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    Axonics Reports Third Quarter 2024 Financial Results

    11/7/24 4:01:00 PM ET
    $AXNX
    Medical/Dental Instruments
    Health Care
    Get the next $AXNX alert in real time by email

    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 strong clinical support continues to expand the market for life-changing incontinence therapies and propel Axonics on its path to market leadership. We look forward to the global impact the Axonics portfolio can make as part of Boston Scientific as we endeavor to treat more patients than ever before."

    Third Quarter 2024 Financial Results

    • Net revenue was $116.2 million, an increase of 25% compared to the prior year period.
      • Sacral neuromodulation revenue was $92.3 million, an increase of 25% compared to the prior year period.
      • Bulkamid revenue was $23.8 million, an increase of 25% compared to the prior year period.
    • Gross margin was 77.2% compared to 74.2% in the prior year period.
    • Loss from operations was $6.3 million and includes $8 million of one-time legal and acquisition-related costs. This compares to a loss from operations of $0.7 million in the prior year period.
    • Net loss was $21,000 compared to net income of $3.9 million in the prior year period.
    • Adjusted EBITDA was $23.6 million compared to $14.0 million in the prior year period.
    • Cash, cash equivalents, short-term investments and restricted cash were $367 million as of September 30, 2024.

    About Axonics

    Axonics is a global medical technology company that is developing and commercializing novel products for adults with bladder and bowel dysfunction. Axonics ranked No. 2 on the 2023 Financial Times ranking of the fastest growing companies in the Americas after being ranked No. 1 in 2022.

    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, Axonics' 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.

    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 loss before other income/expense (including interest), income tax expense (benefit), depreciation and amortization expense, stock-based compensation expense, acquisition-related costs, cash compensation in lieu of equity compensation due to pending merger, one-time litigation-related expense, 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 (Loss) Income 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.

    Cautionary Statement Regarding Forward-Looking Statements

    This press release contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words like "may," "will," "likely," "should," "expect," "anticipate," "future," "plan," "believe," "intend," "goal," "seek," "endeavor," "estimate," "project," "continue," and variations of such words and similar expressions. These forward-looking statements are not guarantees of future performance and involve risks, assumptions, and uncertainties, including, but not limited to, risks related to: Axonics' ability to consummate the transactions contemplated by the Agreement and Plan of Merger, dated January 8, 2024 (the "Merger Agreement"), by and among Axonics, Boston Scientific Corporation ("Boston Scientific"), and Sadie Merger Sub, Inc., a wholly owned subsidiary of Boston Scientific ("Merger Sub"), providing for the merger of Merger Sub with and into Axonics with Axonics continuing as the surviving company and a wholly owned subsidiary of Boston Scientific (the "Merger"), in a timely manner or at all; the risk that the Merger Agreement may be terminated in circumstances requiring the payment by Axonics of a termination fee; the satisfaction (or waiver) of the conditions to the closing of the Merger; potential delays in consummating the Merger; the occurrence of any event, change or other circumstance or condition that could give rise to termination of the Merger Agreement; Axonics' ability to timely and successfully realize the anticipated benefits of the Merger; the ability to successfully integrate the businesses of Axonics and Boston Scientific; the effect of the announcement or pendency of the Merger on Axonics' current plans, business relationships, operating results and business generally; the effect of limitations placed on Axonics' business under the Merger Agreement; significant transaction costs and unknown liabilities; litigation or regulatory actions related to the Merger Agreement or Merger; FDA or other U.S. or foreign regulatory or legal actions or changes affecting Axonics or Axonics' industry; the results of any ongoing or future legal proceedings, including the litigation with Medtronic, Inc., Medtronic Puerto Rico Operations Co., Medtronic Logistics LLC and Medtronic USA, Inc. (the "Medtronic Litigation"); any termination or loss of intellectual property rights, including as a result of the Medtronic Litigation; introductions and announcements of new technologies by Axonics, any commercialization partners or Axonics' competitors, and the timing of these introductions and announcements; changes in macroeconomic and market conditions and volatility, including the risk of recession, inflation, supply chain constraints or disruptions and rising interest rates; and economic and market conditions in general and in the medical technology industry specifically, including the size and growth, if any, of Axonics' markets, and risks related to other factors described under "Risk Factors" in other reports and statements filed with the U.S. Securities and Exchange Commission ("SEC"), including Axonics' most recent Annual Report on Form 10-K, which is available on the investor relations section of Axonics' website at www.axonics.com and on the SEC's website at www.sec.gov. Should one or more of these risks or uncertainties materialize, or should underlying assumptions prove incorrect, actual results may vary materially from those indicated or anticipated by these forward-looking statements. Therefore, you should not rely on any of these forward-looking statements.

