Silk Road Medical, Inc (NASDAQ:SILK) Q1 2024 Earnings Call Transcript

In following enrollment completion, we look forward to the investigator sharing 30 day outcomes data, followed by the one year outcomes data down the road. Now I’d like to shift gears to discuss how we are expanding our competitive moat in carotid disease treatment through our product innovation. Last year, we launched a dedicated TCAR balloon, the Enflate balloon, which continues to track well to utilization expectations while maintaining a premium pricing strategy in the marketplace. More recently, we launched the tapered version of our ENROUTE transcarotid stent to offer additional options to fit individual patient anatomy. We initiated the full market release of our tapered stents ahead of plan in early March, and we are encouraged by the initial interest and uptake from customers.

Lucas will offer more details on the uptake in his remarks. The ENROUTE stent is the only carotid stent on the market that is available both in standard and high surgical risk indications, as well as both tapered and cylindrical configurations. And finally, in early April, we announced the release of our next generation ENROUTE transcarotid neuroprotection system or NPS Plus. This fourth generation device builds upon the prior ENROUTE transcarotid nerve protection system to deliver smoother arterial sheet insertion, greater flow protection and a simplified prep experience for endovascular teams, all while maintaining exquisite flow reversal neuro protection during the TCAR procedure. In initial cases with the NPS Plus, customers have noted the improved ease of use and faster case prep.

These features help further improve confidence in achieving an excellent outcome in patients undergoing TCAR and support continued progress along the adoption curve. And all three product launches are a direct result of carefully listening to feedback from our customers and delivering next generation solutions to enhance the TCAR experience. Beyond our efforts to bolster our core product offerings, we are investing in additional long term drivers of growth for the business, including international expansion. Our initial efforts have been focused on China and Japan where we’ve received regulatory approvals for ENROUTE stents and our ENROUTE NPS and and recently signed distribution agreements with respected regional market leaders with local expertise and capabilities.

Regulatory efforts to support clearance of the ENROUTE NPS Plus underway in both markets, as our market access, launch prep and post market study activities with our distributor partners and their provider and payer stakeholders. We will continue these efforts through 2024 and look forward to sharing more over the course of this year. Before I turn the call over to Lucas, I’d like to touch briefly on our efforts to deliver a strong, sustainable financial profile. We are pleased with our strong first quarter and the long-term growth trajectory we see for the business. We are also pleased to be driving operating leverage after years of significant investment. This progress was reflected in our first quarter adjusted EBITDA loss of $3.9 million, which is a significant improvement year-over-year as well as a modest sequential improvement.

We remain confident in our ability to drive full year 2024 adjusted EBITDA improvement relative to 2023 and also in our ability to reach profitability with the capital we have on hand. And with that, I’ll now turn the call over to Lucas Buchanan, our CFO and COO, to review financial results for the quarter.

Lucas Buchanan: Thank you, Chas. Revenue for the three months ended March 31, 2024 was $48.5 million, a 21% increase from $40.1 million in the same period of the prior year. Growth was driven primarily by increased TCAR adoption and continued healthy demand for our expanding portfolio of differentiated products. Our team supported over 6,725 TCAR procedures within the quarter, a 15% increase from the same period of the prior year. As our results demonstrate, Q1 revenue growth moderately outpaced our Q1 procedure growth. This was partially, but not entirely, due to a revenue benefit from our tapered stent launch in early March ahead of our original plan due to great preparation work from our team and notable customer demand. We also saw strong demand for our cylindrical stents within the quarter.

Together, these stent orders partially reflected a stocking dynamic as hospitals establish new par levels across size variations. As we have said in the past, we expect some variation between revenue growth and procedure growth from time to time. And looking forward, we continue to expect that revenue growth will sometimes outpace procedure growth and vice versa. That said, we view our Q1 procedure growth as the most reflective metric of current end market demand trends for TCAR and we are pleased that those demand trends remain healthy today. Gross margin for the first quarter of 2024 was 75% compared to 69% in the first quarter of the prior year. The increase in gross margin reflects unfavorable production variances we encountered in the prior year period, as well as the benefit to first quarter 2024 from favorable purchase price variances that we experienced in Q4 and expected in Q1 as called out in the prior earnings call.

Also, as mentioned prior, we expect gross margin to decline modestly in Q2 and begin to normalize thereafter. Accordingly, we continue to expect a modest improvement in full year 2024 gross margin over 2023. Total operating expenses for the first quarter of 2024 were $51.4 million, a 16% increase from $44.5 million in the first quarter of 2023. R&D expenses for the first quarter of 2024 were $10.7 million compared to $10.4 million in the first quarter of 2023. Sales, general and administrative expenses for the first quarter of 2024 were $40.8 million compared to $34.1 million in the first quarter of 2023. The increase was primarily driven by increased headcount and related expense in our commercial organization. As we leverage our stable commercial base and our at scale R&D and back office infrastructure, we continue to expect our forward revenue growth rate to outpace growth and operating expenses on a full year basis.

And in dollar terms, we expect steady quarterly operating expenses through the remainder of 2024 as compared to Q1. Net loss for the first quarter was $14.1 million or a loss of $0.36 per share as compared to a net loss of $16.5 million or a loss of $0.43 per share for the same period of the prior year. As a reminder, we introduced adjusted EBITDA into our reporting framework on our last call to further illuminate our operating profile and path to sustained operating profitability. Adjusted EBITDA for the first quarter of 2024 was a loss of $3.9 million compared to an adjusted EBITDA loss of $7.4 million in the prior year period. Today, we are pleased to maintain our expectation to recognize adjusted EBITDA improvement in the full year 2024 relative to 2023 when we recorded an adjusted EBITDA loss of $17.7 million.