Item 1. Financial Statements
Item 1. Financial Statements.
EYENOVIA, INC.
Condensed Balance Sheets
June 30,
December 31,
2021
2020
(unaudited)
Assets
Current Assets:
Cash and cash equivalents
$
27,176,843
$
28,371,828
Deferred license costs
—
1,600,000
License fee and expense reimbursements receivables
899,332
2,966,039
Prepaid expenses and other current assets
1,418,834
453,478
Total Current Assets
29,495,009
33,391,345
Property and equipment, net
968,881
396,380
Security deposit
119,035
119,035
Total Assets
$
30,582,925
$
33,906,760
Liabilities and Stockholders’ Equity
Current Liabilities:
Accounts payable
$
1,667,634
$
1,461,665
Accrued compensation
870,666
1,150,672
Accrued expenses and other current liabilities
1,054,923
1,480,692
Deferred rent - current portion
6,857
7,809
Deferred license fee
10,000,000
14,000,000
Notes payable - current portion
959,763
97,539
Total Current Liabilities
14,559,843
18,198,377
Deferred rent - non-current portion
37,632
38,684
Notes payable - non-current portion
6,994,893
365,814
Total Liabilities
21,592,368
18,602,875
Commitments and contingencies (Note 7)
Stockholders’ Equity:
Preferred stock, $ 0.0001 par value, 6,000,000 shares authorized; 0 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively
—
—
Common stock, $ 0.0001 par value, 90,000,000 shares authorized; 25,946,646 and 24,978,585 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively
2,595
2,498
Additional paid-in capital
96,621,948
92,742,306
Accumulated deficit
( 87,633,986 )
( 77,440,919 )
Total Stockholders’ Equity
8,990,557
15,303,885
Total Liabilities and Stockholders’ Equity
$
30,582,925
$
33,906,760
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Operations
(unaudited)
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Operating Income
Revenue
$
2,000,000
$
—
$
4,000,000
$
—
Cost of revenue
( 800,000 )
—
( 1,600,000 )
—
Gross Profit
1,200,000
—
2,400,000
—
Operating Expenses:
Research and development
3,616,382
2,915,250
7,864,108
6,549,537
General and administrative
2,347,191
2,104,163
4,647,518
3,940,945
Total Operating Expenses
5,963,573
5,019,413
12,511,626
10,490,482
Loss From Operations
( 4,763,573 )
( 5,019,413 )
( 10,111,626 )
( 10,490,482 )
Other Income (Expense):
Small Business Administration Economic Injury Disaster Grant
—
10,000
—
10,000
Interest expense
( 78,047 )
( 6,351 )
( 83,195 )
( 10,032 )
Interest income
220
199
1,754
24,039
Net Loss
$
( 4,841,400 )
$
( 5,015,565 )
$
( 10,193,067 )
$
( 10,466,475 )
Net Loss Per Share
- Basic and Diluted
$
( 0.19 )
$
( 0.25 )
$
( 0.40 )
$
( 0.56 )
Weighted Average Number of Common Shares Outstanding
- Basic and Diluted
25,927,303
19,821,215
25,630,572
18,563,864
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Changes in Stockholders’ Equity
(unaudited)
For the Three and Six Months Ended June 30, 2021
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance - January 1, 2021
24,978,585
$
2,498
$
92,742,306
$
( 77,440,919 )
$
15,303,885
Exercise of stock warrants
644,992
65
1,530,925
—
1,530,990
Stock-based compensation
—
—
656,913
—
656,913
Net loss
—
—
—
( 5,351,667 )
( 5,351,667 )
Balance - March 31, 2021
25,623,577
2,563
94,930,144
( 82,792,586 )
12,140,121
Exercise of stock warrants
232,022
23
572,978
—
573,001
Exercise of stock options
91,047
9
130,081
—
130,090
Issuance of SVB warrants [1]
—
—
351,390
—
351,390
Stock-based compensation
—
—
637,355
—
637,355
Net loss
—
—
—
( 4,841,400 )
( 4,841,400 )
Balance - June 30, 2021
25,946,646
2,595
$
96,621,948
$
( 87,633,986 )
$
8,990,557
[1] Allocated fair value of warrants of $ 354,539 , less allocated issuance costs of $ 3,149 .
For the Three and Six Months Ended June 30, 2020
Additional
Total
Common Stock
Paid-In
Accumulated
Stockholders’
Shares
Amount
Capital
Deficit
Equity
Balance - January 1, 2020
17,100,726
$
1,710
$
69,409,949
$
( 57,671,052 )
$
11,740,607
Issuance of common stock and warrants in public offering [2]
2,675,293
267
5,451,475
—
5,451,742
Stock-based compensation
—
—
583,865
—
583,865
Net loss
—
—
—
( 5,450,910 )
( 5,450,910 )
Balance - March 31, 2020
19,776,019
1,977
75,445,289
( 63,121,962 )
12,325,304
Exercise of stock warrants
167,664
17
376,404
—
376,421
Stock-based compensation
—
—
633,146
—
633,146
Net loss
—
—
—
( 5,015,565 )
( 5,015,565 )
Balance -June 30, 2020
19,943,683
$
1,994
$
76,454,839
$
( 68,137,527 )
$
8,319,306
[2] Includes gross proceeds of $ 5,984,931 , less total issuance costs of $ 533,189 .
