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Axonics Reports Third Quarter 2023 Financial Results

Generated quarterly revenue of $93.1 million, an increase of 32% year over year

Fiscal year 2023 revenue guidance increased to $362 million

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, 2023.

“Our commercial team continues to execute at a high level, generating over 30% revenue growth in the third quarter,” said Raymond W. Cohen, chief executive officer. “Our growth was driven by higher utilization and share of wallet at existing customers and the onboarding of new accounts. Based on the strong results generated in the third quarter, we are raising our fiscal year 2023 revenue guidance to $362 million, representing growth of 32% year over year.”

Mr. Cohen continued, “In the third quarter, the company also generated adjusted EBITDA of $14 million and GAAP net income of $4 million, demonstrating the significant operating leverage of our business. Axonics is growing rapidly and profitably as we advance on our path to incontinence market leadership.”

3Q23 Financial Results

  • Net revenue was $93.1 million in 3Q23, an increase of 32% compared to the prior year period.
    • Sacral neuromodulation revenue was $73.9 million, of which $72.2 million was generated in the U.S. and the remainder in international markets.
    • Bulkamid revenue was $19.2 million, of which $15.6 million was generated in the U.S. and the remainder in international markets.
  • Gross margin was 74.2% in 3Q23 compared to 72.8% in the prior year period.
  • Operating expenses were $69.8 million in 3Q23 compared to $67.6 million in the prior year period.
    • Excluding acquisition-related costs, adjusted operating expenses were $59.4 million in the prior year period.
  • Adjusted EBITDA was $14.0 million in 3Q23 compared to $3.3 million in the prior year period.
  • Net income was $3.9 million in 3Q23 compared to a net loss of $16.3 million in the prior year period.
  • Cash, cash equivalents and short-term investments were $344.7 million as of September 30, 2023, an increase of $13.2 million compared to June 30, 2023.

Fiscal Year 2023 Revenue Guidance

Axonics has updated its fiscal year 2023 revenue guidance as follows:

  • Total company revenue of $362 million, an increase of 32% compared to fiscal year 2022. This compares to prior fiscal year 2023 revenue guidance of $358 million.
    • Sacral neuromodulation revenue of $288.5 million, an increase of 30% compared to fiscal year 2022.
    • Bulkamid revenue of $73.5 million, an increase of 42% compared to fiscal year 2022.

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 access the conference call by telephone, interested parties may register at the following link: Axonics 3Q23 registration.

For those not planning to ask a question, the company recommends accessing the conference call by webcast at the following link: Axonics 3Q23 webcast. A replay of the webcast will be archived in the Events section of the Axonics investor relations website.

About Axonics

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. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas and No. 4 on the 2022 Deloitte Technology Fast 500.

Axonics® sacral neuromodulation systems provide adults with 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. In the U.S., moderate to severe urinary incontinence affects an estimated 28 million women and fecal incontinence affects an estimated 19 million adults. 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,” “designs,” 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.

Use of Non-GAAP Financial Measures

To supplement Axonics’ consolidated financial statements prepared in accordance with generally accepted accounting principles (GAAP), Axonics provides certain non-GAAP financial measures in this release as supplemental financial metrics.

Adjusted EBITDA is calculated as net income (loss) before other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense, acquisition-related costs, acquired in-process research and development expense, loss on disposal of property and equipment, and expense related to impairment of intangible assets. Management believes that in order to properly understand short-term and long-term financial trends, investors may want to consider the impact of these excluded items in addition to GAAP measures. The excluded items vary in frequency and/or impact on our results of operations and management believes that the excluded items are typically not reflective of our ongoing core business operations and financial condition. Further, management uses adjusted EBITDA for both strategic and annual operating planning. A reconciliation of adjusted EBITDA reported in this release to the most comparable GAAP measure for the respective periods appears in the table captioned “Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA” later in this release.

The non-GAAP financial measures used by Axonics may not be the same or calculated in the same manner as those used and calculated by other companies. Non-GAAP financial measures have limitations as analytical tools and should not be considered in isolation or as a substitute for Axonics’ financial results prepared and reported in accordance with GAAP. We urge investors to review the reconciliation of these non-GAAP financial measures to the comparable GAAP financial measures included in this press release, and not to rely on any single financial measure to evaluate our business.

