Q1 2020 Earnings Call
Ladies and gentlemen, this is Peter today's conference just catch it stick and momentarily until that time your line to look at between Oh. Thank you for your pension.
Ladies and gentlemen did you see all theater today's conference just catch the Kid momentarily until that time your line to again be placed on cool. Thank you for your patience.
[music].
Good afternoon, ladies and gentlemen, and welcome to the Retrophin Inc. first quarter financial results in corporate update call. At this time all participants are in a listen only mode. Later, we'll conduct a question and answer session and instructions will follow at that time, It's I don't want you've acquired since you're the conference.
Please press Star then here on your Touchtone telephone as a reminder, this conference call is being recorded I would now like to turn the conference over to host Mr., Chris Cline Senior Vice President Investor Relations and corporate communication.
Great. Thank you Bella.
Afternoon, and walking or trophies first quarter 2020 financial results and corporate update call.
You all for taking the time to join US. This afternoon I Hope you and your families for Meanwhile, during this time.
Today's call will be led by our Chief Executive Officer Dr., Eric today, Eric will be join for the prepared remarks by our Chief Medical Officer, Dr., No Rosenberg, Peter Heerema, our Chief commercial officer, and our Chief Financial Officer Barclays.
Dr. Bill Rhodes Senior Vice President of research and development will join us for the QNX session.
Before we begin I'd like to remind everyone that statements made during this call regarding matters that are not historical facts forward looking statements within safe Harbor provisions of the private Securities Litigation Reform Act of 1995.
Forward looking statements are not guarantees of performance they involve known and unknown risks uncertainties and assumptions that may cause actual results performance and achievements to differ materially from those expressed or implied by the statement.
We see the forward looking statement disclaimer on the company's press release issued earlier today as well as the risk factor section in our forms 10-Q, and 10-K filed with the FCC.
In addition, any forward looking statements represent our views only as of the date such statements are made May 11, 2020, and her shopping specifically disclaims any obligation to update such statements to reflect future information events or circumstances with that let me now turn the call over to Eric Eric.
Thank you, Chris and good afternoon.
Organization demonstrated great execution to start 2020.
Prior to the advent of cope with Nike this translated to our strongest momentum and enrollment trend yet for our pivotal duplex and protect studies of sports sentence that best yes, and RJ nephropathy, and notably to achieving critical milestone of enrolling the first 190 patients in duplex during the first.
Quarter.
It also translated to a strong performance by our commercial organization.
The first quarter figure, we continued our consistent track record of reaching new patients without proof products and further demonstrated our ability to deliver therapies to patients in the rare nephrology and hepatology communities.
Later in the first quarter to cope with my team has done it spreads and disrupted the lives of people around the world.
We recognize that these are difficult times for everyone and especially for those families living with rare disease.
Well this but then it has required us to adjust our ways of working it has not altered or strong operational and financial foundation and it has not changed our goals.
We're continuing to make progress and are focusing on completing enrollment and maintaining high quality conduct in our two pivotal studies of sparsentan, while simultaneously preparing for regulatory submissions.
And in parallel we are building upon our existing commercial capabilities in order to support continued organic growth of our crew products.
And to position us to ultimately be able to maximize for sentence potential for patients if approved in the future.
Importantly, we have a light as an organization on the priorities that we believe will allow us to best mitigate the impact of the cobot 19 pandemic as it has evolved today and continue advancing towards these goals.
We will continue to focus on the safety support and wellbeing of our employees by safeguarding the health and wellbeing of our employees as well, it's providing them support and flexibility. During this time, we can continue our work on behalf of patients.
Like most companies.
We have shifted to a bird flu working environment, where possible and for US. This is translated to having nearly all of our employees work remotely from home.
I have been very proud of our organizations resilience ability to adapt and dedication thus far which gives me great confidence that we will continue to evolve together and deliver on our mission during this pandemic and beyond.
For patients receiving our crude products, we're participating in our studies, we have implemented heightened procedures to ensure safety access and continuity of care. During this time.
Over the last several years, we're focused on building a supply chain with flexibility and contingency plans for events like this.
I'm pleased to report that as a result of these ongoing efforts to supply of arc fruit and investigational therapies has been on interrupted today.
As of today, we have ready access to 12 months for more worth of finished goods for all products.
And we're confident in our ability to provide continuous treatment in the pen Demicks current state.
Our clinical studies as far sets and have continued despite the challenging conditions.
We are working within the recent after <unk> yeah. They guidance regarding cope at 19 in an effort to ensure patient safety.
Continuous delivery of medication and maintain quality of data, especially key endpoint data for duplex and protect.
