Q1 2021 Brickell Biotech Inc Earnings Call

<unk> bromide gel in 2022 pending a successful outcome phase III pivotal program.

Let's now turn the call over to <unk> to provide a clinical update D var.

Thanks, Rob.

Greetings to everyone as stated by Rob in his opening remarks, we have been pleased with patient enrollment to date in the two U S phase III pivotal studies evaluating saw premium bromide gel, 15% for the treatment of primary axillary hyperhidrosis and approximately 350 patients each study.

As announced in April.

The Cardigan, one study completed enrollment and the cardio <unk> study, which started enrolling patients approximately two months. After cardigan one has now exceeded 70% enrollment.

Based on the current enrollment rate for cardiac <unk>.

We remain on track to complete enrollment in the per quarter and report top line data for both studies in the fourth quarter of this year.

As a reminder.

Each subject participating in the phase III Cardigan studies will be treated with either short premium bromide gel, 15% or placebo for six weeks with two week follow up period.

Core primary efficacy endpoints as agreed with the U S. FDA are the proportion of subjects achieving at least two point improvement on the patient reported outcome assessment that is the hyperhidrosis disease severity measure axillary or etch DSM ex scale and the change in gravimetric set production.

Each from baseline to the end of treatment.

This is a good time to mention that we have recently published validation results for breakout proprietary S. GSM ex scale in the peer reviewed journal of drugs in dermatology.

The published cycle metric analyses conclude that the SBS on <unk> scale is a well defined reliable and consistent measure that is expected to improve the assessment of hyperhidrosis treatment effect compared to pre existing scale, such as the hyperhidrosis disease severity scale.

Or spss.

Furthermore, the results demonstrate that a one point change in S. DSM ex severity score on a five point scale of zero to four represents a clinically meaningful change in primary axillary hyperhidrosis severity.

Turning now to our previously completed phase III open label long term safety study.

It's worth noting that the Standalone study was not conducted as a conventional phase III open label extension study where patients from pivotal studies roll over into an open label extension study has this study provides a more complete clinical datasets evaluating treatment naive primary.

<unk> accelerated hyperhidrosis patients who were not previously acclimated to stop Coronium bromide gel pizza.

As many of you may already be aware the results from this study.

Dented last month in a late breaking oral presentation at the American Academy of Dermatology 2021 virtual meeting experience.

This study assess the long term safety and efficacy of softening in bromide gel five person and 15% for 48 weeks of treatment in patients nine years and older with primary axillary hyperhidrosis.

300 patients across 30 U S sites were randomized and one is to two ratio to receive either software <unk> bromide gel, 5% or 15%.

Based on the outcome of the study daily treatment. That's operating in bromide gel was generally well tolerated and efficacy assessment showed clinically meaningful and sustained improvement and stretch severity through 48 weeks of treatment.

For those interested in reviewing the results of this study in further detail feel free to visit the events and presentations page in the investors section on our website for a replay of the conference call will be hosted in April discussing that data.

Finally, the past few months have been very productive for the company and we are well positioned to execute on our growth this year.

The progress we continue to make speaks not only to the strength and resilience of our efficient and committed team, but also the excitement.

About the potential of Sop premium per Mike to be an important treatment option for the millions of patients in the U S that suffer with primary axillary hyperhidrosis.

With that I will now turn the call over to Bert to provide a financial overview Bert.

Thanks, Deepak and good afternoon to everyone on the call.

Before I provide a summary of the first quarter financial results I want to encourage you to read our full consolidated financial statements and MD&A contained in our quarterly report on form 10-Q, which can be accessed through the investors section of our website once filed with.

The SEC.

Starting with cash and investments as of March 31, 2021, we reported $34 $8 million on cash and cash equivalents.

<unk> spent $5 9 million in cash for operating activities during the first quarter of 2021.

We believe our current cash position will support our operations beyond the top line results of the U S phase III pivotal program and into 2022.

Revenue for the first quarter was approximately 17000, which was the royalty revenue we recognized from the sales of E clock in Japan by our Japanese development partner Kotkin.

This was compared to $1 million in total revenue reported for the same period in 2020.

Which was attributable to the recognition of an R&D payment, we received pursuant to our license agreement with <unk>.

R&D expenses were $6 1 million for the first quarter of 2021 compared to $2 7 million for the first quarter of 2020.

This increase was primarily due to an increase in clinical costs related to the phase III Cardigan studies that were initiated in the fourth quarter of last year.

G&A expenses totaled $3 million for the first quarter of this year compared to $2 5 million for the first quarter of the prior year.