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
Condensed Statements of Cash Flows
(unaudited)
For the Six Months Ended
June 30,
2021
2020
Cash Flows From Operating Activities
Net loss
$
( 10,193,067 )
$
( 10,466,475 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation of property and equipment
75,243
49,343
Amortization of debt discount
15,514
—
Stock-based compensation
1,294,268
1,217,011
Changes in operating assets and liabilities:
Prepaid expenses and other current assets
( 259,996 )
( 137,187 )
License fee and expense reimbursements receivables
2,066,707
—
Deferred license costs
1,600,000
—
Accounts payable
205,969
—
Accrued compensation
( 280,006 )
( 462,658 )
Accrued expenses and other current liabilities
( 425,769 )
( 342,967 )
Deferred license fee
( 4,000,000 )
227,795
Security deposit
—
( 1,235 )
Deferred rent
( 2,004 )
( 6 )
Net Cash Used In Operating Activities
( 9,903,141 )
( 9,916,379 )
Cash Flows From Investing Activities
Purchases of property and equipment
( 647,744 )
( 132,243 )
Net Cash Used In Investing Activities
( 647,744 )
( 132,243 )
Cash Flows From Financing Activities
Proceeds from sale of common stock and warrants in private placement [1]
—
5,569,136
Proceeds from exercise of stock warrants
2,103,991
376,421
Proceeds from PPP 7(a) Loan
—
463,353
Proceeds from SVB loan
7,500,000
—
Repayments of notes payable
( 311,563 )
( 209,324 )
Payment of offering issuance costs
—
( 117,394 )
Payment of loan issuance costs
( 66,618 )
—
Proceeds from exercise of stock options
130,090
—
Net Cash Provided By Financing Activities
9,355,900
6,082,192
Net Decrease in Cash and Cash Equivalents
( 1,194,985 )
( 3,966,430 )
Cash and cash equivalents - Beginning of Period
28,371,828
14,152,601
Cash and cash equivalents - End of Period
$
27,176,843
$
10,186,171
[1] Includes gross proceeds of $ 5,984,931 , less issuance costs of $ 415,795 deducted directly from the private placement.
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Supplemental Disclosure of Cash Flow Information:
Cash paid during the periods for:
Interest
$
70,457
$
6,032
Income taxes
$
—
$
—
Supplemental Disclosure of Non-Cash Investing and Financing Activities
Purchase of insurance premium financed by note payable
$
( 705,360 )
$
( 475,216 )
Issuance of SVB stock warrants
$
( 351,390 )
$
—
The accompanying notes are an integral part of these condensed financial statements.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 1 – Business Organization, Nature of Operations and Basis of Presentation
Eyenovia, Inc. (“Eyenovia” or the “Company”) is a clinical stage ophthalmic company developing a pipeline of advanced therapeutics based on its propriety array print (MAP TM ) platform technology. Eyenovia aims to achieve clinical microdosing of next-generation formulations of novel and existing ophthalmic pharmaceutical agents using its high-precision targeted ocular delivery system, branded the Optejet ® , which has the potential to replace conventional eye dropper delivery and improve safety, tolerability, patient compliance and topical delivery success for ophthalmic eye treatments. In clinical trials, the Optejet has demonstrated that Eyenovia’s targeted horizontal microdose delivery can achieve a significantly higher rate of successful ocular topical delivery compared to the established rate reported with traditional eye drops (~ 90 % vs. ~ 50 %). Using its proprietary delivery technology, Eyenovia is developing the next generation of smart ophthalmic therapies which target new indications or new combinations where there are currently no comparable drug therapies approved by the U.S. Food and Drug Administration (the “FDA”). Eyenovia’s microdose therapeutics follow the FDA-designated pharmaceutical registration and regulatory process. Its products are classified by the FDA as drugs, and not medical devices or drug-device combination products.
The accompanying unaudited condensed financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America (“U.S. GAAP”) for interim financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and disclosures required by U.S. GAAP for complete financial statements. In the opinion of management, such statements include all adjustments (consisting only of normal recurring items) which are considered necessary for a fair presentation of the condensed financial statements of the Company as of June 30, 2021 and for the three and six months ended June 30, 2021 and 2020. The results of operations for the six months ended June 30, 2021 are not necessarily indicative of the operating results for the full year ending December 31, 2021 or any other period. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and related disclosures of the Company as of December 31, 2020 and for the year then ended, which were included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission (“SEC”) on March 30, 2021.
Note 2 – Summary of Significant Accounting Policies
Since the date of the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, there have been no material changes to the Company’s significant accounting policies, except as disclosed below.
Liquidity and Going Concern
As of June 30, 2021, the Company had cash of approximately $ 27.2 million and an accumulated deficit of approximately $87.6 million. For the six months ended June 30, 2021 and 2020, the Company incurred net losses of approximately $10.2 million and $10.5 million, respectively, and used cash in operations of approximately $9.9 million and $9.9 million, respectively. The Company does not have recurring revenue and has not yet achieved profitability. The Company expects to continue to incur cash outflows from operations. The Company expects that its research and development and general and administrative expenses will continue to increase and, as a result, it will eventually need to generate significant product revenues to achieve profitability. These circumstances raise substantial doubt about the Company’s ability to continue as a going concern for at least one year from the date that these financial statements are issued. Implementation of the Company’s plans and its ability to continue as a going concern will depend upon the Company’s ability to raise further capital, through the sale of additional equity or debt securities or otherwise, to support its future operations.
The Company’s operating needs include the planned costs to operate its business, including amounts required to fund working capital and capital expenditures. The Company’s future capital requirements and the adequacy of its available funds will depend on many factors, including the Company’s ability to successfully commercialize its products and services, competing technological and market developments, and the need to enter into collaborations with other companies or acquire other companies or technologies to enhance or complement its product and service offerings. If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Cash and Cash Equivalents
The Company considers all highly liquid investments with an original maturity of three months or less to be cash equivalents in the financial statements.