Achieving 190 patients enrolled in duplex during the first quarter was a critical milestones that brought us one step closer to realizing our goal for sparsentan to potentially shake the treatment paradigm for Fscs if approved.
I've been pleased with the results from our teams and partners efforts to expeditiously implement the measures necessary to preserve monitoring data integrity for our studies in the face up the disruption of the pandemic.
As you're well aware in many cases access to study centers across clinical trials has been restricted.
In order to protect.
Site staff and patients for possible Corona virus exposure they have to augment the capacity of the cobot 19 response.
This is unsurprisingly resulted in a recent slowdown in screening and enrollment for our ongoing clinical studies.
Based upon what we know today, we believe the timelines provided at the beginning a bit here are still achievable.
However, we do not yet know the full impact to covert 19, and if an extended slowed down in enrollment what you occur it could impact our timeline.
We're working closely with clinical sites physicians are see arose and the patient community to learn more each day and support site activity, where and when appropriate.
We have also been taking steps to be in position to accelerate clinical trial execution when pressures on the health care system.
This will be instrumental as we leverage our existing clinical trial footprint to rebuild our momentum towards completing enrollment in duplex protect and restore at the appropriate time.
For our commercial business, we are ensuring that our existing patients are receiving to support and access they need during this time.
I'm proud to report that today, our total care hub has remained fully operational and has been able to meet the increase needs of our patients. During this time, we've also seen new patients initiate treatment.
While it is encouraging that patients continue to be diagnose and received the treatment. They need during this time, we do anticipate that if you were patient visits during dependent it could reduce the number of patients initiating treatment and subsequent months.
Importantly through our field based teens virtual interactions, we're continuing to engage with health care providers, so that they have the necessary support and information.
We're continuing to monitor this dynamic and the impact it could have on the previously expected growth for our approved product portfolio. This year.
We certainly recognize the extraordinary challenges that our society, our industry and especially the rare disease communities are currently facing.
We also understand that the unmet needs within these communities will remain beyond that its pandemics.
This is why our organization will remain resilient as we continue to work through the cobot 19 pandemic and beyond.
Let me I'll turn the call over to Noah So that he can provide additional detail on the steps, we're taking to advance our clinical studies Noah.
Thank you Eric and good afternoon, everyone.
As mentioned earlier, we started the year with great momentum in our pivotal duplex and protect studies on Sparsentan.
Later in the first quarter, the Coburn 19 paid them it began to impact global clinical trials.
Our clinical teams near term priorities shifted to implementing measures to support our sites and patients during this korea and to mitigate the impact.
To these important studies.
The broad clinical network, we have implemented pretty studies in rare disease setting has enabled a level of connectivity with our sites that provides free deep understanding of the individual site needs as well as visibility if each patient visits we provide the right level of support.
We are in close contact with all of our study sites principal investigators consider all partners and their continuing dedication as serves an important reminder of the significant need for new treatments for she has an idea in the prophecy.
Their collective insights have helped us develop and institute the following five priorities. We believe will help us best navigate this pandemic first patient safety remains Paramount.
Every decision we make its clinical team his insights mature.
Patient safety, we recognize the increase need for flexibility during this time and while we've been pleased with the hearings to study plants, thus far with matrix sites and patients have a support as needed to leverage technologies, such as telemedicine and remote monitoring to ensure patients.
The.
Second is providing continuous drug supply.
Taking extra shipments a blinded clinical supply the sites and have the ability to arrange for shipments directly to patients under control protocols if necessary.
Third as protesting the key endpoints and safety data for our studies.
The duplex and protect studies are critical to developing potential approved first approved therapy.
Yes, and actually in the property, we're prioritizing monitoring and maintain the data and lab results that will support high quality study readout today, we have seen across both sites and patients the motivation to continue with visits and thus far it seems strong efforts to adhere to study plans.
Fourth is clear documentation of actions taken as a result of cope with 19 as many of you are aware yep Yep Yep I provided guidance.
Sure patient safety data integrity in clinical studies during this time.
And we are clearly documenting the steps.
We are taking to adhere to reduce debt.
Yes.
We are taking steps today that should enable us to regain strong enrollment momentum in our studies once the pandemic related conditions needs as many of you will recall, we have a broad clinical footprint, what's more the 200 sites supporting duplex architect studies.
This is allowed for some regions to continue uninterrupted and continue to randomize patients, but understandably the global systems have resulted in any meaningful slowdown in these activities recently.
While we cannot control the links in which there will be restrictions at sites form actually the pandemic, we have been able to continue prescreening activities to keep identifying trough candidates and we are implementing practices to leverage our broad clinical footprint to be in position to reaccelerate activity.
Appropriate time.
