Q1 2020 Earnings Call
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I'd now like to have the conference over to your speaker today mini gentle Vice President of corporate Communications and strategy. Please go ahead Sir.
Thank you Chris.
Hello, and welcome to Reatta management's called to discuss our financial results for the first quarter of 2020 and to provide a review of our development programs.
This morning, we issued a press release with a summary of these results and the press release can be found on the Investor section of our web site at reactor pharma dotcom.
I'm joined today by our Chief Executive Officer warrant <unk>.
Our Chief Medical Officer, calling Meyer and our Chief Financial Officer Monday Sony.
Turning to slide three I'll now turn the call over to warrant.
Thanks, Manny good afternoon, everyone and thank you for joining us on our quarterly call I'll start on slide four.
As for many businesses worldwide. The first quarter of 2020 for Reatta was defined by the emergence of cobot 19, as a global destabilizing pandemic.
Early on we recognize the disruptive potential as a pandemic and we took steps during the quarter to mitigate its effect on our clinical programs, our drug supply chain and our business operations.
In each case the adjustments that we have made reflect our concern for the safety and well being at the patience and healthcare workers participating in our clinical studies as well as our employees and partners.
With respect to our clinical programs, we evaluated each ongoing study to determine if it was possible to continue the study without imposing undue risk to the study participants.
Based on this analysis and in consultation with the data safety monitoring board.
We decided to stop the phase three catalyst study a bar docs alone in patients with connected tissue disease associated pulmonary arterial hypertension.
These patients have very compromised cardio pulmonary function are often receiving immuno suppressant internet and inherently high risk of adverse outcomes in the event of an infection.
We decided to continued exposure or these high risk patients to clinic or in person visits presented an unacceptable risk.
With respect to our other ongoing clinical programs, we determined that we could continue the studies by implementing changes that mitigate risk to patients and caregivers, while maintaining the integrity of the studies.
In our phase three Cardinal and Falcon studies, we're fortunate that study drug is self administered in the key endpoints or blood based.
Colin of will provide more details on the steps we've taken to maintain the integrity of the studies.
But in summary, we implemented the use of at home visits to collect blood draws and to assess safety isn't alternative to in clinic visits when necessary. We also arranged for home delivery of the study drug to patients when a clinic visit because not possible.
These measures have been working as planned and at this time, we did not believe that the cobot 19 pandemic, we'll have a significant impact on our ability to complete the studies.
For the Cardinal study the continuity of data collection is very important because we need to complete the second year of the study to have the data necessary for full approval and bird oxygen for Alport syndrome.
For the Falcon study, we've been able to continue treatment of patients enrolled in the study because in clinic visits are necessary to enroll new patients we've had to pause enrollment of new patients into the study.
Pinnacle trial sites are starting to reopen and we're hopeful that we maybe able to resume screening of patients for fountain as early as this quarter at some sites.
As a reminder, the pivotable part two of the Moxy study of Omega have in Friedrichs attacks here was completed the Ford the emergence of covered 19 and thankfully the pandemic will have no impact on that study.
[noise] regarding our regulatory paths for paradox alone and O'malley, our policy is to comment only when we have a major event to announce and so it was in our earlier calls will not be answering questions regarding regulatory activities on this call having said that I will take this opportunity to reiterate that our plan is to file.
In da's for each of our Doxil and Omar this year of course subject the ongoing discussions with the FDA.
Finally, with respect to our business operations, we implemented work from home measures in additional safety protocols to protect our employees and to maintain business continuity. Our infrastructure investments have allowed us to continue to operate and in particular to continue to pursue our key goals for the year.
Moving to slide five I'll turn the call over to call on to provide an overview of our clinical programs in a look into our ongoing medical affairs activities.
Thank you Warren.
Well turn now to slide six is weren't mentioned, our top clinical Powerton arts and maintaining the integrity and complete the Cardinal study of Murdoch's, one in CKD costs by Alport syndrome, and presuming enrollment and Falcon early this year in prior to Cobot 19, becoming a global pandemic our team recognized the potential negative impact.
The virus could have if it spread globally, causing quarantines and affecting patients about <unk> ability to participate in our clinical trials, including conducting in clinic visit stoping efficacy and safety data and receive study drug for many clinical studies site visits are necessary to administer study drugs.
