Full Press Release Details
CVRx Reports Fourth Quarter and Full Year 2021
Financial and Operating Results
Fourth Quarter 2021 Revenue of $3.7 million,
a 75% Increase Over Prior Year
MINNEAPOLIS, February 15, 2022 (GLOBE NEWSWIRE) -- CVRx, Inc. (NASDAQ:
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
"We are very proud of everything we accomplished in 2021 despite
the challenging global environment. We more than doubled our revenue as a result of the successful launch of Barostim for heart failure
in the United States and we also made significant progress advancing our product innovation pipeline," said Nadim Yared, President
and Chief Executive Officer of CVRx. "We are excited about the position we are in as we move into 2022. Throughout the year we will
be focused on driving accelerated adoption by executing on our commercial strategy, which includes the continued expansion of our salesforce
and the efforts to educate healthcare providers and consumers on the benefits of Barostim."
Fourth Quarter 2021 Financial and Operating Results
| Revenue by Product Category/Geography | ||||||||||||
| Three months ended December 31, | ||||||||||||
| 2021 | 2020 | |||||||||||
| Amount | Amount | % Change | ||||||||||
| (dollars in thousands) | ||||||||||||
| U.S. Heart Failure (HF) | $ | 2,702 | $ | 607 | 345 | % | ||||||
| U.S. Legacy Hypertension | $ | 156 | $ | 224 | (30 | )% | ||||||
| United States | $ | 2,858 | $ | 831 | 244 | % | ||||||
| Europe | $ | 800 | $ | 1,257 | (36 | )% | ||||||
| Total Revenue | $ | 3,658 | $ | 2,088 | 75 | % |
Revenue was $3.7 million for the
three months ended December 31, 2021, an increase of $1.6 million, or 75%, over the three months ended December 31, 2020.
Revenue generated in the U.S. was $2.9 million for the three months
ended December 31, 2021, an increase of $2.0 million, or 244%, over the three months ended December 31, 2020. HF revenue units in the
U.S. totaled 95 and 21 for the three months ended December 31, 2021 and 2020, respectively. HF revenue in the U.S. totaled $2.7 million
and $0.6 million for the three months ended December 31, 2021 and 2020, 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, 2021, the Company had a total of 46 active
implanting centers, as compared to 38 as of September 30, 2021. 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 14
during the three months ended December 31, 2021.
Revenue generated in Europe was $0.8 million for the three months ended
December 31, 2021, a decrease of $0.5 million, or 36%, over the three months ended December 31, 2020. Total revenue units in Europe decreased
to 39 for the three months ended December 31, 2021 from 55 in the prior year period. The decrease is due to the reduced procedure volumes
in Germany in December 2021 due to COVID-related headwinds. The number of sales territories in Europe remained consistent at six during
three months ended December 31, 2021.
profit was $2.7 million for the three months ended December 31, 2021, an increase of $1.0 million, or 63%, over the three months ended
December 31, 2020. Gross margin decreased to 73% for the three months ended December 31, 2021 compared to 78% for the three months ended
December 31, 2020. Gross margin for the three months ended December 31, 2021 was lower due to a larger percentage of our revenue
units coming from full systems versus battery replacements for existing patients. New patients receive a full system that includes
an IPG and a stimulation lead and have a lower gross margin than a stand-alone IPG used for a battery replacement. This was partially
offset by an increase in our average selling price.
R&D expenses increased $1.3 million, or 252%, to $1.8 million for
the three months ended December 31, 2021 compared to the three months ended December 31, 2020. This change was primarily due to an increase
in clinical study expenses due to a $1 million non-recurring reduction in a clinical accrual in the fourth quarter of 2020. Additionally,
this increase was driven by a $0.2 million increase in compensation expenses as a result of increased headcount and a $0.1 million increase
in non-cash stock-based compensation expense.
SG&A expenses increased $6.4 million, or 196%, to $9.7 million
for the three months ended December 31, 2021 compared to the three months ended December 31, 2020. This change was driven by an increase
of $3.0 million in compensation expenses as a result of increased headcount, a $1.2 million increase in marketing and advertising expenses,
primarily related to the commercialization of Barostim in the U.S., a $0.6 million increase in non-cash stock-based compensation expense,
a $0.7 million increase related to D&O insurance costs incurred as a result of becoming a public company and a $0.5 million increase
Other expense, net was $1.4 million for the three months ended December
31, 2021 compared to $0.6 million for the three months ended December 31, 2020. The expense 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.
The expense in the fourth quarter of 2020 was primarily driven by the increase in the fair value of the convertible preferred stock warrant
liability from September 30, 2020 to December 31, 2020.
