optn-20220331

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, 2022


			☐			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 6, 2022 was 82,681,048 shares.


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

Item 1.		4
	Consolidated Balance Sheets as of March 31, 2022 and December 31, 2021	4
	Consolidated Statements of Operations for the three months ended March 31, 2022 and 2021	5
	Consolidated Statements of Comprehensive Loss for the three months ended March 31, 2022 and 2021	6
	Consolidated Statements of Changes in Stockholders' Equity (Deficit) for the three months ended March 31, 2022 and 2021	7
	Consolidated Statements of Cash Flows for the three months ended March 31, 2022 and 2021	8
	Notes to Unaudited Interim Consolidated Financial Statements	9
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	19
Item 3.	Qualitative and Quantitative Disclosure About Market Risk	29
Item 4.	Controls and Procedures	29
	PART II — OTHER INFORMATION	30






Item 1.	Legal Proceedings	36
Item 1A.	Risk Factors	36
Item 6.	Exhibits	30
	Signatures	32


	March 31, 2022		December 31, 2021
	(unaudited)
Assets
Current assets:
Cash and cash equivalents	$	91,367	$	110,502
Accounts receivable, net	22,702		35,449
Inventory	11,380		11,847
Prepaid expenses and other current assets	2,970		2,581
Total current assets	128,419		160,379
Property and equipment, net	1,218		1,347
Other assets	4,178		4,345
Total assets	$	133,815	$	166,071
Liabilities and stockholders' equity (deficit)
Current liabilities:
Accounts payable	$	7,642	$	8,013
Accrued expenses and other current liabilities	42,381		51,222
Total current liabilities	50,023		59,235
Long-term debt, net	126,954		126,418
Other liabilities	1,696		2,190
Total liabilities	178,673		187,843
Stockholders' equity (deficit):
Common stock, $0.001 par value; 200,000,000 shares authorized at March 31, 2022 and December 31, 2021; 82,681,048 and 82,238,900 shares issued and outstanding at March 31, 2022 and December 31, 2021, respectively	83		82
Additional paid-in capital	590,535		588,288
Accumulated deficit	(635,394)		(610,061)
Accumulated other comprehensive loss	(82)		(81)
Total stockholders' equity (deficit)	(44,858)		(21,772)
Total liabilities and stockholders' equity (deficit)	$	133,815	$	166,071


	Three Months Ended March 31,		Three Months Ended March 31,
	2022		2021
Revenues:
Net product revenues	$	14,760	$	10,960
Licensing revenues	—		1,000
Total revenues	14,760		11,960
Costs and expenses:
Cost of product sales	2,014		1,740
Research and development	4,802		5,225
Selling, general and administrative	29,339		27,184
Total operating expenses	36,155		34,149
Loss from operations	(21,395)		(22,189)
Other (income) expense:
Interest income	(134)		(20)
Interest expense	4,073		3,876
Foreign currency (gains) losses	$	(1)	$	8

Net loss	$	(25,333)	$	(26,053)
Net loss per share of common stock, basic and diluted	$	(0.31)	$	(0.49)
Weighted average common shares outstanding, basic and diluted	82,447,861		52,997,730


Three Months Ended March 31, 2022
	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, 2021	82,238,900	$	82	$	588,288	$	(610,061)	$	(81)	$	(21,772)
Stock compensation expense	—	—		1,998		—		—		1,998
Vesting of restricted stock units	262,942	—		—		—		—		—
Issuance of common stock under employee stock purchase plan	179,206	1		249		—		—		250
Foreign currency translation adjustment	—	—		—		—		(1)		(1)
Net loss	—	—		—		(25,333)		—		(25,333)
Balance at March 31, 2022	82,681,048	$	83	$	590,535	$	(635,394)	$	(82)	$	(44,858)


