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Axonics® Reports Second Quarter 2022 Financial Results

·8 min read

Generated record quarterly revenue of $69 million in 2Q22, an increase of 50% compared to 2Q21

Fiscal year 2022 revenue guidance increased to $253 million, an increase of 40% compared to fiscal year 2021

IRVINE, Calif., August 01, 2022--(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 June 30, 2022.

"This quarter’s record revenue result reflects the growing demand for our best-in-class incontinence solutions," said Raymond W. Cohen, chief executive officer of Axonics. "Sacral neuromodulation revenue grew 39% year over year, benefiting from the broad commercial launch of the Axonics F15™, our newly developed, long-lived, recharge-free sacral neuromodulation system. Bulkamid® generated another quarter of record revenue and we now expect approximately 50,000 women will have their stress urinary incontinence symptoms treated with Bulkamid in 2022."

Cohen continued, "Our direct-to-consumer television advertising campaign, which we launched in April, is achieving our objective of increasing awareness for Axonics therapies, reducing stigma and encouraging women to consult physicians who specialize in bladder and bowel dysfunction. We remain confident that our commitment to innovation, quality and providing physicians and patients strong support will continue to drive market expansion and advance Axonics on its path to market leadership."

Second Quarter 2022 Financial Results

  • Net revenue was $69.0 million in second quarter 2022, an increase of 50% compared to $45.9 million in the prior year period.

    • Sacral neuromodulation revenue was $55.8 million, of which $54.5 million was generated in the U.S. and the remainder in international markets.

    • Bulkamid revenue was $13.2 million, of which $10.2 million was generated in the U.S. and the remainder in international markets.

  • Gross margin was 72.8% in second quarter 2022 compared to 62.6% in the prior year period.

  • Operating expenses were $71.6 million in second quarter 2022 inclusive of $12.2 million of non-cash costs for the change in fair value of contingent consideration related to the acquisition of Bulkamid.

    • Excluding non-cash acquisition-related costs, operating expenses were $59.4 million compared to $44.7 million in the prior year period.

  • Net loss was $21.4 million in second quarter 2022 compared to net loss of $25.1 million in the prior year period.

  • Cash, cash equivalents and short-term investments were $213.2 million as of June 30, 2022.

Fiscal Year 2022 Revenue Guidance

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

  • Total company revenue of $253 million, an increase of 40% compared to fiscal year 2021. This compares to prior revenue guidance of $238 million.

  • Sacral neuromodulation revenue of $205 million, an increase of 30% compared to fiscal year 2021.

  • Bulkamid revenue of $48 million, an increase of 111% 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 2Q22 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 2Q22 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 patients 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 "planned," "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)

June 30,

December 31,

2022

2021

(unaudited)

ASSETS

Current assets

Cash and cash equivalents

$

203,236

$

220,878

Short-term investments

9,998

Accounts receivable, net of allowance for credit losses of $305 and $355 at June 30, 2022 and December 31, 2021, respectively

36,115

29,044

Inventory, net

58,412

64,946

Prepaid expenses and other current assets

5,366

6,449

Total current assets

313,127

321,317

Property and equipment, net

7,228

6,915

Intangible assets, net

91,627

106,469

Other assets

7,254

7,734

Goodwill

94,852

105,510

Total assets

$

514,088

$

547,945

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities

Accounts payable

$

10,207

$

7,654

Accrued liabilities

7,301

5,435

Accrued compensation and benefits

10,922

12,413

Operating lease liability, current portion

1,429

1,366

Total current liabilities

29,859

26,868

Operating lease liability, net of current portion

8,321

9,052

Deferred tax liabilities, net

15,782

19,217

Other long-term liabilities

22,400

10,370

Total liabilities

76,362

65,507

Stockholders’ equity

Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at June 30, 2022 and December 31, 2021

Common stock, par value $0.0001, 75,000,000 and 50,000,000 shares authorized at June 30, 2022 and December 31, 2021, respectively; 47,117,716 and 46,330,167 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively

5

5

Additional paid-in capital

820,526

803,559

Accumulated deficit

(358,677

)

(314,566

)

Accumulated other comprehensive loss

(24,128

)

(6,560

)

Total stockholders’ equity

437,726

482,438

Total liabilities and stockholders’ equity

$

514,088

$

547,945

Axonics, Inc.

Condensed Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)

Three Months Ended

June 30,

Six Months Ended

June 30,

2022

2021

2022

2021

Net revenue

$

68,980

$

45,869

$

117,400

$

80,242

Cost of goods sold

18,784

17,135

33,962

31,109

Gross profit

50,196

28,734

83,438

49,133

Operating expenses

Research and development

7,135

9,098

18,371

18,467

General and administrative

10,572

8,035

20,585

14,661

Sales and marketing

39,381

25,411

72,444

46,339

Amortization of intangible assets

2,332

2,200

4,795

2,878

Acquisition-related costs

12,205

12,205

4,414

Total operating expenses

71,625

44,744

128,400

86,759

Loss from operations

(21,429

)

(16,010

)

(44,962

)

(37,626

)

Other income (expense)

Interest income

360

7

403

15

Interest and other expense

(839

)

(5,849

)

(1,128

)

(7,299

)

Other expense, net

(479

)

(5,842

)

(725

)

(7,284

)

Loss before income tax (benefit) expense

(21,908

)

(21,852

)

(45,687

)

(44,910

)

Income tax (benefit) expense

(465

)

3,296

(1,576

)

2,741

Net loss

(21,443

)

(25,148

)

(44,111

)

(47,651

)

Foreign currency translation adjustment

(12,648

)

859

(17,568

)

(1,343

)

Comprehensive loss

$

(34,091

)

$

(24,289

)

$

(61,679

)

$

(48,994

)

Net loss per share, basic and diluted

$

(0.47

)

$

(0.59

)

$

(0.98

)

$

(1.16

)

Weighted-average shares used to compute basic and diluted net loss per share

45,311,001

42,788,678

45,225,494

41,210,091

Axonics, Inc.

Net Revenue by Product and Region

(in thousands)

(unaudited)

Three Months Ended

June 30,

Six Months Ended

June 30,

2022

2021

2022

2021

Sacral neuromodulation

United States

$

54,468

$

39,243

$

92,183

$

70,988

International

1,290

951

2,645

2,109

Sacral neuromodulation total

$

55,758

$

40,194

$

94,828

$

73,097

Bulkamid

United States

$

10,223

$

2,371

$

16,792

$

2,949

International

2,999

3,304

5,780

4,196

Bulkamid total

$

13,222

$

5,675

$

22,572

$

7,145

Total net revenue

$

68,980

$

45,869

$

117,400

$

80,242

View source version on businesswire.com: https://www.businesswire.com/news/home/20220801005281/en/

Contacts

Axonics contact:
Neil Bhalodkar
Investor Relations
949-336-5293
IR@axonics.com