Cvrx, Inc.
A maker of implantable medical devices, CVRx builds Barostim, a tiny device that sits under the skin and gently pulses the body's own carotid baroreceptors to ease the symptoms of heart failure — the first device of its kind approved by the FDA. Founded in 2001 by two engineers, it took its name from a mashup of "cardiovascular" and "Rx," the shorthand for prescription or therapy.
10-Q · Quarter ended Jun 30, 2026 · SEC filing ↗
The original filing sections are available below.
Overview We are a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular disease. Our proprietary platform technology, Barostim, is designed to…
Overview We are a commercial-stage medical device company focused on developing, manufacturing, and commercializing innovative and minimally invasive neuromodulation solutions for patients with cardiovascular disease. Our proprietary platform technology, Barostim, is designed to leverage the power of the brain and nervous system to address the imbalance of the Autonomic Nervous System, which causes HF with reduced Ejection Fraction (“HFrEF”) and other cardiovascular diseases. Our second-generation product, Barostim, is the first and only commercially available neuromodulation device indicated to improve symptoms for patients with HFrEF. Barostim provides Baroreflex Activation Therapy by sending imperceptible and persistent electrical pulses to baroreceptors located in the wall of the carotid artery to signal the brain to modulate cardiovascular function. Barostim is currently indicated by the U.S. Food and Drug Administration (“FDA”) for patients who are NYHA Class III or II (who had a recent history of Class III) despite treatment with guideline-directed medical therapies (medications and devices), have a LVEF ≤ 35% and a NT-proBNP < 1,600 pg/ml and is CE Marked for HFrEF and resistant hypertension. 20 Table of Contents Since our inception, our activities have consisted primarily of developing Barostim Therapy, conducting our BeAT-HF pre-market and post-market pivotal studies in the U.S., and filing for regulatory approvals. Our ability to generate significant revenue from product sales and become profitable will depend on our ability to continue to successfully commercialize Barostim and any product enhancements we may advance in the future. We expect to derive future revenue by continuing to both expand our own dedicated salesforce and increase awareness of Barostim among payers, physicians, and patients. Our sales and marketing efforts are directed at electrophysiologists, HF specialists, interventional and general cardiologists, and vascular surgeons because they are the primary users of our technology. However, we consider hospitals, where the procedures are performed primarily in an outpatient setting, to be our customers, as they are the purchasing entities of Barostim in the U.S. We intend to continue making significant investments building our U.S. commercial infrastructure by expanding and training our U.S. sales force. We have dedicated significant resources to educate physicians and advanced practice providers who treat HFrEF about the advantages of Barostim and train them on the implant procedure. The costs for the device and implantation procedure are reimbursed through various third-party payers, such as government agencies and commercial payers. In the U.S., we estimate that 67% of our target patient population is Medicare-eligible based on the age demographic of the HFrEF patient population indicated for Barostim. As a result, we have prioritized coverage by the Centers for Medicare and Medicaid Services while simultaneously developing processes to engage commercial payers. All Medicare Administrative Contractors have retired their official automatic coverage denial policies for our Current Procedural Terminology ("CPT") codes, thereby allowing hospitals to submit payment requests for the Barostim procedure to be adjudicated on a claim-by-claim basis. Our reimbursement strategy involves continuing to broaden our current coverage and build our in-house market access team to obtain appropriate prior authorization approvals in advance of treatment on a case-by-case basis where positive coverage policies currently do not exist. Outside the U.S., reimbursement levels vary by country and within some countries by region. Barostim is eligible for reimbursement in certain countries in the European Economic Area, such as Germany, where annual healthcare budgets for the hospital generally determine the number of patients to be treated and the prices to be paid for the related devices that may be purchased. We manage all aspects of manufacturing operations and product supply of Barostim, which include final assembly, testing and packaging of our implantable pulse generator (“IPG”) and stimulation lead, at our headquarters in Minneapolis, Minnesota. We utilize components or various subassemblies manufactured by