Axonics, Inc.

Consolidated Balance Sheets

(in thousands, except share and per share data)

 

 

September 30,

 

December 31,

 

 

2023

 

 

 

2022

 

 

(unaudited)

 

 

ASSETS

 

 

 

Current assets

 

 

 

Cash and cash equivalents

$

147,323

 

 

$

238,846

 

Short-term investments

 

197,393

 

 

 

118,365

 

Accounts receivable, net of allowance for credit losses of $380 and $321 at September 30, 2023 and December 31, 2022, respectively

 

48,944

 

 

 

44,817

 

Inventory, net

 

74,909

 

 

 

55,765

 

Prepaid expenses and other current assets

 

6,816

 

 

 

7,282

 

Total current assets

 

475,385

 

 

 

465,075

 

Property and equipment, net

 

6,556

 

 

 

6,798

 

Intangible assets, net

 

80,274

 

 

 

86,253

 

Other assets

 

3,245

 

 

 

6,813

 

Goodwill

 

95,287

 

 

 

94,414

 

Total assets

$

660,747

 

 

$

659,353

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

Current liabilities

 

 

 

Accounts payable

$

14,666

 

 

$

9,070

 

Accrued liabilities

 

5,962

 

 

 

6,520

 

Accrued compensation and benefits

 

12,994

 

 

 

15,495

 

Operating lease liabilities, current portion

 

1,971

 

 

 

1,562

 

Other current liabilities

 

 

 

 

32,600

 

Total current liabilities

 

35,593

 

 

 

65,247

 

Operating lease liabilities, net of current portion

 

876

 

 

 

7,555

 

Deferred tax liabilities, net

 

13,658

 

 

 

16,412

 

Total liabilities

 

50,127

 

 

 

89,214

 

Commitments and contingencies

 

 

 

Stockholders’ equity

 

 

 

Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2023 and December 31, 2022

 

 

 

 

 

Common stock, par value $0.0001, 75,000,000 shares authorized at September 30, 2023 and December 31, 2022; 50,669,203 and 49,546,727 shares issued and outstanding at September 30, 2023 and December 31, 2022, respectively

 

5

 

 

 

5

 

Additional paid-in capital

 

1,022,052

 

 

 

969,545

 

Accumulated deficit

 

(386,926

)

 

 

(374,264

)

Accumulated other comprehensive loss

 

(24,511

)

 

 

(25,147

)

Total stockholders’ equity

 

610,620

 

 

 

570,139

 

Total liabilities and stockholders’ equity

$

660,747

 

 

$

659,353

 

 

Axonics, Inc.

Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

Net revenue

$

93,100

 

 

$

70,384

 

 

$

256,644

 

 

$

187,784

 

Cost of goods sold

 

23,996

 

 

 

19,124

 

 

 

64,850

 

 

 

53,086

 

Gross profit

 

69,104

 

 

 

51,260

 

 

 

191,794

 

 

 

134,698

 

Operating expenses

 

 

 

 

 

 

 

Research and development

 

8,167

 

 

 

7,936

 

 

 

25,172

 

 

 

26,307

 

General and administrative

 

11,778

 

 

 

9,389

 

 

 

34,659

 

 

 

29,974

 

Sales and marketing

 

47,544

 

 

 

39,751

 

 

 

134,468

 

 

 

112,195

 

Amortization of intangible assets

 

2,302

 

 

 

2,317

 

 

 

6,803

 

 

 

7,112

 

Acquisition-related costs

 

 

 

 

8,242

 

 

 

2,368

 

 

 

20,447

 

Acquired in-process research & development

 

 

 

 

 

 

 

15,447

 

 

 

 

Total operating expenses

 

69,791

 

 

 

67,635

 

 

 

218,917

 

 

 

196,035

 

Loss from operations

 

(687

)

 

 

(16,375

)

 

 

(27,123

)

 

 

(61,337

)

Other income (expense)

 

 

 

 

 

 

 

Interest and other income

 

4,271

 

 

 

1,501

 

 

 

12,149

 

 

 

1,904

 

Interest and other expense

 

