UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended SeptemberJune 30, 20212022

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from ______________ to _______________

 

Commission File Number 1-11388

 

VIVEVE MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

04-3153858

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

 

345 Inverness Drive South

Building B, Suite 250

Englewood, CO 80112

(Address of principal executive offices)

(Zip Code)

 

(720) 696-8100

(Registrant’s telephone number, including area code)     

 

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

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, smaller reporting company or an emerging growth company. See definition of “accelerated filer,” and “large accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):

 

Large accelerated filer ☐

Accelerated filer ☐

  

Non-accelerated filer ☒

Smaller reporting company ☒

  

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. ☐

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes ☐  No ☒

 

As of November 11, 2021,August 10, 2022, the issuer had 10,602,56010,665,042 shares of common stock, par value $0.0001 per share, outstanding.

 


 

 

TABLE OF CONTENTS

 

Note About Forward-Looking Statements

 
  

Page 

No.

PART I

FINANCIAL INFORMATION  

 
   

Item 1.

Condensed Consolidated Financial Statements (unaudited)

4

   

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

3127

   

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

4434

   

Item 4.

Controls and Procedures

4434

   

PART II

OTHER INFORMATION

 
   

Item 1.

Legal Proceedings

44

34

   

Item 1A.

Risk Factors

44

34

   

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

44

34

   

Item 3.

Defaults Upon Senior Securities

4535

   

Item 4.

Mine Safety Disclosures

4535

   

Item 5.

Other Information

4535

   

Item 6.

Exhibits

4535

   

SIGNATURES

4738

 


 

NOTE ABOUT FORWARD-LOOKING STATEMENTS 

 

This Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Quarterly Report other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A. "Risk Factors" in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.

 

You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results, performance or achievements may be materially different from what we expect. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.

 

Unless expressly indicated or the context requires otherwise, the terms "Viveve Medical," the "Company," "we," "us," and "our" in this document refer to Viveve Medical, Inc., a Delaware corporation, and, where appropriate, its wholly owned subsidiaries.

 


 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1. 

Financial Statements (unaudited)  

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(in thousands, except share and per share data)

(unaudited)

 

 

September 30,

 

December 31,

  

June 30,

 

December 31,

 
 

2021

  

2020

  

2022

  

2021

 

ASSETS

     (1)         

Current assets:

      

Cash and cash equivalents

 $22,665  $6,523  $9,431  $19,162 

Accounts receivable, net of allowance for doubtful accounts of $49 and $124 as of September 30, 2021 and December 31, 2020, respectively

 514  770 

Accounts receivable, net of allowance for doubtful accounts of $5 and $66 as of June 30, 2022 and December 31, 2021, respectively

 801  549 

Inventory

 2,150  3,254  1,599  1,472 

Prepaid expenses and other current assets

  2,083   2,296   1,407   1,055 

Total current assets

 27,412  12,843  13,238  22,238 

Property and equipment, net

 1,678  2,759  1,114  1,554 

Investment in limited liability company

 645  833 

Investment in unconsolidated limited liability company

 0  577 

Other assets

  649   195   1,136   1,544 

Total assets

 $30,384  $16,630  $15,488  $25,913 

LIABILITIES AND STOCKHOLDERS' EQUITY

                

Current liabilities:

      

Accounts payable

 $1,292  $881  $904  $1,480 

Accrued liabilities

 2,557  2,416  3,655  3,053 

Paycheck Protection Program loan, current portion

  0   918 

Note payable, current portion

  5,453   0 

Total current liabilities

 3,849  4,215  10,012  4,533 

Note payable, noncurrent portion

 4,964  4,518  0  5,124 

Paycheck Protection Program loan, noncurrent portion

 0  425 

Other noncurrent liabilities

  1,206   498   200   1,190 

Total liabilities

  10,019   9,656   10,212   10,847 

Commitments and contingences (Note 9)

             

Stockholders’ equity:

      

Convertible preferred stock; 10,000,000 shares authorized as of September 30, 2021 and December 31, 2020; Series B preferred stock, $0.0001 par value; 39,279 and 35,819 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

 0  0 

Series C preferred stock, $0.0001 par value; 0 shares issued and outstanding as of September 30, 2021 and outstanding as of September 30, 2021

 0  0 

Common stock, $0.0001 par value; 75,000,000 shares authorized as of September 30, 2021 and December 31, 2020; 10,602,560 and 2,171,316 shares issued and outstanding as of September 30, 2021 and December 31, 2020, respectively

 1  0 

Convertible preferred stock; 10,000,000 shares authorized as of June 30, 2022 and December 31, 2021; Series B preferred stock, $0.0001 par value; 43,069 and 40,504 shares issuedand outstanding as of June 30, 2022 and December 31, 2021, respectively

 0  0 

Series C preferred stock, $0.0001 par value; 0 shares issued and outstanding as of December 31, 2021

    - 

Common stock, $0.0001 par value; 75,000,000 shares authorized as of June 30, 2022 and December 31, 2021; 10,665,042 and 10,619,846 shares issued and outstanding as of June 30, 2022 and December 31, 2021, respectively

     

Additional paid-in capital

 255,889  226,800  258,813  256,918 

Accumulated deficit

  (235,525)  (219,826)  (253,538)  (241,853)

Total stockholders’ equity

  20,365   6,974   5,276   15,066 

Total liabilities and stockholders’ equity

 $30,384  $16,630  $15,488  $25,913 

 

(1)

The condensed consolidated balance sheet as of December 31, 2020 has been derived from the audited consolidated financial statements as of that date. 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 


 

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(in thousands, except share and per share data)

(unaudited)

 

 

Three Months Ended

 

Nine Months Ended

  

Three Months Ended

 

Six Months Ended

 
 

September 30,

  

September 30,

  

June 30,

  

June 30,

 
 

2021

  

2020

  

2021

  

2020

  

2022

  

2021

  

2022

  

2021

 
          

Revenue

 $1,616  $1,524  $4,720  $3,532  $1,795  $1,654  $3,436  $3,104 

Cost of revenue

  1,502   1,283   4,059   3,483   1,501   1,489   2,822   2,557 

Gross profit

  114   241   661   49   294   165   614   547 
          

Operating expenses:

          

Research and development

 2,695  884  6,804  3,745  1,921  2,180  4,061  4,110 

Selling, general and administrative

  2,911   2,761   9,423   10,476   3,393   2,930   7,046   6,511 

Total operating expenses

  5,606   3,645   16,227   14,221   5,314   5,110   11,107   10,621 

Loss from operations

 (5,492) (3,404) (15,566) (14,172) (5,020) (4,945) (10,493) (10,074)

Gain on forgiveness of Paycheck Protection Program loan

 0  0  1,358  0  0  1,358  0  1,358 

Modification of warrants

 0  0  (373) (1,838) 0  (86) 0  (373)

Interest expense, net

 (255) (235) (734) (668) (284) (245) (554) (479)

Other expense, net

  (78)  (41)  (196)  (159)  (40)  (53)  (61)  (118)

Net loss from consolidated companies

 (5,825) (3,680) (15,511) (16,837) (5,344) (3,971) (11,108) (9,686)

Loss from minority interest in limited liability company

  (33)  (55)  (188)  (323)

Impairment loss on investment in unconsolidated limited liability company

 (455) 0  (455) 0 

Loss from investment in unconsolidated limited liability company

  0   (79)  (122)  (155)

Comprehensive and net loss

 (5,858) (3,735) (15,699) (17,160) (5,799) (4,050) (11,685) (9,841)

Series B convertible preferred stock dividends

  (1,190)  (1,053)  (3,463)  (3,064)  (1,305)  (1,119)  (2,571)  (2,273)

Net loss attributable to common stockholders

 $(7,048) $(4,788) $(19,162) $(20,224) $(7,104) $(5,169) $(14,256) $(12,114)
          

Net loss per share of common stock:

          

Basic and diluted

 $(0.67) $(2.65) $(1.93) $(14.71) $(0.67) $(0.49) $(1.34) $(1.27)
          

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

          

Basic and diluted

  10,591,834   1,807,931   9,916,834   1,374,800   10,640,806   10,501,057   10,630,498   9,573,740 

 

Note: All share and per share data has been adjusted to reflect the 1-for-10 reverse stock split which became effective after market close on December 1, 2020, as discussed in Note 2.

 

The accompanying notes are an integral part of these condensed consolidated financial statements. 

 


 

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS EQUITY

(in thousands, except share and per share data)

(unaudited)

 

Series A Convertible

Preferred Stock,

$0.0001 par value

  

Series B Convertible

Preferred Stock,

$0.0001 par value

  

Common Stock,

$0.0001 par value

  

Additional

Paid-In

  Accumulated  

Total Stockholders

      

Series B Convertible

Preferred Stock

      

Series C Convertible

Preferred Stock

      Common Stock 

Paid-In

 

Accumulated

 

Stockholders

 
 

Shares

  

Amount

  

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Deficit

  

Equity

 

Shares

 

Amount

 

Shares

 

Amount

 

Shares

 

Amount

 

Capital

 

Deficit

 

Equity

 
                                      

Balances as of January 1, 2021

  0  $0   35,819  $0   2,171,316  $0  $226,800  $(219,826) $6,974 

January 2021 Offering, net issuance costs

  0   0   0   0  5,666,760  1  25,121   0  25,122 

Conversion of Series C convertible preferred stock into common stock

  0   0   0   0  2,450,880   0   0   0  0 

Issuance of common shares in connection with common warrant exercises

  0   0   0   0  52,760   0  179   0  179 

Modification of exercise price of warrants in connection with January 2021 Offering

  -   0   -   0   -   0  287   0  287 

Transaction costs in connection with Purchase Agreement with LPC

  -   0   -   0   -   0  (40)  0  (40)

Dividend on Series B convertible preferred stock

  -   0   -   0   -   0  (1,119)  0  (1,119)

Dividend on Series B convertible preferred stock paid in PIK shares

  0   0  1,118   0   0   0  1,118   0  1,118 

Stock-based compensation expense

  -   0  -   0   -   0  810   0  810 

Net loss

  -   0   -   0   -   0   0   (5,791)  (5,791)

Balances as of March 31, 2021

  0   0   36,937   0   10,341,716   1   253,156   (225,617)  27,540 

Issuance of purchased common shares under the Purchase Agreement with LPC

  0   0   0   0  250,000   0  704   0  704 

Transaction costs in connection with First Amendment to Purchase Agreement with LPC

  -   0   -   0   -   0  (31)  0  (31)

Modification of exercise price of warrants in connection with First Amendment to Purchase Agreement with LPC

                   

Purchase Agreement with LPC

  -   0   -   0   -   0  86   0  86 

Dividend on Series B convertible preferred stock

  -   0   -   0   -   0  (1,154)  0  (1,154)

Dividend on Series B convertible preferred stock paid in PIK shares

  0   0  1,153  0   0   0  1,153   0  1,153 

Stock-based compensation expense

  -   0  -  0   -   0  867   0  867 

Net loss

  -   0   -   0   -   0   0   (4,050)  (4,050)

Balances as of June 30, 2021

  0   0   38,090   0   10,591,716   1   254,781   (229,667)  25,115 

Balances as of January 1, 2022

 40,504 $0  0 $0  10,619,846 $1 $256,918 $(241,853)$15,066 

Dividend on Series B convertible preferred stock

  -   0   -   0   -   0  (1,190)  0  (1,190) -  0  -  0  -  0  (1,266) 0  (1,266)

Dividend on Series B convertible preferred stock paid in PIK shares

  0   0  1,189   0   0   0  1,189   0  1,189  1,263  0  0  0  0  0  1,263  0  1,263 

Stock-based compensation expense

  -   0   -   0   -   0  1,088   0  1,088  -  0  -  0  -  0  960  0  960 

Issuance of common shares from employee stock purchase plan

  0   0   0   0  10,844   0  21   0  21  0  0  0  0  20,691  0  19  0  19 

Net loss

  -   0   -   0   -   0   0   (5,858)  (5,858) -  0  -  0  -  0  0  (5,886) (5,886)

Balances as of September 30, 2021

  0  $0   39,279  $0   10,602,560  $1  $255,889  $(235,525) $20,365 

Balances as of March 31, 2022

 41,767  0  0  0  10,640,537  1  257,894  (247,739) 10,156 

Dividend on Series B convertible preferred stock

 -  0  -  0  -  0  (1,305) 0  (1,305)

Dividend on Series B convertible preferred stock paid in PIK shares

 1,302  0  0  0  0  0  1,302  0  1,302 

Stock-based compensation expense

 -  0  -  0  -  0  909  0  909 

Issuance of common shares from employee stock purchase plan

 0  0  0  0  24,505  0  13  0  13 

Net loss

 -  0  -  0  -  0  0  (5,799) (5,799)

Balances as of June 30, 2022

 43,069 $0  0 $0  10,665,042 $1 $258,813 $(253,538)$5,276 

 

6

 

 

 

 

 

 

 

Additional

    

Total

 
      Series B Convertible Preferred Stock      Series C Convertible Preferred Stock      Common Stock 

Paid-In

 

Accumulated

 

Stockholders

 
 

Shares

 

Amount

 

Shares

 

Amount

 

Shares

 

Amount

 

Capital

 

Deficit

 

Equity

 
                            

Balances as of January 1, 2021

 35,819 $0  0 $0  2,171,316 $0 $226,800 $(219,826)$6,974 

January 2021 Offering, net issuance costs

 0  0  0  0  5,666,760  1  25,121  0  25,122 

Conversion of Series C convertible preferred stock into common stock

 0  0  0  0  2,450,880  0  0  0  0 

Issuance of common shares in connection with common warrant exercises

 0  0  0  0  52,760  0  179  0  179 

Modification of exercise price of warrants in connection with January 2021 Offering

 -  0  -  0  -  0  287  0  287 

Transaction costs in connection with Purchase Agreement with LPC

 -  0  -  0  -  0  (40) 0  (40)

Dividend on Series B convertible preferred stock

 -  0  -  0  -  0  (1,119) 0  (1,119)

Dividend on Series B convertible preferred stock paid in PIK shares

 1,118  0  0  0  0  0  1,118  0  1,118 

Stock-based compensation expense

 -  0  -  0  -  0  810  0  810 

Net loss

 -  0  -  0  -  0  0  (5,791) (5,791)

Balances as of March 31, 2021

 36,937  0  0  0  10,341,716  1  253,156  (225,617) 27,540 

Issuance of purchased common shares under the Purchase Agreement with LPC

 0  0  0  0  250,000  0  704  0  704 

Transaction costs in connection with First Amendment to Purchase Agreement with LPC

 -  0  -  0  -  0  (31) 0  (31)

Modification of exercise price of warrants in connection with First Amendment to Purchase Agreement with LPC

                           

Purchase Agreement with LPC

 -  0  -  0  -  0  86  0  86 

Dividend on Series B convertible preferred stock

 -  0  -  0  -  0  (1,154) 0  (1,154)

Dividend on Series B convertible preferred stock paid in PIK shares

 1,153  0  0  0  0  0  1,153  0  1,153 

Stock-based compensation expense

 -  0  -  0  -  0  867  0  867 

Net loss

 -  0  -  0  -  0  0  (4,050) (4,050)

Balances as of June 30, 2021

 38,090 $0  0 $0  10,591,716 $1 $254,781 $(229,667)$25,115 

 

  

Series A Convertible

Preferred Stock,

$0.0001 par value

  

Series B Convertible

Preferred Stock,

$0.0001 par value

  

Common Stock,

$0.0001 par value

  

Additional

Paid-In

  Accumulated  

Total Stockholders

 
  

Shares

  

Amount

  

Shares

  

Amount

  

Shares

  

Amount

  

Capital

  

Deficit

  

Equity

 
                                     

Balances as of January 1, 2020

  185,218  $0   31,678  $0   707,571  $0  $214,431  $(197,911) $16,521 

Issuance costs in connection with November 2019 Offering

  -   0   -   0   -   0   (30)  0   (30)

Conversion of Series A convertible preferred stock into common stock

  (185,218)  0   0   0   185,218   0   0   0   0 

Issuance of common shares in connection with common warrant exercises

  0   0   0   0   107,172   0   1,661   0   1,661 

Series B convertible preferred stock dividends

  -   0   -   0   -   0   (990)  0   (990)

Series B convertible preferred stock dividends paid in PIK shares

  0   0   989   0   0   0   989   0   989 

Stock-based compensation expense

  -   0   -   0   -   0   686   0   686 

Issuance of common shares from employee stock purchase plan

  -   0   -   0   32   0   0   0   0 

Issuance of restricted common shares in connection with consulting agreement

  0   0   0   0   2,832   0   24   0   24 

Net loss

  -   0   -   0   -   0   0   (6,310)  (6,310)

Balances as of March 31, 2020

  0   0   32,667   0   1,002,825   0   216,771   (204,221)  12,551 

Issuance costs in connection with November 2019 Offering

  -   0   -   0   -   0   (3)  0   (3)

Issuance of common shares in connection with Series A and B warrant exercises

  0   0   0   0   514,578   0   3,139   0   3,139 

Modification of exercise price of warrants in connection with 2020 Warrant Offering

  -   0   -   0   -   0   1,838   0   1,838 

Issuance of Series A-2 and B-2 warrants in connection with 2020 Warrant Offering

  -   0   -   0   -   0   1,838   0   1,838 

Issuance costs for Series A-2 and B-2 warrants in connection with 2020 Warrant Offering

  -   0   -   0   -   0   (1,838)  0   (1,838)

Transaction costs in connection with 2020 Warrant Offering

  -   0   -   0   -   0   (326)  0   (326)

Issuance of initial purchase common shares under the Purchase Agreement with LPC

  0   0   0   0   52,500   0   341   0   341 

Issuance costs in connection with Purchase Agreement with LPC

  -   0   -   0   -   0   (452)  0   (452)

Series B convertible preferred stock dividends

  -   0   -   0   -   0   (1,021)  0   (1,021)

Series B convertible preferred stock dividends paid in PIK shares

  0   0   1,018   0   0   0   1,018   0   1,018 

Stock-based compensation expense

  -   0   -   0   -   0   632   0   632 

Issuance of common shares from employee stock purchase plan

  0   0   0   0   30   0   0   0   0 

Issuance of common shares for vesting of restricted stock award granted to consultant

  0   0   0   0   25   0   0   0   0 

Issuance of restricted common shares in connection with consulting agreement

  0   0   0   0   3,454   0   25   0   25 

Net loss

  -   0   -   0   -   0   0   (7,115)  (7,115)

Balances as of June 30, 2020

  0   0   33,685   0   1,573,412   0   221,962   (211,336)  10,627 

Issuance of common shares in connection with Series A and B warrant exercises

  0   0   0   0   494,113   0   3,014   0   3,014 

Issuance costs for Series A-2 and B-2 warrants in connection with 2020 Warrant Offering

  0   0   0   0   93,129   0   593   0   593 

Transaction costs in connection with 2020 Warrant Offering

  -   0   -   0   -   0   (7)  0   (7)

Transaction costs in connection with Purchase Agreement with LPC

  -   0   -   0   -   0   (42)  0   (42)

Dividend on Series B convertible preferred stock

  -   0   -   0   -   0   (1,053)  0   (1,053)

Dividend on Series B convertible preferred stock paid in PIK shares

  0   0   1,050   0   0   0   1,050   0   1,050 

Stock-based compensation expense

  -   0   -   0   -   0   617   0   617 

Issuance of common shares in connection with ESPP

  0   0   0   0   22   0   0   0   0 

Issuance of restricted common shares in connection with consulting agreement

  0   0   0   0   4,709   0   25   0   25 

Reverse stock split (December 2020) - rounding adjustment

  0   0   0   0   5,931   0   0   0   0 

Net loss

  -   0   -   0   -   0   0   (3,735)  (3,735)

Balances as of September 30, 2020

  0  $0   34,735   0   2,171,316  $0  $226,159  $(215,071) $11,089 

Note: All share and per share data has been adjusted to reflect the 1-for-10 reverse stock split which became effective after market close on December 1, 2020, as discussed in Note 2.

 

The accompanying notes are an integral part of these condensed consolidated financial statements. 

 


 

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(in thousands)

(unaudited)

 

 

Nine Months Ended

  

Six Months Ended

 
 

September 30,

  

June 30,

 
 

2021

  

2020

  

2022

  

2021

 
  

Cash flows from operating activities:

  

Net loss

 $(15,699) $(17,160) $(11,685) $(9,841)

Adjustments to reconcile net loss to net cash used in operating activities:

  

Provision for doubtful accounts

 104  335  (3) 89 

Depreciation and amortization

 884  965  392  636 

Stock-based compensation

 2,765  2,009  1,869  1,677 

Non-cash interest expense

 446  394  329  291 

Amortization of operating lease right-of-use assets and accretion of operating lease liabilities

 15  3  0  17 

Loss from minority interest in limited liability company

 188  323 
Impairment loss on investment in unconsolidated limited liability company 455  0 

Loss from investment in unconsolidated limited liability company

 122  155 

Loss on disposal of property and equipment

 40  14  19  9 

Modification of warrants

 373  1,838  0  373 

Forgiveness of Paycheck Protection Program loan

 (1,358) 0 

Gain on forgiveness of Paycheck Protection Program loan

 0  (1,358)

Changes in assets and liabilities:

  

Accounts receivable

 152  549  (249) (15)

Inventory

 1,423  233  10  855 

Prepaid expenses and other current assets

 213  683  (352) 308 

Other noncurrent assets

 (3) 444 

Other assets

 300  141 

Accounts payable

 411  (913) (576) (219)

Accrued and other liabilities

 71  (2,918)

Accrued liabilities

 577  (317)

Other noncurrent liabilities

  324   265   (863)  211 

Net cash used in operating activities

  (9,651)  (12,936)  (9,655)  (6,988)
  

Cash flows from investing activities:

  

Purchase of property and equipment

  (162)  (403)  (108)  (78)

Net cash used in investing activities

  (162)  (403)  (108)  (78)
  

Cash flows from financing activities:

  

Proceeds from January 2021 Offering, net of issuance costs

 25,122  0  0  25,122 

Proceeds from exercise of common warrants

 179  8,407  0  179 

Transaction costs in connection with 2020 Warrant Offering

 0  (333)

Proceeds from purchase of common shares under Purchase Agreement with LPC

 704  341  0  704 

Transaction costs in connection with Purchase Agreement with LPC

 (71) (494) 0  (71)

Proceeds from Paycheck Protection Program loan

 0  1,343 

Transaction costs in connection with November 2019 Offering

 0  (33)

Proceeds from issuance of common shares from employee stock purchase plan

  21   0   32   0 

Net cash provided by financing activities

  25,955   9,231   32   25,934 

Net increase (decrease) in cash and cash equivalents

 16,142  (4,108) (9,731) 18,868 
  

Cash and cash equivalents - beginning of period

  6,523   13,308   19,162   6,523 

Cash and cash equivalents - end of period

 $22,665  $9,200  $9,431  $25,391 
  

Supplemental disclosure:

        

Cash paid for interest

 $0  $0  $0  $0 

Cash paid for income taxes

 $0  $0  $0  $0 
  
  

Supplemental disclosure of cash flow information as of end of period:

        

Forgiveness of Paycheck Protection Program loan

 $1,358  $0  $0  $1,358 

Issuance of Series B convertible preferred stock in settlement of dividends

 $3,460  $3,057  $2,565  $2,271 

Issuance of note payable in settlement of accrued interest

 $443  $392  $327  $289 

Net transfer of equipment between inventory and property and equipment

 $(319) $37  $(137) $(233)

Supplemental cash flow information related to leases was as follows:

        

Operating cash outflows from operating leases

 $195  $226  $138  $126 

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 


 

VIVEVE MEDICAL, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

 

1.

