Q4 2021 Viveve Medical Inc Earnings Call

Good afternoon, and welcome to <unk> full year, 2021 financial results and corporate update conference call.

All participants will be in listen only mode.

If you need assistance. Please signal conference specialist by pressing the star key followed by zero.

Please note this event is being recorded.

I will now turn the call over to Jeannie Swindle senior director of corporate Communications.

Thank you operator and welcome everybody 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 corporation's timing progress and results of its clinical trials fluctuation of global market economic conditions impact of the novel Corona virus on clinical development regulatory review and clearance of manufacturing system placements and utilization projections expectations.

<unk> 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 are described more fully in the company's annual report on Form 10-K and other.

Fillings made with the Securities and Exchange Commission, 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 management's views as of any subsequent date.

On today's call will be Scott Durbin, because he's chief Executive Officer, and Jim Robbins, Senior Vice President of Finance and administration.

I'll now turn the call over to Scott Durbin.

Thank you Jeanie good afternoon, everyone. We appreciate you joining us for our call on the St. Patrick's day in the United States.

I'll begin our call. This afternoon with a brief business summary, and then have Jim Robbins provide the 2021 year end financial results I will then provide a detailed corporate update.

To begin 2021 was a transformational year for the eve attributable to the significant advancement of our stress urinary incontinence or S. U Y clinical development program.

Namely initiation and completion of full enrollment in our U S pivotal pursuit trial for S. UI in women.

Achievement of this critical milestone was the focus of our entire organization in 2020 one.

The fact that many clinical trials were delayed or halted during the past year due to the continuing impact of COVID-19, precautions and patient concerns highlights the extraordinary work performed by our entire team.

And our investigational sites to enroll randomize and complete these phases of this landmark trial.

I will also add that it speaks to the high level of interest from women living with incontinence, who are actively seeking a noninvasive treatment option.

The success of our S. U I program continues to be our focus as we execute the final phase of our pursuit trial throughout 2022 towards the top line readout anticipated at year end with the ultimate goal of obtaining a new commercial S. U Y indication in the future. If the results are positive.

Yeah.

I will expand on our clinical and commercial progress following Jim's report of our financial results, but importantly that leave us in a strong financial position with the capital resources to support operations into early 2023, including the planned completion of the pursuit trial.

In 2022, our strategic focus continues to be to successfully execute the currently underway pursuit trial and achieve a positive top line data readout anticipated at the end of the year and if positive preparing to commercially launch the first F. D. A approved.

Patent protected and do vaginal dual energy office based treatment for urethral hypermobility to improve S. UI in women.

Secondly, continuing to focus our commercial and market development efforts in the U S and Asia Pacific regions due to the expansion of our installed base targeting urology Euro gynecology and gynecology core specialties.

And third supporting our customers with successful initiatives to continue to drive increased consumable treatment tip utilization and sales.

With that I will now turn the call over to Jim Robbins.

Thank you Tom Good afternoon, everyone and thank you for joining the call.

Today, we reported total revenue for 2021 of approximately $6 $4 million from the global sell a 46 systems and then in the U S. Under a recurring revenue model program. The placement of an additional 24 systems as.

As of December 31, 2021 we had a total installed base of 884 systems worldwide. Additionally.

Additionally, a total of approximately 10750 disposable treatment tips sold globally in 2021.

Total operating expenses for the year were approximately $22 2 million compared to $18 $8 million for 2020.

The increase is a result of the company's efforts to advance our <unk> development program and complete enrollment in our pursuit clinical trial in the U S.

Spending on research and development for 2020, one was approximately $9.7 million compared to approximately $5 $1 million in 2020 the.

The increase in R&D spending was primarily due to cost associated with engineering and development work related to product line improvements and <unk>.

To advance our <unk> clinical development program.

Total selling general and administrative expenses during 2021 were approximately $12 $5 million compared to approximately $13 $7 million in 2020.

The decrease in SG&A spending in 2020, one was primarily due to operational measures to lower cost and reduce our cash burn rate.

We ended the year with cash and cash equivalents of $19 $2 million as of December 31, 2021.

Third to $6.5 million as of December 31, 2020, I will now turn the call back over to stop.

Thank you Jim.

I'd now like to further my remarks on our opportunity in S. UI and fully enrolled pursuit trial that is underway.

It's important for me to state that S. UI as a condition that affects an estimated 25 to 30 million women in the United States alone and based on our estimates represents a $10 billion to $12 billion total available consumable market opportunity.

Today few effective noninvasive treatments exist that reduce urinary leakage associated with S. UI. In fact, there is a large gap in the current treatment spectrum between physiotherapy at one end such as Keagle exercises and electrical muscle stimulation designed to strengthen the pelvic floor.

Musculature to.

To the other end of the spectrum, such as invasive approaches like bulking agents or sling procedures.

