November 14, 2023 - 10-Q: Quarterly report pursuant to Section 13 or 15(d)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

☒QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended September 30, 2023

☐TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number 001-36193

Trevena, Inc.

(Exact Name of Registrant as Specified in Its Charter)

Delaware
(State or Other Jurisdiction of Incorporation or Organization)

26-1469215
(I.R.S. Employer Identification No.)

955 Chesterbrook Boulevard, Suite 110
Chesterbrook, PA
(Address of Principal Executive Offices)

19087
(Zip Code)

Registrant’s telephone number, including area code: (610) 354-8840

Securities registered pursuant to Section 12(b) of the Exchange Act:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, $0.001 par value

TRVN

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes ☒ No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.:

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer☒

Smaller reporting company ☒

Emerging growth company ☐

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☒

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practical date.

Common Stock, $0.001 par value

Shares outstanding as of November 13, 2023: 15,172,929

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Page

Cautionary Note Regarding Forward-Looking Statements

PART I- FINANCIAL INFORMATION

Item 1.

Consolidated Financial Statements (Unaudited)

Consolidated Balance Sheets

Consolidated Statements of Operations and Comprehensive Loss

Consolidated Statements of Stockholders’ Equity

Consolidated Statements of Cash Flows

Notes to Unaudited Consolidated Financial Statements

Item 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

Item 4.

Controls and Procedures

PART II- OTHER INFORMATION

Unregistered Sales of Equity Securities, Use of Proceeds, and Issuer Purchases of Equity Securities

Item 3.

Defaults Upon Senior Securities

Item 4.

Mine Safety Disclosures

Cautionary Note Regarding Forward-Looking Statements

This Quarterly Report on Form 10-Q, or this “Quarterly Report,” contains forward-looking statements that involve substantial risks and uncertainties. The forward-looking statements are contained principally in the section entitled “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” but also are contained elsewhere in this Quarterly Report, as well as in sections such as “Risk Factors” that are incorporated by reference into this Quarterly Report from our most recent Annual Report on Form 10-K, or the “Annual Report” and our most recent Quarterly Reports on Form 10-Q for the periods ended March 31, 2023 and June 30, 2023. In some cases, you can identify forward-looking statements by the words “may,” “might,” “will,” “could,” “would,” “should,” “expect,” “intend,” “plan,” “objective,” “anticipate,” “believe,” “estimate,” “predict,” “project,” “potential,” “continue” and “ongoing,” or the negative of these terms, or other comparable terminology intended to identify statements about the future. These statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained in this Quarterly Report, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. Forward-looking statements include statements about:

●

our ability to successfully commercialize OLINVYK and any other product candidates for which we may obtain regulatory approval;

●

our sales, marketing and manufacturing capabilities and strategies;

●

any ongoing or planned clinical trials and nonclinical studies for our product candidates;

●

the extent of future clinical trials potentially required by the U.S. Food and Drug Administration for our product candidates;

●

our ability to fund future operating expenses and capital expenditures with our current cash resources or to secure additional funding in the future;

●

the timing and likelihood of obtaining and maintaining regulatory approvals for our product candidates;

●

our plan to develop and potentially commercialize our product candidates;

●

the clinical utility and potential market acceptance of our product candidates, particularly in light of existing and future competition;

●

the size of the markets for our product candidates;

●

the performance of third-parties upon which we depend, including contract manufacturing organizations, suppliers, contract research organizations, distributors and logistics providers;

●

our ability to identify or acquire additional product candidates with significant commercial potential that are consistent with our commercial objectives;

●

the extent to which health epidemics and other outbreaks of communicable diseases could disrupt our operations and/or materially and adversely affect our business and financial conditions;

●

our intellectual property position and our ability to obtain and maintain patent protection and defend our intellectual property rights against third parties; and

●

our ability to satisfy and maintain all applicable Nasdaq continued listing requirements.

You should refer to the “Risk Factors” section of this Quarterly Report, our Quarterly Reports for the periods ended March 31, 2023 and June 30, 2023, and our Annual Report for a discussion of important factors that may cause

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our actual results to differ materially from those expressed or implied by our forward-looking statements. As a result of these factors, we cannot assure you that the forward-looking statements in this Quarterly Report will prove to be accurate. Furthermore, if our forward-looking statements prove to be inaccurate, the inaccuracy may be material. In light of the significant uncertainties in these forward-looking statements, you should not regard these statements as a representation or warranty by us or any other person that we will achieve our objectives and plans in any specified time frame, or at all. We undertake no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

iii

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PART I

ITEM 1. CONSOLIDATED FINANCIAL STATEMENTS

TREVENA, INC.