third-party suppliers, some of which have significant lead times. Many of these components are from a limited number of suppliers. We believe that our component manufacturers are recognized in their field for their competency to manufacture the respective portions of Barostim and have quality systems established that meet FDA requirements. We seek to maintain higher levels of inventory to protect ourselves from supply interruptions and continue to seek to broaden and strengthen our supply chain through additional sourcing channels. On October 31, 2022, we entered into the Loan Agreement allowing borrowing, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of Term Loans described in Note 4 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the term loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones, and the maturity date was extended to 2031. In connection with the Amendment, we borrowed an additional $10.0 million under the Loan Agreement. We had $60.0 million in outstanding Term Loans under the Loan Agreement as of June 30, 2026. As a result of the planned investments to fund our commercialization efforts, we expect to continue to incur net losses for the next several years, which may require additional funding and could include future equity and debt financing. Recent Developments Humana, a national health insurance company with the second largest Medicare Advantage program in the U.S., announced that it issued a Medicare Advantage coverage policy for Barostim therapy, effective May 1, 2026. The new policy covers Barostim for patients meeting its current FDA-approved indication as well as 21 Table of Contents patients enrolled in the BENEFIT-HF trial, the landmark heart failure study evaluating Barostim in a significantly expanded patient population initiated earlier this year. In July 2026, the Centers for Medicare & Medicaid Services, as part of the proposed rule for the 2027 Outpatient Prospective Payment System, proposed to retain the Barostim implant procedure under New Technology Ambulatory Payment Classification 1580, with an associated outpatient payment rate of approximately $45,000. The final rule is expected to be issued in November and take effect January 1, 2027. We expect a lower rate of year-over-year revenue growth in the second half of fiscal 2026 than we experienced in the first half of fiscal 2026. This outlook is driven by fewer sales territories than anticipated, lower sales force productivity and a prolonged challenge with one of the largest payers. We are taking direct action to address these headwinds, including continuing to improve our hiring process, investing in onboarding and training and creating multiple field-based reimbursement and business management roles, funded through a reallocation of resources. We also continue to appeal prior authorization denials to advocate on behalf of patients. We continue to see strong growth in our most stable regions, while at the same time we continue to advance our BENEFIT-HF trial and our broader clinical and reimbursement strategies. Factors affecting our performance We believe there are several important factors that have impacted and that we expect will continue to impact our business and results of operations. These factors include: •Growing and supporting our U.S. commercial organization; •Promoting awareness among physicians, hospitals, and patients to accelerate adoption of Barostim; •Continuing to develop and disseminate clinical evidence supporting the benefits of Barostim; •Raising awareness among payers to build upon reimbursement for Barostim; •Investing in research and development to foster innovation; and •Leveraging our manufacturing capacity to further improve our gross margins. Components of results of operations Revenue Our U.S. sales have steadily increased since the pre-market approval of Barostim by the FDA in August 2019, and the subsequent reimbursement changes. We expect to continue to drive increases in revenue through our efforts to increase awareness of Barostim among physicians, patients and payers, and by the expansion of our U.S. sales force, as well as by seeking expanded labeling for Barostim. As a result, we expect that U.S. sales will continue to account for the majority of our revenue going forward. We derive a portion of our revenue from the sale of Barostim to hospitals in Germany and other select countries in Europe. Revenue from sales of Barostim in Europe fluctuates based on the average selling price of Barostim as determined by location of sale and channel mix, each of which may vary significantly from country to country. Our revenue from international sales can also be significantly impacted by fluctuations in foreign currency exchange rates. Cost of goods sold and gross margin Cost of goods sold consists primarily of acquisition costs of the components and subassemblies of Barostim, allocated manufacturing overhead and scrap and inventory obsolescence, as well as distribution-related expenses such as logistics and shipping costs. We expect cost of goods sold to increase in absolute dollars primarily as, and to the extent, our revenue grows. Gross margin may also vary based on regional differences in rebates and incentives negotiated with certain customers. 