Item 7.01 Regulation FD Disclosure.
Neuronetics, Inc. (the "Company") has provided the following business overview
updates:
We are 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, to
treat adult patients with major depressive disorder, or MDD, that have failed to
achieve satisfactory improvement from prior antidepressant medication in the
current MDD episode. NeuroStar Advanced Therapy is also available in other parts
of the world, including Japan, where it is listed under Japan's national health
insurance. NeuroStar Advanced Therapy is safe, clinically effective,
reproducible and precise and we believe is supported by the largest clinical
data set of any competing TMS system. We are a market leader in TMS therapy
based on our U.S. installed base of 1,143 active NeuroStar Advanced Therapy
Systems in approximately 909 psychiatrist offices as of September 30, 2020 and
the estimated 94,609 patients treated with approximately 3.4 million of our
treatment sessions through such date. We recently added twenty-two new field
sales personnel. These individuals have considerable experience in capital
sales, though the majority of their experience is outside the mental health
field. We are currently training these sales personnel with the expectation that
they will be fully productive by the second quarter of 2021; however, our
ability to achieve full productivity may be delayed as our sales force develops
experience in our field. We generated revenues of $12.4 million and
$33.7 million for the three and nine months ended September 30, 2020.
Item 8.01 Other Events.
The Company is making available the attached presentation (the "Investor
Presentation") which contains information that the company may use, in whole or
in part, in connection with presentations to certain investors.
Cautionary Statement Regarding Forward-Looking Statements
The Investor Presentation includes statements that may be forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of
1995. The words "believe," "estimate," "expect," "anticipate," "project,"
"forecast" and similar expressions, or the negative thereof, among others,
generally identify forward-looking statements. Forward-looking statements used
in the Investor Presentation include statements regarding revenue guidance;
future revenue and revenue growth; liquidity to fund growth; new product
launches and market
--------------------------------------------------------------------------------
opportunity, market share and market share growth; future gross margin.
Neuronetics cautions that these forward-looking statements are based on
management's current expectations, estimates, forecasts and projections about
Neuronetics, and assumptions management believes are reasonable, and are subject
to risks and uncertainties that may cause actual results to differ materially
from those indicated in the forward-looking statements. Such risks and
uncertainties include, but are not limited to, surgeons' willingness to use the
Company's existing and newly launched products; the Company's ability to
continue to invest in medical education and training, product development,
and/or sales and marketing initiatives at levels sufficient to drive future
revenue growth; the Company's ability to attract new, high-quality distributors
and potential disruption to the Company's existing distribution network;
continued pricing pressure, as well as exclusion from major healthcare systems;
the risk of supply shortages and the associated, potentially long-term
disruption to product sales; unexpected expense and delay; changes to laws and
regulations applicable to the Company and the industry in which it competes; and
general economic and business conditions in the markets in which the Company
does business, both in the U.S. and abroad. Additional information about the
factors that may affect the operations of Neuronetics and results is set forth
in Neuronetics' annual and quarterly reports filed with the U.S. Securities and
Exchange Commission. Forward-looking statements contained in the Investor
Presentation are made only as of the first day of the month and year set forth
on the cover hereof and Neuronetics undertakes no obligation to release publicly
any revisions or updates to forward-looking statements as a result of subsequent
events or developments, except as required by law.
Item 9.01 Financial Statements and Exhibits.
(d) Exhibits.
Exhibit
Number Description
99.1 Investor Presentation dated January 27, 2021.
104 Cover Page Interactive Data File (embedded within the Inline XBRL
document).
--------------------------------------------------------------------------------
© Edgar Online, source Glimpses
NEURONETICS, INC. 
