Quarterly report pursuant to Section 13 or 15(d)

Summary of Significant Accounting Policies

v3.10.0.1
Summary of Significant Accounting Policies
9 Months Ended
Sep. 30, 2018
Significant Accounting Policies [Text Block]
2.
Summary of Significant Accounting Policies
 
Basis of Presentation and Principles of Consolidation
 
The accompanying Condensed Consolidated Financial Statements include the accounts of the Company and its subsidiaries, EyeGate Pharma S.A.S. and Jade (since date of acquisition), collectively referred to as “the Company”. All inter-company balances and transactions have been eliminated in consolidation. These Condensed Consolidated Financial Statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial information. Certain information and disclosures normally included in Condensed Consolidated Financial Statements prepared in accordance with U.S. GAAP have been condensed or eliminated. Accordingly, these unaudited Condensed Consolidated Financial Statements should be read in conjunction with the annual financial statements of the Company as of and for the year ended December 31, 2017.
 
Unaudited Interim Financial Information
 
The accompanying interim financial statements and related disclosures are unaudited, have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which consist of normal recurring adjustments, necessary for a fair presentation of the results of operations for the periods presented. The year-end balance sheet was derived from audited financial statements, but does not include all disclosures required by U.S. GAAP. The results of operations for an interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period.
 
Use of Estimates
 
The preparation of financial statements in conformity with U.S. GAAP requires management to make significant estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, at the date of the financial statements, and the reported amounts of expenses during the reporting periods. The Company makes significant estimates and assumptions in recording the accruals for its clinical trial and research activities, establishing the useful lives of intangible assets and property and equipment, and conducting impairment reviews of long-lived assets. The Company bases its estimates on historical experience and various other assumptions that it believes to be reasonable under the circumstances. Although the Company monitors and regularly assesses these estimates, actual results could differ significantly from these estimates. The Company records changes in estimates in the period that it becomes aware of the change.
 
 
Research and Development Expenses
 
The Company expenses research and development (“R&D”) expenditures as incurred. R&D expenses are comprised of costs incurred in performing R&D activities, including salaries, benefits, facilities, research-related overhead, sponsored research costs, contracted services, license fees, expenses related to generating, filing, and maintaining intellectual property, and other external costs. Because the Company believes that, under its current process for developing its products, the viability of the products is essentially concurrent with the establishment of technological feasibility, no costs have been capitalized to date.
 
In-process Research and Development
 
The Company records in-process R&D projects acquired in asset acquisitions that have not reached technological feasibility and which have no alternative future use. For in-process R&D projects acquired in business combinations, the Company capitalizes the in-process R&D project and periodically evaluates this asset for impairment until the R&D process has been completed. Once the R&D process is complete, the Company amortizes the R&D asset over its remaining useful life. At September 30, 2018 there is $3,912,314 of in-process R&D, as part of intangible asset and in-process R&D on the Condensed Consolidated Balance Sheet.
 
Intangible Assets
 
The Company records intangible assets acquired in asset acquisitions of proprietary technology. The Company capitalizes intangible assets, amortizes them over the estimated useful life, and periodically evaluates the assets for impairment. At September 30, 2018 there is $250,000 of intangible assets, as part of intangible assets and in-process R&D on the Condensed Consolidated Balance Sheet.
 
Accrued Clinical Expenses
 
As part of the Company’s process of preparing the Condensed Consolidated Financial Statements, the Company is required to estimate its accrued expenses. This process includes reviewing open contracts and purchase orders, communicating with its applicable personnel to identify services that have been performed on its behalf and estimating the level of service performed and the associated costs incurred for the service when the Company has not yet been invoiced or otherwise notified of actual costs. The majority of the Company’s service providers invoice monthly in arrears for services performed. The Company makes estimates of its accrued expenses as of each balance sheet date in the financial statements based on facts and circumstances known at the time. The Company periodically confirms the accuracy of these estimates with the service providers and makes adjustments if necessary.
 
Related Party Transactions
 
The Company has entered into certain related-party transactions, making payments for services to one vendor, seven consultants and one public university for the three months ending September 30, 2018, all of whom also are stockholders of the Company. These transactions generally are ones that involve a stockholder or option holder of the Company to whom we also make payments during the year, typically as a consultant or a service provider. The amounts recorded or paid are not material to the accompanying Condensed Consolidated Financial Statements.
 
Net Loss per Share
 
The computation of Net Loss per Common Share – Basic and Diluted, is based on the weighted-average number of shares outstanding of Common Stock. In computing diluted loss per share, no effect has been given to the shares of common stock issuable upon the conversion or exercise of the following dilutive securities, as the Company’s net loss would make the effect anti-dilutive.
 
 
 
September 30,
2018
(unaudited)
 
 
September 30,
2017
(unaudited)
 
Common Stock Warrants
 
 
41,194,086
 
 
 
9,519,403
 
Employee Stock Options
 
 
2,187,525
 
 
 
1,858,300
 
Preferred Stock
 
 
12,787,500
 
 
 
400,000
 
Total Shares of Common Stock Issuable
 
 
56,169,111
 
 
 
11,777,703
 
 
Fair Value of Financial Instruments
 
The carrying amounts of Accounts Receivable and Accounts Payable approximate their fair values due to the short-term nature of these items. As of September 30, 2018 and December 31, 2017, the fair value of the Company’s money market funds and contingent consideration was $0 and $1,210,000, and $750,965 and $1,210,000, respectively.
 
At September 30, 2018 and December 31, 2017, the Company had no other assets or liabilities that are subject to fair value methodology and estimation in accordance with U.S. GAAP.
 
Revenue Recognition
 
The Company’s revenues are generated primarily through arrangements which generally contain multiple elements, or deliverables, including licenses and R&D activities to be performed by the Company on behalf of the licensor or grantor. Payments to EyeGate under these arrangements typically include one or more of the following: (1) nonrefundable, upfront license fees, (2) funding of discovery research efforts on a full-time equivalent basis, (3) reimbursement of research, development and intellectual property costs, (4) milestone payments, and (5) royalties on future product sales.
 
On July 9, 2015, the Company entered into an exclusive, worldwide licensing agreement with a subsidiary of Bausch Health Companies, Inc. (“BHC”), formerly known as Valeant Pharmaceuticals, Inc., through which the Company granted to BHC an exclusive, worldwide commercial and manufacturing right to the Company’s EGP-437 Product in the field of anterior uveitis, as well as a right of last negotiation to license its EGP-437 Product for indications other than anterior uveitis (the “BHC Agreement”). There are four principal R&D milestones under the BHC Agreement: (i) the Phase 3 Clinical Trial, (ii) the Endothelial Cell Count Safety Trial (a trial to determine that treatment has not adversely affected a patient’s corneal endothelial cell density), (iii) the CMC Validation, and (iv) the New Drug Application, or “NDA”, filing with the FDA (collectively, the “Four Milestones”, and each individually, a “Milestone”). Under the BHC Agreement, BHC paid to the Company an initial upfront payment of $1.0 million and the Company is eligible to receive milestone payments totaling up to $32.5 million, upon and subject to the achievement of certain specified development and commercial progress of the EGP-437 Product for the treatment of anterior uveitis. The Company has received milestone payments totaling $5.4 million through September 30, 2018. The Company receives payments both when it crosses certain thresholds on the way to each Milestone (each, a “Progress Payment”), as well as once it achieves each Milestone. The Company is entitled to retain all of these payments. In accordance with its former revenue recognition policy, through December 31, 2017 the initial upfront payment and milestone payments were recorded as Deferred Revenue. In addition, the Company is eligible under the BHC Agreement to receive royalties based on a specified percent of net sales of its EGP-437 Product for the field of anterior uveitis throughout the world, subject to adjustment in certain circumstances.
 
On February 21, 2017, the Company entered into another exclusive, worldwide licensing agreement with a subsidiary of BHC (the “New BHC Agreement”), through which the Company granted BHC exclusive, worldwide commercial and manufacturing rights to its EGP-437 Product in the field of ocular iontophoretic treatment for post-operative ocular inflammation and pain in ocular surgery patients (the “New Field”). Under the New BHC Agreement, BHC paid the Company an initial upfront payment of $4.0 million, and the Company is eligible to receive milestone payments totaling up to approximately $99.0 million, upon and subject to the achievement of certain specified developmental and commercial progress of the EGP-437 Product for the New Field. The Company has received milestone payments totaling $3.4 million through September 30, 2018. In accordance with its former revenue recognition policy, through December 31, 2017 the initial upfront payment and milestone payments were recorded as Deferred Revenue. In addition, the Company is eligible under the New BHC Agreement to receive royalties based on a specified percent of net sales of its EGP-437 Product for the New Field throughout the world, subject to adjustment in certain circumstances.
 
