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    Axonics Reports Third Quarter 2023 Financial Results

    10/30/23 4:01:00 PM ET
    $AXNX
    Medical/Dental Instruments
    Health Care
    Get the next $AXNX alert in real time by email

    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

    )

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20231030019757/en/

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      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 announced that Dan L. Dearen, president and chief financial officer, is retiring from the company. Kari Keese, vice president of finance and accounting, will succeed Mr. Dearen on Monday, October 2. "On behalf of the Axonics team and the board of directors, I want to thank Dan, my co-founder and longtime colleague, for his many contributions to the company over the last 10 years," said Raymond W. Cohen, chief executive officer. "Dan has played an instrumental role in Axonics' success and the significant value that

      8/21/23 6:00:00 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care

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    Insider Trading

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    • Director Kiernan Jane E returned $1,410,131 worth of shares to the company (19,861 units at $71.00), closing all direct ownership in the company (SEC Form 4)

      4 - Axonics, Inc. (0001603756) (Issuer)

      11/15/24 9:00:20 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care
    • EVP, Chief Mktg/Strtgy Officer Woock John returned $5,495,613 worth of shares to the company (77,403 units at $71.00), closing all direct ownership in the company (SEC Form 4)

      4 - Axonics, Inc. (0001603756) (Issuer)

      11/15/24 9:00:14 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care
    • Director Snyderman Nancy Lynn Md returned $1,061,024 worth of shares to the company (14,944 units at $71.00), closing all direct ownership in the company (SEC Form 4)

      4 - Axonics, Inc. (0001603756) (Issuer)

      11/15/24 9:00:06 AM ET
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      Medical/Dental Instruments
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    • SEC Form SC 13G/A filed by Axonics Inc. (Amendment)

      SC 13G/A - Axonics, Inc. (0001603756) (Subject)

      2/13/24 4:59:03 PM ET
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      Medical/Dental Instruments
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    • SEC Form SC 13G/A filed by Axonics Inc. (Amendment)

      SC 13G/A - Axonics, Inc. (0001603756) (Subject)

      2/12/24 12:03:27 PM ET
      $AXNX
      Medical/Dental Instruments
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    • SEC Form SC 13G/A filed by Axonics Inc. (Amendment)

      SC 13G/A - Axonics, Inc. (0001603756) (Subject)

      2/9/24 8:35:54 AM ET
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      Medical/Dental Instruments
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    • SEC Form 15-12G filed by Axonics Inc.

      15-12G - Axonics, Inc. (0001603756) (Filer)

      11/25/24 9:05:44 AM ET
      $AXNX
      Medical/Dental Instruments
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    • SEC Form EFFECT filed by Axonics Inc.

      EFFECT - Axonics, Inc. (0001603756) (Filer)

      11/21/24 12:15:05 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care
    • SEC Form 25-NSE filed by Axonics Inc.

      25-NSE - Axonics, Inc. (0001603756) (Subject)

      11/15/24 2:23:54 PM ET
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      Medical/Dental Instruments
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    • Boston Scientific Closes Acquisition of Axonics, Inc.

      MARLBOROUGH, Mass., Nov. 15, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) today announced the close of its acquisition of Axonics, Inc. (NASDAQ:AXNX), a medical technology company focused on the development and commercialization of differentiated devices to treat urinary and bowel dysfunction. "Over the last decade, it has been impressive to see the meaningful innovations Axonics has delivered for patients with overactive bladder and incontinence," said Meghan Scanlon, senior vice president and president, Urology, Boston Scientific. "By closing this acquisiti

      11/15/24 8:43:00 AM ET
      $AXNX
      $BSX
      Medical/Dental Instruments
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    • Axonics Reports Third Quarter 2024 Financial Results

      Axonics, Inc. (NASDAQ:AXNX), a medical technology company that develops, manufactures and commercializes innovative and minimally invasive products to treat bladder and bowel dysfunction, today reported financial results for the three months ended September 30, 2024. "Axonics continued to execute at a high level in the third quarter, generating revenue growth of 25% year over year," said Raymond W. Cohen, chief executive officer. "Revenue growth for both sacral neuromodulation and Bulkamid® was driven by higher utilization at existing customers and the onboarding of new accounts." Mr. Cohen continued, "Our commitment to innovation, quality, direct-to-consumer advertising and providing str

      11/7/24 4:01:00 PM ET
      $AXNX
      Medical/Dental Instruments
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    • Axonics Receives Regulatory Approval for Fourth-Generation Rechargeable SNM System in Australia

      Axonics, Inc. (NASDAQ:AXNX) today announced that it has received regulatory approval from the Therapeutic Goods Administration (TGA) for marketing the Axonics R20® rechargeable sacral neuromodulation (SNM) system in Australia to treat adults with overactive bladder and fecal incontinence. The R20 neurostimulator is labeled for a functional life in the body of at least 20 years and reduces how frequently a patient needs to recharge their implanted device to once every 6 to 10 months for only one hour. The implant utilizes the same small 5cc form factor as the previous generation (Axonics R15®) and is paired with the same tined lead and intuitive, easy to use patient remote control. The R20

      9/26/24 6:00:00 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care