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NeuroMetrix Reports Q2 2024 Business Highlights and Update on Review of Strategic Options

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NeuroMetrix reported Q2 2024 financial results and business highlights. Key points include:

1. Quell revenue increased 47% to $192,000, driven by growth in the fibromyalgia indication.

2. DPNCheck revenue declined 62% to $536,000 due to Medicare Advantage changes.

3. The company is proceeding with a De Novo submission for a chemotherapy-induced peripheral neuropathy indication for Quell technology.

4. Q2 2024 net loss was $1.5 million ($0.74 per share) compared to $1.5 million ($1.56 per share) in Q2 2023.

5. The company continues its strategic review process to enhance shareholder value, including exploring asset monetization and reducing operating expenses.

NeuroMetrix ha riportato i risultati finanziari e i punti salienti aziendali del secondo trimestre del 2024. I punti chiave includono:

1. I ricavi di Quell sono aumentati del 47% raggiungendo $192.000, grazie alla crescita nell'indicazione della fibromialgia.

2. I ricavi di DPNCheck sono diminuiti del 62%, scendendo a $536.000, a causa delle modifiche al Medicare Advantage.

3. L'azienda sta procedendo con una sottomissione De Novo per un'indicazione di neuropatia periferica indotta da chemioterapia per la tecnologia Quell.

4. La perdita netta del secondo trimestre 2024 è stata di $1,5 milioni ($0,74 per azione) rispetto ai $1,5 milioni ($1,56 per azione) del secondo trimestre 2023.

5. L'azienda continua il suo processo di revisione strategica per aumentare il valore per gli azionisti, inclusa l'esplorazione della monetizzazione degli asset e la riduzione delle spese operative.

NeuroMetrix reportó los resultados financieros y los aspectos destacados del negocio del segundo trimestre de 2024. Los puntos clave incluyen:

1. Los ingresos de Quell aumentaron un 47% a $192,000, impulsados por el crecimiento en la indicación de fibromialgia.

2. Los ingresos de DPNCheck cayeron un 62% a $536,000 debido a cambios en Medicare Advantage.

3. La empresa está avanzando con una presentación De Novo para una indicación de neuropatía periférica inducida por quimioterapia para la tecnología Quell.

4. La pérdida neta del segundo trimestre de 2024 fue de $1.5 millones ($0.74 por acción) en comparación con $1.5 millones ($1.56 por acción) en el segundo trimestre de 2023.

5. La empresa continúa su proceso de revisión estratégica para aumentar el valor para los accionistas, explorando la monetización de activos y reduciendo los gastos operativos.

NeuroMetrix는 2024년 2분기 재무 성과 및 비즈니스 하이라이트를 보고했습니다. 주요 사항은 다음과 같습니다:

1. Quell 매출은 섬유근육통 지표의 성장에 힘입어 47% 증가하여 192,000달러에 달했습니다.

2. DPNCheck 매출은 Medicare Advantage 변화로 인해 62% 감소하여 536,000달러에 이르렀습니다.

3. 회사는 Quell 기술에 대한 화학요법 유발 말초신경병증 지표를 위한 De Novo 제출을 진행하고 있습니다.

4. 2024년 2분기 순손실은 150만 달러($0.74 per share)로, 2023년 2분기의 150만 달러($1.56 per share)와 동일합니다.

5. 회사는 자산 수익화를 탐색하고 운영 비용을 줄이는 등 주주 가치를 높이기 위한 전략적 검토 과정을 계속하고 있습니다.

NeuroMetrix a publié les résultats financiers et les points saillants commerciaux du deuxième trimestre 2024. Les principaux points incluent :

1. Les revenus de Quell ont augmenté de 47 % pour atteindre 192 000 dollars, grâce à la croissance de l'indication de fibromyalgie.

2. Les revenus de DPNCheck ont diminué de 62 % pour s'établir à 536 000 dollars en raison des changements apportés à Medicare Advantage.

3. L'entreprise poursuit une demande De Novo pour une indication de neuropathie périphérique induite par chimiothérapie pour la technologie Quell.

4. La perte nette au deuxième trimestre 2024 s'élevait à 1,5 million de dollars (0,74 dollar par action), contre 1,5 million de dollars (1,56 dollar par action) au deuxième trimestre 2023.

