What changed in this filing

/stocks — the workspaceLOADING

Item 9A. Controls and Procedures

2023-03-06 compared with 2022-02-28 · 425 added, 477 removed, 634 unchanged (59% of the section changed)

1 unchanged sentence

Evaluation of Disclosure Controls and Procedures

Our management, with the participation of our President and Chief Executive Officer and Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of December 31, 2021.

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 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 Securities and Exchange Commission’s rules and forms.

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, 2022.

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 President and 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, 2021, our President and 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, 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, 2022, 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:

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;

6 unchanged sentences

Based on that assessment, our management concluded that, as of December 31, 2022, our internal control over financial reporting was effective.

The effectiveness of our internal control over financial reporting as of December 31, 2021, has been audited by PricewaterhouseCoopers LLP, an independent registered public accounting firm, as stated in their report, which appears herein.

Changes in Internal Control Over Financial Reporting

18 unchanged sentences

Audit Committee Financial Expert

Our board of directors has determined that each of Bruce Peacock, who has provided us with notice of his intent to resign immediately following the 2022 Annual Meeting of Stockholders, and Merilee Raines, qualify 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.

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.

Executive Compensation

2 unchanged sentences

The information required by this item will be set forth in our Proxy Statement for the 2023 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.

Securities Authorized for Issuance under Equity Compensation Plans

The information required by this item will be set forth in our Proxy Statement for the 2022 Annual Meeting of Stockholders and is incorporated in this Annual Report on Form 10-K by reference.

Certain Relationships and Related Transactions, and Director Independence

41 unchanged sentences

Lease Agreement dated June 17, 2016 between the WS NF 15 Crosby Drive, LLC and the Registrant

Open Market Sale Agreement SM , dated as of August 9, 2021, by and between the Registrant and Jefferies LLC

Open Market Sale Agreement, dated as of August 9, 2021, by and between the Registrant and Jefferies LLC

Employment Agreement, by and between the Registrant and Philip Strassburger, dated August 28, 2020

5 unchanged sentences

Mattessich dated as of June 20, 2017

Employment Agreement, by and between the Registrant and Donald Notman, dated as of September 25, 2017

Incorporated by Reference

Description of Exhibit

Employment Agreement, by and between the Registrant and Donald Notman, dated as of September 25, 2017

Second Amendment to Lease, by and between the Registrant and CCC Investors LLC, dated October 10, 2017

6 unchanged sentences

Note Purchase Agreement (including Form of Senior Subordinated Convertible Note), dated as of February 21, 2019, by and among the Registrant and the Purchasers listed therein

Sublease, dated as of April 4, 2019, by and among Ocular Therapeutix, Inc.

and Holcim (US) Inc.

Incorporated by Reference

Description of Exhibit

Sublease, dated as of April 4, 2019, by and among Ocular Therapeutix, Inc.

and Holcim (US) Inc.

License Agreement, by and between the Registrant and AffaMed Therapeutics Limited, dated as of October 29, 2020

1 unchanged sentence

Fourth Amended and Restated Credit and Security Agreement dated June 4, 2021 by and among the Registrant, MidCap Financial Trust, as administrative agent, and the Lenders listen therein

2021 Stock Incentive Plan

2021 Stock Incentive Plan, as amended

Form of Option Grant Agreement under 2021 Stock Incentive Plan

2 unchanged sentences

1 to License Agreement, by and between the Registrant and AffaMed Therapeutics (HK) Limited, dated as of October 28, 2021

Consulting Agreement by and between the Registrant and Dr.

Michael Goldstein, dated as of June 7, 2022

Consulting Agreement by and between the Registrant and Dr.

Jeffrey Heier, dated as of October 17, 2022

Employment Agreement, by and between the Registrant and Rabia Ozden-Gurses, dated as of September 28, 2022

Incorporated by Reference

Description of Exhibit

Employment Agreement, by and between the Registrant and Christopher White, dated as of October 13, 2022

Subsidiaries of the Registrant

9 unchanged sentences

Inline XBRL Taxonomy Extension Calculation Linkbase Document

Incorporated by Reference

Description of Exhibit

Inline XBRL Taxonomy Extension Label Linkbase Database

6 unchanged sentences

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.

February 28, 2022

March 6, 2023

OCULAR THERAPEUTIX, INC.

8 unchanged sentences

(Principal Executive Officer)

February 28, 2022

March 6, 2023

/s/ Donald Notman

Chief Financial Officer

February 28, 2022

March 6, 2023

Donald Notman

2 unchanged sentences

Chairman of the Board

February 28, 2022

March 6, 2023

Charles Warden

/s/ Jeffrey S.

February 28, 2022

March 6, 2023

/s/ Seung Suh Hong, PH.D.

February 28, 2022

March 6, 2023

Seung Suh Hong, PH.D.

1 unchanged sentence

Lindstrom, M.D.

February 28, 2022

March 6, 2023

Lindstrom, M.D.

/s/ Merilee Raines

February 28, 2022

March 6, 2023

Merilee Raines

February 28, 2022

/s/ Leslie Williams

February 28, 2022

March 6, 2023

Leslie Williams

9 unchanged sentences

To the Board of Directors and Stockholders of Ocular Therapeutix, Inc.

Opinions on the Financial Statements and Internal Control over Financial Reporting

Opinions 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, 2021 and 2020, 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, 2021, including the related notes (collectively referred to as the “consolidated financial statements”).

We also have audited the Company's internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the Committee of Sponsoring Organizations of the Treadway Commission (COSO).

In our opinion, the consolidated financial statements referred to above present fairly, in all material respects, the financial position of the Company as of December 31, 2021 and 2020, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2021 in conformity with accounting principles generally accepted in the United States of America.

Also in our opinion, the Company maintained, in all material respects, effective internal control over financial reporting as of December 31, 2021, based on criteria established in Internal Control - Integrated Framework (2013) issued by the COSO.

Basis for Opinions

The Company's management is responsible for these consolidated financial statements, for maintaining effective internal control over financial reporting, and for its assessment of the effectiveness of internal control over financial reporting, included in Management’s Annual Report on Internal Control Over Financial Reporting appearing under Item 9A.

Our responsibility is to express opinions on the Company’s consolidated financial statements and on the Company's internal control over financial reporting based on our audits.

and its subsidiaries (the “Company”) as of December 31, 2022 and 2021, and the related consolidated statements of operations and comprehensive loss, of stockholders’ equity (deficit) and of cash flows for each of the three years in the period ended December 31, 2022, 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, 2022 and 2021, and the results of its operations and its cash flows for each of the three years in the period ended December 31, 2022 in conformity with accounting principles generally accepted in the United States of America.

Emphasis of Matter

As discussed in Note 1 to the consolidated financial statements, the Company will require additional financing to fund future operations.

Management’s evaluation of the events and conditions and management’s plans to mitigate these matters are also described in Note 1.

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 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, and whether effective internal control over financial reporting was maintained in all material respects.

Our audits of the consolidated financial statements 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.

We conducted our audits of these consolidated financial statements in accordance with the standards of the PCAOB.

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.

Our audit of internal control over financial reporting included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, and testing and evaluating the design and operating effectiveness of internal control based on the assessed risk.

Our audits also included performing such other procedures as we considered necessary in the circumstances.

We believe that our audits provide a reasonable basis for our opinions.

Definition and Limitations of Internal Control over Financial Reporting

A company’s internal control over financial reporting is a process designed 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.

A company’s internal control over financial reporting includes those policies and procedures that (i) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the transactions and dispositions of the assets of the company;

(ii) 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 the company are being made only in accordance with authorizations of management and directors of the company;

and (iii) 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.

We believe that our audits provide a reasonable basis for our opinion.

Critical Audit Matters

3 unchanged sentences

As described in Notes 2, 10 and 11 to the consolidated financial statements, the Company’s derivative liability balance was $6.4 million as of December 31, 2022 and the change in fair value recorded in other income (expense), net was $13.8 million for the year ended December 31, 2022.

The derivative liability was recorded at fair value upon the issuance of the 2026 convertible notes and is subsequently remeasured to fair value at each reporting period.

The derivative liability was recorded at fair value upon the

issuance of the 2026 convertible notes and is subsequently remeasured to fair value at each reporting period.

