Q3 2020 Viveve Medical Inc Earnings Call

Good afternoon, and welcome to the Viiv third quarter 2020 financial results Conference call.

All participants will be in listen only mode should you need assistance. Please signal a conference specialist by pressing the star key followed by zero.

Speaking today.

They are but these chief Executive Officer, Scott Durbin, and Genie Swindle senior director of corporate Communications.

Please note this event is being recorded.

I'll now turn the call over to Jeanie Swindle. Please go ahead.

Thank you operator and welcome everyone before we begin.

We would like to remind you that this conference call may contain forward looking statements regarding future events or the future financial performance of the company any statement that is not a statement of historical fact is a forward looking statement. This includes remarks about the corporations projections expectations plans.

Plans beliefs and prospects.

These statements are based on judgments and analysis as of the date of this conference call and are subject to numerous important risks and uncertainties that could cause actual results to differ materially from those described in the forward looking statements.

These risks and uncertainties.

They are described more fully in the Companys annual report on form 10-K, and other filings made with the FCC, which are also available on the company's website also any forward looking statements represent managements view only as of the date of this conference call and should not be relied upon as representing me.

Management's views as of any subsequent date.

I would like to now turn the conference call over to Scott Durbin Chief Executive Officer.

Thank you Jamie good afternoon, everyone. We really appreciate you joining us today.

I'd like to begin the call. This afternoon with a short business summary, then review our.

Our third quarter financial results and highlight certain milestones.

As well as summarize our forthcoming pivotal U.S. clinical trial pursuit in the context of the multibillion dollar market opportunity it may afford us in the future.

As a result of positive preclinical and clinical labs.

<unk> results release during the third quarter. The Viiv has transitioned to a euro gynecology company with a core focus on stress urinary incontinence or as you lie.

As a result, we pivoted to focus of the entire organization in the third quarter to three core areas.

First to continue to grow our installed base through our recurring revenue model into our core specialties of euro gynecology urology and gynecology.

Second to continue to support our customers through our novel internal customer care team efforts, which.

She will drive increased consumable treatment tip utilization and sales.

And third to rapidly advance our pivotal clinical program and now she why to achieve enough da label and to commercially launch the first patented protected and do that you know office space tree.

Treatment for urethral hypermobility to improve as you lie in women.

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Like most companies in the third quarter Viiv continue to experience the negative impact of the COVID-19 crisis on business operations, particularly in the United States.

Well.

[noise] plan to continue to operate at a significantly reduced cash burn rate as we execute and complete our pivotal pursue trial towards a new FDIC approval in the us the commercial environment overall is improving.

Today, we reported total revenue for the third quarter of 1.5.

$5 million with a global installed base of 865 systems as of September Thirtyth.

Through our new recurring revenue model, we've placed nearly 100 systems in the United States since June of last year. This.

This commercial model continues to be met with great enthusiasm from.

Practitioners and we anticipate increasing its success in the future due to its scalability lower selling cost and the potential to rapidly improve profitability.

Internationally third quarter was also a strong quarter, we grew water installed base to 380 sixes.

Since and continue a high rate of consumable utilization throughout the Asia Pacific region.

Where we continue our focus on key markets like South Korea, China, Taiwan, Thailand and others.

Total operating expenses for the third quarter decrease substantially to three points.

$6 million down from $6.5 million for the same period last year.

The decrease resulted from the company's organizational realignments and efforts implemented in response to the impact of the COVID-19 crisis.

Finally, cash and cash equivalents.

Since September Thirtyth were $9.2 million, and we expect a cash burn rate of $3 million to $4 million per quarter going forward until our pivotal pursue trial is completed.

I'd now like to shift the focus to our stress urinary incontinence program.

As I mentioned, a few moments ago. The recent milestones we achieved have enhanced our long term commercial opportunity Ines you lie.

Specifically these include positive results from both a three arm S.U.I. feasibility and in vivo preclinical studies issue.

The issuance of a.

Wes as you I'm method patent covering the use of both radio frequency and cryogenic to treat asked you lie.

Formation of a world class clinical advisory board and urinary incontinence and after the approval of our I'd to conduct the pursuit trial.