5. L'entreprise poursuit son processus de révision stratégique pour accroître la valeur pour les actionnaires, en explorant la monétisation des actifs et la réduction des dépenses opérationnelles.

NeuroMetrix hat die finanziellen Ergebnisse und Geschäftshighlights des zweiten Quartals 2024 veröffentlicht. Die wichtigsten Punkte sind:

1. Der Umsatz von Quell stieg um 47% auf 192.000 USD, was auf das Wachstum im Bereich der Fibromyalgie zurückzuführen ist.

2. Der Umsatz von DPNCheck ging um 62% auf 536.000 USD zurück, bedingt durch Veränderungen bei Medicare Advantage.

3. Das Unternehmen geht mit einem De Novo-Antrag für einen chemotherapy-induzierten peripheren Neuropathie-Indikator für die Quell-Technologie vor.

4. Der Nettoverlust im zweiten Quartal 2024 betrug 1,5 Millionen USD (0,74 USD pro Aktie), verglichen mit 1,5 Millionen USD (1,56 USD pro Aktie) im zweiten Quartal 2023.

5. Das Unternehmen setzt seinen strategischen Überprüfungsprozess fort, um den Shareholder-Wert zu steigern, einschließlich der Erkundung von Vermögensmonetarisierung und der Reduzierung der Betriebskosten.

Positive
  • Quell revenue increased by 47% to $192,000 in Q2 2024
  • Quell starter kit sales grew by 165% from Q2 2023
  • Company plans to restart Quell OTC sales in Q4 2024
  • De Novo submission for CIPN indication expected in Q4 2024
  • Operating expenses decreased by $0.4 million compared to Q2 2023
Negative
  • DPNCheck revenue declined by 62% to $536,000 in Q2 2024
  • Overall revenue decreased by 54% to $0.8 million in Q2 2024
  • Gross margin rate declined from 68% in Q2 2023 to 64% in Q2 2024
  • Net loss for H1 2024 increased to $4.5 million from $3.1 million in H1 2023
  • Company implemented a substantial reduction-in-force to lower operating expenses

Insights

NeuroMetrix's Q2 2024 results reveal significant challenges. Revenue dropped 54% to $0.8 million, primarily due to a 62% decline in DPNCheck sales. This was largely attributed to changes in Medicare Advantage risk-adjustment compensation. The company's gross margin decreased to 64% from 68% year-over-year.

Despite a $0.4 million reduction in operating expenses, NeuroMetrix reported a net loss of $1.5 million ($0.74 per share). The company's cash burn remains a concern, although efforts to monetize assets and reduce expenses are underway. The 47% increase in Quell revenue to $192,000 is a positive sign, but it's not yet sufficient to offset the DPNCheck decline.

The ongoing strategic review and potential De Novo submission for a CIPN indication could provide future catalysts, but near-term financial pressures persist.

NeuroMetrix's Q2 results highlight the challenges in the medical device market, particularly in the Medicare Advantage sector. The significant decline in DPNCheck sales underscores the impact of regulatory changes on product viability. However, the company's pivot towards new markets and indications shows adaptability.

The growth in Quell Fibromyalgia sales and planned restart of OTC sales indicate potential in the pain management sector. The 165% increase in Quell starter kit sales suggests growing adoption, although the base is still small. The planned De Novo submission for CIPN could open a new market in oncology, potentially diversifying revenue streams.

NeuroMetrix's strategy to expand beyond Medicare Advantage for DPNCheck and its international approvals (e.g., Health Canada) demonstrate efforts to mitigate market risks. However, the company needs to accelerate these initiatives to offset the rapid decline in its core business.

The Q2 2024 results for NeuroMetrix highlight the profound impact of healthcare policy changes on medical device companies. The CMS phase-out of risk-adjustment compensation for patient screening in Medicare Advantage has significantly affected DPNCheck sales, demonstrating the vulnerability of business models heavily reliant on specific reimbursement structures.

NeuroMetrix's pivot towards direct-to-patient telemedicine and exploration of VA reimbursement channels for Quell Fibromyalgia shows adaptability to the changing healthcare landscape. The potential De Novo submission for CIPN aligns with the trend towards more specialized, indication-specific devices.

