UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒ |
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the quarterly period ended June 30 , 2018
OR
☐ |
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 |
For the transition period from ______________ to _______________
Commission File Number 1-11388
VIVEVE MEDICAL, INC.
(Exact name of registrant as specified in its charter)
Delaware |
04-3153858 |
(State or other jurisdiction of incorporation or organization) |
(I.R.S. Employer Identification No.) |
345 Inverness Drive South
Building B, Suite 250
Englewood, CO 80112
(Address of principal executive offices)
(Zip Code)
(720) 696-8100
(Registrant’s telephone number, including area code)
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 that 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, a non-accelerated filer or an emerging growth company. See definition of “accelerated filer,” and “large accelerated filer”, “smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act. (Check one):
Large accelerated filer ☐ |
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Accelerated filer ☒ |
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Non-accelerated filer ☐ |
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Smaller reporting company ☐ |
(Do not check if a smaller reporting company) |
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Emerging growth company ☐ |
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒
As of August 8, 2018 the issuer had 31,488,506 shares of common stock, par value $0.0001 per share, outstanding.
TABLE OF CONTENTS
Note About Forward-Looking Statements |
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Page No . |
PART I |
FINANCIAL INFORMATION |
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Item 1. |
Condensed Consolidated Financial Statements (unaudited) |
4 |
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Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
24 |
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Item 3. |
Quantitative and Qualitative Disclosures About Market Risk |
33 |
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Item 4. |
Controls and Procedures |
34 |
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PART II |
OTHER INFORMATION |
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Item 1. |
Legal Proceedings |
34 |
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Item 1A. |
Risk Factors |
34 |
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Item 2. |
Unregistered Sales of Equity Securities and Use of Proceeds |
34 |
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Item 3. |
Defaults Upon Senior Securities |
35 |
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Item 4. |
Mine Safety Disclosures |
35 |
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Item 5. |
Other Information |
35 |
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Item 6. |
Exhibits |
36 |
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SIGNATURES |
37 |
NOTE ABOUT FORWARD-LOOKING STATEMENTS
This Quarterly Report on Form 10-Q (the “Quarterly Report”) contains forward-looking statements that involve substantial risks and uncertainties. All statements contained in this Quarterly Report other than statements of historical fact, including statements regarding our future results of operations and financial position, our business strategy and plans, and our objectives for future operations, are forward-looking statements. The words "believe," "may," "will," "estimate," "continue," "anticipate," "intend," "expect," and similar expressions are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and trends that we believe may affect our financial condition, results of operations, business strategy, short-term and long-term business operations and objectives, and financial needs. These forward-looking statements are subject to a number of risks, uncertainties and assumptions, including those described in Part II, Item 1A. "Risk Factors" in this Quarterly Report. Moreover, we operate in a very competitive and rapidly changing environment. New risks emerge from time to time. It is not possible for our management to predict all risks, nor can we assess the impact of all factors on our business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in any forward-looking statements we may make. In light of these risks, uncertainties and assumptions, the future events and trends discussed in this Quarterly Report may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements.
You should read this Quarterly Report on Form 10-Q and the documents that we have filed as exhibits to this Quarterly Report on Form 10-Q completely and with the understanding that our actual future results, performance or achievements may be materially different from what we expect. We undertake no obligation to revise or publicly release the results of any revision to these forward-looking statements, except as required by law. Given these risks and uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements.
Unless expressly indicated or the context requires otherwise, the terms "Viveve Medical," the "Company," "we," "us," and "our" in this document refer to Viveve Medical, Inc., a Delaware corporation, and, where appropriate, its wholly owned subsidiaries.
PART I. FINANCIAL INFORMATION
ITEM 1. Financial Statements (unaudited)
VIVEVE MEDICAL, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
(in thousands, except share and per share data)
June 30, |
December 31, |
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2018 |
2017 |
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(unaudited) |
(1) | ||||||
ASSETS | ||||||||
Current assets: |
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Cash and cash equivalents |
$ | 30,213 | $ | 20,730 | ||||
Accounts receivable, net of allowance for doubtful accounts of $253 and $221 as of June 30, 2018 and December 31, 2017, respectively |
7,241 | 6,213 | ||||||
Inventory |
4,161 | 2,390 | ||||||
Prepaid expenses and other current assets |
3,024 | 2,741 | ||||||
Total current assets |
44,639 | 32,074 | ||||||
Property and equipment, net |
1,931 | 1,303 | ||||||
Investment in limited liability company |
2,093 | 2,500 | ||||||
Other assets |
188 | 202 | ||||||
Total assets |
$ | 48,851 | $ | 36,079 | ||||
LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
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Current liabilities: |
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Accounts payable |
$ | 4,867 | $ | 4,799 | ||||
Accrued liabilities |
5,258 | 4,605 | ||||||
Total current liabilities |
10,125 | 9,404 | ||||||
Note payable, noncurrent portion |
29,724 | 28,948 | ||||||
Other noncurrent liabilities |
305 | 327 | ||||||
Total liabilities |
40,154 | 38,679 | ||||||
Commitments and contingences (Note 7) |
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Stockholders’ equity (deficit): |
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Common stock, $0.0001 par value; 75,000,000 shares authorized as of June 30, 2018 and December 31, 2017; 31,466,508 and 19,503,558 shares issued and outstanding as of June 30, 2018 and December 31, 2017, respectively |
3 | 2 | ||||||
Additional paid-in capital |
138,283 | 102,979 | ||||||
Accumulated deficit |
(129,589 | ) | (105,581 | ) | ||||
Total stockholders’equity (deficit) |
8,697 | (2,600 | ) | |||||
Total liabilities and stockholders’ equity (deficit) |
$ | 48,851 | $ | 36,079 |
(1) The condensed consolidated balance sheet as of December 31, 2017 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 |
Six months Ended |
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June 30, |
June 30, |
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2018 |
2017 |
2018 |
2017 |
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Revenue |
$ | 5,525 | $ | 3,076 | $ | 9,224 | $ | 6,117 | ||||||||
Cost of revenue |
2,711 | 1,837 | 5,063 | 3,456 | ||||||||||||
Gross profit |
2,814 | 1,239 | 4,161 | 2,661 | ||||||||||||
Operating expenses: |
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Research and development |
3,672 | 3,440 | 7,428 | 5,828 | ||||||||||||
Selling, general and administrative |
9,437 | 6,862 | 18,368 | 12,312 | ||||||||||||
Total operating expenses |
13,109 | 10,302 | 25,796 | 18,140 | ||||||||||||
Loss from operations |
(10,295 | ) | (9,063 | ) | (21,635 | ) | (15,479 | ) | ||||||||
Interest expense, net |
(1,063 | ) | (1,345 | ) | (2,133 | ) | (1,608 | ) | ||||||||
Other expense, net |
- | (17 | ) | (10 | ) | (33 | ) | |||||||||
Net loss from consolidated companies |
(11,358 | ) | (10,425 | ) | (23,778 | ) | (17,120 | ) | ||||||||
Loss from minority interest in limited liability company |
(158 | ) | - | (407 | ) | - | ||||||||||
Comprehensive and net loss |
$ | (11,516 | ) | $ | (10,425 | ) | $ | (24,185 | ) | $ | (17,120 | ) | ||||
Net loss per share: |
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Basic and diluted |
$ | (0.37 | ) | $ | (0.54 | ) | $ | (0.85 | ) | $ | (1.10 | ) | ||||
Weighted average shares used in computing net loss per common share: |
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Basic and diluted |
31,305,386 | 19,373,322 | 28,591,134 | 15,539,840 |
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)
Six Months Ended |
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June 30, |
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2018 |
2017 |
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Cash flows from operating activities: |
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Net loss |
$ | (24,185 | ) | $ | (17,120 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: |
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Provision for doubtful accounts |
32 | - | ||||||
Depreciation and amortization |
334 | 188 | ||||||
Stock-based compensation |
1,529 | 827 | ||||||
Fair value of common stock issued |
256 | 260 | ||||||
Non-cash interest expense |
776 | 489 | ||||||
Loss from minority interest in limited liability company |
407 | - | ||||||
Changes in assets and liabilities: |
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Accounts receivable |
(1,060 | ) | (1,709 | ) | ||||
Inventory |
(1,930 | ) | 352 | |||||
Prepaid expenses and other current assets |
(283 | ) | (822 | ) | ||||
Other noncurrent assets |
14 | 4 | ||||||
Accounts payable |
68 | 258 | ||||||
Accrued and other liabilities |
635 | (5 | ) | |||||
Other noncurrent liabilities |
173 | (53 | ) | |||||
Net cash used in operating activities |
(23,234 | ) | (17,331 | ) | ||||
Cash flows from investing activities: |
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Purchase of property and equipment |
(803 | ) | (400 | ) | ||||
Net cash used in investing activities |
(803 | ) | (400 | ) | ||||
Cash flows from financing activities: |
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Proceeds from sale of common stock, net of issuance costs |
33,396 | 31,440 | ||||||
Proceeds from note payable |
- | 19,214 | ||||||
Repayments of note payable |
- | (10,000 | ) | |||||
Proceeds from issuance of common shares from employee stock purchase plan | 124 | - | ||||||
Proceeds from exercise of stock options |
- | 31 | ||||||
Proceeds from exercise of warrant |
- | 20 | ||||||
Net cash provided by financing activities |
33,520 | 40,705 | ||||||
Net increase in cash and cash equivalents |
9,483 | 22,974 | ||||||
Cash and cash equivalents - beginning of period |
20,730 | 8,086 | ||||||
Cash and cash equivalents - end of period |
$ | 30,213 | $ | 31,060 | ||||
Supplemental disclosure: |
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Cash paid for interest |
$ | 1,315 | $ | 1,183 | ||||
Cash paid for income taxes |
$ | 2 | $ | - | ||||
Supplemental disclosure of cash flow information as of end of period: |
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Issuance of warrants in connection with note payable |
$ | - | $ | 940 | ||||
Issuance of note payable in settlement of accrued interest |
$ | 616 | $ | - | ||||
Net transfer of equipment between inventory and property and equipment |
$ | 159 | $ | 292 |
The accompanying notes are an integral part of these condensed consolidated financial statements.
VIVEVE MEDICAL, INC.
NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
1. |
The Company and Basis of Presentation |
Viveve Medical, Inc. (“Viveve Medical”, the “Company”, “we”, “our”, or “us”) competes in the women’s intimate health industry in some countries by marketing the Viveve System as a way to improve the overall well-being and quality of life of women suffering from vaginal introital laxity, for improved sexual function, or stress urinary incontinence, depending on the relevant country-specific clearance or approval. In the United States, the Viveve System is currently indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Public Offerings
On February 12, 2018, in connection with the closing of a public offering (the “February 2018 Offering”), the Company issued an aggregate of 11,500,000 shares of common stock, including the shares issued in connection with the exercise of the underwriters’ overallotment option, at a public offering price of $3.00 per share for gross proceeds of approximately $34,500,000. The net proceeds to the Company, after deducting underwriting discounts and commissions and other offering expenses, were approximately $32,213,000.
The Company established an “at-the-market” equity offering program through the filing of a prospectus supplement to its shelf registration statement on Form S-3, which was filed on November 8, 2017, under which the Company may offer and sell, from time-to-time, up to $25,000,000 aggregate offering price of shares of its common stock (the “November 2017 ATM Facility”). During the three and six months ended June 30, 2018, the Company sold 65,252 shares and 273,529 shares of common stock under the November 2017 ATM Facility for net proceeds of approximately $172,000 and $1,183,000. As of June 30, 2018, the Company has sold 332,778 shares of common stock under the November 2017 ATM Facility for net proceeds of approximately $1,308,000.
On March 22, 2017, in connection with the closing of a public offering (the “March 2017 Offering”), the Company issued an aggregate of 8,625,000 shares of common stock, including the shares issued in connection with the exercise of the underwriters’ overallotment option, at a public offering price of $4.00 per share for gross proceeds of approximately $34,500,000. The net proceeds to the Company, after the deduction of underwriting discounts, commissions and other offering expenses, were approximately $31,440,000.
Interim Unaudited Financial Information
The accompanying unaudited condensed consolidated financial statements of Viveve Medical have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and pursuant to the instructions to Form 10-Q and Article 8-03 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by U.S. GAAP for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring adjustments, considered necessary for a fair presentation of the condensed consolidated financial statements have been included.
The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Annual Report on Form 10-K for the year ended December 31, 2017, which was filed with the Securities and Exchange Commission on March 16, 2018. The results of operations for the three and six months ended June 30, 2018 are not necessarily indicative of the results for the year ending December 31, 2018 or any future interim period.
2. |
Summary of Significant Accounting Policies |
Financial Statement Presentation
The condensed consolidated financial statements include the accounts of the Company and our wholly-owned subsidiaries, Viveve, Inc. and Viveve BV. All significant intercompany accounts and transactions have been eliminated in consolidation.
Use of Estimates
The preparation of condensed consolidated financial statements in conformity with U.S. GAAP requires us to make estimates and judgments that affect the reported amounts of assets, liabilities, revenues, 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.
Changes in Accounting Policies
Except for the changes for the adoption of the new revenue recognition accounting standard, the Company has consistently applied the accounting policies to all periods presented in these condensed consolidated financial statements.
Adoption of New Accounting Standard
On January 1, 2018, the Company adopted Revenue from Contracts with Customers (Topic 606), which created Accounting Standards Codification Topic 606 (“ASC 606”), using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under Accounting Standards Codification Topic 605 (“ASC 605”).
Previously under ASC 605, revenue from extended assurance warranties was deferred and recognized over the period of the warranty. Under ASC 606, these warranties are not considered a separate performance obligation. Accordingly, on the transition date, the Company recorded a net cumulative adjustment in accumulated deficit of $177,000, resulting from the release of $195,000 for the amount of extended warranties previously recorded in noncurrent liabilities, offset by $18,000 recorded in accrued liabilities for future costs associated with the assurance-type extended warranties.
The details for the impact of the adoption of ASC 606 are provided below:
Balance as of December 31, 2017 |
Adjustment Due to Adoption of ASC 606 |
Balance as of January 1, 2018 |
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Consolidated Balance Sheet: |
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Liabilities |
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Accrued liabilities |
$ | 4,605 | $ | 18 | (1) | $ | 4,623 | ||||||
Other noncurrent liabilities |
$ | 327 | $ | (195 | ) | (2) | $ | 132 | |||||
Equity |
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Accumulated deficit |
$ | (105,581 | ) | $ | 177 | (3) | $ | (105,404 | ) |
(1) |
Change relates to future costs associated with extended warranties required to be recorded on adoption of ASC 606. |
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(2) |
Change relates to long-term deferred revenue related to the extended warranties not required to be recorded under ASC 606. |
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(3) |
Change relates to cumulative effect adjustment upon adoption of ASC 606. |
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with an original maturity of three months or less, at the time of purchase, to be cash equivalents. The Company’s cash and cash equivalents are deposited in demand accounts primarily at one financial institution. Deposits in this institution may, from time to time, exceed the federally insured amounts.
Concentration of Credit Risk and Other Risks and Uncertainties
To achieve profitable operations, the Company must successfully develop, manufacture, and market its products. There can be no assurance that any such products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed. These factors could have a material adverse effect upon the Company’s financial results, financial position, and future cash flows.
The Company’s products to date require clearance or approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commencing commercial sales. There can be no assurance that the Company’s products will receive any of these required clearances or approvals or for the indications requested. If the Company was denied such clearances or approvals or if such clearances or approvals were delayed, it would have a material adverse effect on the Company’s financial results, financial position and future cash flows.
The Company is subject to risks common to companies in the medical device industry including, but not limited to, new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, product liability, and the need to obtain additional financing. The Company’s ultimate success is dependent upon its ability to raise additional capital and to successfully develop and market its products.
The Company designs, develops, manufactures and markets a medical device that it refers to as the Viveve System, which is intended for the non-invasive treatment of vaginal introital laxity, for improved sexual function, for vaginal rejuvenation, for use in general surgical procedures for electrocoagulation and hemostasis, and stress urinary incontinence, depending on the relevant country-specific clearance or approval. The Viveve System consists of three main components: a RF, or radio frequency, generator housed in a table-top console, a reusable handpiece and a single-use treatment tip. Included with the system are single-use accessories (e.g. RF return pad, coupling fluid), as well as a cryogen canister that can be used for approximately four to five procedures, and a foot pedal. The Company outsources the manufacture and repair of the Viveve System to a single contract manufacturer. Also, certain other components and materials that comprise the device are currently manufactured by a single supplier or a limited number of suppliers. A significant supply interruption or disruption in the operations of the contract manufacturer or these third-party suppliers would adversely impact the production of our products for a substantial period of time, which could have a material adverse effect on our business, financial condition, operating results and cash flows.
In North America, the Company sells its products primarily through a direct sales force to health care practitioners. Outside North America, the Company sells through an extensive network of distribution partners. During the three months ended June 30, 2018, one distributor accounted for 13% of the Company’s revenue. During the three months ended June 30, 2017, three distributors together accounted for 37% of the Company’s revenue. During the six months ended June 30, 2018, one distributor accounted for 23% of the Company’s revenue. During the six months ended June 30, 2017, two distributors together accounted for 26% of the Company’s revenue.
There were no direct sales customers that accounted for more than 10% of the Company’s revenue during the three and six months ended June 30, 2018 and 2017.
As of June 30, 2018, two distributors, collectively, accounted for 49% of total accounts receivable, net. As of December 31, 2017, two distributors, collectively, accounted for 57% of total accounts receivable, net.
Accounts Receivable and Allowance for Doubtful Accounts
Accounts receivable are recorded at the invoiced amount and are not interest bearing. Our typical payment terms vary by region and type of customer (distributor or physician). Occasionally, payment terms of up to six months may be granted to customers with an established history of collections without concessions. Should we grant payment terms greater than six months or terms that are not in accordance with established history for similar arrangements, revenue would be recognized as payments become due and payable assuming all other criteria for revenue recognition have been met. The Company maintains an allowance for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectibility of its accounts receivable in its calculation of the allowance for doubtful accounts. In determining the amount of the allowance, the Company makes judgments about the creditworthiness of customers based on ongoing credit evaluations and assesses current economic trends affecting its customers that might impact the level of credit losses in the future and result in different rates of bad debts than previously seen. The Company also considers its historical level of credit losses. The allowance for doubtful accounts was $253,000 as of June 30, 2018 and $221,000 as of December 31, 2017.