Net loss was $10.6 million, or $0.52 per share, for the three months
ended December 31, 2021, compared to a net loss of $3.4 million, or $10.04 per share, for the three months ended December 31, 2020. Net
loss per share was based on 20,367,064 weighted average shares outstanding for three months ended December 31, 2021 and 360,412 weighted
average shares outstanding for the fourth quarter of 2020.
Full Year 2021 Financial and Operating Results
| Revenue by Product Category/Geography | ||||||||||||
| Full year ended December 31, | ||||||||||||
| 2021 | 2020 | |||||||||||
| Amount | Amount | % Change | ||||||||||
| (dollars in thousands) | ||||||||||||
| U.S. Heart Failure (HF) | $ | 8,429 | $ | 987 | 754 | % | ||||||
| U.S. Legacy Hypertension | $ | 718 | $ | 746 | (4 | )% | ||||||
| United States | $ | 9,147 | $ | 1,733 | 428 | % | ||||||
| Europe | $ | 3,889 | $ | 4,320 | (10 | )% | ||||||
| Total Revenue | $ | 13,036 | $ | 6,053 | 115 | % |
Revenue was $13.0 million for the
full year ended December 31, 2021, an increase of $7.0 million, or 115%, over the full year ended December 31, 2020.
Revenue generated in the U.S. was $9.1 million for the full year ended
December 31, 2021, an increase of $7.4 million, or 428%, over the full year ended December 31, 2020. HF revenue units in the U.S. totaled
290 and 32 for the full years ended December 31, 2021 and 2020, respectively. HF revenue in the U.S. totaled $8.4 million and $1.0 million
for the full years ended December 31, 2021 and 2020, respectively. The increase was primarily driven by continued growth following the
commercial launch in 2020, which resulted in the expansion into new sales territories, new accounts and increased physician and patient
awareness of Barostim.
As of December 31, 2021, the Company had a total of 46 active implanting
centers, as compared to 11 as of December 31, 2020. The number of sales territories in the U.S. increased by eight to a total of 14 during
the full year ended December 31, 2021.
Revenue generated in Europe was $3.9 million for the full year ended
December 31, 2021, a decrease of $0.4 million, or 10%, over the full year ended December 31, 2020. Total revenue units in Europe decreased
to 176 for the full year ended December 31, 2021 from 193 for the prior year period. The decrease is due to reduced procedure volumes
resulting from the Delta and Omicron variants of COVID-19 in 2021.
profit was $9.4 million for the full year ended December 31, 2021, an increase of $4.8 million, or 104%, over the full year ended December
31, 2020. Gross margin decreased to 72% for the full year ended December 31, 2021 compared to 76% for the full year ended December 31,
2020. Gross margin for the year ended December 31, 2021 was lower due to a larger percentage of our revenue units coming from full
systems versus battery replacements for existing patients. This was partially offset by an increase in the average selling price.
R&D expenses increased $1.1 million, or 17%, to $7.5 million for
the full year ended December 31, 2021 compared to the full year ended December 31, 2020. This change was primarily driven by a $0.4 million
increase in clinical study expenses, a $0.4 million increase in compensation expenses as a result of increased headcount and a $0.4 million
increase in non-cash stock-based compensation expense.
SG&A expenses increased $18.1 million, or 187%, to $27.9 million
for the full year ended December 31, 2021 compared to the full year ended December 31, 2020. This change was driven by an increase of
$9.0 million in compensation expenses as a result of increased headcount, a $3.1 million increase in marketing and advertising expenses,
primarily related to the commercialization of Barostim in the U.S., a $1.4 million increase in non-cash stock-based compensation expense,
a $1.3 million increase related to D&O insurance costs incurred as a result of becoming a public company, a $1.2 million increase
in travel expenses and a $1.0 million increase in consulting expenses.
Other expense, net was $14.8 million for the full year ended December
31, 2021 compared to $40,000 for the full year ended December 31, 2020. The expense in 2021 was primarily driven by a $13.7 million increase
in expense related to the increase in the fair value of our convertible preferred stock warrants due to the change in the value of our
common stock from December 31, 2020 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 $43.1 million, or $4.16 per share, for the full year ended
December 31, 2021, compared to a net loss of $14.1 million, or $37.01 per share, for the full year ended December 31, 2020.
As of December 31, 2021, cash and cash equivalents were $142.1 million.
Net cash used in operating and investing activities was $28.9 million for the year ended December 31, 2021, compared to $16.4 million
for the year ended December 31, 2020.
For the full year of 2022, the Company expects: