Axonics® Reports Third Quarter 2021 Financial Results

November 4, 2021 at 4:01 PM EDT
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IRVINE, Calif.--(BUSINESS WIRE)--Nov. 4, 2021-- 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 third quarter ended September 30, 2021.

“We are pleased with this quarter’s revenue result considering the significant impact the surge in Covid-19 Delta variant cases had on elective procedure volumes in August and September, in addition to staffing shortages at hospitals and seasonality from summer vacations,” said Raymond W. Cohen, chief executive officer of Axonics. “Bulkamid® posted its highest revenue quarter to date and has proven to be more insulated from Covid-19 impact due to physicians having the option to perform the procedure in their offices.”

Cohen continued, “Over the last four months, we have had the pleasure of hosting 325 physicians at six regional seminars to introduce Bulkamid and provide proctored wet lab training. The programs also provided us with an opportunity to introduce our sacral neuromodulation system to physicians who are less familiar with Axonics and have them hear firsthand from their peers who have already experienced the difference of working with Axonics. The overwhelmingly positive feedback from physicians at these seminars reinforces our confidence that the SNM market will grow considerably once Covid-19 subsides and that Axonics’ best-in-class incontinence solutions will drive durable growth for years to come.”

Third Quarter 2021 Financial Results

  • Net revenue was $46.9 million in third quarter 2021, an increase of 33% compared to $35.2 million in the prior year period.
    • Sacral neuromodulation (SNM) revenue was $40.1 million, of which $39.1 million was generated in the U.S. and the remainder in select international markets.
    • Bulkamid revenue was $6.8 million, of which $3.9 million was generated in the U.S. and the remainder in international markets.
  • Gross margin was 66.5% in third quarter 2021 compared to 61.9% in the prior year period.
  • Operating expenses were $47.7 million in third quarter 2021 compared to $30.6 million in the prior year period.
  • Net loss was $17.3 million in third quarter 2021 compared to a net loss of $9.2 million in the prior year period.
  • As of September 30, 2021, cash and cash equivalents were $228.8 million.

2021 Revenue Guidance

Axonics continues to closely monitor the impact that the Covid-19 pandemic has had, and continues to have, on elective procedure volumes. Based on third quarter results as well as continuing disruptions from Covid-19 and hospital staffing shortages potentially slowing the recovery in elective procedure volumes, Axonics is updating its 2021 guidance as follows:

  • Fiscal year 2021 total company revenue of $177.0 million, an increase of 59% compared to fiscal year 2020.
    • 4Q21 total company revenue of $49.8 million, an increase of 43% compared to 4Q20.
  • Fiscal year 2021 SNM revenue of $155.2 million, an increase of 39% compared to fiscal year 2020.
    • 4Q21 SNM revenue of $42.0 million, an increase of 21% compared to 4Q20.
  • Fiscal year 2021 Bulkamid revenue of $21.8 million.
    • 4Q21 Bulkamid revenue of $7.8 million.

Webcast and Conference Call

Axonics will host a conference call today, November 4, 2021, at 4:30 p.m. Eastern Time, to discuss financial results and recent business developments. The live teleconference may be accessed by dialing 866-687-5771 (U.S.) or 409-217-8725 (international) and using passcode 8798817.

A live webcast of the conference call may be accessed by visiting the Events & Presentations section of the Axonics investor relations website. A replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Axonics 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. The company’s rechargeable sacral neuromodulation (SNM) system provides patients suffering from overactive bladder and/or fecal incontinence with long-lived, easy to use, safe, clinically effective therapy. In addition, Axonics’ best-in-class urethral bulking agent, 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 20 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)

 

 

September 30,

 

December 31,

 

2021

 

2020

 

(unaudited)

 

 

ASSETS

 

 

 

Current assets

 

 

 

Cash and cash equivalents

$

228,797

 

 

 

$

241,181

 

 

Accounts receivable, net of allowance for doubtful accounts of $385 and $465 at September 30, 2021 and December 31, 2020, respectively

26,641

 

 

 

18,270

 

 

Inventory, net

70,358

 

 

 

63,060

 

 

Prepaid expenses and other current assets

4,433

 

 

 

5,435

 

 

Total current assets

330,229

 

 

 

327,946

 

 

Property and equipment, net

6,168

 

 

 

6,328

 

 

Intangible assets, net

108,302

 

 

 

196

 

 

Other assets

7,041

 

 

 

7,736

 

 

Goodwill

109,565

 

 

 

—

 

 

Total assets

$

561,305

 

 

 

$

342,206

 

 

 

 

 

 

LIABILITIES AND STOCKHOLDERS’ EQUITY

 

 

 

Current liabilities

 

 

 

Accounts payable

$

10,512

 

 

 

$

10,660

 

 

Accrued liabilities

6,424

 

 

 

6,684

 

 

Accrued compensation and benefits

9,305

 

 

 

5,948

 

 

Operating lease liability, current portion

1,401

 

 

 

1,280

 

 

Debt, net of unamortized debt issuance costs, current portion

109

 

 

 

21,110

 

 

Total current liabilities

27,751

 

