Adam Elsesser
Analyst · Bank of America. Your line is open
Thank you, Dan. Good afternoon, and thank you for joining Penumbra’s Second Quarter 2018 Conference Call. I’m joined today by members of our senior management team. I will begin our call today with several business updates, and then Sri will provide commentary on our financial results, as well as an update on our revenue guidance. Our total revenues for the second quarter of 2018 were $109.6 million, representing a year-over-year increase of 36% as reported and 33.8% in constant currency. We had operating income in the quarter of $9.3 million, compared to an operating loss of $1.3 million for the same period last year. We had another quarter of exceptionally strong financial results. Both of our major markets in Neuro and Vascular are continuing to grow well and we believe that both have long-term durability. Additionally, we continue to have confidence in our capacity to innovate, and to add new products that can positively impact patients. Within our Neuro franchise, our growth is being driven by the market growth in ischemic stroke. We saw steady market growth this quarter, following the strong market growth that we observed in the first quarter. It is important to remind everyone that this growth is not necessarily linear as the past years have shown. On our last call, we highlighted several positive market developments in stroke. Data on extending the window to treat patients and the Tennessee State Legislation to direct EMS to triage and transport patients to the best stroke center as quickly as possible. Though we see enthusiasm from these developments we believe they will take time before they translate into market practice. Two weeks ago, The Society of NeuroInterventional Surgery held their 15th Annual Meeting. I was struck by the ongoing energy and passion of the decisions to improve stroke systems of care. The efforts today are primarily manifested in the local work to bring stroke patients to an appropriate hospital. The discussions around the systems of care give us great confidence in this long-term effort. Additionally, they were broader discussions around additional patient populations where mechanical thrombectomy could bring better clinical outcomes. Another notable update from the meeting was around direct aspiration. The final results from the COMPASS trial were presented at the late-breaking session on July 25. As you might recall, COMPASS is a randomized control trial that compares direct aspirations to stent retriever as a first-line approach for mechanical thrombectomy. The trial met its primary endpoint of non-inferior clinical outcome with direct aspiration arm being numerically higher. The new data that was presented at the meeting showed an approximate $5000 per case, total cost difference in favor of aspiration when using either list price or supply chain price. These data provide level-1 evidence of non-inferior clinical outcome and also confirm the direct aspiration as economic benefits versus stent retriever therapy. This evidence only supports the ongoing trend toward aspiration and may further catalyze competitive entry. We continue to believe that our system’s performance is the greatest advantage we provide our customers and their patients. It is clear that physicians in the field are motivated to continue to improve stroke treatment. We believe that Penumbra will play an important role in helping to make the procedure better, and faster for patients. Over the past decade, we have constantly worked to improve our stroke technology. Through our experience in tens of thousands of cases, we are confident that we can make the procedure even better. Until now, when thinking about direct aspiration techniques, physicians have generally focused on the aspiration catheter. However, our team has historically focused on both the catheter and the aspiration source. Three years ago, our development team began a project to design our third-generation aspiration source. This past June, we received FDA clearance for Engine, which represents a major enhance to the Penumbra system. Our team has combined the science of aspiration with our vast clinical experience to develop and aspiration source with improved vacuum power and ease of use which we believe can help the system’s performance. We are ready to begin rolling out Engine and look forward to educating our physician customers on this latest technology improvement to the Penumbra system. I would also like to provide a brief update on competition within the stroke market. The current competitive products are consistent with what we have expected. The efforts to market these products began towards the end of the second quarter and we expect to see continued in earnest through the third and fourth quarters. As I have said before, we have great respect for our competitors. However, our development team is up to this competitive challenge and we believe we can continue to set the standard in providing the best complete product system for direct aspiration. Our amazing commercial team is energized and fully ready to make sure their customer know the true benefit of Penumbra’s products. Moving to our Vascular franchise, we saw notably stronger financial growth this quarter in both embolization and thrombectomy. I want to take a moment to commend our commercial team on their incredible focus and execution. But a year ago, we began investing in efforts that broadened our reach into the Vascular surgery community. This past June at The Society of Vascular Surgery Meeting, we began to notice real signs of progress from our initial efforts. While it is still early, we are encouraged by the work that we are doing with Vascular surgeons to bring better treatment to patients. I’d like to end my remarks with sharing a brief story that a physician shared with me recently about a patient that was treated with our Indigo System. A woman was admitted to a hospital with a cold leg caused by a blood clot in her artery. The leg was getting worse. So they started to treat her by gripping TPA which they did for 36 hours. After that therapy the leg below the knee was still completely impacted. So they scheduled that portion of her leg to be amputated. Right before the scheduled amputation, the physician decided to try aspirate the clot with Indigo. It worked. They removed a very large clot. The patient’s leg was saved. The scheduled amputation canceled and according to the physician she literally walked out of the hospital. Stories like these inspire our entire team but they also provide huge motivation and a deeper understanding with healthcare providers involved in these treatments. I’ll now turn the call over to Sri to cover the financials.