Item 1. Financial Statements
Item 1.
Financial Statements.
Ocular Therapeutix, Inc.
Condensed Consolidated Balance Sheets
(In thousands, except share and per share data)
(Unaudited)
September 30,
December 31,
2021
2020
Assets
Current assets:
Cash and cash equivalents
$
179,281
$
228,057
Accounts receivable, net
19,552
12,252
Inventory
1,222
1,201
Prepaid expenses and other current assets
3,877
4,650
Total current assets
203,932
246,160
Property and equipment, net
6,914
8,095
Restricted cash
1,764
1,764
Operating lease assets
5,129
5,844
Total assets
$
217,739
$
261,863
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
4,246
$
2,709
Accrued expenses and other current liabilities
19,358
14,307
Operating lease liabilities
1,554
1,358
Notes payable, net of discount, current
—
8,290
Total current liabilities
25,158
26,664
Other liabilities:
Operating lease liabilities, net of current portion
6,355
7,548
Derivative liability
36,064
98,313
Deferred revenue
12,000
12,000
Notes payable, net of discount
24,936
16,936
2026 convertible notes, net
25,886
24,307
Total liabilities
130,399
185,768
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at September 30, 2021 and December 31, 2020, respectively
—
—
Common stock, $ 0.0001 par value; 200,000,000 shares authorized and 76,606,968 and 75,996,732 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively
8
8
Additional paid-in capital
629,286
615,338
Accumulated deficit
( 541,954 )
( 539,251 )
Total stockholders’ equity
87,340
76,095
Total liabilities and stockholders’ equity
$
217,739
$
261,863
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Operations and Comprehensive Income (Loss )
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Revenue:
Product revenue, net
$
12,153
$
5,876
$
31,214
$
10,054
Total revenue, net
12,153
5,876
31,214
10,054
Costs and operating expenses:
Cost of product revenue
1,310
450
3,298
1,403
Research and development
12,719
6,951
37,505
21,070
Selling and marketing
9,576
6,520
26,054
19,803
General and administrative
8,077
5,961
24,345
16,282
Total costs and operating expenses
31,682
19,882
91,202
58,558
Loss from operations
( 19,529 )
( 14,006 )
( 59,988 )
( 48,504 )
Other income (expense):
Interest income
7
6
27
162
Interest expense
( 1,658 )
( 1,715 )
( 4,991 )
( 5,042 )
Change in fair value of derivative liability
23,837
3,771
62,249
( 16,640 )
Total other income (expense), net
22,186
2,062
57,285
( 21,520 )
Net income (loss) and comprehensive income (loss)
$
2,657
$
( 11,944 )
$
( 2,703 )
$
( 70,024 )
Net income (loss) per share, basic
$
0.03
$
( 0.19 )
$
( 0.04 )
$
( 1.22 )
Weighted average common shares outstanding, basic
76,552,060
62,992,558
76,317,563
57,440,885
Net loss per share, diluted
$
( 0.23 )
$
( 0.21 )
$
( 0.75 )
$
( 1.22 )
Weighted average common shares outstanding, diluted
85,446,886
68,761,790
82,086,795
57,440,885
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Cash Flows
(In thousands)
(Unaudited)
Nine Months Ended
September 30,
2021
2020
Cash flows from operating activities:
Net loss
$
( 2,703 )
$
( 70,024 )
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation expense
11,136
5,427
Non-cash interest expense
3,440
3,279
Change in fair value of derivative liability
( 62,249 )
16,640
Depreciation and amortization expense
1,851
2,106
Gain on disposal of property and equipment
( 1 )
—
Changes in operating assets and liabilities:
Accounts receivable
( 7,300 )
( 5,231 )
Prepaid expenses and other current assets
773
( 97 )
Inventory
( 21 )
( 200 )
Operating lease assets
715
593
Accounts payable
1,430
113
Accrued expenses
3,529
911
Operating lease liabilities
( 997 )
( 825 )
Net cash used in operating activities
( 50,397 )
( 47,308 )
Cash flows from investing activities:
Purchases of property and equipment
( 563 )
( 588 )
Net cash used in investing activities
( 563 )
( 588 )
Cash flows from financing activities:
Proceeds from issuance of notes payable, net
3,722
—
Proceeds from exercise of stock options
2,414
1,044
Proceeds from issuance of common stock pursuant to employee stock purchase plan
490
350
Proceeds from the Paycheck Protection Program Loan
—
3,201
Repayment of the Paycheck Protection Program Loan
—
( 3,201 )
Proceeds from issuance of common stock upon public offering, net of issuance costs
( 275 )
62,707
Repayment of notes payable
( 4,167 )
—
Net cash provided by financing activities
2,184
64,101
Net (decrease) increase in cash, cash equivalents and restricted cash
( 48,776 )
16,205
Cash, cash equivalents and restricted cash at beginning of period
229,821
56,201
Cash, cash equivalents and restricted cash at end of period
$
181,045
$
72,406
Supplemental disclosure of cash flow information:
Cash paid for interest
