Viveve Medical, Inc.
Q3 2022 Earnings Call Transcript

Published: 10 Nov 2022

[Operator:]

Good afternoon. Welcome to the Viveve Third Quarter 2022 Financial Results and Corporate Update Conference Call. Please note that this event is recorded. I’ll turn the call over to Ms. Jeannie Swindle, Viveve Senior Director of Corporate Communications. Please go ahead.

[Jeannie Swindle:]

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 corporation’s cost, timing, progress and results of its clinical trials, including the initiation, progress of and results from our PURSUIT trial and whether the clinical trial will support the intended uses for treatment of stress urinary incontinence in the United States, fluctuation of global market economic conditions, impact of COVID-19 on clinical development, regulatory review and clearances, manufacturing, system placements and utilization, projections, expectations, 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, which 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 filings made with the SEC, which are also available on the Company’s website. Also, any forward-looking statements represent management’s 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. Speaking on the call today will be Scott Durbin, Viveve’s Chief Executive Officer; and Jim Robbins, Senior Vice President of Finance and Administration. I will now turn the call over to Jim.

[Jim Robbins:]

Thank you, Jeannie. Good afternoon, everyone, and thank you for joining the call today. I will begin today’s call with a brief review of our third quarter 2022 financial results. I will then turn the call over to Scott, who will provide a corporate update. Today, we reported total revenue for the third quarter of $1.7 million from the global sale of 11 systems and approximately 3,100 disposable treatment tips. As of the end of the third quarter 2022, the Company had an installed base of 915 Viveve Systems worldwide. Third quarter total operating expenses were $5.2 million compared to $5.6 million for the same period last year. The decrease is primarily due to reduced clinical study costs during the period as we advanced our fully enrolled PURSUIT trial. Operating expense reductions were partially offset by costs associated with increased engineering and development work related to our next-generation products and strategic planning efforts in anticipation of the PURSUIT clinical trial completion. As of September 30, 2022, we reported cash and cash equivalents of $5.9 million. Thanks. I’ll now turn the conference call over to Scott.

[Scott Durbin:]

Thanks, Jim. Good afternoon, everyone, and thanks again for listening to our conference call today. I’d like to begin today by stating that our positive financial results this quarter are the result of the efforts of our entire organization which continues its focus on our core initiatives as we rapidly advance our stress urinary incontinence program towards a potential SUI indication. Follow-up visits from our landmark U.S. PURSUIT clinical trial are expected to be completed by the end of this year. Our confidence level continues to remain high in the strength of the PURSUIT study design and in our ability to execute our strategy to achieve a potential SUI indication in the United States. As we move forward towards the readout of top line results, our strategic efforts continue to be focused on the following core areas. First, to complete patient follow-up visits by the end of the year and report top line results shortly thereafter. If the trial results are positive, preparing to quickly submit our de novo application to FDA for approval and preparing to commercially launch what could be the first FDA-approved patent-protected endovaginal dual-energy office-based treatment for urethral hypermobility to improve female SUI. Secondly, continuing to focus our commercial and market development efforts on the U.S. and Asia Pacific regions through the expansion of our installed base, targeting urogynecology, urology and gynecology core specialties. And third, continuing to support our current and future customers with successful initiatives to drive increased disposable treatment tip utilization and sales. As I’ve stated previously, our entire organization is committed to these core areas of strategic focus as we continue to advance our SUI clinical development program towards a potential new indication in the U.S. With that, I’d now like to discuss some specifics around our fully enrolled U.S. pivotal PURSUIT trial for female SUI. As a reminder, PURSUIT is a randomized double-blinded sham-controlled trial, which enrolled 415 subjects with moderate SUI. This is defined as greater than 10 mls up to 50 mls of urine leakage on the standardized one-hour pad weight test. We did this at approximately 30 study sites in the United States. Randomized in a 2

[End of Q&A:]

Thank you. Thank you for attending today’s presentation. You may now disconnect.