Such as infusing biologic switching therapies and to collect key efficacy data through performing sophisticated assessments exams imaging or other procedures closure of trial sites do Coburn 19 has prison a challenging set of obstacles for many of the ongoing clinical studies.
We are fortunate that the key efficacy endpoints for CKD trial, including Cardinal or blood based markers of kidney function and that our drug as a small molecule formulated and capsules that is self administered orally does not need to be infuse had a medical facility, providing us options to complete our CKD studies.
In prior trials, we have occasionally used home health nurses to conduct at home visits for important study. This is the patients weren't able to intend and in clinic visit.
As Koby cases began to increase outside of China, we utilized our established relationships with these vendors to quickly mobilized our nurses to conduct cardinal visits and geographies they've now been affected by the pandemic, including the U.S. in Europe.
The first home health this that occurred in March and to date approximately 30 patients in the U.S.
Spain, and France has had a home health visit.
We have observed no significant impact on data integrity during this period.
As of today more than half at 157 patients who are enrolled in the pivotal phase three Cardinal trial have now completed the study.
We were also able to ensure that are patients were able to receive study drug if their sites were closed.
Typically drug supply is dispensed from clinic sites, while patients are conducting their regularly scheduled visits.
We were able to work with their manufacturing vendor to have drug supply shipped directly to patients homes to ensure continuity of treatment, we were able to ship to ship additional months of drug supply to most patients. So they had sufficient supply to last until mid summer.
We will continue shipping drug supply directly to the homes of patients were affected by site closures throughout the duration of the trial.
During the pandemic sites in Japan, and Australia have remained open and patients in those countries have been able to conduct in clinic visits.
Well, we will continue to use home health visits in direct shipment of drug supply is needed through the remainder of the trial trial sites and less densely populated regions in the U.S., Spain, and Germany have recently been able to conduct in clinic visits. We hope this trend continues but a sites remain closed and definitely we are prepared to complete.
The trial using the solutions I described.
Turning to slide seven.
The Falcon trial, the paradox flown in 80 PKD was actively enrolling patients when cobot 19 turned into a pandemic.
For patients who are already enrolled we implemented the same procedures that we have in the Cardinal trial, including home health visits and direct shipping the drug supply to patients homes.
These solutions have allowed us to continue patients who are already in the trial and we've observed no significant effect on data integrity.
The screening process in any trial is fairly intensive and as we previously disclosed we paused screening and enrollment and Falcon in March when sites were starting to close to research patients as I mentioned during the Cardinal discussion. Some geography is have not been affected by Copel 19, some or all sites in the U.S. and Europe have remained.
Open and some of our sites that were previously closed are now starting to reopen.
We haven't communicating with our Falcon sites and are planning to restart screening soon we will make decisions on a site by site basis based on their individual capabilities to safely screen and enroll patients as we're in said, we're hopeful that patient screening can begin this quarter.
Moving to slide eight.
In addition to trial execution and or India preparations, we're continuing to published and presented new data on our lead programs.
The European Renal Association European dialysis and transplant Association.
Also known as IRET you'd see a has accepted three abstracts from our collaborators and us for presentation at an upcoming international Congress taking place.
Actually in early June as many of you know the or a gay meeting is the major European and second best globally attendant Nephrology conference for the year.
These accepted abstracts include a poster entitled kidney effects in the Moxy trial. The study of 'em Avelox alone in patients with Peter So taxi.
And our pivotal Moxy trial, we prospectively assess kidney function in ethane patients over the course of year.
Kidney function in essay patients has not been well studied impart because these patients do not have traditional risk factors for progression of CKD, such as high blood pressure or proteinuria and in stage can you disease, requiring dialysis or kidney transplant is uncommon in this very rare disease.
As they think is a disease caused by mutations in the mitochondrial protein copper toxin that lead to mitochondrial dysfunction. The hallmarks of mitochondrial dysfunction, our impaired energy production and activation of inflammatory pathways clinically. These effects have been studied and several oregons that they patients including the brain.
Spinal cord heart pancreas, and liver our Moxy data are the first to show that epay patients have rapidly progressive loss of kidney function.
