Will Moore
Analyst · Singular Research. Your line is open
Thank you, Lynn. Good afternoon everyone and thank you for joining us. Our first quarter was marked by combination of lower than expected financial results and significant progress towards the commercialization of our G6 platform. Starting with our commercialization process, we have obtained the support of numerous additional KOLs across the globe. Two, we have repeat customers that are purchasing multiple systems based on their positive experience from clinical and economic perspective. Three, we are continuing to see a broadening base of clinical data that support our value proposition. And four, we recently received regulatory approval in Japan, which came in early than our expectations. This ongoing momentum fuels evolutions [ph] about the prospects of G6 platform to transform our business for years to come. We have also made significant progress towards our two primary execution objectives, to expand our commercial infrastructure, so that we have adequate resources to pursue this opportunity and two, to develop new product and enhancements to existing products so we can continue to stay ahead of any potential competition from a product feature and cost perspective. Our first quarter revenues however were below our expectations with total revenue of 10.5 million versus 11.9 million in the comparable quarter last year. Our overall business was impacted by the significant expansion in transition of our sales organization over the past several months as we ramped up to meet the growing opportunity worldwide. While these activities such as hiring and on boarding of new reps, sales training, revised compensation structure, and alignment of territories to maximize the reach and penetration were all vital to our long-term success. They do result in some near-term disruption that we have been actively managing. I'd like to take the next few minutes to review several business highlights as relative progress we have made against our strategic objective this year. As a quickly reminder, we have three primary business segments, first our Cyclo G6 systems for the treatment of glaucoma; Second, our medical retina product line for the treatment of diabetic macular edema or DME and other retinal diseases. And third, our surgical retina line products used in vitrectomy procedures, such as the treatment of retinal tears and detachments. Starting with our Cyclo G6, as I've noted in prior calls we believe the G6 business is truly transformational for us and I remain as confident as ever in our opportunity. The scalable platform was designed to address the 5. billion [ph] expense annually on pharmaceutical and device treatment. By offering a lower cost laser system and a portfolio of probes for the full continuum of care from early to late stage glaucoma G6 revenues in the first quarter of this year grew year over year in low double digits. In the first quarter we sold 64 G6 systems which brings our total to 561 since our launch in March 2015. In addition we shipped approximately 6,600 G probes in the first quarter which brings the total probes shipped since launch to 41,500. Reimbursement trends for our procedures have remained stable and we expect this to continue. In the U.S. we are experiencing a lengthening of the sales cycle for the G6 system as we've transitioned to larger customer such as hospitals and ASP networks, as well as increasing adoption by comprehensive ophthalmologists versus our history of primarily to selling to glaucoma specialists. This transition to larger customers and comprehensives is happening sooner than we expected but it's a good thing for us in the long term, as they represent a large segment of our target market and indication for the broad level interest in our products. However, in the near term it has an effect of pushing out some of our G6 orders as we worked through the purchasing committee at these customers. We are currently evaluating our overall margin process and sales approach in order to be well prepared for this emerging positive shift in our customer base, separately we're also experienced some weaker than expected probe utilization at first quarter which we believe was largely due to the lack of follow up with customers after a system sale. This was a key premise behind our decisions to expand our sales force that we can improve our bandwidth for better customer follow up. We've also implemented additional steps such as new marketing programs, new trainings of our sales reps and revisions for our comp plan addressed in this dynamic and expect to have higher utilization rates in the second half of 2017. Encouragingly, we are beginning to see repeat system orders from many of our customers including large hospital networks, in addition to a growing body of support for our technology is emerging from KOLs. We're looking forward to the upcoming ASCRS annual meeting which is this Friday, designated as glaucoma day. Presentations highlighting the features and benefits of our G6 platform and MicroPulse technology are planned including those by Dr. Jeffrey Kammer from Vanderbilt Eye Institute who is scheduled to speak on cyclophotocoagulation and by another comprehensive ophthalmologist Dr. Rilando Toyas who is scheduled to speak on the results of his peer reviewed clinical study recently published in the Journal of Clinical and Experimental Ophthalmology. The study evaluated clinical outcomes of patients diagnosed with open-angle glaucoma range from mild to severe. 