Full Press Release Details
CVRx Reports Fourth Quarter and Full Year 2022
Financial and Operating Results
Fourth Quarter 2022 Revenue of $7.2 million,
a 96% Increase Over Prior Year
MINNEAPOLIS, January 26, 2023 (GLOBE NEWSWIRE) -- 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 fourth quarter and full year of 2022, and provided a 2023 business outlook.
"The growth of our commercial organization combined with the
success of our marketing efforts have continued to deliver increased adoption of Barostim, resulting in the more than doubling of our
U.S. heart failure business as compared to 2021. Importantly, patients continued to report a positive and meaningful impact from the therapy"
said Nadim Yared, President and Chief Executive Officer of CVRx. "This has been a fantastic final quarter to a strong year and we
are very excited to see these trends continue heading into 2023 as we work to promote further awareness among physicians, hospitals and
patients in order to accelerate the adoption of Barostim."
Fourth Quarter 2022 Financial and Operating Results
Revenue was $7.2 million for the three months ended December 31,
2022, an increase of $3.5 million, or 96%, over the three months ended December 31, 2021.
Revenue generated in the U.S. was $6.0 million for the three months
ended December 31, 2022, an increase of $3.1 million, or 109%, over the three months ended December 31, 2021. HF revenue units
in the U.S. totaled 193 and 95 for the three months ended December 31, 2022 and 2021, respectively. HF revenue in the U.S. totaled
$6.0 million and $2.7 million for the three months ended December 31, 2022 and 2021, respectively. The increase was primarily driven
by continued growth in the U.S. heart failure business as a result of the expansion into new sales territories, new accounts and increased
physician and patient awareness of Barostim.
As of December 31, 2022, the Company had a total of 106 active
implanting centers, as compared to 91 as of September 30, 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 26 during
the three months ended December 31, 2022.
Revenue generated in Europe was $1.2 million for the three months ended
December 31, 2022, an increase of $0.4 million, or 49%, over the three months ended December 31, 2021. Total revenue units in
Europe increased to 68 for the three months ended December 31, 2022 from 39 in the prior year period. The revenue increase was primarily
due to the lessening impact of the COVID-19 pandemic in Europe. The number of sales territories in Europe remained consistent at six during
three months ended December 31, 2022.
Gross profit was $5.7 million for the three months ended December 31,
2022, an increase of $3.0 million, or 112%, over the three months ended December 31, 2021. Gross margin increased to 79% for the
three months ended December 31, 2022 compared to 73% for the three months ended December 31, 2021. Gross margin for the three
months ended December 31, 2022 was higher due to a decrease in the cost per unit and an increase in the average selling price. This
was partially offset by a larger percentage of our revenue units coming from full systems versus battery replacements.
R&D expenses increased $1.2 million, or 70%, to $3.0 million for
the three months ended December 31, 2022 compared to the three months ended December 31, 2021. This change was driven by a $0.8
million increase in consulting fees and a $0.5 million increase in compensation expenses as a result of increased headcount.
SG&A expenses increased $4.4 million, or 46%, to $14.1 million
for the three months ended December 31, 2022 compared to the three months ended December 31, 2021. This change was driven by
a $2.4 million increase in compensation expenses, mainly as a result of increased headcount, a $0.6 million increase in travel expenses,
a $0.3 million increase in non-cash stock-based compensation expense, a $0.2 million increase in marketing and advertising expenses, primarily
related to the commercialization of Barostim in the U.S., a $0.2 million increase in professional fees, and a $0.1 million increase in
consulting expenses.
Other income, net was $1.1 million for the three months ended December 31,
2022 compared to other expense, net of $1.4 million for the three months ended December 31, 2021. Other income, net in the fourth
quarter of 2022 was primarily driven by $0.9 million in interest income on our interest-bearing account. Other expense, net in the fourth
quarter of 2021 was primarily driven by a $1.3 million loss on debt extinguishment in connection with the repayment of the outstanding
debt under the Horizon loan agreement.