We believe that the beef has the potential to address this tremendous unmet need with a clinically proven treatment option in plain terms to expand the continuum of care for S. UI with our noninvasive Endo vaginal office based treatment, which can be completed in approximately 45 minutes to safely.

And effectively improve urethral hypermobility the primary cause of the best UI and significantly reduce leakage for women.

But these landmark pursuit trial.

Is a randomized double blinded sham controlled trial that enrolled 415 subjects with moderate S U y differ.

Defined as greater than 10 MLS up to 50 M. L's of urine leakage on the standardized one hour pad weight test.

30 study sites in the United States.

Randomized in a two to one ratio subjects in the active arm received the cryogen cooled monopolar radiofrequency or C. M. RF treatment, while subjects in the control arm received an inert or energy less sham treatment.

The primary efficacy endpoint of the pursuit trial is a comparison of the proportion of patients who experience greater than 50% reduction in urine linkage compared to baseline on the standardized one hour pad weight test at 12 months.

Versus the inert sham procedure.

This study also includes several secondary endpoints also assessed using the one hour pad weight test the three day bladder voiding diary, and other behavioral and quality of life questionnaires.

Subject safety is also monitored throughout the study.

The pursuit trial was initiated in January 'twenty, 'twenty, one and 30 investigational sites were onboard it in the following months.

Full enrollment was reported in mid December 2021.

And post treatment follow up visits at 369 and 12 months are currently underway.

Recognizing that this is a double blind trial, we can state that as of early this week approximately 86% of trials subjects have completed the three months post treatment visit fee.

52% of subjects, who have completed their six month post treatment visit just over 20% their nine months follow up and the final 12 months post treatment visit has been completed by 3% of pursuit trial subjects.

But these expert clinical and medical affairs team is tracking and monitoring progress at all investigational sites, maintaining regular communication and providing continuous clinical support.

In essence the months ahead represent account down as we diligently execute our pursuit trial towards the announcement of topline results at the end of this year.

We have a high level of confidence and pursuits trial designed to assess the primary efficacy endpoint and if positive we are equally confident in our ability to execute our strategy to achieve a potential S. You eye indication in the United States, which again would expand the continuum of care for women by providing a.

Durable noninvasive treatment option with a multibillion dollar total available market opportunity.

On the commercial and market development front, we demonstrated growth in 'twenty, 'twenty, one and new system placements as well as treatment tip sales.

As Jim reported total year end revenue.

Was approximately $6 $4 million this represents 17% year over year growth.

Throughout 2021, we saw steady improvement worldwide for medical practitioners and clinics, although the effects of COVID-19, and its variance continued.

In the U S and Asia Pacific regions or areas of focus practices continued to regain operations patient flow and elective procedure volumes.

Our dedicated customer care team in the U S and distribution partners internationally continue to provide high quality quality service and support to drive increase procedure volumes and treatment tip utilization.

Receptivity and adoption by physicians to our innovative dual energy technology in the U S and Asia Pacific markets continues to grow as our small commercial sales organization directs their efforts towards core medical specialties of urology Euro gynecology and gynecology.

Our goal is to continue to increase awareness of and build upon our growing body of clinical evidence that supports the safety and efficacy of our treatment as we advance our clinical program towards a potential new S. U Y indication in the United States.

But the strategic market development efforts in 2021 where additionally, rewarded mid year by the approval of a new technology category three CPT code from the American Medical Association for our Noninvasive single session durable last few I procedure.

Supported by key medical societies issuance of the New code established a long term pathway for future payer reimbursement and reflects the clinical evidence and potential benefit of our treatment for improving S. UI in women.

Contingent upon a positive pursuit trial readout and FDA approval of an S. U I indication obtaining reimbursement as a long term process, but one that we plan to pursue to support and expand the company's potential long term commercial opportunity.

It is our belief that the beads dual energy procedure could ultimately become a preferred noninvasive S. U I treatment option that may be broadly covered by insurance in the future.

The long term importance of the milestones achieved by the V. Even 2021 with significant yet our drive and strategic focus continues in 2022 to successfully complete our landmark pursuit trial achieve a positive top line readout at the end of this year and thereafter.

Pain, a new S. You eye indication in the U S.

The success of our Upsized public offering in January of 2021 was a testament to the confidence in our ability to execute our strategic path and provided us with the capital resources to support operations into early 'twenty two 'twenty three.

We will continue to expand our install base in the U S and Asia Pacific regions with core medical specialties support our existing customers to drive increased treatment tip utilization and sales and continue the operational measures that has lowered our cash burn rate considerably.

I want to thank the talented team at <unk> for their tireless determination and efforts throughout 2021 and for their continuing resolved towards the goal of providing our noninvasive endovascular treatment to the millions of women, who suffer daily from S. You why.

Thank you again to everyone for participating in our conference call today, Operator. This concludes our prepared remarks.

The conference has now concluded. Thank you for attending today's presentation you may now disconnect.

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