I'll now provide a brief update on each of our pivotal Sparsentan studies, starting with duplex, especially yes.
In early March.
We achieved a critical milestone of enrolling the first 190 patients and duplex.
As many of you will recall the duplex study protocol provides pretty pre specified interim analysis to volume for Koertner efficacy endpoint. We first 190 patients after 36 weeks of treatment.
Successful achievement of this 36 week Courtney endpoint is expected to serve as the basis for submission of filings for accelerated approval in the U.S. and Europe.
Thus far we have been pleased with patients following plant site visits and follow ups. Despite depends on it and we are working within the regulatory framework to preserve the ongoing study conduct.
We continue to believe that he topline readout in the first quarter of next year is achievable. However.
If the recent slowdown in enrollment extend as result of covert 19, it could delay the topline readout.
We will update you at the appropriate time, it's that materializes.
Turning to the protect study a phase three clinical trial in IP opposite.
As we mentioned during our last update there has been a growing body of evidence to support the link between Portman production.
Movements in Egypt far specifically in Argentina prophecy.
After applying the latest learnings to our current study design and in consultation with us.
Adopting the National let me just far over 110 weeks of treatment as the confirmatory endpoint and increasing the total sample size to 380 patients.
We believe this adjustment increases are probability for full approval importantly, the primary endpoint analysis of change a partner area. After 36 weeks of treatment of the first 280 patients remains unchanged.
And our plan to pursue accelerated filings with these data remains on changed.
Eric mentioned earlier prior to the initial coping 19 response, we had seen strong enrollment trends and protect and we're making good progress toward enrollment upturn 80 patients to support the 36 week ordinary analysis.
Protect continues to enroll patients and we continue to believe that a topline read out the 36, we partner endpoint analysis in the first half of Twentytwenty too is achievable.
However.
If the recent slowdown in enrollment where do we prolonged as result of Coburn 19, it could have an impact on our timelines.
Will update you at the appropriate scientists that materializes.
Notable for both of these studies at the end of April completed our third scheduled independent data monitoring Committee meeting.
I am pleased to report, but the DMC recommended that both duplex and protect proceed as planned.
So to summarize despite the challenges presented by Copel 19, we continue to advance both of our pivotal studies with a clear focus on patient safety, enabling continuous supply preserving dean integrity documentation.
Well, we had understandably seen a slowdown in recent enrollment trends you continue to see new patients comments, our studies and we're confident in steps being taken to leverage our clinical footprint.
Position us to regain momentum at the appropriate time.
We have an organization diligently working deliver high quality data from our studies.
Look forward to providing additional updates as we learn more in the coming months, Let me now turn the call over to Peter Peter.
Thank you know.
Our commercial organization continues to demonstrate an ability to understand the leasable space use is rare disease formulate excuse alone Slam and I didn't decide you patients.
In the first quarter, we saw new faces diagnosis and treatment initiation cost full suite approved products.
This resulted in net motor skills 47.8 million.
Which is written petrochemicals is we'd have increased prices nearly five years.
Notably in the first quarter, we saw strong demands we feel that easy.
This is consistent with our audio research insights will community.
Indicated it's just annuity updates on understood the additional flexibility in the treatment regimen.
This is expected in our business, we experienced higher gross to net discounts in the first quarter driven by the insurance resets in the beginning of the new year.
The shift was in line with our expectations as we anticipate is will return to normal levels beginning the second quarter.
In the second homes March we began to see an increase in Liberty request for resales as well as some increase in patient compliance lakes in response to evolving going and I wish them then.
We estimate that this is contributors to approximately one half to 2 million go forward revenue that we likely not received during the first quarter normal circumstances.
Good slightly reduced expected revenue.
Subsequent quarters.
You read the response to the Corona buyers our teams and partners working diligently to ensure continued access and support to patients receiving on a go center.
We have taken steps, including appropriate levels inventory and flexible options to maintain competing with delivery soon its initial insightful.
I have been incredibly proud of our teams to be lucky to deliver continuing support patients' needs. During this compressed into time.
I will still seems looks I know lot eco bomb has transitioned exclusively to fruitful interactions with eight gpus.
Given that we have relatively small teams and gober blood geographies in United States searches engagements 50 Gore for how we have worked with healthcare providers for many years.
This made the transition to relying solely on this message seamless for many of our team members and we have seen sort engagements with these efforts.
As we look ahead, we are closely monitoring good patient base, how to increase equally employment rates could change stations inserts your instruments in our fuel visits with physicians the.
New patient starts.
As it relates to all good patient base, we did not anticipate Golden 90 pandemic as it has most to date, we'll have a meaningful impact for those that are already piece right I'll have to sports.