Revenue Recognition
Revenue consists primarily of the sale of the Viveve System, single-use treatment tips and ancillary consumables. The Company applies the following five steps: (1) identify the contract with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract, and (5) recognize revenue when a performance obligation is satisfied. The Company considers customer purchase orders to be the contracts with a customer. Revenues, net of expected discounts, are recognized when the performance obligations of the contract with the customer are satisfied and when control of the promised goods are transferred to the customer, typically when products, which have been determined to be the only distinct performance obligations, are shipped to the customer. Expected costs of assurance warranties and claims are recognized as expense. Revenue is recognized net of any sales taxes from the sale of the products.
Sales of our products are subject to regulatory requirements that vary from country to country. The Company has regulatory clearance for differing indications, or can sell its products without a clearance, in many countries throughout the world, including countries within the following regions: North America, Latin America, Europe, the Middle East and Asia Pacific. In North America, we market and sell primarily through a direct sales force. Outside of North America, we market and sell primarily through distribution partners.
The Company does not provide its customers with a right of return.
Customer Advance Payments
From time to time, customers will pay for a portion of the products ordered in advance. Upon receipt of such payments, the Company records the customer advance payment as a component of accrued liabilities. The Company will remove the customer advance payment from accrued liabilities when revenue is recognized upon shipment of the products.
Contract Assets and Liabilities
The Company continually evaluates whether the revenue generating activities and advanced payment arrangements with customers result in the recognition of contract assets or liabilities. No such assets existed as of June 30, 2018 or December 31, 2017. The Company had customer contract liabilities in the amount of $182,000 primarily related to marketing programs that performance had not yet been delivered to its customers as of June 30, 2018. No such contract liabilities existed as of December 31, 2017. Separately, accounts receivable, net represents receivables from contracts with customers.
Significant Financing Component
The Company applies the practical expedient to not make any adjustment for a significant financing component if, at contract inception, the Company does not expect the period between customer payment and transfer of control of the promised goods or services to the customer to exceed one year. During the three and six months ended June 30, 2018, the Company did not have any contracts for the sale of its products with its customers with a significant financing component.
Contract Costs
The Company has elected the practical expedient to recognize the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that the Company otherwise would have recognized is one year or less. During the three and six months ended June 30, 2018, the Company expensed the incremental costs of obtaining the contract as an expense when incurred as the amortization period was one year or less.
Shipping and Handling
Shipping costs billed to customers are recorded as revenue. Shipping and handling expense related to costs incurred to deliver product are recognized within cost of goods sold. The Company accounts for shipping and handling activities that occur after control has transferred as a fulfillment cost as opposed to a separate performance obligation, and the costs of shipping and handling are recognized concurrently with the related revenue.
In accordance with the new revenue standard requirements, the disclosure of the impact of adoption on our consolidated statement of operations for the three and six months ended June 30, 2018 and consolidated balance sheet as of June 30, 2018 was as follows (in thousands):
For three months ended June 30, 2018 |
For six months ended June 30, 2018 |
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As Reported |
Balances Without Adoption of ASC 606 |
Effect of Change
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As Reported |
Balances Without Adoption of ASC 606 |
Effect of Change
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Consolidated Statement of Operations |
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Revenue |
$ | 5,525 | $ | 5,405 | $ | 120 |
(1) |
$ | 9,224 | $ | 8,894 | $ | 330 |
(1) |
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Cost of revenue |
$ | 2,711 | $ | 2,705 | $ | 6 |
(2) |
$ | 5,063 | $ | 5,048 | $ | 15 |
(2) |
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Gross profit |
$ | 2,814 | $ | 2,700 | $ | 114 |
(3) |
$ | 4,161 | $ | 3,846 | $ | 315 |
(3) |
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Loss from operations |
$ | (10,295 | ) | $ | (10,409 | ) | $ | 114 |
(3) |
$ | (21,635 | ) | $ | (21,950 | ) | $ | 315 |
(3) |
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Comprehensive and net loss |
$ | (11,516 | ) | $ | (11,630 | ) | $ | 114 |
(3) |
$ | (24,185 | ) | $ | (24,500 | ) | $ | 315 |
(3) |
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Net loss per share: |
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Basic and diluted |
$ | (0.37 | ) | $ | (0.37 | ) | $ | - | $ | (0.85 | ) | $ | (0.86 | ) | $ | 0.01 |
(1) |
Change relates to revenue from extended assurance warranties for which no deferral is required on the adoption of ASC 606. |
(2) |
Change relates to the future costs associated with extended assurance warranties required to be recorded on the adoption of ASC 606. |
(3) |
Change relates to the net gain adjustment on the adoption of ASC 606. |
As of June 30, 2018 |
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As Reported |
Balances Without Adoption of ASC 606 |
Effect of Change
|
|||||||||||
Consolidated Balance Sheets |
|||||||||||||
Liabilities |
|||||||||||||
Accrued liabilities |
$ | 5,258 | $ | 5,302 | $ | 44 |
(1) |
||||||
Other noncurrent liabilities |
$ | 305 | $ | 753 | $ | 448 |
(2) |
||||||
Equity |
|||||||||||||
Accumulated deficit |
$ | (129,589 | ) | $ | (130,081 | ) | $ | (492 | ) |
(3) |
(1) |
Change relates to future costs associated with extended warranties required to be recorded on the adoption of ASC 606, partially offset by the current portion of deferred revenue in connection with the extended warranties not required to be recorded under ASC 606. |
(2) |
Change relates to noncurrent portion of deferred revenue in connection with the extended warranties not required to be recorded under ASC 606. |
(3) |
Change relates to $177,000 cumulative effect adjustment on the adoption of ASC 606 and the net gain adjustment of $315,000 for the six months ended June 30, 2018. |
Revenue by Geographic Area:
Management has determined that the sales by geography is a key indicator for understanding the Company’s financials because of the different sales and business models that are required in the various regions of the world (including regulatory, selling channels, pricing, customers and marketing efforts).
The following table presents the revenue from unaffiliated customers disaggregated by geographic area for the three and six months ended June 30, 2018 (in thousands):
Three Months Ended |
Six Months Ended |
|||||||||||||||
June 30, |
June 30, |
|||||||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||||||
United States |
$ | 4,552 | $ | 1,895 | $ | 7,158 | $ | 3,791 | ||||||||
Asia Pacific |
630 | 690 | 1,521 | 1,433 | ||||||||||||
Europe and Middle East |
329 | 456 | 531 | 568 | ||||||||||||
Latin America |
14 | 35 | 14 | 325 | ||||||||||||
Total |
$ | 5,525 | $ | 3,076 | $ | 9,224 | $ | 6,117 |
The Company determines geographic location of its revenue based upon the destination of the shipments of its products.
Investments in Unconsolidated Affiliates
The Company uses the equity method to account for its investments in entities that it does not control but have the ability to exercise significant influence over the investee. Equity method investments are recorded at original cost and adjusted periodically to recognize (1) the proportionate share of the investees’ net income or losses after the date of investment, (2) additional contributions made and dividends or distributions received, and (3) impairment losses resulting from adjustments to net realizable value. The Company eliminates all intercompany transactions in accounting for equity method investments. The Company records the proportionate share of the investees’ net income or losses in equity in earnings of unconsolidated affiliates on the condensed consolidated statements of operations. We utilize a three-month lag in reporting equity income from our investments, adjusted for known amounts and events, when the investee’s financial information is not available timely or when the investee’s reporting period differs from our reporting period.
The Company assesses the potential impairment of the equity method investments when indicators such as a history of operating losses, a negative earnings and cash flow outlook, and the financial condition and prospects for the investee’s business segment might indicate a loss in value. The carrying value of the investments are reviewed annually for changes in circumstances or the occurrence of events that suggest the investment may not be recoverable. No impairment charges have been recorded in the condensed consolidated statements of operations during the three and six months ended June 30, 2018.
Product Warranty
The Company’s products are generally subject to warranties between one and three years, which provides for the repair, rework or replacement of products (at the Company’s option) that fail to perform within stated specifications. The Company has assessed the historical claims and, to date, product warranty claims have not been significant.
Accounting for Stock-Based Compensation
Share-based compensation cost is measured at grant date, based on the fair value of the award, and is recognized as expense over the employee’s service period. The Company recognizes compensation expense on a straight-line basis over the requisite service period of the award.
We determined that the Black-Scholes option pricing model is the most appropriate method for determining the estimated fair value for stock options and purchase rights under the employee stock purchase plan. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions which determine the fair value of share-based awards, including the option’s expected term and the price volatility of the underlying stock.
Equity instruments issued to nonemployees are recorded at their fair value on the measurement date and are subject to periodic adjustment as the underlying equity instruments vest.
Comprehensive Loss
Comprehensive loss represents the changes in equity of an enterprise, other than those resulting from stockholder transactions. Accordingly, comprehensive loss may include certain changes in equity that are excluded from net loss. For the three and six months ended June 30, 2018 and 2017, 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, stock options and warrants to purchase common stock and restricted common stock awards are considered common stock equivalents. For periods in which the Company has reported net losses, diluted net loss per share is the same as basic net loss per share, since dilutive common shares are not assumed to have been issued if their effect is anti-dilutive.
The following securities were excluded from the calculation of net loss per share because the inclusion would be anti-dilutive.
Six Months Ended |
||||||||
June 30, |
||||||||
2018 |
2017 |
|||||||
Stock options to purchase common stock |
4,209,355 | 2,287,572 | ||||||
Warrants to purchase common stock |
642,622 | 642,622 | ||||||
Restricted common stock awards |
66,250 | 6,250 |
Reclassification of Prior Year Presentation
Certain prior year amounts have been reclassified for consistency with the current period presentation. These reclassifications had no effect on the reported results of operations. The Company has revised the classification in the consolidated statements of cash flows to report other noncurrent liabilities as a separate line item for the six months ended June 30, 2018. This resulted in a decrease in the amount previously reported for accrued and other liabilities of $53,000 for the six months ended June 30, 2017.
Recently Issued and Adopted Accounting Standards
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, “Leases (Topic 842)”. Under this guidance, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. This guidance is effective for annual reporting periods beginning after December 15, 2018, including interim periods within the reporting period, and requires a modified retrospective adoption, with early adoption permitted. We are currently evaluating the effect of the adoption of this guidance on our condensed consolidated financial statements.
In August 2016, the FASB issued ASU No. 2016-15, “Statement of Cash Flows, Classification of Certain Cash Receipts and Cash Payments (Topic 230)”. This guidance addresses specific cash flow issues with the objective of reducing the diversity in practice for the treatment of these issues. The areas identified include: debt prepayment or debt extinguishment costs; settlement of zero-coupon debt instruments; contingent consideration payments made after a business combination; proceeds from the settlement of insurance claims; proceeds from the settlement of corporate-owned life insurance policies; distributions received from equity method investees; beneficial interests in securitization transactions and application of the predominance principle with respect to separately identifiable cash flows. This guidance is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, with early adoption permitted. We adopted this guidance as of January 1, 2018 and the adoption of the guidance did not have a significant impact on the condensed consolidated financial statements.
In August 2016, the FASB issued ASU No. 2016-18, “Statement of Cash Flows, Restricted Cash (Topic 230)”. This guidance requires that a statement of cash flows explain the total change during the period of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Amounts described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning of period and end of period to total amounts shown on the statement of cash flows. This guidance is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, with early adoption permitted. We adopted this guidance as of January 1, 2018 and the adoption of the guidance did not have a significant impact on the condensed consolidated financial statements.
In May 2017, the FASB issued ASU No. 2017-09, “Compensation - Stock Compensation (Topic 718), Scope of Modification Accounting”. This pronouncement provides guidance about which changes to the terms or conditions of a share-based payment award may require an entity to apply modification accounting under Topic 718. This guidance is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, with early adoption permitted. We adopted this guidance as of January 1, 2018 and the adoption of the guidance did not have a significant impact on the condensed consolidated financial statements.
In June 2018, the FASB issued ASU 2016-07, “Stock Compensation (Topic 718) – Improvements to Nonemployee Share-Based Payment Accounting”. The intent of this guidance is to simplify the accounting for nonemployee share-based payment accounting. The amendments in this guidance expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Consistent with the accounting requirement for employee share-based payment awards, nonemployee share-based payment awards within the scope of Topic 718 are measured at grant-date fair value of the equity instruments that an entity is obligated to issue when the good has been delivered or the service has been rendered and any other conditions necessary to earn the right to benefit from the instruments have been satisfied. Equity-classified nonemployee share-based payment awards are measured at the grant date. Consistent with the accounting for employee share-based payment awards, an entity considers the probability of satisfying performance conditions when nonemployee share-based payment awards contain such conditions. This guidance is effective for annual reporting periods beginning after December 15, 2018, including interim periods within the reporting period. We are currently evaluating the effect of the adoption of this guidance on our condensed consolidated financial statements.
We have reviewed other recent accounting pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the condensed consolidated financial statements as a result of future adoption.
3. |
Fair Value Measurements |
The Company recognizes and discloses the fair value of its assets and liabilities using a hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to valuations based upon unadjusted quoted prices in active markets for identical assets or liabilities (Level 1 measurements) and the lowest priority to valuations based upon unobservable inputs that are significant to the valuation (Level 3 measurements). Each level of input has different levels of subjectivity and difficulty involved in determining fair value.
|
Level 1 |
Inputs used to measure fair value are unadjusted quoted prices that are available in active markets for the identical assets or liabilities as of the reporting date. Therefore, determining fair value for Level 1 investments generally does not require significant judgment, and the estimation is not difficult. |
|
|
|
|
Level 2 |
Pricing is provided by third party sources of market information obtained through investment advisors. The Company does not adjust for or apply any additional assumptions or estimates to the pricing information received from its advisors. |
|
|
|
|
Level 3 |
Inputs used to measure fair value are unobservable inputs that are supported by little or no market activity and reflect the use of significant management judgment. These values are generally determined using pricing models for which the assumptions utilize management’s estimates of market participant assumptions. The determination of fair value for Level 3 instruments involves the most management judgment and subjectivity. |
Assets and liabilities measured at fair value are classified in their entirety based on the lowest level of input that is significant to the fair value measurement. The Company’s assessment of the significance of a particular input to the fair value measurement in its entirety requires management to make judgments and consider factors specific to the asset or liability.
There were no financial instruments that were measured at fair value on a recurring basis as of June 30, 2018 and December 31, 2017.
The carrying amounts of the Company’s financial assets and liabilities, including cash and cash equivalents, accounts receivable, accounts payable, and accrued expenses as of June 30, 2018, and December 31, 2017 approximate fair value because of the short maturity of these instruments. Based on borrowing rates currently available to the Company for loans with similar terms, the carrying value of the note payable approximates fair value.
There were no changes in valuation techniques from prior periods.
4. |
Investment in Limited Liability Company |
On August 8, 2017, the Company entered into an exclusive Distributorship Agreement (the “Distributorship Agreement”) with InControl Medical, LLC (“ICM”), a Wisconsin limited liability company focused on women's health, pursuant to which the Company will directly market, promote, distribute and sell ICM’s products to licensed medical professional offices and hospitals in North America.
Under the terms of the Distributorship Agreement, ICM agreed to not directly or indirectly appoint or authorize any third party to market, promote, distribute or sell any of the licensed products to any licensed medical professional offices and hospitals in the United States. In exchange, the Company agreed to not market, promote, distribute or sell (or contract to do so) any product which substantially replicates all or almost all of the key features of the licensed products. The Company has a minimum purchase requirement to purchase a certain quantity of ICM products per month during the term of this Distributorship Agreement. In addition, the parties agreed to certain mutual marketing obligations to promote sales of the licensed products. As of June 30, 2018, the Company has purchased approximately 2,700 units of ICM products. The Company paid ICM approximately $63,000 and $143,000 for product related costs during the three and six months ended June 30, 2018, respectively.
In connection with the Distributorship Agreement, the Company also entered into a Membership Unit Subscription Agreement with ICM and the associated limited liability company operating agreement of ICM, pursuant to which the Company invested $2,500,000 in, and acquired membership units of, ICM. This investment has been recorded in investment in a limited liability company in the condensed consolidated balance sheets. The Company used the equity method to account for the investment in ICM because the Company does not control it but has the ability to exercise significant influence over it. As of June 30, 2018, the Company owns approximately 11% ownership interest in ICM. The Company recognizes its allocated portion of ICM’s results of operations on a three-month lag due to the timing of financial information. For the three and six months ended June 30, 2018, the allocated net loss from ICM’s operations was $158,000 and $407,000, respectively that was recorded as loss from minority interest in limited liability company in the condensed consolidated statements of operations.
5. |
Accrued Liabilities |
Accrued liabilities consisted of the following as of June 30, 2018 and December 31, 2017 (in thousands):
June 30, |
December 31, |
|||||||
2018 |
2017 |
|||||||
Accrued sales commission |
$ | 1,550 | $ | 1,067 | ||||
Accrued professional fees |
762 | 562 | ||||||
Accrued interest |
662 | 447 | ||||||
Accrued bonuses |
613 | 1,597 | ||||||
Accrued payroll and other related expenses |
521 | 488 | ||||||
Travel and entertainment |
272 | 156 | ||||||
Customer contracts liabilities |
182 | - | ||||||
Accrued sales & use tax |
161 | 149 | ||||||
Other accruals |
535 | 139 | ||||||
Total accrued liabilities |
$ | 5,258 | $ | 4,605 |
6. |
Note Payable |
On June 20, 2016, the Company entered into a Loan and Security Agreement, as amended January 13, 2017 (the “2016 Loan Agreement”) with Western Alliance Bank (“WAB”), pursuant to which WAB agreed to loan the Company up to an aggregate of $10,000,000 payable in two tranches of $7,500,000 and $2,500,000. The funding conditions for both tranches were satisfied as of the closing date, and therefore, the aggregate principal amount of $10,000,000 was provided on June 20, 2016. The terms of the loan also required the Company to meet certain financial and other covenants in connection with the 2016 Loan Agreement. In addition to all outstanding principal and accrued interest on the term loan, the terms of the loan required the Company to pay a final payment fee equal to 4.00% of the original principal amount of the term loan. All borrowings under the 2016 Loan Agreement were collateralized by substantially all of the Company’s assets, including intellectual property. The outstanding principal balance and accrued interest related to this note payable were repaid in May 2017.
