stim-8k_20190107.htm

 

 

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) January 7, 2019

 

 

NEURONETICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware

 

001-38546

 

33-1051425

(State or other jurisdiction

of incorporation)

 

(Commission

File Number)

 

(I.R.S. Employer

Identification No.)

 

3222 Phoenixville Pike, Malvern, PA

 

19355

(Address of principal executive offices)

 

(Zip Code)

 

Registrants telephone number, including area code (610) 640-4202

 

(Former name or former address, if changed since last report.) Not applicable.

 

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:

 

[   ]

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

[   ]

 Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

 

[   ]

 Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

[   ]

 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 [X]

 

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 2.02 Results of Operations and Financial Condition.

Neuronetics, Inc., or the Company, issued a press release on January 7, 2019 announcing its preliminary revenue for the three months and twelve months ended December 31, 2018. A copy of the press release is being furnished to the Securities and Exchange Commission as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference to this Item 2.02.

***

The information furnished pursuant to Item 2.02 shall not be deemed to be filed for purposes of Section 18 of the Securities Exchange Act of 1934, or the Exchange Act, or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference into any of the Companys filings with the Securities and Exchange Commission under the Exchange Act or the Securities Act of 1933, whether made before or after the date hereof, regardless of any general incorporation language in such a filing, except as expressly set forth by specific reference in such a filing. Except as required by law, we undertake no duty or obligation to publicly update or revise the information so furnished.

 

Item 9.01 Financial Statements and Exhibits.

 

(d) Exhibits.

 

Exhibit

Number

 

Description

 

 

 

99.1

 

Press Release, dated January 7, 2019, of Neuronetics, Inc.

 

 

 

 


 


 

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.

 

 

Neuronetics, INC.

 

(Registrant)

 

Date: January 7, 2019

By:

 

/s/ Peter Donato

 

Name:

 

Peter Donato

 

Title:

 

VP, Finance and Chief Financial Officer

 

 

 

(Principal Financial and Accounting Officer)

 

 

stim-ex991_6.htm

 

Exhibit 99.1

 

 

Neuronetics Announces Preliminary Fourth Quarter and Full Year Revenue

Preliminary full year 2018 total revenue of approximately $52.8 million, an increase of approximately 31% over the full year 2017, exceeding previously issued guidance

MALVERN, PA January 7, 2019 (GLOBE NEWSWIRE) -- Neuronetics, Inc. (NASDAQ: STIM), a commercial stage medical technology company focused on designing, developing and marketing products that improve the quality of life for patients who suffer from psychiatric disorders, today announced certain unaudited preliminary fourth quarter and full year 2018 revenue.

 

Preliminary fourth quarter 2018 revenue of approximately $15.6 million, an increase of approximately 29% over the fourth quarter of 2017

 

Preliminary fourth quarter 2018 U.S. treatment session revenue of approximately $9.9 million, an increase of approximately 23% over the fourth quarter of 2017

 

Preliminary fourth quarter 2018 U.S. NeuroStar® Advanced Therapy revenue of approximately $4.8 million, an increase of approximately 37% over the fourth quarter of 2018, driven by a 46% increase in capital revenue growth

“We finished 2018 on a high note, as we continue to successfully execute on our strategy to drive higher NeuroStar Advanced Therapy penetration in the U.S.,” said Chris Thatcher, President and Chief Executive Officer of Neuronetics. “As we move into 2019, given the success we have seen to date, we will continue to drive adoption through our key growth drivers -- expanding our salesforce and related marketing efforts, continuing to focus on high-value accounts and pursuing additional indications for use for the NeuroStar Advanced Therapy system.”

Preliminary total revenue for the fourth quarter of 2018 was approximately $15.6 million, an increase of approximately 29% compared with $12.1 million for the fourth quarter of 2017. Preliminary U.S. revenue was approximately $15.1 million for the fourth quarter of 2018, an approximate 27% growth over fourth quarter 2017 revenue of $11.8 million. Preliminary international revenue was approximately $0.5 million for the fourth quarter of 2018. Preliminary total revenue for the full year 2018 was approximately $52.8 million, an increase of approximately 31% compared with $40.4 million for 2017. This exceeds previously issued full year 2018 revenue guidance of between $51.0 and $52.5 million.

Preliminary fourth quarter 2018 U.S. NeuroStar Advanced Therapy revenue of approximately $4.8 million increased approximately 37% compared with $3.5 million for the fourth quarter of 2017. The increase in U.S. NeuroStar revenue was driven by higher capital revenue growth of 46% due to higher unit sales, partially offset by a 4% decrease in average selling price, as well as lower upgrade and rent-to-own revenue. Preliminary full year 2018 U.S. NeuroStar Advanced Therapy revenue increased approximately 44% to approximately $14.6 million.

Preliminary fourth quarter 2018 U.S. treatment session revenue of $9.9 million increased approximately 23% compared with $8.0 million for the fourth quarter of 2017. The increase in U.S. treatment session revenue was primarily the result of an approximate 26% increase in the number of treatment sessions sold, partially offset by an approximate 6% decline in the average selling price due to certain volume


pricing discounts within our existing customer base, plus an increase in other treatment session revenue. Preliminary full year 2018 U.S. treatment session revenue increased approximately 24% to approximately $35.3 million.

As of December 31, 2018, the active unit installed base in the U.S. was 907. This represents an increase of 155 units over the active unit installed base as of December 31, 2017, and an increase of 49 units over the active unit installed base as of September 30, 2018.

Japan Reimbursement

Based on recent discussions with the Ministry of Health, Labour and Welfare (MHLW), a decision on reimbursement in Japan is now anticipated to occur in the second half of 2019. Japan represents a large and potentially attractive market for NeuroStar Advanced Therapy and the Company remains focused on achieving appropriate reimbursement levels in this market.

About Neuronetics

Neuronetics, Inc. is a commercial-stage medical technology company focused on designing, developing, and marketing products that improve the quality of life for patients who suffer from psychiatric disorders. Our first commercial product, the NeuroStar® Advanced Therapy System, is a non-invasive and non-systemic office-based treatment that uses transcranial magnetic stimulation, or TMS, to create a pulsed, MRI-strength magnetic field that induces electrical currents designed to stimulate specific areas of the brain associated with mood.  The system is cleared by the United States Food and Drug Administration, or FDA.  NeuroStar Advanced TMS Therapy is indicated for the treatment of major depressive disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.  Additional information can be found at www.neuronetics.com.

 

"Safe Harbor" statement under the Private Securities Litigation Reform Act of 1995:

 

Statements in the press 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 quarter and fiscal year, including with respect to any specific projections provided; the Company’s expectations regarding growth opportunities and the build out of its NeuroStar Advanced Therapy System platform; expectations or beliefs regarding future events, potential markets or market size, and technological developments; 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 achieve or sustain profitable operations due to its history of losses; the Company’s reliance on the sale and usage of its NeuroStar Advanced Therapy System to generate revenues; 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 respect of competing technologies and therapies for the indications that the Company’s products treat; product defects; the Company’s ability to obtain and maintain intellectual property protection for its technology; and developments in regulation in the United States and other applicable

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jurisdictions. For a discussion of these and other related risks, please refer to the Company’s recent SEC filings 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 press release. Except as required by law, the Company undertakes no duty or obligation to update any forward-looking statements contained in this press release as a result of new information, future events or changes in the Company's expectations.

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Investor Contact:

 

Mark R. Klausner

Westwicke Partners

443-213-0501

ir@neuronetics.com

 

Media Contact:

 

Leanne Scott Brown

Vault Communications

610-455-2742

Lbrown@vaultcommunications.com

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