$
1,443
$
1,769
Supplemental disclosure of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable and accrued expenses at balance sheet dates
$
199
$
71
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Stockholders’ Equity
(In thousands, except share data)
(Unaudited)
Additional
Total
Common Stock
Paid-in
Accumulated
Stockholders’
Shares
Par Value
Capital
Deficit
Equity
Balances at December 31, 2020
75,996,732
$
8
$
615,338
$
( 539,251 )
$
76,095
Issuance of common stock upon exercise of stock options
228,241
—
1,197
—
1,197
Issuance of common stock upon cashless exercise of warrant
11,737
—
—
—
—
Issuance costs associated with common stock public offering
—
—
( 91 )
—
( 91 )
Stock-based compensation expense
—
—
3,086
—
3,086
Net income
—
—
—
3,121
3,121
Balances at March 31, 2021
76,236,710
$
8
$
619,530
$
( 536,130 )
$
83,408
Issuance of common stock upon exercise of stock options
177,256
—
538
—
538
Issuance of common stock in connection with employee stock purchase plan
40,631
—
490
—
490
Stock-based compensation expense
—
—
4,292
—
4,292
Net loss
—
—
—
( 8,481 )
( 8,481 )
Balances at June 30, 2021
76,454,597
$
8
$
624,850
$
( 544,611 )
$
80,247
Issuance of common stock upon exercise of stock options
152,371
—
678
—
678
Stock-based compensation expense
—
—
3,758
—
3,758
Net income
—
—
—
2,657
2,657
Balances at September 30, 2021
76,606,968
$
8
$
629,286
$
( 541,954 )
$
87,340
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Condensed Consolidated Statements of Stockholders’ Equity (Deficit)
(In thousands, except share data)
(Unaudited)
Additional
Total
Common Stock
Paid-in
Accumulated
Stockholders’
Shares
Par Value
Capital
Deficit
Equity (Deficit)
Balances at December 31, 2019
50,333,559
$
5
$
379,980
$
( 383,615 )
$
( 3,630 )
Issuance of common stock upon exercise of stock options
46,321
—
128
—
128
Issuance of common stock upon public offering, net of issuance costs
2,657,823
—
12,690
—
12,690
Stock-based compensation expense
—
—
1,665
—
1,665
Net loss
—
—
—
( 21,512 )
( 21,512 )
Balances at March 31, 2020
53,037,703
$
5
$
394,463
$
( 405,127 )
$
( 10,659 )
Issuance of common stock upon exercise of stock options
75,862
—
378
—
378
Issuance of common stock in connection with employee stock purchase plan
104,579
—
350
—
350
Issuance of common stock upon public offering, net of issuance costs
9,735,649
1
50,016
—
50,017
Stock-based compensation expense
—
—
1,826
—
1,826
Net loss
—
—
—
( 36,568 )
( 36,568 )
Balances at June 30, 2020
62,953,793
$
6
$
447,033
$
( 441,695 )
$
5,344
Issuance of common stock upon exercise of stock options
117,187
—
538
—
538
Stock-based compensation expense
—
—
1,936
—
1,936
Net loss
—
—
—
( 11,944 )
( 11,944 )
Balances at September 30, 2020
63,070,980
$
6
$
449,507
$
( 453,639 )
$
( 4,126 )
The accompanying notes are an integral part of these condensed consolidated financial statements.
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Ocular Therapeutix, Inc.
Notes to the Condensed Consolidated Financial Statements
(Amounts in thousands, except share and per share data)
(Unaudited)
1. Nature of the Business and Basis of Presentation
Ocular Therapeutix, Inc. (the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware. The Company is a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary, bioresorbable hydrogel platform technology. The Company’s product pipeline candidates provide differentiated drug delivery solutions that reduce the complexity and burden of the current standard of care by creating local programmed-release alternatives. Since inception, the Company’s operations have been primarily focused on organizing and staffing the Company, acquiring rights to intellectual property, business planning, raising capital, developing its technology, identifying potential product candidates, undertaking preclinical studies and clinical trials, manufacturing initial quantities of its products and product candidates and building the initial sales and marketing infrastructure for the commercialization of the Company’s approved products and product candidates and launching its initial product.
The Company is subject to risks common to companies in the biotechnology industry including, but not limited to, new technological innovations, protection of proprietary technology, dependence on key personnel, compliance with government regulations, regulatory approval and compliance, reimbursement, uncertainty of market acceptance of products and the need to obtain additional financing. Recently approved products will require significant sales, marketing and distribution support up to and including upon their launch. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization.
