0001558370-23-017989 | 10-Q | XBRL Viewer

Cash Equivalents and Restricted Cash

9 Months Ended

Sep. 30, 2023

Cash Equivalents and Restricted Cash

4. Cash Equivalents and Restricted Cash

As of September 30, 2023 and December 31, 2022, the Company held restricted cash of $1,764, respectively, on its unaudited condensed consolidated balance sheets. The Company held restricted cash as security deposits for its real estate leases.

The Company’s unaudited condensed consolidated statements of cash flows include restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on such statements. A

reconciliation of the cash, cash equivalents, and restricted cash reported within the balance sheets that sum to the total of the same amounts shown in the unaudited condensed consolidated statement of cash flows is as follows:


	September 30,		September 30,
	2023		2022
Cash and cash equivalents	$	110,550	$	120,950
Restricted cash		1,764		1,764
Total cash, cash equivalents and restricted cash	$	112,314	$	122,714

Equity - Additional information (Details) - USD ($) $ in Thousands		3 Months Ended			9 Months Ended
	Aug. 09, 2021	Sep. 30, 2023	Jun. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Equity
Net proceeds from issuance of common stock					$ 9,532
Common Stock
Equity
Number of shares issued		144,718	1,370,208
Common Stock \| 2021 Sales Agreement
Equity
Maximum aggregate proceeds from offering	$ 100,000
Number of shares issued		144,718		0	1,514,926	0
Gross proceeds		$ 734			$ 9,897
Net proceeds from issuance of common stock		$ 708			$ 9,532

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

Reference 1: http://www.xbrl.org/2003/role/exampleRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (d)
-Publisher FASB
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Reference 2: http://www.xbrl.org/2003/role/recommendedDisclosureRef
-Topic 272
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-Paragraph 3
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483014/272-10-45-3

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2009/role/commonPracticeRef
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-Subparagraph (SX 210.4-08(d))
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-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
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-Subparagraph (h)
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-14

Reference 10: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-2

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 210
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-URI https://asc.fasb.org//1943274/2147479886/946-10-S99-3

+ Details

Financial Liabilities - Barings Credit Agreement - Summary (Details) - Barings Credit Facility $ in Thousands	Sep. 30, 2023 USD ($)
Credit Agreement
Debt instrument carrying amount	$ 82,474
Less: unamortized discount	(17,350)
Total	65,124
Due for repayment in 2029	$ 82,474

Expenses

9 Months Ended

Sep. 30, 2023

Expenses

Expenses

6. Expenses

Accrued expenses and other current liabilities consisted of the following:


	September 30,		December 31,
	2023		2022
Accrued payroll and related expenses	$	7,862	$	7,509
Accrued rebates and programs		4,679		3,560
Accrued professional fees		1,347		1,228
Accrued research and development expenses		2,285		1,816
Accrued interest payable on Convertible Notes		10,319		8,756
Accrued interest payable on Barings Note		858		—
Accrued other		1,537		1,228
	$	28,887	$	24,097

Licensing Agreements and Deferred Revenue

9 Months Ended

Sep. 30, 2023

Licensing Agreements and Deferred Revenue

Licensing Agreements and Deferred Revenue

3. Licensing Agreements and Deferred Revenue

Incept License Agreement (in-licensing)

On September 13, 2018, the Company entered into a second amended and restated license agreement with Incept, LLC (“Incept”) to use and develop certain intellectual property (the “Incept License”). Under the Incept License, as amended and restated, the Company was granted a worldwide, perpetual, exclusive license to use specific Incept technology to develop and commercialize products that are delivered to or around the human eye for diagnostic, therapeutic or prophylactic purposes relating to ophthalmic diseases or conditions. The Company is obligated to pay low single-digit royalties on net sales of commercial products developed using the licensed technology, commencing with the date of the first commercial sale of such products and until the expiration of the last to expire of the patents covered by the license.

The terms and conditions of the Incept License are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023.

Royalties paid under this agreement related to product sales (the “Incept Royalties”) were $451 and $1,264 for the three and nine months ended September 30, 2023, respectively, and $0 and $744 for the three and nine months ended September 30, 2022, respectively. The Incept Royalties have been charged to cost of product revenue.

AffaMed License Agreement (out-licensing)

On October 29, 2020, the Company entered into a license agreement (“License Agreement”) with AffaMed Therapeutic Limited (“AffaMed”) for the development and commercialization of the Company’s DEXTENZA product regarding ocular inflammation and pain following cataract surgery and allergic conjunctivitis and for the Company’s OTX-TIC product candidate (collectively the “AffaMed Licensed Products”) regarding open-angle glaucoma or ocular hypertension, in each case in mainland China, Taiwan, Hong Kong, Macau, South Korea, and the countries of the Association of Southeast Asian Nations. The Company retains development and commercialization rights for the AffaMed Licensed Products in the rest of the world.

The terms and conditions of the License Agreement are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023.

In June 2023, the Company received a milestone payment of $1,000 from AffaMed in connection with AffaMed receiving approval of its Clinical Trial Application to initiate a Phase 3 registrational study in China to investigate the efficacy and safety of DEXTENZA in subjects following ophthalmic surgery by China’s National Medical Products Administration. The Company has allocated the amount to the performance obligation regarding the license, regulatory filings and manufacturing of DEXTENZA as an addition to deferred revenue.

In March 2022, the Company invoiced AffaMed $2,000 for a clinical trial support payment in connection with the initiation by the Company of the OTX-TIC Phase 2 clinical trial and allocated the amount to the performance obligation regarding the conduct of a Phase 2 clinical trial of OTX-TIC (the “Phase 2 Clinical Trial of OTX-TIC performance obligation”) as an addition to deferred revenue. Payment was received by the Company during the three months ended June 30, 2022.

The Company recognized collaboration revenue related to the Phase 2 Clinical Trial of OTX-TIC performance obligation of $131 and $449 for the three and nine months ended September 30, 2023, respectively, and $52 and $864 for the three and nine months ended September 30, 2022, respectively.

As of September 30, 2023, the aggregate amount of the transaction price allocated to the partially unsatisfied Phase 2 Clinical Trial of OTX-TIC performance obligation was $514. This amount is expected to be recognized as this performance obligation is satisfied through June 2025.

Deferred revenue activity for the three and nine months ended September 30, 2023 was as follows:



	Deferred Revenue
Deferred revenue at December 31, 2022	$	13,963
Additions		1,000
Amounts recognized into revenue		(449)
Deferred revenue at September 30, 2023	$	14,514

Financial Liabilities - Convertible Notes, Summary (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Financial Liabilities
Convertible Notes	$ 37,500	$ 37,500
Less: unamortized discount and current portion	(28,735)	(8,751)
Total	$ 8,765	$ 28,749

Condensed Consolidated Statements of Stockholders' Equity - USD ($) $ in Thousands	Common Stock	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at Dec. 31, 2021	$ 8	$ 633,795	$ (545,804)	$ 87,999
Balance, shares at Dec. 31, 2021	76,731,940
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		129		129
Issuance of common stock upon exercise of stock options, shares	27,674
Stock-based compensation expense		4,209		4,209
Net loss			(12,542)	(12,542)
Balance at Mar. 31, 2022	$ 8	638,133	(558,346)	79,795
Balance, shares at Mar. 31, 2022	76,759,614
Balance at Dec. 31, 2021	$ 8	633,795	(545,804)	87,999
Balance, shares at Dec. 31, 2021	76,731,940
Stockholders' Equity (Deficit)
Net loss				(55,496)
Balance at Sep. 30, 2022	$ 8	647,521	(601,300)	46,229
Balance, shares at Sep. 30, 2022	77,010,385
Balance at Mar. 31, 2022	$ 8	638,133	(558,346)	79,795
Balance, shares at Mar. 31, 2022	76,759,614
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		11		11
Issuance of common stock upon exercise of stock options, shares	9,469
Issuance of common stock in connection with employee stock purchase plan		482		482
Issuance of common stock in connection with employee stock purchase plan, shares	140,943
Stock-based compensation expense		4,281		4,281
Net loss			(18,766)	(18,766)
Balance at Jun. 30, 2022	$ 8	642,907	(577,112)	65,803
Balance, shares at Jun. 30, 2022	76,910,026
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		374		374
Issuance of common stock upon exercise of stock options, shares	100,359
Stock-based compensation expense		4,240		4,240
Net loss			(24,188)	(24,188)
Balance at Sep. 30, 2022	$ 8	647,521	(601,300)	46,229
Balance, shares at Sep. 30, 2022	77,010,385
Balance at Dec. 31, 2022	$ 8	652,213	(616,842)	35,379
Balance, shares at Dec. 31, 2022	77,201,819
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		78		78
Issuance of common stock upon exercise of stock options, shares	26,443
Issuance of common stock upon vesting of restricted stock units (in shares)	288,376
Stock-based compensation expense		4,572		4,572
Net loss			(30,318)	(30,318)
Balance at Mar. 31, 2023	$ 8	656,863	(647,160)	9,711
Balance, shares at Mar. 31, 2023	77,516,638
Balance at Dec. 31, 2022	$ 8	652,213	(616,842)	35,379
Balance, shares at Dec. 31, 2022	77,201,819
Stockholders' Equity (Deficit)
Net loss				(51,516)
Balance at Sep. 30, 2023	$ 8	676,203	(668,358)	7,853
Balance, shares at Sep. 30, 2023	79,412,114
Balance at Mar. 31, 2023	$ 8	656,863	(647,160)	9,711
Balance, shares at Mar. 31, 2023	77,516,638
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		403		403
Issuance of common stock upon exercise of stock options, shares	97,435
Issuance of common stock in connection with employee stock purchase plan		418		418
Issuance of common stock in connection with employee stock purchase plan, shares	176,406
Issuance of common stock upon vesting of restricted stock units (in shares)	73,117
Issuance of common stock upon public offering, net of issuance costs		8,824		8,824
Issuance of common stock upon public offering, net of issuance costs, shares	1,370,208
Stock-based compensation expense		4,413		4,413
Net loss			(20,682)	(20,682)
Balance at Jun. 30, 2023	$ 8	670,921	(667,842)	3,087
Balance, shares at Jun. 30, 2023	79,233,804
Stockholders' Equity (Deficit)
Issuance of common stock upon exercise of stock options		62		62
Issuance of common stock upon exercise of stock options, shares	16,216
Issuance of common stock upon vesting of restricted stock units (in shares)	17,376
Issuance of common stock upon public offering, net of issuance costs		708		708
Issuance of common stock upon public offering, net of issuance costs, shares	144,718
Stock-based compensation expense		4,512		4,512
Net loss			(516)	(516)
Balance at Sep. 30, 2023	$ 8	$ 676,203	$ (668,358)	$ 7,853
Balance, shares at Sep. 30, 2023	79,412,114