This increase was primarily attributable to increases in compensation related expense and professional fees less.

Lastly, net loss for the first quarter of 2021 was $9 million.

Compared to $4 1 million for the first quarter of 2020.

With that I will now turn the call back over to Rob Rob.

Thanks, Deepak and burst through your recap. This is really an exciting time per brickell as we continue to work together and build momentum behind our ongoing phase III.

Pivotal clinical program. This concludes our prepared prepared remarks, I'll now turn it over to the operator to open it up for questions operator.

Thank you ladies and gentlemen at this time, we'll be conducting a question and answer session.

You'd like to ask a question you May press star one on your telephone keypad, a confirmation tone will indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the Q4 participants using speaker equipment. It may be necessary to pick up your handset before pressing the star gate.

Our first question comes from the line of Leland <unk> with Oppenheimer <unk> Company. Please proceed with your question.

We learned on your lives.

Are you muted on your side.

Oh, sorry, I'll put it on you didn't hear we are sorry about that good afternoon. Thanks for taking my questions.

Can you hear me Okay now.

Just a couple of questions for you one looking back to the long term safety study uptake you provided talked through.

At the end of last month's wanted to asking on as we look at the data from that understand thats on if there wasn't a formal efficacy study, but a long term.

Thank you study Nonetheless, if you look at the two different doses of the five versus 15% it looks like you approach.

Efficacy of the 15% with the 5%, albeit with perhaps some much more favorable tolerability profile I'm wondering how that information may affect your thoughts going forward with product development.

B.

<unk>.

Congrats on extension strategy on the Hooker for the U S market, obviously, 5% I believe that day.

The Japanese strength to want to hear your thoughts there and then also the question with regard to the sale, but it really a few Brexit to another company and how that may affect.

Marketplace dynamics.

<unk> space going forward.

Great. Thanks, Thanks for the question Leland.

I'll start with the long term safety as you talk to you if you want to net.

Feel free so.

Obviously, we were excited about the efficacy data we saw the fact that the both the debt.

Did quite well and and held and sustained efficacy over the.

Over the whole study.

No.

The <unk>.

<unk> that was used for the long term safety study was similar to the one we use the same as we used in the <unk> and is one of our primary endpoints in the phase III and into <unk>. We also saw that the 5% and 15% on the hero had relatively similar efficacy.

We didn't see that in the reduction of sweat sweat measurement, the GSP tool, which is why we focus on the 15%, but it does give us encouragement.

There may be the potential to look at a 5% down the road to the company Deepak anything you'd like to add.

I think you covered it'll be aspects, but the GSP.

And meeting the second co primary endpoint day reduction in sweat.

The GSP and that's the primary reason we are taking the high concentration 15 person as part of the phase III assets and always feel like we'll be interest as part of the lifecycle management.

<unk> brings on lower concentration of soft timber line.

And then in terms of the second question Leland.

In terms of the sale of <unk>, we were encouraged by that obviously.

The launch acute Brexit has been hindered by.

Drew mirrors decision to focus their resources on a different assets sell the company.

Obviously, a pandemic and then literally acquiring the asset right at the beginning of the pandemic so never really got fully.

Engaged if you will and then obviously them selling it to another another party that's a pretty tough launch for some for a product go through so we're encouraged that there is a company that's focused on dermatology, that's going to go out and talk about hyperhidrosis. When you have a marketplace like this where there's a big unmet need and a lot of people who arent.

Seeking treatment.

Awareness of the condition that net there are treatments as the most important challenge and in many ways all of the companies involved help each other in the sense of they create greater awareness and greater noise and when you do that you get a bigger marketplace. So we see one of our biggest competitors being ignorance or a lack of understanding of theirs.

Treatments out there and so having somebody who's committed dedicated and excited about the space that I think can only help us as we go forward.

Thanks, very much with any additional color on.

Yeah.

There are no further questions I would like to hand, it back to Robert Brown for closing remarks.

Okay. Thank you operator, and thanks for everyone to take on.

This afternoon to listen to our update I wanted to close out the call by thanking the clinical trial sites and the hyperhidrosis patients for their ongoing interest and support of our phase III clinical program as I mentioned differentially Brickell team on the contract research organization for their outstanding commitment and tremendous contributions we look forward to keeping you all.

Updated on the progress of these studies over the coming months as always please feel free to reach out to us anytime with any questions and we hope you all have a great rest of your day.

Okay.

Ladies and gentlemen, this does conclude today's teleconference. Thank you for your participation you may disconnect. Your lines at this time and have a wonderful day.

Okay.

Okay.