As of September 30, 2021, the Company had two FDA-approved products in commercialization in the United States: DEXTENZA ® (dexamethasone insert) 0.4mg, an intracanalicular insert for the treatment of post-surgical ocular inflammation and pain and ReSure ® Sealant, an ophthalmic device designed to prevent wound leaks in corneal incisions following cataract surgery. In October 2021, DEXTENZA received approval for the treatment of ocular itching associated with allergic conjunctivitis. While ReSure Sealant is commercially available in the United States, it does not receive sales support, is not currently being manufactured by the Company, and has not in the past generated, nor is it anticipated to in the future to generate, material revenues. The Company’s most advanced product candidates are in either Phase 1 or Phase 2 of clinical stage development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval and adequate reimbursement or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapidly changing technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The Company may not be able to generate significant revenue from sales of any product for several years, if at all. Accordingly, the Company will need to obtain additional capital to finance its operations.
While net income was recorded for the three-month period ended September 30, 2021, the Company has a history of losses and negative cash flows from operations, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of September 30, 2021, the Company had an accumulated deficit of $ 541,954 . The Company believes that its existing cash and cash equivalents of $ 179,281 , as of September 30, 2021, along with its current operating plan, which includes anticipated revenues from the sale of DEXTENZA, will enable it to fund its planned operating expenses, debt service obligations and capital expenditure requirements through at least the next 12 months. The future viability of the Company beyond that point is dependent on its ability to continue to generate cash flows from the sale of DEXTENZA and raise additional capital to finance its operations. The Company will need to finance its operations through public or private securities offerings, debt financings or other sources, which may include licensing, collaborations or other strategic transactions or arrangements. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and
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development programs for product candidates, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations.
The accompanying financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).
Unaudited Interim Financial Information
The balance sheet at December 31, 2020 was derived from audited financial statements but does not include all disclosures required by GAAP. The accompanying unaudited financial statements as of September 30, 2021 and for the three and nine months ended September 30, 2021 and 2020 have been prepared by the Company, pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2020 included in the Company’s Annual Report on Form 10-K filed with the SEC on March 11, 2021. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2021 and results of operations and cash flows for the three and nine months ended September 30, 2021 and 2020 have been made. The results of operations for the three and nine months ended September 30, 2021 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2021.
Risks and Uncertainties
The Company is monitoring the potential impact of the COVID-19 pandemic, if any, on the carrying value of certain assets. To date, the Company has been impacted by the COVID-19 pandemic but has not experienced material business disruption, nor has it incurred impairment of any assets as a result of the COVID-19 pandemic. The implementation of travel bans and restrictions, quarantines, shelter-in-place/stay-at-home and social distancing orders and shutdowns, for example, affected our business in 2020 and the nine months ending September 30, 2021. The extent to which the COVID-19 pandemic will continue to directly or indirectly impact our business, results of operations and financial condition and those of our customers, vendors, suppliers, and collaboration partners in the remainder of 2021 and beyond will depend on future developments that are highly uncertain and cannot be accurately predicted, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international markets. The duration and intensity of the COVID-19 pandemic and any resulting disruption to the Company’s operations is uncertain, and the Company will continue to assess the impact of the COVID-19 pandemic on its financial position.
2. Summary of Significant Accounting Policies
Use of Estimates
The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these financial statements include, but are not limited to, revenue recognition, clinical trial accruals and the fair value of derivatives. Actual results may differ from these estimates. The full extent to which the COVID-19 pandemic will directly or indirectly impact the Company’s business, results of operations and financial condition, and those of its customers, vendors, suppliers, and collaboration partners, will depend on future developments that are highly uncertain, subject to change and difficult to predict, including new information that may emerge concerning COVID-19, the actions taken to contain it or treat its impact and the economic impact on local, regional, national and international customers and markets.
Concentration of Credit Risk and of Significant Suppliers and Customers
The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development
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programs as well as revenue from future sales of its product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.
For the three and nine months ended September 30, 2021, three specialty distributor customers accounted for 44 %, 28 %, and 16 %, and 44 %, 26 % and 15 % , respectively, of the Company’s total revenue, and no other customer accounted for more than 10% of the Company’s total revenue. At September 30, 2021, three specialty distributor customers accounted for 49 %, 27 % and 16 % of the Company’s total accounts receivable and no other customer accounted for more than 10% of the Company’s total accounts receivable at September 30, 2021.