As mentioned earlier today, we have successfully prioritizing excess and delivery.
[music].
Our total care Hall is currently operating losses.
Lighting to support our patients.
[music].
Regarding patient insurance coverage, we have not seen shades in the bigger makes sense for because we will continue to monitor this dynamic.
In terms of identifying patients we continued to see strong base additions across holds great promise for the most in April.
Impacting future loans. However, it's currently unpredictable as we anticipate fewer patients will assist physicians as a result gold at 90.
We do look yet no.
This may have.
Two algos potential in 2020.
Well, we are currently navigating uncertain times, our commercial organization continues to demonstrate an ability to work closely together with HCP. These and other stakeholders in identifying tweaking and supporting patients really was liver diseases.
This is continues to give us a high degree of confidence that we will be able to continue treating patients you good states all dependent.
What sounded she ecology too long sparsentan is with groups.
Not to Nicole over to lower for the financials.
Huh.
Thank you Peter.
During the first quarter net product sales from our commercial portfolio grew to 47.8 million.
Any 1% increase over the same period in 2019.
Reported a GAAP net income point 8 million for the first quarter 2019.
After adjusting for non cash expenses and income tax we recorded a non-GAAP net loss of 8.5.
On a GAAP basis, R&D expenses were 30.2 million for the first quarter of 2020.
The decrease compared to the same period in 2019 is largely attributable to the discontinuation of the thoughts that panto terminate development program.
On an adjusted basis R&D expenses were 27.8 million for the first quarter.
Relevant noncash expenses for the first quarter included 2.4 million of stock based compensation and amortization.
On a GAAP basis, selling general and administrative expenses for the first quarter were 33.1 million.
The minimal increase over the same period in 2019 is largely attributable to increased compensation expense and higher professional fees.
On an adjusted basis.
<unk> expenses for the first quarter were 24 million.
Significant non cash adjustments for the quarter consisted of 9.2 million and stock based compensation and depreciation and amortization.
Approximately 21 million non operating cash during the quarter as a result of a onetime pull bumps sales milestone of 10 million and contingent consideration and debt interest payments.
During the quarter, we recorded an income tax benefit of 19 million this benefit resulting from the cares DAP legislation, which provides for net operating losses to be carried that preceding taxable years.
Generate a refund of previously paid income taxes.
The pieces resigned will be distributed to the company in installments during 2020 in 2021.
Importantly, we ended the quarter with a solid financial foundation, and 356.5 million of cash and cash equivalence as of March 31st 2020.
Well, our near term operating expenses, maybe difficult to predict as we mitigate the impact of phobic 19, and adjust our ways of working we will remain disciplined in our use of capital and we continue to believe that our cash on hand is sufficient to fund our operations beyond the read outs from our phase three study for Sparsentan.
Let me now turn the call back to Eric for his closing remarks.
Right.
Thank you Laura as we continue to navigate the challenging pandemic presented by covert Nike we have shifted how we work, but not the why.
We continued pursuit of our mission has never been more critical.
Rare diseases do not wait for Pandemics and our organization remains steadfast in its dedication to serving our patients and caregivers.
We have a strong financial foundation to support our operations and our goals remain unchanged. We are focused on the continued development of Sparsentan to support our goal of delivering the potential first treatment approved for Fscs and getting the property.
And we will also work to reach new patients with our approved products, while strengthening our commercial capabilities to ultimately maximize for a sentence potential if approved.
I am confident that the actions we are taking to mitigate the disruptions caused by the 10th and Nick will protect our employees and patients.
Position us to accelerate enrollment quickly when conditions east and ultimately deliver high quality data from the duplex and protect studies.
Finally, I would like to thank each of our dedicated Retrophin team members with their continued focus on the priorities outlined today I am confident that we will continue to deliver the highest level of support for our patients and ultimately emerge from the cobot 19 pandemic as a stronger company, let me know turn the call back over to Chris for Q.
Today, Chris.
Thanks, Eric can we please open up one for you and I.
Sure sure ladies and gentlemen, if the other question at this time. Please press the star other than a very warm T I hear touchstone telephone.
Your question testing answered or you wish to yourself from the Q you press the pound.
Our first question comes from the line of Maury Raycroft with Jefferies. Your line is now open.
Hi, This is by then on Maui.
So a couple of questions commotion sales continue to do better than expected Guinea provide any specifics on what's proportional is driven by pricing lessons volume and what proportion was driven by payer, let you see versus the prior Jim.
Thank you very much on for the question Peter why don't I have you take that one.
Very good. Thank you I think you can think you like for the question.
So.
Glossed over the last ideas, we have not increase prices. So the growth that you saw in the first quarter was solely.
But organic growth like you patients coming into the mix.
It's building component destroying quality that we saw on first before squadron 2019.
We saw great new additions will face we continue to see that into first quarter 2020 as well.
It is both failla failed he see.
As well as Colm.
Thank you and but one thank you appreciate that yet.
Yes that is so can you go into specific south what happens basin becomes.
It's not.
Cannot come flooding.
Basically.
I would have ticked up out.
Yes, yes, certainly I know what would you like to take that.
Sure.
They perceive that you know we've been following very carefully closely with the sites. The study conduct and we're very pleased with the sites.
Any to conduct the study and maintain trial integrity.
With regard to not be able to come to say too there are common decency based on the regulatory guidance on some of the sites are equal to our utilized satellite locations.
In some cases.
Thanks, So using local labs for us safety, which were drawing.
And as I said.
Very pleased with the conduct the sites they've done a nice job of continues to maintain a focus on on the clarity as I said earlier.
In terms of Cobra 19, if they develop covering two which obviously we have special protocols within.
Our protocol to view to address that.
Patients can actually doubled coded potentially go off drug and then come back on drug as soon as they are feeling better and improve their condition. So hopefully that addresses your questions.
Okay.
Your next question comes with a line of Jewish Schwartz with SPP Leerink. Your line is now open.
Good afternoon. This is Chris Clark on for Joe.
Do you think the degree of protein area reduction from Sparsentan and aging Roxy may compare to Fscs can you talk about any insight you have from preclinical or clinical data.
Yes. Thank you. So we certainly do have data on Fscs with Sparsentan from our phase twos and not.
Yeah, Hi, Jay in a property, we've looked at existing databases and other areas no. Perhaps you can share a little bit about the potential differences there.
Yes, I mean, I think that we clearly got heard that duplex studies at the right either to rely upon.
You can clearly see this precedent it's a very similar population in terms of the reduction of proteinuria.
We expect something similar along the same winds what we saw there with regard to again, there is preclinical data as well as some clinical data showing that the addition of endo feeling inhibition on top of interest Tencent Joaquin does provide incremental benefit and additional.
Production. So it's hard to say exactly what the differences are I think youd see reductions for probably in a similar range in both but I would say overall one thing we saw duplexer do add if you recall was patients who are above and below.
On to our in terms of their overall your PCR saw similar reduction. So I think that's that's a daily habit I think that's really confident in that.
Thank you very much.
Thank you know Chris had one thing that I would add on that is just in the disease state itself Fscs patients are often times.
Exhibiting higher levels of proteinuria, and so that may or may not play into what ultimately we see but there's no mentioned, we expect to see a consistent effect because the mechanism of both the disease and the mechanism in which far sensing works is consistent and both of those.
We believe.
Very helpful. Thanks again.
Your next question comes from the line up Michelle consumed with Canaccord Genuity. Your line is now open.
Hi, guys. So.
Hi.
Michelle.
Hi, there.
So maybe.
Ben.
Yes, so the first question.
Can you maybe remind us about that tiller ability that you sold with Percentand with regards to 400 versus the 800 and I guess, how many patients.
It is difficult.
You are using now for phase three if you would that downtime creation protocol.
I see how many patients with you.
The gentry site graded under death clinical into duet study.
And thank you bye now.
Oh, yes, yes, sorry, your second question.
Okay.
Uh huh.
Thanks.
Thank you, yes, no why don't you why don't you addressed the short question on Tolerability.
I think we know what you're referring to three question is referring to the duet study design. The latest study was designed patients restarted on 200 400 or 800.
And what we saw his patients around the 800 had some symptom consistent with the blood pressure drop ins lightheadedness on in Tolerability and had to draw back to 400 milligram dose and as a result, we weren't really adequately able to pass the 400 versus the 800 on when we designed the duplex study reaction design that without mine.
And that's why there's a two we type accretion stuff. So the patients will start in the lower dose and then after two weeks ago tolerate they'll tightened up to the higher dose we expect that a pretty considerable number of patients are going to be able to achieve the 800 milligram dose and hopefully stay there.
I think that that's as much as I can say, but I would say in addition that.
The 400 milligram dose if you recall from the way it was an effective dose and.
The drug works quite well, whether its 400 or 800. So we would be very pleased with the 400, but we feel comfortable with the current strada tightening up to 800, and we think we have a pretty good chance showing up in effect you heard as well.
Got it thank you and then.
The difference.
Treatments and.
Therapy.
Trial can you maybe talk a little bit more broadly.
Yes market.
First time.
Linda landscape.
Yes, so I'll start and then no. It's certainly feel free to add anything further we do see that the fscs.
Patients are quite broad and in the U.S. There are over 40000 patients with Fscs and very consistent numbers within Europe. What we see is that these patients in the prevalence is actually growing.
Likely because of perhaps the conditions that that drive.
The starring and the injury at the Mccullum areas.
What how these patients are currently treated today is with an ace or an art and if we look at that duet study over 80, 85% at the patients that went into that duet study, we're on pace or an art and what we also know from that study, but also from many other studies is that.
Unfortunately, the currently available treatments all off label do not effectively control the proteinuria to a degree that it's going to slow the progression that this disease and so we believe that it's far sets and is effective is safe and is approved that it would become the standard of care in the treatment of Fs chip.
Yes.
Whether it replaces an eastern our four patients. Our first started there and then a stepped up quickly to sparsentan to get greater.
Reduction at Proteinuria remains to be thing, but some of the work that Peter and his team are doing to understand how physicians may think about this role, but that's largely how we see the.
The role that is far sets and would play there are certainly would be.
Use the other.
Treatments use we know that some of these patients are treated with other classes therapies such as their ROI, but we also here very consistently from patients and their clinicians that there really is a hope for something that treats the common pathway of this disease and.
Not going to be immunocompromised say, no anything else he'd like to add on the future role.
I think he called me when I say well, Eric if I could just said two points of just to reiterate number one there are no approved therapies as Eric said four Fscs I think those critical number two we are the only compound in phase three at this stage in the game and we're very proud of that us for setting has over 500.
Since you've been treated to kind of large for the speed safety database to draw off of and the duet data is really Great example, that I think in terms of other therapies that are emerging really there or really any therapies approval that have established the CP yet in this area ERC alluded many of them our immune suppressive.
There are concerns in those classes around safety. So let me first say, let's say we are further patients we want to make soon as many therapies out there as possible.
And there's no reason that first like it wouldn't be complementary with you therapies that we can see.
But again in the position that right we believe that.
With that position.
Got it thank you congrats on the corner.
Thank you Atlanta, Thank you.
Your next question comes from the line of Christopher married with Nomura Instinet. Your line is now open.
Good afternoon, thanks for taking the questions and congratulations on strong performance in the quarter I know it hasn't been easy.
I want to task with respect to them.
The benefit the pull through you're seeing with respect to coated.
How much of that is is you know.
The bile acid products versus.
You know title a sales and then if you could comment you're seeing or you had highlighted earlier in your comments on enhanced compliance and I was wondering if you comment on that is that enhanced compliance due to the new formulation.
First or those who have switched to that formulation or is it is a compliance that it's more coded repeated thank you.
Alright, Thank you, Chris Peter wanting to take this one.
Yes. Thank you, thank you and things sort of question.
Well the gross first of all we saw consistent across all three products.
So that continues ability to identify new patients for all three product lines I think there was a.
Drydock for controls with regards to your second question on compliance.
It's an interesting question I think the concept of compliance and adherence is a broader.
Question.
And we start to see yet although it's still early days, we start to see that isn't impact.
The pools.
Impact on compliance with the easy it's too early to the mental like its specific numbers, but in addition to debt in second half. This morning. We also started to see across based products increased compliance lately.
You too cold days.
And I think that speaks to the be hook behavioral components.
Treatment as well in particular for Cystinuria, you can imagine that patients will stay away from the hospital in these days.
So that could have an impact when the compliance and additional elements here could be.
You see is like.
Treatments three times, a day and especially the middle treatments.
Ms patients being at home being more at home.
I have more ability to take that treatment. This walls that could also.
Have a decrease you thanks.
Blades so to your question lagged the broader complaints sector, we saw an increase.
Likely you do you see been in addition, the second half of more tools will increase.
At least through the corporate situation.
Okay. That's really thank you Peter.
Chris Yes, sorry, before you basket Jack's question, let me just had one thing that both bio and coal bomb had a pull forward of shipments.
As you know might be expected for for these drugs and these conditions, we did see more of that with Faiola.
You know that drove some of that but also that's probably where we saw more of the compliance impact as well sorry to interrupt you go ahead.
Oh, Yes, no I was just that's very helpful and I guess I was.
Curious about the second half of March increasing compliance generally that you saw.
You know it's at your expectation that this will continue through second quarter, and then perhaps given the dynamic you've seen.
Q1 in the emerging impact out of coated on you know how do you look at.
Benefit or potential impact.
And to Q.
I have a follow up.
Peter.
Yes, I think it's too early to say as I've mentioned like the second topic margins, where do you went up and Debbie.
Starting to see we saw a slight increase in compliance there how to translate into the second quarter I think it's too early to say I think what you see I think.
You see allows for greater flexibility of patients so it.
