Axonics® Reports Second Quarter 2022 Financial Results

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

Axonics, Inc. 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

 

Posted In: Press Releases