In May 2014, the FASB issued ASU No. 2014-09,
Revenues from Contracts with Customers
(“Topic 606”), as subsequently amended, that outlines a single comprehensive model for entities to use in accounting for revenue arising from contracts with customers and supersedes most recent revenue recognition guidance, including industry-specific guidance. The core principle of the revenue model is that an entity recognizes revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. This standard is effective for public companies for years ending after December 15, 2017, with early adoption permitted.
 
The Company did not elect to early adopt and adopted the new standard on January 1, 2018, using the modified retrospective method, which resulted in a cumulative effect adjustment in the amount of $9.5 million to beginning 2018 accumulated deficit and to deferred and unbilled revenue for the BHC contracts impacted by the adoption of the new standard. The changes to the method and/or timing of the Company’s revenue recognition associated with the adoption of the new standard primarily relate to the determination that there is one performance obligation in each contract with BHC and that the license combined with the R&D services is the performance obligation.
 
The cumulative effect of initially applying the new revenue recognition guidance to the Company’s Condensed Consolidated Balance Sheet on January 1, 2018 was as follows:
 
 
 
Balance as of

 December 31,

2017
 
 
Cumulative Impact

from Adopting New

Revenue Guidance
 
 
Balance as of

January 1, 2018
 
Assets:
 
 
 
 
 
 
 
 
 
 
 
 
Unbilled Revenue
 
$
-
 
 
$
116,280
 
 
$
116,280
 
Liabilities:
 
 
 
 
 
 
 
 
 
 
 
 
Deferred Revenue
 
 
12,313,600
 
 
 
(9,361,600
)
 
 
2,952,000
 
Stockholders' Equity:
 
 
 
 
 
 
 
 
 
 
 
 
Accumulated Deficit
 
$
(91,816,655
)
 
$
9,477,880
 
 
$
(82,338,775
)
 
The impact from adopting the new revenue recognition guidance on the Company’s Condensed Consolidated Balance Sheet for the nine months ending September 30, 2018 was as follows:
 
 
 
As Reported
 
 
Previous

Accounting

Guidance
 
 
Impact from

Adopting New

Revenue

Guidance
 
Liabilities:
 
 
 
 
 
 
 
 
 
Deferred Revenue
 
$
2,686,000
 
 
$
13,618,600
 
 
$
(10,932,600
)
Stockholders' Equity:
 
 
 
 
 
 
 
 
 
 
 
 
Accumulated Deficit
 
$
(90,622,193
)
 
$
(101,517,793
)
 
$
10,895,600
 
 
The impact from adopting the new revenue recognition guidance on the Company’s Condensed Consolidated Statement of Operations and Comprehensive Loss for the three and nine months ended September 30, 2018 was as follows:
 
 
 
Three Months Ended
 
 
Nine Months Ended
 
 
 
As Reported
 
 
Previous

Accounting

Guidance
 
 
Impact from

Adopting

New Revenue

Guidance
 
 
As

Reported
 
 
Previous

Accounting

Guidance
 
 
Impact from

Adopting New

Revenue

Guidance
 
Collaboration Revenue
 
$
314,500
 
 
$
-
 
 
$
314,500
 
 
$
1,652,520
 
 
$
-
 
 
$
1,652,520
 
Operating Loss Before Other Expenses
 
 
(3,177,878
)
 
 
(3,492,378
)
 
 
314,500
 
 
 
(8,355,245
)
 
 
(10,007,765
)
 
 
1,652,520
 
Net Loss
 
 
(3,123,836
)
 
 
(3,438,336
)
 
 
314,500
 
 
 
(8,283,418
)
 
 
(9,935,938
)
 
 
1,652,520
 
Comprehensive Loss
 
$
(3,117,454
)
 
$
(3,431,954
)
 
$
314,500
 
 
$
(8,273,796
)
 
$
(9,926,316
)
 
