CVRx Inc

Previous wording

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 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.

Current wording

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 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.

Previous wording

On October 31, 2022, we entered into the Loan Agreement under which we may 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, and we borrowed $7.5 million of such total on that date to fund our commercial and investment efforts. On March 10, 2023, we borrowed the $7.5 million remaining under the first tranche of the Loan Agreement. On December 15, 2023, we borrowed $15.0 million under the second tranche of the Loan Agreement. On September 30, 2024, we borrowed the remaining $20.0 million under the third and final tranche of the Loan Agreement. We had $50.0 million in outstanding Term Loans under the Loan Agreement as of September 30, 2024. As a result of these investments and 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.

Current wording

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. We had $50.0 million in outstanding Term Loans under the Loan Agreement as of March 31, 2025. As a result of these investments and 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.

Previous wording

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.

Current wording

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

Previous wording

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

Current wording

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.

Previous wording

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 products and adopt new manufacturing processes and technologies.

Current wording

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.

Previous wording

Revenue generated in the U.S. was $12.3 million for the three months ended September 30, 2024, an increase of $2.7 million, or 28%, over the three months ended September 30, 2023. HF revenue units in the U.S. totaled 391 and 303 for the three months ended September 30, 2024 and 2023, respectively. HF revenue in the U.S. totaled $12.2 million and $9.4 million for the three months ended September 30, 2024 and 2023, 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.

Current wording

Revenue generated in the U.S. was $11.2 million for the three months ended March 31, 2025, an increase of $1.4 million, or 14%, over the three months ended March 31, 2024. HF revenue in the U.S. totaled $11.1 million and $9.7 million for the three months ended March 31, 2025 and 2024, respectively. HF revenue units in the U.S. totaled 353 and 319 for the three months ended March 31, 2025 and 2024, 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.

Previous wording

As of September 30, 2024, we had a total of 208 active implanting centers in the U.S., as compared to 159 as of September 30, 2023. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of September 30, 2024, we had a total of 45 sales territories in the U.S. as compared to 35 sales territories as of September 30, 2023.

Current wording

As of March 31, 2025, we had a total of 227 active implanting centers in the U.S., as compared to 190 as of March 31, 2024. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. As of March 31, 2025, we had a total of 45 sales territories in the U.S. as compared to 39 sales territories as of March 31, 2024.

Previous wording

Revenue generated in Europe was $1.1 million for the three months ended September 30, 2024, a nominal increase compared to the three months ended September 30, 2023. Total revenue units in Europe increased to 56 for the three months ended September 30, 2024, as compared to 47 in the prior year period. As of both September 30, 2024 and 2023, we had six sales territories in Europe.

Current wording

Revenue generated in Europe was $1.1 million for the three months ended March 31, 2025, a $0.2 million increase compared to the three months ended March 31, 2024. Total revenue units in Europe increased to 59 for the three months ended March 31, 2025, as compared to 44 in the prior year period. As of March 31, 2025 we had five sales territories in Europe as compared to six sales territories as of March 31, 2024.

Previous wording

Cost of goods sold increased $0.6 million, or 33%, to $2.2 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. This increase was driven by higher sales of Barostim.

Current wording

Cost of goods sold increased $0.4 million, or 26%, to $2.0 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This increase was driven by higher sales of Barostim.

Previous wording

Gross profit was $11.1 million for the three months ended September 30, 2024, an increase of $2.3 million, or 26%, over the three months ended September 30, 2023. Gross margin was 83% and 84% for the three months ended September 30, 2024 and September 30, 2023, respectively.

Current wording

Gross profit was $10.3 million for the three months ended March 31, 2025, an increase of $1.2 million, or 13%, over the three months ended March 31, 2024. Gross margin was 84% and 85% for the three months ended March 31, 2025 and March 31, 2024, respectively.

Previous wording

R&D expenses decreased $0.2 million, or 7%, to $2.5 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. This change was driven by a $0.2 million decrease in consulting expenses.

