345 Inverness Drive South
Englewood, CO 80112
Viveve Medical, Inc. designs, develops, manufactures and markets a medical device, Geneveve, for the non-invasive treatment of vaginal laxity, for improved sexual function, and for vaginal rejuvenation. The Company's Geneveve is a non-invasive solution for vaginal laxity which includes three components: the Viveve System (a radio frequency (RF), generator housed in a table-top console), a reusable handpiece and a single-use treatment tip, as well as several other consumable accessories. Physicians attach the single-use treatment tip to the handpiece which is connected to the console. The generator authenticates the treatment tip and programs the system for the desired treatment without further physician intervention. The treatment is performed in a physician's office, in less than 30 minutes, and does not require the use of anesthesia. Geneveve is indicated for use in general surgical procedures for electrocoagulation and hemostasis in the United States.
Cryogen-Cooled Monopolar Radiofrequency
One 30-45 minute session
Safe and comfortable
Respectable and discreet
The Viveve System provides sustained tissue tightening and strengthening by substantially heating the tissue at depth. The Viveve System’s patented, cryogen-cooled monopolar radiofrequency (CMRF) is unique in its ability to deliver volumetric heat (90 J/cm2) in order to stimulate robust neocollagenesis. This can be accomplished in just ONE session.
The Viveve System delivers a single-session treatment to generate collagen and restore tissue. The dual mode VIVEVE TREATMENT COOLS AND PROTECTS THE SURFACE WHILE HEATING THE DEEPER TISSUE. The Viveve Treatment is both safe and effective.
INCONTROL PRODUCTS BY VIVEVE strengthen the pelvic floor muscles and calm the detrusor muscle using a patented electrostimulation device with high and low levels of stimulation to treat urinary and fecal incontinence. InTone, InToneMV and ApexM are FDA-cleared devices.
ENGLEWOOD, CO / ACCESSWIRE / March 14, 2019 / Viveve Medical Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today reported financial results for the three months and full year ended December 31, 2018.
"2018 was a year of solid progress even as we worked to address some considerable challenges. We grew revenue despite facing significant market headwinds in the second half of the year that affected the entire women's intimate health industry. We also continued our paths forward in our clinical programs as we advanced our U.S. sexual function trial and launched our programs in stress urinary incontinence (SUI) with Viveve's cryogen-cooled, monopolar radiofrequency (CMRF) technology," said Scott Durbin, Viveve's chief executive officer. "In January, we also realigned our organization to reduce expenses and focus on our core initiatives of expanding system placements, increasing treatment tip utilization, reducing cost of goods and completing our clinical development programs in female sexual function and SUI."
2018 and Recent Business Highlights
- Achieved continued growth in global revenue: Reported 2018 total revenue of approximately $18.5 million from the sale of 259 Viveve Systems and over 18,000 disposable treatment tips, representing a 21% year-over-year revenue increase.
Advanced and fully enrolled U.S. clinical trial for the improvement of sexual function in women: Following U.S. Food and Drug Administration (FDA) approval of the Investigational Device Exemption (IDE) and successful review of patient safety data submitted to the Agency, Viveve received approval to proceed to full patient enrollment in late December 2018. In March 2019 Viveve completed enrollment of 250 patients in VIVEVE II, our U.S. multi-center randomized, double-blind, sham-controlled trial for improved sexual function in women.
Advanced clinical programs in stress urinary incontinence (SUI): Reported positive 12-month results from a pilot study and separate feasibility study using the Viveve System for the treatment of SUI. Viveve initiated and completed patient enrollment in the LIBERATE-International trial with results expected in the third quarter of 2019. The company also worked closely with FDA throughout 2018 to define the data needed in 2019 to support starting a U.S. registration study for SUI.
Introduced an enhanced technology platform: Successfully executed the initial launch of Viveve 2.0., the company's next generation system, with the potential to deliver improved gross margins in 2019.
Expanded awareness of Viveve's CMRF technology: Data was reported in more than 20 clinical publications and presented by gynecology, urology, women's intimate health and aesthetic physician opinion leaders at 15 leading global medical conferences and meetings.
Successfully protected Viveve's IP estate: Announced a favorable settlement of the company's patent infringement litigation, further protecting Viveve's intellectual property portfolio.
Expanded Board: Appointed two new, independent, and seasoned commercial executives to Viveve's Board of Directors; Steven Basta and Karen Zaderej.
Mr. Durbin continued, "With the sale of 259 Viveve Systems in 2018, we now have a commercial installed base of over 700 systems worldwide. We anticipate reporting continued momentum in system sales and consumable treatment tip utilization in 2019 as we advance our global commercial, regulatory, and market development strategies."
Fourth Quarter 2018 Financial Results
Revenue for the fourth quarter of 2018 totaled approximately $4.5 million from the sale of 57 Viveve Systems and approximately 4,600 treatment tips, compared to revenue of approximately $5.1 million for the same period in 2017, representing a 12% decrease over the fourth quarter of 2017.
Gross profit for the fourth quarter of 2018 was approximately $1.7 million, or 37% of revenue, compared to gross profit of approximately $2.8 million, or 54% of revenue in the fourth quarter of 2017.
Total operating expenses for the fourth quarter of 2018 was $13.9 million compared to total operating expenses of $12.2 million in the same period in 2017. The increase was primarily the result of increased efforts to support the commercialization of Viveve's products in the U.S. and clinical studies in SUI and sexual function.
Spending on research and development during the fourth quarter of 2018 was $2.8 million compared to $3.1 million in the fourth quarter of 2017.
Selling, general and administrative expenses for the fourth quarter of 2018 were $11.1 million compared to $9.2 million in the fourth quarter of 2017.
Net loss for the fourth quarter of 2018 was $13.5 million, or a net loss of $0.38 per share based on 35,484,596 weighted average shares outstanding during the period.
Cash and cash equivalents were approximately $29.5 million as of December 31, 2018.
Full Year 2018 Financial Results
Revenue for 2018 totaled approximately $18.5 million from the sale of 259 Viveve Systems and approximately 18,450 treatment tips, compared to revenue of approximately $15.3 million for the full year of 2017, an increase of 21% year-over-year.
Gross profit for 2018 was approximately $7.3 million, or 40% of revenue, compared to gross profit of approximately $7.4 million, or 49% of revenue for the full year of 2017.
Total operating expenses for 2018 was approximately $52.3 million compared to $41.2 million for the full year of 2017.
Spending on research and development for 2018 was approximately $13.7 million compared to approximately $12.3 million in 2017 and increased due to costs associated with engineering and development work with the company's contract manufacturer related to product line improvement and expansion efforts.
Selling, general and administrative (SG&A) expenses during 2018 were approximately $38.6 million compared to $28.8 million in 2017. The increase in SG&A spending was primarily the result of increased costs associated with Viveve's expansion of the commercial sales organization, marketing efforts to build brand and market awareness, expenses associated with being a public company and financing efforts.
Net loss for 2018 was approximately $50.0 million, or a net loss of $1.61 per share based on 31,059,483 weighted average shares outstanding during the period, compared with a net loss of $37.0 million, or a net loss of $2.11 per share for 2017.
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