Inventory

9 Months Ended

Sep. 30, 2023

Inventory

Inventory

5. Inventory

Inventory consisted of the following:


	September 30,		December 31,
	2023		2022
Raw materials	$	293	$	309
Work-in-process		947		899
Finished goods		1,017		766
	$	2,257	$	1,974

Financial Liabilities

9 Months Ended

Sep. 30, 2023

Financial Liabilities

Financial Liabilities

7. Financial Liabilities

Barings Credit Agreement

On August 2, 2023 (the “Closing Date”), the Company entered into a credit and security agreement (the “Barings Credit Agreement”) with Barings Finance LLC (“Barings”), as administrative agent, and the lenders party thereto, providing for a secured term loan facility for the Company (the “Barings Credit Facility”) in the aggregate principal amount of $82,474 (the “Total Credit Facility Amount”). The Company borrowed the full amount of $82,474 at closing and received proceeds of $77,790, after the application of an original issue discount and fees. Indebtedness under the Barings Credit Facility matures on the earlier to occur of (i) the six-year anniversary of the Closing Date and (ii) the date that is 91 days prior to the maturity date for the Company’s Convertible Notes (as defined below). Indebtedness under the Barings Credit Facility incurs interest at a SOFR-based rate, subject to a minimum 1.50% floor, plus 6.75%. The Company is obligated to make interest payments on its indebtedness under the Barings Credit Facility on a monthly basis, commencing on the Closing Date; to pay annual administration fees; and to pay, on the maturity date, any principal and accrued interest that remains outstanding as of such date. In addition, the Company is obligated to pay a fee in an amount equal to the Total Credit Facility Amount, which amount shall be reduced by the total amount of interest and principal prepayment fees paid under the Barings Credit Agreement (such fee, the “Barings Royalty Fee”). The Company is required to pay the Barings Royalty Fee in installments to Barings, for the benefit of the lenders, on a quarterly basis in an amount equal to three and one-half percent (3.5%) of the net sales of DEXTENZA occurring during such quarter, subject to the terms, conditions and limitations specified in the Barings Credit Agreement, until the Barings Royalty Fee is paid in full. The Barings Royalty Fee is due and payable upon a change of control of the Company. In the event the Company completes a change of control transaction on or prior to the twelve-month anniversary of the

Closing Date, the Barings Royalty Fee is subject to a reduction to an amount that is equal to (i) 20% of the Total Credit Facility Amount, in the event that a signed letter of intent evidencing such change of control transaction was entered into by the Company on or prior to the date that is six months after the Closing Date and (ii) 30% of the Total Credit Facility Amount, in the event that a signed letter of intent evidencing such change of control transaction was entered into by the Company after the date that is six months, but before the date that is twelve months, after the Closing Date. The Company may, at its option, prepay any or all of the Barings Royalty Fee at any time without penalty. In connection with the Barings Credit Agreement, the Company granted the lenders thereto a first-priority security interest in all assets of the Company, including its intellectual property, subject to certain agreed-upon exceptions. The Barings Credit Agreement includes negative covenants restricting the Company from making payments to the holders of the Convertible Notes, except in connection with a proposed conversion to equity and with respect to certain permitted expenses and requiring the Company to maintain a minimum liquidity amount of $20,000. The Barings Credit Agreement also includes customary affirmative and negative covenants.

The Company determined that the embedded obligation to pay the Barings Royalty Fee (the “Royalty Fee Obligation”) is required to be separated from the Barings Credit Facility and accounted for as a freestanding derivative instrument subject to derivative accounting. The allocation of proceeds to the Barings Royalty Fee Obligation resulted in a discount on the Barings Credit Facility. The Company is amortizing the discount to interest expense over the term of the Barings Credit Facility using the effective interest method. Accrued or paid Barings Royalty Fees are included in the change in fair value of derivative liabilities on the consolidated statements of operations and comprehensive loss. For the three and nine months ended September 30, 2023, Barings Royalty Fees were $388 and $388, respectively.

A summary of the Barings Credit Facility at September 30, 2023 is as follows:


	September 30,
	2023
Barings Credit Facility	$	82,474
Less: unamortized discount		(17,350)
Total	$	65,124

As of September 30, 2023, the full principal for the Barings Credit Facility of $82,474 was due for repayment in 2029.

Convertible Notes

On March 1, 2019, the Company issued $37,500 of convertible notes, which accrue interest at an annual rate of 6% of their outstanding principal amount which is payable, along with the principal amount, at maturity (as amended the “Convertible Notes”). The terms and conditions of the Convertible Notes are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023, except with respect to the amendment as described below.

Concurrently with entering into the Barings Credit Agreement, on August 2, 2023, the Company and the holders of the Convertible Notes extended the maturity of the Convertible Notes, which would otherwise have matured on March 1, 2026, to a date 91 days following the maturity of the indebtedness under the Barings Credit Facility, unless earlier converted, repurchased or redeemed (the “Amendment”). The Company accounted for the Amendment as an extinguishment of debt in accordance with the guidance in Accounting Standards Codification Topic 470-50 Debt (“ASC 470-50”) and derecognized all liabilities related to the Convertible Notes, including the outstanding principal less unamortized discount, a derivative liability, and accrued interest, with a total carrying value of $51,090 as of the date of the Amendment. The Company determined that, after the Amendment, the embedded conversion option continues to be required to be separated from the Convertible Notes and accounted for the embedded conversion option as a freestanding derivative instrument subject to derivative accounting (the “Conversion Option Derivative Liability”). The total fair value of the Convertible Notes on August 2, 2023 after the Amendment, including the conversion option, was $36,183. The Company recognized the Convertible Notes and the Conversion Option Derivative Liability after the Amendment at their fair values as of the date of the Amendment of $18,482 and $17,701, respectively. A portion of the fair value of the Convertible Notes as of the date of the Amendment of $9,943 is presented in accrued expenses and other current liabilities on the unaudited condensed consolidated balance sheets because the Convertible Notes are currently convertible, and this amount represents interest that was accrued before the Amendment and that would be payable in

cash upon conversion. The allocation of a portion of the total fair value of the Convertible Notes to the Conversion Option Derivative Liability results in a discount on the Convertible Notes. Application of ASC 470-50 resulted in a gain on extinguishment of $14,907, which was charged to gains and losses on extinguishment of debt, net on the consolidated statements of operations and comprehensive loss for the quarter ended September 30, 2023.

The Company presents accrued interest after the Amendment in accrued expenses and other current liabilities on the unaudited condensed consolidated balance sheets because the Convertible Notes are currently convertible, and the interest is payable in cash. The Company is amortizing the discount to interest expense over the term of the Convertible Notes using the effective interest method. The effective annual interest rate for the Convertible Notes was 19.4% as of September 30, 2023.

A summary of the Convertible Notes at September 30, 2023 and December 31, 2022 is as follows:





Convertible Notes	September 30,		December 31,
	2023		2022
Convertible Notes	$	37,500	$	37,500
Less: unamortized discount and current portion		(28,735)		(8,751)
Total	$	8,765	$	28,749

MidCap Credit Agreement

The Company entered into a credit and security agreement in 2014 (as amended, the “MidCap Credit Agreement”) establishing a credit facility (the “MidCap Credit Facility”). The terms and conditions of the MidCap Credit Agreement and the MidCap Credit Facility are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023, except with respect to Amendments No. 1 and 2 to the MidCap Credit Agreement as described in the Company’s Quarterly Report on Form 10-Q for the quarter ended June 30, 2023, filed with the SEC on August 7, 2023.

Under the MidCap Credit Facility, the Company had a total borrowing capacity of $25,000, which was fully drawn down as of June 30, 2023. In August 2023, in connection with the Company’s establishment of the Barings Credit Facility, the Company paid an aggregate of $26,157 to MidCap Financial Trust and the other lenders party to the MidCap Credit Agreement, comprised of $25,017 in principal and interest accrued thereunder and $1,140 in exit and prepayment fees, in satisfaction of the Company’s obligations under the MidCap Credit Agreement. In connection with the payment, all liens and security interests securing the indebtedness under the MidCap Credit Agreement were released. The extinguishment of the MidCap Credit Facility has resulted in a loss of $717, which was charged to gains and losses on extinguishment of debt, net on the consolidated statements of operations and comprehensive loss for the quarter ended September 30, 2023.

On March 12, 2023, the Company requested, and received, a protective advance of $2,000 under the MidCap Credit Agreement as a short-term bridge loan in response to the closure of Silicon Valley Bank by the California Department of Financial Protection and Innovation. This protective advance was deemed a credit extension. The Company repaid the full principal amount of $2,000 in March 2023.

