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Axonics® Reports Fourth Quarter and Fiscal Year 2020 Results

·8 min read

Axonics Modulation Technologies, Inc. (Nasdaq: AXNX), a medical technology company that has developed and is commercializing novel implantable sacral neuromodulation (SNM) devices for the treatment of urinary and bowel dysfunction, today reported results for the fourth quarter and fiscal year ended December 31, 2020.

Raymond W. Cohen, Axonics CEO, said, "In the first year of Axonics’ commercial launch in the United States, we exceeded our ambitious goals despite the pandemic and only having approximately ten months of selling time. We are grateful for the overwhelmingly positive response from physicians and patients to the introduction of our r-SNM System. We look forward to more Americans getting vaccinated and a return to a more normalized elective procedure environment in which we can take full advantage of the strong growth outlook for Axonics and the SNM market."

Fourth Quarter 2020 Financial Results

  • Net revenue was $34.8 million in the fourth quarter 2020, as compared to net revenue of $9.9 million for the same period of the prior year. Net revenue was consistent with the preliminary revenue result Axonics previously reported in January.

    • U.S. net revenue accounted for $33.7 million, with select international markets accounting for $1.1 million of net revenue.

  • Management estimates that in the fourth quarter 2020, approximately 320 confirmed and scheduled permanent implants were canceled due to COVID-19 based upon a detailed territory by territory analysis. These cancellations represented approximately $5 million of revenue that was not recognized in fourth quarter 2020. Management expects the majority of deferred cases to be rescheduled for the second half of 2021 as more individuals are vaccinated.

  • Gross margin was 63.6% in the fourth quarter 2020, as compared to 54.4% for the same period of the prior year.

  • Operating expenses were $33.0 million in the fourth quarter 2020, as compared to $28.1 million for the same period of the prior year.

  • Net loss was $11.3 million in the fourth quarter 2020, as compared to a net loss of $22.8 million for the same period of the prior year.

  • As of December 31, 2020, cash and cash equivalents were $241.2 million.

Fiscal Year 2020 Financial Results

  • Net revenue was $111.5 million in fiscal year 2020, as compared to net revenue of $13.8 million in fiscal year 2019.

    • U.S. net revenue accounted for $107.5 million, with select international markets accounting for $4.0 million of net revenue.

  • Gross margin was 60.2% in fiscal year 2020, as compared to 53.0% in fiscal year 2019.

  • Operating expenses were $120.9 million in fiscal year 2020, as compared to $87.9 million in fiscal year 2019.

  • Net loss was $54.9 million in fiscal year 2020, as compared to a net loss of $79.9 million in fiscal year 2019.

Clinical and Regulatory Highlights

  • On October 5, 2020, Axonics published survey results of patients treated with the Axonics r-SNM System that were previously implanted with InterStim™ II.

  • On October 20, 2020, Axonics launched the ARTISTRY study, a post-market clinical registry following patients treated with the Axonics r-SNM System.

  • On October 29, 2020, Axonics announced the submission of a premarket approval supplement to the FDA for the purpose of gaining detachable extremity coil MRI conditional labeling for 1.5T and 3.0T MR scanners. The filing is currently under review by FDA.

  • On November 10, 2020, Axonics announced the publication of fecal incontinence study results for patients treated with its r-SNM System.

  • On January 28, 2021, a manuscript was published online in Neurourology and Urodynamics discussing the two-year outcomes of the ARTISAN-SNM study.

  • On February 16, 2021, Axonics announced FDA approval of its third-generation implantable neurostimulator.

Webcast and Conference Call

Axonics will host a conference call today, February 25, 2021, at 4:30 p.m. Eastern Time, to discuss financial results and recent business developments. The live teleconference may be accessed by dialing 888-771-4371 (U.S.) or 847-585-4405 (International) and using passcode 50112306.

The live webcast of the conference call may be accessed by visiting the Events & Presentations section of the Axonics investor relations website. The replay of the webcast will be available shortly after the conclusion of the call and will be archived on the Axonics website for 90 days.