The derivative liability was initially valued and remeasured using a “with-and-without” method.

8 unchanged sentences

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 testing the effectiveness of controls relating to the derivative liability, including controls over the main inputs and significant assumption used to estimate the derivative liability.

These procedures also 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.

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.

1 unchanged sentence

Boston, Massachusetts

February 28, 2022

March 6, 2023

We have served as the Company’s auditor since 2008.

14 unchanged sentences

Accrued expenses and other current liabilities

Deferred revenue

Operating lease liabilities

Notes payable, net of discount, current

Total current liabilities

2 unchanged sentences

Derivative liability

Deferred revenue

Deferred revenue, net of current portion

Notes payable, net of discount

Other Non-Current Liabilities

2026 convertible notes, net

Total liabilities

Commitments and contingencies

Commitments and contingencies (Note 17)

Stockholders’ equity:

2 unchanged sentences

Common stock, $ 0.0001 par value;

200,000,000 and 100,000,000 shares authorized and 76,731,940 and 75,996,732 shares issued and outstanding at December 31, 2021 and December 31, 2020, respectively

200,000,000 shares authorized and 77,201,819 and 76,731,940 shares issued and outstanding at December 31, 2022 and December 31, 2021, respectively

Additional paid-in capital

8 unchanged sentences

Product revenue, net

Collaboration revenue

Total revenue, net

11 unchanged sentences

Other income (expense), net

Total other income (expense), net

Net loss and comprehensive loss

Total other (expense) income, net

Net loss per share, basic

15 unchanged sentences

Issuance of common stock in connection with employee stock purchase plan

Issuance of common stock upon public offering, net of issuance costs

Issuance of common stock upon cashless exercise of warrant

Common stock issuance costs

Stock-based compensation expense

2 unchanged sentences

Issuance of common stock in connection with employee stock purchase plan

Issuance of common stock upon cashless exercise of warrant

Common stock issuance costs

Stock-based compensation expense

11 unchanged sentences

Depreciation and amortization expense

Gain on disposal of property and equipment

Gain (loss) on disposal of property and equipment

Changes in operating assets and liabilities:

12 unchanged sentences

Proceeds from issuance of notes payable, net

Proceeds from issuance of 2026 convertible notes, net of issuance costs

Proceeds from exercise of stock options

6 unchanged sentences

Net cash provided by financing activities

Net (decrease) increase in cash, cash equivalents and restricted cash

Net decrease in cash, cash equivalents and restricted cash

Cash, cash equivalents and restricted cash at beginning of period

3 unchanged sentences

Supplemental disclosure of non-cash investing and financing activities:

Additional right of use asset and related lease liability

Additions to property and equipment included in accounts payable and accrued expenses at balance sheet dates

Cashless exercise of warrant

Derivative liability in connection with issuance of 2026 convertible notes

Additions to property and equipment included in accounts payable and accrued expenses

Public offering costs included in accounts payable and accrued expenses at balance sheet dates

6 unchanged sentences

(the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware.

The Company is a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary, bioresorbable hydrogel platform technology.

The Company’s product pipeline candidates provide differentiated drug delivery solutions that reduce the complexity and burden of the current standard of care by creating local programmed-release alternatives.

Since inception, the Company’s operations have been primarily focused on organizing and staffing the Company, acquiring rights to intellectual property, business planning, raising capital, developing its technology, identifying product candidates, undertaking preclinical studies and clinical trials, manufacturing initial quantities of its products and product candidates and building the initial sales and marketing infrastructure for the commercialization of the Company’s approved products and product candidates and launching its initial product.

The Company’s mission is to build an ophthalmology-focused biopharmaceutical company that capitalizes on the gaps that the Company believes increasingly exist in the ophthalmology sector between single product companies and large, multi-product pharmaceutical companies.

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.

1 unchanged sentence

Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization.

As of December 31, 2021, the Company had two FDA-approved products in commercialization in the United States:

DEXTENZA® (dexamethasone insert) 0.4mg, an intracanalicular insert for the treatment of post-surgical ocular inflammation and pain and ReSure® Sealant, an ophthalmic device designed to prevent wound leaks in corneal incisions following cataract surgery.

In October 2021, DEXTENZA received approval for the treatment of ocular itching associated with allergic conjunctivitis.

While ReSure Sealant is commercially available in the United States, it does not receive sales support, is not currently being manufactured by the Company, and has not in the past generated, nor is it anticipated to in the future to generate, material revenues.

The Company 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 suspended the production of ReSure® Sealant, an ophthalmic device designed to prevent wound leaks in corneal incisions following cataract surgery, as of the fourth quarter of 2021 in order to focus our manufacturing resources on DEXTENZA.

Currently, ReSure Sealant is not commercially available in the United States, and we have received only limited revenues from ReSure Sealant to date.

The Company’s most advanced product candidates are in either Phase 1 or Phase 2 of clinical stage development.

7 unchanged sentences

As of December 31, 2022, the Company had an accumulated deficit of $ 616,842 .

The Company believes that its existing cash and cash equivalents of $ 164,164 , as of December 31, 2021, along with its current operating plan, which includes revenues from the sale of DEXTENZA, will enable it to fund its planned operating expenses, debt service obligations and capital expenditure at least through the next 12 months.

Based on its current operating plan which includes estimates of anticipated cash inflows from product sales and cash outflows from operating expenses, the Company believes that its existing cash and cash equivalents of $ 102,300 as of December 31, 2022 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.

The future viability of the Company beyond that point is dependent on its 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 or other sources, which may include licensing, collaborations or other strategic transactions or arrangements.

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.

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”).

Risks and Uncertainties

The Company is monitoring the potential impact of the COVID-19 pandemic, if any, on the carrying value of certain assets.

To date, the Company has not experienced a material business disruption, nor has it incurred impairment of any assets as a result of the COVID-19 pandemic.

The extent to which these events may impact the Company’s business will depend on future developments, which are highly uncertain and cannot be predicted at this time.

The duration and intensity of the COVID-19 pandemic and any resulting disruption to the Company’s operations is uncertain, and the Company will continue to assess the impact of the COVID-19 pandemic on its financial position.

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.

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.

2 unchanged sentences

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, revenue recognition, and the fair value of derivatives.

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.

2 unchanged sentences

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 money market accounts, are stated at fair value.

Cash equivalents, which primarily consist of investments in money market funds, are stated at fair value.

Revenue Recognition

Product Revenue

The Company recognizes product revenue from DEXTENZA for the treatment of post-surgical ocular inflammation and pain, which it began selling to customers in June 2019, and ReSure Sealant.

The Company has generated limited revenues from ReSure Sealant to date and does not expect significant future sales.

In November 2018, the FDA approved DEXTENZA for the treatment of ocular pain following ophthalmic surgery.

The Company entered into a limited number of arrangements with specialty distributors in the United States to distribute DEXTENZA.

The Company recognizes revenue in accordance with Accounting Standards Codification 606 – Revenue from Contracts with Customers (“Topic 606”).

Topic 606 applies to all contracts with customers, except for contracts that are within the scope of other standards, such as leases, insurance arrangements and financial instruments.

Under Topic 606, an entity recognizes revenue when its 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 Topic 606, the entity performs the following five steps:

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.

Company only applies the five-step model to arrangements that meet the definition of a contract with a customer under Topic 606, including when it is probable that the Company will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.

At contract inception, once the contract is determined to be within the scope of Topic 606, 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.

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.

For a complete discussion of accounting for product revenue, see Product Revenue, Net (below).

Product Revenue, Net — The Company derives its product revenues from the sale of DEXTENZA in the United States to customers, which includes a limited number of specialty distributors, who then subsequently resell DEXTENZA to physicians, clinics and certain medical centers or hospitals.

In addition to distribution agreements with customers, the Company enters into arrangements with government payors that provide for government mandated rebates and chargebacks with respect to the purchase of DEXTENZA.

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, or 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).

The Company has determined that the delivery of DEXTENZA to its customers constitutes a single performance obligation.

There are no other promises to deliver goods or services beyond what is specified in each accepted customer order.

The Company has assessed the existence of a significant financing component in the agreements with its customers.