The Company and Basis of Presentation

 

Viveve Medical, Inc. (“Viveve Medical”, the “Company”, “we”, “our”, or “us”) designs, develops, manufactures and markets a platform medical technology, which we refer to as Cryogen-cooled Monopolar RadioFrequency, or CMRF. (“CMRF”). Our proprietary CMRF technology is delivered through a radiofrequency generator, handpiece and treatment tip, which collectively, we refer to as the Viveve® System. Viveve Medical competes in the women’s intimate health industry in some countries by marketing the Viveve System as a way to improve the overall well-being and quality of life of women suffering from vaginal introital laxity, for improved sexual function, or stress urinary incontinence, depending on the relevant country-specific clearance or approval.  In the United States, the Viveve System is currently indicated for use in general surgical procedures for electrocoagulation and hemostasis.

 

Effective Shelf Registration Statement

 

On July 2, 2021, we filed a universal shelf registration statement with the SECSecurities and Exchange Commission (the “SEC”) on Form S-3 for the proposed offering from time to time of up to $75,000,000 of our securities, including common stock, preferred stock, and/or warrants. This registration statement currently has a capacity of $75,000,000. However, as a result of the limitations of General Instruction I.B.6. of Form S-3, or the so-called “baby shelf rules”,rules,” the amount of shares of our common stock available for sale under a registration statement on Form S-3 is limited to one-third of the aggregate market value of our common equity held by non- affiliatesnon-affiliates of the Company over any rolling 12-month period. As of SeptemberJune 30, 2021,2022, we have not issued any shares or received any proceeds pursuant to the universal shelf registration statement.

 

Purchase Agreement with LPC Reduction of Common Warrant Exercise Price

On January 19, 2021, the Company closed a public offering at an effective price of $3.40 per share of its common stock. As a result, the per share exercise price of our previously issued Series B, A-2 and B-2 common stock warrants was automatically reduced pursuant to the terms of the warrants. The exercise price for Series B warrants was reduced from $6.10 per share to $3.40 per share. The exercise price for Series A-2 and B-2 warrants was reduced from $6.371 per share to $3.40 per share. There was no change to the quantity of warrant shares. As a result of this reduction of warrant exercise price, the Company recognized a modification charge of $287,000.

In February and March 2021, a total of 40,000 shares of common stock were issued in connection with the exercise of Series B warrants for gross proceeds of approximately $136,000 and a total of 12,760 shares of common stock were issued in connection with the exercise of January 2021 warrants for gross proceeds of approximately $43,000.

 

On May 4, 2021, pursuant to the provisions under the Purchase Agreement as amended, LPC purchased 250,000 shares at $2.817 per share of the Company’s common stock. As a result, the per share exercise price of our previously issued Series B, A-2 and B-2 common stock warrants was automatically reduced from $3.40 to $2.817 pursuant to the terms of the warrants. There was no0 change to the quantity of warrant shares. As a result of this reduction of warrant exercise price, the Company recognized a modification charge of $86,000.

 

As of June 30, 2022, there were Series B warrants to purchase a total of 285,632 shares of common stock, Series A-2 warrants to purchase a total of 392,830 shares of common stock, and Series B-2 warrants to purchase a total of 20,380 shares of common stock still remaining and outstanding.

2021 Public Offering

 

On January 19, 2021, the Company closed an upsized underwritten public offering of units (the “January 2021 Offering”) for gross proceeds of approximately $27,600,000, which included the exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by Viveve.Viveve Medical.

 

8

The offering comprised of: (1)(1) 4,607,940 Class A Units, priced at a public offering price of $3.40 per Class A Unit, with each unit consisting of one1 share of common stock and one1 warrant to purchase one1 share of common stock, at an exercise price of $3.40 per share that expires on the fifth anniversary of the date of issuance; and (2) 2,450,880 Class B Units, priced at a public offering price of $3.40 per Class B Unit, with each unit consisting of one share of Series C convertible preferred stock and one warrant to purchase one share of common stock, at an exercise price of $3.40 per share that expires on the fifth anniversary of the date of issuance. The underwriter exercised an over-allotment option to purchase an additional 1,058,820 shares of common stock and warrants to purchase 1,058,820 shares of common stock in the offering. The net proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses payable by the Company, were approximately $25,122,000.

 

A total of 2,450,880 shares of Series C convertible preferred stock were issued in the January 2021 Offering. In January 2021, all Series C convertible preferred stock were converted into common stock and there are 0 remaining shares of Series C convertible preferred stock outstanding.

 

Warrants to purchase a total of 8,117,640 shares of common stock were issued in the January 2021 Offering. In February and March 2021, holders exercised January 2021 warrants to purchase 12,760 shares of common stock for aggregate exercise proceeds to the Company of approximately $43,000. As of SeptemberJune 30, 2021,2022, there were January 2021 warrants to purchase a total of 8,104,880 shares of common stock still remaining and outstanding.

 

9

Series C Convertible Preferred Stock

 

In connection with the closing of the January 2021 Offering, the Company filed the Certificate of Designation of Preferences, Rights and Limitations of Series C convertible preferred stock (the “Series C Certificate of Designation”) with the Secretary of State of the State of Delaware. The Series C Certificate of Designation provides for the issuance of the shares of Series C convertible preferred stock. The shares of Series C convertible preferred stock rank on par with the shares of the common stock, in each case, as to dividend rights and distributions of assets upon liquidation, dissolution or winding up of the Company.

 

With certain exceptions, as described in the Series C Certificate of Designation, the shares of Series C convertible preferred stock have no voting rights.

 

Each share of Series C convertible preferred stock is convertible at any time at the holder’s option into one1 share of common stock, which conversion ratio will be subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations and other similar transactions as specified in the Series C Certificate of Designation.

 

All Series C convertible preferred stock have been converted into common stock and there are 0 remaining shares outstanding.

 

November 2019 Offering Reduction of Warrant Exercise Price

On January 19, 2021, the Company closed a public offering at an effective price of $3.40 per share of its common stock. As a result, the per share exercise price of our previously issued Series B, A-2 and B-2 common stock warrants was automatically reduced pursuant to the terms of the warrants. The exercise price for Series B warrants was reduced from $6.10 per share to $3.40 per share. The exercise price for Series A-2 and B-2 warrants was reduced from $6.371 per share to $3.40 per share. There was no change to the quantity of warrant shares. As a result of this reduction of warrant exercise price, the Company recognized a modification charge of $287,000.

Elimination of Series AC Convertible Preferred Stock

 

On December 16, 2020,March 14, 2022, the Company filed a Certificate of Elimination (the “Certificate of Elimination”) with the Delaware Secretary of State with respect to 547,345the authorized shares of Series AC convertible preferred stock, par value $0.0001 per share. The Series A convertible preferred stock had been designated pursuant to the Certificate of Designation of Preferences, Rights and Limitations of Series A Convertible Preferred Stock filed with the Delaware Secretary of State on November 25, 2019. stock. As of the date of the filing of the Certificate of Elimination, 0 shares of Series AC convertible preferred stock were outstanding. Upon filing the Certificate of Elimination, the 547,3452,450,880 authorized shares of Series AC convertible preferred stock were returned to the status of authorized but unissued shares of preferred stock of the Company, without designation as to series or rights, preferences, privileges or limitations.

 

Purchase Agreement with Lincoln Park Capital, LLC

 

The Company previously entered into a purchase agreement on June 8, 2020,as amended on March 31, 2021 (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), which provided that the Company had the right, in its sole discretion, to sell to LPC, and LPC has committed to purchase from us, up to $10,000,000 of our common stock, subject to certain limitations, from time to time over a 30-month period pursuant to the terms of the Purchase Agreement. The Purchase Agreement limited the Company’s sale of shares of common stock to LPC to 301,762 shares of common stock (after giving effect to the Company’s reverse stock split in(See Note December 2020), 11representing 19.99% of the shares of the common stock outstanding on the date of the Purchase Agreement unless (i) shareholder approval was obtained to issue more than such amount or (ii) the average price of all applicable sales of common stock to LPC under the Purchase Agreement equaled or exceeded $6.46 per share (after giving effect to the Company’s reverse stock split). On June 9, 2020, LPC purchased 52,500 shares of common stock at a price per share of $6.50 (the “Initial Purchase Shares” – Common Stock.) under the Purchase Agreement for gross proceeds of approximately $341,000.

On March 31, 2021, the Company and LPC entered into a First Amendment to the Purchase Agreement. The amendment limited the Company’s sale of shares of common stock to LPC from the date thereof to 2,068,342 shares of shares of common stock, representing 19.99% of the shares of the common stock outstanding on the date of amendment unless (i) shareholder approval is obtained to issue more than such amount or (ii) the average price of all applicable sales of common stock to LPC under the Purchase Agreement, as amended equals or exceeds $2.99 per share. On May 4, 2021, LPC purchased 250,000 shares of common stock at price per share of $2.817 under the Purchase Agreement for gross proceeds of approximately $704,000.

 

As of SeptemberJune 30, 2021,2022, the equity facility with LPC has a remaining financing commitment of approximately $9,000,000.

 

The equity facility with LPC has a maturity date of January 9, 2023.

109

 

2020 Warrant Offering

On April 15, 2020, the Company reduced the exercise price of the outstanding Series A warrants and Series B warrants from $15.50 per share to $6.10 per share. On April 16, 2020, the Company entered into inducement letter agreements with certain institutional and accredited holders of Series A warrants and Series B warrants pursuant to which such holders agreed to exercise Series A warrants to purchase 482,059 shares of common stock and Series B warrants to purchase 24,279 shares of common stock for aggregate exercise proceeds to the Company of approximately $3,089,000. In conjunction, the Company also agreed to issue new Series A-2 warrants to purchase up to 482,059 shares of common stock as an inducement for the exercise of Series A warrants, and new Series B-2 warrants to purchase up to 24,279 shares of common stock as an inducement for the exercise of Series B warrants, in each case at an exercise price of $6.371 per share and for a term of five years. The transaction closed on April 20, 2020. Transaction costs in connection with the 2020 Warrant Offering totaled approximately $326,000. (See Note 11 – Common Stock for the calculation of the modification expense for the Series A and B warrants and the issuance of Series A-2 and B-2 warrants.) As of September 30, 2021, there were Series A-2 warrants to purchase a total of 392,830 shares of common stock and Series B-2 warrants to purchase a total of 20,380 shares of common stock still remaining and outstanding. 

Interim Unaudited Financial Information

 

The accompanying unaudited condensed consolidated financial statements of Viveve Medical have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the condensed consolidated financial statements have been included. 

 

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2020,2021, which was filed with the Securities and Exchange CommissionSEC on March 18, 2021.17, 2022. The results of operations for the ninethree and six months ended SeptemberJune 30, 20212022 are not necessarily indicative of the results for the year ending December 31, 20212022 or any future interim period.

 

Liquidity and Management Plans

The Company has adopted the Financial Accounting Standards Board’s (“FASB”) Accounting Standard Codification (“ASC”) Topic 205-40, Presentation of Financial Statements – Going Concern, which requires that management evaluate whether there are relevant conditions and events that, in the aggregate, raise substantial doubt about the entity’s ability to continue as a going concern and to meet its obligations as they become due within one year after the date that the financial statements are issued.

 

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. However, since inception, the Company has sustained significant operating losses and such losses are expected to continue for the foreseeable future. TheAs of June 30, 2022, the Company had an accumulated deficit of $235,525,000 as of September 30, 2021. Additionally, the Company used $9,651,000 in cash for operations in the nine months ended September 30, 2021. However, the Company's financing activities provided cash of $25,955,000 during the nine months ended September 30, 2021, including $25,122,000 in net proceeds from the January 2021 Offering, $633,000 in net proceeds from purchase of common shares under the Purchase Agreement with LPC, $179,000 in proceeds from the exercise of common warrants and $21,000 in proceeds from issuance of common shares from employee stock purchase plan. As of September 30, 2021, the Company had$253,538,000, cash and cash equivalents of $22,665,000$9,431,000 and working capital of $23,563,000. Accordingly, management expects that$3,226,000. The Company used cash of $9,655,000 in operations in the six months ended June 30, 2022. Additionally, the outstanding principal balance under the 2017 Loan Agreement was $5,453,000 as of June 30, 2022 and the term loan has a maturity date of March 31, 2023. As of the date our cash along withcondensed consolidated financial statements for the remaining equity financing commitment from LPC of approximately $9,000,000 will besix months ended June 30, 2022 were issued, the Company did not have sufficient cash to fund our activities for at leastits operations through August 31, 2023, without additional financing and, therefore, the nextCompany concluded there was substantial doubt about its ability to continue as a going concern within twelveone months through November 2022; however, we may require additional funds fromyear after the sale of equity or debt securities to fully implement our plan of operation.date the condensed consolidated financial statements were issued.

 

To fund further operations, the Company may will need to raise additional capital. The Company may obtain additional financing in the future through the issuance of its common stock, or through other equity or debt financings. The Company’s ability to continue as a going concern or meet the minimum liquidity requirements in the future is dependent on its ability to raise significant additional capital, of which there can be no assurance. If the necessary financing is not obtained or achieved, the Company will likely be required to reduce its planned expenditures, which could have an adverse impact on the results of operations, financial condition, and the Company’s ability to achieve its strategic objective. There can be no assurance that financing will be available on acceptable terms, or at all.  

 

Nasdaq Notice

On 11May 31, 2022,


the Company received a letter from the Listing Qualifications Department of The Nasdaq Stock Market stating that for the 30 consecutive business days prior to the date of the letter, it did not meet the minimum bid price of $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq has provided the Company with 180 calendar days, or until November 28, 2022, to regain compliance. Compliance can be achieved by meeting the minimum bid price of $1.00 for ten (10) consecutive trading days. In the event the Company does not regain compliance with the Nasdaq listing rules prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting.

In the event that the Company’s common stock is delisted from Nasdaq, trading of its common stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, the Company’s common stock, and there would likely also be a reduction in its coverage by security analysts and the news media, which could cause the price of the Company’s common stock to decline further. Also, it may be difficult for the Company to raise additional capital if it is not listed on a major exchange.

 

2.

Summary of Significant Accounting Policies

 

Financial Statement Presentation

 

The condensed consolidated financial statements include the accounts of the Company and our wholly-owned subsidiaries, Viveve, Inc. and Viveve BV. All significant intercompany accounts and transactions have been eliminated in consolidation.

 

Reverse Stock Split - December 2020

The Company effected a 1-for-10 reverse stock split of its common stock that became effective after market close on December 1, 2020. The reverse stock split uniformly affected all issued and outstanding shares of the Company’s common stock. The reverse stock split provided that every ten shares of the Company’s issued and outstanding common stock was automatically combined into one issued and outstanding share of common stock, without any change in par value per share. The number of authorized shares of common stock remained at 75,000,000 shares. 

As a result of the reverse stock split, proportionate adjustments were made to the per share exercise price and/or the number of shares issuable upon the exercise or vesting of all then outstanding stock options, deferred restricted stock awards and warrants, which will result in a proportional decrease in the number of shares of the Company’s common stock reserved for issuance upon exercise or vesting of such stock options, deferred restricted stock awards and warrants, and, in the case of stock options and warrants, a proportional increase in the exercise price of all such stock options and warrants. In addition, the number of shares reserved for issuance under the Company’s equity compensation plans immediately prior to the effective date will be reduced proportionately. The Company issued 5,931 shares of common stock as a result of this adjustment.

NaN fractional shares were issued as a result of the reverse stock split. Stockholders of record who would otherwise have been entitled to receive a fractional share were rounded up to the nearest whole number.

All of the share numbers, share prices, and exercise prices have been adjusted, on a retroactive basis, to reflect this 1-for-10 reverse stock split.

Use of Estimates

 

The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues,revenue, and expenses and the related disclosure of contingent assets and liabilities. We base our estimates on historical experience and on various other assumptions that we believe to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates. In addition, any change in these estimates or their related assumptions could have an adverse effect on our operating results. 

 

Cash and Cash Equivalents

 

The Company considers all highly liquid investments purchased with an original maturity of three months or less, at the time of purchase, to be cash equivalents. The Company’s cash and cash equivalents are deposited in demand accounts primarily at one1 financial institution. Deposits in this institution may, from time to time, exceed the federally insured amounts.

 

10

Concentration of Credit Risk and Other Risks and Uncertainties

 

To achieve profitable operations, the Company must successfully develop, manufacture, and market its products. There can be no assurance that any such products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed. These factors could have a material adverse effect upon the Company’s financial results, financial position, and future cash flows.

 

Most of the Company’s products to date require clearance or approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commencing commercial sales. There can be no assurance that the Company’s products will receive any of these required clearances or approvals or for the indications requested. If the Company was denied such clearances or approvals or if such clearances or approvals were delayed, it would have a material adverse effect on the Company’s financial results, financial position and future cash flows.

 

The Company is subject to risks common to companies in the medical device industry including, but not limited to, new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, product liability, and the need to obtain additional financing. The Company’s ultimate success is dependent upon its ability to raise additional capital and to successfully develop and market its products. 

 

12

The Company designs, develops, manufactures and markets a medical device that it refers to as the Viveve System, which is intended for the non-invasive treatment of vaginal introital laxity, for improved sexual function, for vaginal rejuvenation, for use in general surgical procedures for electrocoagulation and hemostasis, and stress urinary incontinence, depending on the relevant country-specific clearance or approval. The Viveve System consists of three main components: a radiofrequency generator housed in a table-top console, a reusable handpiece and a single-use treatment tip. Included with the system are single-use accessories (e.g. return pad, coupling fluid), as well as a cryogen canister that can be used for approximately four to five procedures, and a foot pedal. The Company outsources the manufacture and repair of the Viveve System to a single contract manufacturer.manufacturing partners. Also, certain other components and materials that comprise the device are currently manufactured by a single supplier or a limited number of suppliers. A significant supply interruption or disruption in the operations of the contract manufacturer or these third-party suppliers would adversely impact the production of our products for a substantial period of time, which could have a material adverse effect on our business, financial condition, operating results and cash flows. 

 

In North America,the United States, the Company sells its products primarily through a direct sales force to health care practitioners. Outside North America,the United States, the Company sells through an extensive network of distribution partners. During the three and ninemonths ended SeptemberJune 30, 2021,2022, one1 distributor accounted for 36% and 29% of the Company’s revenue, respectively.revenue. During the three andmonths ended nineJune 30, 2021, 1 distributor accounted for 34% of the Company’s revenue. During the six months ended SeptemberJune 30, 2020,2022, one1 distributor accounted for 40% and 45%35% of the Company’s revenue, respectively.revenue. During the six months ended June 30, 2021, 1 distributor accounted for 26% of the Company’s revenue.

 

As of SeptemberJune 30, 2021,2022, no customer1 distributor accounted for more than 10%39% of the Company’s accounts receivable, net. As of December 31, 2020,2021, one distributor1 direct customer accounted for 37%10% of total accounts receivable, net.

Accounts Receivable and Allowance for Doubtful Accounts

 

Accounts receivable are recorded at the invoiced amount and are not interest bearing. Our typical payment terms vary by region and type of customer (distributor or physician). Occasionally, payment terms of up to six months may be granted to customers with an established history of collections without concessions. Should we grant payment terms greater than six months or terms that are not in accordance with established history for similar arrangements, revenue would be recognized as payments become due and payable assuming all other criteria for revenue recognition have been met. The Company maintains an allowance for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for doubtful accounts. In determining the amount of the allowance, the Company makes judgments about the creditworthiness of customers based on ongoing credit evaluations and assesses current economic trends affecting its customers that might impact the level of credit losses in the future and result in different rates of bad debts than previously seen. The Company also considers its historical level of credit losses. The allowance for doubtful accounts was $49,000 as of September 30, 2021 and $124,000 as of December 31, 2020.

 

During the three month and ninesix months ended SeptemberJune 30, 2022, the Company wrote-off accounts receivable totaling approximately $30,000 and $58,000, respectively, primarily related to U.S. customers. During the three month and six months ended June 30, 2021, the Company wrote-off accounts receivable totaling approximately $115,000$64,000 and $179,000,$74,000, respectively, primarily related to U.S. customers. There were 0 write-offs of customers’ accounts receivable during the three months ended September 30, 2020. During the nine months ended September 30, 2020, the Company wrote-off accounts receivable totaling approximately $173,000 primarily related to Latin America distributors in connection with the Company’s shift in its international business model and the withdrawal from certain countries in Latin America.

 

11

Revenue from Contracts with Customers

 

Revenue consists primarily of the sale of the Viveve System, single-use treatment tips and ancillary consumables. The Company applies the following five steps: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when a performance obligation is satisfied. The Company considers customer purchase orders to be the contracts with a customer. Revenues,Revenue, net of expected discounts, are recognized when the performance obligations of the contract with the customer are satisfied and when control of the promised goods are transferred to the customer, typically when products, which have been determined to be the only distinct performance obligations, are shipped to the customer. Expected costs of assurance warranties and claims are recognized as expense. Revenue is recognized net of any sales taxes from the sale of the products.

 

13

Rental revenue is generated through the lease of the Viveve System. The Company’s operating leases for the Viveve System generally have a rental period of six6 to twelve12 months and can be extended or terminated by the customer after that time or the Viveve System could be purchased by the customer. Rental revenue on those operating leases is recognized on a straight-line basis over the terms of the underlying leases. The Company began this rental program in the quarter ended June 30, 2019. For the three and ninesix months ended SeptemberJune 30, 2022, rental revenue recognized during the period was $273,000 and $534,000, respectively. For the three and six months ended June 30, 2021, rental revenue recognized during the period was $261,000$323,000 and $950,000, respectively. For the three and nine months ended September 30, 2020, rental revenue recognized during the period was $471,000 and $829,000,$689,000, respectively. As of SeptemberJune 30, 20212022 and December 31, 2020,2021, the Company had deferred revenue in the amounts of $436,000$464,000 and $345,000,$452,000, respectively, related to its rental program, which is included in accrued liabilities on the condensed consolidated balance sheets. During the three and ninesix months ended SeptemberJune 30, 2022, the Company recognized revenue of $118,000 and $315,000 which was deferred as of December 31, 2021. During the three and six months ended June 30, 2021, the Company recognized revenue of $14,000$66,000 and $310,000$296,000 which was deferred revenue as of December 31, 2020.

Late in the first quarter of 2020 and through the third quarter of 2021, the negative impact of the COVID-19 pandemic on medical facilities and practitioners was in full effect in the United States. Federal, regional, and local government and public health agencies issued directives halting performance of non-essential medical treatments and elective procedures in an effort to combat the spread of the coronavirus and protect public health and safety. As a result, a large percentage of Viveve’s U.S. customers either temporarily closed their medical practices or dramatically reduced services and staff. The consequence has been both a public health and economic crisis that is continuing for existing and prospective Viveve customers. In a supportive partnership response, in the second quarter of 2020 Viveve contacted all of its subscription customers and provided them with a three-month deferral of the rental payment. Although clinics in various regions continue to re-open and gradually increase their limited services, we anticipate that until the COVID-19 pandemic abates, more practices re-open and elective patient’s safety concerns are reduced, that we will continue to experience reduced revenue from existing subscription customers, as well as a greatly reduced number of new and prospective customers. 

 

In connection with the lease of the Viveve System, the Company offers single-use treatment tips and ancillary consumables that are considered non-lease components. In the contracts with lease and non-lease components, the Company follows the relevant guidance in ASCAccounting Standards Codification 606, Revenue from Contracts with Customers, to determine how to allocate contractual consideration between the lease and non-lease components.

 

Sales of our products are subject to regulatory requirements that vary from country to country. The Company has regulatory clearance for differing indications, or can sell its products without a clearance, in many countries throughout the world, including countries within the following regions: North America, Asia Pacific, Europe, the Middle East and Latin America. In North America,the United States, we market and sell primarily through a direct sales force. Outside of North America,the United States, we market and sell primarily through distribution partners.

 

The Company does not provide its customers with a right of return.

 

Customer Advance Payments

 

From time to time, customers will pay for a portion of the products ordered in advance.  Upon receipt of such payments, the Company records the customer advance payment as a component of accrued liabilities.liabilities on the condensed consolidated balance sheets. The Company will remove the customer advance payment from accrued liabilities when revenue is recognized upon shipment of the products. 

 

Contract Assets and Liabilities

 

The Company continually evaluates whether the revenue generating activities and advanced payment arrangements with customers result in the recognition of contract assets or liabilities. NaN such assets existed as of SeptemberJune 30, 20212022, or December 31, 2020.2021. The Company had customer contract liabilities in the amount of $25,000$6,000 and $17,000$7,000 that performance had not yet been delivered to its customers as of SeptemberJune 30, 20212022 and December 31, 2020,2021, respectively. Contract liabilities are recorded in accrued liabilities on the condensed consolidated balance sheet.  sheets.

 

Separately, accounts receivable, net represents receivables from contracts with customers.

 

Significant Financing Component

 

The Company applies the practical expedient to not make any adjustment for a significant financing component if, at contract inception, the Company does not expect the period between customer payment and transfer of control of the promised goods or services to the customer to exceed one year. During the three and ninesix months ended SeptemberJune 30, 20212022, and 2020,the Company did not have any contracts for the sale of its products with its customers with a significant financing component. 

 

1412

 

Contract Costs 

 

The Company began its rental program in the quarter ended June 30, 2019. The Company expects that commissions paid to obtain subscriptions are recoverable and has therefore capitalized them as a contract cost in the amount of $53,000$48,000 and $32,000 at$84,000 as of SeptemberJune 30, 20212022 and December 31, 2020,2021, respectively. Capitalized commissions are amortized based on the subscription periods to which the assets relate and are included in selling, general and administrative expenses. For the three months ended SeptemberJune 30, 20212022 and 2020,2021, the amount of amortization was $13,000$20,000 and $58,000,$20,000, respectively. For the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, the amount of amortization was $47,000$37,000 and $538,000,$34,000, respectively. There was no impairment loss in relation to the costs capitalized. The Company has elected the practical expedient to recognize the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that the Company otherwise would have recognized is one year or less.

 

Shipping and Handling

 

Shipping costs billed to customers are recorded as revenue. Shipping and handling expense related to costs incurred to deliver product are recognized within cost of goods sold.revenue. The Company accounts for shipping and handling activities that occur after control has transferred as a fulfillment cost as opposed to a separate performance obligation, and the costs of shipping and handling are recognized concurrently with the related revenue. 

 

Revenue by Geographic Area

 

Management has determined that the sales by geography is a key indicator for understanding the Company’s financialsfinancial performance because of the different sales and business models that are required in the various regions of the world (including regulatory, selling channels, pricing, customers and marketing efforts). The following table presents the revenue from unaffiliated customers disaggregated by geographic area for the three and ninesix months ended SeptemberJune 30, 20212022 and 20202021 (in thousands):

 

 

Three Months Ended

 

Nine Months Ended

  

Three Months Ended

 

Six Months Ended

 
 

September 30,

  

September 30,

  

June 30,

  

June 30,

 
 

2021

  

2020

  

2021

  

2020

  

2022

  

2021

  

2022

  

2021

 
          

North America

 $939  $845  $2,857  $1,648  $1,101  $994  $1,871  $1,919 

Asia Pacific

 677  679  1,855  1,865  694  658  1,562  1,177 

Europe and Middle East

 0  0  8  5   0   2   3   8 

Latin America

  0   0   0   14 

Total

 $1,616  $1,524  $4,720  $3,532  $1,795  $1,654  $3,436  $3,104 

 

The Company determines geographic location of its revenue based upon the destination of the shipments of its products.

Investments in Unconsolidated Affiliates

 

The Company uses the equity method to account for its investments in entities that it does not control but havehas the ability to exercise significant influence over the investee. Equity method investments are recorded at original cost and adjusted periodically to recognize (1) the proportionate share of the investees’ net income or losses after the date of investment, (2) additional contributions made and dividends or distributions received, and (3) impairment losses resulting from adjustments to net realizable value. The Company eliminates all intercompany transactions in accounting for equity method investments. The Company records the proportionate share of the investees’ net income or losses in equityloss from investment in earnings of unconsolidated affiliateslimited liability company on the condensed consolidated statements of operations.operations and comprehensive loss. The Company utilizes a three-month lag in reporting equity income from its investments, adjusted for known amounts and events, when the investee’s financial information is not available timely or when the investee’s reporting period differs from our reporting period. 

 

The Company assesses the potential impairment of the equity method investments when indicators such as a history of operating losses, a negative earnings and cash flow outlook, and the financial condition and prospects for the investee’s business segment might indicate a loss in value. The carrying value of the investments is reviewed annually for changes in circumstances or the occurrence of events that suggest the investment may not be recoverable. NaNDuring the three and six months ended June 30, 2022, the Company recognized an impairment chargesloss charge on its investment in InControl Medical, LLC (“ICM”) of $455,000 which has been recorded in the condensed consolidated statements of operations and comprehensive loss. (See Note 4 – Investment in Unconsolidated Limited Liability Company.) During the three and six months ended June 30, 2021, 0 impairment losses have been recorded in the condensed consolidated statements of operations during the threeand nine months ended September 30, 2021 and 2020.comprehensive loss. 

 

13

Product Warranty

 

The Company’s products sold to customers are generally subject to warranties between one and three years, which provides for the repair rework or replacement of products (at the Company’s option) that fail to perform within stated specifications. The Company has assessed the historical claims and, to date, product warranty claims have not been significant.

15

Accounting for Stock-Based Compensation

 

Share-based compensation cost is measured at grant date, based on the fair value of the award, and is recognized as expense over the employee’s service period. The Company recognizes compensation expense on a straight-line basis over the requisite service period of the award.

 

The Company determined that the Black-Scholes option pricing model is the most appropriate method for determining the estimated fair value for stock options and purchase rights under the employee stock purchase plan. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions which determine the fair value of share-based awards, including the option’s expected term and the price volatility of the underlying stock.

 

Equity instruments issued to nonemployees are recorded in the same manner as similar instruments issued to employees. 

Comprehensive Loss

 

Comprehensive loss represents the changes in equity of an enterprise, other than those resulting from stockholder transactions. Accordingly, comprehensive loss may include certain changes in equity that are excluded from net loss. For the three and ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, the Company’s comprehensive loss is the same as its net loss. 

Net Loss per Share

 

The Company’s basic net loss per share is calculated by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share is computed by giving effect to all potentially dilutive common stock equivalents outstanding during the period. For purposes of this calculation, stock options and warrants to purchase common stock and restricted common stock awards are considered common stock equivalents. For periods in which the Company has reported net losses, diluted net loss per share is the same as basic net loss per share since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.

 

The following securities were excluded from the calculation of net loss per share because the inclusion would be anti-dilutive: 

 

 

Nine Months Ended

  

Six Months Ended

 
 

September 30,

  

June 30,

 
 

2021

  

2020

  

2022

  

2021

 
       

Convertible preferred stock:

       

Series A convertible preferred stock

(a) 0  0 

Series B convertible preferred stock

(b) 2,567,255  2,270,261  (a)2,814,967  2,489,542 

Series C convertible preferred stock

(c) 0  0  (b)0  0 

Warrants to purchase common stock

  9,793,599  1,771,088   9,793,599  9,793,599 

Stock options to purchase common stock

  3,195,742  975,605   4,124,009  3,188,628 

Deferred restricted common stock units

  679,000  0   674,000  684,000 

Deferred restricted common stock awards

  228  234   228  232 

 

 

(a)

Each share of Series A convertible preferred stock was convertible at any time at the holder's option into one share of common stock. As of September 30, 2020, all Series A convertible preferred stock had been converted into common stock and there were no remaining shares outstanding. In December 2020, the Company filed a Certificate of Elimination with the Delaware Secretary of State with respect to the authorized shares of Series A convertible preferred stock.

(b) 

As of SeptemberJune 30, 20212022 and 2020,2021, a total of 39,27943,069 and 34,73538,090 shares of Series B convertible preferred stock were outstanding and convertible into 2,567,2552,814,967 and 2,270,2612,489,542 shares of common stock, respectively. Each share of Series B convertible preferred stock is convertible at the holder's option into shares of common stock at a conversion ratio of 1-for-65.36 per share determined by dividing the Series B liquidation amount of $1,000 per share by the Series B conversion price of $15.30 per share. However, under the terms of the Series B Preferred Stock and Warrant Purchase Agreement, as amended, CRG LP (“CRG”) will not convert the Series B preferred stock or exercise the CRG warrants until the Company’s stockholders act to authorize additional number of shares of common stock sufficient to cover the conversion shares.

 

1614

 
 

(c) (b)

Each share of Series C convertible preferred stock iswas convertible at any time at the holder'sholder’s option into one1 share of common stock. As of September 30, 2021, allAll Series C convertible preferred stock had been converted into common stock and there are nowere 0 remaining shares outstanding. In March 2022, the Company filed a Certificate of Elimination with the Delaware Secretary of State with respect to the authorized shares of Series C convertible preferred stock outstanding.stock.

 

Recently Issued and Adopted Accounting Standards

 

In December 2019,June 2016, the FASBFinancial Standards Board issued Accounting Standards Update 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, as amended, which revises the measurement of credit losses for most financial instruments measured at amortized cost, including trade receivables, from an incurred loss methodology to an expected loss methodology which results in earlier recognition of credit losses. Under the incurred loss model, a loss is not recognized until it is probable that the loss-causing event has already occurred. The new standard introduces a forward-looking expected credit loss model that requires an estimate of the expected credit losses over the life of the instrument by considering all relevant information including historical experience, current conditions, and reasonable and supportable forecasts that affect collectability. The guidance in ASU 20192016-12,13 “Income Taxes (Topic 740). The amendments in this Update provide further simplification of accounting standards for the accounting for income taxes. Certain exceptions for are removed and requirements regarding the accounting for franchise taxes, tax basis of goodwill, and tax law rate changes are made. This guidance is effective for annual reporting periodsthe Company for financial statements issued for fiscal years beginning after December 15, 2020,2022 includingand interim periods within that reporting period,those fiscal years, with early adoption permitted. We adopted this guidance asThe Company is still evaluating the impact ofJanuary 1, 2021, and the adoption of the guidance did not have a significant impact on the condensed consolidated financial statements. this standard.

 

We have reviewed other recent accounting pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the condensed consolidated financial statements as a result of future adoption.

 

 

3.

Fair Value Measurements

 

The Company recognizes and discloses the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). Each level of input has different levels of subjectivity and difficulty involved in determining fair value.

 

 

Level 1

Inputs used to measure fair value are unadjusted quoted prices that are available in active markets for the identical assets or liabilities as of the reporting date. Therefore, determining fair value for Level 1 investments generally does not require significant judgment, and the estimation is not difficult.

 

 

Level 2

Pricing is provided by third party sources of market information obtained through investment advisors. The Company does not adjust for or apply any additional assumptions or estimates to the pricing information received from its advisors.

 

 

Level 3

Inputs used to measure fair value are unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions. The determination of fair value for Level 3 instruments involves the most management judgment and subjectivity.

 

Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability. 

 

There were no financial instruments that were measured at fair value on a recurring basis as of SeptemberJune 30, 20212022 and December 31, 2020.2021.

 

The carrying amounts of the Company’s financial assets and liabilities, including cash and cash equivalents, accounts receivable, accounts payable, and accrued expensesliabilities as of SeptemberJune 30, 2021,2022, and December 31, 20202021 approximate fair value because of the short maturity of these instruments. Based on borrowing rates currently available to the Company for loans with similar terms, the carrying value of the note payable approximates fair value. 

 

There were no changes in valuation techniques from prior periods.     

 

15

 

 

4.

Investment in Unconsolidated Limited Liability Company

 

On August 8, 2017, the Company entered into an exclusive Distributorship Agreement (the “Distributorship Agreement”) with InControl Medical, LLC (“ICM”),ICM, a Wisconsin limited liability company focused on women’s health, pursuant to which the Company will directly market, promote, distribute and sell ICM’s products to licensed medical professional offices and hospitals in North America.

17

Under the terms of the Distributorship Agreement, ICM agreed to not directly or indirectly appoint or authorize any third party to market, promote, distribute or sell any of the licensed products to any licensed medical professional offices and hospitals in the United States. In exchange, the Company agreed to not market, promote, distribute or sell (or contract to do so) any product which substantially replicates all or almost all of the key features of the licensed products. The terms of the Distribution Agreement also included a minimum purchase requirement to purchase a certain quantity of ICM products per month. In addition, the parties agreed to certain mutual marketing obligations to promote sales of the licensed products. During the three months ended September 30, 2021 and 2020, the Company has purchased 40 and 185 units of ICM products for approximately $5,000 and $26,000, respectively. During the nine months ended September 30, 2021 and 2020, the Company has purchased 140 and 425 units of ICM products for approximately $17,000 and $46,000, respectively. As of September 30, 2021, the Company has purchased approximately 5,425 units of ICM products. The Company paid ICM approximately $7,000 and $10,000 for product-related costs during the three months ended September 30, 2021 and 2020, respectively. The Company paid ICM approximately $17,000 and $30,000 for product-related costs during the nine months ended September 30, 2021 and 2020, respectively. There were 0 amounts due to ICM for the accounts payable as of September 30, 2021 and December 31, 2020.

 

In connection with the Distributorship Agreement, the Company also entered into a Membership Unit Subscription Agreement with ICM and the associated limited liability company operating agreement of ICM, pursuant to which the Company invested $2,500,000 in, and acquired membership units of, ICM. This investment has been recorded in investment in aan unconsolidated limited liability company inon the condensed consolidated balance sheets. The Company used the equity method to account for the investment in ICM because the Company does not control it but has the ability to exercise significant influence over it. As of SeptemberJune 30, 2021,2022, the Company ownedholds an approximately 7% ownership interest in ICM. The Company recognizes its allocated portion of ICM’s results of operations on a three-month lag due to the timing of financial information. For the three months ended SeptemberJune 30, 20212022 and 2020,2021, the allocated net loss from ICM’s operations was $33,000$0 and $55,000,$79,000, respectively. For the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, the allocated net loss from ICM’s operations was $188,000$122,000 and $323,000,$155,000, respectively.  The allocated net loss from ICM’s operations was recorded as loss from minority interestinvestment in unconsolidated limited liability company inon the condensed consolidated statements of operations.operations and comprehensive loss. 

 

In February 2019, the Company executed a mutual termination of the Distributorship Agreement with ICM. As a result, the Company no longer has a minimum purchase requirement to purchase a certain quantity of ICM products per month.   

 

As a result of a difficult business operating environment, which led to ICM laying off all of its employees and closing its office, and consideration of the financial results of ICM during the three and six months ended June 30, 2022, the Company recorded an impairment loss on investment in unconsolidated limited liability company on the condensed consolidated statements of operations and comprehensive loss in the amount of $455,000.

During the three and six months ended June 30, 2022 and 2021, the Company purchased 0 and 100 units of ICM products for approximately $0 and $12,000, respectively. Through June 30, 2022, the Company has purchased approximately 5,425 units of ICM products. The Company paid ICM $0 and $10,000 for product related costs during the three and six months ended June 30, 2022 and 2021, respectively. There were 0 amounts due to ICM for accounts payable as of June 30, 2022 and December 31, 2021.

 

 

5.

Accrued Liabilities

 

Accrued liabilities consisted of the following as of SeptemberJune 30, 20212022 and December 31, 20202021 (in thousands): 

 

  

September 30,

  

December 31,

 
  

2021

  

2020

 
         

Accrued bonuses

  786   744 

Accrued payroll and other related expenses

  435   473 

Deferred revenue - subscription rental program

  436   345 

Accrued clinical trial costs

  361   91 

Current operating lease liabilities

  214   132 

Accrued professional fees

  119   290 

Accrued sales commission

  43   37 

Accrued inventory

  0   87 

Other accruals

  163   217 

Total accrued liabilities

 $2,557  $2,416 

  

June 30,

  

December 31,

 
  

2022

  

2021

 
         

Accrued interest

 $1,102  $0 

Accrued bonuses

  606   1,209 

Accrued payroll and other related expenses

  545   495 

Deferred revenue - subscription rental program

  464   452 

Accrued clinical trial costs

  306   337 

Current operating lease liabilities

  244   225 

Accrued professional fees

  201   120 

Other accruals

  187   215 

Total accrued liabilities

 $3,655  $3,053 

 

 

6.

Note Payable

 

On May 22, 2017, the Company entered into a Term Loan Agreement as amended on December 12, 2017 and November 29, 2018 (collectively the “2017 Loan Agreement”) with affiliates of CRG LP (“CRG”).CRG. The credit facility consists of $20,000,000 drawn at closing and access to additional funding of up to an aggregate of $10,000,000 for a total of $30,000,000 available under the credit facility. On December 29, 2017, the Company accessed the remaining $10,000,000 available under the credit facility.

 

1816

 

In connection with the 2017 Loan Agreement, the Company issued two 10-year warrants to CRG to purchase a total of 223 shares of the Company’s common stock at an exercise price of $9,500.00 per share. (See Note 11 – Common Stock.)

Under the 2017 Loan Agreement, as in effect prior to the November 12, 2019 amendment, the credit facility had a six-year term with four years of interest-only payments after which quarterly principal and interest payments were to be due through the maturity date. Amounts borrowed under the 2017 Loan Agreement accrued interest at an annual fixed rate of 12.5%, 4.0% of which may, at the election of the Company, be paid in-kind during the interest-only period by adding such accrued amount to the principal loan amount each quarter. The Company was also required to pay CRG a final payment fee upon repayment of the loans in full equal to 5.0% of the sum of the aggregate principal amount plus the deferred interest added to the principal loan amount during the interest-only period. 

As collateral for its obligations under the 2017 Loan Agreement, the Company entered into security agreements with CRG whereby the Company granted CRG a lien on substantially all of the Company’s assets, including intellectual property.

The terms of the 2017 Loan Agreement also required the Company to meet certain financial and other covenants. The 2017 Loan Agreement also contained customary affirmative and negative covenants for a credit facility of this size and type.

On November 12, 2019, the Company and CRG amended the 2017 Loan Agreement (the “Amendment No. 3”). In connection with the amendment, the Company converted approximately $28,981,000 of the outstanding principal amount under the term loan plus accrued interest, the prepayment premium and the back-end facility fee for an aggregate amount of converted debt obligations of approximately $31,300,000. The debt obligations converted into 31,300 shares of the newly authorized Series B convertible preferred stock and warrants to purchase up to 989,379 shares of common stock were also issued. The warrants have a term of 5 years and an exercise price equal to 120% of the Series convertible B preferred stock conversion price of $15.30 or $18.36 per share. (See Note 11 – Common Stock.) CRG entered into a one year lock up-year lock-up agreement on all securities that it holds.

 

The Amendment No. 3 to the 2017 Loan Agreement addressed, among other things:

 

 

repayment provisions were amended such that repayment is permitted only with, or after, the redemption in full of the Series B convertible preferred stock issued to CRG;

 

 

the interest only payment period and the period during which the Company may elect to pay the full interest in PIKPaid In-Kind (“PIK”) interest payments was extended through the 23rd date after the first payment date. Pursuant to the amendment, CRG shall consent to the payment of such interest in the form of PIK loans, provided that (i) as of such payment date, no default shall have occurred and be continuing, and (ii) the principal amount of each PIK loan shall accrue interest in accordance with the provisions of the 2017 Loan Agreement;

 

 

modified certain of the covenants, including (i) to permit issuance of the Series B convertible preferred stock and any preferred stock issued in the equity financing and the exercise and performance by the Company of its rights and obligations in connection with such CRG preferred stock and any preferred stock issued in the equity financing, (ii) eliminate the Company’s ability to enter into permitted acquisitions, (iii) further restrict the incurrence of additional indebtedness and removal of the equity cure right, and (iv) eliminate the minimum revenue requirement; and

 

 

the back-end facility fee on the aggregate remaining principal balance on the term loan shall be increased from 5% to 25%.

 

Pursuant to the Amendment No.3,amendment, the Company paid interest in-kind of $154,000$167,000 and $443,000$327,000 during the three and ninesix months ended SeptemberJune 30, 20212022, which was added to the total outstanding principal loan amount. During the three and ninesix months ended SeptemberJune 30, 2020,2021, the Company paid interest in-kind of $136,000$148,000 and $443,000,$289,000, respectively, which was added to the total outstanding principal loan amount. Additionally, the back-end facility fee of $1,446,000 is due upon maturity, of which the Company had accrued $747,000 included in other noncurrent liabilities on the condensed consolidated balance sheet as of September 30, 2021.

