CVRx misses in Q4, wins FDA approval for new IPG

CVRx (NSDQ:CVRX) posted fourth-quarter results today that fell short of the consensus forecast on Wall Street and offered its outlook for the year ahead.

The Brooklyn Park, Minnesota-based neuromodulation implant developer reported a loss of $10.57 million, or $0.52 per diluted share, on sales of $3.7 million for the three months ended Dec. 31, 2021, for a bottom-line loss of 210% and sales growth of 75% compared with Q4 2020.

The loss was $0.08 per share deeper than expected by the Street, where analysts were looking for EPS of -$0.44 on sales of $3.86 million.

Full-year revenue climbed to $13 million, a 115% increase over the year before, but just short of the company’s projection after the third quarter.

The company lost nearly $43.1 million in 2021, compared to a $14.1 million loss in 2020. Significant costs included $27.9 million for selling, general and administrative expenses (up 187%) as the company hires employees and spends on marketing and advertising related to the commercialization of CVRx’s Barostim therapy for heart failure. The company also reported a $13.7 million increase in stock-related expenses, and in November paid $21.3 million to fully repay a $20 million loan from Horizon Technology Finance Corp.

Though the loss grew by total dollar value, when calculated on a per-share basis, it fell from $10.04 in Q4 2020 due to the growth of the number of shares outstanding. CVRx went public with a $126 million IPO in June 2021; the company reported 360,412 shares outstanding around the end of 2020 and nearly 20.4 million at the end of 2021.

CVRx said it expects $3.6 million to $4 million in first-quarter revenue and full-year revenue of $20 million to $23 million in 2022.

“We are excited about the position we are in as we move into 2022,” CVRx CEO Nadim Yared said in a news release. “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.”

CVRx won FDA approval for its Barostim Neo system — the first heart failure neuromodulation device — in 2019. The company describes its technology as “designed to electrically activate the baroreflex, the body’s natural mechanism to regulate cardiovascular function.”

More recently, the company won FDA approval in December 2021 for a new, smaller IPG (implantable pulse generator) that the company said will deliver 20% longer battery life.

CVRx expects FDA approval in the first half of 2022 for MRI conditional labeling (allowing magnetic scanning with specific instructions for Barostim patients) and a new programmer to simplify the software in a tablet form.

The company’s early backers included GlaxoSmithKline and Johnson & Johnson, the latter of which remains the largest shareholder.

UPDATE: CVRx stock was trading around $8.33 per share, down about 3%, the day after the company released its financial results.