The Company has cash deposits in a financial institution which, at times, may be in excess of Federal Deposit Insurance Corporation (“FDIC”) insurance limits. The Company has not experienced losses in such accounts and periodically evaluates the creditworthiness of its financial institutions. As of June 30, 2021 and December 31, 2020, the Company had cash balances in excess of FDIC insurance limits of $ 26,676,843 and $ 28,121,828 , respectively.
Net Loss Per Common Share
Basic net loss per common share is computed by dividing net loss by the weighted average number of common shares outstanding during the period plus fully vested shares that are subject to issuance for little or no monetary consideration. Diluted earnings per share reflects the potential dilution that could occur if securities or other instruments to issue common stock were exercised or converted into common stock.
The following securities are excluded from the calculation of weighted average diluted common shares because their inclusion would have been anti-dilutive:
June 30,
2021
2020
Options
4,104,519
3,290,357
Warrants
1,226,183
3,344,154
Total potentially dilutive shares
5,330,702
6,634,511
Revenue Recognition
Our revenues are generated primarily through research, development and commercialization agreements. The terms of such agreements may contain multiple promised goods and services, which may include (i) licenses to our intellectual property, and (ii) in certain cases, payment in connection with the manufacturing and delivery of clinical supply materials. Payments to us under these arrangements typically include one or more of the following: non-refundable, upfront license fees; milestone payments; payments for clinical product supply, and royalties on future product sales.
We analyze our arrangements to assess whether such arrangements involve joint operating activities. For collaboration arrangements that are deemed to be within the scope of Accounting Standards Codification (“ASC”) Topic 808, “Collaborative Arrangements” (“ASC 808”), we allocate the contract consideration between such joint operating activities and elements that are reflective of a vendor-customer relationship and, therefore, within the scope of ASC Topic 606, “Revenue from Contracts with Customers” (“ASC 606”). Our policy is to recognize amounts allocated to joint operating activities as a reduction in research and development expense.
Under ASC 606, we recognize revenue when our customers obtain control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. To determine revenue recognition for arrangements that we determine are within the scope of ASC 606, we perform the following five steps:
● Step 1: Identify the contract with the customer;
● Step 2: Identify the performance obligations in the contract;
● Step 3: Determine the transaction price;
● Step 4: Allocate the transaction price to the performance obligations in the contract; and
● Step 5: Recognize revenue when the company satisfies a performance obligation.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
We must make significant judgments in our revenue recognition process, including 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 performance obligation. In addition, arrangements that include rights to additional goods or services that are exercisable at a customer’s discretion are generally considered discretionary purchase options. We assess if these options provide a material right to the customer and if so, they are considered performance obligations.
For upfront license fees, we must consider how many performance obligations are in the contract and, if more than one, how to allocate the fee to those performance obligations upon satisfaction of the performance obligation(s). Milestone payments represent variable consideration that will be recognized when the performance obligation is achieved. Sales-based royalty payments derived from usage of intellectual property are recognized when those sales occur.
During 2020, the Company entered into a license agreement (the “Arctic Vision License Agreement”) with Arctic Vision (Hong Kong) Limited (“Arctic Vision”) and a license agreement (the “Bausch License Agreement”) with Bausch Health Companies, Inc. (“Bausch Health”). Each license has three revenue components: 1) an upfront license fee; 2) milestone payments; and 3) royalty payments. See Note 7 – Commitments and Contingencies for additional details.
Deferred License Fee
The Company enters into license agreements which provide for the receipt of non-refundable, upfront licensing payments. These payments are recorded as deferred license fees and will be earned and recognized as revenue upon the satisfaction of performance obligations. See Note 7 – Commitments and Contingencies for additional details.
Deferred License Costs
The Company enters into license agreements which provide for payment of license costs in connection with the Company’s receipt of license fees. These payments are recorded as deferred license costs and will be recorded as an expense when the related license fee revenue is recognized. See Note 8 – Related Party Transactions for additional details.
Recently Adopted Accounting Standards
In August 2018, the FASB issued Accounting Standards Update (“ASU”) No. 2018-13 “Fair Value Measurement (Topic 820): Disclosure Framework—Changes to the Disclosure Requirements for Fair Value Measurement” (“ASU 2018-13”). The amendments in ASU 2018-13 modify the disclosure requirements on fair value measurements based on the concepts in the FASB Concepts Statement, including the consideration of costs and benefits. The amendments on changes in unrealized gains and losses, the range and weighted average of significant unobservable inputs used to develop Level 3 fair value measurements, and the narrative description of measurement uncertainty should be applied prospectively for only the most recent interim or annual period presented in the initial fiscal year of adoption. All other amendments should be applied retrospectively to all periods presented upon their effective date. The amendments are effective for fiscal years beginning after December 15, 2020. The Company adopted ASU 2018-13 effective January 1, 2021. This standard did not have a material impact on the Company’s financial position, results of operations or cash flow.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Recently Issued Accounting Standards
In February 2016, the FASB issued ASU 2016-02 “Leases (Topic 842)” (“ASU 2016-02”). ASU 2016-02 requires that a lessee recognize the assets and liabilities that arise from operating 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. For leases with a term of 12 months or less, a lessee is permitted to make an accounting policy election by class of underlying asset not to recognize lease assets and lease liabilities. In transition, lessees and lessors are required to recognize and measure leases at the beginning of the earliest period presented using a modified retrospective approach. ASU 2016-02, as amended, is now effective for fiscal years beginning after December 15, 2021, and interim periods within fiscal years beginning after December 15, 2022. The FASB issued ASU 2019-01 “Leases (Topic 842) Codification Improvements” in March 2019 and ASU 2018-10 “Codification Improvements to Topic 842, Leases” and ASU 2018-11 “Leases (Topic 842) Targeted Improvements” in July 2018, and ASU 2018-20 “Leases (Topic 842) - Narrow Scope Improvements for Lessors” in December 2018. ASU 2019-01, ASU 2018-10 and ASU 2018-20 provide certain amendments that affect narrow aspects of the guidance issued in ASU 2016-02. ASU 2018-11 allows all entities adopting ASU 2016-02 to choose an additional (and optional) transition method of adoption, under which 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. The Company is currently evaluating ASU 2016-02 and its impact on its financial position, results of operations, and cash flows.
