interest valued to Jaguar as well as parallel product development activities for cross sell them or in Europe .
I'm going to begin today with a few brief updates and then Carolina Jaguars, Chief Financial Officer will provide a recap of key financial results for the fourth quarter of 2021.
Hear from Carol we're pleased to report that fourth quarter 2021, Mike Hussey net revenue was approximately $2 $1 million versus approximately $600000 in the third quarter of 2021, an increase of 230%.
This increase largely represents the important realization of financial benefits from Jaguars recently completed shift to distributing my tessie through a closed network of specialty pharmacies.
Typically for example, a decrease in distribution costs and an improvement in our gross to net ratio you'll hear more about that transition from Ian Wendt Jaguar as Chief commercial officer, who will speak after Carol.
As a reminder, cribellum her under the trade name My Tessie.
Is our plant based.
Da approved anti Diarrheal drug indicated for the symptomatic relief of non infectious diarrhea in adult patients with HIV AIDS on anti retroviral therapy.
Fulfillment is also the focus of our two core pipeline indications in clinical development each expected to bring transformative value to Jaguar in the next 12 to 18 months.
And this includes prophylaxis of cancer therapy related diarrhea, which I'm going to refer to as CTD throughout this presentation cancer therapy related diarrhea C. T D.
And as the short bowel syndrome.
Which is a catastrophic health situation, which has received orphan drug designation in the United States and Europe .
Let me speak to CTD the cancer indications first we are currently in the midst of continued enrollment for the phase III trial for CTD and that trial is known as the on target steady.
We're aiming to complete 256 patient enrollment of the first half of 2023.
We're in the process now of adding additional clinical trial sites, both in the United States and outside the United States to help ensure patient enrollment despite COVID-19 related restrictions and in global unrest stays on track.
The successful completion of this pivotal trial will result in a supplemental new drug application filing for my Tessie Copolymer, which of course as I mentioned is already approved for the HIV related diarrhea indication in which is approved for a chronic use and has a full FDA comply.
In supply chain in place from the rainforest, so all pharmacies in our U S specialty pharmacy network.
As a note safety and manufacturing are the two most common reasons that new drug application sale, hence we spent much care and communication with the FDA in the design and execution of this final clinical and regulatory steps to bring <unk> to cancer patients suffering with diarrhea.
Diarrhea is the most common side effect of cancer therapy.
80% of patients with CTD. This continue their chemotherapy or targeted therapy, they're lifesaving treatment because of the diarrhea.
And this is not your garden variety traveler's diarrhea patients are often hospitalized for dehydration fluctuating balance and organ failure and some patients have even died from the impact of their diarrhea during clinical trial investigation by the targeted therapy manufacturers.
Okay.
Second core development focus for <unk> in 2022 is the orphan designated disease Sps.
The investigator initiated proof of concept study is expected to be initiated and completed in 2022 sites in the United States and Middle East.
As a parallel clinical development effort by the skills focused in rare disease experience Snapple Therapeutics management team in Europe .
<unk> leadership, including our managing director and Chief Medical Officer, and a head of regulatory and quality and let me expand that the investigator initiated proof of concept studies may include sites in Europe as well.
This study will be for patients with DDD congenital diarrheal disorders are rare inhibit inherited disease clothing lifelong intestinal failure and SBS.
Again for which the European Medicines agency.
Referred to as the ebay the equivalent of the FDA here in the United States granted orphan drug designation to fulfill them or as I mentioned on.
December 13th 2021 key event for the Napa, there, our rare disease business model and business plan.
So why did we established this company Napa third in Europe , and Europe . The EMA is committed to enabling early access to new medicines with orphan drug status, indicating the important unmet medical need.
And they do this to patients through an early patient access program participation in an early access program will provide patients with access to <unk> as early as 2023 potentially impacting in a positive way and morbidity mortality and the cost of care for this.
Chronic indication that has no good therapeutic options.
Abstention cost of care.
<unk> and SBS patients with intestinal failure typically require parental nutrition up to 20 hours a day seven days a week to survive a tremendous cost and with accompanying medical complications, which adds even more costs.
The ability to decrease that by even 20% would provide a huge medical and quality of life improvement in it.
Rare disease business model.
The substantial benefits are highly valued for relatively small patient population.
