Quarterly report pursuant to Section 13 or 15(d)

Significant Accounting Policies (Policies)

v3.10.0.1
Significant Accounting Policies (Policies)
9 Months Ended
Sep. 30, 2018
Accounting Policies [Abstract]  
Basis of Accounting, Policy [Policy Text Block]
a.
Basis of Presentation:
The information presented as of
September 30, 2018
and for the
three
-month and
nine
-month periods ended
September 30, 2018
and
2017
is unaudited, but includes all adjustments (which consist only of normal recurring adjustments) that the management of Navidea Biopharmaceuticals, Inc. (“Navidea”, the “Company,” or “we”) believes to be necessary for the fair presentation of results for the periods presented. Certain information and footnote disclosures normally included in financial statements prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) have been condensed or omitted pursuant to the rules and regulations of the U.S. Securities and Exchange Commission. The balances as of
September 30, 2018
and the results for the interim periods are
not
necessarily indicative of results to be expected for the year. The consolidated financial statements should be read in conjunction with Navidea’s audited consolidated financial statements for the year ended
December 
31,
2017,
which were included as part of our Annual Report on Form
10
-K.
 
In
March 2017,
the Company completed the sale to Cardinal Health
414,
LLC (“Cardinal Health
414”
) of its assets used in developing, manufacturing and commercializing Lymphoseek
®
in North America. See Note
3.
Following the sale to Cardinal Health
414,
the Company is primarily focused on commercializing its
Tc99m
tilmanocept products in markets outside the U.S. and on developing additional products based on our Manocept™ platform.
 
Our consolidated financial statements include the accounts of Navidea and our wholly-owned subsidiaries, Navidea Biopharmaceuticals Limited and Cardiosonix Ltd, as well as those of our majority-owned subsidiary, Macrophage Therapeutics, Inc. (“MT”). All significant inter-company accounts were eliminated in consolidation. Cardiosonix was legally dissolved in
September 2017.
 
Our consolidated balance sheets and statements of operations have been reclassified, as required, for all periods presented to reflect the Business as a discontinued operation. Cash flows associated with the operation of the Business have been combined with operating, investing and financing cash flows, as appropriate, in our consolidated statements of cash flows. See Note
3.
 
Certain prior period amounts also have been reclassified to conform to the current year’s presentation, including the adoption of Accounting Standards Update (“ASU”)
No.
2014
-
09,
Revenue from Contracts with Customers
,
and cash flows related to loss on extinguishment of debt.
Fair Value of Financial Instruments, Policy [Policy Text Block]
b.
Financial Instruments and Fair Value:
The following methods and assumptions were used to estimate the fair value of each class of financial instruments:
 
 
(
1
)
Cash, available-for-sale securities, accounts and other receivables, and accounts payable:
The carrying amounts approximate fair value because of the short maturity of these instruments. At
September 30, 2018
and
December 31, 2017,
approximately
$
96,000
of accounts payable was being disputed by the Company related to unauthorized expenditures by a former executive during
2016.
 
 
(
2
)
Notes payable:
The carrying value of our debt at
September 30, 2018
and
December 
31,
2017
primarily consisted of the face amount of the notes less unamortized discounts. At
September 30, 2018,
the fair value of our notes payable was approximately
$2.2
million, equal to the carrying value of
$2.2
million. At
December 31, 2017,
the fair value of our notes payable was approximately
$2.4
million, equal to the carrying value of
$2.4
million. See Note
9.
 
 
(
3
)
Derivative liabilities:
Derivative liabilities are related to certain outstanding warrants which are recorded at fair value. Derivative liabilities totaling
$
63,000
as of
September 30, 2018
and
December 31, 2017
are included in other liabilities on the consolidated balance sheets. The assumptions used to calculate fair value as of
September 30, 2018
and
December 31, 2017
included volatility, a risk-free rate and expected dividends. In addition, we considered non-performance risk and determined that such risk is minimal. Unrealized gains and losses on the derivatives are classified in other expenses as a change in the fair value of financial instruments in the statements of operations. See Note
5.
 