 

As of SeptemberJune 30, 2021,2022, the Company was in compliance with all covenants. 

 

The term loan has a maturity date of March 31, 2023.

17

As of SeptemberJune 30, 20212022, and$5,453,000 was recorded on the condensed consolidated balance sheets, as note payable, current portion, which is net of the remaining unamortized debt discount. As December 31, 2020,2021, $4,964,000 and $4,518,000, respectively,5,124,000 was recorded on the condensed consolidated balance sheets, as note payable, noncurrent portion, which is net of the remaining unamortized debt discount. The term loan has a maturity date of March 31, 2023.

 

As of SeptemberJune 30, 2021,2022, future minimum payments under the note payable were as follows (in thousands): 

 

Year Ending December 31,

    

2021 (remaining 3 months)

 $0 

2022

 0 

2022 (remaining six months)

 $0 

2023

  5,992   5,992 

Total Payments

 5,992 

Total payments

 5,992 

Less: Amount representing interest

  (1,022)  (536)

Present value of obligations

 4,970  5,456 

Less: Unamortized debt discount

  (6)  (3)

Note payable, noncurrent portion

  4,964 

Note payable, current portion

 $5,453 

 

19

 

7.

Paycheck Protection Program Loan

 

The Paycheck Protection Program (“PPP”) was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration (“SBA”).Administration. On April 24, 2020, Viveve, Inc. (“Viveve”), a wholly-owned subsidiary of the Company, entered into a promissory note evidencing an unsecured loan in the aggregate amount of approximately $1,343,000 made to Viveve under the PPP (the “PPP Loan”). The PPP Loan to Viveve is beingwas made through Western Alliance Bank (“WAB”).Bank. The interest rate on the PPP Loan iswas 1.00% and the term iswas two years. In accordance with

On May 25, 2021, the updated Small Business guidance, the PPP Loan was modified so that, beginning ten months from the date of the PPP Loan, Viveve is required to make monthly payments of principal and interest. The promissory note evidencing the PPP Loan contains customary events of default relating to, among other things, payment defaults or breaching the terms of the PPP Loan documents. The occurrence of an event of default may result in the repayment of all amounts outstanding, collection of all amounts owing from Viveve, or filing suit and obtaining judgment against Viveve. Under the terms of the CARES Act, PPP Loan recipients can apply for and be granted forgiveness for all or a portion of the loan granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for payment of payroll costs and any payments of mortgage interest, rent, and utilities. No assurance is provided that Viveve will obtain forgivenessentire amount of the PPP Loan in whole or in part.

In October 2020, the Company was notified that the terms of its PPP Loan with WAB were modified. Theaggregate amount of time that$1,358,000, including the Company had to spend the proceeds of the PPP Loan (the “covered period”) was extended from 8 weeks to 24 weeks. The date to begin repaying unforgiven portions of the PPP Loan was also extended from six months after the funding date to up to 10 months after the end of the covered period (approximately 16 months from the funding date) depending on when the Company applies for forgiveness. The SBA will also cover interest on the forgiveness portion of the loan during this period. There was no change to the maturity date of the loan. All PPP Loans must be repaid or forgiven within two years after the funding date. The Company submitted its PPP Loan forgiveness application to the SBA in October 2020.

In May 2021, the Company was notified by WAB that its request for forgiveness of the PPP Loan had been approved in full. The total principal amount and the accrued interest through the forgiveness payment date of May 21, 2021, was forgiven. The Company has recognized a gain on the extinguishment of debt in the condensed consolidated statements of operations during the three months ended June 30, 2021 in the amount of $1,358,000.

 

 

8.

Leases

 

Lessee:

 

The following information pertains to those operating lease agreements where the Company is the lessee. 

 

OnIn February 1, 2017, the Company entered into a sublease agreement (the “Sublease”) for approximately 12,400 square feet of building space for the relocation of the Company’s corporate headquarters to Englewood, Colorado (the “Sublease Premises”), which was effective as of January 26, 2017. Colorado. The lease term commenced on June 1, 2017 and was to terminate in May 2021. The Company relocated its corporate headquarters from Sunnyvale, California to Englewood, Colorado in June 2017. 

The monthly base rent under the Sublease was equal to $20.50 per rentable square foot of the Sublease Premises during the first year. The monthly base rent was equal to $21.12 and $21.75 per rentable square foot during the second and third years, respectively.36 months. In connection with the execution of the Sublease,sublease, the Company also agreed to paypaid a security deposit of approximately $22,000. The Company was also providedentitled to an allowance of approximately $88,000 for certain tenant improvements relating to the engineering, design and construction of the Sublease Premises which has been reimbursed.  

sublease premises. The lease term commenced in June 2017 and was to terminate in May 2021. In March 2021, the Company amended the Subleasesublease for its office building space. The lease term was extended for a period of 34 months and will terminate on March 31, 2024.  The monthly gross rent for the first, second and third years of the lease extension is $21,028, $21,643 and $22,258 per month, respectively. The Company was also provided a rent abatement for the month of June 2021. Additionally, the sublandlord has agreed to perform certain construction, repair, maintenance or other tenant improvements to the Subleased Premisessubleased premises with estimated costs of approximately $19,000.

 

In September 2018,October 2020, the Company entered into a 36-month noncancelable operating lease agreement for office equipment. The lease term commenced onin September 20, 2018.December 2020 The monthly lease payment is approximately $3,000. and will terminate in December 2023.

 

Operating lease rentals are expensed on a straight-line basis over the life of the lease beginning on the date the Company takes possession of the property. At lease inception, the Company determines the lease term by assuming the exercise of those renewal options that are reasonably assured. The lease term is used to determine whether a lease is financing or operating and is used to calculate straight-line rent expense. Additionally, the depreciable life of leasehold improvements is limited by the expected lease term. Leases with an initial term of 12 months or less are not recorded on the condensed consolidated balance sheet; the Company recognizes lease expense for these leases on a straight-line basis over the lease term.

 

2018

 

The following table reflects the Company’s lease assets and lease liabilities atas of SeptemberJune 30, 20212022 and December 31, 20202021 (in thousands):

 

  

September 30,

  

December 31,

 
  

2021

  

2020

 
         

Assets:

        

Operating lease right-of-use assets

 $581  $130 
         

Liabilities:

        

Current operating lease liabilities

 $214  $132 

Noncurrent operating lease liabilities

  384   0 
  $598  $132 

  

June 30,

  

December 31,

 
  

2022

  

2021

 
         

Assets:

        

Operating lease right-of-use assets

 $426  $534 
         

Liabilities:

        

Current operating lease liabilities

 $244  $225 

Noncurrent operating lease liabilities

  200   327 
  $444  $552 

 

The operating lease right-of-use assets are included in other assets on the condensed consolidated balance sheets. The operating lease liabilities are included in accrued liabilities and other noncurrent liabilities on the condensed consolidated balance sheets.

 

The operating leaseslease expense for the three months ended SeptemberJune 30, 20212022 and 20202021 was $69,000 and $77,000,$69,000, respectively. The operating leases expense for the ninesix months ended SeptemberJune 30, 20212022 and 20202021 was $211,000$138,000 and $226,000,$149,000, respectively.

 

As of SeptemberJune 30, 2021,2022, the maturity of operating lease liabilities was as follows (in thousands):

 

Year Ending December 31,

    

2021 (remaining 3 months)

 $69 

2022

 279 

2022 (remaining six months)

 $142 

2023

 285  287 

2024

  67   67 

Total lease payments

 700  496 

Less: Amount representing interest

  (102)  (52)

Present value of lease liabilities

 $598  $444 

 

The weighted average remaining lease term was approximately 2921 months as of SeptemberJune 30, 2021.2022. The weighted average discount rate for the three months ended SeptemberJune 30, 20212022 was 12.5%.

 

Lessor:

 

The following information pertains to those operating lease agreements where the Company is the lessor. 

 

As of SeptemberJune 30, 2021,2022, minimum future rentals from customers on operating leases of Viveve Systems were as follows (in thousands):

 

Year Ending December 31,

    

2021 (remaining 3 months)

 $195 

Thereafter

  241 

Total

 $436 

Year Ending December 31,

    

2022 (remaining six months)

 $346 

2023

  118 

Total

 $464 

 

As of SeptemberJune 30, 2021,2022, $465,000 of property andthe Company included rental program equipment is related to these operating lease agreements.agreements with a net value of $397,000 in property and equipment, net on the condensed consolidated balance sheets. The depreciation expense for that property and equipment for the three and ninesix months ended SeptemberJune 30, 20212022 is $68,000was $55,000 and $273,000,$113,000, respectively. The depreciation expense for that property and equipment for the three and ninesix months ended SeptemberJune 30, 20202021, is $117,000was $60,000 and $345,000,$170,000, respectively.   

 

21

 

9.

Commitments and Contingencies

 

Indemnification Agreements

 

The Company enters into standard indemnification arrangements in the ordinary course of business. Pursuant to these arrangements, the Company indemnifies, holds harmless and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified party, in connection with performance of services within the scope of the agreement, breach of the agreement by the Company, or noncompliance of regulations or laws by the Company, in all cases provided the indemnified party has not breached the agreement and/or the loss is not attributable to the indemnified party’s negligence or willful malfeasance. The term of these indemnification agreements is generally perpetual any time after the execution of the agreement. The maximum potential amounts of future payments the Company could be required to make under these arrangements is not determinable. The Company has never incurred costs to defend lawsuits or settle claims related to these indemnification agreements. As a result, the Company believes the estimated fair value of these agreements is minimal. 

 

19

Loss Contingencies

 

The Company is or has been subject to proceedings, lawsuits and other claims arising in the ordinary course of business. The Company evaluates contingent liabilities, including threatened or pending litigation, for potential losses. If the potential loss from any claim or legal proceeding is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Because of uncertainties related to these matters, accruals are based upon the best information available. For potential losses for which there is a reasonable possibility (meaning the likelihood is more than remote but less than probable) that a loss exists, the Company will disclose an estimate of the potential loss or range of such potential loss or include a statement that an estimate of the potential loss cannot be made. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation and may revise its estimates, which could materially impact its condensed consolidated financial statements.  Management does not believe that the outcome of any outstanding legal matters will have a material adverse effect on the Company’s consolidated financial position, results of operations and cash flows.   

 

 

 

10.

Preferred Stock

 

Series A Convertible Preferred Stock

On December 16, 2020, the Company filed a Certificate of Elimination with the Delaware Secretary of State with respect to the authorized shares of Series A convertible preferred stock. As of the date of the filing of the Certificate of Elimination, 0 shares of Series A convertible preferred stock were outstanding. Upon filing the Certificate of Elimination, the 547,345 authorized shares of Series A convertible preferred stock were returned to the status of authorized but unissued shares of preferred stock of the Company, without designation as to series or rights, preferences, privileges or limitations.

Series B Convertible Preferred Stock

 

As previously reported (see Note 6 – Note Payable), the CRG debt obligations converted into 31,300 shares of the newly authorized Series B convertible preferred stock and warrants to purchase up to 989,379 shares of common stock were also issued.

 

In connection with the CRG debt conversion, on November 26, 2019, the Company filed the Certificate of Designation of Preferences, Rights and Limitations of Series B Convertible Preferred Stock (the “Series B Certificate of Designation”) with the Secretary of State of the State of Delaware. The Series B Certificate of Designation provides for the issuance of the shares of Series B convertible preferred stock. The holders of Series B convertible preferred stock are entitled to receive compounding dividends at a rate of 12.5% per annum payable quarterly at the Company’s option through additional paid in-kind shares of Series B convertible preferred stock or in cash. During the three months ended SeptemberJune 30, 2022, the Company paid a dividend in-kind of an additional 1,302 shares of Series B convertible preferred stock and a cash dividend of approximately $3,000 for the remaining fractional shares. During the three months ended June 30, 2021, the Company paid a dividend in-kind of an additional 1,1891,153 shares of Series B convertible preferred stock and a cash dividend of approximately $1,000 for the remaining fractional shares. During the ninesix months ended SeptemberJune 30, 2021,2022, the Company paid dividend in-kind of an additional 3,4602,565 shares of Series B convertible preferred stock and a cash dividend of approximately $4,000$6,000 for the remaining fractional shares. During the six months ended June 30, 2021, the Company paid dividend in-kind of an additional 2,271 shares of Series B convertible preferred stock and a cash dividend of approximately $2,000 for the remaining fractional shares. The Company has issued a total of 7,97911,769 shares of Series B convertible preferred stock and paid approximately $14,000$22,000 in cash as preferred dividenddividends to the holders of Series B convertible preferred stock through SeptemberJune 30, 2021.2022.

 

As of SeptemberJune 30, 20212022 and December 31, 2020,2021, there were 39,27943,069 and 35,81940,504 shares of Series B convertible preferred stock outstanding and convertible into 2,567,2552,814,967 and 2,341,1112,647,320 shares of common stock, respectively. Each share of Series B convertible preferred stock is convertible at the holder's option into shares of common stock at a conversion ratio of 1-for-65.36 per share determined by dividing the Series B liquidation amount of $1,000 per share by the Series B conversion price of $15.30 per share. However, under the terms of the Series B Preferred Stock and Warrant Purchase Agreement, as amended, CRG will not convert the Series B preferred stock or exercise the CRG warrants until the Company’s stockholders act to authorize additional number of shares of common stock sufficient to cover the conversion shares.

 

22

The shares of Series B convertible preferred stock have no voting rights and rank senior to all other classes and series of our equity in terms of repayment and certain other rights. 

 

20

The Series B convertible preferred stock also provides that for so long as any shares are outstanding, the consent of the holders of the Series B convertible preferred stockholders would be required to amend the Company’s organizational documents, approve any merger, sale of assets, or other major corporate transaction, or incur additional indebtedness, among other items. 

 

Series C Convertible Preferred Stock

 

In connection with the closing of the public offering, on January 19, 2021, the Company filed the Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (the “Series C Certificate of Designation”) with the Secretary of State of the State of Delaware. The Series C Certificate of Designation provides for the issuance of the shares of Series C convertible preferred stock. The shares of Series C convertible preferred stock rank on par with the shares of the common stock, in each case, as to dividend rights and distributions of assets upon liquidation, dissolution or winding up of the Company.

 

With certain exceptions, as described in the Series C Certificate of Designation, the shares of Series C convertible preferred stock have no voting rights.

 

Each share of Series C convertible preferred stock is convertible at any time at the holder’s option into one share of common stock, which conversion ratio will be subject to adjustment for stock splits, stock dividends, distributions, subdivisions and combinations and other similar transactions as specified in the Series C Certificate of Designation.

 

A total of 2,450,880 shares of Series C convertible preferred stock were issued in the January 2021 Offering. In January 2021, all Series C convertible preferred stock were converted into common stock and there are 0 remaining shares of Series C convertible preferred stock outstanding.

 

On March 14, 2022, the Company filed a Certificate of Elimination with the Delaware Secretary of State with respect to the authorized shares of Series C convertible preferred stock. As of the date of the filing of the Certificate of Elimination, 0 shares of Series C convertible preferred stock were outstanding. Upon filing the Certificate of Elimination, the 2,450,880 authorized shares of Series C convertible preferred stock were returned to the status of authorized but unissued shares of preferred stock of the Company, without designation as to series or rights, preferences, privileges or limitations.

 

 

11.

Common Stock

 

Purchase Agreement with Lincoln Park Capital, LLC

 

On June 8, 2020, theThe Company previously entered into the Purchase Agreement with LPC, which provided that the Company had the right, in its sole discretion, to sell to LPC, and LPC has committed to purchase from us up to $10,000,000 of our common stock, subject to certain limitations, from time to time over a 30-month period pursuant to the termsterm of the Purchase Agreement.

The Purchase Agreement limited the Company’s sale of shares of common stock to LPC to 301,762 shares of common stock, (after giving effect to the Company’s reverse stock split in December 2020), representing 19.99% of the shares of the common stock outstanding on the date of the Purchase Agreement unless (i) shareholder approval was obtained to issue more than such amount or (ii) the average price of all applicable sales of common stock to LPC under the Purchase Agreement equaled or exceeded $6.46 per share (after giving effect to the Company’s reverse stock split), which represented the lower of (a) the closing price of our common stock on the Nasdaq Capital Market immediately preceding the date of the Purchase Agreement or (b) the average of the closing price of the common stock on the Nasdaq Capital Market for the five business days immediately preceding the date of the Purchase Agreement, as calculated in accordance with Nasdaq Rules.share. On June 9, 2020, LPC purchased 52,500 shares of common stock at a price per share of $6.50 (the “Initial Purchase Shares”) under the Purchase Agreement for gross proceeds of approximately $341,000. Transaction costs in connection with the Purchase Agreement with LPC totaled approximately $494,000.

 

On March 31, 2021, the Company and LPC entered into the first amendment to the Purchase Agreement. The amendment limited the Company’s sale shares of common stock to LPC from the date thereof to 2,068,342 shares of shares of common stock, representing 19.99% of the shares of the common stock outstanding on the date of amendment unless (i) shareholder approval is obtained to issue more than such amount or (ii) the average price of all applicable sales of common stock to LPC under the Purchase Agreement, as amended equals or exceeds $2.99 per share, which represents the lower of (a) the closing price of the common stock on the Nasdaq Capital Market immediately preceding the date of the Amendment or (b) the average of the closing prices of our common stock on the Nasdaq Capital Market for the five business days immediately preceding the date of the Amendment, as calculated in accordance with Nasdaq Rules. Transaction costs in connection with the amendment to Purchase Agreement with LPC totaled approximately $70,000.

On May 4, 2021, pursuant to the provisions under the Purchase Agreement as amended, LPC purchased 250,000 shares of common stock at price per share of $2.817 for gross proceeds of approximately $704,000.

 

21

On June 23, 2021, the Company’s stockholders approved the proposal for the potential issuance of 20% or more of the Company’s outstanding common stock to LPC pursuant to the provisions under the Purchase Agreement, as amended.

As of SeptemberJune 30, 2021,2022, the equity facility with LPC has a remaining financing commitment of approximately $9,000,000.

 

The equity facility with LPC has a maturity date of 23January 9, 2023.


2021 Public Offering

 

On January 19, 2021, the Company closed an upsized underwritten public offering of units (thethe January 2021 Offering”)Offering for gross proceeds of approximately $27,600,000, which included the exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by Viveve.Viveve Medical.

 

The offering comprised of: (1) 4,607,940 Class A Units, priced at a public offering price of $3.40 per Class A Unit, with each unit consisting of one1 share of common stock and one1 warrant to purchase one1 share of common stock, at an exercise price of $3.40 per share that expires on the fifth anniversary of the date of issuance; and (2) 2,450,880 Class B Units, priced at a public offering price of $3.40 per Class B Unit, with each unit consisting of one1 share of Series C convertible preferred stock and one1 warrant to purchase one1 share of common stock, at an exercise price of $3.40 per share that expires on the fifth anniversary of the date of issuance. The underwriter exercised an over-allotment option to purchase an additional 1,058,820 shares of common stock and warrants to purchase 1,058,820 shares of common stock in the offering. The net proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses payable by the Company, were approximately $25,122,000.

 

A total of 2,450,880 shares of Series C convertible preferred stock were issued in the January 2021 Offering. In January 2021, all Series C convertible preferred stock were converted into common stock and there are 0 remaining shares of Series C convertible preferred stock outstanding.

 

Warrants to purchase a total of 8,117,640 shares of common stock were issued in the January 2021 Offering. In February and March 2021, holders exercised January 2021 warrants to purchase 12,760 shares of common stock for aggregate exercise proceeds to the Company of approximately $43,000. As of SeptemberJune 30, 2021,2022, there were January 2021 warrants to purchase a total of 8,104,880 shares of common stock still remaining and outstanding.

 

Restricted Common Shares

 

There were 0 restricted common shares issued during the ninethree and six months ended SeptemberJune 30, 2022 and 2021.

The activity of restricted common shares during the nine months ended September 30, 2020 is described as follows:

In September 2020, the Company issued 47,090 restricted shares of its common stock at an aggregate value of approximately $25,000.

In June 2020, the Company issued 3,453 restricted shares of its common stock at an aggregate value of approximately $25,000.

In March 2020, the Company issued 2,832 restricted shares of its common stock at an aggregate value of approximately $24,000.

 

2422

 

Warrants for Common Stock

 

As of SeptemberJune 30, 2021,2022, outstanding warrants to purchase shares of common stock were as follows: 

 

         

Number of

 
         

Shares

 
         

Outstanding

 
  

Exercisable

 

Expiration

 

Exercise

 

Under

 

Issuance Date

 

for

 

Date

 

Price

 

Warrants

 
            

February 2015

 

Common Shares

 

February 17, 2025

 $4,000.00  79 

March 2015

 

Common Shares

 

March 26, 2025

 $2,720.00  2 

May 2015

 

Common Shares

 

May 12, 2025

 $4,240.00  37 

December 2015

 

Common Shares

 

December 16, 2025

 $5,600.00  31 

April 2016

 

Common Shares

 

April 1, 2026

 $6,080.00  25 

June 2016

 

Common Shares

 

June 20, 2026

 $4,980.00  101 

May 2017

 

Common Shares

 

May 25, 2027

 $9,500.00  223 

November 2019

 

Common Shares

 

November 26, 2024

 $18.36  989,379 

November 2019

 

Common Shares

 

November 26, 2024

 $2.82  285,632 

April 2020

 

Common Shares

 

April 21, 2025

 $2.82  413,210 

January 2021

 

Common Shares

 

January 19, 2026

 $3.40  8,104,880 
          9,793,599 

 

In connection with the 2017 Loan Agreement, the Company issued warrants to purchase a total of 223 shares of common stock at an exercise price of $9,500.00 per share. The warrants have a contractual life of ten years and are exercisable immediately in whole or in part. The fair value of the warrants, along with financing and legal fees, are recorded as debt issuance costs and presented inon the condensed consolidated balance sheets as a deduction from the carrying amount of the note payable. The debt issuance costs are amortized to interest expense over the loan term. During the three and ninesix months ended SeptemberJune 30, 2021,2022, the Company recorded $1,000 and $3,000,$2,000, respectively, of interest expense relating to the debt issuance costs using the effective interest method. During the three and ninesix months ended SeptemberJune 30, 2020,2021, the Company recorded $1,000 and $2,000, respectively, of interest expense relating to the debt issuance costs using the effective interest method. As of SeptemberJune 30, 2021,2022, the unamortized debt discount was $6,000.