Global SBS market of approximately 40 to 60000 patients worldwide is expected to reach $4 6 billion by 2027. According to a report from visiting vision Research reports.
<unk> operates under an exclusive license to cross sell and they're from Jaguar rewards Jaguar receives typical license payments, including an upfront payment milestone payments royalties and transfer pricing of copolymer.
Doug will also receive the value of the clinical data generated by Napa therapy thereof.
As reciprocally that both thereof receives the value and ability to utilize CTD the cancer phase III data and Jaguar is developing.
The apparel complementary and geographically focused development effort to fulfill them or two these two core indications CTD in Sps are progressing simultaneously and collaboratively with dedicated teams respectively.
One final advantage of the Napa or upward to Jaguar is that Napa. There is well over a majority owned by Jaguar, providing the equity accretion value to Jaguar shareholders and stakeholders, which we believe is unrecognized at this time.
So once again these are the two core pipeline events, transforming cross selling or two pipeline from pipeline to which we believe will be tangible value in the next 12 to 18 months.
What else as we look forward to an exciting 2022.
<unk> 2022 is the year of the dog in.
<unk> 2021, we received conditional approval from the FDA Center for veterinary medicine for cross sell them or for chemotherapy induced diarrhea, I'm going to refer to that as CIB chemotherapy induced diarrhea in dogs.
This is an exciting.
And important and it's important for so many reasons first and foremost.
This is the key to canine survivability from cancer and the dog pair in consideration of the cancer care decision process there.
There are approximately 100 million dogs in the U S. Thanks to the pandemic post pandemic dogs.
The 25% will deal with the tumor at some point over 50% of dogs over the age of 10.
Does are remarkably predictive of and similar to the human Cid's situation, 40% of the time the dog cannot complete its therapeutic dose of chemotherapy because of diarrhea as is the case in humans.
Extremely relevant in the dog market, though is the comfort factor for the dogs are key factor influencing the dog parents' decision to treat the dog's cancer.
Quality of life of the whole family of dog, losing control on the rugs beds. The couch is an important consideration for the family household.
Well, we do not provide financial guidance, we do feel the dog's civ market to be about the size of the human HIV specialty market.
And the dog market the veterinary market provides much greater predictability of the gross to net ratio since dog parents are typically paying out of pocket for treatment and medications.
You can expect many PR IR educational and promotional events around CIB in dogs throughout 2022.
Education as to the devastating impact to the patient of diarrhea in cancer therapy build awareness.
Regardless of whether the patient is a human or a dog.
And there's more candidly renewed we completed the filing of the major sections with the C V N centre in veterinary medicine for candidly via <unk>.
For our proposed exercise induced diarrhea, I'm going to refer to that as E. D exercise induced diarrhea indication and we hope that in the fourth quarter of this year can leave yeah, we will be available for all working dogs suffering from E. D, which includes for example, I did a rock dogs in this.
It will be known as <unk> two.
Our team is as tenacious and dedicated as the mushers and the teams are dogs currently competing in the Ididerod Trail sled dog race, which officially kicked off.
March six and Willow Alaska.
This is the 15th anniversary of this rugged world renowned 1000 mile race.
Interestingly last year, Brendan Mackey, a well known lusher.
Had to withdraw winter dog experienced E D.
And just two days ago.
In the race this year musher units withdrew halfway into the race after his dogs develop diarrhea.
<unk> said he was upset he had to call. It quits you plan to take his dogs to a friend's house and Ruby to decide what to do next imagine in the future. What he could do next is treat the dogs with candidly via for E D.
Once we have it approved by the <unk>.
Other exciting plans for 2022 include continuing efforts to forge license and business development relationships in key markets around the globe for cross selling or our pipeline within a product.
Also multiple investigator initiated trials that are ongoing that may come to conclusion for other chronic situations, such as functional diarrhea, and irritable bowel syndrome.
And several new initiatives in the commercialization of my Tessie for people living with HIV AIDS to address new behaviors during the pandemic such as adopting a telehealth option for patients and you'll hear more from Ian on that topic.
Finally, a third key clinical milestones for 2022 is the filing of an investigational new drug application with the FDA in the middle of this year for the symptomatic relief of diarrhea from cholera with luck warmer luck Widmer is a different chemical collection of CRO Anthos antigens.