 
(
4
)
Warrants:
In
March 2017,
in connection with the Asset Sale, the Company granted to each of Cardinal Health
414
and the University of California, San Diego, (“UCSD”), a
five
-year warrant to purchase up to
10
million shares and
1
million shares, respectively, of the Company’s common stock at an exercise price of
$1.50
per share, each of which warrant is subject to anti-dilution and other customary terms and conditions (the “Series NN warrants”). The assumptions used to calculate fair value at the date of issuance included volatility, a risk-free rate and expected dividends. The Series NN warrants granted to Cardinal Health
414
had an estimated fair value of
$3.3
million, which was recorded as a reduction of the gain on sale in the consolidated statement of operations for the
nine
-month period ended
September 30, 2017.
The Series NN warrants granted to UCSD had an estimated fair value of
$334,000,
which was recorded as an intangible asset related to the UCSD license in the consolidated balance sheet at the time of issuance. See Note
13.
New Accounting Pronouncements, Policy [Policy Text Block]
c.
Recently Adopted Accounting Standards:
In
May 2014,
the Financial Accounting Standards Board (“FASB”) issued ASU
2014
-
09,
Revenue from Contracts with Customers (Topic
606
)
, which supersedes existing revenue recognition guidance under U.S. GAAP. The core principle of ASU
2014
-
09
is that a company should recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which the company expects to be entitled in exchange for those goods or services. ASU
2014
-
09
defines a
five
-step process that requires companies to exercise more judgment and make more estimates than under the current guidance. These
may
include identifying performance obligations in the contract, estimating the amount of variable consideration to include in the transaction price, and allocating the transaction price to each separate performance obligation. Since the issuance of ASU
2014
-
09,
several additional ASUs have been issued and incorporated within Topic
606
to clarify various elements of the guidance. We adopted ASU
2014
-
09,
along with additional related ASUs
2016
-
08,
2016
-
10,
2016
-
12
and
2016
-
20,
effective
January 1, 2018,
using the modified retrospective method of adoption. The adoption of ASU
2014
-
09
and related ASUs resulted in increases in deferred revenue and accumulated deficit of
$
700,000
.
See Note
4.
 
In
November 2016,
the FASB issued ASU
No.
2016
-
18,
Statement of Cash Flows – Restricted Cash
. ASU
2016
-
18
requires that the statement of cash flows explain the change during the period in the total of cash, cash equivalents, and restricted cash or equivalents. Therefore, restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU
2016
-
18
is effective for public business entities for fiscal years beginning after
December 15, 2017,
and interim periods within those fiscal years. Early adoption is permitted, including adoption in an interim period. If an entity early adopts ASU
2016
-
18
in an interim period, any adjustments should be reflected as of the beginning of the fiscal year that includes the interim period. We adopted ASU
2016
-
18
effective
January 1, 2018.
The adoption of ASU
2016
-
18
resulted in reclassification of
$5.0
million of restricted cash in the consolidated statement of cash flows for the
nine
-month period ended
September 30, 2017.
 
In
March 2018,
the FASB issued ASU
No.
2018
-
05,
Income Taxes
(Topic
740
)
– Amendments to SEC Paragraphs Pursuant to SEC Staff Accounting Bulletin
No.
118
. ASU
2018
-
05
amends Accounting Standards Codification (“ASC”) Topic
740
to provide guidance on accounting for the tax effects of the Tax Cuts and Jobs Act (the “Tax Act”) pursuant to Staff Accounting Bulletin
No.
118.
ASU
2018
-
05
addresses situations where the accounting under ASC Topic
740
is incomplete for certain income tax effects of the Tax Act upon issuance of the entity’s financial statements for the reporting period in which the Tax Act was enacted. The adoption of ASU
2018
-
05
in
March 2018
did
not
have a material effect on our consolidated financial statements.
 
 
d
.
Recent
ly Issued A
ccounting Standards:
In
February 2016,
the FASB issued ASU
No.
2016
-
02,
Leases (Topic
842
)
. ASU
2016
-
02
requires the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under previous U.S. GAAP. The core principle of Topic
842
is that a lessee should recognize the assets and liabilities that arise from leases. A lessee should recognize in the statement of financial position a liability to make lease payments (the lease liability) and a right-of-use asset representing its right to use the underlying asset for the lease term. ASU
2016
-
02
is effective for public business entities for fiscal years beginning after
December 15, 2018,
including interim periods within those fiscal years. Early adoption is permitted. We have begun our assessment of the impact of adopting ASU
2016
-
02,
and expect to complete that process during the
fourth
quarter of
2018.
We expect the adoption of ASU
2016
-
02
to result in an increase in right-of-use assets and related liabilities of approximately
$
300,000
on our balance sheet related to our leases that are currently classified as operating leases, primarily for office space.
 