In February 2020, a total of 102,626 shares of common stock were issued in connection with the exercise of Series A warrants for gross proceeds of approximately $1,591,000, and a total of 4,548 shares of common stock were issued in connection with the exercise of Series B warrants for gross proceeds of approximately $70,000. $3,000.

 

In connection with the January 2021 Offering, warrants to purchase up to 8,117,640 shares of common stock were issued in the offering. The warrants to purchase one1 share of common stock have an exercise price of $3.40 per share and expiresexpire on the fifth anniversary of the date of issuance.

 

OnAs a result of the closing of the January 19, 2021 the Company closed a public offeringOffering at an effective price of $3.40 per share, of its common stock. As a result, the per share exercise price of our previously issued Series B, A-2 and B-2 common stock warrants was automatically reduced pursuant to the terms of the warrants. The exercise price for Series B warrants was reduced from $6.10 per share to $3.40 per share. The exercise price for Series A-2 and B-2 warrants was reduced from $6.371 per share to $3.40 per share. There was no change to the quantity of warrant shares. The Company determined the incremental fair value on Series B, A-2 and B-2 warrants due to the reduction of exercise price on the date of such modification to be approximately $287,000 using the Black-Scholes option pricing model. Assumptions used were as follows: 

 

 

Immediately

 

Immediately

 
 

Immediately

 

Immediately

  before  After 

Series B Warrants

 

before

Modification

  

After

Modification

  

Modification

  

Modification

 
  

Exercise price

 $6.10  $3.40  $6.10  $3.40 

Common stock price

 $3.19  $3.19  $3.19  $3.19 

Expected term (in years)

 3.9  3.9  3.9  3.9 

Average volatility

 90% 90% 90% 90%

Risk-free interest rate

 0.33% 0.33% 0.33% 0.33%

Dividend yield

 0% 0% 0% 0%

  

Immediately

  

Immediately

 
  before  After 

Series A-2 and B-2 Warrants

 

Modification

  

Modification

 
         

Exercise price

 $6.37  $3.40 

Common stock price

 $3.19  $3.19 

Expected term (in years)

  4.3   4.3 

Average volatility

  90%  90%

Risk-free interest rate

  0.33%  0.33%

Dividend yield

  0%  0%

 

2523

 
  

Immediately

  

Immediately

 

Series A-2 and B-2 Warrants

 

before

Modification

  

After

Modification

 
         

Exercise price

 $6.37  $3.40 

Common stock price

 $3.19  $3.19 

Expected term (in years)

  4.3   4.3 

Average volatility

  90%  90%

Risk-free interest rate

  0.33%  0.33%

Dividend yield

  0%  0%

On May 4, 2021, pursuant to the provisions under the Purchase Agreement as amended, LPC purchased 250,000 shares at $2.817 per share of the Company’s common stock. As a result, the per share exercise price of our previously issued Series B, A-2 and B-2 common stock warrants was automatically reduced from $3.40 to $2.817 pursuant to the terms of the warrants. There was no change to the quantity of warrant shares. The Company determined the incremental fair value on Series B, A-2 and B-2 warrants due to the reduction of exercise price on the date of such modification to be approximately $86,000 using the Black-Scholes option pricing model. Assumptions used were as follows:

 

 

Immediately

 

Immediately

 
 

Immediately

 

Immediately

  before  After 

Series B, A-2 and B-2 Warrants

 

before

Modification

  

After

Modification

  

Modification

  

Modification

 
  

Exercise price

 $3.40  $2.82  $3.40  $2.82 

Common stock price

 $3.01  $3.01  $3.01  $3.01 

Expected term (in years)

 3.6  3.6  3.6  3.6 

Average volatility

 80% 80% 80% 80%

Risk-free interest rate

 0.58% 0.58% 0.58% 0.58%

Dividend yield

 0% 0% 0% 0%

 

The incremental fair value of the Series B, A-2 and B-2 warrants is recorded asincluded in other expense, net on the condensed consolidated statements of operations and ascomprehensive loss, with a corresponding increase to additional paid-in capital.capital on the condensed consolidated balance sheets.

 

In February 2021, a total of 40,000 shares of common stock were issued in connection with the exercise of Series B warrants for gross proceeds of approximately $136,000 and a total of 8,760 shares of common stock were issued in connection with the exercise of January 2021 warrants for gross proceeds of approximately $30,000.

 

In March 2021, a total of 4,000 shares of common stock were issued in connection with the exercise of January 2021 warrants for gross proceeds of approximately $13,000.

 

NaN shares issuable pursuant to warrants have been cancelled during the three and six months ended June 30, 2022 and 2021.

NaN shares issuable pursuant to warrants expired during the three and six months ended June 30, 2022. A total of 6 shares issuable pursuant to warrants expired during the three and six months ended June 30, 2021

As of SeptemberJune 30, 2021,2022, there were 0 Series A warrants remaining to purchase shares of common stock and Series B warrants to purchase a total of 285,632 shares of common stock still remaining and outstanding.

 

As of SeptemberJune 30, 2021,2022, there were Series A-2 warrants to purchase a total of 392,830 shares of common stock and Series B-2 warrants to purchase a total of 20,380 shares of common stock still remaining and outstanding.

 

As of SeptemberJune 30, 2021,2022, there were January 2021 warrants to purchase a total of 8,104,880 shares of common stock still remaining and outstanding.

NaN shares issuable pursuant to warrants have been cancelled during the three and nine months ended September 30, 2021.

NaN shares issuable pursuant to warrants expired during the three months ended September 30, 2021. A total of 6 shares issuable pursuant to warrants expired during the nine months ended September 30, 2021. NaN shares issuable pursuant to warrants expired during the three months ended September 30, 2020. A total of 22 shares issuable pursuant to warrants expired during the nine months ended September 30, 2020.

 

 

 

12.

Summary of Stock Options

 

Stock Option Plans

 

The Company has issued equity awards in the form of stock options (both incentive stock options and non-qualified stock options) and deferred restricted stock awards or units, from two employee benefit plans. The plans include the Viveve Amended and Restated 2006 Stock Plan (the “2006 Plan”) and the Company’s Amended and Restated 2013 Stock Option and Incentive Plan (the “2013 Plan”).

 

26

As of SeptemberJune 30, 2021,2022, there were outstanding stock option awards issued from the 2006 Plan covering a total of 12 shares of the Company’s common stock and 0 shares are available for future awards. The weighted average exercise price of the outstanding stock options is $9,920.00 per share and the weighted average remaining contractual term is 1.30.6 years.

 

24

InEffective January 2021,1, 2022, the total common stock reserved for issuance under the 2013 Plan was increased by 307,7051,076,833 shares from 1,451,2463,940,136 shares to a total of 1,758,9515,016,969 shares under the evergreen provision of the 2013 Plan.

 

In June 2021, the Company’s stockholders approved an amendment to the 2013 Plan to increase the number of shares of common stock reserved for issuance thereunder from 1,758,951 to a total of 3,940,136 shares.

As of SeptemberJune 30, 2021,2022, there were outstanding stock option awards issued from the 2013 Plan covering a total of 3,195,7304,123,997 shares of the Company’s common stock and there remain reserved for future awards 66,753220,319 shares of the Company’s common stock. The weighted average exercise price of the outstanding stock options is $7.48$6.03 per share and the remaining contractual term is 9.38.8 years. 

 

Activity under the 2006 Plan and the 2013 Plan is as follows: 

 

  

Number

  

Average

  

Remaining

  

Aggregate

 
  

of

  

Exercise

  

Contractual

  

Intrinsic

 
  

Shares

  

Price

  

Term (years)

  

Value

 

Options outstanding, beginning of period

  986,399  $19.10   -  $- 

Options granted

  2,251,000  $2.73         

Options exercised

  0   0         

Options canceled

  (41,657) $23.35         

Options outstanding, end of period

  3,195,742  $7.52   9.3  $0 
                 

Vested and exercisable and expected to vest, end of period

  2,932,744  $7.88   9.3  $0 
                 

Vested and exercisable, end of period

  581,757  $23.17   8.5  $0 
  

Six Months Ended June 30, 2022

 
          

Weighted

     
      

Weighted

  

Average

     
  

Number

  

Average

  

Remaining

  

Aggregate

 
  

of

  

Exercise

  

Contractual

  

Intrinsic

 
  

Shares

  

Price

  

Term (years)

  

Value

 

Options outstanding, January 1, 2022

  3,173,103  $7.51   9.0  $0 

Options granted

  955,000  $1.25         

Options exercised

  0   0         

Options canceled

  (4,094) $7.69         

Options outstanding, June 30, 2022

  4,124,009  $6.06   8.8  $0 
                 

Vested and exercisable and expected to vest, June 30, 2022

  3,873,550  $6.29   8.8  $0 
                 

Vested and exercisable, June 30, 2022

  1,266,335  $13.10   8.3  $0 

 

The aggregate intrinsic value reflects the difference between the exercise price of the underlying stock options and the Company’s closing share price as of SeptemberJune 30, 2021.2022. 

 

The options outstanding and exercisable as of SeptemberJune 30, 20212022 were as follows:

 

           

Weighted

                  

Weighted

        
   

Number

 

Weighted

 

Average

 

Number

 

Weighted

   

Number

 

Weighted

 

Average

 

Number

 

Weighted

 
   

Outstanding

 

Average

 

Remaining

 

Exercisable

 

Average

   

Outstanding

 

Average

 

Remaining

 

Exercisable

 

Average

 

Range of

Range of

 

as of

 

Exercise

 

Contractual

 

as of

 

Exercise

 

Range of

as of

 

Exercise

 

Contractual

 

as of

 

Exercise

 

Exercise Prices

Exercise Prices

 

September 30, 2021

  

Price

  

Term (Years)

  

September 30, 2021

  

Price

 

Exercise Prices

June 30, 2022

  

Price

  

Term (Years)

  

June 30, 2022

  

Price

 
                          
$0.71

-

$1.26 955,000  $1.25  9.5  98,024  $1.26 

$2.28

-$2.96 2,224,354  $2.73  9.7  130,533  $2.73 

-

$2.96 2,207,000  $2.73  9.0  544,316  $2.73 

$3.06

-$3.40 10,000  $3.20  9.5  0  $0 

-

$3.40 10,000  $3.20  8.7  3,146  $3.20 

$4.45

-$4.80 11,900  $4.72  9.2  1,219  $4.80 

-

$4.80 11,900  $4.72  8.4  4,576  $4.71 

$5.10

-$5.40 88,000  $5.28  9.0  50,875  $5.40 

-

$5.40 88,000  $5.28  8.3  62,907  $5.34 

$6.90

-$6.90 5,400  $6.90  8.5  2,026  $6.90 

-

$6.90 5,400  $6.90  7.8  3,038  $6.90 

$8.60

-$8.91 837,150  $8.69  8.1  384,272  $8.69 

-

$8.91 827,800  $8.69  7.4  533,718  $8.69 

$10.90

-$13.60 15,500  $12.64  8.4  9,678  $12.99 

-

$13.60 15,500  $12.64  7.7  13,209  $12.94 

$380.00

-$9,920.00  3,438  $2,876.47  6.5   3,154  $2,968.91 

-

$9,920.00 3,409  $2,878.01   5.8   3,401  $2,882.61 

Total:

    3,195,742  $7.52  9.3   581,757  $23.17 

 

  4,124,009  $6.06   8.8  1,266,335  $13.10 

 

Deferred Restricted Stock Units

 

As of SeptemberJune 30, 2021,2022, there are 679,000674,000 shares of unvested restricted stock outstanding that have been granted by the Company pursuant to deferred restricted stock units (“RSUs”) under the 2013 Plan.

During the three and six months ended June 30, 2022, 0 RSUs for shares of common stock were granted by the Company.

 

2725

 

In January 2021, the Company granted annual equity awards to employees and board members for 690,000 shares of common stock issuable upon vesting of RSUs under the 2013 Plan. The RSUs vest in full on the second anniversary of the grant date.

 

During the three and ninesix months ended SeptemberJune 30, 2021,2022, RSUs for 5,000 and 11,000 shares of common stock were cancelled, respectively.

There were 0 RSUs for shares of common stock granted bywere cancelled. During the Company during the ninethree and six months ended SeptemberJune 30, 2021.2021, RSUs for 3,000 and 6,000 shares of common stock under the 2013 Plan were cancelled, respectively.

 

Deferred Restricted Stock Awards

 

As of SeptemberJune 30, 2021,2022, there are 228 shares of unvested restricted stock outstanding that have been granted by the Company pursuant to deferred restricted stock awards (“RSAs”) under the 2013 Plan.

 

During the three and ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, 0 RSAs for shares of common stock were granted by the Company.

 

During the three and sixmonths ended SeptemberJune 30, 2021,2022, 40 RSAs for shares of common stock were cancelled. During the nine months ended September 30, 2021, RSAs for 6 shares of common stock were cancelled.

During the three months ended SeptemberJune 30, 2020,2021, 150 RSAs for shares of common stock under the 2013 Plan were cancelled. During the ninesix months ended SeptemberJune 30, 2020,2021, RSAs for 432 shares of common stock under the 2013 Plan were cancelled.

 

2017 Employee Stock Purchase Plan

 

In September 2020, the board of directors approved the suspension of the Company’s 2017 Employee Stock Purchase Plan (the “2017 ESPP”) following the twelfth offering period and the ESPP purchase on September 30, 2020.

The activity of the Company’s 2017 ESPP for the nine months ended September 30, 2020 is described as follows:

The tenth offering period under the Company’s 2017 ESPP began on January 1, 2020 and ended on March 31, 2020, and 32 shares were issued on March 31, 2020 at a purchase price of $5.86.

The eleventh offering period under the Company’s 2017 ESPP began on April 1, 2020 and ended on June 30, 2020, and 30 shares were issued on June 30, 2020 at a purchase price of $4.79.

The twelfth offering period under the Company’s 2017 ESPP began on July 1, 2020, and ended on September 30, 2020, and 22 shares were issued on September 30, 2020 at a purchase price of $4.44.

 

In June 2021, the Company’s stockholders approved an amendment to the 2017 ESPP to increase the number of shares of common stock reserved for issuance thereunder from 400 to 500,378 shares and to increase the number of shares available in an offering period from 2 to 2,000 per participant (subject to adjustment in the event of certain changes to the Company’s capital structure and other similar events).

 

Following the Company’s annual stockholders’ meeting, the board of directors approved to reactivate the ESPP effective with the offering period beginning on July 1, 2021. 

 

The activity of the Company’s 2017 ESPP for the ninethree and six months ended SeptemberJune 30, 20212022 is described as follows:

 

 

The thirteenthfifteenth offering period under the Company’s 2017 ESPP began on JulyJanuary 1, 2021,2022, and ended on September 30, 2021,March 31, 2022, and 10,84420,691 shares were issued on September 30, 2020March 31, 2022 at a purchase price of $1.94.$0.90 per share.

The sixteenth offering period under the Company’s 2017 ESPP began on April 1, 2022, and ended on June 30, 2022, and 24,505 shares were issued on June 30, 2022 at a purchase price of $0.56 per share.

 

The Company estimated the fair value of purchase rights under the2017 ESPP using the Black-Scholes option valuation model and the straight-line attribution approach.

 

As of SeptemberJune 30, 2021,2022, the remaining shares available for issuance under the 2017 ESPP were 489,156426,674 shares.

 

28

Stock-Based Compensation

 

During the three months ended SeptemberJune 30, 2022, the Company granted stock options to employees and nonemployees to purchase 14,000 shares of common stock with a weighted average grant date fair value of $0.53 per share. During the three months ended June 30, 2021, the Company granted stock options to employees and nonemployees to purchase 30,4002,213,600 shares of common stock with a weighted average grant date fair value of $1.60$1.87 per share. During the threesix months ended SeptemberJune 30, 2020,2022, the Company granted stock options to employees and nonemployees to purchase 55,000955,000 shares of common stock with a weighted average grant date fair value of $3.60$0.92 per share. During the ninesix months ended SeptemberJune 30, 2021, the Company granted stock options to employees and nonemployees to purchase 2,251,0002,200,600 shares of common stock with a weighted average grant date fair value of $1.75 per share. During the nine months ended September 30, 2020, the Company granted stock options to employees and nonemployees to purchase 101,800 shares of common stock with a weighted average grant date fair value of $53.25$1.87 per share.

 

26

The Company estimated the fair value of stock options using the Black-Scholes option pricing model. The fair value of stock options is being amortized on a straight-line basis over the requisite service period of the awards. The fair value of stock options granted was estimated using the following weighted average assumptions: 

 

 

Three Months Ended

 

Nine Months Ended

  

Three Months Ended

 

Six Months Ended

 
 

September 30,

  

September 30,

  

June 30,

  

June 30,

 
 

2021

  

2020

  

2021

  

2020

  

2022

  

2021

  

2022

  

2021

 
          

Expected term (in years)

 5  5  6  5  6  6  6  6 

Average volatility

 84% 87% 76% 81% 89% 83% 88% 83%

Risk-free interest rate

 0.81% 0.27% 0.97% 0.34% 2.94% 0.98% 1.45% 0.98%

Dividend yield

 0% 0% 0% 0% 0% 0% 0% 0%

 

Option-pricing models require the input of various subjective assumptions, including the option’s expected life and the price volatility of the underlying stock. The expected stock price volatility is based on analysis of the Company’s stock price history over a period commensurate with the expected term of the options, trading volume of comparable companies’ stock, look-back volatilities and the Company specific events that affected volatility in a prior period. The expected term of stock options represents the weighted average period the stock options are expected to remain outstanding and is based on the history of exercises and cancellations on all past option grants made by the Company, the contractual term, the vesting period and the expected remaining term of the outstanding options. The risk-free interest rate is based on the U.S. Treasury interest rates whose term is consistent with the expected life of the stock options. NaN dividend yield is included as the Company has not issued any dividends and does not anticipate issuing any dividends in the future.  

 

The following table shows stock-based compensation expense for options, RSUs and ESPP shares included in the condensed consolidated statements of operations for the three and ninesix months ended SeptemberJune 30 20212022 and 20202021 (in thousands):

 

 

Three Months Ended

 

Nine Months Ended

  

Three Months Ended

 

Six Months Ended

 
 

September 30,

  

September 30,

  

June 30,

  

June 30,

 
 

2021

  

2020

  

2021

  

2020

  

2022

  

2021

  

2022

  

2021

 
  

Cost of revenue

 $76  $42  $191  $163  $64  $60  $129  $115 

Research and development

 131  78  330  250  120  102  243  200 

Selling, general and administrative

  881   522   2,244   1,596   725   705   1,497   1,362 

Total

 $1,088  $642  $2,765  $2,009  $909  $867  $1,869  $1,677 

 

As of SeptemberJune 30, 2021,2022, the total unrecognized compensation cost in connection with unvested stock options was approximately $6,618,000.$5,401,000. These costs are expected to be recognized over a period of approximately 2.952.6 years.   

 

The fair value of the RSUs is determined on the grant date based on the fair value of the Company’s common stock. The fair value of the RSUs is recognized as expense ratably over the vesting period of two years. For the three and ninemonths ended SeptemberJune 30, 2022 and 2021,the stock-based compensation expense for RSUs was $272,000$274,000 and $771,000,$276,000, respectively.  For the six months ended June 30, 2022 and 2021, the stock-based compensation expense for RSUs was $548,000 and $500,000, respectively.  

 

As of SeptemberJune 30, 2021,2022, the total unrecognized compensation cost in connection with unvested RSUs was approximately $1,436,000.$603,000. These costs are expected to be recognized over a period of approximately 1.250.6 years.  

 

For the three and ninesix months ended SeptemberJune 30, 2021,2022, the stock-based compensation expense for ESPP shares was not significant.  $8,000 and $15,000 respectively.

 

29

 

13.

Income Taxes

 

NaN provision for income taxes has been recorded due to the net operating losses incurred from inception to date, for which no0 benefit has been recorded.

 

For interim periods, the Company estimates its annual effective income tax rate and applies the estimated rate to the year-to-date income or loss before income taxes. The Company also computes the tax provision or benefit related to items reported separately and recognizes the items net of their related tax effect in the interim periods in which they occur. The Company also recognizes the effect of changes in enacted tax laws or rates in the interim periods in which the changes occur.

 

27

The Company’s effective tax rate is 0% for the three and sixmonths ended SeptemberJune 30, 20212022 and 2020.2021. The Company expects that its effective tax rate for the full year 20212022 will be 0%.

The Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) was enacted on March 27, 2020 in the United States. The CARES Act includes several significant provisions for corporations, including the usage of net operating losses and payroll benefits. The Company is evaluating the impact, if any, the CARES Act and other economic stimulus measures will have on the Company’s financials and disclosures. 

 

 

 

14.

Related Party Transactions

 

In June 2006, the Company entered into a Development and Manufacturing Agreement (the “Agreement”) with Stellartech Research Corporation (“Stellartech”). The Agreement was amended on October 4, 2007. The Company’s first generation Viveve System which consists of a generator, handpiece and disposable treatment tip was designed and manufactured by Stellartech. Stellartech was the sole source supplier for this version of the Viveve System. Under the Agreement, the Company agreed to purchase 300 generators manufactured by Stellartech. As of September 30, 2021, the Company has purchased 855 units. The price per unit iswas variable and dependent on the volume and timing of units ordered. The Company purchased 855 units through September 2019. The Company no longer manufacture generators, handpieces or disposable treatment tips at Stellartech. However, the Company continues to have technology licenses with Stellartech. In conjunction with the Agreement, Stellartech purchased 38 shares of Viveve, Inc.’s common stock. Under the Agreement, the Company paid Stellartech $50,000approximately $0 and $199,000$77,000 for goods and services during the three months ended SeptemberJune 30, 20212022 and 2020,2021, respectively and approximately $203,000$0 and $948,000$154,000 for the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, respectively. The amounts due to Stellartech for accounts payable as of SeptemberJune 30, 20212022 and December 31, 20202021 were approximately $1,000was $0 and $9,000,$0, respectively.

 

30


 

Item 2.

Managements Discussion and Analysis of Financial Condition and Results of Operations.

 

You should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report and with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2020,2021, as filed with the Securities and Exchange Commission on March 18, 2021.17, 2022. In addition to historical condensed consolidated financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in Part II, Item 1A. Risk Factors.

 

Overview of Our Business

 

In the discussion below, when we use the terms “we”, “us” and “our”, we are referring to Viveve Medical, Inc. and our wholly-owned subsidiaries, Viveve, Inc. and Viveve BV.

