CVRx Reports Second Quarter 2024 Financial and Operating Results

Rhea-AI Summary

CVRx, Inc. (NASDAQ: CVRX) reported strong Q2 2024 financial results, with total revenue reaching $11.8 million, a 24% increase year-over-year. U.S. Heart Failure revenue grew 27% to $10.5 million. The company expanded its active implanting centers in the U.S. by 35% compared to Q2 2023. CVRx appointed new executives, including a Chief Revenue Officer, to strengthen its leadership team. Despite revenue growth, the company reported a net loss of $14.0 million, or $0.65 per share. CVRx updated its full-year 2024 guidance, projecting total revenue between $50.0 million and $53.0 million. The company remains focused on expanding therapy awareness, strengthening clinical evidence, and improving patient access for its Barostim technology.

Positive

• Total revenue increased 24% year-over-year to $11.8 million in Q2 2024
• U.S. Heart Failure revenue grew 27% to $10.5 million
• Active implanting centers in the U.S. increased by 35% compared to Q2 2023
• Gross profit increased 24% to $9.9 million with a stable gross margin of 84%
• Number of sales territories in the U.S. increased by three to a total of 42
• Strengthened executive team with key appointments to drive market development

Negative

• Net loss increased to $14.0 million in Q2 2024 from $11.6 million in Q2 2023
• SG&A expenses increased 28% to $21.1 million
• Revenue generated in Europe decreased by 6% to $1.1 million
• Cash and cash equivalents decreased to $70.4 million as of June 30, 2024

Financial Analyst

CVRx's Q2 2024 results demonstrate solid growth, particularly in the U.S. Heart Failure (HF) segment. The 24% year-over-year revenue increase to $11.8 million is impressive, with U.S. HF revenue growing 27% to $10.5 million. This growth is driven by expansion into new sales territories and increased awareness of their Barostim technology.

Key financial metrics to note:

• Gross margin remained stable at 84%, indicating consistent production efficiency.
• R&D expenses decreased by 16%, which could be a concern if it impacts future innovation.
• SG&A expenses increased by 28%, primarily due to increased headcount and stock-based compensation. This investment in sales and marketing could drive future growth but also impacts profitability in the short term.
• Net loss widened to $14.0 million ($0.65 per share) from $11.6 million ($0.56 per share) in Q2 2023.
• Cash position of $70.4 million provides runway for continued growth initiatives.

The company's updated guidance for 2024, with expected revenue between $50.0 million and $53.0 million, suggests confidence in continued growth. However, investors should monitor the increasing operating expenses and widening net loss, as the path to profitability remains a key concern for early-stage medical device companies.

Medical Research Analyst

CVRx's Barostim technology represents an innovative approach to treating heart failure through neuromodulation. The 35% increase in active implanting centers to 189 in the U.S. indicates growing acceptance among healthcare providers. This expansion is important for market penetration and suggests increasing confidence in the technology's efficacy.

The company's focus on strengthening clinical evidence is prudent. The appointment of Dr. Philip Adamson as Chief Medical Officer and Jennifer Englund as SVP of Global Clinical Research underscores CVRx's commitment to enhancing their clinical data. This strategy is vital in the medical device industry, where robust clinical evidence can drive adoption and potentially influence reimbursement decisions.

However, it's important to note that while the technology shows promise, long-term clinical outcomes and comparative effectiveness studies will be important for Barostim to become the standard of care in heart failure treatment. Investors should closely monitor upcoming clinical data and real-world evidence, as these will be key drivers for future growth and market acceptance.

Market Research Analyst

CVRx's market strategy appears well-aligned with the growing demand for innovative heart failure treatments. The expansion to 42 sales territories in the U.S. and consistent presence in Europe with 6 territories demonstrate a focused approach to market penetration. The 27% growth in U.S. Heart Failure revenue suggests strong market traction.