$
1,652,520
 
 
Under this new guidance, the Company recognizes revenue when its customer obtains control of promised services, in an amount that reflects the consideration which the Company expects to receive in exchange for those services. To determine whether arrangements are within the scope of this new guidance, the Company performs the following five steps: (i) identifies the contract with a customer; (ii) identifies the performance obligations in the contract; (iii) determines the transaction price; (iv) allocates the transaction price to the performance obligations in the contract; and (v) recognizes revenue when (or as) the Company satisfies its performance obligation. The Company applies the five-step model to contracts when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer. Upon adoption of ASU No. 2014-09, the Company recognizes revenue from the transaction price applied to each single performance obligation over time as milestones are reached for each performance obligation. The Company only recognizes revenue on those milestones that are within the Company’s control and any constrained variable consideration that requires regulatory approval will only be included in the transaction price when performance is complete.
 
The below table represents the changes in the Company’s contract assets and contract liabilities:
 
 
 
September 30,

2018
 
 
January 1, 2018
 
Contract Asset:
 
 
 
 
 
 
 
 
Unbilled Revenue
 
$
-
 
 
$
116,280
 
Contract Liabilities:
 
 
 
 
 
 
 
 
Deferred Revenue
 
$
2,686,000
 
 
$
2,952,000
 
  
 
 
Three Months

Ended  

September 30,

2018
 
 
Nine Months

Ended

September 30,

2018
 
Revenue recognized in the period from:
 
 
 
 
 
 
 
 
Amounts included in contract liability at the beginning of the period
 
$
37,000
 
 
$
266,000
 
 
In addition, the Company may receive government grant funds for specified ocular therapeutic research activities. Revenue under these grants will be recorded when the Company performs the activities specified by the terms of each grant and is entitled to the funds.
 
Recent Accounting Pronouncements
 
In February 2016, the FASB issued ASU No. 2016-02,
Leases
, which is effective for fiscal years, and interim periods within those years, beginning after December 15, 2018, with early adoption permitted. Under ASU No. 2016-02, lessees will be required to recognize for all leases at the commencement date a lease liability, which is a lessee’s obligation to make lease payments arising from a lease measured on a discounted basis, and the right-to-use assets, which are asset that represents the lessee’s right to use or control the use of a specified asset for the lease term. The Company does not expect to early adopt this standard and currently has leases (
see
Note 10) that will be in place at the effective date. The Company has evaluated the effect of the new guidance and does not expect the adoption of this guidance to have a material impact on its Consolidated Financial Statements and related disclosures.
 
On January 26, 2017, the FASB issued ASU No. 2017-04,
Intangibles
Goodwill and Other
, which simplifies the accounting for goodwill impairment. The guidance removes Step 2 of the goodwill impairment test, which requires a hypothetical purchase price allocation. A goodwill impairment will now be the amount by which a reporting unit’s carrying value exceeds its fair value, not to exceed the carrying amount of goodwill. All other goodwill impairment guidance will remain largely unchanged. Entities will continue to have the option to perform a qualitative assessment to determine if a quantitative impairment test is necessary. The same one-step impairment test will be applied to goodwill at all reporting units, even those with zero or negative carrying amounts. Entities will be required to disclose the amount of goodwill at reporting units with zero or negative carrying amounts. The new standard is effective for the Company on January 1, 2020. The new standard is required to be applied prospectively. Early adoption is permitted for any impairment tests performed after January 1, 2017. The Company did not early adopt ASU No. 2017-04 prior to its December 2017 impairment evaluation and is evaluating the effect that ASU No. 2017-04 will have on its Consolidated Financial Statements and related disclosures.
 
In June 2018, the FASB issued ASU No. 2018-07,
Compensation-Stock Compensation: Improvements to Nonemployee Share-Based Payment Accounting
(“Topic 718”), which simplifies several aspects of the accounting for nonemployee share-based payment transactions resulting from expanding the scope of Topic 718 to include share-based payment transactions for acquiring goods and services from nonemployees. Some of the areas for simplification apply only to nonpublic entities. The amendments specify 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. The amendments also clarify 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
. The amendments in this update are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted. The Company has elected to early adopt Topic 718 effective for the third quarter of 2018. The adoption of this guidance did not have a material impact on its Consolidated Financial Statements and related disclosures.