Significant Accounting Policies (Policies)
|9 Months Ended|
Sep. 30, 2017
|Accounting Policies [Abstract]|
|Basis of Accounting, Policy [Policy Text Block]||
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.Prior to termination of Navidea’s joint venture with R-NAV, LLC (“R-NAV”) in
May 2016,Navidea's investment in R-NAV was being accounted for using the equity method of accounting and was therefore
March 3, 2017,pursuant to an Asset Purchase Agreement dated
November 23, 2016, (the “Purchase Agreement”), the Company completed its previously announced sale to Cardinal Health
414,LLC (“Cardinal Health
414”) of its assets used, held for use, or intended to be used in operating its business of developing, manufacturing and commercializing a product used for lymphatic mapping, lymph node biopsy, and the diagnosis of metastatic spread to lymph nodes for staging of cancer (the “Business”), including the Company
’s radioactive diagnostic agent marketed under the Lymphoseek
®trademark for current approved indications by the U.S. Food and Drug Administration (“FDA”) and similar indications approved by the FDA in the future (the “Product”), in Canada, Mexico and the United States (the “Territory”) (giving effect to the License-Back described below and excluding certain assets specifically retained by the Company) (the “Asset Sale”). Such assets sold in the Asset Sale consist primarily of, without limitation, (i) intellectual property used in or reasonably necessary for the conduct of the Business, (ii) inventory of, and customer, distribution, and product manufacturing agreements related to, the Business, (iii) all product registrations related to the Product, including the new drug application approved by the FDA for the Product and all regulatory submissions in the United States that have been made with respect to the Product and all Health Canada regulatory submissions and, in each case, all files and records related thereto, (iv) all related clinical trials and clinical trial authorizations and all files and records related thereto, and (v) all rights, title and interest in and to the Product, as specified in the Purchase Agreement (the “Acquired Assets”).
Upon closing of the Asset Sale, the Supply and Distribution Agreement, dated
November 15, 2007 (as amended, the “Supply and Distribution Agreement”), between Cardinal Health
414and the Company was terminated and, as a result, the provisions thereof are of
nofurther force or effect (other than any indemnification, payment, notification or data sharing obligations which survive the termination).
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 statement
s of cash flows. See Note
|Fair Value of Financial Instruments, Policy [Policy Text Block]||
– Unadjusted quoted prices in active markets that are accessible at the measurement date for identical, unrestricted assets or liabilities;
– Quoted prices in markets that are
notactive or financial instruments for which all significant inputs are observable, either directly or indirectly; and
– Prices or valuations that require inputs that are both significant to the fair value measurement and unobservable.
A financial instrument
’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement. In determining the appropriate levels, we perform a detailed analysis of the assets and liabilities whose fair value is measured on a recurring basis. At each reporting period, all assets and liabilities for which the fair value measurement is based on significant unobservable inputs or instruments which trade infrequently and therefore have little or
noprice transparency are classified as Level
The following methods and assumptions were used to estimate the fair value of each class of financial instruments:
|Revenue Recognition, Policy [Policy Text Block]||
We also earn revenues related to our licensing and distribution agreements. The terms of these agreements
mayinclude payment to us of non-refundable upfront license fees, funding or reimbursement of research and development efforts, milestone payments if specified objectives are achieved, and/or royalties on product sales. We evaluate all deliverables within an arrangement to determine whether or
notthey provide value on a stand-alone basis. We recognize a contingent milestone payment as revenue in its entirety upon our achievement of a substantive milestone if the consideration earned from the achievement of the milestone (i) is consistent with performance required to achieve the milestone or the increase in value to the delivered item, (ii) relates solely to past performance and (iii) is reasonable relative to all of the other deliverables and payments within the arrangement. We received a non-refundable upfront cash payment of
$2.0million from SpePharm AG upon execution of the SpePharm License Agreement in
March 2015.We determined that the license and other non-contingent deliverables d
nothave stand-alone value because the license could
notbe deemed to be fully delivered for its intended purpose unless we performed our other obligations, including specified development work. Accordingly, they did
notmeet the separation criteria, resulting in these deliverables being considered a single unit of account. As a result, revenue relating to the upfront cash payment was deferred and was being recognized on a straight-line basis over the estimated obligation period of
twoyears. However, the remaining deferred revenue of
$417,000was recognized upon obtaining European approval of a reduced-mass vial in
September 2016,several months earlier than originally anticipated.