Net loss was $10.5 million, or $0.51 per share, for the three months
ended December 31, 2022, compared to a net loss of $10.6 million, or $0.52 per share, for the three months ended December 31,
2021. Net loss per share was based on 20,593,312 weighted average shares outstanding for the three months ended December 31, 2022
and 20,367,064 weighted average shares outstanding for the fourth quarter of 2021.
Full Year 2022 Financial and Operating Results
Revenue was $22.5 million for the year ended December 31, 2022,
an increase of $9.4 million, or 72%, over the year ended December 31, 2021.
Revenue generated in the U.S. was $18.0 million for the year ended
December 31, 2022, an increase of $8.9 million, or 97%, over the year ended December 31, 2021. Total HF revenue units in the
U.S. totaled 587 and 290 for the years ended December 31, 2022 and 2021, respectively. HF revenue in the U.S. totaled $17.6 million
and $8.4 million for the years ended December 31, 2022 and 2021, 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.
As of December 31, 2022, the Company had a total of 106 active
implanting centers, as compared to 46 as of December 31, 2021. The number of sales territories in the U.S. increased by 12 to a total
of 26 during the year ended December 31, 2022.
Legacy hypertension revenue in the U.S. totaled $0.5 million and $0.7
million for each of the years ended December 31, 2022 and 2021, respectively.
Revenue generated in Europe was $4.4 million for the year ended December 31,
2022, an increase of $0.6 million, or 14%, over the year ended December 31, 2021. Total revenue units in Europe increased to 231
for the year ended December 31, 2022, from 176 for the prior year period. The revenue increase was primarily due to the lessening
impact of the COVID-19 pandemic in Europe. The number of sales territories in Europe remained consistent at six during the year ended
Gross profit was $17.5 million for the year ended December 31,
2022, an increase of $8.1 million, or 86%, over the year ended December 31, 2021. Gross margin increased to 78% for the year ended
December 31, 2022, compared to 72% for the year ended December 31, 2021. Gross margin for the year ended December 31, 2022
was higher due to a decrease in the cost per unit and an increase in the average selling price. This was partially offset by a larger
percentage of our revenue units coming from full systems versus battery replacements.
R&D expenses increased $2.5 million, or 33%, to $10.0 million for
the year ended December 31, 2022, compared to the year ended December 31, 2021. This change was primarily driven by a $1.8 million
increase in compensation expenses, mainly as a result of increased headcount, a $0.4 million increase in consulting fees, a $0.2 million
increase in clinical study expenses and a $0.1 million increase in non-cash stock-based compensation expense.
SG&A expenses increased $22.2 million, or 80%, to $50.0 million
for the year ended December 31, 2022, compared to the year ended December 31, 2021. This change was driven by a $12.3 million
increase in compensation expenses, mainly as a result of increased headcount, a $2.4 million increase in travel expenses, a $1.8 million
increase in non-cash stock-based compensation expense, a $1.7 million increase in marketing and advertising expenses, primarily related
to the commercialization of Barostim in the U.S., a $1.2 million increase related to D&O insurance costs incurred as a result of becoming
a public company, a $0.9 million increase in professional fees, and a $0.6 million increase in consulting expenses.
Other income, net was $1.4 million for the year ended December 31,
2022, compared to other expense, net of $14.8 million for the year ended December 31, 2021. Other income, net in 2022 was primarily
driven by $1.5 million in interest income on our interest-bearing account. Other expense, net in 2021 was primarily driven by a $13.7
million increase in expense related to the increase in fair value of our convertible preferred stock warrants due to the change in the
value of our common stock from December 31, 2021 to July 2, 2021, which is the date the warrants converted to common stock warrants.
The expense in 2021 was also due to a $1.3 million loss on debt extinguishment in connection with the November 2021 repayment of
the outstanding debt under the Horizon loan agreement.
Net loss was $41.4 million, or $2.02 per share, for the full year ended
December 31, 2022, compared to a net loss of $43.1 million, or $4.16 per share, for the full year ended December 31, 2021.
As of December 31, 2022, cash and cash equivalents were $106.2
million. Net cash used in operating and investing activities was $43.4 million for the year ended December 31, 2022, compared to
$28.9 million for the year ended December 31, 2021.
For the full year of 2023, the Company expects: