UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 04-3308180 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) FORM 10-K _____________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission ...

NeuroMetrix, Inc. (NASDAQ:NURO) Q4 2021 Earnings Conference Call January 27, 2022 8:00 AM ET Company Participants Thomas Higgins - Senior Vice President and Chief Financial Officer Dr. Shai Gozani - President and Chief Executive Officer Conference Call Participants Disclaimer*: This transcript is designed to be used alongside the freely available audio recording on this page. Timestamps within the transcript are designed to help you navigate the audio should the corresponding text be unclear. The machine-as ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2021 OR NEUROMETRIX, INC. (Exact name of registrant as specified in its charter) Delaware 04-3308180 (State or other jurisdiction of (I.R.S. Employer Identification No.) incorporation or organization) 4B Gill Street Woburn, Massachusetts 01801 (Address of principal executive offices) ...

Financial Data and Key Metrics Changes - Revenue for Q3 2021 was $2.1 million, a slight increase of 1% from Q3 2020 [7] - Gross profit was $1.4 million, with a gross profit margin of 70%, down from 73.6% in Q3 2020, attributed to unfavorable purchase price variances due to global parts shortages [8] - Net loss for the quarter was $687,000, compared to a net loss of $257,000 in Q3 2020, reflecting margin contraction and increased operating expenses [10] - Operating expenses totaled $2.1 million, an increase of $376,000 from Q3 2020 [9] - Cash on hand at the end of the quarter was $23.2 million, with stockholders' equity of $24.2 million [11] Business Line Data and Key Metrics Changes - DPNCheck, the diagnostic for peripheral neuropathy, contributed the majority of sales and grew 7% year-on-year, primarily in the US Medicare Advantage market [7] - Sales of ADVANCE electrodes showed slight year-on-year growth, while Quell revenue declined due to reduced promotional spending [7] Market Data and Key Metrics Changes - DPNCheck saw growth in Asia, particularly in Japan and China, in consumables biosensors [7] - The company is focusing on expanding DPNCheck in Medicare Advantage and other value-based markets [16] Company Strategy and Development Direction - The company plans to launch a second-generation DPNCheck device in the US in Q1 2022, which is expected to enhance adoption in Medicare Advantage [15] - The Quell platform is expanding into prescription treatments for specific pain syndromes, with a focus on fibromyalgia, for which the company received FDA breakthrough designation [17] - The company is also involved in a trial for Quell in patients with chemotherapy-induced peripheral neuropathy (CIPN), with results expected in the second half of next year [18] Management's Comments on Operating Environment and Future Outlook - Management highlighted challenges in sourcing critical parts and components, with no expected resolution in the near term, leading to anticipated further margin contraction [8] - The company has completed a recapitalization process and now has adequate capital to invest in new opportunities [12][13] Other Important Information - The company announced the addition of Su Bell to the management team to enhance growth in DPNCheck within value-based care markets [16] - The company is debt-free and has a clean capital structure, focusing on operational efficiency and novel product development [12][19] Q&A Session Summary - No questions were raised during the Q&A session, and the call concluded with management expressing appreciation for participation and anticipation for future updates [21][22]

NeuroMetrix, Inc. (NASDAQ:NURO) Q2 2021 Results Conference Call July 22, 2021 8:00 AM ET Company Participants Thomas Higgins - Senior Vice President & Chief Financial Officer Dr. Shai Gozani - President & Chief Executive Officer Conference Call Participants Jerry Noury - Little West 12th Street Operator Good morning and welcome to the NeuroMetrix First Quarter 2021 Earnings Call. My name is Michelle and I will be your moderator on the call. On this call, the Company may make statements which are not histori ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2021 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____ to ____ Commission File Number 001-33351 _________________________________________________ NEUROMETRIX, INC. (Exact name of registrant as specified in its ...

Financial Performance - Revenues for the first quarter of 2021 were approximately $2.2 million, a decrease of $16.5 thousand or 0.8% compared to the same period in 2020[54] - Gross profit increased to $1,579.2 thousand in Q1 2021, resulting in a gross margin of 73.3%, up from 71.4% in Q1 2020[55] - Total operating expenses decreased by 25.8% to $1,639.4 thousand in Q1 2021, primarily due to a significant reduction in research and development expenses[56] - Research and development expenses fell by 56.3% to $233.3 thousand, influenced by a reversal of a $450,000 technology fees accrual[57] - The company reported net cash used in operating activities of $33.8 thousand in Q1 2021, a significant improvement from $763.2 thousand in Q1 2020[65] Cash and Liquidity - Cash and cash equivalents were $5.1 million as of March 31, 2021, reflecting a decrease of $81.0 thousand from the previous quarter[62] - The company may need to raise additional funds to support operations in the second quarter of 2022 and beyond due to recurring losses and negative cash flows[66] - The company has an effective shelf registration statement on file with the SEC, allowing for potential future fundraising through the sale of common stock[67] Investment Strategy - The company has no derivative financial instruments or foreign exchange contracts in its investment portfolio[70] - The investment strategy focuses on preserving principal, maintaining liquidity for operating needs, and maximizing yields[70] - The company primarily invests in cash equivalents and short-term investments with a maturity of twelve months or less[70] - The average maturity of the company's investments is maintained at twelve months or less[70] - A hypothetical 10% change in interest rates is not expected to materially impact the fair value of the investment portfolio or interest income[70] Operational Efficiency - Days sales outstanding (DSO) increased to 17 days in Q1 2021 from 14 days in the prior year, indicating longer customer payment terms[63] - Inventory turnover rate improved to 2.3 turns in Q1 2021 compared to 2.1 turns in the prior year, driven by higher sales of unreserved inventory[64]

