Full Press Release Details
Fourth Quarter and Full Year 2024 Financial and Operating Results
Feb. 4, 2025 (GLOBE NEWSWIRE) -- CVRx, Inc. ("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 fourth quarter and full year of 2024.
capped off a very strong 2024 with a solid fourth quarter, which included 41% growth in U.S. heart failure revenue as well the successful
achievement of multiple critical reimbursement milestones," said Kevin Hykes, President and CEO of CVRx. "As we look to 2025,
we are focused on three key strategic priorities to drive Barostim toward becoming the standard of care - building a world-class
sales organization, supporting the development of sustainable Barostim programs to drive deeper utilization, and addressing barriers
to adoption. With the organization-wide success we saw in 2024, in combination with our key priorities for 2025, we are well-positioned
to drive the continued adoption of Barostim therapy."
Quarter 2024 Financial and Operating Results
was $15.3 million for the three months ended December 31, 2024, an increase of $4.0 million, or 36%, over the three months ended
generated in the U.S. was $14.4 million for the three months ended December 31, 2024, an increase of $4.1 million, or 39%, over
the three months ended December 31, 2023. HF revenue units in the U.S. totaled 457 and 330 for the three months ended December 31,
2024 and 2023, respectively. HF revenue in the U.S. totaled $14.3 million and $10.2 million for the three months ended December 31,
2024 and 2023, respectively. The increase was primarily driven by continued growth as a result of the expansion into new sales territories
and new accounts, as well as increased physician and patient awareness of Barostim.
of December 31, 2024, the Company had a total of 223 active implanting centers, as compared to 208 as of September 30, 2024.
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 48 during the three months ended December 31, 2024.
generated in Europe was $1.0 million for both the three months ended December 31, 2024 and December 31, 2023. Total revenue
units in Europe decreased to 41 for the three months ended December 31, 2024 from 52 in the prior year period. As of December 31,
2024, we had five sales territories in Europe as compared to six sales territories as of September 30, 2024.
profit was $12.8 million for the three months ended December 31, 2024, an increase of $3.2 million, or 33%, over the three months
ended December 31, 2023. Gross margin decreased to 83% for the three months ended December 31, 2024 compared to 85% for the
three months ended December 31, 2023. Gross margin for the three months December 31, 2024 was lower due to an increase in the
expenses increased $0.6 million, or 25%, to $2.8 million for the three months ended December 31, 2024 compared to the three months
ended December 31, 2023. This change was primarily driven by a $0.5 million increase in clinical study expenses, a $0.2 million
increase in consulting expenses, and a $0.1 million increase in non-cash stock-based compensation expense, partially offset by a $0.2
million decrease in compensation expenses.
expenses increased $3.2 million, or 19%, to $20.2 million for the three months ended December 31, 2024 compared to the three months
ended December 31, 2023. This change was driven by a $2.9 million increase in compensation expenses, mainly as a result of increased
headcount, a $1.0 million increase in non-cash stock-based compensation expense, and a $0.3 million increase in travel expenses, partially
offset by a $1.1 million decrease in advertising expenses.
expense increased $0.9 million to $1.5 million for the three months ended December 31, 2024 compared to the three months ended December 31,
2023. This increase was driven by the interest expense on higher levels of borrowings under the term loan agreement with Innovatus Capital
income, net was $1.1 million for each of the three months ended December 31, 2024 and 2023. Other income, net consisted primarily
of income on interest-bearing accounts.
loss was $10.7 million, or $0.43 per share, for the three months ended December 31, 2024, compared to a net loss of $9.2 million,
or $0.44 per share, for the three months ended December 31, 2023. Net loss per share was based on 24.7 million weighted average
shares outstanding for three months ended December 31, 2024 and 20.8 million weighted average shares outstanding for the fourth
the three months ended December 31, 2024, the Company issued 869,059 shares of common stock for gross proceeds of $12.8 million
under its at-the-market offering.
