Q1 2020 Earnings Call

Andy to want to answer that or you want me to.

Yes, no restaurant, Hi, Jessica Andy So we have not yet had these discussions with FDA.

But the timing is not dependent on our results for it to.

Great and just as a follow up question.

Curious if you could elaborate on whether you think the lack of need for titration could be.

Helpful in the current environment, where.

Patients or maybe trying to minimize their interactions.

Okay.

Andy shaking his head, yes, I see him I'm, sorry, I know I've got it.

But I'd ask you Clark.

Go ahead.

[laughter].

[laughter] Andy why don't you go ahead, and then Mark if you want it answered yes sure.

After that.

Well I think the lack of need for tight Grayson is definitely an advantage and we've already heard that from psychiatrists, where there are treating a patient and both before and now after the launch as well. So I think anything that does facilitate the ability to use this drug safely and effectively.

It's going to be an advantage in any environment, including this one.

I don't know Mark have you heard anything more about that yeah. We've actually heard comments very similar to what Andy just describe that in this environment, having the single dose and being able to start at the effective dose.

As being viewed as a as a positive but I I think across the board whether we're in this type of environment or not as Andy said, we do view it very much as a benefit for patients.

Great. Thank you.

Thank you.

Our next question comes from both Chen with Evercore ISI your.

Your line is open.

Hi, Thank if we'll take our questions we'd like to focus on the adjunctive trial first a question is based on that and dynamic situation should we expect that the patient follow up will mostly be through telecom friends. All fall interview and if so how would that add.

Any variability in the primary endpoint assessment and also related to this trial is what shall we expect all the placebo effect. Thank you.

So Andy do you want to take that but I'll give you the older all statement and that is so far.

We haven't been very it hasn't been affected very much at all that well before out to study weve been very fortunate there but for that particular, it's about what you're asking I'll ask Andy to give you.

Yep.

Yes, yes, there is absolutely right, we've really seen very little impact to this point on the conduct a war expectations for completing study for owed to us.

So as you know we completed the clinical portion in the U.S. So the remaining a clinical portion of the study is in Europe.

We did allow for some flexibility based on the FDA guidelines are in case, there was a need.

To do that in order to be able to complete the trial with good data integrity as well as good patient safety, but assurance as what we've seen so far is very little league two years that flexibility so that.

Vast majority of visits are still being done as they were before we don't anticipate any issue with that and then we are on track a as we've said before to complete this trial and be able to provide.

Topline results by mid year.

And with regard to placebo effect, we don't think that there's any again, where most of the trial is complete we don't think there theres any impact to the current environment or any changes that may occur from here to the end of the study that would have any impact on that.

Yeah. Thanks, a lot just for the second part of the question were not trying to compare or get any.

Estimate of the impacts of the dynamic, but also inch but just in general what's the placebo effect, we should expect compare tool with a tool finished in monotherapy trials.

Yes so.

We had.

The very high placebo response and study for a one which therefore ER was not as successful trial and the placebo response was managed quite well in study World War, which was positive we think that.

The there a number of aspects of study for all too.

Including the global.

Distribution of the study.

That are in favor of having and a well controlled placebo response.

We have no reason to have any additional concerned about that.

So and another respects you know were adequately powered study for road to for a range of outcomes and be able to detect a clinically meaningful results. So we don't think that theres or we're not concerned about an issue there.

Thank you very much.

Thank you.

Next question comes from Sumant Kulkarni with Canaccord. Your line is now open.

Good morning, Thanks for taking my questions. The first one is on the bipolar depression trial, and then I have a follow up so on bipolar depression is it fair to assume that you would wait until you have the results of the global adjunct therapy trial before you put it under quest to speak with the agency and about doing that Cindy filing and you have any specific expectations on when that meeting my doctor.

So I know as I mentioned before the two or not depending on each other we are still planning to.

Meet with FD, a [noise] again to discuss.

The potential for filing under GAAP number different scenarios, but in particular with a single positive trial in support of data.

And that we're we're moving ahead with that.

And then a question on the commercial front some markets a bit of a big picture question. So do you think this environment levels, the playing field in more for a relatively small company and might we see any fundamental long term changes and the classic therapeutic sales and marketing model, especially in the nudo psychiatric space that lend itself relatively relative telemedicine.

Yeah. Thanks, Thanks Im on for for the question Yeah. The as as Sharon mentioned the this environment has caused a lot of changes into healthcare industry as well as in our own industry we successfully.

Inverted many of our selling activities and our medical education activities over to virtual platforms and.

In some ways on the medical education side, we're actually able to attract even a larger audience for these programs because they are being done virtually then we would have in a more traditional environment.

We've also had the opportunity to really expand in a variety of areas in a variety of tactics. The nonpersonal types of promotion through digital means that we may not have done.