Financial Data and Key Metrics Changes - Q1 2021 revenue was $2.2 million, representing a 19% sequential growth from Q4 2020 and approximately flat revenue compared to Q1 2020 [6] - Gross profit was $1.6 million with a margin rate of 73.3%, an improvement of 190 basis points from the previous year [7] - Net loss for the quarter was approximately $60,000, significantly improved from a net loss of $657,000 in Q1 of the previous year [9] Business Line Data and Key Metrics Changes - DPNCheck was the lead revenue generator, with domestic Medicare Advantage sales increasing both sequentially and year-on-year [7] - ADVANCE sales also saw sequential and year-on-year growth due to higher volume and improved pricing [7] - Quell maintained a positive operating margin, with 60% of revenue coming from reusable components [32] Market Data and Key Metrics Changes - The Medicare Advantage market is growing at nearly 10% annually, providing a favorable environment for DPNCheck [21] - The global fibromyalgia treatment market is several billion dollars, with the U.S. representing a significant portion [15] Company Strategy and Development Direction - The company’s strategy focuses on R&D investment in DPNCheck and Quell technologies, transitioning to profitability, and establishing consistent top-line growth [10] - Upcoming product launches include a second-generation DPNCheck and a prescription treatment for fibromyalgia based on Quell technology, expected to launch by the end of 2022 [12][16] Management's Comments on Operating Environment and Future Outlook - Management expressed caution regarding the growth of the DPNCheck business and regulatory timelines for new products, indicating that the path to profitability may not be linear [20] - The company anticipates continued progress towards profitability in 2021, with a potential crossover in 2022 [19] Other Important Information - Operating expenses totaled $1.6 million, reduced by 26% from the previous year, aided by a one-time credit of $450,000 [8] - The company ended the quarter with $5.1 million in cash, sufficient to fund operations well into Q2 of the following year [9] Q&A Session Summary Question: Comment on management taking salary in stock - Management appreciated the support for the company and shareholders [27] Question: Revenue breakdown between DPN and Quell - Management indicated that DPNCheck is the dominant revenue source, while Quell operates at a lower level but is still profitable [31] Question: Revenue from reusable components in Quell - Approximately 60% of Quell's revenue comes from reusable components [32] Question: Opportunities for Quell in acute pain management - Management stated that while Quell technology could have utility in acute settings, the focus remains on chronic conditions [36] Question: Driving greater persistence with consumables - Management mentioned ongoing programs to enhance user engagement and retention through the mobile app [42] Question: Long-term benefits of Quell usage - Management noted that it typically takes two to three weeks for Quell to show effects for chronic pain conditions [48]

Financial Data and Key Metrics Changes - Q4 2020 revenues were $1.8 million, showing improvement compared to Q4 2019 [5] - Gross profit was $1.3 million, with a margin rate of 73.7%, up from 62% in Q4 2019, representing an 11.5 percentage point increase [6] - Operating expenses totaled $1.7 million, down 39% from Q4 2019, contributing to a reduced loss from operations of $326,000 compared to nearly $1.7 million in the prior year [6][10] - Full year 2020 revenues were $7.4 million, a decrease from $9.3 million in 2019, but gross profit margin improved to 71.2% from 24% in 2019 [9][10] - Net loss for 2020 was $2.1 million, an improvement of $1.7 million from the prior year [10] Business Line Data and Key Metrics Changes - DPNCheck showed year-on-year growth, while Medicare Advantage remained strong, offsetting weaknesses in international orders [5] - Advanced electrode sales were stable compared to the prior quarter and Q4 2019 [5] - Quell continued to contribute positively to operations with improved advertising efficiency [5] Market Data and Key Metrics Changes - The Quell Health Cloud now includes data from nearly 100,000 users, making it one of the largest chronic pain data repositories [18] - The company is targeting specific clinical indications for Quell, including chronic lower extremity musculoskeletal pain, fibromyalgia, chemotherapy-induced peripheral neuropathy, and restless leg syndrome, representing a market of up to 20 million individuals in the U.S. [19] Company Strategy and Development Direction - The company aims for near-term profitability while continuing product innovation for long-term growth [13][22] - A focus on establishing an efficient cost structure has led to lower operating expenses and improved gross margins [14] - The company is updating the DPNCheck platform and plans to file a 510(k) for Quell to treat fibromyalgia symptoms in Q3 2021 [16][20] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism for 2021, anticipating year-over-year improvement in net income despite uncertainties related to COVID-19 [15] - The company is committed to operational efficiency while supporting growth initiatives [22] Other Important Information - Cash at the end of 2020 was $5.2 million, sufficient to fund operations into 2022, with a debt-free capital structure [10][11] Q&A Session Summary Question: When will the company achieve operating profitability? - Management indicated they cannot provide specific targets due to uncertainties around COVID-19 but expect year-over-year improvement in net income [15] Question: What are the next steps for the Quell prescription business? - The company is working on regulatory strategies for fibromyalgia and chemotherapy-induced peripheral neuropathy, with updates expected in the second half of the year [21]