Consolidated Balance Sheets (Unaudited)

(in thousands, except share and per share data)


	September 30, 2023		December 31, 2022
Assets
Current assets:
Cash and cash equivalents	$	34,952	$	38,320
Accounts Receivable, net		179		—
Inventories		900		906
Prepaid expenses and other current assets		3,447		1,782
Total current assets		39,478		41,008
Restricted cash		540		1,960
Property and equipment, net		1,259		1,488
Right-of-use lease assets		3,813		4,224
Other assets		43		—
Total assets	$	45,133	$	48,680
Liabilities and stockholders’ equity
Current liabilities:
Accounts payable, net	$	1,545	$	2,372
Accrued expenses and other current liabilities		3,629		5,461
Lease liabilities		982		899
Total current liabilities		6,156		8,732
Loan payable, net		29,642		13,430
Leases, net of current portion		4,689		5,436
Warrant liability		1,097		5,483
Total liabilities		41,584		33,081
Stockholders’ equity:
Preferred stock—$0.001 par value; 5,000,000 shares authorized, none issued or outstanding at September 30, 2023 and December 31, 2022		—		—
Common stock—$0.001 par value; 200,000,000 shares authorized at September 30, 2023 and December 31, 2022; 14,721,342 and 7,744,692 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively		15		8
Additional paid-in capital		575,067		563,362
Accumulated deficit		(571,533)		(547,772)
Accumulated other comprehensive income		—		1
Total stockholders’ equity		3,549		15,599
Total liabilities and stockholders’ equity	$	45,133	$	48,680

See accompanying notes to consolidated financial statements.

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TREVENA, INC.

Consolidated Statements of Operations and Comprehensive Loss (Unaudited)

(in thousands, except share and per share data)


	Three Months Ended				Nine Months Ended
	September 30,				September 30,
	2023		2022		2023		2022
Revenue:
Product revenue	$	1	$	(438)	$	28	$	(438)
License and royalty revenue		179		—		3,179		20
Total revenue		180		(438)		3,207		(418)
Operating expenses:
Cost of goods sold		175		2,368		389		2,791
Selling, general and administrative		4,572		7,683		15,799		29,003
Research and development		4,260		5,266		12,160		14,816
Total operating expenses		9,007		15,317		28,348		46,610
Loss from operations		(8,827)		(15,755)		(25,141)		(47,028)
Other income (expense):
Change in fair value of warrant liability		682		651		2,385		651
Other income, net		61		65		118		174
Interest income		377		127		989		246
Interest expense		(210)		(401)		(1,778)		(726)
(Loss) gain on foreign currency exchange		(13)		18		(34)		18
Foreign income tax expense		—		—		(300)		—
Total other income, net		897		460		1,380		363
Net Loss		(7,930)		(15,295)		(23,761)		(46,665)
Unrealized gain (loss) on marketable securities		—		32		—		(28)
Comprehensive loss	$	(7,930)	$	(15,263)	$	(23,761)	$	(46,693)
Per share information:
Net loss per share of common stock, basic and diluted	$	(0.57)	$	(2.24)	$	(2.03)	$	(6.97)
Weighted average common shares outstanding, basic and diluted		13,964,301		6,829,013		11,728,842		6,691,061

See accompanying notes to consolidated financial statements.

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TREVENA, INC.

Consolidated Statements of Stockholders’ Equity (Unaudited)
(in thousands, except share data)


	Stockholders' Equity
											Accumulated
	Common Stock			Preferred Stock							Other
	Number	$0.001		Number	$0.001		Additional				Comprehensive		Total
	of	Par		of	Par		Paid-in		Accumulated		Income		Stockholders'
	Shares	Value		Shares	Value		Capital		Deficit		(Loss)		Equity
Balance, January 1, 2023	7,744,692	$	8	—	$	—	$	563,362	$	(547,772)	$	1	$	15,599
Stock-based compensation expense	—		—	—		—		806		—		—		806
Unrealized loss on marketable securities	—		—	—		—		—		—		(1)		(1)
Exercise of pre-funded warrants and related reclassification of warrant liability	1,230,380		1	—		—		1,568		—		—		1,569
Net loss	—		—	—		—		—		(7,819)		—		(7,819)
Balance, March 31, 2023	8,975,072	$	9	—	$	—	$	565,736	$	(555,591)	$	—	$	10,154
Stock-based compensation expense	—		—	—		—		702		—		—		702
Issuance of common stock, net of issuance costs	4,116,039		4	—		—		6,500		—		—		6,504
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes	2,028		—	—		—		—		—		—		—
Exercise of pre-funded warrants and related reclassification of warrant liability	619,000		1	—		—		433		—		—		434
Net loss	—		—	—		—		—		(8,012)		—		(8,012)
Balance, June 30, 2023	13,712,139	$	14	—	$	—	$	573,371	$	(563,603)	$	—	$	9,782
Stock-based compensation expense	—		—	—		—		689		—		—		689
Issuance of common stock, net of issuance costs	1,009,000		1	—		—		1,007		—		—		1,008
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes	203		—	—		—		—		—		—		—
Net loss	—		—	—		—		—		(7,930)		—		(7,930)
Balance, September 30, 2023	14,721,342	$	15	—	$	—	$	575,067	$	(571,533)	$	—	$	3,549

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	Stockholders' Equity
													Accumulated
	Common Stock			Preferred Stock									Other
	Number	$0.001		Number	$0.001		Additional						Comprehensive		Total
	of	Par		of	Par		Paid-in		Subscription		Accumulated		Income		Stockholders'
	Shares	Value		Shares	Value		Capital		Receivable		Deficit		(Loss)		Equity
Balance, January 1, 2022	6,618,096	$	7	—	$	—	$	558,724	$	—	$	(494,102)	$	—	$	64,629
Stock-based compensation expense	—		—	—		—		1,155		—		—		—		1,155
Net loss	—		—	—		—		—		—		(16,389)		—		(16,389)
Balance, March 31, 2022	6,618,096	$	7	—	$	—	$	559,879	$	—	$	(510,491)	$	—	$	49,395
Stock-based compensation expense	—		—	—		—		1,008		—		—		—		1,008
Issuance of common stock warrants in connection with loan payable	—		—	—		—		603		—		—		—		603
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes	6,441		—	—		—		—		(23)		—		—		(23)
Unrealized loss on marketable securities	—		—	—		—		—		—		—		(60)		(60)
Net loss	—		—	—		—		—		—		(14,981)		—		(14,981)
Balance, June 30, 2022	6,624,537	$	7	—	$	—	$	561,490	$	(23)	$	(525,472)	$	(60)	$	35,942
Stock-based compensation expense	—		—	—		—		764		—		—		—		764
Issuance of Preferred Stock	—		—	2,000		397		—		—		—		—		397
Conversion of Preferred Stock to Common Stock	320,000		—	(2,000)		(397)		389		—		—		—		(8)
Issuance of common stock upon vesting of RSUs, net of shares withheld for employee taxes	203		—	—		—		—		23		—		—		23
Unrealized loss on marketable securities	—		—	—		—		—		—		—		32		32
Net loss	—		—	—		—		—		—		(15,295)		—		(15,295)
Balance, September 30, 2022	6,944,740	$	7	—	$	—	$	562,643	$	—	$	(540,767)	$	(28)	$	21,855

See accompanying notes to consolidated financial statements.

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TREVENA, INC.

Consolidated Statements of Cash Flows (Unaudited)

(in thousands)


	Nine Months Ended
	September 30,
	2023		2022
Operating activities:
Net loss	$	(23,761)	$	(46,665)
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation		249		300
Stock-based compensation		2,197		2,927
Noncash interest expense on loan		1,004		230
Inventory valuation adjustment		—		2,070
Change in fair value of warrant liability		(2,385)		(651)
Returns reserve adjustment		—		383
Accretion of bond discount on marketable securities		—		(36)
Change in right-of-use asset		411		354
Changes in operating assets and liabilities:
Accounts receivable, prepaid expenses and other assets		(1,454)		1,628
Inventories		6		(503)
Operating lease liabilities		(656)		(552)
Accounts payable, accrued expenses and other liabilities		(2,661)		(298)
Net cash used in operating activities		(27,050)		(40,813)
Investing activities:
Purchases of property and equipment		(20)		(28)
Maturities of marketable securities		—		15,000
Purchases of marketable securities		—		(32,954)
Net cash used in investing activities		(20)		(17,982)
Financing activities:
Proceeds from issuance of common stock, net of issuance costs		7,513		—
Proceeds from exercise of pre-funded warrants		2		—
Finance lease payments		(8)		(4)
Proceeds from debt		14,775		13,906
Proceeds from issuance of convertible Series A and Series B preferred stock warrants, net of issuance costs		—		1,647
Net cash provided by financing activities		22,282		15,549
Net decrease in cash, cash equivalents and restricted cash		(4,788)		(43,246)
Cash, cash equivalents and restricted cash—beginning of period		40,280		68,234
Cash, cash equivalents and restricted cash—end of period	$	35,492	$	24,988
Supplemental disclosure of cash flow information:
Cash paid for interest	$	801	$	268
Allocation of loan payable proceeds to common stock warrants	$	—	$	603
Preferred stock proceeds allocated to warrant liability	$	—	$	(603)
Reclassification of warrant liability upon exercise of pre-funded warrants	$	2,001	$	—
Conversion of Series A and Series B preferred stock to common stock	$	—	$	396

See accompanying notes to consolidated financial statements.

