Will Moore
Analyst · ROTH Capital Partners. Your line is now open
Thank you, Susan. Good afternoon everyone and thank you for joining us. 2016 was a strong year for IRIDEX, marked by continued growth of our G6 platform for the treatment of glaucoma. During the year, we grew both system placements and disposal probes utilization, broadened our platform offering, saw compelling clinical outcomes and continue to increase our global presence. In short, our success in 2016 with the G6 has given us the confidence that the G6 platform represents a significant opportunity to transform our business for many years to come. As we enter 2017 our focus is on executing on a plan to expand our commercial infrastructures so we have adequate resources to pursue this opportunity and to develop new products and enhance means to existing products so we can continue to stay ahead of any potential competition from a product feature and cost perspective. These are crucial investments that are key to our long-term success. In the fourth quarter we did an equity offering and put in place a credit facility putting us in a much stronger position to fully pursue these initiatives. Turning to the fourth quarter financial results, total revenue was a record $12.5 million, up from $12.1 in the comparable quarter last year. Our G6 platform continues to exceed our expectations with revenue growth of 67% in the fourth quarter. As a quick reminder, we have three primary business segments. First, our Cyclo G6 system targets the global glaucoma market with more than $5 billion spent annually on pharmaceutical and device treatments. This is our fastest growing segment and accounts for roughly 25% of our revenues. Second, is our medical retina product line for the treatment of diabetic macular edema or DME and other retinal diseases. This market for treating diseases of the retina is estimated to be $9 billion due in large part to an aging population and the increase in diabetes. Our medical retina business is also approximately 25% of our total revenue today. Third, our surgical retina line of products used in vitrectomy procedures, such as the treatment of retinal tears and detachments makes up the balance of our revenues. I like to take the next few minutes to highlight our recent progress in each of these segments. Starting with the G6. Two years ago we introduced the G6 platform. The system is powered by a proprietary MicroPulse laser technology, which is a method of delivering laser energy using a mode which chops the continuous wave laser beam and do short microsecond-long laser pulses. We are very excited about the prospects for this segment of our business and truly believe the opportunity has the potential to be transformational for us. Saleable laser systems along with the range of single use probes have continued to gain momentum with growing utilization driving the strong recurring revenue stream. In the fourth quarter we sold 96 G6 systems which brings the total systems sold to 497 since our launch in March 2015. In addition, we shipped approximately 8,000 G-Probes in the fourth quarter which brings the total probes shipped since launch to 35,000. Note that in 2016, which is their first full-year of launch, we sold 386 G6 systems and shipped 27,000 G6 probes, which compares favorably with other recent successful launches in the glaucoma device market. We believe that continued adoption of the G6 is based on several attributes of the system, including a strong safety profile. We also maintain a proven and durable efficacy profile. Data from numerous sources across the globe illustrate consistent clinical efficacy results. Our procedure is also repeatable and address the full continuum of care for the treatment of glaucoma, from early to late stage disease. And in line with current healthcare objectives today our G6 platform provides outstanding clinical outcomes at a lower cost to both the patient and the health care system, compared to pharmaceutical and other alternative treatments. Importantly, we have a permanently established reimbursement code that provides sufficient economics to the physicians and medical facilities to support adoption of our technology. Reimbursement trends for our procedure have remained stable and we expect them to continue. The G6 is a scalable platform that we have designed to offer a low cost laser system and a portfolio of probes for the treatment of early to late-stage glaucoma, as well as refractory glaucoma. Because of the intelligence was designed into probe and not in the system we’re able to provide physicians with a range of treatment options without substantial upfront capital equipment expense. Consequently the payback is rapid with the potential for investment in the equipment to be repaid in as little as two months of procedures. This is a win-win, as it significantly lowers the investment risk for our physician customers, while providing us with long-term upside recurring revenue product sales. Initially, the MP3 Probe was primarily used by physician customers to treat mid-to-late stage glaucoma. As physicians have become more comfortable with our technology, and particularly with our safety and efficacy profile relative to other treatment alternatives many are