For the three and nine months ended September 30, 2020, three specialty distributor customers accounted for 39 %, 38 % and 10 % and 40 %, 30 % and 12 % , respectively, of the Company’s total revenue and no other customer accounted for more than 10% of total revenue. At December 31, 2020, three specialty distributor customers accounted for 45 %, 33 % and 15 % of the Company’s total accounts receivable and no other customer accounted for more than 10% of the Company’s total accounts receivable at December 31, 2020.
Recently Issued Accounting Pronouncements
In August 2020, the FASB issued ASU No. 2020-06, Debt – Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) (“ASU 2020-06”). This standard amends the guidance on convertible instruments and the derivatives scope exception for contracts in an entity’s own equity and improves and amends the related earnings per share guidance for both Subtopics. The amendments in the ASU are effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years. The FASB also specified that an entity should adopt the guidance as of the beginning of its fiscal year and is not permitted to adopt the guidance in an interim period. The Company is assessing the potential impact of ASU 2020-06 on its condensed consolidated financial statements.
3. Fair Value of Financial Assets and Liabilities
The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2021 and December 31, 2020 and indicate the level of the fair value hierarchy utilized to determine such fair value:
Fair Value Measurements as of
September 30, 2021 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
175,388
$
—
$
—
$
175,388
Liability:
Derivative liability (Note 7)
$
—
$
—
$
36,064
$
36,064
Fair Value Measurements as of
December 31, 2020 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
213,372
$
—
$
—
$
213,372
Liability:
Derivative liability (Note 7)
$
—
$
—
$
98,313
$
98,313
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4. Restricted Cash
The Company held restricted cash of $ 1,764 at September 30, 2021 and December 31, 2020, on its condensed consolidated balance sheet. The Company held restricted cash as security deposits for the lease of its manufacturing space and corporate headquarters.
The Company’s condensed consolidated statements of cash flows include restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on such statements. A reconciliation of the cash, cash equivalents, and restricted cash reported within the balance sheet that sum to the total of the same amounts shown in the condensed consolidated statement of cash flows is as follows:
September 30,
September 30,
2021
2020
Cash and cash equivalents
$
179,281
$
70,642
Restricted cash
1,764
1,764
Total cash, cash equivalents and restricted cash
$
181,045
$
72,406
5. Inventory
The Company values its inventories at the lower of cost or estimated net realizable value.
Inventory consisted of the following:
September 30,
December 31,
2021
2020
Raw materials
$
370
$
384
Work-in-process
563
232
Finished goods
289
585
$
1,222
$
1,201
6. Accrued Expenses and Other Current Liabilities
Accrued expenses and other current liabilities as of September 30, 2021 and December 31, 2020 consisted of the following:
September 30,
December 31,
2021
2020
Accrued payroll and related expenses
$
6,757
$
5,853
Accrued rebates and programs
3,100
1,438
Accrued professional fees
1,387
868
Accrued research and development expenses
1,180
1,013
Accrued interest payable on 2026 convertible notes
5,900
4,194
Accrued other
1,034
941
$
19,358
$
14,307
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7. Derivative Liability
The unsecured senior subordinated convertible notes (the “2026 Convertible Notes”) (Note 8) contained an embedded conversion option that met the criteria to be bifurcated and accounted for separately (the “Derivative Liability”) from the 2026 Convertible Notes. The Derivative Liability was recorded at fair value upon the issuance of the 2026 Convertible Notes and is subsequently remeasured to fair value at each reporting period. The Derivative Liability was initially valued and remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the embedded conversion option. The difference between the entire instrument with the embedded conversion option compared to the instrument without the embedded conversion option is the fair value of the derivative, recorded as the Derivative Liability in the Company’s condensed consolidated balance sheet.
The estimated fair value of the 2026 Convertible Notes was $ 69,051 at September 30, 2021. The fair value of the 2026 Convertible Notes was estimated utilizing a binomial lattice model which requires the use of Level 3 unobservable inputs. The main inputs when determining the fair value for disclosure purposes are the stock price and bond yield which is updated each period to reflect the yield of a comparable instrument issued as of the valuation date. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value. The main inputs to valuing the 2026 Convertible Notes with the conversion option are as follows:
As of
September 30,
December 31,
2021
2020
Company's stock price
$
10.00
$
20.70
Expected annual volatility
92.6
%
105.5
%
Bond yield
11.7
%
12.0
%
A roll-forward of the derivative liability is as follows:
As of
Balance at December 31, 2020
$
98,313
Change in fair value
( 62,249 )
Balance at September 30, 2021
$
36,064
8. Convertible Notes
On March 1, 2019, the Company issued $ 37,500 of 2026 Convertible Notes. Each 2026 Convertible Note accrues interest at an annual rate of 6 % of its outstanding principal amount, which is payable, along with the principal amount at maturity, on March 1, 2026, unless earlier converted, repurchased or redeemed. The Company presents deferred interest in accrued current liabilities because the 2026 Convertible Notes are currently convertible and the interest is payable in cash. The effective annual interest rate for the 2026 Convertible Notes was 14.8 % through September 30, 2021.