The trade payment terms with the Company’s customers do not exceed one year and therefore the Company has elected to apply the practical expedient and no amount of consideration has been allocated as a financing component.

Product revenues are recorded net of applicable reserves for variable consideration, including discounts and allowances.

Transaction Price, including Variable Consideration — Revenues from product sales are recorded at the net sales price (transaction price), which includes estimates of variable consideration for which reserves are established.

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 relating to the Company’s sale of DEXTENZA.

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.

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 Topic 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.

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.

4 unchanged sentences

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 in certain circumstances as further discussed below.

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.

The Company has received no returns to date and believes the returns of DEXTENZA will be minimal.

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 340B entities at prices lower than the list prices charged to customers who directly purchase the product from the Company.

The 340B Drug Discount Program is a U.S.

federal government program created in 1992 that requires drug manufacturers to provide outpatient drugs to eligible health care organizations and covered entities at significantly reduced prices.

Customers charge the Company for the difference between what they pay for the product and the statutory selling price to the qualified government entity.

Department of Veterans Affairs hospitals and entities that are subject to the U.S.

federal government 340B Drug Discount Program entities 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.

Chargeback amounts are generally determined at the time of resale to the qualified government healthcare provider by 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 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.

Government Rebates — The Company is subject to discount obligations under state Medicaid programs and Medicare.

3 unchanged sentences

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.

Rebates — The Company offers rebate payments for which ambulatory surgical centers, hospital out-patient departments and other prescribers qualify by meeting quarterly purchase volumes of DEXTENZA under the Company’s rebate program.

The Company calculates rebate payment amounts due under this program quarterly, based on actual qualifying purchase and applies a contractual discount rate.

The calculation of the accrual for rebates is based on an estimate of claims 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.

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.

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.

2 unchanged sentences

Collaboration Revenue

To determine the appropriate amount of revenue to be recognized for arrangements the Company determines are within the scope of Topic 606, the Company performs the following steps:

(i) identify the contract(s) with its 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 each performance obligation is satisfied.

The Company accounts for a contract with a customer that is within the scope of Topic 606 when all of the following criteria are met:

(i) the arrangement has been approved by the parties and the parties are committed to perform their respective obligations;

(ii) each party’s rights regarding the goods and/or services to be transferred can be

(iii) the payment terms for the goods and/or services to be transferred can be identified;

(iv) the arrangement has commercial substance;

and (v) collection of substantially all of the consideration to which the Company will be entitled in exchange for the goods and/or services that will be transferred to the customer is probable.

The Company also determines the term of the contract based on the period in which the Company and its customer have present and enforceable rights and obligations for purposes of identifying the performance obligations and determining the transaction price.

The Company evaluates contracts that contain multiple promises to determine which promises are distinct.

10 unchanged sentences

If not, the option is considered a marketing offer which would be accounted for as a separate contract upon the customer’s election.

The transaction price is generally comprised of an upfront payment due at contract inception and variable consideration in the form of payments for the Company’s goods and services and materials and milestone payments due upon the achievement of specified events.

Other payments the Company could be entitled to include tiered royalties earned when customers recognize net sales of licensed products.

The Company considers the existence of any significant financing component within its arrangements and have determined that a significant financing component does not exist in its arrangements as substantive business purposes exist to support the payment structure other than to provide a significant benefit of financing.

The Company considers the existence of any significant financing component within its arrangements based on whether a substantive business purposes exist 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.

4 unchanged sentences

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, adjust its estimate of the overall transaction price.

Any such adjustments are recorded on a cumulative catch-up basis, which would affect revenue and net loss in the period of adjustment.

Any such adjustments 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:

1 unchanged sentence

Consideration that would be received for optional goods and/or services is excluded from the transaction price at contract inception.

The Company recognizes as an asset the incremental costs of obtaining a contract with a customer if the costs are expected to be recovered.

The Company has elected a practical expedient wherein it recognizes the incremental costs of obtaining a contract as an expense when incurred if the amortization period of the asset that it otherwise would have recognized is one year or less.

To date, the Company has not incurred any incremental costs of obtaining a contract with a customer.

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.

The Company values its inventories at the lower of cost or estimated net realizable value.

The Company determines the cost of its inventories, which includes amounts related to materials and manufacturing overhead, on a first-in, first-out basis.

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 determination of whether inventory costs will be realizable requires estimates by management.

If actual market conditions are less favorable than projected by management, additional write-downs of inventory may be required, which would be recorded as a cost of product revenue in the consolidated statements of operations and comprehensive loss.

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.

2 unchanged sentences

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.

Inventory consisted of the following:

Raw materials

Work-in-process

Finished goods

Restricted Cash

As of December 31, 2021, 2020 and 2019, the Company held restricted cash of $ 1,764 , respectively, on its consolidated balance sheet.

The Company held restricted cash as security deposits for the lease of its manufacturing space and corporate headquarters.

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:

Cash and cash equivalents

Restricted cash

Total cash, cash equivalents and restricted cash as shown on the statements of cash flows

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 all cash and cash equivalents balances at one accredited financial institution, 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 sales of its product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.

For the year ended December 31, 2021, three specialty distributor customers accounted for 42 %, 26 % and 17 % of the Company’s total revenue and three specialty distributor customers accounted for 42 %, 26 % and 21 % of the Company’s total accounts receivable.

No other customer accounted for more than 10% of total revenue or accounts receivable for the year ended December 31, 2021.

For the year ended December 31, 2020, three specialty distributor customers accounted for 42 %, 29 % and 12 % of the Company’s total revenue and three specialty distributor customers accounted for 42 %, 33 % and 15 % of the Company’s total accounts receivable.

No other customer accounted for more than 10% of total revenue or accounts receivable for the year ended December 31, 2020.

Fair Value Measurements

6 unchanged sentences

● 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.

The Company’s cash equivalents at December 31, 2021 and 2020 were carried at fair value determined according to the fair value hierarchy described above (Note 3).

The Company’s derivative liability at December 31, 2021 and 2020 was carried at fair value determined according to the fair value hierarchy described above and classified as a Level 3 measurement.

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 notes payable (Note 9) are recorded at amortized costs, which approximates fair value due to their short-term nature.

On March 1, 2019, the Company issued $ 37,500 aggregate principal amount of unsecured senior subordinated convertible notes (the “2026 Convertible Notes”) (Note 5) which is carried, net of derivative liability, at its amortized cost of $ 26,435 at December 31, 2021.

The estimated fair value of the 2026 Convertible Notes was $ 52,790 and $ 129,362 at December 31, 2021 and 2020.

The fair value of the 2026 Convertible Notes was estimated utilizing a binomial lattice model which requires the use of Level 3 unobservable inputs.

The main input when determining the fair value of the 2026 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.

Derivative Liability

The 2026 Convertible Notes allow the holders to convert all or part of the outstanding principal of their 2026 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.

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.

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 2026 Convertible Notes, as discussed in Note 9, allow the holders to convert all or part of the outstanding principal of their 2026 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 2026 Convertible Notes and accounted for as a freestanding derivative instrument subject to derivative accounting.

10 unchanged sentences

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.

Impairment of Long-Lived Assets and Right of Use Assets

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.

8 unchanged sentences

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.

Research Contract Costs and Accruals

The Company has entered into various research and development contracts with research institutions and other companies both inside and outside of the United States.

Certain of these agreements have cancellation clauses, and related payments are recorded as research and development expenses as incurred.

The Company records accruals for estimated ongoing research costs.

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 and contracted costs.

2 unchanged sentences

The Company’s historical accrual estimates have not been materially different from the actual costs.

All patent-related costs incurred in connection with filing and prosecuting patent applications are recorded as general and administrative expenses as incurred, as recoverability of such expenditures is uncertain.

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 and directors at the fair value on the date of the grant using the Black-Scholes option-pricing model.

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.

Following the Company’s adoption of Accounting Standards Update (“ASU”) 2018-07, Compensation—Stock Compensation (Topic 718), Improvements to Nonemployee Share-Based Payment Accounting (“ASU 2018-07”), on January 1, 2019, for stock-based awards issued to non-employees, the Company no longer revalues non-employee awards at each reporting date and instead calculates the fair value of the awards as of the grant date using the Black-Scholes option-pricing model.

Compensation expense for these awards is recognized over the related service period.

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.

The Company recognizes compensation expense for only the portion of awards that are expected to vest.

1 unchanged sentence

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 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.

4 unchanged sentences

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.

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 as well as the related net interest and penalties.

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.

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 tangible assets are held in the United States.

Revenue to date has been generated through product sales, all of which has been earned in the United States.

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

3 unchanged sentences

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, including the assumed conversion of the Company’s 2026 Convertible Notes, 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 the 2026 Convertible Notes, 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 the 2026 Convertible Notes (which includes amortization of the discount created upon bifurcation of the conversion option from the debt) and, the mark-to-market gain or loss each period to the bifurcated conversion option, if the impact was not anti-dilutive.

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 Adopted Accounting Pronouncements

In December 2019, the FASB issued ASU No.

2019-12, Income Taxes Topic 740, Simplifying the Accounting for Income Taxes (“ASU 2019-12”).

ASU 2019-12 removes certain exceptions for investments, intra-period allocations and interim calculations, and adds guidance to reduce complexity in accounting for income taxes.

The guidance is effective for fiscal years beginning after December 15, 2020, including interim periods within those fiscal years.

The Company adopted this accounting pronouncement as required effective January 1, 2021 and its adoption did not have a material impact on the consolidated financial statements.

In June 2016, the FASB issued ASU No.

2016-13, Financial Instruments—Credit Losses (Topic 326):

Measurement of Credit Losses on Financial Instruments (‘‘ASU 2016-13’’), which requires the measurement and recognition of expected credit losses for financial assets held at amortized cost.

ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss model.

It also eliminates the concept of other-than-temporary impairment and requires credit losses related to available-for-sale debt securities to be recorded through an allowance for credit losses rather than as a reduction in the amortized cost basis of the securities.

These changes may result in earlier recognition of credit losses.

In November 2018, the FASB issued ASU No.

2018-19, Codification Improvements to Topic 326, Financial Instruments—Credit Losses, which narrowed the scope and changed the effective date for non-public entities for ASU 2016-13.

The FASB subsequently issued supplemental guidance within ASU No.

2019-05, Financial Instruments—Credit Losses (Topic 326):

Targeted Transition Relief (‘‘ASU 2019-05’’).

ASU 2019-05 provides an option to irrevocably elect the fair value option for certain financial assets previously measured at amortized cost basis.

The Company adopted this accounting pronouncement as required and its adoption did not have a material impact on the consolidated financial statements.

Recently Issued Accounting Pronouncements

In August 2020, the FASB issued ASU No.

2 unchanged sentences

The amendments in the ASU are effective for public business entities that meet the definition of an SEC filer, excluding entities eligible to be smaller reporting companies as defined by the SEC, for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years.

Early adoption is permitted, but no earlier than fiscal years beginning after December 15, 2020, including interim periods within those fiscal years.

The FASB also specified that an entity should adopt the guidance as of the beginning of its fiscal year and is not permitted to adopt the guidance in an interim period.

The Company is assessing the potential impact of ASU 2020-06 and does not expect it to have a material impact on its consolidated financial statements.

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, 2021 and 2020 and indicate the level of the fair value hierarchy utilized to determine such fair value:

Fair Value Measurements as of

December 31, 2021 Using:

Cash equivalents:

Money market funds

Derivative liability (Note 4)

Fair Value Measurements as of

December 31, 2020 Using:

Cash equivalents:

Money market funds

Derivative liability (Note 4)

During the year ended December 31, 2021 and 2020, there were no transfers between Level 1 and 2.

Derivative Liability

The 2026 Convertible Notes (Note 5) contained an embedded conversion option that met the criteria to be bifurcated and accounted for separately from the 2026 Convertible Notes (the "Derivative Liability").

The Derivative Liability was recorded at fair value upon the issuance of the 2026 Convertible Notes and is subsequently remeasured to fair value at each reporting period.

The Derivative Liability was initially valued and remeasured using a "with-and-without"

The "with-and-without"

methodology involves valuing the whole instrument on an as-is basis and then valuing the instrument without the embedded conversion option.

The difference between the entire instrument with the embedded conversion option compared to the instrument without the embedded conversion option is the fair value of the derivative, recorded as the Derivative Liability.

The fair value of the 2026 Convertible Notes with and without the conversion option is estimated using a binomial lattice approach.

The main inputs to valuing the 2026 Convertible Notes with the conversion option are as follows:

Company's stock price

Expected annual volatility

The bond yield was derived by making the fair value of the 2026 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.

A roll forward of the derivative liability is as follows:

Balance at December 31, 2019

Change in fair value

Balance at December 31, 2020

Change in fair value

Balance at December 31, 2021

Convertible Notes

On March 1, 2019, the Company issued $ 37,500 of 2026 Convertible Notes.

Each 2026 Convertible Note accrues interest at an annual rate of 6 % of its outstanding principal amount, which is payable, along with the principal amount at maturity, on March 1, 2026, unless earlier converted, repurchased or redeemed.

The Company presents 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 2026 Convertible Notes was 14.8 % through December 31, 2021.

The holders of the 2026 Convertible Notes may convert all or part of the outstanding principal amount of their 2026 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 2026 Convertible Notes, which is equivalent to an initial conversion price of $ 6.50 per share.

The conversion rate is subject to adjustment in customary circumstances such as stock splits or similar changes to the Company’s capitalization.

At its election, the Company may choose to make such conversion payment in cash, in shares of common stock, or a combination thereof.

Upon any conversion of any 2026 Convertible Note, the Company is obligated to make a cash payment to the holder of such 2026 Convertible Note for any interest accrued but unpaid on the principal amount converted.

Upon the occurrence of a Corporate Transaction (as defined below), each holder has the option to require the Company to repurchase all or part of the outstanding principal amount of such note at a repurchase price equal to 100 % of the outstanding principal amount of the 2026 Convertible Note to be repurchased, plus accrued and unpaid interest to, but excluding the repurchase date.

In addition, each holder is entitled to receive an additional make-whole cash payment in accordance with a table set forth in each 2026 Convertible Note.

Upon conversion by the holder, the Company has the right to select the settlement of the conversion in either shares of common stock, cash, or in a combination thereof.

In addition, the Company is obligated to make a cash payment to the holder of such 2026 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 2026 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 2026 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 2026 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

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 2026 Convertible Note to, but excluding, the corporate transaction conversion date (to the extent such date occurs prior to March 1, 2026, the maturity date of the 2026 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 2026 Convertible Note at a repurchase price equal to 100 % of the outstanding principal amount of the 2026 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”).

On or after March 1, 2022, 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 2026 Convertible Notes, on a pro rata basis, at an optional redemption price equal to 100 % of the outstanding principal amount of the 2026 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date.

The 2026 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.

As discussed in Note 4, the Company determined that the embedded conversion option is required to be separated from the 2026 Convertible Notes and accounted for as a freestanding derivative instrument subject to derivative accounting.

The allocation of proceeds to the conversion option results in a discount on the 2026 Convertible Notes.

The Company is amortizing the discount to interest expense over the term of the 2026 Convertible Notes using the effective interest method.

A summary of the 2026 Convertible Notes at December 31, 2021 and 2020 is as follows:

2026 Convertible Notes

unamortized discount

Property and Equipment, net

Property and equipment, net consisted of the following:

Leasehold improvements

Furniture and fixtures

Construction in progress

Accumulated depreciation and amortization

Depreciation and amortization expense was $ 2,421 , $ 2,773 and $ 2,530 for the years ended December 31, 2021, 2020 and 2019, respectively.

Accrued Expenses

Accrued expenses consisted of the following:

Accrued payroll and related expenses

Accrued rebates and programs

Accrued professional fees

Accrued research and development expenses

Accrued interest payable on 2026 convertible notes

Accrued other

Collaboration Agreements

AffaMed License Agreement

The Company adopted this accounting pronouncement as required effective January 1, 2022 and its adoption did not have a material impact on the consolidated financial statements.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the FASB and adopted by us 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.

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 (the “Second Amended 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 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 $ 1,466 , $ 1,333 and $ 269 for the years ended December 31, 2022, 2021 and 2020, respectively.

Royalties have been charged to cost of product revenue.

