optn-20240331

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 March 31, 2024


			☐			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: 001-38241

OPTINOSE, INC.

(Exact name of registrant as specified in its charter)


Delaware			42-1771610
(State of other jurisdiction of incorporation or organization)			(I.R.S. Employer Identification Number)

1020 Stony Hill Road, Suite 300

Yardley, Pennsylvania 19067

(Address of principal executive offices, including zip code)

(267) 364-3500

(Registrant’s telephone number including area code)

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

Title of each class

Trading symbol(s)

Name of each exchange on which registered

Common stock, par value $0.001 per share

OPTN

Nasdaq Global Select Market

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, 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 Act).Yes ☐ No ☒

The number of shares of the registrant's common stock outstanding at May 1, 2024 was 113,038,726 shares.


	NOTE REGARDING FORWARD-LOOKING STATEMENTS	1
	PART I — FINANCIAL INFORMATION

Item 1.		4
	Consolidated Balance Sheets as of March 31, 2024 and December 31, 2023	4
	Consolidated Statements of Operations for the three months ended March 31 , 202 4 and 20 23	5
	Consolidated Statements of Comprehensive Loss for the three months ended March 31 , 202 4 and 202 3	6
	Consolidated Statements of Changes in Stockholders' Equity (Deficit) for the three months ended March 31 , 202 4 and 202 3	7
	Consolidated Statements of Cash Flows for the thre e months ended March 31 , 202 4 and 20 23	8
	Notes to Unaudited Interim Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	23
Item 3.	Qualitative and Quantitative Disclosure About Market Risk	31
Item 4.	Controls and Procedures	31
	PART II — OTHER INFORMATION	33






Item 5.	Other Information	33
Item 6.	Exhibits	33
	Signatures	35


	March 31, 2024		December 31, 2023
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	51,644	$	73,684
Accounts receivable, net	14,227		19,926
Inventory	10,315		8,052
Prepaid expenses and other current assets	4,936		3,671
Total current assets	81,122		105,333
Property and equipment, net	754		815
Other assets	1,831		1,581
Total assets	$	83,707	$	107,729
Liabilities and stockholders' deficit
Current liabilities:
Accounts payable	$	1,912	$	3,886
Accrued expenses and other current liabilities	30,793		42,411
Short term debt, net	—		130,227
Total current liabilities	32,705		176,524
Long term debt, net	130,653		—
Warrant liability	18,500		17,200
Other liabilities	1,065		611
Total liabilities	182,923		194,335
Stockholders' deficit
Preferred stock, no par value; 5,000,000 shares authorized; no shares issued in 2024 or 2023	—		—
Common stock, $0.001 par value; 350,000,000 shares authorized; 113,038,726 and 112,399,495 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively.	113		112
Additional paid-in capital	635,198		633,742
Accumulated deficit	(734,443)		(720,376)
Accumulated other comprehensive loss	(84)		(84)
Total stockholders' deficit	(99,216)		(86,606)
Total liabilities and stockholders' deficit	$	83,707	$	107,729


	Three Months Ended March 31,
	2024		2023
Revenues:
Net product revenues	$	14,880	$	11,846

Total revenues	14,880		11,846
Costs and expenses:
Cost of product sales	1,231		1,706
Research and development	1,206		1,785
Selling, general and administrative	20,518		22,723
Total costs and expenses	22,955		26,214
Loss from operations	(8,075)		(14,368)
Other (income) expense:
Unrealized loss on fair value of warrants	1,300		510
Interest income	(296)		(705)
Interest expense	4,970		4,672
Foreign currency loss	18		2
Net loss	$	(14,067)	$	(18,847)



Net loss per share of common stock, basic and diluted	$	(0.12)	$	(0.17)
Weighted average common shares outstanding, basic and diluted	112,594,852		111,774,425


Three months ended March 31, 2024
	Stockholders' Equity (Deficit)
	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Accumulated Other Comprehensive Loss		Total Stockholders' Equity (Deficit)
	Shares	Amount
Balance at December 31, 2023	112,399,495	$	112	$	633,742	$	(720,376)	$	(84)	$	(86,606)
Stock compensation expense	—	—		1,456		—		—		1,456
Vesting of restricted stock units	478,520	1		—		—		—		1
Issuance of common stock under employee stock purchase plan	160,711	—		—		—		—		—
Foreign currency translation adjustment	—	—		—		—		—		—
Net loss	—	—		—		(14,067)				(14,067)
Balance at March 31, 2024	113,038,726	$	113	$	635,198	$	(734,443)	$	(84)	$	(99,216)


Three Months Ended March 31, 2023
	Stockholders' Equity (Deficit)
	Common Stock			Additional Paid-in Capital		Accumulated Deficit		Accumulated Other Comprehensive Loss		Total Stockholders' Equity (Deficit)
	Shares	Amount
Balance at December 31, 2022	111,492,791	$	111	$	628,242	$	(684,893)	$	(84)	$	(56,624)
Stock compensation expense	—	—		1,520		—		—		1,520
Vesting of restricted stock units	343,406	1								1
Issuance of common stock under employee stock purchase plan	119,727	—		164		—		—		164
Foreign currency translation adjustment	—	—		—		—		—		—
Net loss	—	—		—		(18,847)		—		(18,847)
Balance at March 31, 2023	111,955,924	$	112	$	629,926	$	(703,740)	$	(84)	$	(73,786)