    The forward-looking statements included in this press release are made only as of the date of this press release, and except as otherwise required by federal securities law, Axonics does not assume any obligation nor does it intend to publicly update or revise any forward-looking statements to reflect new information, changed circumstances or unanticipated events.

    Axonics, Inc.

    Consolidated Balance Sheets

    (in thousands, except share and per share data)

     

     

    September 30,

     

    December 31,

     

    2024

     

    2023

     

    (unaudited)

     

     

    ASSETS

     

     

     

    Current assets

     

     

     

    Cash and cash equivalents

    $

    239,452

     

     

    $

    104,811

     

    Short-term investments

     

    105,773

     

     

     

    240,149

     

    Accounts receivable, net of allowance for credit losses of $1,198 and $442 at September 30, 2024 and December 31, 2023, respectively

     

    62,644

     

     

     

    57,243

     

    Inventory, net

     

    113,861

     

     

     

    79,940

     

    Prepaid expenses and other current assets

     

    4,184

     

     

     

    9,279

     

    Total current assets

     

    525,914

     

     

     

    491,422

     

    Restricted cash

     

    22,082

     

     

     

    12,714

     

    Property and equipment, net

     

    20,698

     

     

     

    10,760

     

    Intangible assets, net

     

    78,454

     

     

     

    81,375

     

    Other assets

     

    22,478

     

     

     

    24,235

     

    Goodwill

     

    104,545

     

     

     

    99,417

     

    Total assets

    $

    774,171

     

     

    $

    719,923

     

     

     

     

     

    LIABILITIES AND STOCKHOLDERS' EQUITY

     

     

     

    Current liabilities

     

     

     

    Accounts payable

    $

    20,109

     

     

    $

    18,452

     

    Accrued liabilities

     

    5,701

     

     

     

    10,527

     

    Accrued compensation and benefits

     

    35,998

     

     

     

    15,060

     

    Operating lease liabilities, current portion

     

    2,611

     

     

     

    1,777

     

    Total current liabilities

     

    64,419

     

     

     

    45,816

     

    Operating lease liabilities, net of current portion

     

    29,900

     

     

     

    25,840

     

    Deferred tax liabilities, net

     

    15,363

     

     

     

    10,703

     

    Total liabilities

     

    109,682

     

     

     

    82,359

     

    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, 2024 and December 31, 2023

     

    —

     

     

     

    —

     

    Common stock, par value $0.0001, 75,000,000 shares authorized at September 30, 2024 and December 31, 2023; 51,110,021 and 50,770,520 shares issued and outstanding at September 30, 2024 and December 31, 2023, respectively

     

    5

     

     

     

    5

     

    Additional paid-in capital

     

    1,063,185

     

     

     

    1,033,778

     

    Accumulated deficit

     

    (392,586

    )

     

     

    (380,352

    )

    Accumulated other comprehensive loss

     

    (6,115

    )

     

     

    (15,867

    )

    Total stockholders' equity

     

    664,489

     

     

     

    637,564

     

    Total liabilities and stockholders' equity

    $

    774,171

     

     

    $

    719,923

     

    Axonics, Inc.

    Consolidated Statements of Comprehensive Income (Loss)

    (in thousands, except share and per share data)

    (unaudited)

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2024

     

    2023

     

    2024

     

    2023

    Net revenue

    $

    116,193

     

     

    $

    93,100

     

     

    $

    322,167

     

     

    $

    256,644

     

    Cost of goods sold

     

    26,542

     

     

     

    23,996

     

     

     

    74,120

     

     

     

    64,850

     

    Gross profit

     

    89,651

     

     

     

    69,104

     

     

     

    248,047

     

     

     

    191,794

     

    Operating expenses

     

     

     

     

     

     

     

    Research and development

     

    13,491

     