Could it be expected that could be a slight increase from complaints. There I think that's what we're starting to see the particular aspect or goals I think it's too early to goal how to translate into the second quarter.
Okay, Great and then just with respect to.
I guess you guys.
We're going to initiate a pivotal trial in.
CTX with China doll.
And I was wondering how that's being impacted or are you did initiate that pivotal trial pump I'm, sorry, and how to how that may have been impacted and then finally I'm just with respect to BD I know you had been looking at many different potential opportunities.
And has that slowed down or sped up thinking with respect to cope with thank you.
Sure. Thank you, Chris so with regard to.
The capital CTX study. This is the restore study we did initiate that trial and similar to the impact of screening and enrollment that we saw with duplex and protect we also are saying that with restore so I'd say at this point, it's too early for us to be able to project timelines for that one but it isn't on.
Going study.
And with regard to business development I would say this is not set up or slow down we continue to remain focused on that as a priority for us and we believe that there still are a number of assets within the rare disease space that would leverage the strength and the footprint that we have booked for clinical development.
And for commercial so stay tuned on that.
Our team is continuing to evaluate different NASA.
Great. Thank you very much congrats on a quarter. Thank you.
Thank you.
Your next question comes from the line, Tim Lugo with William Blair. Your line is now open.
Thanks for taking the questions and congratulations managing through a difficult situation.
And I guess, maybe a question for now I think we all understand this fall we down a patient screening.
Okay.
I mean, all Seneca can you comment you mentioned you had 20 calls around if a patient were diagnosed with colder.
I'm just wondering more about the general difficulty in collecting urine and blood sample during the pandemic.
And if patients can come in within the protocol defined windows, how those patients are managed and if you're able to maybe employee home nursing business for how you're just managing.
The situation.
Yes, great Great question I hate some great question so.
You know with regard to the collection of the year in specimens and I think you're referencing the key endpoint visits.
We have a great deal focus on say the week 36 urine collection, because that's pivotal whether thats a key endpoint for us and in we've got trackers. They track each patient down to each visit so we don't exactly where those those patient samples will be quite good working closely with the site.
I will tell you. They you know in many sites, it's still being collected centrally and that's still occurring there are some sites where they.
Those collections will either be dropped off at a clinical site, sometimes always meeting the parking lot. I mean, there are there things like that where the sites are ensuring that they continue to collect that.
Data and get that off and frankly looking across.
Again, an aggregated dataset that we have I can say that we are pleased again with the overall conducting the study.
There there is.
Room at some point potentially for our visiting nursing I think you had mentioned that we haven't seen a huge need forward at this point, but we are looking at that option and or in the process of contracting a group to do that work for us in Keith This is prolonged and the sites do require that additional.
Support.
So I think it's a great question.
Hopefully that answers your question.
Yes, no definitely sounds like.
Thank you.
Integrated India, India code to.
Yeah.
I guess more people talk about easing.
Okay.
In ethically focusing easing.
Yes, because if we've got for the June how many sorry, you expect could be.
The impacted just maybe a director standards.
Okay.
Yeah, that's a tough question to answer because it is a dynamic process.
But I will say this that the team is we're engaged with every site. We've had no sites dropped in the study.
The sites are very interested in maintaining continuing and driving the study the understand devalue site engagement. If you recall prior to this is regardless of the Oneninety, that's what drove the momentum.
And they're engaged and excited and the conversations that I have typically Tim with the pie isn't it talk with a great number there, which can imagine is when right can we start to see prescreening activities. Some are doing it now some they're not ready and when can we start seeing.
Wrapping up of screening and randomization they'll tie it to the opening up the clinics as the clinic start to open up you'll start to see more and more screening and recruitment because the capacity.
But there are no without over promising I think talking number these sites there quite excited engaged and they're paying us close attention as we are all this and making sure that we can take advantage once things ramp up.
Okay and.
And.
You mentioned you are the only.
Fscs phase three up and running is that.
I guess can you give me.
And it goes to you've heard from investigators and maybe their views on immune suppressive therapy. This indication.
The team given a pandemic I don't know side.
Great.
Yes, the to maybe I'll take that what it will take it from the conversations that I've had with some of the patient advocacy leaders within the rare renal space, but actually beyond there was a very consistent.
Heightened awareness our ground.
Immunosuppression.
And the risk of an of infection and so I think this is something that the rare disease communities are have a heightened awareness anyway and that's even more so during this pandemic and so I think that there is.
Really this question of is a potential treatment or clinical trial going to put me a greater risk given that many of these patient phase regardless of their treatment and immunocompromised state I think thats driving a lot of this and I suspect that the.
The clinicians are going to be thinking the same way know anything quickly you want to add.