The recent leadership appointments, particularly Robert John as Chief Revenue Officer and Bonnie Handke as SVP of Patient Access, Reimbursement and Healthcare Economics, indicate a strategic focus on market development and addressing key barriers to adoption. These hires could potentially accelerate market penetration and improve patient access to Barostim therapy.

However, the slight decrease in European revenue (down 6% year-over-year) warrants attention. CVRx may need to reassess its European strategy to ensure balanced global growth. The company's ability to navigate regulatory landscapes, secure favorable reimbursement policies and compete with established heart failure treatments will be important for long-term success.

The projected revenue growth for Q3 2024 ($12.7 million to $13.7 million) suggests continued momentum. However, investors should monitor market adoption rates, reimbursement progress and competitive dynamics in the neuromodulation and heart failure treatment spaces to gauge CVRx's long-term market potential.

MINNEAPOLIS, July 29, 2024 (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 second quarter of 2024.

Recent Highlights

• Total revenue for the second quarter 2024 was $11.8 million, an increase of 24% over the prior year quarter
• U.S. Heart Failure (HF) revenue for the second quarter of 2024 was $10.5 million, an increase of 27% over the prior year quarter
• Active implanting centers in the U.S. were 189, an increase of 35% over the second quarter of 2023
• Hired new Chief Revenue Officer and completed expansion of executive leadership team

“We are pleased with our solid second quarter results, driven by another record quarter in our U.S. Heart Failure business. We remain extremely optimistic about the Barostim technology and our market opportunity. Our recent leadership appointments have significantly bolstered our executive team, positioning us well to address key market development priorities,” said Kevin Hykes, President and Chief Executive Officer of CVRx. “Our focus is on continuing to broaden therapy awareness, strengthen our clinical evidence, and improve patient access. With our innovative technology, expanding market presence, and the depth of expertise on our expanded leadership team, we're well-positioned to drive Barostim towards becoming standard of care, making a meaningful difference in the lives of those suffering from heart failure and other cardiovascular diseases.”

Second Quarter 2024 Financial and Operating Results

Revenue was $11.8 million for the three months ended June 30, 2024, an increase of $2.3 million, or 24%, over the three months ended June 30, 2023.

Revenue generated in the U.S. was $10.7 million for the three months ended June 30, 2024, an increase of $2.4 million, or 29%, over the three months ended June 30, 2023. HF revenue units in the U.S. totaled 339 and 265 for the three months ended June 30, 2024 and 2023, respectively. HF revenue in the U.S. totaled $10.5 million and $8.3 million for the three months ended June 30, 2024 and 2023, 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 June 30, 2024, the Company had a total of 189 active implanting centers, as compared to 190 as of March 31, 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 42 during the three months ended June 30, 2024.

Revenue generated in Europe was $1.1 million for the three months ended June 30, 2024, a decrease of $0.1 million, or 6%, over the three months ended June 30, 2023. Total revenue units in Europe increased to 63 for the three months ended June 30, 2024 from 56 in the prior year period. The number of sales territories in Europe remained consistent at six for the three months ended June 30, 2024.

Gross profit was $9.9 million for the three months ended June 30, 2024, an increase of $1.9 million, or 24%, over the three months ended June 30, 2023. Gross margin was 84% for each of the three months ended June 30, 2024 and June 30, 2023.

R&D expenses decreased $0.5 million, or 16%, to $2.8 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This change was driven by a $0.4 million decrease in consulting expenses and a $0.1 million decrease in compensation expenses.

SG&A expenses increased $4.7 million, or 28%, to $21.1 million for the three months ended June 30, 2024 compared to the three months ended June 30, 2023. This change was primarily driven by a $2.6 million increase in compensation expenses, mainly as a result of increased headcount, a $1.0 million increase in non-cash stock-based compensation expense, a $0.4 million increase in advertising expenses, a $0.2 million increase in travel expenses, and a $0.2 million increase in consulting expenses.

