Q1 2022 Concert Pharmaceuticals Inc Earnings Call

May 5, 2022

Okay.

Good day and thank you for standing by welcome to the concert Pharmaceuticals first quarter 2022 investor update call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question. During the session you will need to press star one on your telephone please be advised that.

Today's conference is being recorded.

You require any further assistance. Please press star zero I would now like to hand, the conference over to Justine Koenigsberg Senior Vice President Corporate Communications and Investor Relations. Please go ahead.

Good morning, and welcome to concert Pharmaceuticals, first quarter 2022 Investor update.

Our prepared comments today will be brief so we can jump right into the Q&A portion of the call. Joining me. This morning with prepared remarks are Roger Tung, President and CEO and Mark Decker, our Chief Financial Officer.

Nancy Stuart our Chief operating Officer, and Jim Cassella, Our Chief Development Officer will join the team for Q&A.

A reminder, today's discussion will include forward looking statements about our future expectations plans and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected.

Description of these risks can be found in our most recent 10-Q filed with the SEC any forward looking statements speak only as of today's date and we assume no obligation to update any forward looking statements made on today's call with that I would now like to turn the call over to Roger.

Thank you Justin and thank you everyone for joining us for today's update with.

With top line results from our pivotal clinical trials coming during this and the next quarter. We remained focused on bringing CGP $5 43 to the finish line and assuming phase III success, we're well position to file our NDA in the first half of 2023.

Both of our phase III trial a.

Clinical trials whole randomized placebo controlled double blinded multicenter studies evaluating the safety and efficacy of <unk> 543 in adults, aged 18 to 65 years old with 50% or greater scalp hair loss.

Each study is evaluating two doses of <unk> 543, eight milligrams and 12 milligrams twice daily compared with placebo for 24 weeks. The primary endpoint is the percentage of patients achieving an absolute salt score of less than or equal to 20, which is believed to represent a clinically meaningful.

<unk>.

Our topline data announcements from tried a one will include its primary end point and key safety data.

We will look to present more detailed findings from the study at future medical meetings.

Recall that in our phase II dose ranging study both the eight milligram and 12 milligram twice daily doses achieved a significantly greater proportion of patients with a salt score of less than or equal to 20 relative to placebo.

For those not familiar with sold or the severity of alopecia tool is familiar to determine the amount of sculpsure coverage by assessing all regions of the scope that contribute to the total score which ranges from zero to 100.

Salt score of zero corresponds to no scope or loss, both salt score of 100 corresponds to a total like her.

Here on the scope.

As we shared in the past there could be up to approximately $1 million and have alopecia area out of patients in the U S with a sizable subset having moderate to severe disease.

Currently there are no FDA approved treatments.

Even with other potential players in the market given the extensive patient need and the clinical profile. We've seen to date with CCP Slide 43, we believe it has blockbuster potential in the treatment of alopecia areata.

We're hopeful that the phase III results will confirm our phase II and long term open label extension observations and Thats <unk> 543 will be an effective and durable treatment for alopecia areata with a generally well tolerated safety profile consistent with its intended use.

Among the JAK inhibitors being developed for the treatment of alopecia area, Although our phase III results of <unk> 543 appear to have a highly competitive profile and we're working to bring it to patients as quickly as possible.

I'd like to pause here and turn the discussion to Mark who will provide an overview of our financial results.

Thanks, Roger as I review, our first quarter of 2022 financial results. Please reference the financial tables found in today's press release.

Research and development expenses were $30 5 million during the first quarter of 2022 compared to $18 5 million during the first quarter of 2021.

While the phase III trials are winding down this year, we continue to have clinical costs associated with the open label extension studies.

North American extension study is expected to continue until approval Gen.

General and administrative expenses were $5 5 million for both the first quarter of 'twenty, two and 2021.

Our net loss for the first quarter was $37 7 million or $1 <unk> per share compared to a net loss of $22 7 million or <unk> 67 per share for the same period in 2021.

We ended the first quarter of 'twenty, two with $109 million in cash cash equivalents and investments, which we expect to fund the company into the fourth quarter of 2022 based on our current operating plan, we have the potential to receive an additional 103 million upon the full exercise of warrants that were issued in our November 2021 financing.

The warrants are tied to the thrive AA, one and two data readouts. If the warrants are fully exercised we expect our cash runway will extend beyond the anticipated NDA filing which is planned for the first half of 2023.

We are at an exciting inflection point for the company as we prepare to release topline thrive AA. One data. This quarter, we've worked hard to advance <unk> 543, and assuming success. The team here is very excited about this drug candidate moving toward an NDA filing next year. This concludes our prepared remarks, and we would be happy to address any.

Questions.

Thank you.

As a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key please standby, while we compile the Q&A roster.

Our first question comes from Jason Butler with JMP Securities. Your line is now open.

Hi, Thanks for taking the questions.

I mean.

Obviously exciting data coming out maybe you could just frame a little bit more based on the competitive landscape.

What we should be looking for from from the Salt 20, and then again just current thoughts on safety language on approved products.

For the class and just how you plan to approach the FDA.

With regards to the $5 43 label. Thank you.

Hi, Jason and Jim here so.

Thank.

Patients for our phase III trials are.

Consistent with what we saw for our phase two so I think we're looking for.

And the data readout on the 12 milligram.

Dosing, so I think we.

We have been experiencing we had a couple of trials in phase two that gives us confidence that our trial design for phase III, which is very similar to what we saw in <unk>.

Dose ranging trial, so I think we're feeling pretty comfortable with the design and with the data we had.

A major release of our phase III study. So I think we are.

We're looking for consistency there as we had consistency in our phase two trials I think the competitive landscape you see.

Pfizer and Lilly competitors out there.

With data I think our data.

Very competitive with.

What we've seen in phase II and our expectation is that we'll see consistency with our phase III results I think as far as safety goes.

<unk> has quit.

Language out there.

If it moves across the great technology.

Copies of aerospace I think that.

Everyone's coming to grips with the Fda's position on JAK inhibitors, but I think theres going to be.

A little different with alopecia, Areata, where theres no drugs for.

The treatment of alopecia areata, there might be some consistency in the safety language across the drugs.

The difference will be LTE share yada.

<unk> has significant unmet need.

It will need.

Zinc JAK inhibition is a very important mechanism in the treatment of alopecia area. So it's very important for patients.

In terms of.

It is I'm here and I think the data shows across this field John .

<unk> inhibitors are very important as a mechanism to treat alopecia areata.

So I think that's very important consideration as we look at alopecia areata on the background of what the FDA.

Perspective.

Great. Thanks, Tim and then just one more for me can you just speak a little bit to the.

The medical Affairs Medical Education planning.

Planning you are putting in place now for once you have data and starting to get physicians up to speed on.

Being aware of the product in your.

Your dataset.

Sure absolutely.

You can imagine it's a very good area of interest to us.

One thing just as a little bit of background is.

We are working with a lot of the Kols in this space as trial is we have a very good representation.

U S as well as some.

Europe and Canada.

One of the experts these efforts are treaters.

Great.

Yes.

The experience in treating alopecia.

Our with these kols and these kols are involved.

Trial. So we have a very good network of investigators who are probably the main treaters in the space as well I also think that what we're seeing is.

For medical Affairs.

Will it be education of patients.

Education of other dermatology.

Experts.

Or in the aerospace and I think those are going to be very important aspect of the medical affairs team.

There's a lot of patients who has been.

We will have alopecia reata, who are maybe not in the mainstream with treatment because there is nothing available. So part of it is going to be to let them know that there is going to be treatments available and I think it will bring sort of that latency population basket to discretely include as well so part of that.

Old Medical affairs team is going to be right.

Treating dermatologists up to speed on the JAK mechanism the importance of it it really does work.

The safety profile of it but also getting patients to be aware that there is now a treatment option available.

Great very helpful. Thanks, Jim.

Excited waiting for the data thanks for taking my questions.

Yes.

Thank you. Our next question comes from Pharma <unk> with Mizuho Securities. Your line is now open.

Great. Thanks for taking my questions one to follow up on the discussion around that.

<unk> landscape and then one other separate question on the commercial side I'm just curious there's obviously.

Bloomington Jackson on the market already Im curious, how youre thinking about pricing in this market is obviously still a mechanism maybe even the same drug in terms of on demand, but obviously those are targeted for much larger patient population than what you'd be going after with alopecia side I know if you can just share some of your thoughts on what you're going to see what the data Hall.

And the next few months here, but but what your thoughts are sort of going into that data.

And then my second question is just around the ex U S opportunity that you guys talked about this a little bit before but just can you sort of share your thoughts at this point again, obviously, we're all waiting for the data kind of how do you. How do you view that X gene was opportunity for this product and.

How are you thinking about doing it yourself versus looking for a partner potentially thank you.

Hi, This is Roger Thank you very much for the question.

With regard to pricing.

It's a little early for us to watch locomotive right now.

If our phase III data, yet and frankly.

I think it's just us any good to assist that prospectively, we have said in the past that we think that we're seeing structure.

For LP Sherry audit.

Quickly.

Probably consistent with the pricing for other autoimmune dermatological diseases, and we know that drugs in that space.

Range.

In the mid <unk> to about 60000 per patient here.

At this point.

Good luck.

<unk> three per se.

Terms of ex U S. We do have.

If you have an interest of course in commercializing.

We do not see ourselves at this time yielding.

Yielding at Salesforce.

Yes.

Yes, some interest in subscription is ongoing.

Sure.

Okay. Thank you I'm not sure if my line on something else, so a little bit painted on the required but I think I caught.

What you are saying, okay. Thank you so much.

Sure.

Our next question comes from Maury Raycroft with Jefferies. Your line is now open.

Hi, good morning, Thanks for taking my questions.

Just wondering if you can tell us where you are in terms of closing out the phase III with database lock and analysis.

Hi, Good morning. This is Jim So I think what we can say is that things are on track for our data readout this quarter and things have been moving very nicely as you can imagine it's a large trial.

Lots of data to clean and make sure. His is ready to go into database lock.

I'm very confident that we're going to hit.

Our scheduled deadline and we'll be reporting data this quarter.

Got it okay. Thanks, and then.

Also just wanted to ask how youre thinking about the <unk> decision on our 609 patent expected next week and if you can provide any specifics on what next steps are going to be for either outcome of that decision.

Sure.

Yes. This is Roger Moore.

Well, we feel like we had very good oral arguments.

Our legal team conscious legal team did a great job. So we're very hopeful that we'll get a positive decision on that and clearly if we get a positive decision, we think that we're well set going forward.

Well into the.

Into the 2000 series.

If it is not a positive decision we had the ability to and we intend to.

Go to an appeal on that decision, which.

Which would probably.

Involve either an appeal choose the director or or going directly to the U S Court of the circuit Court of Appeals and we think that we are in the right weekly. So that's that's how we proceed.

As I've mentioned in the past we have other patent applications that are moving forward, which we think could also provide strong protection for <unk> 543, and we will move in parallel along with defense of the $66 69 and by the way the 149 patents.

To gain additional intellectual property protection.

Got it okay. Okay. Thanks for taking my questions.

Thank you.

Next question comes from Joon Lee with two Securities. Your line is now open.

Thank you. Good morning. This is less on for <unk>. Thanks for taking my question.

Do you foresee any challenges and reimbursement discussions or do you think competitors essentially paved the way for you given that there are slightly ahead of filing.

Hi, Les.

I think there are clearly the education, that's required to get full reimbursement here.

As a medical disease and one of the things that we need to ensure that the payers understand is that this is an autoimmune indication.

In discussions that we've had up to date.

When we have.

Hedge initial exploratory discussions with payers, we believe that that's an argument that we'll be able to successfully make.

Clearly, it's something that we'll have to work on rolling out the commercialization.

Got it. Thank you and then how should we model R&D expense.

Tapering off as we head into the NDA filing.

And at what stage will you take off.

Congratulations commercialization hiring thank you.

Hey, Ross this is mark.

So R&D will be tapering off I mean, we have the phase III trials that are winding down this year and so clinically those will be tapering off but as you might imagine as we prepare for commercialization and those costs will be coming back up so there will be sort of a switching cost if you will.

Into 'twenty, three and then into 'twenty four.

The OLED trial by the way is continuing right through approval. So that's that remains but the actual phase III themselves be winding down.

Got it thank you.

Thank you as a reminder, ladies and gentlemen, Thats star one to ask a question. Our next question comes from Esther Hong with Baron Burns. Your line is now open.

Hi, Thanks for taking my questions congratulations on getting towards the finish line.