|New Accounting Pronouncements, Policy [Policy Text Block]||
Following the sale of the Business to Cardinal Health
we generate revenue primarily from grants to support certain of our product development programs. Such grant revenues are recognized only after expenses reimbursable under the grants have been paid. We also earn revenues related to our licensing and distribution agreements. The consideration we are eligible to receive under our licensing and distribution agreements typically includes upfront payments, reimbursement for research and development costs, milestone payments, and royalties. Each licensing and distribution agreement is unique and will require separate assessment using the
five-step process under ASU
09.Management is working to complete its evaluation of the impact of adopting ASU
09,however we currently do
notanticipate that it will have a material effect on our consolidated financial statements. We will adopt ASU
09along with additional related ASUs effective
January 1, 2018.We currently plan to use the modified retrospective method of adoption.
January 2017,the FASB issued ASU
01,Business Combinations (Topic
805), Clarifying the Definition of a Business
01provides a screen to determine when a set of assets and activities (collectively, a “set”) is
nota business. The screen requires that when substantially all of the fair market value of the gross assets acquired (or disposed of) is concentrated in a single identifiable asset or a group of similar identifiable assets, the set is
nota business. If the screen is
1) requires that to be considered a business, a set must include, at a minimum, an input and a substantive process that together significantly contribute to the ability to create output, and (
2) removes the evaluation of whether a market participant could replace missing elements. ASU
01is effective for public business entities for annual periods beginning after
December 15, 2017,including interim periods within those periods. ASU
01should be applied prospectively on or after the effective date.
Nodisclosures are required at transition. Early adoption is permitted for certain transactions as described in ASU
01.Management is currently evaluating the impact that the adoption of ASU
01will have on our consolidated financial statements.
May 2017,the FASB issued ASU
Compensation-Stock Compensation (Topic. ASU
718), Scope of Modification Accounting
09provides guidance about which changes to the terms or conditions of a share-based payment award require an entity to apply modification accounting. An entity should account for the effects of a modification unless all of the following criteria are met: (
1) The fair value of the modified award is the same as the fair value of the original award immediately before the original award is modified. If the modification does
notaffect any of the inputs to the valuation technique that the entity uses to value the award, the entity is
notrequired to estimate the value immediately before and after the modification. (
2) The vesting conditions of the modified award are the same as the vesting conditions of the original award immediately before the original award is modified. (
3) The classification of the modified award as an equity instrument or a liability instrument is the same as the classification of the original award immediately before the original award is modified. Disclosure requirements remain unchanged. ASU
09is effective for all entities for annual periods, and interim periods within those annual periods, beginning after
December 15, 2017.Early adoption is permitted as described in ASU
09.Management is currently evaluating the impact that the adoption of ASU
09will have on our consolidated financial statements.
September 2017,the FASB issued ASU
Revenue Recognition (Topic. ASU
605), Revenue from Contracts with Customers (Topic
606), Leases (Topic
840), and Leases (Topic
13adds SEC paragraphs pursuant to an SEC Staff Announcement made in
July 2017and clarifies several issues related to transition and implementation of the covered topics, including clarification of the definition of a public business entity, the effect of a change in tax law or rates on leveraged leases, and related amendments to the eXstensible Business Reporting Language (“XBRL”) taxonomy. Management is currently evaluating the impact that the adoption of ASU
13will have on our consolidated financial statements.
Disclosure of accounting policy for basis of accounting, or basis of presentation, used to prepare the financial statements (for example, US Generally Accepted Accounting Principles, Other Comprehensive Basis of Accounting, IFRS).
No definition available.
Disclosure of accounting policy for determining the fair value of financial instruments.
Reference 1: http://www.xbrl.org/2003/role/presentationRef
Disclosure of accounting policy pertaining to new accounting pronouncements that may impact the entity's financial reporting. Includes, but is not limited to, quantification of the expected or actual impact.
No definition available.
Disclosure of accounting policy for revenue recognition. If the entity has different policies for different types of revenue transactions, the policy for each material type of transaction is generally disclosed. If a sales transaction has multiple element arrangements (for example, delivery of multiple products, services or the rights to use assets) the disclosure may indicate the accounting policy for each unit of accounting as well as how units of accounting are determined and valued. The disclosure may encompass important judgment as to appropriateness of principles related to recognition of revenue. The disclosure also may indicate the entity's treatment of any unearned or deferred revenue that arises from the transaction.
Reference 1: http://www.xbrl.org/2003/role/presentationRef