In
June 2018,
the FASB issued ASU
No.
2018
-
07,
Compensation—Stock Compensation (Topic
718
) – Improvements to Nonemployee Share-Based Payment Accounting
. ASU
2018
-
07
expands the scope of Topic
718
to include share-based payment transactions for acquiring goods and services from nonemployees. An entity should apply the requirements of Topic
718
to nonemployee awards except for specific guidance on inputs to an option pricing model and the attribution of cost. ASU
2018
-
07
specifies that Topic
718
applies to all share-based payment transactions in which a grantor acquires goods or services to be used or consumed in a grantor’s own operations by issuing share-based payment awards, and that Topic
718
does
not
apply to share-based payments used to effectively provide (
1
) financing to the issuer or (
2
) awards granted in conjunction with selling goods or services to customers as part of a contract accounted for under Topic
606,
Revenue from Contracts with Customers
. ASU
2018
-
07
is effective for public business entities for fiscal years beginning after
December 15, 2018,
including interim periods within that fiscal year. The adoption of ASU
2018
-
07
is
not
expected to have a significant impact on our consolidated financial statements.
 
In
July 2018,
the FASB issued ASU
No.
2018
-
09,
Codification Improvements
. ASU
2018
-
09
updates a variety of topics in order to clarify, correct errors, or make minor improvements to the Codification, making it easier to understand and easier to apply by eliminating inconsistencies and providing clarifications. Certain amendments in ASU
2018
-
09
are effective upon issuance, others are effective for annual periods beginning after
December 15, 2018
for public business entities, and some have been made to recently issued guidance and will be subject to the effective dates within the relevant guidance. The adoption of ASU
2018
-
09
is
not
expected to have a significant impact on our consolidated financial statements.
 
Also in
July 2018,
the FASB issued ASU
No.
2018
-
10,
Codification Improvements to Topic
842,
Leases
, and ASU
No.
2018
-
11,
Targeted Improvements to Topic
842,
Leases
. ASU
2018
-
10
updates Topic
842
in order to clarify narrow aspects of the guidance issued in ASU
2016
-
02,
Leases (Topic
842
)
. ASU
2018
-
11
provides entities with an additional (and optional) transition method to adopt the new leases standard. Under this new transition method, an entity initially applies the new leases standard at the adoption date and recognizes a cumulative-effect adjustment to the opening balance of retained earnings in the period of adoption. Consequently, an entity’s reporting for the comparative periods presented in the financial statements in which it adopts the new leases standard will continue to be in accordance with current GAAP (Topic
840,
Leases
). An entity that elects this transition method must prove the required Topic
840
disclosures for all periods that continue to be in accordance with Topic
840.
The amendments in ASU
2018
-
10
and ASU
2018
-
11
are effective when ASU
2016
-
02
is effective, for fiscal years beginning after
December 15, 2018.
We do
not
expect the adoption of ASU
2018
-
10
and ASU
2018
-
11
to have a significant impact on our consolidated financial statements.
 
In
August 2018,
the FASB issued ASU
No.
2018
-
13,
Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement
. ASU
2018
-
13
modifies the disclosure requirements on fair value measurements in Topic
280,
Fair Value Measurement, including the consideration of costs and benefits. ASU
2018
-
13
removes the requirements to disclose (
1
) the amount of and reasons for transfers between Level
1
and Level
2
of the fair value hierarchy, (
2
) the policy for timing of transfers between levels, (
3
) the valuation processes for Level
3
fair value measurements, and (
4
) for nonpublic entities, the changes in unrealized gains and losses for the period included in earnings for recurring Level
3
fair value measurements held at the end of the reporting period. ASU
2018
-
13
also modifies certain disclosure requirements as follows: (
1
) in lieu of a rollforward for Level
3
fair value measurements, a nonpublic entity is required to disclose transfers into and out of Level
3
and purchase and issuances of Level
3
assets and liabilities, (
2
) for investments in certain entities that calculate net asset value, an entity is required to disclose the timing of liquidation of an investee’s assets and the date when restrictions from redemption might lapse only if the investee has communicated the timing to the entity or announced the timing publicly, and (
3
) the amendments clarify that the measurement uncertainty disclosure is to communicate information about the uncertainty in measurement as of the reporting date. Finally, ASU
2018
-
13
adds the requirements to disclose (
1
) the changes in unrealized gains and losses for the period included in other comprehensive income for recurring Level
3
fair value measurements held at the end of the reporting period, and (
2
) the range and weighted average of significant unobservable inputs used to develop Level
3
fair value measurements. The amendments in ASU
2018
-
13
are effective for fiscal years, and interim periods within those fiscal years, beginning after
December 15, 2019.
We do
not
expect the adoption of ASU
2018
-
13
to have any impact on our consolidated financial statements, however it
may
have an impact on our fair value disclosures.