Navidea is focused on the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. We manage our business based on primary types of drug products: (i) diagnostic substances, including tilmanocept and other diagnostic applications of our Manocept platform, and (ii) therapeutic development programs, including all therapeutic applications of our Manocept platform. tilmanocept, which the Company has a license to distribute outside of Canada, Mexico and the United States, is the only of the Company’s drug product candidates that has been approved for sale in any market. The Company has license and distribution agreements in place in Europe, India and China, however tilmanocept has only been approved for sale in Europe.

 

The Company also has an agreement in place to provide Meilleur Technologies, Inc., (“Meilleur”), a wholly-owned subsidiary of Cerveau Technologies, Inc. (“Cerveau”), worldwide rights to conduct research using as well as an exclusive license for the development and commercialization of in Australia, Canada, China, and Singapore. Meilleur also has an option to commercialize worldwide.

 

Currently, the Company recognizes revenue from up-front license fees and pre-market milestones after the cash has been received from its customers and the performance obligations have been met. Payments for sales-based royalties and milestones are generally received after the related revenue has been recognized and invoiced. Normal payment terms generally range from to days following milestone achievement or royalty invoice, in accordance with each contract.

 

Up-front and milestone payments received related to our license and distribution agreements in India and China are deferred until tilmanocept has been approved by the regulatory authorities in each of those countries. It is possible to determine with any degree of certainty whether or when regulatory approval for this product will be achieved in India or China, if at all. In addition, since sales of tilmanocept have yet begun in India or China, there is basis for estimating whether, to what degree, or the rate at which the product will be accepted and utilized in these markets. Therefore, it is possible to determine with any degree of certainty the expected sales in future periods in those countries. As such, the Company intends to recognize revenue from up-front and milestone payments on a straight-line basis beginning at the time of regulatory approval in each country through the end of the initial term of each agreement. The initial term of each agreement is years in India and years in China.

 

The transaction price of a contract is the amount of consideration to which the Company expects to be entitled in exchange for transferring promised goods or services to a customer. Transaction prices do include amounts collected on behalf of parties (e.g., sales taxes). To determine the transaction price of a contract, the Company considers the terms of the contract. For the purpose of determining transaction prices, the Company assumes that the goods or services will be transferred to the customer as promised in accordance with existing contracts and that the contracts will be cancelled, renewed, or modified.

 

When estimating a contract’s transaction price, the Company considers all the information (historical, current, and forecasted) that is reasonably available to it and identifies possible consideration amounts. Most of the Company’s contracts with customers include both fixed and variable components of the transaction price. Under those contracts, some or all of the consideration for satisfied performance obligations is contingent on events over which the Company has direct influence. For example, regulatory approval or product sales volume milestones are contingent upon the achievement of those milestones by the distributor. Additionally, the prices charged to end users of tilmanocept, upon which royalty payments are based in Europe, India and China, are set by the distributor in each of those countries.

 

The milestone payments have a binary outcome (that is, the Company will either receive all or of each milestone payment) and can be estimated using the most-likely-amount method. Taking into account the constraint on variable consideration, the Company has assessed the likelihood of achieving the non-sales-based milestone payments in our contracts and has determined that it is probable the milestones will be achieved and the Company will receive the consideration. Accordingly, it is probable that including those payments in the transaction price will result in a significant revenue reversal when the contingency is resolved. Therefore, the amount of the non-sales-based milestone payments is included in the transaction price.

 

Royalties are estimated based on the expected value method because they are based on a variable amount of sales representing a range of possible outcomes. However, when taking into account the constraint on variable consideration, the estimate of future royalties included in the transaction price is generally This conclusion is based on the fact that tilmanocept is early in the commercial launch process in Europe and sales have yet begun in India or China, therefore there is currently basis for estimating whether, to what degree, or the rate at which the product will be accepted and utilized in these markets. Similarly, we currently have basis for estimating whether sales-based milestones will ever be achieved. Accordingly, the Company recognizes revenue from royalties when the related sales occur and from sales-based milestones when they are achieved.

 

The sublicense of to Meilleur provides for payments to Navidea including up-front payments, milestones, an option for worldwide commercial rights, royalties on net sales, and reimbursement for product development assistance during the initial transition period. In accordance with the revenue recognition standard, the upfront payments were recognized upon contract inception, and reimbursement for product development assistance will be recognized on a monthly basis. Should some or all of the variable consideration from milestones, the option and royalties meet the requirements of the revenue recognition standard to be included in the transaction price, those amounts will be recognized as revenue in future periods.

