Jeff Dunn
Analyst · Morgan Stanley
Thanks, Lynn. Good afternoon and thank you for joining us. I am pleased to welcome you to SI-BONE’s third quarter 2019 earnings call. During the third quarter, we continue to execute and saw benefits from growing payer coverage, increased surgeon training and sales force expansion. Total revenue for the third quarter was $16.2 million, up 21% year-over-year. We are particularly pleased with our continued progress in the U.S., where revenue grew 22% over the prior year period to $14.9 million. Our team is working strategically to expand our commercial footprint. We ended the third quarter with a sales force of 106 total reps comprised of 53 direct sales reps and 53 clinical support specialists reaching a one for one target. As you may recall, we started the year with 67 total reps including 45 direct sales reps and 22 clinical support specialists. Our goal was to reach 102 to 112 total reps by the end of this year, hiring 10 to 15 direct sales reps and 25 to 30 clinical support specialist. With the hiring of eight direct sales reps so far this year, we are on track to meet the sales rep goal. And we have already exceeded our target by hiring 31 clinical support specialists through the end of the third quarter. We have primarily focused our hiring efforts to-date on clinical support specialists, who are responsible for identifying new surgeons and covering cases. The addition of a clinical support specialist to a territory gives the senior direct sales rep the ability to target the most promising new surgeons, facilitating the transition to surgeon training, conversion to first case and ultimately integration of the diagnosis and treatment of patients suffering from SI joint pain into surgeon practices. We are pleased that we have been able to meet and exceed our hiring goals while maintaining a high level of talent across our sales organization. We are not only committed to bringing on top quality reps, but also ensuring their success once they have come on board. Once we hire a direct sales rep or clinical support specialist, we put the rep through a rigorous two-week training course that requires classroom and lab training. We also recently hired a senior Director of Sales enablement to enhance and build our sales and leadership training processes for the entire commercial organization. His work will go beyond initial sales training moving into ongoing education for the worldwide sales organization through a combination of in-person training and online educational platforms. In the near-term, his efforts will be primarily focused on intensive training for junior clinical support specialists to ensure they rapidly come up to speed. Our U.S. sales team works closely with the medical affairs team on training, educating and supporting new surgeons. We have seen a market year-over-year increase in the number of U.S. surgeons who are interested in our new surgeon training. We believe the increase is due to growth in the number of public lives in the U.S. and growing awareness of the SI joint as a pain generator amongst ortho and neurosurgeons. Our larger sales force is increasing our ability to reach these new surgeons. The primary measure that we use to identify our overall success with surgeons is our active surgeon metric. These are surgeons who are performed at least one procedure over the last three months. We are on track to increase the number of active surgeons from 450 during the fourth quarter of 2018 to 550 by the fourth quarter of 2019. Moving to our international opportunity turnaround efforts remained underway in Germany and we are seeing progress from our investments. Third quarter results were in line with our mid-teens expectations for OUS growth. Excuse me, we expect to see continuing incremental improvement over the next 12 months as the new fully staffed German team ramps to greater productivity while other countries continue to execute. Historically, two of the primary hurdles to adoption of iFuse have been the lack of awareness of the role of the SI joint and lower back pain and lack of prior education in SI joint diagnosis. At SI-BONE, we are continuing to invest a great deal of time with the surgeon community to eliminate these obstacles. To that end, we finished the quarter with a strong presence at the North American Spine Society Annual Meeting in Chicago. At NASS, we hosted several meet the expert events at our booth, and engaged in productive conversations with both current and potential surgeon customers. We were also involved in several NASS workshops and labs that provided hands on experiences for surgeons. As well, 10 days ago with the Society of Minimally Invasive Spine Surgery, there was a session entitled Novel SI Joint Fusion Applications for Adult Deformity. Physicians were pulled by moderators, Dr. Lieberman and Dr. Eslack [ph] as to whether they believe the SI joint was a pain generator and whether they now believe the SI joint was important to pay attention to. More than 30 surgeons were pulled and 100% responded positively. We are seeing this change in interest and believe reflect the number surgeons asking to attend training. On September 26th, we announced the publication of our five-year follow-up results from LOIS, a long-term perspective study. The studies show the results of on 103 patients treated with the iFuse implant system. At five years the data demonstrated durability of the clinical response and positive long-term radiographic fusion outcomes related to the