Silk Road Medical, Inc (NASDAQ:SILK) Q3 2023 Earnings Call Transcript

Silk Road Medical, Inc (NASDAQ:SILK) Q3 2023 Earnings Call Transcript November 9, 2023

Operator: Good day and thank you for standing by. Welcome to the Silk Road Medical Third Quarter 2023 Conference Call. At this time, all participants are in a listen-only mode. After speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your first speaker today, Marissa Bych with Gilmartin Group, Director of Investor Relations. Marissa, please go ahead.

Marissa Bych: Great. Thank you for joining today’s call. Earlier today Silk Road Medical released financial results for the three months ended September 30, 2023. A copy of the press release is available on the company’s website. Before we begin, I’d like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws, which are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results or performance are forward-looking statements. All forward-looking statements, including, without limitation, those relating to our operating trends and future financial performance, expense management, expectations for hiring and growth in our organization and our business, physician training and adoption, market opportunity and penetration, commercial and international expansion, regulatory approvals, reimbursement, competition and product development are based upon our current estimates and various assumptions.

These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of the risks and uncertainties associated with our business, please refer to the risk factors section of our latest quarterly report on Form 10-Q filed with the Securities and Exchange Commission. This conference call contains time-sensitive information and is accurate only as of the live broadcast today, November 8, 2023. Silk Road Medical disclaims any intention or obligation, except as required by law to update or revise any financial projections or forward-looking statements, whether because of new information, future events or otherwise.

I will now turn the call over to Jack Lasersohn, Chairman of Silk Road Medical’s Board of Directors.

Jack Lasersohn: Good afternoon, everybody, and thank you for joining us. I am the Chairman of Silk Road Medical and have been a Director on the Board for over 15 years. I wanted to start our call today by welcoming Chas McKhann, our new Chief Executive Officer, and offering my excitement for the future of the company. Chas is on the line with us today and alongside Lucas Buchanan, our Chief Financial Officer and Chief Operating Officer. I will turn the line over to Lucas shortly to review our recent performance and drivers of the business. But first, I would like to thank Erica Rogers for her tremendous contributions to the company over the past 11 years. To-date, more than 75,000 patients have benefited from the TCAR procedure, which speaks to the incredible impact that the team here at Silk Road has had.

Erica has been instrumental in cultivating and enduring mission-focused culture at Silk Road and setting the company apart. We appreciate her leadership and wish her the very best looking forward. Meanwhile, we are thrilled to welcome Chas McKhann to the company. Chas has more than 25 years of experience in the medical device industry with over 20 years in C-suite positions building and scaling commercial businesses. Most recently, Chas served as President and CEO of Apollo Endosurgery, which was acquired by Boston Scientific in April of this year. At Apollo, Chas created and led a transformational growth strategy for the company’s minimally invasive technologies for gastrointestinal and bariatric conditions. Previously, he held commercial officer roles at Torax Medical and Intersect ENT, as well as leadership positions at Boston Scientific and Johnson & Johnson.

We are confident that Chas is the right leader alongside Lucas and the full leadership team to leverage our strong infrastructure, skilled commercial team and substantial body of clinical evidence to take the company further on the journey to treat patients with carotid artery disease. Under his leadership, Silk Road remains committed to the same mission, vision and values that have guided us since its founding. We look forward to executing a smooth transition and continue expanding our impact for patients. Our company faces a substantial underpenetrated market opportunity and we will continue to prioritize the growth and adoption of TCAR in this context. With that, I will turn the line over to Lucas to review third quarter performance and trends in the business.

Thank you.

Lucas Buchanan: Thanks, Jack. As communicated in our preannouncement, we achieved third quarter revenue of $44.4 million, representing 19% year-over-year growth and approximately 6,350 TCAR procedures, representing 20% year-over-year growth. Our results were primarily driven by strong TCAR growth and adoption, offset by pockets of weaker than anticipated procedural volume. Our commercial team across approximately 85 territories today is hard at work to build upon their physician relationships and strengthen adoption trends in areas where we have seen variability. Chas and I plan to spend substantial time digging into our commercial performance, including a comprehensive review of trends and drivers of physician behavior and adoption over the coming months.