 

 

45,682

 

 

Operating lease liability, net of current portion

8,152

 

 

 

9,154

 

 

Deferred tax liabilities, net

26,432

 

 

 

—

 

 

Other long-term liabilities

8,880

 

 

 

—

 

 

Total liabilities

71,215

 

 

 

54,836

 

 

Stockholders’ equity

 

 

 

Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at September 30, 2021 and December 31, 2020

—

 

 

 

—

 

 

Common stock, par value $0.0001, 50,000,000 shares authorized at September 30, 2021 and December 31, 2020; 46,258,758 and 39,931,030 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively

5

 

 

 

4

 

 

Additional paid-in capital

796,397

 

 

 

522,296

 

 

Accumulated deficit

(299,400

)

 

 

(234,499

)

 

Accumulated other comprehensive loss

(6,912

)

 

 

(431

)

 

Total stockholders’ equity

490,090

 

 

 

287,370

 

 

Total liabilities and stockholders’ equity

$

561,305

 

 

$

342,206

 

 

 

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,

 

2021

 

2020

 

2021

 

2020

Net revenue

$

46,913

 

 

 

$

35,243

 

 

 

$

127,155

 

 

 

$

76,752

 

 

Cost of goods sold

15,719

 

 

 

13,434

 

 

 

46,828

 

 

 

31,792

 

 

Gross profit

31,194

 

 

 

21,809

 

 

 

80,327

 

 

 

44,960

 

 

Operating Expenses

 

 

 

 

 

 

 

Research and development

8,648

 

 

 

7,719

 

 

 

27,115

 

 

 

20,944

 

 

General and administrative

8,720

 

 

 

5,773

 

 

 

23,381

 

 

 

18,963

 

 

Sales and marketing

28,112

 

 

 

17,057

 

 

 

74,451

 

 

 

47,846

 

 

Amortization of intangible assets

2,216

 

 

 

29

 

 

 

5,094

 

 

 

86

 

 

Acquisition-related costs

—

 

 

 

—

 

 

 

4,414

 

 

 

—

 

 

Total operating expenses

47,696

 

 

 

30,578

 

 

 

134,455

 

 

 

87,839

 

 

Loss from operations

(16,502

)

 

 

(8,769

)

 

 

(54,128

)

 

 

(42,879

)

 

Other Expense

 

 

 

 

 

 

 

Interest income

9

 

 

 

35

 

 

 

24

 

 

 

742

 

 

Interest and other expense

(229

)

 

 

(434

)

 

 

(7,528

)

 

 

(1,429

)

 

Other expense, net

(220

)

 

 

(399

)

 

 

(7,504

)

 

 

(687

)

 

Loss before income tax expense

(16,722

)

 

 

(9,168

)

 

 

(61,632

)

 

 

(43,566

)

 

Income tax expense

528

 

 

 

—

 

 

 

3,269

 

 

 

1

 

 

Net loss

(17,250

)

 

 

(9,168

)

 

 

(64,901

)

 

 

(43,567

)

 

Foreign currency translation adjustment

(5,138

)

 

 

99

 

 

 

(6,481

)

 

 

(186

)

 

Comprehensive loss

$

(22,388

)

 

 

$

(9,069

)

 

 

$

(71,382

)

 

 

$

(43,753

)

 

 

 

 

 

 

 

 

 

Net loss per share, basic and diluted

$

(0.38

)

 

 

$

(0.24

)

 

 

$

(1.53

)

 

 

$

(1.20

)

 

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

44,848,023

 

 

 

38,830,924

 

 

 

42,436,061

 

 

 

36,312,984

 

 

 

 

Axonics, Inc.

Net Revenue Growth by Product and Geographic Region

(in thousands, except percentages)

(unaudited)

 

 

 

Three Months Ended

September 30,

 

 

 

Nine Months Ended

September 30,

 

 

 

2021

 

2020

 

% Change

 

2021

 

2020

 

% Change

SNM

 

 

 

 

 

 

 

 

 

 

 

United States

$

39,147

 

 

$

34,139

 

 

14.7%

 

$

110,135

 

 

$

73,833

 

 

49.2%

International

922

 

 

1,104

 

 

(16.5)%

 

3,031

 

 

2,919

 

 

3.8%

SNM Total

$

40,069

 

 

$

35,243

 

 

13.7%

 

$

113,166

 

 

$

76,752

 

 

47.4%

 

 

 

 

 

 

 

 

 

 

 

 

Bulkamid

 

 

 

 

 

 

 

 

 

 

 

United States

$

3,921

 

 

$

—

 

 

N/A

 

$

6,870

 

 

$

—

 

 

N/A

International

2,923

 

 

—

 

 

N/A

 

7,119

 

 

—

 

 

N/A

Bulkamid Total

$

6,844

 

 

$

—

 

 

N/A

 

$

13,989

 

 

$

—

 

 

N/A

Total net revenue

$

46,913

 

 

$

35,243

 

 

33.1%

 

$

127,155

 

 

$

76,752

 

 

65.7%

 

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

Source: Axonics, Inc.

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