Form 8-K - Current report
06 Junho 2024 - 7:05AM
Edgar (US Regulatory)
false 0001227636 0001227636 2024-06-06 2024-06-06
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d)
of The Securities Exchange Act of 1934
Date of Report (Date of earliest event reported) June 6, 2024
NEURONETICS, INC.
(Exact name of registrant as specified in its charter)
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| Delaware |
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001-38546 |
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33-1051425 |
(State or other jurisdiction
of incorporation) |
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(Commission
File Number) |
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(I.R.S. Employer
Identification No.) |
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| 3222 Phoenixville Pike, Malvern, PA |
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19355 |
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(Zip Code) |
Registrant’s telephone number, including area code (610) 640-4202
(Former name or former address, if changed since last report.) Not applicable.
Securities registered pursuant to Section 12(b) of the Act:
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| Title of each class |
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Trading
Symbol (s) |
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Name on each exchange
on which registered |
| Common Stock ($0.01 par value) |
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STIM |
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The Nasdaq Global Market |
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Item 7.01 Regulation FD Disclosure.
On June 6, 2024, Neuronetics, Inc. (the “Company”) is presenting information relating to its financial and operational outlook at the William Blair 44th Annual Growth Stock Conference. A live audio webcast of the presentation will be available online at the investor relations page of the Company’s website at ir.neuronetics.com. A copy of the presentation prepared by the Company (the “Presentation”) in connection therewith is attached hereto as Exhibit 99.1 and the information contained therein is incorporated herein by reference. The outlook provided in the Presentation is only an estimate of what the Company believes is realizable as of the date of this Current Report on Form 8-K (this “Form 8-K”). Actual results may vary from the outlook and the variations may be material. The Company undertakes no intent or obligation to publicly update or revise any of these projections, whether as a result of new information, future events or otherwise, except as required by law.
The information in this report furnished pursuant to Item 7.01, including exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, or incorporated by reference in any filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, whether made before or after the date of this report, except as shall be expressly set forth by specific reference in such a filing.
Forward-Looking Statements
This Form 8-K contains forward-looking statements within the federal securities laws. These forward-looking statements may be identified by terms such as “outlook,” “potential,” “believe,” “expect,” “plan,” “anticipate,” “predict,” “may,” “will,” “could,” “would” and “should” as well as the negative of these terms and similar expressions. These statements include those relating to the Company’s business outlook and current expectations for upcoming quarters and fiscal year 2024, including with respect to revenue, expenses, growth, and any statements of assumptions underlying any of the foregoing items. These statements are subject to significant risks and uncertainties and actual results could differ materially from those projected. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and uncertainties include, without limitation, risks and uncertainties related to: the Company’s ability to execute its business strategy; the Company’s ability to achieve or sustain profitable operations due to its history of losses; the Company’s reliance on the sale and use of its NeuroStar Advanced Therapy system to generate revenues; the scale and efficacy of the Company’s salesforce; the Company’s ability to retain talent; availability of coverage and reimbursement from third-party payors for treatments using the Company’s products; physician and patient demand for treatments using the Company’s products; developments in competing technologies and therapies for the indications that the Company’s products treat; product defects; revenue concentration among a small number of customers; the Company’s ability to obtain and maintain intellectual property protection for its technology; developments in clinical trials or regulatory review of NeuroStar Advanced Therapy system for additional indications; developments in regulation in the U.S. and other applicable jurisdictions; the terms of the Company’s credit facility; the Company’s ability to successfully roll-out its Better Me Provider program on the planned timeline; the Company’s self-sustainability and existing cash balances; and the Company’s ability to achieve cash flow break-even for the fourth quarter 2024 and on a full-year basis in 2025. For a discussion of these and other related risks, please refer to the Company’s recent filings with the Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www.sec.gov. These forward-looking statements are based on the Company’s expectations and assumptions as of the date of this Form 8-K. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in the Presentation or this Form 8-K as a result of new information, future events, or changes in the Company’s expectations.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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NEURONETICS, INC. |
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(Registrant) |
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| Date: June 6, 2024 |
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By: |
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/s/ W. Andrew Macan |
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Name: |
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W. Andrew Macan |
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Title: |
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Executive Vice President, General Counsel, Chief Compliance Officer and Corporate Secretary |
Exhibit 99.1 William Blair th 44 Annual Growth Stock Conference June 6,
2024
“Safe harbor” statement under the Private Securities
Litigation Reform Act of 1995: Statements in this presentation regarding Neuronetics, Inc. (the “Company”) that are not historical facts constitute “forward-looking statements” within the meaning of the Private Securities
Litigation Reform Act of 1995. These forward-looking statements may be identified by terms such as “outlook,” “potential,” “believe,” “expect,” “plan,” “anticipate,”
“predict,” “may,” “will,” “could,” “would” and “should” as well as the negative of these terms and similar expressions. These statements include those relating to the
Company’s business outlook and current expectations for upcoming quarters and fiscal year 2024, including with respect to revenue, expenses, growth, and any statements of assumptions underlying any of the foregoing items. These statements are
subject to significant risks and uncertainties and actual results could differ materially from those projected. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this release. These risks and
uncertainties include, without limitation, risks and uncertainties related to: the Company’s ability to execute its business strategy; the Company’s ability to achieve or sustain profitable operations due to its history of losses; the
Company’s reliance on the sale and use of its NeuroStar Advanced Therapy system to generate revenues; the scale and efficacy of the Company’s salesforce; the Company’s ability to retain talent; availability of coverage and
reimbursement from third-party payors for treatments using the Company’s products; physician and patient demand for treatments using the Company’s products; developments in competing technologies and therapies for the indications that
the Company’s products treat; product defects; our revenue has been concentrated among a small number of customers; the Company’s ability to obtain and maintain intellectual property protection for its technology; developments in
clinical trials or regulatory review of NeuroStar Advanced Therapy system for additional indications; developments in regulation in the U.S. and other applicable jurisdictions; the terms of our credit facility; our ability to successfully roll-out
our Better Me Provider program on the planned timeline; our self-sustainability and existing cash balances; and our ability to achieve cash flow break-even for the fourth quarter 2024 and on a full-year basis in 2025. For a discussion of these and
other related risks, please refer to the Company’s recent filings with the U.S. Securities and Exchange Commission (the “SEC”), which are available on the SEC’s website at www.sec.gov. These forward-looking statements are
based on the Company’s expectations and assumptions as of the date of this presentation. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this presentation as a
result of new information, future events, or changes in the Company’s expectations. Company Confidential 2
Agenda ◼ NeuroStar Patient Trends ◼ Better Me Provider
Program ◼ Adolescent Indication Launch ◼ Road to Profitability Company Confidential 3
Weekly New Patient Starts by Month 600 500 400 300 200 100 - Company
Confidential 4
Weekly New Patient Starts by Customer Type Up +22% YTD 275 250 225 200
175 150 125 100 75 50 25 - Local Consumables Company Confidential 5
NSU Attendees Help More Patients Receive Treatment 58% Greater
Utilization for NSU Attendees Practices that attend NSU consistently outperform practices that do not on a month-to-month basis. In March 2024, NSU practices performed 58% better over baseline Jan 2022 data, than sites that have not attended. NSU.