Part three.

Alright.

Recently.

That has been more pushback from FDA on MD, and then experienced a few years ago and so wanted to get your thoughts on some of this pushback, including some of the deficiency letters any learnings from there that.

Maybe are new that you're taking into account as you prepare your NDA.

And then.

A quick follow up thanks.

Thanks.

Hi, This is Jim so thanks, great question.

I think the most important thing for filing the NDA is to really make sure that you have the complete package that you need in terms of the all the datasets to clinical and non clinical and CMC I think it's very important to make sure that you have an open communication plan with the FDA to make sure that the expectations are met from both sides.

We have had good discussions with the FDA, we know what we need to do we have a large safety database. We have the endpoints that we know have been agreed upon with the FDA.

The phase III and we've seen no consistently across the even the competitor trials I mean saw 'twenty is really what everyone's looking for so I think the key is really to make sure that we are.

Really fulfilling our obligation as a sponsor to have all the data necessary for showing efficacy and safety. We have a very large safety database. We have long term open label extension study, we have some subjects that have been on drug for over three years now. So I think we're doing our best to make sure that we are answering all the questions and checking all the boxes.

As including for some of the the supportive studies Youll see in our clinical trial Dot Gov listings that we've done.

<unk> studies and things like that that are also important for the filing as well. So I think it really is a matter of making sure that we have a good plan and we have buy in from the FDA and we've had good meetings with the FDA of course, we're not giving the details, but we will have pre NDA meetings on both the CMC and the clinical side because those.

<unk> expected and required and we will also be doing those as well. So we will be also confirming with the FDA on the NDA submission piece as well. So I think we're in good shape and we really know what we're doing here.

Great and then just wanted to follow up any updates on.

What youre seeing in the open label extension study. Thanks, so much.

I think that.

The bottom line with the open label extension study is that.

First of all we've had a very high percentage of.

Patients.

Rollover into the open label extension study, we have reported on that at previous meetings, where we've done.

The data to date.

And I think it's fair to say that.

That trend has continued throughout our program. There is still is a lot of interest for patients to rollover from.

The phase II or the phase III studies into the open label extension study.

I think the take home messages are really.

Continuation of effect and again these are things that we've reported at meetings in the past we've seen the maintenance of efficacy, we haven't seen any new or troublesome emerging adverse events that are of any concerns. So I think that the long term.

Exposure is really being.

Looked at very carefully in terms of safety and efficacy and I think we continue to see the similar profile that we saw.

<unk> from our phase III trials, but I think thats really where we are with the open label extension no surprises in this case is a very good thing.

Fantastic. Thank you.

Yes.

Thank you and I'm currently showing no further questions at this time I would like to hand, the conference back to.

Justine Koenigsberg for any closing remarks.

We'd like to thank everyone for joining us. This morning, if there are any follow up questions. Please don't hesitate to reach out and this concludes today's call.

Ladies and gentlemen, thank you for your participation you may now disconnect everyone have a wonderful day.

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Good day, and thank you for standing by and welcome to the concert Pharmaceuticals first quarter 2022 investor update call. At this time all participants are in a listen only mode. After the speaker's presentation there'll be a question and answer session to ask a question during the session you'll need to press star one on your telephone please.

Please be advised that today's conference is being recorded if you require any further assistance. Please press star zero I would now like to hand, the conference over to Justine Koenigsberg Senior Vice President Corporate Communications and Investor Relations. Please go ahead.

Okay.

Good morning, and welcome to concert Pharmaceuticals, first quarter 2022, Investor update our prepared comments today will be brief so we can jump right into the Q&A portion of the call. Joining me. This morning with prepared remarks are Roger Tung President and CEO .

And Marc Becker, Chief Financial Officer, Nancy Stuart, Our Chief operating Officer, and Jim Cassella, Our Chief Development Officer will join the team for Q&A.

As a reminder, today's discussion will include forward looking statements about our future expectations plans and prospects. These statements are subject to risks and uncertainties that may cause actual results to differ materially from those projected a description of these risks can be found in our most recent 10-Q filed with the SEC.

Forward looking statements speak only as of today's date and we assume no obligation to update any forward looking statements made on today's call with that I would now like to turn the call over to Roger.

Thank you Justin and thank you everyone for joining us for today's update.