On May 3, 2021, the Financial Accounting Standards Board (the “FASB”) issued ASU 2021-04, Earnings Per Share (Topic 260), Debt—Modifications and Extinguishments (Subtopic 470-50), Compensation—Stock Compensation (Topic 718), and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain Modifications or Exchanges of Freestanding Equity-Classified Written Call Options. This new standard provides clarification and reduces diversity in an issuer’s accounting for modifications or exchanges of freestanding equity-classified written call options (such as warrants) that remain equity classified after modification or exchange. This standard is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Issuers should apply the new standard prospectively to modifications or exchanges occurring after the effective date of the new standard. Early adoption is permitted, including adoption in an interim period. If an issuer elects to early adopt the new standard in an interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period. The Company is currently evaluating ASU 2021-04 and its impact on its financial position, results of operations, and cash flows.
Note 3 – Prepaid Expenses and Other Current Assets
As of June 30, 2021 and December 31, 2020, prepaid expenses and other current assets consisted of the following:
June 30,
December 31,
2021
2020
Payroll tax receivable
$
272,008
$
151,942
Prepaid insurance expenses
647,710
110,094
Prepaid research and development expenses
91,625
—
Prepaid general and administrative expenses
130,025
—
Prepaid licenses and subscriptions
—
57,051
Prepaid conference expenses
70,340
29,403
Prepaid board of directors fees
77,000
68,250
Prepaid rent and security deposit
32,254
25,004
Other
97,872
11,734
Total prepaid expenses and other current assets
$
1,418,834
$
453,478
Note 4 – Accrued Compensation
As of June 30, 2021 and December 31, 2020, accrued compensation consisted of the following:
June 30,
December 31,
2021
2020
Accrued bonus expenses
$
571,670
$
938,873
Accrued payroll expenses
298,996
211,799
Total accrued compensation
$
870,666
$
1,150,672
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 5 – Accrued Expenses and Other Current Liabilities
As of June 30, 2021 and December 31, 2020, accrued expenses and other current liabilities consisted of the following:
June 30,
December 31,
2021
2020
Accrued research and development expenses
$
712,062
$
348,254
Accrued consulting and professional services
221,303
235,355
Credit card payable
32,509
50,002
Accrued franchise tax
26,200
32,480
Accrued licensing fees
—
804,447
Accrued interest
36,636
3,068
Accrued expense reimbursements
—
5,459
Other
26,213
1,627
Total accrued expenses and other current liabilities
$
1,054,923
$
1,480,692
Note 6 – Notes Payable
As of June 30, 2021 and December 31, 2020, notes payable consisted of the following:
June 30, 2021
December 31, 2020
Non-
Non-
Current
Current
Current
Current
Portion
Portion
Total
Portion
Portion
Total
BankDirect Capital Finance loan
$
393,797
$
—
$
393,797
$
—
$
—
$
—
Paycheck Protection Program loan
463,353
—
463,353
97,539
365,814
463,353
Silicon Valley Bank loan
102,613
6,994,893
7,097,506
—
—
—
Total
$
959,763
$
6,994,893
$
7,954,656
$
97,539
$
365,814
$
463,353
BankDirect Capital Finance Loan
On February 24, 2021, the Company issued a note payable for the purchase of a directors and officers liability insurance policy. The note payable is payable in nine month ly payments consisting of principal and interest amounting to $ 79,343 for an aggregate principal amount of $ 705,360 . The note accrues interest at a rate of 2.96 % per year and matures on November 24, 2021.
Paycheck Protection Program Loan
On May 8, 2020, the Company received cash proceeds of $ 463,353 pursuant to a loan provided in connection with the Paycheck Protection Program under the CARES Act (the “PPP Loan”). The PPP Loan provides for monthly installment payments of $ 19,508 beginning in August 2021 with the remaining balance due on May 3, 2022, the maturity date. The PPP Loan bears interest at a fixed rate of 1.00 % per annum.