Year 2024 Financial and Operating Results
was $51.3 million for the year ended December 31, 2024, an increase of $12.0 million, or 31%, over the year ended December 31,
generated in the U.S. was $47.2 million for the year ended December 31, 2024, an increase of $12.1 million, or 34%, over the year
ended December 31, 2023. HF revenue units in the U.S. totaled 1,506 and 1,123 for the years ended December 31, 2024 and 2023,
respectively. HF revenue in the U.S. totaled $46.8 million and $34.6 million for the years ended December 31, 2024 and 2023, respectively.
of December 31, 2024, the Company had a total of 223 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. As of December 31,
2024, we had 48 sales territories in the U.S. as compared to 38 sales territories as of December 31, 2023.
generated in Europe was $4.1 million for the year ended December 31, 2024, a decrease of $0.1 million, or 1%, over the year ended
December 31, 2023. Total revenue units in Europe decreased to 204 for the year ended December 31, 2024, from 207 for the prior
year period. As of December 31, 2024, we had five sales territories in Europe as compared to six sales territories as of December 31,
profit was $43.0 million for the year ended December 31, 2024, an increase of $9.9 million, or 30%, over the year ended December 31,
2023. Gross margin was 84% for both the years ended December 31, 2024 and December 31, 2023.
expenses decreased $0.5 million, or 4%, to $11.1 million for the year ended December 31, 2024, compared to the year ended December 31,
2023. This change was primarily driven by a $0.5 million decrease in consulting expenses, a $0.3 million decrease in compensation expenses,
and a $0.2 million decrease in travel expenses, partially offset by a $0.5 million increase in clinical study expenses.
expenses increased $26.8 million, or 42%, to $91.3 million for the year ended December 31, 2024, compared to the year ended December 31,
2023. This change was driven by a $12.7 million increase in non-cash stock-based compensation expense, an $11.0 million increase in compensation
expenses, mainly as a result of increased headcount, a $1.3 million increase in travel expenses, a $0.6 million increase in bad debt
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
expense increased $2.6 million, to $4.4 million for the year ended December 31, 2024, compared to the year ended December 31,
2023. This increase was driven by the interest expense on higher levels of borrowings under the term loan agreement with Innovatus Capital
income, net was $4.0 million for the year ended December 31, 2024, compared to $3.9 million for the year ended December 31,
2023. This increase was primarily driven by greater interest income on our interest-bearing accounts.
loss was $60.0 million, or $2.65 per share, for the year ended December 31, 2024, compared to a net loss of $41.2 million, or $1.99
per share, for the year ended December 31, 2023. Net loss per share was based on 22.6 million weighted average shares outstanding
for year ended December 31, 2024 and 20.8 million weighted average shares outstanding for the year ended December 31, 2023.
the year ended December 31, 2024, the Company issued 3,251,198 shares of common stock for gross proceeds of $33.8 million under
its at-the-market offering.
of December 31, 2024, cash and cash equivalents were $105.9 million. Net cash used in operating and investing activities was $40.5
million for the year ended December 31, 2024, compared to $39.6 million for the year ended December 31, 2023.
the full year of 2025, the Company continues to expect:
the first quarter of 2025, the Company expects to report total revenue between $14.5 million and $15.0 million.
Webcast and Conference Call Information
will host a conference call to review its results at 4:30 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.
CVRx is focused on the development and
commercialization of the Barostim System, the first medical technology approved by FDA that uses neuromodulation to improve the
symptoms of heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of
the carotid artery. Baroreceptors activate the body's baroreflex, which in turn triggers an autonomic response to the heart. The therapy
is designed to restore balance to the autonomic nervous system and thereby reduce the symptoms of heart failure. Barostim received the
FDA Breakthrough Device designation and is FDA-approved for use in heart failure patients in the U.S. It has also received the CE Mark
for heart failure and resistant hypertension in the European Economic Area. To learn more about Barostim, visit www.cvrx.com.
Forward-Looking Statements
This press release contains forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical
facts are forward-looking statements, including statements regarding our future financial performance (including our financial guidance
regarding full year and first quarter 2025 results), our anticipated growth strategies, anticipated trends in our industry, our business
prospects and our opportunities. In some cases, you can identify forward-looking statements by terms such as "may,"
"will," "should," "expect," "plan," "anticipate," "could," "outlook,"
"guidance," "intend," "target," "project," "contemplate," "believe,"
"estimate," "predict," "potential" or "continue" or the negative of these terms or other
similar expressions, although not all forward-looking statements contain these words.
The forward-looking statements in this