UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM10-Q

(Mark One)

 

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

 

For thethe quarterly period ended September 30, 2014March 31, 2015

 

OR

 

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

 

For the transitiontransition period from______________ to _______________

 

Commission File Number 1-11388

 

VIVEVE MEDICAL, INC.

(Exact name of registrant as specified in its charter)

 

Yukon Territory, Canada

(State or other jurisdiction of incorporation or organization)

04-3153858

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

 

150 Commercial Street

Sunnyvale, California 94086

(Address of principal executive offices)

(Zip Code)

 

(408)(408) 530-1900

(Registrant’s telephone number, including area code)

 

 

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period than the registrant was required to submit and post such files). Yes ☒ No ☐

 

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

 

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☐

Smaller reporting company ☒

(Do not check if a smaller reporting company)

 

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, 2014May 15, 2015 the issuer had 18,016,66250,773,566 shares of common stock, no par value, issued and outstanding.

 
 

 

 

TABLE OF CONTENTS

 

PART I

FINANCIAL INFORMATION

Page No.

Item 1.

Condensed Consolidated Financial Statements (unaudited)

Condensed Consolidated Balance Sheets as of September 30, 2014 and December 31, 2013

  1

Condensed Consolidated Statements of Operations for the three and nine months ended September 30, 2014 and 2013

 2

Condensed Consolidated Statements of Cash Flows for the nine months ended September 30, 2014 and 2013

  3

Notes to Condensed Consolidated Financial Statements

  4

3

Item 2.

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

  2617

 

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

  3225

 

Item 4.

Controls and Procedures

  3225

 

PART II

OTHER INFORMATION

 32

25

Item 1.

Legal Proceedings

 32

25

Item 1A.

Risk Factors

 32

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

  3225

 

Item 3.

Defaults Upon Senior Securities

  3226

 

Item 4.

Mine Safety Disclosures

  3326

 

Item 5.

Other Information

  3326

 

Item 6.

Exhibits

  3427

 

SIGNATURES

  3528

 

 
i 

 

 

PART I. FINANCIAL INFORMATION

 

ITEM 1.     CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)

 

VIVEVE MEDICAL, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

____________(in thousands, except share and per share data)

 

 

September 30,

2014

  

December 31,

2013

  

March 31,

  

December 31,

 
 

(unaudited)

  (1)  

2015

  

2014

 
ASSETS        

ASSETS

 

(unaudited)

   (1) 
Current assets:                

Cash and cash equivalents

 $1,976,980  $430,107  $221  $895 

Accounts receivable

  3,750   -   35   6 

Inventory

  136,902   228,163   167   131 

Prepaids and other current assets

  188,006   308,183 

Prepaid expenses and other current assets

  881   923 
Total current assets  2,305,638   966,453   1,304   1,955 
Property and equipment, net  191,663   127,524   170   187 
Other assets  652,045   43,783   160   156 
Total assets $3,149,346  $1,137,760  $1,634  $2,298 
LIABILITIES ANDSTOCKHOLDERS' EQUITY (DEFICIT)        

LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT)

        
Current liabilities:                

Accounts payable

 $566,059  $967,315  $612  $416 

Accrued liabilities

  387,538   516,152   583   223 

Note payable

  1,471,799   1,463,244   3,500   2,500 

Related party convertible bridge notes

  -   4,875,000 
Total current liabilities  2,425,396   7,821,711   4,695   3,139 
Preferred stock warrant liabilities  -   623,672 
Total liabilities  2,425,396   8,445,383   4,695   3,139 
Commitments and contingences (Note 7)        

Commitments and contingences (Note 6)

        
Stockholders’ equity (deficit):                

Series A convertible preferred stock, $0.001 par value; 0 and 24,543,626 shares authorized as of September 30, 2014 and December 31, 2013; 0 and 23,863,302 shares issued and outstanding as of September 30, 2014 and December 31, 2013, respectively (Liquidation value of $14,556,614 as of December 31, 2013)

  -   23,863 

Series B convertible preferred stock, $0.001 par value; 0 and 227,000,000 shares authorized as of September 30, 2014 and December 31, 2013; 0 and 171,199,348 shares issued and outstanding as of September 30, 2014 and December 31, 2013, respectively (Liquidation value of $8,559,967 as of December 31, 2013)

  -   171,199 
Preferred stock, no par value; unlimited shares authorized; 0 shares issued and outstanding as of September 30, 2014 and December 31, 2013  -   - 

Common stock, $0.001 par value; 612,000,000 shares authorized as of December 31, 2013; 0 and 6,555,305 shares issued and outstanding as of September 30, 2014 and December 31, 2013, respectively

  -   6,556 

Common stock and paid-in capital, no par value; unlimited shares authorized; 18,016,662 and 0 shares issued and outstanding as of September 30, 2014 and December 31, 2013, respectively

  35,066,274   - 

Additional paid-in capital

  -   22,395,684 

Preferred stock, no par value; unlimited shares authorized;no shares issued and outstanding as of March 31, 2015 andDecember 31, 2014

  -   - 

Common stock and paid-in capital, no par value;unlimited shares authorized as of March 31, 2015 and December 31 2014;18,341,294 shares issued and outstanding as of March 31, 2015and December 31, 2014

  35,548   35,244 

Accumulated deficit

  (34,342,324)  (29,904,925)  (38,609)  (36,085)
Total stockholders’ equity (deficit)  723,950   (7,307,623)  (3,061)  (841)
Total liabilities and stockholders’ equity (deficit) $3,149,346  $1,137,760  $1,634  $2,298 

 

(1) The balance sheet as of December 31, 2013

(1) The condensed consolidated balance sheet as of December 31, 2014 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

(in thousands, except share and per share data)

(unaudited)

 

____________

  

Three Months Ended

 
  

March 31,

 
  

2015

  

2014

 
         

Revenue

 $38  $47 

Cost of revenue

  50   22 

Gross profit (loss)

  (12)  25 
         

Operating expenses:

        

Research and development

  845   174 

Selling, general and administrative

  1,577   516 

Total operating expenses

  2,422   690 

Loss from operations

  (2,434)  (665)

Interest expense

  (83)  (158)

Other income (expense), net

  (7)  21 

Net loss

 $(2,524) $(802)
         
         

Net loss per share:

        

Basic and diluted

 $(0.14) $(15.20)
         

Weighted average shares used incomputing net loss per common share

        

Basic and diluted

  18,341,294   52,768 

 

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  

2014

  

2013

  

2014

  

2013

 
                 

Revenue

 $17,180  $4,610  $64,475  $147,660 

Cost of revenue

  14,724   1,493   40,075   110,528 
Gross profit  2,456   3,117   24,400   37,132 
                 

Operating expenses:

                

Research and development

  572,134   177,203   940,954   628,545 

Selling, general and administrative

  1,790,014   532,369   3,085,580   2,517,791 
Total operating expenses  2,362,148   709,572   4,026,534   3,146,336 
Loss from operations  (2,359,692)  (706,455)  (4,002,134)  (3,109,204)

Interest income

  2   2   5   5 

Interest expense

  (152,296)  (156,727)  (486,582)  (334,380)

Other income (expense), net

  7,827   (8,713)  51,312   11,230 
Net loss $(2,504,159) $(871,893) $(4,437,399) $(3,432,349)
                 

Net loss per share:

                
Basic and diluted $(0.52) $(0.23) $(1.08) $(0.92)

 

                
Weighted average shares used in computing net loss per common share                
Basic and diluted  4,829,300   3,743,282   4,109,266   3,743,282 

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)

 

 

Three Months Ended

 
 

Nine Months Ended

September 30,

  

March 31,

 
 

2014

  

2013

  

2015

  

2014

 
                
Cash flows from operating activities:                
Net loss $(4,437,399) $(3,432,349) $(2,524) $(802)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization expense  42,220   35,871 
Stock-based compensation expense  143,643   66,001 

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

        

Depreciation and amortization

  17   15 

Stock-based compensation

  42   13 

Fair value of warrants issued to employees for bonuses

  244   - 

Fair value of warrants issued to service providers

  18   - 
Revaluation of fair value of warrant liability  (50,762)  (11,230)  -   (21)
Noncash interest expense  369,677   227,911 

Non-cash interest expense

  48   123 
Changes in assets and liabilities:                
Accounts receivable  (3,750)  849   (29)  - 
Inventory  91,261   (574)  (36)  22 
Prepaid and other current assets  120,177   (209,711)

Prepaid expenses and other current assets

  (6)  25 
Other noncurrent assets  13,908   13,908   (4)  14 
Accounts payable  (401,256)  439,849   196   76 
Accrued liabilities  61,293   (80,357)  360   (39)
Net cash used in operating activities  (4,050,988)  (2,949,832)  (1,674)  (574)
                
Cash flows from investing activities:        

Purchase of property and equipment

  (106,359)  (4,214)
Net cash used in investing activities  (106,359)  (4,214)
        
Cash flows from financing activities:                

Net cash proceeds from issuance of common stock in connection with private placement offering

  4,204,220   - 

Proceeds from note payable

  1,000   - 

Proceeds from related party convertible bridge notes

  1,500,000   3,000,000   -   200 

Repayments of notes payable

  -   (134,814)
Net cash provided by financing activities  5,704,220   2,865,186   1,000   200 
Net increase (decrease) in cash and cash equivalents  1,546,873   (88,860)

Net decrease in cash and cash equivalents

  (674)  (374)
                
Cash and cash equivalents - beginning of period  430,107   448,754   895   430 
Cash and cash equivalents - end of period $1,976,980  $359,894  $221  $56 
                
Supplemental disclosure:                

Cash paid for interest

 $116,905  $106,469  $35  $35 

Cash paid for income taxes

 $800  $800  $1  $1 
        
Supplemental disclosure of cash flow information as of end of period:        
Conversion of certain bridge notes and related accrued interest in connection with private placement offering $1,545,678  $- 
Extinguishment of convertible bridge notes and related accrued interest pursuant to Merger Agreement $5,397,278  $- 
Extinguishment of warrant liabilities pursuant to Merger Agreement $572,910  $- 

Issuance of warrants in connection with note payable

 $622,170  $- 
Payable to non-accredited investors in connection with Merger Agreement $16,498     

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

 

 

 

VIVEVE MEDICAL, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS

 

1.

1.        The Company and Basis of Presentation

 

On September 23, 2014, Viveve Medical, Inc. (formerly PLC Systems, Inc.), a Yukon Territory corporation (“PLC”Viveve Medical”, the “Company”, “we”, “our”, or “us”) completed a reverse acquisition and recapitalization pursuant to the terms and conditions of an Agreement and Plan of Merger (“Merger Agreement” or “Merger”) withby and among the Company, Viveve®, Inc., a Delaware corportationcorporation (“Viveve”) and PLC Systems Acquisition Corp., a wholly owned subsidiary of the Company (the “Merger”). As of that date, Viveve operates as a wholly-owned subsidiary of PLCthe Company and PLC is known asthe Company changed its name to Viveve Medical, Inc. (“Viveve Medical”, the “Company”, “we”, “our”, or “us”). Viveve Medical will competecompetes in the women’s health market with a focus on the Viveve System™ to improve women’s overall sexual well-being and quality of life, will retainretained all its personnel and continuecontinues to be headquartered in Sunnyvale, California.

 

At the effective time of the Merger, PLCthe Company divested itsthe ownership of its former operating subsidiaries, PLC Medical Systems, Inc. and PLC Systemas Medicos Internacionais, which will operate as independent entities going forward under new ownership.

 

In preparation for the stock exchange pursuant toconnection with the Merger, Vivevecertain outstanding convertible bridge notes in the aggregate principal amount of $4,875,000 and related accrued interest of approximately $522,000 were extinguished.  

 

Additionally, Viveve warrant liabilities of Viveve for approximately $573,000$572,000 were extinguished in preparation of the stock exchange pursuant toconnection with the Merger.

 

Pursuant to the Merger Agreement, all shares of capital stock (including common and preferred stock) of Viveve owned by accredited investors were converted into 3,743,282 shares of the Company's common stock which represented approximately 62% of the issued and outstanding shares of common stock of the Company on a fully diluted basis. In addition, non-accredited investors of Viveve were entitled to receive approximately $16,500$16,000 in exchange for the shares of common stock of Viveve owned by such holders upon closing. Upon the closing of the Merger, the Company issued an additional 943,596 shares of the Company’s common stock were issued upon the automatic conversion of a warrant issued in exchange for the cancellation of related party convertible bridge notes.

 

The acquisition was accounted for as a reverse merger and recapitalization effected by a share exchange. Viveve is considered the acquirer for accounting and financial reporting purposes. The assets and liabilities of the acquired entity have been brought forward at their book value and no goodwill has been recognized. 

 

Concurrent with the Merger, Viveve Medical completed a private placement for total gross proceeds of approximately $6 million (including the conversion of approximately $1.5 million ofin outstanding convertible bridge note conversion)notes). As a result, Viveve Medical issued 11,305,567 shares of common stock (which excludes an additional 101,365 shares of common stock which were not issued as a result of beneficial ownership limitations) and 5-year warrants to purchase up to 940,189 shares of common stock at an exercise price of $0.53 per share.

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 (“US GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US 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 proxy statementAnnual Report on Form 10-K for the year ended December 31, 2014, which was filed with the Securities and Exchange Commission on August 11, 2014.TheMarch 16, 2015.The results of operations for the three and nine months ended September 30, 2014March 31, 2015 are not necessarily indicative of the results for the year ending December 31, 20142015 or any future interim period.

 

2.


2.         Summary of Significant Accounting Policies

 

Financial Statement Presentation

 

The condensed consolidated financial statements include the accounts of the Company and our wholly-owned subsidiary.subsidiaries, Viveve and Viveve BV (which was established in January 2015). All significant intercompany accounts and transactions have been eliminated in consolidation.

 

Use of Estimates

 

The preparation of condensed consolidated financial statements in conformity with US GAAP requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, 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.

  


ReclassificationsConcentration of Credit Risk and Other Risks and Uncertainties

 

CertainTo 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.

The Company’s products may require approval from the U.S. Food and Drug Administration or other international regulatory agencies prior year financial statement amountsto commencing commercial sales. There can be no assurance that the Company’s products will receive any of these required approvals. If the Company was denied such approvals or such approvals were delayed, it would have been reclassified to conform to the current year’s presentation. These reclassifications had noa material adverse impact on previously reported total assets, stockholders’ deficit or net loss.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.

During the three months ended March 31, 2015, one customer accounted for 93% of the Company’s revenue. During the three months ended March 31, 2014, three customers accounted for 100% of the Company’s revenue.

  

Revenue Recognition

 

The Company recognizes revenue from the sale of its product,products, the Viveve® System, and single-use treatment tips.tips and ancillary consumables. Revenue is recognized upon delivery, provided that persuasive evidence of an arrangement exists, the price is fixed or determinable and collection of the resulting receivable is reasonably assured. Sales of Viveve’s products are subject to regulatory requirements that vary from country to country. The Company has regulatory clearance outside the U.S. and currently sells the Viveve System in Canada, Hong Kong, Japan and Japan.Europe.

 

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

Product Warranty

The Company’s products are generally subject to a one year warranty, which provides for the repair, rework or replacement of products (at its option) that fail to perform within stated specification. The Company has assessed the historical claims and, to date, product warranty claims have not been significant. The Company will continue to assess the need to record a warranty accrual at the time of sale going forward.

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 months ended March 31, 2015 and 2014, 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 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, convertible preferred stock, warrants to purchase convertible preferred stock and common stock, stock options and rights to common stock 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. Potential common shares will always be anti-dilutive for periods in which the Company has reported a net loss.

For the three months ended March 31, 2015 and 2014, the following securities were excluded from the calculation of net loss per share because the inclusion would be anti-dilutive.

  

Three Months Ended

 
  

March 31,

 
  

2015

  

2014

 

Convertible preferred stock

  -   195,062,650 

Warrants to purchase convertible preferred stock

  -   16,680,324 

Stock options to purchase common stock

  2,905,783   363,413 

Warrants to purchase common stock

  2,411,071   - 

Rights to common stock

  566,038   - 

 

Recently Issued and Adopted Accounting Standards

 

In May 2014, as part of its ongoing efforts to assist in the convergence of US GAAP and International Financial Reporting Standards (“IFRS”), the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers (Topic 606).” The new guidance sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed in U.S. GAAP. The underlying principle of the new standard is that a business or other organization will recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects what it expects in exchange for the goods or services. The standard also requires more detailed disclosures and provides additional guidance for transactions that were not addressed completely in the prior accounting guidance. The ASU provides alternative methods of initial adoption and is effective for annual and interim periods beginning after December 15, 2016. We are currently evaluating the impact that this standard will have on our condensed consolidated financial statements.