procedure. The study further supports the benefits of minimally invasive SI joint fusion with iFuse. We believe our superior clinical data is a key component of growing positive support from clinical evaluation organizations and garnering payer wins, many of which are exclusive to iFuse based on this clinic evidence. Effective July 1, 2019, Vermont, Blue Cross, Blue Shield, which ensures approximately 1.5 million members in South Dakota and Iowa establish positive coverage for minimally invasive SI joint fusion. Additionally, effective September 1, 2019, Health New England, which ensures approximately 200,000 members in Massachusetts, upgraded its medical policy to include coverage on minimally invasive SI joint fusion only with the iFuse implant system, and when performed by a surgeon. We will continue to leverage the extended results from LOIS along with other published clinical data to drive progress on the reimbursement front and pick up the remaining U.S. commercial payers that currently do not cover iFuse. As covered lives continued to grow in the U.S., we are strategically placing new sales force hires in areas of increasing insurance coverage to lay the groundwork to capture this opportunity. Another key hurdle to iFuse adoption has been the level of surgeon payment for the iFuse procedure. As a reminder in July 2017 the code was identified as miss-valued by the CMS and the Federal Register. This past July CMS proposed to maintain the current surgeon payment based upon the recommendation of the RUC, but solicited public comment on whether an alternate evaluation would be more appropriate. Over 80 surgeons and societies responded the request supporting a higher valuation for the code. CMS agreed with the surgeon and society input that the payment understated the inherent work effort and intensity of the procedure. As such, CMS increased the CPT codes national average overall surgeon payment by 27% to $915 from $720 in the final rule released November 1st. Many private payers set their payment amounts with reference to the Medicare payment typically 10% to 33% higher than the Medicare payment for the procedure. The Medicare fee schedule will be updated to reflect this new amount effective January 1, 2020. The change in payment may impact the behavior of certain surgeons. For example, it is possible that we may see some surgeons delay two, four cases in Q1 to receive the higher payment. It is difficult for us to gauge the impact on our business in 2020 until we see the response from surgeons, but we believe the 27% increase will affect iFuse adoption over time. In addition to the progress on our core business, we are continuing to see increasing interest in our iFuse Bedrock technique, which we believe is an important advance in how surgeons treat adult deformity patients. We were part of the official NASS program with a surgical symposium on pelvic fixation, faculty including Dr. Chris Shaffrey from Duke and Dr. David Polly from the University of Minnesota discussed available fixation options in their alternatives, addressing the biomechanicals -- biomechanics of loading at the lumbo-sacral junction. The program highlighted the adjacent segment impact to the SI joint a fusing the lower spine and identified our new iFuse Bedrock technique as an improved approach for long construct adult deformity cases. In Europe, all Bedrock regulatory reviews are now complete. We anticipate that we will receive formal notification of the CE Mark certification later this November, once received we will launch iFuse Bedrock in Europe. As we have mentioned, acknowledgement of the SI joint as a pain generator by key opinion leaders is foundational important to our iFuse business. We are starting to see previously skeptical KOLs now pay attention to the SI joint. Evidence of the shift is coming from the early adoption of the Bedrock technique, completion of iFuse cases at these academic institutions and requests for education of their residents and fellows. We are beginning to see the KOL trickle-down effect on our iFuse business encouraging ortho and neurosurgeons to include the SI joint and their differential diagnosis of lower back pain. The results should be increased penetration of iFuse for the 279,000 people in the U.S. that we believe are newly impacted each year by debilitating SI joint pain. SI-BONE has always been a company grounded in robust and high quality long-term data and we remain committed to building on our vast body of clinical evidence. We have initiated a clinical study called SILVIA or SI Joint Stabilization in Long Fusions to the Pelvis randomized controlled trial. SILVIA is a prospective blinded randomized controlled trial with one to one randomization. One arm of the study will include patients receiving standard multi-level fusion surgery with fixation to the pelvis using S2AI screws. The second arm will include patients who received the multi-level fusion surgery with S2AI screws, and iFuse Bedrock. Over two years, we expect to roll 200 patients across up to 20 centers with meaningful data readouts at two years post procedures. We expect the first patients to enroll in the first quarter of 2020. Overall, we are continuing to execute on our hiring, surgeon training, reimbursement and product plans. We are confident that we are well-positioned to take advantage of the large opportunity in front of us. With that, I will now turn the call over to Laura for details on our financial performance. Then we will return with closing comments.