Market Opportunity and Product Demand - The annual direct cost of treating diabetes in the United States exceeds $100 billion, with peripheral neuropathy affecting over 50% of the diabetic population [15]. - Chronic pain affects nearly 100 million adults in the United States, with an estimated incremental impact on healthcare costs exceeding $250 billion per year [18]. - The U.S. market for pain relief products exceeds $4 billion annually, indicating a significant opportunity for the company's offerings [46]. - The market for chronic pain management is substantial, with estimated annual costs exceeding $250 billion in the U.S. alone, highlighting the potential for the company's products [170]. - The company is targeting the Medicare Advantage managed care market segment for DPNCheck sales, emphasizing the clinical and economic benefits of its testing [59]. Product Development and Innovation - NeuroMetrix's DPNCheck technology has posted average growth rates exceeding 25% over the five years through 2018, with a rebound expected in 2021 as pandemic effects ease [21]. - NeuroMetrix's R&D efforts in 2021 include the launch of the DPNCheck Generation 2 product and continued innovation of the Quell platform [24]. - The DPNCheck device has been on the market since 2011, and the company plans to enhance its features to improve user experience and manufacturing processes during 2021 [47]. - The company’s DPNCheck technology provides a rapid, low-cost test for peripheral neuropathies, validated in numerous clinical studies, addressing a critical medical need [168]. Financial Performance and Challenges - Revenues for the year ended December 31, 2020, were $7.4 million, a decrease of 20.4% from $9.3 million in 2019, primarily due to the economic effects of the COVID-19 pandemic [172]. - The company has incurred an accumulated deficit of $196.9 million as of December 31, 2020, and cannot assure future profitability [89]. - The company expects to incur further losses while growing sales of DPNCheck and Quell, with substantial doubt about continuing as a going concern [91]. - Cash and cash equivalents were reported at $5.2 million as of December 31, 2020, with a need for additional funding anticipated in Q1 2022 [90]. - The company anticipates needing to raise additional funds to support operating and capital needs in the first quarter of 2022 and beyond [186]. Regulatory Compliance and Risks - The FDA has classified the company’s products as Class II medical devices, requiring them to undergo the 510(k) pre-market notification process for market clearance [63]. - The company is subject to Federal Trade Commission regulatory oversight, which can result in penalties for non-compliance [75]. - Compliance with FDA's quality system regulation is critical; failure could disrupt manufacturing and distribution, harming sales and operating results [110]. - The company faces competition from larger firms in the neurodiagnostic device market, which may impact its market share and growth potential [50]. - Products may be subject to recalls even after FDA approval, which could harm reputation and financial results [113]. Operational Efficiency and Cost Management - Total operating expenses decreased by 46.7% in 2020 to $7.3 million, down from $13.8 million in 2019, driven by reductions in research and development, sales and marketing, and general and administrative expenses [174]. - Sales and marketing expenses dropped by 69.8% in 2020, primarily due to reduced advertising and trade show spending, totaling a decrease of $3.3 million [176]. - General and administrative expenses decreased by 40.6% in 2020, attributed to lower professional service costs of $2.0 million [177]. - The company does not intend to pay cash dividends and plans to retain all available funds for business operations and expansion [151]. Intellectual Property and Competitive Landscape - The company holds 47 issued U.S. patents and 15 foreign patents as of December 31, 2020, covering important aspects of its products, including Quell and DPNCheck [52]. - Patent rights may not be adequate to protect intellectual property, allowing competitors to use similar technologies [116]. - The company faces risks related to patent enforcement in foreign jurisdictions, which may limit the ability to prevent infringement [117]. Employee and Management Considerations - The company had 20 full-time employees as of December 31, 2020, with an average tenure of over 11 years [82]. - As of December 31, 2020, the company had 20 employees, and its ability to attract and retain skilled personnel is critical for future performance [134]. - The company does not maintain key person life insurance for its executive officers, which could weaken management expertise if key personnel are lost [133]. Market Expansion and International Revenue - Foreign markets accounted for approximately 15% of the company's revenues in 2020, up from 13% in 2019, indicating a focus on market expansion, particularly in Asia [142]. - The company is relying on local suppliers for key components of its Quell and DPNCheck devices, maintaining close relationships to ensure quality and compliance with FDA and ISO standards [38].