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): May 14, 2020

 

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 May 14, 2020, Viveve Medical, Inc. (the “Company”) issued a press release announcing its results for the quarter ended March 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.

 

 

 

Item 9.01.

Financial Statements and Exhibits.

 

(d) Exhibits

 

Exhibit

No.

  

Description

  

  

99.1

 

Press Release issued by the Company on May 14, 2020, announcing results for the quarter and fiscal year ended December 31, 2019, furnished herewith.

 

 

 

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: May 14, 2020 

Viveve Medical, Inc.

  

     

  

By:  

/s/ Scott Durbin

  

  

  

Scott Durbin 

  

  

  

Chief Executive Officer

  

 

 

 

 

Exhibit 99.1

 

Viveve Reports First Quarter 2020 Financial Results and Provides Corporate Update

 

-

First quarter continued to demonstrate success of the recurring revenue model

 

 

-

Organization focused on advancing stress urinary incontinence clinical strategy

 

 

-

Company to host conference call at 5:00 PM ET today

 

 

 

ENGLEWOOD, CO – May 14, 2020 – Viveve Medical, Inc. (NASDAQ: VIVE), a medical technology company focused on women's intimate health, today reported financial results for the quarter ended March 31, 2020, and will provide a corporate update on its scheduled conference call at 5:00 PM ET today.

 

During the first quarter of 2020, before the full public health and economic impact of the COVID-19 crisis was felt in the U.S., Viveve continued to demonstrate significant commercial traction of the new recurring revenue rental model in the U.S., advanced the clinical development programs for its proprietary Cryogen-cooled Monopolar Radiofrequency (CMRF) technology platform and implemented improved organizational and cost-efficient operations.

 

Q1 2020 and Recent Business Highlights

 

Reported $1.3 million total revenue for the first quarter 2020, bringing the installed base of Viveve® Systems to 849 systems worldwide;

 

Initiated and completed enrollment in the 3-arm stress urinary incontinence (SUI) feasibility study;

 

Resubmitted the Investigational Device Exemption (IDE) to the U.S. Food and Drug Administration (FDA) to conduct the new PURSUIT clinical trial in the United States for improvement of SUI in women;

 

Expanded commercial availability of the Viveve 2.0 next generation platform in Taiwan and Canada; and

 

Realigned the organization to reduce costs and secured additional capital to strengthen the balance sheet to ensure sustainability during the continuing COVID-19 crisis.

 

In April, Viveve implemented operational measures to reduce cash burn, reducing and refocusing the Company’s commercial organization to support existing customers while retaining the ability to re-scale swiftly in the future when market conditions improve. The Company is advancing its SUI clinical development program and is planning for important near-term clinical milestones including completion and data readout of the fully enrolled SUI 3-arm feasibility study in Canada targeted for late summer of this year and initiation of the PURSUIT SUI trial in the U.S. pending FDA approval of the resubmitted IDE as reported in April 2020.

 

“At all times, and especially as we face the challenge of the COVID-19 pandemic, I am very proud of the dedication and perseverance demonstrated by the talented individuals within the Viveve organization. Their health, safety, and well-being continue to be our priority during these challenging times. I am also confident that our collective belief in our CMRF technology’s ability to improve women’s intimate health conditions, specifically SUI, will help ensure Viveve’s continued progress in the coming months and beyond,” said Scott Durbin, Viveve’s chief executive officer.

 

 

 

Q1 2020 Financial Results

Revenue for the quarter ended March 31, 2020 totaled $1.3 million from the placement of 9 Viveve Systems in the U.S. and global sales of approximately 2,300 disposable treatment tips, compared to revenue of $3.0 million for the same period in 2019. As of March 31, 2020, the Company had an installed base of 849 Viveve Systems worldwide, 479 in the U.S. and 370 internationally.

 

Gross profit for the first quarter of 2020 was $175 thousand, or 13% of revenue, compared to gross profit of $1.1 million or 36% of revenue, for the same period in 2019.

 

Total operating expenses for the first quarter of 2020 were $6.0 million, compared to $9.1 million for the same period in 2019, which excludes a one-time restructuring charge of approximately $742,000. The decrease is mainly a result of sales cost reductions associated with the change to the recurring revenue rental model in June 2019 and the Company’s organizational realignment in early 2019.

 

Net loss attributable to common stockholders for the first quarter of 2020 was $7.3 million, or ($0.82) per share, compared to a net loss of $10.0 million, or ($21.63) per share, for the same period in 2019. All share and per share data have been adjusted to reflect the 1-for-100 reverse stock split on September 18, 2019.

 

Cash and cash equivalents were $9.0 million as of March 31, 2020, compared to $13.3 million as of December 31, 2019.

 

In April, Viveve also announced a successful warrant exercise with current company investors resulting in aggregate proceeds to the Company of approximately $3.1 million. This capital, together with the Company’s existing cash, strengthened Viveve’s balance sheet and provides the resources necessary to maintain the Company’s commercial business and advance the SUI clinical development strategy.

 

Conference Call Information

The Company will host a conference call and webcast at 5:00 PM ET today. 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/vive200514.html. Participants may also pre-register for the conference call at http://dpregister.com/10143564.

 

A recording of the webcast will be posted on the Company's investor relations website following the call at ir.viveve.com and will be 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 CMRF 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 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 and is conducting a short-term feasibility study under an Investigational Testing Application approved by the Canadian Ministry of Health. The feasibility study is a single-blind, three-arm study to compare Viveve's CMRF treatment and a cryogen-only sham to an inert sham treatment in order to capture short-term safety and effectiveness data on use of the Viveve System for the improvement of SUI in women. Subject enrollment in the study was completed in March 2020. Results of the SUI feasibility study are targeted for readout in late summer of 2020. If positive, the feasibility study results could support our initiation of our pivotal PURSUIT trial pending FDA’s approval of Viveve’s IDE application.

 

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, the outcome of our assessment of strategic alternatives, 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.

 

Investor Relations contacts:
Amato and Partners, LLC
Investor Relations Counsel
admin@amatoandpartners.com

Media contact:
Bill Berry
Berry & Company Public Relations
(212) 253-8881
bberry@berrypr.com

 

 

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands)

(unaudited)

 

   

March 31,

   

December 31,

 
   

2020

   

2019

 

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 9,042     $ 13,308  

Accounts receivable, net

    1,279       1,573  

Inventory

    4,459       4,861  

Prepaid expenses and other current assets

    2,204       2,447  

Total current assets

    16,984       22,189  

Property and equipment, net

    2,973       3,046  

Investment in limited liability company

    1,034       1,216  

Other assets

    441       526  

Total assets

  $ 21,432     $ 26,977  

LIABILITIES AND STOCKHOLDERS' EQUITY

               

Current liabilities:

               

Accounts payable

  $ 2,262     $ 1,608  

Accrued liabilities

    2,323       4,698  

Total current liabilities

    4,585       6,306  

Note payable, noncurrent portion

    4,110       3,983  

Other noncurrent liabilities

    186       167  

Total liabilities

    8,881       10,456  

Stockholders’ equity:

               

Capital stock and additional paid-in capital

    216,772       214,432  

Accumulated deficit

    (204,221 )     (197,911 )

Total stockholders’ equity

    12,551       16,521  

Total liabilities and stockholders’ equity

  $ 21,432     $ 26,977  

 

 

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(in thousands, except share and per share data)

(unaudited)

 

   

Three Months Ended

 
   

March 31,

 
   

2020

   

2019

 
                 

Revenue

  $ 1,304     $ 3,012  

Cost of revenue

    1,129       1,941  

Gross profit

    175       1,071  
                 

Operating expenses:

               

Research and development

    1,637       2,480  

Selling, general and administrative

    4,365       6,626  

Restructuring costs

    -       742  

Total operating expenses

    6,002       9,848  

Loss from operations

    (5,827 )     (8,777 )

Interest expense, net

    (210 )     (1,116 )

Other expense, net

    (91 )     (11 )

Net loss from consolidated companies

    (6,128 )     (9,904 )

Loss from minority interest in limited liability company

    (182 )     (125 )

Comprehensive and net loss

    (6,310 )     (10,029 )

Series B convertible preferred stock dividends

    (989 )     -  

Net loss attributable to common stockholders

  $ (7,299 )   $ (10,029 )
                 

Net loss per share of common stock:

               

Basic and diluted

  $ (0.82 )   $ (21.63 )
                 

Weighted average shares used in computing net loss per common share:

               

Basic and diluted

    8,930,744       463,719  

 

Note: All share and per share data has been adjusted to reflect the 1-for-100 reverse stock split which became effective after the Nasdaq Capital Market trading closed on September 18, 2019.