NeuroMetrix Reports Q4 and Full Year 2023 Business Highlights
- Quell Fibromyalgia demonstrated solid growth and increasing market traction in Q4 2023.
- The company filed a premarket notification with the FDA for marketing Quell for chemotherapy induced peripheral neuropathy.
- The company reported encouraging results from a pilot clinical trial of Quell in post-acute COVID-19 Syndrome.
- Quell received FDA breakthrough device designation for chemotherapy induced peripheral neuropathy in January 2022.
- Pressure on the DPNCheck market due to changes in CMS regulations poses a challenge.
The disclosed financial and operational metrics for NeuroMetrix, Inc. indicate a significant uptick in the adoption of Quell® Fibromyalgia, as evidenced by the increases in unique prescribers and prescriptions. The strategic expansion of their sales force and the introduction of telemedicine services are likely contributors to this growth. The prescription fill rate of approximately 60% is noteworthy; however, it may also suggest room for improvement in market penetration or patient adherence. The impact on the stock market will depend on investor perception of the company's growth trajectory and its ability to navigate reimbursement changes. The discontinuation of CMS compensation for peripheral neuropathy screening could pose a risk to future revenue streams, particularly for their DPNCheck® product.
NeuroMetrix's progress in obtaining FDA breakthrough device designation for Quell in treating chemotherapy induced peripheral neuropathy (CIPN) and the subsequent filing of a premarket notification represent significant milestones. CIPN is a common and debilitating side effect of chemotherapy and the lack of effective treatments makes this a substantial unmet medical need. The potential market expansion into this new indication could be transformative for the company. However, the actual impact will hinge on FDA approval and the effectiveness of the device in a larger population. The pilot clinical trial results for Quell in treating post-acute COVID-19 Syndrome (Long COVID) also open new avenues for the company's growth, though the long-term implications will depend on the robustness of the clinical data and the prevalence of Long COVID as a chronic condition.
Understanding the broader healthcare landscape is crucial when evaluating NeuroMetrix's strategic moves. The addition of field business development managers and direct-to-physician sales channels are indicative of a more aggressive market penetration strategy. However, the looming changes in CMS risk adjustment and the discontinuation of certain CMS compensations present a challenging environment for the Medicare Advantage market, which is a key customer base for their DPNCheck® product. Stakeholders should monitor how the company adapts to these changes and seeks opportunities outside of Medicare Advantage to mitigate potential revenue losses. Additionally, the company's ability to leverage the FDA's breakthrough device designation and navigate the regulatory pathway efficiently will be critical to its long-term success and impact on the stock market.
WOBURN, Mass., Feb. 22, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter and full year ended December 31, 2023. The Company's mission is to reduce the impact of neurological disorders and pain syndromes through innovative non-invasive medical devices.
"Quell® Fibromyalgia growth accelerated in Q4 2023 reflecting the addition in Q3 2023 of two field business development managers and optimized clinical messaging. We also introduced direct-to-patient telemedicine capabilities, direct to physician sales, and reimbursement at select Veterans Administration (VA) facilities,” said Shai N. Gozani, M.D., Ph.D., Chief Executive Officer of NeuroMetrix. “Also, during Q4 2023 we achieved our goal of filing a premarket notification (510(k)) with the FDA to market Quell for chemotherapy induced peripheral neuropathy (CIPN). Quell received FDA breakthrough device designation for this indication in January 2022.”
Dr. Gozani continued, “Our primary DPNCheck® market, Medicare Advantage (MA) is under pressure as changes to risk adjustment implemented by the Centers for Medicare and Medicaid Services (CMS) in 2023 continue to impact our customers. Compensation by CMS for patient screening for a variety of diseases, including peripheral neuropathy, will be discontinued in 2025. This is a challenging environment; however, we continue to support our existing accounts and explore opportunities outside MA.”