 

In June 2014, the FASB issued ASU No. 2014-12, “Compensation — Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could be Achieved After a Requisite Service Period” (“ASU 2014-12”). Companies commonly issue share-based payment awards that require a specific performance target to be achieved in order for employees to become eligible to vest in the awards. ASU 2014-12 requires that a performance target that affects vesting and that could be achieved after the requisite service period should be treated as a performance condition. The performance target should not be reflected in estimating the grant date fair value of the award. Compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved. ASU 2014-12 will be effective for the Company’s fiscal years beginning fiscal 2016 and interim reporting periods within that year, using either the retrospective or prospective transition method. Early adoption is permitted. We are currently evaluating the effect of the adoption of this guidance on our condensed consolidated financial statements.

   


In June 2014, the FASB issued ASU 2014-10,  “Development Stage Entities (Topic 915):  Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in topic 810, Consolidation” (“ASU 2014-10”). ASU 2014-10 removes the definition of a development stage entity from the Master Glossary of the Accounting Standards Codification, thereby removing the financial reporting distinction between development stage entities and other reporting entities from U.S. GAAP. ASU 2014-10 also eliminates the requirements for development stage entities to (1) present inception-to-date information in the statements of income, cash flows, and shareholder equity, (2) label the financial statements as those of a development stage entity, (3) disclose a description of the development stage activities in which the entity is engaged, and (4) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage. The amendments also clarify that the guidance in Topic 275, Risks and Uncertainties, is applicable to entities that have not commenced planned principal operations. The amendments in ASU 2014-10 will be effective retrospectively except for the clarification to Topic 275, which shall be applied prospectively for annual reporting periods beginning after December 15, 2014, and interim periods therein. Early application of each of the amendments is permitted for any annual reporting period or interim period for which the entity’s financial statements have not yet been issued. We elected to early adopt the provisions of ASU 2014-10 in the second quarter of 2014.

In August 2014, the FASB issued ASU No. 2014-15, “Presentation of Financial Statements - Going Concern (Subtopic 310-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”), to provide guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and to provide related footnote disclosures. ASU 2014-15 is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Since ASU 2014-15 only impacts financial statement disclosure requirements regarding whether there is  substantial doubt about an entity’s ability to continue as a going concern, we do not expect itsWe are currently evaluating the effect of the adoption to have an impactof this guidance on our ccondensed onsolidatedcondensed consolidated financial statements.

Concentration of Credit Riskstatements 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.

The Company’s future products may require approval from the U.S. Food and Drug Administration or other international regulatory agencies prior to commencing commercial sales. There can be no assurance that the Company’s future products will receive any of these required approvals. If the Company was denied such approvals or such approvals were delayed, it would have a material adverse impact 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.

During the nine months ended September 30, 2014, three customers accounted for 94% of the Company’s revenue.

During the nine months ended September 30, 2013, one customer accounted for 100% of the Company’s revenue.

During the three months ended September 30, 2014, two customers accounted for 79% of the Company’s revenue.

During the three months ended September 30, 2013, one customer accounted for 100% of the Company’s revenue.


Inventory

Inventory is stated at the lower of cost or market, cost being determined on an actual cost basis on a first-in, first-out basis and market being determined as the lower of replacement cost or net realizable value.disclosures.

 

Product Warranty3.        Fair Value Measurements

The Company’s products are generally subject to a one year warranty, which provides for the repair, rework or replacement of products (at its option) that fail to perform within stated specification. The Company has assessed the historical claims and, to date, product warranty claims have not been significant. The Company will continue to assess if there should be a warranty accrual.

Comprehensive Loss

Comprehensive loss represents the changes in equity of an enterprise, except those resulting from stockholder transactions. Accordingly, comprehensive loss may include certain changes in equity that are excluded from net loss. For the three and nine months ended September 31, 2014 and 2013, the Company’s comprehensive loss is the same as its net loss. There were no components of comprehensive loss for any of the periods presented.

Net Loss per Share Attributable to Common Stockholders

The Company’s basic net loss per share attributable to common stockholders is calculated by dividing the net loss by the weighted average number of shares of common stock outstanding for the period. The diluted net loss per share attributable to common stockholders is computed by giving effect to all potentially dilutive common stock equivalents outstanding for the period. For purposes of this calculation, options and warrants to purchase common stock are considered common stock equivalents. For periods in which the Company has reported net losses, diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive. Potential common shares will always be anti-dilutive for periods in which the Company has reported a net loss. Diluted net loss per share attributable to common stockholders is the same as basic net loss per share attributable to common stockholders for the three and nine months ended September 30, 2014 and 2013.

For the three and nine months ended September 30, 2014 and 2013, the following weighted average common stock equivalent shares were excluded from the calculation of net loss per share because the inclusion would be anti-dilutive.

  

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

 
  

2014

  

2013

  

2014

  

2013

 

Stock options to purchase common stock

  476,671   409,488   445,804   491,609 

Warrants to purchase common stock

  72,322   -   24,107   - 
   548,993   409,488   469,911   491,609 


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.

 

The Company’s Level 1 financial asset is a money market fund with a fair value that is based on quoted market prices. The money market fund is included in cash and cash equivalents on the Company’s condensed consolidated balance sheet. The Company’s Level 3 liability consists of convertible preferred stock warrant liabilities. The valuation of the warrant liabilities is discussed in Note 8.

For the period ended September 30, 2014, the Company did not have any transfers between Level 1, Level 2 and Level 3.


The following tables set forth the Company’sThere were no financial instruments that were measured at fair value on a recurring basis as of September 30, 2014March 31, 2015 and December 31, 2013 by level within the fair value hierarchy:2014.

  

Assets and Liabilities at Fair Value as of September 30, 2014

 
  

Quoted prices in active markets for identical assets

  

Significant

other observable inputs

  

Significant unobservable

inputs

     
  

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets

                

Money market fund

 $190  $-  $-  $190 
Total assets $190  $-  $-  $190 

Liabilities

                

Preferred stock warrant liabilities

 $-  $-  $-  $- 
Total liabilities $-  $-  $-  $- 

  

Assets and Liabilities at Fair Value as of December 31, 2013

 
  

Quoted prices in active markets for identical assets

  

Significant

other observable inputs

  

Significant unobservable

inputs

     
  

Level 1

  

Level 2

  

Level 3

  

Total

 

Assets

                

Money market fund

 $324  $-  $-  $324 
Total assets $324  $-  $-  $324 

Liabilities

                

Preferred stock warrant liabilities

 $-  $-  $623,672  $623,672 
Total liabilities $-  $-  $623,672  $623,672 

 

The change incarrying amounts of the Company’s financial assets and liabilities, including cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses 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 preferred stock warrant liabilities is summarized below:note payable approximates fair value.

 

Fair value as of  December 31, 2013

 $623,672 

Change in fair value recorded in other income (expense), net

  (21,484)

Fair value as of March 31, 2014

  602,188 

Change in fair value recorded in other income (expense), net

  (22,001)

Fair value as of June 30, 2014

  580,187 

Change in fair value recorded in other income (expense), net, as of September 23, 2014, date of the Merger Agreement

  (7,277)

Extinguishment of warrant liabilities pursuant to the Merger Agreement (reclassified to equity)

  (572,910)

Fair value as of September 30, 2014

 $- 


All assets and liabilities carried at fair value have been valued using a market approach, except for Level 3. The following table describes the valuation techniques used to calculate fair value for Level 3 liabilities. For Level 3 liabilities, the Company determines the fair value measurement valuation policies and procedures. Annually, the Board of Directors assess and approve the fair value measurement policies and procedures. At least annually, the Company determines if the current valuation techniques used in the fair value measurements are still appropriate and evaluates and adjusts the unobservable inputs used in the fair value measurements based on current market conditions and third-party information.

  

Fair Value as of

 

Valuation

 

Unobservable

 

Range

 
  

December 31, 2013

 

Techniques

 

Input

 

(Weighted-Average)

 
            

Preferred stock warrant liabilities

 $623,672 

Black-Scholes

 

Preferred series

    
     

option pricing

 

prices

  $0.04-$0.44 ($0.06) 
     

model

      
       

Volatility

  70.62%-84.23% (76%) 

There were no changes in valuation technique from prior periods.

4.

4.         Accrued Liabilities

 

Accrued liabilities consisted of the following as of March 31, 2015 and December 31, 2014 (in thousands):

  

March 31,

  

December 31,

 
  

2015

  

2014

 
         

Accrued professional fees

 $269  $117 

Accrued clinical trial costs

  126   - 

Accrued vacation

  97   86 

Accrued payroll and other related expenses

  45   - 

Accrued interest

  14   - 

Other accruals

  32   20 

Total accrued liabilities

 $583  $223 


5.       Note Payable

On September 30, 2014, and December 31, 2013:

  

September 30,

  

December 31,

 
  

2014

  

2013

 
         

Accrued interest

 $13,792  $235,603 

Accrued professional fees

  125,671   15,000 

Accrued loan balloon payment

  85,000   76,472 

Accrued vacation

  73,809   81,499 

Accrued loan restructuring fees

  47,500   27,288 

Accrued severence pay

  -   58,846 

Other accruals

  41,766   21,444 
Total accrued liabilities $387,538  $516,152 

5.

Note Payable

In April 2012, the Companywe entered into a loan and security agreement, for upas amended on February 19, 2015, pursuant to $2,135,159which we received a term loan in term loans thatthe amount of $5 million, funded in 3 tranches. The first tranche of $2.5 million was provided to us on October 1, 2014. The proceeds from the first tranche were used to pay offrepay the existing loan with a financial institution.institution which totaled approximately $1,631,000 and the balance was used for general working capital purposes and capital expenditures. The full amount was drawn down in April 2012. In connection with the agreement, the Company issued a warrant to the lender to purchase a total of 73,770 shares of the Company’s Series A convertible preferred stock at $0.61 per share (Note 9). The borrowings werefirst tranche borrowing is repayable in interest only payments until MayNovember 1, 20122015 and then 30 equal installments of principal and interest at a rate of 9.5%5.25% per annum. An additional 4%The second tranche of the term loan is equal to $1.5 million, of which $500,000 was provided to us on February 19, 2015 and an additional $1 million was subject to (i) evidence acceptable to the lender of at least 50% enrollment in the Company’s randomized, blinded and sham-controlled clinical trial in Europe and Canada (the “OUS Clinical Trial”) no later than March 9, 2015, which has been satisfied, and (ii) when documentation or other evidence acceptable to the lender of a prospective equity financing was provided. On March 16, 2015, we received an additional $500,000 in connection with a drawdown of funds from the second tranche, for a total of $1,000,000 received under the second tranche as of March 31, 2015. The second tranche borrowings in February and March 2015 are repayable in interest only payments until March 1, 2016 and then 30 equal installments of principal or approximately $85,000and interest at a rate of 5.00% and 5.06% per annum, respectively. The Company may receive up to $1 million in connection with the third tranche at any time during the period in which it has provided evidence to lender of positive 3-month interim results with respect to the OUS Clinical Trial until June 30, 2015. The proceeds from the second and third tranches will be due as the final payment at the end of the loan term. The Company recorded $8,528used for general working capital purposes and $28,785 as additional interest expense during the nine months ended September 30, 2014 and 2013, respectively, related to the $85,000 payment. The Company will continue to accrue the balance of the $85,000 cash payment over the remaining term of the loan using the effective interest rate method.capital expenditures. As of September 30, 2014March 31, 2015 and December 31, 2013, $85,0002014, the note payable had an outstanding balance of $3,500,000 and $76,472 was$2,500,000, respectively, which is recorded in accrued liabilitiesas a current liability on the condensed consolidated balance sheets relating to this payment.sheets. All borrowings under the agreement are collateralized by substantially all of the Company’s assets, including intellectual property. As of September 30, 2014 and December 31, 2013, the note payable had an outstanding balance of $1,471,799 and $1,462,244, respectively. The term loan has a maturity date of October 1, 2014 and was repaid on that date as discussed in Note 13.

In February 2013, the Company and lender amended the loan and security agreement to defer up to 3 months of principal payments contingent upon the receipt of bridge loan proceeds in increments of $500,000, up to $1,500,000 on or before April 30, 2013, beginning March 1, 2013. This amendment also included a $15,000 restructuring fee that would be due upon the maturity date of the loan.

In May 2013, the Company and lender amended the loan and security agreement to defer an additional 2 months of principal payments contingent upon the receipt of bridge loan proceeds of $500,000 or more, on or before September 30, 2013. The principal payments were to be deferred and payable on August 1, 2013. This amendment also included a $10,000 restructuring fee that would be due upon the maturity date of the loan.


In July 2013, the Company and lender agreed to further amend the loan and security agreement to defer an additional 2 months of principal payments contingent upon the receipt of bridge loan proceeds of $500,000 or more, on or before August 28, 2013, and an additional month deferral provided a 2013 equity event was completed resulting in net cash proceeds of not less than $10 million from the sale of the Company’s equity securities consummated by September 27, 2013. Principal payments would be deferred and payable on October 1, 2013, provided both of these conditions were met. This amendment also included a $10,000 restructuring fee that would be due upon the maturity date of the loan.

In September 2013, the Company and lender agreed to further amend the loan and security agreement to defer an additional 2 months of principal payments contingent upon the receipt of bridge loan proceeds of $500,000 or more on or before August 28, 2013 and another $500,000 or more on or before October 28, 2013. Principal payments would be deferred until December 1, 2013. This amendment also included a $10,000 restructuring fee that would be due upon the maturity date of the loan.

In November 2013, the Company and lender agreed to further amend the loan and security agreement to defer an additional 2 months of principal payments contingent upon the receipt of bridge loan proceeds of $500,000 or more on or before December 27, 2013 and upon the consummation of a 2014 equity event requiring the receipt of not less than $7 million in net cash proceeds by no later than January 24, 2014. Principal payments would be deferred until February 1, 2014. This amendment also included a $10,000 restructuring fee that would be due upon the maturity date of the loan.

In January 2014, the Company and lender agreed to further amend the loan and security agreement to defer an additional 2 months of principal payments contingent upon the receipt of bridge loan proceeds of $500,000 or more on or before February 25, 2014 and consummation of an equity event by April 25, 2014. This amendment included an additional $5,000 restructuring fee for each month principal payments are deferred beginning February 1, 2014 through April 1, 2014, provided restructuring fees in this amendment shall not exceed $15,000 in total that would also be due upon the maturity date of the loan.

In February 2014, the Company and lender agreed to further amend the loan and security agreement to defer an additional 2 months of principal payments contingent upon the receipt of bridge loan proceeds of $500,000 or more on or before April 25, 2014 and consummation of an equity event by June 27, 2014. This amendment included an additional $5,000 restructuring fee for each month principal payments are deferred beginning March 1, 2014 through June 1, 2014, provided restructuring fees in this amendment shall not exceed $20,000. This amendment also amended the January 2014 restructuring fee such that the January 2014 restructuring fee shall not exceed $5,000 in total that would also be due upon the maturity date of the loan.

In June 2014, the Company and lender agreed to further amend the loan and security agreement such that the remaining 3 months of principal payments would be deferred until the maturity date of the term loan when all unpaid principal and interest will be immediately due. This amendment also includes an additional $5,000 restructuring fee for each month principal payments are deferred beginning July 1, 2014 through September 1, 2014, provided restructuring fees in this amendment do not exceed $15,000 in total that would also be due upon the maturity date of the loan.


In September 2014, the lender agreed to reduce the total restructuring fees to $47,500. The Company recorded $20,212, net of the reduction in fees, and $45,000 as additional interest expense during the nine months ended September 30, 2014 and 2013, respectively, related to these restructuring fees. The Company has been accruing the balance of the cash restructuring payment over the term of the loan using the effective interest rate method. As of September 30, 2014 and December 31, 2013, $47,500 and $27,288 was recorded as an accrued liability on the condensed consolidated balance sheets relating to this restructuring payment.