 

We design, develop, manufacture and market a platform medical technology, which we refer to as Cryogen-cooled Monopolar Radiofrequency or CMRF. (“CMRF”). Our proprietary CMRF technology is delivered through a radiofrequency generator,RF, handpiece and treatment tip that, collectively, we refer to as the Viveve® System. The Viveve System is currently marketed and sold for a number of indications, depending on the relevant country-specific clearance or approval. Currently, the Viveve System is cleared for marketing in 5048 countries throughout the world under the following indications for use:   

 

Indication for Use:

No. of

Countries:

General surgical procedures for electrocoagulation and hemostasis

4

3 (including the U.S.)

General surgical procedures for electrocoagulation and hemostasis of vaginal tissue and for the treatment of vaginal laxity

29

For treatment of vaginal laxity

5

For treatment of the vaginal introitus, after vaginal childbirth, to improve sexual function

9

General surgical procedures for electrocoagulation and hemostasis as well asand for the treatment of vaginal laxity

1

For vaginal rejuvenation

1

For treatment of vaginal laxity, and to improve mild urinary incontinence and sexual function

1

 

In the U.S., the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis and we market and sell primarily through a direct sales force. Outside the U.S., we primarily market and sell through distribution partners. As of SeptemberJune 30, 2021,2022, we have a global installed base of 870905 Viveve Systems and we have sold approximately 58,30066,400 single-use treatment tips worldwide. 

Because the revenues we have earned to date have not been sufficient to support our operations, we have relied on sales of our securities, bank term loans and loans from related parties to fund our operations.

 

We are subject to risks, expenses and uncertainties frequently encountered by companies in the medical device industry. These risks include, but are not limited to, intense competition, whether we can be successful in obtaining the U.S. Food and Drug Administration (“FDA”) and other governmental clearance or approval for the sale of our product for all desired indications and whether there will be a demand for the Viveve System, given that the cost of the procedure will likely not be reimbursed by the government or private health insurers. In addition, we will continue to require substantial funds to support our clinical trials and fund our efforts to expand regulatory clearance or approval for our products, including in the U.S. We cannot be certain that any additional required financing will be available when needed or on terms which are favorable to us. As noted above,Because the revenue we have earned to date has not been sufficient to support our operations, to datewe have been primarily funded through the sales of our securities, bank term loans and loans from related parties. Various factors, including our limited operating history with limited revenuesrevenue to date and our limited ability to market and sell our products have resulted in limited working capital available to fund our operations. There are no assurances that we will be successful in securing additional financing in the future to fund our operations going forward. Failure to generate sufficient cash flows from operations, raise additional capital or reduce certain discretionary spending could have a material adverse effect on our ability to achieve our intended business objectives.

 

On December 1, 2020, the Company effected a 1-for-10 reverse stock split of all outstanding common stock of the Company. All share numbers, exercise prices for options and warrants, conversion price of preferred stock and other capitalization information in this Quarterly Report on Form 10-Q is represented on a post-split basis, unless as otherwise indicated.

31

Recent Events

Effective Shelf Registration Statement

On July 2, 2021, we filed a universal shelf registration statement with the SEC on Form S-3 for the proposed offering from time to time of up to $75,000,000 of our securities, including common stock, preferred stock, and/or warrants. This registration statement currently has a capacity of $75,000,000. However, as a result of the limitations of General Instruction I.B.6. of Form S-3, or the so-called “baby shelf rules”, the amount of shares of our common stock available for sale under a registration statement on Form S-3 is limited to one-third of the aggregate market value of our common equity held by non-affiliates of the Company over any rolling 12-month period. As of September 30, 2021, we have not issued any shares or received any proceeds pursuant to the universal shelf registration statement.

2021 Public Offering

On January 19, 2021, the Company closed an upsized underwritten public offering of units (the “January 2021 Offering”) for gross proceeds of approximately $27,600,000, which included the exercise of the underwriter’s over-allotment option to purchase additional shares and warrants, prior to deducting underwriting discounts and commissions and offering expenses payable by Viveve.

In connection with the closing of the public offering, on January 19, 2021, the Company filed a Certificate of Designation of Preferences, Rights and Limitations of Series C Convertible Preferred Stock (the “Series C Certificate of Designation”) with the Secretary of State of the State of Delaware. The Series C Certificate of Designation provides for the issuance of shares of Series C convertible preferred stock. The shares of Series C convertible preferred stock rank on par with the shares of the common stock. With certain exceptions, as described in the Series C Certificate of Designation, the shares of Series C convertible preferred stock have no voting rights. Each share of Series C convertible preferred stock is convertible at any time at the holder’s option into one share of common stock.

The offering comprised of: (1) 4,607,940 Class A Units, priced at a public offering price of $3.40 per Class A Unit, with each unit consisting of one share of common stock and one warrant to purchase one share of common stock, at an exercise price of $3.40 per share that expires on the fifth anniversary of the date of issuance; and (2) 2,450,880 Class B Units, priced at a public offering price of $3.40 per Class B Unit, with each unit consisting of one share of Series C convertible preferred stock and one warrant to purchase one share of common stock, at an exercise price of $3.40 per share that expires on the fifth anniversary of the date of issuance. The underwriter exercised an over-allotment option to purchase an additional 1,058,820 shares of common stock and warrants to purchase 1,058,820 shares of common stock in the offering. The net proceeds to the Company, after deducting underwriting discounts and commissions and offering expenses payable by the Company, were approximately $25,122,000.

A total of 2,450,880 shares of Series C convertible preferred stock were issued in the January 2021 Offering. In January 2021, all Series C convertible preferred stock were converted into common stock and there are no remaining shares of Series C convertible preferred stock outstanding.

Purchase Agreement with Lincoln Park Capital, LLC

The Company previously entered into a purchase agreement on June 8, 2020 (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), which provided that the Company had the right, in its sole discretion, to sell to LPC, and LPC has committed to purchase from us, up to $10,000,000 of our common stock, subject to certain limitations, from time to time over a 30-month period pursuant to the terms of the Purchase Agreement. The Purchase Agreement limited the Company’s sale of shares of common stock to LPC to 301,762 shares of common stock (after giving effect to the Company’s reverse stock split in December 2020), representing 19.99% of the shares of the common stock outstanding on the date of the Purchase Agreement unless (i) shareholder approval was obtained to issue more than such amount or (ii) the average price of all applicable sales of common stock to LPC under the Purchase Agreement equaled or exceeded $6.46 per share (after giving effect to the Company’s reverse stock split).

On March 31, 2021, the Company and LPC entered into a first amendment to Purchase Agreement. The amendment limited the Company’s sale of shares of common stock to LPC from the date thereof to 2,068,342 shares of shares of common stock, representing 19.99% of the shares of the common stock outstanding on the date of amendment unless (i) shareholder approval is obtained to issue more than such amount or (ii) the average price of all applicable sales of Common Stock to Lincoln Park under the Purchase Agreement, as amended equals or exceeds $2.99 per share.

On May 4, 2021, pursuant to the provisions under the Purchase Agreement as amended, LPC purchased 250,000 shares of the Company’s common stock at $2.817 per share for gross proceeds of approximately $704,000.

As of September 30, 2021, the equity facility with LPC has a remaining financing commitment of approximately $9,000,000.

Purchase Agreement with LPC Reduction of Warrant Exercise Price

On May 4, 2021, LPC purchased 250,000 shares at $2.817 per share of the Company’s common stock. As a result, the per share exercise price of our previously issued Series B, A-2 and B-2 common stock warrants was automatically reduced from $3.40 to $2.817 pursuant to the terms of the warrants. There was no change to the quantity of warrant shares. As a result of this reduction of warrant exercise price, the Company recognized a modification charge of $86,000.

32

Paycheck Protection Program Loan

The Paycheck Protection Program (“PPP”) was established under the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”) and is administered by the U.S. Small Business Administration. On April 24, 2020, Viveve, Inc. (“Viveve”), a wholly-owned subsidiary of the Company, entered into a promissory note evidencing an unsecured loan in the aggregate amount of approximately $1,343,000 made to Viveve under the PPP (the “PPP Loan”). The PPP Loan to Viveve is being made through Western Alliance Bank. The interest rate on the PPP Loan is 1.00% and the term is two years. Beginning seven months from the date of the PPP Loan, Viveve is required to make monthly payments of principal and interest. The promissory note evidencing the PPP Loan contains customary events of default relating to, among other things, payment defaults or breaching the terms of the PPP Loan documents. The occurrence of an event of default may result in the repayment of all amounts outstanding, collection of all amounts owing from Viveve, or filing suit and obtaining judgment against Viveve. Under the terms of the CARES Act, PPP Loan recipients can apply for and be granted forgiveness for all or a portion of the loan granted under the PPP. Such forgiveness will be determined, subject to limitations, based on the use of loan proceeds for payment of payroll costs and any payments of mortgage interest, rent, and utilities.

On October 8, 2020, the Company was notified that the terms of its PPP Loan with Western Alliance Bank have been modified. The amount of time that the Company has to spend the proceeds of the PPP Loan (the “covered period”) has been extended from 8 weeks to 24 weeks. The date to begin repaying unforgiven portions of the PPP Loan has also been extended from six months after the funding date to up to 10 months after the end of the covered period (approximately 16 months) depending on when the Company applies for forgiveness. The SBA will also cover interest on the forgiveness portion of the loan during this period. There has been no change to the maturity date of the loan. All PPP Loans must be repaid or forgiven within two years after the funding date. We submitted our PPP Loan forgiveness application to the SBA in October 2020.

On May 25, 2021, the Company was notified by WAB that its request for forgiveness of the PPP Loan had been approved in full. The total principal amount and the accrued interest through the forgiveness payment date of May 21, 2021 was forgiven. The Company has recognized a gain on the extinguishment of debt in the amount of $1,358,000.

510(k) Clearance from the U.S. Food and Drug Administration

On November 18, 2020, we received clearance from the U.S. Food and Drug Administration, or FDA, under Section 510(k), to expand manufacturing capacity for consumable treatment tips used with our CMRF technology. The expansion of our manufacturing capabilities offers a significant reduction in tip manufacturing costs, strengthens our supply chain, reduces manufacturing risk, and positions us to support increases in treatment tip demand and utilization.

 

PURSUIT U.S. Pivotal SUI Trial

 

The Company received FDA approval of its investigational device exemption (IDE) application to conduct its U.S. pivotal, multicenter PURSUIT trial for improvement of Stress Urinary Incontinence (SUI) in women in July 2020, as well as FDA approval of requested amendments to the IDE protocol in December 2020. Initiation of the PURSUIT trial was announced by the Company on January 21, 2021 and completion of subject enrollment is underway with an expected completion inwas reported on December 14, 2021. We remain on track to complete patient follow-up visits from our pivotal U.S. PURSUIT clinical trial by the fourth quarterend of 2021.the year 2022 and we expect to report topline results shortly thereafter.

29

 

PURSUIT is a randomized, double-blinded, sham-controlled trial with an intended enrollment of approximately 390415 subjects with moderate SUI (≥ 10ml – 50ml urine leakage on the 1-hour Pad Weight Test) at up toapproximately 30 study sites in the U.S. Randomized in a 2:1 ratio for active and sham treatments, subjects in the active treatment arm (260 subjects) will receivereceived a CMRF treatment (90J/cm2 RF and cryogen-cooling), while subjects in the control arm (130 subjects) will receivereceived an inert sham treatment.

 

The primary efficacy endpoint of the PURSUIT trial is a comparison of the proportion of patients who experience greater than 50% reduction in urine leakage compared to baseline on the standardized 1-hour Pad Weight Test at 12 months post-treatment versus the newan inert sham procedure. The study also includes several secondary endpoints, including: proportion of patients who experience greater than 50% reduction in urine leakage on the standardized 1-hour Pad Weight Test at three and six months post-treatment, percentage change from baseline in the 1-hour Pad Weight Test at three, six and 12 months, percent of subjects with no incontinence episodes at three, six and 12 months post treatment as assessed with the three-day bladder voiding diary, and change from baseline in the MESA Questionnaire (Medical, Epidemiologic and Social Aspects of Aging), Incontinence Quality of Life (I-QOL), Patient Global Impression of Improvement (PGI-1) Questionnaire, and International Consultation on Incontinence Modular Questionnaire-Urinary Incontinence Short Form (ICIQ-UI-SF). at three, six, nine and 12 months post-treatment. Subject safety will be monitored throughout the study.

33

Three-Arm SUI Feasibility Study

In December 2019, the Company received approval of an Investigational Testing Application (ITA) from the Canadian Ministry of Health and in January 2020 initiated a three-arm, three-month feasibility study to compare Viveve’s CMRF treatment and a cryogen-only sham to an inert sham treatment for the improvement of SUI in women. Completion of subject enrollment in the study was reported in March 2020. Study subjects were randomized in a 1:1:1 ratio to the three arms and were assessed using the 1-hour Pad Weight Test, 3-day Voiding Diary, the 24-hour Pad Weight Test and I-QOL at five months post treatment. Due to patient, provider and medical facility health and safety concerns caused by the COVID-19 pandemic, the final subject follow-up visit was changed to 5 months versus 3 months.

Final results were reported in August 2020, indicating the primary efficacy endpoint (i.e., change from baseline in the standardized 1-hour Pad Weight Test at five months post treatment) was positively achieved. The median change from baseline in the active CMRF treatment group (N=13) and the cryogen-only sham treatment group (N=12) was -9.5 grams and -6.8 grams respectively, as compared to -4.4 grams in the inert sham treatment group (N=11). The study also assessed several secondary endpoints but showed no differentiation between groups. No device-related safety issues were reported. The meaningful separation demonstrated between the CMRF treatment arm and the inert sham arm in the feasibility study is believed to help provide confidence in the potential to achieve positive separation between the two treatment arms in the underway U.S. pivotal PURSUIT trial.

In-vivo Preclinical Study and Results for New Sham Treatment Tip

In response to the inconclusive results in which the treated arm showed no separation versus the sham control arm reported in July 2019 from the Company’s LIBERATE-International SUI trial conducted in Canada (aimed at supporting SUI indications in Canada, the European Union and several other international countries), Viveve conducted an in-vivo preclinical temperature and immunohistochemistry study to evaluate a new inert sham treatment tip. The Good Laboratory Practices study was initiated in June of this year following several months of engineering, validation, and development work. The study assessed both in-vivo tissue temperature changes during treatment, and histopathology at 30 days post-treatment compared to baseline, in three parous ewes using Viveve’s CMRF treatment tip (Active), cryogen-cooling only tip (“Old” sham treatment used in previous LIBERATE-International SUI study), and a new inert sham treatment tip. Histopathology of vaginal biopsies were performed and included use of α-smooth muscle actin, or α-SMA, staining for fibroblast activation and formation. All tissue samples were evaluated by an independent and blinded pathologist.

The positive preclinical findings demonstrated, as reported in August 2020, that both temperature and immunohistochemistry results support the validity of the new inert sham tip to provide a true inert or placebo treatment. Only minor tissue temperature change (less than 2 degrees centigrade) was generated by the new inert sham tip and no fibroblast activation was shown through elevated a-SMA staining. In contrast, both the Active and cryogen-cooling sham tips demonstrated meaningful tissue temperature changes during treatment and increased fibroblast activation 30 days post-treatment. We believe that the positive in-vivo preclinical study validates our new inert sham tip for use in the U.S. pivotal PURSUIT trial that is currently underway.

Issuance of Patents

Australia

On September 23, 2021 the Company announced that the Australian Patent Office had issued Patent No. 2016324168 covering Viveve’s unique method of treatment to address stress urinary incontinence (SUI) in women. The issuance is the second SUI specific patent for Viveve.

Canada

On August 3, 2021, the Company announced that the Canadian Intellectual Property Office (CIPO) recently issued Canadian Patent No. 3028905 for Viveve’s dual-energy technology device and method.

Taiwan and South Korea

The Company announced in April 2021 that the Taiwan Intellectual Property Office (TIPO) had issued Taiwan Patent No. 1720358 for Viveve’s dual-energy technology device and in February 2021 that the Korean Intellectual Property Office (KIPO) had issued Korean Patent No. 10-2197234 titled, Vaginal Remodeling Device and Method.

United States

On October 28, 2021, the Company announced that the United States Patent and Trademark Office (USPTO) had issued U.S. Patent No. 11,154,349 for Viveve’s dual-energy device and method. The awarded patent strengthens the Company’s intellectual property portfolio and provides further coverage for Viveve’s innovative technology and treatment methods.of remodeling tissue.

In June 2021, the Company announced issuance of U.S. Patent No. 10,980,596 by the United States Patent and Trademark Office (USPTO). The awarded patent strengthens the Company’s intellectual property portfolio for its dual-energy technology device and expands its patent claims in the U.S.

34

In September 2020, the Company announced that the United States Patent and Trademark Office (USPTO) had issued U.S. Patent No. 10,779,874 covering Viveve’s unique method of treatment to address SUI in women. The granted patent is the first SUI specific patent for Viveve as it advances the pivotal U.S. PURSUIT clinical trial for improvement of SUI in women.

The above issued patents serve to further strengthen and expand Viveve’s already robust intellectual property estate. The Company continues to advance its global commercialization strategy for its dual-energy technology and treatment methods that includes securing the highest achievable levels of protection for its intellectual property portfolio.

 

New Category III CPT Code for SUI Procedure

 

In early July 2021, the Company announced that the American Medical Association (AMA) had(“AMA”) issued a new Category III Current Procedural Terminology (CPT®(“CPT”®) code for the Company’s dual-energy procedure effective January 1, 2022. The new code establishes a long-term pathway for potential reimbursement for Viveve’s noninvasive treatment under evaluation in the PURSUIT trial to improve SUI in women if approved by the U.S. Food and Drug AdministrationFDA for this indication. The new Category III CPT code for Viveve’s SUI procedure is defined as: endovaginal cryogen-cooled, monopolar radiofrequency remodeling of the tissue surrounding the female bladder neck and proximal urethra for urinary incontinence.

 

U.S. Commercial Sales Transition to Recurring Revenue Rental ModelIssuance of Patent in Taiwan

 

In June 2019, U.S. salesJuly, the Taiwan Intellectual Property Office (TIPO) issued Taiwan Patent No. I766557 for Viveve’s dual-energy technology. The awarded patent further expands and strengthens Viveve's intellectual property portfolio in one of the Viveve System transitioned from a capital equipment sales model to a recurring revenue rental model. The new U.S. commercial sales model is intended to lower up-front costs for customers and thus lower hurdles to adoption, increase placement rates, and improve profitability by significantly reducing selling time per unit. The new commercial sales model successfully increased physician adoption rates in the months following its implementation and continued to gain traction in the U.S. market well into the first quarter of 2020. In December 2019, Viveve Systems placed with new customers represented higher monthly productivity rates and lower costs per system placed per sales representative. Sale of Viveve products outside of the U.S. continue to be supported by the Company’s current distributors without significant change to the international business model.

Late in the first quarter of 2020, the negative impact of the COVID-19 pandemic on medical facilities and practitioners was in full effect in the United States. Federal, regional, and local government and public health agencies issued directives halting performance of non-essential medical treatments and elective procedures in an effort to combat the spread of the coronavirus and protect public health and safety. As a result, a large percentage of Viveve’s U.S. customers either temporarily closed their medical practices or dramatically reduced services and staff. The consequence has been both a public health and economic crisis that is continuing for existing and prospective Viveve customers. In a supportive partnership response, Viveve contacted all of its subscription customers and provided them with a three-month deferral of the rental payment. Although clinics in various regions have re-opened and are providing limited services, we anticipate that until the COVID-19 pandemic abates, more practices re-open and elective patient’s safety concerns are reduced that we will continue to experience reduced revenue from existing subscription customers, as well as a greatly reduced number of new and prospective customers.       

Under the recurring revenue rental model, customers may lease the Viveve System for a set initial term. After the initial term, the customer may purchase the Viveve System, continue to pay a monthly rental amount or terminate the contract.

The rental program is accounted for under the Financial Standards Board’s (“FASB”) Accounting Standards Codification (“ASC”) No. 2016-02, Leases (Topic 842) and meets the classification criteria for an operating lease. Revenue from the rental program is included in total revenue. For the three and nine months ended September 30, 2021, rental revenue recognized during the period was $261,000 and $950,000, respectively. For the three and nine months ended September 30 ,2020, rental revenue recognized during the period was $471,000 and $829,000, respectively. The Viveve Systems that are being leased are included in property and equipment, net and depreciated over their expected useful lives of five years. When other products (“non-lease components”), such as single-use treatment tips or ancillary consumables, are included in the offering, the Company follows the relevant guidance in ASC Topic 606, Revenue from Contracts with Customers, to determine how to allocate contractual consideration between the lease and non-lease components.Asia's key markets.

 

Impact of the Coronavirus

 

As of the filing of this Quarterly Report, on Form 10-Q, the United States and many other countries continue to face outbreaks or resurgences of the highly transmissible pathogenic coronavirus and its variants, which has resulted in an increasinglya widespread global health crisis, adversely affected general commercial activity and the economies and financial markets of many countries and is likely tomay continue to adversely affect our business, financial condition and results of operations. The extent to which the coronavirus impacts us will depend on future developments, which are highly uncertain and cannot be accurately predicted, including new information which may emerge concerning the severity of the coronavirus and the actions to contain the coronavirus or treat its impact, among others.

 

35

Plan of Operation

 

We intend to increase our sales both internationally and in the U.S. market by seeking additional regulatory clearances or approvals for the sale and distribution of our products, identifying and training qualified distributors, and expanding the scope of physicians who offer the Viveve System to include plastic surgeons, general surgeons, urologists and urogynecologists.System. 

 

In June 2019, we transitioned fromin addition to a capital equipment sales model, towe began a new recurring revenue rental model infor the U.S. market. The new U.S. commercial sales model is intended to lower up-front costs for customers and thus lower hurdles to adoption, increase placement rates, and improve profitability by significantly reducing selling time per unit.of the Viveve System. Sale of Viveve products outside of the U.S. will continue to be supported by our international distributors. 

 

In addition, we intend to use the strategic relationships that we have developed with outside contractors and medical experts to improve our products by focusing our research and development efforts on various areas including, but not limited to:

 

 

designing new treatment tips optimized for both ease-of-use and to reduce procedure times for patients and physicians; and

 

 

developing new RF consoles.

 

30

The net proceeds received from sales of our securities and the term loans have been used to support commercialization of our product in existing and new markets, for our research and development efforts and for protection of our intellectual property, as well as for working capital and other general corporate purposes. We expect that our cash along with the remaining equity financing commitment from LPC of approximately $9,000,000 will be sufficient to fund our activities for at least the next 12 monthscurrent operations through NovemberDecember 2022; however, we maywill continue to require additional capital from the sale of equity or debt securitiesfunds to fully implement our plan of operation. Our operating costs include employee salaries and benefits, compensation paid to consultants, professional fees and expenses, costs associated with our clinical trials, capital costs for research and other equipment, costs associated with research and development activities including travel and administration, legal expenses, sales and marketing costs, general and administrative expenses, and other costs associated with an early stage public company subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We also expect to incur expenses related to obtaining regulatory clearance and approvals in the U.S. and internationally as well as legal and related expenses to protect our intellectual property. We expect capital expenditures, for the foreseeable future, to be less than $1,000,000$500,000 annually.