In connection with the 2016 Loan Agreement, the Company issued a 10-year warrant to WAB to purchase a total of 100,402 shares of the Company’s common stock at an exercise price of $4.98 per share (See Note 8).
On May 22, 2017, the Company entered into a Term Loan Agreement (the “2017 Loan Agreement”) with affiliates of CRG LP (“CRG”). The credit facility consists of $20,000,000 drawn at closing and access to additional funding of up to an aggregate of $10,000,000 for a total of $30,000,000 available under the credit facility. On December 29, 2017, the Company accessed the remaining $10,000,000 available under the credit facility.
A portion of the initial loan proceeds were used to repay all of the amounts owed by the Company under its 2016 Loan Agreement with WAB. The remainder of the loan proceeds (after deducting loan origination costs and other fees and expenses incurred in connection with the 2017 Loan Agreement), plus any additional amounts that may be borrowed in the future, will be used for general corporate purposes and working capital.
The 2017 Loan Agreement has a six-year term with four years of interest-only payments after which quarterly principal and interest payments will be due through the maturity date. Amounts borrowed under the 2017 Loan Agreement accrue interest at an annual fixed rate of 12.5%, 4.0% of which may, at the election of the Company, be paid in-kind during the interest-only period by adding such accrued amount to the principal loan amount each quarter. During the three and six months ended June 30, 2018, the Company paid interest in-kind of $311,000 and $616,000, respectively, which was added to the total outstanding principal loan amount as of June 30, 2018. During the three and six months ended June 30, 2017, the Company paid interest in-kind of $80,000. The Company is also required to pay CRG a final payment fee upon repayment of the loans in full equal to 5.0% of the sum of the aggregate principal amount plus the deferred interest added to the principal loan amount during the interest-only period. The Company accounts for the final payment fee by accruing the fee over the term of the loan using the effective interest rate method. As of June 30, 2018, interest accrued related to the final payment fee in the amount of $305,000 was included in other noncurrent liabilities in the condensed consolidated balance sheets.
The Company may prepay all or a portion of the outstanding principal and accrued unpaid interest under the 2017 Loan Agreement at any time upon prior notice to CRG, subject to a prepayment fee during the first five years of the term (which reduces each year) and no prepayment fee thereafter.
As security for its obligations under the 2017 Loan Agreement, the Company entered into security agreements with CRG whereby the Company granted CRG a lien on substantially all of the Company’s assets, including intellectual property.
The terms of the 2017 Loan Agreement also require the Company to meet certain financial and other covenants. These covenants require the Company to maintain cash and cash equivalents of $2.0 million and, each year through the end of 2022, to meet a minimum total annual revenue threshold. In the event that the Company does not meet the minimum total annual revenue threshold for a particular year, then the Company can retroactively cure the shortfall by either issuing additional equity in exchange for cash or incurring certain additional permitted indebtedness, in each case, in an amount equal to 2.0 times the shortfall. Any such amounts shall be applied to prepay the loans. The 2017 Loan Agreement also contains customary affirmative and negative covenants for a credit facility of this size and type, including covenants that limit or restrict the Company’s ability to, among other things, incur indebtedness, grant liens, merge or consolidate, dispose of assets, make investments, make acquisitions, enter into transactions with affiliates, pay dividends or make distributions, license intellectual property rights on an exclusive basis or repurchase stock, in each case subject to customary exceptions. As of June 30, 2018, the Company was in compliance with all covenants.
In connection with the 2017 Loan Agreement, the Company issued two 10-year warrants to CRG to purchase a total of 222,049 shares of the Company’s common stock at an exercise price of $9.50 per share (See Note 8).
As of June 30, 2018, future minimum payments under the note payable are as follows (in thousands):
Year Ending December 31, |
||||
2018 (remaining six months) |
$ | 1,359 | ||
2019 |
2,778 | |||
2020 |
2,901 | |||
2021 |
16,672 | |||
2022 |
19,306 | |||
Thereafter |
6,221 | |||
Total payments |
49,237 | |||
Less: Amount representing interest |
(18,125 | ) | ||
Present value of obligations |
31,112 | |||
Less: Unamortized debt discount |
(1,388 | ) | ||
Note payable, noncurrent portion |
$ | 29,724 |
7. |
Commitments and Contingencies |
Operating Lease
In January 2012, the Company entered into a lease agreement for office and laboratory facilities in Sunnyvale, California. The lease agreement, as amended, commenced in March 2012 and terminated in April 2018.
On February 1, 2017, the Company entered into a sublease agreement (the “Sublease”) for approximately 12,400 square feet of building space for the relocation of the Company’s corporate headquarters to Englewood, Colorado (the “Sublease Premises”), which was effective as of January 26, 2017. The lease term commenced on June 1, 2017 and will terminate in May 2020. We relocated our corporate headquarters from Sunnyvale, California to Englewood, Colorado in June 2017.
The monthly base rent under the Sublease is equal to $20.50 per rentable square foot of the Sublease Premises during the first year. The monthly base rent is equal to $21.12 and $21.75 per rentable square foot during the second and third years, respectively. In connection with the execution of the Sublease, the Company also agreed to pay a security deposit of approximately $22,000. The Company is entitled to an allowance of approximately $88,000 for certain tenant improvements relating to the engineering, design and construction of the Sublease Premises.
Rent expense for the three months ended June 30, 2018 and 2017 was $90,000 and $94,000, respectively. Rent expense for the six months ended June 30, 2018 and 2017 was $228,000 and $167,000, respectively.
As of June 30, 2018, future minimum payments under the leases are as follows (in thousands):
Year Ending December 31, |
||||
2018 (remaining six months) |
$ | 130 | ||
2019 |
264 | |||
2020 |
112 | |||
Total minimum lease payments |
$ | 506 |
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
The Company is or has been subject to proceedings, lawsuits and other claims arising in the ordinary course of business. The Company evaluates contingent liabilities, including threatened or pending litigation, for potential losses. If the potential loss from any claim or legal proceeding is considered probable and the amount can be estimated, the Company accrues a liability for the estimated loss. Because of uncertainties related to these matters, accruals are based upon the best information available. For potential losses for which there is a reasonable possibility (meaning the likelihood is more than remote but less than probable) that a loss exists, the Company will disclose an estimate of the potential loss or range of such potential loss or include a statement that an estimate of the potential loss cannot be made. As additional information becomes available, the Company reassesses the potential liability related to pending claims and litigation and may revise its estimates, which could materially impact its condensed consolidated financial statements. Management does not believe that the outcome of any outstanding legal matters will have a material adverse effect on the Company's consolidated financial position, results of operations and cash flows.
Legal Proceedings
On March 11, 2016, the Company filed a demand for Arbitration with the American Arbitration Association ("AAA") against a former employee asserting common law and statutory negligence claims against the former employee arising from the former employee's negligent performance of certain work duties. The demand seeks damages for lost profits, along with attorney's fees, interest, and costs. The former employee filed a counterclaim in the proceeding, alleging discrimination, retaliation, wrongful termination, and various claims for alleged wage and hour violations under the California Labor Code, stemming from the cessation of her employment with the Company. The former employee seeks damages for lost wages, punitive damages, statutory penalties, injunctive relief, and attorney’s fees, interest and costs.
On June 4, 2018, the Company entered into a Settlement and License Agreement (the “Settlement Agreement”) with ThermiGen LLC and ThermiAesthetics LLC (“ThermiGen,” collectively) as well as Red Alinsod, M.D. resolving the Company’s patent litigation against ThermiGen and Dr. Alinsod. The litigation arose from the Company’s claim that ThermiGen and Dr. Alinsod were improperly using the Company’s patented technology without consent. Pursuant to the Settlement Agreement, the parties agreed to resolve all currently pending disputes between them.
Under the terms of the Settlement Agreement, the Company received an initial monetary payment to settle the litigation and past claims and an on-going royalty for future sales. Viveve granted to ThermiGen a non-exclusive, non-transferable license to use the Company’s U.S. patent for the current version of ThermiGen’s ThermiVa system (which includes RF generators and consumables). The Company has recorded the monetary payment as a gain on litigation settlement in selling, general and administrative expenses on the condensed consolidated statements of operations during the three and six months ended June 30, 2018.
8. |
Common Stock |
On June 8, 2018, the Company issued 100,000 restricted shares of its common stock at a value of $2.56 a share, or an aggregate value of approximately $256,000.
On February 12, 2018, in connection with the closing of the February 2018 Offering, the Company issued an aggregate of 11,500,000 shares of common stock, including the shares issued in connection with the exercise of the underwriters’ overallotment option, at a public offering price of $3.00 per share for gross proceeds of approximately $34,500,000. The net proceeds to the Company, after deducting underwriting discounts and commissions and other offering expenses, were approximately $32,213,000.
Through the November 2017 ATM Facility, the Company may offer and sell, from time-to-time, up to $25,000,000 aggregate offering price of shares of its common stock. During the three and six months ended June 30, 2018, the Company sold 65,252 shares and 273,529 shares, respectively, of common stock under the November 2017 ATM Facility for net proceeds of approximately $172,000 and $1,183,000. As of June 30, 2018, the Company has sold 332,778 shares of common stock under the November 2017 ATM Facility for net proceeds of approximately $1,308,000.
Warrants for Common Stock
As of June 30, 2018, outstanding warrants to purchase shares of common stock were as follows:
Number of |
||||||||||||
Shares |
||||||||||||
Outstanding |
||||||||||||
Exercisable |
Expiration |
Exercise |
Under |
|||||||||
Issuance Date |
for |
Date |
Price |
Warrants |
||||||||
September 2014 |
Common Shares |
September 23, 2019 |
$ | 4.24 | 86,831 | |||||||
October 2014 |
Common Shares |
October 13, 2019 |
$ | 4.24 | 29,000 | |||||||
November 2014 |
Common Shares |
November 12, 2019 |
$ | 4.24 | 12,500 | |||||||
February 2015 |
Common Shares |
February 17, 2025 |
$ | 4.00 | 75,697 | |||||||
March 2015 |
Common Shares |
March 26, 2025 |
$ | 2.72 | 1,454 | |||||||
May 2015 |
Common Shares |
May 12, 2025 |
$ | 4.24 | 36,229 | |||||||
May 2015 |
Common Shares |
May 17, 2020 |
$ | 4.24 | 21,585 | |||||||
December 2015 |
Common Shares |
December 16, 2025 |
$ | 5.60 | 26,875 | |||||||
April 2016 |
Common Shares |
April 1, 2026 |
$ | 6.08 | 25,000 | |||||||
May 2016 |
Common Shares |
May 11, 2021 |
$ | 7.74 | 5,000 | |||||||
June 2016 |
Common Shares |
June 20, 2026 |
$ | 4.98 | 100,402 | |||||||
May 2017 |
Common Shares |
May 25, 2027 |
$ | 9.50 | 222,049 | |||||||
642,622 |
In connection with the 2016 Loan Agreement, the Company issued a warrant to purchase a total of 100,402 shares of common stock at an exercise price of $4.98 per share. The Company determined the fair value of the warrant on the date of issuance to be $350,000. The fair value along with legal fees totaling $90,000, was recorded as debt issuance costs and was amortized to interest expense over the loan term. The debt issuance costs were presented in the condensed consolidated balance sheet as a deduction from the carrying amount of the note payable. The outstanding indebtedness was repaid in May 2017 from the proceeds of the new term loan in connection with the 2017 Loan Agreement and the remaining unamortized balance of debt issuance costs was recorded to interest expense for the quarter ended June 30, 2017. During the three and six months ended June 30, 2017, the Company recorded $336,000 and $371,000 respectively, of interest expense relating to the debt issuance costs.
In connection with the 2017 Loan Agreement, the Company issued warrants to purchase a total of 222,049, shares of common stock at an exercise price of $9.50 per share. The warrants have a contractual life of ten years and are exercisable immediately in whole or in part. The Company determined the fair value of the warrants on the date of issuance to be $940,000 using the Black-Scholes option pricing model. Assumptions used were dividend yield of 0%, volatility of 55.1%, risk free interest rate of 2.25% and a contractual life of ten years. The fair value of the warrants along with financing and legal fees totaling $786,000, are recorded as debt issuance costs and presented in the condensed consolidated balance sheets as a deduction from the carrying amount of the note payable. The debt issuance costs are amortized to interest expense over the loan term. During the three and six months ended June 30, 2018, the Company recorded $83,000 and $160,000, respectively, of interest expense relating to the debt issuance costs using the effective interest method. During the three and six months ended June 30, 2017, the Company recorded $38,000 of interest expense relating to the debt issuance costs using the effective interest method. As of June 30, 2018, the unamortized debt discount was $1,388,000.
No shares issuable pursuant to warrants have been exercised during the three and six months ended June 30, 2018 and 2017.
No shares issuable pursuant to warrants have been cancelled during the three and six months ended June 30, 2018 and 2017.
The stock-based compensation expense related to warrants issued was zero for both the three and six months ended June 30, 2018 and 2017.
9. |
Summary of Stock Options |
Stock Option Plans
The Company has issued equity awards in the form of stock options and restricted stock awards (“RSAs”) from two employee benefit plans. The plans include the Viveve Amended and Restated 2006 Stock Plan (the “2006 Plan”) and the Company’s Amended and Restated 2013 Stock Option and Incentive Plan (the “2013 Plan”).
As of June 30, 2018, there are outstanding stock option awards issued from the 2006 Plan covering a total of 38,378 shares of the Company’s common stock and no shares are available for future awards. The weighted average exercise price of the outstanding stock options is $10.49 per share and the weighted average remaining contractual term is 4.4 years.
On December 6, 2017, the board of directors approved the 2018 evergreen provision increasing the total stock reserved for issuance under the 2013 Plan by 914,016 shares from 4,000,000 shares to a total of 4,914,016 shares, which was effective January 1, 2018.
As of June 30, 2018, there are outstanding stock option awards issued from the 2013 Plan covering a total of 4,170,977 shares of the Company’s common stock and there remain reserved for future awards 486,103 shares of the Company’s common stock. The weighted average exercise price of the outstanding stock options is $4.71 per share, and the remaining contractual term is 8.8 years.
Activity under the 2006 Plan and the 2013 Plan is as follows:
Six Months Ended June 30, 2018 |
||||||||||||||||
Weighted |
||||||||||||||||
Weighted |
Average |
|||||||||||||||
Number |
Average |
Remaining |
Aggregate |
|||||||||||||
of |
Exercise |
Contractual |
Intrinsic |
|||||||||||||
Shares |
Price |
Term (years) |
Value |
|||||||||||||
Options outstanding, beginning of period |
2,694,224 | $ | 5.80 | 8.6 | $ | 249,154 | ||||||||||
Options granted |
2,023,559 | $ | 3.60 | |||||||||||||
Options exercised |
- | $ | - | |||||||||||||
Options canceled |
(508,428 | ) | $ | 5.66 | ||||||||||||
Options outstanding, end of period |
4,209,355 | $ | 4.76 | 8.8 | $ | 433,626 | ||||||||||
Vested and exercisable and expected to vest, end of period |
3,935,007 | $ | 4.80 | 8.7 | $ | 392,290 | ||||||||||
Vested and exercisable, end of period |
1,124,400 | $ | 5.65 | 7.5 | $ | 10,167 |
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 June 30, 2018.
The options outstanding and exercisable as of June 30, 2018 are as follows:
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 |
June 30, 2018 |
Price |
Term (Years) |
June 30, 2018 |
Price |
||||||||||||||||||
$1.75 | - |
$1.97 |
552,500 | $ | 1.94 | 9.9 | 12,500 | $ | 1.97 | ||||||||||||||
$2.64 | - |
$2.72 |
82,500 | $ | 2.67 | 9.5 | 9,896 | $ | 2.64 | ||||||||||||||
$3.11 | - |
$3.82 |
319,376 | $ | 3.63 | 9.2 | 55,730 | $ | 3.76 | ||||||||||||||
$4.30 | - |
$4.97 |
1,477,533 | $ | 4.52 | 9.0 | 336,424 | $ | 4.65 | ||||||||||||||
$5.01 | - |
$5.67 |
822,652 | $ | 5.34 | 8.7 | 195,456 | $ | 5.22 | ||||||||||||||
$6.00 | - |
$6.61 |
567,878 | $ | 6.05 | 7.6 | 326,724 | $ | 6.00 | ||||||||||||||
$7.00 | - |
$7.92 |
348,538 | $ | 7.65 | 8.2 | 149,292 | $ | 7.68 | ||||||||||||||
$9.92 | 38,135 | $ | 9.92 | 4.4 | 38,135 | $ | 9.92 | ||||||||||||||||
$59.60 | - |
$149.04 |
243 | $ | 100.46 | 2.5 | 243 | $ | 100.46 | ||||||||||||||
4,209,355 | $ | 4.76 | 8.8 | 1,124,400 | $ | 5.65 |
Stock Option Modifications
On May 30, 2018, under approval by the Company’s Board of Directors, the Company entered in to a Separation and Release Agreement with the former Chief Executive Officer. The provisions of the agreement specify that the stock options previously granted to her will continue to vest through the earlier of the date she ends her consulting services to the Company or December 31, 2018. As of May 30, 2018, these stock options are being accounted for as a non-employee option through the consulting term and are being marked-to-market. Additionally, the former Chief Executive Officer will receive six months of accelerated vesting of the stock options and the post-termination exercise period was extended from three months to one year after the effective date of the agreement. The Company recognized stock-based compensation expense of $97,000 for the incremental value of the accelerated vesting and the change in the exercise period upon the signing of the agreement.
Restricted Stock Awards
In June 2018, the Company granted an RSA for 50,000 shares to a consultant with a weighted average grant date fair value of $3.58 per share, based on the market price of the Company’s common stock on the award date. The RSA vests over two years beginning as of the award date. As of June 30, 2018, zero shares were vested and issued.
In April 2018, the Company granted RSAs for 14,672 shares of common stock under the 2013 Plan to board members as director compensation with a weighted average grant date fair value of $3.44 per share, based on the market price of the Company’s common stock on the award date. The RSAs were fully vested on the date of grant and 14,672 shares of common stock were issued.
In January 2018, the Company granted RSAs for 9,637 shares of common stock under the 2013 Plan to board members as director compensation with a weighted average grant date fair value of $5.19 per share, based on the market price of the Company’s common stock on the award date. The RSAs were fully vested on the date of grant and 9,637 shares of common stock were issued.
