axnx-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: 001-38721

_________________________________________________________________

Axonics, Inc.

(Exact name of registrant as specified in its charter)

_________________________________________________________________

Delaware

45-4744083

(State or other jurisdiction of
incorporation or organization)

(I.R.S. Employer
Identification Number)

26 Technology Drive

Irvine,

California

92618

(Address of principal executive offices)

(Zip Code)

(949)

396-6322

(Registrant’s telephone number, including area code)

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


Title of class	Trading symbol	Name of exchange on which registered
Common stock, par value $0.0001 per share	AXNX	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 Exchange Act). Yes ☐ No ☒

As of April 26, 2024, 51,018,478 shares of the registrant’s common stock, par value $0.0001 per share, were outstanding.

TABLE OF CONTENTS


		Page

	Special Note Regarding Forward-Looking Statements

	PART I—FINANCIAL INFORMATION

Item 1.	Condensed Consolidated Financial Statements (unaudited)	1
	Condensed Consolidated Balance Sheets	1
	Condensed Consolidated Statements of Comprehensive Loss	2

	Condensed Consolidated Statements of Stockholders’ Equity	3
	Condensed Consolidated Statements of Cash Flows	4
	Notes to Condensed Consolidated Financial Statements	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	25
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	33
Item 4.	Controls and Procedures	34

	PART II—OTHER INFORMATION

Item 1.	Legal Proceedings	36
Item 1A.	Risk Factors	36
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	36
Item 3.	Defaults Upon Senior Securities	36
Item 4.	Mine Safety Disclosures	36
Item 5.	Other Information	36
Item 6.	Exhibits	37
	Signatures	38


	March 31,		December 31,
	2024		2023
	(unaudited)
ASSETS
Current assets
Cash and cash equivalents	$	232,645	$	104,811
Short-term investments	100,161		240,149
Accounts receivable, net of allowance for credit losses of $1,079 and $442 at March 31, 2024 and December 31, 2023, respectively	50,529		57,243
Inventory, net	93,187		79,940
Prepaid expenses and other current assets	5,508		9,279
Total current assets	482,030		491,422
Restricted cash	15,826		12,714
Property and equipment, net	17,037		10,760
Intangible assets, net	78,422		81,375
Other assets	23,703		24,235
Goodwill	98,543		99,417
Total assets	$	715,561	$	719,923

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable	$	15,770	$	18,452
Accrued liabilities	14,752		10,527
Accrued compensation and benefits	16,409		15,060
Operating lease liabilities, current portion	1,456		1,777


Total current liabilities	48,387		45,816
Operating lease liabilities, net of current portion	30,154		25,840

Deferred tax liabilities, net	9,921		10,703

Total liabilities	88,462		82,359
Commitments and contingencies (Note 3)
Stockholders’ equity
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at March 31, 2024 and December 31, 2023	—		—
Common stock, par value $0.0001, 75,000,000 shares authorized at March 31, 2024 and December 31, 2023; 51,018,179 and 50,770,520 shares issued and outstanding at March 31, 2024 and December 31, 2023, respectively	5		5
Additional paid-in capital	1,043,577		1,033,778
Accumulated deficit	(399,464)		(380,352)
Accumulated other comprehensive loss	(17,019)		(15,867)
Total stockholders’ equity	627,099		637,564
Total liabilities and stockholders’ equity	$	715,561	$	719,923


	Three Months Ended March 31,
		2024		2023
Net revenue		$	91,409	$	70,650
Cost of goods sold		22,156		18,150
Gross profit		69,253		52,500
Operating expenses
Research and development		11,056		8,056
General and administrative		15,104		12,168
Sales and marketing		56,191		42,654
Amortization of intangible assets		2,254		2,222
Acquisition-related costs		3,827		1,766

Total operating expenses		88,432		66,866
Loss from operations		(19,179)		(14,366)
Other income (expense)
Interest and other income		3,973		3,628

Interest and other expense		(59)		683
Other income, net		3,914		4,311
Loss before income tax expense (benefit)		(15,265)		(10,055)
Income tax expense (benefit)		3,847		(807)
Net loss		(19,112)		(9,248)




Foreign currency translation adjustment		(1,152)		3,071
Comprehensive loss		$	(20,264)	$	(6,177)

Net loss per share, basic and diluted		$	(0.38)	$	(0.19)
Weighted-average shares used to compute basic and diluted net loss per share		50,928,171		48,579,084


								Accumulated
				Additional				Other
	Common Stock			Paid-in		Accumulated		Comprehensive
	Shares	Amount		Capital		Deficit		Loss		Total
Balance at December 31, 2023	50,770,520	$	5	$	1,033,778	$	(380,352)	$	(15,867)	$	637,564
Issuance of common stock for employee stock option exercises for cash	16,068	—		248		—		—		248
Restricted Shares Award (RSA) issuances and forfeitures for terminations, net and stock-based compensation	24,857	—		8,106		—		—		8,106
Issuance of common stock for vesting of Restricted Stock Units (RSU) and stock-based compensation	206,734	—		1,445		—		—		1,445


Foreign currency translation adjustment	—	—		—		—		(1,152)		(1,152)
Net loss	—	—		—		(19,112)		—		(19,112)
Balance at March 31, 2024	51,018,179	$	5	$	1,043,577	$	(399,464)	$	(17,019)	$	627,099




Liabilities
Contingent consideration:
Balance at beginning of period	$	32,600

Change in fair value included in earnings (loss)	1,800

Balance at end of period	$	34,400


	Fair Value Measurements at March 31, 2024
Assets:	Level 1		Level 2		Level 3		Total
Commercial paper	$	—	$	77,249	$	—	$	77,249
Corporate notes	—		16,122		—		16,122
U.S. government and agency securities	31,705		—		—		31,705
	$	31,705	$	93,371	$	—	$	125,076


	Fair Value Measurements at December 31, 2023
Assets:	Level 1		Level 2		Level 3		Total
Commercial paper	$	—	$	179,881	$	—	$	179,881
Corporate notes	—		18,279		—		18,279
U.S. government and agency securities	91,703		—		—		91,703
	$	91,703	$	198,160	$	—	$	289,863


	March 31, 2024
	Cost		Unrealized gains		Unrealized losses		Fair value
Cash equivalents:
Commercial paper	$	24,915	$	—	$	—	$	24,915


Total cash equivalents	$	24,915	$	—	$	—	$	24,915
Short-term investments:
Commercial paper	$	52,333	$	2	$	(1)	$	52,334
Corporate notes	16,123		4		(5)		16,122
U.S. government and agency securities	31,709		3		(7)		31,705
Total short-term investments	$	100,165	$	9	$	(13)	$	100,161

Total	$	125,080


	Three Months Ended March 31,
		2024		2023
SNM net revenue
United States		$	69,840	$	53,853
International markets		1,839		1,305
		$	71,679	$	55,158
Bulkamid net revenue
United States		$	15,219	$	11,613
International markets		4,511		3,879
		$	19,730	$	15,492
Total net revenue		$	91,409	$	70,650

SEC Form 10-Q filed by Axonics Inc.