Neuronetics, Inc. (NASDAQ: STIM) (the “Company” or
“Neuronetics”) a commercial stage medical technology company with a
strategic vision of transforming the lives of patients whenever and
wherever they need help with the best neurohealth therapies in the
world, today announced its financial and operating results for the
second quarter of 2023.
Second Quarter 2023 Highlights
- Second quarter 2023 revenue of $17.6 million, an increase of 8%
over the second quarter of 2022
- U.S. treatment session revenue increased 9% over the second
quarter of 2022
- Shipped 54 NeuroStar systems
Recent Operational Highlights
- BlueCross BlueShield (BCBS) of Michigan updated its healthcare
policy, reducing the number of antidepressant medication attempts
from four down to two prior to transcranial magnetic stimulation
(TMS) treatment eligibility
- Aetna improved its healthcare policy to allow behavioral health
nurse practitioners to prescribe TMS and remove a four-month
psychotherapy trial before a patient becomes eligible for
treatment
- Received 510(k) clearance for obsessive-compulsive disorder
(OCD) motor threshold (MT) cap technology
- Transitioning to a more advanced contract manufacturer
Recent Marketing Highlights
- Achieved milestone of over 156,000 global patients treated with
5.6 million of our treatment sessions, another Company record
“We are pleased to report a solid second quarter, driven in part
by a robust 19% year-over-year growth in our local consumable
segment. The positive outcomes of our initiatives, such as
NeuroStar University, the 5-STARS training program, the PHQ-10
tool, and practice management training, have all contributed to
this success,” said Keith J. Sullivan, President and Chief
Executive Officer of Neuronetics. “As we move forward, we remain
fully committed to executing our strategic vision and building on
this positive momentum. With a strong track record of execution, we
are well-positioned to continue delivering results and making a
meaningful impact in the lives of those suffering from mental
health disorders.”
Second Quarter 2023 Financial and Operating Results for
the Three Months Ended June 30, 2023
|
|
Revenues by Geography |
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
|
|
2023 |
|
2022 |
|
|
|
|
|
Amount |
|
Amount |
|
% Change |
|
|
|
(in thousands, except percentages) |
|
U.S. |
|
$ |
17,289 |
|
$ |
16,132 |
|
7 |
% |
International |
|
|
321 |
|
|
197 |
|
63 |
% |
Total revenues |
|
$ |
17,610 |
|
$ |
16,329 |
|
8 |
% |
|
Total revenue for the three months ended June 30, 2023, was
$17.6 million, an increase of 8% compared to the revenue of $16.3
million in the second quarter of 2022. During the quarter, total
U.S. revenue increased by 7% and international revenue increased by
63% over the second quarter of 2022. The U.S. growth was primarily
driven by an increase in NeuroStar treatment session sales. The
increase in international growth was mainly due to an increase in
NeuroStar Advanced Therapy system sales and treatment session
revenue.
|
|
U.S. Revenues by Product Category |
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
|
|
2023 |
|
2022 |
|
|
|
|
|
Amount |
|
Amount |
|
% Change |
|
|
|
(in thousands, except percentages) |
|
NeuroStar Advanced Therapy System |
|
$ |
4,489 |
|
$ |
4,382 |
|
2 |
% |
Treatment sessions |
|
|
12,314 |
|
$ |
11,295 |
|
9 |
% |
Other |
|
|
486 |
|
$ |
455 |
|
7 |
% |
Total U.S. revenues |
|
$ |
17,289 |
|
$ |
16,132 |
|
7 |
% |
|
|
U.S. NeuroStar Advanced Therapy System |
|
|
|
|
|
Revenues by Type |
|
|
|
|
|
Three Months Ended June 30, |
|
|
|
|
|
2023 |
|
2022 |
|
|
|
|
|
Amount |
|
Amount |
|
% Change |
|
|
|
(in thousands, except percentages) |
|
NeuroStar capital |
|
$ |
4,301 |
|
$ |
4,272 |
|
1 |
% |
Operating lease |
|
|
67 |
|
|
49 |
|
37 |
% |
Other |
|
|
121 |
|
|
61 |
|
98 |
% |
Total U.S. NeuroStar Advanced Therapy system revenues |
|
$ |
4,489 |
|
$ |
4,382 |
|
2 |
% |
|
U.S. NeuroStar Advanced Therapy system revenue for the three
months ended June 30, 2023, was $4.5 million, an increase of 2%
compared to the revenue of $4.4 million in the second quarter of
2022. For the three months ended June 30, 2023, and 2022, the
Company shipped 54 and 59 systems, respectively.