In January 2018, the Company granted an RSA for 25,000 shares to a consultant with a weighted average grant date fair value of $5.19 per share, based on the market price of the Company’s common stock on the award date. The RSA vests over one year beginning as of the award date. As of June 30, 2018, 18,750 shares were vested and issued.
As of June 30, 2018, there are 66,250 shares of unvested restricted stock outstanding that have been granted pursuant to RSAs.
2017 Employee Stock Purchase Plan
The second offering period under the Company’s 2017 Employee Stock Purchase Plan (the “2017 ESPP”) began on January 1, 2018 and ended on March 31, 2018, and 20,744 shares were issued on March 29, 2018 at a purchase price of $3.11. The third offering period under the Company’s 2017 Employee Stock Purchase Plan (the “2017 ESPP”) began on April 1, 2018 and ended on June 30, 2018, and 25,618 shares were issued on June 29, 2018 at a purchase price of $2.31.
As of June 30, 2018, the remaining shares available for issuance under the 2017 ESPP were 335,744 shares.
The Company estimates the fair value of purchase rights under the ESPP using a Black-Scholes valuation model. The fair value of each purchase right was estimated on the date of grant using the Black-Scholes option valuation model and the straight-line attribution approach with the following weighted-average assumptions:
Three Months Ended |
Six Months Ended |
|||||
June 30, 2018 |
June 30, 2018 |
|||||
Expected term (in years) |
0.25 | 0.25 | ||||
Average volatility |
74% | 67% | ||||
Risk-free interest rate |
1.73% | 1.58% | ||||
Dividend yield |
0% | 0% |
The weighted average grant date fair value of the purchase rights issued under the 2017 ESPP during the three and six months ended June 30, 2018 was $0.95 and $1.11, respectively.
Stock-Based Compensation
During the three months ended June 30, 2018 and 2017, the Company granted stock options to employees to purchase 570,000 and 185,250 shares of common stock with a weighted average grant date fair value of $1.34 and $3.31 per share, respectively. During the six months ended June 30, 2018 and 2017, the Company granted stock options to employees to purchase 1,821,171 and 415,110 shares of common stock with a weighted average grant date fair value of $2.32 and $2.56 per share, respectively. There were no stock options exercised during the three and six months ended June 30, 2018. A total of 7,730 shares pursuant to stock options issued to employees were exercised during the three and six months ended June 30, 2017. The aggregate intrinsic value of options exercised during the six months ended June 30, 2017 was $30,785, respectively.
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 weighted average assumptions:
Three Months Ended |
Six Months Ended |
|||||||||||
June 30, |
June 30, |
|||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||
Expected term (in years) |
5 | 5 | 5 | 5 | ||||||||
Average volatility |
69% | 48% | 75% | 48% | ||||||||
Risk-free interest rate |
2.82% | 1.76% | 2.63% | 1.90% | ||||||||
Dividend yield |
0% | 0% | 0% | 0% |
During the three and six months ended June 30, 2018, the Company granted stock options to nonemployees to purchase 200,000 and 202,388 shares of common stock with a weighted average grant date fair value of $1.59 and $1.61 respectively. During the three and six months ended June 30, 2017, the Company granted stock options to nonemployees to purchase 5,875 shares of common stock with a weighted average grant date fair value of $5.11. There were no stock options exercised by nonemployees during the three and six months ended June 30, 2018 and 2017.
The fair value of nonemployee stock options granted was estimated using the following weighted average assumptions:
Three Months Ended |
Six Months Ended |
|||||||||||
June 30, |
June 30, |
|||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||
Expected term (in years) |
10 | 10 | 10 | 10 | ||||||||
Average volatility |
91% | 55% | 91% | 55% | ||||||||
Risk-free interest rate |
2.85% | 2.00% | 2.85% | 2.29% | ||||||||
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 the 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 six months ended June 30, 2018 and 2017 (in thousands):
Three Months Ended |
Six Months Ended |
|||||||||||||||
June 30, |
June 30, |
|||||||||||||||
2018 |
2017 |
2018 |
2017 |
|||||||||||||
Cost of revenue |
$ | 17 | $ | 4 | $ | 28 | $ | 7 | ||||||||
Research and development |
65 | 57 | 187 | 108 | ||||||||||||
Selling, general and administrative |
694 | 394 | 1,314 | 712 | ||||||||||||
Total |
$ | 776 | $ | 455 | $ | 1,529 | $ | 827 |
As of June 30, 2018, the total unrecognized compensation cost in connection with unvested stock options was approximately $6,341,000. These costs are expected to be recognized over a period of approximately 3.0 years.
10. |
Income Taxes |
No provision for income taxes has been recorded due to the net operating losses incurred from inception to date, for which no benefit has been recorded.
For interim periods, the Company estimates its annual effective income tax rate and applies the estimated rate to the year-to-date income or loss before income taxes. The Company also computes the tax provision or benefit related to items reported separately and recognizes the items net of their related tax effect in the interim periods in which they occur. The Company also recognizes the effect of changes in enacted tax laws or rates in the interim periods in which the changes occur.
The Company’s effective tax rate is 0% for the three and six months ended June 30, 2018 and 2017. The Company expects that its effective tax rate for the full year 2018 will be 0%.
On December 22, 2017, the United States enacted a law commonly known as the Tax Cuts and Jobs Act (“TCJA”) which makes widespread changes to the Internal Revenue Code, including a reduction in the federal corporate tax rate to 21%, and repatriation of accumulated foreign accumulated earnings and profits, effective January 1, 2018.
11. |
Related Party Transactions |
In June 2006, the Company entered into a Development and Manufacturing Agreement (the “Agreement”) with Stellartech Research Corporation (“Stellartech”). The Agreement was amended on October 4, 2007. Under the Agreement, the Company agreed to purchase 300 generators manufactured by Stellartech. As of June 30, 2018, the Company has purchased 709 units. The price per unit is variable and dependent on the volume and timing of units ordered. In conjunction with the Agreement, Stellartech purchased 37,500 shares of Viveve, Inc.’s common stock. Under the Agreement, the Company paid Stellartech approximately $2,325,000 and $1,681,000 for goods and services during the three months ended June 30, 2018 and 2017, respectively, and approximately $5,598,000 and $3,706,000 for the six months ended June 30, 2018 and 2017, respectively. The amounts due to Stellartech for accounts payable as of June 30, 2018 and December 31, 2017 were approximately $1,258,000 and $1,380,000, respectively.
In connection with the Distributorship Agreement entered into with ICM in August 2017, the Company also entered into a Membership Unit Subscription Agreement with ICM and the Company invested $2,500,000 in ICM. As of June 30, 2018, the Company has purchased approximately 2,700 units of ICM products. The Company paid ICM approximately $63,000 and $143,000 for product related costs during the three and six months ended June 30, 2018, respectively. The amounts due to ICM for the accounts payable as of June 30, 2018 and December 31, 2017 were approximately $22,000 and $28,000, respectively.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.
You should read the following discussion of our financial condition and results of operations in conjunction with the condensed consolidated financial statements and the related notes included elsewhere in this Quarterly Report and with our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission on March 16, 2018. In addition to historical condensed consolidated financial information, the following discussion contains forward-looking statements that reflect our plans, estimates, and beliefs. Our actual results could differ materially from those discussed in the forward-looking statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Quarterly Report, particularly in Part II, Item 1A. "Risk Factors."
Overview of Our Business
In the discussion below, when we use the terms “we”, “us” and “our”, we are referring to Viveve Medical, Inc. and our wholly-owned subsidiaries, Viveve, Inc. and Viveve BV.
We design, develop, manufacture and market a platform medical technology, which we refer to as Cryogen-cooled Monopolar Radiofrequency , or CMRF. Our proprietary CMRF technology is delivered through a radiofrequency generator, handpiece and treatment tip that, collectively, we refer to as the Viveve® System. The Viveve System is currently marketed and sold for a number of indications, depending on the relevant country-specific clearance or approval. Currently, the Viveve System is cleared for marketing in 66 countries throughout the world under the following indications for use:
Indication for Use: |
No. of Countries: |
|||
General Surgical procedures for electrocoagulation and hemostasis |
4 (including the U.S.) |
|||
General Surgical procedures for electrocoagulation and hemostasis and for the treatment of vaginal laxity |
1 | |||
For treatment of vaginal laxity |
41 | |||
For treatment of the vaginal introitus, after vaginal childbirth, to improve sexual function |
18 | |||
For vaginal rejuvenation |
1 | |||
For treatment of vaginal laxity, urinary incontinence and sexual function |
1 |
In the U.S., the Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis and we market and sell primarily through a direct sales force. Outside the U.S., we market and sell primarily through distribution partners. As of June 30, 2018, we have sold 582 Viveve Systems and approximately 23,000 single-use treatment tips worldwide.
Because the revenues we have earned to date have not been sufficient to support our operations, we have relied on sales of our securities, bank term loans and loans from related parties to fund our operations.
We are subject to risks, expenses and uncertainties frequently encountered by companies in the medical device industry. These risks include, but are not limited to, intense competition, whether we can be successful in obtaining U.S. Food and Drug Administration (“FDA”) and other governmental clearance or approval for the sale of our product for all indications and whether there will be a demand for the Viveve System, given that the cost of the procedure will likely not be reimbursed by the government or private health insurers. In addition, we will continue to require substantial funds to support our clinical trials and fund our efforts to expand regulatory clearance or approval for our products, including in the U.S. We cannot be certain that any additional required financing will be available when needed or on terms which are favorable to us. As noted above, our operations to date have been primarily funded through the sales of our securities, bank term loans and loans from related parties. Various factors, including our limited operating history with limited revenues to date and our limited ability to market and sell our products have resulted in limited working capital available to fund our operations. There are no assurances that we will be successful in securing additional financing in the future to fund our operations going forward. Failure to generate sufficient cash flows from operations, raise additional capital or reduce certain discretionary spending could have a material adverse effect on our ability to achieve our intended business objectives.
Recent Events
Settlement of Patent Infringement Litigation with ThermiGen
On June 4, 2018, we entered into a Settlement and License Agreement (the “Settlement Agreement”) with ThermiGen LLC and ThermiAesthetics LLC (“ThermiGen,” collectively) as well as Red Alinsod, M.D. resolving our patent litigation against ThermiGen and Dr. Alinsod. The litigation arose from our claim that ThermiGen and Dr. Alinsod were improperly using our patented technology without consent. Pursuant to the Settlement Agreement, the parties agreed to resolve all currently pending disputes between them.
Under the terms of the Settlement Agreement, we received an initial monetary payment to settle the litigation and past claims and an on-going royalty for future sales. We granted to ThermiGen a non-exclusive, non-transferable license to use our U.S. patent for the current version of ThermiGen’s ThermiVa system (which includes RF generators and consumables).
Effective Shelf Registration Statements
In October 2016, we filed a universal shelf registration statement with the SEC on Form S-3 for the proposed offering from time to time of up to $50,000,000 of our securities, including common stock, preferred stock, and/or warrants (the “2016 Shelf Registration Statement”). The 2016 Shelf Registration Statement currently has a remaining capacity of $15,500,000. In November 2017, we filed a universal shelf registration statement with the SEC on Form S-3 for the proposed offering from time to time of up to $50,000,000 of our securities, including common stock, preferred stock, and/or warrants (the “2017 Shelf Registration Statement”). The 2017 Shelf Registration Statement currently has a remaining capacity of $25,000,000.
“At-the-Market” Offering
The Company established, through the filing of a prospectus supplement to its shelf registration statement on Form S-3 (filed November 8, 2017), an “at-the-market” equity offering program under which the Company may offer and sell, from time to time, up to $25,000,000 aggregate offering price of shares of its common stock (the “November 2017 ATM Facility”). During the three and six months ended June 30, 2018, the Company sold 65,252 shares and 273,529 shares, respectively, of common stock under the November 2017 ATM Facility for net proceeds of approximately $172,000 and $1,183,000, respectively. As of June 30, 2018, the Company has sold 332,778 shares of common stock under the November 2017 ATM Facility for net proceeds of approximately $1,308,000. Based on the closing price of $2.72 as of June 29, 2018, approximately 8,595,634 remaining shares may be issued under the "at-the-market" equity offering program.
February 2018 Offering
In connection with the closing of the February 2018 Offering, the Company issued an aggregate of 11,500,000 shares of common stock, including the shares issued in connection with the exercise of the underwriters’ overallotment option, at a public offering price of $3.00 per share for gross proceeds of approximately $34,500,000. The net proceeds to the Company, after deducting underwriting discounts and commissions and other offering expenses, were approximately $32,213,000.
Adoption of New Accounting Standard
On January 1, 2018, the Company adopted Revenue from Contracts with Customers (Topic 606), which created Accounting Standards Codification Topic 606 (“ASC 606”), using the modified retrospective method applied to those contracts which were not completed as of January 1, 2018. Results for reporting periods beginning after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and continue to be reported in accordance with our historic accounting under ASC 605.
Under ASC 605, revenue from extended assurance warranties was deferred and recognized over the period of the warranty. On the adoption of ASC 606, these warranties are not considered a separate performance obligation. Accordingly, on the transition date, the Company recorded a net adjustment in retained earnings of $177,000, resulting from the reclassification of $195,000 for the amount of extended warranties previously recorded in noncurrent liabilities, offset by $18,000 recorded in accrued liabilities for future costs associated with the assurance-type extended warranties.
Reported Positive Six-Month Data from Stress Urinary Incon tinence (SUI) Feasibility Study
In June 2018, the Company reported positive six-month interim data from its SUI feasibility study. At six months post-treatment, 83% of women experienced improvement in one-hour pad weight test with an overall mean improvement of 73% and clinically meaningful benefit achieved across all quality of life outcome measures. This single-arm feasibility study included 36 subjects with mild to moderate SUI (based on the one-hour pad weight test) who underwent treatment with Viveve’s CMRF technology under a proprietary treatment protocol. Clinical results included the objective one-hour pad weight assessment and seven-day bladder voiding diary, as well as composite scores from multiple validated patient-reported outcomes, including: UDI-6 (Urogenital Distress Inventory-Short Form), IIQ-7 (Incontinence Impact Questionnaire) and ICIQ-UI-SF (International Consultation on Incontinence Questionnaire-Urinary Incontinence-Short Form). No device-related safety issues were reported in any of the patients. This ongoing study received both ethics committee and Health Canada approval. Subjects will be followed for a total of 12 months.
FDA Approval to Continue VIVEVE II Clinical Study
In March 2018, the Company received approval of its Investigational Device Exemption (IDE) application from the U.S. Food and Drug Administration (FDA). The approval allows us to conduct the VI veve Treatment of the V aginal Introitus to EV aluate Safety and E fficacy (VIVEVE II) clinical trial to assess the safety and effectiveness of the Viveve® System for the improvement of sexual function in women following vaginal childbirth. The VIVEVE II clinical study is a randomized, double-blinded, and sham-controlled trial with a planned enrollment of approximately 250 patients at up to 25 study sites in the United States and Canada. Subjects will be randomized in a 1:1 ratio for active and sham treatments.
A staged approach, or roll-in, for clinical enrollment was required by the FDA in its IDE approval letter to the Company. In the first stage, enrollment is limited to 50 subjects. The roll-in required safety review by the FDA of a minimum of 25 subjects, one-month post-treatment. Viveve submitted the required first stage 30-day safety data to the FDA for review on the initial 25 subjects in the trial as well as an IDE Supplement to expand the study up to its intended 250 subjects. Enrollment in the trial continued up to the 50 subject first stage limit while FDA reviewed the safety data. In early August, Viveve received an approval letter from the FDA stating the Agency had completed their first requested safety review and granted continued enrollment of up to 100 subjects in a second stage of the trial. A second safety review will now occur after safety data are collected from an additional 25 subjects out to one-month follow-up, and from the first 50 subjects at three-month follow-up. While safety data are being reviewed from the second stage, enrollment in the trial will continue up to 100 subjects. Following FDA review of second stage safety data, and approval of an IDE to expand the study, Viveve plans to continue enrollment up to 250 subjects.
The primary efficacy endpoint is the mean change from baseline in the total FSFI (Female Sexual Function Index) score at 12 months. Subjects will also be assessed for safety over the 12 months. The approved protocol also includes a variety of secondary and exploratory endpoints, including various endpoints measured at 6 months post-treatment.
Plan of Operation
We intend to increase our sales both internationally and in the U.S. market by seeking additional regulatory clearances or approvals for the sale and distribution of our products, identifying and training qualified distributors and expanding the scope of physicians who offer the Viveve System to include plastic surgeons, 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 our products by focusing our research and development efforts on various areas including, but not limited to:
● |
designing new treatment tips optimized for both ease-of-use and to potentially reduce procedure times for patients and physicians; and |
|
|
|
|
● |
developing new RF consoles. |
The net proceeds received from sales of our securities and the term loans have been used to support commercialization of our product in existing and new markets, for our research and development efforts and for protection of our intellectual property, as well as for working capital and other general corporate purposes. We expect that our cash will be sufficient to fund our activities for at least the next twelve months; however, we may require additional capital from the sale of equity or debt securities to fully implement our plan of operation. Our operating costs include employee salaries and benefits, compensation paid to consultants, professional fees and expenses, costs associated with our clinical trials, capital costs for research and other equipment, costs associated with research and development activities including travel and administration, legal expenses, sales and marketing costs, general and administrative expenses, and other costs associated with an early stage public company subject to the reporting requirements of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). We also expect to incur expenses related to obtaining regulatory clearances and approvals in the U.S. and internationally as well as legal and related expenses to protect our intellectual property. We expect capital expenditures, for the foreseeable future, to be less than $500,000 annually.
We intend to continue to meet our operating cash flow requirements through the sales of our products and by raising additional capital from the sale of equity or debt securities. If we sell our equity securities, or securities convertible into equity, to raise capital, our current stockholders will likely be substantially diluted. We may also consider the sale of certain assets, or entering into a strategic transaction, such as a merger, with a business complimentary to ours, although we do not currently have plans for any such transaction. While we have been successful in raising capital to fund our operations since inception, other than as discussed in this Quarterly Report on Form 10-Q, we do not have any committed sources of financing and there are no assurances that we will be able to secure additional funding, or if we do secure additional financing that it will be on terms that are favorable to us. If we cannot obtain financing, then we may be forced to curtail our operations or consider other strategic alternatives.
