Item 9A. Controls and Procedures
Item 9A.
Controls and Procedures
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2023. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended, or the Exchange Act, means controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported, within the time periods specified in the SEC’s rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated to the company’s management, including its principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Management, including our Chief Executive Officer and Chief Financial Officer recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives and management necessarily applies its judgment in evaluating the cost-benefit relationship of possible controls and procedures. Based on the evaluation of our disclosure controls and procedures as of December 31, 2023, our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective at the reasonable assurance level.
Management’s Annual Report on Internal Control Over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting for Ocular Therapeutix, Inc. Internal control over financial reporting is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act as a process designed by, or under the supervision of, the company’s principal executive and principal financial officers and effected by the company’s board of directors, management and other personnel, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles and includes those policies and procedures that:
● Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the company;
● Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of
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the company are being made only in accordance with authorizations of management and directors of the company; and
● Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the company’s assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with the policies or procedures may deteriorate.
Our management, including our President and Chief Executive Officer and Chief Financial Officer, assessed the effectiveness of our internal control over financial reporting as of December 31, 2023. In making this assessment, management used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission (COSO) in Internal Control—Integrated Framework (2013) . Based on that assessment, our management concluded that, as of December 31, 2023, our internal control over financial reporting was effective.
Changes in Internal Control Over Financial Reporting
No change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) occurred during the three months ended December 31, 2023 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
Item 9B.
Other Information
N o n e .
Item 9C.
Disclosure Regarding Foreign Jurisdictions That Prevent Inspections
Not Applicable.
125
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PART III
Item 10.
Directors, Executive Officers and Corporate Governance
Directors and Executive Officers
The information required by this item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.
Delinquent Section 16(a) Reports
The information required by this item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders, if applicable, and is incorporated in this Annual Report on Form 10-K by reference.
Code of Ethics
We have adopted a code of business conduct and ethics that applies to our directors and officers (including our principal executive officer, principal financial officer, principal accounting officer or controller, or persons performing similar functions) as well as our other employees. A copy of our code of business conduct and ethics is available on our website. We intend to post on our website all disclosures that are required by applicable law, the rules of the Securities and Exchange Commission or the Nasdaq Global Market concerning any amendment to, or waiver of, our code of business conduct and ethics.
Director Nominees
The information required by this item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.
Audit Committee
We have separately designated a standing Audit Committee established in accordance with Section 3(a)(58)(A) of the Securities Exchange Act of 1934, as amended, or the Exchange Act. Additional information regarding the Audit Committee that is required by this item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.
Audit Committee Financial Expert
Our board of directors has determined that Merilee Raines qualifies as an “audit committee financial expert” as defined by Item 407(d)(5) of Regulation S-K of the Exchange Act and is “independent” under the rules of the Nasdaq Global Market.
Item 11.
Executive Compensation
The information required by this item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.
Item 12.
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
The information required by this item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.
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Item 13.
Certain Relationships and Related Transactions, and Director Independence
The information required by this item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.
Item 14.
Principal Accounting Fees and Services
The information required by this item will be set forth in our Proxy Statement for the 2024 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.
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PART IV
Item 15.
Exhibits, Financial Statement Schedules
The following financial statements are filed as part of this Annual Report on Form 10-K:
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 238 )
F-2
Consolidated Balance Sheets
F-4
Consolidated Statements of Operations and Comprehensive Loss
F-5
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
F-6
Consolidated Statements of Cash Flows
F-7
Notes to Consolidated Financial Statements
F-8
No financial statement schedules have been filed as part of this Annual Report on Form 10-K because they are not applicable, not required or because the information is otherwise included in our consolidated financial statements or notes thereto.
The exhibits filed as part of this Annual Report on Form 10-K are set forth on the Exhibit Index immediately following Item 16. The Exhibit Index is incorporated herein by reference.
Item 16.
Form 10-K Summary
None.
128
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EXHIBIT INDEX
Incorporated by Reference
Exhibit
Number
Description of Exhibit
Form
File Number
Date of
Filing
Exhibit
Number
Filed
Herewith
3.1
Restated Certificate of Incorporation of the Registrant, as amended
10-Q
001-36554
8/9/2021
3.1
3.2
Amended and Restated By-laws of the Registrant
8-K
001-36554
7/30/2014
3.2
4.1
Specimen Stock Certificate evidencing the shares of common stock
S-1/A
333-196932
7/11/2014
4.1
4.2
Registration Rights Agreement, dated as of March 1, 2019, by and among the Registrant and the Purchasers identified therein
10-K
001-36554
3/7/2019
4.2
4.3
Registration Rights Agreement, dated as of February 21, 2024, by and among the Registrant and the other parties thereto
8-K
001-36554
2/22/2024
10.2
4.4
Form of Pre-Funded Warrant
8-K
001-36554
2/22/2024
4.1
4.5
Description of Securities Registered under Section 12 of the Exchange Act
10-K
001-36554
2/28/2022
4.3
10.1+
2006 Stock Incentive Plan, as amended
S-1
333-196932
6/20/2014
10.1
10.2+
Form of Stock Option Agreement under 2006 Stock Incentive Plan
S-1
333-196932
6/20/2014
10.2
10.3+
Form of Restricted Stock Agreement under 2006 Stock Incentive Plan
S-1
333-196932
6/20/2014
10.3
10.4+
2014 Stock Incentive Plan
S-1/A
333-196932
7/11/2014
10.4
10.5+
Form of Incentive Stock Option Agreement under 2014 Stock Incentive Plan
S-1/A
333-196932
7/11/2014
10.5
10.6+
Form of Non-statutory Stock Option Agreement under 2014 Stock Incentive Plan
S-1/A
333-196932
7/11/2014
10.6
10.7+
Form of Restricted Stock Agreement under 2014 Stock Incentive Plan
S-1/A
333-196932
7/11/2014
10.7
10.8+
2019 Inducement Stock Incentive Plan
10-Q
001-36554
11/12/2019
10.1
129
Table of Contents
Incorporated by Reference
Exhibit
Number
Description of Exhibit
Form
File Number
Date of
Filing
Exhibit
Number
Filed
Herewith
10.9+
Amendment to 2019 Inducement Stock Incentive Plan
10-K
001-36554
3/11/2021
10.9
10.10+
Amendment No. 2 to 2019 Inducement Stock Incentive Plan
8-K
001-36554
2/22/2024
10.5
10.11+
Form of Non-statutory Stock Option Agreement under 2019 Inducement Stock Incentive Plan
10-Q
001-36554
11/12/2019
10.2
10.12+
Form of Restricted Stock Unit Agreement under 2019 Inducement Stock Incentive Plan
X
10.13†
Amended and Restated License Agreement, dated January 27, 2012, between the Registrant and Incept LLC
S-1
333-196932
6/20/2014
10.8
10.14
Lease Agreement dated September 2, 2009, by and between the Registrant and RAR2-Crosby Corporate Center QRS, Inc., as amended.
S-1
333-196932
6/20/2014
10.9
10.15+
2014 Employee Stock Purchase Plan
S-1/A
333-196932
7/11/2014
10.10
10.16+
Amendment No. 1 to Employee Stock Purchase Plan, effective October 4, 2023
10-Q
001-36554
11/7/2023
10.3
10.17
Form of Indemnification Agreement by and between the Registrant and each of its directors and executive officers
S-1
333-196932
6/20/2014
10.12
10.18
Lease Agreement dated June 17, 2016 between the WS NF 15 Crosby Drive, LLC and the Registrant
10-Q
001-36554
8/9/2016
10.1
10.19
Open Market Sale Agreement, dated as of August 9, 2021, by and between the Registrant and Jefferies LLC
8-K
001-36554
8/9/2021
1.1
10.20+
Employment Agreement, by and between the Registrant and Philip Strassburger, dated August 28, 2020
10-K
001-36554
3/11/2021
10.19
130
Table of Contents
Incorporated by Reference
Exhibit
Number
Description of Exhibit
Form
File Number
Date of
Filing
Exhibit
Number
Filed
Herewith
10.21+
Employment Agreement, by and between the Registrant and Antony C. Mattessich, dated as of June 20, 2017
8-K
001-36554
6/22/2017
10.2
10.22+
Amendment to Employment Agreement by and between the Registrant and Antony C. Mattessich, dated as of February 21, 2024
8-K
001-36554
2/22/2024
10.4
10.23+
Non-Statutory Stock Option Agreement, by and between the Registrant and Antony C. Mattessich dated as of June 20, 2017
8-K
001-36554
6/22/2017
10.3
10.24+
Employment Agreement, by and between the Registrant and Donald Notman, dated as of September 25, 2017
8-K
001-36554
9/25/2017
10.1
10.25
Second Amendment to Lease, by and between the Registrant and CCC Investors LLC, dated October 10, 2017
8-K
001-36554
10/16/2017
10.1
10.26
Third Amendment to Lease, by and between the Registrant and Cobalt PropCo 2020 LLC, dated June 30, 2023
8-K
001-36554
7/7/2023
10.1
10.27†
Second Amended and Restated License Agreement, dated September 13, 2018, by and between the Registrant and Incept LLC
8-K
001-36554
9/19/2018
10.1
10.28
Note Purchase Agreement (including Form of Senior Subordinated Convertible Notes), dated as of February 21, 2019, by and among the Registrant and the Purchasers listed therein
8-K
001-36554
2/22/2019
10.1
10.29
Amendment No. 1 to Senior Subordinated Convertible Note, dated as of August 2, 2023, between the Registrant and the holders thereof
10-Q
001-36554
11/7/2023
10.2
10.30
Securities Purchase Agreement, dated February 21, 2024, by and among the Registrant and the other parties thereto
8-K
001-36554
2/22/2024
10.1
131
Table of Contents
Incorporated by Reference
Exhibit
Number
Description of Exhibit
Form
File Number
Date of
Filing
Exhibit
Number
Filed
Herewith
10.31
Sublease, dated as of April 4, 2019, by and among Ocular Therapeutix, Inc. and Holcim (US) Inc.
10-Q
001-36554
5/10/2019
10.4
10.32*
License Agreement, by and between the Registrant and AffaMed Therapeutics Limited, dated as of October 29, 2020
10-Q
001-36554
11/5/2020
10.1
10.33*
Supplement to License Agreement, by and between the Registrant and AffaMed Therapeutics Limited, dated as of January 18, 2021
10-K
001-36554
3/11/2021
10.36
10.34
Credit and Security Agreement, dated August 2, 2023, by and among Barings Finance LLC, as administrative agent, the Registrant, and the Lenders listed therein
10-Q
001-36554
11/7/2023
10.1
10.35+
2021 Stock Incentive Plan, as amended
10-Q
001-36554
8/7/2023
10.2
10.36+
Form of Option Grant Agreement under 2021 Stock Incentive Plan
10-K
001-36554
2/28/2022
10.39
10.37+
Form of Restricted Stock Unit Agreement under 2021 Stock Incentive Plan
X
10.38
Amendment No. 1 to License Agreement, by and between the Registrant and AffaMed Therapeutics (HK) Limited, dated as of October 28, 2021
10-K
001-36554
2/28/2022
10.41
10.39+
Employment Agreement, by and between the Registrant and Rabia Ozden-Gurses, dated as of September 28, 2022
10-K
001-36554
3/6/2023
10.44
10.40+
Employment Agreement, by and between the Registrant and Christopher White, dated as of October 13, 2022
10-K
001-36554
3/6/2023
10.45
10.41+
Employment Agreement, by and between the Registrant and Dr. Pravin U. Dugel, dated as of February 21, 2024
8-K
001-36554
2/22/2024
10.3
132
Table of Contents
Incorporated by Reference
Exhibit
Number
Description of Exhibit
Form
File Number
Date of
Filing
Exhibit
Number
Filed
Herewith
10.42+
Employment Agreement, by and between the Registrant and Dr. Sanjay Nayak, dated as of February 21, 2024
X
21.1
Subsidiaries of the Registrant
X
23.1
Consent of PricewaterhouseCoopers LLP
X
31.1
Certification of principal executive officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended
X
31.2
Certification of principal financial officer pursuant to Rule 13a-14(a)/15d-14(a) of the Securities Exchange Act of 1934, as amended
X
32.1
Certification of principal executive officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
32.2
Certification of principal financial officer pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
X
97.1
Ocular Therapeutix, Inc. Compensation Recovery Policy
X
101.INS
Inline XBRL Instance Document (the instance document does not appear in the Interactive Data File because XBRL tags are embedded within the Inline XBRL document)
X
101.SCH
Inline XBRL Taxonomy Extension Schema Document
X
101.CAL
Inline XBRL Taxonomy Extension Calculation Linkbase Document
X
101.LAB
Inline XBRL Taxonomy Extension Label Linkbase Database
X
101.PRE
Inline XBRL Taxonomy Extension Presentation Linkbase Document
X
101.DEF
Inline XBRL Taxonomy Extension Definition Linkbase Document
X
104
The cover page from this Annual Report on Form 10-K, formatted in Inline XBRL and contained in Exhibit 101
X
†
Confidential treatment has been granted as to certain portions, which portions have been omitted and separately filed with the Securities and Exchange Commission.
+
Management contract or compensatory plan or arrangement filed in response to Item 15(a)(3) of the Instructions to the Annual Report on Form 10-K.
*
Certain portions of this exhibit have been omitted pursuant to Item 601(b)(10)(iv) of Regulation S-K.