AffaMed License Agreement (out-licensing)

On October 29, 2020, the Company entered into 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 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 and additional $ 1,000 milestone in the fourth quarter of 2021.

The Company is also eligible to receive up to an additional $ 90,000 in aggregate, inclusive of a low-seven-figure clinical support payment, upon the achievement of certain regulatory, development and commercial milestones.

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 and a $ 2,000 clinical support payment in the second quarter of 2022.

The Company is also eligible to receive up to an additional $ 88,000 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.

8 unchanged sentences

AffaMed has the right to terminate the License Agreement at any time after completion of a Phase 3 clinical trial for OTX-TIC 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.

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 license, regulatory filings and manufacturing for the Company’s OTX-TIC product candidate regarding open-angle glaucoma or ocular hypertension in the Territories;

● the license, regulatory filings and manufacturing of DEXTENZA (the “DEXTENZA Field performance obligation”);

● the license, regulatory filings and manufacturing for the Company’s OTX-TIC product candidate regarding open-angle glaucoma or ocular hypertension in the Territories (the “OTX-TIC Field performance obligation”);

● the conduct of a Phase 2 clinical trial of OTX-TIC (the “Phase 2 Clinical Trial of OTX-TIC performance obligation”);

● obligations to participate on various joint research, development and project committees;

● the conduct of a Phase 2 clinical trial of OTX-TIC

The Company has concluded there is a combined performance obligation for a development and commercialization license and manufacturing obligations for DEXTENZA Field and the Company’s OTX-TIC product candidate regarding open-angle glaucoma or ocular hypertension in the Territories.

Further, AffaMed cannot exploit the value of the development and commercialization license for DEXTENZA Field and the Company’s OTX-TIC product candidate regarding open-angle glaucoma or ocular hypertension in the Territories without receipt of supply as the development and commercialization license does not convey to AffaMed the right to manufacture and therefore the Company has combined the development and commercialization license and the manufacturing obligations into one performance obligation.

The Company has concluded that the right of AffaMed to opt into the Global Studies for DEXTENZA and OTX-TIC are options that do not convey a material right to AffaMed.

Therefore, these have not been recognized as performance obligations upon the inception of the License Agreement.

With respect to the obligation of the Company to participate in joint research, development and project committees the Company has concluded that these obligations are not material.

the Company has concluded that this performance obligation is not material.

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 obligation, 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 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.

3 unchanged sentences

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 combined performance obligations for DEXTENZA Field and the Company’s OTX-TIC product candidate based on the point in time upon which control of supply is transferred to AffaMed for each delivery of the associated supply.

We recognize revenue related to the amounts allocated to the DEXTENZA Field performance obligation and the OTX-TIC 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 has not recognized any revenue under the License Agreement as of December 31, 2021 and 2020 as there has been an insignificant amount of delivery of product under the License Agreement.

The Company does not expect to recognize material revenue from the License Agreement in 2022.

The entire transaction price is recorded as deferred revenue as of December 31, 2021 and 2020.

The Company recognized $ 1,037 , $ 0 and $ 0 of collaboration revenue related to the Phase 2 Clinical Trial of OTX-TIC performance obligation for the years ended December 31, 2022, 2021 and 2020, respectively.

As of December 31, 2022, the aggregate amount of the transaction price allocated to the partially unsatisfied Phase 2 Clinical Trial of OTX-TIC performance obligation was $ 963 .

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, 2022 was as follows:

Deferred Revenue

Deferred revenue at December 31, 2021

Amounts recognized into revenue

Deferred revenue at December 31, 2022

Regeneron Collaboration Agreement

On October 10, 2016, the Company entered into a Collaboration, Option and License Agreement (the “Collaboration Agreement”) with Regeneron Pharmaceuticals, Inc.

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.

On August 5, 2021, Regeneron notified the Company of its termination of the Collaboration Agreement.

The termination became effective immediately.

Under the terms of the Collaboration Agreement, the Company and Regeneron had agreed to conduct a joint research program with the aim of developing a sustained-release formulation of aflibercept, currently marketed under the tradename Eylea, that is suitable for advancement into clinical development.

1 unchanged sentence

Under the term of the Collaboration Agreement, Regeneron was responsible for funding an initial preclinical tolerability study.

In connection with the termination of the Collaboration Agreement, all licenses, options and other rights granted to either party under the Collaboration Agreement automatically terminated, other than the surviving joint intellectual property rights described below.

The 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.

of specified development and regulatory milestones of the Regeneron Licensed Products, or (iv) tiered, escalating royalties in a range from a high-single digit to a low-to-mid teen percentage of net sales of Regeneron Licensed Products, in each case pursuant to the Collaboration Agreement.

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.

On May 8, 2020, the Company entered into an amendment (the “Regeneron Amendment”) to the Collaboration Agreement.

Pursuant to the Regeneron Amendment, the Company and Regeneron have adopted a new work plan to transition joint efforts under the Collaboration Agreement to the research and development of an extended-delivery formulation of aflibercept to be delivered to the suprachoroidal space.

Regeneron has 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 provides for the modification of the terms of the Option previously granted to Regeneron under the Collaboration Agreement.

As amended, the Option is exclusive for twenty-four months following May 8, 2020.

As of December 31, 2021 and 2020, the Company had recorded $ 768 and $ 1,256 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 business activities.

As of December 31, 2021 and 2020, the Company had included the $ 0 and $ 1,256 in prepaid expenses and other current assets.

For the years ended December 31, 2022, 2021 and 2020, the Company had recorded $ 0 , $ 768 and $ 1,256 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 business activities.

As of December 31, 2022 and 2021, the Company had not recorded any assets or liabilities with regard to the Regeneron Collaboration Agreement.

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:

Cash and cash equivalents

Restricted cash

Total cash, cash equivalents and restricted cash as shown on the statements of cash flows

As of December 31, 2022, 2021 and 2020, the Company held restricted cash of $ 1,764 , respectively, on its consolidated balance sheet.

The Company held restricted cash as security deposits for its real estate leases.

Inventory consisted of the following:

Raw materials

Work-in-process

Finished goods

Property and Equipment, net

Property and equipment, net consisted of the following:

Leasehold improvements

Furniture and fixtures

Construction in progress

Accumulated depreciation and amortization

Depreciation and amortization expense was $ 2,109 , $ 2,421 and $ 2,773 for the years ended December 31, 2022, 2021 and 2020, respectively.

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.

Certain leases include one or more options to renew , exercised at the Company’s sole discretion, with renewal terms that can extend the lease term from one year to six years .

All of the Company’s leases qualify as operating leases.

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 and is scheduled to expire on July 31, 2023.

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 will be 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.

We have estimated the prevailing market rental rates at the time when we exercised the renewal option, and have included these in our remeasurement of the operating lease asset and the lease liability.

This has 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, we will not remeasure the payments for the five -year renewal period even if actual rent as of the commencement date of the five -year extension term, August 1, 2023, is different from our estimate.

The lease 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 24, 2024 and does not include any lease renewal options .

Recognized lease costs were as follows:

Operating lease costs

Variable lease costs

Total lease costs

The minimum lease payments for the next five years and thereafter are expected to be as follows:

Year Ending December 31,

Total lease payments

Present value of operating lease liabilities

The following table summarizes the weighted average remaining lease term and the weighted average incremental borrowing rate used to determine the operating lease liability:

Weighted average remaining lease term in years

Weighted average discount rate

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:

Cash paid for amounts included in the measurement of lease liabilities

The Company recognized $ 1,166 , $ 1,925 , and $ 1,344 of advertising expenses for the years ended December 31, 2022, 2021 and 2020, respectively.

Accrued expenses consisted of the following:

Accrued payroll and related expenses

Accrued rebates and programs

Accrued professional fees

Accrued research and development expenses

Accrued interest payable on 2026 convertible notes

Accrued other

Financial Liabilities

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, on March 1, 2026, unless earlier converted, repurchased or redeemed (the “2026 Convertible Notes”).

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 2026 Convertible Notes was 14.8 % through December 31, 2022.

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.

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 2026 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 2026 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.

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 2026 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;

The “Daily Measurement Value” is defined as the Specified Dollar Amount (as defined below), if any, divided by 20.

(ii) a sale, lease, transfer, of all or substantially all of the assets of the Company;

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 2026 Convertible Notes, on a pro rata basis, at an optional redemption price equal to 100 % of the outstanding principal amount of the 2026 Convertible Notes to be redeemed, plus accrued and unpaid interest to, but excluding, the optional redemption date.

The Company determined that the embedded conversion option is required to be separated from the 2026 Convertible Notes and accounted for as a freestanding derivative instrument subject to derivative accounting.

The allocation of proceeds to the conversion option results in a discount on the 2026 Convertible Notes.

The Company is amortizing the discount to interest expense over the term of the 2026 Convertible Notes using the effective interest method.

A summary of the 2026 Convertible Notes at December 31, 2022 and 2021 is as follows:

2026 Convertible Notes

unamortized discount

Notes Payable

The Company entered into a credit and security agreement in 2014 (as amended to date, the “Credit Agreement”) establishing the Company’s credit facility (the “Credit Facility”).

The Company has a total borrowing capacity of $ 25,000 under the Credit Facility, which was fully drawn down as of December 31, 2021.

In December 2018, the Company amended the terms of the Credit Agreement to increase total indebtedness under the Credit Facility to $ 25,000 which was used primarily to pay-off outstanding balances as of the closing date.

In December 2018, the Company’s total indebtedness under the Credit Facility was increased to $ 25,000 .

The Company was required to make interest-only payments under the Credit Facility until December 2020.

1 unchanged sentence

Amounts borrowed under the Credit Facility were at LIBOR base rate, subject to 2.00 % floor, plus 7.25 %.

Prior to the Fourth Amendment (as defined below), the interest rate was 9.25 %.

The exit fee equal to 3.5 %, or $ 429 that was previously accrued, has been paid.

Prior to the Fourth Amendment (as defined below), the effective interest rate was 9.25 % .

In June 2021, the Company entered into a Fourth Amended and Restated Credit and Security Agreement (the “Fourth Amendment”) to amend the terms of its debt with existing lenders for total indebtedness of $ 20,833 and borrowed an incremental $ 4,167 , for a total of $ 25,000 (the “2021 Amended Credit Facility”).

The Company is required to make interest-only payments under the 2021 Amended Credit Facility through April 2024.

Commencing in May 2024, the Company is required to make 19 equal monthly installments of principal in the amount of $ 1,042 , plus interest, then on the maturity date, November 30, 2025 the remaining balance of $ 5,208 plus the exit fee.

In the event the Company achieves certain milestones under the 2021 Amended Credit Facility, the Company has the right to extend through April 1, 2026 and make 5 equal monthly installments of principal in the amount of $ 1,042 , plus interest.

12 unchanged sentences

paying dividends;

making certain

making certain investments;

and engaging in certain other business transactions.

4 unchanged sentences

The amendment added to the Credit Agreement, among other provisions, a negative covenant restricting the Company from paying the holders of the 2026 Convertible Notes ahead in priority to the existing lenders, for so long as indebtedness remains outstanding under the Credit Facility, and a cross-default provision to establish that an event of default under the purchase agreement for the 2026 Convertible Notes also constitutes an event of default under the Credit Agreement.

The Company has a total borrowing capacity of $ 25,000 under the 2021 Amended Credit Facility, which was fully drawn down as of December 31, 2022.

Borrowings outstanding are as follows:

2 unchanged sentences

Unamortized discount

current portion

Long-term notes payable

2 unchanged sentences

Final Payment

Derivative Liability

The 2026 Convertible Notes (Note 9) contain an embedded conversion option that meets the criteria to be bifurcated and accounted for separately from the 2026 Convertible Notes (the "Derivative Liability").

The Derivative Liability was recorded at fair value upon the issuance of the 2026 Convertible Notes and is subsequently remeasured to fair value at each reporting period.

The 2026 Convertible Notes, including the Derivative Liability, were initially valued and are remeasured using a "with-and-without"

The "with-and-without"

methodology involves valuing the whole instrument on an as-is basis and then valuing the 2026 Convertible Notes without the embedded conversion option.

Refer to Note 11 for details regarding the determination of fair value.

A roll forward of the derivative liability is as follows:

Balance at December 31, 2020

Change in fair value

Balance at December 31, 2021

Change in fair value

Balance at December 31, 2022

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.

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, 2021.

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, 2022 and 2021, respectively.

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 all cash and cash equivalents balances at one accredited financial institution, 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’s development programs as well as revenue from future sales of its product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.

For the year ended December 31, 2022, three specialty distributor customers accounted for 44 %, 25 % and 17 % of the Company’s total revenue, and at December 31, 2022, three specialty distributor customers accounted for 52 %, 24 % and 15 % of the Company’s total accounts receivable.

No other customer accounted for more than 10% of total revenue for the year ended December 31, 2022, or accounts receivable at December 31, 2022.

For the year ended December 31, 2021, three specialty distributor customers accounted for 42 %, 26 % and 17 % of the Company’s total revenue, and at December 31, 2021 and three specialty distributor customers accounted for 42 %, 26 % and 21 % of the Company’s total accounts receivable.

No other customer accounted for more than 10% of total revenue for the year ended December 31, 2022, or accounts receivable at December 31, 2021.

For the year ended December 31, 2020, three specialty distributor customers accounted for 42 %, 29 % and 12 % of the Company’s total revenue.

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, 2022 and 2021 and indicate the level of the fair value hierarchy utilized to determine such fair value:

Fair Value Measurements as of

December 31, 2022 Using:

Cash equivalents:

Money market funds

Derivative liability (Note 10)

Fair Value Measurements as of

December 31, 2021 Using:

Cash equivalents:

Money market funds

Derivative liability (Note 10)

During the year ended December 31, 2022 and 2021, there were no transfers between Level 1 and 2.

The carrying value of the Company’s variable interest rate notes payable are recorded at amortized costs, which approximates fair value due to the variable interest rate.

At December 31, 2022, the 2026 Convertible Notes, net of the 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).

At December 31, 2021, the 2026 Convertible Notes, net of the Derivative Liability, were carried at amortized cost totaling $ 32,910 , comprised of the $ 26,435 non-current liability (Note 9) and $ 6,475 accrued interest (Note 8).

The estimated fair value of the 2026 Convertible Notes, without the Derivative Liability, was $ 33,177 and $ 32,598 at December 31, 2022 and 2021, respectively.

The fair value of the 2026 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 2026 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 2026 Convertible Notes with the conversion option are as follows:

Company's stock price

The bond yield was derived by making the fair value of the 2026 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.

Preferred Stock

3 unchanged sentences

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, 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.

In the twelve months ended December 31, 2020, the Company sold 2,984,381 shares of common stock under the 2019 Sales Agreement, resulting in net proceeds of approximately

$ 14,359 , respectively, after commissions and expenses.

From inception through March 1, 2021, the Company sold an aggregate of 10,321,840 shares of common stock under the 2019 Sales Agreement, resulting in net proceeds of approximately $ 46,985 after commissions and expenses.

On August 9, 2021, the Company and Jefferies mutually terminated the 2019 Sales Agreement and entered into another Open Market Sale Agreement (the “2021 Sales Agreement”) under which the Company may offer and sell shares of common stock of the Company having an aggregate offering price of up to $ 100,000 from time to time through Jefferies, acting as agent.

As of February 27, 2022, the Company has no t sold any shares of common stock under the 2021 Sales Agreement.

As of March 3, 2023, the Company has no t sold any shares of common stock under the 2021 Sales Agreement.

On December 14, 2020, the Company entered into an underwriting agreement with Jefferies LLC (“Jefferies”) and Piper Sandler & Co.

14 unchanged sentences

After deducting underwriting discounts and commissions and offering expenses, the Company received net proceeds from the offering of $ 48,327 .

On April 5, 2019, the Company entered into an Open Market Sales Agreement SM (the “2019 Sales Agreement”) with 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.

In the twelve months ended December 31, 2020, the Company sold 2,984,381 shares of common stock under the 2019 Sales Agreement, resulting in net proceeds of approximately $ 14,359 , respectively, after commissions and expenses.