Results of Operations
Comparison of the Three Months Ended June 30 , 2018 and 2017
Revenue
Three Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Revenue |
$ | 5,525 | $ | 3,076 | $ | 2,449 | 80 | % |
We recorded revenue of $5,525,000 for the three months ended June 30, 2018, compared to revenue of $3,076,000 for the three months ended June 30, 2017, an increase of $2,449,000, or approximately 80%. The increase in revenue was primarily due to sales of 85 Viveve Systems (which included 69 Viveve Systems sold in the U.S. market through direct sales). Sales in the second quarter of 2017 included 45 Viveve Systems (which included 27 Viveve Systems sold in the U.S. market through direct sales).
Gross profit
Three Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Gross profit |
$ | 2,814 | $ | 1,239 | $ | 1,575 | 127 | % |
Gross profit was $2,814,000, or 51% of revenue, for the three months ended June 30, 2018, compared to a gross profit of $1,239,000, or 40% of revenue, for the three months ended June 30, 2017, an increase of $1,575,000, or approximately 127%. The increase in gross profit was primarily due to sales of 85 Viveve Systems in the second quarter of 2018, which included 69 Viveve Systems sold in the U.S. market through direct sales.
The increase in gross margin was primarily due to an increase in revenue from direct sales with higher margin products. We expect our gross margin to fluctuate in future periods based on the mix of our product and direct sales versus distributor sales.
Research and development expenses
Three Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Research and development |
$ | 3,672 | $ | 3,440 | $ | 232 | 7 | % |
Research and development expenses totaled $3,672,000, for the three months ended June 30, 2018, compared to research and development expense of $3,440,000 for the three months ended June 30, 2017, an increase of $232,000, or approximately 7%. Spending on research and development increased in the three months ended June 30, 2018 primarily due to costs associated with increased engineering and development work with our contract manufacturer related to product improvement efforts. Research and development expense during the three months ended June 30, 2018 also included higher personnel costs for new employees and related additional stock-based compensation expense for stock options granted to new employees and additional stock options granted to existing employees for performance bonuses.
Selling, general and administrative expenses
Three Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Selling, general and administrative |
$ | 9,437 | $ | 6,862 | $ | 2,575 | 38 | % |
Selling, general and administrative expenses totaled $9,437,000 for the three months ended June 30, 2018, compared to $6,862,000 for the three months ended June 20, 2017, an increase of $2,575,000, or approximately 38%. The increase in selling, general and administrative expenses was primarily attributable to increased sales and marketing efforts to build brand and market awareness, expenses associated with being a public company and financing efforts. Selling, general and administrative expenses during 2018 also included higher personnel costs for new employees (primarily in connection with our sales and marketing efforts) and related additional stock-based compensation expense for stock options granted to new employees and additional stock options granted to existing employees for performance bonuses, partially offset by litigation settlement payments.
Interest expense, net
Three Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Interest expense, net |
$ | 1,063 | $ | 1,345 | $ | (282 | ) | (21 | )% |
During the three months ended June 30, 2018, we had interest expense, net of $1,063,000, compared to $1,345,000 for the three months ended June 30, 2017. The decrease of $282,000, or approximately 21%, resulted primarily from the additional interest expense in the second quarter of 2017 in connection with the May 2017 payoff of the previous term loan under the 2016 Loan Agreement, partially offset by the additional interest expense in the second quarter of 2018 in connection with the 2017 Loan Agreement, which was computed on a higher loan balance compared to the previous term loan under the 2016 Loan Agreement.
Loss from minority interest in limited liability company
Three Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Loss from minority interest in limited liability company |
$ | 158 | $ | - | $ | 158 | - |
The Company uses the equity method to account for its investment in InControl Medical, LLC (“ICM”). For the three months ended June 30, 2018, the allocated net loss from ICM’s operations was $158,000.
Other expense, net
Three Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Other expense, net |
$ | - | $ | (17 | ) | $ | 17 | (100 | )% |
During the three months ended June 30, 2018, we had other expense, net, of zero, compared to $17,000 for the three months ended June 30, 2017.
Comparison of the Six Months Ended June 30, 2018 and 2017
Revenue
Six Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Revenue |
$ | 9,224 | $ | 6,117 | $ | 3,107 | 51 | % |
We recorded revenue of $9,224,000 for the six months ended June 30, 2018, compared to revenue of $6,117,000 for the six months ended June 30, 2017, an increase of $3,107,000, or approximately 51%. The increase in revenue was primarily due to sales of 138 Viveve Systems (which included 107 Viveve Systems sold in the U.S. market through direct sales), disposable treatment tips and other ancillary consumables in the six months ended June 30, 2018. Sales in the six months ended June 30, 2017 included 87 Viveve Systems (which included 56 Viveve Systems sold in the U.S. market through direct sales), disposable treatment tips and other ancillary consumables.
Gross profit
Six Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Gross profit |
$ | 4,161 | $ | 2,661 | $ | 1,500 | 56 | % |
Gross profit was $4,161,000, or 45% of revenue, for the six months ended June 30, 2018, compared to a gross profit of $2,661,000, or 44% of revenue, for the six months ended June 30, 2017, an increase of $1,500,000, or approximately 56%. The increase in gross profit was primarily due to sales of 138 Viveve Systems in the six months ended June 30, 2018, which included 107 Viveve Systems sold in the U.S. market through direct sales. Sales in the six months ended June 30, 2017 included 87 Viveve Systems, which included 56 Viveve Systems sold in the U.S. market through direct sales, and smaller quantities of disposable treatment tips and other ancillary consumables.
The increase in gross margin was primarily due to an increase in revenue from direct sales with higher margin products. We expect our gross margin to fluctuate in future periods based on the mix of our product and direct sales versus distributor sales.
Research and development expenses
Six Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Research and development |
$ | 7,428 | $ | 5,828 | $ | 1,600 | 27 | % |
Research and development expenses totaled $7,428,000 for the six months ended June 30, 2018, compared to research and development expense of $5,828,000 for the six months ended June 30, 2017, an increase of $1,600,000 or approximately 27%. Spending on research and development increased in the six months ended June 30, 2018 primarily due to costs associated with increased engineering and development work with our contract manufacturer related to product improvement efforts. Research and development expense during the six months ended June 30, 2018 also included higher personnel costs for new employees and related additional stock-based compensation expense for stock options granted to new employees and additional stock options granted to existing employees for performance bonuses.
Selling, general and administrative expenses
Six Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Selling, general and administrative |
$ | 18,368 | $ | 12,312 | $ | 6,056 | 49 | % |
Selling, general and administrative expenses totaled $18,368,000 for the six months ended June 30, 2018, compared to $12,312,000 for the six months ended June 30, 2017, an increase of $6,056,000 or approximately 49%. The increase in selling, general and administrative expenses was primarily attributable to increased sales and marketing efforts to build brand and market awareness, expenses associated with being a public company and financing efforts. Selling, general and administrative expenses during 2018 also included higher personnel costs for new employees (primarily in connection with our sales and marketing efforts) and related additional stock-based compensation expense for stock options granted to new employees and additional stock options granted to existing employees for performance bonuses, partially offset by litigation settlement payments.
Interest expense, net
Six Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Interest expense, net |
$ | 2,133 | $ | 1,608 | $ | 525 | 33 | % |
During the six months ended June 30, 2018, we had interest expense, net of $2,133,000, compared to $1,608,000 for the six months ended June 30, 2017. The increase of $525,000, or approximately 33%, resulted primarily from the additional interest expense in 2018 in connection with the 2017 Loan Agreement, which was computed on a higher loan balance compared to the previous term loan under the 2016 Loan Agreement, partially offset by the additional interest expense in 2017 in connection with the May 2017 payoff of the previous term loan under the 2016 Loan Agreement.
Loss from minority interest in limited liability company
Six Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Loss from minority interest in limited liability company |
$ | 407 | $ | - | $ | 407 | - |
The Company uses the equity method to account for its investment in ICM. For the six months ended June 30, 2018, the allocated net loss from ICM’s operations was $407,000.
Other expense, net
Six Months Ended |
||||||||||||||||
June 30, |
Change |
|||||||||||||||
2018 |
2017 |
$ |
% |
|||||||||||||
(in thousands, except percentages) |
||||||||||||||||
Other expense, net |
$ | 10 | $ | 33 | $ | (23 | ) | (70 | )% |
During the six months ended June 30, 2018, we had other expense, net, of $ 10,000, compared to $33,000 for the six months ended June 30, 2017.
Liquidity and Capital Resources
Comparison of the Six Months Ended June 30, 2018 and 2017
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 our securities, bank term loans and loans from related parties. 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 expect that our cash will be sufficient to fund our activities for at least the next twelve months, however, we will continue to require funds from financing sources to fully implement our plan of operation.
The following table summarizes the primary sources and uses of cash for the periods presented below (in thousands):
Six Months Ended |
||||||||
June 30, |
||||||||
2018 |
2017 |
|||||||
Net cash used in operating activities |
$ | (23,234 | ) | $ | (17,331 | ) | ||
Net cash used in investing activities |
(803 | ) | (400 | ) | ||||
Net cash provided by financing activities |
33,520 | 40,705 | ||||||
Net increase in cash and cash equivalents |
$ | 9,483 | $ | 22,974 |
Operating Activities
We have incurred, and expect to continue to incur, significant expenses in the areas of research and development, regulatory and clinical study costs, associated with the Viveve System.
Operating activities used $23,233,000 for the six months ended June 30, 2018 compared to $17,331,000 used for the six months ended June 30, 2017. The primary use of our cash was to fund selling, general and administrative expenses and research and development expenses associated with the Viveve System. Net cash used during the six months ended June 30, 2018 consisted of a net loss of $24,185,000 adjusted for non-cash expenses including provision for doubtful accounts of $32,000, depreciation and amortization of $334,000, stock-based compensation of $1,529,000, fair value of common stock issued of $256,000, non-cash interest expense of $776,000, loss from minority interest in limited liability company of $407,000, and cash outflows from changes in operating assets and liabilities of $2,383,000. The change in operating assets and liabilities was primarily due to an increase in accounts receivable of $1,060,000, increase in inventory of $1,930,000, an increase in prepaid expenses and other current assets of $283,000, an increase in accounts payable of $68,000, and an increase in accrued and other liabilities of $635,000, and an increase in other noncurrent liabilities of $173,000. Net cash used during the six months ended June 30, 2017 consisted of a net loss of $17,120,000 adjusted for non-cash expenses including depreciation and amortization of $188,000, stock-based compensation of $827,000, fair value of common stock issued of $260,000, non-cash interest expense of $489,000, and cash outflows from changes in operating assets and liabilities of $1,975,000. The change in operating assets and liabilities was primarily due to an increase in accounts receivable of $1,709,000, an increase in prepaid expenses and other current assets of $822,000 and a decrease in accrued and other liabilities of $58,000, partially offset by a decrease in inventory of $352,000 and an increase in accounts payable of $258,000.
Investing Activities
Net cash used in investing activities during the six months ended June 30, 2018 and 2017 was $803,000 and $400,000, respectively. Net cash used in investing activities during the six months ended June 30, 2018 and 2017 was used for the purchase of property and equipment. We expect to continue to purchase property and equipment in the normal course of our business. The amount and timing of these purchases and the related cash outflows in future periods is difficult to predict and is dependent on a number of factors including, but not limited to, any increase in the number of our employees and any changes to the capital equipment requirements related to our development programs and clinical trials.
Financing Activities
Net cash provided by financing activities during the six months ended June 30, 2018 was $33,520,000, which was the result of the gross proceeds of $34,500,000 from our February 2018 Offering (partially offset by transaction costs of $2,287,000) and gross proceeds of $1,316,000 from our November 2017 ATM Facility (partially offset by transaction costs of $133,000). Net cash provided by financing activities during the six months ended June 30, 2017 was $40,705,000, which was the result of the gross proceeds of $34,500,000 from our March 2017 Offering (partially offset by transaction costs of $3,060,000) the proceeds of $20,000,000 from the drawdown of funds under the 2017 Loan Agreement (partially offset by debt issuance costs of $786,000), and proceeds from the exercise of a warrant and stock options, partially offset by the repayment of the term loan under the 2016 Loan Agreement of $10,000,000.
As of June 30, 2018, there is a balance of $15,500,000 available for future issuance under the 2016 Shelf Registration Statement, $25,000,000 available for future issuance under the 2017 Shelf Registration Statement, and approximately $23,380,000 available for future issuance under the November 2017 ATM Facility.
Contractual Payment Obligations
We have obligations under a bank term loan and non-cancelable operating leases. As of June 30, 2018, our contractual obligations are as follows (in thousands):
Less than |
More than |
|||||||||||||||||||
Contractual Obligations: |
Total |
1 Year |
1 - 3 Year |
3 -5 Years |
5 Years |
|||||||||||||||
Debt obligations (including interest) |
$ | 49,237 | $ | 2,722 | $ | 30,908 | $ | 15,607 | $ | - | ||||||||||
Non-cancellable operating lease obligations |
506 | 260 | 246 | - | - | |||||||||||||||
Total |
$ | 49,743 | $ | 2,982 | $ | 31,154 | $ | 15,607 | $ | - |
In January 2012, we entered into a lease agreement for office and laboratory facilities in Sunnyvale, California. The lease agreement, as amended, commenced in March 2012 and terminated in April 2018.
On February 1, 2017, we entered into a Sublease for approximately 12,400 square feet of building space for the relocation of the Company’s corporate headquarters to Englewood, Colorado. The lease term is 36 months and the monthly base rent for the first, second and third years is $20.50, $21.12 and $21.75 per rentable square foot, respectively. In connection with the execution of the Sublease, the Company paid a security deposit of approximately $22,000. The Company is also entitled to an allowance of approximately $88,000 for certain tenant improvements relating to the engineering, design and construction of the Sublease Premises. The lease term commenced in June 2017 and will terminate in May 2020.
On May 22, 2017, the Company entered into the 2017 Loan Agreement with affiliates of CRG LP (“CRG”). The credit facility consists of $20,000,000 that was drawn at closing and the ability to access additional funding of up to an aggregate of $10,000,000 for a total of $30,000,000 under the credit facility. On December 29, 2017, the Company accessed the remaining $10,000,000 available under the credit facility. The term of the loan is six years with the first four years being interest only. The outstanding principal balance under the 2017 Loan Agreement is $31,112,000 as of June 30, 2018.
Critical Accounting Policies and Estimates
The discussion and analysis of financial condition and results of operations is based upon our condensed consolidated financial statements, which have been prepared in conformity with accounting principles generally accepted in the United States of America Certain accounting policies and estimates are particularly important to the understanding of our financial position and results of operations and require the application of significant judgment by our management or can be materially affected by changes from period to period in economic factors or conditions that are outside of our control. As a result, they are subject to an inherent degree of uncertainty. In applying these policies, management uses their judgment to determine the appropriate assumptions to be used in the determination of certain estimates. Those estimates are based on our historical operations, our future business plans and projected financial results, the terms of existing contracts, observance of trends in the industry, information provided by our customers and information available from other outside sources, as appropriate. Please see Note 2 to our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2017, that was filed with the SEC on March 16, 2018, for a more complete description of our significant accounting policies. Except for the adoption of the new revenue recognition accounting standard on January 1, 2018, there have been no material changes to the significant accounting policies during the six months ended June 30, 2018.
Recent Accounting Pronouncements
In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2016-02, “Leases (Topic 842)”. Under this guidance, an entity is required to recognize right-of-use assets and lease liabilities on its balance sheet and disclose key information about leasing arrangements. This guidance offers specific accounting guidance for a lessee, a lessor and sale and leaseback transactions. Lessees and lessors are required to disclose qualitative and quantitative information about leasing arrangements to enable a user of the financial statements to assess the amount, timing and uncertainty of cash flows arising from leases. This guidance is effective for annual reporting periods beginning after December 15, 2018, including interim periods within the reporting period, and requires a modified retrospective adoption, with early adoption permitted. We are currently evaluating the effect of the adoption of this guidance on our condensed consolidated financial statements.
In August 2016, the FASB issued ASU No. 2016-15, “Statement of Cash Flows, Classification of Certain Cash Receipts and Cash Payments (Topic 230)”. This guidance addresses specific cash flow issues with the objective of reducing the diversity in practice for the treatment of these issues. The areas identified include: debt prepayment or debt extinguishment costs; settlement of zero-coupon debt instruments; contingent consideration payments made after a business combination; proceeds from the settlement of insurance claims; proceeds from the settlement of corporate-owned life insurance policies; distributions received from equity method investees; beneficial interests in securitization transactions and application of the predominance principle with respect to separately identifiable cash flows. This guidance is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, with early adoption permitted. We adopted this guidance as of January 1, 2018 and the adoption of the guidance did not have a significant impact on the condensed consolidated financial statements.
In August 2016, the FASB issued ASU No. 2016-18, “Statement of Cash Flows, Restricted Cash (Topic 230)”. This guidance requires that a statement of cash flows explain the total change during the period of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Amounts described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning of period and end of period to total amounts shown on the statement of cash flows. This guidance is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, with early adoption permitted. We adopted this guidance as of January 1, 2018 and the adoption of the guidance did not have a significant impact on the condensed consolidated financial statements.
In May 2017, the FASB issued ASU No. 2017-09, “Compensation - Stock Compensation (Topic 718), Scope of Modification Accounting”. This pronouncement provides guidance about which changes to the terms or conditions of a share-based payment award may require an entity to apply modification accounting under Topic 718. This guidance is effective for annual reporting periods beginning after December 15, 2017, including interim periods within that reporting period, with early adoption permitted. We adopted this guidance as of January 1, 2018 and the adoption of the guidance did not have a significant impact on the condensed consolidated financial statements.
In June 2018, the FASB issued ASU 2016-07, “Stock Compensation (Topic 718) – Improvements to Nonemployee Share-Based Payment Accounting”. The intent of this guidance is to simplify the accounting for nonemployee share-based payment accounting. The amendments in this guidance expand the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Consistent with the accounting requirement for employee share-based payment awards, nonemployee share-based payment awards within the scope of Topic 718 are measured at grant-date fair value of the equity instruments that an entity is obligated to issue when the good has been delivered or the service has been rendered and any other conditions necessary to earn the right to benefit from the instruments have been satisfied. Equity-classified nonemployee share-based payment awards are measured at the grant date. Consistent with the accounting for employee share-based payment awards, an entity considers the probability of satisfying performance conditions when nonemployee share-based payment awards contain such conditions. This guidance is effective for annual reporting periods beginning after December 15, 2018, including interim periods within the reporting period. We are currently evaluating the effect of the adoption of this guidance on our condensed consolidated financial statements.
