NeuroMetrix Reports Q2 2023 Business Highlights
27 Julho 2023 - 8:00AM
NeuroMetrix, Inc. (Nasdaq: NURO) today reported business and
financial highlights for the quarter and six months period ended
June 30, 2023. The Company's mission is to reduce the impact of
neurological disorders and pain syndromes through innovative
non-invasive medical devices.
"We have taken an important step to expand the availability of
Quell® Fibromyalgia in key U.S. markets,” said Shai N. Gozani,
M.D., Ph.D., Chief Executive Officer of NeuroMetrix. “This follows
positive evidence of physician and patient traction from our
strategic launch this year. Also, we were encouraged by recently
reported results from a phase 2 randomized controlled trial (RCT)
of Quell in chemotherapy induced peripheral neuropathy (CIPN),
which may help address a large unmet need. We are finalizing our
CIPN regulatory strategy. These developments highlight the growth
opportunities for our Quell prescription neurotherapeutics
portfolio.”
Dr. Gozani continued, “We believe that there remains an
attractive growth opportunity for DPNCheck® despite the recent
instability in the Medicare Advantage market created by changes in
risk-adjustment announced by the Centers for Medicare and Medicaid
Services (CMS) earlier this year. We will continue to develop the
DPNCheck market through a patient and flexible strategy that
carefully deploys resources in line with emerging
opportunities.”
Recent Business Highlights:
- The Company reported positive results from its strategic launch
of Quell Fibromyalgia. There were 123 unique prescribers during Q2
compared to 92 during Q1. The cumulative number of Quell
Fibromyalgia prescriptions that have been written increased to 490
in Q2 from 234 in Q1, with approximately 60% of prescriptions
filled by patients. The cumulative number of month-refills
increased to 348 in Q2 from 141 in Q1.
- In light of the encouraging early Quell Fibromyalgia
experience, the Company announced a sales force expansion to drive
further adoption. The next stage of the commercialization process
will focus on the Texas, California and Florida markets.
- The University of Rochester School of Medicine and Dentistry
reported results of an NIH-funded multi-center randomized
sham-controlled trial of Quell for CIPN. Subjects with moderate to
severe CIPN symptoms of hot/burning pain, sharp/shooting pain or
muscle cramping experienced about a 50% reduction in symptoms for
active Quell treatment compared to about 30% for sham Quell
treatment. The Company expects to make a 510(k) filing with
the FDA in Q4 of this year. The use of Quell for moderate to severe
CIPN received a FDA breakthrough designation in January 2022.
- Several Quell clinical trials are active and enrolling,
including for fibromyalgia-like long COVID, chronic overlapping
pain conditions (COPC) and peripheral edema. These indications
represent potential new or expanded labels for the Quell
prescription neurotherapeutics platform.
- The University of Sheffield diabetes research group reported
results of a prospective study of abnormal sural nerve function,
detected using DPNCheck and a complimentary technology, which
predicts all-cause mortality in type 2 diabetes, even after
adjusting for cardiovascular and other risk factors. Hence,
early-stage diagnosis using DPNCheck is vital to identifying the
risk of potentially devastating health complications.
- Two large recently published clinical studies support the
clinical utility of DPNCheck in screening people with diabetes. Ke
and colleagues developed an algorithm to predict progression to
vision threatening diabetic retinopathy based on DPNCheck testing.
Fukuda and colleagues analyzed the correlation of diabetic
peripheral neuropathy to kidney function and found that DPNCheck
test results were an independent predictor of kidney disease.
Financial Results:
Financial results in Q2 2023 were in line with the Company’s
expectations. This follows the Q1 2023 disruption to the Medicare
Advantage market by CMS with its changes to Risk Adjustment Data
Validation (RADV) and to risk adjustment calculations. Revenue in
Q2 2023 of $1.7 million was lower by $0.5 million or 23% from Q2
2022 primarily due to reduced sales volume for DPNCheck in the
Medicare Advantage market. The gross margin rate of 68% in Q2 2023
was flat with Q2 2022. Operating expenses of $2.7 million were
approximately level with the prior year quarter. The Q2 2023 net
loss was $1.5 million ($0.19 per share) versus a net loss of $1.2
million ($0.17 per share) in Q2 2022.
Revenues in H1 2023 of $3.4 million were lower by $1.1 million
or 24% from H1 2022. Net loss of $3.1 million or ($0.40) per share
in H1 2023 increased from $2.1 million or ($0.30) per share in H1
2022.
The Company ended the period with $19.6 million in cash and
securities.
