Quarterly report pursuant to Section 13 or 15(d)

Significant Accounting Policies (Policies)

v3.19.1
Significant Accounting Policies (Policies)
3 Months Ended
Mar. 31, 2019
Accounting Policies [Abstract]  
Basis of Accounting, Policy [Policy Text Block]
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, Policy [Policy Text Block]
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, Policy [Policy Text Block]
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
- Leases
 
The Company adopted FASB’s Accounting Standards Update (“ASU”)
No.
2016
-
02,
Leases (Topic
842
), as of
January 1, 2019,
using the modified retrospective approach. The modified retrospective approach provides a method for recording existing leases at the beginning of the period of adoption. In addition, the Company elected the package of practical expedients permitted under the transition guidance within the new standard, which among other things, allowed us to carry forward the historical lease classification and we elected the hindsight practical expedient to determine the lease term for existing leases. We determined that the renewal options for the facilities lease would be reasonably certain to be renewed and as such, included that renewal period in determining the expected lease term of that lease. Adoption of the new standard resulted in the recording of operating lease right-of-use assets of
$629,000
and operating lease liabilities of
$629,000,
as of
January 1, 2019.
The standard did
not
have an impact on our consolidated results of operations, cash flows or stockholders’ equity previously reported. The comparative information has
not
been restated and continues to be reported under the accounting standards in effect for those periods.
 
The effect of the changes made to our consolidated
January 1, 2019
balance sheet for the adoption of the new lease standard was as follows (in thousands):
 
   
 
 
 
 
Adjustments
   
 
 
 
   
 
 
 
 
Due to
   
 
 
 
   
December 31,
   
Adoption of
 
 
January 1,
 
   
2018
   
ASC 842
 
 
2019
 
                         
Other assets
  $
171
    $
629
(1)
  $
800
 
Total assets
  $
46,834
    $
629
(1)
  $
47,463
 
Accrued liabilities
  $
6,766
    $
230
(2)
  $
6,996
 
Total current liabilities
  $
10,760
    $
230
(2)
  $
10,990
 
Other noncurrent liabilities
  $
634
    $
399
(2)
  $
1,033
 
Total liabilities
  $
41,922
    $
629
(2)
  $
42,551
 
Total liabilities and stockholders' equity
  $
46,834
    $
629
(2)
  $
47,463
 
 
 
(
1
)
Represents capitalization of operating lease right-of-use assets and reclassification of deferred rent. 
 
(
2
)
Represents recognition of operating lease liabilities.
Cash and Cash Equivalents, Policy [Policy Text Block]
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 Risk, Credit Risk, Policy [Policy Text Block]
Concentration of Credit Risk and Other Risks and Uncertainties
 
To achieve profitable operations, the Company must successfully develop, manufacture, and market its products. There can be
no
assurance that any such products can be developed or manufactured at an acceptable cost and with appropriate performance characteristics, or that such products will be successfully marketed. These factors could have a material adverse effect upon the Company’s financial results, financial position, and future cash flows.
 
Most of the Company’s products to date require clearance or approvals from the U.S. Food and Drug Administration (“FDA”) or other international regulatory agencies prior to commencing commercial sales. There can be
no
assurance that the Company’s products will receive any of these required clearances or approvals or for the indications requested. If the Company was denied such clearances or approvals or if such clearances or approvals were delayed, it would have a material adverse effect on the Company’s financial results, financial position and future cash flows.
 
The Company is subject to risks common to companies in the medical device industry including, but
not
limited to, new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, uncertainty of market acceptance of products, product liability, and the need to obtain additional financing. The Company’s ultimate success is dependent upon its ability to raise additional capital and to successfully develop and market its products. 
 
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
March 31, 2019,
three
distributors, collectively, accounted for
42%
of the Company’s revenue. During the
three
months ended
March 31, 2018,
two
distributors, collectively, accounted for
54%
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
months ended
March 31, 2019
and
2018.
 