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SIGNATURES
Pursuant to the requirements of Section 13 or 15(d) of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.
Date: March 11, 2024
OCULAR THERAPEUTIX, INC.
By:
/s/ Donald Notman
Donald Notman
Chief Financial Officer
(Principal Financial and Accounting Officer)
Pursuant to the requirements of the Securities Exchange Act of 1934, this report has been signed by the following persons on behalf of the registrant in the capacities and on the dates indicated.
Signature
Title
Date
/s/ Antony Mattessich
President, Chief Executive Officer and Director
Antony Mattessich
(Principal Executive Officer)
March 11, 2024
/s/ Donald Notman
Chief Financial Officer
March 11, 2024
Donald Notman
(Principal Financial and Accounting Officer)
/s/ Pravin Dugel, M.D.
Executive Chairman of the Board of Directors
March 11, 2024
Pravin Dugel, M.D.
/s/ Adrienne Graves, Ph.D.
Director
March 11, 2024
Adrienne Graves, Ph.D.
/s/ Seung Suh Hong, Ph.D.
Director
March 11, 2024
Seung Suh Hong, Ph.D.
/s/ Richard L. Lindstrom, M.D.
Director
March 11, 2024
Richard L. Lindstrom, M.D.
/s/ Merilee Raines
Director
March 11, 2024
Merilee Raines
/s/ Charles Warden
Director
March 11, 2024
Charles Warden
/s/ Leslie Williams
Director
March 11, 2024
Leslie Williams
Table of Contents
OCULAR THERAPEUTIX, INC.
Index to CONSOLIDATED FINANCIAL STATEMENTS
Page
Report of Independent Registered Public Accounting Firm (PCAOB ID 238)
F-2
Consolidated Balance Sheets
F-4
Consolidated Statements of Operations and Comprehensive Loss
F-5
Consolidated Statements of Changes in Stockholders’ Equity (Deficit)
F-6
Consolidated Statements of Cash Flows
F-7
Notes to Consolidated Financial Statements
F-8
F-1
Table of Contents
Report of Independent Registered Public Accounting Firm
To the Board of Directors and Stockholders of Ocular Therapeutix, Inc.
Opinion on the Financial Statements
We have audited the accompanying consolidated balance sheets of Ocular Therapeutix, Inc. and its subsidiaries (the “Company”) as of December 31, 2023 and 2022, and the related consolidated statements of operations and comprehensive loss, of changes in stockholders’ equity (deficit) and of cash flows for each of the three years in the period ended December 31, 2023, including the related notes (collectively referred to as the “consolidated financial statements”). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 2023 and 2022, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2023 in conformity with accounting principles generally accepted in the United States of America.
Basis for Opinion
These consolidated financial statements are the responsibility of the Company’s management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.
We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audits to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company's internal control over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matter communicated below is a matter arising from the current period audit of the consolidated financial statements that was communicated or required to be communicated to the audit committee and that (i) relates to accounts or disclosures that are material to the consolidated financial statements and (ii) involved our especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matter below, providing a separate opinion on the critical audit matter or on the accounts or disclosures to which it relates.
Valuation of the Convertible Notes Derivative Liability
As described in Notes 2, 10, and 11 to the consolidated financial statements, the Company’s Convertible Notes Derivative Liability balance was $17.6 million as of December 31, 2023 and the change in fair value recorded in other income (expense), net was $(4.5) million for the year ended December 31, 2023. The Conversion Option Derivative Liability was recorded at fair value upon the issuance of the Convertible Notes and is subsequently remeasured to fair value at each reporting period. The Conversion Option 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
F-2
Table of Contents
conversion option compared to the instrument without the embedded conversion option is the fair value of the derivative, recorded as the Conversion Option Derivative Liability. The fair value of the Convertible Notes with and without the conversion option is estimated using a binomial lattice approach. The main inputs to valuing the Convertible Notes with the conversion option as of December 31, 2023 include the Company’s stock price on the valuation date, the expected annual volatility of the Company’s stock and the bond yield. The significant assumption used in determining the bond yield is the market yield movements of a comparable instrument issued as of the valuation date, which is assessed and updated each period.
The principal considerations for our determination that performing procedures relating to the valuation of the derivative liability is a critical audit matter are the significant judgment by management to determine the fair value of the derivative liability using a binomial lattice approach; this in turn led to a high degree of auditor judgment, subjectivity, and effort in performing procedures and in evaluating the audit evidence obtained related to the valuation of the derivative liability and management’s significant assumption related to market yield movements used in determining the bond yield input. In addition, the audit effort involved the use of professionals with specialized skill and knowledge.
Addressing the matter involved performing procedures and evaluating audit evidence in connection with forming our overall opinion on the consolidated financial statements. These procedures included, among others (i) the involvement of professionals with specialized skill and knowledge to assist in developing an independent range of fair values for the derivative liability and (ii) comparing the independent estimate to management’s fair value estimate to evaluate the reasonableness of management’s estimate. Developing the independent estimate involved testing the completeness and accuracy of the inputs provided by management and evaluating the reasonableness of management’s significant assumption related to market yield movements used in determining the bond yield by considering observable data.
/s/ PricewaterhouseCoopers LLP
Boston, Massachusetts
March 11, 2024
We have served as the Company’s auditor since 2008.
F-3
Table of Contents
OCULAR THERAPEUTIX, INC.
CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
December 31,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
195,807
$
102,300
Accounts receivable, net
26,179
21,325
Inventory
2,305
1,974
Restricted cash
150
—
Prepaid expenses and other current assets
7,794
4,028
Total current assets
232,235
129,627
Property and equipment, net
11,739
9,856
Restricted cash
1,614
1,764
Operating lease assets
6,472
8,042
Total assets
$
252,060
$
149,289
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable
$
4,389
$
5,123
Accrued expenses and other current liabilities
28,666
24,097
Deferred revenue
255
576
Operating lease liabilities
1,586
1,599
Total current liabilities
34,896
31,395
Other liabilities:
Operating lease liabilities, net of current portion
6,878
8,678
Derivative liabilities
29,987
6,351
Deferred revenue, net of current portion
14,135
13,387
Notes payable, net
65,787
25,257
Other non-current liabilities
108
93
Convertible Notes, net
9,138
28,749
Total liabilities
160,929
113,910
Commitments and contingencies (Note 17)
Stockholders’ equity:
Preferred stock, $ 0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at December 31, 2023 and December 31, 2022, respectively
—
—
Common stock, $ 0.0001 par value; 200,000,000 shares authorized and 114,963,193 and 77,201,819 shares issued and outstanding at December 31, 2023 and December 31, 2022, respectively
12
8
Additional paid-in capital
788,697
652,213
Accumulated deficit
( 697,578 )
( 616,842 )
Total stockholders’ equity
91,131
35,379
Total liabilities and stockholders’ equity
$
252,060
$
149,289
The accompanying notes are an integral part of these consolidated financial statements.
F-4
Table of Contents
OCULAR THERAPEUTIX, INC.
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
Year Ended December 31,
2023
2022
2021
Revenue:
Product revenue, net
$
57,870
$
50,457
$
43,522
Collaboration revenue
573
1,037
—
Total revenue, net
58,443
51,494
43,522
Costs and operating expenses:
Cost of product revenue
5,281
4,540
4,406
Research and development
61,055
53,462
50,083
Selling and marketing
40,549
39,922
35,190
General and administrative
33,940
32,224
31,880
Total costs and operating expenses
140,825
130,148
121,559
Loss from operations
( 82,382 )
( 78,654 )
( 78,037 )
Other income (expense):
Interest income
3,983
798
33
Interest expense
( 11,338 )
( 7,022 )
( 6,671 )
Change in fair value of derivative liabilities
( 5,188 )
13,841
78,121
Gains and losses on extinguishment of debt, net
14,190
—
—
Other income (expense), net
( 1 )
( 1 )
1
Total other income, net
1,646
7,616
71,484
Net loss
$
( 80,736 )
$
( 71,038 )
$
( 6,553 )
Net loss per share, basic
$
( 1.01 )
$
( 0.92 )
$
( 0.09 )
Weighted average common shares outstanding, basic
79,827,362
76,875,035
76,392,870
Net loss per share, diluted
$
( 1.02 )
$
( 0.97 )
$
( 0.98 )
Weighted average common shares outstanding, diluted
85,596,594
82,644,267
82,162,102
The accompanying notes are an integral part of these consolidated financial statements.
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OCULAR THERAPEUTIX, INC.
CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY (DEFICIT)
(In thousands, except share data)
Total
Additional
Stockholders’
Common Stock
Paid-in
Accumulated
Equity
Shares
Par Value
Capital
Deficit
(Deficit)
Balances at December 31, 2020
75,996,732
8
615,338
( 539,251 )
76,095
Issuance of common stock upon exercise of stock options
598,923
—
2,586
—
2,586
Issuance of common stock in connection with employee stock purchase plan
124,548
—
985
—
985
Issuance of common stock upon cashless exercise of warrant
11,737
—
—
—
—
Common stock issuance costs
—
—
( 91 )
—
( 91 )
Stock-based compensation expense
—
—
14,977
—
14,977
Net loss
—
—
—
( 6,553 )
( 6,553 )
Balances at December 31, 2021
76,731,940
8
633,795
( 545,804 )
87,999
Issuance of common stock upon exercise of stock options
137,502
—
514
—
514
Issuance of common stock in connection with employee stock purchase plan
332,377
—
940
—
940
Stock-based compensation expense
—
—
16,964
—
16,964
Net loss
—
—
—
( 71,038 )
( 71,038 )
Balances at December 31, 2022
77,201,819
8
652,213
( 616,842 )
35,379
Issuance of common stock upon exercise of stock options
141,952
—
551
—
551
Issuance of common stock in connection with employee stock purchase plan
290,691
—
851
—
851
Issuance of common stock upon public offering, net of issuance costs
36,934,926
4
117,257
—
117,261
Issuance of common stock upon vesting of restricted stock units
393,805
—
—
—
—
Stock-based compensation expense
—
—
17,825
—
17,825
Net Loss
—
—
—
( 80,736 )
( 80,736 )
Balances at December 31, 2023
114,963,193
$
12
$
788,697
$
( 697,578 )
$
91,131
The accompanying notes are an integral part of these consolidated financial statements.
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OCULAR THERAPEUTIX, INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
Year Ended December 31,
2023
2022
2021
Cash flows from operating activities:
Net loss
$
( 80,736 )
$
( 71,038 )
$
( 6,553 )
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation expense
17,825
16,964
14,977
Non-cash interest expense
6,106
4,853
4,628
Change in fair value of derivative liabilities
5,188
( 13,841 )
( 78,121 )
Depreciation and amortization expense
2,983
2,109
2,421
Gains and losses on extinguishment of debt, net
( 14,190 )
—
—
Gain (loss) on disposal of property and equipment
1
1
( 1 )
Changes in operating assets and liabilities:
Accounts receivable
( 4,854 )
( 190 )
( 8,883 )
Prepaid expenses and other current assets
( 3,766 )
723
( 101 )
Inventory
( 331 )
( 724 )
( 49 )
Accounts payable
583
( 621 )
1,796
Operating lease assets
1,570
( 3,175 )
977
Accrued expenses
773
1,644
3,717
Deferred revenue
427
963
1,000
Operating lease liabilities
( 1,813 )
2,729
( 1,358 )
Net cash used in operating activities
( 70,234 )
( 59,603 )
( 65,550 )
Cash flows from investing activities:
Purchases of property and equipment
( 6,087 )
( 3,715 )
( 1,194 )
Net cash used in investing activities
( 6,087 )
( 3,715 )
( 1,194 )
Cash flows from financing activities:
Proceeds from issuance of short-term bridge loan
2,000
—
—
Proceeds from issuance of Barings notes payable
82,474
—
—
Proceeds from issuance of notes payable, net
—
—
3,722
Proceeds from exercise of stock options
551
514
2,586
Proceeds from issuance of common stock pursuant to employee stock purchase plan
851
940
985
Payments of debt financing costs
( 5,184 )
—
—
Proceeds from issuance of common stock upon public offering, net of issuance costs
117,261
—
—
Issuance costs from the issuance of common stock upon public offering in prior period
—
—
( 275 )
Repayment of MidCap notes payable
( 26,125 )
—
—
Repayment of notes payable
—
—
( 4,167 )
Repayment of short-term bridge loan
( 2,000 )
—
—
Net cash provided by financing activities
169,828
1,454
2,851
Net increase (decrease) in cash, cash equivalents and restricted cash
93,507
( 61,864 )
( 63,893 )
Cash, cash equivalents and restricted cash at beginning of period
104,064
165,928
229,821
Cash, cash equivalents and restricted cash at end of period
$
197,571
$
104,064
$
165,928
Supplemental disclosure of cash flow information:
Cash paid for interest
$
5,464
$
2,147
$
1,932
Supplemental disclosure of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable and accrued expenses
$
16
$
1,384
$
181
The accompanying notes are an integral part of these consolidated financial statements.
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OCULAR THERAPEUTIX, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
(Amounts in thousands, except share and per share data)
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 committed to enhancing people’s vision and quality of life through the development and commercialization of innovative therapies for diseases and conditions of the eye, with a specific focus on retinal disease. The Company’s program for retinal disease is led by AXPAXLI (axitinib intravitreal implant, also known as OTX-TKI), which is based on its ELUTYX proprietary bioresorbable hydrogel-based formulation technology.