Company to Host Live Conference Call and
Webcast
NeuroMetrix will host a conference call at 8:00 a.m. Eastern
today, July 27, 2023. Participants who wish to access the call live
via telephone and be able to ask questions must register in advance
here. Upon registering, a dial-in and unique PIN will be provided
on screen and via email to join the call. An audio-only webcast of
the call may be accessed in the “Investors Relations” section of
the Company’s website at www.NeuroMetrix.com. A replay of the call
will be available for one year on the Company's website under the
"Investor Relations" tab.
About NeuroMetrix
NeuroMetrix is a commercial stage healthcare company that
develops and commercializes neurotechnology devices to address
unmet needs in the chronic pain and diabetes markets. The Company's
products are wearable or hand-held medical devices enabled by
proprietary consumables and software solutions that include mobile
apps, enterprise software and cloud-based systems. The Company has
two commercial brands. Quell® is a wearable neuromodulation
platform. DPNCheck® is a point-of-care screening test for
peripheral neuropathy. For more information, visit
www.neurometrix.com.
Safe Harbor Statement
The statements contained in this press release include
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, including, without
limitation, statements regarding the company’s or management’s
expectations regarding the business, as well as events that could
have a meaningful impact on the company’s revenues and cash
resources. While the company believes the forward-looking
statements contained in this press release are accurate, there are
a number of factors that could cause actual events or results to
differ materially from those indicated by such forward-looking
statements, including, without limitation, estimates of future
performance, and the ability to successfully develop, receive
regulatory clearance, commercialize and achieve market acceptance
for any products. There can be no assurance that future
developments will be those that the company has anticipated. Such
forward-looking statements involve known and unknown risks,
uncertainties and other factors including those risks,
uncertainties and factors referred to in the company’s most recent
Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, as well
as other documents that may be filed from time to time with the
Securities and Exchange Commission or otherwise made public. The
company is providing the information in this press release only as
of the date hereof, and expressly disclaims any intent or
obligation to update the information included in this press release
or revise any forward-looking statements.
Source: NeuroMetrix, Inc.
Thomas T. HigginsSVP and Chief Financial
Officerneurometrix.ir@neurometrix.com
NeuroMetrix, Inc.Statements of
Operations(Unaudited) |
|
|
|
|
|
Quarters Ended June 30, |
|
Six Months Ended June 30, |
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
Revenues |
$ |
1,655,744 |
|
|
$ |
2,138,301 |
|
|
$ |
3,380,515 |
|
|
$ |
4,440,692 |
|
|
|
|
|
|
|
|
|
Cost of revenues |
536,486 |
|
|
686,121 |
|
|
1,062,858 |
|
|
1,194,995 |
|
|
|
|
|
|
|
|
|
Gross profit |
1,119,258 |
|
|
1,452,180 |
|
|
2,317,657 |
|
|
3,245,697 |
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
Research and development |
753,509 |
|
|
915,799 |
|
|
1,452,934 |
|
|
1,626,376 |
|
Sales and marketing |
744,963 |
|
|
566,598 |
|
|
1,560,835 |
|
|
1,425,437 |
|
General and administrative |
1,244,241 |
|
|
1,180,101 |
|
|
2,637,412 |
|
|
2,366,192 |
|
|
|
|
|
|
|
|
|
Total operating expenses |
2,742,713 |
|
|
2,662,498 |
|
|
5,651,181 |
|
|
5,418,005 |
|
|
|
|
|
|
|
|
|
Loss from operations |
(1,623,455 |
) |
|
(1,210,318 |
) |
|
(3,333,524 |
) |
|
(2,172,308 |
) |
|
|
|
|
|
|
|
|
Other income |
86,426 |
|
|
50,395 |
|
|
222,321 |
|
|
53,823 |
|
|
|
|
|
|
|
|
|
Net loss |
$ |
(1,537,029 |
) |
|
$ |
(1,159,923 |
) |
|
$ |
(3,111,203 |
) |
|
$ |
(2,118,485 |
) |
NeuroMetrix, Inc.Condensed Balance
Sheets(Unaudited) |
|
|
|
June 30,2023 |
|
|
December 31,2022 |
|
|
|
|
|
|
|
|
Cash, cash equivalents and securities |
|
$ |
19,627,209 |
|
|
$ |
21,199,727 |
|
Other current assets |
|
|
2,662,197 |
|
|
|
2,907,260 |
|
Noncurrent assets |
|
|
484,097 |
|
|
|
562,628 |
|
Total assets |
|
$ |
22,773,503 |
|
|
$ |
24,669,615 |
|
|
|
|
|
|
|
|
|
|
Current liabilities |
|
$ |
1,209,929 |
|
|
$ |
1,106,412 |
|
Lease obligation, net of
current portion |
|
|
152,143 |
|
|
|
207,516 |
|
Stockholders’ equity |
|
|
21,411,431 |
|
|
|
23,355,687 |
|
Total liabilities and stockholders’ equity |
|
$ |
22,773,503 |
|
|
$ |
24,669,615 |
|
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