migrating to treating patients earlier in the treatment continuum with success. Our goal is to make the G6 platform the standard of care used to treat patients across the full continuum of care as the first line therapy through refactory glaucoma patients. A big driver towards reaching this goal is the volume of data that we have amassed to date and continues to be generated. Over the next – excuse me – over the past few months there has been to peer-reviewed MP3 clinical studies and numerous podium presentations and abstracts by leading physicians at the Hawaiian Eye, Glaucoma 360 and American Glaucoma Society Meeting. We also recently hosted our first live surgery event via webcast at the Asia-Pacific Academy of Ophthalmology or APAO, meeting in Singapore. With participation by leading positions in the region, at the live surgery event we had approximately 200 doctors attending in person and perform three surgeries with our MP3 probe in about 30 minutes. Lastly, we expect to continue a cadence of activity, including the podium presentation at the upcoming ASCRS Meeting. Our medical retina product line, which also powered by a our proprietary MicroPulse laser technology, has historically been a good driver of growth for us. The supply chain and salesforce trending issues that arose in the third quarter of 2016 were quickly resolved and work through our backlog in the fourth quarter. We remain bullish on the value-based medicine physician that our technology represents which continues to be supported by several publications and presentations over the last few months. The discovery of MicroPulse effects on heat shock proteins was presented at the Japanese Society Meeting in December, which we expect we’ll have a positive impact on our business. On the third quarter of 2016 earnings conference call, we discussed our National Health Service or NHS funded study in the UK. Patient recruitment has started at several of the ten centers with the other centers to be opened in the near-term. Demand for medical retina products continues to be strong and I’m confident that we have the opportunity to achieve standard – or excuse me sustained long-term growth with this product line. However, we expect our current emphasis on driving sales of the G6 to continue to take precedent and as a result in the near-term we expect medical retina revenues to be relatively flat throughout the year with some quarter-to-quarter lumpiness given the capital equipment nature of these sales. Finally, our surgical retina business, for the treatment of retinal tears and detachment is a mature segment with flat to declining revenues. In the fourth quarter, this business performed as planned as the market dynamics were consistent with the prior several quarters with ongoing competitive pricing pressure in a mature segment. While sales of our surgical retina products generate higher margin – gross margins contribution, we continue to expect flat to declining revenues for the segment. Before I turn the call over to Atabak for review our recent financial results, I want to highlight two key execution goals for 2017 that I mentioned in the beginning of the call. First, regarding the expansion of our commercial infrastructure. In the U.S., we are sharply focused on hiring new qualified sales representatives to meet growing demand for our G6 platform, while maintaining the sales and support capacity of our other product areas to address the broader geographic, that they each of our reps cover. The growing demand for our G6 platform has enabled us to confidently make investments in the expansion of our sales infrastructure. We are taking a highly disciplined and measured approach to hiring, which is paying off as of today we have hired 17 direct reps in the U.S. that is a net addition of four reps, while new hire sales trainees to be conducted next week and expect to reach our stated goal of 24 in the next several quarters. We also recently added one area sales manager to help oversee our larger sales force.
– : Internationally, we are expanding our team to improve our ability to actively manage a growing book of business by our international distributors and providing direct sales capabilities in selected countries. We established IRIDEX GmbH to facilitate our direct sales initiative in Germany and have started to make progress and building out our commercial infrastructure there. Second, regarding product enhancements, for competitive reasons I can’t go into a lot of detail regarding our plans, but I want to be clear that we are not talking about high science product development, but rather a repurposing of existing technologies that will improve the features and benefits of our products and improve our product quality and reliability while reducing our cost. And example of this is the launch of the G6 – G-Probe Illuminate at the recent AGS Meeting. We believe that the G6 Illuminate is a differentiated product that will enable and improve glaucoma treatment alternatives. We plan to continue to advance and defend our MicroPulse patent portfolio around the world, as well as remaining vigilant to the unauthorized use of the MicroPulse trademark. With that, I’d like to turn the call over to Atabak for financial details. Atabak?