As of
March 31, 2019,
four
distributors, collectively, accounted for
62%
of total accounts receivable, net. As of
December 31, 2018,
three
distributors, collectively, accounted for
54%
of total accounts receivable, net.
Receivables, Trade and Other Accounts Receivable, Allowance for Doubtful Accounts, Policy [Policy Text Block]
Accounts Receivable and Allowance for Doubtful Accounts
 
Accounts receivable are recorded at the invoiced amount and are
not
interest bearing. Our typical payment terms vary by region and type of customer (distributor or physician). Occasionally, payment terms of up to
six
months
may
be granted to customers with an established history of collections without concessions. Should we grant payment terms greater than
six
months or terms that are
not
in accordance with established history for similar arrangements, revenue would be recognized as payments become due and payable assuming all other criteria for revenue recognition have been met. The Company maintains an allowance for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. The Company makes ongoing assumptions relating to the collectability of its accounts receivable in its calculation of the allowance for doubtful accounts. In determining the amount of the allowance, the Company makes judgments about the creditworthiness of customers based on ongoing credit evaluations and assesses current economic trends affecting its customers that might impact the level of credit losses in the future and result in different rates of bad debts than previously seen. The Company also considers its historical level of credit losses. The allowance for doubtful accounts was
$395,000
as of
March 31, 2019
and
$284,000
as of
December 31, 2018.
Revenue [Policy Text Block]
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 
March 31, 2019
or 
December 
31,
2018.
The Company had customer contracts liabilities in the amount of
$679,000,
primarily related to marketing programs that performance had
not
yet been delivered to its customers as of
March 31, 2019
and
$686,000
as of
December 31, 2018.
 
The following table reflects the changes in our customer contract liabilities for the
three
months ended
March 31, 2019:
 
   
March 31,
   
December 31,
   
Three Months
 
   
2019
   
2018
   
Change
 
                         
Customer contracts liabilities:
                       
Marketing programs
  $
627
    $
639
    $
(12
)
Other
   
52
     
47
     
5
 
Total
  $
679
    $
686
    $
(7
)
 
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
months ended
March 31, 2019
and
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
months ended
March 31, 2019
and
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.
   
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
months ended
March 31, 2019
and
2018
(in thousands):
 
   
Three Months Ended
 
   
March 31,
 
   
2019
   
2018
 
                 
North America
  $
1,792
    $
2,606
 
Asia Pacific
   
967
     
891
 
Europe and Middle East
   
246
     
202
 
Latin America
   
7
     
-
 
Total
  $
3,012
    $
3,699
 
 
The Company determines geographic location of its revenue based upon the destination of the shipments of its products.
Equity Method Investments [Policy Text Block]
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. The Company utilizes a
three
-month lag in reporting equity income from its investments, adjusted for known amounts and events, when the investee’s financial information is
not
available timely or when the investee’s reporting period differs from our reporting period.
 
The Company assesses the potential impairment of the equity method investments when indicators such as a history of operating losses, a negative earnings and cash flow outlook, and the financial condition and prospects for the investee’s business segment might indicate a loss in value. The carrying value of the investments is reviewed annually for changes in circumstances or the occurrence of events that suggest the investment
may
not
be recoverable.
No
impairment charges have been recorded in the condensed consolidated statements of operations during the
three
months ended
March 31, 2019
and
2018.
Standard Product Warranty, Policy [Policy Text Block]
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.
Share-based Payment Arrangement [Policy Text Block]
Accounting for Stock-Based Compensation
 
Share-based compensation cost is measured at grant date, based on the fair value of the award, and is recognized as expense over the employee’s service period. The Company recognizes compensation expense on a straight-line basis over the requisite service period of the award.
 
The Company determined that the Black-Scholes option pricing model is the most appropriate method for determining the estimated fair value for stock options and purchase rights under the employee stock purchase plan. The Black-Scholes option pricing model requires the use of highly subjective and complex assumptions which determine the fair value of share-based awards, including the option’s expected term and the price volatility of the underlying stock.
 
Equity instruments issued to nonemployees are recorded at their fair value on the measurement date and are subject to periodic adjustment as the underlying equity instruments vest.
Comprehensive Income, Policy [Policy Text Block]
Comprehensive Loss
 
Comprehensive loss represents the changes in equity of an enterprise, other than those resulting from stockholder transactions. Accordingly, comprehensive loss
may
include certain changes in equity that are excluded from net loss. For the
three
months ended
March 31, 2019
and
2018,
the Company’s comprehensive loss is the same as its net loss. 
Earnings Per Share, Policy [Policy Text Block]
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. 
 
   
Three Months Ended
 
   
March 31,
 
   
2019
   
2018
 
                 
Stock options to purchase common stock
   
5,593,130
     
3,690,902
 
Warrants to purchase common stock
   
642,622
     
642,622
 
Restricted common stock awards
   
419,147
     
22,500
 
 
New Accounting Pronouncements, Policy [Policy Text Block]
Other
Recently Issued and Adopted Accounting Standards
 
In
June 2018,
the FASB issued ASU
2018
-
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 adopted this guidance as of
January 1, 2019
and the adoption of the guidance did
not
have a significant impact on the 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 consolidated financial statements as a result of future adoption.