For the full year 2023, we continue to expect revenue of $170 million to $174 million, representing 23% to 26% growth over the prior year. I would now like to shift to touch briefly on CMS coverage dynamics. Early in the fourth quarter, CMS released their national coverage decision for carotid stenting procedures. The final decision was largely consistent with our July proposed ruling, extending coverage to both high and standard surgical risk patients that are either asymptomatic with greater than 70% stenosis or symptomatic with greater than 50% stenosis. The final decision was in line with our expectations and our perspective on the implications for our business remain unchanged. The primary takeaway from this proposal is access. Broader access to less invasive options for patients with carotid artery disease, including for underserved and underdiagnosed populations.

We see expanded coverage as an indicator of the importance of treating carotid disease with the likely impact of more awareness and interest in screening, yielding more diagnoses and procedures over time. We are proud of the incredible body of TCAR clinical evidence generated in just the last few years that helped support CMS’ decision. With broad reimbursement coverage and broad FDA labeling, the industry’s only commercial infrastructure dedicated to carotid disease and significant experience born from over 75,000 procedures performed to-date, we believe our opportunity is vast and we are confident that TCAR’s value proposition will carry the procedure to standard-of-care in the long run. Shifting to our pipeline initiatives. Last year, we achieved FDA label expansion to standard surgical risk patients for our ENROUTE stent and initiated a large post-approval study called ROADSTER 3, which will yield prospective data in this patient population.

Enrollment is tracking to our expectations and we are excited about our progress in this study. Earlier this year, we launched the fifth product in our TCAR portfolio, the Enflate Balloon, which is the only balloon purpose built for carotid arteries in the TCAR procedure. We have entered the market with a premium pricing strategy and utilization continues to ramp. Looking ahead, we are planning for the upcoming launches of our next-generation neuroprotection system, as well as tapered configurations of our stent and look forward to sharing more detail when appropriate. Our R&D and clinical organizations continue to progress other ongoing and new programs to maintain and extend our position as the leaders in carotid disease. Lastly, I will review our financial results for the quarter in greater detail.

As mentioned, revenue for the three months ended September 30, 2023, was $44.4 million, a 19% increase from $37.4 million in the same period of the prior year. The number of TCAR procedures in the quarter was approximately 6,350, equating to a 20% increase from the same period of the prior year. Growth in revenue and procedures over the prior year period were driven by increasing TCAR demand. Gross margin for the third quarter of 2023 was 73%, compared to 75% in the third quarter of 2022. The decrease was driven by a revaluation of standard costs in the prior year period, which benefited margins, as well as higher manufacturing costs associated with having two manufacturing facilities fully operational in the third quarter of 2023. Total operating expenses for the third quarter of 2023 were $46.1 million, a 24% increase from $37.3 million in the third quarter of 2022.

R&D expenses for the third quarter of 2023 were $10.0 million, compared to $8.5 million in the third quarter of 2022. Sales, general and administrative expenses for the third quarter of 2023 were $36.0 million, compared to $28.8 million in the third quarter of 2022. The increase was largely driven by growth in personnel and personnel-related expenses and continued commercial expansion. Net loss for the third quarter was $12.8 million or a loss of $0.33 per share, as compared to a net loss of $10.3 million or a loss of $0.29 per share for the same period of the prior year. We ended the quarter with over $197 million in cash, cash equivalents and investments. We are confident that we can accomplish our current growth and organizational objectives, including executing on our pathway to profitability with our current capital.

Finally, I will echo Jack’s remarks. We are incredibly excited to have Chas on Board and we are looking forward to delivering together for patients, providers and shareholders. Our long-term belief in the value of TCAR remains steadfast and we are confident that we can drive meaningful value through deeper penetration. With that, I will turn the line over to Chas for a brief introduction.

Chas McKhann: Thank you, Jack, and Lucas for the warm welcome and thank you all for joining us today. It truly is an honor and a pleasure to step into the CEO role here at Silk Road. I have been fortunate to lead several businesses in my 25-year career in med tech. And I’d like to highlight one commonality that has really inspired me throughout my career and is one of the reasons why I came here and that is the potential for innovative minimally invasive therapies to dramatically improve patient outcomes, especially in very large disease states and end markets. But for me, Silk Road Medical also has a very personal appeal. I come from a family of brain physicians. My father was the founding Chairman of Neurology at Johns Hopkins, starting back in 1969.

