Viveve Medical, Inc.
Q4 2021 Earnings Call Transcript

Published: 17 Mar 2022

[Operator:]

Good afternoon, and welcome to the Viveve Full Year 2021 Financial Results and Corporate Update Conference Call. Please note this event is being recorded. I will now turn the call over to Jeannie Swindle, Viveve's Senior Director of Corporate Communications.

[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 timing, progress and results of its clinical trials, fluctuation of global market economic conditions, impact of the novel coronavirus 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 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 filings made with the Securities and Exchange Commission, 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 today's call 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 Scott Durbin.

[Scott Durbin:]

Thank you, Jeannie. 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 Viveve, attributable to the significant advancement of our stress urinary incontinence or SUI clinical development program, namely initiation and completion of full enrollment in our U.S. pivotal PURSUIT trial for SUI in women. Achievement of this critical milestone was the focus of our entire organization in 2021. 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 SUI program continues to be our focus as we execute the final phase of our PURSUIT trial throughout 2022 towards a top line readout anticipated at year-end, with the ultimate goal of obtaining a new commercial SUI indication in the future if the results are positive. I will expand on our clinical and commercial progress following Jim's report of our financial results. But importantly, Viveve is 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 FDA-approved patent-protected endovaginal dual-energy office-based treatment for urethral hypermobility to improve SUI in women. Secondly, continuing to focus our commercial and market development efforts in the U.S. and Asia Pacific regions through the expansion of our installed base targeting urology, urogynecology 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.

[Jim Robbins:]

Thank you, Scott. 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 sale of 46 systems. And in the U.S. under our recurring revenue model program, the placement of an additional 24 systems. As of December 31, 2021, we had a total installed base of 884 systems worldwide. Additionally, a total of approximately 10,750 disposable treatment tips were 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 SUI development program and complete enrollment in our PURSUIT clinical trial in the U.S. Spending on research and development for 2021 was approximately $9.7 million compared to approximately $5.1 million in 2020. The increase in R&D spending was primarily due to costs associated with engineering and development work related to product line improvements and efforts to advance our SUI 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 2021 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, compared to $6.5 million as of December 31, 2020. I will now turn the call back over to Scott.

[Scott Durbin:]

Thank you, Jim. I'd now like to further my remarks on our opportunity in SUI and fully enrolled PURSUIT trial that is underway. It's important for me to state that SUI is a condition that affects an estimated 25 million 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 SUI. In fact, there is a large gap in the current treatment spectrum between physiotherapy at one end such as kegel exercises and electrical muscle stimulation designed to strengthen the pelvic floor musculature, to the other end of the spectrum, such as invasive approaches like bulking agents or sling procedures. We believe that Viveve 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 SUI with our noninvasive endovaginal, office-based treatment, which can be completed in approximately 45 minutes to safely and effectively improve urethral hypermobility, the primary cause of SUI and significantly reduced leakage for women. Viveve's Landmark PURSUIT trial is a randomized, double-blinded, sham-controlled trial that enrolled 415 subjects with moderate SUI, defined as greater than 10 mls up to 50 mls of urine leakage on the standardized 1-hour pad weight test at 30 study sites in the United States. Randomized in a 2

[Operator:]