Welcome!

News Feed Item

Viveve Reports Fourth Quarter and Full Year 2016 Financial Results

Company projects $14-$16 million in revenue for 2017

SUNNYVALE, CA--(Marketwired - February 16, 2017) - Viveve Medical Inc. ("Viveve") (NASDAQ: VIVE), a medical technology company focused on women's health, today reported financial results for the three months and year ended December 31, 2016.

"We have continued to exceed our commercial expectations with six consecutive quarters of double digit revenue growth and with extensive positive feedback from distributors, physicians and patients. In January, we launched our initial U.S. commercial team and we recently announced publication of the VIVEVE I study results, further validating the safety and efficacy of our cryogen-cooled monopolar radiofrequency (CMRF) technology and the GENEVEVE™ treatment to improve vaginal laxity and sexual function. The interest and increasing demand we are experiencing reinforces the opportunity for rapid worldwide adoption throughout 2017," said Patricia Scheller, chief executive officer of Viveve.

"We now have a commercial installed base of 217 systems, 102 of which were sold during the last two quarters of 2016. We anticipate a significant increase in our installed base in 2017 as we continue to advance our global commercial strategy," said Scott Durbin, Viveve's chief financial officer. "Based on the increased momentum of our commercialization efforts, we believe we are well positioned to build on our 2016 success and project revenue for 2017 between $14 million and $16 million."

Q4 2016 Financial Results

Revenue for the fourth quarter of 2016 totaled $2,452,000 from the sale of 55 systems and more than 1,300 treatment tips, compared to revenue of $752,000 for the same period in 2015, an increase of $1,700,000.

Gross profit for the fourth quarter of 2016 was $956,000, or 39% of revenue, compared to gross profit of $287,000, or 38% of revenue, for the same period in 2015. The increase in gross profit was primarily due to sales of 55 systems to our new distributors in 2016.

Total operating expenses for the fourth quarter of 2016 increased 68% to $6,485,000 from $3,851,000 in the same period in 2015, primarily as a result of increased efforts to support commercialization of our product in existing and new markets, research and development efforts and strategies to protect our intellectual property, as well as for working capital and other general corporate purposes. Spending on research and development during the fourth quarter of 2016 increased due to costs associated with increased engineering and development work with our contract manufacturer related to product design. Selling, general and administrative expenses for the fourth quarter of 2016 increased primarily due to increased sales and marketing efforts to build brand and market awareness, expenses associated with being a public company and financing efforts.

Net loss for the fourth quarter of 2016 was $5,820,000, or a loss of $0.55 per share, compared with a net loss of $3,677,000, or a loss of $0.54 per share, for the same period in 2015.

Cash and cash equivalents were $8,086,000 as of December 31, 2016, an increase of $726,000 from $7,360,000 as of December 31, 2015.

Full Year 2016 Financial Results

Revenue for the full year 2016 totaled $7,141,000 from the sale of 175 systems and more than 2,700 treatment tips, compared to revenue of $1,441,000 for the full year 2015, an increase of $5,694,000.

Gross profit for the full year 2016 was $2,529,000, or 35% of revenue, compared to gross profit of $462,000, or 32% of revenue, for the full year 2015. The increase in gross profit was primarily due to sales of 175 systems to our new distributors in 2016.

Total operating expenses for the full year 2016 increased 71% to $21,233,000 from $12,452,000 for the full year 2015, primarily as a result of increased efforts to support commercialization of our product in existing and new markets, research and development efforts and strategies to protect our intellectual property, as well as for working capital and other general corporate purposes. Spending on research and development during the full year 2016 increased due to costs associated with engineering and development work with our contract manufacturer related to product improvement efforts. Selling, general and administrative expenses during the full year 2016 increased primarily due to increased sales and marketing efforts to build brand and market awareness, expenses associated with being a public company and financing efforts.

Net loss for the full year 2016 was $20,111,000, or a loss of $2.18 per share, compared with a net loss of $12,426,000, or a loss of $2.47 per share, for the full year 2015.

2016 Business Highlights

"2016 was a monumental year for Viveve. The company rigorously pursued and achieved key milestones in our global commercialization strategy," said Ms. Scheller. "Our focus will continue to be generating additional differentiating clinical data, supporting the efforts of our direct sales teams and global distribution partners, driving commercialization through the attainment of additional regulatory clearances, and increasing awareness of vaginal laxity, a condition that affects millions of women worldwide. We believe that the Geneveve treatment provides the only safe and effective non-surgical option to successfully address vaginal laxity and improve sexual function. An Investigational Device Exemption (IDE) was submitted in late 2016 to the Food and Drug Administration (FDA) and is currently under review for authorization to begin a multicenter pivotal trial with the goal of obtaining a new U.S. indication for the improvement of sexual function."