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.
The Company is currently commercializing DEXTENZA (dexamethasone insert) 0.4mg, an intracanalicular insert for the treatment of post-surgical ocular inflammation and pain and for the treatment of ocular itching associated with allergic conjunctivitis, in the United States. The Company’s most advanced product candidate, AXPAXLI, formerly referred to as OTX-TKI, is in Phase 3 clinical development; the Company’s other advanced product candidates are in either Phase 1 or Phase 2 clinical 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.
The Company has incurred losses and negative cash flows from operations since its inception, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of December 31, 2023, the Company had an accumulated deficit of $ 697,578 . Based on its current operating plan which includes estimates of anticipated cash inflows from product sales and cash outflows from operating expenses and capital expenditures, the Company believes that its existing cash and cash equivalents of $ 195,807 as of December 31, 2023, plus the cash received from a private placement of the Company’s common stock in February 2024 of $ 325,000 before deducting placement agent fees and other offering expenses, will enable it to fund its planned operating expenses, debt service obligations and capital expenditures at least through the next 12 months from the issuance date of these consolidated financial statements while the Company observes a minimum liquidity covenant of $ 20,000 in its credit facility (Note 9). The future viability of the Company beyond that point is dependent on the Company’s ability 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, collaborations, strategic alliances, licensing agreements, royalty agreements, or marketing and distribution agreements. 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 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.
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2. Summary of Significant Accounting Policies
Basis of Presentation and Principles of Consolidation
The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The accompanying consolidated financial statements reflect the operations of the Company and its wholly-owned subsidiaries. All intercompany accounts and transactions have been eliminated.
Use of Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these consolidated financial statements include, but are not limited to, the measurement and recognition of reserves for variable consideration related to product sales, revenue recognition related to a collaboration agreement that contains multiple promises, the fair value of derivatives, stock-based compensation, and realizability of net deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.
Cash Equivalents
The Company considers all short-term, highly liquid investments with original maturities of ninety days or less at date of purchase to be cash equivalents. Cash equivalents, which primarily consist of investments in money market funds, are stated at fair value.
Revenue Recognition
The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”) Topic 606 – Revenue from Contracts with Customers (“ASC 606”). Under ASC 606, an entity recognizes revenue when a customer obtains control of promised goods or services, in an amount that reflects the consideration which the entity expects to be entitled to in exchange for those goods or services.
To determine revenue recognition for arrangements that an entity determines are within the scope of ASC 606, the entity performs the following five steps: (i) identify the contract(s) with a customer, (ii) identify the performance obligations in the contract, (iii) determine the transaction price, (iv) allocate the transaction price to the performance obligations in the contract, and (v) recognize revenue when (or as) the entity satisfies a performance obligation. At contract inception, the Company assesses the goods or services promised within each contract, determines those that are performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
Product Revenue
The Company sells DEXTENZA in the United States primarily to a limited number of specialty distributors (“SDs”) under individually negotiated distribution agreements. These customers then subsequently resell DEXTENZA to physicians, clinics and certain medical centers or hospitals. The Company also sells DEXTENZA directly to a small population of ambulatory surgery centers (“ASCs”) based on individually negotiated direct distribution agreements (the “Direct Customers”). In addition, the Company enters into arrangements with health care providers and payors that provide for government mandated or privately negotiated rebates and chargebacks with respect to the purchase of DEXTENZA.
The Company recognizes revenue on product sales when the customer obtains control of the Company's product, which occurs at a point in time (upon delivery to the customer). Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.
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Transaction Price, including Variable Consideration — Revenues from product sales are recorded net of off-invoice discounts and reserves which are established for our estimate of variable consideration. Components of variable consideration include trade discounts and allowances, product returns, government chargebacks, discounts and rebates, and other incentives, such as voluntary patient assistance, and other fee-for-service amounts that are detailed within contracts between the Company and its customers. These reserves, as detailed below, are based on the amounts earned, or to be claimed on the related sales, and are classified as reductions of accounts receivable or a current liability. These estimates take into consideration a range of possible outcomes which are probability-weighted in accordance with the expected value method in ASC 606 for relevant factors such as current contractual and statutory requirements, specific known market events and trends, industry data, and forecasted customer buying and payment patterns. Overall, these reserves reflect the Company’s best estimates of the amount of consideration to which it is entitled based on the terms of the respective underlying contracts.
The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price, only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized under the contract will not occur in a future period. Actual amounts of consideration ultimately received may differ from the Company’s estimates. If actual results in the future vary from the Company’s original estimates, the Company will adjust these estimates, which would affect net product revenue and earnings in the period such variances become known.
Trade Discounts and Allowances —The Company compensates (through trade discounts and allowances) its customers for sales order management, data, and distribution services. However, the Company has determined such services received to date are not distinct from the Company’s sale of products to the customer and, therefore, these payments have been recorded as a reduction of revenue within the statement of operations and comprehensive loss, as well as a reduction to accounts receivables, net on the consolidated balance sheets.
Product Returns — Consistent with industry practice, the Company generally offers customers a limited right of return for product that has been purchased from the Company based on the products expiration date. The Company estimates the amount of its product sales that may be returned by its customers and records this estimate as a reduction of revenue in the period the related product revenue is recognized, as well as within accrued expenses and other current liabilities, in the accompanying consolidated balance sheets. The Company currently estimates product return reserves using available industry data and its own sales information, including its visibility into the inventory remaining in the distribution channel.
Government Chargebacks — Chargebacks for fees and discounts to qualified government healthcare providers represent the estimated obligations resulting from contractual commitments to sell products to qualified U.S. Department of Veterans Affairs hospitals and entities that are subject to the U.S. federal government 340B Drug Discount Program at prices lower than the list prices charged to SDs and Direct Customers. Chargeback amounts are generally determined at the time of resale to the qualified government healthcare provider by SDs and Direct Customers, and the Company generally issues credits for such amounts within a few weeks of the customer’s notification to the Company of the resale. Allowance for chargebacks also consist of credits that the Company expects to issue for units that remain in the distribution channel inventories at each reporting period-end that the Company expects will be sold to qualified healthcare providers, and chargebacks that customers have claimed, but for which the Company has not yet issued a credit. These allowances are established in the same period that the related revenue is recognized, resulting in a reduction of product revenue and accounts receivables, net.
Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare. These reserves are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included in accrued expenses and other current liabilities on the consolidated balance sheets. For Medicare, the Company also estimates the number of patients in the prescription drug coverage gap for whom the Company will owe an additional liability under the Medicare Part D program. For Medicaid programs, the Company estimates the portion of sales attributed to Medicaid patients and records a liability for the rebates to be paid to the respective state Medicaid programs. The Company’s liability for these rebates consists of invoices received for claims from prior quarters that have not been paid or for which an invoice has not yet been received, estimates of claims for the current quarter, and estimated future claims that will be made for product that has been recognized as revenue, but which remains in the distribution channel inventories at the end of each reporting period.
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Purchaser/Provider Discounts and Rebates — The Company offers rebate payments for which ASCs, hospital out-patient departments and other prescribers qualify by meeting quarterly purchase volumes of DEXTENZA under the Company’s volume-based rebate program. The Company calculates rebate payment amounts due under this program quarterly, based on actual qualifying purchases and applies a contractual discount rate. In the third quarter of 2022, the Company implemented a separate off-invoice discount (“OID”) rebate program whereby end- users receive the discounted price immediately upon purchase, rather than having to wait until the end of the quarter for a rebate payment. The OID amounts are generally determined at the time of resale by SDs or direct sales to ASCs by the Company. The Company generally issues credits for such amounts within a few weeks of the SD’s notification to the Company of the resale. The Company includes the OID on the invoice when it sells to an ASC directly. The calculation of the accrual for all rebates is based on an estimate of claims that the Company expects to receive associated with product that has been recognized as revenue but also remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as an accrued expenses and other current liabilities for volume-based rebates and as a reduction of accounts receivable for OID rebates.
Other Incentives — Other incentives which the Company offers include voluntary patient assistance programs, such as the co-pay assistance program, which are intended to provide financial assistance to qualified commercially-insured patients with prescription drug co-payments required by payors. The calculation of the accrual for co-pay assistance is based on an estimate of claims and the cost per claim that the Company expects to receive associated with product that has been recognized as revenue, but remains in the distribution channel inventories at the end of each reporting period. The adjustments are recorded in the same period the related revenue is recognized, resulting in a reduction of product revenue and the establishment of a current liability which is included as an accrued expenses and other current liabilities on the consolidated balance sheets.
Collaboration Revenue
The Company evaluates contracts that contain multiple promises to determine which promises are distinct. Promises are considered to be distinct and therefore, accounted for as separate performance obligations, provided that: (i) the customer can benefit from the good or service either on its own or together with other resources that are readily available to the customer and (ii) the promise to transfer the good or service to the customer is separately identifiable from other promises in the contract. In assessing whether a promise is distinct, the Company considers factors such as whether: (i) the Company provides a significant service of integrating goods and/or services with other goods and/or services promised in the contract; (ii) one or more of the goods and/or services significantly modifies or customizes, or are significantly modified or customized by one or more of the other goods and/or services promised in the contract; and (iii) the goods and/or services are highly interdependent or highly interrelated. Individual goods or services (or bundles of goods and/or services) that meet both criteria for being distinct are accounted for as separate performance obligations. Promises that are not distinct at contract inception are combined and accounted for as a single performance obligation. Options to acquire additional goods and/or services are evaluated to determine if such option provides a material right to the customer that it would not have received without entering into the contract. If so, the option is accounted for as a separate performance obligation. If not, the option is considered a marketing offer which would be accounted for as a separate contract upon the customer’s election.
The Company considers the existence of any significant financing component within its arrangements based on whether a substantive business purpose exists to support the payment structure other than to provide a significant benefit of financing. The Company measures the transaction price based on the amount of consideration to which the Company expects to be entitled in exchange for transferring the promised goods and/or services to the customer. The Company utilizes either the expected value method or the most likely amount method to estimate the amount of variable consideration, depending on which method is expected to better predict the amount of consideration to which the Company will be entitled. Amounts of variable consideration are included in the transaction price to the extent that it is probable that a significant reversal in the amount of cumulative revenue recognized will not occur when the uncertainty associated with the variable consideration is subsequently resolved. With respect to arrangements that include payments for a development or regulatory milestone payment, the Company evaluates whether the associated event is considered likely of achievement and estimates the amount to be included in the transaction price using the most likely amount method. Milestone payments that are not within the Company’s control or the control of the licensee, such as those dependent upon receipt of regulatory approval, are not considered to be likely of achievement until the triggering event occurs. At the end of each reporting period, the Company re-evaluates the probability of achievement of each milestone and any related constraint and, if necessary, adjusts its estimate of the overall transaction price. Any such adjustments
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are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment. For arrangements that include sales-based royalties, including milestone payments based upon the achievement of a certain level of product sales, wherein the license is deemed to be the sole or predominant item to which the payments relate, the Company recognizes revenue upon the later of: (i) when the related sales occur or (ii) when the performance obligation to which some or all of the payment has been allocated has been satisfied (or partially satisfied). Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception.
Accounts Receivable
Accounts receivable arise from product sales and are recognized at the amounts invoiced to customers, net of applicable reserves for variable consideration. The Company analyzes the actual payment history of its customers, the aging of receivables, current customer-specific developments and economic trends to estimate the reserve for current expected credit losses.
Inventory
The Company values its inventories at the lower of cost or estimated net realizable value. Costs, which include amounts related to direct labor, materials and manufacturing overhead, are determined using standard costs, which approximate average cost. The Company performs an assessment of the recoverability of capitalized inventory during each reporting period, and it writes down any excess and obsolete inventories to their estimated realizable value in the period in which the impairment is first identified. Such impairment charges, should they occur, are recorded within cost of product revenue.
The Company capitalizes inventory costs associated with the Company’s products after regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized. Inventory acquired prior to receipt of marketing approval of a product candidate is expensed as research and development expense as incurred. Inventory that can be used in either the production of clinical or commercial product is expensed as research and development expense when selected for use in a clinical manufacturing campaign. Inventory produced that will be used in promotional marketing campaigns is expensed to selling and marketing expense when it is selected for use in a marketing program.
Fair Value Measurements
Certain assets and liabilities are carried at fair value under GAAP. Fair value is defined as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date. Valuation techniques used to measure fair value must maximize the use of observable inputs and minimize the use of unobservable inputs. Financial assets and liabilities carried at fair value are to be classified and disclosed in one of the following three levels of the fair value hierarchy, of which the first two are considered observable and the last is considered unobservable:
● Level 1—Quoted prices in active markets for identical assets or liabilities.
● Level 2—Observable inputs (other than Level 1 quoted prices) such as quoted prices in active markets for similar assets or liabilities, quoted prices in markets that are not active for identical or similar assets or liabilities, or other inputs that are observable or can be corroborated by observable market data.
● Level 3—Unobservable inputs that are supported by little or no market activity and that are significant to determining the fair value of the assets or liabilities, including pricing models, discounted cash flow methodologies and similar techniques.
Derivative Instruments
The Company recognizes all derivative instruments as either assets or liabilities at fair value through profit or loss on the Company's consolidated balance sheet. Changes in the estimated fair value of derivative instruments are recognized in other income (expense), net in the consolidated statements of operations and comprehensive loss.