 

We intend to continue to meet our operating cash flow requirements through the sales of our products and by raising additional capital from the sale of equity or debt securities. If we sell our equity securities, or securities convertible into equity, to raise capital, our current stockholders will likely be substantially diluted. We may also consider the sale of certain assets, or entering into a strategic transaction, such as a merger, with a business complimentary to ours although we do not currently have plans for any such transaction. While we have been successful in raising capital to fund our operations since inception, other than as discussed in this Quarterly Report, on Form 10-Q, we do not have any committed sources of financing and there are no assurances that we will be able to secure additional funding, or if we do secure additional financing that it will be on terms that are favorable to us. If we cannot obtain financing, then we may be forced to curtail our operations or consider other strategic alternatives.

 

Results of Operations 

 

Comparison of the Three Months Ended SeptemberJune 30, 20212022 and 20202021

 

Revenue

 

  

Three Months Ended

         
  

Sepember 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Revenue

 $1,616  $1,524  $92   6%
  

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

    $  

%

 
  

(in thousands, except percentages)

 
                 

Revenue

 $1,795  $1,654  $141   9%

 

We recorded revenue of $1,616,000$1,795,000 for the three months ended SeptemberJune 30, 2021,2022, compared to revenue of $1,524,000$1,654,000 for the three months ended SeptemberJune 30, 2020,2021, an increase of $92,000,$141,000, or approximately 6%9%. The increase in revenue was primarily due to higher sales volume of Viveve Systems and treatment tips sold during the period. Sales in the thirdsecond quarter of 20212022 included sixteen14 Viveve Systems sold and approximately 2,3002,850 disposable treatment tips sold globally. Sales in the thirdsecond quarter of 20202021 included twelveseven Viveve Systems sold and approximately 2,1003,500 disposable treatment tips sold globally.

 

Under the subscription offeringrecurring revenue rental program, which was launched in June 2019, we placed eightfive Viveve Systems in the U.S. market in the thirdsecond quarter of 2021;2022; however, these new placements were offset by the non-renewal of subscriptions for seven Viveve Systems during the period. In the second quarter of 2021, we placed six Viveve Systems in the U.S. market; however, these new placements were offset by the negative impact of the COVID-19 crisis on our sales activity in the period which resulted in the return of nine Viveve Systems during the period. In the third quarter of 2020, we placed seven Viveve Systems under the subscription offering program in the U.S. market; however, these new placements were offset by the return of nine14 Viveve Systems during the period. Rental revenue on these leases is recognized on a straight-line basis over the term of the lease. For the three months ended SeptemberJune 30, 20212022 and 2020,2021, rental revenue recognized during the period was $261,000$273,000 and $471,000,$323,000, respectively.

36

Late in the first quarter of 2020 and through the third quarter of 2021, the COVID-19 pandemic has been in full effect adversely impacting commercial activity and the economies in the United States and most other countries and is likely to continue to adversely affect businesses and results of operations. Government and public health agencies issued directives halting performance of non-essential medical treatments and elective procedures in an effort to combat the spread of the coronavirus and protect public health and safety. As a result, Viveve’s customers either temporarily closed their medical practices or dramatically reduced services and staff. The consequence has been both a public health and economic crisis that continues for existing and prospective Viveve customers. In a supportive partnership response, in the second quarter of 2020 Viveve contacted all of its subscription customers and provided them with a three-month deferral of their rental payment. Although clinics in various regions continue to re-open and gradually increase their limited services, we anticipate that until the COVID-19 pandemic abates, more practices re-open and elective patient’s safety concerns are reduced that we will continue to experience reduced revenue from existing customers, as well as a greatly reduced number of new and prospective customers.  

 

Gross profit

 

  

Three Months Ended

         
  

Sepember 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Gross profit

 $114  $241  $(127)  (53)%
  

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Gross profit

 $294  $165  $129   78%

 

Gross profit was $114,000 or 7% of revenue, for the three months ended September 30, 2021, compared to a gross profit of $241,000,$294,000, or 16% of revenue, for the three months ended SeptemberJune 30, 2020,2022, compared to a decrease of $127,000, or approximately 53%. The decrease in gross profit was primarily due to a decrease in subscriptionof $165,000, or 10% of revenue, from a lower rental installed base and higher inventory related costs in the third quarter of 2021.

Research and development expenses

  

Three Months Ended

         
  

Sepember 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Research and development

 $2,695  $884  $1,811   205%

Research and development expenses totaled $2,695,000 for the three months ended SeptemberJune 30, 2021, compared to research and development expense of $884,000 for the three months ended September 30, 2020, an increase of $1,811,000,$129,000, or approximately 205%78%. Spending on research and development increased primarily due to higher clinical study costs due to the initiation of the pivotal U.S. PURSUIT clinical trial for the treatment of SUI in the first quarter of 2021 with subject enrollment rapidly advancing in the period. We expect completion of subject enrollment in the trial in the fourth quarter. Furthermore, spending on research and development in the third quarter of 2021 also included increased engineering and development work related to our products. Spending on research and development in the third quarter of 2020 was lower as it included reduced engineering and development work related to our products as a result of our overall strategic organizational realignment to focus efforts to advance our SUI clinical development program and operational measures to lower costs and reduce cash burn in response to the economic conditions caused by the COVID-19 crisis.

Selling, general and administrative expenses

  

Three Months Ended

         
  

Sepember 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Selling, general and administrative

 $2,911  $2,761  $150   5%

Selling, general and administrative expenses totaled $2,911,000 for the three months ended September 30, 2021, compared to $2,761,000 for the three months ended September 30, 2020, an increase of $150,000, or approximately 5%. The slight increase in selling, general and administrative expenses was primarily due to higher personnel costs related to additional stock-based compensation expense for equity awards granted to existing employees.

37

Interest expense, net

  

Three Months Ended

         
  

Sepember 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Interest expense, net

 $255  $235  $20   9%

During the three months ended September 30, 2021, we had interest expense, net of $255,000 compared to interest expense, net of $235,000 for the three months ended September 30, 2020, a change of $20,000, or approximately 9%. The increase resulted primarily from a higher term loan balance compared to the third quarter of 2020 due to the interest in-kind which was added to the total outstanding principal loan amount.  

Other expense, net

  

Three Months Ended

         
  

Sepember 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Other expense, net

 $78  $41  $37   90%

During the three months ended September 30, 2021, we had other expense, net of $78,000 compared to $41,000 for the three months ended September 30, 2020. 

Loss from minority interest in limited liability company

  

Sepember 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Loss from minority interest in limited liability company

 $33  $55  $(22)  (40)%

The Company uses the equity method to account for its investment in InControl Medical, LLC (“ICM”). For the three months ended September 30, 2021, the allocated net loss from ICM’s operations was $33,000 compared to $55,000 for the three months ended September 30, 2020.   

Comparison of the Nine Months Ended September 30, 2021 and 2020

Revenue

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Revenue

 $4,720  $3,532  $1,188   34%

We recorded revenue of $4,720,000 for the nine months ended September 30, 2021, compared to revenue of $3,532,000 for the nine months ended September 30, 2020, an increase of $1,188,000, or approximately 34%. The increase in revenue was primarily due higher sales volume of Viveve Systems and treatment tips sold during the period. Sales in 2021 included sales of 31 Viveve Systems and approximately 8,200 disposable treatment tips sold globally. Sales in 2020 included sales of 16 Viveve Systems and approximately 5,900 disposable treatment tips sold globally.

38

Under the subscription offering program, we placed 18 Viveve Systems in the U.S. market in 2021; however, these new placements were offset by the negative impact of the COVID-19 crisis on our sales activity in the period which resulted in the return of 29 Viveve Systems during the period. In 2020, we placed 27 Viveve Systems under the subscription offering program in the U.S. market but these new placements were offset by the return of 18 Viveve Systems during the period. Rental revenue on these leases is recognized on a straight-line basis over the term of the lease. For the nine months ended September 30, 2021 and 2020, rental revenue recognized during the period was $950,000 and $829,000, respectively.

Late in the first quarter of 2020 and through the third quarter of 2021, the COVID-19 pandemic was in full effect adversely impacting commercial activity and the economies in the United States and most other countries and is likely to continue to adversely affect businesses and results of operations. Government and public health agencies issued directives halting performance of non-essential medical treatments and elective procedures in an effort to combat the spread of the coronavirus and protect public health and safety. As a result, Viveve’s customers either temporarily closed their medical practices or dramatically reduced services and staff. The consequence has been both a public health and economic crisis that continues for existing and prospective Viveve customers. In a supportive partnership response, in the second quarter of 2020 Viveve contacted all of its subscription customers and provided them with a three-month deferral of their rental payment. Although clinics in various regions continue tore-open and gradually increase their limited services, we anticipate that until the COVID-19 pandemic abates, more practices re-open and elective patient’s safety concerns are reduced that we will continue to experience reduced revenue from existing customers, as well as a greatly reduced number of new and prospective customers.  

Gross profit

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Gross profit

 $661  $49  $612   NM 

Gross profit was $661,000 or 14% of revenue for the nine months ended September 30, 2021, compared to gross profit of $49,000, or 1% of revenue, for the nine months ended September 30, 2020, an increase of $612,000. The increase in gross profit was primarily due to the higher sales volume of Viveve Systems and treatment tips sold during the period. Additionally, fixed manufacturing costs in 2020 were spread over a lower sales volume thereby lowering gross margins.

31

 

Research and development expenses

 

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Research and development

 $6,804  $3,745  $3,059   82%
  

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

    $  

%

 
  

(in thousands, except percentages)

 
                 

Research and development

 $1,921  $2,180  $(259)  (12)%

 

Research and development expenses totaled $6,804,000 for$1,921,000 or the ninethree months ended SeptemberJune 30, 20212022, compared to research and development expense of $3,745,000$2,180,000 for the ninethree months ended September 30, 2020, an increaseJune 30,2021, a decrease of $3,059,000,$259,000, or approximately 82%12%. Spending on research and development increaseddecreased primarily due to reduced clinical study costs, partially offset by higher personnel costs and increased engineering and development work related to our next generation products. Research and development expense in the second quarter of 2021 had higher clinical study costs primarily due to the initiation of the pivotal U.S. PURSUIT clinical trial for the treatment of SUI in the firstwith subject enrollment underway. The second quarter of 2021 with subjectalso included additional spending on advertising and marketing services related to the enrollment advancingof subjects for the PURSUIT trial; such spending was no longer needed in the period. We expect2022 due to completion of subject enrollment in the trial in the fourth quarter. Furthermore, spending on research and development in 2021 also included increased engineering and development work related to our products. Spending on research and development in 2020 was lower as it included reduced engineering and development work related to our products as a resultquarter of our overall strategic organizational realignment to focus efforts to advance our SUI clinical development program and operational measures to lower costs and reduce cash burn in response to the economic conditions caused by the COVID-19 crisis.2021.

 

Selling, general and administrative expenses 

 

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Selling, general and administrative

 $9,423  $10,476  $(1,053)  (10)%

39

  

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Selling, general and administrative

 $3,393  $2,930  $463   16%

 

Selling, general and administrative expenses totaled $9,423,000$3,393,000 for the ninethree months ended SeptemberJune 30, 2022, compared to $2,930,000 for the three months ended June 30, 2021, compared to $10,476,000 for the nine months ended September 30, 2020, a decreasean increase of $1,053,000,$463,000, or approximately 10%16%. The decreaseincrease in selling, general and administrative expenses was primarily due to reduced spending as a result of the Company's organizational realignment to advance our SUI clinical development program and operational measures to lower costs and reduce cash burn in response to the continuing economic conditions caused by the COVID-19 crisis, partially offset by higher personnel costs and higher professional fees related to our strategic planning for existing employees in 2021.the Company’s upcoming SUI product commercialization.

 

Gain on forgiveness of Paycheck Protection Program loan

 

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Gain on forgiveness of Paycheck Protection Program loan

 $1,358  $-  $1,358   NM 

  

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

    $  

%

 
  

(in thousands, except percentages)

 

Gain on forgiveness of Paycheck Protection Program loan

 $-  $(1,358) $1,358   (100)%

 

In May 2021, the Company’s request for forgiveness of the PPP Loan was approved in full. The total principal amount and the accrued interest through the forgiveness payment date was forgiven. The Company recognized a gain on the extinguishment of debt in the amount of $1,358,000.

 

Modification of warrants

  

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

    $  

%

 
  

(in thousands, except percentages)

 
                 

Modification of warrants

 $-  $86  $(86)  (100)%

In May 2021, the Company reduced the exercise price of the outstanding Series B, A-2 and B-2 warrants from $3.40 per share to $2.817 per share pursuant to the terms of the warrants. The Series B, A-2 and B-2 warrant exercise price reduction resulted in the recognition of a modification expense of $86,000.

32

Interest expense, net

  

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Interest expense, net

 $284  $245  $39   16%

During the three months ended June 30, 2022, we had interest expense, net of $284,000 compared to interest expense, net of $245,000 for the three months ended June 30, 2021, a change of $39,000, or approximately 16%. The increase resulted primarily from a higher term loan balance compared to the second quarter of 2021 due to the interest in-kind which was added to the total outstanding principal loan amount.  

Other expense, net

  

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

 

2021

    $  

%

 
  

(in thousands, except percentages)

 
                

Other expense, net

 $40 $53  $(13)  (25)%

During the three months ended June 30, 2022, we had other expense, net of $40,000 compared to $53,000 for the three months ended June 30, 2021. 

Impairment loss on investment in unconsolidated limited liability company

   Three Months Ended   Three Months Ended 
   June 30,   Change 
   2022   2021   $   % 
   (in thousands, except percentages) 
                 

Impairment loss on investment in unconsolidated limited liability company

 $455  $-  $455   NM 

During the three months ended June 30, 2022, the Company recognized an impairment loss of $455,000 on its investment in InControl Medical, LLC (“ICM”) due to the distressed financial condition of ICM.

Loss from investment in unconsolidated limited liability company

  

 

Three Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
    

Loss from investment in unconsolidated limited liability company

 $-  $79  $(79)  (100)%

The Company uses the equity method to account for its investment in ICM. Due to the impairment loss recognized on its investment in ICM in the second quarter of 2022, the Company did not allocate any net loss from ICM’s operations for the three months ended June 30, 2022.

33

Comparison of the Six Months Ended June 30, 2022 and 2021

Revenue

  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Revenue

 $3,436  $3,104  $332   11%

We recorded revenue of $3,436,000 for the six months ended June 30, 2022, compared to revenue of $3,104,000 for the six months ended June 30, 2021, an increase of $332,000, or approximately 11%. The increase in revenue was primarily due to higher sales volume of Viveve Systems and higher average selling prices of treatment tips sold during the period, partially offset by a decrease in rental revenue from a lower rental installed base. Sales in the first half of 2022 included sales of 22 Viveve Systems and approximately 5,600 disposable treatment tips sold globally. Sales in the first half of 2021 included sales of 15 Viveve System and approximately 5,900 disposable treatment tips sold globally.

Under the subscription offering program, we placed 12 Viveve Systems in the U.S. market in the first half of 2022; however, these new placements were offset by the non-renewal of subscriptions for 11 Viveve Systems during the period. In the first half of 2021, we placed 10 Viveve Systems under the subscription offering program in the U.S. market; but these new placements were offset by the negative impact of the COVID-19 crisis on our sales activity in the period which resulted in the non-renewal of subscriptions for 20 Viveve Systems during the period. Rental revenue on these leases is recognized on a straight-line basis over the term of the lease. For the six months ended June 30, 2022 and 2021, rental revenue recognized during the period was $534,000 and $689,000, respectively.

Gross profit

  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Gross profit

 $614  $547  $67   12%

Gross profit was $614,000, or 18% of revenue for the six months ended June 30, 2022, compared to gross profit of $547,000, or 18% of revenue, for the six months ended June 30, 2021, an increase of $67,000, or approximately 12%. The increase in gross profit was primarily due to the higher sales volume of Viveve Systems and higher average selling prices of treatment tips sold during the period.

Research and development expenses

  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Research and development

 $4,061  $4,110  $(49)  (1)%

Research and development expenses totaled $4,061,000 for the six months ended June 30, 2022 compared to research and development expense of $4,110,000 for the six months ended June 30, 2021, a decrease of $49,000 or approximately 1%. Spending on research and development decreased primarily due to reduced clinical study costs, partially offset by higher personnel costs and increased engineering and development work related to our next generation products. Research and development expense in the first half of 2021 had higher clinical study costs primarily due to the initiation of the pivotal U.S. PURSUIT clinical trial for the treatment of SUI with subject enrollment underway. The first half of 2021also included additional spending on advertising and marketing services related to the enrollment of subjects for the PURSUIT trial; such spending was no longer needed in 2022 due to completion of subject enrollment in the fourth quarter of 2021.

34

Selling, general and administrative expenses

  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Selling, general and administrative

 $7,046  $6,511  $535   8%

Selling, general and administrative expenses totaled $7,046,000 for the six months ended June 30, 2022, compared to $6,511,000 for the six months ended June 30, 2021, an increase of $535,000 or approximately 8%. The increase in selling, general and administrative expenses was primarily due to higher personnel costs and higher professional fees related to our strategic planning for the Company’s upcoming SUI product commercialization, partially offset by reduced spending for sales and marketing efforts during the period.

Gain on forgiveness of Paycheck Protection Program loan

  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

    $  

%

 
  

(in thousands, except percentages)

 

Gain on forgiveness of Paycheck Protection Program loan

 $-  $(1,358) $1,358   (100)%

In May 2021, the Company’s request for forgveness of the PPP Loan was approved in full. The total principal amount and the accrued interest through the forgiveness payment date was forgiven. The Company recognized a gain on the extinguishment of debt in the amount of $1,358,000.

Modification of Warrants

 

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Modification of warrants

 $373  $1,838  $(1,465)  (80)%
  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Modification of warrants

 $-  $373  $(373)  (100)%

 

In January 2021, the Company reduced the exercise price of the outstanding Series B, A-2 and B-2 warrants pursuant to the terms of the warrants. The exercise price for Series B warrants was reduced from $6.10 per share to $3.40 per share. The exercise price for Series A-2 and B-2 warrants was reduced from $6.371 per share to $3.40 per share. The Series B, A-2 and B-2 warrant exercise price reduction resulted in the recognition of a modification expense of $287,000.

 

In May 2021, the Company reduced the exercise price of the outstanding Series B, A-2 and B-2 warrants from $3.40 per share to $2.817 per share pursuant to the terms of the warrants. The Series B, A-2 and B-2 warrant exercise price reduction resulted in the recognition of a modification expense of $86,000.

 

In April 2020, the Company reduced the exercise price of the outstanding Series A and B warrants from $15.50 per share to $6.10 per share. The Series A and B warrant exercise price adjustment resulted in the recognition of a modification expense of $1,838,000.

Interest expense, net  

 

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Interest expense, net

 $734  $668  $66   10%
  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Interest expense, net

 $554  $479  $75   16%

 

During the ninesix months ended SeptemberJune 30, 2021,2022, we had interest expense, net of $734,000,$554,000, compared to interest expense, net of $668,000$479,000 for the ninesix months ended SeptemberJune 30, 2020,2021, a change of $66,000,$75,000, or approximately 10%16%. The increase resulted primarily from a higher term loan balance compared to 2020the first half of 2021 due to the interest in-kind which was added to the total outstanding principal loan amount. 

 

4035

 

Other expense, net 

 

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Other expense, net

 $196  $159  $37   23%
  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 
                 

Other expense, net

 $61  $118  $(57)  (48)%

 

During the ninesix months ended SeptemberJune 30, 2021,2022, we had other expense, net, of $196,000,$61,000, compared to $159,000$118,000 for the ninesix months ended SeptemberJune 30, 2020.2021.

Impairment loss on investment in unconsolidated limited liability company

   Six Months Ended     
   June 30,   Change 
   2022  2021   $   % 
   (in thousands, except percentages) 

Impairment loss on investment in unconsolidated limited liability company

 $455 $-  $455   NM 

During the six months ended June 30, 2022, the Company recognized an impairment loss of $455,000 on its investment in ICM due to the distressed financial condition of ICM.

 

Loss from minority interest in limited liability company

 

  

Nine Months Ended

         
  

September 30,

  

Change

 
  

2021

  

2020

  

$

  

%

 
  

(in thousands, except percentages)

 
                 

Loss from minority interest in limited liability company

 $188  $323  $(135)  (42)%
  

Six Months Ended

         
  

June 30,

  

Change

 
  

2022

  

2021

   $  

%

 
  

(in thousands, except percentages)

 

Loss from minority interest in limited liability company

 $122  $155  $(33)  (21)%

 

The Company uses the equity method to account for its investment in ICM. For the ninesix months ended SeptemberJune 30, 2021,2022, the allocated net loss from ICM’s operations was $188,000,$122,000, compared to $323,000$155,000 for the ninesix months ended SeptemberJune 30, 2020.2021. Due to the impairment loss recognized on its investment in ICM in the second quarter of 2022, the Company did not allocate any net loss from ICM’s operations for the three months ended June 30, 2022.

 

Liquidity and Capital Resources

 

Comparison of the NineThree Months Ended SeptemberJune 30, 20212022 and 20202021

 

Since inception, the Company has sustained significant operating losses and such losses are expected to continue for the foreseeable future. The CompanyAs of June 30, 2022, we had an accumulated deficit of $235,525,000 as of September 30, 2021. Additionally, the Company used $9,651,000 in cash for operations in the nine months ended September 30, 2021. However, the Company's financing activities provided cash of $25,955,000 during the nine months ended September 30, 2021, including $25,122,000 in net proceeds from the January 2021 Offering, $633,000 in net proceeds from purchase of common shares under the Purchase Agreement with LPC, $179,000 proceeds from the exercise of common warrants and $21,000 from proceeds from issuance of common shares from employee purchase plan. As of September 30, 2021, the Company had$253,538,000, cash and cash equivalents of $22,665,000$9,431,000 and working capital of $23,563,000. Accordingly, management expects that$3,226,000. We used cash of $9,655,000 for operations during the three months ended June 30, 2022. As of the date our cash along withcondensed consolidated financial statements for the remaining equity financing commitment from LPC of approximately $9,000,000 will bethree months ended June 30, 2022 were issued, we did not have sufficient cash to fund our activities for at leastoperations through August 31, 2023, without additional financing and, therefore, we concluded there was substantial doubt about our ability to continue as a going concern within one year after the next twelve months through November 2022; however, we may require additional funds to fully implement our plan of operation.date the condensed consolidated financial statements were issued.