Under the terms of the CARES Act, as amended by the Paycheck Protection Program Flexibility Act of 2020, the Company is eligible to apply for and receive forgiveness for all or a portion of its PPP Loan. The Company applied for loan forgiveness on the PPP Loan in March 2021. Such forgiveness will be determined, subject to limitations, based on the use of the loan proceeds for certain permissible purposes as set forth in the PPP Loan, including, but not limited to, payroll costs and mortgage interest, rent or utility costs (collectively, “Qualifying Expenses”) incurred during the 24 weeks subsequent to funding, and on the maintenance of employee and compensation levels following the funding of the PPP Loan. The Company has used the proceeds of its PPP Loan for Qualifying Expenses. However, no assurance is provided that the Company will be able to obtain forgiveness of its PPP Loan in whole or in part. Any amounts that are not forgiven incur interest at 1.0 % per annum and monthly repayments of principal and interest are deferred until six months after the Small Business Administration makes a determination on forgiveness. While the PPP Loan currently has a two-year maturity, the amended law permits the borrower to request a five-year maturity from its lender. During the three months ended June 30, 2021 and 2020, the Company recorded interest expense of $ 4,481 and $ 4,333 , respectively. During the six months ended June 30, 2021 and 2020, the Company recorded interest expense of $ 6,963 and $ 6,032 , respectively.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Silicon Valley Bank Loan
On May 7, 2021 (the “Effective Date”), the Company entered into a Loan and Security Agreement (the “Loan”) with Silicon Valley Bank (the “Lender”, or “SVB”) for an aggregate principal amount of up to $ 25.0 million. The Loan bears interest at an annual rate equal to the greater of (a) the sum of 1.25% plus the prime rate as reported in The Wall Street Journal and (b) 5.00 %. The Loan is secured by all of the Company’s tangible assets. The Loan matures on May 1, 2025 . The Loan requires monthly interest-only payments until June 1, 2022. The interest-only period can be extended to June 1, 2023, upon the occurrence of a milestone event. Upon the end of the interest-only period, the Company will make regular monthly amortizing payments of principal and interest through the maturity date. The Loan indicates a prepayment fee of 1.0 % to 3.0 %, as follows: i) prepayment fee of 3.0 % of the principal balance made on or prior to the first anniversary of the Effective Date; ii) prepayment fee of 2.0 % of the principal balance made on or prior to the second anniversary of the Effective Date; or iii) prepayment fee of 1.0 % of the principal balance made on or prior to the third anniversary of the Effective Date. The Loan also provides for a final payment. The final payment is in addition to and not a substitution for the regular monthly payments of principal plus accrued interest due on the earliest to occur of the loan maturity date, the repayment of the loan in full or the termination of the Loan Agreement, in an amount equal to the original aggregate principal amount of the multiplied by 5.0 %.
The initial tranche of the Loan, in the amount of $ 7.5 million was received by the Company on May 7, 2021. In connection with the Loan, the Company issued to the Lender warrants to purchase 91,884 shares of common stock at an exercise price per share equal to $ 4.76 . The warrants are exercisable for a period of ten years from the date of issuance. At the Company’s option, Eyenovia has the ability to draw down the remaining $ 17.5 million in gross proceeds in two tranches over the next two years based upon the achievement of several milestones in accordance with the terms of the Loan. During the period ended June 30, 2021, the Company recorded interest expense relating to the Loan of $ 54,516 .
The following are the scheduled future annual maturities, subject to an extension of the interest-only period:
Remainder of 2021
$
—
2022
1,458,333
2023
2,500,000
2024
2,500,000
2025
1,041,667
$
7,500,000
The Company determined that the warrants should be equity-classified and that the relative fair value was $ 354,539 , by using the Black-Scholes option pricing methodology using the following assumptions: stock price of $ 4.76 ; expected term of 10.0 years; volatility of 89.0 % and a risk-free interest rate of 1.60 %. The Company incurred $ 66,618 of debt issuance costs, of which $ 63,469 was allocated to the debt and $ 3,149 was allocated to the warrants. The relative fair value of the warrants and the issuance costs allocated to the debt were recorded as debt discount and are being amortized over the four-year term of the note. See the table below for additional details.
June 30, 2021
Gross loan proceeds
$
7,500,000
Debt discount:
Relative fair value of warrants
( 354,539 )
Relative fair value of issuance costs
( 63,469 )
Amortization of debt discount
15,514
7,097,506
Note payable - current portion
102,613
Note payable - non-current portion
$
6,994,893
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 7 – Commitments and Contingencies
See Note 8 - Related Party Transactions for certain commitments and contingencies entered into with certain related parties.
Litigations, Claims and Assessments
The Company may be involved in legal proceedings, claims and assessments arising in the ordinary course of business. The Company records legal costs associated with loss contingencies as incurred and accrues for all probable and estimable settlements.
Arctic Vision License Agreement
On August 10, 2020, the Company entered into the Arctic Vision License Agreement pursuant to which Arctic Vision may develop and commercialize MicroPine for the treatment of progressive myopia and MicroLine for the treatment of presbyopia in Greater China (mainland China, Hong Kong, Macau and Taiwan) and South Korea.
Under the terms of the Arctic Vision License Agreement, the Company received a non-refundable, upfront payment of $ 4.0 million, before any payments to Senju Pharmaceutical Co., Ltd. (“Senju”), due under the Exclusive License Agreement between the Company and Senju, as amended on April 8, 2020 and a Letter Agreement dated August 10, 2020 (the “Senju License Agreement”). The Company had recorded the $ 4.0 million payment as a deferred license fee until the payment is earned. The Company considers payment earned once certain trial data has been fully submitted to Arctic Vision, permitting Arctic Vision to seek regulatory approval with the National Medical Products Administration of China. The trial data for one of the two products (MicroPine) was fully submitted to Arctic Vision in March 2021. As a result, the Company recognized $ 2.0 million of deferred license fees (one-half of the $ 4.0 million upfront license fee) and recognized $ 0.8 million of deferred license costs related to the Senju payment during the three months ended March 31, 2021. The trial data for the other product (MicroLine) was fully submitted to Arctic Vision in June 2021. As a result, the Company recognized the remaining $ 2.0 million of deferred license fees and recognized the remaining $ 0.8 million of deferred license costs related to the Senju payment during the three months ended June 30, 2021.
