Axonics® Reports Third Quarter 2022 Financial Results

Rhea-AI Summary

Axonics reported record quarterly revenue of $70 million, marking a 50% increase year-over-year. The company raised its fiscal year 2022 revenue guidance to $262 million, up 45% from the previous year. Sacral neuromodulation revenue reached $56.9 million, driven by the successful launch of the Axonics F15™ system. Gross margin improved to 72.8% from 66.5%. Though operating expenses rose to $67.6 million, the net loss narrowed to $16.3 million from $17.3 million in the prior year. Cash reserves stood at $350 million as of September 30, 2022.

Positive

• Quarterly revenue increased by 50% to $70 million.
• Fiscal year 2022 revenue guidance raised to $262 million, a 45% increase.
• Sacral neuromodulation revenue grew by 42% year-over-year.
• Gross margin improved to 72.8%, up from 66.5%.

Negative

• Operating expenses rose to $67.6 million, up from $47.7 million in the prior year.

Generated record quarterly revenue of $70 million, an increase of 50% year over year

Fiscal year 2022 revenue guidance raised to $262 million, an increase of 45% year over year

IRVINE, Calif.--(BUSINESS WIRE)-- Axonics, Inc. (Nasdaq: AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, today reported financial results for the three months ended September 30, 2022.

“This quarter’s record revenue result reflects growing demand from physicians and their patients for our best-in-class incontinence products,” said Raymond W. Cohen, chief executive officer of Axonics. “In the third quarter, total revenue increased by 50% compared to the prior year period. Sacral neuromodulation revenue grew 42% year over year, benefiting from the overwhelmingly positive physician response to the commercial launch of the Axonics F15™ recharge-free SNM system. Bulkamid^® generated another record revenue quarter and we now expect this product to generate $50 million of revenue in 2022, which is two years ahead of our original forecast at the time of the acquisition in February 2021.”

Cohen continued, “In addition to strong commercial execution, we continue to make progress on several key initiatives, including our direct-to-consumer advertising campaign, expansion of our in-house manufacturing capabilities that has benefited gross margin, and FDA review for approval of our fourth-generation rechargeable SNM system. We remain confident that our commitment to innovation, quality and providing physicians and patients strong clinical support will continue to drive market expansion and advance Axonics on its path to incontinence market leadership.”

Third Quarter 2022 Financial Results

• Net revenue was $70.4 million in third quarter 2022, an increase of 50% compared to $46.9 million in the prior year period.
  • Sacral neuromodulation revenue was $56.9 million, of which $55.6 million was generated in the U.S. and the remainder in international markets.
  • Bulkamid revenue was $13.5 million, of which $11.0 million was generated in the U.S. and the remainder in international markets.
• Gross margin was 72.8% in third quarter 2022 compared to 66.5% in the prior year period.
• Operating expenses were $67.6 million in third quarter 2022 and includes $8.2 million of non-cash costs for the change in fair value of contingent consideration related to the acquisition of Bulkamid. Operating expenses were $47.7 million in the prior year period.
  • Excluding acquisition-related costs, adjusted operating expenses were $59.4 million in third quarter 2022.
• Net loss was $16.3 million in third quarter 2022 compared to net loss of $17.3 million in the prior year period.
• Cash, cash equivalents and short-term investments were $350 million as of September 30, 2022.

Fiscal Year 2022 Revenue Guidance

Axonics has updated its fiscal year 2022 revenue guidance as follows:

• Total company revenue of $262 million, an increase of 45% compared to fiscal year 2021. This compares to prior revenue guidance of $253 million.
• Sacral neuromodulation revenue of $212 million, an increase of 35% compared to fiscal year 2021.
• Bulkamid revenue of $50 million, an increase of 120% compared to fiscal year 2021.

Webcast and Conference Call

Axonics will host a conference call today at 4:30 p.m. Eastern Time to discuss financial results and recent business developments. To join the conference call by telephone, interested parties are required to register in advance by using the following link: Axonics 3Q22 registration. After registering, a confirmation email will be sent that includes the dial-in number and unique access code required to join the conference call by telephone.

For those not planning to ask a question on the conference call, the company recommends joining the live webcast, which can be accessed by using the following link: Axonics 3Q22 webcast. A replay of the webcast will be available shortly after the conclusion of the conference call and will be archived in the Events section of the Axonics investor relations website.

About Axonics

Based in Irvine, Calif., Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics recently ranked No. 1 on the 2021 Deloitte Technology Fast 500™ and the 2022 Financial Times ranking of the 500 fastest growing companies in the Americas.

Axonics sacral neuromodulation (SNM) systems provide adults suffering from overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, the company’s best-in-class urethral bulking hydrogel, Bulkamid^®, provides safe and durable symptom relief to women with stress urinary incontinence (SUI). Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, with an additional 40 million adults estimated to suffer from fecal incontinence. SUI affects an estimated 29 million women in the U.S. alone. Axonics’ clinically proven products are offered at hundreds of medical centers across the U.S. and abroad. Reimbursement coverage is well established in the U.S. and is a covered service in most European countries. For more information, visit www.axonics.com.