In our original.

Original plan.

I do think some onto that that when companies are faced with this type of a challenge.

It is important to be able to be nimble and adapt and be creative and innovative.

And I think that will carry through.

Even beyond this pandemic situation as the country begins to reopen.

As things begin to return to normal I'm sure there's going to be approaches that we creatively took during the pandemic that will continue even when we get back to more normal types of operating procedures.

Got it thank you.

Thank you. Our next question comes down like gunmen with SBB link.

That's good morning, more can you talk about just schizophrenia patients in general in this environment or we are we seeing as many.

You know.

Starts virtually as you expected I mean, you know just trying to get a sense for.

You know.

How much this environment has really impacted what what your expectations were kind of going in and if you think about like all dock programs that you were expecting it to in person for instance, and now they're virtual you know is the participation level the same as.

You know significantly worse, better just trying to get a sense for you know the reaching out and how much touching.

Doctors as well.

You know give us a sense of of whether you know the patients that are starting on quite or these are the switches are these new patients and maybe just a little more color. If is it possible on whats happening behind the scenes. Thanks.

Yeah. Thanks, Mark for the for the question and I'll try to answer at the best I can what I would say across all of the questions that you asked is it we are in very early days of the launch we have been out there for about a month now we don't have a lot of data yet coming back in.

On.

You know the types of patients that were seeing we are getting some anecdotal.

Information in the market research that we are doing with those prescribers, who have had the opportunity to prescribe a cap like and as as Sharon mentioned.

Before we we do believe that really any physician in any patient looking to switch.

He is an opportunity for them to be considering kept flight on so we're seeing across the board different types of patients being tried on cap lighter.

As it relates to the programs and our interactions with physicians as I mentioned before in the last question Oh, I think one of the silver linings. In this situation is we are actually attracting a larger audience to these virtual programs than we would've expected. If these were being done.

In person in cities around the country. So our reach from a medical education perspective.

Has been even better than if we were in more of a a traditional environment.

And as far as the dot the overall schizophrenia patient physician interaction I think what what we've read as being consistent with what we've heard is that overall there are fewer inpatient a in person patient visits.

That's being offset to some degree by the increase in tell us psychiatry.

But I think across the board across different categories, including the anti psychotic category there are fewer new to brand prescriptions.

In the early going here, we would expect that as the country begins to reopen as our operations, including our Salesforce operations normalize we would expect to see an acceleration in those prescriptions and as I mentioned in my prepared remarks, we don't see any negative.

Impact on the long term potential of cap lighter.

Are there plans for T T C on the television.

We are we're looking at that and we're considering that is as part of our marketing mix.

Thanks.

Thank you.

Our next question comes from buying Abrahams at RBC capital markets.

Hi, developing.

I'm not sure taking my question I.

I guess first off I'm I'm curious how providers had been on virtually monitoring for side effects on for patients on existing anti psychotics potentially fine patients eligible to switch to capitalize on what's been the perception their perception overall I have the potential efficacy profile.

Quick follow up thanks.

Mark do you want to take that I think I think we addressed this in part before but yeah I think we'll expand.

Yeah, Let me, let me start with the second part of the question first the the feedback that we've received again with the market research that we've done with the early adopters is it is still very early on in the process, but they are satisfied with the efficacy that they are seeing.

In the patients that they've been able to to try this on.

And again that would be consistent with what we would have expected from the marketing research and as far as monitoring of the side effects <unk> again, they there's a variety of ways in this environment that patients are being seen by the physician. Some continued to do in office visits while others have switched to tele medicine.

We haven't gotten a lot of feedback on that other than to say that the tele medicine, the tell us psychiatry.

<unk> has been.

Working very effectively and providers can monitor a any side effects that the patients are having that might require a switch or it seems as effectively through tele psychiatry as they could within person ER visits but again this is all anecdotal.

And for US very our early on in the launch so we hope over the next couple of months certainly to have a lot more.

Useful data that we could share with you, but that's what we're hearing at this point.

Got it maybe it could actually just clarify that the latter part of my question. I know you guys have talked about see positive feedback from physicians, who are who have experienced with topline I guess I was wondering.

If you're seeing what the overall perception among physicians, who maybe have not just the aging yet are there I know there's been some back and forth in literature or there is there a perception that there may be efficacy any efficacy tradeoffs for some of them improve safety profile are there any skeptical physicians out there that.

Additional education.

On the robustness of the data.

But to describe the agent.

No I would win I would remind you the sharing and I'll start and I'll turn it over to Mark and Candy, but I would remind you that our approval was based on the efficacy and safety seamless cap why that into positive studies and the ASCII I have seen this and effective product and.

That is what the FDA remarks on.

On products that they approve in this area.

And our side effect profile again has demonstrated in the label.