U.S. treatment session revenue for the three months ended June
30, 2023, was $12.3 million, an increase of 9% compared to the
revenue of $11.3 million in the second quarter of 2022. The revenue
growth was primarily driven by an increase in utilization, in
particular within our local consumable customer segment.
In the second quarter of 2023, U.S. treatment session revenue
per active site was approximately $11,392 compared to approximately
$11,280 in the second quarter of 2022.
Gross margin for the second quarter of 2023 was 72.5%, a
decrease of approximately 280 basis points from the second quarter
of 2022 gross margin of 75.3%. The decline in gross margin was
driven by an increase in amortization expense associated with the
latest product release. We also incurred one-time expenses related
to our transition to a new contract manufacturer. Without these
expenses, gross margin would have been 75.6%.
Operating expenses during the second quarter of 2023 were $20.1
million, a decrease of $2.0 million, or 9%, compared to $22.1
million in the second quarter of 2022.
Net loss for the second quarter of 2023 was $(4.9) million, or
$(0.17) per share, as compared to the second quarter 2022 net loss
of $(10.4) million, or $(0.39) per share. Net loss per share was
based on 28,589,976 and 26,786,778 weighted-average common shares
outstanding for the second quarters of 2023 and 2022,
respectively.
EBITDA for the second quarter of 2023 was $(3.3) million as
compared to the second quarter of 2022 EBITDA of $(9.1) million.
See the accompanying financial table that reconciles EBITDA, which
is a non-GAAP financial measure, to net loss.
Cash and cash equivalents were $45.9 million as of June 30,
2023. This compares to cash and cash equivalents of $70.3 million
as of December 31, 2022, and $70.9 million as of June 30, 2022.
BlueCross BlueShield of Michigan Reduces Prior Number of
Antidepressant Medication Attempts
BlueCross BlueShield of Michigan expanded transcranial magnetic
stimulation (“TMS”) treatment access for depression patients,
reducing antidepressant medication attempts from four to two. As
the largest payer in the state with over 5.6 million covered lives,
BCBS of Michigan’s policy update reflects the momentum in the
industry to expand TMS therapy coverage.
Aetna to Allow Behavioral Health Nurse Practitioners to
Prescribe TMS
Aetna announced a healthcare policy update that improves access
to NeuroStar. The update allows behavioral health nurse
practitioners to order and conduct TMS treatment for patients with
major depressive disorder and removes the four-month psychotherapy
trial requirement before starting TMS treatment. This change aims
to reduce access barriers and provide earlier mental health
treatment for patients in need.
Received 510(k) Clearance for Obsessive-Compulsive
Disorder (“OCD”) Motor Threshold (“MT”) Cap Technology
The Company received U.S. Food and Drug Administration (“FDA”)
clearance for OCD MT cap technology. The OCD MT cap simplifies
initial coil placement, shortening treatment time and reducing
steps, while offering the same advantages as the current MDD MT
cap, including compatibility with Fast MT™ for up to 40%-time
savings. The OCD MT cap will be available nationwide in the fourth
quarter of 2023.
Business Outlook
For the full year 2023, the Company now expects total revenue to
be between $69.0 million and $73.0 million, increasing the bottom
end of the range by $1.0 million.
For the full year 2023, the Company now expects total operating
expenses to be between $82.0 million and $86.0 million, an
improvement from prior guidance of $84.0 million to $88.0
million.
For the third quarter of 2023, the Company expects total revenue
between $17.0 million and $18.0 million.
Webcast and Conference Call Information
Neuronetics’ management team will host a conference call on
August 8, 2023, beginning at 8:30 a.m. Eastern Time.