In addition, the Company may receive up to a total of $ 41.75 million in additional payments, based on various development and regulatory milestones, including the initiation of clinical research and regulatory approvals in Greater China and South Korea, and development costs. In December 2020, the Company satisfied a performance obligation which resulted in the Company recognizing $ 2.0 million of milestone revenues, pursuant to the Arctic Vision License Agreement.
Arctic Vision also will purchase its supply of MicroPine and MicroLine from the Company or, for such products not supplied by the Company, pay the Company a mid-single digit percentage royalty on net sales of such products, subject to certain adjustments. No royalty payments were earned through June 30, 2021. The Company will pay a mid-double digit percentage of such payments, royalties, or net proceeds of such supply to Senju pursuant to the Senju License Agreement. See Note 8 – Related Party Transactions for additional details.
Bausch License Agreement
On October 9, 2020, the Company entered into the Bausch License Agreement pursuant to which Bausch Health may develop and commercialize the Bausch Licensed Product in the Licensed Territory.
In connection with the Bausch License Agreement, Bausch Health paid the Company a non-refundable, upfront payment of $ 10.0 million. The Company has recorded this payment as a deferred license fee until the payment is earned. The Company will consider payment earned once certain administrative functions are transferred to Bausch Health, permitting Bausch Health to assume supervisory oversight of the ongoing MicroPine study (the CHAPERONE study). The upfront payment has not been earned as of June 30, 2021.
Bausch Health could also pay the Company up to an aggregate of approximately $ 35.0 million in additional payments, depending on the achievement of certain regulatory and launch-based milestones. No milestone payments were earned through June 30, 2021.
Under the terms of the Bausch License Agreement, on a country-by-country basis and Bausch Licensed Product-by- Bausch Licensed Product basis, Bausch Health will pay the Company royalties on a tiered basis (ranging from mid-single digit to mid-teen percentages) on gross profits from the sales of the Bausch Licensed Product in the Licensed Territory, subject to certain adjustments in the event of generic entry, negative gross profits or patent expiration, for a period of the later to occur of the 10th anniversary of the first commercial
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
sale of a Bausch Licensed Product in such country in the Licensed Territory or the expiration of the last valid patent claim for a Bausch Licensed Product in such country in the Licensed Territory. No royalty payments were earned through June 30, 2021.
Note 8 – Related Party Transactions
Lease Agreements
The Company’s Vice President of Research and Development and Manufacturing (“VP of R&D”) owns a company that entered into a lease agreement with the Company on September 15, 2016 to lease 953 square feet of space located in Reno, Nevada with respect to research and development activities. The initial monthly base rent was $ 3,895 per month over the term of the lease and the security deposit was $ 3,895 . On September 15, 2018, the Company amended the lease agreement to extend it until September 14, 2020 and increase the monthly base rent and security deposit to $ 4,012 . On September 15, 2020, the Company amended the lease agreement to extend it until September 14, 2022 and increase the monthly base rent and security deposit to $ 5,404 . The Company made $ 82,500 of leasehold improvements related to this lease which are included on the condensed balance sheet. The Company’s rent expense for this space is recorded in Research and Development on the condensed statement of operations and amounted to $ 16,212 and $ 15,494 for the three months ended June 30, 2021 and 2020, respectively, and $ 32,424 and $ 27,530 , respectively, for the six months ended June 30, 2021 and 2020.
Senju License Agreement
During 2015, the Company entered into an Exclusive License Agreement with Senju whereby the Company agreed to grant to Senju an exclusive, royalty-bearing license for its microdose product candidates for Asia to sublicense, develop, make, have made, manufacture, use, import, market, sell, and otherwise distribute the microdose product candidates. In consideration for the license, Senju agreed to pay to Eyenovia five percent ( 5 %) royalties for the term of the license agreement. The agreement will continue in full force and effect, on a country-by-country basis, until the latest to occur of: (i) the tenth (10th) anniversary of the first commercial sale of a microdose product candidate in Asia; or (ii) the expiration of the licensed patents. As of the date of this filing, there had been no commercial sales of a microdose product candidate in Asia, such that no royalties had been earned. Senju is owned by the family of a former member of the Company’s Board of Directors and, together, they beneficially own greater than 5 % of the Company’s common stock.
On April 8, 2020, Eyenovia entered into an amendment (the “License Amendment”) to the Exclusive License Agreement. Pursuant to the License Amendment, the Company can license to any third party the right to research, develop, commercialize, manufacture or use certain products identified below (the “Senju Licensed Products”) previously licensed to Senju in China (including the People’s Republic of China, Hong Kong, Macao, and Taiwan) and South Korea (the “Territory”) if such a license was executed by the Company by April 8, 2021. The Senju Licensed Products are those using piezo-print technology in a microdose dispenser with (i) atropine sulfate as its sole active ingredient to treat myopia in humans and (ii) pilocarpine as its sole active ingredient to treat presbyopia in humans.
Pursuant to the License Amendment, the Company must pay Senju (a) close to a mid-double digit percentage of revenue on any lump-sum payments the Company receives from the third party, revenue (net of costs) obtained by the Company from contract research and/or development of the Senju Licensed Product in the Territory, and revenue (net of costs) obtained by the Company from contract manufacture for the device of the Senju Licensed Product in the Territory, the aggregate of which must be at least a high seven figure dollar amount minimum payment to Senju; and (b) a lower-double digit percentage of any sales royalty revenue the Company receives from the third party. Since the Company executed a third-party license prior to April 8, 2021, the License Amendment will remain in effect for the duration of the license, subject to early termination.