 

The loan and security agreement also requires that the Company comply with certain financial and other covenants for borrowings to be permitted. The terms of the loan require that the Company meet certain financial covenants and milestones in connection with the OUS Clinical Trial, including but not limited to, (a) full enrollment as of March 31, 2015, (b) positive 3-month interim data as of April 15, 2015, subject to postponement until June 30, 2015 by the lender upon achievement of certain other milestones under the loan, as amended, and (c) positive results from the trial as of January 31, 2016. As of March 31, 2015, full enrollment of the OUS Clinical Trial has been achieved. As of March 31, 2015 the Company was in compliance with all covenants of the loan agreement.

In connection with the loan and security agreement, the Company issued a 10-year warrant to the lender for the purchase of 471,698 shares of the Company’s common stock at $0.53 per share. In connection with the loan amendment, the Company also amended the terms of the warrant issued to the lender to provide for an automatic increase of the number of shares the lender may acquire in the event the Company fails to meet certain covenants (see Note 7).

The loan and security agreement with the financial institution contains a material adverse change clause, as defined in the agreement, which would result in an event of default if the lender deems a material adverse change to have occurred to the Company’s business. The continuing liquidity issues the Company faces could be construed by the note holder as a material adverse change which could trigger an acceleration of all of the outstanding debt. As such, the Company has classified all of its outstanding debt balance as a current liability as of September 30, 2014March 31, 2015 and December 31, 2013.2014.

 

As of September 30, 2014,March 31, 2015, future minimum payments under the note payable are as follows:follows (in thousands):

 

Year Ending December 31, 2014

 $1,618,091 
  1,618,091 

Year Ending December 31,

    

2015 (remaining 9 months)

 $299 

2016

  1,473 

2017

  1,469 

2018

  609 

Total payments

  3,850 

Less: Amount representing interest

  (146,292)  (350)
Present value of obligations  1,471,799   3,500 

Less: Unamortized debt discount

  - 
  1,471,799 

Less: Notes payable, current portion

  1,471,799   3,500 
Notes payable, noncurrent portion $- 

Note payable, noncurrent portion

 $- 

 

On September 30, 2014, the Company entered into a Loan and Security Agreement pursuant to which we received a term loan in the amount of $5 million, which will be funded in three tranches. The first tranche of $2.5 million was provided to the Company on October 1, 2014. The proceeds from the first tranche were used to repay the existing loan (including interest and restructuring fees) with a financial institution which totaled $1,630,925. Before the second and third tranches of the term loan will be funded, we must meet certain enrollment milestones and achieve certain positive results relating to our OUS Clinical Trials, among other things. In connection with the loan agreement, the Company issued a 10-year warrant to the lender for the purchase of 471,698 shares of the Company’s common stock at $0.53 per share (Note 8).

6.

Related Party Convertible Bridge Notes

In November 2012, the Company issued $1,000,000 in convertible promissory notes to related parties. The notes accrue interest at 8% per annum and mature at the earlier of i) the date upon which the majority note holders demand repayment after May 15, 2013 or ii) the date of the closing of a qualified financing in which the Company issues common or preferred stock for gross proceeds of not less than $5,000,000. As of September 30, 2014 and December 31, 2013, the outstanding principal balance was $0 and $1,000,000. Because the holders had the ability to demand repayment after May 15, 2013, the Company classified all of the outstanding debt balance and related accrued interest of $88,986 as a current liability as of December 31, 2013. In connection with the Merger, these convertible promissory notes were extinguished.


On February 13, 2013, the Company entered into a note purchase agreement (“2013 Note Purchase Agreement”) with related parties to which it was authorized to issue and sell convertible promissory notes up to $1,500,000 in the aggregate, of which $1,000,000 was issued. These notes were intended as bridge financing to a planned alternative public offering in the second quarter of 2013.The notes accrue interest at 8% per annum and mature at the earlier of the date upon which the majority note holders demand repayment after August 13, 2013 or the date of the closing of a qualified financing in which the Company issues common or preferred stock for gross proceeds of not less than $5,000,000 excluding the conversion of these notes and the November 2012 notes. The notes convert into the number of shares equal to the principal and unpaid accrued interest divided by the conversion price, which is defined as 80% of the purchase price in the qualified financing. If the Company does not execute a qualified financing, the holders may elect conversion of the notes prior to the maturity date of August 13, 2013. Under the elective conversion, the notes convert into the number of the next equity financing shares or shares of Series B convertible preferred stock that are equal to the principal and the unpaid accrued interest divided by the conversion price. The conversion price is defined as 80% of the price paid by the investors in the next equity financing series or $0.05, if the notes are converted into the Series B convertible preferred stock. In April 2013, the Company completed another closing of the 2013 Note Purchase Agreement for $500,000. On June 3, 2013, the Company entered into an amendment to the 2013 Note Purchase Agreement to increase the total amount of the convertible promissory notes up to $2,000,000 in the aggregate if issued before June 30, 2013. In June 2013, the Company completed another closing of the 2013 Note Purchase Agreement for $500,000. On August 7, 2013, the Company entered into an amendment to the 2013 Note Purchase Agreement to increase the total amount of the convertible promissory notes up to $2,500,000 in the aggregate if issued before August 28, 2013. In August 2013, the Company completed another closing of the 2013 Note Purchase Agreement for $500,000. As of September 30, 2014 and December 31, 2013, the outstanding principal balance was $0 and $2,500,000.Because the holders had the ability to demand repayment after August 13, 2013, the Company classified all of the outstanding debt balance and related accrued interest of $130,466 as a current liability as of December 31, 2013. In connection with the Merger, these convertible promissory notes were extinguished.

On September 27, 2013, the Company entered into a note purchase agreement (“September 2013 Note Purchase Agreement”) with related parties to which it was authorized to issue and sell convertible promissory notes up to $500,000 in the aggregate. These notes were intended as bridge financing to a planned APO in the third quarter of 2013.The notes accrue interest at 8% per annum and mature at the earlier of the date upon which the majority note holders demand repayment after March 31, 2014 or the date of the closing of a qualified financing in which the Company issues common or preferred stock for gross proceeds of not less than $5,000,000 excluding the conversion of these notes, the November 2012 notes and the 2013 Note Purchase Agreement. The notes convert into the number of shares equal to the principal and unpaid accrued interest divided by the conversion price, which is defined as 70% of the purchase price in the qualified financing. If the Company does not execute a qualified financing, the holders may elect conversion of the notes prior to the maturity date of March 31, 2014. Under the elective conversion, the notes convert into the number of the next equity financing shares or shares of Series B convertible preferred stock that are equal to the principal and the unpaid accrued interest divided by the conversion price. The conversion price is defined as 70% of the price paid by the investors in the next equity financing series or $0.05, if the notes are converted into the Series B convertible preferred stock. As of September 30, 2014 and December 31, 2013, the outstanding principal balance was $0 and $500,000.Because the holders had the ability to demand repayment after March 31, 2014, the Company classified all of the outstanding debt balance and related accrued interest of $10,411 as a current liability as of December 31, 2013. In connection with the Merger, these convertible promissory notes were extinguished.


On November 12, 2013, the Company entered into a note purchase agreement (“November 2013 Note Purchase Agreement”) with related parties to which it was authorized to issue and sell convertible promissory notes up to $500,000 in the aggregate. These notes were intended as bridge financing to a planned APO in the fourth quarter of 2013.The notes accrue interest at 8% per annum and mature at the earlier of the date upon which the majority note holders demand repayment after March 31, 2014 or the date of the closing of a qualified financing in which the Company issues common or preferred stock for gross proceeds of not less than $5,000,000 excluding the conversion of these notes, the November 2012 notes and the 2013 Note Purchase Agreement. The notes convert into the number of shares equal to the principal and unpaid accrued interest divided by the conversion price, which is defined as 70% of the purchase price in the qualified financing. If the Company does not execute a qualified financing, the holders may elect conversion of the notes prior to the maturity date of March 31, 2014. Under the elective conversion, the notes convert into the number of the next equity financing shares or shares of Series B convertible preferred stock that are equal to the principal and the unpaid accrued interest divided by the conversion price. The conversion price is defined as 70% of the price paid by the investors in the next equity financing series or $0.05, if the notes are converted into the Series B convertible preferred stock. As of September 30, 2014 and December 31, 2013, the outstanding principal balance was $0 and $500,000.Because the holders had the ability to demand repayment after March 31, 2014, the Company classified all of the outstanding debt balance and related accrued interest of $5,370 as a current liability as of December 31, 2013. In connection with the Merger, these convertible promissory notes were extinguished.

On December 27, 2013, the Company entered into a note purchase agreement (“December 2013 Note Purchase Agreement”) with related parties to which it was authorized to issue and sell convertible promissory notes up to $375,000 in the aggregate. These notes were intended as bridge financing to a planned APO in the first quarter of 2014.The notes accrue interest at 9% per annum and mature at the earlier of the date upon which the majority note holders demand repayment after March 31, 2014 or the date of the closing of a qualified financing in which the Company issues common or preferred stock for gross proceeds of not less than $5,000,000 excluding the conversion of these notes, the November 2012 notes and the 2013 Note Purchase Agreement. The notes convert into the number of shares equal to the principal and unpaid accrued interest divided by the conversion price, which is defined as 70% of the purchase price in the qualified financing. If the Company does not execute a qualified financing, the holders may elect conversion of the notes prior to the maturity date of March 31, 2014. Under the elective conversion, the notes convert into the number of the next equity financing shares or shares of Series B convertible preferred stock that are equal to the principal and the unpaid accrued interest divided by the conversion price. The conversion price is defined as 70% of the price paid by the investors in the next equity financing series or $0.05, if the notes are converted into the Series B convertible preferred stock. As of September 30, 2014 and December 31, 2013, the outstanding principal balance was $0 and $375,000.Because the holders had the ability to demand repayment after March 31, 2014, the Company classified all of the outstanding debt balance and related accrued interest of $370 as a current liability as of December 31, 2013. In connection with the Merger, these convertible promissory notes were extinguished.

On March 5, 2014, the Company entered into a note purchase agreement in which it was authorized to issue and sell up to $1,250,000 in aggregate principal amount of convertible promissory notes of which $200,000 was issued. In May 2014, the Company completed another sale of convertible promissory notes in the aggregate principal amount of $1,050,000. The notes accrued interest at 9% per annum and converted into common stock in connection with the private placement.

On July 7, 2014, the Company entered into a note purchase agreement in which it was authorized to issue convertible promissory notes up to $250,000 in the aggregate. The notes accrue interest at 9% per annum and converted into common stock in connection with the private placement.

Pursuant to the Company’s amendment to the note purchase agreement dated November 20, 2012, effective February 13, 2013, the above notes payable would be redeemable upon a change of control of the Company at an amount equal to 300% of the outstanding principal amount and accrued and unpaid interest on the notes as of the time of a change of control. A change of control will occur in the event the Company enters into a transaction where the holders of the voting securities no longer own a majority of the total outstanding voting securities once the transaction is completed or a disposition of substantially all assets occurs. The sale of stock for capital raising purposes or an alternative public offering involving a reverse merger into a public shell company for capital raising purposes is excluded from the Company’s definition of a change of control. The Company has determined that the value of this provision is not material and as such did not record a liability on the Company’s condensed consolidated financial statements as of December 31, 2013. All of these notes were extinguished as part of the Merger Agreement.


7.

6.         Commitments and Contingencies

 

Operating Lease

 

In January 2012, the Company relocated and entered into a lease agreement for a new facility.office and laboratory facilities. The new lease agreement, as amended in January 2015, commenced in March 2012 and will terminate in February 2015.March 2017. Rent expense for the ninethree months ended September 30,March 31, 2015 and 2014 was $47,000 and 2013 was $128,359 and $128,359,$43,000, respectively.

 

As of September 30, 2014,March 31, 2015, future minimum payments under the lease are as follows:follows (in thousands):

 

Year Ending December 31,

        

2014

 $46,428 

2015

  30,952 

2015 (remaining 9 months)

 $168 

2016

  229 

2017

  58 
Total minimum lease payments $77,380  $455 


 

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 amount 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.

 

Loss Contingencies

 

From timeThe Company is or has been subject to time, the Company may have certain contingent liabilities that ariseproceedings, lawsuits and other claims arising in the ordinary course of business activities.business. The Company evaluates contingent liabilities, including threatened or pending litigation, for potential losses. If the potential loss from any claim or legal proceedings in 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 matters when it is probablepotential loss or include a statement that future expenditures willan estimate of the potential loss cannot be mademade. As additional information becomes available, the Company reassesses the potential liability related to pending claims and such expenditures can be reasonably estimated.litigation and may revise its estimates, which could materially impact its condensed consolidated financial statements.  

 

8.

7.        Common Stock

 

In connectionconjunction with the Merger, all shares of Viveve Series A convertible preferred stock and Series B convertible preferred stock were converted to common stock and2014 private placement, the Company exchangedentered into a Right to Shares Agreement with certain investors. Pursuant to this agreement, 854,989 shares of common stock withpurchased by the former stockholders of Viveve.investors were cancelled. The total common shares issued for these transactions was 3,743,282 shares based onCompany is obligated to issue, and the exchange ratio of 0.0080497.


In connection withinvestors have the proposed Merger, on May 9, 2014, Viveve issuedright to GBS Venture Partners Limited (“GBS”), a convertible debenture holder, a warrantreceive up to purchase956,354 shares of ourthe Company’s common stock, equalwhich includes 101,365 shares that were not issued in the private placement due to approximately 5%beneficial ownership limitations. No additional consideration will bepaid upon the issuance of the outstandingshares and the subscription amount has been paid in full by the investors and is non-refundable. The Company is obligated to deliver the shares to the investors within 3 days of the investors’ request for the share issuance. If the Company fails to deliver the shares within 3 days of the request, under certain circumstances defined in the Right to Shares Agreement, the Company may be obligated to reimburse the investors in cash for losses that the investors incur as a result of not having access to the shares (the “Buy-In Shares”). In December 2014, certain investors exercised their right to such shares and the Company issued 390,316 shares of common stock. As of March 31, 2015, the Company has reserved, but not issued 566,038 shares of common stock on a post-Merger basis in consideration forpursuant to the cancellation of convertible promissory notes inRight to Shares Agreement.

The Company assessed the aggregate principal amount of $1,750,000 and accrued interest of approximately $211,000 held by GBS. As partprovisions of the closingBuy-In Share feature of the Merger,Right to Shares Agreements as an embedded derivative and has concluded that the Company issued 943,596 sharesfeature meets the definition of common stocka derivative and is not clearly and closely related to GBS upon the automatic exerciseRights to Shares equity host agreement. The Buy-In Shares feature has been bifurcated from the Rights to Shares agreement and accounted for separately. The value of this feature was nominal as of the warrant.

Concurrent with the Merger, the Company completed a separate private placement of 11,305,567 shares of our common stock, together with warrants for the purchase of 940,189 shares of common stock, for gross proceeds of approximately $6,000,000, which included the conversion of $1,545,678 of convertible promissory notesissuance date, December 31, 2014 and related accrued interest. The price per unit was $0.53.March 31, 2015.  

 

Warrants for Common Stock

 

In connection with the private placement, the Company issued warrants to purchase a total of 940,189 shares of common stock at an exercise price of $0.53 per share. The warrants have a contractual life of five years and are exercisable immediately in whole or in part, on or before five years from the issuance date.

 

In connection with the Loanloan and Security Agreementsecurity agreement entered into on September 30, 2014, the Company issued a warrant to purchase a total of 471,698 shares of common stock at an exercise price of $0.53 per share. The warrant has a contractual life of ten years and is exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the fair value of the warrant on the date of issuance to be $622,170$622,000 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 77%, risk free interest rate of 2.5% and a contractual life of ten years. The warrant will expire on September 30, 2024. The fair value of the warrant was recorded as a deferred financing costdebt issuance costs, included in prepaid expenses and other current assets on the consolidated balance sheets and will be amortized to interest expense over the loan term.

During the three months ended March 31, 2015 and 2014, the Company recorded $48,000 and $0, respectively, of interest expense relating to the debt issuance costs. As of Septemeber 30, 2014, all of these warrants remain outstanding.

9.

Convertible Preferred Stock

As part ofMarch 31, 2015, the Merger Agreement, all shares of the Series A convertible preferred stock and Series B convertible preferred stock converted to common stock, pursuant to the conversion rights.