After 48 weeks of treatment. The mean decrease in Egypt far for placebo patients was 4.4 mill per minute and then the pediatric patients who have more rapidly progressive neurological disease. It was 11.3 more permanent.
The overall average loss of each year far of 4.4 more per minute is higher than what has observed for many forms of CKD, they're considered severe in highly aggressive in contemporary CKD trial of diabetics hypertensive 80, PKD identify property fscs and other forms of seed.
80 patients on average lose less than 4.4 mile per minute as mentioned this loss occurred and patience and Remoxy trial without traditional risk factors for progression of CKD.
Because unfortunately, most EFI patients will not survive long enough to reach in stage can disease. This finding does not have direct relevance to the clinical management as I say patients. It does however highlights the importance the role that mitochondrial dysfunction in CKD.
As we have extensively discussed in the context of the development of Murdoch's loan for several forms of CKD impairments and mitochondrial function have now been observed in are thought to be critical and the pathogen assists across many distinct forms of CKD caused by very different installs that ultimately lead to a final comment pathway progression.
Characterized by impaired metabolism energy production and activation of inflammatory pathways.
Addition to human biopsies studies as CKD patients that we have cited these clinical data from patients with a pure form of mitochondrial disease or in our view. The most persuasive evidence that mitochondria are key regulators of kidney function.
Beyond the conceptual insights that these data provide the also demonstrate that like Barack Sloane Omar can improve kidney function. The placebo corrected on treatment improvement in kidney function was 11.4 mill permanent weak 48 across all patients.
And in the pediatric patients the magnitude was higher at 16.8 more permanent.
We conducted a safety this at 28 days after patients discontinued drug and as part of this visit we assessed each CFR at week 52, after wash out of Omar the placebo corrected off treatment easier for our change was 5.4.
Demonstrating that Omar not only dynamically improved kidney function, but it also had a structural stuck on the kidney unlikely slowed fibrosis.
At the rate DTA will also be presenting a poster entitled kidney code eight genetic testing program for patients with chronic kidney disease, which describes an important aspect of our ongoing medical affairs activities.
As you can see on slide nine.
Kidney code is the genetic testing program, we are sponsoring in partnership with in detail to help nephrologist identify the genetic basis various forms of CKD.
This initiative was launched in recognition of recent literature, which suggests that approximately 10% of patients with CKD have an underlying genetic cause.
Well Alport syndrome has been known to be the second most common hereditary form of CKD. Recent data suggests there's more calm and then once thought in a large number of patients with Alport syndrome are either undiagnosed or miss diagnosed with other forms of CKD further patients who are not diagnose correctly, maybe receiving a treatment.
That may not be relevant are helpful to their actual form of CKD.
The test consists of a panel of 17 genes that are linked to the most common causes of hereditary CKD, including 80, PKD Alport syndrome, Fscs and others, which provides a broad interest to the nephrology community is available in the U.S. and has a rapid turnaround time blood or saliva can be collected.
During a clinic visit resupply bucket can be directly shipped with patients home.
Hi to receive stayed away from certain due to identify patients, including imitation results demographics and ordering physician.
In the first several months of the pilot phase we have had excellent uptake of the test in the nephrology community and received very positive feedback to the test is easy to order as rapid turnaround time and is easy to interpret.
Other tests that have results that we can access approximately half have been positive for Alport syndrome and half of these patients were previously miss diagnosed with other forms of CKD. These include 80, PKD Fscs hypertensive CKD hygiene of property and several.
No clinical diagnoses that have generally been considered to be benign.
Well these patients are usually under the care for Nephrologist. They may be receiving incorrect care for instance in Alport syndrome patients should not received 12, afton, where immunosuppressants, which would typically be given to patients with 80, PKD or as you know property. These data alone nephrologist appropriately diagnosing care for their patients which.
As precision medicine in action.
Importantly, we have learned that identifying patients with Alport syndrome, who are misdiagnosed are not yet diagnosed is straightforward based on prior literature from one of our Cardinal investigators and his colleagues three straight for clinical criteria can be used to identify upwards sooner patients. We have now prospectively shown.
That using these criteria of one.
Patient with CKD defined as an easier far below normal to a family history of CKD and three the presence of he materia or blood or urine has been effective 78% of patients with all three risk factors happen pound Alport syndrome indicate eco program.
I'll now turn the call over to meet to provide a summary of our business operations and financial results for the quarter.
Thanks, Colin and good afternoon, everyone.
Thanks for joining us today.
We had on slide 10.
Please refer to our press release issued earlier today or somebody off our financial results for the full score of 2020.
Before I walk through that summary, I want to emphasize a few key points related to what watering and Golden have described.
Specifically related to the fact that color spec often shooting the continuity off our ongoing trials.
Our current inventory off investigational product is adequate to support these ongoing clinical trials.
Based on current evaluations, we anticipate that our supply chains are adequate to meet our clinical nonclinical and chemistry manufacturing and control supply demand across all programs.
We have not experienced any significant disruptions and manufacturing to date for offline commercial production for bar and all map.
Additionally, we do not have.
Blackchin exposure to China, either barred almost.
Moving to the financial results Slide 11.
We maintained a strong balance sheet ending the first core of 2020, but approximately $624.5 million in cash and cash equivalents.
We continue to expect out of little cash to fund operations through 2021.
Collaboration revenues for the quarter were $1.4 million compared to $7.8 million into first quarter of 29.
This reduction was due to the write off all remaining deferred balance permitting to our agreement with Abbvie to reacquire licensed rights for another two activity programs, which occurred in 2019.
Accordingly, and our current quarter been installed revenue from our Abbvie agreement and do not anticipate any revenue from the accident, but obviously going forward.
Moving to expenses R&D expenses for the quarter were $47.7 million compared to $26.1 million for the first quarter of 29.
Our gn expenses for the quarter were $20.8 million compared to $10 million, while the first quarter of 2019.
Our operating expenses for the quarter was $68.7 million compared to $36.3 million for the first quarter off 2019.
Our net loss for the quarter was $48.9 million or $1.47 or share.
On both a basic and diluted basis.
Compared to a net loss of 29.2 million dollar or 98 cents per share on both basic and diluted basis for the first quarter of 29 King.
Now moving to slide 12, looking at our non-GAAP measures, which exclude stock based compensation expenses non-GAAP R&D expenses were $46.1 million Walter quarter.
As compared to $24.4 million for the first quarter of 2019.
Non-GAAP GNS expenses were putting million dollars for the quarter as compared to $7.5 million for the first quarter off when you Nike.
Our non-GAAP R&D expenses increased primarily due to increased development cost to advance our pipeline in late stage clinical development programs and to higher personal cost as we increased our headcount to support our expanded activities.
Our non-GAAP GNS expenses also experienced increases in personal to support growth and our development activities aswell as increases due to rent and commercial readiness activities.
Our non-GAAP operating expenses, what $49.4 million Walter quarter.
Bear to $42.1 million for the first quarter of 2019.
These increases are consistent with our development growth disco sodium.
Looking at non-GAAP net loss.
It was not $29.6 million for the quarter or 89 cents Porsche on both a basic and diluted basis.
Compared to a net loss off $24.9 million for the first quarter of 2019.
Our 84 cents per share on both.
Basic and diluted basis.
The increase and bolt.
GAAP and non-GAAP net loss measures reflect the change in revenue and expenses I just discussed but one additional change.
During the fourth quarter of 2020.
Good night with docs, and if it off $22.1 million due to the enactment of the contract.
Got it allowed us to recognize some fire yet.
Animals against our taxable income from a proceeding here.
Now moving onto slide 13, looking at non-GAAP measures in the fourth quarter 2019. These measure also exclude stock based compensation expense and required.
Its rights expenses.
Our non-GAAP net loss for the quarter was $29.6 million compared to a net loss off $50.3 million for the fourth quarter off 2090.
The decrease in net cost during the fourth quarter, primarily related to the recording of docs benefit of 22.1 million dollar as I mentioned above.
Finally, taking a look taking a look at the change in total non-GAAP operating expenses, which were 49.4 million dollar for the first quarter of 2020.
Which resulted in a decrease of $1 million compared to a $50.4 million for the fourth quarter of 2019.
This quarter to quarter decreased and our non-GAAP operating expenses highlights our financial discipline inefficient capital allocation.
Moving to slide 14, I will not on the call back over to water for concluding remarks.
Thanks Manny.
Thanks, Matt maybe moving to slide 15, a few thoughts I want to make sure to convey before we close.
Despite the disruption to the global Corona virus pandemic Riyadh has an excellent position to achieve substantial growth in the years ahead.
Late last year, we generated positive pivotal data in each of our to lead programs paradox loan Alport syndrome, and Oman and friedrichs attacks here.
Subject ongoing discussions with regulators, we plan to file for marketing approval for each program. This year. Each therapy has several potential expansion opportunities in which we've already generated proof of concept data.
We're well capitalized and we've built a team capable of launching and commercializing these products worldwide.
That concludes our prepared remarks, I'd like to thank everyone, who dialed in for listening and we'll now open the line for questions.
Thank you.
And as a reminder to ask a question depressed star one of your telephone to withdraw your question. Please press the pound key.
Please stand by we compile the culinary roster.
And our first question comes from the line of Yahoo that some of its with Citigroup. Your line is now open.
Hi, great. Thanks, very much for taking the question.
Well on the comments on the kidney code test are interesting.
I think previously referenced.
Got it 30 to 60000 U.S. population for outboards.
Hospital at this point given the the early data from the kidney code tests to potentially revise that estimate.
Can you extrapolate what the what the revised estimate might be at this point.
We could potentially revise our estimates I mean, we aren't pricing ours right now, but I think I'll reference a new internal paper recruitment at all that that we probably discussed with you published last year and showed that of patients whoever hereditary caused a GDP Katie was the most common I believe is 30 month.
Kind of patients in that cohort.
Two large set to patients and New York in Sweden.
No had.
80, PKD and Alport syndrome. When you include all three type for college and jeans accounted for 30% of patients who had hereditary CKD and so.
We do think it's larger.
On our initial estimates.
And the data from the literature suggests.
That is that likely approaching the ATP opportunity.
Got it.
And then with regard to own Evan neurological diseases, you've obviously listed a variety of other avenues to explore parkinson dementia epilepsy, Huntington and so forth.
At this point can you provide any more details as to which Avenue you would most likely to pursue next in a in the late stage study.
Yeah. So I think that obviously our approach as a company right now is too.
Execute on or indeed submissions.
We started falcon.
And following here behind would be initiating new trials.
With that won't happen. So we've already done a lot of work to determine what.
Type of patient population, we want to treat and what the trial designs would entail we've reached out to investigators and so we have distilled down the list and from our perspective theres going to two major categories.
And so one is other movement disorders, and so I say like diseases.
In that there's clear up mitochondrial dysfunction that affected patients ability to move.
We prefer to stay obviously in rare patient populations set for the time being and so as I mentioned before familial Parkinson's.
Yes.
A clear setting where mitochondrial dysfunction caused by mutations in light of control proteins causes the disease and we have evidence.
Of activity.
From patient biopsy samples just like what I say that Omar can restore mitochondrial dysfunction in those samples. We also have preclinical data and kind of broad.
PD models.
Theres a regulatory path.
Forward with endpoints that I've been used with other products that primarily treat symptoms.
So thats one setting that's of high interest to us.
Hereditary.
Or from a parkinson disease accounts for about 15% of all PD cases, another one is progressive Super nuclear policy.
And so it's more common NFV that less common than familial Parkinson's disease, it's on the parkinsonian spectrum.
And notably if you search literature, there is evidence that interest to mutations.
At our that activate in rough to our protective.
Mutations.
The press interact twos activity actually enhance susceptibility.
To PSP.
And so those are two settings that are very high analysts and then related set for interest and testing.
Omar.
Non movement disorders, and so frontotemporal dementia.
The broad set of Dementias and there's a few.
Sub types.
That involve.
Proteins.
That are mutated therefore, their hereditary where mitochondrial dysfunction appears to play a key role.
And so those are three settings that are at the higher list right now the patients are readily identifiable.
And there aren't too a large number of ongoing competitive trials in those things.
Okay. That's that's super helpful. I think it just squeeze in one more quickly.
I know you may be may not be able to answer this given the positive enrollment with Falcon given coded but can you say at this point.
How far along you are with enrollment Falcon and if you have any rough idea when you might be able to.
Disclose the topline data for that trial.
So we're well into enrollment we can't disclose a specific number right now.
As I mentioned, we've been in contact with our sites and many of several are actually wanting to enroll patients now and so that's a reason why we're considering reopening as long as.
Sites can safely screen and C patients, especially during that hydration phase and we'll considering we'll consider them for opening.
But until we really understand the extent of the sites and the effective coded on our ability to its screening and we're not going to give specific guidance.
Understood Alright, thank you very much fun.
Thank you.
And our next question comes from the line of Maury Raycroft with Jefferies. Your line is now open.
Hi, everyone. Thanks for taking my questions.
I think in the prepared remarks, he said, 75% it completed the phase three upward study.
Just wondering if you can speak to the merits of potentially waiting to head static difference on tier data and filing to get full approval and if this could be one reason why you're waiting for approval in Alport syndrome.
Yes. So first of all we were not going to comment beyond what we have about the regulatory status and as we're instead, we're planning to file the NDA Frankfurt syndrome. This year I think secondly to clarify about half of patients have completed the full two year treatment duration.
Ill treatment period.
Cardinal.
Got it okay.
And second question was just on Oh man Vinay year, a EPA data or that you talked about.
I'm just wondering if you've got you've gotten any our preliminary feedback from predicts is actually a K walls and their views on the data and.
I guess could the kidney benefit make its way into the OMAP label.
So I think that view of the neurologists who were involved in our fate trial has set the kidney that are intriguing I mean, they're not nephrologists I think it points to another organ or that is obviously affected it's well described that EFI patients have.
Adverse effects in their heart liver pancreas, as I mentioned and so this isn't really surprising to them.
But it's actually really exciting to nephrologists.
And so that's why we're having this data presented at a kidney meeting.
Because it's for some nephrologist, it's difficult to understand how patients could progress.
If they don't have hypertension, and proteinuria and so this is a setting with these patients had very normal blood pressure. They did not have proteinuria get they progress at a very rapid rate.
Mention faster rate than almost all common forms of CKD and so I really think it helps too.
Augment our understanding of how how box loan this likely affecting alport syndrome patients PPD patients and others, where we see no clear effects on kidney function. It just shows how important the mitochondria or to regulating.
Metabolism and inflammation within the kidney and so I think this is a much more.
Interesting story to the nephrology community.
And I I'm not sure I doubt this will make it on the F. a label on it was at an efficacy endpoint.
As I said, it won't really affect clinical management as patients because unfortunately, they they died before they're cutting disease results in the need for transplant or dialysis, but I think it is a very exciting story for the nephrology community.
Got it okay. Thanks for taking my questions.
You're welcome.
Thank you.
Our next question comes from the line up Adam Walsh with Stifel. Your line is now.
Hey, guys. Thanks for taking my questions. Just the first one is a follow up on the 80 PKD Falcon trial on there's been a lot of talk about the potential for Cove at 19 to return in the fall and I'm just curious as the clinical trial sites reopen and your screening for new patients are there any strategies that you can employ.
Okay to potentially accelerate new patient.
Enrollment in that trial during perhaps what may be a window of opportunity to get all patients onboard that the first and then I have one follow up.
Sure. So I would say that yes, a reason to open enrollment soon is to get patients and before a potential second wave.
And as I discussed pretty extensively in the call. We're fortunate that our drug is administered orally can be shipped to patients homes if needed and.
And once patients on drug they can be seen at home and we can just draw draw applied and so.
For the reopening of Falcon and we're anticipating that this would occur at sites clinical trial sites that are open for patients to come and so we had been exploring the possibility.
Doing screening and enrollment more remotely.
And so but I think one benefit of opening up soon is that we could get patients and quickly.
That's terrific and then just could you give us an update on the commercial preparations for.
Paradox alone and Alport and potentially ultimately an 80 BK D and what have your learnings spend from the Jun RQ launch to date and how might those be applied to your strategy. Thank you.
My meet you want to take that.
Sure.
As you all know we have actively preparing.
For the launch of our both products, obviously pending approval from the FDA.
Yep already launched many diseases of an offence imputing disease, but nesbitt types that you have seen.
Finishing it does kidney code, which is helping us and undefined.
New patients both Columbus CKD side.
For Alport syndrome, and ATP Judy.
We have already deployed on medical affairs resources and performing.
You know vide ending up activities.
Both.
The launch.
[music].
On on the learnings from the Janovsky side, I think that's been very evident in clear dot.
Dan is a big number of patients right of label in the market and obviously just on the product profile, which we believe our productive.
I will be much.
Efficacious and save based on once we have the clinical trial results a readout.
We would be able to capture a pretty significant market share it off that.
And the anything more than you would like to us.
Yes, I would call and just to add to that and so I think what the 12. After launch is taught us is that a.
A drug that has.
Modest efficacy and these are clearly works, but the treatment separation and occupant analysis was 1.27 no per minute.
And in the one year Cardinal data, it's four times larger.
Tobacco and has.
Tolerability.
Issues because of.
Constant thirst.
Our nation.
And then there is a black box warning for potential liver toxicity to Rems program and so despite all of that.
Excuse me, it's doing very well.
Here in the U.S. and so.
We think that products loan.
Can be.
Likely use without those tolerability issues.
And the clinical trial data at the state has thus far.
As far as shown us that it has been quite active and welcome and so we think that.
That that bodes well for launch yet this is Warren I just I just add I think it's just it's an exclamation point on how big the patient need is in the severe forms of CKD.
Because the 80 PKD patients are at high risk being on dialysis in their lifetime, that's different from many more common forms.
CKD and of course. This is also true for the Alport syndrome patients who are also very high risk of being on dialysis in their lifetime. It tells you how much they desire a therapy.
Thanks very much.
Thank you.
And our next question comes from the line of Joseph Schwartz with with SVB Leerink. Your line is now.
Great. Thanks, so much congrats on all the progress.
I was wondering.
Sort of the follow up on Adam's question.
How prepared are you adjust your clinical operations for Cardinal or Falcon, if we get a second wave that causes more disruption next year.
Are you prepared to collect and point evaluation such as EG, if our remotely for example.
Yeah, we're already doing that for Cardinal.
And so.
If the pandemic does not improve we will be able to complete the trial and as we stated today.
We've had no meaningful impact on the integrity, the trial or data collection and so we could continue.
With.
The home health visits which allow for blood collection from home to assess FRS efficacy as well as safety and direct shipment of drugs by the patients homes and so weve. So we don't anticipate at this point any.
You know effect on Cardinal and then for Falcon and 80 PKD.
We've employed.
The same measures for the patients already in the trial.
And don't anticipate any.
For effect on the integrity of Falcon as well for patients who are not yet enrolled obviously, we're about to start reopening clinical trial sites.
Well as I mentioned before we'll be doing that at sites that are open for business and are able to see patients.
If the pandemic.
It's worse.
We're able to do so.
Then we'll have to further adjust.
Our operational strategy at.
Countries that are impacted but as I mentioned right now.
Japan has not been affected.
Australia has not been affected in our Cardinal trial.
There are rural sites.
In the U.S. that.
That have not been affected and are able to see patients.
We even have patients in Spain, and Germany recently who've been seen it after clinical trial sites.
So I think we're going to be measured and make sure that we have the clinical trial sites investigators as tight staff that patients their families in our employees.
In our best interest.
But we do anticipate here that we will be able to executing on both trials.
Okay. That's encouraging thanks, and then I understand you won't comment on your regulatory interactions, but since there's so much investor interest around these anda filings I was wondering if you can give us some more insight into the bandwidth of your regulatory affairs team such as how many people are working on these very important initiatives our experience Jardiance who.
Leading them how are they are they being.
Passed and allocated.
Hi personnel for example.
Yes, we have a significant in house staff I think it's about 15 or so people.
Many of you may know that we recently added Andrei low end.
As our head of regulatory to our team.
But for both programs of course, there is substantial outside support.
To consulting groups and except the reviewers who are very.
Very familiar with the divisions.
We're working with.
And so again, we're well we're well staffed.
And Resourced.
Two to two I do the job of course, we do have to too.
Filings that are running in parallel.
But we believe that were adequately resourced to advance them in the time frames that we've talked about.
Great Super helpful. Thanks for taking my questions again.
Thank you.
And our next question comes from the line to Brian Skorney with Baird. Your line is now open.
Hi, Thank you so much for taking my questions. This is Jack dialing in for Brian.
