Joe Sardano
Analyst · Craig-Hallum Capital Group. Please go ahead
Thank you, Kim, and Happy Valentine’s Day to everyone. Since the beginning of Sensus, we’ve had a track record of double-digit growth. We are thrilled that Sensus continues to keep up the momentum since our IPO in June of 2016 with our 11th consecutive quarter of double-digit year-over-year revenue growth. More specifically, our fourth quarter revenues increased by 25%, and reached an all time high of $8.1 million. In addition, we are very pleased that Sensus consistently achieves our short and long-term business product goals. We expect to continue to build on these achievements throughout 2019. We shipped 27 systems during the quarter, 15 of them were our premium, excuse me, premium SRT-100 Visions. Recall that these systems have enhanced capabilities such as image guidance, treatment planning software, and comprehensive enterprise integration. As a point of pride, we shipped our 100th Vision system during Q4, and our global installed base is now approaching 400 units. In August of 2018, Sensus received FDA 510(k) clearance to market our new SRT-100+ which adds several innovative features to our SRT-100 product for the treatment of non-melanoma skin cancer and keloids, including an expanded energy range for customized, more precise treatment. We shipped three of these systems during the quarter, including two to plastic surgeons who installed the unit specifically for use in treating keloid scars. I pointed out in the past that the keloid market is a very important one for us and one where we can have an enormous impact on patients’ lives. We expect continued interest in our SRT systems for the treatment of keloids on the heels of a peer-reviewed paper published in the November issue of SKIN, Journal of Cutaneous Medicine. The paper noted a recurrence rate of only 3% among keloidectomy patients treated post-operatively with SRT, compared with a reported recurrence rate of approximately 71% following keloidectomy without use of SRT. This is a major breakthrough for patients worldwide who have keloids. We have now trained over 100 facilities, who have SRT technology on how to treat keloids. During the fourth quarter, we also shipped two SRT-100 units to a two-site physician practice in China. Clearly, this reflects demand for our products despite the current geopolitical uncertainty between the US and China and China’s economic environment. China has the world’s highest incidence of post-surgical keloid scar formation and we are pleased to be furthering our efforts to eliminate the suffering of millions of people with this condition in that country. While tariffs may have an impact on product demand, I believe the SRT-100 largely transcends that issue as it provides such an important medical solution. Still, the bulk of our customers are using SRT for the treatment of non-melanoma skin cancer and we continue to build supportive evidence for its success. Just this week, a few retrospective studies were published in the February issue of the Journal of Drugs in Dermatology. That study showed a high cure rates exceeding 97% among patients with a mean age of 82.5 and treated with SRT-100 for basal and squamous cell carcinomas on the lower extremities. Surgery in this area presents many challenges relating to the healing process and SRT is a wonderful option for those patients in that situation. We continue to support our sales organization with a full range of marketing activities and the first quarter is actually quite robust for us in this regard. Just last week, we were at the 17th Annual South Beach Symposium in Miami, where we generated many new sales leads and we have already begun to follow up with them. Our presence there extended from our booth beyond to the trade show floor to include sponsorship to the keynote address of the President of the American Medical Association, Dr. Barbara McAneny, who by the way is a customer of ours with an SRT-100 Vision product. We delivered a state of healthcare presentation. In addition, Dr. Mark Nestor ensured the symposium delivered an introductory presentation on superficial radiation therapy, while Dr. Clay Cockerell, Dr. Michael Gold, Dr. William Roth and Dr. David Goldberg each delivered talks related to treatment of non-melanoma skin cancer with SRT. These physicians are some of the top KOLs in the industry and are internationally recognized. I also participated in the CEO panel that dealt with industry partnerships between manufacturers and physicians. We’re looking forward to reinforcing our presence in the dermatology field with our attendance at the American Academy of Dermatology, Annual Meeting next month in Washington, DC, as well as the Annual Meeting of the American College of Radiation Oncology later in the year, during which we will feature our intraoperative radiation therapy product Sculptura. Turning to Sculptura. We continue to spend significantly on R&D in the fourth quarter, however, less than the prior year. Following a months long process of addressing all FDA questions, we are hopeful this system will be cleared for sale in the coming weeks. In preparation for launch, we manufactured several units to be used in key research institutions with whom we are in discussion. We also completed an expansion of our oncology sales force by hiring four experienced territory Managers that have already started January 1. We shipped the unit in December to the Perelman Center for Advanced Medicine at the University of Pennsylvania and expect this prestigious medical center will provide us with additional supportive data for the market. We expect our Sculptura system, which features key technological advances and carries a list price of $1.5 million will play an important role in the growth of Sensus in the coming years. We’ve also begun research studies for psoriasis and eczema, which are ongoing and the results are expected to form the basis for marketing to physicians for both the SRT-100 Vision and the SRT-100+. As a reminder, these studies are being conducted at sites in Austin and Tallahassee and results are expected to be published towards the end of 2019. I want to briefly address the topic of reimbursement. As most of you know, the Centers for Medicare & Medicaid Services or CMS has stated that the main SRT CPT code 77401 is mostly undervalued. Unfortunately, CMS took no action in December – November with respect to the main code. CMS did however, issue a clarification that permits evaluation and management codes or E&M codes to be reimbursed. Previously some of the administrative contractors were erroneously not allowing E&M reimbursement. We estimate that the effect of assuring this reimbursement is providing physicians access to approximately $1,000 per patient for the episode of care with SRT treatment. CMS has indicated it will review our CPT code 77401 as early as 2020. But no later than 2021. Why we would like this code to have been revalued for the benefit of our physician customers. We note that SRT is still a very lucrative procedure for our physicians. Before I turn the call over to Arthur Levine, our CFO for more detailed discussion of our financial results, I’d like to touch on our multiple achievements during 2019. The fourth quarter capped an excellent and active year during which we increased revenues by 28% to $26.4 million. We raised almost $16 million in net proceeds in an underwritten offering of common stock, we opened a new subsidiary in Israel for R&D and to serve as the sales base for Europe and the Middle East and received multiple of US and overseas regulatory clearances for our products. We strengthened our management team with new hires in sales, marketing and clinical development and engaged additional international distributors. We have an active plan for 2019, including the commercial launch of our Sculptura system increasing awareness for the use of SRT in keloid treatment and prevention and signing additional distributors outside the US and introducing cutting edge lasers. Now I’d like to turn the call over to Arthur, Arthur Levine. Thank you.