Current wording

R&D expenses decreased $0.5 million, or 18%, to $2.5 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This change was driven by a $0.4 million decrease in consulting expenses and a $0.1 million decrease in non-cash stock-based compensation expense.

Previous wording

SG&A expenses increased $23.6 million, or 50%, to $71.1 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. This change was primarily driven by an $11.7 million increase in non-cash stock-based compensation expense, an $8.2 million increase in compensation expenses, mainly as a result of increased headcount, a $1.2 million increase in travel expenses, a $0.9 million increase in advertising expenses, and a $0.5 million increase in consulting expenses. Approximately $8.4 million of the increase in non-cash stock-based compensation expense is related to the modification of stock options held by the former CEO in connection with his retirement in the first quarter of 2024 described in Note 7 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Current wording

SG&A expenses decreased $7.1 million, or 25%, to $21.2 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This change was primarily driven by an $8.6 million decrease in non-cash stock-based compensation expense, partially offset by a $1.6 million increase in compensation expenses, mainly as a result of increased headcount. Approximately $8.4 million of the decrease in non-cash stock-based compensation expense is related to the modification of stock options held by our former Chief Executive Officer in connection with his retirement in the first quarter of 2024 described in Note 7 to our condensed consolidated financial statements included elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

Interest expense increased $0.5 million for the three months ended September 30, 2024, compared to the three months ended September 30, 2023. This increase was driven by the interest expense on higher levels of borrowings under the Loan Agreement entered into on October 31, 2022.

Current wording

Interest expense increased $0.5 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This increase was driven by the interest expense on higher levels of borrowings under the Loan Agreement.

Previous wording

Other income, net increased $0.2 million for the nine months ended September 30, 2024, compared to the nine months ended September 30, 2023. This increase was primarily driven by greater interest income on our interest-bearing accounts.

Current wording

Other income, net increased $0.1 million for the three months ended March 31, 2025, compared to the three months ended March 31, 2024. This increase was primarily driven by more interest income on our interest-bearing accounts.

Previous wording

Provision for income taxes was nominal for each of the three months ended September 30, 2024 and September 30, 2023.

Current wording

Benefit (provision) for income taxes was nominal for each of the three months ended March 31, 2025 and March 31, 2024.

Previous wording

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 September 30, 2024 and December 31, 2023, we had cash and cash equivalents of $100.2 million and $90.6 million, respectively. For the three months ended September 30, 2024 and 2023, our net losses were $13.1 million and $9.0 million, respectively. For the nine months ended September 30, 2024 and 2023, our net losses were $49.3 million and $32.0 million, respectively. Our net cash used in operating activities for the nine months ended September 30, 2024 and 2023 was $31.1 million and $31.2 million, respectively.

Current wording

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 March 31, 2025 and December 31, 2024, we had cash and cash equivalents of $102.7 million and $105.9 million, respectively. For the three months ended March 31, 2025 and 2024, our net losses were $13.8 million and $22.2 million, respectively. Our net cash used in operating activities for the three months ended March 31, 2025 and 2024 was $12.8 million and $10.9 million, respectively.

Previous wording

On October 31, 2022, we entered into the Loan Agreement under which we may 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, and we borrowed $7.5 million of such total on that date to fund our commercial and investment efforts. On March 10, 2023, we borrowed the $7.5 million remaining under the first tranche of the Loan Agreement. On December 15, 2023, we borrowed $15.0 million under the second tranche of the Loan Agreement. On September 30, 2024, we borrowed the remaining $20.0 million under the third and final tranche of the Loan Agreement. We had $50.0 millionin outstanding Term Loans under the Loan Agreement as of September 30, 2024.

Current wording

On October 31, 2022, we entered into the Loan Agreement under which we may 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. We had $50.0 millionin outstanding Term Loans under the Loan Agreement as of March 31, 2025.