As of December 31, 2021, the Company had reserved 10,934,828 shares of common stock for the exercise of outstanding stock options and the number of shares remaining available for grant under the Company’s 2021 Stock Incentive Plan (the “2021 Plan”), 2014 Stock Incentive Plan (the “2014 Plan”) and the 2019 Inducement Stock Incentive

Plan (the “2019 Inducement Plan”), and the number of shares available for issuance under the 2014 Employee Stock Purchase Plan (Note 13).

As of December 31, 2022, the Company had reserved 21,653,015 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 the Company’s 2021 Stock Incentive Plan, 2014 Stock Incentive Plan, the 2019 Inducement Stock Incentive Plan, and the 2014 Employee Stock Purchase Plan (Note 13).

Stock-Based Awards

2014 Stock Incentive Plan

The 2014 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards.

The number of shares initially reserved for issuance under the 2014 Plan was 1,336,907 shares of common stock, which was increased to 2,126,907 on January 1, 2015.

The number of shares reserved for issuance may be increased by the number of shares under the 2006 Stock Option Plan (the “2006 Plan”) that expire, terminate or are otherwise surrendered, cancelled, forfeited or repurchased by the Company.

The number of shares of common stock that may be issued under the 2014 Plan is subject to increase on the first day of each fiscal year, beginning on January 1, 2015 and ending on December 31, 2024, equal to the least of 1,659,218 shares of the Company’s common stock, 4 % 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, 2021, the number of shares available for issuance under the 2014 Plan increased by 1,659,218 .

For the years ended December 31, 2022 and 2021, 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 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, 2022 and 2021, respectively, the Company 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, 2022, 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 will be granted under the 2014 Plan.

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, 2022, all then-outstanding awards under the 2014 Plan remained in effect and continued to be governed by the terms of the 2014 Plan.

2021 Stock Incentive Plan

The 2021 Plan provides for the grant of incentive stock options, non-statutory stock options, restricted stock awards, restricted stock units, stock appreciation rights and other stock-based awards.

The number of shares of common stock that may be issued under the 2021 Plan is 6,000,000 shares of common stock;

plus 456,334 shares remaining available for grant under the 2014 Plan as of immediately prior to the effective date of the 2021 Plan and 9,766,336 shares subject to awards granted under the 2014 Plan or the Company’s 2006 Stock Incentive Plan, which awards expire, terminate or are otherwise surrendered, canceled, forfeited or repurchased by the Company at their original issuance price pursuant to a contractual repurchase right (subject to certain limitations).

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 increase of the number of shares of common stock that is reserved for issuance by 3,600,000 .

As of December 31, 2022, 5,863,174 shares remained available for issuance under the 2021 Plan.

As required by the 2006 Plan, 2014 Plan and 2021 Plan, the exercise price for stock options granted is not to be less than the fair value of common shares as of the date of grant.

Inducement Stock Option Awards

On June 20, 2017, the Company issued to Antony Mattessich, who became a director of the Company on June 20, 2017 and the Company’s President and Chief Executive Officer on July 26, 2017, a non-statutory stock option to purchase an aggregate of 590,000 shares of the Company’s common stock at an exercise price of $ 10.94 per share.

Subject to Mr.

Mattessich’s continued service to the Company, the stock option will vest over a four-year period, with 25 % of the shares underlying the option award vesting on the one year anniversary of the grant date and the remaining 75 % of the shares underlying the award vesting monthly thereafter.

The stock option was issued outside of the Company’s 2014 Plan as an inducement material to Mr.

Mattessich’s acceptance of an offer of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

On July 9, 2019, the Company issued to the Senior Vice President, Head of Business Development, a non-statutory stock option to purchase an aggregate of 60,000 shares of its common stock at an exercise price of $ 5.13 per share.

Subject to his continued service to the Company, the stock option will vest over a four-year period, with 25 % of the shares underlying the option award vesting on the one-year anniversary of the grant date and the remaining 75 % of the shares underlying the award vesting monthly thereafter.

The stock option was issued outside of the Company’s 2014 Plan as an inducement material to the individual’s acceptance of an offer of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

On October 29, 2019, the 2019 Inducement Plan was approved by the Board of Directors of the Company.

The 2019 Inducement Plan provides for the following types of awards, each of which is referred to as an “Award”:

statutory stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards.

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).

1 unchanged sentence

Each person who is granted an Award under the 2019 Inducement Plan is deemed a “Participant”.

On February 1, 2021, the Company issued to the Senior Vice President, Clinical Development, a non-statutory stock option to purchase an aggregate of 100,000 shares of its common stock at an exercise price of $ 18.70 per share subject to a time-based vesting and a non-statutory stock option to purchase 50,000 shares of its common stock at an exercise price of $ 18.70 per share subject to performance-based vesting.

The stock option was issued under the Company’s 2019 Inducement Plan as an inducement material to such individual’s acceptance of an offer of employment with the Company in accordance with Nasdaq Listing Rule 5635(c)(4).

Subject to her continued service to the Company, the time-based stock option will vest over a four-year period, with 25 % of the shares underlying the option award vesting on the one-year anniversary of the grant date and the remaining 75 % of the shares underlying the award vesting monthly thereafter.

The performance-based stock option vests and becomes exercisable in whole or in part if the Company achieves specified milestones, subject to continued service to the Company through the applicable vesting dates.

The stock options are subject to the terms and conditions of stock option agreements covering the grant and the Company’s 2019 Inducement Plan, as amended to date.

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, 2022, 545,375 shares remained available for issuance under the 2019 Inducement Plan.

2014 Employee Stock Purchase Plan

The Company’s has a 2014 Employee Stock Purchase Plan (the “ESPP”) with a total of 207,402 shares of common stock reserved for issuance under this plan which increased to 232,402 shares of common stock on January 1, 2015.

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.

1 unchanged sentence

As of December 31, 2022, 482,073 shares of common stock remained available for issuance.

Stock Option Valuation

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.

1 unchanged sentence

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 utilized the simplified method because the Company did not have sufficient historical exercise data over the life of awards to provide a reasonable basis upon which to estimate expected term.

The Company utilizes the simplified method because the Company does not have sufficient historical exercise data over 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.

2 unchanged sentences

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.

As of December 31, 2021, there were 27,903 outstanding unvested service-based stock options held by nonemployees.

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:

3 unchanged sentences

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:

2 unchanged sentences

Outstanding as of December 31, 2021

Cancelled/forfeited

Outstanding as of December 31, 2022

4 unchanged sentences

The weighted average grant date fair value of stock options granted to employees and directors during the years ended December 31, 2022, 2021 and 2020 was $ 4.95 , $ 12.48 and $ 5.93 per share, respectively.

As of December 31, 2022, there were 563,880 outstanding unvested service-based stock options held by nonemployees.

The following table summarizes the Company’s activity of unvested RSUs:

Unvested balance at December 31, 2021

Cancelled/forfeited

Unvested balance at December 31, 2022

Each RSU is equivalent to one share of common stock upon vesting.

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 related to stock options in the following expense categories of its statements of operations:

The Company recorded stock-based compensation expense in the following expense categories of its statements of operations and comprehensive loss:

Year Ended December 31,

3 unchanged sentences

As of December 31, 2022, the Company had an aggregate of $ 20,620 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.4 years.

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, 2020 and 2019:

Year Ended December 31,

Weighted average common shares outstanding, basic and diluted

Net loss per share - basic and diluted

For the year ended December 31, 2020 and 2019, there is no dilutive impact.

Therefore, diluted net loss per share is the same as basic net loss per share.

Basic and diluted net loss per share was calculated as follows for the year ended December 31, 2021:

Year Ended December 31,

Net loss attributable to common stockholders, basic

Interest expense on 2026 Convertible Notes

Change in fair value of derivative liability

Net loss attributable to common stockholders, diluted

Weighted average common shares outstanding, basic

Shares issuable upon conversion of 2026 Convertible Notes, as if converted

Weighted average common shares outstanding, diluted

Net loss per share attributable to common stockholders, basic

Net loss per share attributable to common stockholders, diluted

The Company excluded the following common stock equivalents, outstanding as of December 31, 2021, 2020 and 2019 from the computation of diluted net loss per share attributable to common stockholders for the years ended December 31, 2021, 2020 and 2019 because they had an anti-dilutive impact due to the net loss incurred for the periods.