Over more than 50 years, he and his colleagues built arguably one of the leading neurology departments in the world, of course, I am a little bit biased. My brother followed in his footsteps and is a neurosurgeon at Columbia. So brain health has been very much part of our family for many, many years. But later in life, starting about 10 years to 15 years ago, my father suffered from a series of debilitating strokes and we experienced stroke as patients and caregivers. Had TCAR been available, I really believe he may have been an excellent candidate for the procedure and so Silk Road Medical’s mission to reduce the risk and impact of stroke is very meaningful and personal to me. In addition to the tremendous impact that we can make for patients, I choose to take this role because of the unmatched benefits of the TCAR procedure, as well as the immense opportunity that we still have in front of us, the strength of the business, the unique company and culture that Erica, Jack, Lucas and the rest of the Silk Road leadership team have created over the past decade and more.

There is a significant opportunity ahead to establish TCAR as the standard-of-care in carotid artery disease. I have admired the innovation and growth that Silk Road has achieved over the years and I am very excited for the journey ahead. I look forward to diving into the business with Lucas, the broader leadership team and our Board, as well as connecting with many of you over the months ahead. And with that, we will turn it over back to the Operator, Stacy, for questions, and Lucas and I are here and happy to address them.

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Q&A Session

Operator: Thank you. [Operator Instructions] Our first question comes from Rick Wise of Stifel. Rick, please go ahead with your question.

John McAulay: Hey, Lucas. Hi, Chas. Welcome to Silk. This is John on for Rick today. I wanted to start off with…

Jack Lasersohn: Hi, John.

John McAulay: …with the fourth quarter guidance here. It’s another sequential step down versus the third quarter and you called out in the 10-Q filing that you are facing some sort of sales force disruptions and you are expecting that to continue into the first half of 2024. I just want a better — want to get a better sense of what’s going on with the sales force and why you are expecting that disruption to continue into the first half of next year?

Lucas Buchanan: Thanks, John. I will take that. Just to take a step back for a moment. We have been building and expanding our presence in commercial team in this market over many years now. Really trying to establish that broad clinical footprint and get a lot of physicians going on this new therapy and this year is really the pivot point where we are leveraging all that we have built over many years to really deepen adoption. At the same time, we continue to expand the commercial team. So we really understand this market and have gained tremendous learnings around what it takes to be successful and we are executing that go-deep strategy, we are doing work to strengthen referral networks, we are engaging allied health care professionals, we are doing lots of patient preference initiatives.

But as we make that evolution at the same time that we are expanding our team, with those wins come some choppiness, right, as we have got new territories and restructured territories and promotions and normal attrition. And so this is our area of focus going forward where Chas and I are going to spend a lot of time with our commercial and marketing and other leaders to really learn from and double down on what’s working well and reduce and mitigate the choppiness we have seen, which per the guidance in the Q, as you mentioned, we expect will persist for a little bit of time until we hit our stride.

John McAulay: That’s helpful, Lucas. And Chas, maybe one for you. Coming into Silk, you talked a bit about what you are excited about. I just want to get a better sense of where your priorities are in the sense of optimizing the sales force, investing in new technologies. I just want to get a sense of what your vision is for this company and where your areas of focus are going to be?

Chas McKhann: Yeah. No. Thanks, John. I appreciate the question. Really, I am not going to get into a lot of detail today. It truly is day five for me at this point. Except to iterate, I really — I did my homework and I am tremendously excited about the opportunity that we have. And clearly, as Lucas just said, we know we need to dig into some of the recent results and come forward with the kind of updates and build on take a step back, very impressive growth that’s happened over the time since launch, but now moving forward, kind of dig into that. So the obvious area to focus in on. And then beyond that, I am going to spend a lot of time getting to know the business, getting to know the team, spending time with customers.

We are going to be at the [inaudible] meeting next week, which many of our top customers will be at and spending time digging in to learn what’s made us so successful up to this point and then one of the areas we need to do to focus on going forward.

John McAulay: Thanks, Chas. That’s helpful and thanks for taking the questions.

Operator: Standby for our next question. Our next question comes from Robbie Marcus of JPMorgan. Robbie, please go ahead with your question.