As discussed in Note 7, the Company determined that the embedded conversion option is required to be separated from the 2026 Convertible Notes and accounted for as a freestanding derivative instrument subject to derivative accounting. The allocation of proceeds to the conversion option results in a discount on the 2026 Convertible Notes. The Company is amortizing the discount to interest expense over the term of the 2026 Convertible Notes using the effective interest method.
The terms and conditions of the 2026 Convertible Notes are described in the Company’s periodic reports including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2021 and its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2021.
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A summary of the 2026 Convertible Notes at September 30, 2021 and December 31, 2020 is as follows:
September 30,
December 31,
2021
2020
2026 Convertible Notes
$
37,500
$
37,500
Less: unamortized discount
( 11,614 )
( 13,193 )
Total
$
25,886
$
24,307
Accrued interest related to the 2026 Convertible Notes amounted to $ 5,900 and $ 4,194 at September 30, 2021 and December 31, 2020, respectively.
9. Income Taxes
The Company did not provide for any income taxes in its condensed consolidated statement of operations and comprehensive income (loss) for the three and nine month periods ended September 30, 2021 or 2020. While the Company has net income for the three months ended September 30, 2021, the Company is projecting book and tax losses for the full year ended 2021, for which it is more likely than not that the Company will not realize a benefit for, as the Company has recorded a full valuation allowance against its deferred tax assets, thus the Company has not recorded any income taxes for the three months ended September 30, 2021. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at September 30, 2021 and December 31, 2020, it was more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized.
The Company has not recorded any amounts for unrecognized tax benefits as of September 30, 2021 or December 31, 2020. As of September 30, 2021 and December 31, 2020, the Company had no accrued interest or tax penalties recorded related to income taxes. The Company’s income tax return reporting periods since December 31, 2018 are open to income tax audit examination by the federal and state tax authorities. In addition, because the Company has net operating loss carryforwards, the Internal Revenue Service is permitted to audit earlier years and propose adjustments up to the amount of net operating losses generated in those years.
10. Collaboration Agreements
AffaMed License Agreement
On October 29, 2020, the Company entered into license agreement (“License Agreement”) with AffaMed Therapeutics Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and ocular itching associated with allergic conjunctivitis and for the Company’s OTX-TIC product candidate (collectively with DEXTENZA, the “AffaMed Licensed Products”) regarding open-angle glaucoma and ocular hypertension, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations. The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world.
The terms and conditions of the License Agreement are described in the Company’s periodic reports including its Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 11, 2021 and its Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission on August 9, 2021.
The Company has not recognized any revenue under the License Agreement as of September 30, 2021 as there has not been any delivery of product under the License Agreement. The entire transaction price is recorded as deferred revenue as of September 30, 2021 and December 31, 2020.
Regeneron Collaboration Agreement
In October 2016, the Company entered into a Collaboration, Option and License Agreement (the “Collaboration Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) for the development and potential commercialization of products containing the Company’s extended-delivery hydrogel formulation in combination with Regeneron’s large molecule vascular endothelial growth factor (“VEGF”)-targeting compounds for the treatment of retinal diseases. On
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August 5, 2021, Regeneron notified the Company of its termination of the Collaboration Agreement. The termination became effective immediately.
Under the terms of the Collaboration Agreement, the Company and Regeneron had agreed to conduct a joint research program with the aim of developing an extended-delivery formulation of aflibercept, currently marketed under the tradename EYLEA, that was suitable for advancement into clinical development. The Company had granted Regeneron an option (the “Option”) to enter into an exclusive, worldwide license to develop and commercialize products containing the Company’s hydrogel in combination with Regeneron’s large molecule VEGF-targeting compounds (“Regeneron Licensed Products”). Under the term of the Collaboration Agreement, Regeneron was responsible for funding an initial preclinical tolerability study. In May 2020, the Company and Regeneron entered into an amendment to the Collaboration Agreement, pursuant to which the Company and Regeneron transitioned joint efforts under the Collaboration Agreement to the research and development of an extended-delivery formulation of aflibercept to be delivered to the suprachoroidal space. Regeneron agreed to pay personnel and material costs of the Company for specified preclinical development activities in connection with the revised work plan, as well as certain other costs.
In connection with the termination of the Collaboration Agreement, all licenses, options and other rights granted to either party under the Collaboration Agreement automatically terminated, other than the surviving joint intellectual property rights described below. The Company and Regeneron also became obligated to undertake certain transition activities upon the termination, including the return of specified property of the other party. Each party retains an equal, undivided ownership interest, which may be transferred, licensed and otherwise exploited without a duty to account to the other party, in certain intellectual property rights jointly developed under the collaboration.