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If the Company determines that a financial or non-financial contract, a ‘host contract’, includes implicit or explicit terms that affect the cash flows of the contract in a manner similar to a stand-alone derivative instrument, an ‘embedded derivative’, the Company analyzes whether to account for the embedded derivative separately. The Company accounts for an embedded derivative not separately from the host contract if it is clearly and closely related to the host contract or if the entire contract is measured at fair value through profit or loss. In other cases, the Company accounts for an embedded derivative separately.
The Company measures the value of embedded derivatives that are accounted for separately at their respective fair values and recognizes changes in the respective estimated fair values in other income (expense), net in the consolidated statements of operations and comprehensive loss during the period of change. Embedded derivatives that are accounted for separately are recognized as derivative liabilities in the Company’s consolidated balance sheet.
The Convertible Notes, as discussed in Note 9, allow the holders to convert all or part of the outstanding principal of their Convertible Notes into shares of the Company’s common stock provided that no conversion results in a holder beneficially owning more than 19.99 % of the issued and outstanding common stock of the Company. The entire embedded conversion option is required to be separated from the Convertible Notes and accounted for as a freestanding derivative instrument subject to derivative accounting. The main input when determining the fair value of the Convertible Notes is the bond yield that pertains to the host instrument without the conversion option. The significant assumption used in determining the bond yield is the market yield movements of a comparable instrument issued as of the valuation date, which is assessed and updated each period. Therefore, the entire conversion option is bifurcated from the underlying debt instrument and accounted for and valued separately from the host instrument.
The Barings Credit Agreement, as discussed in Note 9, contains an embedded obligation to pay a royalty fee that meets the criteria to be bifurcated and accounted for separately from the Barings Credit Facility, as discussed in Note 9, subject to derivative accounting. The main inputs when determining the fair value of the derivative liability are the amount and timing of our expected future revenue, the estimated volatility of these revenues, and the discount rate corresponding to the risk of revenue.
Property and Equipment
Property and equipment are stated at cost less accumulated depreciation. Depreciation expense is recognized using the straight-line method over a three - to five-year estimated useful life. Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. Expenditures for repairs and maintenance of assets are charged to expense as incurred. Upon retirement or sale, the cost and related accumulated depreciation of assets disposed of are removed from the accounts and any resulting gain or loss is included in loss from operations.
Leases
The Company determines whether an arrangement is or contains a lease at inception. Operating leases are recognized on the consolidated balance sheets as operating lease assets, current portion of lease liabilities and long-term lease liabilities. Operating lease assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation to make lease payments arising from the lease. Operating lease liabilities and their corresponding operating lease assets are recorded based on the present value of lease payments over the expected remaining lease term. The operating lease assets also include any lease payments made and adjustments for prepayments and lease incentives. The interest rate implicit in lease contracts is typically not readily determinable. As a result, the Company utilized its incremental borrowing rate, which is the rate incurred to borrow on a collateralized basis over a similar term an amount equal to the lease payments in a similar economic environment. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. The Company reassesses the lease term and remeasures the lease liability if triggering events occur. Lease expense for lease payments is recognized on a straight-line basis over the lease term.
Impairment of Long-Lived Assets
Long-lived assets consist of property and equipment and right-of-use assets. Long-lived assets to be held and used are tested for recoverability whenever events or changes in business circumstances indicate that the carrying amount of the assets may not be fully recoverable. Factors that the Company considers in deciding when to perform an impairment review include significant underperformance of the business in relation to expectations, significant negative industry or
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economic trends, and significant changes or planned changes in the use of the assets. If an impairment review is performed to evaluate a long-lived asset for recoverability, the Company compares forecasts of undiscounted cash flows expected to result from the use and eventual disposition of the long-lived asset to its carrying value. An impairment loss would be recognized when estimated undiscounted future cash flows expected to result from the use of an asset are less than its carrying amount. The impairment loss would be based on the excess of the carrying value of the impaired asset over its fair value, determined based on discounted cash flows. The Company has had no impairment triggers of long-lived assets.
Research and Development Costs
Research and development costs are expensed as incurred. Included in research and development expenses are salaries, stock-based compensation and benefits of employees and other operational costs related to the Company’s research and development activities, including external costs of outside vendors engaged to conduct preclinical studies and clinical trials, manufacturing costs of the Company’s products prior to regulatory approval, costs related to collaboration agreements and facility-related expenses.
The Company records accruals for estimated ongoing research and development costs. When evaluating the adequacy of the accrued liabilities, the Company analyzes progress of the studies, including the phase or completion of events, invoices received, estimates provided by vendors, and contracted costs. Judgments and estimates are made in determining the accrued balances at the end of any reporting period. Actual results could differ from the Company’s estimates. The Company’s historical accrual estimates have not been materially different from the actual costs.
Advertising Costs
Advertising costs are expensed as incurred.
Accounting for Stock-Based Compensation
The Company measures all stock options and other stock-based awards granted to employees, directors, and nonemployees at the fair value on the date of the grant. The fair value of the awards is recognized as expense, net of estimated forfeitures, over the requisite service period, which is generally the vesting period of the respective award. The straight-line method of expense recognition is applied to all awards with service-only conditions.
The Company recognizes compensation expense for only the portion of awards that are expected to vest. In developing a forfeiture rate estimate, the Company has considered its historical experience to estimate pre-vesting forfeitures for service-based awards. The impact of a forfeiture rate adjustment will be recognized in full in the period of adjustment, and if the actual forfeiture rate is materially different from the Company’s estimate, the Company may be required to record adjustments to stock-based compensation expense in future periods.
Compensation cost related to shares purchased through the Company’s employee stock purchase plan, which is considered compensatory, is based on the estimated fair value of the shares on the offering date, including consideration of the discount and the look-back period. The Company estimates the fair value of the shares using a Black-Scholes option pricing model. Compensation expense is recognized over the six -month withholding period prior to the purchase date.
The Company classifies stock-based compensation expense in its consolidated statement of operations and comprehensive loss in the same manner in which the award recipient’s payroll costs are classified or in which the award recipient’s service payments are classified.
Income Taxes
The Company accounts for income taxes using the asset and liability method, which requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of events that have been recognized in the consolidated financial statements or in the Company’s tax returns. Deferred taxes are determined based on the difference between the financial statement and tax basis of assets and liabilities using enacted tax rates in effect in the years in which the differences are expected to reverse. Changes in deferred tax assets and liabilities are recorded in the provision for income taxes. The Company assesses the likelihood that its deferred tax assets will be recovered from future taxable
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income and, to the extent it believes, based upon the weight of available evidence, that it is more likely than not that all or a portion of deferred tax assets will not be realized, a valuation allowance is established through a charge to income tax expense.
The Company accounts for uncertainty in income taxes recognized in the consolidated financial statements by applying a two-step process to determine the amount of tax benefit to be recognized. First, the tax position must be evaluated to determine the likelihood that it will be sustained upon external examination by the taxing authorities. If the tax position is deemed more-likely-than-not to be sustained, the tax position is then assessed to determine the amount of benefit to recognize in the consolidated financial statements. The amount of the benefit that may be recognized is the largest amount that has a greater than 50% likelihood of being realized upon ultimate settlement. The provision for income taxes includes the effects of any resulting tax reserves, or unrecognized tax benefits, that are considered appropriate.
Interest and penalties related to income taxes are recorded as part of the income tax provision.
Segment Data
The Company manages its operations as a single segment for the purposes of assessing performance and making operating decisions. The Company’s singular focus is on advancing its bioresorbable hydrogel product candidates for the programed-release delivery of therapeutic agents, specifically for ophthalmology. All property and equipment, net and all operating lease assets are held in the United States. All product revenue, net is attributable to the United States. Collaboration revenue is attributable to a customer in China (Note 3).
Comprehensive Loss
Comprehensive loss includes net loss as well as other changes in stockholders’ equity that result from transactions and economic events other than those with stockholders. For the years ended December 31, 2023, 2022 and 2021, there were no items that gave rise to other comprehensive loss and therefore, there was no difference between net loss and comprehensive loss.
Net Loss Per Share
Basic net loss per share attributable to common stockholders is computed by dividing the net loss attributable to common stockholders by the weighted average number of shares of common stock outstanding for the period. Diluted net loss attributable to common stockholders is computed by adjusting net loss attributable to common stockholders to reallocate undistributed earnings based on the potential impact of dilutive securities, outstanding stock options and common stock warrants, except where the result would be anti-dilutive. Diluted net loss per share attributable to common stockholders is computed by dividing the diluted net loss attributable to common stockholders by the weighted average number of common shares outstanding for the period, including potential dilutive common shares assuming the dilutive effect of the conversion of convertible debt securities, the exercise of outstanding stock options and common stock warrants. In the diluted net loss per share calculation, net loss would also be adjusted for the elimination of interest expense on convertible debt securities and the mark-to-market gain or loss on bifurcated conversion options, if the impact was not anti-dilutive.
Recently Issued Accounting Pronouncements
From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) and adopted by the Company as of the specified effective date. The Company believes that recently issued accounting pronouncements that are not yet effective will not have a material impact on our consolidated financial statements and disclosures.
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3. Licensing Agreements and Deferred Revenue
Incept License Agreement (in-licensing)
On September 13, 2018, the Company entered into a second amended and restated license agreement with Incept, LLC (“Incept”) to use and develop certain intellectual property (the “Incept License”). Under the Incept License, as amended and restated, the Company was granted a worldwide, perpetual, exclusive license to use specific Incept technology to develop and commercialize products that are delivered to or around the human eye for diagnostic, therapeutic or prophylactic purposes relating to ophthalmic diseases or conditions. The Company is obligated to pay low single-digit royalties on net sales of commercial products developed using the licensed technology, commencing with the date of the first commercial sale of such products and until the expiration of the last to expire of the patents covered by the license. Any of the Company’s sublicensees also will be obligated to pay Incept a royalty equal to a low single-digit percentage of net sales made by it and will be bound by the terms of the agreement to the same extent as the Company. The Company is obligated to reimburse Incept for its share of the reasonable fees and costs incurred by Incept in connection with the prosecution of the patent applications licensed to the Company under the Incept License.
Royalties paid under this agreement related to product sales were $ 1,713 , $ 1,466 and $ 1,333 for the years ended December 31, 2023, 2022 and 2021, respectively. Royalties have been charged to cost of product revenue.
AffaMed License Agreement (out-licensing)
On October 29, 2020, the Company entered into a license agreement (“License Agreement”) with AffaMed Therapeutic Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis (collectively, the “DEXTENZA Field”) and for the Company’s PAXTRAVA, formerly known as OTX-TIC, product candidate (collectively with DEXTENZA, the “AffaMed Licensed Products”) regarding open-angle glaucoma or ocular hypertension (collectively, the “TIC Field” and, with the DEXTENZA Field, each a “Field”), in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations (collectively, the “Territories”). The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world.
Under the License Agreement, the Company received a non-refundable upfront payment of $ 12,000 in December 2020, a $ 1,000 milestone in the fourth quarter of 2021, a $ 2,000 clinical support payment in the second quarter of 2022, and a $ 1,000 milestone payment in the second quarter of 2023. The Company is also eligible to receive up to an additional $ 87,000 in aggregate upon the achievement of certain regulatory, development and commercial milestones. The Company is also entitled to receive tiered, escalating royalties on the net sales of the AffaMed Licensed Products ranging from a low-teen to low-twenties percentage. Royalties under the License Agreement are payable on an AffaMed Licensed Product-by-AffaMed Licensed Product and jurisdiction-by-jurisdiction basis and are subject to potential reductions in specified circumstances, subject to a specified floor.
Under the License Agreement, the Company is generally responsible for expenses related to the development of the AffaMed Licensed Products in the applicable Fields in the Territories, provided that AffaMed (i) reimburse the Company a low-teen percentage of expenses incurred in connection with certain clinical trials conducted by the Company and designed to support marketing approval of the AffaMed Licensed Product by the FDA or the European Medicines Agency (“Global Studies”); (ii) is solely responsible for expenses incurred in connection with territory-specific clinical trials that it conducts in furtherance of the development plan agreed between the parties in the applicable Fields in the Territories (“Local Studies”); and (iii) reimburse the Company in full for expenses incurred in connection with obtaining and maintaining regulatory approvals of the AffaMed Licensed Products in the applicable Fields in the Territories. In the event AffaMed declines to participate in a Global Study or to conduct a Local Study in any jurisdiction in which the Company determines to conduct such a study, the Company is relieved of its obligation to provide AffaMed clinical data from such study, other than safety data, unless AffaMed subsequently reimburses the Company in the amounts described above plus a prespecified premium.
The License Agreement expires upon the expiration of the last royalty term for the last AffaMed Licensed Product in any applicable Field in the Territories. Either party may, subject to specified cure periods, terminate the License Agreement in the event of the other party’s uncured breach. Either party may also terminate the License Agreement under specified circumstances relating to the other party’s insolvency. AffaMed has the right to terminate the License
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Agreement at any time after completion of a Phase 3 clinical trial for PAXTRAVA for any or no reason upon providing the Company three months’ notice. During an established period following its change of control or its entry into a global licensing agreement that includes the Territories with a third party, the Company has the option to terminate the License Agreement, subject to a specified notice period and the repayment of any costs and expenses incurred by AffaMed in connection with the License Agreement, including upfront and milestone payments AffaMed has previously paid to the Company, at a prespecified premium.