- Definition

The entire disclosure for information about short-term and long-term debt arrangements, which includes amounts of borrowings under each line of credit, note payable, commercial paper issue, bonds indenture, debenture issue, own-share lending arrangements and any other contractual agreement to repay funds, and about the underlying arrangements, rationale for a classification as long-term, including repayment terms, interest rates, collateral provided, restrictions on use of assets and activities, whether or not in compliance with debt covenants, and other matters important to users of the financial statements, such as the effects of refinancing and noncompliance with debt covenants.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (h)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(c))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 470
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//470/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 1B
-Subparagraph (g)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1B
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1B

Reference 7: http://www.xbrl.org/2003/role/disclosureRef
-Topic 470
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-URI https://asc.fasb.org//1943274/2147481139/470-20-50-1I

+ Details

Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares	Sep. 30, 2023	Dec. 31, 2022
Condensed Consolidated Balance Sheets
Preferred stock, par value	$ 0.0001	$ 0.0001
Preferred stock, shares authorized	5,000,000	5,000,000
Preferred stock, shares issued	0	0
Preferred stock, shares outstanding	0	0
Common stock, par value	$ 0.0001	$ 0.0001
Common stock, shares authorized	200,000,000	200,000,000
Common stock, shares issued	79,412,114	77,201,819
Common stock, shares outstanding	79,412,114	77,201,819

Net Loss Per Share (Tables)

9 Months Ended

Sep. 30, 2023

Net Loss Per Share

Schedule of basic and diluted net (loss) income per share attributable to common stockholders

Basic net loss per share was calculated as follows for the three and nine months ended September 30, 2023 and 2022:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023			2022	2023			2022
Numerator:
Net loss attributable to common stockholders	$	(516)	$	(24,188)	$	(51,516)	$	(55,496)
Denominator:
Weighted average common shares outstanding, basic		79,373,272		76,975,839		78,276,341		76,829,434
Net loss per share - basic	$	(0.01)	$	(0.31)	$	(0.66)	$	(0.72)

Diluted net loss per share was calculated as follows for the three months ended September 30, 2023 and the nine months ended September 30, 2023 and 2022:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2023		2023			2022
Net loss attributable to common stockholders, basic	$	(516)	$	(51,516)	$	(55,496)
Interest expense on Convertible Notes		1,004		3,232		3,425
Change in fair value of derivative liability and gains on extinguishment of debt		(22,051)		(16,619)		(8,598)
Net loss attributable to common stockholders, diluted	$	(21,563)	$	(64,903)	$	(60,669)

Weighted average common shares outstanding, basic		79,373,272		78,276,341		76,829,434
Shares issuable upon conversion of Convertible Notes, as if converted		5,769,232		5,769,232		5,769,232

Weighted average common shares outstanding, diluted		85,142,504		84,045,573		82,598,666


Net loss per share attributable to common stockholders, diluted	$	(0.25)	$	(0.77)	$	(0.73)

Schedule of antidilutive securities, excluded from computation of diluted net loss per share


	Three Months Ended September 30,		Nine Months Ended September 30,
	2023	2022	2023	2022
Options to purchase common stock	16,306,543	13,795,937	16,306,543	13,795,937
Restricted stock units	1,653,363	1,050,339	1,653,363	1,050,339
Shares issuable upon conversion of Convertible Notes, if converted	—	—	—	—
	17,959,906	14,846,276	17,959,906	14,846,276

Cash Equivalents and Restricted Cash (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022	Sep. 30, 2022	Dec. 31, 2021
Cash Equivalents and Restricted Cash
Cash and cash equivalents	$ 110,550	$ 102,300	$ 120,950
Restricted cash	1,764	1,764	1,764
Total cash, cash equivalents and restricted cash as shown on the statements of cash flows	$ 112,314	$ 104,064	$ 122,714	$ 165,928

Nature of the Business

9 Months Ended

Sep. 30, 2023

Nature of the Business

Nature of the Business

1. Nature of the Business

Ocular Therapeutix, Inc. (the “Company”) was incorporated on September 12, 2006 under the laws of the State of Delaware. The Company is a biopharmaceutical company focused on the formulation, development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary bioresorbable hydrogel-based formulation technology ELUTYX. 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. Recently approved products will require significant sales, marketing and distribution support up to and including upon their launch. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval, prior to commercialization.

The Company is currently commercializing DEXTENZA (dexamethasone insert) 0.4mg, an intracanalicular insert for the treatment of post-surgical ocular inflammation and pain and for the treatment of ocular itching associated with allergic conjunctivitis, in the United States. The Company’s most advanced product candidate, AXPAXLI, is in Phase 3 clinical development; the Company’s other advanced product candidates are in either Phase 1 or Phase 2 clinical development. There can be no assurance that the Company’s research and development will be successfully completed, that adequate protection for the Company’s intellectual property will be obtained, that any products developed will obtain necessary government regulatory approval and adequate reimbursement or that any approved products will be commercially viable. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will generate significant revenue from product sales. The Company operates in an environment of rapidly changing technology and substantial competition from pharmaceutical and biotechnology companies. In addition, the Company is dependent upon the services of its employees and consultants. The Company may not be able to generate significant revenue from sales of any product for several years, if at all. Accordingly, the Company will need to obtain additional capital to finance its operations.

The Company has incurred losses and negative cash flows from operations since its inception, and the Company expects to continue to generate operating losses and negative cash flows from operations in the foreseeable future. As of September 30, 2023, the Company had an accumulated deficit of $668,358. As of September 30, 2023, the Company had existing cash and cash equivalents of $110,550. Based on the Company’s current operating plan, which includes estimates of anticipated cash inflows from product sales and cash outflows from operating expenses and capital expenditures, the Company believes that its existing cash and cash equivalents as of September 30, 2023 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 unaudited condensed consolidated financial statements while the Company observes a minimum liquidity covenant of $20,000 in its credit facility (Note 7). The future viability of the Company beyond that point is dependent on the Company’s ability to generate cash flows from the sale of DEXTENZA and raise additional capital to finance its operations. The Company will need to finance its operations through public or private securities offerings, debt financings, collaborations, strategic alliances, licensing agreements, royalty agreements, or marketing and distribution agreements. Although the Company has been successful in raising capital in the past, there is no assurance that it will be successful in obtaining such additional financing on terms acceptable to the Company, if at all. If the Company is unable to obtain funding, the Company could be forced to delay, reduce or eliminate some or all of its research and development programs for product candidates, product portfolio expansion or commercialization efforts, which could adversely affect its business prospects, or the Company may be unable to continue operations.

Equity

9 Months Ended

Sep. 30, 2023

Equity

Equity

10. Equity

On August 9, 2021, the Company and Jefferies LLC (“Jefferies”) entered into an Open Market Sale Agreement (the “2021 Sales Agreement”) under which the Company may offer and sell shares of its common stock having an aggregate offering price of up to $100,000 from time to time through Jefferies, acting as agent. During the three and nine months ended September 30, 2023, the Company sold 144,718 and 1,514,926 shares of common stock, respectively, under the 2021 Sales Agreement, resulting in gross proceeds to the Company of $734 and $9,897, respectively, and net proceeds, after accounting for issuance costs, of $708 and $9,532, respectively. The Company did not offer or sell shares of its common stock under the 2021 Sales Agreement during the three and nine months ended September 30, 2022.

- Definition

The entire disclosure for equity.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481062/946-235-50-2

Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 1
-Subparagraph (SX 210.4-08(e)(1))
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-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 10: http://fasb.org/us-gaap/role/ref/legacyRef
-Topic 505
-Name Accounting Standards Codification
-Publisher FASB
-URI https://asc.fasb.org//505/tableOfContent

Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 12: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 13: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Subparagraph (i)
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-13

Reference 14: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 15: http://www.xbrl.org/2003/role/disclosureRef
-Topic 505
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Reference 16: http://www.xbrl.org/2003/role/disclosureRef
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Reference 17: http://www.xbrl.org/2003/role/disclosureRef
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Reference 18: http://www.xbrl.org/2003/role/disclosureRef
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Reference 19: http://www.xbrl.org/2003/role/disclosureRef
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-URI https://asc.fasb.org//1943274/2147481112/505-10-50-18

+ Details

Nature of the Business (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Aug. 02, 2023	Dec. 31, 2022	Sep. 30, 2022
Nature of Business
Accumulated deficit	$ 668,358		$ 616,842
Cash and cash equivalents	110,550		$ 102,300	$ 120,950
Barings Credit Facility
Nature of Business
Debt Instrument, covenants, minimum liquidity requirement	$ 20,000	$ 20,000

- Definition

Amount of accumulated undistributed earnings (deficit).