Previous wording

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 “at-the-market” or ATM offering, to or through the agent. In January 2024, we commenced this ATM offering and issued 2,382,139 shares of common stock for gross proceeds of $21.0 million under the ATM offering during the nine months ended September 30, 2024. We have remaining capacity to issue and sell up to $29.0 million of additional shares of common stock under this ATM offering.

Current wording

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 “at-the-market” (“ATM”) offering, to or through the agent. In January 2024, we commenced this ATM offering and issued 543,462 shares of common stock for gross proceeds of $9.5 million under the ATM offering during the three months ended March 31, 2025. We have remaining capacity to issue and sell up to $6.7 million of additional shares of common stock under this ATM offering.

Previous wording

Net cash used in operating activities for the nine months ended September 30, 2024 was $31.1 million and consisted primarily of a net loss of $49.3 million, partially offset by a non-cash charge of $16.4 million related to stock-based compensation expense and a change in net operating assets of $1.2 million. Net operating assets consisted primarily of accounts receivable, inventory, prepaid expenses and other current assets, accounts payable and accrued expenses to support the growth of our operations.

Current wording

Net cash used in operating activities for the three months ended March 31, 2025 was $12.8 million and consisted primarily of a net loss of $13.8 million and a change in net operating assets of $1.7 million, partially offset by a non-cash charge of $2.5 million related to stock-based compensation expense. Net operating assets consisted primarily of accrued expenses, inventory, prepaid expenses and other current assets, accounts receivable, and accounts payableto support the growth of our operations.

Previous wording

Net cash used in operating activities for the nine months ended September 30, 2023 was $31.2 million and consisted primarily of a net loss of $32.0 million and a change in net operating assets of $4.4 million, partially offset by a non-cash charge of $4.7 million related to stock-based compensation expense. Net operating assets consisted primarily of accounts receivable, inventory, prepaid expenses and other current assets, accounts payable and accrued expenses to support the growth of our operations.

Current wording

Net cash used in operating activities for the three months ended March 31, 2024 was $10.9 million and consisted primarily of a net loss of $22.2 million, partially offset by a non-cash charge of $11.1 million related to stock-based compensation expense.

Previous wording

Cash used in investing activities was $1.3 million and $0.4 million for the nine months ended September 30, 2024 and 2023, respectively, and consisted of purchases of property and equipment.

Current wording

Cash used in investing activities was $0.1 million and $0.9 million for the three months ended March 31, 2025 and 2024, respectively, and consisted of purchases of property and equipment.

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2024 was $42.0 million and consisted of $20.2 million related to proceeds from the issuance of common stock through the ATM offering, $20.0 million related to proceeds under the Loan Agreement, $1.6 million related to proceeds from the exercise of common stock options, and $0.4 million related to proceeds from the ESPP, partially offset by $0.2 million related to debt financing costs.

Current wording

Net cash provided by financing activities for the three months ended March 31, 2025 was $9.6 million and consisted of $9.2 million related to net proceeds from the issuance of common stock through the ATM offering and $0.4 million related to proceeds from the exercise of common stock options.

Previous wording

Net cash provided by financing activities for the nine months ended September 30, 2023 was $8.4 million and consisted of $7.5 million related to proceeds under the Loan Agreement, $0.5 million related to proceeds from the ESPP, and $0.5 million related to proceeds from the exercise of common stock options, partially offset by $0.1 million related to debt financing costs.

Current wording

Net cash provided by financing activities for the three months ended March 31, 2024 was $1.4 million and consisted of $0.8 million related to proceeds from the exercise of common stock options and $0.5 million related to net proceeds from the issuance of common stock through the ATM offering.

Previous wording

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, 2023. We have reviewed and determined that those critical accounting policies and estimates remain our critical accounting policies and estimates as of and for the nine months ended September 30, 2024.

Current wording

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, 2024. We have reviewed and determined that those critical accounting policies and estimates remain our critical accounting policies and estimates as of and for the three months ended March 31, 2025.