The holders of preferred stock had various rights and preferences as follows:

Dividends

The preferred stockholdersremaining unamortized debt issuance costs were entitled to receive, when and as declared by the Board of Directors, out of funds legally available, cash dividends in the amount of $0.0488 and $0.004, respectively, per share, per year for each share of Series A and Series B outstanding in preference and priority to any declaration or payment of any distribution on common stock in such calendar year. These dividends are noncumulative. No distributions could be made to common stock unless all declared dividends on preferred stock have been paid or set aside for payment. No dividends have been declared to date.$526,000.

 

 

 

Liquidation

Upon liquidation, dissolution or winding upIn connection with the loan amendment in February 2015, the Company also amended the terms of the Company, either voluntary or involuntary,warrant issued to the holderslender to provide for an automatic increase of the Series A and Series B were entitlednumber of shares the lender may acquire in the event the Company fails to receive an amount per sharemeet certain covenants to achieve certain OUS Clinical Trial milestones or capital raising requirements as set forth in the loan agreement, as amended, by a number equal to the original issuance price for the preferred stock (as adjusted for any stock dividends, stock splits or recapitalization and similar events), plus all declared and unpaid dividends thereon to the date fixed for such distribution. If upon the liquidation event, there were insufficient funds to permit the payment to stockholdersquotient derived by dividing (i) 1% of the full preferential amounts, thenprincipal balance outstanding under the entire assetsloan agreement by (ii) the exercise price of $0.53 per share. 

In the October and fundsNovember of 2014, the Company would be distributed ratably among the holders of preferred stock.

Conversion

At the option of the holder thereof, each share of preferred stock was convertible, at the option of the holder at any time after the date of issuance into fully paid and non-assessable shares ofissued common stock as determined by dividing the applicable original issue price for such series by the conversion price for such series. The conversion price was $0.05 for Series Awarrants to various vendors and Series B.

Each sharenonemployee contractors to purchase a total of preferred stock was to automatically be converted into382,000 shares of common stock at their respective conversion price immediately upon the earlier of (A) immediately prior to the closing of a firm commitment underwritten initial public offering pursuant to a registration statement under the Securities Act of 1933 covering the offering and sale of the Company’s common stock provided the aggregate gross proceeds to the Company and/or selling stockholders was not less than $30,000,000 prior to underwriters’ commissions and expenses, or (B) upon receipt of a written request for conversion from the holders of a majority of the voting power of the outstanding shares of preferred stock.

Voting

Each holder of preferred stock was entitled to the number of votes equal to the number of shares of common stock into which such holder’s shares of preferred stock could be converted as of the record date. The holders of shares of the preferred stock were entitled to vote on all matters on which the common stock was entitled to vote. The holders of preferred stock, voting as a separate class, were entitled to elect two members of the Board of Directors. The holders of common stock, voting as a separate class, were entitled to elect one member of the Board of Directors. Any additional members of the Board of Directors were to be elected by the holders of common stock and preferred stock, voting together as a single class.

Warrants for Convertible Preferred Stock

In connection with the loan and security agreement entered into in December 2008, the Company issued a warrant to purchase a total of 196,721 shares of Series A at an exercise price of $0.61$0.53 per share. The warrant hadwarrants have a contractual life of tenfive years and wasare exercisable either immediately in wholeupon grant or in part, onsome cases upon achieving certain milestones or before ten years from the issuance date.vesting terms. The Company determined the fair value of the warrant on the date of issuance to be $53,863warrants using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 79%61.3%, risk free interest rate of 2.7%1.55% to 1.65% and a contractual life of tenfive years. The warrant was to expire on December 2, 2018. The fair valuevalues of the warrant waswarrants were recorded as a debt issuance costprofessional consulting fees or clinical costs, which are included in other assetsselling, general and was amortized to interest expense overadministrative and research and development expenses in the draw down termcondensed consolidated statements of the loan. The entire amount of the warrant was amortized to interest expense inoperations for the year ended December 31, 2008. The fair value2014, depending on the nature of the warrantservices provided. Stock-based compensation expense related to these warrants is recognized as the warrants are earned and was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $9,639 and $(2,361) were recorded to other income (expense), net, respectively,$15,000 for the ninethree months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.March 31, 2015.


 

In connection with the Series A offering in 2009,February 2015, the Company issued common stock warrants to employees for performance bonuses to purchase 245,900a total of 605,556 shares of Series A for $0.61common stock at an exercise price of $0.50 per share in April 2009.share. The warrants hadhave a contractual life of ten years and wereare exercisable immediately in whole or in part, on or before ten years from the issuance date.immediately. The Company determined the fair value of the warrants on the date of issuance to be $70,082 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 79%77.6%, risk free interest rate of 2.8%2.14% and a contractual life of ten years. The warrants were to expire on April 2, 2019. The fair valuevalues of the warrants waswere recorded as an equity issuance cost. The fair valuein selling, general and administrative and research and development expenses in the condensed consolidated statements of operations for the three months ended March 31, 2015, depending on the department classification of the employee. Stock-based compensation expense related to these warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $11,803 and $(984) were recorded to other income (expense), net, respectively,$244,000 for the ninethree months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.March 31, 2015.

 

In connection with the loan and security agreement entered into in November 2010,March 2015, the Company issued a common stock warrant to a nonemployee contractor to purchase a total of 163,93411,628 shares of Series Acommon stock at an exercise price of $0.61$0.34 per share. The warrant hadhas a contractual life of ten years and wasis exercisable immediately in whole or in part, on or before ten years from the issuance date.immediately. The Company determined the fair value of the warrant on the date of issuance to be $46,721warrants using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 79%78.9%, risk free interest rate of 2.9%1.94% and a contractual life of ten years. The warrant was to expire on November 19, 2020. The fair value of the warrant was recorded as a debt discountprofessional consulting fees, which are included in selling, general and amortized to interest expense overadministrative in the lifecondensed consolidated statements of the loan. The fair value of the warrant was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $2,295 and $(1,311) were recorded to other income (expense), net, respectively,operations for the ninethree months ended September 30, 2014 and 2013. TheMarch 31, 2015. Stock-based compensation expense related to these warrants were extinguished in connection withwas $3,000 for the Merger.three months ended March 31, 2015.

 

In connection with the loan and security agreement entered intoAs of March 31, 2015, all of these warrants (2,411,071 shares in April 2012, the Company issued a warrant to purchase a total of 73,770 shares of Series A at an exercise price of $0.61 per share. The warrant had a contractual life of ten years and was exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrant on the date of issuance to be $27,443 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 92%, risk free interest rate of 1.98% and a contractual life of ten years. The warrant was to expire on April 19, 2022. The fair value of the warrant was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrant was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $3,025 and $885 was recorded to other income (expense), net, respectively, for the nine months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.total) remain outstanding.

 

In May 2011, in connection with the issuance of convertible promissory notes, the Company issued warrants to purchase 2,000,000 shares of Series B at an exercise price of $0.05 per share. The warrants had a contractual life of ten years and were exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrants on the date of issuance to be $84,000 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 84%, risk free interest rate of 3.2% and a contractual life of ten years. The warrants were to expire on May 9, 2021. The fair value of the warrants was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $2,000 and $2,000 were recorded to other income (expense), net, respectively, for the nine months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.

In June 2011, in connection with the issuance of convertible promissory notes, the Company issued warrants to purchase 4,000,000 shares of Series B at an exercise price of $0.05 per share. The warrants had a contractual life of ten years and were exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrants on the date of issuance to be $168,000 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 84%, risk free interest rate of 3.2% and a contractual life of ten years. The warrants were to expire on June 30, 2021. The fair value of the warrants was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $4,000 and $4,000 were recorded to other income (expense), net, respectively, for the nine months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.


In September 2011, in connection with the issuance of convertible promissory notes, the Company issued warrants to purchase 4,000,000 shares of Series B at an exercise price of $0.05 per share. The warrants had a contractual life of ten years and were exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrants on the date of issuance to be $168,000 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 84%, risk free interest rate of 2.0% and a contractual life of ten years. The warrants were to expire on September 9, 2021. The fair value of the warrants was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $0 and $4,000 was recorded to other income (expense), net, respectively, for the nine months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.

In November 2011, in connection with the issuance of convertible promissory notes, the Company issued warrants to purchase 1,000,000 shares of Series B at an exercise price of $0.05 per share. The warrants had a contractual life of ten years and were exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrants on the date of issuance to be $42,000 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 84%, risk free interest rate of 2.1% and a contractual life of ten years. The warrants were to expire on November 30, 2021. The fair value of the warrants was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $1,000 and $1,000 were recorded to other income (expense), net, respectively, for the nine months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.

In December 2011, in connection with the issuance of convertible promissory notes, the Company issued warrants to purchase 1,000,000 shares of Series B at an exercise price of $0.05 per share. The warrants had a contractual life of ten years and were exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrants on the date of issuance to be $41,000 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 84%, risk free interest rate of 1.8% and a contractual life of ten years. The warrants were to expire on December 19, 2021. The fair value of the warrants was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $1,000 and $0 were recorded to other income (expense), net, respectively, for the nine months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.

In January 2012, in connection with the issuance of convertible promissory notes, the Company issued warrants to purchase 910,445 shares of Series B at an exercise price of $0.05 per share. The warrants had a contractual life of ten years and were exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrants on the date of issuance to be $37,328 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 84%, risk free interest rate of 1.8% and a contractual life of ten years. The warrants were to expire on January 31, 2022. The fair value of the warrants was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $3,642 and $910 were recorded to other income (expense), net, respectively, for the nine months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.


In February 2012, in connection with the issuance of convertible promissory notes, the Company issued warrants to purchase 738,535 shares of Series B at an exercise price of $0.05 per share. The warrants had a contractual life of ten years and were exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrants on the date of issuance to be $31,018 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 84%, risk free interest rate of 1.98% and a contractual life of ten years. The warrants were to expire on February 27, 2022. The fair value of the warrants was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $2,954 and $740 were recorded to other income (expense), net, respectively, for the nine months ended September 30 2014 and 2013. The warrants were extinguished in connection with the Merger.

In April 2012, in connection with the issuance of convertible promissory notes, the Company issued warrants to purchase 2,351,019 shares of Series B at an exercise price of $0.05 per share. The warrants had a contractual life of ten years and were exercisable immediately in whole or in part, on or before ten years from the issuance date. The Company determined the value of the warrants on the date of issuance to be $98,743 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 84%, risk free interest rate of 2.0% and a contractual life of ten years. The warrants were to expire on April 16, 2022. The fair value of the warrants was recorded as a debt discount and amortized to interest expense over the life of the loan. The fair value of the warrants was re-measured as of the date of the Merger, September 23, 2014, and September 30, 2013 and $9,404 and $2,351 were recorded to other income (expense), net, respectively, for the nine months ended September 30, 2014 and 2013. The warrants were extinguished in connection with the Merger.

Convertible preferred stock warrants outstanding as of December 31, 2013 were as follows:

          

Number of

     
          

Shares

     
  

Series

       

Outstanding

  

Fair Value

 
  

Exercisable

 

Expiration

 

Exercise

  

Under

  

December 31,

 

Issuance Date

 

for

 

Date

 

Price

  

Warrants

  

2013

 
                 

December 2008

 

Series A

 

December 2, 2018

 $0.61   196,721  $44,066 

April 2009

 

Series A

 

April 2, 2019

  0.61   245,900   58,278 

November 2010

 

Series A

 

November 19, 2020

  0.61   163,934   46,393 

May 2011

 

Series B

 

May 6, 2021

  0.05   2,000,000   54,000 

June 2011

 

Series B

 

June 30, 2021

  0.05   4,000,000   108,000 

September 2011

 

Series B

 

September 9, 2021

  0.05   4,000,000   108,000 

November 2011

 

Series B

 

November 30, 2021

  0.05   1,000,000   28,000 

December 2011

 

Series B

 

December 19, 2021

  0.05   1,000,000   28,000 

January 2012

 

Series B

 

January 31, 2022

  0.05   910,445   28,224 

February 2012

 

Series B

 

February 28, 2022

  0.05   738,535   22,895 

April 2012

 

Series B

 

April 16, 2022

  0.05   2,351,019   72,882 

April 2012

 

Series A

 

April 19, 2022

  0.61   73,770   24,934 
           16,680,324  $623,672 


10.

8.       Summary of Stock Options

 

Stock Option Plans

 

The Company has issued equity awards in the form of stock options from three employee benefit plans. The plans include the PLC 2005 Stock Incentive Plan (the “2005 Plan”), the Viveve Amended and Restated 2006 Stock Plan (the “2006 Plan”) and the PLC 2013 Stock Option and Incentive Plan (the “2013 Plan”).

 

The 2005 Plan was adopted by PLC's Board of Directors and approved by its stockholders. As of March 31, 2015, 22,095 shares of common stock remain reserved for issuance under the 2005 Plan. The Company does not intend to grant further awards from the 2005 Plan, however, it will continue to administer the 2005 Plan until all outstanding awards are exercised, expire, terminate or are forfeited. There are currently outstanding stock option awards issued from the 2005 Plan covering a total of 22,095 shares of the Company’s common stock. The weighted average exercise price of the outstanding stock options is $12.83 per share and the weighted average remaining contractual term is 8.802.11 years.

 


The 2006 Plan was adopted by the Board of Directors of Viveve and was terminated in conjunction with the Merger. Outstanding stock option awards have been assumed by the Company and will continue to be administered in accordance with the terms of the 2006 Plan until such awards are exercised, expire, terminate or are forfeited. There are currently outstanding stock option awards issued from the 2006 Plan covering a total of 324,820322,069 shares of the Company’s common stock and no shares available for future awards. The weighted average exercise price of the outstanding stock options is $1.55$1.54 per share and the weighted average remaining contractual term is 8.067.57 years. Additionally, prior to the Merger, the Board of Directors voted to accelerate the vesting of all unvested options that were outstanding as of the date of the Merger such that all options would be immediately vested and exercisable by the holders.Furthermore, at the Merger, outstanding options to purchase shares of Viveve, Inc. common stock issued from the 2006 Plan were converted into options to purchase shares of the Company’s Common Stock (rounded down to the nearest whole share). The number of shares of the Company’s common stock into which the 2006 Plan options were converted was determined by multiplying the number of shares covered by each 2006 Plan option by the exchange ratio of 0.0080497. The exercise price of each 2006 Plan option was determined by dividing the exercise price of each 2006 Plan option immediately prior to the Merger by the exchange ratio of 0.0080497 (rounded up to the nearest cent).

  

The 2013 Plan was also adopted by PLC's Board of Directors and approved by its stockholders. The 2013 Plan is administered by the Compensation Committee of the Company’s Board of Directors (the “Administrator”). Under the 2013 Plan, the Company may grant to eligible participants equity awards of equity which may take the form of stock options (both incentive stock options and non-qualified stock options), stock appreciation rights, restricted, deferred or unrestricted stock awards, performance based awards or dividend equivalent rights. Awards may be granted to officers, employees, non-employeenonemployee Directors (as defined in the 2013 Plan) and other key persons (including consultants and prospective employees). The term of any stock option award may not exceed 10 years and may be subject to vesting conditions, as determined by the Administrator. Options granted generally vest over four years. Incentive stock options may be granted only to employees of the Company or any subsidiary that is a “subsidiary corporation” within the meaning of Section 424(f) of the Internal Revenue Code. The exercise price of any stock option award cannot be less than the fair market value of the Company’s common stock, provided, however, that an incentive stock option granted to an employee who owns more than 10% of the Company’s outstanding voting power must have an exercise price of no less than 110% of the fair market value of the Company’s common stock and a term that does not exceed five years. There are currently outstanding stock option awards issued from the 2013 Plan covering a total of 1,947,6192,561,619 shares of the Company’s common stock and there remain reserved for future awards 839,148227,739 shares of the Company’s common stock. The weighted average exercise price of the outstanding stock options is $0.80$0.72 per share. Concurrent withshare, and the Merger, the stockholders approved an amendment to the 2013 Plan to increase the number of shares reserved under the 2013 Plan from 113,826 to 3,111,587.remaining contractual term is 9.46 years.