We have reviewed other recent accounting pronouncements and concluded they are either not applicable to the business, or no material effect is expected on the condensed consolidated financial statements as a result of future adoption.
Off-Balance Sheet Transactions
We do not have any off-balance sheet transactions.
Trends, Events and Uncertainties
Research, development and commercialization of new technologies and products is, by its nature, unpredictable. Although we will undertake development efforts, including efforts with commercially reasonable diligence, there can be no assurance that we will have adequate capital to develop or commercialize our technology to the extent needed to create future sales to sustain our operations.
We cannot assure you that our technology will be adopted, that we will ever earn revenues sufficient to support our operations, or that we will ever be profitable. Furthermore, since we have no committed source of financing, we cannot assure you that we will be able to raise money as and when we need it to continue our operations. If we cannot raise funds as and when we need them, we may be required to severely curtail, or even to cease, our operations.
Other than as discussed above and elsewhere in this Quarterly Report on Form 10-Q, we are not aware of any trends, events or uncertainties that are likely to have a material effect on our financial condition.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We are exposed to market risk related to changes in interest rates. As of June 30, 2018, our cash and cash equivalents consisted of cash and interest-bearing accounts. Our primary exposure to market risk is interest income sensitivity, which is affected by changes in the general level of U.S. interest rates. However, since a majority of our investments are in highly liquid interest-bearing accounts, we do not believe we are subject to any material market risk exposure. As of June 30, 2018, we did not have any material derivative financial instruments. The fair value of our cash and cash equivalents was $30.2 million as of June 30, 2018.
We are also exposed to market risk related to changes in foreign currency exchange rates. From time to time, we contract with vendors or service providers that are located outside the U.S., which are denominated in foreign currencies. We are subject to fluctuations in foreign currency rates in connection with these agreements. We do not currently hedge our foreign currency exchange rate risk. As of June 30, 2018, and December 31, 2017, we had minimal liabilities denominated in foreign currencies.
We do not believe that inflation had a material effect on our business, financial condition or results of operations during the three and six months ended June 30, 2018 and 2017.
Item 4. Controls and Procedures.
Evaluation of Disclosure Controls and Procedures
We maintain disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) that are designed to ensure that information required to be disclosed in our reports filed under the Exchange Act, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission’s rules and forms, and that such information is accumulated and communicated to our management, including our principal executive officer and principal financial and accounting officer, as appropriate, to allow timely decisions regarding required disclosure.
We carried out an evaluation under the supervision and with the participation of management, including our principal executive officer and principal financial and accounting officer, of the effectiveness of the design and operation of our disclosure controls and procedures as of June 30, 2018, the end of the period covered by this Quarterly Report. Based upon the evaluation of our disclosure controls and procedures as of June 30, 2018, our Chief Executive Officer (principal executive officer) and Vice President of Finance and Administration (principal accounting officer) concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Changes in Internal Control over Financial Reporting
No changes in the Company's internal control over financial reporting have come to management's attention during the Company's last fiscal quarter that have materially affected, or are likely to materially affect, the Company's internal control over financial reporting.
PART II-OTHER INFORMATION
Item 1. Legal Proceedings.
Except as disclosed below and in our Annual Report on Form 10-K for the year ended December 31, 2017, we are not subject to any material pending legal proceedings. From time to time, we may be involved in routine legal proceedings, as well as demands, claims and threatened litigation, which arise in the normal course of our business.
On June 4, 2018, we entered into a Settlement and License Agreement (the “Settlement Agreement”) with ThermiGen LLC and ThermiAesthetics LLC (“ThermiGen,” collectively) as well as Red Alinsod, M.D. resolving our patent litigation against ThermiGen and Dr. Alinsod. The litigation arose from our claim that ThermiGen and Dr. Alinsod were improperly using our patented technology without consent. Pursuant to the Settlement Agreement, the parties agreed to resolve all currently pending disputes between them.
Under the terms of the Settlement Agreement, Viveve received a monetary payment and an on-going royalty. Viveve granted to ThermiGen a non-exclusive, non-transferable license to use our U.S. patent for the current version of ThermiGen’s ThermiVa system (which includes RF generators and consumables).
Item 1A. Risk Factors.
We incorporate herein by reference the risk factors included in the Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 16, 2018.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Unregistered Sales of Securities
None.
Use of Proceeds from Registered Securities
During the quarter ended June 30, 2018, the Company sold 65,252 shares of common stock under the November 2017 ATM Facility for net proceeds of approximately $172,000. As of June 30, 2018, the Company has sold 332,778 shares of common stock under the November 2017 ATM Facility for net proceeds of approximately $1,308,000. Based on the closing price of $2.72 as of June 29, 2018, approximately 8,595,634 remaining shares may be issued under the "at-the-market" equity offering program.
Issuer Repurchases of Company Equity Securities.
None.
Item 3. Defaults Upon Senior Securities.
Not applicable.
Item 4. Mine Safety Disclosures.
Not applicable.
Item 5. Other Information.
Not applicable.
Item 6. Exhibits.
Exhibit
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Document |
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3.1.1(1) |
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3.1.2(2) |
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3.1.3(3) |
Articles of Amendment to the Articles of Continuance of Viveve Medical, Inc. |
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3.2(2) |
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10.1 (4)# |
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10.2 (4)# |
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10.3 (5)# |
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10.4 (5)# |
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10.5** |
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10.6* |
Consulting Agreement by and between the Registrant and Debora Jorn, dated May 11, 2018. |
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31.1* |
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31.2* |
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32.1+ |
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32.2+ |
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101.INS* |
XBRL Instance |
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101.SCH* |
XBRL Taxonomy Extension Schema Document |
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101.CAL* |
XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF* |
XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB* |
XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE* |
XBRL Taxonomy Extension Presentation Linkbase Document |
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* Filed herewith.
+ This document is deemed not filed for purposes of Section 18 of the Exchange Act, or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference into any filing under the Securities Act or the Exchange Act.
# Represents management compensation plan, contract or arrangement.
** Certain provisions of this Exhibit have been redacted pursuant to a request for confidential treatment.
(1) |
Incorporated by reference from the Form 10-Q filed with the Securities and Exchange Commission on May 13, 2016. |
(2) |
Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on August 16, 2017. |
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(3) |
Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on April 14, 2016. |
(4) |
Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on June 5, 2018. |
(5) |
Incorporated by reference from the Form 8-K filed with the Securities and Exchange Commission on May 17, 2018. |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated: August 9, 2018 |
VIVEVE MEDICAL, INC. |
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(Registrant) |
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By: |
/s/ Scott Dur b in |
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Scott Durbin |
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Chief Executive Officer (Principal Executive Officer) |
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By: |
/s/ Jim Robbins |
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Jim Robbins |
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Vice President of Finance and Administration (Principal Accounting Officer) |
37
Exhibit 10.5
Confidential treatment has been requested for portions of this exhibit. The copy filed herewith omits the information subject to the confidentiality request. Omissions are designated as [****]. A complete version of this exhibit has been filed separately with the Securities and Exchange Commission.
Settlement and License Agreement
This confidential agreement (the “Agreement”) is made as of the date of full execution hereof (the “Effective Date”) by and between Viveve, Inc., a corporation organized and existing under the laws of the State of Delaware, having its principal place of business at 345 Inverness Drive South, Suite 250, Englewood, Colorado (“Viveve”), and ThermiGen LLC and ThermiAesthetics LLC, limited liability companies organized and existing under the laws of the State of Texas, having their principal place of business at at 3131 West Royal Lane, Suite 100, Irving, Texas 75063 (collectively, “ThermiGen”), and Dr. Red Alinsod, an individual having a principal place of business at 31852 Coast Highway, Suite 203, Laguna Beach, California, (collectively with ThermiGen, “Defendants”), each a “Party” and, collectively, the “Parties”;
Whereas Viveve filed suit against Defendants for infringement of U.S. Patent No. 8,961,511 (“the ‘511 patent”), captioned Viveve, Inc. v. Thermigen LLC, et al., No. 2:16-1189 (E.D. Tex.) (“the Litigation”);
Whereas Defendants filed counterclaims that the ‘511 Patent was not infringed, invalid and unenforceable as well as other counterclaims that have since been dismissed without prejudice, and ThermiGen through an Affiliate filed two petitions for inter partes review of the ‘511 patent, Petitions Nos. 2018-0088 and 2018-0089, (the “IPR Proceedings”) before the United States Patent and Trademark Office (“USPTO”) Patent Trial and Appeal Board (“PTAB”) and inter partes review was instituted on May 8, 2018;
Whereas , trial in the Litigation was scheduled for June 4, 2018 and the Parties wish to resolve the Litigation and IPR proceedings without the necessity of further litigation and trial, and appeals therefrom, the Parties agreed to participate and did participate in settlement discussions;
Whereas , the Parties have agreed, following an arms-length negotiation, to fully and finally settle and discharge the Litigation and IPR proceedings and resolve all past and current disputes including those involving the ‘511 Patent consistent with the terms of this Agreement;
Whereas the Litigation pending final settlement was stayed; and Now, therefore, in consideration of the promises and mutual covenants contained herein, the Parties agree as follows:
1. Defined Terms
In this agreement, the following terms and expressions have the following meanings:
1.1 |
“ Affiliates ” means, as of the Effective Date, with respect to Viveve or ThermiGen, persons or entities directly or indirectly: (1) controlling that Party; (2) controlled by that Party; or (3) under common control with that Party, where “control” means direct or indirect ownership of greater than fifty percent (50%) of equity or other voting interest therein; and with respect to Dr. Alinsod, refers to his own businesses and medical clinics, including but not limited to South Coast Urogynecology. |
1.2 |
“ Capital Equipment Revenue ” means net revenue (less discounts returns, and rebates as generally accepted in the ordinary course of business) collected by ThermiGen or its Affiliates in connection with the sale, rentals, or lease to customers in the United States subsequent to the Effective Date of this agreement, of ThermiGen radiofrequency generators that have been shipped to the ThermiGen Customer with unlocked ThermiVA functionality or are subsequently unlocked and or are upgraded to have the ThermiVa functionality enabled, and ThermiVA radiofrequency generators. |
1.3 |
“ Licensed Products ” means ThermiGen’s and ThermiGen’s Affiliates’ existing ThermiVa products (including reasonable revisions but excluding any material expansions or redesigns). The existing ThermiVa products include the ThermiRF generators sold with, or that have been upgraded to use, the ThermiVa application, ThermiVa generators, and ThermiVa electrodes, and return pads made, sold, used, imported or offered for sale in the United States by or on behalf of ThermiGen. |
1.4 |
“ Licensed Patents ” means the ‘511 Patent, and any related patents, including continuations, divisional, and/or any other patent claiming priority to or through U.S. Serial No. 11/704,067. |
1.5 |
“ Proceeding ” means any judicial, administrative, or other proceeding |
1.6 |
“ ThermiVa Consumables Revenue ” means net sales (less discounts returns, and rebates as generally accepted in the ordinary course of business) collected by or on behalf of ThermiGen in connection with sales to ThermiGen Customers in the United States of all ThermiVa single-use electrodes and ThermiVA-specific associated consumables (gel, return pads, etc.) and any combination thereof. For purposes of determining the Royalty due under Section 6, ThermiGen shall account for any ThermiVa single use electrodes that are provided to a customer as a package in connection with Thermi Capital Equipment, and shall calculate the ThermiVa Consumable Revenue associated with such electrodes at the average sales price for the ThermiVa electrodes for that quarter. |
1.7 |
“ Third Party ” means any trust, corporation, partnership, joint venture, limited liability company, proprietorship, association, unincorporated organization, or association, individual, or other legal entity other than a Party to this Agreement. |
1.8 |
“ ThermiGen’s Customers ” means customers or users of ThermiGen’s Licensed Products. |
2. Viveve’s License, Release, and Covenant
2.1 | Viveve’s License Grant . Viveve, on behalf of itself and its Affiliates, hereby grants to Defendants, including ThermiGen and its Affiliates and its ThermiVa customers, and Alinsod and his Affiliates, a non-exclusive, non-transferable (except as described in Section 8), non-assignable, right, without the right to sublicense, to make, have made, sell, offer for sale, use, import, export, distribute, and advertise and instruct others on the uses of the Licensed Products, including the Licensed Products, in, into, or from the United States, as the case may be, from the Effective Date of this Agreement through the expiration date of the Licensed Patents. |
2.2 | Viveve’s Release. Viveve, on behalf of itself and its Affiliates, hereby releases Defendants and their Affiliates and ThermiGen’s Customers from liability for all claims (whether known or unknown) that were brought, or reasonably could have been brought, relating to the Licensed Products, and their use, marketing, advertisement and sale by or before the Effective Date of this Agreement. |
3. Defendants’ Release and Covenants
3.1 | Thermi Defendants’ Release. ThermiGen and Affiliates, release Viveve and its Affiliates from liability for any claims that were brought, or reasonably could have been brought, by or before the Effective Date of this Agreement. |
3.1.1 | Alinsod Release . Dr. Alinsod and Affiliates release Viveve and its Affiliates from any liability for any pending claims that were to be tried in the Litigation in the trial scheduled to begin on June 4, 2018. |
3.2 | Defendants’ Covenants related to Licensed Patents. Defendants, on behalf of themselves and Affiliates, covenant during the term of this Agreement unless in response to a duly issued subpoena or under an order from a court or governmental administrative agency (1) to not contest affirmatively in any forum including Federal Courts, whether under 28 U.S.C. §§ 2201, 02 or not, the USPTO, and/or the International Trade Commission that the Licensed Patents are valid and enforceable; (2) to not voluntarily assist in the contesting by a Third Party, in any forum, including Federal Courts, whether under 28 U.S.C. §§ 2201-02 or not, the USPTO, and/or the International Trade Commission, that the Licensed Patents are valid and enforceable; (3) not assist, or participate in any way, in the contesting by a Third Party of any allegations of infringement of the Licensed Patents or of alleged damages related thereto; and (4) not to provide any funding or assistance to any Third Party for the specific purpose of funding any Proceeding challenging the validity and enforceability of the Licensed Patents at the USPTO, including but not limited to ex parte re-examination, Inter Partes Review, Post Grant Review, and Covered Business Method review. Notwithstanding the foregoing, nothing in this Agreement prohibits ThermiGen from defending itself or its Affiliates in any action including challenging the Licensed Patents if Viveve threatens or takes enforcement action with respect to any activity by ThermiGen or its Affiliates that are not subject to the obligations herein. For example, if Viveve brings a future action to enforce one or more Licensed Patents against ThermiGen products that are not subject to the license provided in Section 2.1, this agreement not to challenge or participate in the challenge to the Licensed Patents does not apply. |
3.2.1 | ThermiGen’s Covenant relating to its own IP. ThermiGen, on behalf of itself and its Affiliates, covenants not to sue Viveve or any of its Affiliates or customers for any claims for the infringement of intellectual property rights for which they have filed US patent applications in the USPTO as of the Effective Date or claim priority to any patent applications filed prior to the Effective Date relating to the application of monopolar radiofrequency in vaginal tissue, including without limitation claims relating to the making, using, selling, or offering to sell the Geneveve® system by or on behalf of Viveve in the United States. |
4. Termination of Pending Litigation and Administrative Actions
4.1 | Termination of Litigation. The Parties agree to move for dismissal, with prejudice, of their respective claims pending in the Litigation as of the Effective Date. The Parties shall cooperate in good faith to bring about the dismissals as promptly as is reasonably possible after the Effective Date, but in no event later than 9:00 A.M, CST, on June 4, 2018. The Parties shall be responsible for payment of their own costs and fees, including attorneys’ fees, incurred in the Litigation. |
4.2 | Termination of Administrative Actions. ThermiGen agrees to cause Almirall to move the PTAB to dismiss the IPR Proceedings. The Parties shall cooperate in good faith to bring about the withdrawal of the IPR petitions as promptly as is reasonably possible after the Effective Date. The Parties shall be responsible for payment of their own costs and fees, including attorneys’ fees, incurred in the IPR Proceedings. If the PTAB does not agree to terminate the IPR proceedings upon the joint request of the Parties, ThermiGen agrees to cause Almirall to not participate further in the IPR Proceeding, to the extent, however, that Almirall is not exposed to liability or any punitive measure under controlling law or regulations. |
5. Payment
5.1 | ThermiGen’s Payment. As consideration for its rights granted under this Agreement, ThermiGen agrees to pay Viveve a total of [*** * ] (the “Upfront Payment”), as conditioned by, and provided for, under this Section 5.1 of the Agreement. |
* Confidential material redacted and filed separately with the Securities and Exchange Commission. |
5.1.1 | Defendants’ Credit . The Parties agree and acknowledge that the Upfront Payment is inclusive of a credit to Defendants of [*** * ] (the “Credit”), which credit is provided by Viveve as specific consideration for the covenants granted to Viveve by ThermiGen in Section 3.2.1 and the minimum royalty term described below. |
5.1.2 | ThermiGen’s Net Payment. The Parties agree and acknowledge that the amount owed by ThermiGen to Viveve as provided for in this Section 5.1.2 (the “Net Payment”) is the Upfront Payment less the Credits, amounting to [****], and is payable by ThermiGen or its Affiliates no later than [****] after the Effective Date by wire transfer to the following account: | |
[****] |
6. ThermiGen’s Royalty Payments
6.1 | Capital Equipment. ThermiGen will pay Viveve a [****] royalty on all Capital Equipment Revenue (“Capital Equipment Royalty”) received by or on behalf of ThermiGen or its Affiliates on or after June 1, 2018, for a period of [****]. |
6.2 | ThermiVa Consumables. ThermiGen will pay Viveve a [****] royalty on all ThermiVa Consumables Revenue (“ThermiVa Consumables Royalty”) that is received by or on behalf of ThermiGen or its Affiliates on or after June 1, 2018, for a period of [****]. |
6.3 | Payment Terms. ThermiGen agrees that it will provide the Capital Equipment Royalty and ThermiVa Consumables Royalty payments on [****] basis, with payment due on sales made during [****] on the [****]. Any Capital Equipment Royalty and ThermiVa Consumables Royalty payment made after the due date for [****] will be subject to accrual of interest until such payment is made at a rate that is the lesser of [****]. ThermiGen is responsible for any duties, taxes, or levies to which it is subject as a result of the payment hereunder, and Viveve shall not be liable at any time for any of ThermiGen’s taxes incurred in connection with or related to amounts paid under or the transactions described in this Agreement. Payment shall be made by electronic transfer to the same account described in Section 5. |
