Laura Francis
Analyst · Bank of America
Thanks, Matt. Good afternoon, and thank you for joining us. Before I cover our second quarter results, I want to share some exciting news on the reimbursement front. Based on the strength of our long-term Level 1 clinical data, Anthem has adopted coverage guidelines that are exclusive to our iFuse triangular titanium implants for minimally invasive SI joint fusion. Anthem is the second largest commercial health insurer in the United States. With over 40 million members, Anthem joins more than 35 other plans to cover iFuse exclusively in the U.S., amounting to over 120 million exclusively covered lives in total. With Anthem exclusive coverage, we see reimbursement as a tailwind for our business. We will capitalize on the opportunity through our 2021 commercial growth plan, which includes sales infrastructure expansion, surgeon engagement, products and solutions, and patient awareness initiatives. Now on to the quarter. I'm pleased to report that SI-BONE had a record revenue quarter as our employees continue to relentlessly execute through this unique operating environment. In the second quarter, we generated revenues of $22.2 million, representing growth of 58% compared to the second quarter of 2020. As a reminder, the prior year quarter was significantly impacted by COVID. Sequentially, our second quarter revenue grew by 9% due to increased underlying demand for our products and solutions. Our strong results in the second quarter give us confidence that as the operating environment normalizes, our industry-leading diverse portfolio will accelerate our capture of the multibillion-dollar opportunity in the sacropelvic space. Now let me provide an update on our key growth initiatives as we look to extend our leadership position and drive durable long-term growth, starting with sales infrastructure expansion. At the end of the quarter, our 133 person sales organization was comprised of 74 territory managers and 59 clinical support specialists. We continue to be strategic about our mix of territory managers and clinical support specialists. Specifically, our clinical support specialists are crucial to driving revenue productivity for our territory managers while also serving as an important training ground for future territory managers. Additionally, we continue to methodically expand our sales organization to support our surgeons. And as of July 1, added 2 new regions for a total of 16 regions in the U.S. Moving on to surgeon engagement. The investment in our sales organization, our expanded product portfolio and training infrastructure drove a significant increase in the number of active surgeons in the quarter to approximately 640, an all-time high. During the quarter, we had 24 SImulators deployed worldwide, including 21 SImulators in the U.S. SImulators, which accounted for more than half of our trainings in the quarter, not only allowed us to train new surgeons efficiently, but also reengage with inactive surgeons and drive adoption. Going forward, with travel restrictions easing, we believe the combination of in-person local training and SImulator training will continue to drive surgeon engagement for new and previously inactive surgeons. As a reminder, we are targeting the approximately 7,500 spine surgeons in the U.S., of which 1,700 have been trained and completed a procedure to date. Turning to products and solutions, starting with iFuse. We recently announced results from SALLY, our 2-year prospective multicenter trial of iFuse-3D for chronic SI joint pain. Clinical results at 24 months showed marked and sustained improvement in SI joint pain, patient function and quality of life. The results demonstrated a significant reduction in the proportion of study subjects taking opioids for SI joint pain, 59% at baseline to 18% at 24 months. In addition, the study included 3 objective physical function tests; active straight leg raise, 5x sit to stand, and transitional timed up and go, all of which showed statistically significant improvements from baseline. An earlier publication of 12-month results from SALLY reported radiographic analysis of CT scans showing accelerated bony bridging across the SI joint. 100% of treated SI joints showed bone integration to iFuse implant surface on both the sacral and iliac site and 77% of treated joints showed bony bridging across the joint. There are now 95 peer-reviewed publications demonstrating the safety, effectiveness, biomechanical or economic benefits of our iFuse technology, further substantiating iFuse as the gold standard for SI joint fusion. Moving on to iFuse-TORQ. We're pleased with the initial reception for iFuse-TORQ following its commercial launch in April. While still in the early days, we are seeing adoption in trauma as well as several competitive conversions. As a reminder, TORQ is a highly differentiated 3D print threaded implant, which was developed to solve unmet clinical needs for pelvic trauma, an attractive $350 million adjacent market. iFuse-TORQ also has applications in the primary SI joint fusion market. Last year, we estimate that our competitors generated approximately $40 million of business in primary SI joint fusion. And iFuse-TORQ allows us to offer a product that leapfrogs the competitor's screw-based implants and extends our leadership and market share. In adult deformity, Bedrock is driving revenue growth as interest in the Bedrock technique among deformity surgeons and key opinion leaders continues to increase. We currently anticipate that our second-generation adult deformity product, a first of its kind design based on feedback from KOLs, will enter market preference testing in early 2022, a bit later than previously scheduled. While we're not experiencing supply chain issues with our implants, we are experiencing longer-than-normal delivery times with some of our instrumentation suppliers due to raw material, labor and capacity challenges due to the COVID-19 impact. The instrumentation delays impacted our validation and verification testing, causing the delay in our second-generation adult deformity product launch. However, we are developing plans to mitigate this risk in the future. Next on to our patient awareness initiatives. We have completed our second TV marketing test program in multiple cities and compared the broadcast results to our digital marketing initiatives, including search, social media, display and video. We're seeing a higher return on investment in the digital marketing initiatives. Based upon these results, we're focusing incremental investment toward digital marketing in the second half of 2021. These investments are expected to fuel revenue growth through patient and professional experiences, amplifying our reach to health care professionals and empowering patients through their SI journey. Our digital initiatives will allow us to be highly targeted, data-driven, technology-enabled, measurable and allow for continuously improved marketing. We expect to see the revenue impact from these programs beginning in 2022. Finally, let me provide some more updates on health economics. Effective July 3, Centene Corporation established positive coverage for minimally invasive SI joint fusion. Centene is a major intermediary for both government-sponsored and privately insured health care programs and covers more than 25 million members. With the decisions from Anthem and Centene, substantially all of the U.S. insured population now has access to minimally invasive SI joint fusion. Internationally, in June, the French Health Ministry granted national reimbursement for iFuse-3D. This reimbursement decision by the French national health care system provides coverage for SI joint fusion procedures exclusively using SI-BONE's iFuse-3D implants. With that, I will now turn the call over to Anshul to provide more details on our financial results.