Q2 2024 Earnings Summary
- The On-X mechanical valve segment is growing at 15%, consistently taking market share both in the U.S. and internationally. New clinical data shows an 85% reduction in major bleeding, making it more comparable to bioprosthetic valves and attracting patients under 70.
- Strong financial performance with 10% top-line growth and 35% bottom-line growth, demonstrating significant operational leverage. The company expects to grow double digits on the top line and twice that on the bottom line going forward, leveraging their scalable sales force and infrastructure.
- Promising pipeline with the NEXUS aortic arch stent graft system, targeting a $600 million total addressable market. Early data is excellent, with the U.S. IDE trial nearing completion. The NEXUS device can significantly reduce hospital stays for chronic dissection patients, potentially capturing half of the global chronic dissection market.
- The company expects Q3 growth to be lighter than Q2 due to timing issues, with Q3 typically being their lowest revenue quarter, which could indicate potential slowdown in growth momentum.
- There is a significant decline in 'Other revenue' caused by reduced PerClot orders from Baxter, with limited visibility into underlying sales, introducing uncertainty about this revenue stream.
- The CEO mentions that the launch of NEXUS is expected to have modest uptake initially, and further trials are needed, suggesting that significant revenue impact from NEXUS may be delayed.
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Long-Term Growth Outlook
Q: Can we expect continued double-digit growth ahead?
A: Yes, we feel confident about being a consistent double-digit grower for an extended period, with the ability to grow the bottom line at least 2x the top line. This year, our guidance is 3x the top-line growth at the midpoint. We have a dependable core business and an amazing pipeline. -
NEXUS Device Adoption
Q: How should we think about NEXUS's commercial adoption?
A: We're investing in future aortic technology with NEXUS. We've enrolled 50 out of 60 patients in the U.S. IDE trial and expect to complete enrollment by year-end. We aim to capture half of the $600 million chronic dissection market. The data has been excellent, and the trial is almost done. -
On-X Valve Growth
Q: What's driving On-X Valve's double-digit growth?
A: We're growing the mechanical valve segment at 15%, continuing to take share in both U.S. and international markets. Recent data shows an 85% reduction in major bleeding, making it compelling for patients under 70. We're increasing prices due to our differentiated clinical outcomes. -
Sales Force Leverage
Q: How does sales force productivity impact margins?
A: Our experienced sales force allows us to grow the top line 10% and the bottom line 35% without scaling reps one-to-one with revenue. Most U.S. reps have over 10 years with the company, enabling us to leverage existing relationships and products like On-X, SynerGraft, and BioGlue, and future products like AMDS. -
Pricing Strategy
Q: Is there room for further price increases?
A: We will charge premium prices where warranted, especially for highly differentiated products backed by compelling clinical data. For example, our SynerGraft pulmonary valves with 25-year results and On-X valve with new data justify higher prices. We'll continue to charge what we consider a fair price. -
EBITDA Guidance
Q: Why is EBITDA growth flat in the back half?
A: There's some timing of spend between Q2 and Q3. We had a strong Q2 EBITDA and expect a strong second half, though Q3 growth may be lighter due to timing. Q3 is typically our lowest revenue quarter, impacting EBITDA. -
BioGlue Outlook
Q: What's behind BioGlue's strong Q2 performance?
A: BioGlue grew 12% in Q2, up from 1% in Q1, but we expect mid-single-digit growth on average due to the lumpy nature of the business. We sell in 110 countries, so revenue phasing can vary each quarter. -
Stent Graft Growth
Q: How is the stent graft portfolio performing?
A: Our highly differentiated, higher-margin stent graft segment is growing double digits in every category. Even in the more competitive areas, we're seeing double-digit growth. The whole portfolio is doing extremely well. -
PerClot Revenue Impact
Q: Any updates on PerClot and Baxter's impact?
A: PerClot isn't meaningful to us, and fluctuations are due to Baxter's inventory management. They're continuing to ramp up, but it's not significant to either company at this time.