Business Highlights:
- Quell Fibromyalgia demonstrated solid growth and increasing market traction during Q4 2023. In the successive quarters of Q4 2023 versus Q3 2023, all key operating metrics showed substantial growth. In Q4 there were 199 unique prescribers (
59% increase), 583 prescriptions were written (123% increase) and there were 525 refill months (73% increase). The prescription fill rate was approximately60% . - On December 12, 2023, the Company reported encouraging results from a pilot clinical trial of Quell in post-acute COVID-19 Syndrome (Long COVID). The trial was conducted by the Baylor College of Medicine. According to the Centers for Disease Control and Prevention (CDC), about ten million Americans have Long COVID and it may affect 10
-20% of individuals who had COVID-19. - On November 21, 2023, the Company successfully executed a reverse split of its common stock in the ratio of 1:8 to increase the trading price of its common stock and to comply with the minimum bid requirements for continued listing on Nasdaq.
- Common stock sales under the Company’s ATM facility during Q4 2023 were approximately
$1.9 million , net. Funding from common stock sales will help offset future operating expenses, including the potential expansion of Quell marketing efforts. The Company ended the quarter with$18M in cash and securities. - Dr. Gozani updated investors on business strategy at the Emerging Growth Conferences in November 2023 and January 2024. Links to the presentations are located on the Company’s website.
- The Company announced an initiative to review strategic options to promote growth and maximize shareholder value. Ladenburg Thalmann was retained as financial advisor to the Company to assist in the process.
Financial Results:
Financial results in Q4 and for the full year 2023 reflect the adverse effects on DPNCheck, the Company’s primary product line, of CMS risk-adjustment reimbursement changes in the MA market which were initiated in Q1 2023. Revenue in Q4 2023 of
Revenues in the twelve months ended December 31, 2023 were
Company to Host Live Conference Call and Webcast
NeuroMetrix will host a conference call at 8:00 a.m. Eastern today, February 22, 2024. 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. Higgins
SVP and Chief Financial Officer
neurometrix.ir@neurometrix.com
| NeuroMetrix, Inc. | |||||||||||||||
| Statements of Operations | |||||||||||||||
| (Unaudited) | |||||||||||||||
| Quarters Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
| 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Revenues | $ | 1,317,746 | $ | 1,847,378 | $ | 5,901,425 | $ | 8,256,073 | |||||||
| Cost of revenues | 469,772 | 617,267 | 1,954,012 | 2,505,833 | |||||||||||
| Gross profit | 847,974 | 1,230,111 | 3,947,413 | 5,750,240 | |||||||||||
| Operating expenses: | |||||||||||||||
| Research and development | 732,372 | 538,395 | 2,777,960 | 3,239,725 | |||||||||||
| Sales and marketing | 860,635 | 629,969 | 3,365,265 | 2,865,615 | |||||||||||
| General and administrative | 1,112,066 | 918,214 | 4,955,709 | 4,386,666 | |||||||||||
| Total operating expenses | 2,705,073 | 2,086,578 | 11,098,934 | 10,492,006 | |||||||||||
| Loss from operations | (1,857,099 | ) | (856,467 | ) | (7,151,521 | ) | (4,741,766 | ) | |||||||
| Other income | 207,552 | 164,597 | 622,034 | 325,157 | |||||||||||
| Net loss | $ | (1,649,547 | ) | $ | (691,870 | ) | $ | (6,529,487 | ) | $ | (4,416,609 | ) | |||
| NeuroMetrix, Inc. | ||||||||
| Condensed Balance Sheets | ||||||||
| (Unaudited) | ||||||||
| December 31, 2023 | December 31, 2022 | |||||||
| Cash, cash equivalents and securities | $ | 17,997,151 | $ | 21,199,727 | ||||
| Other current assets | 2,857,291 | 2,907,260 | ||||||
| Noncurrent assets | 569,999 | 562,628 | ||||||
| Total assets | $ | 21,424,441 | $ | 24,669,615 | ||||
| Current liabilities | $ | 1,240,639 | $ | 1,106,412 | ||||
| Lease Obligation, net of current portion | 92,485 | 207,516 | ||||||
| Stockholders’ equity | 20,091,317 | 23,355,687 | ||||||
| Total liabilities and stockholders’ equity | $ | 21,424,441 | $ | 24,669,615 | ||||