22 Table of Contents We calculate gross margin as revenue less cost of goods sold divided by revenue. Our gross margin has been and will continue to be affected by a variety of factors, but is primarily driven by the average sale price of our product, the percentage of products sold that include a full system (i.e., an IPG and a stimulation lead), as compared to individual IPG sales, and the allocated manufacturing overhead. Although we sell the majority of our devices directly to hospitals, the impact of the average selling price on gross margin is driven by the percentage of products we sold to distributors as compared to those sold directly to hospitals, as our average selling price is typically higher on products we sell directly. The full system sales typically have a lower gross margin as they include the cost of an IPG and a stimulation lead whereas individual IPG sales only include the cost of an IPG. The manufacturing overhead costs of Barostim are directly aligned to our production volume and therefore the cost per product is reduced if production levels increase. While we expect our gross margin to be positively affected over time to the extent we are successful in selling more product through our direct sales force and by increasing our production volumes, it will likely fluctuate from period to period as we continue to introduce new or modified products and adopt new manufacturing processes and technologies. Research and development expenses Research and development (“R&D”) expenses consist primarily of personnel costs, including salaries, bonuses, employee benefits and stock-based compensation expenses for our R&D employees. R&D expenses also include costs associated with product design efforts, development prototypes, testing, clinical trial programs and regulatory activities, contractors, consultants, equipment and software to support our development, facilities, and information technology. We expense R&D costs as they are incurred. We expect R&D expenses to increase in absolute dollars as we continue to develop enhancements to Barostim. Our R&D expenses may fluctuate from period to period due to the timing and extent of our product development and clinical trial expenses. Selling, general and administrative expenses Selling, general and administrative (“SG&A”) expenses consist primarily of personnel costs, including base salaries, bonuses, employee benefits and stock-based compensation expense for our sales and marketing personnel, including sales commissions, and for administrative personnel that support our general operations such as executive management, financial accounting, information technology and human resources personnel. SG&A expenses also include costs attributable to marketing, as well as travel, legal fees, financial audit fees, insurance, fees for other consulting services, depreciation, and facilities. We expense commissions at the time of the sale. We expect SG&A expenses to increase in absolute dollars as we continue to expand our direct sales force and commercial organization in the U.S. In addition, we will continue to increase our international presence and to develop and assist our channel partners. However, we expect our SG&A expenses to decrease as a percentage of revenue as our revenue grows. Interest expense Interest expense consists of interest on our debt and amortization of associated financing costs. Other income, net Other income, net consists primarily of interest income on our interest-bearing accounts, partially offset by the effect of exchange rates on our foreign currency-denominated asset and liability balances. Benefit (provision) for income taxes Benefit (provision) for income taxes consists primarily of income taxes in foreign jurisdictions in which we conduct business. We maintain a full valuation allowance for deferred tax assets including NOL carryforwards, R&D credits, and other tax credits. 