UNITED STATES SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 8-K

 

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the

Securities Exchange Act of 1934

 

Date of Report (Date of earliest event reported): February 18, 2021

 

VIVEVE MEDICAL, INC.

(Exact name of registrant as specified in its charter)

  

  

  

  

  

  

  

  

  

  

Delaware

  

1-11388

  

04-3153858

(State or other jurisdiction of

incorporation)

  

(Commission File Number)

  

(I.R.S. Employer

Identification No.)

 

  

  

  

  

  

  

345 Inverness Drive South, Building B, Suite 250

Englewood, Colorado

  

80112

(Address of principal executive offices)

  

(Zip Code)

 

Registrant’s telephone number, including area code: (720) 696-8100

 

 

 

 Securities registered pursuant to Section 12(b) of the Act:

 

 

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common Stock

VIVE

Nasdaq Capital Market

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

  

  

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

 

Emerging growth company     ☐

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.     ☐



  

 

 

Item 2.02.

Results of Operations and Financial Conditions.

 

On February 18, 2021, Viveve Medical, Inc. (the “Company”) issued a press release announcing its topline financial results for the quarter ended December 31, 2020. A copy of the Company’s press release is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

 

The information in Item 2.02 of this Current Report on Form 8-K, including Exhibit 99.1, is being furnished and shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, regardless of any general incorporation language in such a filing, except as shall be expressly set forth by specific reference in such a filing.

 

The information contained in Item 2.02 of this Form 8-K is unaudited and preliminary and does not present all information necessary for an understanding of the Company’s financial condition as of December 31, 2020 and its results of operations for the three months and year ended December 31, 2020. The audit of the Company’s consolidated financial statements for the year ended December 31, 2020 is ongoing and could result in changes to the information set forth above.

 

 

 

Item 9.01.

Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.

  

Description

  

  

99.1

 

Press Release issued by the Company on February 18, 2021, announcing results for the quarter ended December 31, 2020.

 

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

Date: February 18, 2021 

Viveve Medical, Inc.

 

  

  

By:  

/s/ Scott Durbin

  

  

  

Scott Durbin 

  

  

  

Chief Executive Officer

  

 

 

 

 

Exhibit 99.1

 

Viveve Announces Preliminary Topline Financial Results for Fourth Quarter 2020

 

-     Q4 revenue growth, reduced operating expenses and successful closing of public offering in January position Company with capital resources through end of 2022

 

-    Company to host year-end conference call on March 18, 2021 at 5:00 PM ET

 

Englewood, CO – February 18, 2021 – Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today announced topline financial results for the quarter ended December 31, 2020. Based on fourth quarter 2020 estimated total revenue of $1.9 million, a continued reduction in operating expenses, and a strengthened cash position following the close of the Company's recent upsized financing of $27.6 million in gross proceeds, Viveve is positioned with the capital resources to support operations through year-end 2022, including the planned completion of its pivotal U.S. PURSUIT trial in stress urinary incontinence (SUI).

 

“We are very pleased with our preliminary fourth quarter 2020 financial results, which demonstrate continuing adoption and increasing consumable utilization. I credit the talented team at Viveve for achieving the results reported this quarter as we close out a year of unprecedented challenges,” said Scott Durbin, Viveve’s chief executive officer. Importantly, our operational efficiency and the capital raised from our January public offering provide the Company with the resources to support our operations through 2022. Today, Viveve is in a strong position as we advance our pivotal U.S. PURSUIT trial toward a potential new indication in the U.S.”

 

Preliminary Fourth Quarter 2020 Financial Results

 

Revenue for the fourth quarter ended December 31, 2020 totaled $1.9 million, compared to revenue of $1.5 million for the same period in 2019. Global sales of approximately 2,950 disposable treatment tips were reported for the fourth quarter of 2020, a 48% increase compared to 2,000 treatment tips for the same period in 2019. As of December 31, 2020, the Company had an installed base of 857 Viveve® Systems worldwide.

 

Total operating expenses for the fourth quarter of 2020 are expected to be approximately $4.6 million, down from $6.9 million for the same period in 2019. This decrease is anticipated due to the Company's organizational realignment focusing on its stress urinary incontinence (SUI) clinical development program, and continuing cost-saving efforts implemented during the second quarter of 2020.

 

Cash and cash equivalents were $6.5 million as of December 31, 2020, compared to $13.3 million as of December 31, 2019. On a pro forma basis, cash and cash equivalents as of December 31, 2020, including the estimated net proceeds of $25.2 million from the Company’s January 2021 financing, is approximately $31.7 million.

 

Conference Call Information

 

Viveve will host a conference call and webcast on March 18, 2021, at 5:00 PM ET to report fourth quarter and year-end 2020 financial results and provide a corporate update. The conference call may be accessed by dialing 1-833-255-2833 (domestic) or 1-412-902-6728 (international) or via live webcast at https://services.choruscall.com/links/vive210318.html. Participants may also pre-register for the conference call at https://dpregister.com/sreg/10152326/e2989167c4.

 

 

 

A recording of the webcast will be posted on the Company's investor relations website following the call at ir.viveve.com and available online for 90 days.

 

About Viveve

 

Viveve Medical, Inc. is a medical technology company focused on women's intimate health. Viveve is committed to advancing new solutions to improve women's overall well-being and quality of life. The internationally patented Viveve® System incorporates Cryogen-cooled Monopolar Radiofrequency technology to uniformly deliver volumetric heating while gently cooling surface tissue to generate neocollagenesis in a single in-office session. In the United States, the Viveve® System is cleared by the Food and Drug Administration (FDA) for use in general surgical procedures for electrocoagulation and hemostasis. International regulatory approvals and clearances have been received for vaginal laxity and/or improvement in sexual function indications in more than 50 countries.

 

Viveve continues to advance its clinical development program in SUI. Recently reported FDA approved changes to the U.S. pivotal PURSUIT trial protocol are intended to strengthen the overall study and its potential to achieve its primary efficacy endpoint. Study changes including an increase in the trial's size and more strict patient selection criteria were a result of guidance from Viveve's Clinical Advisory Board upon review of positive results from the Company's SUI feasibility and preclinical studies. Viveve received FDA approval of its IDE application to conduct the multicenter, randomized, double-blinded, sham-controlled PURSUIT trial for improvement of SUI in women in July 2020 and FDA approval of its requested amendments to the IDE protocol as reported on December 10, 2020. Initiation of the trial was reported on January 21, 2021. If positive, results from the PURSUIT trial may support a new SUI indication in the U.S.

 

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 impact of the novel coronavirus termed COVID-19 on our clinical development and regulatory review and clearances and on the manufacturing, placements and patient utilization of our Viveve Systems, the performance of management and our employees, our ability to obtain financing, our evaluation of strategic alternatives, our ability to obtain approval or clearance for sale of our medical device for all indications sought, 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, unless required by law.

 

 

 

Viveve is a registered trademark of Viveve, Inc.

 

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