  • Received FDA 510(k) clearance for the Viveve® System in the U.S. for use in general surgical procedures for electrocoagulation and hemostasis.
  • Achieved regulatory approvals in several large international markets, including South Korea, Brazil, and Colombia, as well as approvals in other key countries including Lebanon, Singapore, and the United Arab Emirates. Viveve has received regulatory approvals in 51 countries worldwide.
  • Announced seven distribution agreements, representing some of the largest worldwide markets for aesthetic medical procedures. Viveve has 26 distribution partnerships established covering 67 countries.
  • Announced positive results for both the primary and key secondary endpoints for the VIVEVE I clinical study and acceptance for publication of the results in the Journal of Sexual Medicine. The VIVEVE I Study is the first and to date the only large-scale, randomized, blinded and sham-controlled study of an energy based treatment conducted in vaginal tissue.
  • Submitted our IDE to the FDA to conduct VIVEVE II: randomized, controlled and double-blinded trial to improve sexual function in women.

Conference Call Information

The company will host a live conference call at 5:00 p.m. ET today. The conference call can be accessed at http://dpregister.com/10100786. The dial-in telephone number will be provided upon registration either in advance of or at the time of the conference call. The conference call will be archived on the company's website at http://ir.viveve.com/ir-calendar.

About Viveve

Viveve Medical, Inc. is a women's health and wellness company passionately committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented GENEVEVE™ treatment, incorporates clinically-proven, cryogen-cooled, monopolar radiofrequency (CMRF) to uniformly deliver volumetric heating while gently cooling surface tissue to generate robust neocollagenesis in one 30-minute in-office session.

In the United States, the GENEVEVE treatment is cleared by the FDA for general surgical procedures for electrocoagulation and hemostasis. Consistent with approvals in many countries internationally, Viveve is currently seeking regulatory clearance in the United States for improvement in sexual function. For more information visit Viveve's website at www.viveve.com.

Safe Harbor Statement

All statements in this press release that are not based on historical fact are "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing, competition, general economic conditions and other factors that are detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a highly competitive and rapidly changing environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Viveve is a registered trademark of Viveve, Inc.

Geneveve is a trademark of Viveve, Inc.

                                                                            
                            VIVEVE MEDICAL, INC.                            
                    CONDENSED CONSOLIDATED BALANCE SHEETS                   
                               (in thousands)                               
                                 (unaudited)                                
                                                                            
                                                 December 31,   December 31,
                                                     2016           2015    
                                                -------------- -------------
                     ASSETS                                                 
Current assets:                                                             
  Cash and cash equivalents                        $     8,086   $     7,360
  Accounts receivable                                    2,091           593
  Inventory                                              2,687         1,549
  Prepaid expenses and other current assets              1,066         1,228
                                                -------------- -------------
    Total current assets                                13,930        10,730
Property and equipment, net                                483           239
Other assets                                               136           138
                                                -------------- -------------
    Total assets                                   $    14,549   $    11,107
                                                ============== =============
 LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)                             
Current liabilities:                                                        
  Accounts payable                                 $     3,086   $     1,432
  Accrued liabilities                                    2,186         1,293
  Note payable, current portion                          1,867         4,446
                                                -------------- -------------
    Total current liabilities                            7,139         7,171
Note payable, noncurrent portion                         7,762             -
Other noncurrent liabilities                                53             -
                                                -------------- -------------
    Total liabilities                                   14,954         7,171
                                                -------------- -------------
                                                                            
Stockholders' equity (deficit):                                             
  Common stock and paid-in capital                      68,217        52,447
  Accumulated deficit                                 (68,622)      (48,511)
                                                -------------- -------------
    Total stockholders' equity (deficit)                 (405)         3,936
                                                -------------- -------------
    Total liabilities and stockholders' equity                              
     (deficit)                                     $    14,549   $    11,107
                                                ============== =============
                                                                            
                                                                            
                            VIVEVE MEDICAL, INC.                            
               CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS              
               (in thousands, except share and per share data)              
                                 (unaudited)                                
                                                                            
                             Three Months Ended            Year Ended       
                                December 31,              December 31,      
                         ------------------------- -------------------------
                             2016         2015         2016         2015    
                         ------------ ------------ ------------ ------------
                                                                            
Revenue                   $     2,452  $       752  $     7,141  $     1,447
Cost of revenue                 1,496          465        4,612          985
                         ------------ ------------ ------------ ------------
  Gross profit                    956          287        2,529          462
                         ------------ ------------ ------------ ------------
                                                                            
Operating expenses:                                                         
Research and development        2,052        1,542        8,365        4,988
Selling, general and                                                        
 administrative                 4,433        2,309       12,868        7,464
                         ------------ ------------ ------------ ------------
  Total operating                                                           
   expenses                     6,485        3,851       21,233       12,452
                         ------------ ------------ ------------ ------------
  Loss from operations        (5,529)      (3,564)     (18,704)     (11,990)
Interest expense, net           (276)        (113)      (1,370)        (415)
Other expense, net               (15)            -         (37)         (21)
                         ------------ ------------ ------------ ------------
  Net loss                $   (5,820)  $   (3,677)  $  (20,111)  $  (12,426)
                         ============ ============ ============ ============
                                                                            
                                                                            
Net loss per share:                                                         
  Basic and diluted       $    (0.55)  $    (0.54)  $    (2.18)  $    (2.47)
                         ============ ============ ============ ============
                                                                            