Before I summarize these and there are important so I'd like to provide a brief overview of asks you lie for those on the call who may be new to the Viiv.

I see why as a condition that affects an estimated 25 to 30 million women worldwide and based on our estimates represent a $10 billion to $12 billion toll.

Total available consumable market opportunity.

Today few effective non invasive treatments exist that reduce leakage associated with US you lie.

In fact, the current spectrum a therapeutic options for women is limited to physiotherapy at one end of the spectrum such as.

Eagle's or electrical muscle stimulation designed to strengthen the pelvic floor musculature to.

To surgical approaches at the highly invasive end of the spectrum, such as bulking agents or sling procedures.

We believe that our Endo VAT, you know office based cryogenic cooled Monopolar radio.

Frequency treatment, which can be done and approximately 45 minutes can safely and effectively improve urethral hypermobility and thereby significantly reduce leakage for women with that she why.

Following the inconclusive clinical results of last year's liberate.

International trial, whereby our control arm performed equally as well as our treatment arm across six different endpoints, we developed and validated a new sham cap.

Conducted a preclinical tissue study to make sure the new tip was not causing any temperature.

Or cellular changes in tissue.

And conducted a small clinical feasibility study to demonstrate that the new sham tip would not result in a meaningful clinical outcome versus RCM RF treatment.

The combined results from each of these efforts is of significant importance.

Sure. We believe these results support our thesis that the cryogenic cooling treatment tip uses a sham treatment in our prior liberate international ask you I trial likely produced the positive therapeutic effect we saw.

And the fact that we now have a true interchange.

Some tip provides us with confidence that our upcoming pursue trial can achieve its primary endpoint positioning us for a potential ash you why indication in the United States.

With respect to the U.S. pursue trial I cannot overstate the importance of this trial it's just.

And I mean and implications for our future.

Positive results from pursuit may enable a new label at NASS, you I from the FDA and open a multibillion dollar commercial opportunity.

The current AFE da approved I'd. He trial is designed as.

As a randomized double blind Sham controlled study intended to enroll approximately 240 subjects at up to 24 study sites in the United States randomized in a two to one ratio.

The primary efficacy endpoint is the proportion of patients who experience.

More than a 50% reduction in leakage as measured using the standardized one hour pad weight test at 12 months post treatment.

In the treated group and as a reminder, this is using our C. MRF active tip versus the control group, which is now a virtue.

The energy less sham cap.

Again, I want to highlight that unlike our previously completed liberate international as you I study the sham treatment that will be administered to the cruise control group in pursuit will be a clinically in IRT or a true sham treatment.

The minimal RF energy.

Sure and cryogenic cooling delivered by the Sham treatment TEP will be at a sub therapeutic level.

And again, we have demonstrated that it should not induce a meaningful cellular nor clinical response within subjects in the control group.

Initiation of the U.S. pursue try.

Trial is targeted for the end of this year.

The tremendous milestones accomplished in the third quarter have now set the course for Viiv towards a commercial label Ines, you lie and a multibillion dollar market opportunity.

Our focus is to provide a clinically proven.

Safe and effective noninvasive treatment option to the millions of women worldwide, who suffer from stress urinary incontinence.

In this effort we are extremely fortunate to have strategically assembled an elite group, a preeminent urology and euro gynecology experts to help guide and.

Advance our Ashu I program.

Equally important the issuance of our new S. You I'm methods patent during the third quarter strengthens our intellectual property portfolio.

And we believe we'll protect our technology and this market in the future.

As we.

We have transformed our strategy to focus on S. You lie we have solidified the path of our clinical development program and enhanced our long term commercial opportunity.

I am extremely pleased with the significant milestones that were achieved this quarter and equally proud of the talented and dedicated.

And effort of the entire Viiv team.

As a result of our collective focus and dedication I'm confident that we can continue to successfully navigate the current commercial conditions and know that the perseverance demonstrated by the entire organization will position the viiv in the future as.

As a global leader in stress urinary incontinence.

Again, I'd like to thank everyone for participating in our third quarter conference call. Today. Operator. This is the end of our prepared remarks. Thank you.

The conference has now concluded thank you for attending today's presentation.

And then you may now disconnect.

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