Yes, I think just to support what you said, our we've heard that from the FBI institutional level as well so what they're saying anecdotally is the studies that are not putting patients at risk are likely to be the first of the volume of sites those things to get back up and running on the site level as well.
Great. Thanks for the question.
Thank you Tim.
Your next question comes the line of at least what they call with JMP Securities. Your line is now.
Hi, John Waldron on for Lisa Thanks for taking the questions and congrats on the progress.
Just one on the protect study could you discuss kind of this new confirmatory endpoint house might have evolved or change over time.
What is the meaningful difference between update and what were previously expected.
Yes. Thank you John I'm going to have built take that question.
Certainly thank for the question John the changes really relatively straight forward, we're essentially removing the post cessation of therapy measurements. So it's the observation window is four week shorter than what was listed before because that really wasn't that right measurement for sparsentan and we believe this change.
De risks our potential for full approval.
We originally designed the study based on robust data from duet and our knowledge of Fscs as well as registry data from patients with gain a profit thing.
At that time, the FDA had asked us to look at pre and post because there was precedent but that measurement.
Other therapies.
Since we started the protect study we've gained access to a robust trial level analysis specific for IBG into property trials, that's allowed us to demonstrate using modeling that measuring Egypt far from zero to 110 weeks, while on therapy is really the optimal weight understand sports and put into effect on outcomes.
We shared this with the agency subsequently made the change the protocol.
It's important for me to point out that this was done based on the modeling from the Tri level analysis. It wasn't done with study data, we're still blinded to the study and we don't have patience out at this point.
Protect yet.
Okay, Great and then just kind of the commercial portfolio. You mentioned that you expect perhaps new patient starts will be a little more difficult obviously with pandemic ongoing.
How are you feeling about your previous guidance mid single digit growth for net product sales for the year.
Yes, so John I would say that we started off very strongly for the year in new patient growth and.
I would have seen a very strong quarter, even without some of the pull forward of some of the some of the prescriptions.
And you know it's as Peter mentioned, our April New patient starts were also strong that said, we need to be very careful in thinking about the duration and severity of the pandemic through the rest of the year. So we're cautious.
But at this point, we believe that it is possible to achieve that mid single digit growth and we'll continue to monitor and report as we see anything any potential change from that.
Great. Thanks again.
Thank you John.
Your next question comes from the line of General line with Barclays. Your line is now.
I think it for taking my questions David dye Gina.
Currently clinicians on the great quarter.
Question on the commercial franchise.
The file that you'd see do you see what patient switching to the east Reformulations because a common 19, you know probably because of convenience and whatnot.
And then he just help us understand what's the strongest split.
With that between the I'll, let you see formation the original from issue. Thank you.
Thank you very much David Peter you want to take those question.
Yes, I get to take that question and then six thanks for that the Dave.
So I think in the last quarterly earnings we reported that about two thirds of the patients.
Yes started using failed E C, which was very much in line was the research we had done previously.
And since then we continue to see an increase on.
That number we don't provide to specifics.
If that is more rapidly increased due to go visit I don't think we see that contract.
That's very helpful. Thank you.
Thank you.
Your next question comes from the line is still came with BMO capital markets. Your line is now.
Hey, good evening, everyone. This is 8-K on for Joe Congrats on a quarter I said a quick question regarding thiola.
Turns of the Q over Q decrease.
Sales.
Is that primarily due to the DTN upsetting the.
New patient starts in a little bit of nalley going on there.
Yes, Peter which I pick up.
Yes, absolutely, yes, I think it's a continual nicely across all three lines, we still see basin that are currently using.
Or formulation that moves towards the C, which he also new patients that are being diagnosed and and get treatments that they get a failed you see and we continue to see patients depth.
Did you use to have failed and restarts therapy with which you can see so across all three lines we see.
That patients.
Using easy.
And I think one of the other things that I would add just in the first quarter, we do see that overall the gross to net is usually higher in the first quarter versus Q4.
As you would imagine that with the volume shift of file with the file that you see.
That there would be a differential potentially with with gross to net there, but I think largely what we see is that pattern that is consistent quarter over quarter, what a previous years as as patient insurance reset for the year.
So I think largely in terms of the market dynamics as Peter mentioned, but then you also have this unique dynamic of gross to net within Q1 versus the prior quarter.
Okay. Thank you for the clarification.
Thank you.
In time, showing no further questions at this time I would now like to turn the conference back to Chris Cline.
Great. Thank you.
Thank you everybody for joining US today. This concludes our call I hope you all remain safe and well.
Hi.
This concludes today's conference. Thank you for your participation and have a wonderful thing moving all disconnect.
[music].