26 eyes were resulting in a 30% reduction in ILP and 45% reduction in topical medications at six to 12 month follow ups. We also look forward to two paper presentations, one is authored by coronial specialist Dr. Thomas John, Clinical Associate Professor at Loyola University of Chicago, Dr. John's study evaluated the treatment of 20 eyes resulting in a reduction in ILP and topical medications with no adverse effects. The other is by Dr. Tom Sanderson, a Minnesota eye consultant who is also the incoming vice president of ASDRS and influential in ophthalmology community. Dr. Sanderson's study reviewed 119 procedures and concludes that MicroPulse is an effective non-invasive treatment to lower ILP and is a vital option for all types of glaucoma at various stages. We're also looking forward to the upcoming AAO [ph] annual meeting where there are five poster presentations scheduled to be given on the use of MicroPulse for glaucoma by Ophthalmology, [indiscernible] of UCLA, University of Missouri, Will's Eye Hospitals, University of Washington and UCSF. Presentations review results of studies looking at clinical outcome safety mechanisms of action of our MP3 procedure. Internationally the G6 is currently sold in more than 50 countries and we are pleased with the recently received regulatory approval for our G6 in Japan. Japan is a significant market for us which could be as big as U.S. given the prevalence of the disease and attractive reimbursement and positive feedback from KOLs. We are actively working with their distributor partner and KOL relationships to initially a launch in the near term. In closing on the G6 our goal remains the same, to make the G6 platform the global standard of care used to treat patients across the full continuum of care as a first line therapy to retractive glaucoma patients. Turning to our medical retina products. For the treatment of diabetic macular edema or DME and other retinal diseases. We remain bullish on the value base medicine proposition that our technology represented in an estimated 9 billion market and the demand remains relatively stable. Revenues in the first quarter for this segment declined versus our expectation for flat revenue growth. In addition to the anticipated quarter-to-quarter lumpiness the capital equipment made sure this product line sales in the quarter were also somewhere impacted by our near-term focus on building out our sales infrastructure that I discussed earlier. On the clinical front the NHS funded study in the UK to evaluate the clinical economic benefits of our MicroPulse technology for DME is progressing nicely with 11 centers opened and enabled to recruit patients. Also, the discovery of MicroPulse effects on heat shock proteins which was presented at the Japanese society meeting in December is being submitted for peer review and we expect publication and additional society presentations over the coming months. Also at the upcoming AAO meeting there are four studies scheduled to be presented on MicroPulse therapy for retina, specifically DME and CSC, results from a three-year study that demonstrates that MicroPulse laser monotherapy for DME maintains its effectiveness and stabilizing and improving visual acuity and reducing or eliminating DME. Two of these studies examine retina layer changes post MicroPulse or DME and found improvements both logically and functional our retina sensitivity outcome and no structural damage to the underlying photo receptor layer which while still achieving effective results. In addition, results from a six months study on MicroPulse monotherapy for treatment for chronic CSC demonstrated safety and clinical efficacy. Lastly turning to our surgical retina business which delivers treatment of retinal tears and detachments. Revenues declined in the first quarter at a fast rate than we had anticipated. While the market dynamics were consistent with prior several quarters in an ongoing competitive pricing pressure and matured segment. Internationally we did experience some weakness due to few factors and included several large tenders [ph] in the comparable quarter of 2016. Some personal shifting giving promotions and realignment in territories and -- excuse me -- transitioned to direct sales in Germany. Before I turn the call over Atabak to review the financials, I would like to make a few additional comments regarding our primary execution goals for 2017. That I mentioned in the beginning of the call. On the commercial infrastructure plan the growing demand for G6 platform has enabled us to top line expand our sales infrastructure while maintaining the sales and support capacity for our other product areas to address the broad geographies that each of our reps cover. We are taking a highly disciplined and measured approach towards building our sale infrastructure and continues to seeing higher highly qualified candidates. As of today, we have 18 direct reps in the U.S. and planned to continue to recruit qualified talent to our team in order to achieve our stated goal of 24 in the next several quarters. We are taking a short pause in addition to the U.S. sales teams, so we can focus on training of our new hires. In Germany we are making progress and establishing our direct sales and service operations. We have hired our first employee and are making progress towards additional hires in securing office space. As we have noted previously, we have seen historically that it takes approximately 4 to 6 months for a new sales hire to begin contributing in an average two to three years to reach peak productivity, which we currently view as approximately $2 million per year. Therefore, we do not expect to see impact by our recent new hire until at least the second half of this year. On a product enhancement front, we are continuing our R&D activities around advancing our product line by republishing existing technologies that are expected to improve the features and benefits by products and improve productivity, quality and reliability while reducing cost. For competitive reason, it's a bit early to go into more detail other than to say we are making nice progress, but I look forward to sharing more details upon updates when appropriate. With that I would like to turn the call over to Atabak for more financial details. Atabak?