Other income, net increased $0.3 million for the three months ended June 30, 2024, compared to the three months ended June 30, 2023. This increase was primarily driven by greater interest income on our interest-bearing accounts.

Net loss was $14.0 million, or $0.65 per share, for the three months ended June 30, 2024, compared to a net loss of $11.6 million, or $0.56 per share, for the three months ended June 30, 2023. Net loss per share was based on 21.6 million weighted average shares outstanding for three months ended June 30, 2024 and 20.7 million weighted average shares outstanding for the three months ended June 30, 2023.

As of June 30, 2024, cash and cash equivalents were $70.4 million. Net cash used in operating and investing activities was $10.2 million for the quarter ended June 30, 2024. This is compared to net cash used in operating and investing activities of $11.8 million for the three months ended March 31, 2024.

Leadership Team Expansion

During the quarter, the Company strengthened its executive team to drive market development priorities. Key appointments include Robert John as Chief Revenue Officer, bringing over 25 years of sales leadership experience in the medical device industry; Dr. Philip Adamson as Chief Medical Officer; Bonnie Handke as SVP of Patient Access, Reimbursement, and Healthcare Economics; Jennifer Englund as SVP of Global Clinical Research to enhance clinical evidence; and Tonya Austin as Chief Human Resources Officer. These strategic hires position CVRx to effectively address awareness, clinical, and patient access barriers as it drives Barostim towards becoming standard of care for heart failure.

Business Outlook

For the full year of 2024, the Company now expects:

• Total revenue between $50.0 million and $53.0 million;
• Gross margin between 83.0% and 85.0%; and
• Operating expenses between $95.0 million and $98.0 million, up from previously issued guidance of $92.0 million and $98.0 million
  

For the third quarter of 2024, the Company expects to report total revenue between $12.7 million and $13.7 million.

Webcast and Conference Call Information

The Company 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.

About CVRx, Inc.

CVRx is a commercial-stage medical device company focused on developing, manufacturing and commercializing innovative neuromodulation solutions for patients with cardiovascular diseases. Barostim™ is the first medical technology approved by FDA that uses neuromodulation to improve the symptoms of patients with heart failure. Barostim is an implantable device that delivers electrical pulses to baroreceptors located in the wall of the carotid artery. 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 third quarter 2024 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 press release are only predictions and are based largely on our current expectations and projections about future events and financial trends that we believe may affect our business, financial condition, and results of operations. These forward-looking statements speak only as of the date of this press release and are subject to a number of known and unknown risks, uncertainties and assumptions, including, but not limited to, our history of significant losses, which we expect to continue; our limited history operating as a commercial company and our dependence on a single product, Barostim; our limited commercial sales experience marketing and selling Barostim; our ability to demonstrate to physicians and patients the merits of our Barostim; any failure by third-party payors to provide adequate coverage and reimbursement for the use of Barostim; our competitors’ success in developing and marketing products that are safer, more effective, less costly, easier to use or otherwise more attractive than Barostim; any failure to receive access to hospitals; our dependence upon third-party manufacturers and suppliers, and in some cases a limited number of suppliers; a pandemic, epidemic or outbreak of an infectious disease in the U.S. or worldwide; product liability claims; future lawsuits to protect or enforce our intellectual property, which could be expensive, time consuming and ultimately unsuccessful; any failure to retain our key executives or recruit and hire new employees; impacts on adoption and regulatory approvals resulting from additional long-term clinical data about our product; and other important factors that could cause actual results, performance or achievements to differ materially from those that are found in “Part I, Item 1A. Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2023, as such factors may be updated from time to time in our other filings with the Securities and Exchange Commission. Except as required by applicable law, we do not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise. 