However, the company's challenges underscore the need for diversified revenue streams and a robust pipeline of products at various stages of regulatory approval. The ongoing strategic review suggests that NeuroMetrix recognizes the need for significant changes to navigate the evolving healthcare policy environment effectively.

WOBURN, Mass., Aug. 06, 2024 (GLOBE NEWSWIRE) -- NeuroMetrix, Inc. (Nasdaq: NURO) today reported financial and business highlights for the quarter and six months ended June 30, 2024. The Company's mission is to reduce the impact of neurological disorders and pain syndromes through innovative non-invasive medical devices.

In February of this year, the Company announced that it had initiated a review of strategic options with an objective of enhancing shareholder value. Over the past six months, the Company has invested considerable effort in evaluating a number of specific strategic directions and also making financial, operational and commercial optimizations.

  • In collaboration with a financial advisor, the Company conducted an extensive survey of potential transactions. Detailed diligence was performed on multiple opportunities; however, the Company determined that none of these opportunities were in the best interests of its shareholders at this time.
  • The Company implemented a substantial reduction-in-force at the end of Q1 to lower operating expenses by over $0.5M per quarter.
  • The Company has been exploring opportunities to monetize certain assets to offset operating cash consumption. Particular attention has been placed on international markets that are not central to the Company's domestic sales focus.
  • The Company engaged in discussions with one of its largest shareholders that led to the addition of Joshua S. Horowitz as a new independent director and termination of its at-the-market (ATM) equity facility in April 2024.

The Company believes it is in the best interests of shareholders that the strategic review process continues. There can be no assurance that this process will result in the Company pursuing or consummating any particular transaction or other strategic outcome. The Company has not set a timetable for completion of this evaluation process and may not disclose further developments unless disclosure is appropriate or necessary.

Business Highlights:

  • Quell® revenue increased by 47% to $192,000 in Q2 2024 from $131,000 in Q2 2023. Quell revenue includes sales of Quell Fibromyalgia (prescription) and Quell Relief (OTC). The increase was entirely from growth in the fibromyalgia indication, which offset a decrease in OTC revenue due to a commercial pause initiated in late 2022. The Company is planning to restart OTC sales in Q4 2024.
  • A total of 540 Quell starter kits (fibromyalgia and OTC) were sold and there were 3,682 1-month refills ordered, for both indications, in Q2 2024. This represented starter kit growth of 165% and refill growth of 13% from Q2 2023.
  • Following engagement with the FDA, the Company decided to proceed with a De Novo submission for a chemotherapy induced peripheral neuropathy (CIPN) indication for Quell technology. The filing is expected to be made in Q4 2024, which may enable a commercial launch into the oncology market as early as Q4 2025.
  • DPNCheck® revenue of $536,000 in Q2 2024 declined by $869,000 or 62% from Q2 2023. The primary DPNCheck market, Medicare Advantage (MA), is in the final year of the CMS phase-out of risk-adjustment compensation for many types of patient screening, including peripheral neuropathy. The resulting decline in domestic DPNCheck sales has not yet been offset by alternative markets that the Company is pursuing. International sales of DPNCheck also declined from the prior year quarter due to excess inventory at the Japan distributor. The Company believes this situation is transient, and these biosensor orders should resume later this year.
  • Several scientific abstracts demonstrating the diagnostic accuracy and positive clinical outcomes of DPNCheck in patients with diabetic peripheral neuropathy (DPN) were presented at the Japanese Diabetes Society meeting in May 2024 and the American Diabetes Association Scientific Sessions in June 2024.
  • The Company received Health Canada approval to market DPNCheck 2.0, the latest generation of its point-of-care neurodiagnostic technology.
  • The Company implemented a wind down of its legacy ADVANCE® business, which has been managed for cash flow for the past 5 years. This will free up resources and reduce IT overhead that had become an operational burden relative to the product's declining financial contribution.

"Quell prescription and OTC indications represent a substantial growth opportunity. The deliberate and strategic launch of Quell Fibromyalgia has provided valuable market insight and clarified tactics. Our initial approach of direct-to-physician promotion has now been broadened with a direct-to-patient telemedicine option. In addition, our original patient cash-pay approach is now complemented by a reimbursed Veterans Administration (VA) channel. We are also planning to reactivate our OTC business for lower extremity chronic pain. These steps should lead to continued top line growth with steadily improving gross and operating margins," said Shai N. Gozani, M.D., Ph.D., Chairman and CEO of NeuroMetrix. "In addition, our efforts to expand beyond Medicare Advantage and return the DPNCheck business to growth continue. We are optimistic about several opportunities and hope to have meaningful updates later this year."