* Confidential material redacted and filed separately with the Securities and Exchange Commission. |
6.4 | Accounting . ThermiGen and its Affiliates will keep accurate and complete books and records showing all records of sales, rentals, leases or other monetizing of ThermiGen products resulting in Capital Equipment Revenue or ThermiGen Consumables Revenue for the greater of [****] from the termination or expiration of this Agreement. Such records and books shall be made available for examination upon reasonable advanced written notice. The examination of the records and books shall be at Viveve’s sole expense, but if the results of an audit disclose a deficiency between the amount found to be due to Viveve and the amount actually received by Viveve, and if the deficiency is more than [*** * ] of the amount due to Viveve, then either ThermiGen or its Affiliates will pay Viveve’s costs and expenses of such audit. Viveve may credit any over-payment of the Capital Equipment Royalty or ThermiGen Consumables Royalty against future amounts owed to Viveve under Section 6, but otherwise Viveve shall not be obligated to reimburse any such over-payment. The examination shall be performed by an independent auditor or certified public accounting appointed by Viveve, subject to ThermiGen’s reasonable acceptance of that appointment. Such examination shall occur only during regular business hours, and, absent requirement under applicable law, may not be requested or otherwise noticed more than once in any calendar year. All information examined pursuant to this Section shall be deemed to be the Confidential Information of ThermiGen. Further, the independent auditor or certified public accountant will, within 30 days of the conclusion of such audit, provide Viveve with a written statement of said auditor, setting forth the calculation of amounts due to Viveve over the time period audited, as determined from the books and records of ThermiGen or its Affiliate. If the Capital Equipment Revenue or ThermiGen Consumables Revenue has been understated, ThermiGen shall pay to Viveve within five (5) business days after the auditor’s report is provided to Viveve the royalty owing on such understated revenues plus interest at the lesser of [****]. |
7. Covenants
Without limiting the generality of any other provision hereof, including the Covenants herein, each Party hereby expressly agrees, understands, acknowledges, and confirms that:
7.1 |
such Party’s respective Covenants are intended to and do prevent such Party from, directly or indirectly, causing, inducing, or authorizing a Proceeding to be brought by a Third Party against the other Party which, if it had been brought by such Party, would constitute a violation of such Party’s Covenants, and are intended to and do prevent such Party from, directly or indirectly, assisting, participating, or cooperating in any such Proceeding to the extent permitted by law; and |
7.2 |
no Party’s respective Covenants prevent Viveve from engaging in discussions or entering into any agreement with any Third Party regarding the licensing of the Licensed Patents generally, unrelated to any ThermiGen Licensed Products, or from enforcing or seeking to enforce the Licensed Patents against any entity other than ThermiGen, ThermiGen’s Affiliates, ThermiGen’s Customers, and Dr. Alinsod and his Affiliates as set forth herein. |
8. Assignments
8.1 | Limitations on Assignment. Except as expressly permitted in this Section, or as contrary to law, including without limitation the patent law doctrine of exhaustion, neither Party, including any of their Affiliates, may grant or assign any rights or delegate any duties under this Agreement to any Third Party (including by way of a “change in control”) without providing prior written notice to the other Party. |
* Confidential material redacted and filed separately with the Securities and Exchange Commission. |
8.2 | Change of Control. In the event that, after the Effective Date, ThermiGen or any of its Affiliates, or a portion of a business of ThermiGen or any of its Affiliates, is acquired or otherwise comes under the control of a Third Party, Viveve’s License (Section 2.1) and Release (Section 2.2), shall remain in force with respect to ThermiGen or its Affiliate and its Licensed Products, but will not extend to such Third Party for that Third Party’s products or services that exist or are in development as of the Effective Date or that come into existence after the Effective Date. In such event, the Parties agree and acknowledge that ThermiGen’s obligations to pay royalties under Section 6 will be assumed as a liability of the acquiring Third Party. |
8.3 | Assignment by Viveve; Agreement Runs With the Patents. Viveve may sell, assign, or otherwise transfer its rights in the Licensed Patents or under this Agreement without notice to ThermiGen to: (1) an Affiliate; or (2) a Third Party, provided the covenant under Sec. 3.2.1 will not extend to such Third Party for that Third Party’s products or services that exist or are in development as of the Effective Date or that come into existence after the Effective Date, and that Viveve shall ensure that the terms and conditions of this Agreement shall bind such successor, purchaser, assignee, and/or transferee. If, after the Effective Date, Viveve has granted or grants an Affiliate or such acquiring Third Party the right to enforce any of the Licensed Patents, Viveve will cause such Third Party to abide by the terms and conditions of the license granted under Section 2.1 of this Agreement. The license granted under Section 2.1 of this Agreement runs with the Licensed Patents. |
8.4 | Assignment by ThermiGen; Agreement Runs With the Intellectual Property. To the extent that ThermiGen has intellectual property relating to monopolar radiofrequency in vaginal tissue that would be subject to the Covenant provided in Section 3.2.1, ThermiGen may sell, assign, or otherwise transfer its rights without notice to Viveve to: (1) an Affiliate; or (2) a Third Party provided that ThermiGen shall ensure that the terms and conditions of this Agreement shall bind such successor, purchaser, assignee, and/or transferee. If, prior to or after the Effective Date, ThermiGen has granted or grants an Affiliate or a Third Party the right to enforce any of the intellectual property subject to this Agreement, ThermiGen will cause such Third Party to abide by the terms and conditions of this Agreement with respect to such intellectual property. The terms and conditions of this Agreement run with the intellectual property. |
8.5 | Unpermitted Assignment Void . Any attempted transfer, license, assignment, or grant in contravention of this Section shall be null and void. This Agreement shall only be binding upon, inure to the benefit of, and be enforceable by the Parties and their permitted successors and assigns. |
9. Term and Terminations
9.1 | Termination. Other than as set forth in this section, this Agreement may only be terminated by mutual written agreement of the Parties. |
9.1.1 |
If ThermiGen materially breaches this Agreement by failing to pay the amount due under Section 5 or the Royalties due under Section 6, and does not cure such breach within 14 business days after receipt of written notice (the “Breach Notice”) from Viveve, then this Agreement may be terminated by Viveve upon written notice to that effect (the “Termination Notice”) from Viveve at any time after the expiration of sixty (60) days following receipt by ThermiGen of the Breach Notice, or at its sole option, Viveve may pursue in Court an action for breach of the Agreement due to non-payment of royalties, and if successful. |
9.2 | Survival. Only the Parties’ rights and obligations under Sections 2.2, 3.1, 3.2.1, and 11 shall survive any termination of this Agreement. |
9.3 | Agreement Obligations Not Released. Notwithstanding anything to the contrary herein, the Parties reserve all rights and remedies, including damages and equitable relief (other than recession, termination, or reformation of this Agreement to the extent not expressly provided for herein) for breach of this Agreement by the other Party, and nothing herein releases any Party from its respective obligations under this Agreement or prevents any Party from enforcing the terms and conditions of this Agreement against the another Party. |
10. Representations and Warranties
10.1 | Viveve’s Representations. Viveve represents and warrants, on behalf of itself and its Affiliates, as of the Effective Date, that: (1) it has the full, sole, and exclusive right to grant the license, release, and covenants with respect to the Licensed Patents of the full scope set forth herein; (2) it has not assigned or otherwise transferred any rights to the Licensed Patents that would prevent Viveve from conveying the full scope of rights set forth herein; and (3) the person executing this Agreement on behalf of Viveve has the full right and authority to enter into this Agreement on Viveve’s behalf. |
10.2 | Defendants’ Representations. Defendants represent and warrant, on behalf of themselves and Affiliates, as of the Effective Date, that: (1) they have the right to grant the release and covenants of the full scope set forth herein; (2) the person executing this Agreement on behalf of ThermiGen has the full right and authority to enter into this Agreement on ThermiGen’s behalf; and (3) they have the right to cause Almirall to terminate and no longer participate in the IPR Proceedings. |
10.3 | No Warranties. Nothing contained in this Agreement shall be construed as: (1) an agreement by either Party to bring or prosecute actions or suits against Third Parties for infringement, or conferring any right to the other Party to bring or prosecute actions or suits against Third Parties for infringement; (2) conferring any right to the other Party to use in advertising, publicity, or otherwise, any trademark, trade name, or names of either Party, or any contraction, abbreviation, or simulation thereof without prior written consent of the other Party; or (3) conferring by implication, estoppel, or otherwise, upon either Party, any right (including a license) under other patents except for the rights expressly granted hereunder. |
11. Confidentiality
From and after the Effective Date, neither Party shall disclose the terms of this Agreement except:
11.1 |
with the prior written consent of the other Party; |
11.2 |
to any governmental body having jurisdiction and specifically requiring such disclosures; |
11.3 |
in response to a valid subpoena or as otherwise may be required by law, but in no event shall the terms of this Agreement be disclosed without first affording the non-subpoenaed Party to file a motion to quash or take other appropriate action; |
11.4 |
for the purposes of disclosure in connection with the Securities and Exchange Act of 1934, as amended, the Securities Act of 1933, as amended, and any other reports filed with the Securities and Exchange Commission, or any other filings, reports, or disclosures that are required under applicable laws or regulations; |
11.5 |
to a Party’s accountants, legal counsel, tax advisors, and other financial, legal, and other professional advisors, subject to obligations of confidentiality and/or privilege at least as stringent as those contained herein; |
11.6 |
as required during the course of litigation and subject to a protective order, and that any production would be protected under an “Attorneys’ Eyes Only” or higher confidentiality designation; |
11.7 |
for the purposes of Viveve negotiating with a Third Party for a future license agreement to one or more of the Licensed Patents, but only for the terms necessary and to the counsel or representatives of the Third Party necessary, and with an obligation of confidentiality by the Third Party; or |
11.8 |
with obligations of confidentiality at least as stringent as those contained herein, to a counterparty in connection with a request for indemnification, proposed or actual merger, acquisition, sale of patents, financing, or similar transaction. With the exception of Section 2.1 herein, ThermiGen may not disclose the terms of this Agreement to any of its vendors without its vendors first agreeing to obligations of confidentiality at least as stringent as those contained herein (including a commitment not to disclose the terms of this Agreement to any of the vendor’s other customers besides ThermiGen). |
12. Notices
All notices required or permitted to be given hereunder shall be in writing and shall be delivered by electronic mail, addressed as follows:
If to Viveve: |
If to ThermiGen: |
Scott Durbin |
_Vlad Paul-Blanc |
Chief Executive Officer |
Chief Executive Officer |
345 Inverness Drive South, Suite 250, |
3131 West Royal Lane, Suite 100 |
Englewood, Colorado 80112 |
Irving, Texas 75063 |
sdurbin@viveve.com |
VPaulBlanc@thermi.com |
copy to: |
copy to: |
Michele Frank |
_Amita Kent |
Venable LLP |
Sr. Vice President, Corporate Legal |
600 Massachusetts Ave. NW |
Almirall, SA |
Washington DC 20001 |
Ronda General Mitre, 151 |
MFrank@Venable.com |
08022 Barcelona, Spain |
amita.kent@almirall.com |
Such notices shall be deemed to have been served when received by the addressee. Either Party may give written notice of a change of address and, after notice of such change has been received, any notice or request shall thereafter be given to such other Party as above provided at such changed address,
13. Equitable Relief
The Parties acknowledge that either Party’s breach of this Agreement may cause the other Party irreparable and continuous damage for which the non-breaching Party may have no adequate remedy at law. Consequently, the Parties agree that in the event of a breach of this Agreement, equitable relief, including but not limited to specific performance of the terms of this Agreement, may be an appropriate remedy as well as any other relief as may be available.
14. Other Provisions
14.1 | Affiliates Bound. Each Party agrees to cause each of its respective Affiliates to be bound by the terms of this Agreement. |
14.2 | No Agency. Nothing in this Agreement is intended or shall be deemed to constitute a partnership, agency, employer-employee, or joint venture relationship between the Parties. Neither Party shall incur any debts or make any commitments for the other. There is no fiduciary duty or special relationship of any kind between the Parties to this Agreement. Each Party expressly disclaims any reliance on any act, word, or deed of the other Party in entering into this Agreement. |
14.3 | No Other Rights. Except as expressly stated in this Agreement, nothing in this Agreement grants any additional express or implied license whatsoever under any intellectual property rights to either Party or to any Third Party. No right to grant covenants, rights, sub-licenses or to become a foundry for any Third Party is granted under this Agreement. |
14.4 | Sophisticated Parties Represented by Counsel. The Parties each acknowledge, accept, warrant, and represent that: (1) they are sophisticated parties represented at all relevant times during the negotiations and execution of this Agreement by counsel of their choice, and that they have executed this Agreement with the consent and on the advice of such independent legal counsel; and (2) they and their counsel have determined through independent investigation and robust, arms’ length negotiation that the terms of this Agreement shall exclusively embody and govern the subject matter of this Agreement. |
14.5 | Bankruptcy. Each party irrevocably waives all arguments and defenses arising under 11 U.S.C. § 365(c)(1) or successor provisions to the effect that applicable law excuses the Party, other than the debtor, from accepting performance from or rendering performance to a person or entity other than the debtor or debtor in possession as a basis for opposing assumption of the Agreements by the other Party in a case under Chapter 11 of the Bankruptcy Code to the extent that such consent is required under 11 U.S.C. § 365(c)(1) or any successor statute. Any change of control resulting from any such bankruptcy proceeding shall remain subject to Section 8.2 above. |
14.6 | Severability. Any provision of this Agreement which is invalid, prohibited, or unenforceable in any jurisdiction will, as to that jurisdiction, be ineffective to the extent of such invalidity, prohibition, or unenforceability and will be severed from the balance of this Agreement, all without affecting the remaining provisions of this Agreement or affecting the validity or enforceability of such severed provision in any other jurisdiction. The Parties agree in good faith to reformulate any such invalid, prohibited, or unenforceable provision to preserve the original intentions and objectives hereof and to remove such illegality, invalidity, or unenforceability to the extent possible without materially reducing the value of this Agreement to either Party. |
14.7 | Entire Agreement. The Parties acknowledge, accept, warrant, and represent that: (1) this is an enforceable agreement; (2) this Agreement embodies the entire and only understanding of each of them with respect to the subject matter of the Agreement, and merges, supersedes, and cancels all previous representations, warranties, assurances, communications, conditions, definitions, understandings, or any other statement, express, implied, or arising by operation of law, whether oral or written, whether by omission or commission, between and among them with respect to the subject matter of this Agreement, including the Term Sheet; (3) no oral explanation or oral information by either Party hereto shall alter the meaning or interpretation of this Agreement; (4) the terms and conditions of this Agreement may be altered, modified, changed, or amended only by a written agreement executed by duly authorized representatives of the Parties; (5) the language of this Agreement shall be construed as a whole according to its fair meaning; and (6) none of the Parties (nor their respective counsel) shall be deemed to be the draftsman of this Agreement in any action which may hereafter arise with respect to the Agreement. |
14.8 | Modification / Waiver. No modification or amendment to this Agreement, nor any waiver of any rights, will be effective unless assented to in writing by the Party to be charged, and the waiver of any breach or default will not constitute a waiver of any other right hereunder or any subsequent breach or default. |
14.9 | Construction / Language. Any rule of construction to the effect that ambiguities are to be resolved against the drafting party will not be applied in the construction or interpretation of this Agreement. As used in this Agreement, the words “include” and “including” and variations thereof will not be deemed to be terms of limitation, but rather will be deemed to be followed by the words “without limitation.” The headings in this Agreement will not be referred to in connection with the construction or interpretation of this Agreement. This Agreement is in the English language only, which language shall be controlling in all respects, and all notices under this Agreement shall be in the English language. |
14.10 | Choice of Law. This Agreement shall be construed, and the relationship between the Parties determined, in accordance with the laws of the State of Delaware, notwithstanding any choice-of-law principle that might dictate a different governing law. The Parties agree that any proceeding relating to this Agreement will be brought in the U.S. District Court for the Eastern District of Texas, and the Parties irrevocably submit to the jurisdiction and venue of the Court for such purposes. |
14.11 | Counterparts. This Agreement may be executed in several counterparts or duplicate originals, each of which shall be regarded as one and the same instrument, and which shall be the official and governing version in the interpretation of this Agreement. This Agreement may be executed by facsimile signatures or other electronic mean and such signatures shall be deemed to bind each Party as if they were original signatures. |
14.12 | Duty to Effectuate. The Parties agree to perform any lawful additional acts, including the execution of additional agreements, as are reasonably necessary to effectuate the purpose of this Agreement. |
[SIGNATURES CONTINUED ON NEXT PAGE]
In witness whereof , each of the Parties has caused this Agreement to be executed by their respective duly authorized officers.
Viveve Inc. |
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ThermiGen, LLC and |
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ThermiAesthetics, LLC | |||||
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/s/ Scott Durbin | /s/ Anita Kent /s/ Peter Guenter | ||||
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Name: | Scott Durbin |
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Name: |
Anita Kent and Peter Guenter |
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Title: | Title:Chief Executive Officer | Title: | Proxies | ||
Date: | June 3, 2018 |
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Date: |
June 3, 2018 |
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Dr. Red Alinsod |
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/s/ Red Alinsod, MD |
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Name: |
Red Alinsod, MD |
Title: |
Director, Owner SCU |
Date: |
June 3, 2018 |
Exhibit 10.6
CONSULTING AGREEMENT
Effective as of April 23, 2018, Debora Jorn (“Consultant”) and Viveve Medical, Inc. (“Company”) agree as follows:
1. Services; Payment; No Violation of Rights or Obligations . Consultant agrees to undertake and complete the Services (as defined in Exhibit A ) in accordance with and on the schedule specified in Exhibit A . As the only consideration due Consultant regarding the subject matter of this Agreement, Company will pay Consultant in accordance with Exhibit A . Unless otherwise specifically agreed upon by Company in writing (and notwithstanding any other provision of this Agreement), all activity relating to Services will be performed by and only by Consultant or by employees of Consultant and only those such employees who have been approved in writing in advance by Company. Consultant agrees that Consultant will not (and will not permit others to) violate any agreement with or rights of any third party or, except as expressly authorized by Company in writing hereafter, use or disclose at any time Consultant’s own or any third party’s confidential information or intellectual property in connection with the Services or otherwise for or on behalf of Company.