About Axonics Modulation Technologies, Inc.

Based in Irvine, Calif, Axonics has developed and is commercializing novel implantable SNM devices for patients with urinary and bowel dysfunction, and through its acquisition of Bulkamid, offers solutions for patients with stress urinary incontinence. These conditions significantly impact quality of life. Overactive bladder affects an estimated 87 million adults in the U.S. and Europe, and another estimated 40 million adults are reported to suffer from fecal incontinence/accidental bowel leakage. Stress urinary incontinence affects an estimated 20 million women in the U.S. 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 Modulation Technologies, Inc.

Consolidated Balance Sheets

(in thousands, except share and per share data)

December 31,

2020

2019

ASSETS

Current assets

Cash and cash equivalents

$

241,181

$

171,082

Short-term investments

12,592

Accounts receivable, net of allowance for doubtful accounts of $465 and $75 at December 31, 2020 and 2019, respectively

18,270

7,879

Inventory, net

63,060

15,659

Prepaid expenses and other current assets

5,435

4,468

Total current assets

327,946

211,680

Property and equipment, net

6,328

3,047

Intangible asset, net

196

311

Other assets

7,736

4,784

Total assets

$

342,206

$

219,822

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities

Accounts payable

$

10,660

$

5,882

Accrued liabilities

6,684

2,174

Accrued compensation and benefits

5,948

3,375

Operating lease liability, current portion

1,280

602

Debt, net of unamortized debt issuance costs, current portion

21,110

Total current liabilities

45,682

12,033

Operating lease liability, net of current portion

9,154

4,450

Debt, net of unamortized debt issuance costs

20,336

Total liabilities

54,836

36,819

Stockholders’ Equity

Preferred stock, par value $0.0001 per share; 10,000,000 shares authorized, no shares issued and outstanding at December 31, 2020 and 2019

Common stock, par value $0.0001 per share, 50,000,000 shares authorized at December 31, 2020 and 2019; 39,931,030 and 34,110,995 shares issued and outstanding at December 31, 2020 and 2019, respectively

4

3

Additional paid-in capital

522,296

363,012

Accumulated deficit

(234,499

)

(179,584

)

Accumulated other comprehensive loss

(431

)

(428

)

Total stockholders’ equity

287,370

183,003

Total liabilities and stockholders’ equity

$

342,206

$

219,822

Axonics Modulation Technologies, Inc.

Consolidated Statements of Comprehensive Loss

(in thousands, except share and per share data)

Three Months Ended December 31,

Years Ended December 31,

2020

2019

2020

2019

(unaudited)

(unaudited)

Net revenue

$

34,783

$

9,946

$

111,535

$

13,820

Cost of goods sold

12,652

4,538

44,444

6,490

Gross profit

22,131

5,408

67,091

7,330

Operating Expenses

Research and development

8,140

6,233

29,170

20,181

General and administrative

6,588

5,537

25,551

19,076

Sales and marketing

18,284

16,301

66,130

48,672

Total operating expenses

33,012

28,071

120,851

87,929

Loss from operations

(10,881

)

(22,663

)

(53,760

)

(80,599

)

Other Income (Expense)

Interest income

19

474

761

2,974

Loss on disposal of property and equipment

(41

)

(41

)

Interest and other expense

(445

)

(562

)

(1,874

)

(2,309

)

Other income (expense), net

(467

)

(88

)

(1,154

)

665

Loss before income tax expense

(11,348

)

(22,751

)

(54,914

)

(79,934

)

Income tax expense

1

1

Net loss

(11,348

)

(22,751

)

(54,915

)

(79,935

)

Foreign currency translation adjustment

183

153

(3

)

(12

)

Comprehensive loss

$

(11,165

)

$

(22,598

)

$

(54,918

)

$

(79,947

)

Net loss per share, basic and diluted

$

(0.29

)

$

(0.75

)

$

(1.48

)

$

(2.80

)

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

38,971,859

30,374,223

36,981,335

28,567,302

View source version on businesswire.com: https://www.businesswire.com/news/home/20210225005944/en/

Contacts

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