The Exclusive License Agreement was further amended in a Letter Agreement by and between the Company and Senju on August 10, 2020 (the “Letter Agreement”). Pursuant to the Letter Agreement, the Company will pay a mid-double digit percentage of certain payments, royalties, or net proceeds received from Arctic Vision in connection with the Arctic Vision License Agreement to Senju.
See Note 7 – Commitments and Contingencies – Arctic Vision License Agreement for additional details.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Note 9 – Stockholders’ Equity
Securities Purchase Agreement
On March 24, 2020, the Company closed on a private placement of approximately $ 6.0 million of Units. Each Unit consists of (i) one share of the Company’s common stock, (ii) a one-year warrant to purchase 0.5 of a share of common stock (“Class A Warrant”), and (iii) a five-year warrant to purchase 0.75 of a share of common stock (“Class B Warrant”) (collectively, the Class A Warrants and Class B Warrants, the “Warrants”). The Units were sold to the public at a price of $ 2.21425 per Unit and to certain directors and executive officers at a price of $ 2.42625 per Unit. The Company generated approximately $ 5.3 million of net proceeds in the offering after deducting placement agent fees and offering expenses. In the offering, the Company issued an aggregate of 2,675,293 shares of common stock, Class A Warrants to purchase up to 1,337,659 shares of common stock, and Class B Warrants to purchase up to 2,006,495 shares of common stock. The exercise price of the Class A Warrants issued to the public is $ 2.058 per share and the exercise price of the Class A Warrants issued to the directors and officers is $ 2.27 per share. The exercise price of the Class B Warrants issued to the public is $ 2.4696 per share and the exercise price of the Class B Warrants issued to the directors and officers is $ 2.724 per share.
In connection with the private placement, on March 24, 2020, the Company also entered into a Registration Rights Agreement with the investors. Pursuant to the Registration Rights Agreement, the Company was obligated to file with the SEC, no later than 30 days following the date on which the Company filed its Form 10-K for the year ended December 31, 2019 with the SEC, a registration statement on Form S-3 covering the shares of common stock issued in the offering and the shares of common stock underlying the Warrants. The Company timely filed the registration statement on Form S-3 (Registration Statement No. 333-237790), which was declared effective by the SEC on May 13, 2020.
Stock Options
In applying the Black-Scholes option pricing model to stock options granted, the Company used the following approximate assumptions:
For the Three Months Ended
For the Six Months Ended
June 30,
June 30,
2021
2020
2021
2020
Expected term (years)
5.85 - 10.00
5.85
5.85 - 10.00
5.85
Risk free interest rate
0.80 % - 1.58
%
0.34 % - 0.38
%
0.45 % - 1.58
%
0.34 % - 1.32
%
Expected volatility
93
%
99
%
93 % - 94
%
96 % - 99
%
Expected dividends
0.00
%
0.00
%
0.00
%
0.00
%
The Company has computed the fair value of stock options granted using the Black-Scholes option pricing model. Option forfeitures are accounted for at the time of occurrence. The expected term is the estimated period of time that options granted are expected to be outstanding. The Company utilizes the “simplified” method to develop an estimate of the expected term of “plain vanilla” employee option grants. The Company uses a blended volatility calculation, the components of which are the Company’s historical volatility for the period from its initial public offering through the valuation date and the average peer-group data of six comparable entities to supplement the Company’s own historical data for the preceding years in computing the expected volatility. Accordingly, the Company is utilizing an expected volatility figure based on a review of the historical volatility of comparable entities over a period of time equivalent to the expected life of the instrument being valued. The risk-free interest rate was determined from the implied yields from U.S. Treasury zero-coupon bonds with a remaining term consistent with the expected term of the instrument being valued.
The weighted average estimated grant date fair value of the stock options granted for the three months ended June 30, 2021 and 2020 was approximately $ 3.48 and $ 2.13 per share, respectively. The weighted average estimated grant date fair value of the stock options granted for the six months ended June 30, 2021 and 2020 was approximately $ 4.33 and $ 2.17 per share, respectively.
On June 17, 2021, an employee exercised an option to purchase common shares on a cashless basis, which resulted in 13,675 shares being withheld and not issued, to cover the cost to exercise and all payroll taxes.
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
A summary of the option activity during the six months ended June 30, 2021 is presented below:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number of
Exercise
Life
Intrinsic
Options
Price
(in Years)
Value
Outstanding January 1, 2021
3,427,705
$
3.37
Granted
781,536
5.77
Exercised
( 104,722 )
1.95
Outstanding June 30, 2021
4,104,519
$
3.83
7.9
$
6,445,166
Exercisable June 30, 2021
2,185,978
$
3.52
6.9
$
4,241,183
The following table presents information related to stock options as of June 30, 2021:
Options Outstanding
Options Exercisable
Weighted
Outstanding
Average
Exercisable
Exercise
Number of
Remaining Life
Number of
Price
Options
In Years
Options
$
1.24
260,000
3.7
260,000
$
1.95
568,822
6.0
568,822
$
2.72
764,419
8.9
254,807
$
2.74
6,000
7.5
4,833
$
2.89
263,500
8.9
95,158
$
3.11
659,849
8.1
420,859
$
3.43
58,920
—
—
$
3.48
45,000
—
—
$
3.71
43,000
—
—
$
4.00
2,000
7.4
1,723
$
4.53
127,000
—
—
$
4.68
25,000
8.6
11,112
$
5.10
6,000
7.2
5,500
$
5.11
1,637
—
—
$
5.19
16,500
7.2
15,125
$
5.25
26,668
5.3
26,668
$
5.77
50,000
—
—
$
6.01
652,899
—
—
$
6.20
300,387
7.1
296,119
$
6.30
60,000
7.0
58,333
$
8.72
166,918
6.8
166,918
4,104,519
6.9
2,185,978
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
Warrants
A summary of the Warrant activity for the six months ended June 30, 2021 is presented below:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Number of
Exercise
Life
Intrinsic
Warrants
Price
In Years
Value
Outstanding January 1, 2021
2,011,313
$
2.43
Granted
91,884
4.76
Exercised
( 877,014 )
2.40
Outstanding June 30, 2021
1,226,183
$
2.69
4.2
$
2,788,188
Exercisable June 30, 2021
1,226,183
$
2.69
4.2
$
2,788,188
The following table presents information related to Warrants as of June 30, 2021:
Warrants Outstanding
Warrants Exercisable
Weighted
Outstanding
Average
Exercisable
Exercise
Number of
Remaining Life
Number of
Price
Warrants
In Years
Warrants
$ 2.4696
917,919
3.7
917,919
$ 2.7240
216,380
3.7
216,380
$ 4.7600
91,884
9.9
91,884
1,226,183
4.2
1,226,183
See Note 6 – Notes Payable – for details on the warrant issued in connection with the Silicon Valley Bank loan.