2. Ownership Rights; Proprietary Information; Publicity .
a. Company shall own all right, title and interest (including all intellectual property rights of any sort throughout the world) relating to any and all inventions, works of authorship, designs, know-how, ideas and information made or conceived or reduced to practice, in whole or in part, by or for or on behalf of Consultant during the term of this Agreement that relate to the subject matter of or arise out of or in connection with the Services or any Proprietary Information (as defined below) (collectively, “Inventions”) and Consultant will promptly disclose and provide all Inventions to Company. Consultant hereby makes all assignments necessary to accomplish the foregoing ownership. Consultant shall assist Company, at Company’s expense, to further evidence, record and perfect such assignments, and to perfect, obtain, maintain, enforce and defend any rights assigned. Consultant hereby irrevocably designates and appoints Company as its agents and attorneys-in-fact, coupled with an interest, to act for and on Consultant’s behalf to execute and file any document and to do all other lawfully permitted acts to further the foregoing with the same legal force and effect as if executed by Consultant and all other creators or owners of the applicable Invention.
b. Consultant agrees that all Inventions and all other business, technical and financial information (including, without limitation, the identity of and information relating to customers or employees) developed, learned or obtained by or on behalf of Consultant during the period that Consultant is to be providing the Services that relate to Company or the business or demonstrably anticipated business of Company or in connection with the Services or that are received by or for Company in confidence, constitute “Proprietary Information.” Proprietary information also includes information received in confidence by Company from its customers or suppliers or other third parties. Consultant shall hold in confidence and not disclose or, except in performing the Services, use, or permit to be used, any Proprietary Information. However, Consultant shall not be obligated under this paragraph with respect to information Consultant can document is or becomes readily publicly available without restriction through no fault of Consultant. Upon termination or as otherwise requested by Company, Consultant will promptly provide to Company all items and copies containing or embodying Proprietary Information, except that Consultant may keep its personal copies of its compensation records and this Agreement. Consultant also recognizes and agrees that Consultant has no expectation of privacy with respect to Company’s telecommunications, networking or information processing systems (including, without limitation, stored computer files, email messages and voice messages) and that Consultant’s activity, and any files or messages, on or using any of those systems may be monitored at any time without notice.
c. As additional protection for Proprietary Information, Consultant agrees that during the period over which Consultant is to be providing the Services, Consultant shall not engage, invest, participate, or prepare to engage, invest or participate in any activity that is competitive or substantially similar to the business of the Company or that otherwise could create a conflict of interest with the Company. Consultant must obtain prior approval from the Company prior to engaging in or being employed in any other business, trade, profession or other activity while providing services to Company to ensure there is no conflict of interest. In addition, both during the consulting period and for one (1) year thereafter, Consultant will not directly or indirectly encourage or solicit any employee or consultant of Company to leave Company for any reason.
d. To the extent allowed by law, Section 2(a) and any license granted Company hereunder includes all rights of paternity, integrity, disclosure and withdrawal and any other rights that may be known as or referred to as “moral rights,” “artist’s rights,” “droit moral,” or the like (collectively “Moral Rights”). Furthermore, Consultant agrees that notwithstanding any rights of publicity, privacy or otherwise (whether or not statutory) anywhere in the world, and without any further compensation, Company may and is hereby authorized to (and to allow others to) use Consultant’s name in connection with promotion of its business, products or services. To the extent any of the foregoing is ineffective under applicable law, Consultant hereby provides any and all ratifications and consents necessary to accomplish the purposes of the foregoing to the extent possible and agrees not to assert any Moral Rights with respect thereto. Consultant will confirm any such ratifications and consents from time to time as requested by Company. If any other person is in any way involved in any Services, Consultant will obtain the foregoing ratifications, consents and authorizations from such person for Company’s exclusive benefit.
e. If any part of the Services or Inventions or information provided hereunder is based on, incorporates, or is an improvement or derivative of, or cannot be reasonably and fully made, used, reproduced, distributed and otherwise exploited without using or violating technology or intellectual property rights owned by or licensed to Consultant (or any person involved in the Services) and not assigned hereunder, Consultant hereby grants Company and its successors a perpetual, irrevocable, worldwide royalty-free, non-exclusive, sublicensable right and license to exploit and exercise all such technology and intellectual property rights in support of Company’s exercise or exploitation of the Services, Inventions, other work or information performed or provided hereunder, or any assigned rights (including any modifications, improvements and derivatives of any of them).
3. Warranties and Other Obligations . Consultant represents, warrants and covenants that: (i) the Services will be performed in a professional and workmanlike manner and that none of such Services nor any part of this Agreement is or will be inconsistent with any obligation Consultant may have to others; (ii) all work under this Agreement shall be Consultant’s original work and none of the Services or Inventions nor any development, use, production, distribution or exploitation thereof will infringe, misappropriate or violate any intellectual property or other right of any person or entity (including, without limitation, Consultant); (iii) Consultant has the full right to allow Consultant to provide Company with the assignments and rights provided for herein (and has written enforceable agreements with all persons necessary to give Consultant the rights to do the foregoing and otherwise fully perform this Agreement); (iv) Consultant shall comply with all applicable laws and Company safety rules in the course of performing the Services; and (v) if Consultant’s work requires a license, Consultant has obtained that license and the license is in full force and effect.
4. Avoidance of Conflict of Interest . Consultant represents and warrants that there exist no actual or potential conflicts of interest concerning the Services to be performed under this Agreement. Consultant has not brought and will not bring to Company or use in the performance of the Services any materials or documents of another party considered confidential unless Consultant has first obtained written authorization from such party for the possession and use of such materials and has received Company’s prior written consent to use such materials. Consultant will advise Company at such time as any activity of either Company or another business presents Consultant with a conflict of interest or the appearance of a conflict of interest. Consultant will take whatever action is requested by Company to resolve any conflict or appearance of conflict which it finds to exist. Consultant further represents and warrants that Consultant has full power and authority to enter into this Agreement and perform Consultant’s obligations hereunder.
5. Termination . If either party breaches a material provision of this Agreement, the other party may terminate this Agreement immediately. Either party may terminate this Agreement at any time, with or without cause, upon thirty (30) days’ notice. Company shall pay Consultant all unpaid, undisputed amounts due for the Services completed prior to notice of such termination. Sections 2 (subject to the limitations set forth in Section 2(c)) through 9 of this Agreement and any remedies for breach of this Agreement shall survive any termination or expiration. Company may communicate the obligations contained in this Agreement to any other (or potential) client or employer of Consultant.
6. Relationship of the Parties; Independent Contractor; No Employee Benefits; Taxes . Notwithstanding any provision hereof, Consultant is an independent contractor and is not an employee, agent, partner or joint venturer of Company and shall not bind nor attempt to bind Company to any contract. Nothing in this Agreement shall be interpreted or construed as creating or establishing a relationship of employer and employee between Company and Consultant, or any employee or agent of Consultant. Consultant shall accept any directions issued by Company pertaining to the goals to be attained and the results to be achieved by Consultant, but Consultant shall be solely responsible for the manner and hours in which the Services are performed under this Agreement. Consultant shall not be eligible to participate in any of Company’s employee benefit plans, fringe benefit programs, group insurance arrangements or similar programs. Company shall not provide workers’ compensation, disability insurance, Social Security or unemployment compensation coverage or any other statutory benefit to Consultant. Consultant shall comply at Consultant’s expense with all applicable provisions of workers’ compensation laws, unemployment compensation laws, federal Social Security law, the Fair Labor Standards Act, federal, state and local income tax laws, and all other applicable federal, state and local laws, regulations and codes relating to terms and conditions of employment required to be fulfilled by employers or independent contractors. Consultant will ensure that its employees, contractors and others involved in the Services, if any, are bound in writing to the foregoing, and to all of Consultant’s obligations under any provision of this Agreement, for Company’s benefit and Consultant will be responsible for any noncompliance by them. Consultant shall be responsible for and, and shall indemnify Company against all such taxes or contributions including penalties and interest.
7. Indemnification . Consultant agrees to defend, indemnify and hold harmless Company and its affiliates, and their officers, directors, employees, agents, successors and permitted assigns from and against all losses, damages, liabilities, deficiencies, actions, judgments, interest, awards, penalties, fines, costs, attorneys’ fees or expenses of whatever kind (including reasonable attorneys' fees) arising out of or resulting from (a) bodily injury, death of any person or damage to real or tangible, personal property resulting from Consultant’s acts or omissions; and (b) Consultant’s breach of any representation, warranty or obligation under this Agreement. Company may satisfy such indemnity (in whole or in part) by way of deduction from any payment due to Consultant.
8. Assignment . This Agreement and the services contemplated hereunder are personal to Consultant and Consultant shall not have the right or ability to assign, transfer or subcontract any rights or obligations under this Agreement without the written consent of Company. Any attempt to do so shall be void. Company may fully assign and transfer this Agreement in whole or part.
9. Notice . All notices under this Agreement shall be in writing and shall be deemed given when personally delivered, or three days after being sent by prepaid certified or registered U.S. mail to the address of the party to be noticed as set forth herein or to such other address as such party last provided to the other by written notice.
10. Miscellaneous . Any breach of Sections 2 -4 will cause irreparable harm to Company for which damages would not be an adequate remedy, and therefore, Company will be entitled to injunctive relief with respect thereto in addition to any other remedies. The failure of either party to enforce its rights under this Agreement at any time for any period shall not be construed as a waiver of such rights. No changes or modifications or waivers to this Agreement will be effective unless in writing and signed by both parties. In the event that any provision of this Agreement shall be determined to be illegal or unenforceable, that provision will be limited or eliminated to the minimum extent necessary so that this Agreement shall otherwise remain in full force and effect and enforceable. This Agreement shall be governed by and construed in accordance with the laws of the State of Colorado without regard to the conflicts of laws provisions thereof. Each party irrevocably submits to the exclusive jurisdiction and venue of the federal and state courts located in Denver, Colorado in any legal suit, action or proceeding arising out of or based upon this Agreement or the Services provided hereunder. In any action or proceeding to enforce rights under this Agreement, the prevailing party will be entitled to recover costs and attorneys’ fees. Headings herein are for convenience of reference only and shall in no way affect interpretation of the Agreement.
11. Defend Trade Secrets Act of 2016; Other Notices . Consultant understands that pursuant to the federal Defend Trade Secrets Act of 2016, Consultant shall not be held criminally or civilly liable under any federal or state trade secret law for the disclosure of a trade secret that (A) is made (i) in confidence to a federal, state, or local government official, either directly or indirectly, or to an attorney; and (ii) solely for the purpose of reporting or investigating a suspected violation of law; or (B) is made in a complaint or other document filed in a lawsuit or other proceeding, if such filing is made under seal. Consultant further understands that nothing contained in this Agreement limits Consultant’s ability to communicate with any federal, state or local governmental agency or commission, including to provide documents or other information, without notice to the Company.
12. Entire Agreement . This Agreement and the Exhibits hereto constitute the entire agreement between the parties and supersede all previous agreements or representations, written or oral, with respect to the subject matter hereof. Consultant represents and warrants that Consultant is not relying on any statement or representation not contained in this Agreement. To the extent any terms set forth in any exhibit or schedule conflict with the terms set forth in this Agreement, the terms of this Agreement shall control unless otherwise expressly agreed by the Parties in such exhibit or schedule.
[Remainder of Page Intentionally Left Blank]
VIVEVE MEDICAL, INC. | ||
Dated: 5/11/18 | By: | /s/ Scott Durbin |
Name: | Scott Durbin | |
Title: | Chief Executive Officer |
Debora Jorn | ||
Dated: 5/11/18 | /s/ Debora Jorn | |
Address: | 6 Firethorn Ct. | |
Warren, New Jersey 07059 |
EXHIBIT A
TERM
The term of engagement pursuant to this Agreement shall commence on the Effective Date and continue for a six (6) month period, and shall automatically renew for successive six (6) month periods thereafter, unless terminated earlier in accordance with Section 5 of this Agreement (the “ Consulting Period ”).
SERVICES
Consultant shall be a senior advisor to the Company and shall make herself available to provide general advisory assistance and such services to the Company as may be requested from time to time by the Chief Executive Officer of the Company or his or her designee (collectively the “ Services ”). Unless the circumstances reasonably dictate otherwise, the Services can be performed at a time and location of the Consultant’s choosing.
FEES/EXPENSES
The Company agrees to pay Consultant a fee of $30,000 per month (the “ Consulting Fee ”) for the Services performed during the Consulting Period. The Consulting Fee shall be earned and made in arrears on a monthly basis.
Consultant shall supply all tools, equipment, materials, supplies, information technologies, hardware, software and office space (except to the extent specific Services must be performed at the Company’s premises) necessary to perform the Services under this Agreement.
Subject to the approval of the Board of Directors of the Company (the “Board”) or its Compensation Committee, Consultant will be granted an option to purchase 150,000 shares of the Company’s Common Stock (the “Option”), as of the Effective Date. The exercise price per share of the Option will be determined by the Board based on the fair market value of the Common Stock of the Company on the date the option is granted. The Option shall be subject to the terms and conditions of the Company’s 2013 Stock Option and Incentive Plan, as amended (the “Plan”) and the applicable Stock Option Agreement, including vesting requirements. The shares subject to the option shall vest and become exercisable in 24 equal monthly installments commencing on the Effective Date and shall be exercisable for a period of 90 days following the termination of Consultant’s status as a service provider to the Company (including as a member of the Company’s Board of Directors). In addition, if during the Consulting Period, (i) the Company is subject to a Change in Control (as defined below) or (ii) the Consulting Period is terminated for any reason by the Company, then, subject to Consultant signing and not revoking a release of claims agreement containing, among other provisions, a general release of claims in favor of the Company and related persons and entities, in a form and manner satisfactory to the Company (the “Release”), Consultant will immediately vest in 100% of Consultant’s then-unvested shares.
For purposes of this Agreement, “Change in Control” shall mean any of the following:
1. |
any “person,” as such term is used in Sections 13(d) and 14(d) of the Securities Exchange Act of 1934, as amended (the “Act”), any of its subsidiaries, or any trustee, fiduciary or other person or entity holding securities under any employee benefit plan or trust of the Company or any of its subsidiaries), together with all “affiliates” and “associates” (as such terms are defined in Rule 12b-2 under the Act) of such person, shall become the “beneficial owner” (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, of securities of the Company representing 50 percent or more of the combined voting power of the Company’s then outstanding securities having the right to vote in an election of the Board (“Voting Securities”) (in such case other than as a result of an acquisition of securities directly from the Company); or |
2. |
the date a majority of the members of the Board is replaced during any 12-month period by directors whose appointment or election is not endorsed by a majority of the members of the Board before the date of the appointment or election; or |
3. |
the consummation of (A) any consolidation or merger of the Company where the stockholders of the Company, immediately prior to the consolidation or merger, would not, immediately after the consolidation or merger, beneficially own (as such term is defined in Rule 13d-3 under the Act), directly or indirectly, shares representing in the aggregate more than 50 percent of the voting shares of the Company issuing cash or securities in the consolidation or merger (or of its ultimate parent corporation, if any), or (B) any sale or other transfer (in one transaction or a series of transactions contemplated or arranged by any party as a single plan) of all or substantially all of the assets of the Company. |
Notwithstanding the foregoing, a “Change in Control” shall not be deemed to have occurred for purposes of the foregoing clause (i) solely as the result of an acquisition of securities by the Company which, by reducing the number of shares of Voting Securities outstanding, increases the proportionate number of Voting Securities beneficially owned by any person to 50 percent or more of the combined voting power of all of the then outstanding Voting Securities; provided, however, that if any person referred to in this sentence shall thereafter become the beneficial owner of any additional shares of Voting Securities (other than pursuant to a stock split, stock dividend, or similar transaction or as a result of an acquisition of securities directly from the Company) and immediately thereafter beneficially owns 50 percent or more of the combined voting power of all of the then outstanding Voting Securities, then a “Change in Control” shall be deemed to have occurred for purposes of the foregoing clause (i).
The Company shall reimburse Consultant for reasonable and documented business expenses incurred or paid by Consultant in connection with, or related to, the performance of Consultant’s services under this Agreement (including travel to the Company’s Colorado office as may be requested by the CEO from time to time), provided such expenses are authorized by the Company in advance and are submitted in accordance with applicable Company policy.
Exhibit 31.1
Certification of Principal Executive Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
I, Scott Durbin, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q for Viveve Medical, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: August 9, 2018 |
/s/ Scott Durbin |
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Scott Durbin |
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Chief Executive Officer |
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(Principal Executive Officer) |
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Exhibit 31.2
Certification of Principal Accounting Officer
Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
I, Jim Robbins, certify that:
1. I have reviewed this Quarterly Report on Form 10-Q for Viveve Medical, Inc.;
2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
c. Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
d. Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and
5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):
a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and
b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.
Date: August 9, 2018 |
/s/ Jim Robbins |
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Jim Robbins |
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Vice President of Finance and Administration |
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(Principal Accounting Officer) |
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Exhibit 32.1
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (A) and (B) of Section 1350, Chapter 63 of Title 18,
United States Code)
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of Title 18, United States Code), the undersigned officer of Viveve Medical, Inc. (the “Company”), does hereby certify with respect to the Quarterly Report of the Company on Form 10-Q for the period ended June 30, 2018 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), that, to the best of their knowledge:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 9, 2018 |
/s/ Scott Durbin |
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Scott Durbin |
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Chief Executive Officer |
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(Principal Executive Officer) |
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Exhibit 32.2
Certification
Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
(Subsections (A) and (B) of Section 1350, Chapter 63 of Title 18,
United States Code)
Pursuant to section 906 of the Sarbanes-Oxley Act of 2002 (subsections (a) and (b) of section 1350, chapter 63 of Title 18, United States Code), the undersigned officer of Viveve Medical, Inc. (the “Company”), does hereby certify with respect to the Quarterly Report of the Company on Form 10-Q for the period ended June 30, 2018 as filed with the Securities and Exchange Commission on the date hereof (the “Report”), that, to the best of their knowledge:
(1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
(2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
Date: August 9, 2018 |
/s/ Jim Robbins |
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Jim Robbins |
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Vice President of Finance and Administration |
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(Principal Accounting Officer) |
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