<unk> has been a very favorable side effect profile. So so the short answer to your question is no. We're not we're not.

We're not seeing anything like what you have.

Suggested and Mark do you want to comment more Andy do you want.

I I would just reinforce what you said and say that it certainly in our market research before the launch and nothing has changed that view since the launch in the feedback that we've been getting from our sales representatives when we ask them receptivity to the message and that is.

All of the anti Psychotics are generally considered to be efficacious and similarly, so and it just depends there is patient to patient variability and there's been nothing that we've heard back from our sales representatives that would indicate that physicians.

Have any kind of concern about the efficacy of of cap later as I mentioned, they are very much seeing the a differentiated safety and tolerability profile and.

Seem to have really been pleased with the single dose where they can start at the effective dose and maintain the patient on that same dose.

That's great sounds like great receptivity, one quick follow up any expected inventory build or other staggered buying patterns just to be aware up as we modeled a quarterly cadence of launched about 20, Tony. Thanks again, congrats on all the progress.

But so share enough to attack that yeah, I I wouldn't expect anything out of the ordinary you've you've seen our first quarter results, which is largely the.

Initial stocking up the wholesalers the supply chain in our industry has become very efficient and product flows.

Very effectively from manufactured wholesaler and then out to pharmacies, where most pharmacies certainly within 24 hours can get.

Product.

Whenever they have patients who come into the pharmacy and need to be need to be felt so the answer your question, though I I wouldn't expect anything unusual.

Thanks again.

Thank you.

Our next question comes and Andrew side with Jefferies.

And is now open.

Thanks, Good morning on.

Glad to hear that everyone's doing well. So first question is just on the prescribing dynamics so far.

Can you speak to just how much sampling is going on and what percentage of scripts coming in are being blocked by payers, maybe speak to that dynamic little bit.

And then Oh second part of the my question is really just what in terms of a long term drivers longer term drivers for a second how 2020 are going in 2021, what do you think it'll take four scripts to inflect CESL that more what more needs to be done on your end is it DTC adds isn't more marketing is it more calling.

Yeah. If you can just speak to the drivers little bit that'd be very helpful. Thank you.

So that was lot of questions [laughter], that's or any of us captured all of them I I would just start by saying.

We don't expect.

Payers to block a script. However, again were very early in the launch so I think right now were not.

Commenting on that and then for the other questions.

I would turn I think over to mark for the answers.

Yeah, and so maybe maybe just a follow on Sharon's comment about the payers or as we both mentioned in our prepared remarks.

We are very pleased with the progress that we're making a with payers and the coverage determination outcomes and we highlighted Medicare part D, where we have a 90% of the covered lives.

Now have access on formulary to cap lighter.

And the other channels, we expect a it's going very much. According to plan as we expected. It would in addition, what I would say where where there are prior authorizations in place we have an industry, leading a reimbursement support program that can be utilized by physicians and their stuff.

Half to help navigate that process, but I Sharon said it is it's very early on in in our launch it's too early to tell any kind of patterns or have any kind of useful data associated with that but we we have been pleased with the progress that we're making on the access side.

From a sampling perspective, I guess, what I would say there is in in this environment. It has caused us to adapt and be creative in how we get samples to physician. So they can provide them to patients and I would just say that regardless of whether the physician continues to practice in their office, where they are participating from.

Their home remotely in Tele medicine, and regardless of whether patients are coming in in person where patients are taking advantage of the tele psychiatry, we have procedures in place that allow us to get a samples to the physician for them to be able to distribute that to the patients. So we have a innovated our way.

Through that process.

I think the last part of your question was it you know as we proceed through the year, what more will it take I think with any new product launch. It is a matter of raising awareness communicating and effective message and providing the kind of programs where physicians can be appropriately educated on cap light.

As to what the benefits are in the types of patients that they may want to consider capitalized and and I would just say we have a full marketing mix, where right now in the pandemic environment as I mentioned.

We are in a virtual environment for our Salesforce, a virtual environment for our medical education as the company as the country begins to reopen and as our field force begins to normalize once again I think the interactions.

With physicians will return to normal levels, and I think that will contribute to what we believed to be will be an acceleration to further acceleration of the prescription performance. So I hope that answers. Your question. If there if there was a part that we didn't answer just just let us know.

Thanks for the color its parent.

Operator.

Thanks, Andy Operator, I think we have time for one more question.

I'm not showing any other questions when it came out.

Great terrific and my perfect.

Well.

Okay, then I would guess Ah thank everyone for participating today on our call and we look forward to updating you and we hope that.

During these challenging times everybody.

<unk> safe remain healthy and.

And that we return that our country returns to a new normal.

As soon as possible. So thanks everybody.

Operator, you can now disconnect.

Ladies and gentlemen, this concludes today's conference call. Thank you for participating you may now disconnect.

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