Investor Contact:
Mark Klausner or Mike Vallie
ICR Westwicke
443-213-0501
ir@cvrx.com

Media Contact:
Laura O’Neill
Finn Partners
402-499-8203
laura.oneill@finnpartners.com

CVRx, INC. Condensed Consolidated Balance Sheets (In thousands, except share and per share data) (Unaudited)
		June 30,				December 31,
		2024				2023
Assets
Current assets:
Cash and cash equivalents		$	70,400			$	90,569
Accounts receivable, net of allowances of $656 and $508, respectively			8,606				7,551
Inventory			11,224				10,983
Prepaid expenses and other current assets			1,762				2,987
Total current assets			91,992				112,090
Property and equipment, net			2,763				1,763
Operating lease right-of-use asset			1,200				1,349
Other non-current assets			26				27
Total assets		$	95,981			$	115,229
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable		$	3,516			$	1,884
Accrued expenses			5,610				5,980
Total current liabilities			9,126				7,864
Long-term debt			29,319				29,222
Operating lease liability, non-current portion			1,023				1,160
Other long-term liabilities			1,265				1,036
Total liabilities			40,733				39,282
Commitments and contingencies
Stockholders’ equity:
Common stock, $0.01 par value, 200,000,000 authorized as of June 30, 2024 and December 31, 2023; 21,712,357 and 20,879,199 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively			217				209
Additional paid-in capital			568,837				553,326
Accumulated deficit			(513,596	)			(477,381	)
Accumulated other comprehensive loss			(210	)			(207	)
Total stockholders’ equity			55,248				75,947
Total liabilities and stockholders’ equity		$	95,981			$	115,229

CVRx, INC. Condensed Consolidated Statements of Operations and Comprehensive Loss (In thousands, except share and per share data) (Unaudited)
		Three months ended								Six months ended
		June 30,								June 30,
		2024				2023				2024				2023
Revenue		$	11,807			$	9,500			$	22,577			$	17,479
Cost of goods sold			1,900				1,517				3,515				2,845
Gross profit			9,907				7,983				19,062				14,634
Operating expenses:
Research and development			2,765				3,280				5,822				6,696
Selling, general and administrative			21,115				16,455				49,445				31,852
Total operating expenses			23,880				19,735				55,267				38,548
Loss from operations			(13,973	)			(11,752	)			(36,205	)			(23,914	)
Interest expense			(959	)			(481	)			(1,919	)			(721	)
Other income, net			944				616				1,988				1,678
Loss before income taxes			(13,988	)			(11,617	)			(36,136	)			(22,957	)
Provision for income taxes			(41	)			(34	)			(79	)			(68	)
Net loss			(14,029	)			(11,651	)			(36,215	)			(23,025	)
Cumulative translation adjustment			—				17				(3	)			20
Comprehensive loss		$	(14,029	)		$	(11,634	)		$	(36,218	)		$	(23,005	)
Net loss per share, basic and diluted		$	(0.65	)		$	(0.56	)		$	(1.69	)		$	(1.11	)
Weighted-average common shares used to compute net loss per share, basic and diluted			21,628,542				20,711,850				21,430,276				20,702,589

FAQ

What was CVRx's total revenue for Q2 2024?

CVRx reported total revenue of $11.8 million for Q2 2024, representing a 24% increase compared to the same period in 2023.

How much did CVRx's U.S. Heart Failure revenue grow in Q2 2024?

CVRx's U.S. Heart Failure revenue grew by 27% to $10.5 million in Q2 2024 compared to the prior year quarter.

What is CVRx's updated revenue guidance for full-year 2024?

CVRx updated its full-year 2024 revenue guidance to between $50.0 million and $53.0 million.

How many active implanting centers did CVRx have in the U.S. as of Q2 2024?

CVRx had 189 active implanting centers in the U.S. as of Q2 2024, representing a 35% increase over Q2 2023.

What was CVRx's net loss per share for Q2 2024?

CVRx reported a net loss of $0.65 per share for Q2 2024, compared to a net loss of $0.56 per share in Q2 2023.