 

Activity under the 2005 Plan, the 2006 Plan and the 2013 Plan is as follows:

 

  

Outstanding Options

 
          

Weighted-

 
      

Weighted-

  

Average

 
  

Number

  

Average

  

Remaining

 
  

of

  

Exercise

  

Contractual

 
  

Shares

  

Price

  

Term (years)

 
             

Options outstanding as of December 31, 2013

  363,413  $2.94   8.80 

Options granted

  1,901,476  $0.60     

Options assumed from PLC

  68,238  $10.24     

Options canceled

  (38,593) $1.75     

Options outstanding as of September 30, 2014

  2,294,534  $1.02   9.67 
  

Three Months Ended March 31, 2015

 
          

Weighted

     
      

Weighted

  

Average

  

Aggregate

 
  

Number

  

Average

  

Remaining

  

Intrinsic

 
  

of

  

Exercise

  

Contractual

  

Value

 
  

Shares

  

Price

  

Term (years)

  

(in thousands)

 
                 

Options outstanding, beginning of period

  2,291,783  $1.02   9.32     

Options granted

  635,000  $0.47         

Options exercised

  -  $-         

Options canceled

  (21,000) $1.00         

Options outstanding, end of period

  2,905,783  $0.90   9.20  $- 
                 

Vested and exercisable and expected to vest, end of period

  2,664,185  $0.93   9.16  $- 
                 

Vested and exercisable, end of period

  608,492  $2.16   7.69  $- 

 

As of September 30, 2014,March 31, 2015, the Company had 839,148227,739 shares available for grant.

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 March 31, 2015.


 

The options outstanding and exercisable as of September 30, 2014March 31, 2015 are as follows:follows (in thousands except share and per share data):

 

      Options Outstanding  Options Exercisable    
              

Weighted-

            
      

Number

  

Weighted-

  

Average

  

Number

  

Weighted-

    
      

Outstanding

  

Average

  

Remaining

  

Exercisable

  

Average

    
 

Range of

  

as of

  

Exercise

  

Contractual

  

as of

  

Exercise

    
 

Exercise Prices

  

September 30, 2014

  

Price

  

Term (Years)

  

September 30, 2014

  

Price

    
                            
  $0.12    320  $0.12   2.21   320  $0.12    
  $0.60    1,901,476  $0.60   10.00   20,000  $0.60    
  $1.24    314,036  $1.24   8.15   314,036  $1.24    
 $7.00-$9.00   59,372  $8.63   8.28   59,372  $8.63    
 $12.00-$18.63   19,081  $15.29   6.79   19,081  $15.29    
  $37.00    250  $37.00   3.72   250  $37.00    
       2,294,535  $1.02   9.67   413,059  $2.94    
       

Options Outstanding

  

Options Exercisable

 
               

Weighted

         
       

Number

  

Weighted

  

Average

  

Number

  

Weighted

 
       

Outstanding

  

Average

  

Remaining

  

Exercisable

  

Average

 
 

Range of

  

as of

  

Exercise

  

Contractual

  

as of

  

Exercise

 
 

Exercise Prices

  

March 31, 2015

  

Price

  

Term (Years)

  

March 31, 2015

  

Price

 
                          
 $0.46-$0.47   635,000  $0.47   9.86   -  $- 
 $  0.60   1,881,476  $0.60   9.50   219,185  $0.60 
 $  1.24   312,373  $1.24   7.65   312,373  $1.24 
 $7.00-$9.00   57,603  $8.64   2.58   57,603  $8.64 
 $12.00-$18.63   19,081  $15.29   3.07   19,081  $15.29 
 $  37.00   250  $37.00   2.48   250  $37.00 
        2,905,783  $0.90   9.20   608,492  $2.16 

 

Stock-Based Compensation

 

During the three and nine months ended September 30, 2014,March 31, 2015, the Company granted stock options to employees to purchase 1,901,476635,000 shares of common stock with a weighted-averageweighted average grant date fair value of $0.32$0.25 per share. Stock-based compensation expense recognized during the three months ended September 30,March 31, 2015 and 2014 was $42,000 and 2013 was $113,345 and $16,284 respectively. Stock-based compensation expense recognized during the nine months ended September 30, 2014 and 2013 was $143,643 and $66,001,$13,000, respectively. As of September 30, 2014,March 31, 2015, the total unrecognized compensation cost in connection with unvested stock options was approximately $567,000.$597,000. These costs are expected to be recognized over a period of approximately 3.263.56 years. The aggregate intrinsic value of options outstanding as of September 30, 2014 was approximately $1.7 million. There were no options exercised during the nine months ended September 30, 2014 and 2013.


 

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

 

 

Nine Months Ended

  

Three Months Ended

 
 

September 30,

  

March 31,

 
 

2014

  

2013

  

2015

  

2014

 
                  

Expected term (in years)

  5   5   5    5  

Average volatility

  61%   67%   62%    67%  

Risk-free interest rate

  1.80%   0.87%  1.29%-1.49%  0.80%-0.88% 

Dividend yield

  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 Company specific events that affected volatility in a prior period. The expected term of employee 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. No 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 included in the condensed consolidated statements of operations for the three and nine months ended September 30,March 31, 2015 and 2014 and 2013:(in thousands):

 

 

Three Months Ended

 
 

Three Months Ended

September 30,

  

Nine Months Ended

September 30,

  

March 31,

 
 

2014

  

2013

  

2014

  

2013

  

2015

  

2014

 
                        

Research and development

 $101  $976  $667  $(7,016) $4  $- 

General and administrative

  113,245   15,308   142,976   73,017 

Selling, general and administrative

  38   13 

Total

 $113,346  $16,284  $143,643  $66,001  $42  $13 

 

11.


9.         

Income Taxes

 

Provision for Income Tax

The Company calculates its interim tax provision in accordance with the provisions of Accounting Standards Codification (“ASC”) 740-270, “Income Taxes; Interim Reporting”. 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.

 

The Company’s effective tax rate is 0% for the three and nine months ended September 30, 2014March 31, 2015 and the2014. The Company expects that its effective tax rate for the full year 20142015 will be 0%. Based on

Deferred Income Taxes

The Company accounts for income taxes in accordance with ASC 740, “Income Taxes” (“ASC 740”), which requires that deferred tax assets and liabilities be recognized using enacted tax rates for the weighteffect of available evidence, including cumulative losses since inceptiontemporary differences between book and expected future losses, the Company has determinedtax bases of recorded assets and liabilities. ASC 740 also requires that deferred tax assets be reduced by a valuation allowance if it is more likely than not that some or all of the deferred tax asset amountassets will not be realized. As of December 31, 2014, the Company had a deferred tax asset of approximately $13,900,000 which was fully offset by a valuation allowance. If realized, the asset will be reflected on the Company’s balance sheet and therefore a fullthe reversal of the corresponding valuation allowance will result in a tax benefit being recorded in the statement of operations in the respective period. No additional deferred income tax asset has been provided on net deferred tax assets.recorded during the three months ended March 31, 2015.

 

As of September 30,December 31, 2014, the Company had net operating loss carryforwards of approximately $11,188,000$14,487,000 and $11,176,000$14,475,000 available to offset future taxable income, if any, for both federal and California state income tax purposes, respectively. The Company’s federal and state net operating loss carry-forwardscarryforwards begin to expire in 2027 and 2016,2017, respectively, and valuation allowances have been provided, where necessary.

 

Utilization of the net operating loss carry-forwardcarryforward may be subject to an annual limitation due to the ownership percentage change limitations provided by the Internal Revenue Code of 1986 and similar state provisions. The annual limitation may result in the expiration of the net operating loss before utilization.

 


All of the Company’s tax years will remain open for examination by the federal and state authorities for three and four years, respectively, from the date of utilization of any net operating loss or credits.

Uncertain Tax Positions

 

The gross amountCompany accounts for its uncertain tax positions in accordance with ASC 740. As of December 31, 2014, the Company had $97,000 of unrecognized tax benefits, as of September 30, 2014 is approximately $78 thousand related to reserves on research and development credits, none of which will affect the effective tax rate if recognized due to the valuation allowance.

The Company doesis not expectaware of any other uncertain tax positions that could result in significant additional payments, accruals or other material changesdeviation in this estimate during the fiscal year.

The Company files US federal and state returns. All tax years remain open in the next 12 months in unrecognized tax benefits.jurisdictions, none of which have individual significance.

 

The Company recognizes interest and/or penalties related to uncertain tax positions as other expense and not tax expense. The Company currently has no interest and penalties related to uncertain tax positions.

 

12.

10.      Related Party Transactions

 

In June 2006, the Company entered into a Development and Manufacturing Agreement with Stellartech Research Corporation (the “Agreement”). The Agreement was amended on October 4, 2007. Under the Agreement, the Company agreed to purchase 300 units of generators manufactured by Stellartech. As of March 31, 2015, the Company has purchased 23 units. The price per unit is variable and dependent on the volume and timing of units ordered. In conjunction with the Agreement, Stellartech purchased 300,000 shares of common stock at par value. These shares are subject to a right of repurchase by the Company, which lapse over a four-year period. As of March 31, 2015 and December 31, 2012,2014, none of the shares of common stock were subject to repurchase. Under the Agreement, the Company paid Stellartech $345,472$129,000 and $33,000$0 for goods and services induring the ninethree months ended September 30,March 31, 2015 and 2014, and 2013, respectively.

13.

Subsequent Events

On September 30, 2014, the Company entered into a Loan and Security Agreement pursuant to which we received a term loan in the amount of $5 million, which will be funded in 3 tranches. The first tranch of $2.5 million was provided to the Company on October 1, 2014. The proceeds from the first tranche were used to repay the existing loan with a financial institution which totaled $1,630,925. Before the second and the third tranches of the term loan will be funded, we must meet certain enrollment milestones and achieve certain positive results relating to our OUS Clinical Trials, among other things.

  

 

 

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS AND OTHER INFORMATION

CONTAINED IN THIS REPORT11.      Subsequent Events

 

On April 6, 2015, the Company received the final $500,000 in connection with a drawdown of funds from the second tranche of the term loan, for a total of $1,500,000 received under the second tranche. This report contains forward-looking statements. Forward-looking statements give our current expectations or forecastsportion of future events. You can identify these statementsthe second tranche borrowing is repayable in interest only payments until March 1, 2016 and then 30 equal installments of principal and interest at rate of 5.00% per annum.

On May 14, 2015, in connection with the closing of a private placement, we issued an aggregate of 32,432,432 shares of common stock at $0.37 per share for gross proceeds of approximately $12,000,000 in accordance with the terms and conditions of those certain Securities Purchase Agreements by and between the factCompany and certain accredited investors.

On May 14, 2015, the Company entered into a second amendment to the loan and security agreement dated September 30, 2014, as amended February 19, 2015, pursuant to which certain milestone and financial covenants were amended. The amendment permits the Company to draw down up to $1,000,000 in connection with the third tranche at any time during the period beginning on the date that they do not relate strictlywe have provided evidence acceptable to historical or current facts. You can find many (but not all)the lender of these statements by looking for words such as “approximates,” “believes,” “hopes,” “expects,” “anticipates,” “estimates,” “projects,” “intends,” “plans,” “would,” “should,” “could,” “may” or other similar expressions in this report. In particular, forward-looking statements include statements relating to future actions, prospective products and applications, customers, technologies, future performance or future financial results. These forward-looking statements are subject to certain risks and uncertainties that could cause actualpositive interim 3-month results to differ materially from our historical experience and our present expectations or projections. Factors that could cause actual results to differ from those discussedthe OUS Clinical Trial until July 15, 2015. The amendment also extended the milestone covenant requiring evidence of positive 3-month interim data in the forward-looking statements include, but are not limited to:OUS Clinical Trial to July 10, 2015.

 

our limited cash and our history of losses;

our ability to achieve profitability;

our limited operating history;

emerging competition and rapidly advancing technology;

whether we are successful in having our medical device approved for sale by the FDA;

the effect of changes in foreign and domestic regulatory requirements

whether demand develops for our medical device;

the impact of competitive or alternative products, technologies and pricing;

the adequacy of protections afforded to us by the patents that we own and the cost to us of maintaining, enforcing and defending those patents;

our ability to obtain, expand and maintain patent protection in the future, and to protect our non-patented intellectual property;

our exposure to and ability to defend third-party claims and challenges to our patents and other intellectual property rights;

our ability to obtain adequate financing in the future, as and when we need it;

our ability to continue as a going concern;

our success at managing the risks involved in the foregoing items; and

other factors discussed in this report.

Although we believe thatIn connection with the expectations reflectedsecond amendment to the loan and security agreement, the Company issued a warrant to purchase a total of 25,000 shares of common stock at an exercise price of $0.37 per share. The warrant has a contractual life of ten years and is exercisable immediately in whole or in part, on or before ten years from the forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements.The forward-looking statements are based upon management’s beliefs and assumptions and are made as of the date of this report. We undertake no obligation to publicly update or revise any forward-looking statements included in this report to conform such statements to actual results or changes in our expectations. You should not place undue reliance on these forward-looking statements.issuance date.

 

 

 

ITEM 2.     MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION ANDRESULTS OF OPERATIONS

 

Forward-Looking Statements

This report contains forward-looking statements that involve risks and uncertainties. These statements relate to future events or our future financial performance. In some cases, you can identify forward-looking statements by terminology including, "could" "may", "will", "should", "expect", "plan", "anticipate", "believe", "estimate", "predict", "potential" and the negative of these terms or other comparable terminology. These statements are only predictions. Actual events or results may differ materially.

While these forward-looking statements, and any assumptions upon which they are based, are made in good faith and reflect our current judgment regarding the direction of our business, actual results will almost always vary, sometimes materially, from any estimates, predictions, projections, assumptions or other future performance suggested in this Quarterly Report.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with the unaudited condensedconsolidated financial statementsand the related notes includedcontained elsewhere in this Quarterly Report on Form 10-Q as well asouraudited 2013financial statements and related notesincluded in the proxy statement which was filed with the Securities and Exchange Commission on August 11, 2014.Report. In addition to historical information, the following discussion contains forward looking statements based upon current expectations that are subject to risks and analysis here and throughout this Form 10-Q contains forward-looking statements that involve risks, uncertainties and assumptions. Our actualuncertainties. Actual results may differ materiallysubstantially from those anticipated in these forward-looking statements asreferred to herein due to a resultnumber of certain factors, including, but not limited to, those set forth underrisks described in the section entitledItem 1A.Risk Factors”Factors.

 

OVERVIEWOverview of Our Business

 

In the discussion below, when we use the terms “we”, “us” and “our”, we are referring to Viveve Medical, Inc. and its wholly-owned subsidiary, Viveve, Inc., which was acquired on September 23, 2014.

 

We design, develop, manufacture and market a medical devicedevices for the non-invasive treatment of vaginal introital laxity. PriorVaginal laxity occurs in many women as a result of natural childbirth, during which the vaginal opening, or introitus, is over-stretched and fails to our merger with PLC Systems Acquisition Corp.,return to its pre-childbirth state. Vaginal laxity can often cause decreased sexual function and satisfaction in women. The Viveve Treatment is a wholly-owned subsidiarynon-invasive solution for vaginal laxity that is performed in less than 30 minutes, in a physician’s office, and does not require the use of PLC Systems Inc., which occurred on September 23, 2014anesthesia. The Viveve System uses patented monopolar radiofrequency, or RF, energy to generate low temperature heat. The vaginal mucosa is simultaneously cooled while this non-ablative heat is delivered into the submucosal layer. The RF energy stimulates the formation of collagen and causes the collagen fibers to remodel thereby tightening the submucosal tissue of the vaginal introitus. The RF stimulation causes subtle alterations in the collagen that can renew the tissue and further tighten the vaginal introitus over the next one to three months following treatment (the “Merger”“Viveve Treatment”), we devoted substantially all and lead to increased sexual function as shown by the results of our timeclinical trials. The Viveve Treatment provides patients suffering from vaginal laxity and effortdecreased sexual function a non-invasive alternative to developing products, raising capitalsurgical procedures, which in contrast, can cost up to tens of thousands of dollars and recruiting personnel. To date, we have not generated significant revenuesinvolve weeks of recovery. The tissue tightening effect caused from the application of RF energy has been demonstrated by our own pre-clinical and priorclinical. The technology underlying the Viveve System is identical to the Merger, we funded our operations primarily throughtechnology underlying the sale of our common and preferred stock and borrowings from related parties and financial institutions.Thermage System, except for certain system modifications required for use in a different indication than that used by the Thermage System.