23 Table of Contents Results of operations Consolidated results of operations for the three months ended June 30, 2026, compared to the three months ended June 30, 2025 Three months ended June 30, Change (unaudited and in thousands) 2026 2025 $ % Revenue $ 15,705 $ 13,589 $ 2,116 16 % Cost of goods sold 1,981 2,139 (158) (7) % Gross profit 13,724 11,450 2,274 20 % Gross margin 87 % 84 % Operating expenses: Research and development 3,130 2,469 661 27 % Selling, general and administrative 23,617 23,357 260 1 % Total operating expenses 26,747 25,826 921 4 % Loss from operations (13,023) (14,376) 1,353 (9) % Interest expense (1,578) (1,473) (105) 7 % Other income, net 560 1,110 (550) (50) % Loss before income taxes (14,041) (14,739) 698 (5) % Benefit (provision) for income taxes (3) 3 (6) (200) % Net loss $ (14,044) $ (14,736) $ 692 (5) % The following table provides revenue by geography: Three months ended June 30, Change (unaudited and in thousands) 2026 2025 $ % United States $ 14,775 $ 12,243 $ 2,532 21 % Europe 930 1,346 (416) (31) % Total Revenue $ 15,705 $ 13,589 $ 2,116 16 % Revenue was $15.7 million for the three months ended June 30, 2026, an increase of $2.1 million, or 16%, over the three months ended June 30, 2025. Revenue generated in the U.S. was $14.8 million for the three months ended June 30, 2026, an increase of $2.5 million, or 21%, compared to the three months ended June 30, 2025. Revenue units in the U.S. totaled 466 and 391 for the three months ended June 30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. As of June 30, 2026, we had a total of 258 active implanting centers in the U.S., as compared to 240 as of June 30, 2025. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of June 30, 2026, we had a total of 56 sales territories in the U.S. as compared to 47 sales territories as of June 30, 2025. Revenue generated in Europe was $0.9 million for the three months ended June 30, 2026, a $0.4 million decrease, or 31%, compared to the three months ended June 30, 2025. Total revenue units in Europe decreased to 40 for the three months ended June 30, 2026, as compared to 61 in the prior year period. We had five sales territories in Europe as of June 30, 2026 and June 30, 2025. 24 Table of Contents Cost of goods sold and gross margin Cost of goods sold decreased $0.2 million, or 7%, to $2.0 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This decrease was driven by a lower cost per unit, primarily due to an increase in manufacturing efficiencies. Gross profit was $13.7 million for the three months ended June 30, 2026, an increase of $2.3 million, or 20%, over the three months ended June 30, 2025. Gross margin increased to 87% for the three months ended June 30, 2026, compared to 84% for the three months ended June 30, 2025. Gross margin for the three months ended June 30, 2026 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies. Research and development expenses R&D expenses increased $0.7 million, or 27%, to $3.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was driven by a $0.6 million increase in headcount expenses and a $0.1 million increase in clinical trial expenses. Selling, general and administrative expenses SG&A expenses increased $0.3 million, or 1%, to $23.6 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This change was primarily driven by a $0.7 million increase in non-cash stock-based compensation expenses and a $0.5 million increase in legal expenses, partially offset by a $0.6 million decrease in advertising expenses and a $0.3 million decrease in travel expenses. Interest expense Interest expense increased $0.1 million for the three months ended June 30, 2026, compared to the three months ended June 30, 2025. This increase was driven by the interest expense on higher levels of borrowings under the Loan Agreement. Other income, net Other income, net decreased $0.6 million for the three months ended June 30, 2026 compared to the three months ended June 30, 2025. This decrease was driven by the interest income on lower balances of our interest-bearing accounts. Benefit (provision) for income taxes Benefit (provision) for income taxes was nominal for each of the three months ended June 30, 2026 and 2025. 25 Table of Contents Consolidated results of operations for the six months ended June 30, 2026, compared to the six months ended June 30, 2025 Six months ended June 30, Change (unaudited and in thousands) 2026 2025 $ % Revenue $ 30,474 $ 25,937 $ 4,537 17 % Cost of goods sold 3,869 4,175 (306) (7) % Gross profit 26,605 21,762 4,843 22 % Gross margin 87 % 84 % Operating expenses: Research and development 6,214 4,986 1,228 25 % Selling, general and administrative 45,575 44,589 986 2 % Total operating expenses 51,789 49,575 2,214 4 % Loss from operations (25,184) (27,813) 2,629 (9) % Interest expense (3,129) (2,930) (199) 7 % Other income, net 1,153 2,233 (1,080) (48) % Loss before income taxes (27,160) (28,510) 1,350 (5) % Benefit (provision) for income taxes (4) 8 (12) (150) % Net loss $ (27,164) $ (28,502) $ 1,338 (5) % The following table provides revenue by geography: Six months ended June 30, Change (unaudited and in thousands) 2026 2025 $ % United States $ 28,425 $ 23,444 $ 4,981 21 % Europe 2,049 2,493 (444) (18) % Total Revenue $ 30,474 $ 25,937 $ 4,537 17 % Revenue was $30.5 million for the six months ended June 30, 2026, an increase of $4.5 million, or 17%, over the six months ended June 30, 2025. Revenue generated in the U.S. was $28.4 million for the six months ended June 30, 2026, an increase of $5.0 million, or 21%, compared to the six months ended June 30, 2025. Revenue units in the U.S. totaled 895 and 750 for the six months ended June 30, 2026 and 2025, respectively. The increases were primarily driven by continued growth in the U.S. HF business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim. Revenue generated in Europe was $2.0 million for the six months ended June 30, 2026, a $0.4 million decrease, or 18%, compared to the six months ended June 30, 2025. Total revenue units in Europe decreased to 96 for the six months ended June 30, 2026, as compared to 120 in the prior year period. Cost of goods sold and gross margin Cost of goods sold decreased $0.3 million, or 7%, to $3.9 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This decrease was driven by a lower cost per unit, primarily due to an increase in manufacturing efficiencies. Gross profit was $26.6 million for the six months ended June 30, 2026, an increase of $4.8 million, or 22%, over the six months ended June 30, 2025. Gross margin increased to 87% for the six months ended June 30, 2026, compared to 84% for the six months ended June 30, 2025. Gross margin for the six months ended June 30, 26 Table of Contents 2026 was higher due to an increase in the average selling price and a decrease in the cost per unit, primarily due to an increase in manufacturing efficiencies. Research and development expenses R&D expenses increased $1.2 million, or 25%, to $6.2 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This change was driven by a $0.9 million increase in headcount expenses and a $0.4 million increase in consulting expense. Selling, general and administrative expenses SG&A expenses increased $1.0 million, or 2%, to $45.6 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This change was primarily driven by a $1.0 million increase in non-cash stock-based compensation expense, a $0.9 million increase in headcount expense, and a $0.6 million increase in legal expenses, partially offset by a $0.9 million decrease in advertising expenses, a $0.3 million decrease in consulting expense, and a $0.3 million decrease in travel expenses. Interest expense Interest expense increased $0.2 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This increase was driven by the interest expense on higher levels of borrowings under the Loan Agreement. Other income, net Other income, net decreased $1.1 million for the six months ended June 30, 2026, compared to the six months ended June 30, 2025. This decrease was primarily driven by decreased interest income on our interest-bearing accounts. Benefit (provision) for income taxes Benefit (provision) for income taxes was nominal for each of the six months ended June 30, 2026 and 2025. Liquidity, capital resources and plan of operations We have incurred significant operating losses and negative cash flows from operations since our inception, and we anticipate that we will incur significant losses for at least the next several years. As of June 30, 2026 and December 31, 2025, we had cash and cash equivalents of $64.6 million and $75.7 million, respectively. For the three months ended June 30, 2026 and 2025, our net losses were $14.0 million and $14.7 million, respectively. For the six months ended June 30, 2026 and 2025, our net losses were $27.2 million and $28.5 million, respectively. Our net cash used in operating activities for the six months ended June 30, 2026 and 2025 was $21.0 million and $20.7 million, respectively. On October 31, 2022, we entered into the Loan Agreement under which we were allowed to borrow, subject to our achievement of certain milestones, up to a total of $50.0 million in a series of Term Loans described in Note 4 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q. On January 9, 2026, we entered into an Amendment to our existing Loan Agreement. Pursuant to the Amendment, the term loans available were increased by $50.0 million, to an aggregate principal amount of up to $100.0 million, subject to our achievement of certain milestones. In connection with the Amendment, we borrowed an additional $10.0 million under the Loan Agreement. We had $60.0 million in outstanding Term Loans under the Loan Agreement as of June 30, 2026. On November 4, 2022, we entered into an Equity Distribution Agreement with Piper Sandler & Co., as agent, under which we may offer and sell, from time to time at our sole discretion, shares of our common stock having an aggregate offering price of up to $50.0 million in an ATM offering, to or through the agent. We issued 543,462 shares of common stock for gross proceeds of $9.5 million during the year ended December 31, 2025. On November 4, 2025, we and the agent mutually agreed to terminate the Equity Distribution Agreement for the ATM, effective on November 6, 2025. On January 12, 2026, we entered into a Sale Agreement with Jefferies 27 Table of Contents LLC, as agent. Pursuant to the terms of the Sale Agreement, we may offer