From cross selling or extracted from the CRO ton Westbury tree, the same tree from which we get crowfoot limor.
And which we believe defines lucquin mirrors are distinct products from cross sell them or under F. D. A botanical guidance, which is the guidance upon which <unk> is approved.
And let them or has the lower manufacturing cost and <unk> and works by the same novel anti secret <unk> mechanism of action.
We are planning to initiate phase one clinical styles trials Lucquin Mers study in.
In the second half of 2022 as I mentioned for the symptomatic relief of diarrhea from cholera.
Which is what kills patients with cholera, it's not the cholera infection, it's the dehydration from the massive diarrhea.
And supportive as clinical activity, we received comprehensive animal toxicity preclinical services supported by NIH D for for pre clinical studies.
We plan to pursue a tropical disease priority review voucher for Lucquin or under the Fda's financial incentive program to develop drugs for tropical diseases, such a cholera which provides for an immediate return on investment.
Upon the approval of the product for cholera indication.
On a financial now before I hand, the conversation over to Carol Liza I want to highlight the fact that as of March 11th This past Friday, the Companys cash position was approximately $18 $5 million and Jaguar had a public float exceeding $75 million.
Therefore, the company remains shelf eligible and FCC designation that provides continuing flexibility to issue registered shares quickly and opportunistically, including in connection with potential future business transactions, such as potential asset acquisition.
<unk> purchases of progress payments for services license deal.
And then at the market financing program, we've had in place and currently have in place.
Additionally, as announced Jaguar received a letter from NASDAQ listing qualification staff on February 17th 2022, indicating that the Big prize for the company's common stock for the last 30 consecutive business days had closed below the minimum $1 per share required for continued listing.
We have a six month compliance period and plan to meet the requirements for continued listing on NASDAQ through value recognition.
Of our various milestones in pipeline pipeline progress as I've discussed at this time there are no plans for Jaguar to conduct a reverse split.
Lastly, I'd like to let all of you participating to know today know that we will have a brief Q&A segment at the end of this webcast to address questions. If any submitted in writing questions can be submitted via the webcast link for today's event that appears on the events and presentations page of the Investor Relations section.
<unk> of Jaguar Jaguar website, and the Euro for Jaguar's website is Jaguar Dot health.
We will now move along to key financial results for the fourth quarter of 2021, Carol you are on.
Thank you Lisa and thank you all for joining our webcast today.
I'll begin my review of our 2021 financial results.
With our main focus being on the fourth quarter over the third quarter of 2021.
And year over year performance.
My testing new prescription volume.
Indicator of growth in patient demand increased 10, 4% in the fourth quarter of 2021 <unk>.
Compared to the prior quarter.
<unk> increased two 1% in the year 2021.
Over the year 2020.
Prescription volume diverse one invoice sales volume, which reflects among other factors varying volume patterns among wholesalers in the retail channel and specialty pharmacies in the closed network as they manage their inventory levels.
My testing that revenue during the fourth quarter of 2021 was approximately $2 1 million and approximately $600000.
In the third quarter of 2021.
The increase of $1 5 million.
With 230% quarter over quarter.
The transition to a closed network of specialty pharmacies has resulted in the meaningful reduction you might Turkey distribution costs and higher average that place.
Mike touching that revenue for the year 2021, with approximately $4 $3 million.
Proximately.
$9 4 million for the year 2020.
A decrease of approximately $5 $1 million year on year.
As part of the process of transitioning to the closed specialty pharmacy network.
Third and fourth quarters of 2021 were significantly impacted by the inventory drawdown of approximately 1300 bottles of might've fee across the company's third party logistics warehouse wholesalers distributors and retail stores.
My Turkey gross revenue.
non-GAAP measure.
Was approximately $3 million and $3 2 million during the fourth and third quarters of 2021, respectively.
Representing a decrease of $200000 quarter over quarter.
My test gross revenue for the year 2021 was approximately $15 $7 million for.
With approximately $24 million for the year 2020.
A decrease of $4 7 million year over year.
As mentioned the third and fourth quarters of 2021 were significantly impacted by the engine.
Tori drawdown of approximately 1300 bottles and white custody.
The transition to distribution through the close specialty pharmacy network improved the mitel to gross to net revenue ratio.