The Company concluded that AffaMed is a customer in this arrangement, and as such, the arrangement falls within the scope of the revenue recognition guidance in ASC 606.
At the inception of the License Agreement, the Company identified the following performance obligations in the agreement:
● the license, regulatory filings and manufacturing of DEXTENZA (the “DEXTENZA Field performance obligation”);
● the license, regulatory filings and manufacturing for the Company’s PAXTRAVA product candidate regarding open-angle glaucoma or ocular hypertension in the Territories (the “PAXTRAVA Field performance obligation”);
● the conduct of a Phase 2 clinical trial of PAXTRAVA (the “Phase 2 Clinical Trial of PAXTRAVA performance obligation”); and
● obligations to participate on various joint research, development and project committees, which the Company has concluded is not a material performance obligation.
The transaction price was allocated to the performance obligations based on the relative estimated standalone selling prices of each performance obligation.
The Company developed the estimated standalone selling price for the services and/or manufacturing and supply included in each of the performance obligations, as applicable, primarily based on the nature of the services to be performed and/or goods to be manufactured and estimates of the associated costs, adjusted for a reasonable profit margin that would be expected to be realized under similar contracts.
The Company has determined that any sales-based royalties and milestones will be recognized as the Company delivers the clinical and commercial manufactured product to AffaMed. Any changes in estimates may result in a cumulative catch-up based on the number of units of manufactured product delivered.
As of December 31, 2023, the transaction price was determined to be $ 16,000 . All potential regulatory, development and commercial milestone payments in the amount of $ 87,000 did not meet the recognition criteria under the most likely method, because their achievement was highly dependent on factors outside the control of the Company and therefore, were excluded from the transaction price as of December 31, 2023. Furthermore, under the expected value method the Company excluded the potential royalties from the transaction price.
We recognize revenue related to the amounts allocated to the DEXTENZA Field performance obligation and the PAXTRAVA Field performance obligation based on the point in time upon which control of supply is transferred to AffaMed for each delivery of the associated supply. The Company currently expects to recognize the revenue over a period of approximately seven to eight years commencing on the date the Company begins delivering product to AffaMed. This estimate of this period considers the timing of development and commercial activities under the License Agreement and may be reduced or increased based on the various activities as directed by the joint committees, decisions made by AffaMed, regulatory feedback or other factors not currently known.
The Company recognized $ 573 , $ 1,037 and $ 0 of collaboration revenue related to the Phase 2 Clinical Trial of PAXTRAVA performance obligation for the years ended December 31, 2023, 2022 and 2021, respectively.
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As of December 31, 2023, the aggregate amount of the transaction price allocated to the partially unsatisfied Phase 2 Clinical Trial of PAXTRAVA performance obligation was $ 390 . This amount is expected to be recognized as this performance obligation is satisfied through June 2025.
Deferred revenue activity for the year ended December 31, 2023 was as follows:
Deferred Revenue
Deferred revenue at December 31, 2022
$
13,963
Additions
1,000
Amounts recognized into revenue
( 573 )
Deferred revenue at December 31, 2023
$
14,390
Regeneron Collaboration Agreement
On October 10, 2016, the Company entered into a Collaboration, Option and License Agreement (the “Regeneron Collaboration Agreement”) with Regeneron Pharmaceuticals, Inc. (“Regeneron”) for the development and potential commercialization of products using the Company’s hydrogel in combination with Regeneron’s large molecule VEGF-targeting compounds for the treatment of retinal diseases.
Under the terms of the Collaboration Agreement, the Company and Regeneron had agreed to conduct a joint research program with the aim of developing a sustained-release formulation of aflibercept, currently marketed under the tradename Eylea, that is 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 using the Company’s hydrogel in combination with Regeneron’s large molecule VEGF-targeting compounds (“Licensed Products”). Under the term of the Collaboration Agreement, Regeneron was responsible for funding an initial preclinical tolerability study. The Regeneron Collaboration Agreement was subsequently amended on May 8, 2020 (the “Regeneron Amendment”). Pursuant to the Regeneron Amendment, the Company and Regeneron had adopted a new work plan to transition joint efforts under the Regeneron Collaboration Agreement to the research and development of an extended-delivery formulation of aflibercept to be delivered to the suprachoroidal space. Regeneron had 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 addition, the Regeneron Amendment provided for the modification of the terms of the Option previously granted to Regeneron under the Regeneron Collaboration Agreement. As amended, the Option was exclusive for twenty-four months following May 8, 2020. On August 5, 2021, Regeneron notified the Company of its termination of the Regeneron Collaboration Agreement, as amended. The termination became effective immediately.
In connection with the termination of the Regeneron Collaboration Agreement, all licenses, options and other rights granted to either party under the Regeneron 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 Regeneron 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 years ended December 31, 2023, 2022 and 2021, the Company had recorded $ 0 , $ 0 and $ 768 related to work performed for preclinical development activities in connection with the revised work plan which the Company has recorded as a reduction of research and development expense as this research is not an output of the Company’s ordinary
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business activities. As of December 31, 2023 and 2022, the Company had not recorded any assets or liabilities with regard to the Regeneron Collaboration Agreement.
4. Cash Equivalents and Restricted Cash
The Company’s 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 statement of cash flows is as follows:
December 31,
December 31,
December 31,
2023
2022
2021
Cash and cash equivalents
$
195,807
$
102,300
$
164,164
Restricted cash (current)
150
—
—
Restricted cash (non-current)
1,614
1,764
1,764
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows
$
197,571
$
104,064
$
165,928
The Company held restricted cash as security deposits for its real estate leases.
5. Inventory
Inventory consisted of the following:
December 31,
December 31,
2023
2022
Raw materials
$
302
$
309
Work-in-process
1,012
899
Finished goods
991
766
$
2,305
$
1,974
6. Property and Equipment, net
Property and equipment, net consisted of the following:
December 31,
December 31,
2023
2022
Equipment
$
15,515
$
12,485
Leasehold improvements
14,699
9,074
Furniture and fixtures
1,268
1,268
Software
236
236
Construction in progress
281
4,071
31,999
27,134
Less: Accumulated depreciation and amortization
( 20,260 )
( 17,278 )
$
11,739
$
9,856
Depreciation and amortization expense was $ 2,983 , $ 2,109 and $ 2,421 for the years ended December 31, 2023, 2022 and 2021, respectively.
7. Leases
The Company leases real estate, including laboratory, manufacturing and office space. The Company’s leases have remaining lease terms ranging from less than 1 year to approximately 4.5 years. All of the Company’s leases qualify as operating leases.
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The lease for the Company’s 20,445 square feet of manufacturing space located at 36 Crosby Drive in Bedford, Massachusetts commenced on June 30, 2018. On October 18, 2022, the Company exercised its option to extend the lease agreement by an additional five -year term, resulting in a new expiration date of July 31, 2028. Under the terms of the existing lease, rent for the five -year extension period was based on the current fair market rent for comparable space in the building and in other similar buildings in the same rental market as of August 1, 2023, the commencement date of the additional five -year term. The Company estimated the prevailing market rental rates at the time when the Company exercised the renewal option and included these in the remeasurement of the operating lease asset and the lease liability. This resulted in an increase of the operating lease assets and operating lease liabilities of $ 4,284 as of the remeasurement date. As this is an estimate for variable payments that depend on an index or a rate, the Company has not remeasured the payments for the five -year renewal period as of the commencement date of the five -year extension term. On June 30, 2023, the Company and the landlord executed an amendment to this lease, formally extending the term of the lease through July 31, 2028. This lease does not include any additional renewal options.
The lease is for approximately 70,712 square feet of general office, research and development and manufacturing space located at 15 Crosby Drive in Bedford, Massachusetts. The lease term commenced on February 1, 2017 and will expire on July 31, 2027. The Company has the option to extend the lease for two additional periods of five years each by delivering written notice of the exercise not earlier than fifteen months nor later than 12 months before expiration of the original term.
The lease for 30,036 square feet of office space located at 24 Crosby Drive in Bedford, Massachusetts commenced on April 18, 2019 and terminates on March 31, 2024 and does not include any lease renewal options .
Recognized lease costs were as follows:
For the
For the
For the
Year Ended
Year Ended
Year Ended
December 31,
December 31,
December 31,
2023
2022
2021
Operating lease costs
$
2,663
$
2,369
$
2,482
Variable lease costs
987
756
629
Total lease costs
$
3,650
$
3,125
$
3,111
The minimum lease payments for the next five years and thereafter are expected to be as follows:
December 31,
Year Ending December 31,
2023
2024
2,504
2025
2,673
2026
2,709
2027
2,111
2028
716
Thereafter
—
Total lease payments
$
10,713
Less: interest
2,249
Present value of operating lease liabilities
$
8,464
The following table summarizes the weighted average remaining lease term and the weighted average incremental borrowing rate used to determine the operating lease liability:
December 31,
December 31,
2023
2022
Weighted average remaining lease term in years
4.1
4.9
Weighted average discount rate
12.00
%
13.41
%
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Supplemental disclosure of cash flow information related to the Company’s operating leases included in cash flows provided by operating activities in its consolidated statements of cash flows is as follows:
For the
For the
For the
Year Ended
Year Ended
Year Ended
December 31,
December 31,
December 31,
2023
2022
2021
Cash paid for amounts included in the measurement of lease liabilities
$
2,663
$
2,549
$
2,482
8. Expenses
The Company recognized $ 880 , $ 1,166 , and $ 1,925 of advertising expenses for the years ended December 31, 2023, 2022 and 2021, respectively.
Accrued expenses consisted of the following:
December 31,
December 31,
2023
2022
Accrued interest payable on Convertible Notes (Note 9)
10,886
8,756
Accrued payroll and related expenses
$
8,156
$
7,509
Accrued rebates and programs
5,117
3,560
Accrued research and development expenses
1,488
1,816
Accrued interest payable on Barings Credit Facility (Note 9)
803
—
Accrued professional fees
691
1,228
Accrued other
1,525
1,228
$
28,666
$
24,097
9. Financial Liabilities
Barings Credit Agreement
On August 2, 2023 (the “Closing Date”), the Company entered into a credit and security agreement (the “Barings Credit Agreement”) with Barings Finance LLC (“Barings”), as administrative agent, and the lenders party thereto, providing for a secured term loan facility for the Company (the “Barings Credit Facility”) in the aggregate principal amount of $ 82,474 (the “Total Credit Facility Amount”). The Company borrowed the full amount of $ 82,474 at closing and received proceeds of $ 77,290 , after the application of an original issue discount and fees. Indebtedness under the Barings Credit Facility matures on the earlier to occur of (i) the six-year anniversary of the Closing Date and (ii) the date that is 91 days prior to the maturity date for the Company’s Convertible Notes (as defined below). Indebtedness under the Barings Credit Facility incurs interest based on the Secured Overnight Financing Rate (“SOFR”), subject to a minimum 1.50 % floor, plus 6.75 %. The Company is obligated to make interest payments on its indebtedness under the Barings Credit Facility on a monthly basis, commencing on the Closing Date; to pay annual administration fees; and to pay, on the maturity date, any principal and accrued interest that remains outstanding as of such date. In addition, the Company is obligated to pay a fee in an amount equal to the Total Credit Facility Amount, which amount shall be reduced by the total amount of interest and principal prepayment fees paid under the Barings Credit Agreement (such fee, the “Barings Royalty Fee”). The Company is required to pay the Barings Royalty Fee in installments to Barings, for the benefit of the lenders, on a quarterly basis in an amount equal to three and one-half percent ( 3.5 %) of the net sales of DEXTENZA occurring during such quarter, subject to the terms, conditions and limitations specified in the Barings Credit Agreement, until the Barings Royalty Fee is paid in full. The Barings Royalty Fee is due and payable upon a change of control of the Company. In the event the Company completes a change of control transaction or a sale of all or substantially all of its assets on or prior to the twelve-month anniversary of the Closing Date, the Barings Royalty Fee is subject to a reduction to an amount that is equal to (i) 20 % of the Total Credit Facility Amount, in the event that a signed letter of intent evidencing such transaction was entered into by the Company on or prior to the date that is six months after the Closing Date and (ii) 30 % of the Total Credit Facility Amount, in the event that a signed letter of intent evidencing such transaction was entered into by the Company after the date that is six months, but before the date that is twelve months, after the Closing Date. The Company may, at its option, prepay any or all of the Barings Royalty Fee at any time without penalty. In connection with the Barings Credit Agreement, the Company granted the lenders thereto a
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first-priority security interest in all assets of the Company, including its intellectual property, subject to certain agreed-upon exceptions. The Barings Credit Agreement includes negative covenants restricting the Company from making payments to the holders of the Convertible Notes, except in connection with a proposed conversion to equity and with respect to certain permitted expenses and requiring the Company to maintain a minimum liquidity amount of $ 20,000 . The Barings Credit Agreement also includes customary affirmative and negative covenants.
The Company determined that the embedded obligation to pay the Barings Royalty Fee (the “Barings Royalty Fee Obligation”) is required to be separated from the Barings Credit Facility and accounted for as a freestanding derivative instrument subject to derivative accounting. The allocation of proceeds to the Barings Royalty Fee Obligation resulted in a discount on the Barings Credit Facility. The Company is amortizing the discount to interest expense over the term of the Barings Credit Facility using the effective interest method. Accrued or paid Barings Royalty Fees are included in the change in fair value of derivative liabilities on the consolidated statements of operations and comprehensive loss. For the year ended December 31, 2023, Barings Royalty Fees were $ 901 .