+ References + Details

Inventory (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Inventory
Raw materials	$ 293	$ 309
Work-in-process	947	899
Finished goods	1,017	766
Total inventory	$ 2,257	$ 1,974

Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2023	Nov. 03, 2023
Document And Entity Information [Abstract]
Document Type	10-Q
Document Quarterly Report	true
Document Period End Date	Sep. 30, 2023
Document Transition Report	false
Entity File Number	001-36554
Entity Registrant Name	Ocular Therapeutix, Inc.
Entity Incorporation, State or Country Code	DE
Entity Tax Identification Number	20-5560161
Entity Address, Address Line One	24 Crosby Drive
Entity Address, City or Town	Bedford
Entity Address, State or Province	MA
Entity Address, Postal Zip Code	01730
City Area Code	781
Local Phone Number	357-4000
Title of 12(b) Security	Common Stock, $0.0001 par value per share
Trading Symbol	OCUL
Security Exchange Name	NASDAQ
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		79,418,626
Current Fiscal Year End Date	--12-31
Document Fiscal Year Focus	2023
Document Fiscal Period Focus	Q3
Entity Central Index Key	0001393434
Amendment Flag	false

Licensing Agreements and Deferred Revenue (Tables)

9 Months Ended

Sep. 30, 2023

Licensing Agreements and Deferred Revenue

Schedule of deferred revenue



	Deferred Revenue
Deferred revenue at December 31, 2022	$	13,963
Additions		1,000
Amounts recognized into revenue		(449)
Deferred revenue at September 30, 2023	$	14,514

Financial Liabilities - Convertible Notes, Terms (Details) - USD ($) $ in Thousands		3 Months Ended	9 Months Ended
	Aug. 02, 2023	Sep. 30, 2023	Sep. 30, 2023	Dec. 31, 2022	Mar. 01, 2019
Financial Liabilities
Principal amount of debt issued		$ 37,500	$ 37,500	$ 37,500
Gain (loss) on extinguishment of debt		$ 14,190	$ 14,190
Convertible Notes
Financial Liabilities
Principal amount of debt issued					$ 37,500
Interest rate (as a percent)					6.00%
Effective annual interest rate (as a percent)		19.40%	19.40%
Extinguishment of debt, amount	$ 51,090
Fair value of convertible notes including conversion option	36,183
Debt instrument fair value	18,482	$ 19,357	$ 19,357	$ 33,177
Conversion option derivative liability, fair value	17,701
Convertible Notes, fair value portion included in accrued expenses	$ 9,943
Gain (loss) on extinguishment of debt		$ 14,907

Stock-Based Awards

9 Months Ended

Sep. 30, 2023

Stock-Based Awards

Stock-Based Awards

11. Stock-Based Awards

For the three and nine months ended September 30, 2023, the Company had three stock-based compensation plans under which it was able to grant stock-based awards, the 2021 Stock Incentive Plan, as amended (the “2021 Plan”), the 2019 Inducement Stock Incentive Plan, as amended (the “2019 Inducement Plan”), and the 2014 Employee Stock Purchase Plan (the “ESPP”) (collectively, the “Stock Plans”). The terms and conditions of the Stock Plans are described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023.

During the three and nine months ended September 30, 2023, the Company granted options to purchase 190,250 and 3,430,991 shares of common stock, respectively at a weighted exercise price of $4.50 and $4.04 per share, respectively, all under the 2021 Plan.

During the three and nine months ended September 30, 2023, the Company granted 47,800 and 1,078,631 restricted stock units, or RSUs, respectively, all under the 2021 Plan. Each RSU is equivalent to one share of common stock upon vesting.

During the three and nine months ended September 30, 2023, a total of 232,939 and 793,146, respectively, stock options and RSUs expired or were forfeited.

At the Company’s Annual Meeting of Stockholders held on June 14, 2023, the Company’s stockholders approved an amendment of the Company’s 2021 Plan which increased the number of shares of common stock of the Company issuable under the 2021 Plan by 3,900,000 shares. As of September 30, 2023, 6,046,323, 545,750, and 513,069 shares of common stock remained available for issuance under the 2021 Plan, the 2019 Inducement Plan, and the ESPP, respectively.

The Company recorded stock-based compensation expense related to stock options and RSUs in the following expense categories of its unaudited condensed consolidated statements of operations and comprehensive loss:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Research and development	$	1,115	$	1,060	$	3,390	$	3,157
Selling and marketing		934		1,169		2,948		3,499
General and administrative		2,463		2,011		7,159		6,074
	$	4,512	$	4,240	$	13,497	$	12,730

As of September 30, 2023, the Company had an aggregate of $20,573 of unrecognized stock-based compensation cost, which is expected to be recognized over a weighted average period of 2.14 years.

Net Loss Per Share

9 Months Ended

Sep. 30, 2023

Net Loss Per Share

Net Loss Per Share

13. Net Loss Per Share

Basic net loss per share was calculated as follows for the three and nine months ended September 30, 2023 and 2022:


	Three Months Ended September 30,				Nine Months Ended September 30,
	2023			2022	2023			2022
Numerator:
Net loss attributable to common stockholders	$	(516)	$	(24,188)	$	(51,516)	$	(55,496)
Denominator:
Weighted average common shares outstanding, basic		79,373,272		76,975,839		78,276,341		76,829,434
Net loss per share - basic	$	(0.01)	$	(0.31)	$	(0.66)	$	(0.72)

Diluted net loss per share was calculated as follows for the three months ended September 30, 2023 and the nine months ended September 30, 2023 and 2022:


	Three Months Ended September 30,		Nine Months Ended September 30,
	2023		2023			2022
Net loss attributable to common stockholders, basic	$	(516)	$	(51,516)	$	(55,496)
Interest expense on Convertible Notes		1,004		3,232		3,425
Change in fair value of derivative liability and gains on extinguishment of debt		(22,051)		(16,619)		(8,598)
Net loss attributable to common stockholders, diluted	$	(21,563)	$	(64,903)	$	(60,669)

Weighted average common shares outstanding, basic		79,373,272		78,276,341		76,829,434
Shares issuable upon conversion of Convertible Notes, as if converted		5,769,232		5,769,232		5,769,232

Weighted average common shares outstanding, diluted		85,142,504		84,045,573		82,598,666


Net loss per share attributable to common stockholders, diluted	$	(0.25)	$	(0.77)	$	(0.73)

For the three months ended September 30, 2022 there was no dilutive impact from potentially issuable common shares, therefore, diluted net loss per share was the same as basic net loss per share.

The Company excluded the following potentially issuable common shares, outstanding as of September 30, 2023 and 2022, from the computation of diluted net loss per share for the three and nine months ended September 30, 2023 and 2022 because they had an anti-dilutive impact.


	Three Months Ended September 30,		Nine Months Ended September 30,
	2023	2022	2023	2022
Options to purchase common stock	16,306,543	13,795,937	16,306,543	13,795,937
Restricted stock units	1,653,363	1,050,339	1,653,363	1,050,339
Shares issuable upon conversion of Convertible Notes, if converted	—	—	—	—
	17,959,906	14,846,276	17,959,906	14,846,276

Licensing Agreements and Deferred Revenue (Details) - USD ($) $ in Thousands	1 Months Ended		3 Months Ended		9 Months Ended
	Jun. 30, 2023	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Collaboration Agreement
Revenue recognized			$ 15,081	$ 11,965	$ 43,642	$ 37,419
Total deferred revenue:
Deferred revenue, beginning balance					13,963
Additions					1,000
Amounts recognized into revenue					(449)
Deferred revenue, ending balance			14,514		14,514
License Agreement \| AffaMed
Collaboration Agreement
Milestone payment received	$ 1,000
License Agreement \| AffaMed \| OTX-TIC Product
Collaboration Agreement
Revenue recognized			131	52	449	864
Amount invoiced for initiation of OTX-TIC program		$ 2,000
Transaction price allocated to performance obligations partially unsatisfied			514		514
License Agreement \| Incept
Collaboration Agreement
Royalties paid			$ 451	$ 0	$ 1,264	$ 744

Inventory (Tables)

9 Months Ended

Sep. 30, 2023

Inventory

Components of inventory


	September 30,		December 31,
	2023		2022
Raw materials	$	293	$	309
Work-in-process		947		899
Finished goods		1,017		766
	$	2,257	$	1,974

Expenses (Tables)

9 Months Ended

Sep. 30, 2023

Expenses

Schedule of accrued expenses


	September 30,		December 31,
	2023		2022
Accrued payroll and related expenses	$	7,862	$	7,509
Accrued rebates and programs		4,679		3,560
Accrued professional fees		1,347		1,228
Accrued research and development expenses		2,285		1,816
Accrued interest payable on Convertible Notes		10,319		8,756
Accrued interest payable on Barings Note		858		—
Accrued other		1,537		1,228
	$	28,887	$	24,097

Risks and Fair Value

9 Months Ended

Sep. 30, 2023

Risks and Fair Value

Risks and Fair Value

9. Risks and Fair Value

Concentration of Credit Risk and of Significant Suppliers and Customers

Financial instruments that potentially expose the Company to concentrations of credit risk consist primarily of cash and cash equivalents and accounts receivable. The Company has its cash and cash equivalents balances at two accredited financial institutions, in amounts that exceed federally insured limits. The Company does not believe that it is subject to unusual credit risk beyond the normal credit risk associated with commercial banking relationships.

The Company is dependent on a small number of third-party manufacturers to supply products for research and development activities in its preclinical and clinical programs and for sales of its products. The Company’s development programs as well as revenue from future product sales could be adversely affected by a significant interruption in the supply of any of the components of these products.

For the three and nine months ended September 30, 2023, three specialty distributor customers accounted for 47%, 24% and 12%, and 51%, 23%, and 11%, respectively, of the Company’s gross product revenue, and at September 30, 2023, three specialty distributor customers accounted for 51%, 26%, and 11% of the Company’s total accounts receivable. No other customer accounted for more than 10% of total revenue for the three and nine months ended September 30, 2023, or accounts receivable at September 30, 2023.

For the three and nine months ended September 30, 2022, three specialty distributor customers accounted for 42%, 30%, and 14%, and 41%, 27% and 18%, respectively, of the Company’s gross product revenue. 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 three and nine months ended September 30, 2022, or accounts receivable at December 31, 2022.

Change in Fair Value of Derivative Liabilities

Other income (expenses) from the change in the fair values of derivative liabilities as presented on the Company’s consolidated statements of operations and comprehensive loss includes the following:


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Change in the fair value of the Conversion Option Derivative Liability	$	7,144	$	(1,133)	$	1,712	$	8,598
Change in the fair value of Royalty Fee Derivative Liability		(34)		—		(34)		—
Barings Royalty Fees (Note 7)		(388)		—		(388)		—
	$	6,722	$	(1,133)	$	1,290	$	8,598

Fair Value of Financial Assets and Liabilities

The following tables present information about the Company’s financial assets and liabilities that are measured at fair value on a recurring basis as of September 30, 2023 and December 31, 2022 and indicate the level of the fair value hierarchy utilized to determine such fair value:


	Fair Value Measurements as of
	September 30, 2023 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	101,480	$	—	$	—	$	101,480

Liability:
Derivative liabilities	$	—	$	—	$	24,022	$	24,022


	Fair Value Measurements as of
	December 31, 2022 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	30,188	$	—	$	—	$	30,188

Liability:
Derivative liabilities	$	—	$	—	$	6,351	$	6,351

At September 30, 2023, the Barings Credit Facility, net of the Royalty Fee Derivative Liability, was carried at amortized cost totaling $65,982 comprised of the $65,124 non-current liability (Note 7) and $858 accrued interest (Note 6). The estimated fair value of the Barings Credit Facility, without the Royalty Fee Derivative Liability, was $69,159 at September 30, 2023.

The fair value of the Royalty Fee Derivative Liability is estimated using a Monte Carlo simulation. The use of this approach requires the use of Level 3 unobservable inputs. The main inputs when determining the fair value of the Royalty Fee Derivative Liability are the amount and timing of the expected future revenue of the Company, the estimated volatility of these revenues, and the discount rate corresponding to the risk of revenue. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value.

The main inputs to valuing the Royalty Fee Derivative Liability are as follows:


	As of September 30, 2023
Revenue volatility		60.0 %
Revenue discount rate		16.4 %

The main inputs to valuing the Royalty Fee Derivative Liability as of the Closing Date were revenue volatility of 61.0% and a revenue discount rate of 15.8%.

A roll-forward of the Royalty Fee Derivative Liability is as follows:


	As of
Balance at August 2, 2023	$	12,604
Change in fair value		34
Balance at September 30, 2023	$	12,638

At September 30, 2023, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $19,084, comprised of the $8,765 non-current liability (Note 7) and $10,319 accrued interest (Note 6). At December 31, 2022, the Convertible Notes, net of the Conversion Option Derivative Liability, were carried at amortized cost totaling $37,505, comprised of the $28,749 non-current liability (Note 7) and $8,756 accrued interest (Note 6). The estimated fair value of the Convertible Notes, without the Conversion Option Derivative Liability, was $19,357 and $33,177 at September 30, 2023 and December 31, 2022, respectively.

The fair value of the Convertible Notes with and without the conversion option is estimated using a binomial lattice approach. The use of this approach requires the use of Level 3 unobservable inputs. The main input when determining the fair value of the Convertible Notes is the bond yield that pertains to the host instrument without the conversion option. The significant assumption used in determining the bond yield is the market yield movements of a comparable instrument issued as of the valuation date, which is assessed and updated each period. The main input when determining the fair value for disclosure purposes is the bond yield which is updated each period to reflect the yield of a comparable instrument issued as of the valuation date. To determine the gain on extinguishment related to the Amendment of the Convertible Notes as of August 2, 2023 (Note 7), the Company has determined the fair value of the Convertible Notes with and without the conversion option immediately before and immediately after the Amendment based on the same approach. The estimated fair value presented is not necessarily indicative of an amount that could be realized in a current market exchange. The use of alternative inputs and estimation methodologies could have a material effect on these estimates of fair value.

The main inputs to valuing the Convertible Notes with the conversion option on a recurring basis are as follows:


		As of
	September 30,			December 31,
	2023			2022
Company's stock price	$	3.14		$	2.81
Volatility		76.3	%		93.8	%
Bond yield		22.7	%		16.2	%

The main inputs to valuing the Convertible Notes with the conversion option immediately before the Amendment on August 2, 2023 were the Company’s stock price of $4.30, volatility of 78.5%, and a bond yield of 22.6%. The main inputs to valuing the Convertible Notes with the conversion option immediately after the Amendment on August 2, 2023 were the Company’s stock price of $4.30, volatility of 77.8%, and a bond yield of 22.9%.

A roll-forward of the Conversion Option Derivative Liability, including the impact from accounting for the Convertible Notes Amendment, is as follows:


	As of
Balance at December 31, 2022	$	6,351
Change in fair value		5,432
Balance at June 30, 2023		11,783
Change in fair value		(827)
Balance at August 2, 2023 before the Convertible Notes Amendment		10,956
Change in fair value from Convertible Notes Amendment		6,745
Balance at August 2, 2023 after the Convertible Notes Amendment		17,701
Change in fair value		(6,317)
Balance at September 30, 2023	$	11,384

Summary of Significant Accounting Policies

9 Months Ended

Sep. 30, 2023

Summary of Significant Accounting Policies

Summary of Significant Accounting Policies

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are consistent with those described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 6, 2023.

Use of Estimates

The preparation of these unaudited condensed 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 these unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, the measurement and recognition of reserves for variable consideration related to product sales, revenue recognition related to a collaboration agreement that contains multiple promises, the fair value of derivatives, stock-based compensation, and realizability of net deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.

Unaudited Interim Financial Information

The balance sheet at December 31, 2022 was derived from audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022 have been prepared by the Company, pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2023 and results of operations and cash flows for the three and nine months ended September 30, 2023 and 2022 have been made. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.

Recently Issued Accounting Pronouncements

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board 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.

Net Loss Per Share - Diluted Net Loss Per Share (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Reconciliation of net loss attributable to common stockholders for basic and diluted net loss per share
Net income (loss) attributable to common stockholders, basic	$ (516)		$ (51,516)	$ (55,496)
Interest expense Convertible Notes	1,004		3,232	3,425
Change in fair value of derivative liability and gains on extinguishment of debt	(22,051)		(16,619)	(8,598)
Net loss attributable to common stockholders, diluted	$ (21,563)		$ (64,903)	$ (60,669)
Weighted average common shares outstanding, basic	79,373,272	76,975,839	78,276,341	76,829,434
Shares issuable upon conversion of Convertible Notes, as if converted	5,769,232		5,769,232	5,769,232
Weighted average common shares outstanding, diluted	85,142,504	76,975,839	84,045,573	82,598,666
Net loss per share attributable to common stockholders, diluted	$ (0.25)	$ (0.31)	$ (0.77)	$ (0.73)

- Definition

The amount of net income (loss) for the period available to each share of common stock or common unit outstanding during the reporting period and to each share or unit that would have been outstanding assuming the issuance of common shares or units for all dilutive potential common shares or units outstanding during the reporting period.

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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities; of income (loss) available to common shareholders.

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Amount, after deduction of tax, noncontrolling interests, dividends on preferred stock and participating securities, and addition from assumption of issuance of common shares for dilutive potential common shares; of income (loss) available to common shareholders.

+ References + Details

Risks and Fair Value - Fair Value Measurement (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Aug. 02, 2023	Jun. 30, 2023	Dec. 31, 2022
Liability:
Derivative liabilities	$ 11,384		$ 11,783	$ 6,351
Notes Payable, Noncurrent	65,124			25,257
Non-current liability	8,765			28,749
Barings Credit Facility
Liability:
Notes payable, amortized cost, including accrued interest	65,982
Notes Payable, Noncurrent	65,124
Accrued interest	858
Estimated fair value	69,159
Convertible Notes
Liability:
Convertible debt, amortized cost, including accrued interest	19,084			37,505
Non-current liability	8,765			28,749
Accrued interest	10,319			8,756
Estimated fair value	19,357	$ 18,482		33,177
Recurring Basis
Liability:
Derivative liabilities	24,022			6,351
Money Market Funds \| Recurring Basis
Assets:
Cash equivalents	101,480			30,188
Level 1 \| Money Market Funds \| Recurring Basis
Assets:
Cash equivalents	101,480			30,188
Level 3 \| Recurring Basis
Liability:
Derivative liabilities	$ 24,022			$ 6,351

Financial Liabilities - MidCap Credit Agreement (Details) - USD ($) $ in Thousands		1 Months Ended		3 Months Ended	9 Months Ended
	Mar. 12, 2023	Aug. 31, 2023	Mar. 31, 2023	Sep. 30, 2023	Sep. 30, 2023	Jun. 30, 2023
Financial Liabilities
Repayment of debt					$ 26,125
Gain (loss) on extinguishment of debt				$ 14,190	14,190
Repayment of Protective Advance					2,000
Proceeds From Issuance of Protective Advance					$ 2,000
MidCap Credit Facility
Financial Liabilities
Borrowing capacity under the agreement						$ 25,000
Repayment of debt including principal, interest, exit and prepayment fees		$ 26,157
Repayment of debt		25,017
Payment of exit and prepayment fees in satisfaction of debt obligation		1,140
Gain (loss) on extinguishment of debt		$ 717
Repayment of Protective Advance			$ 2,000
Proceeds From Issuance of Protective Advance	$ 2,000

