November 2020

(Nasdaq: AXNX)

Disclaimer

This presentation contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in this presentation are forward-looking statements. Any statements contained in this presentation that are not statements of historical facts may be deemed to be forward-looking statements. We intend such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 27A of the Securities Act and Section 21E of the Securities Exchange Act of 1934, as amended (the "Exchange Act"). In some cases, you can identify forward-looking statements by terms such as "anticipate," "believe," "could," "estimate," "expect," "intend," "may," "plan," "potential," "predict," "project," "should," "will," "would" or the negative of those terms, or other comparable terms intended to identify statements about the future. Forward-looking statements include, but are not limited to, statements about unanticipated safety concerns related to the use of our r-SNM System; FDA or other U.S. or foreign regulatory or legal actions or changes affecting us or our industry; intellectual property, product liability or other litigation against us, our third-party manufacturers or other parties on which we rely or litigation against our general industry; any termination or loss of intellectual property rights; any voluntary or regulatory mandated product recalls; adverse developments concerning our manufacturers or suppliers or any future strategic partnerships; introductions and announcements of new technologies by us, any commercialization partners or our competitors, and the timing of these introductions and announcements; announcements of regulatory approval or disapproval of our r-SNM and any future enhancements to our r-SNM System; adverse results from or delays in clinical studies of our r-SNM System; variations in our financial results or those of companies that are perceived to be similar to us; success or failure of competitive products or therapies in the SNM market; changes in the structure of healthcare payment of our r-SNM System; announcements by us or our competitors of significant acquisitions, licenses, strategic partnerships, joint ventures or capital commitments; market conditions in the medical technology industry and issuance of securities analysts' reports or recommendations; rumors and market speculation involving us or other companies in our industry; sales of substantial amounts of our stock by directors, officers or significant stockholders, or the expectation that such sales might occur; general economic, industry and market conditions, including the size and growth, if any, of the market; the expected or potential impact of the novel coronavirus (COVID-19) pandemic, and the related responses of the government, consumers, and the Company, on our business, financial condition and results of operations; additions or departures of key personnel; changes in our capital structure, such as future issuances of securities and the incurrence of additional debt; the results of any future legal proceedings; and the volatility of the trading price of our common stock. Other important factors that could cause actual results, performance or achievements to differ materially from those contemplated in this presentation can be found in Part I, Item 1. Business," "Part I, Item 1A. Risk Factors," and "Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations" our Annual Report on Form 10-K and "Part I, Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations" and "Part II, Item 1A. Risk Factors" of our Quarterly Report on Form 10-Q, which are accessible on the SEC's website at www.sec.gov.

These forward-looking statements are subject to a number of risks, uncertainties and assumptions. We also operate in a very competitive and rapidly changing environment. New risks emerge from time to time and it is not possible for management to predict all risks, nor can the Company assess the impact of all factors on its business or the extent to which any factor, or combination of factors, may cause actual results to differ materially from those contained in, or implied by, any forward-looking statements. In light of these risks, uncertainties and assumptions, the forward-looking events and circumstances described in this presentation may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements contained in this presentation. You should not rely upon forward-looking statements as predictions of future events. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the future results, levels of activity, performance, events, circumstances or achievements reflected in the forward-looking statements may never be achieved or occur. Except as required by law, the Company undertakes no obligation to update publicly any forward-looking statements for any reason after the date of this presentation to conform these statements to actual results or to changes in the Company's expectations.

The Company obtained the industry, statistical and market data, including its general expectations, market position and market opportunity, in this presentation from its own internal estimates and research as well as from industry and general publications and research, surveys and studies conducted by third parties. All of the market data used in this presentation involves a number of assumptions and limitations. While the Company believes that the information from these industry publications, surveys and studies is reliable, the industry in which it operates is subject to a high degree of uncertainty and risk due to a variety of important factors.

These and other factors could cause results to differ materially from those expressed in the estimates made by third parties and by the Company. This presentation contains trademarks, trade names and service marks of other companies, which are the property of their respective owners. The Company does not intend its use or display of other parties' trademarks, trade names or service marks to imply, and such use or display should not be construed to imply, a relationship with, or endorsement or sponsorship of the Company by, these other parties.

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Axonics® Vision and Philosophy

To be the global leader in sacral neuromodulation by providing customer- centric solutions to treat urinary and bowel dysfunction and improve the quality of life for patients and their families

Clarity of Purpose

Thoughtful Innovation

Integrity and Quality

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Axonics Overview

Large and Significantly

Underpenetrated Market

Innovative Technology

Strong Clinical Data

Regulatory Status and IP

Large Commercial Footprint

Early Commercial Success

  • The sacral neuromodulation (SNM) market is significantly underpenetrated
  • Medtronic is the legacy player with estimated global sales of ~$650 million in 2018
  • Implanters expect to grow procedure volume by 15-20% annually, driven by innovation Axonics has brought to SNM
  • First rechargeable SNM system. Designed to last at least 15 years with a patient-friendly recharging experience
  • Axonics implantable neurostimulator (INS) is 60% smaller than Medtronic's non-rechargeable InterStim II
  • First full-body MRI compatible SNM system, with 1.5T and 3T labeling
  • Completed 24-month clinical data of 129-subject FDA pivotal study
  • Completed 24-month clinical data of 51-subject European clinical study
  • Currently have U.S. FDA approval for OAB, FI, and UR; additional regulatory approvals in Europe, Canada & Australia
  • 25 wholly-owned, 29 licensed from AMF (54 total) issued or licensed U.S. patents covering miniaturization of generators, charging and communication
  • U.S. commercial operations launched in November 2019; select E.U. markets and Canada launched in November 2018
  • 185+ U.S. field team members; 8 field team members in E.U.
  • Net revenue of $35.2 million in 3Q20
  • 600+ unique accounts (hospitals and ambulatory surgery centers) in the U.S. as of September 30, 2020
  • Agreements in place with virtually all national and regional hospital systems in the United States

Experienced senior management team with >140 years of combined experience in the medical technology industry

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Axonics Modulation Technologies Inc. published this content on 09 November 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 10 November 2020 00:54:04 UTC