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TREVENA, INC.

Notes to Unaudited Consolidated Financial Statements

September 30, 2023

1. Organization and Description of the Business

Trevena, Inc., or the Company, was incorporated in Delaware as Parallax Therapeutics, Inc. on November 9, 2007. The Company began operations in December 2007, and its name was changed to Trevena, Inc. on January 3, 2008. The Company is a biopharmaceutical company focused on the development and commercialization of novel medicines for patients affected by central nervous system, or CNS, disorders. The Company operates in one segment and has its principal office in Chesterbrook, Pennsylvania.

Since commencing operations in 2007, the Company has devoted substantially all of its financial resources and efforts to commercializing its lead asset, OLINVYK® (oliceridine) injection, or OLINVYK, and to research and development, including nonclinical studies and clinical trials. The Company has never been profitable. In August 2020, the FDA approved the NDA for OLINVYK and the Company initiated commercial launch of OLINVYK in the first quarter of 2021.

Since its inception, the Company has incurred losses and negative cash flows from operations. At September 30, 2023, the Company had an accumulated deficit of $571.5 million. The Company’s net loss was $23.8 million and $46.7 million for the nine months ended September 30, 2023 and 2022, respectively. The Company follows the provisions of Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or ASC, Topic 205-40, Presentation of Financial Statements—Going Concern, or ASC 205-40, which requires management to assess the Company’s ability to continue as a going concern for one year after the date the financial statements are issued. The Company expects that its existing balance of cash and cash equivalents as of September 30, 2023 is not sufficient to fund operations for more than one year after the date of this filing and therefore management has concluded that substantial doubt exists about the Company’s ability to continue as a going concern. Management’s plans to mitigate this risk include raising additional capital through equity or debt financings, or through strategic transactions. Management’s plans may also include the deferral of certain operating expenses unless and until additional capital is received. However, there can be no assurance that the Company will be successful in raising additional capital or that such capital, if available, will be on terms that are acceptable to the Company, or that the Company will be successful in deferring certain operating expenses. If the Company is unable to raise sufficient additional capital or defer sufficient operating expenses, the Company may be compelled to reduce the scope of its operations and planned capital expenditures.

2. Summary of Significant Accounting Policies

Basis of Presentation

The accompanying consolidated financial statements have been prepared in conformity with accounting principles generally accepted in the United States of America, or U.S. GAAP. Any reference in these notes to applicable guidance is meant to refer to the authoritative United States generally accepted accounting principles as found in the ASC and Accounting Standards Updates, or ASUs, of the FASB. The Company’s functional currency is the U.S. dollar.

The consolidated financial statements include all normal and recurring adjustments that are considered necessary for the fair presentation of the Company’s consolidated balance sheets as of September 30, 2023, its results of operations and its comprehensive loss for the three and nine months ended September 30, 2023 and 2022, its consolidated statements of stockholders’ equity for the period from January 1, 2023 to September 30, 2023 and for the period January 1, 2022 to September 30, 2022, and its consolidated statements of cash flows for the nine months ended September 30, 2023 and 2022. The information included in this Quarterly Report on Form 10-Q should be read in conjunction with the financial statements and accompanying notes included in the Company’s most recent Annual Report on Form 10-K for the year ended December 31, 2022. Since the date of those financial statements, there have been no changes to the Company’s significant accounting policies. The financial data and other information disclosed in these notes related to the nine months ended September 30, 2023 are not necessarily indicative of the results to be expected for the year ending December 31, 2023, any other interim periods, or any future year or period.

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Principles of Consolidation

In connection with the royalty-based financing agreement disclosed in Note 5, the Company established three wholly owned subsidiaries, Trevena Royalty Corporation, Trevena SPV1 LLC and Trevena SPV2 LLC to facilitate the financing. The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries as of September 30, 2023. All significant intercompany accounts and transactions have been eliminated in consolidation.

Use of Estimates

The preparation of consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates and assumptions are based on current facts, historical experience as well as other pertinent industry and regulatory authority information. Actual results may differ materially and adversely from these estimates. To the extent there are material differences between the estimates and actual results, the Company’s future results of operations will be affected.