 

The Viveve System is currently being offered for distribution for use by physicians in 12 countries throughout Canada, China, Japan, Europe and Southeast Asia. Experienced OBGYN physicians who use the Viveve System provide initial training for new physicians on its proper use, and our sales consultants and distributors maintain frequent interactions with customers to promote repeat sales of our single-use treatment tips. As of the date of this filing, we have sold one Viveve System in Canada and placed three systems under a beta site program that we anticipate may convert to sales in 2015. As of the date of this filing, we have also sold two Viveve Systems in Hong Kong, five Viveve Systems in Japan, one Viveve System in Europe, three Viveve Systems in Southeast Asia and 460 single-use treatment tips.

The Viveve Solution

We believe that the Viveve System provides a compelling, safe, non-invasive treatment for vaginal laxity and improvement of sexual function. The Viveve System consists of an RF generator with cooling capability that protects the mucosa from over-heating and a handpiece that, in conjunction with a single-use treatment tip, regulates the application of RF energy and monitors treatment data. The Viveve Treatment is typically performed in a medical office setting by, or under the supervision of, trained and qualified physicians, which may include obstetricians and gynecologists, plastic surgeons, dermatologists, general surgeons, urologists, urogynecologists or family practitioners.


The Viveve System

        The Viveve System includes three major components: an RF generator housed in a table-top console, a reusable handpiece and a single-use treatment tip, as well as several other consumable accessories. Physicians attach the single-use treatment tip to the handpiece, which is connected to the console. The generator authenticates the treatment tip and programs the system for the desired treatment without further physician intervention.

           The Viveve System also includes other consumable components. The console houses a canister of coolant that can be used for approximately five to six procedures. Each procedure requires a new return pad, which is typically adhered to the patient’s upper leg to allow a path of travel for the RF current through the body and back to the generator. We also sell proprietary single-use bottles of coupling fluid, a viscous liquid that helps ensure electrical and thermal contact with the treatment tip.

The Viveve Treatment

                The Viveve Treatment is conducted on an outpatient basis in a physician’s office. The procedure typically takes less than 30 minutes and does not require any form of anesthesia. To perform the procedure, a physician attaches the single-use treatment tip to the handpiece. The return pad is then adhered to the patient’s upper leg to allow a path of travel for the RF current back to the generator. Prior to treatment, the treatment area is bathed in coupling fluid, which is used for conduction and lubrication. The area from the 1:00 o’clock position to the 11:00 o’clock position just inside the hymenal ring is treated using the Viveve Treatment Tip by delivering a three-phased pulse: Phase 1 – cooling, Phase 2 – 90 Joules/cm2 of RF energy, and Phase 3 – cooling. Each pulse lasts approximately eight seconds. The Viveve treatment tip is then repositioned in an overlapping fashion clockwise and the three-phased treatment pulse is repeated. The entire circumferential treatment area from the 1:00 o’clock position to the 11:00 o’clock position is treated five times with overlapping pulses. Treatment of the urethral area is avoided. During the treatment procedure patients are expected to feel a sensation of warmth when the RF phase is delivered and a cooling sensation when the cooling phases are delivered. Based on our current clinical results, the Viveve Treatment is only required once, with efficacy lasting for at least 12 months.

Recent Events

On September 23, 2014, PLC Systems, Inc.,we completed a Yukon Territory corporation (“PLC”), completedreverse acquisition and recapitalization pursuant to the terms and conditions of an Agreement and Plan of Merger (“Merger Agreement” or “Merger”) by and among PLC Systems Acquisition Corp., a wholly owned subsidiary of Viveve Medical, Inc. (formerly PLC Systems Inc.) with and into Viveve, Inc., a Delaware corportation (“Viveve”corporation (the “Merger”). In connection with the Merger, we changed our name from PLC Systems Inc. to Viveve will operateMedical, Inc. and Viveve, Inc. is operating as athe wholly-owned subsidiary of PLC and PLC will now be known as Viveve Medical, Inc. (“Viveve Medical” orMedical.  As a result of the “the Company”). 

In preparation for the stock exchange pursuant toreverse acquisition resulting from the Merger, Viveve, convertible bridge notesInc. is considered the accounting acquirer in the aggregate amountMerger and the assets and liabilities and the historical operations that are reflected in our financial statements are those of $4,875,000 and related accrued interestViveve, Inc. Therefore, the historical financial data of approximately $522,000 were extinguished, along with Viveve, warrant liabilities of approximately $573,000.  Inc. is deemed to be our historical financial data.

 

Pursuant to the Merger Agreement, all shares of capital stock (including common and preferred stock) of Viveve, Inc. were converted into 3,743,282 shares of the Company'sViveve Medical, Inc.’s common stock which represented approximately 62% of the issued and outstanding shares of common stock of the Company on a fully diluted basis. In addition, non-accredited investors were entitled to receive approximately $16,500 upon closing.

 In addition, as a condition to and upon the closing of the Merger, an aggregate amount of $4,875,000 and related accrued interest of approximately $522,000 were extinguished pursuant to the terms and conditions of a Convertible Note Termination Agreement, dated May 9, 2014, by and between Viveve, Inc. and 5AM Co-Investors II, LP, a Convertible Note Termination Agreement, dated May 9, 2014 (collectively, the “5AM Note Termination Agreements”), by and between Viveve, Inc. and 5AM Ventures II, LP (together with 5AM Co-Investors II, LP, the “5AM Parties”) and a Convertible Note Exchange Agreement, dated May 9, 2014 (the “GBS Note Exchange Agreement”) by and between Viveve, Inc. and GBS Venture Partners Limited, trustee for GBS BioVentures III (“GBS”). In accordance with the terms and conditions of the 5AM Note Termination Agreements, the 5AM Parties acknowledged and agreed that the benefits received from the closing of the Merger, including the portion of the merger consideration issued to the 5AM Parties as shareholders of Viveve, Inc. in accordance with the terms of the merger agreement, was full and fair consideration to cancel or extinguish all principal and interest underlying the notes held by such holders. Pursuant to the terms of the Note Exchange Agreement, GBS agreed to cancel and extinguish all principal and interest underlying the notes held by GBS in exchange for a warrant to acquire such number of shares of common stock of the Company equal to 5% of the issued and outstanding common stock of the Company following the effective date of the Merger (the “GBS Warrant”). Upon the closing of the Merger, the Company issued an additionalaggregate of 943,596 shares of common stock to GBS upon the automatic conversion of the warrant


Upon the closing of the Merger, all rights, title or interest in outstanding warrants to purchase securities of Viveve, Inc. were also terminated, extinguishing approximately $572,000 in outstanding warrant liabilities, in accordance with the terms and conditions of a warrant issued in exchange forWarrant Termination Agreement, dated May 9, 2014, by and between Viveve, Inc. and each of the 5AM Parties, a Warrant Termination Agreement, dated May 9, 2014, by and between Viveve, Inc. and GBS, a Warrant Termination Agreement, dated May 9, 2014, by and between Viveve, Inc. and Oxford Finance LLC (“Oxford”), and a Warrant Termination Agreement, dated May 9, 2014 (collectively, the “Warrant Termination Agreements”), by and between Viveve, Inc. and SVB Financial Group (“SVB Financial”). The cancellation of the outstanding principal amount and related partyaccrued interest underlying the convertible bridge notes.

notes and the warrant liabilities were accounted for as part of the Merger transaction and no gain was recorded in the statement of operations.
 

The acquisition was accounted for as a reverse merger and recapitalization effected by a share exchange. Viveve is considered the acquirer for accounting and financial reporting purposes. The assets and liabilities of the acquired entity have been brought forward at their book value and no goodwill has been recognized.

In connection with the Merger, on May 9, 2014, we issued to GBS Venture Partners Limited (“GBS”), a convertible debenture holder, a warrant to purchase shares of our common stock equal to approximately 5% of the outstanding shares of common stock on a post-Merger basis in consideration for the cancellation of convertible promissory notes in the aggregate principal amount of $1,750,000 held by GBS. As part of the closing of the Merger, we issued 943,596 shares of common stock to GBS upon the exercise of the warrant.

  

Concurrent with the consummation of the Merger, we completed a separate private placement of 11,406,932 shares of our common stock (of which 11,305,567 shares of our common stock were issued at the closing as a result of beneficial ownership limitations), together with five-year warrants for the purchase of up to 940,189 shares of common stock, at an exercise price of $0.53 per share, for gross proceeds of approximately $6,000,000, which included the conversion of $1,500,000 of convertible notes. The price per unit was $0.53 per share.

 

On September 30, 2014, we entered into a Loan and Security Agreement, as amended on February 19, 2015 and May 14, 2015 (“Loan Agreement”), with Square 1 Bank (the “Lender”) pursuant to which we received a term loan in the amount of $5 million, which will be funded in 3 tranches. The first tranche of $2.5 million was provided to us on October 1, 2014. The2014 and proceeds of $500,000 from the firstsecond tranche were usedreceived on each of February 19, 2015, March 16, 2015 and April 6, 2015 for aggregate proceeds of $1,500,000. The terms of the loan also require that the Company meet certain financial covenants and milestones in connection with the randomized, blinded and sham-controlled clinical trial initiated by the Company in Europe and Canada which is designed to repay certain indebtedness owed by us,demonstrate the efficacy of the Viveve Treatment versus a sham controlled procedure for the treatment of vaginal introital laxity (the “OUS Clinical Trial”), including, but not limited to, (a) full enrollment as of March 31, 2015, (b) positive 3-month interim data as of July 10, 2015, and specifically(c) positive results from the indebtedness owedtrial as of January 31, 2016. Full enrollment of the OUS Clinical Trial was achieved prior to Oxford Finance LLCMarch 31, 2015. The Company may receive up to $1 million in connection with the third tranche at any time during the period in which totaled $1,630,925. Beforeit has provided evidence to the secondLender of positive 3-month interim results with respect to the OUS Clinical Trials until July 15, 2015. Interest accrues at a fixed per annum rate equal to the Basic Rate, as defined in the Loan Agreement, in effect on the date of any tranche 1 advance or tranche 2 advance, respectively, plus the Applicable Margin, as defined in the Loan Agreement, not in any case less than 5.0% per annum. Interest accrues on each tranche 3 advance at a fixed per annum rate equal to the Base Rate, as defined in the Loan Agreement, in effect on the date of the tranche 3 advance plus the Applicable Margin, as defined in the Loan Agreement, not in any case less than 6.5% per annum. Each advance is due to be repaid 42 months after the date of the advance (the “Term Loan Maturity Date.”) Interest only is due and payable monthly during the first 12 months of the loan term (the “Interest Only Period”). The principal balance of each advance that is outstanding at the end of the applicable Interest Only Period must be paid in 30 equal monthly installments of principal, plus all accrued interest, beginning on the first day of the first month following the end of the Interest Only Period, and continuing on the same day of each month thereafter through the Term Loan Maturity Date, at which time all amounts outstanding in connection with any advance shall be immediately due and payable. The failure to satisfy the conditions to draw down on the third tranchestranche of the term loan, will be funded, we must meet certain enrollment milestones and achieve certain positive results relatingan inability to our outside ofrenegotiate the U.S. (“OUS”) Clinical Trials, among other things. A descriptionterms of the loan we received from Square 1 Bank is includedwith the lender to permit a drawdown of the funds in the Current Reportevent such conditions are not satisfied could have a material adverse effect on Form 8-Kthe Company and its operations.

In connection with the terms of the Loan Agreement, we entered into the Intellectual Property Security Agreement, dated as of September 30, 2014, pursuant to which a first priority security interest was created in all of our intellectual property and issued a 10-year warrant to the Lender for the purchase of 471,698 shares of the Company’s common stock at an exercise price of $0.53 per share (the “Warrant”), such number of shares to automatically increase in the event that we filed withfail to meet certain covenants to achieve certain OUS Clinical Trial milestones or capital raising requirements as set forth in the Securities and Exchange Commission on October 3, 2014.Loan Agreement, as amended, by a number equal to the quotient derived by dividing (i) 1% of the principal balance outstanding under the Loan Agreement by (ii) the exercise price $0.53 per share (the “Amended Warrant”).


Plan of Operation

 

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 FDA approval for the sale of our product, whether there will be a demand for our product, the Viveve System,Treatment, given that the cost of the procedure will likely not be reimbursed by the government or private health insurers,insurers. In addition, we will continue to require substantial funds to support our clinical trials and fund our efforts to expand regulatory approval for our products in locations in which we do not currently have approval to market our product, including the uncertainty of availability of additional financing when and if we need it, and the uncertainty of achieving future profitability.U.S. We cannot be certain that in the event we requireany additional financing, suchrequired financing will be available when needed or on terms which are favorable to us. As noted above, our operations to date have been primarily funded through the sale of debt and equity securities. Various factors, including our limited operating history with minimal revenues to date and our limited ability to market and sell our product have resulted in limited working capital available to fund our operations. The recent Merger and concurrent Private Placement was consummated in an effort to raise additional capital and increase public awareness of Viveve, as well as create opportunities for access to additional capital by increasing liquidity that investors may find more attractive in a public company. While we believe that our recent going public transaction will be attractive to investors, there are no assurances that we will be successful in securing additional financing 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. These factors raise substantial doubt about our ability to continue as a going concern.

 


Plan of Operation

We intend to increase our sales and exposure both internationally and in the United States market by seeking regulatory approval for the sale and distribution of our product, identifying and training qualified distributors and expanding the scope of physicians who offer the Viveve Treatment™Treatment to include plastic surgeons, dermatologists, general surgeons, urologists, urogynecologists and primary care physicians. In addition, we intend to use the strategic relationships that we have developed with outside contractors and medical experts to improve the Viveve System 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;

 

● 

increasing security to prevent the re-use of treatment tips, resulting in improved procedure efficacy and reduced safety concerns; and

 

● 

developing a new cooling system that integrates a substitute for hydroflurocarbon, to maintain compliance with changes in international environmental regulations.

 

We are using the net proceeds received from the private placement discussed above 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 we will continue to require funds to fully implement our plan of operation. The net proceeds of approximately $4.2 million received from the September 2014 private placement, together with our debt financing of up to $5 million and net proceeds of approximately $11.1 million received in connection with sales of our common stock subsequent to the quarter ended March 31, 2015, are expected to be sufficient to fund our activities through June 2015.for the next twelve months. 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. We also expect to incur expenses related to obtaining regulatory approvals in the U.S. and internationally as well as legal and related expenses to protect our intellectual property. We expect capital expenditures to be less than $250,000 annually.

 

We intend to continue to meet our operating cash flow requirements through the sales of our products and by raising additional funds 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 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, we do not have any committed sources of financing and there are no assurances that we will be able to secure additional funding. If we cannot obtain financing, then we may be forced to curtail our operations or consider other strategic alternatives.

 


 

ResultsResults of Operations

Comparison of the Three Months Ended September 30,March 31, 2015 and 2014 and 2013

 

Revenue

 

  

Three Months Ended

September 30,

  

Change

 
  

2014

  

2013

     

%

 
                 

Revenue

 $17,180  $4,610  $12,570   273%
  

Three Months Ended

         
  

March 31,

  

Change

 
  

2015

  

2014

   $   % 
  

(in thousands, except percentages)

         
                 

Revenue

 $38  $47  $(9)  (19)%


 

We recorded revenue of $17,180$38,000 for the three months ended September 30, 2014March 31, 2015 as compared to revenue of $4,610$47,000 for the three months ended September 30, 2013, an increaseMarch 31, 2014, a decrease of $12,570,$9,000 or approximately 273%19%. This increaseThe decrease in revenue during the three months ended March 31, 2015 as compared to the three months ended March 31, 2014 was primarily due to salesa result of our disposable treatment tips to existing customers. Despite this increase, we significantly slowed the production oflimited commercial inventory available for salesales as the majority of inventory was utilized for our OUS Clinical Trial and sales and marketing efforts in late 2013 and throughoutproduction slowed down during the second half of 2014 due to funding constraints. Asas a result we experienced low sales volumes during both third quarter periods.of funding constraints.