and sell, from time to time at our sole discretion, shares of common stock having an aggregate offering price up to $50.0 million in an ATM offering, to or through the agent. We issued 102,154 shares of common stock for gross proceeds of $0.8 million during the six months ended June 30, 2026. We have remaining capacity to issue and sell up to approximately $49.2 million of additional shares of common stock under this ATM offering. Our future liquidity and capital funding requirements will depend on numerous factors, including: •our investment in our U.S. commercial infrastructure and sales forces; •the degree and rate of market acceptance of Barostim and the ability for our customers to obtain appropriate levels of reimbursement; •the costs of commercialization activities, including product sales, marketing, manufacturing, and distribution; •our R&D activities for product enhancements and to expand our indications; •the costs of filing, prosecuting, defending, and enforcing any patent claims and other intellectual property rights; •our need to implement additional infrastructure and internal systems; •our ability to hire additional personnel to support our operations as a public company; and •the emergence of competing technologies or other adverse market developments. We believe that our existing cash resources together with cash from operations will be sufficient to meet our forecasted requirements for operating liquidity, capital expenditures and debt services for more than eighteen months. If these sources are insufficient to meet our liquidity requirements, or to fund the execution or acceleration of our growth strategies, we may seek additional equity financing or enter into an additional loan agreement. If we raise additional funds by issuing equity securities, our stockholders would experience dilution. Additional debt financing, if available, may involve covenants further restricting our operations or our ability to incur additional debt. Any such debt financing or additional equity that we raise may contain terms that are not favorable to us or our stockholders. Additional financing may not be available at all or may only be available in amounts or on terms that we do not deem to be favorable. If we are unable to obtain additional financing when needed to satisfy our liquidity requirements, we may be required to delay the commercialization and marketing of Barostim. Cash flows The following table sets forth the primary sources and uses of cash for each of the periods presented below: Six months ended June 30, (unaudited) (in thousands) 2026 2025 Net cash (used in) provided by: Operating activities $ (20,990) $ (20,703) Investing activities (234) (217) Financing activities 10,103 10,007 Effect of currency exchange on cash and cash equivalents (1) 5 Net change in cash and cash equivalents $ (11,122) $ (10,908) 28 Table of Contents Cash used in operating activities Net cash used in operating activities for the six months ended June 30, 2026 was $21.0 million and consisted primarily of a net loss of $27.2 million, partially offset by a non-cash charge of $6.6 million related to stock-based compensation expense, and a change in net operating assets of $1.0 million. Net operating assets consisted primarily of accrued expenses, accounts receivable, inventory, prepaid expenses and other current assets, and accounts payable to support the growth of our operations. Net cash used in operating activities for the six months ended June 30, 2025 was $20.7 million and consisted primarily of a net loss of $28.5 million, partially offset by a non-cash charge of $5.4 million related to stock-based compensation expense and a change in net operating assets of $1.9 million. Net operating assets consisted primarily of accounts receivable, accrued expenses, accounts payable, inventory, and prepaid expenses and other current assets to support the growth of our operations. Cash used in investing activities: Cash used in investing activities was $0.2 million for each of the six months ended June 30, 2026 and 2025, respectively, and consisted of purchases of property and equipment. Cash provided by financing activities: Net cash provided by financing activities for the six months ended June 30, 2026 was $10.1 million and consisted of $8.9 million related to net proceeds from the debt financing, $0.7 million related to proceeds from the issuance of common stock, $0.4 million related to proceeds from the ESPP, and $0.1 million related to proceeds from the exercise of common stock options. Net cash provided by financing activities for the six months ended June 30, 2025 was $10.0 million and consisted of $9.2 million related to net proceeds from the issuance of common stock through the ATM offering, $0.4 million related to proceeds from the exercise of common stock options and $0.4 million related to proceeds from the ESPP. Contractual obligations and commitments There