Company Confidential 6
Change Healthcare Cyber Attack More than Half of our Customers were
Impacted Has your practice been impacted by the How has your practice been impacted Change Healthcare cyber attack? by the Change Healthcare cyber attack? 54% 40% 24% 22% 60% NO YES TMS TMS TMS Prior-authorizations Patient Starts Reimbursement
Representing 105 practices *Data on file Company Confidential 7
NeuroStar Better Me Provider Pilot Program 222 Providers are
participants required to: in pilot * Clinical evidence demonstrates superior outcomes for patients who complete a course of NeuroStar therapy compared to those who do not complete treatment. However, the actual number of sessions performed is
subject to the medical judgment of the prescribing physician. The number of treatment sessions performed is not a selection criteria for entry into the Better Me Guarantee Program and will not be used as a basis to remove a provider from the
program. | 1. Data on file, Neuronetics, Inc. 8 Company Confidential 8
BMP Raises the Bar for Patient Response Time BMP Non-BMP Active BMP
PHQ-10s (Inside the Practice) Committed Rate of Successful Follow-up 13% 46% 78% (1 Business Day) BMP Non-BMP Active BMP NPL Leads (Outside the Practice) Committed Rate of Successful Follow-up 14% 58% 90% (1 Business Day) Phase 2: Feb 1, 2024
– Apr 7, 2024 Company Confidential 9
Following the 5-Standards, BMP Practices Transform the Lives of More
Patients Avg New MT’s BMP Status Per Site for Q1 2024 Non-BMP Provider 3.0 Committed BMP Provider 7.3 Active BMP Provider 10.7 * Sites included were active as of Q1 2024 Company Confidential 10
BMP Practices are Helping Patients Faster Q1 2023 Q1 2024 82 days 17
days 5x Faster from potential patient interest to MT All patient interest in Local Consumable Offices; Phase 2: Feb 1, 2024 – Apr 7, 2024 vs. PY Company Confidential 11
Adolescent Launch 12
New Opportunity with Adolescent Psychiatrists New Customers 1,100+
Existing Customers Supported by Supported by 17 Capital Sales Representatives 45 Practice Development Managers • Expanded opportunity • Increases the value of NeuroStar system by broadening label to • 8,000+ adolescent and
additional patients child psychiatrists • 50% of customers treated • 6,000 adolescent psych adolescents 15-21 in past year nurse practitioners Actual NeuroStar • Increase awareness and Patient and Mom education among adolescents
and highly motivated parents through digital, social media, and mass media outreach Sales force size remains the same Company Confidential 13
NeuroStar is Actively Driving Consumer Awareness Hosted
Adolescent-Focused Media Event in NYC May 15, 2024 PR 22 articles & 60M+ reach to date • 120%+ Google search lift • 30+ social posts reaching 1.4M • 2 articles within 1 week Actual NeuroStar Digital Social Patient and Mom Ads
Media Evaluating Company Confidential 14
The Neurostar Q2 Summit was the largest since inception May 17-18, 2024
The Westin Kierland, Scottsdale AZ Day 1 Day 2 • Technology Overview• Clinical • Operationalizing• Marketing • System Demo• Reimbursement PANEL OF EXPERTS 50% of systems sold to adolescent-focused practices! Brian
Banks, CNP Sobia Kirmani-Moe, MD Kenneth Pages, MD Shahrzad Sims, DO Founder and Managing Psychiatrist,Creator and Medical Director, Medical Director Director of Light Mental Owner of Collaborative TMS of South Tampa Aster Mental Health Wellness,
PLLC Solutions Company Confidential 15
Road to Profitability
Dollars in $000 Operating Expense Trends Variance Increase/(decrease)
Operating Expenses as % of Revenue 140% 120% 130% -3% YOY 115% Change -4% 100% YOY 100% Change 80% 60% 40% 20% 0 2022 2023 2024* Full Year Operating Expenses $84,834 $82,259 $79,000* Company Confidential 17
We Expect our Focused Strategies to Continue Building Momentum ◼
Achieved record results in Q1 ◼ Better Me Provider Program key performance indicators: Ÿ Raises the bar for response time Ÿ Helps people in need 5x faster ◼ Generated awareness for adolescent indication among over 1.5 Million
people ◼ Customer impact from Change Healthcare cyber attack is improving ◼ On track to achieve cash flow breakeven in 2025 ◼ Continuing to invest in customer growth while reducing OPEX from non-commercial spend Company
Confidential 18
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