CVRx reports first quarter 2024 financial and operating results

CVRx, Inc. announced its financial and operating results for the first quarter of 2024.

“We had a solid first quarter, which was offset by some commercial execution challenges in our U.S. Heart Failure business during our recent management transition in February. We are taking steps to address these challenges, including a change in sales leadership, which we are announcing today. I’ve also begun the process of broadening our leadership team and intensifying our efforts on therapy awareness, clinical evidence, and patient access, which will be important in order to scale the business to address the tremendous opportunity in front of us,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “In my first two months, I have seen first-hand that Barostim is a highly impactful therapy, which has been proven to significantly improve the lives of patients suffering from heart failure. Based on my prior industry experience, I appreciate the remarkable opportunity that Barostim represents and am convinced that we can successfully advance this therapy towards standard of care.”

First quarter 2024 financial and operating results
Revenue was $10.8 million for the three months ended March 31, 2024, an increase of $2.8 million, or 35%, over the three months ended March 31, 2023.

Revenue generated in the U.S. was $9.8 million for the three months ended March 31, 2024, an increase of $2.9 million, or 42%, over the three months ended March 31, 2023. HF revenue units in the U.S. totaled 319 and 225 for the three months ended March 31, 2024 and 2023, respectively. HF revenue in the U.S. totaled $9.7 million and $6.8 million for the three months ended March 31, 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.

As of March 31, 2024, the Company had a total of 190 active implanting centers, as compared to 178 as of December 31, 2023. Active implanting centers are customers that have completed at least one commercial HF implant in the last 12 months. The number of sales territories in the U.S. increased by one to a total of 39 during the three months ended March 31, 2024.

Revenue generated in Europe was $0.9 million for the three months ended March 31, 2024, an increase of $0.1 million, or 10%, over the three months ended March 31, 2023. Total revenue units in Europe decreased to 44 for the three months ended March 31, 2024 from 52 in the prior year period. The number of sales territories in Europe remained consistent at six for the three months ended March 31, 2024.

Gross profit was $9.2 million for the three months ended March 31, 2024, an increase of $2.5 million, or 38%, over the three months ended March 31, 2023. Gross margin increased to 85% for the three months ended March 31, 2024. compared to 83% for the three months ended March 31, 2023. This increase was due primarily to a decrease in the cost per unit driven by an increase in the production volume.

R&D expenses decreased $0.4 million, or 11%, to $3.1 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023. This change was driven by a $0.2 million decrease in non-cash stock-based compensation expense, and a $0.2 million decrease in consulting expenses.

SG&A expenses increased $12.9 million, or 84%, to $28.3 million for the three months ended March 31, 2024 compared to the three months ended March 31, 2023. This change was primarily driven by a $9.6 million increase in non-cash stock-based compensation expense, a $2.0 million increase in compensation expense and a $0.6 million increase in travel expenses. Approximately $8.4 million of the increase in non-cash stock-based compensation expense is related to the previously disclosed modification of stock options held by the former CEO in connection with his retirement in the first quarter of 2024.

Other income, net decreased $18,000 for the three months ended March 31, 2024, compared to the three months ended March 31, 2023. This decrease was primarily driven a lower cash balance in our interest-bearing accounts.

Net loss was $22.2 million, or $1.04 per share, for the three months ended March 31, 2024, compared to a net loss of $11.4 million, or $0.55 per share, for the three months ended March 31, 2023. Net loss per share was based on 21.2 million weighted average shares outstanding for three months ended March 31, 2024 and 20.7 million weighted average shares outstanding for the three months ended March 31, 2023.

As of March 31, 2024, cash and cash equivalents were $80.1 million. Net cash used in operating and investing activities was $11.8 million for the quarter ended March 31, 2024. This is compared to net cash used in operating and investing activities of $8.0 million for the three months ended December 31, 2023.

Business outlook
For the full year of 2024, the Company now expects:

• Total revenue between $50.0 million and $53.0 million;
• Gross margin between 83.0% and 85.0%; and
• Operating expenses between $92.0 million and $98.0 million.

For the second quarter of 2024, the Company expects to report total revenue between $11.3 million and $12.3 million.
MB Bureau