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Medical device company Nevro Corp. stock is trading higher on Tuesday after it announced receiving CE Mark Certification in Europe for its HFX iQ spinal cord stimulation (SCS) system.
The company says HFX iQ is the first and only SCS system with artificial intelligence (AI) technology that combines high-frequency (10 kHz) therapy built on landmark evidence that uses ongoing cloud data insights to deliver personalized pain relief.
HFX iQ starts patients on the program most likely to provide pain relief, based on the HFX Algorithm, built from over 20 million data points and 80,000 implanted patients.
HFX iQ combines clinical inputs, such as pain relief and pain score, along with Quality of Life inputs, such as pain medication and activity level changes, to provide an individualized program setting for each patient.
HFX iQ can program low frequency and Nevro’s proprietary 10 kHz Therapy, representing the widest range of frequencies of any SCS system on the market.
The Senza HFX iQ system includes the HFX iQ Implantable Pulse Generator (IPG), HFX Trial Stimulator, and HFX App.
In addition to receiving CE marking, HFX iQ received FDA approval in 2022.
Nevro will offer the HFX iQ system in select European countries starting in the first quarter of 2025.
Nevro reported an EPS loss of $(0.41), beating the consensus of $(0.76). Sales were $96.91 million, surpassing the consensus of $93.1 million.
Guidance: Nevro expects 2024 revenue of $400 million-$405 million compared to the consensus of $402.6 million.
The company raised its full-year 2024 adjusted EBITDA loss guidance to $18 million-$16 million from its previous loss guidance of $20 million-$18 million.
Analyst Reaction:
Price Action: NVRO stock is up 8.46% at $5.77 at last check Tuesday.
Read Next:
Photo: Gorodenkoff/Shutterstock.com
© 2024 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.
Nevro Corp. NVRO reported a loss per share of 41 cents in the third quarter of 2024, narrower than the year-ago quarter’s loss of 65 cents. The Zacks Consensus Estimate is pegged at a loss per share of 82 cents.
Revenues in Detail
Nevro registered worldwide revenues of $96.9 million in the third quarter, down 6.7% year over year on a reported basis and 7% on a constant-currency basis. The year-over-year decline was primarily due to competitive pressures in the U.S. spinal cord stimulation (SCS) market and ongoing softness in the core U.S. SCS market. However, the figure topped the Zacks Consensus Estimate by 4.1%.
Quarterly Highlights
In the quarter under review, international revenues were $13 million, down 7.7% year over year on a reported basis and 9.6% at a constant exchange rate (CER). The year-over-year decline was primarily due to the short-term impact of negative SCS-related media reports in Australia, which resulted in the postponement and cancelation of cases, as well as the impact of healthcare reform in Germany, which caused a delay in procedures in the third quarter of 2024.
U.S. revenues for the quarter totaled $83.9 million, down 6.5% year over year.
Total U.S. permanent implant procedures declined 9.6% year over year, while U.S. trial procedures decreased 15.2% year over year. The year-over-year decrease in U.S. trials was primarily driven by competitive pressures and ongoing softness in the core U.S. SCS market during the quarter.
During the third quarter, Nevro announced the FDA approval and limited market release of HFX iQ AdaptivAI, a responsive, personalized pain management platform powering the HFX iQ SCS system. The company anticipates a full market release of HFX AdaptivAI in the United States in the fourth quarter of 2024.
Nevro also received regulatory approval to sell its HFX iQ system in CE-marked countries in the European Union. It expects to begin the limited market release in select regions of Europe in the fourth quarter of 2024 with the full market release planned for the first quarter of 2025.
During the reported quarter, Nevro’s comparative biomechanical data on Nevro1 was accepted for publication in Medical Devices: Evidence and Research. Nevro1 was found to provide equivalent and superior motion reduction, respectively, with a less invasive and less destructive approach while providing the largest surface area for fusion compared to other commercial SI joint transfixing devices.
Nevro Corp. Price, Consensus and EPS Surprise
Nevro Corp. price-consensus-eps-surprise-chart | Nevro Corp. Quote
Margin Trend
In the quarter under review, Nevro’s gross profit declined 7.1% year over year to $64.6 million. The gross margin in the third quarter of 2024 was 66.7% compared with 66.9% in the prior-year quarter.
Sales, general & administrative expenses decreased 15.6% year over year to $68.5 million. Research and development expenses decreased 24% year over year to $10.6 million. Operating expenses for the third quarter of 2024 were $78.5 million ($83.5 million excluding restructuring charges, intangible amortization, contingent consideration revaluations, and a year-over-year reduction in litigation-related expenses) compared with $95.1 million in the prior-year quarter.
The total operating loss in the reported quarter was $13.9 million ($18.9 million excluding restructuring charges, intangible amortization, contingent consideration revaluations, and year-over-year decrease in litigation-related expenses) compared with $25.6 million in the year-ago quarter.
Financial Position
Nevro exited the third quarter of 2024 with cash and cash equivalents and short-term investments of $277 million compared with $273.7 million at the end of the second quarter. Long-term debt at the end of third-quarter 2024 was $184.4 million compared with $180.6 million at the second-quarter end.
Guidance
Nevro has maintained its outlook for full-year 2024.
The company continues to expect its 2024 worldwide revenues in the range of $400 million-$405 million. The company's revised guidance assumes that U.S. SCS trialing growth rates are not likely to improve from the third quarter of 2024.
Per management, the guidance considers the impact of market challenges that NVRO is facing and reduced direct-to-consumer marketing spend from earlier this year. The guidance also includes some effect in the fourth quarter from the two hurricanes that hit the Southeast, causing a shortage in IV bags and, thus, a delay in procedures. The Zacks Consensus Estimate is pegged at $402.2 million.
Our Take
Nevro exited the third quarter of 2024 with better-than-expected results, with earnings and revenues beating their respective Zacks Consensus Estimate. Shares were up 14.5% during after-market trading. However, the stock plunged 75.3% year to date against the industry’s 6.7% growth and the S&P 500’s 26.1% increase.
Meanwhile, the company’s third-quarter revenues are affected by ongoing softness in the U.S. SCS market and competitive pressures. Total U.S. permanent implant procedures, as well as U.S. trial procedures, declined in the third quarter. However, NVRO is likely to witness growth opportunities in an underpenetrated SCS market with the launches of HFX AdaptivAI in the United States and HFX iQ in the EU. Also, the company’s diversification into the SI joint fusion is likely to generate additional revenues.
The gross margin is likely to face challenges during the second half of fiscal 2024 due to the accounting of inventory variances and overhead that occurred in 2023 as NVRO transitions from contract manufacturing to manufacturing in-house. Thus, NVRO expects a lower gross margin in the fourth quarter compared with the first half of this year. NVRO also expects lower production volumes from decreased sales in 2024 to continue to create certain margin headwinds next year as well.
However, NVRO continues to make progress in shifting additional work to the Costa Rica manufacturing facility to further leverage its investment there and continue on the path toward achieving a long-term gross margin in the mid-70% range and driving toward profitability.
Zacks Rank and Key Picks
Nevro currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the broader medical space are AngioDynamics ANGO, Quest Diagnostics DGX and RadNet RDNT. Each stock presently carries a Zacks Rank of 2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
ANGO’s earnings surpassed estimates in three of the trailing four quarters and missed once, delivering an average surprise of 31.71%.
AngioDynamics’ shares have lost 19.2% year to date against the industry’s6.1% growth.
Quest Diagnostics has an estimated long-term growth rate of 6.8%. DGX's earnings surpassed estimates in each of the trailing four quarters, the average surprise being 3.3%.
Quest Diagnostics’ shares have risen 42% year to date compared with the industry's 14.9% growth.
RadNet’s earnings surpassed estimates in each of the trailing four quarters, the average surprise being 98.2%.
RDNT’s shares have soared 93.7% year to date compared with the industry’s 14.8% growth.
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