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Viveve Medical Inc. (VIVE)

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VIVEVE  
345 Inverness Drive South 
Building B
Suite 250 
Englewood, CO 80112 
(720) 696-8100


https://us.viveve.com/about/

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.

VIVEVE SYSTEM

Quick Facts

Single Session

Cryogen-Cooled Monopolar Radiofrequency

One 30-45 minute session

Safe and comfortable

Clinically-proven

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.

AT HOME

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.


Avg Vol (10-day):  616.3K
52-Wk Range: 0.42 - 4.34
Market Cap:  24.8M
Shares Outstanding:  46.5M
EPS (TTM, GAAP)     - 1.63
68.22% of the Float is held by Institutions
Short Intererst is 5.82% of the Float  

 

 


 

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VIVE News: Current Report Filing (8-k) 05/23/2019 04:12:10 PM
VIVE News: Current Report Filing (8-k) 05/16/2019 04:03:33 PM
VIVE News: Quarterly Report (10-q) 05/09/2019 04:12:16 PM
VIVE News: Current Report Filing (8-k) 05/09/2019 04:05:25 PM
VIVE News: Amended Statement of Beneficial Ownership (3/a) 05/07/2019 04:02:45 PM
News News Alert: Current Report Filing (8-k) 05/23/2019 04:12:10 PM
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#1083   VIVE buy 0.629 stocktrademan 05/17/19 11:21:54 AM
#1082   Opening UP again today. boston127 05/07/19 09:13:49 AM
#1081   Looks like Earnings on 05/13. boston127 05/06/19 01:52:16 PM
#1080   Making a comeback. boston127 05/02/19 03:27:00 PM
#1079   Bought more at .48-.50 range this AM. boston127 05/02/19 10:02:41 AM
#1078   Holding up nicely after yesterday's gains. boston127 05/02/19 09:43:40 AM
#1077   News: $VIVE Viveve to Host Conference Call to whytestocks 05/02/19 08:40:38 AM
#1076   Thanks. I started buying early AM. boston127 05/01/19 06:57:53 PM
#1075   Good day for you if you held. Congrats! CBD_Kindaguy 05/01/19 05:39:05 PM
#1074  Restored * * $VIVE Video Chart 05-01-2019 * * ClayTrader 05/01/19 05:29:51 PM
#1073   Maintaining early morning gains. boston127 05/01/19 02:17:31 PM
#1072   Maintaining its gains nicely. boston127 05/01/19 10:48:11 AM
#1071   I will take .66 or .74 today. boston127 05/01/19 10:08:24 AM
#1070   I jumped out at .74, and then it CBD_Kindaguy 05/01/19 10:01:53 AM
#1069   Decided to jump in here this AM. boston127 05/01/19 10:00:09 AM
#1068   * * $VIVE Video Chart 04-12-2019 * * ClayTrader 04/12/19 06:01:28 PM
#1067   In at .66. This is way over sold!!! CBD_Kindaguy 04/09/19 12:50:00 PM
#1066   Hmmmm.... not big volume...maybe chance to nibble more?? now invest 03/20/19 12:55:29 AM
#1065   Raymond James came out with an outperform rating now invest 03/16/19 08:28:25 AM
#1064   Yeah. Looks great. Huge drop from highs... Brooksda 01/03/19 02:31:47 PM
#1063   Is there a different board for this now ellen780 09/19/18 02:46:10 PM
#1062   Kathy used vive to tighten her's? Jumpinjackas 04/24/18 04:24:43 PM
#1061   Lol Jumpinjackas 03/01/18 11:42:55 AM
#1060   Viveve Medical Inc. is a great company and petunia1 02/14/18 02:48:11 PM
#1059   * * $VIVE Video Chart 02-09-18 * * ClayTrader 02/09/18 05:02:44 PM
#1058   Puchi stuff still selling? Jumpinjackas 09/20/17 06:27:35 PM
#1057   VIVE bullish 8.10 stocktrademan 05/10/17 11:35:08 AM
#1056   What made it jump? 4starman 04/17/17 01:23:42 PM
#1055   lol what a wild rollercoaster Awl416 04/17/17 11:33:49 AM
#1054   VIVE bullish 6.51 stocktrademan 11/17/16 12:05:31 PM
#1053   Uplisted on NASDAQ iDoubt 06/14/16 09:11:35 AM
#1052   VIVMF: effective April 18,2016 a one for 8 Renee 04/15/16 07:45:27 AM
#1051   What happened here??? I really thought women Magnetics 02/16/16 10:08:12 AM
#1050   Good question. They have to get their carusso 07/23/15 11:04:12 PM
#1049   Hank, thanks for the great news. My ProfessorCUNY 07/23/15 04:18:30 PM
#1048   Viveve Medical Inc Rated New 'Buy' at Sterne HankDaisy 07/23/15 12:45:23 PM
#1047   Hello Investors, ProfessorCUNY 07/17/15 01:46:34 AM
#1046   Thanks, Carusso, for asking. After reading the ProfessorCUNY 07/01/15 04:42:28 PM
#1045   ProfessorCUNY, I share your detestation of reverse splits. carusso 07/01/15 02:53:10 PM
#1044   Investors, 153 page S-1 just released by Viveve. ProfessorCUNY 06/16/15 05:32:35 PM
#1043   Not heavily by institutions, but by insiders. ProfessorCUNY 06/11/15 04:10:55 PM
#1042   Hi First things first... I know zip about stocks... fuzzballz 06/11/15 02:02:04 PM
#1041   Schedule 14A-Information, Point 4, filed a few days ProfessorCUNY 06/10/15 04:53:55 PM
#1040   Where did you read about the reverse split? iDoubt 06/10/15 05:33:36 AM
#1039   Hello Again, ProfessorCUNY 06/10/15 01:13:05 AM
#1038   Hello Investors, ProfessorCUNY 06/09/15 06:19:21 PM
#1037   Thanks for your info and validation of the carusso 06/05/15 04:00:31 PM
#1036   Yes, Carusso, I noticed the same thing-- differing stats. ProfessorCUNY 06/02/15 04:48:01 PM
#1035   Regarding the chart posted: another data base carusso 06/01/15 02:46:34 PM
#1034   Look at the EPS and P/E ratio, in carusso 05/29/15 01:32:07 AM
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