My Turkey sales volume distributed to the recently established an expanding closed network of third party specialty pharmacies was 100% of total sales in the fourth quarter of 2021 compared to approximately 38% in the third.
<unk> 2021.
Loss from operation was approximately $10 8 million and.
$95 million during the fourth and third.
Third quarters of 2021, respectively.
The increase of $1 3 million largely from increased R&D expenses of approximately $2 2 million.
Due to our clinical trial costs.
TB and other indications.
Increased G&A expenses of approximately $700000, mostly from the annual shareholder meeting and offset by the increased <unk>.
Revenue in the fourth quarter of 2021 was previously stated.
For the year 2021.
The loss from operations was $47 million <unk>.
Compared to a loss of $26 6 million for the year 2020.
An increase of $14 1 million year over year.
The increase was attributable to the $8 7 million increase in R&D expenses.
This reflects the important R&D activities associated with for example, the conduct of the pivotal phase III trial for CTV.
Including increased personal related expenses.
Manufacturing expenses and contract manufacturing costs in anticipation.
Okay potential launch upon successful clinical trial results.
Sales and marketing expenses increased by $2 3 million related to the expanding market access through specialty pharmacy channels.
G&A expenses increased by $2 7 million.
Largely from the shareholder meeting noncash stock based compensation audit.
Got it and accounting services.
For the year 2021.
Net loss was $52 6 million compared to a net loss of 38 6 million for the year 2020.
An increase of $14 million year over year.
In addition to the loss from operations.
Interest expense increased by $5 6 million from $2 8 million for the year 2020.
To eight 4 million for the year 2021.
Primarily due to the royalty interest agreement.
A noncash change in fair value of financial instruments, and hybrid instruments designated at fair value option or SVO losses decreased 800000 from a loss of $2 7 million for the year 2020.
Two $1 9 million for the year 2021 designated FCO.
The non-GAAP recurring EBITDA for the year ended December 31, 2021 was a net loss of <unk> 37, and a half million dollars.
As compared to.
$24 2 million for the year 2020.
That concludes my recap of high level financials for the fourth quarter.
Year to date 2021.
I will now hand, the discussion over to Ian with John <unk>, Chief Commercial officer.
Thank you Carol and good morning Joel.
Lisa stated the 230% increase in fourth quarter of 2021, my testing net net revenue over the third quarter of 2021, largely represents the realization of the benefits from the company's shift to distributed Mitoses through a closed network of specialty pharmacies, rather than to wholesalers that resell the product.
Our retail pharmacies the process of transitioning to a closed network of specialty pharmacies resulted in a one time short term underrepresentation of my total utilization.
As anticipated Chelsea revenue, primarily in the third quarter of 2021 was impacted by this transition as wholesalers in the retail distribution channel drew down the inventory of typically more than two months volumes are closed network of specialty pharmacies typically orders on a just in time inventory.
This model.
We are pleased to report that the company completed the process of transitioning each mock testing volume to a closed network of specialty pharmacies. This past January .
As a result of the transition no significant marchesi inventory remains in the retail distribution channel.
Carol stated my testing, new prescription volume and indicator of growth in patient demand increased 10, 4% in the fourth quarter of 2021 over the third quarter of 2021.
Creased by two 1% in the year 2021 for the year 2020.
<unk> transitioned to a closed network of specialty pharmacies has resulted in a meaningful reduction in my testing distribution costs and a higher average net price and assist in the preparation of our U S commercial distribution network for future.
Potential future indication expansion of fulfill them or to other populations of patients with complex medical needs such as CTV and SBS.
A key component of the company's market access strategy initiative to transition to a closed networks specialty pharmacies is intended to help remove access barriers for patients prescribed <unk> IC that includes services such as a higher level of support for prior authorizations and appeals adherence counseling and <unk>.
Home delivery options.
Patients often visit retail pharmacies for short term or uncomplicated medical leaves specialty pharmacies focused primarily on serving patients with complex and chronic medical conditions like HIV.
Additionally, in early 2022, we are rolling out new innovative programs that further support identifying appropriate patients and.
Connecting them to care and medication extra services for free.
This program delivers digital mitosis and disease state education directly into a provider's EHR or electronic health record system. So that they learn about my test at the moment. They are seeing their HIV patients. This technology allows us to intelligently deliver ads to a provider based on the profile of the patients that you're seeing in the region.