Fair Value of Financial Instruments

The carrying amount of the Company’s financial instruments, which include cash and cash equivalents, restricted cash, accounts payable, and accrued expenses approximate their fair values, given their short-term nature. Additionally, at September 30, 2023, the Company believes the carrying value of the loan payable approximates its fair value as the interest rate is reflective of the rate the Company could obtain on debt with similar terms and conditions. Certain of the Company’s common stock warrants are carried at fair value, as disclosed in Note 3.

The Company has evaluated the estimated fair value of financial instruments using available market information and management’s estimates. The use of different market assumptions and/or estimation methodologies could have a significant effect on the estimated fair value amounts. See Note 3 for additional information.

Product Revenue

The Company accounts for product revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (ASC 606). The Company performs the following five steps to recognize revenue under ASC 606: (i) identify the contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenue when (or as) the entity satisfies a performance obligation. The Company only recognizes revenue when it believes that it is probable that it will collect the consideration to which it is entitled in exchange for the goods or services that will be transferred to the customer.

The Company sells OLINVYK to wholesalers in the US (collectively, “customers”). These customers subsequently resell the Company’s products generally to hospitals, ambulatory surgical centers and other purchasers of OLINVYK. The Company recognizes revenue from OLINVYK sales at the point customers obtain control of the product, which generally occurs upon delivery. The transaction price that is recognized as revenue for products includes an estimate of variable consideration which is described below.

Variable Consideration

The Company includes an estimate of variable consideration in its transaction price at the time of sale when control of the product transfers to the customer. Variable consideration includes distributor chargebacks, prompt payment (cash) discounts, distribution service fees and product returns.

The Company assesses whether or not an estimate of its variable consideration is constrained based on the probability that a significant reversal in the amount of cumulative revenue may occur in the future when the uncertainty associated with the variable consideration is subsequently resolved. Actual amounts of consideration ultimately received may vary from the Company’s estimates. If actual results in the future vary from the Company’s estimates, the Company will adjust these estimates, which would affect product sales and earnings in the period such variances become known.

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Distributor Chargebacks

When a product that is subject to a contractual price agreement is sold to a third party, the difference between the price paid to the Company by the wholesaler and the price under the specific contract is charged back to the Company by the wholesaler. Utilizing this information, the Company estimates a chargeback percentage for each product and records an allowance for chargebacks as a reduction to revenue when the Company records sales of the products. The Company reduces the chargeback allowance when a chargeback request from a wholesaler is processed.

Prompt Payment (Cash) Discounts

The Company provides customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The Company’s prompt payment discount reserves are based on actual net sales and contractual discount rates.

Distribution Service Fees

The Company pays distribution service fees to its customers based on a fixed percentage of the product price. These fees are not in exchange for a distinct good or service and therefore are recognized as a reduction of the transaction price. The Company reserves for these fees based on actual net sales, contractual fee rates negotiated with the customer and the mix of the products in the distribution channel that remain subject to fees.

Product Returns

Generally, the Company’s customers have the right to return any unopened product during the eighteen (18) month period beginning six (6) months prior to the labeled expiration date and ending twelve (12) months after the labeled expiration date. Since the Company did not have a history of OLINVYK returns when the product was launched, the Company estimated returns based on industry data for comparable products in the market. The Company does not currently rely on industry data in its analysis of returns reserve. As the Company sold OLINVYK and established historical sales over a longer period of time, the Company placed more reliance on historical purchasing, demand from hospitals and ambulatory surgical centers, return patterns of its customers and the amount of OLINVYK held by wholesalers, when evaluating reserves for product returns. OLINVYK has a forty-eight (48) month shelf life.

The Company recognizes the amount of expected returns as a refund liability, representing the obligation to return the customer’s consideration. Since the returns primarily consist of expired and short dated products that will not be resold, the Company does not record a return asset for the right to recover the goods returned by the customer at the time of the initial sale (when recognition of revenue is deferred due to the anticipated return). Accrued product return estimates are recorded in accrued expenses and other current liabilities on the consolidated balance sheet.

3. Fair Value of Financial Instruments

ASC 820, Fair Value Measurement, establishes a fair value hierarchy for instruments measured at fair value that distinguishes between assumptions based on market data (observable inputs) and the Company’s own assumptions (unobservable inputs). Observable inputs are inputs that market participants would use in pricing the asset or liability based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the inputs that market participants would use in pricing the asset or liability and are developed based on the best information available in the circumstances.

ASC 820 identifies fair value as the exchange price, or exit price, representing the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants. As a basis for considering market participant assumptions in fair value measurements, ASC 820 establishes a three-tier fair value hierarchy that distinguishes among the following:

●

Level 1 – Valuations based on unadjusted quoted prices in active markets for identical assets or liabilities that the Company has the ability to access.