Forward-Looking Statements

Statements made in this press release that relate to future plans, events, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. Words such as “plans,” “expects,” “believes,” “anticipates,” “designed,” and similar words are intended to identify forward-looking statements. While these forward-looking statements are based on the current expectations and beliefs of management, such forward-looking statements are subject to a number of risks, uncertainties, assumptions and other factors that could cause actual results to differ materially from the expectations expressed in this press release, including the risks and uncertainties disclosed in Axonics filings with the Securities and Exchange Commission, all of which are available online at www.sec.gov. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Except as required by law, Axonics undertakes no obligation to update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

Axonics, Inc.
Condensed Consolidated Balance Sheets
(in thousands, except share and per share data)
		September 30, 2022				December 31, 2021
		(unaudited)
ASSETS
Current assets
Cash and cash equivalents		$	241,331			$	220,878
Short-term investments			108,682				—
Accounts receivable, net of allowance for credit losses of $298 and $355 at September 30, 2022 and December 31, 2021, respectively			36,960				29,044
Inventory, net			57,827				64,946
Prepaid expenses and other current assets			4,561				6,449
Total current assets			449,361				321,317
Property and equipment, net			7,103				6,915
Intangible assets, net			81,787				106,469
Other assets			7,085				7,734
Goodwill			86,942				105,510
Total assets		$	632,278			$	547,945
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities
Accounts payable		$	9,972			$	7,654
Accrued liabilities			7,106				5,435
Accrued compensation and benefits			11,742				12,413
Operating lease liability, current portion			1,523				1,366
Other current liabilities			30,500				—
Total current liabilities			60,843				26,868
Operating lease liability, net of current portion			7,960				9,052
Deferred tax liabilities, net			13,957				19,217
Other long-term liabilities			—				10,370
Total liabilities			82,760				65,507
Stockholders’ equity
Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2022 and December 31, 2021			—				—
Common stock, par value $0.0001, 75,000,000 and 50,000,000 shares authorized at September 30, 2022 and December 31, 2021, respectively; 49,479,594 and 46,330,167 shares issued and outstanding at September 30, 2022 and December 31, 2021, respectively			5				5
Additional paid-in capital			960,627				803,559
Accumulated deficit			(374,929	)			(314,566	)
Accumulated other comprehensive loss			(36,185	)			(6,560	)
Total stockholders’ equity			549,518				482,438
Total liabilities and stockholders’ equity		$	632,278			$	547,945

Axonics, Inc.
Condensed Consolidated Statements of Comprehensive Loss
(in thousands, except share and per share data)
(unaudited)
		Three Months Ended September 30,								Nine Months Ended September 30,
		2022				2021				2022				2021
Net revenue		$	70,384			$	46,913			$	187,784			$	127,155
Cost of goods sold			19,124				15,719				53,086				46,828
Gross profit			51,260				31,194				134,698				80,327
Operating expenses
Research and development			7,936				8,648				26,307				27,115
General and administrative			9,389				7,443				29,974				22,104
Sales and marketing			39,751				28,112				112,195				74,451
Amortization of intangible assets			2,317				2,216				7,112				5,094
Acquisition-related costs			8,242				1,277				20,447				5,691
Total operating expenses			67,635				47,696				196,035				134,455
Loss from operations			(16,375	)			(16,502	)			(61,337	)			(54,128	)
Other income (expense)
Interest income			1,501				9				1,904				24
Interest and other expense			(1,898	)			(229	)			(3,026	)			(7,528	)
Other expense, net			(397	)			(220	)			(1,122	)			(7,504	)
Loss before income tax (benefit) expense			(16,772	)			(16,722	)			(62,459	)			(61,632	)
Income tax (benefit) expense			(520	)			528				(2,096	)			3,269
Net loss			(16,252	)			(17,250	)			(60,363	)			(64,901	)
Foreign currency translation adjustment			(12,057	)			(5,138	)			(29,625	)			(6,481	)
Comprehensive loss		$	(28,309	)		$	(22,388	)		$	(89,988	)		$	(71,382	)
Net loss per share, basic and diluted		$	(0.34	)		$	(0.38	)		$	(1.31	)		$	(1.53	)
Weighted-average shares used to compute basic and diluted net loss per share			47,208,192				44,848,023				46,185,209				42,436,061

Axonics, Inc.
Net Revenue by Product and Region
(in thousands)
(unaudited)
		Three Months Ended September 30,						Nine Months Ended September 30,
		2022			2021			2022			2021
Sacral neuromodulation
United States		$	55,610		$	39,147		$	147,793		$	110,135
International			1,249			922			3,894			3,031
Sacral neuromodulation total		$	56,859		$	40,069		$	151,687		$	113,166
Bulkamid
United States		$	11,045		$	3,921		$	27,837		$	6,870
International			2,480			2,923			8,260			7,119
Bulkamid total		$	13,525		$	6,844		$	36,097		$	13,989
Total net revenue		$	70,384		$	46,913		$	187,784		$	127,155

 

View source version on businesswire.com: https://www.businesswire.com/news/home/20221031005272/en/

Axonics contact:

Neil Bhalodkar

Investor Relations

949-336-5293

IR@axonics.com

Source: Axonics, Inc.

FAQ

What were Axonics' financial results for Q3 2022?

Axonics reported quarterly revenue of $70 million, a 50% increase from the prior year, with a net loss of $16.3 million.

What is the updated revenue guidance for Axonics in fiscal year 2022?

Axonics raised its fiscal year 2022 revenue guidance to $262 million, which is a 45% increase compared to fiscal year 2021.

How did Axonics' gross margin change in Q3 2022?

Gross margin increased to 72.8% in Q3 2022, compared to 66.5% in the same period last year.

What contributed to the increase in Axonics' sacral neuromodulation revenue?

The increase was driven by strong demand for the Axonics F15™ recharge-free SNM system.

What were operating expenses for Axonics in Q3 2022?

Operating expenses totaled $67.6 million, which includes $8.2 million in non-cash costs related to the acquisition of Bulkamid.