Weighted average shares                                                     
 used in computing net                                                      
 loss per common share                                                      
  Basic and diluted        10,653,943    6,861,259    9,222,348    5,023,080
                         ============ ============ ============ ============

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
WebRTC is the future of browser-to-browser communications, and continues to make inroads into the traditional, difficult, plug-in web communications world. The 6th WebRTC Summit continues our tradition of delivering the latest and greatest presentations within the world of WebRTC. Topics include voice calling, video chat, P2P file sharing, and use cases that have already leveraged the power and convenience of WebRTC.
SYS-CON Events announced today that CA Technologies has been named “Platinum Sponsor” of SYS-CON's 20th International Cloud Expo®, which will take place on June 6-8, 2017, at the Javits Center in New York City, NY, and the 21st International Cloud Expo®, which will take place October 31-November 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA. CA Technologies helps customers succeed in a future where every business – from apparel to energy – is being rewritten by software. From ...
With 10 simultaneous tracks, keynotes, general sessions and targeted breakout classes, Cloud Expo and @ThingsExpo are two of the most important technology events of the year. Since its launch over eight years ago, Cloud Expo and @ThingsExpo have presented a rock star faculty as well as showcased hundreds of sponsors and exhibitors! In this blog post, I provide 7 tips on how, as part of our world-class faculty, you can deliver one of the most popular sessions at our events. But before reading the...
"Storage is growing. All of IDC's estimates say that unstructured data is now 80% of the world's data. We provide storage systems that can actually deal with that scale of data - software-defined storage systems," stated Paul Turner, Chief Product and Marketing Officer at Cloudian, in this SYS-CON.tv interview at 17th Cloud Expo, held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA.
The best way to leverage your Cloud Expo presence as a sponsor and exhibitor is to plan your news announcements around our events. The press covering Cloud Expo and @ThingsExpo will have access to these releases and will amplify your news announcements. More than two dozen Cloud companies either set deals at our shows or have announced their mergers and acquisitions at Cloud Expo. Product announcements during our show provide your company with the most reach through our targeted audiences.
20th Cloud Expo, taking place June 6-8, 2017, at the Javits Center in New York City, NY, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy.
Bert Loomis was a visionary. This general session will highlight how Bert Loomis and people like him inspire us to build great things with small inventions. In their general session at 19th Cloud Expo, Harold Hannon, Architect at IBM Bluemix, and Michael O'Neill, Strategic Business Development at Nvidia, discussed the accelerating pace of AI development and how IBM Cloud and NVIDIA are partnering to bring AI capabilities to "every day," on-demand. They also reviewed two "free infrastructure" pr...
Cloud Expo, Inc. has announced today that Aruna Ravichandran, vice president of DevOps Product and Solutions Marketing at CA Technologies, has been named co-conference chair of DevOps at Cloud Expo 2017. The @DevOpsSummit at Cloud Expo New York will take place on June 6-8, 2017, at the Javits Center in New York City, New York, and @DevOpsSummit at Cloud Expo Silicon Valley will take place Oct. 31-Nov. 2, 2017, at the Santa Clara Convention Center in Santa Clara, CA.
In his general session at 18th Cloud Expo, Lee Atchison, Principal Cloud Architect and Advocate at New Relic, discussed cloud as a ‘better data center’ and how it adds new capacity (faster) and improves application availability (redundancy). The cloud is a ‘Dynamic Tool for Dynamic Apps’ and resource allocation is an integral part of your application architecture, so use only the resources you need and allocate /de-allocate resources on the fly.
Have you ever noticed how some IT people seem to lead successful, rewarding, and satisfying lives and careers, while others struggle? IT author and speaker Don Crawley uncovered the five principles that successful IT people use to build satisfying lives and careers and he shares them in this fast-paced, thought-provoking webinar. You'll learn the importance of striking a balance with technical skills and people skills, challenge your pre-existing ideas about IT customer service, and gain new in...
The Internet of Things will challenge the status quo of how IT and development organizations operate. Or will it? Certainly the fog layer of IoT requires special insights about data ontology, security and transactional integrity. But the developmental challenges are the same: People, Process and Platform. In his session at @ThingsExpo, Craig Sproule, CEO of Metavine, demonstrated how to move beyond today's coding paradigm and shared the must-have mindsets for removing complexity from the develop...
SYS-CON Events announced today that Hitrons Solutions will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Hitrons Solutions Inc. is distributor in the North American market for unique products and services of small and medium-size businesses, including cloud services and solutions, SEO marketing platforms, and mobile applications.
@DevOpsSummit at Cloud taking place June 6-8, 2017, at Javits Center, New York City, is co-located with the 20th International Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long developm...
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Almost two-thirds of companies either have or soon will have IoT as the backbone of their business. Though, IoT is far more complex than most firms expected with a majority of IoT projects having failed. How can you not get trapped in the pitfalls? In his session at @ThingsExpo, Tony Shan, Chief IoTologist at Wipro, will introduce a holistic method of IoTification, which is the process of IoTifying the existing technology portfolios and business models to adopt and leverage IoT. He will delve in...