The conference call will be broadcast live in listen-only mode
via webcast at
https://edge.media-server.com/mmc/p/papp9yri. To
listen to the conference call on your telephone, participants may
register for the call here. While it is not
required, it is recommended you join 10 minutes prior to the event
start.
About Neuronetics
Neuronetics, Inc. believes that mental health is as important as
physical health. As a global leader in neuroscience and the largest
TMS company in the industry, Neuronetics is redefining patient and
physician expectations by designing and developing products that
improve the quality of life for people suffering from psychiatric
disorders. An FDA-cleared, non-drug, noninvasive treatment for
people with depression, Neuronetics’ NeuroStar® Advanced Therapy
system is today’s leading TMS treatment for MDD with over 4.8
million treatments delivered. NeuroStar is widely researched and
backed by the largest clinical data set of any TMS system for
depression, including the world’s largest depression outcomes
registry. Our NeuroStar® Advanced Therapy system is also
FDA-cleared to treat people suffering from obsessive-compulsive
disorder, as well as for the treatment of comorbid anxiety symptoms
(“anxious depression”) for adults with MDD suffering from anxiety
symptoms. Neuronetics is committed to transforming lives by
offering an exceptional treatment option that produces
extraordinary results. For safety information and indications for
use, visit NeuroStar.com.
“Safe harbor” statement under the Private Securities
Litigation Reform Act of 1995:
Statements in the press release regarding 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 2023, 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 impact of public health
crises on the Company’s operations, manufacturing and supply chain
interruptions or delays; 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; 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; and
developments in regulation in the U.S. and other applicable
jurisdictions. 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 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.
Investor Contact:
Mike Vallie or Mark KlausnerWestwicke
Partners443-213-0499ir@neuronetics.com
Media Contact:
EvolveMKD646-517-4220NeuroStar@evolvemkd.com
NEURONETICS, INC.Statements of
Operations(In thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenues |
|
$ |
17,610 |
|
|
$ |
16,329 |
|
|
$ |
33,150 |
|
|
$ |
30,510 |
|
Cost of revenues |
|
|
4,836 |
|
|
|
4,039 |
|
|
|
8,980 |
|
|
|
7,524 |
|
Gross Profit |
|
|
12,774 |
|
|
|
12,290 |
|
|
|
24,170 |
|
|
|
22,986 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
11,559 |
|
|
|
13,685 |
|
|
|
23,461 |
|
|
|
26,334 |
|
General and administrative |
|
|
6,200 |
|
|
|
6,356 |
|
|
|
12,812 |
|
|
|
12,734 |
|
Research and development |
|
|
2,364 |
|
|
|
2,045 |
|
|
|
5,154 |
|
|
|
3,849 |
|
Total operating expenses |
|
|
20,123 |
|
|
|
22,086 |
|
|
|
41,427 |
|
|
|
42,917 |
|
Loss from Operations |
|
|
(7,349 |
) |
|
|
(9,796 |
) |
|
|
(17,257 |
) |
|
|
(19,931 |
) |
Other (income) expense: |
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
1,144 |
|
|
|
1,000 |
|
|
|
2,396 |
|
|
|
1,978 |
|
Other income, net |
|
|
(3,592 |
) |
|
|
(374 |
) |
|
|
(4,232 |