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

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+ Details

Stock-Based Awards - Additional Information (Details)	3 Months Ended		9 Months Ended
Stock-Based Awards - Additional Information (Details)	Sep. 30, 2023 item $ / shares shares	Jun. 30, 2023 shares	Sep. 30, 2023 item $ / shares shares	Jun. 14, 2023 shares
Stock-Based Awards
Stock options and RSUs expired or were forfeited (in shares)	232,939		793,146
Common Stock
Stock-Based Awards
Issuance of common stock upon public offering, net of issuance costs, shares	144,718	1,370,208
2021 Incentive Plan
Stock-Based Awards
Number of shares of common stock available for issuance	6,046,323		6,046,323	3,900,000
2021 Incentive Plan \| Common Stock
Stock-Based Awards
Shares issuable under options, granted (in shares)	190,250		3,430,991
Exercise price (in dollars per share) \| $ / shares	$ 4.50		$ 4.04
2019 Inducement Plan
Stock-Based Awards
Number of shares of common stock available for issuance	545,750		545,750
2014 Employee Stock Purchase Plan
Stock-Based Awards
Number of shares of common stock available for issuance	513,069		513,069
2014 Stock Incentive Plan
Stock-Based Awards
Number of stock based compensation plans \| item	3		3
Restricted Stock Units (RSUs) \| 2021 Incentive Plan
Stock-Based Awards
Granted (in shares)	47,800		1,078,631

Stock-Based Awards - Stock-Based Compensation (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Stock-Based Awards
Stock-based compensation expense	$ 4,512	$ 4,240	$ 13,497	$ 12,730
Unrecognized stock-based compensation cost	20,573		$ 20,573
Weighted average period of unrecognized stock-based compensation cost expected to be recognized			2 years 1 month 20 days
Research and development expense
Stock-Based Awards
Stock-based compensation expense	1,115	1,060	$ 3,390	3,157
Selling and marketing expense
Stock-Based Awards
Stock-based compensation expense	934	1,169	2,948	3,499
General and administrative expense
Stock-Based Awards
Stock-based compensation expense	$ 2,463	$ 2,011	$ 7,159	$ 6,074

Condensed Consolidated Balance Sheets - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Current assets:
Cash and cash equivalents	$ 110,550	$ 102,300
Accounts receivable, net	23,589	21,325
Inventory	2,257	1,974
Prepaid expenses and other current assets	4,862	4,028
Total current assets	141,258	129,627
Property and equipment, net	12,494	9,856
Restricted cash	1,764	1,764
Operating lease assets	6,868	8,042
Total assets	162,384	149,289
Current liabilities:
Accounts payable	3,984	5,123
Accrued expenses and other current liabilities	28,887	24,097
Deferred revenue	317	576
Operating lease liabilities	1,878	1,599
Total current liabilities	35,066	31,395
Other liabilities:
Operating lease liabilities, net of current portion	7,251	8,678
Derivative liabilities	24,022	6,351
Deferred revenue, net of current portion	14,197	13,387
Notes payable, net	65,124	25,257
Other non-current liabilities	106	93
Convertible Notes, net	8,765	28,749
Total liabilities	154,531	113,910
Commitments and contingencies (Note 14)
Stockholders' equity:
Preferred stock, $0.0001 par value; 5,000,000 shares authorized and no shares issued or outstanding at September 30, 2023 and December 31, 2022, respectively
Common stock, $0.0001 par value; 200,000,000 shares authorized and 79,412,114 and 77,201,819 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively	8	8
Additional paid-in capital	676,203	652,213
Accumulated deficit	(668,358)	(616,842)
Total stockholders' equity	7,853	35,379
Total liabilities and stockholders' equity	$ 162,384	$ 149,289

Risks and Fair Value - Change in Fair Value of Derivative lLabilities (Details) - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Derivative Instruments, Gain (Loss) [Line Items]
Barings Royalty Fees	$ (388)		$ (388)
Total	6,722	$ (1,133)	1,290	$ 8,598
Conversion Option Derivative Liability
Derivative Instruments, Gain (Loss) [Line Items]
Change in fair value of derivative liability	$ 7,144	$ (1,133)	$ 1,712	$ 8,598
Derivative, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Total	Total	Total	Total
Royalty Fee Derivative Liability
Derivative Instruments, Gain (Loss) [Line Items]
Change in fair value of derivative liability	$ (34)		$ (34)
Derivative, Gain (Loss), Statement of Income or Comprehensive Income [Extensible Enumeration]	Total	Total	Total	Total

Related Party Transactions

9 Months Ended

Sep. 30, 2023

Related Party Transactions

Related Party Transactions

15. Related Party Transactions

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 $323 and $956 for the three and nine months ended September 30, 2023, respectively, and approximately $342 and $876 for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023 and December 31, 2022, there was $135 and $0 recorded in accounts payable for WilmerHale. As of September 30, 2023 and December 31, 2022, there was $0 and $24 recorded in accrued expenses for WilmerHale.

The Company has engaged Heier Consulting, LLC (“Heier Consulting”), an entity affiliated with Dr. Jeffrey Heier, a member of the Company’s Board of Directors, to provide advice or expertise on one or more of the Company’s development-stage drug or medical device products relating to retinal diseases or conditions under a consultant agreement. Compensation for these services is in the form of cash and stock-based awards. The total grant date fair value of stock-based awards granted to Heier Consulting is $96, which is recognized to expense on a straight-line basis over the respective vesting periods. The Company incurred cash-based fees for services rendered by Heier Consulting of approximately $13 and $18 for the three and nine months ended September 30, 2023, respectively, and approximately $21 and $21 for the three and nine months ended September 30, 2022, respectively. As of September 30, 2023 and December 31, 2022, there was $7 and $3 recorded in accounts payable for Heier Consulting. As of September 30, 2023 and December 31, 2022, there was $0 and $0 recorded in accrued expenses for Heier Consulting.

- Definition

The entire disclosure for related party transactions. Examples of related party transactions include transactions between (a) a parent company and its subsidiary; (b) subsidiaries of a common parent; (c) and entity and its principal owners; and (d) affiliates.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
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-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-2

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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Reference 8: http://www.xbrl.org/2003/role/disclosureRef
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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 11: http://www.xbrl.org/2003/role/disclosureRef
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Reference 13: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands	9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022
Cash flows from operating activities:
Net loss	$ (51,516)	$ (55,496)
Adjustments to reconcile net loss to net cash used in operating activities
Stock-based compensation expense	13,497	12,730
Non-cash interest expense	4,553	3,616
Change in fair value of derivative liabilities	(1,290)	(8,598)
Depreciation and amortization expense	2,025	1,618
Gains and losses on extinguishment of debt, net	(14,190)
Gain (loss) on disposal of property and equipment	(1)	1
Changes in operating assets and liabilities:
Accounts receivable	(2,264)	1,333
Prepaid expenses and other current assets	(834)	1,433
Inventory	(283)	(295)
Accounts payable	(73)	501
Operating lease assets and liabilities	26	(331)
Accrued expenses	2,019	(293)
Deferred revenue	551	1,136
Net cash used in operating activities	(47,780)	(42,645)
Cash flows from investing activities:
Purchases of property and equipment	(5,628)	(1,565)
Net cash used in investing activities	(5,628)	(1,565)
Cash flows from financing activities:
Proceeds from issuance of short-term bridge loan	2,000
Proceeds from issuance of Barings notes payable	82,474
Proceeds from exercise of stock options	543	514
Proceeds from issuance of common stock pursuant to employee stock purchase plan	418	482
Payments of debt refinancing costs	(5,184)
Proceeds from issuance of common stock upon public offering, net of issuance costs	9,532
Repayment of short-term bridge loan	(2,000)
Repayment of MidCap notes payable	(26,125)
Net cash provided by financing activities	61,658	996
Net increase (decrease) in cash, cash equivalents and restricted cash	8,250	(43,214)
Cash, cash equivalents and restricted cash at beginning of period	104,064	165,928
Cash, cash equivalents and restricted cash at end of period	112,314	122,714
Supplemental disclosure of cash flow information:
Cash paid for interest	2,865	1,521
Supplemental disclosure of non-cash investing and financing activities:
Additions to property and equipment included in accounts payable and accrued expenses	$ 267	$ 477

Commitments and Contingencies

9 Months Ended

Sep. 30, 2023

Commitments and Contingencies.

Commitments and Contingencies

14. 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.

Net Loss Per Share - Basic (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended						9 Months Ended
	Sep. 30, 2023	Jun. 30, 2023	Mar. 31, 2023	Sep. 30, 2022	Jun. 30, 2022	Mar. 31, 2022	Sep. 30, 2023	Sep. 30, 2022
Basic net loss per share attributable to common stockholders:
Net loss	$ (516)	$ (20,682)	$ (30,318)	$ (24,188)	$ (18,766)	$ (12,542)	$ (51,516)	$ (55,496)
Weighted average common shares outstanding, basic	79,373,272			76,975,839			78,276,341	76,829,434
Net loss per share, basic	$ (0.01)			$ (0.31)			$ (0.66)	$ (0.72)

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 250
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-URI https://asc.fasb.org//1943274/2147483443/250-10-50-3

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
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Reference 3: http://www.xbrl.org/2003/role/disclosureRef
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Reference 4: http://www.xbrl.org/2003/role/disclosureRef
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+ Details

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References

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Reference 9: http://www.xbrl.org/2003/role/disclosureRef
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Reference 31: http://www.xbrl.org/2003/role/disclosureRef
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Reference 33: http://www.xbrl.org/2003/role/disclosureRef
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Reference 36: http://www.xbrl.org/2003/role/disclosureRef
-Topic 220
-SubTopic 10
-Name Accounting Standards Codification
-Section 45
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Reference 37: http://www.xbrl.org/2003/role/disclosureRef
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-Publisher FASB
-URI https://asc.fasb.org//1943274/2147483589/942-220-S99-1