A summary of the Barings Credit Facility at December 31, 2023 is as follows:
December 31,
2023
Barings Credit Facility
$
82,474
Less: unamortized discount
( 16,687 )
Total
$
65,787
As of December 31, 2023, the full principal for the Barings Credit Facility of $ 82,474 was due for repayment in 2029.
Convertible Notes
On March 1, 2019, the Company issued $ 37,500 of convertible notes which accrue interest at an annual rate of 6 % of their outstanding principal amount, which is payable, along with the principal amount at maturity, unless earlier converted, repurchased or redeemed (as amended the “Convertible Notes”).
Concurrently with entering into the Barings Credit Agreement, on August 2, 2023, the Company and the holders of the Convertible Notes extended the maturity of the Convertible Notes, which would otherwise have matured on March 1, 2026, to a date 91 days following the maturity of the indebtedness under the Barings Credit Facility, unless earlier converted, repurchased or redeemed (the “Amendment”). The Company accounted for the Amendment as an extinguishment of debt in accordance with the guidance in Accounting Standards Codification Topic 470-50 Debt (“ASC 470-50”) and derecognized all liabilities related to the Convertible Notes, including the outstanding principal less unamortized discount, a derivative liability, and accrued interest, with a total carrying value of $ 51,090 as of the date of the Amendment. The Company determined that, after the Amendment, the embedded conversion option continues to be required to be separated from the Convertible Notes and accounted for the embedded conversion option as a freestanding derivative instrument subject to derivative accounting (the “Conversion Option Derivative Liability”). The total fair value of the Convertible Notes on August 2, 2023 after the Amendment, including the conversion option, was $ 36,183 . The Company recognized the Convertible Notes and the Conversion Option Derivative Liability after the Amendment at their fair values as of the date of the Amendment of $ 18,482 and $ 17,701 , respectively. A portion of the fair value of the Convertible Notes as of the date of the Amendment of $ 9,943 is presented in accrued expenses and other current liabilities on the consolidated balance sheets because the Convertible Notes are currently convertible, and this amount represents interest that was accrued before the Amendment and that would be payable in cash upon conversion. The allocation of a portion of the total fair value of the Convertible Notes to the Conversion Option Derivative Liability results in a discount on the Convertible Notes. Application of ASC 470-50 resulted in a gain on extinguishment of $ 14,907 , which was charged to gains and losses on extinguishment of debt, net on the consolidated statements of operations and comprehensive loss for the year ended December 31, 2023.
The holders of the Convertible Notes may convert all or part of the outstanding principal amount of their Convertible Notes into shares of the Company’s common stock, par value $ 0.0001 per share, prior to maturity and provided that no conversion results in a holder beneficially owning more than 19.99 % of the issued and outstanding common stock of the Company. The conversion rate is initially 153.8462 shares of the Company’s common stock per $ 1,000 principal amount of the Convertible Notes, which is equivalent to an initial conversion price of $ 6.50 per share.
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The conversion rate is subject to adjustment in customary circumstances such as stock splits or similar changes to the Company’s capitalization.
Upon conversion by the holder, other than a conversion based on a Corporate Transactions as defined below, the Company has the right to select the settlement of the conversion in either shares of common stock, cash, or in a combination thereof. Upon any conversion of any Convertible Note, the Company is obligated to make a cash payment to the holder of such Convertible Note for any interest accrued but unpaid on the principal amount converted.
●
If the Company elects to satisfy such conversion by shares of common stock, the Company shall deliver to the converting holder in respect of each $ 1,000 principal amount of Convertible Notes being converted a number of common shares equal to the conversion rate in effect on the conversion date;
●
If the Company elects to satisfy such conversion by cash settlement, the Company shall pay to the converting holder in respect of each $ 1,000 principal amount of Convertible Notes being converted cash in an amount equal to the sum of the Daily Conversion Values (as defined below) for each of the twenty (20) consecutive trading days during a specified period. The “Daily Conversion Values” is defined as each of the 20 consecutive trading days during the specified period, 5.0 % of the product of (a) the conversion rate on such trading day and (b) the “Daily VWAP” on such trading day. The Daily VWAP is defined as each of the 20 consecutive trading days during the applicable Observation Period, the per share volume-weighted average price as displayed under the heading “Bloomberg VWAP” on the Bloomberg page for the Company.
●
If the Company elects to satisfy such conversion by combination, the Company shall pay or deliver, as the case may be, in respect of each $ 1,000 principal amount of Convertible Notes being converted, a settlement amount equal to the sum of the “Daily Settlement Amounts” (as defined below) for each of the twenty (20) consecutive trading days during the specified period. The “Daily Settlement Amount” is defined as, for each of the 20 consecutive trading days during the specified period: (a) cash in an amount equal to the lesser of (i) the Daily Measurement Value (as defined below) and (ii) the Daily Conversion Value on such Trading Day; and (b) if the Daily Conversion Value on such trading day exceeds the Daily Measurement Value, a number of Shares equal to (i) the difference between the Daily Conversion Value and the Daily Measurement Value, divided by (ii) the Daily VWAP for such Trading Day. The “Daily Measurement Value” is defined as the Specified Dollar Amount (as defined below), if any, divided by 20. The “Specified Dollar Amount” is defined as the maximum cash amount per $ 1,000 principal amount of Notes to be received upon conversion as specified in the notice specifying the Company’s chosen settlement method.
In the event of a Corporate Transaction, the noteholder shall have the right to either (a) convert all of the unpaid principal at the conversion rate and receive a cash payment equal to (i) the outstanding accrued but unpaid interest under the Convertible Note to, but excluding, the corporate transaction conversion date (to the extent such date occurs prior to a date 91 days following the maturity of the indebtedness under the Barings Credit Facility, the maturity date of the Convertible Notes) plus (ii) and an additional amount of consideration based on a sliding scale depending on the date of such as Corporate transaction or (b) require the Company to repurchase all or part of the outstanding principal amount of such Convertible Note at a repurchase price equal to 100 % of the outstanding principal amount of the Convertible Note to be repurchased, plus accrued and unpaid interest to, but excluding, the repurchase date.
A corporate transaction includes (i) a merger or consolidation executed through a tender offer or change of control (other than one in which stockholders of the Company own a majority by voting power of the outstanding shares of the surviving or acquiring corporation); (ii) a sale, lease, transfer, of all or substantially all of the assets of the Company; or (iii) if the Company’s common stock ceases to be listed or quoted on any of the New York Stock Exchange, the Nasdaq Global Select Market, the Nasdaq Global Market or the Nasdaq Capital Market (the “Corporate Transaction”).
If the last reported sale price of the common stock has been at least 130 % of the conversion rate then in effect for 20 of the preceding 30 trading days (including the last trading day of such period), the Company is entitled, at its option, to redeem all or part of the outstanding principal amount of the Convertible Notes, on a pro rata basis, at an optional redemption price equal to 100 % of the outstanding principal amount of the Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date.
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The Convertible Notes are subject to acceleration upon the occurrence of specified events of default, including a default or breach of certain contracts material to the Company and the delisting and deregistration of the Company’s common stock.
The Company determined that the embedded conversion option is required to be separated from the 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 Convertible Notes. The Company is amortizing the discount to interest expense over the term of the Convertible Notes using the effective interest method.
The Company presents accrued interest in accrued current liabilities because the notes are currently convertible and the interest is payable in cash. The effective annual interest rate for the Convertible Notes was 19.4 %, 14.8 %, and 14.8 % for the years ended December 31, 2023, 2022, and 2021, respectively.
A summary of the Convertible Notes at December 31, 2023 and 2022 is as follows:
December 31,
December 31,
2023
2022
Convertible Notes
$
37,500
$
37,500
Less: unamortized discount and current portion
( 28,362 )
( 8,751 )
Total
$
9,138
$
28,749
Interest recognized with regard to the Convertible Notes was as follows:
Year Ended December 31,
2023
2022
2021
Coupon Interest
$
2,130
2,281
2,281
Amortization of discount
2,042
2,314
2,128
Total
$
4,172
4,595
4,409
Notes Payable
The Company entered into a credit and security agreement in 2014 (as amended, the “MidCap Credit Agreement”) establishing a credit facility (as amended, the “MidCap Credit Facility”). The Company satisfied its obligations under the MidCap Credit Agreement in August 2023, as discussed below. In connection with its satisfaction of its obligations, the Company extinguished the MidCap Credit Facility, and all liens and security interests securing the indebtedness under the MidCap Credit Agreement were released.
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 . Under the Fourth Amendment, the Company was required to make interest-only payments through April 2024. Commencing in May 2024, the Company was 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, as defined below. Amounts borrowed under the MidCap Credit Facility based on the Fourth Amendment were initially at LIBOR base rate, subject to 1.00 % floor, plus 6.75 %. In addition, a final payment (exit fee) equal to 3.5 % of amounts drawn under the MidCap Credit Facility, or $ 875 based on borrowings of $ 25,000 , was due upon the maturity date of November 30, 2025. The Company had accrued 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.
On March 12, 2023, the Company requested, and received, a protective advance of $ 2,000 under the MidCap Credit Agreement as a short-term bridge loan in response to the closure of Silicon Valley Bank by the California Department of Financial Protection and Innovation. This protective advance was deemed a credit extension. The Company repaid the full principal amount of $ 2,000 in March 2023.
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On March 31, 2023, the Company entered into Amendment No. 1 to the MidCap Credit Agreement (“Amendment No. 1”) to replace the LIBOR-based interest rate provisions of the MidCap Credit Agreement with interest rate provisions based on SOFR, establish a benchmark replacement mechanism and make additional administrative updates. The Company accounted for Amendment No. 1 as a modification in accordance with the guidance in ASC 470-50 Debt . Application of the modification accounting guidance did not have a material effect on the carrying amount of the long-term notes payable.
On May 4, 2023, the Company entered into Amendment No. 2 to the MidCap Credit Agreement (“Amendment No. 2”). Amendment No. 2 provided that the Company may maintain up to 50 % of its consolidated cash and cash equivalents with banks or financial institutions other than Silicon Valley Bank and made additional administrative updates.
As of December 31, 2022, the Company had a total borrowing capacity of $ 25,000 under the MidCap Credit Facility, which was fully drawn down. In August 2023, in connection with the Company’s establishment of the Barings Credit Facility, the Company paid an aggregate of $ 26,157 to MidCap Financial Trust and the other lenders party to the MidCap Credit Agreement, comprised of $ 25,017 in principal and interest accrued thereunder and $ 1,140 in exit and prepayment fees, in satisfaction of the Company’s obligations under the MidCap Credit Agreement. In connection with the payment, all liens and security interests securing the indebtedness under the MidCap Credit Agreement were released. The extinguishment of the MidCap Credit Facility has resulted in a loss of $ 717 , which was charged to gains and losses on extinguishment of debt, net on the consolidated statements of operations and comprehensive loss for the year ended December 31, 2023.
Borrowings outstanding were as follows:
December 31,
2022
Borrowings outstanding
$
25,000
Accrued exit fee
335
Unamortized discount
( 78 )
Long-term notes payable
$
25,257
10. Derivatives
Barings Credit Agreement
The Barings Credit Agreement (Note 9) contains an embedded Royalty Fee Obligation that meets the criteria to be bifurcated and accounted for separately from the Barings Credit Facility (the "Royalty Fee Derivative Liability"). The Royalty Fee Derivative Liability was recorded at fair value upon the entering into the Barings Credit Facility and is subsequently remeasured to fair value at each reporting period. The Royalty Fee Derivative Liability was initially valued and is remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded Royalty Fee Obligation and then valuing the instrument without the embedded Royalty Fee Obligation. Royalty payments are estimated using a Monte Carlo simulation. Refer to Note 11 for details regarding the determination of fair value.
A roll-forward of the Royalty Fee Derivative Liability is as follows:
As of
Balance at August 2, 2023
$
12,604
Change in fair value
( 215 )
Balance at December 31, 2023
$
12,389
Convertible Notes
The Convertible Notes (Note 9) contain the Conversion Option Derivative Liability, an embedded conversion option that meets the criteria to be bifurcated and accounted for separately from the Convertible Notes. The Conversion Option Derivative Liability was recorded at fair value upon the issuance of the Convertible Notes and is subsequently remeasured to fair value at each reporting period. The Conversion Option Derivative Liability was initially valued and
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are remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded conversion option 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 Conversion Option Derivative Liability. Refer to Note 11 for details regarding the determination of fair value.
A roll-forward of the Conversion Option Derivative Liability, including the impact from accounting for the Convertible Notes Amendment, is as follows:
As of
Balance at December 31, 2021
$
20,192
Change in fair value
( 13,841 )
Balance at December 31, 2022
6,351
Change in fair value
4,502
Change in fair value from Convertible Notes Amendment
6,745
Balance at December 31, 2023
$
17,598
Warrants
In April 2014, the Company entered into a credit facility with Silicon Valley Bank and MidCap Financial SBIC, LP, and it issued the lenders warrants to purchase 100,000 shares of its Series D-1 redeemable convertible preferred stock with an exercise price of $ 3.00 per share. Upon the closing of the Company’s IPO in July 2014, the preferred stock warrants became warrants to purchase an aggregate of 37,878 shares of its common stock with an exercise price of $ 7.92 per share, with Silicon Valley Bank and MidCap Financial SBIC, LP., each holding warrants of 18,939 shares of common stock.