) |
|
|
(649 |
) |
Net Loss |
|
$ |
(4,901 |
) |
|
$ |
(10,422 |
) |
|
$ |
(15,421 |
) |
|
$ |
(21,260 |
) |
Net loss per share of common
stock outstanding, basic and diluted |
|
$ |
(0.17 |
) |
|
$ |
(0.39 |
) |
|
$ |
(0.54 |
) |
|
$ |
(0.80 |
) |
Weighted-average common shares
outstanding, basic and diluted |
|
|
28,590 |
|
|
|
26,787 |
|
|
|
28,316 |
|
|
|
26,692 |
|
NEURONETICS, INC.Balance
Sheets(In thousands, except per share
data) |
|
|
|
|
|
|
|
|
|
June 30, |
|
December 31, |
|
|
2023 |
|
|
2022 |
|
Assets |
|
|
|
|
|
|
Current assets: |
|
|
|
|
|
|
Cash and cash equivalents |
|
$ |
45,905 |
|
|
$ |
70,340 |
|
Accounts receivable, net |
|
|
13,145 |
|
|
|
13,591 |
|
Inventory |
|
|
8,871 |
|
|
|
8,899 |
|
Current portion of net investments in sales-type leases |
|
|
1,072 |
|
|
|
1,538 |
|
Current portion of prepaid commission expense |
|
|
2,204 |
|
|
|
1,997 |
|
Current portion of note receivables |
|
|
1,975 |
|
|
|
230 |
|
Prepaid expenses and other current assets |
|
|
4,504 |
|
|
|
2,174 |
|
Total current assets |
|
|
77,676 |
|
|
|
98,769 |
|
Property and equipment,
net |
|
|
2,108 |
|
|
|
1,991 |
|
Operating lease right-of-use
assets |
|
|
3,056 |
|
|
|
3,327 |
|
Net investments in sales-type
leases |
|
|
859 |
|
|
|
1,222 |
|
Prepaid commission
expense |
|
|
7,980 |
|
|
|
7,568 |
|
Long-term notes
receivable |
|
|
4,671 |
|
|
|
362 |
|
Other assets |
|
|
4,042 |
|
|
|
3,645 |
|
Total Assets |
|
$ |
100,392 |
|
|
$ |
116,884 |
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
Current liabilities: |
|
|
|
|
|
|
Accounts payable |
|
$ |
4,143 |
|
|
$ |
2,433 |
|
Accrued expenses |
|
|
8,375 |
|
|
|
14,837 |
|
Deferred revenue |
|
|
1,674 |
|
|
|
1,980 |
|
Current portion of operating lease liabilities |
|
|
834 |
|
|
|
824 |
|
Current portion of long-term debt, net |
|
|
— |
|
|
|
13,125 |
|
Total current liabilities |
|
|
15,026 |
|
|
|
33,199 |
|
Long-term debt, net |
|
|
36,713 |
|
|
|
22,829 |
|
Deferred revenue |
|
|
513 |
|
|
|
829 |
|
Operating lease
liabilities |
|
|
2,663 |
|
|
|
2,967 |
|
Total Liabilities |
|
|
54,915 |
|
|
|
59,824 |
|
Commitments and contingencies (Note 17) |
|
|
— |
|
|
|
— |
|
Stockholders’ Equity: |
|
|
|
|
|
|
Preferred stock, $0.01 par value: 10,000 shares authorized; no
shares issued or outstanding on June 30, 2023, and
December 31, 2022 |
|
|
— |
|
|
|
— |
|
Common stock, $0.01 par value: 200,000 shares authorized; 28,813
and 27,268 shares issued and outstanding on
June 30, 2023, and December 31, 2022,
respectively |
|
|
288 |
|
|
|
273 |
|
Additional paid-in capital |
|
|
406,502 |
|
|
|
402,679 |
|
Accumulated deficit |
|
|
(361,313 |
) |
|
|
(345,892 |
) |
Total Stockholders’ Equity |
|
|
45,477 |
|
|
|
57,060 |
|
Total Liabilities and Stockholders’ Equity |
|
$ |
100,392 |
|
|
$ |
116,884 |
|
NEURONETICS, INC.Statements of Cash
Flows(In thousands) |
|
|
|
|
|
|
|
|
|
Six months ended June 30, |
|
|
2023 |
|
|
2022 |
|
Cash Flows from Operating
Activities: |
|
|
|
|
|
|
Net loss |
|
$ |
(15,421 |
) |
|
$ |
(21,260 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
|
|
Depreciation and amortization |
|
|
1,004 |
|
|
|
657 |
|
Allowance for credit losses |
|
|
(266 |
) |
|
|
328 |
|
Share-based compensation |
|
|
3,838 |
|
|
|
4,455 |
|
Non-cash interest expense |