Both of our phase III <unk>.

Clinical trials are randomized placebo controlled double blinded multicenter studies evaluating the safety and efficacy of <unk> 543 in adults, aged 18 to 65 years old where 50% or greater scalp hair loss.

Our topline data announcement from tried a one will include its primary end point and key safety data.

Look to present more detailed findings from the study at future medical meetings.

Call that in our phase II dose ranging study both the eight milligram and 12 milligram twice daily doses achieved a significantly greater proportion of patients with a salt score of less than or equal to 20 relative to placebo.

For those not familiar with salt or the severity of alopecia tool is familiar to determine the amount of scalp hair coverage by assessing all regions of the scope that contribute to the total score which ranges from zero to 100.

The salt score of zero corresponds to no scope or loss will salt score of 100 corresponds to a total lack of hair on the scalp.

As we shared in the past there could be up to approximately 1 million and a half alopecia area out of patients in the U S with a sizable subset having moderate to severe disease.

Currently there are no FDA approved treatments.

Even with other potential players in the market given the extensive patient need and the clinical profile. We've seen to date with <unk> 543, we believe it has blockbuster potential in the treatment of alopecia areata.

We're hopeful that the phase III <unk> results will confirm our phase II and long term open label extension observations and Thats <unk> 543 will be an effective and durable treatment for alopecia areata with a generally well tolerated safety profile consistent with its intended use.

Among the JAK inhibitors being developed for the treatment of alopecia <unk>, our phase III results of <unk> 543 appear to have a highly competitive profile.

Working to bring it to patients as quickly as possible.

I'd like to pause here and turn the discussion to Mark who will provide an overview of our financial results.

Thanks, Roger as I review, our first quarter of 2022 financial results. Please reference the financial tables found in today's press release.

Research and development expenses were $30 5 million during the first quarter of 2022 compared to $18 5 million during the first quarter of 2021, while the phase III trials are winding down. This year, we continue to have clinical costs associated with the open label extension studies, the North American expansion study is expected to.

Continue until approval.

General and administrative expenses were $5 5 million for both the first quarter of 2002 and 2021.

Our net loss for the first quarter was $37 7 million or $1 <unk> per share compared to a net loss of $22 7 million or <unk> 67 per share for the same period in 2021.

<unk>.

Thank you.

As a reminder to ask a question you will need to press star one on your telephone to withdraw your question. Please press the pound key please standby, while we compile the Q&A roster.

Our first question comes from Jason Butler with JMP Securities. Your line is now open.

Hi, Thanks for taking the question.

Yes.

We're obviously excited with data coming up maybe if you could just frame a little bit more based on the competitive landscape, what we should be looking for from from the Salt <unk> and then again just current thoughts on safety language on approved products.

For the class and just how you plan to approach the FDA.

With regards to the 543 label. Thank you.

Hey, Jason Jim here so.

I think our expectation for our phase III trials are.

Consistent with what we saw for our phase two so I think we're looking for.

The data readout on the 12 milligram in the liver.

The IV dosing, so I think we.

We have been experiencing we had a couple of trials in phase two that gave us confidence in our trial design for phase III, which is very similar to what we saw in our.

Dose ranging trial, so I think we're feeling pretty comfortable with the design and with the data we had.

Hey journey for our Phase III study, so I think we are.

We're looking for a consistency there as we had consistency in our phase II trial, I think the competitive landscape you see.

Our Pfizer and Lilly competitors out there with data I think our data is very competitive.

With what we've seen in phase II.

<unk> will see consistency with our phase III results.

Our safety goes.

<unk> has quit.

Language out of the airport exhibitors.

The technology and the atopic derm space I think that.

Everyone's coming to grips with the FDA position on JAK inhibitors, but I think there's going to be.

A little different with alopecia, Areata, where there is no drugs for.

<unk> midstream analysis Syriana, there might be some consistency in the safety language across the drugs, but I think the difference will be that healthy share yada.

A significant unmet medical need.

JAK inhibition is a very important mechanism in the treatment of alopecia area. So it's very important for <unk>.

<unk>.

In terms of the mechanism here and I think the data shows across the field JAK inhibitors are very important as a mechanism to treat alopecia areata.

Very important consideration as we look at alopecia areata on the background of what the FDA as well.