Financial Results:

Revenue in Q2 2024 of $0.8 million was lower by $0.9 million or 54% from Q2 2023. The decline in revenue was attributable to the DPNCheck product line which contracted by $0.9 million or 62%, primarily due to changes in Medicare Advantage risk-adjustment compensation. The gross margin rate of 64% in Q2 2024 declined from 68% in Q2 2023 due primarily to an unfavorable shift in product mix and lower production volumes. Operating expenses were $2.3 million in Q2 2024, a decrease of $0.4 million from the comparable period in 2023. Reduced personnel costs, partially offset by professional service fees associated with the strategic review, contributed to lower operating expenses. The Q2 2024 net loss was $1.5 million ($0.74 per share). This compares to a net loss of $1.5 million or ($1.56 per share) in Q2 2023. Shares outstanding were approximately 2.0 million at the end of Q2 2024 and 1.0 million at the end of Q2 2023.

Revenues in H1 2024 of $1.9 million were lower by $1.5 million or 45% from H1 2023. Net loss of $4.5 million or ($2.37) per share in H1 2024 increased from $3.1 million or ($3.20) per share in H1 2023.

Company to Host Live Conference Call and Webcast

NeuroMetrix will host a conference call at 8:00 a.m. Eastern today, August 6, 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 June 30, Six Months Ended June 30,
 2024 2023 2024 2023
        
Revenues$769,148  $1,655,744  $1,862,704  $3,380,515 
        
Cost of revenues277,229  536,486  853,768  1,062,858 
        
Gross profit491,919  1,119,258  1,008,936  2,317,657 
        
Operating expenses:       
Research and development266,932  753,509  1,210,484  1,452,934 
Sales and marketing435,014  744,963  1,496,743  1,560,835 
General and administrative1,618,628  1,244,241  3,384,355  2,637,412 
        
Total operating expenses2,320,574  2,742,713  6,091,582  5,651,181 
        
Loss from operations(1,828,655) (1,623,455) (5,082,646) (3,333,524)
        
Other income340,723  86,426  565,140  222,321 
        
Net loss$(1,487,932) $(1,537,029) $(4,517,506) $(3,111,203)


NeuroMetrix, Inc.
Condensed Balance Sheets
(Unaudited)
 
  June 30,
2024
 December 31,
2023
     
Cash, cash equivalents and securities $16,429,956 $17,997,151
Other current assets  2,046,633  2,857,291
Noncurrent assets  453,194  569,999
Total assets $18,929,783 $21,424,441
       
Current liabilities $1,589,750 $1,240,639
Lease obligation, net of current portion  28,210  92,485
Stockholders’ equity  17,311,823  20,091,317
Total liabilities and stockholders’ equity $18,929,783 $21,424,441

FAQ

What was NeuroMetrix's (NURO) revenue for Q2 2024?

NeuroMetrix's revenue for Q2 2024 was $0.8 million, which was 54% lower than Q2 2023.

How did Quell sales perform for NeuroMetrix (NURO) in Q2 2024?

Quell revenue increased by 47% to $192,000 in Q2 2024 compared to $131,000 in Q2 2023, driven by growth in the fibromyalgia indication.

What was NeuroMetrix's (NURO) net loss for Q2 2024?

NeuroMetrix reported a net loss of $1.5 million ($0.74 per share) for Q2 2024.

When does NeuroMetrix (NURO) plan to submit the De Novo application for Quell's CIPN indication?

NeuroMetrix plans to submit the De Novo application for Quell's chemotherapy-induced peripheral neuropathy (CIPN) indication in Q4 2024.

How did DPNCheck sales perform for NeuroMetrix (NURO) in Q2 2024?

DPNCheck revenue declined by 62% to $536,000 in Q2 2024 compared to Q2 2023, primarily due to changes in Medicare Advantage risk-adjustment compensation.

NeuroMetrix, Inc.

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