As a result of the termination, the Company is no longer eligible to receive (i) reimbursement from Regeneron for ongoing research and development activities, (ii) a fee upon exercise of the Option, (iii) payments upon the achievement of specified development and regulatory milestones of the Regeneron Licensed Products, or (iv) tiered, escalating royalties in a range from a high-single digit to a low-to-mid teen percentage of net sales of Regeneron Licensed Products, in each case pursuant to the Collaboration Agreement. The Company is also no longer obligated to reimburse Regeneron for certain development costs, up to an aggregate amount of $ 30,000 in certain circumstances, were Regeneron to have exercised the Option.
For the three and nine months ended September 30, 2021, the Company has recorded $ 0 and $ 768 , respectively, related to work performed for preclinical development activities in connection with the revised work plan which the Company had recorded as a reduction of research and development expense as this research is not an output of the Company’s ordinary business activities. As of September 30, 2021 and December 31, 2020, the Company has included the $ 0 and $ 1,256 , respectively in prepaid expenses and other current assets.
11. Notes Payable
The Company entered into a credit and security agreement in 2014 (as amended to date, the “Credit Agreement”) establishing the Company’s credit facility (the “Credit Facility”). The Company has a total borrowing capacity of $ 25,000 under the Credit Facility which has been fully drawn down as of September 30, 2021. The carrying value of the Company’s variable interest rate notes payable are recorded at amortized cost, which approximates fair value due to their short-term nature.
In December 2018, the Company amended the terms of the Credit Agreement to increase total indebtedness under the Credit Facility to $ 25,000 , which was used primarily to pay-off outstanding balances as of the closing date. The Company was required to make interest-only payments under the Credit Facility until December 2020. Commencing in January 2021, the Company was required to make 36 equal monthly installments of principal in the amount of $ 694 , plus interest, through December 2023. Amounts borrowed under the Credit Facility were at LIBOR base rate, subject to 2.00 % floor, plus 7.25 %. Prior to the Fourth Amendment (as defined below), the interest rate was 9.25 % . The exit fee equal to 3.5 %, or $ 429 that was previously accrued, has been paid.
In June 2021, the Company entered into a Fourth Amended and Restated Credit and Security Agreement (the “Fourth Amendment”) to amend the terms of its debt with existing lenders for total indebtedness of $ 20,833 and borrowed an incremental $ 4,167 , for a total of $ 25,000 (the “2021 Amended Credit Facility”). The Company is required to make interest-only payments under the 2021 Amended Credit Facility through April 2024. Commencing in May 2024,
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the Company is required to make 19 equal monthly installments of principal in the amount of $ 1,042 , plus interest, then on the maturity date, November 30, 2025 the remaining balance of $ 5,208 plus the exit fee. In the event the Company achieves certain milestones under the 2021 Amended Credit Facility, the Company has the right to extend through April 1, 2026 and make 5 equal monthly installments of principal in the amount of $ 1,042 , plus interest. The Company has not assumed the achievement of these milestones for purposes of disclosures herein.
Amounts borrowed under the 2021 Amended Credit Facility are at LIBOR base rate, subject to 1.00 % floor, plus 6.75 %. The interest rate on the date of the amendment was 8.8 %. In addition, a final payment (exit fee) equal to 3.5 % of amounts drawn under the Amended Credit Facility, or $ 875 based on borrowings of $ 25,000 , is due upon the maturity date of November 30, 2025. The Company is accruing the exit fee through November 30, 2025.
The Company accounted for the Fourth Amendment as a modification in accordance with the guidance in ASC 470-50, Debt. Amounts paid to the lenders were recorded as debt discount and a new effective interest rate was established. The effective annual interest rate of the outstanding debt under the Fourth Amendment is 8.8 % .
There are no financial covenants associated with the Fourth Amendment. However, the Fourth Amendment does contain negative covenants restricting the Company’s activities, including limitations on dispositions, mergers or acquisitions; encumbering its intellectual property; incurring indebtedness or liens; paying dividends; making certain investments; and engaging in certain other business transactions. As of September 30, 2021, the Company was not in violation of any of its covenants under the Fourth Amendment. The obligations under the Fourth Amendment are subject to acceleration upon the occurrence of specified events of default, including a material adverse change in the Company’s business, operations or financial or other condition. The debt is collateralized by substantially all of the Company’s assets, including its intellectual property.