The safety perspective.

Great. Thanks, Tim and then just one more for me can you just speak a little bit to the.

The medical Affairs and medical education.

Planning you are putting in place now for once you have data and starting to get physicians up to speed on.

Being aware of the product.

And your dataset.

Sure absolutely.

As you can imagine it's a very active area of interest to us.

One thing just as a little bit of background as we are working with a lot of the kols in this space as trial is we have a very good representation in.

In the U S as well as Europe and Canada.

A lot of the experts. These efforts are two years I mean this is.

<unk>.

The experience in treating alopecia areata.

Our with these kols and these kols are involved in clinical trials.

Network of investigators who are probably the main three years in this space as well.

I also think that what we're seeing is.

Our medical affairs, Theres, obviously going to be education of patients.

Location of other dermatology.

Experts.

Our in the in the aerospace and I think those are going to be very important aspect of the medical affairs team, we know that theres a lot of patients who.

We will have alopecia reata, who are maybe not in the mainstream of treatment because there is nothing available. So part of it is going to be and let them know that there is going to be treatments available and I think it will bring sort of that latency population back into the treatment pool as well.

So part of the old Medical Affairs team.

Is going to be right.

Treating dermatologists up to speed on the JAK mechanism the importance of it.

Really does work.

Given the safety profile of it but also getting patients to be aware that there is now a treatment option available.

Great very helpful. Thanks, Jim.

Waiting for the data thanks for taking my questions sure.

Sure.

Thank you. Our next question comes from Shlomo <unk> with Mizuho Securities. Your line is now open.

Great. Thanks for taking my questions, maybe one to follow up on the discussion there on the competitive landscape and then one other separate question.

On the commercial side I'm, just curious there's obviously bloomington.

Bloomington Jack.

<unk> on the market already.

How are you thinking about pricing in this market is obviously still a mechanism maybe even the same drug in terms of ILUVIEN.

But obviously those are turning up a much larger patient population than what you'd be going after with alopecia. So I don't know if you can just share some of your thoughts now that you've got to see what the data holds in the next few months here, but but what your thoughts are sort of going into that data.

And then my second question is just around the ex U S opportunity you guys have talked about this a little bit before but just can you sort of share your thoughts at this point again, obviously, we're all waiting for the data kind of how do you. How do you view the extra was opportunity for this product and.

How are you thinking about doing it yourself versus.

For a partner potentially thank you.

Hi, This is Roger thanks, very much for the question.

With regard to pricing.

A little early for us to was locomotive right now.

If our phase III data, yet and frankly I don't think it does any good choose assistant respectively.

<unk> said in the past.

We're seeing structure or.

For LP Sherry audit is probably.

Notably consistent with the pricing for other autoimmune.

Michael diseases, and we know that drugs in that space.

The new range.

The mid Twenty's to about 60000 patients.

Here.

But at this point.

One for Bob.

40 Threep per se.

In terms of ex U S. We do have.

They have an interest of course in commercializing this was.

Sure. So at this time.

Fine.

Yielding at Salesforce, we have.

Yes, some interest in subscription is ongoing.

Hello.

Okay. Thank you I'm not sure if my line or on something else I was a little bit painted on the client, but I think I caught.

What you are saying, okay. Thank you so much.

Sure.

Our.

Next question comes from Maury Raycroft with Jefferies. Your line is now open.

Hi, good morning, Thanks for taking my questions.

I'm just wondering if you can tell us where you are in terms of closing out the phase III with database lock and analysis.

Hi, Mark this is Jim So I think what we can say is that things are on track for our data readout this quarter and things have been moving very nicely.

You can imagine it's a large trial.

Lots of data to clean and make sure. His is ready to go into the database lock.

Feeling very confident that we're going to hit our kits are scheduled deadline and we will be reporting data this quarter.

Got it okay. Thanks, and then.

Also just wanted to ask how youre thinking about the peak peak App decision on our 609 patent is expected next week and if you can provide any specifics on what next steps are going to be for either outcome of that decision.

Sure.

Yes. This is Roger Moore.

Well, we feel like we had very good oral arguments.

Well into the.

Into the 2000 <unk>.

If it is not a positive decision we had the ability to and we intend to.

Go to an appeal on that decision, which.

Which would probably.