The Company had warrants for the purchase of 18,939 shares of common stock outstanding with MidCap Financial SBIC, LP at December 31, 2020 at a weighted average exercise price of $ 7.92 per share and an expiration date of April 17, 2021. 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 December 31, 2023 and 2022, respectively.
11. Risks and Fair Value
Concentration of Credit Risk and of Significant Suppliers and Customers
Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company has its cash and cash equivalents balances at two accredited financial institutions, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.
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 programs as well as revenue from future product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.
Three specialty distributor customers accounted for the following percentages of the Company’s total revenue:
For the
For the
For the
Year Ended
Year Ended
Year Ended
December 31,
December 31,
December 31,
2023
2022
2021
Customer 1
49
%
44
%
42
%
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Customer 2
25
25
26
Customer 3
11
17
17
Three specialty distributor customers accounted for the following percentages of the Company’s accounts receivables:
As of
December 31,
December 31,
2023
2022
Customer 1
50
%
52
%
Customer 2
28
24
Customer 3
11
15
Change in Fair Value of Derivative Liabilities
Other income (expenses) from the change in the fair values of derivative liabilities as presented on the Company’s consolidated statements of operations and comprehensive loss includes the following:
For the
For the
For the
Year Ended
Year Ended
Year Ended
December 31,
December 31,
December 31,
2023
2022
2021
Change in the fair value of the Conversion Option Derivative Liability
$
( 4,502 )
$
13,841
$
78,121
Change in the fair value of Royalty Fee Derivative Liability
215
—
—
Barings Royalty Fee
( 901 )
—
—
$
( 5,188 )
$
13,841
$
78,121
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 December 31, 2023 and 2022 and indicate the level of the fair value hierarchy utilized to determine such fair value:
Fair Value Measurements as of
December 31, 2023 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
187,951
$
—
$
—
$
187,951
Liability:
Derivative liabilities
$
—
$
—
$
29,987
$
29,987
Fair Value Measurements as of
December 31, 2022 Using:
Level 1
Level 2
Level 3
Total
Assets:
Cash equivalents:
Money market funds
$
30,188
$
—
$
—
$
30,188
Liability:
Derivative liability
$
—
$
—
$
6,351
$
6,351
During the year ended December 31, 2023 and 2022, there were no transfers between Level 1 and 2.
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The carrying value of accounts receivable, prepaid expenses and other current assets, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these assets and liabilities. The carrying value of the Company’s variable interest rate MidCap Credit Facility was recorded at amortized cost, which approximates fair value due to the variable interest rate.
Barings Credit Agreement and Royalty Fee Derivative Liability
At December 31, 2023, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $ 66,590 comprised of the $ 65,787 non-current liability (Note 9) and $ 803 accrued interest (Note 8). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $ 72,295 at December 31, 2023.
The fair value of the Royalty Fee Derivative Liability is estimated using a Monte Carlo simulation. The use of this approach requires the use of Level 3 unobservable inputs. The main inputs when determining the fair value of the Royalty Fee Derivative Liability are the amount and timing of the expected future revenue of the Company, the estimated volatility of these revenues, and the discount rate corresponding to the risk of revenue. 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 Royalty Fee Derivative Liability are as follows:
As of
December 31,
2023
Revenue volatility
67.0
%
Revenue discount rate
15.8
%
The main inputs to valuing the Royalty Fee Derivative Liability as of the Closing Date were revenue volatility of 61.0 %, and a revenue discount rate of 15.8 %.
Convertible Notes and Conversion Option Derivative Liability
At December 31, 2023, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $ 20,024 , comprised of the $ 9,138 non-current liability (Note 9) and $ 10,886 accrued interest (Note 8). At December 31, 2022, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $ 37,505 , comprised of the $ 28,749 non-current liability (Note 9) and $ 8,756 accrued interest (Note 8). The estimated fair value of the Convertible Notes, without the Conversion Option Derivative Liability, was $ 22,665 and $ 33,177 at December 31, 2023 and 2022, respectively.
The fair value of the Convertible Notes with and without the conversion option is estimated using a binomial lattice approach. The use of this approach requires the use of Level 3 unobservable inputs. The main input when determining the fair value of the Convertible Notes is the bond yield that pertains to the host instrument without the conversion option. The significant assumption used in determining the bond yield is the market yield movements of a comparable instrument issued as of the valuation date, which is assessed and updated each period. The main input when determining the fair value for disclosure purposes is the 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 Convertible Notes with the conversion option are as follows:
As of
December 31,
December 31,
2023
2022
Company's stock price
$
4.46
$
2.81
Volatility
88.4
%
93.8
%
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Bond yield
20.8
%
16.2
%
The bond yield was derived by making the fair value of the Convertible Notes equal to the face value on the issuance date. Fair value measurements are highly sensitive to changes in these inputs and significant changes in these inputs would result in a significantly higher or lower fair value.
12. Equity
Preferred Stock
The Amended and Restated Certificate of Incorporation authorized 5,000,000 shares of preferred stock, $ 0.0001 par value, all of which is undesignated and none of which are issued or outstanding at December 31, 2023 and 2022.
Common Stock
The Amended and Restated Certificate of Incorporation authorized 100,000,000 shares of the Company’s common stock. Each share of common stock entitles the holder to one vote on all matters submitted to a vote of the Company’s stockholders. 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 Sales Agreement (the “2019 Sales Agreement”) with Jefferies LLC (“Jefferies”), under which the Company may offer and sell its common stock having aggregate proceeds of up to $ 50,000 from time-to-time through Jefferies, acting as agent. The Company did not sell any shares of common stock under the 2019 Sales Agreement in the twelve months ended December 31, 2021. 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. In the twelve months ended December 31, 2023, the Company sold 1,514,926 shares of common stock under the 2021 Sales Agreement, resulting in gross proceeds to the Company of $ 9,897 , and net proceeds, after accounting for issuance costs, of $ 9,532 . The Company did no t offer or sell shares of its common stock under the 2021 Sales Agreement during the twelve months ended December 31, 2022 and 2021, respectively.
On December 13, 2023, the Company entered into an underwriting agreement with Jefferies, BofA Securities, Inc. and Piper Sandler & Co. (collectively “the Underwriters”) in connection with an underwritten public offering of 30,800,000 shares of the Company’s common stock. Under the terms of this underwriting agreement, the Company also granted the Underwriters an option to purchase up to an additional 4,620,000 shares of common stock at the public offering price, less the underwriting discounts and commissions. On December 17, 2023, the Company sold all 35,420,000 shares of common stock and closed this underwritten public offering. The public offering price of the shares in this offering was $ 3.25 per share, and the Underwriters purchased all of the shares from the Company at a price of $ 3.055 per share. After deducting underwriting discounts and commissions and offering expenses, the Company received net proceeds from the offering of $ 107,725 .
As of December 31, 2023, the Company had reserved 24,933,970 shares of common stock for the exercise of outstanding stock options, the vesting of restricted stock units, and the number of shares remaining available for grant under its stock-based compensation plans (Note 13).
13. Stock-Based Awards
For the years ended December 31, 2023 and 2022, the Company had four stock-based compensation plans under which it was able to grant stock-based awards, the 2014 Stock Incentive Plan (the “2014 Plan”), the 2021 Stock Incentive Plan (the “2021 Plan”), the 2019 Inducement Stock Incentive Plan (the “2019 Inducement Plan”), and the 2014 Employee Stock Purchase Plan (the “ESPP”) (collectively the “Stock Plans”). Certain inducement awards made prior to inception of the 2019 Inducement Plan were issued outside of the Stock Plans. The purpose of the Stock Plans is to provide incentives to employees, directors, and nonemployee consultants. The 2014 Plan and the 2021 Plan provide for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units (“RSUs”), stock appreciation rights and other stock-based awards. As of December 31, 2023 and 2022, respectively, the Company
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had an immaterial number of vested stock awards outstanding that were granted under the Company’s 2006 Stock Incentive Plan (the “2006 Plan”). Effective as of the adoption of the 2014 Plan by the Company’s stockholders in 2014, no new awards have been granted under the 2006 Plan. As of December 31, 2023, all then outstanding awards under the 2006 Plan remained in effect and continued to be governed by the terms of the 2006 Plan.
2014 Plan - The number of shares initially reserved for issuance under the 2014 Plan was 1,336,907 shares of common stock. Between 2014 and 2021, the number of shares reserved for issuance under the 2014 Plan increased to 8,622,647 as of January 1, 2021. On June 18, 2021, the Company’s stockholders approved the adoption of 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 have been granted under the 2014 Plan. However, as of December 31, 2023, all then-outstanding awards under the 2014 Plan remained in effect and continued to be governed by the terms of the 2014 Plan.
2021 Plan - The number of shares initially reserved for issuance under the 2021 Plan was 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 2006 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). On June 16, 2022, the Company’s stockholders approved an amendment (“Amendment No. 1”) to the Company’s 2021 Plan. Amendment No. 1 increased the number of shares of common stock that is reserved for issuance under the 2021 Plan by 3,600,000 . On June 14, 2023, the Company’s stockholders approved an amendment (“Amendment No. 2”) to the Company’s 2021 Plan. Amendment No. 2 increased the number of shares of common stock that is reserved for issuance under the 2021 Plan by 3,900,000 . As of December 31, 2023, 6,219,678 shares remained available for issuance under the 2021 Plan.
2019 Inducement Plan - The 2019 Inducement Plan provides for the following types of awards, each of which is referred to as an “Award”: non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards. Awards under the 2019 Inducement Plan may only be granted to persons who (a) were not previously an employee or director of the Company or (b) are commencing employment with the Company following a bona fide period of non-employment, in either case as an inducement material to the individual’s entering into employment with the Company and in accordance with the requirements of Nasdaq Stock Market Rule 5635(c)(4). For the avoidance of doubt, neither consultants nor advisors shall be eligible to participate in the 2019 Inducement Plan. Each person who is granted an Award under the 2019 Inducement Plan is deemed a “Participant”. On December 10, 2020, the board of directors of the Company amended the 2019 Inducement Plan to increase the aggregate number of shares issuable by 554,000 shares of common stock to 1,054,000 . As of December 31, 2023, 551,375 shares remained available for issuance under the 2019 Inducement Plan.
ESPP – The number of shares initially reserved for issuance under the ESPP was 207,402 shares of common stock. 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 least of 207,402 shares of the Company’s common stock, 0.5 % of the number of shares of the Company’s common stock outstanding on the first day of the applicable fiscal year, and an amount determined by the Company’s board of directors. On January 1, 2023, the number of shares available for issuance under the ESPP increased by 207,402 . As of December 31, 2023, 398,784 shares of common stock remained available for issuance.
Stock options granted pursuant to the Stock Plans, excluding awards under the ESPP, are granted at exercise prices not to be less than the fair value of common shares as of the date of grant. They generally require a service period of 4 years and generally vest monthly, or 1/4 on the first anniversary of the grant date, with the remainder vesting monthly over the remaining three years. Stock Options granted under the 2019 Inducement Plan may in addition be subject to performance-based vesting. The maximum contractual term of Stock Options granted under the Stock Plans is generally 10 years . RSUs granted pursuant to the Stock Plans generally require a service period of 3 years and generally vest 1/3 on each anniversary of the grant date.
Valuation of Awards
The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. The expected life of the options was calculated using the simplified method. The simplified method defines the life as the average of the contractual term of the options and the weighted-average vesting period for all option tranches. The Company utilizes the simplified method because the Company does not have sufficient historical exercise data over
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the life of awards to provide a reasonable basis upon which to estimate expected term. The expected term of stock options granted to nonemployees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The Company uses its historical volatility to estimate expected volatility.
The assumptions that the Company used to determine the fair value of the stock options granted to employees and directors are as follows, presented on a weighted average basis:
Year Ended
December 31,
2023
2022
2021
Risk-free interest rate
3.72
%
2.10
%
0.80
%
Expected term (in years)
6
6
6
Expected volatility
77.32
%
81.14
%
87.65
%
Expected dividend yield
—
%
—
%
—
%
For RSUs, the grant date fair value is the closing price of the Company’s stock on the grant date.
Stock Options
The following table summarizes the Company’s stock option activity:
Weighted
Weighted
Average
Average
Remaining
Aggregate
Shares Issuable
Exercise
Contractual
Intrinsic
Under Options
Price
Term
Value
(In years)
Outstanding as of December 31, 2022
13,669,711
$
8.45
7.0
$
7
Granted
3,542,491
4.00
Exercised
( 141,952 )
3.88
Cancelled/forfeited
( 933,459 )
8.63
Outstanding as of December 31, 2023
16,136,791
$
7.51
6.1
$
3,364
Options vested and expected to vest as of December 31, 2023
14,859,010
$
7.48
5.9
$
2,910
Options exercisable as of December 31, 2023
11,073,110
$
8.18
5.0
$
1,648
The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the stock options and the fair value of the Company’s common stock for those stock options that had exercise prices lower than the fair value of the Company’s common stock. The aggregate intrinsic value of stock options exercised was $ 275 , $ 186 and $ 6,779 during the years ended December 31, 2023, 2022 and 2021, respectively.
The weighted average grant date fair value of stock options granted to employees and directors during the years ended December 31, 2023, 2022 and 2021 was $ 2.74 , $ 4.95 and $ 12.48 per share, respectively.
As of December 31, 2023, there were 67,509 outstanding unvested service-based stock options held by nonemployees.
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RSUs
The following table summarizes the Company’s activity of unvested RSUs:
Weighted
average
grant date
RSU's
fair value
Unvested balance at December 31, 2022
1,092,682
$
5.03
Granted
1,113,964
4.00
Released
( 393,805 )
4.89
Cancelled/forfeited
( 185,500 )
4.75
Unvested balance at December 31, 2023
1,627,341
$
4.40
Each RSU is equivalent to one share of common stock upon vesting. Typically, each RSU award vests on an annual basis over a three-year period. Holders of RSUs are not entitled to vote on any matters and are not entitled to dividends. The Company has determined the fair value of each RSU based on the closing price of the Company’s common stock on the date of grant and recognizes the compensation expense using the straight-line method over the service period, which coincides with the vesting period.
Stock-based Compensation
The Company recorded stock-based compensation expense in the following expense categories of its statements of operations and comprehensive loss:
Year Ended December 31,
2023
2022
2021
Research and development
$
4,508
$
4,166
$
3,750
Selling and marketing
3,682
4,684
4,014
General and administrative
9,635
8,114
7,214
$
17,825
$
16,964
$
14,978
As of December 31, 2023, the Company had an aggregate of $ 16,537 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.02 years.
14. Employee Benefits
The Company established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code (the “401(k) Plan”). The 401(k) Plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Company contributions to the plan may be made at the discretion of the board of directors. For the years ended December 31, 2023, 2022 and 2021, the Company has made contributions of $ 625 , $ 593 , and $ 493 , respectively, to the 401(k) Plan.
15. Income Taxes
During the years ended December 31, 2023, 2022 and 2021, the Company recorded no income tax benefits for the net operating losses incurred or the research and development tax credits generated in each year, due to its uncertainty of realizing a benefit from those items.
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A reconciliation of the U.S. federal statutory income tax rate to the Company’s effective income tax rate is as follows:
Year Ended December 31,
2023
2022
2021
Federal statutory income tax rate
21.0
%
21.0
%
21.0
%
Research and development tax credits
3.6
5.4
35.9
State taxes, net of federal benefit
2.0
2.6
19.3
Stock-based compensation
( 2.3 )
( 2.1 )
( 7.8 )
Derivative liability
—
2.7
244.7
Change in tax rate
( 0.4 )
1.4
( 8.4 )
Other
( 0.2 )
( 0.1 )
( 3.8 )
Change in the valuation allowance
( 23.7 )
( 30.9 )
( 300.9 )
Effective income tax rate
—
%
—
%
—
%
Changes in the valuation of the Royalty Fee Derivative Liability, except to the extent that they relate to actual royalties paid or accrued, do not provide a future tax benefit. To the extent the deferred tax asset related to the Royalty Fee Derivative Liability exceeds the deferred tax liability related to the Barings Credit Agreement, the excess is recorded as a permanent item. Changes in the valuation of the Conversion Option Derivative Liability do not provide a future tax benefit. To the extent the deferred tax asset related to the Conversion Option Derivative Liability exceeds the deferred tax liability related to the Convertible Notes, the excess is recorded as a permanent item.
Net deferred tax assets consisted of the following:
December 31,
2023
2022
Deferred tax assets:
Net operating loss carryforwards
$
120,971
$
113,801
Tax credit carryforwards
22,597
19,653
Capitalized start-up costs
121
255
Capitalized research and development expenses, net - Sec. 59(e) :
3,570
5,773
Capitalized research and development expenses, net Sec. 174
19,491
10,046
Operating lease liabilities
1,970
2,422
Derivative liability
6,981
1,497
Stock-based Awards
10,443
8,783
Accrued expenses and other
8,433
6,274
Total deferred tax assets
194,577
168,504
Valuation allowance
( 183,737 )
( 164,546 )
Net deferred tax assets
10,840
3,958
Deferred tax liabilities:
Operating lease right of use assets
( 1,507 )
( 1,895 )
Convertible Notes
( 6,603 )
( 2,063 )
Barings Credit Facility
( 2,730 )
—
Total deferred tax liabilities
( 10,840 )
( 3,958 )
Net deferred tax assets
$
—
$
—
Changes in the valuation allowance for deferred tax assets during the years ended December 31, 2023, 2022 and 2021 related primarily to the increase in net operating loss carryforwards, amortization of capitalized research and development expenses, and increase in research and development tax credit carryforwards were as follows:
Year Ended December 31,
2023
2022
2021
Valuation allowance as of beginning of year
$
164,546
$
142,637
$
123,020
Increases recorded to income tax provision
19,191
21,909
19,617
Valuation allowance as of end of year
$
183,737
$
164,546
$
142,637
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As of December 31, 2023, the Company had net operating loss (“NOL”) carryforwards for federal and state income tax purposes of $ 482,561 and $ 343,803 , respectively. The federal and state NOLs generated for annual periods prior to January 1, 2018 begin to expire in 2026. The Company’s federal NOLs generated for the years ended since December 31, 2018, which amounted to a total of $ 356,757 , can be carried forward indefinitely. As of December 31, 2023, the Company also had available research and development tax credit carryforwards for federal and state income tax purposes of $ 15,383 and $ 8,794 , respectively, which begin to expire in 2026 and 2025, respectively. Utilization of the NOL carryforwards and research and development tax credit carryforwards may be subject to a substantial annual limitation under Section 382 of the Internal Revenue Code of 1986 (“Section 382”) due to ownership changes that have occurred previously or that could occur in the future. These ownership changes may limit the amount of carryforwards that can be utilized annually to offset future taxable income. In general, an ownership change, as defined by Section 382, results from transactions increasing the ownership of certain shareholders or public groups in the stock of a corporation by more than 50% over a three-year period. The Company has not conducted a study to assess whether a change of control has occurred or whether there have been multiple changes of control since inception due to the significant complexity and cost associated with such a study. If the Company has experienced a change of control, as defined by Section 382, at any time since inception, utilization of the NOL carryforwards or research and development tax credit carryforwards would be subject to an annual limitation under Section 382, which is determined by first multiplying the value of the Company’s stock at the time of the ownership change by the applicable long-term tax-exempt rate, and then could be subject to additional adjustments, as required. Any limitation may result in expiration of a portion of the NOL carryforwards or research and development tax credit carryforwards before utilization. Further, until a study is completed and any limitation is known, no amounts are being presented as an uncertain tax position.
The Company has evaluated the positive and negative evidence bearing upon its ability to realize the deferred tax assets. Management considered the Company’s cumulative net losses and concluded that it is more likely than not that the Company would not realize the benefits of the deferred tax assets. Accordingly, a full valuation allowance was established against the net deferred tax assets as of December 31, 2023, 2022 and 2021.
The Company has no t recorded any amounts for unrecognized tax benefits as of December 31, 2023, 2022 or 2021.
The Company files tax returns as prescribed by the tax laws of the jurisdictions in which it operates. In the normal course of business, the Company is subject to examination by federal and state jurisdictions, where applicable. There are currently no pending income tax examinations. The Company’s tax years are still open under statute from the Company’s fiscal year 2019 to the present. Earlier years may be examined to the extent that tax credit or net operating loss carryforwards are used in future periods.
16. Net Loss Per Share
Basic and diluted net loss per share attributable to common stockholders was calculated as follows for the years ended December 31, 2023, 2022 and 2021:
Year ended December 31,
2023
2022
2021
Numerator:
Net loss attributable to common stockholders
$
( 80,736 )
$
( 71,038 )
$
( 6,553 )
Denominator:
Weighted average common shares outstanding, basic
79,827,362
76,875,035
76,392,870
Net loss per share - basic
$
( 1.01 )
$
( 0.92 )
$
( 0.09 )
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Basic and diluted net loss per share was calculated as follows for the years ended December 31, 2023, 2022 and 2021:
Year Ended December 31,
2023
2022
2021
Net loss attributable to common stockholders, basic
$
( 80,736 )
$
( 71,038 )
$
( 6,553 )
Interest expense on Convertible Notes
4,172
4,596
4,409
Gain on extinguishment of debt (Note 9)
( 14,907 )
—
—
Change in fair value of derivative liability
4,502
( 13,841 )
( 78,121 )
Net loss attributable to common stockholders, diluted
$
( 86,969 )
$
( 80,283 )
$
( 80,265 )
Weighted average common shares outstanding, basic
79,827,362
76,875,035
76,392,870
Dilutive options (treasury stock method)
—
—
—
Shares issuable upon conversion of Convertible Notes, as if converted
5,769,232
5,769,232
5,769,232
Weighted average common shares outstanding, diluted
85,596,594
82,644,267
82,162,102
Net loss per share attributable to common stockholders, diluted
$
( 1.02 )
$
( 0.97 )
$
( 0.98 )
The Company excluded the following common stock equivalents, outstanding as of December 31, 2023, 2022 and 2021 from the computation of diluted net loss per share attributable to common stockholders for the years ended December 31, 2023, 2022 and 2021 because they had an anti-dilutive impact due to the net loss incurred for the periods.
December 31,
2023
2022
2021
Options to purchase common stock
16,136,791
13,669,711
10,934,828
Restricted stock units
1,627,341
1,092,682
—
17,764,132
14,762,393
10,934,828
17. Commitments and Contingencies
Indemnification Agreements
In the ordinary course of business, the Company enters into agreements that may include indemnification provisions. Pursuant to such agreements, the Company may indemnify, hold harmless and defend indemnified parties for losses suffered or incurred by the indemnified party. Some of the provisions will limit losses to those arising from third-party actions. In some cases, the indemnification will continue after the termination of the agreement. The maximum potential amount of future payments the Company could be required to make under these provisions is not determinable. To date, the Company has not incurred any material costs as a result of such indemnifications.
18. Related Party Transactions
The Company has engaged Wilmer Cutler Pickering Hale and Dorr LLP (“WilmerHale”) to provide certain legal services to the Company. The sister of the Company's former Chief Business Officer Christopher White was a managing partner at WilmerHale, who has not participated in providing legal services to the Company. The Company incurred fees for legal services rendered by WilmerHale of approximately $ 1,472 , $ 959 and $ 1,396 for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023 and 2022, there was $ 298 and $ 0 recorded in accounts payable for WilmerHale. As of December 31, 2023 and 2022, there was $ 0 and $ 24 recorded in accrued expenses for WilmerHale.
The Company has engaged Heier Consulting, LLC (“Heier Consulting”), an entity affiliated with Jeffrey Heier, M.D. a former member of the Company’s Board of Directors and the Company’s current Chief Scientific Officer, to provide advice or expertise on one or more of the Company’s development-stage drug or medical device products
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relating to retinal diseases or conditions under a consultant agreement. Compensation for these services is in the form of cash and stock-based awards. The total grant date fair value of stock-based awards granted to Heier Consulting is $ 96 , which is recognized to expense on a straight-line basis over the respective vesting periods. The Company incurred cash-based fees for services rendered by Heier Consulting of approximately $ 32 , 24 , and $ 0 for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023 and 2022, there was $ 6 and $ 3 recorded in accounts payable for Heier Consulting. As of December 31, 2023 and 2022, there was $ 0 and $ 0 recorded in accrued expenses for Heier Consulting. Effective February 21, 2024, the Company and Heier Consulting terminated this relationship.
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. On April 26, 2021, the Company and Specialty Pharma terminated their relationship. The Company incurred fees for quality engineering and validation activities rendered by Specialty Pharma of $ 0 , $ 0 and $ 155 for the years ended December 31, 2023, 2022 and 2021, respectively. As of December 31, 2023 and 2022, there were no liabilities recorded with regard to Specialty Pharma.
19 . Subsequent Events
Securities Purchase Agreement
On February 21, 2024, the Company, entered into a securities purchase agreement (the “Securities Purchase Agreement”) with certain institutional accredited investors (the “Investors”), pursuant to which the Company issued and sold to the Investors in a private placement an aggregate of 32,413,560 shares of the Company’s common stock, par value $ 0.0001 per share (the “Shares”), at a price of $ 7.52 per share, and, to certain Investors in lieu of Shares, pre-funded warrants to purchase 10,805,957 shares of the Company’s common stock (the “Pre-Funded Warrants”), at a price of $ 7.519 per Pre-Funded Warrant (the “2024 Private Placement”). Each Pre-Funded Warrant issued in the 2024 Private Placement has an exercise price of $ 0.001 per share, is currently exercisable and will remain exercisable until the Pre-Funded Warrant is exercised in full. The 2024 Private Placement closed on February 26, 2024. The Company received aggregate gross proceeds from the 2024 Private Placement of approximately $ 325,000 , before deducting placement agent fees and offering expenses.
2019 Inducement Plan
On February 20, 2024, the Company’s board of directors amended the 2019 Inducement Plan to increase the aggregate number of shares issuable thereunder from 1,054,000 to 3,804,000 shares of common stock. On February 22, 2024, the Company granted a total of 1,527,019 non-statutory stock options and a total of 935,279 RSUs under the 2019 Inducement Plan to the Company’s newly appointed Executive Chairman and its new Chief Strategy Officer.
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 least of 207,402 shares of the Company’s common stock, 0.5 % of the number of shares of the Company’s common stock outstanding on the first day of the applicable fiscal year, and an amount determined by the Company’s board of directors. On January 1, 2024, the number of shares available for issuance under the ESPP increased by 207,402 .
F-36