Company Overview
Viveve Medical, Inc. (VIVE) is a pioneering medical technology company dedicated to developing innovative solutions for women’s intimate health. With a strong focus on research and development, the company has carved out a unique position in the highly competitive women’s intimate health industry.
Founded in 2006 and headquartered in Englewood, Colorado, Viveve Medical has a rich history of innovation and perseverance. The company’s flagship product, the Viveve System, utilizes its proprietary Cryogen-cooled Monopolar Radiofrequency (CMRF) technology to address a range of women’s intimate health concerns, including vaginal laxity, stress urinary incontinence, and improved sexual function. The Viveve System consists of a radiofrequency generator, handpiece, and treatment tip, which collectively deliver the CMRF technology.
Regulatory Milestones and Market Expansion
In February 2015, Viveve achieved a significant milestone by obtaining 510(k) clearance from the U.S. Food and Drug Administration (FDA) to market the Viveve System for general surgical procedures for electrocoagulation and hemostasis. This clearance allowed the company to begin commercializing the Viveve System in the United States. Prior to this, Viveve had already secured regulatory clearances or approvals to market its products in several international markets.
Financial Support and Challenges
To support its growth and commercialization efforts, Viveve entered into a Term Loan Agreement with affiliates of CRG LP in 2017, providing the company with up to $30 million in credit facility funding. However, in 2019, the company amended the loan agreement, converting approximately $29 million of the outstanding principal amount into Series B convertible preferred stock.
Viveve has faced its share of challenges over the years. In 2020, the COVID-19 pandemic negatively impacted the company’s sales and operations, as many elective procedures were postponed or canceled. This led to the suspension of Viveve’s 2017 Employee Stock Purchase Plan. Additionally, in 2021, the company experienced a setback when its VIVEVE II clinical trial did not meet its primary endpoint, although Viveve continued to advance its clinical development program for stress urinary incontinence.
Global Expansion and Market Presence
Despite these obstacles, Viveve has successfully expanded its global footprint. As of September 2022, the company had obtained regulatory clearances or approvals to market its products in a total of 48 countries worldwide. Viveve sells its products primarily through a direct sales force in the United States and an extensive network of distribution partners internationally. The company has also been proactive in protecting its intellectual property, obtaining various patents covering its dual-energy technology.
Operational Performance
As of September 30, 2022, Viveve Medical reported a global installed base of 915 Viveve Systems and approximately 69,500 single-use treatment tips sold worldwide. The company’s revenue for the nine months ended September 30, 2022, totaled $5.12 million, representing an 8% increase compared to the same period in 2021. This growth was primarily driven by higher sales volume of Viveve Systems and treatment tips globally, as well as higher average selling prices for the treatment tips.
Financials
Viveve Medical’s financial position remains a concern. For the fiscal year 2021, the company reported revenue of $6.43 million, with a net loss of $22.03 million. Operating cash flow was negative $12.88 million, and free cash flow was negative $13.33 million.
In the most recent quarter (Q3 2022), Viveve reported revenue of $1.68 million, representing a 4% increase compared to Q3 2021. This growth was primarily due to higher sales volume of treatment tips sold globally, partially offset by a decrease in Viveve Systems sold during the period. The net loss for Q3 2022 was $5.29 million, with operating cash flow of negative $3.35 million and free cash flow of negative $3.54 million.
As of September 30, 2022, the company had cash and cash equivalents of $5.91 million and a working capital deficit of $1.23 million. The company’s management has acknowledged that the current cash position may not be sufficient to fund operations through November 30, 2023, without additional financing. This has led the company to conclude that there is substantial doubt about its ability to continue as a going concern within one year after the date the condensed consolidated financial statements were issued.
Liquidity
To address this challenge, Viveve Medical is actively pursuing additional funding, which may come in the form of equity or debt financing. The company has filed a universal shelf registration statement with the SEC, providing the flexibility to raise up to $75 million in securities. However, the company’s ability to successfully execute on this plan remains uncertain, and any additional financing will likely be highly dilutive to existing shareholders.
As of September 30, 2022, Viveve’s debt-to-equity ratio stood at 0.34. The company had a $10 million credit facility, of which $5.63 million was outstanding. The current ratio was 0.89, and the quick ratio was 0.73, indicating potential short-term liquidity challenges.
Performance by Geographic Markets
Viveve Medical operates primarily in three geographic regions: North America, Asia Pacific, and Europe/Middle East. In Q3 2022, North America accounted for 58% of revenue, Asia Pacific accounted for 42% of revenue, and Europe/Middle East accounted for less than 1% of revenue.
Future Outlook and Clinical Developments
Despite the financial headwinds, Viveve Medical remains committed to advancing its clinical development programs, particularly the PURSUIT trial for the treatment of SUI in women. The company expects to complete patient follow-up visits from this pivotal U.S. trial by the end of 2022 and report topline results shortly thereafter. The successful outcome of the PURSUIT trial could be a significant catalyst for the company, potentially paving the way for regulatory approval and commercialization of the Viveve System for the SUI indication in the United States.
Furthermore, Viveve Medical has been proactive in strengthening its intellectual property portfolio, including the recent receipt of a Notice of Allowance for a second U.S. Method Patent for treating female SUI. This patent, along with the company’s existing patents, further solidifies its position in the market and provides additional protection for its innovative CMRF technology.
Conclusion
In conclusion, Viveve Medical, despite the challenges it has faced, remains a resilient player in the women’s intimate health market. The company’s unwavering commitment to research and development, combined with its innovative Viveve System, positions it well to capitalize on the growing demand for effective solutions in this underserved segment. However, the company’s ability to navigate its current financial constraints and secure the necessary funding to sustain its operations will be crucial in determining its long-term success. The outcome of the PURSUIT clinical trial and potential regulatory approvals for new indications could significantly impact the company’s future growth prospects.
Disclaimer: This article is for informational purposes only. It does not constitute financial, legal, or other types of advice. While every effort has been made to ensure the accuracy of the information presented here, the author and the publisher do not make any guarantees about the completeness, reliability, and accuracy of this information.