     

     

    8,167

     

     

     

    37,339

     

     

     

    25,172

     

    General and administrative

     

    23,761

     

     

     

    11,778

     

     

     

    55,192

     

     

     

    34,659

     

    Sales and marketing

     

    52,972

     

     

     

    47,544

     

     

     

    160,607

     

     

     

    134,468

     

    Amortization of intangible assets

     

    2,221

     

     

     

    2,302

     

     

     

    6,722

     

     

     

    6,803

     

    Acquisition-related costs

     

    3,474

     

     

     

    —

     

     

     

    9,953

     

     

     

    2,368

     

    Acquired in-process research & development

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    15,447

     

    Total operating expenses

     

    95,919

     

     

     

    69,791

     

     

     

    269,813

     

     

     

    218,917

     

    Loss from operations

     

    (6,268

    )

     

     

    (687

    )

     

     

    (21,766

    )

     

     

    (27,123

    )

    Other income (expense)

     

     

     

     

     

     

     

    Interest and other income

     

    4,704

     

     

     

    4,271

     

     

     

    13,379

     

     

     

    12,149

     

    Interest and other expense

     

    8

     

     

     

    (83

    )

     

     

    (83

    )

     

     

    774

     

    Other income, net

     

    4,712

     

     

     

    4,188

     

     

     

    13,296

     

     

     

    12,923

     

    (Loss) income before income tax (benefit) expense

     

    (1,556

    )

     

     

    3,501

     

     

     

    (8,470

    )

     

     

    (14,200

    )

    Income tax (benefit) expense

     

    (1,535

    )

     

     

    (427

    )

     

     

    3,764

     

     

     

    (1,538

    )

    Net (loss) income

     

    (21

    )

     

     

    3,928

     

     

     

    (12,234

    )

     

     

    (12,662

    )

    Foreign currency translation adjustment

     

    10,438

     

     

     

    (6,185

    )

     

     

    9,752

     

     

     

    636

     

    Comprehensive income (loss)

    $

    10,417

     

     

    $

    (2,257

    )

     

    $

    (2,482

    )

     

    $

    (12,026

    )

     

     

     

     

     

     

     

     

    Net (loss) income per share, basic

    $

    (0.00

    )

     

    $

    0.08

     

     

    $

    (0.24

    )

     

    $

    (0.26

    )

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

     

    51,088,073

     

     

     

    49,244,981

     

     

     

    51,010,885

     

     

     

    48,973,252

     

    Net (loss) income per share, diluted

    $

    (0.00

    )

     

    $

    0.08

     

     

    $

    (0.24

    )

     

    $

    (0.26

    )

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

     

    51,088,073

     

     

     

    50,086,491

     

     

     

    51,010,885

     

     

     

     

    48,973,252

     

     

    Axonics, Inc.

    Net Revenue by Product and Region

    (in thousands)

    (unaudited)

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2024

     

    2023

     

    2024

     

    2023

    Sacral neuromodulation

     

     

     

     

     

     

     

    United States

    $

    90,072

     

    $

    72,212

     

    $

    248,988

     

    $

    198,270

    International

     

    2,277

     

     

     

    1,737

     

     

     

    6,255

     

     

     

    5,025

     

    Sacral neuromodulation total

    $

    92,349

     

     

    $

    73,949

     

     

    $

    255,243

     

     

    $

    203,295

     

     

     

     

     

     

     

     

     

    Bulkamid

     

     

     

     

     

     

     

    United States

    $

    19,050

     

     

    $

    15,579

     

     

    $

    52,575

     

     

    $

    41,998

     

    International

     

    4,794

     

     

     

    3,572

     

     

     

    14,349

     

     

     

    11,351

     

    Bulkamid total

    $

    23,844

     

     

    $

    19,151

     

     

    $

    66,924

     

     

    $

    53,349

     

    Total net revenue

    $

    116,193

     

     

    $

    93,100

     

     

    $

    322,167

     

     

    $

    256,644

     

    Axonics, Inc.