 

Up-front fees, milestones and royalties are generally non-refundable. Therefore, the Company does estimate expected refunds nor do we adjust revenue downward. The Company will evaluate and update the estimated transaction prices of its contracts with customers at the end of each reporting period.

 

During the -month periods ended and the Company recognized revenue from contracts with customers of approximately and respectively. During the -month periods ended and the Company recognized revenue from contracts with customers of approximately and respectively. During the -month and -month periods ended and the Company did recognize any related impairment losses, nor did the Company recognize any revenue from performance obligations associated with long-term contracts that were satisfied (or partially satisfied) in previous periods.

 

The following tables disaggregate the Company’s revenue from contracts with customers for the -month and -month periods ended and

 

 

T hree Months Ended September 30 , 2019		Diagnostics
Royalty revenue:
Europe		$	4,895

 

T hree Months Ended September 30 , 2018		Diagnostics
Royalty revenue:
Europe		$	2,382
License revenue:
NAV4694 sublicense		$	14,930
Tc99m tilmanocept sublicense, China			5,000
Total		$	19,930

 

Nine Months Ended September 30, 2019		Diagnostics
Royalty revenue:
Europe		$	13,985
License revenue:
NAV4694 sublicense		$	9,953
Other revenue:
Additional stability studies		$	11,024

 

Nine Months Ended September 30 , 201 8		Diagnostics
Royalty revenue:
Europe		$	9,842
License revenue:
NAV4694 sublicense		$	272,639
Tc99m tilmanocept sublicense, China			5,000
Total		$	277,639
Other revenue:
Additional stability studies		$	15,037

 

The following economic factors affect the nature, amount, timing and uncertainty of the Company’s revenue and cash flows as indicated:

 

Drug pricing models vary among different markets, which in turn affect the royalty rates and milestones we are able to negotiate with our distributors in those markets. Royalty rates and milestone payments vary by contract but be based in part on the potential market size in each territory. In the case of tilmanocept, royalty rates for Europe are lower than rates in India but higher than in China.

 

The majority of revenue from contracts with customers will generally be recognized after the product is approved for sale in each market. Each tilmanocept customer operates in its own distinct regulatory environment, and the laws and pathways to drug product approval vary by market. tilmanocept has been approved for sale in Europe, thus the Company has begun to recognize royalties from sales in Europe. tilmanocept has yet been approved for sale in India or China, and never achieve approval in those markets. The regulatory pathways and timelines in those markets will impact whether and when the Company recognizes the related royalties and milestones. Similarly, has yet been approved for sale in any market, thus the timing of any revenue related to that product will be dependent on the regulatory pathways and timelines in each market in which Meilleur seeks regulatory approval.

 

Through the Company has capitalized any contract-related costs as contract assets.

 

The following table summarizes the changes in contract liabilities, the current portion of which is included in accrued liabilities and other in the consolidated balance sheets, during the -month and -month periods ended and

 

		Three Months Ended September 30,								Nine Months Ended September 30,
		2019				2018				2019				2018
Total deferred revenue, beginning of period		$	1,195,000			$	721,024			$	711,024			$	26,061
Impact of adoption of ASU 2014-09 and related standards			—				—				—				700,000
Revenue deferred related to sublicense			—				—				495,000				10,000
Refund of deferred revenue related to sublicense			(495,000	)			—				(495,000	)			—
Revenue recognized from satisfaction of performance obligations			—				(5,000	)			(11,024	)			(20,037	)
Total deferred revenue, end of period		$	700,000			$	716,024			$	700,000			$	716,024

 

 

The Company had trade receivables of approximately and outstanding as of and

 

In addition to revenue from contracts from customers, we also generate revenue from NIH grants to support various product development initiatives. The revenue recognition standard applies to revenue from contracts with customers. A customer is defined as a party that has contracted with an entity to obtain goods or services that are an output of the entity’s ongoing major or central operations in exchange for consideration. The Company’s ongoing major or central operations consist of the development and commercialization of precision immunodiagnostic agents and immunotherapeutics. The NIH and its various institutes are responsible for biomedical and public health research and provide major biomedical research funding to non-NIH research facilities and entities such as Navidea. While the Company will directly benefit from any knowledge gained from the project, there is also a public health benefit provided, which justifies the use of public funds in the form of the grants. Based on the nature of the Company’s operations and the terms of the grant awards, Navidea does have a vendor-customer relationship with the NIH and the grant awards are outside the scope of the revenue recognition standard. Accordingly, the revenue recognition standard need be applied to the NIH grants. During the -month periods ended and the Company recognized grant revenue of and respectively. During the -month periods ended and the Company recognized grant revenue of and respectively.