+ Details

Summary of Significant Accounting Policies (Policies)	9 Months Ended
Summary of Significant Accounting Policies (Policies)	Sep. 30, 2023
Summary of Significant Accounting Policies
Basis of Presentation	Basis of Presentation The accompanying unaudited condensed consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America (“GAAP”). The significant accounting policies used in preparation of these unaudited condensed consolidated financial statements are consistent with those described in Note 2 - Summary of Significant Accounting Policies in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the Securities and Exchange Commission (“SEC”) on March 6, 2023.
Use of Estimates	Use of Estimates The preparation of these unaudited condensed 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 these unaudited condensed consolidated financial statements, and the reported amounts of revenues and expenses during the reporting periods. Significant estimates and assumptions reflected in these unaudited condensed consolidated financial statements include, but are not limited to, the measurement and recognition of reserves for variable consideration related to product sales, revenue recognition related to a collaboration agreement that contains multiple promises, the fair value of derivatives, stock-based compensation, and realizability of net deferred tax assets. Estimates are periodically reviewed in light of changes in circumstances, facts and experience. Actual results could differ from the Company’s estimates.
Unaudited Interim Financial Information	Unaudited Interim Financial Information The balance sheet at December 31, 2022 was derived from audited consolidated financial statements but does not include all disclosures required by GAAP. The accompanying unaudited condensed consolidated financial statements as of September 30, 2023 and for the three and nine months ended September 30, 2023 and 2022 have been prepared by the Company, pursuant to the rules and regulations of the SEC for interim financial statements. Certain information and footnote disclosures normally included in financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. However, the Company believes that the disclosures are adequate to make the information presented not misleading. These unaudited condensed consolidated financial statements should be read in conjunction with the Company’s audited financial statements and the notes thereto for the year ended December 31, 2022 included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2022, filed with the SEC on March 6, 2023. In the opinion of management, all adjustments, consisting only of normal recurring adjustments necessary for a fair statement of the Company’s financial position as of September 30, 2023 and results of operations and cash flows for the three and nine months ended September 30, 2023 and 2022 have been made. The results of operations for the three and nine months ended September 30, 2023 are not necessarily indicative of the results of operations that may be expected for the year ending December 31, 2023.
Recently Issued Accounting Pronouncements	Recently Issued Accounting Pronouncements From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board 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.

Stock-Based Awards (Tables)

9 Months Ended

Sep. 30, 2023

Stock-Based Awards

Schedule of stock-based compensation expense related to stock options


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Research and development	$	1,115	$	1,060	$	3,390	$	3,157
Selling and marketing		934		1,169		2,948		3,499
General and administrative		2,463		2,011		7,159		6,074
	$	4,512	$	4,240	$	13,497	$	12,730

Income Taxes

9 Months Ended

Sep. 30, 2023

Income Taxes

Income Taxes

12. Income Taxes

The Company did not provide for any income taxes in its unaudited condensed consolidated statements of operations and comprehensive loss for the three and nine months ended September 30, 2023 and 2022, respectively. The Company has provided a valuation allowance for the full amount of its net deferred tax assets because, at September 30, 2023 and December 31, 2022, it was more likely than not that any future benefit from deductible temporary differences and net operating loss and tax credit carryforwards would not be realized.

- Definition

The entire disclosure for income taxes. Disclosures may include net deferred tax liability or asset recognized in an enterprise's statement of financial position, net change during the year in the total valuation allowance, approximate tax effect of each type of temporary difference and carryforward that gives rise to a significant portion of deferred tax liabilities and deferred tax assets, utilization of a tax carryback, and tax uncertainties information.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 20
-Name Accounting Standards Codification
-Section 50
-Paragraph 13
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480990/946-20-50-13

Reference 2: http://www.xbrl.org/2003/role/disclosureRef
-Topic 235
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 1
-Subparagraph (SX 210.4-08(h)(2))
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147480678/235-10-S99-1

Reference 3: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-Name Accounting Standards Codification
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-URI https://asc.fasb.org//740/tableOfContent

Reference 4: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
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-Paragraph 14
-Publisher FASB
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Reference 5: http://www.xbrl.org/2003/role/disclosureRef
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Reference 6: http://www.xbrl.org/2003/role/disclosureRef
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Reference 7: http://www.xbrl.org/2003/role/disclosureRef
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-Paragraph 17
-Subparagraph (b)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482685/740-10-50-17

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-Section S99
-Paragraph 1
-Subparagraph (SAB TOPIC 6.I.5.Q1)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147479360/740-10-S99-1

Reference 9: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 10
-Name Accounting Standards Codification
-Section S99
-Paragraph 2
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Reference 10: http://www.xbrl.org/2003/role/disclosureRef
-Topic 740
-SubTopic 30
-Name Accounting Standards Codification
-Section 50
-Paragraph 2
-Subparagraph (a)
-Publisher FASB
-URI https://asc.fasb.org//1943274/2147482603/740-30-50-2

+ Details

Financial Liabilities (Tables)

9 Months Ended

Sep. 30, 2023

Convertible Notes

Debt Instrument [Line Items]

Summary of debt

A summary of the Convertible Notes at September 30, 2023 and December 31, 2022 is as follows:





Convertible Notes	September 30,		December 31,
	2023		2022
Convertible Notes	$	37,500	$	37,500
Less: unamortized discount and current portion		(28,735)		(8,751)
Total	$	8,765	$	28,749

Barings Credit Facility

Debt Instrument [Line Items]

Summary of debt

A summary of the Barings Credit Facility at September 30, 2023 is as follows:


	September 30,
	2023
Barings Credit Facility	$	82,474
Less: unamortized discount		(17,350)
Total	$	65,124

- Definition

Line items represent financial concepts included in a table. These concepts are used to disclose reportable information associated with domain members defined in one or many axes to the table.

+ References

+ Details

Risks and Fair Value - Measurement inputs (Details) - Convertible Notes	Sep. 30, 2023	Dec. 31, 2022
Company's stock price
Derivative Liability
Debt instrument, measurement input	3.14	2.81
Company's stock price \| Conversion option immediately before the amendment
Derivative Liability
Debt instrument, measurement input	0.0430
Company's stock price \| Conversion option immediately after the amendment
Derivative Liability
Debt instrument, measurement input	0.0430
Volatility
Derivative Liability
Debt instrument, measurement input	0.763	0.938
Volatility \| Conversion option immediately before the amendment
Derivative Liability
Debt instrument, measurement input	0.785
Volatility \| Conversion option immediately after the amendment
Derivative Liability
Debt instrument, measurement input	0.778
Bond yield
Derivative Liability
Debt instrument, measurement input	0.227	0.162
Bond yield \| Conversion option immediately before the amendment
Derivative Liability
Debt instrument, measurement input	0.226
Bond yield \| Conversion option immediately after the amendment
Derivative Liability
Debt instrument, measurement input	0.229

Risks and Fair Value (Tables)

9 Months Ended

Sep. 30, 2023

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]

Schedule of change in fair value of derivative liabilities


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Change in the fair value of the Conversion Option Derivative Liability	$	7,144	$	(1,133)	$	1,712	$	8,598
Change in the fair value of Royalty Fee Derivative Liability		(34)		—		(34)		—
Barings Royalty Fees (Note 7)		(388)		—		(388)		—
	$	6,722	$	(1,133)	$	1,290	$	8,598

Schedule of assets and liabilities measured at fair Value on recurring basis


	Fair Value Measurements as of
	September 30, 2023 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	101,480	$	—	$	—	$	101,480

Liability:
Derivative liabilities	$	—	$	—	$	24,022	$	24,022


	Fair Value Measurements as of
	December 31, 2022 Using:
	Level 1		Level 2		Level 3		Total
Assets:
Cash equivalents:
Money market funds	$	30,188	$	—	$	—	$	30,188

Liability:
Derivative liabilities	$	—	$	—	$	6,351	$	6,351

Royalty Fee Derivative Liability [Member]

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]

Schedule of main inputs to valuing the Derivative Liability


	As of September 30, 2023
Revenue volatility		60.0 %
Revenue discount rate		16.4 %


	As of
Balance at August 2, 2023	$	12,604
Change in fair value		34
Balance at September 30, 2023	$	12,638

Convertible Notes

Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation [Line Items]

Schedule of main inputs to valuing the Derivative Liability


		As of
	September 30,			December 31,
	2023			2022
Company's stock price	$	3.14		$	2.81
Volatility		76.3	%		93.8	%
Bond yield		22.7	%		16.2	%

Summary of roll-forward of the derivative liability, including the impact from accounting for the Convertible Notes Amendment


	As of
Balance at December 31, 2022	$	6,351
Change in fair value		5,432
Balance at June 30, 2023		11,783
Change in fair value		(827)
Balance at August 2, 2023 before the Convertible Notes Amendment		10,956
Change in fair value from Convertible Notes Amendment		6,745
Balance at August 2, 2023 after the Convertible Notes Amendment		17,701
Change in fair value		(6,317)
Balance at September 30, 2023	$	11,384

- Definition

Tabular disclosure of pertinent information about a derivative or group of derivatives on a disaggregated basis, such as for individual instruments, or small groups of similar instruments. May include a combination of the type of instrument, risks being hedged, notional amount, hedge designation, related hedged item, inception date, maturity date, or other relevant item.