In accordance with the 2021 Amended Credit Facility, among other provisions, a negative covenant restricting the Company from paying the holders of the 2026 Convertible Notes ahead in priority to the existing lenders, for so long as indebtedness remains outstanding under the Credit Facility, and a cross-default provision to establish that an event of default under the purchase agreement for the 2026 Convertible Notes also constitutes an event of default under the Fourth Amendment.
Borrowings outstanding are as follows :
September 30,
December 31,
2021
2020
Borrowings outstanding
$
25,000
$
25,000
Accrued exit fee
54
355
Unamortized discount
( 118 )
( 129 )
24,936
25,226
Less: current portion
—
( 8,290 )
Long-term notes payable
$
24,936
$
16,936
As of September 30, 2021, the annual repayment requirements for the Credit Facility, inclusive of the final payment of $ 875 due at expiration, were as follows:
Year Ending December 31,
Principal
Final Payment
Total
2021 (October 1 through December 31)
—
—
—
2022
—
—
—
2023
—
—
—
2024
8,333
—
8,333
2025
16,667
875
17,542
$
25,000
$
875
$
25,875
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12. Net Income (Loss) Per Share
Basic net loss per share was calculated as follows for the three and nine months ended September 30, 2021 and 2020.
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Numerator:
Net income (loss) attributable to common stockholders
$
2,657
$
( 11,944 )
$
( 2,703 )
$
( 70,024 )
Denominator:
Weighted average common shares outstanding
76,552,060
62,992,558
76,317,563
57,440,885
Net income (loss) per share - basic
$
0.03
$
( 0.19 )
$
( 0.04 )
$
( 1.22 )
For the nine months ended September 30, 2020, there is no dilutive impact. Therefore, diluted net loss per share is the same as basic net loss per share. Diluted net loss per share was calculated as follows for the three months ended September 30, 2021 and 2020 and for the nine months ended September 30, 2021 :
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
Net income (loss) attributable to common stockholders, basic
$
2,657
$
( 11,944 )
$
( 2,703 )
—
Interest expense on 2026 Convertible Notes
1,113
1,069
3,286
Change in fair value of derivative liability
( 23,837 )
( 3,771 )
( 62,249 )
Net loss attributable to common stockholders, diluted
$
( 20,067 )
$
( 14,646 )
$
( 61,666 )
Weighted average common shares outstanding, basic
76,552,060
62,992,558
76,317,563
Dilutive options (treasury stock method)
3,125,594
—
—
Shares issuable upon conversion of 2026 Convertible Notes, as if converted
5,769,232
5,769,232
5,769,232
Weighted average common shares outstanding, diluted
85,446,886
68,761,790
82,086,795
Net loss per share attributable to common stockholders, diluted
$
( 0.23 )
( 0.21 )
$
( 0.75 )
The Company excluded the following common stock equivalents, outstanding as of September 30, 2021 and 2020, from the computation of diluted net loss per share for the three and nine months ended September 30, 2021 and 2020 because they had an anti-dilutive impact.
Three Months Ended September 30,
Nine Months Ended September 30,
2021
2020
2021
2020
Options to purchase common stock
3,226,777
8,970,789
10,948,312
8,970,789
Warrants for the purchase of common stock
—
18,939
—
18,939
3,226,777
8,989,728
10,948,312
8,989,728
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The Company also excluded the shares issuable upon conversion of the 2026 Convertible notes from the computation of diluted net loss per share for the nine months ended September 30, 2020 because they had an anti-dilutive impact.
13. Stock-Based Awards
2014 Stock Incentive Plan
The 2014 Stock Incentive Plan (the “2014 Plan”) provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards. The number of shares of common stock that may be issued under the 2014 Plan is subject to increase on the first day of each fiscal year, beginning on January 1, 2015 and ending on December 31, 2024 in an amount equal to the lesser of a pre-determined formula or an amount determined by the Company’s board of directors. On January 1, 2021, the number of shares available for issuance under the 2014 Plan was increased by 1,659,218 . During the three months ended September 30, 2021, the Company did no t grant options under the 2014 Plan. During the nine months ended September 30, 2021, the Company granted options under the 2014 Plan to purchase 2,709,019 shares of common stock, at a weighted exercise price of $ 18.19 per share.
On June 18, 2021, the Company’s stockholders approved the adoption of the 2021 Stock Incentive Plan (the “2021 Plan”) previously approved by the board of directors. Effective as of the adoption of the 2021 Plan by the Company’s stockholders, no new awards will be granted under the 2014 Plan. However, as of September 30, 2021, all then-outstanding awards under the 2014 Plan remained in effect and continued to be governed by the terms of the 2014 Plan.
2021 Stock Incentive Plan
The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards. The number of shares of common stock that may be issued under the 2021 Plan is 6,000,000 shares of common stock; plus 456,334 shares remaining available for grant under the 2014 Plan as of immediately prior to the effective date of the 2021 Plan and 9,766,336 shares subject to awards granted under the 2014 Plan or the Company’s 2006 Stock Incentive Plan, which awards expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right (subject to certain limitations). During the three and nine months ended September 30, 2021, the Company granted options to purchase 214,555 and 322,555 shares of common stock, at a weighted exercise price of $ 11.48 and $ 12.16 per share, respectively.
2014 Employee Stock Purchase Plan
The Company has a 2014 Employee Stock Purchase Plan (the “ESPP”). The number of shares of common stock that may be issued under the ESPP will automatically increase on the first day of each fiscal year, commencing on January 1, 2015 and ending on December 31, 2024 in an amount equal to the lesser of a pre-determined formula or as determined by the Company’s board of directors. On January 1, 2021, the number of shares available for issuance under the 2014 Plan was increased by 207,402 . During the three and nine months ended September 30, 2021, 0 and 40,631 shares of common stock were issued under the ESPP. As of September 30, 2021, 690,965 shares remained available for issuance under the ESPP.
Inducement Stock Option Awards
On October 29, 2019, the 2019 Inducement Stock Incentive Plan (the “Inducement Plan”) was approved by the Board of Directors of the Company. Initially, the maximum number of shares of common stock issuable under the Inducement Plan was 500,000 . On December 10, 2020, the Board of Directors of the Company amended the 2019 Inducement Plan to increase the aggregate number of shares issuable from 500,000 to 1,054,000 shares of common stock. As of September 30, 2021, 507,376 shares of common stock remained available for issuance under the Inducement Plan.
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Stock-based Compensation
The Company recorded stock-based compensation expense related to stock options in the following expense categories of its condensed consolidated statements of operations:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2021
2020
2021
2020
Research and development
$
871
$
383
$
2,754
$
1,120
Selling and marketing
1,064
441
2,947
1,245
General and administrative
1,823
1,112
5,435
3,062
$
3,758
$
1,936
$
11,136
$
5,427
As of September 30, 2021, the Company had an aggregate of $ 23,248 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 3.0 years.
14. Related Party Transactions
Since October 2017, the Company has engaged McCarter English LLP (“McCarter”) to provide legal services to the Company, including with respect to intellectual property matters. Jonathan M. Sparks, Ph.D., a partner at McCarter & English, also served as the Company’s in-house counsel from October 2017 through August 31, 2020. The Company incurred fees for legal services rendered by McCarter of $ 221 and $ 512 for the three and nine months ended September 30, 2020, respectively. As of December 31, 2020, there was $ 47 recorded in accounts payable and $ 0 recorded in accrued expenses for McCarter.
In November 2020, the Company engaged Specialty Pharma Consulting, LLC (“Specialty Pharma”), an entity affiliated with Kevin Coughenour, to provide services for quality engineering and validation activities in the ordinary course of business. Mr. Coughenour is married to the Company’s former Chief Operating Officer Patricia Kitchen. The Company incurred fees for quality engineering and validation activities rendered by Specialty Pharma of $ 0 and $ 155 , for the three and nine months ended September 30, 2021, respectively. As of December 31, 2020, there was $ 47 recorded in accounts payable and $ 0 recorded in accrued expenses for Specialty Pharma. On April 26, 2021, the Company and Specialty Pharma terminated their relationship.
15. Warrants
On January 29, 2021, holders of warrants to purchase 18,939 shares of common stock at an exercise price of $ 7.92 exercised their right to purchase their warrants. The exercise price of the warrants was paid through a net share settlement mechanism and as a result the Company issued 11,737 shares of common stock to satisfy the exercise of all the warrants. There are no warrants outstanding as of September 30, 2021.
16. Common Stock
In June 2021, the Company adopted an amended and restated certificate of incorporation increasing the number of its authorized shares of its common stock to 200,000,000 shares.
On April 5, 2019, the Company entered into an Open Market Sale Agreement, (the “2019 Sales Agreement”), with Jefferies LLC (“Jefferies”) under which the Company could offer and sell shares of its common stock having an aggregate offering price of up to $ 50,000 from time to time through Jefferies, acting as agent. Under the 2019 Sales Agreement, the Company sold an aggregate of 10,321,840 shares of common stock, resulting in net proceeds of approximately $ 46,985 after commissions and expenses.
On August 9, 2021, the Company and Jefferies mutually terminated the 2019 Sales Agreement and entered into another Open Market Sale Agreement (the “2021 Sales Agreement”) under which the Company may offer and sell shares of common stock of the Company having an aggregate offering price of up to $ 100,000 from time to time through Jefferies, acting as agent. As of November 7, 2021, the Company has no t sold any shares of common stock under the 2021 Sales Agreement.
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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.