CVRx: 1st Quarter 2023 Financial and Operating Results; 2023 Outlook

 CVRx, Inc. (NASDAQ: CVRX) (“CVRx”), a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases, today announced its financial and operating results for the first quarter of 2023.

Recent Highlights

• Totality of evidence from BeAT-HF post-market study shows long-term benefits for patients with heart failure

• U.S. Heart Failure (HF) revenue for the first quarter of 2023 was $6.8 million compared to $2.9 million in the prior year quarter, an increase of 132% over prior year quarter

• Active implanting centers in the U.S. grew to 122, an increase of 118% over the first quarter of 2022

• Worldwide revenue for the first quarter of 2023 was $8.0 million, an increase of 96% over prior year quarter

“I am thrilled with our first quarter performance, which demonstrated solid execution on multiple fronts. We were able to share the preliminary data from BeAT-HF during the first quarter and grow our US heart failure business. This is a testament to our team’s ability to accelerate adoption of Barostim through the increased capabilities of our commercial organization and our marketing and awareness efforts,” said Nadim Yared, President and Chief Executive Officer of CVRx. “As we look ahead to the rest of 2023, we are excited about the opportunities that lie ahead and confident that we will bring relief to patients suffering from heart failure.”

First Quarter 2023 Financial and Operating Results

Revenue was $8.0 million for the three months ended March 31, 2023, an increase of $3.9 million, or 96%, over the three months ended March 31, 2022.

Revenue generated in the U.S. was $6.9 million for the three months ended March 31, 2023, an increase of $3.9 million, or 127%, over the three months ended March 31, 2022. HF revenue units in the U.S. totaled 225 and 99 for the three months ended March 31, 2023 and 2022, respectively. HF revenue in the U.S. totaled $6.8 million and $2.9 million for the three months ended March 31, 2023 and 2022, 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, 2023, the Company had a total of 122 active implanting centers, as compared to 106 as of December 31, 2022. 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 three to a total of 29 during the three months ended March 31, 2023.

Revenue generated in Europe was $1.0 million for the three months ended March 31, 2023, an increase of $0.02 million, or 2%, over the three months ended March 31, 2022. Total revenue units in Europe increased to 52 for the three months ended March 31, 2023 from 50 in the prior year period. The number of sales territories in Europe remained consistent at six for the three months ended March 31, 2023.

Gross profit was $6.7 million for the three months ended March 31, 2023, an increase of $3.5 million, or 113%, over the three months ended March 31, 2022. Gross margin increased to 83% for the three months ended March 31, 2023 compared to 77% for the three months ended March 31, 2022. Gross margin for the three months ended March 31, 2023 improved due primarily to a decrease in the cost per unit driven by an increase in the production volume.

R&D expenses increased $1.2 million, or 51%, to $3.4 million for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. This change was driven by a $0.5 million increase in compensation expenses as a result of increased headcount, a $0.4 million increase in non-cash stock-based compensation expense and a $0.4 million increase in consulting fees.

SG&A expenses increased $4.6 million, or 43%, to $15.4 million for the three months ended March 31, 2023 compared to the three months ended March 31, 2022. This change was primarily driven by a $2.6 million increase in compensation expenses, mainly as a result of increased headcount, a $0.8 million increase in travel expenses, a $0.6 million increase in marketing and advertising expenses associated with the commercialization of Barostim in the U.S., and a $0.5 million increase in non-cash stock-based compensation expense.

Other income, net was $1.1 million for the three months ended March 31, 2023 compared to other expense, net of $57,000 for the three months ended March 31, 2022. The income in the first quarter of 2023 was primarily driven by interest income on our interest-bearing account.

Net loss was $11.4 million, or $0.55 per share, for the three months ended March 31, 2023, compared to a net loss of $10.0 million, or $0.49 per share, for the three months ended March 31, 2022. Net loss per share was based on 20,693,224 weighted average shares outstanding for the first quarter of 2023 and 20,453,341 weighted average shares outstanding for the first quarter of 2022.

As of March 31, 2023, cash and cash equivalents were $103.3 million. Net cash used in operating and investing activities was $10.5 million for the quarter ended March 31, 2023, compared to $10.9 million for the quarter ended March 31, 2022.

Business Outlook

For the full year of 2023, the Company expects:

• Total revenue between $35.5 million and $38.0 million, compared to prior guidance of between $35.0 million and $38.0 million;

• Gross margin between 80.0% and 83.0%, compared to prior guidance of between 78% and 79%;

• Operating expenses between $76.0 million and $80.0 million.
  

For the second quarter of 2023, the Company expects to report total revenue between $8.2 million and $8.8 million.

Webcast and Conference Call Information

The Company will host a conference call to review its results at 5:00 p.m. Eastern Time today. A live webcast of the investor conference call will be available online at the investor relations page of the Company’s website at ir.cvrx.com. To listen to the conference call on your telephone, please dial 1-877-704-4453 for U.S. callers, or 1-201-389-0920 for international callers, approximately ten minutes prior to the start time.

https://finance.yahoo.com/news/cvrx-reports-first-quarter-2023-201500121.html