    Reconciliation of GAAP Net (Loss) Income to Adjusted EBITDA

    (in thousands)

    (unaudited)

     

     

    Three Months Ended

    September 30,

     

    Nine Months Ended

    September 30,

     

    2024

     

    2023

     

    2024

     

    2023

    GAAP Net (loss) income

    $

    (21

    )

     

    $

    3,928

     

     

    $

    (12,234

    )

     

    $

    (12,662

    )

    Non-GAAP Adjustments:

     

     

     

     

     

     

     

    Interest and other income

     

    (4,704

    )

     

     

    (4,271

    )

     

     

    (13,379

    )

     

     

    (12,149

    )

    Interest and other expense

     

    (8

    )

     

     

    83

     

     

     

    83

     

     

     

    (774

    )

    Income tax (benefit) expense

     

    (1,535

    )

     

     

    (427

    )

     

     

    3,764

     

     

     

    (1,538

    )

    Depreciation and amortization expense

     

    3,215

     

     

     

    3,254

     

     

     

    9,298

     

     

     

    9,295

     

    Stock-based compensation expense

     

    8,231

     

     

     

    11,470

     

     

     

    26,393

     

     

     

    33,388

     

    Acquisition-related costs

     

    3,474

     

     

     

    —

     

     

     

    9,953

     

     

     

    2,368

     

    Cash compensation in lieu of equity compensation due to pending merger

     

    10,404

     

     

     

    —

     

     

     

    21,586

     

     

     

    —

     

    One-time litigation-related expense

     

    4,500

     

     

     

    —

     

     

     

    4,500

     

     

     

    —

     

    Acquired in-process research & development

     

    —

     

     

     

    —

     

     

     

    —

     

     

     

    15,447

     

    Adjusted EBITDA

    $

    23,556

     

     

    $

    14,037

     

     

    $

    49,964

     

     

    $

    33,375

     

     

    View source version on businesswire.com: https://www.businesswire.com/news/home/20241107091750/en/

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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
      Health Care
    • 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
      Health Care
    • 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
    • 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
      $AXNX
      Medical/Dental Instruments
      Health Care
    • 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
      Health Care
    • 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
      $AXNX
      Medical/Dental Instruments
      Health Care
    • Axonics Modulation downgraded by Wolfe Research

      Wolfe Research downgraded Axonics Modulation from Outperform to Peer Perform

      1/9/24 6:49:41 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care
    • Robert W. Baird initiated coverage on Axonics Modulation with a new price target

      Robert W. Baird initiated coverage of Axonics Modulation with a rating of Outperform and set a new price target of $69.00

      7/19/23 7:13:39 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care
    • KeyBanc Capital Markets initiated coverage on Axonics Modulation with a new price target

      KeyBanc Capital Markets initiated coverage of Axonics Modulation with a rating of Overweight and set a new price target of $70.00

      7/13/23 7:29:51 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care

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    SEC Filings

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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
      Health Care
    • 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
      $AXNX
      Medical/Dental Instruments
      Health Care

    $AXNX
    Financials

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    • Boston Scientific Announces Results for Fourth Quarter and Full Year 2023

      MARLBOROUGH, Mass., Jan. 31, 2024 /PRNewswire/ -- Boston Scientific Corporation (NYSE: BSX) generated net sales of $3.725 billion during the fourth quarter of 2023, growing 14.9 percent on a reported basis, 14.5 percent on an operational1 basis and 13.6 percent on an organic2 basis, all compared to the prior year period. The company reported GAAP net income attributable to Boston Scientific common stockholders of $504 million or $0.34 per share (EPS), compared to $126 million or $0.09 per share a year ago and achieved adjusted3 EPS of $0.55 for the period, compared to $0.45 a year ago.

      1/31/24 6:30:00 AM ET
      $AXNX
      $BSX
      Medical/Dental Instruments
      Health Care
    • 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 s

      10/30/23 4:01:00 PM ET
      $AXNX
      Medical/Dental Instruments
      Health Care
    • Axonics to Report Third Quarter 2023 Financial Results on October 30

      Axonics, Inc. (NASDAQ:AXNX), a global medical technology company that is developing and commercializing novel products for the treatment of bladder and bowel dysfunction, is scheduled to report third quarter 2023 financial results after the close of trading on Monday, October 30. Axonics will host a conference call at 4:30 p.m. Eastern Time to discuss financial results. 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 t

      10/2/23 6:00:00 AM ET
      $AXNX
      Medical/Dental Instruments
      Health Care