  

Research and development expenses

 

  

Three Months Ended

September 30,

  

Change

 
  

2014

  

2013

   $  

%

 
                 

Research and development

 $572,134  $177,203  $394,931   223%
  

Three Months Ended

         
  

March 31,

  

Change

 
  

2015

  

2014

   $   % 
  

(in thousands, except percentages)

 
                 

Research and development

 $845  $174  $671   386%

  

Research and development expense totaled $572,134$845,000 for the three months ended September 30, 2014,March 31, 2015, compared to research and development expense of $177,203$174,000 for the three months ended September 30, 2013,March 31, 2014, an increase of $394,931,$671,000 or approximately 223%386%. Spending on research and development primarily increased in the thirdfirst quarter of 2014 as we prepared for2015 due to costs associated with our OUS Clinical Trial and incurred costs associated with the trial’s implementation.Trial. The Viveve OUS Clinical Trial is expected to commencecommenced in the fourth quarter of 2014 and is a post market study designed to evaluate the safety and effectiveness of the Viveve Treatment. ResearchThe study duration is approximately 12-15 months. We also had increased engineering work with our contract manufacturer related to product improvement efforts in 2015 and development further increasedadditional stock-based compensation expense primarily due to additional engineering work related to certain product improvement efforts.performance-based bonuses for employees.

 

Selling, general and administrative expenses

  

Three Months Ended

September 30,

  

Change

 
  

2014

  

2013

    $  

%

 
                 

Selling, general and administrative

 $1,790,014  $532,369  $1,257,645   236%
  

Three Months Ended

         
  

March 31,

  Change 
  

2015

  

2014

   $   % 
  

(in thousands, except percentages)

 
                 

Selling, general and administrative

 $1,577  $516  $1,061   206%

  

Selling, general and administrative expenses totaled $1,790,014$1,577,000 for the three months ended September 30, 2014,March 31, 2015, compared to $532,369$516,000 for the three months ended September 30, 2013,March 31, 2014, an increase of $1,257,645,$1,061,000 or approximately 236%206%. The increase in selling, general and administrative expenses in 2015 was primarily attributable to additional professional services related expenses associated with the Merger transaction that was completed in September 2014increased sales and to a lesser degree greater spendingmarketing efforts to build brand and market awareness.awareness, expenses associated with being a public company and financing efforts. Selling, general and administrative expenses further increasedduring the first quarter of 2015 also included higher personnel costs due to new hires (primarily in connection with our sales and marketing efforts) and additional stock-based compensation expense associated with the acceleration of vestingprimarily due to performance-based bonuses for employees and new stock options granted to existing employees in connection with the Merger. In contrast, selling, general and administrative expenses were lower in 2014 due to funding constraints.

 

Interest expense

 

  

Three Months Ended

September 30,

  

Change

 
  

2014

  

2013

    $  

%

 
                 

Interest expense

 $(152,296) $(156,727) $(4,431  (3)%
  

Three Months Ended

         
  

March 31,

  Change 
  

2015

  

2014

   $   % 
  

(in thousands, except percentages)

 
                 

Interest expense

 $83  $158  $(75)  (47)%

During the three months ended March 31, 2015, we had interest expense of $83,000 as compared to $158,000 for the three months ended March 31, 2014. The decrease of $75,000, or approximately 47%, resulted primarily from interest expense during the first quarter of 2014 on our convertible bridge notes. In connection with the Merger, these convertible promissory notes were extinguished.

 

 

 

Other income (expense), net

  

Three Months Ended

         
  

March 31,

  Change 
  

2015

  

2014

   $   % 
  

(in thousands, except percentages)

 
                 

Other income (expense), net

 $(7) $21  $(28)  (133)%

During the three months ended September 30, 2014,March 31, 2015 we had interestother expense, net, of $152,296$7,000 as compared to $156,727other income, net, of $21,000 for the three months ended September 30, 2013, aMarch 31, 2014. The decrease of $4,431,$28,000, or approximately 3%. The interest expense during these quarterly periods133%, was primarily due to our convertible bridge notes and our note payable. The interest expense for the third quarter of 2014 was partially offset by decreased fees associated with our note payable due to an agreed upon reduction in restructuring fees of $47,500 in September 2014.

Other income (expense) net

  

Three Months Ended

September 30,

  

Change

 
  

2014

  

2013

     

%

 
                 

Other income (expense), net

 $7,827  $(8,713) $16,540   190%

Other income (expense), net, for the three months ended September 30, 2014 and 2013 was $7,827 and $(8,713), respectively. The increase of $16,540, or approximately 190%, was attributable to mark-to-market adjustments in the first quarter of 2014 associated with the change in the fair value for our preferred stock warrants, which were accounted for as liabilities.

Comparison of the Nine Months Ended September 30, 2014 and 2013

Revenue

  

Nine Months Ended

September 30,

  

Change

 
  

2014

  

2013

     

%

 
                 

Revenue

 $64,475  $147,660  $(83,185)  (56%)

We recorded revenue of $64,475 for the nine months ended September 30, 2014 as compared to revenue of $147,660 for the nine months ended September 30, 2013, a decrease of $83,185 or approximately 56%. The decreasewarrants were extinguished in revenue was a result of the limited production of inventory available for sale and reduced sales and marketing efforts in the second half of 2013 and throughout 2014 due to funding constraints.

Research and development expenses

  

Nine Months Ended

September 30,

  

Change

 
  

2014

  

2013

     

%

 
                 

Research and development

 $940,954  $628,545  $312,409   50%

Research and development expense totaled $940,954 for the nine months ended September 30, 2014, compared to research and development expense of $628,545 for the nine months ended September 30, 2013, an increase of $312,409 or approximately 50%. Spending on research and development primarily increased as we prepared for our OUS Clinical Trial in the third quarter of 2014 and incurred costs associatedconnection with the trial’s implementation. The Viveve OUS Clinical Trial is expected to commence in the fourth quarter of 2014 and is designed to evaluate the safety and effectiveness of the Viveve Treatment.

Selling, general and administrative expenses

  

Nine Months Ended

September 30,

  

Change

 
  

2014

  

2013

    $  

%

 
                 

Selling, general and administrative

 $3,085,580  $2,517,791  $567,789   23%


Selling, general and administrative expenses totaled $3,085,580 for the nine months ended September 30, 2014, compared to $2,517,791 for the nine months ended September 30, 2013, an increase of $567,789 or approximately 23%. The increase in selling, general and administrative expenses was primarily attributable to additional professional services related expenses associated with the Merger transaction that was completed in September 2014. The increase was partially offset by greater spending in the first quarter of 2013 as we prepared to launch a major funding effort in the second quarter of 2013 that was later scaled back.

Interest expense

  

Nine Months Ended

September 30,

  

Change

 
  

2014

  

2013

     

%

 
                 

Interest expense

 $(486,582) $(334,380) $152,202   46%

During the nine months ended September 30, 2014, we had interest expense of $486,582 as compared to $334,380 for the nine months ended September 30, 2013. The increase of $152,202 or approximately 46% resulted primarily from greater interest expense of $192,135 on our convertible bridge notes due to the issuance of additional convertible notes in the aggregate principal amount of $2,375,000, partially offset by a decrease of $39,933 of fees and interest expense for our note payable due to an agreed upon reduction in restructuring fees in September 2014.

Other income (expense) net

  

Nine Months Ended

September 30,

  

Change

 
  

2014

  

2013

    $  

%

 
                 

Other income (expense), net

 $51,312  $11,230  $40,082   357%

Other income (expense), net, for the nine months ended September 30, 2014 and 2013 was $51,312 and $11,230, respectively. The increase of $40,082, or approximately 357%, was attributable to mark-to-market adjustments associated with the change in the fair value for our preferred stock warrants, which were accounted for as liabilities.Merger.

 

Liquidity and Capital Resources

Three Months Ended March 31, 2015

 

Liquidity is our ability to generate sufficient cash flows from operating activities to meet our obligations and commitments. In addition, liquidity includes the ability to obtain appropriate financing or to raise capital. We have funded our operations since inception through the sale of common and preferred stock and borrowings from related parties and financial institutions. To date, we have not generated sufficient cash flows from operating activities to meet our obligations and commitments, and we anticipate that we will continue to incur losses for the foreseeable future.

 

We completed ourthe Merger with PLC Systems, Inc. on September 23, 2014. Concurrent with the Merger, we completed athe private placement ofdescribed above, raising total gross proceeds of approximately $6,000,000, which included the conversion of $1,500,000 of convertible notes. The proceeds were partially offset by costs of $295,768$296,000 related to the private placement.

 

On September 30, 2014, we entered into athe Loan Agreement, as amended on February 19, 2015 and Security AgreementMay 14, 2015, pursuant to which we received a term loan in the amount of $5 million, which will be funded in 3 tranches. The first tranche of $2.5 million was provided to us on October 1, 2014. The proceeds from the first tranche were used to repay the existing loan with a financial institution which totaled $1,630,925. Beforeapproximately $1,631,000. The second tranche of the term loan is equal to $1.5 million, of which $500,000 was provided to us on February 19, 2015 and $1 million was subject to (i) evidence acceptable to the Lender of at least 50% enrollment in the OUS Clinical Trial no later than March 9, 2015, which has been satisfied, and (ii) documentation or other evidence acceptable to the Lender of a prospective equity financing. On March 16, 2015 and April 6, 2015, we have received an additional $500,000 in connection with a drawdown of funds from the second tranche, for a total of $1.5$1,500,000 received under the second tranche. The terms of the loan also require that the Company meet certain financial covenants and milestones in connection with the OUS Clinical Trial, including but not limited to, (a) full enrollment as of March 31, 2015, (b) positive 3-month interim data as of July 10, 2015, as amended, and (c) positive results from the trial as of January 31, 2016. As of March 31, 2015, full enrollment of the OUS Clinical Trial has been achieved. The Company may receive up to $1 million in connection with the third tranche at any time during the period in which it has provided evidence to Lender of positive 3-month interim results with respect to the OUS Clinical Trial until July 15, 2015. The proceeds from the second and third tranches will be used for general working capital purposes and capital expenditures. The failure to satisfy the conditions to draw down on the third tranche of $1 million of the term loan, will be funded, we must meet certain enrollment milestones and achieve certain positive results relatingan inability to our OUS Clinical Trials, among other things.renegotiate the terms of the loan with the Lender to permit a drawdown of the funds in the event such conditions are not satisfied could have a material adverse effect on the Company and its operations.

  

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

 

  

Nine Months Ended

September 30,

 
  

2014

  

2013

 
         

Net cash used in operating activities

 $(4,050,988) $(2,949,832)

Net cash used in investing activities

  (106,359)  (4,214)

Net cash provided by financing activities

  5,704,220   2,865,186 

Net increase (decrease) in cash and cash equivalents

 $1,546,873  $(88,860)


  

Three Months Ended

 
  

March 31,

 
  

2015

  

2014

 
         

Net cash used in operating activities

 $(1,674) $(574)

Net cash used in investing activities

  -   - 

Net cash provided by financing activities

  1,000   200 

Net decrease in cash and cash equivalents

 $(674) $(374)

 

Operating Activities

 

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

 


Operating activities used $4,050,988 in$1,674,000 for the ninethree months ended September 30, 2014March 31, 2015 compared to $2,949,832$574,000 used infor the ninethree months ended September 30, 2013.March 31, 2014. 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 in 2014during the three months ended March 31, 2015 consisted of a net loss of $4,437,399$2,524,000 adjusted for non-cash expenses including depreciation and amortization of $42,220,$17,000, stock-based compensation of $143,643, and$42,000, fair value of warrants issued to employees for performance bonuses of $244,000, fair value of warrants issued to service providers of $18,000 (primarily related to nonemployee contractors), non-cash interest expense of $369,677, partially offset by revaluation of warrant$48,000, and changes in operating assets and liabilities of $50,762.$481,000. Net cash used in 2013during the three months ended March 31, 2014 consisted of a net loss of $3,432,349$802,000 adjusted for non-cash expenses including depreciation and amortization of $35,871,$15,000, stock-based compensation of $66,001, and$13,000, gain of $21,000 from the revaluation of the warrant liability, non-cash interest expense of $227,911, partially offset by revaluation of warrant$123,000, and changes in operating assets and liabilities of $11,230.$98,000.

 

Investing Activities

 

Net cash used in investing activities during each of the ninethree months ended September 30,March 31, 2015 and 2014 was $106,359, which was used to purchase property and equipment.$0. Net cash used in investing activities during the nine months ended September 30, 2013 was $4,214, which was usedis typically 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 increase in the number of our employees and any changes to the capital equipment requirements related to our development programs.programs and clinical trials.

  

Financing Activities

 

Net cash provided by financing activities during the ninethree months ended September 30, 2014March 31, 2015 was $5,704,220,$1,000,000, which was the result of proceeds from the drawdown of $1,500,000funds from the second tranche of the term loan. Cash provided by financing activities during the three months ended March 31, 2014 was $200,000, which was the result of proceeds from the issuance of related party convertible bridge notes andwhich were extinguished in connection with the cashMerger.

Subsequent to the quarter ended March 31, 2015,in connection with the closing of a private placement, we issued an aggregate of 32,432,432 shares of common stock at $0.37 per share for gross proceeds of $4,499,988 fromapproximately $12,000,000 in accordance with the terms and conditions of those certain Securities Purchase Agreements by and between the Company and certain accredited investors.

Contractual Payment Obligations

We have obligations under a non-cancelable operating lease, a bank term loan and a purchase commitment for inventory. As of March 31, 2015, our private placement, partially offsetcontractual obligations are as follows (in thousands):

      

Less than

          

More than

 

Contractual Obligations:

 

Total

  

1 Year

  

1 - 3 Year

  

3 -5 Years

  

5 Years

 

Non-cancelable operating lease obligations

 $455  $168  $287  $-  $- 

Debt obligations (including interest)

  3,850   299   2,942   609     
Total $4,305  $467  $3,229  $609  $- 

In June 2006, we entered into a Development and Manufacturing Agreement with Stellartech Research Corporation (the "Agreement"). The Agreement was amended on October 4, 2007. Under the Agreement, we agreed to purchase 300 generators manufactured by transaction costsStellartech. As of $295,768. Cash provided by financing activities duringMarch 31, 2015, we have purchased 23 units. The price per unit is variable and dependent on the nine months endedvolume and timing of units ordered. 

In January 2012, we entered into a lease agreement for office and laboratory facilities. The lease agreement, as amended in January 2015, commenced in March 2012 and will terminate in March 2017.

As described above, on September 30, 20132014, the Company entered into a loan and security agreement pursuant to which we received a term loan in the amount of $5 million, which will be funded in 3 tranches. The first tranche of $2.5 million was $2,865,186, whichprovided to the Company on October 1, 2014. The first tranche borrowing is repayable in interest only payments until November 1, 2015 and then 30 equal installments of principal and interest at a rate of 5.25% per annum. In February 2015, the Company entered into an amendment to the loan and security agreement whereby $500,000 of the second tranche was provided to us on February 19, 2015. This portion of the resultsecond tranche borrowing is repayable in interest only payments until March 1, 2016 and then 30 equal installments of proceedsprincipal and interest at a rate of $3,000,0005.00% per annum. On March 16, 2015, the Company received an additional $500,000 in connection with a drawdown of funds from the issuancesecond tranche. This portion of related party convertible bridge notes, partially offset bythe second tranche borrowing is repayable in interest only payments until March 1, 2016 and then 30 equal installments of principal repayments toand interest at rate of 5.06% per annum. On April 6, 2015, the Company received the final $500,000 in connection with a financial institutiondrawdown of $134,814.funds from the second tranche. This final portion of the second tranche borrowing is repayable in interest only payments until March 1, 2016 and then 30 equal installments of principal and interest at rate of 5.00% per annum.


 

Critical Accounting Policies and Estimates

 

The discussion and analysis of financial condition and results of operations is based upon our consolidated financial statements, which have been prepared in conformity with accounting principles generally accepted in the United States of America.America (“US GAAP”). 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 2 to our consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2014, that was filed with the SEC on March 16, 2015, for a more complete description of our significant accounting policies. There have been no material changes to the significant accounting policies during the three months ended March 31, 2015.


RECENT ACCOUNTING PRONOUNCEMENTS

Recent Accounting Pronouncements

In May 2014, as part of its ongoing efforts to assist in the convergence of US GAAP and International Financial Reporting Standards (“IFRS”), the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2014-09, “Revenue from Contracts with Customers (Topic 606)”. The new guidance sets forth a new five-step revenue recognition model which replaces the prior revenue recognition guidance in its entirety and is intended to eliminate numerous industry-specific pieces of revenue recognition guidance that have historically existed in U.S.US GAAP. The underlying principle of the new standard is that a business or other organization will recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects what it expects in exchange for the goods or services. The standard also requires more detailed disclosures and provides additional guidance for transactions that were not addressed completely in the prior accounting guidance. The ASU provides alternative methods of initial adoption and is effective for annual and interim periods beginning after December 15, 2016. We are currently evaluating the impact that this standard will have on our condensed consolidated financial statements.