 

To fund further operations, the Company may needManagement currently believes that it will be necessary for us to raise additional capital. The Companyfunding. We may obtain additional financingfunding in the future through the issuance of itsour common stock, or through other equity or debt financings.financing. The Company’s ability to continue as a going concern or meet the minimum liquidity requirements in the future is dependent on its abilityfailure to raise significant additional capital, offunding when needed could have a material adverse effect on our business and financial condition. We may not be able to obtain additional financing as needed on acceptable terms, or at all, which there can be no assurance. If the necessary financing is not obtained or achieved, the Company will likely be requiredmay require us to reduce its plannedour operating costs and other expenditures, which could have an adverse impact on the resultsincluding reductions of operations, financial conditionpersonnel, salaries and capital expenditures. Alternatively, or in addition to such potential measures, we may elect to implement additional cost reduction actions as we may determine are necessary and in our best interests. Any such actions undertaken might limit the Company’s ability to achieve its strategic objective. There can be no assurance that financing will be available on acceptable terms, or at all.objectives.  


 

 

The following table summarizes the primary sources and uses of cash for the periods presented below (in thousands): 

 

 

Nine Months Ended

  

Six Months Ended

 
 

Sepember 30,

  

June 30,

 
 

2021

  

2020

  

2022

  

2021

 
  

Net cash used in operating activities

 $(9,651) $(12,936) $(9,655) $(6,988)

Net cash used in investing activities

 (162) (403) (108) (78)

Net cash provided by financing activities

  25,955   9,231   32   25,934 

Net increase (decrease) in cash and cash equivalents

 $16,142  $(4,108) $(9,731) $18,868 

 

Operating Activities

 

We have incurred, and expect to continue to incur, significant expenses in the areas of research and development, regulatory and clinical study costs, associated with the Viveve System.

 

41

Operating activities used $9,651,000$9,655,000 for the ninesix months ended SeptemberJune 30, 20212022 compared to $12,936,000$6,988,000 used for the ninesix months ended September 30, 2020.June 30,2021. The primary use of our cash was to fund selling, general and administrative expenses and research and development expenses associated with the Viveve System. Net cash used during the ninesix months ended SeptemberJune 30, 2022 consisted of a net loss of $11,685,000 adjusted for non-cash expenses including bad debt recovery of $3,000, depreciation and amortization of $392,000, stock-based compensation of $1,869,000, non-cash interest expense of $329,000, impairment loss on investment in unconsolidated limited liability company of $455,000, a loss from investment in unconsolidated limited liability company of $122,000, a loss on disposal of property and equipment of $19,000, and cash outflows from changes in operating assets and liabilities of $1,153,000. The change in operating assets and liabilities was primarily due to increase in accounts receivable of $249,000, a decrease in inventory of $10,000, an increase in prepaid expenses and other current assets of $352,000, a decrease in other assets of $300,000, a decrease in accounts payable $576,000, an increase in accrued liabilities of $577,000, and a decrease of other noncurrent liabilities of $863,000.

Net cash used during the six months ended June 30, 2021 consisted of a net loss of $15,699,000$9,841,000 adjusted for non-cash expenses including provision for doubtful accounts $104,000,$89,000, depreciation and amortization of $884,000,$636,000, stock-based compensation of $2,765,000,$1,677,000, non-cash interest expense of $446,000,$291,000, amortization of operating lease right-of-use assets and accretion of operating lease liabilities of $15,000, $17,000,a loss from minority interest in limited liability company of $188,000,$155,000, a loss on disposal of property and equipment of $40,000,$9,000, a noncash charge for the modification of warrants of $373,000, a gain on the extinguishment of debt of $1,358,000 related to forgiveness of the PPP Loan, and cash inflows from changes in operating assets and liabilities of $2,589,000.$964,000. The change in operating assets and liabilities was primarily due to decreasean increase in accounts receivable of $152,000,$15,000, a decrease in inventory of $1,423,000,$855,000, a decrease in prepaid expenses and other current assets of $213,000, an increase$308,000, a decrease in other noncurrent assets of $3,000, an increase$141,000, a decrease in accounts payable $411,000, an increase$219,000, a decrease in accrued and other liabilities of $71,000,$317,000, and an increase of other noncurrent liabilities of $324,000.

Net cash used during the nine months ended September 30, 2020 consisted of a net loss of $17,160,000 adjusted for non-cash expenses including provision for doubtful accounts and write off of accounts receivable of $335,000, depreciation and amortization of $965,000, stock-based compensation of $2,009,000, non-cash interest expense of $394,000, amortization of operating lease right-of-use assets and accretion of operating lease liabilities of $3,000, a loss from minority interest in limited liability company of $323,000, a loss on disposal of property and equipment of $14,000, a noncash charge for the modification of Series A and B warrants of $1,838,000, and cash outflows from changes in operating assets and liabilities of $1,657,000. The change in operating assets and liabilities was primarily due to a decrease in accounts receivable of $549,000, a decrease in inventory of $233,000, a decrease in prepaid expenses and other current assets of $683,000, a decrease in other noncurrent assets of $444,000, a decrease in accounts payable $913,000, a decrease in accrued and other liabilities of $2,918,000, and an increase of other noncurrent liabilities of $265,000.$211,000.

 

Investing Activities

 

Net cash used in investing activities during the ninesix months ended SeptemberJune 30, 2022 and 2021 was $108,000 and 2020 was $162,000 and $403,000,$78,000, respectively. Net cash used in investing activities during the ninesix months ended SeptemberJune 30, 20212022 and 20202021 was used for the purchase of property and equipment. We expect to continue to purchase property and equipment in the normal course of our business. The amount and timing of these purchases and the related cash outflows in future periods is difficult to predict and is dependent on a number of factors including, but not limited to, any changes to the capital equipment requirements related to our recurring revenue rental model, development programs and clinical trials and increase in the number of our employees.

 

Financing Activities

 

Net cash provided by financing activities during the ninesix months ended SeptemberJune 30, 2022 was $32,000, which was the result of proceeds from issuance of common shares from the employee stock purchase plan.

Net cash provided by financing activities during the six months ended June 30, 2021 was $25,955,000,$25,934,000, which was the result of net proceeds of $25,122,000 from the January 2021 Offering net of issuance costs, $704,000 from purchase of common sharesstock in connection with the Purchase Agreement with LPC and proceeds of $179,000 from exercises of common warrants, and $21,000 of proceeds from issuance of common shares from employee stock purchase plan, partially offset by transaction costs of $71,000 in connection with the Purchase Agreement with LPC.

 

Net cash provided by financing activities duringOn July 2, 2021, we filed a universal shelf registration statement with the nine months ended September 30, 2020 was $9,231,000, which wasSEC on Form S-3 for the proposed offering from time to time of up to $75,000,000 of our securities, including common stock, preferred stock, and/or warrants. This registration statement currently has a capacity of $75,000,000. However, as a result of net proceedsthe limitations of $8,407,000 from exercisesGeneral Instruction I.B.6. of Form S-3, or the so-called “baby shelf rules,” the amount of shares of our common warrants, proceeds of $1,343,000 from the PPP loan and proceeds of $341,000 from the initial purchase of common shares under the Purchase agreement from LPC, partially offset by transaction costs of $333,000 in connection with the 2020 Warrant Offering, transaction costs of $494,000 in connection with the Purchase Agreement with LPC, and additional transaction costs of $33,000 in connection with our November 2019 Offering.

Contractual Payment Obligations

We have obligationsstock available for sale under a bank term loan and non-cancelable operating leases.registration statement on Form S-3 is limited to one-third of the aggregate market value of our common equity held by non-affiliates of the Company over any rolling 12-month period. As of SeptemberJune 30, 2021, our contractual obligations were as follows (in thousands):2022, we have not issued any shares or received any proceeds pursuant to the universal shelf registration statement.

      

Less than

          

More than

 

Contractual Obligations (including interest):

 

Total

  

1 Year

  

1 - 3 Years

  

3 -5 Years

  

5 Years

 

CRG note payable

 $5,992  $-  $5,992  $-  $- 

Non-cancellable operating lease obligations

  700   278   422   -   - 

Total

 $6,692  $278  $6,414  $-  $- 

 

4237

The Company previously entered into a purchase agreement on June 8, 2020, as amended on March 31, 2021 (the “Purchase Agreement”) with Lincoln Park Capital Fund, LLC (“LPC”), which provided that the Company had the right, in its sole discretion, to sell to LPC, and LPC has committed to purchase from us, up to $10,000,000 of our common stock, subject to certain limitations, from time to time over a 30-month period pursuant to the terms of the Purchase Agreement. As of June 30, 2022, the equity facility with LPC has a remaining financing commitment of approximately $9,000,000. The equity facility with LPC has a maturity date of January 9, 2023.

Contractual Payment Obligations

 

In February 2017, we entered into a sublease for approximately 12,400 square feet of building space for the relocation of the Company’s corporate headquarters to Englewood, Colorado. The lease term was 36 months and the monthly base rent for the first, second and third years was $20.50, $21.12 and $21.75 per rentable square foot, respectively. In connection with the execution of the sublease, the Company paid a security deposit of approximately $22,000. The Company was also entitled to an allowance of approximately $88,000 for certain tenant improvements relating to the engineering, design and construction of the sublease premises. The lease term commenced in June 2017 and was to terminate in May 2021. In March 2021, the Company amended the sublease for its office building space. The lease term was extended for a period of 34 months and will terminate on March 31, 2024.  The monthly gross rent for the first, second and third years of the lease extension is $21,028, $21,643$21,027.88, $21,643.03 and $22,258$22,258.18 per month, respectively. The Company was also provided a rent abatement for the month of June 2021. Additionally, the sublandlord has agreed to perform certain construction, repair, maintenance or other tenant improvements to the subleased premises with estimated costs of approximately $19,000.

 

In May 2017, the Company entered into the 2017 Loan Agreement with affiliates of CRG LP (“CRG”). The credit facility consists of $20,000,000 that was drawn at closing and the ability to access additional funding of up to an aggregate of $10,000,000 for a total of $30,000,000 under the credit facility. In December 2017, the Company accessed the remaining $10,000,000 available under the CRG credit facility. The term of the loan is six years with the first four years being interest only. In November 2019, the Company and CRG amended the 2017 Loan Agreement concurrent with the conversion of approximately $29,000,000 of the principal amount under the term loan with CRG (plus accrued interest, the prepayment premium and the back-end fee applicable thereto), for an aggregate amount of converted debt obligations of approximately $31,300,000. The amounts converted into 31,300 shares of the newly authorized Series B convertible preferred stock and warrants to purchase up to 989,379 shares of common stock were also issued. The outstanding principal balance under the 2017 Loan Agreement was $4,964,000$5,453,000 as of SeptemberJune 30, 2021.2022. The term loan has a maturity date of March 31, 2023.

 

In September 2018,October 2020, the Company entered into a 36-month noncancelable operating lease agreement for office equipment.  The lease commenced in December 2020 and will terminate in December 2023. The monthly payment is approximately $3,000.$2,000.  

 

Critical Accounting Policies and Estimates

 

The discussion and analysis of financial condition and results of operations is based upon our condensed consolidated financial statements, which have been prepared in conformity with accounting principles generally accepted in the United States of America Certain accounting policies and estimates are particularly important to the understanding of our financial position and results of operations and require the application of significant judgment by our management or can be materially affected by changes from period to period in economic factors or conditions that are outside of our control. As a result, they are subject to an inherent degree of uncertainty. In applying these policies, management uses their judgment to determine the appropriate assumptions to be used in the determination of certain estimates. Those estimates are based on our historical operations, our future business plans and projected financial results, the terms of existing contracts, observance of trends in the industry, information provided by our customers and information available from other outside sources, as appropriate. Please see Note 2During the three and six months ended June 30, 2022, there were no material changes to our audited consolidated financial statementscritical accounting policies or in the methodology used for estimates from those described in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” included in our Annual Report on Form 10-K for the year ended December 31, 2020,2021, that was filed with the SEC on March 18, 2021. There have been no material changes to the significant accounting policies during the nine months ended September 30, 2021.17, 2022.  

 

Recent Accounting Pronouncements

 

In December 2019,June 2016, the FASBFinancial Standards Board issued Accounting Standards Update 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments, as amended, which revises the measurement of credit losses for most financial instruments measured at amortized cost, including trade receivables, from an incurred loss methodology to an expected loss methodology which results in earlier recognition of credit losses. Under the incurred loss model, a loss is not recognized until it is probable that the loss-causing event has already occurred. The new standard introduces a forward-looking expected credit loss model that requires an estimate of the expected credit losses over the life of the instrument by considering all relevant information including historical experience, current conditions, and reasonable and supportable forecasts that affect collectability. The guidance in ASU 2019-12, “Income Taxes (Topic 740). The amendments in this Update provide further simplification of accounting standards for the accounting for income taxes. Certain exceptions for are removed and requirements regarding the accounting for franchise taxes, tax basis of goodwill, and tax law rate changes are made. This guidance2016-13 is effective for annual reporting periodsthe Company for financial statements issued for fiscal years beginning after December 15, 2020, including2022 and interim periods within that reporting period,those fiscal years, with early adoption permitted. We adopted this guidance asThe Company is still evaluating the impact of January 1, 2021, and the adoption of the guidance did not have a significant impact on the condensed consolidated financial statements.this standard.

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We have reviewed other recent accounting pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the condensed consolidated financial statements as a result of future adoption.

Off-Balance Sheet Transactions

We do not have any off-balance sheet transactions.

 

Trends, Events and Uncertainties

 

Research, development and commercialization of new technologies and products is, by its nature, unpredictable. Although we will undertake development efforts, including efforts with commercially reasonable diligence, there can be no assurance that we will have adequate capital to develop or commercialize our technology to the extent needed to create future sales to sustain our operations.

 

We cannot assure you that our technology will be adopted, that we will ever earn revenues sufficient to support our operations, or that we will ever be profitable. Furthermore, since we have no committed source of financing, we cannot assure you that we will be able to raise money as and when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease, our operations. 

 

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Other than as discussed above and elsewhere in this Quarterly Report, on Form 10-Q, we are not aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition.

 

Inflation

Inflation has increased during the periods covered by this Quarterly Report and is expected to continue to increase for the near future. Inflationary factors, such as increases in the cost of our products (and components thereof), interest rates, overhead costs and transportation costs may adversely affect our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, we may experience some effect in the near future (especially if inflation rates continue to rise) due to supply chain constraints, consequences associated with COVID-19 and increased product pricing due to semiconductor product shortages.

Item 3.

Quantitative and Qualitative Disclosures About Market Risk.

 

We are exposeda smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and are not required to market risk related to changes in interest rates. As of September 30, 2021, our cash and cash equivalents consisted of cash and interest-bearing accounts. Our primary exposure to market risk is interest income sensitivity, which is affected by changes inprovide the general level of U.S. interest rates. However, since a majority of our investments are in highly liquid interest-bearing accounts, we do not believe we are subject to any material market risk exposure.  As of September 30, 2021, we did not have any material derivative financial instruments.  The fair value of our cash and cash equivalents was $22.7 million as of September 30, 2021. information under this item.

 

We are also exposed to market risk related to changes in foreign currency exchange rates. From time to time, we contract with vendors or service providers that are located outside the U.S., which are denominated in foreign currencies. We are subject to fluctuations in foreign currency rates in connection with these agreements. We do not currently hedge our foreign currency exchange rate risk. As of September 30, 2021 and December 31, 2020, we had minimal liabilities denominated in foreign currencies.

We do not believe that inflation had a material effect on our business, financial condition or results of operations during the nine months ended September 30, 2021 and 2020.

Item 4.

Controls and Procedures.

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosure. 

 

We carried out an evaluation under the supervision and with the participation of management, including our principal executive officer and principal financialaccounting and accountingfinancial officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of SeptemberJune 30, 2021,2022, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon the evaluation of our disclosure controls and procedures as of SeptemberJune 30, 2021,2022, our Chief Executive Officer (principal executive officer) and Senior Vice President of Finance and Administration (principal accounting and financial officer) concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level. In addition, our ability to maintain an effective internal control environment has not been impacted by the COVID-19 pandemic.

 

Changes in Internal Control over Financial Reporting

 

No changes in the Company’s internal control over financial reporting have come to management’s attention during the Company's last fiscal quarter that have materially affected, or are likely to materially affect, the Company’s internal control over financial reporting.

 


PART II-OTHER INFORMATION

 

Item 1.

Legal Proceedings.

 

Except as disclosed below and in our Annual Report on Form 10-K for the year ended December 31, 2020, weWe are not subject to any material pending legal proceedings. From time to time, we may be involved in routine legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business.

 

Item 1A.

Risk Factors.

 

We incorporate herein by reference the risk factors included in the Annual Report on Form 10-K for the fiscal year ended December 31, 2020,2021, filed with the Securities and Exchange Commission on March 18, 2021.17, 2022. 

 

We recently received a delisting noticefrom Nasdaq and if we do not regain compliance with Nasdaq listing standards, we will be delisted from Nasdaq.

On May 31, 2022, we received a letter from the Listing Qualifications Department of The Nasdaq Stock Market stating that for the 30 consecutive business days prior to the date of the letter, we did not meet the minimum bid price of $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2). In accordance with Nasdaq Listing Rule 5810(c)(3)(A), Nasdaq has provided us with 180 calendar days, or until November 28, 2022, to regain compliance. Compliance can be achieved by meeting the minimum bid price of $1.00 for ten (10) consecutive trading days. In the event the Company does not regain compliance with the Nasdaq listing rules prior to the expiration of the compliance period, it will receive written notification that its securities are subject to delisting.

In the event that our common stock is delisted from Nasdaq, trading of our common stock could be conducted in the over-the-counter market or on an electronic bulletin board established for unlisted securities such as the Pink Sheets or the OTC Bulletin Board. In such event, it could become more difficult to dispose of, or obtain accurate price quotations for, our common stock, and there would likely also be a reduction in our coverage by security analysts and the news media, which could cause the price of our common stock to decline further. Also, it may be difficult for us to raise additional capital if we are not listed on a major exchange.

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds.

 

UnregisteredRecent Sales of Unregistered Equity Securities

 

Series B Convertible Preferred Stock

 

Pursuant to the Certificate of Designation of the Company’s Series B convertible preferred stock, we issued 1,1891,302 shares of Series B convertible preferred stock in lieu of $1,189,000$1,302,000 in cash dividend to holders of Series B convertible preferred stock, exempt from registration pursuant to Section 4(a)(2) of the Securities Act, on SeptemberJune 30, 2021.2022.

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The shares of Series B convertible preferred stock will only be convertible into common stock, following such time as we have filed an amendment to the certificate of incorporation that authorizes at least 125,000,000 shares of common stock. We may remove the requirement of authorized common stock increase for the conversion of Series B convertible preferred stock to enable CRG to convert its shares to common stock. The conversion or exercise of securities issued to affiliates of CRG are also further subject to certain beneficial ownership restrictions. If the Series B convertible preferred stock becomes convertible into common stock, it will be convertible into that number of shares of common stock determined by dividing $1,000 by the conversion price of $15.30.

 

Item 3.

Defaults Upon Senior Securities.

 

Not applicable.      

 

Item 4.

Mine Safety Disclosures.

 

Not applicable.

 

Item 5.

Other Information.

 

None.

 

Item 6.

Exhibits.

 


 

Exhibit
Number

Document

  

3.1.1(1)

Certificate of Conversion for Delaware.

  

3.1.2(2)

Amended and Restated Certificate of Incorporation.

  

3.1.3(3)

Articles of Amendment to the Articles of Continuance of Viveve Medical, Inc.

  

3.1.4(4)

Certificate of Amendment to the Amended and Restated Certificate of Incorporation filed September 18, 2019.

  

3.1.5(6)3.1.5(5)

Certificate of Amendment to the Amended and Restated Certificate of Incorporation filed November 30, 2020.

  

3.1.6(6)

Certificate of Elimination of Series A Preferred Stock.

3.1.7(7)

Certificate of Designation of Preferences, Rights and Limitations of Series B Preferred Stock.

3.1.8(8)

Form of Certificate of Designation of Preferences, Rights and Limitations of Series C Preferred Stock.

3.1.9(9)

Certificate of Elimination of Series C Preferred Stock.

3.2(2)

Amended and Restated Bylaws.

  

3.3(5)3.3(10)

Amendment to the Amended and Restated Bylaws.

  

31.1*

Certification of the Company’s Principal Executive Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  

31.2*

Certification of the Company’s Principal Accounting and Financial Officer pursuant to Rule 13a-14(a) and 15d-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

  

32.1+32.1**

Certification of the Company’s Principal Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

  

32.2+32.2**

Certification of the Company’s Principal Accounting and Financial Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

  

101.INS*

Inline XBRL Instance

  

101.SCH*

Inline XBRL Taxonomy Extension Schema Document

  

101.CAL*

Inline XBRL Taxonomy Extension Calculation Linkbase Document

 

101.DEF*

Inline XBRL Taxonomy Extension Definition Linkbase Document

 

101.LAB*

Inline XBRL Taxonomy Extension Label Linkbase Document

 

101.PRE*

Inline XBRL Taxonomy Extension Presentation Linkbase Document

  

104

Cover Page Interactive Data File (embedded within the Inline XBRL and contained in Exhibit 101)

 

*  Filed herewith.

+**  This document is deemed not filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.

+  Management contract or compensation plan, contract or arrangement.

41

 

 

(1)

Incorporated by reference from the Form 10-Q filed with the Securities and Exchange Commission on May 13, 2016.

 

(2)

Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on August 16, 2017.

 

(3)

Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on April 14, 2016.

 

(4)

Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on September 18, 2019.

 

(5)

Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on June 16, 2021.December 1, 2020.

 

(6)

Incorporated by reference from the Form 8-K filed with the SEC on December 18, 2020.

(7)

Incorporated by reference from the Form S-1/A filed with the SEC on November 21, 2019.

(8)

Incorporated by reference from the Form 8-K filed with the SEC on January 19, 2021.

(9)

Incorporated by reference from the Form 10-K filed with the Securities and Exchange Commission on March 17, 2022.

(10)

Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on December 1, 2020.June 16, 2021.

 


 

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 thereunto duly authorized.

 

Dated: November 12, 2021August 11, 2022

VIVEVE MEDICAL, INC.

 

(Registrant)

  
 

By:

/s/ Scott Durbin

  

Scott Durbin

  

Chief Executive Officer

(Principal Executive Officer)

   
 

By:

/s/ Jim Robbins

  

Jim Robbins

  

Senior Vice President of Finance and Administration

(Principal Accounting and Financial Officer)

 

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