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Level 2 – Valuations based on quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets or liabilities in markets that are not active and models for which all significant inputs are observable, either directly or indirectly.

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Level 3 – Valuations based on inputs that are unobservable and significant to the overall fair value measurement.

To the extent that the valuation is based on models or inputs that are less observable or unobservable in the market, the determination of fair value requires more judgment. Accordingly, the degree of judgment exercised by the Company in determining fair value is greatest for instruments categorized in Level 3. A financial instrument’s level within the fair value hierarchy is based on the lowest level of any input that is significant to the fair value measurement.

The following table presents fair value of the Company’s cash, cash equivalents, restricted cash and warrant liability as of September 30, 2023 and December 31, 2022 (in thousands):



	September 30,		Quoted Prices in Active Markets		Significant Other Observable Inputs		Unobservable Inputs
Description:	2023		(Level 1)		(Level 2)		(Level 3)
Assets:
Cash	$	3,138	$	3,138	$	—	$	—
Money Market Funds		31,814		31,814		—		—
Restricted Cash		540		540		—		—
Total assets measured and recorded at fair value	$	35,492	$	35,492	$	—	$	—
Liabilities:
Warrant Liability		1,097		—		—		1,097
Total liabilities measured and recorded at fair value	$	1,097	$	—	$	—	$	1,097



	December 31,		Quoted Prices in Active Markets		Significant Other Observable Inputs		Unobservable Inputs
Description:	2022		(Level 1)		(Level 2)		(Level 3)
Assets:
Cash	$	9,651	$	9,651	$	—	$	—
Money Market Funds		28,669		28,669		—		—
Restricted Cash		1,960		1,960		—		—
Total assets measured and recorded at fair value	$	40,280	$	40,280	$	—	$	—
Liabilities:
Warrant Liability		5,483		—		—		5,483
Total liabilities measured and recorded at fair value	$	5,483	$	—	$	—	$	5,483

(1)	The fair value of Level 1 securities is estimated based on quoted prices in active markets for identical assets or liabilities.

The Company recognizes transfers between levels of the fair value hierarchy as of the end of the reporting period. There were no transfers between Level 2 and Level 3 during the nine months ended September 30, 2023.

The common stock warrants issued in connection with the Company’s equity raises in July 2022 and November 2022 were classified as liabilities at the time of issuance due to certain cash settlement adjustment features that were not deemed to be indexed to the Company’s stock. The warrant liability is remeasured each reporting period with the change in fair value recorded to other income (expense) in the consolidated statement of operations and comprehensive loss until the warrants are exercised, expired, reclassified or otherwise settled. The fair value of the warrant liability was estimated using a Black-Scholes Option Pricing Model.

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Registered Direct Stock Offering and Concurrent Warrant Issuance

The fair value of the July 2022 Offering common stock warrant liability was determined using Level 3 inputs and was estimated using the Black-Scholes valuation model. The assumptions used to estimate the fair value were as follows:


	September 30,		December 31,
	2023		2022
Expected term of warrants (in years)	3.7		4.6
Risk-free interest rate	4.7	%	4.0	%
Expected volatility	124.8	%	108.9	%
Dividend yield	—	%	—	%

The following is a roll forward of the July 2022 Offering common stock warrant liability (in thousands):


Balance, December 31, 2022	$	259
Change in fair value		(172)
Balance, September 30, 2023	$	87

November 2022 Equity Offering and Warrant Issuance

The fair value of the November 2022 Offering common stock warrant liability was determined using Level 3 inputs and was estimated using the Black-Scholes valuation model. The assumptions used to estimate the fair value were as follows:



	September 30, 2023			December 31, 2022
Expected term of warrants (in years)		4.1			4.9
Risk-free interest rate		4.7	%		4.0	%
Expected volatility		127.4	%		106.1	%
Dividend yield		—	%		—	%

The following is a roll forward of the November 2022 Offering common stock warrant liability (in thousands):


	Warrant Liability
Balance, December 31, 2022	$	5,224
Change in fair value		(2,213)
Exercise of pre-funded common stock warrants		(2,001)
Balance, September 30, 2023	$	1,010

Warrants

As of September 30, 2023, the Company had the following common stock warrants outstanding:



	Classification	Warrants	Exercise Price	Expiration Date
July 2022 Offering	Liability	320,000	$6.58	12/28/2027
November 2022 Offering	Liability	2,614,380	2.95	11/18/2027
R-Bridge warrants	Equity	200,000	20.50	4/14/2025
Other warrants	Equity	11,014	31.25 - 265.48	1/29/2024 - 3/31/2027
		3,145,394

The Company classifies investments available to fund current operations as current assets on its balance sheet. As of September 30, 2023 and 2022, the Company did not hold any investment securities exceeding a one-year maturity.