 

In June 2014, the FASB issued ASU No. 2014-12, “Compensation — Stock Compensation (Topic 718): Accounting for Share-Based Payments When the Terms of an Award Provide That a Performance Target Could be Achieved After a Requisite Service Period” (“ASU 2014-12”). Companies commonly issue share-based payment awards that require a specific performance target to be achieved in order for employees to become eligible to vest in the awards. ASU 2014-12 requires that a performance target that affects vesting and that could be achieved after the requisite service period should be treated as a performance condition. The performance target should not be reflected in estimating the grant date fair value of the award. Compensation cost should be recognized in the period in which it becomes probable that the performance target will be achieved. ASU 2014-12 will be effective for the Company’s fiscal years beginning fiscal 2016 and interim reporting periods within that year, using either the retrospective or prospective transition method. Early adoption is permitted. We are currently evaluating the effect of the adoption of this guidance on our condensed consolidated financial statements.

 

In June 2014, the FASB issued ASU 2014-10,  “Development Stage Entities (Topic 915):  Elimination of Certain Financial Reporting Requirements, Including an Amendment to Variable Interest Entities Guidance in topic 810, Consolidation” (“ASU 2014-10”). ASU 2014-10 removes the definition of a development stage entity from the Master Glossary of the Accounting Standards Codification, thereby removing the financial reporting distinction between development stage entities and other reporting entities from U.S. GAAP. ASU 2014-10 also eliminates the requirements for development stage entities to (1) present inception-to-date information in the statements of income, cash flows, and shareholder equity, (2) label the financial statements as those of a development stage entity, (3) disclose a description of the development stage activities in which the entity is engaged, and (4) disclose in the first year in which the entity is no longer a development stage entity that in prior years it had been in the development stage. The amendments also clarify that the guidance in Topic 275, Risks and Uncertainties, is applicable to entities that have not commenced planned principal operations. The amendments in ASU 2014-10 will be effective retrospectively except for the clarification to Topic 275, which shall be applied prospectively for annual reporting periods beginning after December 15, 2014, and interim periods therein. Early application of each of the amendments is permitted for any annual reporting period or interim period for which the entity’s financial statements have not yet been issued. The Company elected to early adopt the provisions of ASU 2014-10 in the second quarter of 2014.


In August 2014, the FASB issued ASU No. 2014-15, “Presentation of Financial Statements - Going Concern (subtopic 310-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern” (“ASU 2014-15”), to provide guidance on management’s responsibility in evaluating whether there is substantial doubt about a company’s ability to continue as a going concern and to provide related footnote disclosures. ASU 2014-15 is effective for the annual period ending after December 15, 2016, and for annual periods and interim periods thereafter. Since ASU 2014-15 only impacts financial statement disclosure requirements regarding whether there is  substantial doubt about an entity’s ability to continue as a going concern, we do not expect itsWe are currently evaluating the effect of the adoption to have an impactof this guidance on our condensed consolidated financial statements.statements and disclosures. 

 

Off-BalanceOff-Balance Sheet Transactions

 

We do not have any off-balance sheet transactions.

 

Trends,Trends, Events and Uncertainties

 

Research and development of new technologies is, by its nature, unpredictable. Although we will undertake development efforts with commercially reasonable diligence, there can be no assurance that we will have adequate capital to develop 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.

 

Other than as discussed above and elsewhere in this report,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.

 

ITEM 3.       QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

This item has been omitted based on Viveve Medical's statusAs a "smaller reporting company" as a smaller reporting company.defined by Item 10 of Regulation S-K, the Company is not required to provide information required by this Item.

 

ITEM 4.CONTROLS AND PROCEDURES

 

Evaluation of Disclosure Controls and Procedures

We maintain “disclosuredisclosure controls and procedures” as such term is (as defined in RuleRules 13a-15(e) and 15d-15(e) under the Securities and Exchange Act of 1934, as amended (the “Exchange Act”), that are designed to ensure that information required to be disclosed by us in our reports that we file or submitfiled under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange CommissionCommission’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer (“CEO”)principal executive officer and Chief Financial Officer (“CFO”),principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosures.disclosure. 

 

OurWe carried out an evaluation under the supervision and with the participation of management, is responsible for establishingincluding our principal executive officer and maintaining our disclosure controlsprincipal financial and procedures. Our CEOaccounting officer, of the effectiveness of the design and CFO have evaluated the effectivenessoperation of our disclosure controls and procedures as of September 30, 2014. Our CEOMarch 31, 2015, the end of the period covered by this Quarterly Report on Form 10-Q. Based upon the evaluation of our disclosure controls and CFO haveprocedures as of March 31, 2015, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective as that date and have also concluded that our consolidated financial statements forat the periods covered by and included in this Quarterly Report on Form 10-Q are fairly stated in all material respects in accordance with generally accepted accounting principles in the United States.reasonable assurance level.

 

Changes in Internal Control over Financial Reporting

 

There have been no materialNo changes in ourthe Company's internal controlscontrol over financial reporting have come to management's attention during the most recently completedCompany's last fiscal quarter that have materially affected, or are reasonably likely to materially affect, ourthe Company's internal controlscontrol over financial reporting.

 

PART II-OTHER II-OTHER INFORMATION

 

ITEM 1.        LEGAL PROCEEDINGS

 

Not applicable.We are not currently a party to any legal proceedings.

 

ITEM 1A.     RISK FACTORS

 

We incorporate herein by reference the risk factors included in the proxy statementAnnual Report on Schedule 14A that weForm 10-K filed with the Securities and Exchange Commission on August 11, 2014.March 16, 2015.

 

ITEMITEM 2.        UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

For information relating On February 17, 2015, as performance-based compensation for the 2014 calendar year, the Company issued ten-year warrants to unregistered salespurchase up to an aggregate of equity securities during605,556 shares of common stock to its employees. The warrants were issued in a transaction that was exempt from the quarter ended September 30, 2014, refer to the Current Reports on Form 8-K we filed withregistration requirements of the Securities Act pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended and Exchange Commission on July 16, 2014, August 7, 2014, September 29, 2014Regulation D promulgated thereunder inasmuch as the securities were offered and October 3, 2014.sold solely to employees that had access to substantially the same information as would have been included in a registration statement and we did not engage in any form of general solicitation or general advertising in making the offering.

 

ITEM 3.       DEFAULTS UPON SENIOR SECURITIES

Not applicableOn March 26, 2015, as performance-based compensation for the 2014 calendar year, the Company issued a ten-year warrant to purchase up to 11,628 shares of common stock to a consultant. The warrant was issued in a transaction that was exempt from the registration requirements of the Securities Act pursuant to Section 4(a)(2) of the Securities Act of 1933, as amended and Regulation D promulgated thereunder inasmuch as the securities were offered and sold to a consultant that had access to substantially the same information as would have been included in a registration statement and we did not engage in any form of general solicitation or general advertising in making the offering.

 

 

 

ITEM3.       DEFAULTS UPON SENIOR SECURITIES

Not applicable.      

ITEM4.MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEMITEM 5.      OTHER INFORMATION

Private Placement

 

Attached as Exhibit 99.1 and incorporated herein by reference isOn May 14, 2015, Viveve Medical, Inc., a copyYukon Territory corporation (the “Company”), completed the private placement of 32,432,432 shares of common stock, no par value (the “Shares”), for gross proceeds of approximately $12,000,000 (the “Private Placement”), to twenty (20) accredited investors (the “Purchasers”) pursuant to the terms of a press releaseSecurities Purchase Agreement, by and among the Company and the Purchasers, dated November 14, 2014 reportingas of May 12, 2015 (the “Securities Purchase Agreement”). The placement agent received cash commissions equal to approximately $840,000 representing 7% of the Company’s 2014 third quarter financial results.gross proceeds received from the Private Placement. The information set forth under this Item 5 is intendednet proceeds to the company after the deduction placement agent commissions and other expenses were approximately $11,100,000.

In connection with the Private Placement, the Company entered into a Registration Rights agreement with the Purchasers pursuant to which the Company agreed to register the Shares on a registration statement to be furnished under this Item 5filed with the Securities and also “Item 7.01, Regulation FD Disclosure”Exchange Commission (the “Registration Statement”) within forty-five (45) days after the closing of the Offering (the “Filing Date”) and “Item 2.02, Resultsuse its commercially reasonable efforts to cause the Registration Statement to be declared effective within ninety (90) days after the Filing Date (the “Effectiveness Date”). If the Company (i) does not file the Registration Statement by the Filing Date, (ii) does not obtain effectiveness of Operationsthe Registration Statement by the Effectiveness Date or (iii) allows certain lapses in effectiveness (each an “Event”), the Company is obligated to pay to the Purchasers liquidated damages equal to 1.5% of the original subscription amount paid by the Purchasers upon the occurrence of an Event and Financial Condition”for every thirty (30) days after the occurrence of Form 8-K. Such information, including Exhibit 99.1 attachedan Event until cured. In addition, the Company entered into a letter agreement with the lead investor Stonepine Capital, L.P. (“Stonepine”) pursuant to this Form 10-Q, shall not be deemed “filed”which Stonepine received the right to designate one director to the board for purposesso long as it owns at least 15% of the outstanding common stock of the Company.

The Shares were issued in reliance upon an exemption from registration afforded by Section 184(a)(2) of the Securities Exchange Act and Rule 506 of 1934, nor shall it be deemed incorporated by referenceRegulation D promulgated thereunder. In determining that the issuance of the Shares qualified for an exemption under Rule 506 of Regulation D, the Company relied on the following facts: (i) all of the Purchasers were accredited investors, as defined in any filingRule 501 of Regulation D promulgated under the Securities Act and (ii) the Company did not use any form of 1933, exceptgeneral solicitation or advertising to offer the Shares.

The foregoing summary of the transactions contemplated by the Securities Purchase Agreement, the Registration Rights Agreement and the Letter Agreement do not purport to be complete and is subject to, and qualified in its entirety by, the full text of the Securities Purchase Agreement, the Registration Rights Agreement and the Letter Agreement, which are attached as shall be expressly set forthExhibits 10.6, 10.7and 10.8 hereto, and which are incorporated herein by specific referencereference.

Square 1 Loan Amendment

On May 14, 2015, the Company entered into a second amendment (the “Amendment”) to that certain loan and security agreement dated September 30, 2014, as amended February 19, 2015, with Square 1 Bank (the “Lender”) pursuant to which certain milestone and financial covenants were amended. The Amendment permits the Company to draw down up to $1,000,000 in such filing. connection with the third tranche at any time during the period beginning on the date the Company has provided evidence acceptable to the lender of positive interim 3-month results from the OUS Clinical Trial until July 15, 2015. The Amendment also extended the milestone covenant requiring evidence of positive 3-month interim data in the OUS Clinical Trial to July 10, 2015.

In connection with the Amendment, the Company issued a warrant to the lender to purchase a total of 25,000 shares of common stock at an exercise price of $0.37 per share (the “Warrant”). The warrant has a contractual life of ten years and is exercisable immediately in whole or in part, on or before ten years from the issuance date.

The Warrant was issued in reliance upon an exemption from registration afforded by Section 4(a)(2) of the Securities Act. The issuance of the Warrant qualified for an exemption under Section 4(a)(2) in asmuch as the Lender is an accredited investor and the Company did not engage in any form of general solicitation or general advertising in conjunction with the issuance of the Warrant.

 

 

 

ITEM 6. EXHIBITSEXHIBITS

 

Exhibit
Number

Document

3.1

Articles of Continuance, pursuant to the Yukon Business Corporations Act, as amended (1)Document

3.1.1

Articles of Amendment to Articles of Continuance (2)

3.2

Bylaws, as amended*

4.1

Form of 5% Senior Secured Convertible Debenture due January 16, 2016First Amendment to Warrant to Purchase Stock, dated February 19, 2015, between Viveve, Inc. and issued on July 15, 2014 and August 6, 2014 to GCP IV LLC (4)Square 1 Bank (1)

   

4.2

Form ofWarrant to Purchase Common Stock, Purchase Warrant issued on July 15, 2014dated May 14, 2015 between Viveve Medical, Inc. and August 6, 2014 to GCP IV LLC (4)Square 1 Bank*

   

10.1

4.3*
 

Form of DebentureAmended and Restated Warrant to Purchase Stock, dated May 14, 2015.

10.1*First Amendment to Lease Agreement, dated September 2, 2014 made in favor of each holder of the registrant’s 5% Senior Secured Convertible Debentures (5)

January 2015.
   

10.2

 

Promissory NoteFirst Amendment to Loan and Security Agreement, dated September 2, 2014February 19, 2015 between Viveve, Inc. and issued to GCP IV LCC (5)Square 1 Bank (1)

   

10.3

 

Second Amendment dated September 10, 2014 to Securities PurchaseLoan & Security Agreement, dated February 22, 2013 (6)May 14, 2015 between Viveve, Inc, and Square 1 Bank*

   

10.4

 

AmendmentAmended and Restated Warrant to Purchase Stock, dated September 11, 2014 to Securities Purchase Agreement dated February 22, 2011 (6)

May 14, 2015 between Viveve Medical, Inc. and Square 1 Financial, Inc.*
   

10.5

 

First Amendment to Registration Rights Agreement, dated September 22, 2014 toFebruary 19, 2015 (1)

10.6

Form of Securities Purchase Agreement, dated May 9, 2014 (2)12, 2015, by and between Viveve Medical, Inc, and the Purchasers.*

10.7

Form of Registration Rights Agreement, dated May 12, 2015, by and between Viveve Medical, Inc. and the Purchasers.*

10.8*

Letter Agreement by and between Viveve Medical, Inc. and Stonpine Capital, L.P.

   

31.131.1*

Rule 13a-14(a)/15d-14(a) Certification of the Company’s Principal Executive Officer pursuant to 15d-15(e), under the Securities and Exchange Act of 1934.

31.2*

Certification of the Company’s Principal Financial Officer pursuant to 15d-15(e), under the Securities and Exchange Act of 1934.

32.1*

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

   

31.232.2*

 

Rule 13a-14(a)/15d-14(a) Certification of the Company’s Chief Financial Officer*Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

   

32.1101 .INS 

Section 1350 Certification of Chief Executive Officer and Chief Financial Officer*

99.1Press Release announcing 2014 Third Quarter Financial Results issued on November 14, 2014+

101.INS

XBRL InstantInstance Document *+

   

101.SCH

XBRL Taxonomy Extension Schema Document *

101.CAL

XBRL Taxonomy Extension Calculation Linkbase Document *

101.DEF

XBRL Taxonomy Extension Definition Linkbase Document *

10.LAB

XBRL Taxonomy Extension Label Linkbase Document *

101.PRE

XBRL Taxonomy Extension Presentation Linkbase Document *

 

*Filed herewithherewith.

+Furnished herewith

(1) Incorporated by reference to the Registrant’s Annual Report on Form 10-K for the year ended December 31, 2004 filed with the Securities and Exchange Commission on March 25, 2005.

(2) Incorporated by reference from the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 29, 2014.

(3) Incorporated by reference to the registrant’s Annual Report on Form 10-K for the year ended December 31, 1999 filed with the Securities and Exchange Commission on March 30, 2000.

(4) Incorporated by reference from the registrant’s Current Reports on Form 8-K filed with the Securities and Exchange Commission on July 16, 2014 and on August 7, 2014.

(5) Incorporated by reference from the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 8, 2014.

(6) Incorporated by reference from the registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on September 16, 2014.

Incorporated by reference to the Registrant’s Current Report on Form 8-K filed with the Securities and Exchange Commission on February 25, 2015.

 

 

 

SIGNATURES

 

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

 

Dated November 14, 2014Dated:  May 15, 2015

VIVEVE MEDICAL, INC.

(Registrant)

By:

/s/ Patricia Scheller

Patricia Scheller

Chief Executive Officer

Principal Executive Officer

By:

/s/ Scott Durbin

Scott Durbin

Chief Financial Officer

Principal Financial Officer and Principal Accounting Officer

 

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