NeurAxis, Inc. (“NeurAxis,” or the “Company”) (NYSE American:
NRXS), a medical technology company commercializing neuromodulation
therapies for chronic and debilitating conditions in children and
adults, today announced results for the third quarter period ended
September 30, 2024.
3Q24 Financial Highlights
- Revenues
increased 40% to $667 thousand in the three months ended September
30, 2024 (the “3Q24”) compared to $477 thousand in the three months
ended September 30, 2023 (the “3Q23”).
- Operating loss
improved by 45% compared to the 3Q2023.
Recent Operational
Highlights
- Expanded total
covered lives to approximately 35 million compared to 4.5 million
as of October 1, 2023. Recent medical policy coverages include:
- BCBS licensee in
Florida covering over 6 million lives.
- BCBS plan in the
mid-Atlantic region, providing coverage for approximately 7 million
covered lives.
- BCBS plan in
the mid-Atlantic with approximately 3.5 million covered lives.
- One of the
nation’s largest not for profit health plans, serving over 12
million members, is now providing their members with access to
PENFS treatment, when medically necessary.
- Received a new
Current Procedural Terminology (CPT) Category I code for
Percutaneous Electrical Nerve Field Stimulation (PENFS) procedures
effective January 1, 2026.
- Received new FDA
clearance for the expansion of IB-Stim label:
- to allow for a
larger patient population beyond 11-18 years of age to 8-21
years.
- to increase
devices per patient to 4 devices.
- Submitted to the
FDA its innovative rectal expulsion device (RED) product, which was
licensed from the University of Michigan. RED’s innovative design
simplifies anorectal function testing and can be used without
interrupting clinical workflow. Management is cautiously optimistic
for FDA clearance in the fourth quarter of 2024.
- The Company
remains committed to clinical research in the pediatric space, with
16 peer-reviewed publications. All studies were carried out in US
children’s hospitals using NeurAxis’ PENFS technology. This level
of evidence puts NeurAxis in a great position to continue expanding
payor coverage and increasing adoption of the technology.
- Secured a $5.0
million capital investment from a dedicated life sciences fund that
will close mid-November 2024 to replace $3.2 million in committed
funding from an existing investor.
Management Commentary
Brian Carrico, Chief Executive Officer of
NeurAxis, commented, “We are excited about our strong performance
in the 3Q24, as revenues increased 40% year over year. Demand for
our IB-Stim product is accelerating, as unit sales grew 50% in the
third quarter. Our commercialization, based on strong data
publication leading to insurance coverage, is beginning to bear
fruit. We now have approximately 35 million lives under insurance
coverage, with countless payers in the review and policy writing
stage.
In recent weeks we have achieved very
significant milestones in our commercialization efforts of IB-Stim.
Two weeks ago, we received a new FDA 510(K) clearance, expanding
IB-Stim’s indication from 11-18 year olds to 8-21 year olds, and
from 3 devices, not to exceed 4 weeks, to 1 device per week for 4
weeks. In addition, we recently announced that American Medical
Association has established a new Current Procedural Terminology
(CPT) Category I code for Percutaneous Electrical Nerve Field
Stimulation (PENFS) procedures. Obtaining a Category I code for
this important technology is important for our initiatives to drive
patient access for IB-Stim and future PENFS treatments.”
Our strong momentum has continued, and we are
excited to note that 4Q24 is off to a great start. We are
continuing our efforts for success in the near and long term. As a
result of financings in 2024 with long-term investors in the
healthcare space, our balance sheet is well positioned to execute
our business plans for the foreseeable future.”
Third Quarter 2024 Financial Results
Revenues in the third quarter of 2024 were $667
thousand, up 40% compared to $477 thousand in the third quarter of
2023. Unit sales increased approximately 50%, partially offset by
discounts given to patients without insurance coverage via the
Company’s financial assistance program. The Company has made great
strides in recent months in gaining insurance coverage, and recent
results are indicative of that success.