The Company also excluded the shares issuable upon conversion of the 2026 Convertible Notes from the computation of diluted net loss per share for the year ended December 31, 2020 and 2019 because they had an anti-dilutive impact.

Options to purchase common stock

Shares issuable upon conversion of 2026 Convertible Notes, if converted

Warrants for the purchase of common stock

Commitments and Contingencies

Intellectual Property Licenses

The Company has a license agreement with Incept, LLC (“Incept”) to use and develop certain patent rights (the “Incept License”).

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.

From inception through December 31, 2021, royalties paid under this agreement related to product sales were $ 1,908 and have been charged to cost of product revenue.

On September 13, 2018, the Company entered into a second amended and restated license agreement (the “Second Amended Agreement”) with Incept.

The Second Amended Agreement amends and restates in full the Company’s prior amended and restated Incept License (the “Prior Agreement” or “Original License”) to expand the scope of the Company’s intellectual property license and modify future intellectual property ownership and other rights thereunder.

Indemnification Agreements

In the ordinary course of business, the Company may provide indemnification of varying scope and terms to vendors, lessors, business partners, and other parties with respect to certain matters including, but not limited to, losses arising out of breach of such agreements or from intellectual property infringement claims made by third parties.

In addition, the Company has entered into indemnification agreements with members of its board of directors and senior management team that will require the Company, among other things, to indemnify them against certain liabilities that may arise by reason of their status or service as directors or officers.

The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is, in many cases, unlimited.

To date, the Company has not incurred any material costs as a result of such indemnifications.

As of December 31, 2021, the Company was not aware of any claims that could have a material effect on its financial position, results of operations or cash flows, and it has not accrued any liabilities related to such obligations in its consolidated financial statements as of December 31, 2021.

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 8 years .

Certain leases include one or more options to renew , exercised at the Company’s sole discretion, with renewal terms that can extend the lease term from one year to six years .

All of the Company’s leases qualify as operating leases.

In October 2017, the Company entered into an amendment to a lease agreement for the Company’s laboratory and manufacturing space located at 34 Crosby Drive and 36 Crosby Drive, each in Bedford, Massachusetts.

The lease term commenced on June 30, 2018 and will expire on July 31, 2023.

In June 2016, the Company entered into a lease agreement 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.

On April 4, 2019, the Company entered into a non-cancelable lease for 30,036 square feet of space located at 24 Crosby Drive in Bedford, Massachusetts to be used for office space.

The five-year lease commenced on April 18, 2019 and terminates on March 24, 2024 and does not include any lease renewal options .

Operating lease costs

Variable lease costs

Total lease costs

The following table summarizes the presentation in the Company’s consolidated balance sheet of its operating leases:

Balance sheet location

Operating lease assets

Current operating lease liabilities

Operating lease liabilities

Non-current operating lease liabilities

Operating lease liabilities, net of current portion

Total Operating lease liabilities:

The minimum lease payments for the next five years and thereafter are expected to be as follows:

Year Ending December 31,

Total lease payments

Present value of operating lease liabilities

The following table summarizes the weighted average remaining lease term and the weighted average incremental borrowing rate used to determine the operating lease liability:

Weighted average remaining lease term in years

Weighted average discount rate

Cash paid for amounts included in the measurement of lease liabilities

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, 2022, 2021 and 2020, the Company has made contributions of $ 593 , $ 493 , and $ 0 , respectively, to the 401(k) Plan.

During the years ended December 31, 2022, 2021 and 2020, 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.

7 unchanged sentences

Derivative liability

Change in tax rate

Change in the valuation allowance

7 unchanged sentences

Capitalized start-up costs

Capitalized research and development expenses, net

Capitalized research and development expenses, net - Sec.

Capitalized research and development expenses, net Sec.

Operating lease liabilities

18 unchanged sentences

As of December 31, 2022, the Company also had available research and development tax credit carryforwards for federal and state income tax purposes of $ 13,408 and $ 7,804 , 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 due to ownership changes that have occurred previously or that could occur in the future.

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.

5 unchanged sentences

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.

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, 2022, 2021 and 2020.

3 unchanged sentences

There are currently no pending income tax examinations.

The Company’s tax years are still open under statute from December 31, 2017 to the present.

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.

The Company’s policy is to record interest and penalties related to income taxes as part of its income tax provision.

As of December 31, 2021 and 2020, the Company had no accrued interest or penalties related to uncertain tax positions and no amounts have been recognized in the Company’s statements of operations and comprehensive loss.

401(k) Savings Plan

The Company established a defined contribution savings plan under Section 401(k) of the Internal Revenue Code.

This 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.

Through December 31, 2021, the Company has made contributions of $ 493 made to the plan by the Company.

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, 2022, 2021 and 2020:

Net loss attributable to common stockholders

Weighted average common shares outstanding, basic

Net loss per share - basic

For the year ended December 31, 2020, there is no dilutive impact.

Therefore, diluted net loss per share is the same as basic net loss per share.

Basic and diluted net loss per share was calculated as follows for the years ended December 31, 2022 and 2021:

Year Ended December 31,

Net loss attributable to common stockholders, basic

Interest expense on 2026 Convertible Notes

Change in fair value of derivative liability

Net loss attributable to common stockholders, diluted

Weighted average common shares outstanding, basic

Dilutive options (treasury stock method)

Shares issuable upon conversion of 2026 Convertible Notes, as if converted

Weighted average common shares outstanding, diluted

Net loss per share attributable to common stockholders, diluted

The Company excluded the following common stock equivalents, outstanding as of December 31, 2022, 2021 and 2020 from the computation of diluted net loss per share attributable to common stockholders for the years ended December 31, 2022, 2021 and 2020 because they had an anti-dilutive impact due to the net loss incurred for the periods.

Options to purchase common stock

Restricted stock units

Shares issuable upon conversion of 2026 Convertible Notes, if converted

Warrants for the purchase of common stock

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.

Related Party Transactions

Since October 2017, the Company has engaged McCarter English LLP (“McCarter”) to provide legal services to the Company, including with respect to intellectual property matters.

Sparks, Ph.D., a partner at McCarter & English, served in the capacity as the Company’s in-house counsel from October 2017 through August 31, 2020.

The Company incurred fees for legal services rendered by McCarter of $ 766 and $ 1,119 for the years ended December 31, 2020 and 2019, respectively.

As of December 31, 2020, there was $ 47 recorded in accounts payable for McCarter.

As of December 31, 2021, there was $ 0 recorded in accrued expenses for McCarter.

In November 2020, the Company engaged Specialty Pharma Consulting, LLC (“Specialty Pharma”), an entity affiliated with Kevin Coughenour, to provide services for quality engineering and validation activities in the ordinary course of business.

Coughenour is married to the Company’s former Chief Operating Officer Patricia Kitchen.

The Company incurred fees for quality engineering and validation activities rendered by Specialty Pharma of $ 155 , for the for the year ended December 31, 2021.

As of December 31, 2020, there was $ 47 recorded in accounts payable and $ 0 recorded in accrued expenses for Specialty Pharma.

On April 26, 2021, the Company and Specialty Pharma terminated their relationship.

The Company incurred fees for quality engineering and validation activities rendered by Specialty Pharma of $ 0 , $ 155 and $ 47 for the years ended December 31, 2022, 2021 and 2020, respectively.

As of December 31, 2022 and 2021, there were no liabilities recorded with regard to Specialty Pharma.

The Company has engaged Wilmer Cutler Pickering Hale and Dorr LLP (“WilmerHale”) to provide certain legal services to the Company.

The Company's Chief Business Officer’s sister is 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 $ 1,396 and $ 1,772 for the year ended December 31, 2021 and 2020, respectively.

The Company incurred fees for legal services rendered by WilmerHale of approximately $ 959 , $ 1,396 and $ 1,772 for the years ended December 31, 2022, 2021 and 2020, respectively.

As of December 31, 2022 and 2021, there was $ 0 and $ 119 recorded in accounts payable for WilmerHale.

4 unchanged sentences

Compared sentence by sentence after normalising whitespace, quotation marks, case and digits, so re-formatting and restated figures do not read as changed language. Wording changes appear as one removal and one addition. The current filing and the prior one are authoritative.

What changed 10-K

Item 9A. Controls and Procedures