Doug Bryant
Analyst · Craig-Hallum Capital. Your line is now open
Thank you, Ruben, and good afternoon everyone. There are many positive things to report on this quarter. So let's get started. In terms of the integration of the Alere assets, we achieved the two key milestones for the quarter that we said we would. We officially opened the shared services center in Galway in June and currently have a staff of 20 people employed in functions such as IT, Finance, Legal, Customer Support and Technical Support. And as planned, we went live on August 1 in Europe without a hiccup. European orders are now through our global ERP system, and distributed from our 3PL warehouse in the Netherlands. And we're out from under our TSA's with Abbott for order-to-cash and distribution in those countries. The last milestone - the last major piece of the business to be integrated is China, which we expect to move over in early 2019. And finally, in terms of synergies, we are confident in $11 million in cost reductions as we exit 2018, with potential upside depending on how quickly inventory at the older higher cost sells through the channel. At this point, we are anticipating a bit better gross margins in 2018 for the overall business than we had originally forecasted, due in large part to improvement in manufacturing yields for the Triage products. During the quarter, we used $60 million in cash to pay down a portion of the initial $255 million term loan that we used to finance a part of the Alere asset transaction. At the end of the quarter, the outstanding balance was $83.2 million. In addition, we entered into separate, privately negotiated Exchange agreements with a small number of holders of our Convertible Senior notes. We exchanged roughly $38.6 million in principal amount of the notes for 1.3 million common shares. The remaining principal of the convertible bonds is now $58.5 million, down from the initial $172 million. In summary, since we closed the transaction in October of last year, we have de-levered significantly, and have reduced our risk. In terms of the performance of the acquired businesses, I would say it's going reasonably well. Revenue for the Triage and Beckman BNP Businesses, at $69.9 million, exceeded expectations. The U.S. is holding steady, consistent with our model and ex-US, notably China, is doing well. In the quarter there was favorable timing of orders that occurred in a few smaller countries that are likely not reproducible, that should not necessarily be included in our run rate. Based on all the ins and outs, I think that we are comfortable in saying that our run rate for the businesses in aggregate is about $67 million a quarter at this point, a bit better than we had in our deal model. The legacy Quidel business performed nicely as well, although influenza fell off quite quickly, at least relative to Q2 2017, when higher positivity rates and testing persisted through April. This setback of $4.5 million in revenue, although not wildly significant, would have been hard to solve for in previous years, given the large contribution to profitability of our influenza products. In the new Quidel, this is obviously now less of an issue. Our Solana and Eye Health products grew in the quarter, up $1.3 million and $1.2 million, respectively, versus the prior year quarter. In addition, the launch of Sofia 2 is going well, with more than 10,000 instruments shipped, although in fairness that number includes filling the backorder that was created due to the confluence of a couple events. The significant prevalence of influenza in Q1 and the FDA reclass of rapid flu tests. And we recently replaced a number of analyzers in the field to facilitate a software enhancement for Virena users. Absent an up tick created by the launch of new Sofia assays, the annual rate of Sofia 2 analyzers is probably 8,000 instruments per year. In terms of product development, our R&D teams continue to work and deliver at a nice pace. We have 19 development programs in phases 1 through 4, and 13 programs that we're exploring in Phase 0. We don't have enough time to review everything that we're working on, but I will highlight the three larger potential growth drivers. First, we made significant progress with Strep 98 in the last few months. Our confidence in our ability to develop and manufacture a Sofia Group A Strep assay that exceeds a sensitivity of 98% relative to culture, while maintaining a high specificity is now quite high. Clinical trials are planned to be held during the next respiratory season, with our submission to follow in Q2 2019 and approval in time for a launch in Q4 2019. We continue to believe that the market opportunity for a rapid confirmatory Group A Strep Assay is large and likely to be meaningful for us over our five-year planning cycle. Second, we are also encouraged by the performance data we are seeing thus far with our next generation Triage Troponin assay, which we expect to launch at the end of this year in Europe. And third, we showcased many of our products, including some in development, at the AACC in Chicago. I think the new form factor of Savanna and the new, smaller cartridge design was a big surprise for many who visited the booth. We continue to hear that there is a big gap in the molecular space that the Savanna menu of affordable, smaller syndromic panels, as well as individual assays, will address nicely, and look forward to introducing the product in Q4 2019 in Europe and in the first half of 2020 in the U.S. I should also mention that we had a couple FDA submissions under active review during the quarter. Sofia Whole Blood Lyme is awaiting CLIA waiver pending the FDA's review of follow-up studies that were performed during the quarter. We hope for clearance in August a little later than planned and are ready to go from a marketing perspective. We believe that this has the potential to be a nice growth driver for us in the U.S., with growth driven largely by our introduction of a CLIA waived assay. And, after addressing questions through the quarter, Solana Parapertussis was recently cleared. The addition of parapertussis makes the assay unique and we do have interest from pediatric hospitals, although in fairness this is more of an opportunistic, regionalized market in parts of the U.S. that are not appropriately immunizing children. In summary, we had another nice quarter, a quarter that reflected the continued progress we're making. We said at our Analyst Day earlier in the year that we expected to achieve revenues for the year of $520 million, with a gross margin profile in the high 50s. Two quarters in, allowing for some variability in Q4 to account for the timing of the respiratory season, I am comfortable in saying that we will do slightly better than that, given better visibility to the performance of the acquired businesses. And finally, to the many Quidel employees on the call, or who will listen to the webcast later, thanks for everything that you do to make us successful. We know that there are so many things that need to be done, especially at the moment, but you're getting them done, on time and your work is appreciated. There has never been a greater time to be at Quidel, thanks to your efforts. Randy?