Involve either an appeal choose the director or or going directly to the U S Court of the circuit Court of Appeals and we think that we are in the right legally. So that's that's how we proceed.

As I've mentioned in the past we have other patent applications that are moving forward, which we think could also provide strong protection for <unk> 543.

We will move in parallel along with defense of the $66 69 and by the way the 149 patents.

To gain additional intellectual property protection.

Got it okay. Okay. Thanks for taking my questions.

Thank you.

Our next question comes from Jim Lee with two Securities. Your line is now open.

Thank you. Good morning. This is less on for <unk>. Thanks for taking my question.

Do you foresee any challenges and reimbursement discussions or do you think your competitors essentially paved the way for you given that they are slightly ahead of filing.

Hi, Les.

I think there are clearly the education, that's required to get full reimbursement here.

This is a medical disease and one of the things that we need to ensure that the payers understand is that this is an autoimmune indication.

In discussions that we've had up to date.

When we have.

Hedge initial exploratory discussions with payers, we believe that that's an argument that we'll be able to successfully make.

But clearly it's something that we'll have to work on rolling out the commercialization.

Got it. Thank you and then how should we model R&D expense take tapering off as we head into the NDA filing.

And our stage when you take off.

Congratulations commercialization hiring thank you.

Hey, Ross this is mark.

Into 'twenty, three and then into 'twenty four.

The OLED trial by the way is continuing right through approval. So that's that remains but the actual phase III themselves be winding down.

Got it thank you.

Thank you as a reminder, ladies and gentlemen, Thats star one to ask a question. Our next question comes from Esther Hong with Sternberg. Your line is now open.

Hi, Thanks for taking my question congratulations on getting towards the finish line.

Part three.

So just.

Recently.

That has been more pushback from FDA on MBS than experienced a few years ago and so wanted to get your thoughts on some of this pushback, including some of the deficiency letters any learnings from there that.

<unk>, our new that you're taking into account as you prepare your NDA.

And then.

A quick follow up thanks.

Hi, sorry. This is Jim so thanks, great question.

I think the most important thing for filing the NDA is to really make sure that you have the complete package that you need in terms of the all the data sets of clinical and non clinical and CMC I think it's very important to make sure that you have an open communication plan with the FDA to make sure that the expectations are met from both sides.

We have had good discussions with the FDA, we know what we need to do we have a large safety database. We have the endpoints that we know have been agreed upon with the FDA for the phase III and we've seen no consistently across the even the competitor trials. I mean, you saw 'twenty is really what everyone.

<unk> four so I think the key is really to make sure that we are.

Including for some of the the supportive studies Youll see in our clinical trial Dot Gov listings that we've done DDI studies and things like that that are also important for the filing as well. So I think it really is a matter of making sure that we have a good plan and we have buy in from the FDA and we've had good meetings with the FDA of course.

We're not giving the details, but we will have pre NDA meetings on both the CMC and the clinical side because those are expected and required and we will also be doing those as well. So we will be also confirming with the FDA on the NDA submission piece as well. So I think we're in good shape and we really.

No what we're doing here.

Great.

And then just wanted to follow up any updates on.

And what Youre seeing in the open label extension study. Thanks, so much.

I think that.

The bottom line with the open label extension study is that.

First of all we've had a very high percentage of patients.

Patients.

Our rollover into the open label extension study, we have reported on that at previous meetings, where we've done cuts of the data to date.

And I think it's fair to say that.

That trend has continued throughout our program. There is still is a lot of interest for patients to rollover.

The phase II or the phase III studies into the open label extension study I think the take home messages are really.

<unk> is really being.

Looked at very carefully in terms of safety and efficacy and I think we continue to see the similar profile that we saw.

Reported from our phase II trials, but I think thats really where we are with the open label extension no surprises in this case it was a very good thing.

Fantastic. Thank you.

Thank you and I'm currently showing no further questions at this time I'd like to hand, the conference back to Jim.

The same koenigsberg for any closing remarks. Thank.

Thank you we'd like to thank everyone for joining us. This morning. If there are any follow up questions. Please don't hesitate to reach out and this concludes today's call.

Ladies and gentlemen, thank you for your participation you may now disconnect everyone have a wonderful day.

Q1 2022 Concert Pharmaceuticals Inc Earnings Call

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