Andrew This is strictly a one way communication, we have not received will be protected health information related to this program.
The next program is a telehealth initiatives.
Enable patients seeking help with their HIV related diarrhea to be linked immediately to provider for assistance with their medical needs. This will prevent patients from having to wait until the next scheduled doctor visits to get help or hurt your problem. Both of these programs are designed to drive incremental brand awareness among prescribers, who have not written from HFC previously.
And among patients who have not been able to receive immediate cure for HIV related diarrhea.
Turning to the animal health side of our business, we're referring to 2022 as Jaguars year of the dog.
Launch activities remain underway for <unk>, one in the U S veterinary market for the <unk>.
Treatment of chemotherapy induced diarrhea also known as CIB.
Dogs.
Alluded shady. This included CIB treatment forms on January <unk> and March six for veterinarians Thats very oncologist and members of the media during two well attended national gatherings. The veterinary media Expo also called DMX that conferences in Orlando and the Western Veterinary conference.
UBC and Las Vegas.
As with humans discontinue their disease modifying chemotherapy approximately 40% of the time due to diarrhea, and the reception of cannot leave you see one among general practice.
In veterinary oncologist, we've learned about the product has been extremely positive.
Later in 2022, we're looking forward to the expected addition of another dog brokerage products to the animal health portfolio <unk> been conditionally approved for exercise induced diarrhea, and other rare mums indication.
That concludes my comments. Thank you all for your time today and I'll now pass the conversation back to Lisa.
Thanks, Ian Thanks, Carol I'm going to pause here for a moment to acknowledge that as we in the Jaguar and Napo Pharmaceuticals, and Napa with her family are well aware diarrhea is not always a topic that people outside of the company are comfortable discussing although we have found its not as much of an issue with Dod.
Nevertheless, we're going to play a short video clip now that I hope you will all enjoy video.
Topics of diarrhea, as mentioned in a refreshingly public and candid, Matt or Peter can you do that.
Yes, we'll watch the video now Lisa.
Okay.
So I get really paid off when I read or hear about actors being maligned as a group so easy isn't it that lazy and false assumption Levant of Chi.
In my experience, which by now is considerable the opposite is true.
Love under each of US work together, we lost we were.
We changed clothes, we throw off when we suffered diarrhea.
Don't you.
Sure.
Uh huh.
[laughter] alright, we have heard from.
Many of our patients that it's okay to bring humor to the topics and the love Dame Helen Mirren.
And love acting in theater I have a son in the business. So thank you.
Damn near and for helping to Destigmatize the subject of diarrhea.
I am extremely pleased with all of our achievements of the company in 2021, and we are Jaguar are energized about all of our important initiatives underway for 2022.
And in particular, the expectation for transformative value creation in the next 12 to 18 months as the value of the cross selling her pipeline can be realized.
I continue to be grateful for the ongoing support and dedication of our employees our partners and the Amazon our stock holders and all of our other stakeholders.
And we will now open the floor for written questions that have come in.
Which I can access right here and I'm going to go.
Hang on.
Okay, I'm just going to take these in the order in which they've come in here.
Question number one.
Are there kind of leave your purchase orders yet yes. There are open purchase orders and there are a list the accumulated of veterinarians who have learned about the product for example from the two conferences that Dan spoke about.
Who want.
Want to know about kind of leave it in place orders when the product is available.
And then Theres. Another question lingual kind of leave your sales to the public again we.
We expect that to begin in the second quarter. So we're just around the corner from that.
Let's see there are many investors, who say that you are not confident in investing money in your company. How can you reassure the investors in order to restore confidence.
So first of all I should let you know there are many many blackout periods for buying or selling stock in the company for the CEO and the key officers in the company. Nevertheless, during one of those open windows.
Last quarter, both myself and the C. F O Carol invested at a substantial premium restricted stock. So we couldnt sell it no warrants nothing special at about five times, where the prices now and we're happy to do that to show our confidence in where the stock price needs to be and this was after.
<unk> the reverse split that we had done last year.
I also can tell you that there is not one company or a board member.
Who has options that are in the money. So we're all rowing in the same direction with the shareholders to get the value recognition in the company.