|
|
322 |
|
|
|
340 |
|
Cost of rental units purchased by customers |
|
|
— |
|
|
|
92 |
|
Changes in certain assets and liabilities: |
|
|
|
|
|
|
Accounts receivable, net |
|
|
(5,456 |
) |
|
|
(4,013 |
) |
Inventory |
|
|
(7 |
) |
|
|
(840 |
) |
Net investment in sales-type leases |
|
|
828 |
|
|
|
102 |
|
Prepaid commission expense |
|
|
(620 |
) |
|
|
(610 |
) |
Prepaid expenses and other assets |
|
|
(2,762 |
) |
|
|
1,517 |
|
Accounts payable |
|
|
1,577 |
|
|
|
(2,256 |
) |
Accrued expenses |
|
|
(6,462 |
) |
|
|
1,451 |
|
Deferred revenue |
|
|
(622 |
) |
|
|
(1,095 |
) |
Net Cash Used in Operating Activities |
|
|
(24,047 |
) |
|
|
(21,132 |
) |
|
|
|
|
|
|
|
Cash Flows from Investing
Activities: |
|
|
|
|
|
|
Purchases of property and equipment and capitalized software |
|
|
(938 |
) |
|
|
(2,040 |
) |
Repayment of notes receivable |
|
|
113 |
|
|
|
— |
|
Net Cash Used in Investing Activities |
|
|
(825 |
) |
|
|
(2,040 |
) |
|
|
|
|
|
|
|
Cash Flows from Financing
Activities: |
|
|
|
|
|
|
Payments of debt issuance costs |
|
|
(863 |
) |
|
|
(90 |
) |
Proceeds from issuance of long-term debt |
|
|
2,500 |
|
|
|
— |
|
Repayment of long-term debt |
|
|
(1,200 |
) |
|
|
— |
|
Proceeds from exercises of stock options |
|
|
— |
|
|
|
52 |
|
Net Cash Provided by (Used in) Financing Activities |
|
|
437 |
|
|
|
(38 |
) |
Net Decrease in Cash and Cash Equivalents |
|
|
(24,435 |
) |
|
|
(23,210 |
) |
Cash and Cash Equivalents, Beginning of Period |
|
|
70,340 |
|
|
|
94,141 |
|
Cash and Cash Equivalents, End of Period |
|
$ |
45,905 |
|
|
$ |
70,931 |
|
|
Non-GAAP Financial Measures (Unaudited)
EBITDA is not a measure of financial performance under generally
accepted accounting principles in the U.S. (“GAAP”),
and should not be construed as a substitute for, or superior to,
GAAP net loss. However, management uses both the GAAP and non-GAAP
financial measures internally to evaluate and manage the Company’s
operations and to better understand its business. Further,
management believes the addition of the non-GAAP financial measure
provides meaningful supplementary information to, and facilitates
analysis by, investors in evaluating the Company’s financial
performance, results of operations and trends. The Company’s
calculation of EBITDA may not be comparable to similarly designated
measures reported by other companies, because companies and
investors may differ as to what type of events warrant
adjustment.
The following table reconciles reported net loss to EBITDA:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three Months ended |
|
Six months ended |
|
|
June 30, |
|
June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
|
|
(in thousands) |
|
(in thousands) |
Net loss |
|
$ |
(4,901 |
) |
|
$ |
(10,422 |
) |
|
$ |
(15,421 |
) |
|
$ |
(21,260 |
) |
Interest expense |
|
|
1,144 |
|
|
|
1,000 |
|
|
|
2,396 |
|
|
|
1,978 |
|
Income taxes |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
— |
|
Depreciation and
amortization |
|
|
488 |
|
|
|
338 |
|
|
|
1,004 |
|
|
|
657 |
|
EBITDA |
|
$ |
(3,269 |
) |
|
$ |
(9,084 |
) |
|
$ |
(12,021 |
) |
|
$ |
(18,625 |
) |
Neuronetics (NASDAQ:STIM)
Gráfico Histórico do Ativo
De Abr 2024 até Mai 2024
Neuronetics (NASDAQ:STIM)
Gráfico Histórico do Ativo
De Mai 2023 até Mai 2024