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Accretion of bond discount on marketable securities is included in other income as a separate component of other income (expense) on the statement of operations and comprehensive loss. Interest income on marketable securities is recorded as interest income on the statement of operations and comprehensive loss.

4. Inventories

Inventories are valued at the lower of cost or net realizable value. Cost is determined using the first-in, first-out method for all inventories. Inventory includes the cost of API, raw materials and third-party contract manufacturing and packaging services. Indirect overhead costs associated with production and distribution are recorded as period costs in the period incurred. OLINVYK was approved by the FDA in August 2020. Prior to FDA approval, all manufacturing costs for OLINVYK were expensed to research and development. Upon FDA approval, manufacturing costs for OLINVYK manufactured for commercial sale have been capitalized as inventory cost. Costs of drug product to be consumed in any current or future clinical trials will continue to be recognized as research and development expense.

The Company periodically evaluates the carrying value of inventory on hand using the same lower of cost or net realizable value approach as that used to initially value the inventory. Valuation adjustments may be required for slow-moving or obsolete inventory or in any situations where market conditions have caused net realizable value to fall below the carrying cost of the inventory.

Inventory consists of the following (in thousands):


	September 30, 2023		December 31, 2022
Finished goods	$	900	$	3,111
Inventory Valuation Adjustment		—		(2,205)
Total Inventories	$	900	$	906

5. Loan Payable

In April 2022, the Company, through its wholly owned subsidiary Trevena SPV2 LLC, entered into a royalty-based loan agreement (the “Loan Agreement”) with R-Bridge, pursuant to which the Company may be eligible to receive up to $40.0 million in term loan borrowings (the “R-Bridge Financing”). Term loan borrowings will be advanced in three tranches. The first tranche of $15.0 million was advanced in April 2022. The second tranche of $10.0 million will become available upon achievement of either a commercial or financing milestone as set forth in the Loan Agreement. The third tranche of $15.0 million became available upon the first commercial sale of OLINVYK in China which occurred in August 2023 and the Company elected to receive such proceeds.

The following table summarizes the impact of the Loan Agreement on the Company’s consolidated balance sheet as follows (in thousands):


	September 30,
	2023
Principal and accreted interest	$	31,107
Unamortized debt discount		(1,465)
Loans payable, net	$	29,642

The term loans bear interest at a rate per annum equal to 7.00% and will mature on the earlier of (i) the fifteen (15) year anniversary of the closing date in March 2022 and (ii) the date on which the license agreement with Nhwa expires. Repayment of any borrowings and related interest will be made quarterly beginning June 30, 2022. Repayment will be in the form of (i) a 4.0% royalty payment on the Company’s net sales of OLINVYK in the United States and (ii) proceeds from royalties from the Company’s license agreement with Nhwa. As a result of Nhwa obtaining Chinese approval of OLINVYK in May 2023, royalties from net sales of OLINVYK in the United States are capped at $10.0 million in accordance with the Loan Agreement. Upon a change in control or in the event the Company elects to repay any outstanding borrowings prior to their contractual maturity, the Company is required to pay a control premium equal

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to the greater of (i) principal and interest and (ii) $10.0 million or $20.0 million depending on the timing in which the triggering event occurs as further provided in the Loan Agreement.

In April 2022, the Company placed $2.0 million into an interest reserve account in connection with the Loan Agreement. Payments of interest under the Loan Agreement are made quarterly from the royalty on the Company’s net sales of OLINVYK in the United States and proceeds from royalties from the Company’s license agreement with Nhwa. On each interest payment date, if the royalty payments received do not equal the total interest due for the respective quarter, the interest payment due will be paid from the interest reserve account. The interest reserve account was classified as restricted cash on the Company’s balance sheet at December 31, 2022. During the second quarter of 2023, the Company agreed to transfer the remaining funds, approximately $1.0 million, to R-Bridge to prepay future interest payments. As of September 30, 2023, there was $0.6 million of prepaid interest on the Company’s consolidated balance sheet that will be applied to future payments under the Loan Agreement.

Repayments of all borrowings, interest and other related payments, under the Loan Agreement are secured by substantially all of the assets associated with the license agreement with Nhwa, the Chinese intellectual property related to OLINVYK, and deposit accounts established to hold amounts received on account for repayment of the borrowings and related interest under the Loan Agreement. The Loan Agreement contains certain customary affirmative and negative covenants and contains customary defined events of default, upon which any outstanding principal and unpaid interest shall be due on demand. At September 30, 2023, there were no events of default pursuant to the Loan Agreement and the Company was in compliance with all covenants.