Could you discuss the endpoints for the cancer related diarrhea indication enrollment criteria in sample size, yes, I can.
What is very important is the learning that came into play to define.
The primary endpoint for the cancer study.
My test <unk> is a first in class mechanism of actions and anti secrets.
And what it does is it normalizes stool formation. It takes the water out of the watery stools, Helen Mirren would appreciate this discussion and makes it a formed stool.
And therefore, the appropriate endpoint is looking at.
<unk> formation and the trial, which is called the admin study, which got my test approved for preliminary approved for the HIV indication. The definition of the endpoint was a responder endpoint the patient responding and moving from watery stool two forms tools not.
Eliminating stools as you would have with an opioid like ammonium a little paranoid, but moving to formed normalized stool function.
And this is a prophylaxis study the cancer study.
So the enrollment criteria is the patient needs to be on targeted therapy, which is typically chronic therapy, which they which has a secret Tory mediated diarrhea associated with it.
With or without traditional chemotherapy.
And it's in solid tumors.
And as I said, it's prophylaxis before the patient starts the targeted therapy.
And it's looking at the ratio for the responder analysis essentially the area under the curve comparing the treated patients to the placebo patient and its 256 patients same dose of my testing that is currently commercialized. So its the single dose of <unk> compared to placebo.
Let's see.
On <unk> is the study enrollment impacted by COVID-19 will there be any early reads like interim analysis before reporting the topline results.
So as everybody who is in clinical trials in the United States, Yes, definitely study enrollment was impacted by by Covid and as part of the reason to stay on schedule. If you may have heard me mentioned that we are opening new sites ethylene in the United States, but outside of the United States as well to put as much geographic.
Diversification in place and make sure that we stay on target, which is the name of the study on target for completing patient enrollment.
In the beginning of 2023.
And there's a question can you give more color on the closed network specialty pharmacy strategy, how much spending does that enable you to save on an annual basis, Ian I'm going to turn that question over to you. Please.
Sure Yeah. Thank you great question Luis.
Yes, essentially that theres two pieces to the value of DSP pharmacy, and some of those are related to cost savings and improvement in gross to net.
Payer mix just as an example, we save approximately.
Our distribution fees are about half of what they were prior to the transition to the SB pharmacy.
Set of pain to the title model and through all the wholesalers.
So again, we kept that caution about half going directly to the USPS, but the other piece of the value really is in terms of kind of the market access components for patients and really the metrics. We look at there are time to first fill so how long.
From the patient gets a prescription written until we actually get the drug in their hand.
Sps can do that much more quickly the time between feels so.
Theoretically every patient should fill every 30 days often patients don't in the retail sector that was.
<unk> channel that was up.
Up to 45 days in between sales now we have it down to the low <unk> across most of the USPS.
Then patient persistency, how long do they stay on the drug.
So longer.
Which benefits the patients and the ESP model because they just provide better support.
And kind of access services related to kind of working with the payers.
The Dsp's are just much better equipped to be able to provide.
And.
Can you give me two other questions here is specialty pharmacy revenue was 100% of Q4, my turnkey revenue how may that looks throughout 2022.
So the MSP model is working quite well by many metrics that we originally modeled.
This transition is outperforming many of those metrics. So we're very happy with VSP.
Relationships that we have in place and envision that continuing through 2022 with no significant changes. So we anticipate the vast majority of the volume might actually continuing to be distributed through <unk>.
Just like as we reported in Q4.
Okay and then another question will for Union will you be creating your own our own telehealth platform or leveraging an existing platform.
Yes, great question. So there are a number of vendors out there who provide this technology and connectivity specifically for pharmaceutical brands.
Its actually its pretty complicated in order to be able to to build a.
Platform like this so we have partnered with some of the leading leading industry providers in this space.
We're anticipate we anticipate launching this in Q2.
But we have some some great vendor supporting this rather than trying to build it on our own which I think would be quite difficult.
Terrific and then thank you there's another question about.
Candidly, we are do we expect my testing sales to increase we would not be investing in all these additional initiatives for patient access if we didn't feel that it was going to impact patient access, which therefore would translate to increased prescriptions an increase sales so.
The increased activities as a representation of our confidence.
Let's see.
How do you anticipate the luck wimmer and cholera study could look in terms of number of patients endpoints and timing enrolled.