Three Months Ended March 31, 2021
	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, 2020	52,945,865	$	53	$	534,585	$	(527,765)	$	(85)	$	6,788
Stock compensation expense	—	—		2,596		—		—		2,596
Vesting of restricted stock units	166,709	—		—		—		—		—
Foreign currency translation adjustment	—	—		—		—		2		2
Net loss	—	—		—		(26,053)		—		(26,053)
Balance at March 31, 2021	53,112,574	$	53	$	537,181	$	(553,818)	$	(83)	$	(16,667)


	March 31,
	2022	2021
Stock options	10,462,195	8,296,492
Restricted stock units	2,785,746	2,282,204
Common stock warrants	2,500,000	810,357
Employee stock purchase plan	213,693	114,463
Total	15,961,634	11,503,516


	March 31, 2022		December 31, 2021
Raw materials	$	2,973	$	3,504
Work-in-process	5,237		4,816
Finished goods	3,170		3,527
Total inventory	$	11,380	$	11,847


	March 31, 2022		December 31, 2021
Computer equipment and software	$	1,189	$	1,173
Furniture and fixtures	366		366
Machinery and equipment	3,061		3,367
Leasehold improvements	609		609
Construction in process	115		115
	5,340		5,630
Less: accumulated depreciation	(4,122)		(4,283)
	$	1,218	$	1,347


	March 31, 2022		December 31, 2021
Accrued expenses:
Selling, general and administrative expenses	$	7,362	$	6,124
Research and development expenses	3,957		6,857
Payroll expenses	4,954		7,569
Product revenue allowances	21,483		26,521
Other	2,311		2,057
Total accrued expenses	40,067		49,128
Other current liabilities:
Lease liability	2,314		2,094
Total other current liabilities	2,314		2,094
Total accrued expenses and other current liabilities	$	42,381	$	51,222



	March 31, 2022		December 31, 2021
Face amount	$	130,000	$	130,000
Front end fees	(638)		(717)
Debt issuance costs	(3,708)		(4,165)
Back end fees	1,300		1,300
Long-term debt, net	$	126,954	$	126,418


	Shares	Weighted average exercise price per share		Weighted average remaining contractual life
Outstanding at December 31, 2021	7,958,781	$	8.87	6.50
Granted	2,601,370	1.86
Exercised	—	—
Expired	(37,998)	7.25
Forfeited	(59,958)	8.96
Outstanding at March 31, 2022	10,462,195	$	7.14	6.85
Exercisable at March 31, 2022	5,664,457	$	10.54	5.38
Vested and expected to vest at March 31, 2022	9,502,980	$	7.14	6.85


	Three Months Ended March 31,
	2022			2021
Risk free interest rate	1.61		%	1.00		%
Expected term (in years)	6.08			6.08
Expected volatility	72.65		%	74.37		%
Annual dividend yield	0.00		%	0.00		%
Fair value of common stock	$	1.87		$	3.52


	Three Months Ended March 31,
	2022
Risk free rates of return	1.70	%
Expected volatility	75.00	%
Annual dividend yield	—	%


	Three Months Ended March 31,
	2022		2021
Risk free interest rate	0.22	%	0.09	%
Expected term (in years)	0.5		0.5
Expected volatility	88.56	%	86.88	%
Annual dividend yield	0.00	%	0.00	%


			Shares
Outstanding at December 31, 2021			1,959,358
Granted			1,105,246
Vested and settled			(262,942)
Expired/forfeited/canceled			(15,916)
Outstanding at March 31, 2022			2,785,746
Expected to vest at March 31, 2022			2,785,746



			Trailing Twelve-Months Ending						Requirement under the Note Purchase Agreement After the Second Amendment
			March 31, 2022						70.00
			June 30, 2022						75.00
			September 30, 2022						80.00
			December 31, 2022						90.00
			March 31, 2023						98.75
			June 30, 2023						102.50
			September 30, 2023						106.25
			December 31, 2023						110.00
			March 31, 2024						113.75
			June 30, 2024						117.50

SEC Form 10-Q filed by OptiNose Inc.