Rohin Patel: Hi, everyone. This is actually Rohin on for Robbie. Just want to say congrats Chas on the new role and we look forward to working with you.

Chas McKhann: Thank you.

Rohin Patel: Just to start off, though, I’d just like to maybe ask you another question, piggybacking off of the last one. But is there anything kind of you can share just probably about what excites you generally about the company? Obviously, making the move to come to Silk is pretty significant, it’s obviously very different than Apollo as well. So maybe just talk about some of the ways you could leverage your experiences at Apollo at Silk and then maybe just the drivers behind why you are so excited about this opportunity here?

Chas McKhann: Sure. Yeah. Thanks for the question. As I said, I did my homework, and as I talk to people throughout the industry and inclusive of customers and others. When you take a step back, the benefits of the TCAR procedure are incredibly compelling. It’s rare that you have the combination of benefits to patients, benefits for physicians, benefits to the healthcare system with a lot of evidence to support that now out in the real world with over 75,000 patients treated and knowing that we still have a lot of room to run on that and so I am excited about that. It’s a great organization. And I said in my comments, all credit to Erica and Lucas and the team here for what they have built and so it’s really an honor to be a part of it.

And I like the opportunity. I like — and you mentioned Apollo, but also across my background, I have really enjoyed the challenges, so changing behavior in health care is hard, right? There’s a lot of inertia in the system and so thinking through all of the different tools that we can use, whether it’s education and training and patient programs and all the range of things, I have got a lot of different things in my background that I think I can call on. And to be clear, the team already here has done a lot of great stuff. So this is adding to and enhancing what is already a very good commercial team. And I heard that loud and clear from many different stakeholders. But adding to that, so we can really go after that opportunity. I am excited about it.

Rohin Patel: Great. And I guess the second question I had was more around kind of growth outlook for the remainder of the year and in 2024. Obviously, you called out some more pronounced seasonality in third quarter, and obviously, with the choppiness around the sales force, it’s kind of led to slowdown in growth. And given that kind of single-digit exit rate you are likely going to see in fourth quarter, how should we think about what a reasonable baseline is for 2024 and beyond, just in light of some of these puts and takes that you highlighted?

Lucas Buchanan: Thanks, Rohin, for the follow-up question. I think we will give Chas more than five days on the job to really dig in before we talk meaningfully about 2024. Obviously, I just commented on the 2023 guidance and some of the puts and takes. I think our long-term conviction about being very early in the penetration of this market, assembling a lot of the assets required for durable growth remain steadfast. And the goal now, again, is to really make that transition from broadening adoption to deepening adoption and get our sales team and our customers increasingly tenured together as we drive these benefits for patients over many years to come.

Rohin Patel: Okay. Great. Thanks so much.

Operator: Please standby for our next question. Our next question, excuse me, our next question comes from Joanne Wuensch of Citi. Joanne, please go ahead with your question.

Unidentified Analyst: Good afternoon. This is Anthony [ph] on for Joanne. Thank you for taking our questions. My first Lucas, I think, in your prepared remarks you mentioned there were some pockets of weakness in demand. Can you maybe just elaborate a bit more, are these with certain types of doctors or certain geographies? Just any more granularity would be appreciated?

Lucas Buchanan: Yeah. So we have talked recently about kind of where we stand at 80 territories in Q3 and 85 now in Q4 and roughly 2,600 physicians in Q3, which the math there is about 33 physicians per territory. So we have the ability to look at kind of per territory, per account, per physician metrics and understand what’s going on for folks that are performing ahead of expectations, at expectations or below expectations. So as we have done those forensics, we have each of those buckets, right? Territories and/or docs and/or hospital accounts that are ahead, at or behind expectations. And so this is a business where 100 procedures is about $700,000 in revenue in across 80 territories. That’s 1.25 procedures per territory and that kind of moves the business incrementally in a positive way.

And if we miss that opportunity for a procedure or two or three, because there’s some sort of change or disruption at the local level, there are some opportunities we missed, right? And so that’s really some of the color and context for my comments.

Unidentified Analyst: Helpful. Thank you. And then can you just give an update on where you are in China and Japan. I think on the last earnings call you said you were just about to submit for reimbursement in Japan, but just any additional color would be appreciated?