Gross profit in the third quarter of 2024 was
$570 thousand, a 39% increase compared to $410 thousand in the
third quarter of 2023 due to the higher sales volume. The slight
decline in gross margin of 50 basis points in the third quarter of
2024 compared to the third quarter of 2023 was due to growth in
device deliveries from the Company’s financial assistance programs
that are discounted to patients without insurance coverage.
Operating loss in the third quarter of 2024 was
$1.7 million, a decrease of 45% compared to $3.0 million in the
third quarter of 2023. The improvement was primarily due to higher
sales volumes and 2023 post-initial public offering (“IPO”)
consulting costs that did not recur in 2024.
The net loss in the third quarter of 2024 was
$1.8 million, a decrease of 80% compared to $8.6 million in the
third quarter of 2023. The decrease was primarily due to the lower
operating loss and the absence of debt discount, issuance cost and
debt extinguishment charges triggered by the Company’s IPO in the
third quarter of 2023.
While cash on hand as of September 30, 2024 was
$261 thousand, the Company entered into a $5.0 million investment
agreement on November 9, 2024. This capital replaces $3.2 million
in committed funding from an existing investor. The transaction is
expected to close mid-November. Although the Company had no
long-term debt as of September 30, 2024, short-term debt of $148
thousand represented a note payable related to the financing of
business insurance premiums. Cash used in operations for the nine
months ended September 30, 2024 of $4.3 million was $276 thousand
higher than the nine months ended September 30, 2023 primarily due
to incremental costs of being a publicly-held company such as
legal, insurance, board and stock exchange fees.
Conference Call Details
Date and Time: Tuesday, November 12, 2024, at
9:00am ET
Live Webcast Information: Interested parties
can access the conference call via a live webcast, which is
available in the Investor Relations section of the Company's
website at https://edge.media-server.com/mmc/p/op4xi3gu or
https://ir.neuraxis.com/. For participants listening through the
webcast, questions can be sent in through the portal using the “Ask
a Question” link or by emailing questions to
NRXS@lythampartners.com.
Call-in Information: Interested parties can
also access the live conference call by initially registering at
the following link.
Upon completion of the registration link, call-in participants
will receive the dial-in info and a unique PIN to join the call as
well as an email confirmation with the details.
Replay: A webcast replay will be available in
the Investor Relations section of the Company's website at
https://edge.media-server.com/mmc/p/op4xi3gu or
https://ir.neuraxis.com/.
About NeurAxis, Inc.NeurAxis, Inc., is a
medical technology company focused on neuromodulation therapies to
address chronic and debilitating conditions in children and adults.
NeurAxis is dedicated to advancing science and leveraging
evidence-based medicine to drive the adoption of its IB-Stim™
therapy, which is its proprietary Percutaneous Electrical Nerve
Field Stimulation (PENFS) technology, by the medical, scientific,
and patient communities. IB-Stim™ is FDA-cleared for functional
abdominal pain associated with irritable bowel syndrome (IBS) in
adolescents 8-21 years old. Additional clinical trials of PENFS in
multiple pediatric and adult conditions with large unmet healthcare
needs are underway. For more information, please visit
http://neuraxis.com.
Forward-Looking StatementsCertain statements in
this press release are forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933, as amended,
and Section 21E of the Securities Exchange Act of 1934, as amended.
All statements other than statements of historical fact are
forward-looking statements. Forward-looking statements are based on
management’s current assumptions and expectations of future events
and trends, which affect or may affect the Company’s business,
strategy, operations or financial performance, and actual results
and other events may differ materially from those expressed or
implied in such statements due to numerous risks and uncertainties.
Forward-looking statements are inherently subject to risks and
uncertainties, some of which cannot be predicted or quantified.
