Business Wire | Aug 5, 2021 04:01PM EDT

Axonics(r) Reports Second Quarter 2021 Financial Results

Aug. 05, 2021

IRVINE, Calif.--(BUSINESS WIRE)--Aug. 05, 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 second quarter ended June 30, 2021.

"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. "Clinical outcomes and satisfaction with our rechargeable sacral neuromodulation (SNM) system remain high, with over 12,000 patients having been implanted since our U.S. commercial launch in late 2019. Given the strong commercial momentum for both SNM and Bulkamid, we have increased our fiscal year 2021 revenue guidance to be in the range of $186 million to $188 million."

Cohen continued, "During the second quarter, we trained our entire U.S. field team on Bulkamid and are now executing a broad rollout to physicians across the United States. Physician enthusiasm to incorporate this next-generation bulking agent into their practices to treat female stress urinary incontinence is significant as evidenced by our second quarter results and the six fully booked regional seminars we are hosting this summer to provide Bulkamid wet-lab training. In late June, we filed a PMA supplement with the FDA for our new long-lived, non-rechargeable implantable neurostimulator. We anticipate the 10-year life and fully recharge-free system will be a very attractive proposition for patients and physicians. The progress on these key initiatives and the continued expansion of our U.S. commercial team gives us confidence in achieving our ambitious long-term growth objectives."

Second Quarter 2021 Financial Results

* Net revenue was $45.9 million in the second quarter 2021, an increase of 202% compared to $15.2 million in the prior year period. Sacral neuromodulation revenue was $40.2 million, of which $39.2 million was generated in the U.S. and the remainder in select international markets. Bulkamid revenue was $5.7 million, of which $2.4 million was generated in the U.S. and the remainder in international markets. * Gross margin was 62.6% in the second quarter 2021 compared to 44.4% in the prior year period. * Operating expenses were $44.7 million in the second quarter 2021 compared to $26.2 million in the prior year period. * Net loss was $25.1 million in the second quarter 2021 compared to a net loss of $19.8 million in the prior year period. * As of June 30, 2021, cash and cash equivalents were $231.1 million. In mid-June, Axonics prepaid and terminated its $75 million term loan with Silicon Valley Bank.

Second Quarter 2021 Corporate Highlights

* On May 14, 2021, Axonics completed a public stock offering of 4,025,000 shares at $50 per share, generating gross proceeds of $201.3 million. * On May 18, 2021, Axonics announced CE Mark approval for its second generation rechargeable INS and wireless patient remote control with SmartMRI(tm) technology. * On May 20, 2021, Axonics announced FDA approval allowing the use of detachable extremity coils for patients undergoing 1.5T and 3.0T MRI scans. * On June 24, 2021, Axonics announced the filing of a PMA supplement with the FDA for its non-rechargeable INS.

Fiscal Year 2021 Revenue Guidance

Axonics is increasing its fiscal year 2021 revenue guidance as follows:

* Total net revenue to be in the range of $186 million to $188 million, representing growth of approximately 67% to 69% over fiscal year 2020 net revenue of $111.5 million. This compares to the prior net revenue outlook of $176 million to $180 million. * Sacral neuromodulation (SNM) net revenue to be in the range of $166 million to $168 million. * Bulkamid net revenue of $20 million.

Webcast and Conference Call

Axonics will host a conference call today, August 5, 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 3072186.

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 the treatment of 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(r), provides women suffering from stress urinary incontinence (SUI) with safe and durable symptom relief.

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 Statements of Comprehensive Loss

(in thousands, except share and per share data)

(unaudited)

Three Months Ended Six Months Ended June 30, June 30,

2021 2020 2021 2020

Sacralneuromodulation net $ 40,194 $ 15,213 $ 73,097 $ 41,509 revenue

Bulkamid net 5,675 - 7,145 - revenue

Total net revenue 45,869 15,213 80,242 41,509

Cost of goods sold 17,135 8,463 31,109 18,358

Gross profit 28,734 6,750 49,133 23,151

Operating Expenses

Research and 9,098 6,370 18,467 13,225 development

General and 8,035 5,537 14,661 13,190 administrative

Sales and marketing 25,411 14,220 46,339 30,789

Amortization of 2,200 28 2,878 57 intangible assets

Acquisition-related - - 4,414 - costs

Total operating 44,744 26,155 86,759 57,261 expenses

Loss from (16,010 ) (19,405 ) (37,626 ) (34,110 ) operations

Other Income (Expense)

Interest income 7 65 15 707

Interest and other (5,849 ) (443 ) (7,299 ) (995 ) expense

Other expense, net (5,842 ) (378 ) (7,284 ) (288 )

Loss before income (21,852 ) (19,783 ) (44,910 ) (34,398 ) tax expense

Income tax expense 3,296 - 2,741 1

Net loss (25,148 ) (19,783 ) (47,651 ) (34,399 )

Foreign currencytranslation 859 (108 ) (1,343 ) (285 ) adjustment

Comprehensive loss $ (24,289 ) $ (19,891 ) $ (48,994 ) $ (34,684 )



Net loss per share, $ (0.59 ) $ (0.54 ) $ (1.16 ) $ (0.98 ) basic and diluted

Weighted-averageshares used tocompute basic and 42,788,678 36,440,846 41,210,091 35,040,180 diluted net lossper share

Axonics, Inc.

Condensed Consolidated Balance Sheets

(in thousands, except share and per share data)

June 30,

December 31,

2021

2020

(unaudited)

ASSETS

Current assets

Cash and cash equivalents

$

231,140

$

241,181

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

25,646

18,270

Inventory, net

70,391

63,060

Prepaid expenses and other current assets

5,006

5,435

Total current assets

332,183

327,946

Property and equipment, net

5,958

6,328

Intangible assets, net

113,416

196

Other assets

7,324

7,736

Goodwill

106,631

-

Total assets

$

565,512

$

342,206

LIABILITIES AND STOCKHOLDERS' EQUITY

Current liabilities

Accounts payable

$

9,447

$

10,660

Accrued liabilities

6,305

6,684

Accrued compensation and benefits

7,198

5,948

Operating lease liability, current portion

1,407

1,280

Debt, net of unamortized debt issuance costs, current portion

30

21,110

Total current liabilities

24,387

45,682

Operating lease liability, net of current portion

8,481

9,154

Debt, net of unamortized debt issuance costs, net of current portion

89

-

Deferred tax liabilities, net

20,626

-

Other long-term liabilities

7,664

-

Total liabilities

61,247

54,836

Stockholders' equity

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

-

-

Common stock, par value $0.0001, 50,000,000 shares authorized at June 30, 2021 and December 31, 2020; 46,090,964 and 39,931,030 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

5

4

Additional paid-in capital

788,184

522,296

Accumulated deficit

(282,150

)

(234,499

)

Accumulated other comprehensive loss

(1,774

)

(431

)

Total stockholders' equity

504,265

287,370

Total liabilities and stockholders' equity

$

565,512

$

342,206

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