	Three Months Ended March 31,
	2024		2023
Operating activities:
Net loss	$	(14,067)	$	(18,847)
Adjustments to reconcile net loss to cash used in operating activities:
Depreciation and amortization	83		72
Stock-based compensation	1,456		1,523
Change in fair value of warrant liability	1,300		510
Amortization of debt discount and issuance costs	419		405
Changes in operating assets and liabilities:
Accounts receivable	5,590		16,953
Prepaid expenses and other assets	(1,048)		874
Inventory	(2,263)		1,118
Accounts payable	(1,973)		953
Accrued expenses and other liabilities	(11,522)		(14,039)
Cash used in operating activities	(22,025)		(10,478)
Investing activities:
Purchases of property and equipment	(22)		—
Cash used in investing activities	(22)		—
Financing activities:

Proceeds from issuance of common stock under employee stock purchase plan	—		162
Cash paid for financing costs	7		—
Cash provided by financing activities	7		162

Net decrease in cash, cash equivalents and restricted cash	(22,040)		(10,316)
Cash, cash equivalents and restricted cash at beginning of period	73,684		94,244
Cash, cash equivalents and restricted cash at end of period	$	51,644	$	83,928
Supplemental disclosure of cash flow information:
Cash paid for interest	9,218		4,255
Supplemental disclosure of noncash activities:


Recognition of right-of-use assets and lease liabilities	$	359	$	37


	March 31,
	2024	2023
Stock options	9,289,484	10,489,593
Restricted stock units	4,927,069	2,691,174
Common stock warrants	32,768,000	32,768,000
Total	46,984,553	45,948,767


	March 31, 2024
	Total		Level 1		Level 2		Level 3
Liabilities
Warrant Liability	$	18,500	$	—	$	—	$	18,500
Total Liabilities	$	18,500	$	—	$	—	$	18,500

	December 31, 2023
Liabilities
Warrant Liability	$	17,200	$	—	$	—	$	17,200
Total Liabilities	$	17,200	$	—	$	—	$	17,200



	Warrant Liability
Balance, December 31, 2023	$	17,200
Warrants issued	—
Change in fair value of liability	1,300
Balance, March 31, 2024	$	18,500



	March 31, 2024			December 31, 2023
Stock price	$	1.46		$	1.29
Strike price	$	2.57		$	2.57
Expected volatility	55.0		%	60.0		%
Risk-free interest rate	4.2		%	3.9		%
Expected dividend yield	—		%	—		%
Expected life (years)	3.6			3.9
Fair value per warrant	$	0.61		$	0.57


	March 31, 2024		December 31, 2023
Raw materials	$	2,580	$	2,400
Work-in-process	4,966		3,281
Finished goods	2,769		2,371
Total inventory	$	10,315	$	8,052


	March 31, 2024		December 31, 2023
Computer equipment and software	$	1,465	$	1,443
Furniture and fixtures	366		366
Machinery and equipment	3,146		3,146
Leasehold improvements	609		609
Construction in process	115		115
	5,701		5,679
Less: accumulated depreciation	(4,947)		(4,864)
	$	754	$	815


Trailing Twelve-Months Ending			As Revised Pursuant to Second Amendment
March 31, 2024			$70,000
June 30, 2024			$70,000
September 30, 2024			$72,500
December 31, 2024			$75,000
March 31, 2025			$80,000
June 30, 2025			$87,500
September 30, 2025			$95,000
December 31, 2025			$105,500
March 31, 2026			$120,000
June 30, 2026			$130,000
September 30, 2026			$145,000
December 31, 2026			$150,000
March 31, 2027			$155,000
June 30, 2027			$160,000



	March 31, 2024		December 31, 2023
Face amount	$	130,000	$	130,000
Front end fees	(479)		(518)
Debt issuance costs	(4,848)		(5,235)
Back end fees	5,980		5,980
Debt, net	$	130,653	$	130,227


	March 31, 2024		December 31, 2023
Accrued expenses:
Product revenue allowances	$	16,751	$	20,145
Selling, general and administrative expenses	4,868		6,229
Research and development expenses	334		644
Payroll expenses	5,280		6,801
Accrued interest	—		4,666
Other	2,835		3,015
Total accrued expenses	$	30,068	$	41,500
Other current liabilities:
Lease liability	$	725	$	911
Total other current liabilities	725		911
Total accrued expenses and other current liabilities	$	30,793	$	42,411


	Shares	Weighted average exercise price per share		Weighted average remaining contractual life
Outstanding at December 31, 2023	8,527,626	$	5.03	6.55
Granted	1,139,601	1.81
Exercised	—	—
Expired	(20,838)	2.27
Forfeited	(351,905)	4.93
Outstanding at March31, 2024	9,294,484	$	4.64	7.02
Exercisable at March 31, 2024	4,781,043	$	7.34	5.34


			Shares
Balance at December 31, 2023			1,897,421
Granted			3,574,200
Vested and settled			(478,520)
Expired/forfeited/canceled			(66,032)
Balance at March 31, 2024			4,927,069
Expected to vest at March 31, 2024			4,927,069

SEC Form 10-Q filed by OptiNose Inc.