Q1 2020 Earnings Call

This is just an announcement to let you know we've been very shortly thank you.

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Welcome everyone to the breakout biotech first quarter 2020, <unk> financial results Conference call.

At this time, all participants are in listen only mode.

Following some prepared remarks from the company, we will open the call up to Couponing as a reminder, this conference call is being recorded.

Oh knowledge on the call everybody back managing director Westwicke partners.

Thank you good afternoon, everyone. Joining me on today's call Harpercollins Chief Executive Officer, Rob Brown, Chief Financial Officer, like Crothers, She's R&D Officer, Deepak Contra co founder and Chief Operating Officer, Andy Sklar, Chief Business Officer, Adam Lately and General Counsel.

She had compliance officer, David back away before we begin I would like to remind everyone. At this conference call webcast will contain forward looking statements about the company.

Statements are subject to risks and uncertainties that could cause actual results didn't get furniture like please note. These forward looking statements reflect our opinions only as of the date of this call, but you're not undertake any obligation to revise our publicly released results or any revisions things forward looking statements in light of new information or future. That's.

Factors that could cause actual results or outcomes to differ materially from those expressed or implied by such forward looking statements are discussed in greater detail and our companies. Most recent annual report on form 10-K, and our other filings with the FCC I would now like to turn the call over to the company's Chief Executive Officer.

Brown.

Thank you Paddy and thanks to everyone joining us on our call. This afternoon I will provide a business update then I will turn the call over to Brickell CFO, Mike Carruthers to review the financial results, we reported earlier today.

Brickell continued to make advancements with soft bromine bromides four primary axillary hyperhidrosis during the first quarter as we work towards phase three clinical trials in the United States.

Today, we are pleased to announce the preliminary results from the soft peroni and bromide long term safety study.

Based on our review of the topline data from the phase three.

Open label long term safety study topically applied soft peroni, and bromide gel, 5% and 15% was safe and generally well tolerated and consistent with earlier phase two trial results I.

Additionally, there were no treatment related serious adverse events observed.

This 12 months study involved a total of 300 subjects with primary axillary hyperhidrosis.

Over nine years of age and at 30 clinical testing sites.

We look forward to completing the analysis and the whole study report soon and we'll release more detailed results at the appropriate scientific Forum.

In March we announced that positive results from our Asian development partner cans phase three pivotal study of topically applied soft brownian bromide gel, 5% in Japanese subjects with primary actually hyperhidrosis were selected for an oral presentation at the late breaking research.

Program during the American Academy of Dermatology annual meeting.

It was to be held on March 21st.

As you know the conference was subsequently canceled due to the concerns related to cope with 19.

Conference is now rescheduled to be virtual Forum on June 12.

The presentation will provide the details of specific efficacy and safety results from the phase three pivotal study of soft chromium bromide gel in Japan.

We previously announced the caught can submitted a new drug application for approval of manufacturing and marketing in Japan based on the encouraging results from this study.

I can also has rights to develop and commercialize soft from Needham bromide in Korea, China and certain other Asian countries under the sub licensing agreement with can there are royalties and sales milestone payments due to brickell.

As we look ahead to the next steps for the global development, a soft roni and bromide. The plan in the U.S. is for Brookfield to initiate the phase three pivotal trials. We believe we have a clear phase three regulatory pathway for soft roni and bromide in the U.S.

The protocol and statistical analysis plan have been finalized based on on F. D feedback and see arrows are engaged.

As a reminder, we expect the phase three program to consists of two identical studies of approximately 350 subjects each across 40 to 50 sites.

The studies will be randomized double blinded vehicle controlled evaluating the safety and efficacy of topically applied soft from you in jail in the 15% concentration.

Subjects will be treated for six weeks with a two week follow up.

Co primary efficacy endpoints agreed to with the FDA are the proportion of subjects achieving at least a two point improvement on the patient reported outcome H D S and X scale from baseline to the end of treatment.

And the change in gravimetric sweat production from baseline to the end of treatment.

If you remember we achieved statistically significant results at the 15% concentration on both of these endpoints in our dose ranging phase Twob study.

We're not currently giving guidance on the started the pivotal phase three studies as you can imagine we're working through the cobot situation like other clinically clinical stage companies and securing the appropriate resources to run the study.

We anticipate providing guidance on the timing of these studies when we had gained greater clarity on these variables.

We remain optimistic that the value of soft running bromide can be demonstrated through our planned development program in multiple ways, including its efficacy formulation and delivery system. The molecule is a novel topical anti corner <unk> agent retro metabolic we design with the intent to enhance the local.

Therapeutic benefit while limiting systemic side effects.

I'll thrown even bromide has a short plasma half life with rapid metabolic deactivations and fast elimination potentially leading to a more favorable safety profile or enhanced efficacy at higher concentrations.

To date, there have been over 1300 subjects treated worldwide with soft from bromide in clinical trials conducted by Brickell Hancock can.

Based on this clinical experience, we believe that if approved Soffe Roni and bromide has the potential to be recognized as a best in class therapy for hyperhidrosis by physicians and patients starting in Japan and the U.S.

I will now turn the call over to Mike Ray financial overview.

Thanks, Rob and good afternoon, everyone on the call I appreciate the opportunity to provides a summary of our first quarter financial results.

Also encourage you to read our full consolidated financial statements contained in our quarterly report on form 10-Q for the quarter ended March 31, 2020, which can be accessed through the investors section number website once filed with the FCC.

Starting with cash.

We ended the quarter was 7.1 million in cash and cash equivalents. In addition, we've repaid 4.6 million to third party clinical research organizations in anticipation of commencing the phase three pivotal studies for saw Cronin bromide.

Turning to revenue, we recognize revenue of 1 million for the first quarter.

This compared to 3.5 million for the comparable core quarter in 2019.

The decrease in revenue is because the phase three long term safety study of saw cronyism bromide and other supporting studies that were in full swing. In 2019 were finished are winding down by the first quarter of 2020.

These and other development activities that are now completed our the basis for revenue recognition for the 15.6 million R&D payment we received from call. It can in the second quarter of 2018.

Research and development expenses totaled 2.7 million for the first quarter compared to 6 million for the comparable period in 2019.

This decrease was primarily due to a decrease in clinical study in the other regulatory costs of the phase three long term safety study of South Cronin bromide and other studies that were ongoing in 2019, but were concluded or winding down in the first quarter of 2020.

Now moving to general and administrative expenses.

DNA expenses totaled 2.5 million for the first quarter this compared to 2.1 million for the comparable period in 2019.

The increase is primarily due to $300000 and I are fees for directors and officers liability insurance says we are now a public company.

And with that I'll turn the call over to Steve the operator to open the call for questions.

Steve.

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Using a speaker phone.

These pickup you had said before passing on the keys to withdraw your question. Please press Star then choose we'll pause for a moment that's called has joined the Q.

Once again, if you have a question. Please press Star then one.

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Well, we set up our question and answer session now that you're trying to call back over medicine for any closing.

Yes.

All right well. Thank you for that I'm surprised are all of our guests are so shied today, but appreciate everyone calling in this afternoon.

As you can see we're very encouraged by the phase three data that we have been generated so far for Soc bromine bromide.

Both with the efficacy results in Japan, and now with the preliminary data from the long term safety study, we remain focused on moving this lead candidate into the phase three pivotal trials in the U.S. as a potential therapeutic treatment option for the 10 million people in the U.S. its suffer from primary axillary hyperhidrosis and look.

Forward to keeping you updated on our progress we hope you all see safe in this current and by thanks again for joining.

This concludes todays conference call you may disconnect. Your lines. Thank you for participating and have a pleasant day.

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