(83

)

 

 

(1,898

)

 

 

774

 

 

 

(3,026

)

Other income (expense), net

 

4,188

 

 

 

(397

)

 

 

12,923

 

 

 

(1,122

)

Income (loss) before income tax benefit

 

3,501

 

 

 

(16,772

)

 

 

(14,200

)

 

 

(62,459

)

Income tax benefit

 

(427

)

 

 

(520

)

 

 

(1,538

)

 

 

(2,096

)

Net income (loss)

 

3,928

 

 

 

(16,252

)

 

 

(12,662

)

 

 

(60,363

)

Foreign currency translation adjustment

 

(6,185

)

 

 

(12,057

)

 

 

636

 

 

 

(29,625

)

Comprehensive loss

$

(2,257

)

 

$

(28,309

)

 

$

(12,026

)

 

$

(89,988

)

 

 

 

 

 

 

 

 

Net income (loss) per share, basic

$

0.08

 

 

$

(0.34

)

 

$

(0.26

)

 

$

(1.31

)

Weighted-average shares used to compute basic net income (loss) per share

 

49,244,981

 

 

 

47,208,192

 

 

 

48,973,252

 

 

 

46,185,209

 

Net income (loss) per share, diluted

$

0.08

 

 

$

(0.34

)

 

$

(0.26

)

 

$

(1.31

)

Weighted-average shares used to compute diluted net income (loss) per share

 

50,086,491

 

 

 

47,208,192

 

 

 

48,973,252

 

 

 

46,185,209

 

 

Axonics, Inc.

Net Revenue by Product and Region

(in thousands)

(unaudited)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2023

 

 

2022

 

 

2023

 

 

2022

Sacral neuromodulation

 

 

 

 

 

 

 

United States

$

72,212

 

$

55,610

 

$

198,270

 

$

147,793

International

 

1,737

 

 

1,249

 

 

5,025

 

 

3,894

Sacral neuromodulation total

$

73,949

 

$

56,859

 

$

203,295

 

$

151,687

 

 

 

 

 

 

 

 

Bulkamid

 

 

 

 

 

 

 

United States

$

15,579

 

$

11,045

 

$

41,998

 

$

27,837

International

 

3,572

 

 

2,480

 

 

11,351

 

 

8,260

Bulkamid total

$

19,151

 

$

13,525

 

$

53,349

 

$

36,097

Total net revenue

$

93,100

 

$

70,384

 

$

256,644

 

$

187,784

 

Axonics, Inc.

Reconciliation of GAAP Net Income (Loss) to Adjusted EBITDA

(in thousands)

(unaudited)

 

 

Three Months Ended

September 30,

 

Nine Months Ended

September 30,

 

 

2023

 

 

 

2022

 

 

 

2023

 

 

 

2022

 

GAAP Net income (loss)

$

3,928

 

 

$

(16,252

)

 

$

(12,662

)

 

$

(60,363

)

Non-GAAP Adjustments

 

 

 

 

 

 

 

Interest and other income

 

(4,271

)

 

 

(1,501

)

 

 

(12,149

)

 

 

(1,904

)

Interest and other expense

 

83

 

 

 

1,898

 

 

 

(774

)

 

 

3,026

 

Income tax benefit

 

(427

)

 

 

(520

)

 

 

(1,538

)

 

 

(2,096

)

Depreciation and amortization expense

 

3,254

 

 

 

2,921

 

 

 

9,295

 

 

 

8,841

 

Stock-based compensation expense

 

11,470

 

 

 

8,218

 

 

 

33,388

 

 

 

23,261

 

Acquisition-related costs

 

 

 

 

8,242

 

 

 

2,368

 

 

 

20,447

 

Acquired in-process research & development

 

 

 

 

 

 

 

15,447

 

 

 

 

Impairment expense

 

 

 

 

287

 

 

 

 

 

 

287

 

Adjusted EBITDA

$

14,037

 

 

$

3,293

 

 

$

33,375

 

 

$

(8,501

)

 

"Our growth was driven by higher utilization and share of wallet at existing customers and the onboarding of new accounts. Axonics is growing rapidly and profitably as we advance on our path to incontinence market leadership.”

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