In connection with the first tranche borrowings in April 2022, the Company issued a warrant to R-Bridge to purchase 200,000 shares of the Company’s common stock at an initial exercise price of $20.50 per share and will be exercisable for a period of three years. The Company concluded the warrant was a freestanding equity-classified instrument to which the proceeds from the first tranche was allocated across the debt and warrant on a relative fair value basis. In addition, the Company incurred lender fees and third-party costs of $0.5 million each and were netted against the proceeds allocated to the debt and warrant. Fees netted against debt proceeds represent a debt discount and are amortized into interest expense using the effective interest method. During the nine months ended September 30, 2023, the Company recognized interest expense of $1.8 million, of which $0.1 million pertained to the amortization of the debt discount.

The accounting for the Loan Agreement requires the Company to make certain estimates and assumptions, particularly about future royalties under the license agreement with Nhwa and sales of OLINVYK in the United States and China. Such estimates and assumptions are utilized in determining the expected repayment term, amortization period of the debt discount, accretion of interest expense and classification between current and long-term portions of amounts outstanding. The Company amortizes the debt discount into interest expense over the expected term of the arrangement using the interest method based on projected cash flows. Similarly, the Company classifies as current debt for the Loan Agreement, amounts that are expected to be repaid during the succeeding twelve months after the reporting period end. However, the repayment of amounts due under the Loan Agreement is variable because the cash flows to be utilized for periodic payments is a function of amounts received by the Company with respect to the royalties and net product sales.

Accordingly, the estimates of the magnitude and timing of amounts to be available for debt service are subject to significant variability and thus, subject to significant uncertainty. Therefore, these estimates and assumptions are likely to change, which may result in future adjustments to the portion of the debt that is classified as a current liability, the amortization of debt discount and the accretion of interest expense. Other amounts that may become due and payable under the Loan Agreement, including amounts shared between the parties with respect to cash flows received in excess of pre-defined thresholds, are recognized as additional interest expense when they become probable and estimable. The amount of principal to be repaid in each of the five succeeding years is not fixed and determinable.

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6. Stock Compensation

The estimated grant date fair value of the Company’s share-based awards is amortized on a straight-line basis over the awards’ service periods. Share based compensation expense recognized was as follows (in thousands):


	Nine Months Ended September 30,
	2023		2022
Research and development	$	444	$	672
Selling, general and administrative		1,753		2,257
Cost of goods sold		—		(2)
Total stock-based compensation	$	2,197	$	2,927

Stock Options

A summary of stock option activity and related information through September 30, 2023 follows:


	Options Outstanding
				Weighted
				Average
		Weighted		Remaining
		Average		Contractual
	Number of	Exercise		Term
	Shares	Price		(in years)
Balance, December 31, 2022	351,709	$	49.15	6.94
Granted	130,150		1.01
Forfeited/Cancelled	(51,060)		47.51
Balance, September 30, 2023	430,799	$	34.80	7.12
Vested or expected to vest at September 30, 2023	430,799	$	34.80	7.12
Exercisable at September 30, 2023	263,962	$	48.18	5.87

The aggregate intrinsic value of options exercisable as of September 30, 2023 was zero, based on the difference between the Company’s closing stock price of $0.60 and the exercise price of each stock option. At September 30, 2023, there was $1.7 million of total unrecognized compensation expense related to unvested options that will be recognized over the weighted average remaining vesting period of 1.43 years.

The Company uses the Black Scholes option pricing model to estimate the fair value of stock options at the grant date. The Black Scholes model requires the Company to make certain estimates and assumptions, including estimating the fair value of the Company’s common stock, assumptions related to the expected price volatility of the Company’s common stock, the period during which the options will be outstanding, the rate of return on risk free investments and the expected dividend yield for the Company’s common stock.

The per-share weighted-average grant date fair value of the options granted to employees and directors during the nine months ended September 30, 2023 and 2022 was estimated at $0.82 and $8.88 per share, respectively, on the date of grant using the Black-Scholes option pricing model with the following weighted-average assumptions:


	September 30,
	2023		2022
Expected term of options (in years)	5.7		5.7
Risk-free interest rate	3.9	%	2.7	%
Expected volatility	110.3	%	98.0	%
Dividend yield	—	%	—	%

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Restricted Stock Units

RSU-related expense is recognized on a straight-line basis over the vesting period. Upon vesting, these awards may be settled on a net-exercise basis to cover any required withholding tax with the remaining amount converted into an equivalent number of shares of common stock.

The following is a summary of changes in the status of non-vested RSUs during the nine months ended September 30, 2023:

Form: 10-Q

Documents

Trevena, Inc.

Restricted Stock Units