Two quick ones really exciting news about that kidney code program I'm. Just wondering if you could give some more color as to how broadly that program has been rolled out.
The patients have been kind of enrolled in the program and then I know you mentioned I thought three abstracts presented at the upcoming conference I'm not sure if I caught too much about a third abstract I was wondering if you wanted to touch on that third abstract as well. Thank you so much.
Sure.
So the program as I mentioned that can be co program.
If you buy space Tonight, I believe we've had.
Patients from 48 States who had.
Their data submitted.
I won't disclose.
The number of tests.
But in the poster I think we'll have a current kind of the data.
A time, when we finalize it but it's been a really good uptake it's not just investigators who we know most people. So we get the names of the physicians who order.
Many of the tests and most of them, we don't know and so again, it's not like it's just people involved in a clinical programs.
Our investigators once again your across the us.
Academic institutions as well was done private practice.
So I think because it's not just the opposite syndrome genes. It's we linked the test to contemporary literature.
That has identified the most common causes.
Many forms and of CKD and as I was describing if a patient has 80 PKD top after maybe indicated.
But if they don't have 80 PKD, they should not be receiving top app and we've had patients in kidney code that were diagnosed as having alport syndrome.
And they were previously diagnosis, having 80, PKD and Theres a list of NIS diagnosed.
Our misdiagnoses on the slide and so we had patients who now are known to have albertson, who had those diagnoses and so I think because of that.
Has.
Then a broad interest in that project going and so we'll keep making updates over time.
But.
You should review our poster once its publicly available.
And the third I'm actually.
Blanking about what that with a third.
Abstract is but I could faulty directly.
Okay, maybe as much.
Thank you.
And as a reminder, ladies and gentlemen to ask a question we need to press star one on your telephone and to withdraw your question. Please press the pound key.
Our next question comes from a lot of Matt Kaplan with Ladenburg Thalmann, Glenn is no.
Hi, Good afternoon, guys I wanted to follow up on Adam's question earlier on commercialization preparation can you tell us what you're thinking in terms of here what your commercial organization will look like when you're when you're launching poor alport and say.
Perhaps next year and and I guess, where are you in the build out of it.
Let me would you like to comment on that.
Sure I'll Shove Warren.
As you know.
Obviously, we are working on our customer pocketing and segmentation, including fans for sizing.
Generally territory alignments strategies.
We can do to mind, the optimal headcount and placement off the sales reps that leadership team.
We believe that very small efficient sales team will be deployed to reach and educate identified and from the largest over here.
And if you look at Alport syndrome, we expect it could be in the range of 30 to 40 sales rep.
Focusing on that for a lot trust with current if patients and on top of thought I think people also expect a pretty decent.
Size off medical affairs team, who would be helping in educating on the disease awareness and disease early identification upto patients.
And similar size in effect.
After.
We believe that would be even much more efficiency of being done outreach syndrome, you project on the aside because as you know what did you know.
Ultimately nine to 10.
Centers of excellence, where you can find most of the patients and the patient population is five to 6000 patients we believe.
The sales team should be roughly consisting of around 15.
20 sales reps focusing on actually offenders, hence connected Mds centers and some neurologic practices.
Yes, but it would be again as both a rare diseases, we have pretty efficient 15.
Right and then maybe second question from them I mean, you mentioned in your prepared remarks supply chain was no impact to meet demands for your.
Oh, yes across all the programs.
Can you comment on we won.
In preparation for CMS, the CMC sections of the idea is in terms of.
Stability batches et cetera, and will those be affected at all by by the coated.
And then.
Sure I could say that none of our operations, including both clinical or commercial supply. They didnt sound validation batches I've been in back that but due to covert 19.
So you are working on you know potentially over there, but no impact as well.
Great.
Congrats on the progress thanks.
Sure you book.
Thank you.
And again, ladies and gentlemen, one more time to ask a question you need to press star one or your telephone to withdraw your question. Please press the pound key.
And at this time I'm not showing any further questions on the phone line.
Ladies and gentlemen, this concludes today's conference call and audio recording will be available. Shortly after this conference call on Riyadh is web site at Reata pharma Dot com and the investors section.
Thank you for participating and you may now disconnect.
Yeah.
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