have been no material changes to our contractual obligations as of June 30, 2026, as compared to those disclosed in our Annual Report on Form 10-K for the year ended December 31, 2025. Critical accounting policies and estimates For a discussion of our potential risks and uncertainties, see the information in Part II, Item 7. “Management's Discussion and Analysis of Financial Condition and Results of Operations—Critical accounting policies and estimates" in our Annual Report on Form 10-K for the fiscal year ended December 31, 2025. We have reviewed and determined that those critical accounting policies and estimates remain our critical accounting policies and estimates as of and for the six months ended June 30, 2026. JOBS Act accounting election The JOBS Act permits an “emerging growth company” such as us to take advantage of an extended transition period to comply with new or revised accounting standards applicable to public companies until those standards would otherwise apply to private companies. We have elected to use this extended transition period under the JOBS Act until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements may not be comparable to the financial statements of issuers who are required to comply with the effective dates for new or revised accounting standards that are applicable to public companies, which may make comparison of our financials to those of other public companies more difficult. 29 Table of Contents Recent accounting pronouncements A discussion of recent accounting pronouncements is included in Note 2 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.
Interest rate risk The risk associated with fluctuating interest rates is primarily limited to our cash equivalents and debt issued under the Loan Agreement, which are carried at quoted market prices and the prime rate, respectively. We do not currently use or plan to use financ…
Interest rate risk The risk associated with fluctuating interest rates is primarily limited to our cash equivalents and debt issued under the Loan Agreement, which are carried at quoted market prices and the prime rate, respectively. We do not currently use or plan to use financial derivatives in our investment portfolio. Foreign currency exchange rate risk Portions of our revenue and operating expenses that are incurred outside the U.S. are denominated in foreign currencies and subject to fluctuations due to changes in foreign currency exchange rates, particularly changes in the Euro. Additionally, fluctuations in foreign currency exchange rates may cause us to recognize transaction gains and losses in our condensed consolidated statements of operations and comprehensive loss. To date, realized gains and losses from foreign currency transactions have not been material to our condensed consolidated financial statements, and we have not engaged in any foreign currency hedging transactions. As our international operations grow, we will continue to reassess our approach to managing the risks relating to fluctuations in currency rates. Inflation risk Inflationary factors, such as increases in our cost of goods sold and operating expenses, may adversely affect our operating results. Although we do not believe that inflation has had a material impact on our financial position or results of operations to date, a high rate of inflation in the future may have an adverse effect on our ability to maintain and increase our gross margin and selling and marketing and operating expenses as a percentage of our revenue if the selling prices of our products do not increase as much as or more than these increased costs. Credit risk As of June 30, 2026 and December 31, 2025, our cash and cash equivalents were maintained with financial institutions which we believe have sufficient assets and liquidity to conduct their operations in the ordinary course of business with little or no credit risk to us; however, our cash balances were in excess of insured limits.
Read original filing text →From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. The information included in Note 10 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q…
From time to time, we may become involved in legal proceedings or be subject to claims arising in the ordinary course of our business. The information included in Note 10 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q is incorporated by reference into this Item 1.
Read original filing text →For a discussion of our potential risks and uncertainties, see the information in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to the risk factors disclosed in our Annual Report on For…
For a discussion of our potential risks and uncertainties, see the information in Part I, Item 1A. “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2025. There have been no material changes to the risk factors disclosed in our Annual Report on Form 10-K.
Read original filing text →