+ References + Details

Related Party Transactions - Additional Information (Details) - USD ($) $ / shares in Units, $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Related Party Transactions
Accounts payable	$ 3,984		$ 3,984		$ 5,123
Accrued expenses	28,887		28,887		24,097
WilmerHale \| Legal Fees. \| Chief Business Officer
Related Party Transactions
Expenses incurred	323	$ 342	956	$ 876
Accounts payable	135		135		0
Accrued expenses	0		0		24
Heier Consulting LLC \| Related Party
Related Party Transactions
Accounts payable	7		7		3
Accrued expenses	0		$ 0		$ 0
Total grant date fair value of stock-based awards granted			$ 96
Heier Consulting LLC \| Related Party \| Service
Related Party Transactions
Expenses incurred	$ 13	$ 21	$ 18	$ 21

Financial Liabilities - Barings Credit Agreement - Terms (Details) - USD ($) $ in Thousands		3 Months Ended	9 Months Ended
	Aug. 02, 2023	Sep. 30, 2023	Sep. 30, 2023	Dec. 31, 2022
Financial Liabilities
Principal amount of debt issued		$ 37,500	$ 37,500	$ 37,500
Royalty fees		(388)	(388)
Barings Credit Facility
Financial Liabilities
Borrowing capacity under the agreement	$ 82,474
Principal amount of debt issued	82,474
Proceeds from issuance of debt, net	$ 77,790
Royalty fees payable as percentage of net sales.	(3.50%)
Minimum liquidity amount	$ 20,000	20,000	20,000
Barings Royalty Fees		$ 388	$ 388
Barings Credit Facility \| SOFR-based rate
Financial Liabilities
Interest rate floor (as a percent)	1.50%
Basis spread (as a percent)	6.75%
Change of control, Entered on or Prior to Six Months After the Closing Date \| Barings Credit Facility
Financial Liabilities
Royalty fees payable reduction , percentage of total credit facility amount.	20.00%
Change of control, Entered After Six Months, but Before Twelve Months, After Closing Date. \| Barings Credit Facility
Financial Liabilities
Royalty fees payable reduction , percentage of total credit facility amount.	30.00%

Risks and Fair Value - The main inputs to valuing the Royalty Fee Derivative Liability (Details)) $ in Thousands		2 Months Ended		6 Months Ended
	Aug. 02, 2023 USD ($)	Sep. 30, 2023 USD ($)	Aug. 31, 2023 USD ($)	Jun. 30, 2023 USD ($)
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance at beginning of period			$ 11,783	$ 6,351
Change in fair value		$ 6,317	$ 827	(5,432)
Balance at end of period		11,384		$ 11,783
Royalty Fee Derivative Liability [Member]
Fair Value, Liabilities Measured on Recurring Basis, Unobservable Input Reconciliation, Calculation [Roll Forward]
Balance at beginning of period		12,604
Change in fair value		34
Balance at end of period	$ 12,604	$ 12,638
Revenue volatility \| Royalty Fee Derivative Liability [Member] \| Level 3
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Derivative Liability, Measurement Input	0.610	0.600
Revenue discount rate \| Royalty Fee Derivative Liability [Member] \| Level 3
Fair Value Measurement Inputs and Valuation Techniques [Line Items]
Derivative Liability, Measurement Input	0.158	0.164

- Definition

Fair value, after the effects of master netting arrangements, of a financial liability or contract with one or more underlyings, notional amount or payment provision or both, and the contract can be net settled by means outside the contract or delivery of an asset. Includes liabilities not subject to a master netting arrangement and not elected to be offset.

+ References

Reference 1: http://www.xbrl.org/2003/role/disclosureRef
-Topic 946
-SubTopic 210
-Name Accounting Standards Codification
-Section 50
-Paragraph 6
-Subparagraph (e)
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+ Details

Cash Equivalents and Restricted Cash (Tables)

9 Months Ended

Sep. 30, 2023

Cash Equivalents and Restricted Cash

Reconciliation of cash, cash equivalents, and restricted cash reported within the balance sheet to the total amounts shown in the statement of cash flows


	September 30,		September 30,
	2023		2022
Cash and cash equivalents	$	110,550	$	120,950
Restricted cash		1,764		1,764
Total cash, cash equivalents and restricted cash	$	112,314	$	122,714

Risks and Fair Value - Derivative Roll-Forward (Details) - USD ($) $ in Thousands		2 Months Ended		6 Months Ended
	Aug. 02, 2023	Sep. 30, 2023	Aug. 31, 2023	Jun. 30, 2023
Roll forward of the derivative liability
Balance at beginning of period			$ 11,783	$ 6,351
Change in fair value		$ (6,317)	$ (827)	5,432
Balance at end of period		11,384		$ 11,783
Conversion option immediately after the amendment
Roll forward of the derivative liability
Balance at beginning of period		$ 17,701
Change in fair value	$ 6,745
Balance at end of period	17,701
Conversion option immediately before the amendment
Roll forward of the derivative liability
Balance at beginning of period	$ 10,956

- Definition

+ References

+ Details

Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) $ in Thousands	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Revenue:
Total revenue, net	$ 15,081	$ 11,965	$ 43,642	$ 37,419
Costs and operating expenses:
Cost, Product and Service [Extensible List]	Product revenue, net	Product revenue, net	Product revenue, net	Product revenue, net
Cost of product revenue	$ 1,377	$ 1,073	$ 3,895	$ 3,528
Research and development	15,019	13,719	44,860	39,919
Selling and marketing	9,315	10,186	31,304	29,390
General and administrative	8,584	8,531	25,915	23,875
Total costs and operating expenses	34,295	33,509	105,974	96,712
Loss from operations	(19,214)	(21,544)	(62,332)	(59,293)
Other income (expense):
Interest income	1,212	285	2,524	375
Interest expense	(3,426)	(1,797)	(7,187)	(5,175)
Change in fair value of derivative liabilities	6,722	(1,133)	1,290	8,598
Gains and losses on extinguishment of debt, net	14,190		14,190
Other income (expense), net		1	(1)	(1)
Total other income (expense), net	18,698	(2,644)	10,816	3,797
Net loss	$ (516)	$ (24,188)	$ (51,516)	$ (55,496)
Net loss per share, basic	$ (0.01)	$ (0.31)	$ (0.66)	$ (0.72)
Weighted average common shares outstanding, basic	79,373,272	76,975,839	78,276,341	76,829,434
Net loss per share, diluted	$ (0.25)	$ (0.31)	$ (0.77)	$ (0.73)
Weighted average common shares outstanding, diluted	85,142,504	76,975,839	84,045,573	82,598,666
Product revenue, net
Revenue:
Total revenue, net	$ 14,950	$ 11,913	$ 43,193	$ 36,555
Collaboration revenue
Revenue:
Total revenue, net	$ 131	$ 52	$ 449	$ 864

Risks and Fair Value - Concentration of Credit Risk (Details) - Customer - customer	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022	Dec. 31, 2022
Total revenue
Concentration risk
Number of major customers		3	3
Total revenue \| Customer one
Concentration risk
Concentration risk	47.00%	42.00%	51.00%	41.00%
Total revenue \| Customer two
Concentration risk
Concentration risk	24.00%	30.00%	23.00%	27.00%
Total revenue \| Customer three
Concentration risk
Concentration risk	12.00%	14.00%	11.00%	18.00%
Accounts receivable
Concentration risk
Number of major customers			3		3
Accounts receivable \| Customer one
Concentration risk
Concentration risk			51.00%		52.00%
Accounts receivable \| Customer two
Concentration risk
Concentration risk			26.00%		24.00%
Accounts receivable \| Customer three
Concentration risk
Concentration risk			11.00%		15.00%

Derivative Liability

9 Months Ended

Sep. 30, 2023

Derivative Liability

Derivative Liability

8. Derivative Liability

Barings Credit Agreement

The Barings Credit Agreement (Note 7) contains an embedded Royalty Fee Obligation that meets the criteria to be bifurcated and accounted for separately from the Barings Credit Facility (the "Royalty Fee Derivative Liability"). The Royalty Fee Derivative Liability was recorded at fair value upon the entering into the Barings Credit Facility and is subsequently remeasured to fair value at each reporting period. The Barings Credit Facility was initially valued and is remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded Royalty Fee Obligation and then valuing the Barings Credit Facility without the embedded Royalty Fee Obligation. Royalty payments are estimated using a Monte Carlo simulation. Refer to Note 9 for details regarding the determination of fair value.

Convertible Notes

The Convertible Notes (Note 7) contain the Conversion Option Derivative Liability, an embedded conversion option that meets the criteria to be bifurcated and accounted for separately from the Convertible Notes. The Conversion Option Derivative Liability was recorded at fair value upon the issuance of the Convertible Notes and is subsequently remeasured to fair value at each reporting period. The Convertible Notes were initially valued and are remeasured using a “with-and-without” method. The “with-and-without” methodology involves valuing the whole instrument on an as-is basis with the embedded conversion option and then valuing the Convertible Notes without the embedded conversion option. The difference between the entire instrument with the embedded conversion option compared to the instrument without the embedded conversion option is the fair value of the derivative, recorded as the Conversion Option Derivative Liability. Refer to Note 9 for details regarding the determination of fair value.

Expenses - Summary (Details) - USD ($) $ in Thousands	Sep. 30, 2023	Dec. 31, 2022
Expenses
Accrued payroll and related expenses	$ 7,862	$ 7,509
Accrued rebates and programs	4,679	3,560
Accrued professional fees	1,347	1,228
Accrued research and development expenses	2,285	1,816
Accrued interest payable on Convertible Notes	10,319	8,756
Accrued interest payable on Barings Note	858
Accrued other	1,537	1,228
Total	$ 28,887	$ 24,097

Net Loss Per Share - Schedule of Antidilutive Securities, Excluded from Computation of Diluted Net Loss per Share (Details) - shares	3 Months Ended		9 Months Ended
	Sep. 30, 2023	Sep. 30, 2022	Sep. 30, 2023	Sep. 30, 2022
Net Loss Per Share
Total common stock equivalents	17,959,906	14,846,276	17,959,906	14,846,276
Options to Purchase Common Stock
Net Loss Per Share
Total common stock equivalents	16,306,543	13,795,937	16,306,543	13,795,937
Restricted Stock Units (RSUs)
Net Loss Per Share
Total common stock equivalents	1,653,363	1,050,339	1,653,363	1,050,339