Enrollment in Collegian, So Hollywood very interesting because we have already completed and published studies in Colorado.
With cross.
<unk> that.
We are quite important in terms of the impact on the dehydration, specifically if you could decrease the dehydration by about 30% in the first six months to 18 hours. That's considered the sort of the depth zone for patients with Colorado and again, it's not the Colorado kills the gay hydration and 30% is considered.
Lifesaving impact and that was achieved again these are published.
Posters with cross selling or.
So summer does not qualify for the tropical disease priority review voucher financial incentive program because that program only exists for a drug for their very first indication and of course with element is already approved for HIV luck liver as I mentioned is a second generation anti secretly works by the.
Same mechanism of action comes from the same tree that we spend where we sustainably harvest proton luxury.
But it is a distinct product we believe under botanical guidance, because it's a different collection of Proenza, Canada.
Chemical collection so.
The reason why I'm, saying all that is we would imagine the study design would look remarkably similar to the successful trial design that we had with cross selling or there may be a law.
Larger number of patients as for a pivotal trial, whereas the cross selling of the study was a proof of concept trial, but we are talking patients under under 100.
And.
Really rapid enrollment, which was done in Bangladesh at the International Center for Diarrhoeal disease Research, which is a beautiful center was initially established by John Hopkins leadership now runs on its own.
And.
Completely devoted to Colorado, Colorado patients. So those patients they are all year long.
So that study is expected to start as I mentioned in the second half that will be a phase one study and then we'll go into the phase two in the pivotal trials thereafter.
And this is an acute study. So these are much shorter study is smaller number of patients in three days of treatment so much shorter than the HIV and cancer trials.
Let's see how do we explain the loss from last year.
Financial loss from last year is because we are.
We're a commercial stage company, but we are primarily a development stage company. So we have significant expense going into research and development to expand the indications of cross selling or from a specialty market indications very important HIV patients. This was fast tracked by the FDA.
Another definition of specialty market is a relatively small market versus where we're looking to go with the cancer indication in the short bowel indication and future pipeline indications such as usable bowel syndrome thereafter, and we talked about short bowel syndrome third party projections for that global market are in.
$5 billion range.
There is no other agents that are out there for cancer therapy related diarrhea. However, there is a supportive care market for chemotherapy induced nausea and vomiting.
And those agents typically are used just for the first three days of a chemo cycle yet that market is projected at about $3 billion for this year. So can you give me some idea of the size of the markets that we're going after and the justification for the investment not only in clinical trials research and development, but the preparation.
For the commercial supply and all the manufacturing related expenses once the product is approved it's all about manufacturing and making sure you have product available.
Okay. This is an interesting question as the native American Herbalist, and an investor we have many plants that could change the scope of healing Jaguar health is the only corporation I can find and we believe we have probably the only person I can find I was looking at prescription development of traditional medicines, how can I.
Bring the plants to the table, we are probably the only company that has a department and a chief of Ethno botanical supply.
An investigation.
So through.
Through the website you can send information to the company and we will make sure it gets to our chief Ethnobotany and my co founder Dr. Stephen King I've been working with him for 33 years and I know he will be very interested in responding to you.
Hum.
Let's see I think the last question.
I think the last question.
Is.
Are you going to have a reverse split again that would be the worst idea and in complete agreement with you. There have been no discussions about doing reverse split all the energy and efforts are focused on what we talked about what we expect to see in 2022.
Near term from not only continued efforts for my testing, but can alleviate and then the ongoing support of the clinical investigation for CTD and SBS, which we feel will be transformative.
Value creation the equity that we also have in a plethora of besides the license opportunity there.
Pursuing and I would expect to have a license agreement in another geography of the world as this year as Chris element continues to progress.
And a lot a lot of effort on PR and IR around the importance of managing diarrhea.
In a patient with cancer therapy, regardless of whether the education for that patient, who has a dog or a human.
And I will conclude with that I think I got all the questions.
Concludes our webcast. Thank you for being up early thank you for listening. Thank you for your questions and thank you very much for being a supportive Jaguar, we're very committed to this business pursuit and we're very committed to all our stakeholders.
Thank you.
And with that that does conclude today's call. Thank you for your participation you may now disconnect.
Yeah.
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Okay.
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