Restricted Stock Units
On September 11, 2020 and March 31, 2021, the Company granted members of its Board of Directors an aggregate of 44,951 RSUs under its Amended and Restated 2018 Omnibus Stock Incentive Plan. Each RSU is subject to settlement into one share of the Company’s common stock. The RSUs provided that vesting would occur on the earlier of (i) the one-year anniversary of the date of grant and (ii) the date of the 2021 annual stockholders meeting, subject to the grantee remaining on the Board until then. The 2021 annual stockholders meeting took place on June 16, 2021 which triggered the vesting of the RSUs. The RSUs had an aggregate grant date fair value of $ 156,200 , which was recognized over the vesting period.
Stock Warrant Exercises
During the six months ended June 30, 2021, the Company issued an aggregate of 877,014 shares of common stock pursuant to the exercise of warrants for aggregate proceeds of $ 2,103,991 at exercise prices ranging from $ 2.058 to $ 2.4696 .
Stock-Based Compensation Expense
The Company recorded stock-based compensation expense related to stock options and restricted stock units of $ 637,355 ($ 319,497 of which was included within research and development expenses and $ 317,858 was included within general and administrative expenses on the condensed statements of operations) and $ 633,146 ($ 348,447 of which was included within research and development expenses and $ 284,699 was included within general and administrative expenses on the condensed statements of operations) during the three months ended June 30, 2021 and 2020, respectively. During the six months ended June 30, 2021 and 2020, the Company recorded stock-based compensation expense related to stock options and restricted stock units of $ 1,294,268 ($ 649,210 of which was included within research and development expenses and $ 645,058 was included within general and administrative expenses on the condensed statements of operations) and $ 1,217,011 ($ 655,856 of which was included within research and development expenses and $ 561,155 was included within general and administrative expenses on the condensed statements of operations), respectively. As of June 30, 2021, there was
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EYENOVIA, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)
$ 5,796,853 of unrecognized stock-based compensation expense which the Company expects to recognize over a weighted average period of 2.2 years.
At-The-Market Offering
On May 14, 2021, the Company entered into a Sales Agreement (the “Agreement”) with SVB Leerink LLC (“SVB Leerink”) under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $ 0.0001 per share (the “Common Stock”), having an aggregate offering price of up to $ 30 million through SVB Leerink as its sales agent. Subject to the terms and conditions of the Agreement, SVB Leerink may sell the Common Stock by any method permitted by law deemed to be an “at-the-market offering”. SVB Leerink will use commercially reasonable efforts to sell the Common Stock from time to time, based upon instructions from the Company (including any price, time or size limits or other customary parameters or conditions the Company may impose). The Company will pay SVB Leerink a commission equal to three percent ( 3.0 %) of the gross sales proceeds of any Common Stock sold through SVB Leerink under the Agreement.
The Company is not obligated to make any sales of Common Stock under the Agreement. Through June 30, 2021, the Company has not sold any shares of common stock under the Agreement.
Note 10 – Employee Benefit Plans
401(k) Plan
In April 2019, the Company adopted the Eyenovia 401(k) Plan (the “Plan”), which went into effect in May 2019. All Company employees are able to participate in the Plan, subject to eligibility requirements as outlined in the Plan documents. Under the terms of the Plan, eligible employees are able to defer a percentage of their pay every pay period up to annual limitations set by Congress and the Internal Revenue Service under Section 401(k) of the Internal Revenue Code. For 2021, the Company’s Board of Directors has approved a matching contribution equal to 100 % of elective deferrals up to 4 % of eligible earnings with the matching contribution subject to certain vesting requirements as outlined in the Plan documents. During the three months ended June 30, 2021 and 2020, the Company recorded expense of $ 46,663 and $ 22,515 associated with its matching contributions, respectively. During the six months ended June 30, 2021 and 2020, the Company recorded expense of $ 110,841 and $ 80,486 associated with its matching contributions, respectively.
Note 11 – Subsequent Events
Employee Stock Options
On July 6, 2021, the Company granted ten-year stock options to employees, pursuant to its Amended and Restated 2018 Omnibus Stock Incentive Plan, to purchase an aggregate of 224,000 shares of the Company’s common stock at an exercise price of $ 4.81 per share. The options expire on the tenth anniversary of the grant date and they vest with respect to one-third of the shares underlying the awards on the first anniversary of the grant date and, with respect to the remaining two-thirds of the shares underlying the awards, in equal monthly installments over the subsequent two years.
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.