There are a number of important factors that could cause actual
results, developments, business decisions or other events to differ
materially from those contemplated by the forward-looking
statements in this press release. These factors include, among
other things, the conditions in the U.S. and global economy, the
trading price and volatility of the Company’s stock, public health
issues or other events, the Company’s compliance with applicable
laws, the results of the Company’s clinical trials and perceptions
thereof, the results of submissions to the FDA, the results of the
shareholder vote to enable the issuance of the Preferred Stock, and
factors described in the Risk Factors section of NeurAxis’s public
filings with the Securities and Exchange Commission (SEC). Because
forward-looking statements are inherently subject to risks and
uncertainties, you should not rely on these forward-looking
statements as predictions of future events. These forward-looking
statements speak only as of the date of this press release and,
except to the extent required by applicable law, the Company
undertakes no obligation to update or revise these statements,
whether as a result of any new information, future events and
developments or otherwise.
For contraindications, precaution, warnings, and IFU, please
see: https://ibstim.com/important-information/.
Contacts:
CompanyNeurAxis,
Inc.info@neuraxis.com
Investor Relations Lytham PartnersBen
Shamsian646-829-9701shamsian@lythampartners.com
NeurAxis, Inc. |
Condensed Statements of Operations |
(Unaudited) |
|
|
|
|
|
Three Months Ended September 30, |
|
Nine Months Ended September 30, |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
|
|
|
|
|
|
|
Net sales |
$ |
666,625 |
|
|
$ |
477,460 |
|
|
$ |
1,924,760 |
|
|
$ |
1,928,590 |
|
Cost of goods sold |
|
97,050 |
|
|
|
67,287 |
|
|
|
256,949 |
|
|
|
231,000 |
|
Gross profit |
|
569,575 |
|
|
|
410,173 |
|
|
|
1,667,811 |
|
|
|
1,697,590 |
|
Selling expenses |
|
95,430 |
|
|
|
64,210 |
|
|
|
226,374 |
|
|
|
250,933 |
|
Research and development |
|
72,422 |
|
|
|
44,950 |
|
|
|
132,304 |
|
|
|
171,536 |
|
General and administrative |
|
2,052,996 |
|
|
|
3,323,352 |
|
|
|
6,999,358 |
|
|
|
6,316,411 |
|
Operating loss |
|
(1,651,273 |
) |
|
|
(3,022,339 |
) |
|
|
(5,690,225 |
) |
|
|
(5,041,290 |
) |
Other (expense) income: |
|
|
|
|
|
|
|
Financing charges |
|
- |
|
|
|
- |
|
|
|
(230,824 |
) |
|
|
(2,772 |
) |
Interest expense, net |
|
(64,676 |
) |
|
|
(100,525 |
) |
|
|
(171,934 |
) |
|
|
(451,766 |
) |
Change in fair value of warrant liability |
|
(6,726 |
) |
|
|
592,853 |
|
|
|
(8,434 |
) |
|
|
791,610 |
|
Change in fair value of derivative financial instruments |
|
- |
|
|
|
6,394 |
|
|
|
- |
|
|
|
198,551 |
|
Amortization of debt discount and issuance costs |
|
(40,888 |
) |
|
|
(1,331,030 |
) |
|
|
(126,387 |
) |
|
|
(4,881,622 |
) |
Extinguishment of debt liabilities |
|
- |
|
|
|
(4,779,069 |
) |
|
|
- |
|
|
|
(3,649,571 |
) |
Other income |
|
17,072 |
|
|
|
9,931 |
|
|
|
20,032 |
|
|
|
11,483 |
|
Other expense |
|
(8,743 |
) |
|
|
(1,578 |
) |
|
|
(585,824 |
) |
|
|
(9,008 |
) |
Total other (expense) income, net |
|
(103,961 |
) |
|
|
(5,603,024 |
) |
|
|
(1,103,371 |
) |
|
|
(7,993,095 |
) |
Net loss |
$ |
(1,755,234 |
) |
|
$ |
(8,625,363 |
) |
|
$ |
(6,793,596 |
) |
|
$ |
(13,034,385 |
) |
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