Douglas C. Bryant
Analyst · Cowen Company
Thank you, Randy. For the call today, I'll comment on 3 topics. First, the latest influenza season; second, progress with new products and product development; and third, a summary of where we stand with respect to our aspirational global targets. Let me start first with the characterization of the flu season generally. The predominant circulating straining season was the 2009 H1N1 subtype. This virus disproportionately affected persons aged 18 to 64 versus last year's predominant H3N2 strain, which disproportionately affected persons over 65 years of age. The current flu season was characterized by a lower and narrower ILI peak than last year's ILI peak, suggesting lower influenza prevalence at least in terms of influenza illness as a percentage of physician office visits and shorter duration of the season. Another characteristic of this flu season was its relative mildness in terms of morbidity. According to the CDC, there was a 27% decrease in the number of laboratory confirmed influenza-associated hospitalizations this season from last year, and the number of pediatric deaths was roughly half the number that occurred in the 2012, 2013 season. Through April 5, the CDC sentinel sites have reported 19% fewer ILI visits for this season versus the prior season. Overall, it was a very mild and shorter respiratory disease season. Consequently, demand for respiratory disease products declined versus the prior year's first quarter, partially offset by Sofia and molecular revenues. Total revenues for the first quarter of 2014 were $46.7 million, a 25% decrease from revenue in the first quarter of 2013. Despite the weakness in the season, we continue to make progress with the launch of Sofia, our next-generation automated immunoassay analyzer. Sofia revenues for Q1 were up 57% over the prior year. And on a 12 -- excuse me, trailing 12-month basis, sales of instruments and cartridges exceeded $20 million. Our pricing and margins have held steady, and a number of placements in the quarter was consistent with a number of placements in Q1 of 2013. Our cannibalization rate ticked up slightly to approximately 35%, and Sofia placements in the quarter were about evenly split between hospital and physician office lab accounts. We saw a solid traction with our Sofia RSV product and believe we picked up some share with this product, as well as with our Sofia influenza A+B product. With regard to Sofia development activities, 2 clear labor packages have been submitted, with 1 more remaining to be submitted. And we're on track to complete the development of our first 2 quantitative assays as scheduled. We also saw progress with our molecular products, particularly with AmpliVue, our handheld disposable molecular device. We've recently seen an increase in the size of our average contractual commitment to purchase AmpliVue C. difficile, as several large customers have completed evaluation. In addition, we just recently launched AmpliVue HSV 1+2, and we completed clinical trials for our fourth AmpliVue product. Closing our list of accomplishments with AmpliVue we're in clinical trials for 2 additional AmpliVue products at this time. Assuming all goes well, we could exit 2014 with an AmpliVue meeting with 6 infectious disease assays. We've also made great progress with Lyra, the brand name for our real-time PCR-based assays that are specifically developed to run on a laboratory's existing thermocycling equipment. We recently received FDA clearance for our latest molecular assay for cryogenic Strep A and C or G. The assay followed the FDA's de novo pathway, which means that it's the first of its kind in the marketplace and is now available for sale in the United States. One other de novo Lyra assay is under review by the FDA as well, and 2 other Lyra assays are currently in clinical trials. And finally, a word about Savanna, formerly known as Project Wildcat, which is the highly robust cartridge based fully integrated molecular diagnostic system and tendered initially as a low-cost HIV viral load testing solution for the developing world. We're on track with our previously disclosed timeline. And in fact, because a number of technical hurdles that are now behind us, have made the decision to increase our R&D spend on the project this year, as we now believe that, with the spend, we can start clinical trials in Africa earlier and can accelerate many development for the developed markets. Randy will talk about this and the impact to our overall R&D spend in a few minutes. In summary, while the weak flu season had a dampening effect on our financial performance, we nevertheless had a highly productive quarter, accomplishing a number of tasks and objectives that we believe will contribute ultimately to the achievement of the aspirational targets we first unveiled at our Analyst Day in 2011. At that time, we said that while it will be technically challenging, we intended to become a broader based diagnostic company and that we have the assets and capabilities to expand well beyond our existing rapid point of care business. We said that with the recent FDA clearance, to market Sofia in the United States, we would stabilized our existing business and would develop quantitative assays that would give us access to larger markets. We also said we would enter the molecular diagnostic segment and that we could create brands through the introduction of unique instrument and assay solutions. We noted, of course, that R&D and product development by their nature were always somewhat uncertain and fluid, subject to change in terms of content and timing. While uncertainty around development activities, clinical trials and clearances by regulatory agencies as part of the new product development process, I am very pleased for the most part with our ability to do what we said we would do and to make significant progress towards our goal of becoming a broader based diagnostic company. In 2011, we said that the achievement of the vision of becoming a broader based diagnostic company could occur at the point when we had recorded $100 million in annualized incremental revenue from new products and that we aspire to accomplish this by 2015. As we noted at that time, among other factors critical to our ability to achieve this incremental revenue was success with Sofia. And our objective was to have 10,000 Sofia analyzers online and operational, each billing about $10,000 per year. While timing is subject to change, as I said before, due to the risks, which I'll talk about in a minute, based on our experience thus far, with current Sofia placements and where we are with many development, we still believe that the goals for the number of analyzers placed in the billings replacement are achievable. At our current cannibalization rate, incremental revenue would be $65 million. We also said that our target for revenues for AmpliVue and Lyra customers was $25 million. Currently, our annual run rate for molecular assays is approximately $4 million. Therefore, based on our experience with our current molecular products and customer contracts and what we believe will be demand for the products that we expect to launch in the near term, we still believe that this target is achievable. So clearly, in 2014, there's work to be done and milestones that need to be accomplished, activities and events that could affect the timing of the achievement of our goals. To be specific, our outlook for the following year assumes that we have clear labor for all current Sofia products marketed in the United States. And while we are confident that this will be accomplished, it's not done yet. We also assume that we complete the development of quantitative assays this year in time to realize some level of revenue in 2015. Further, we assume that the acceptance of the AmpliVue workflow creates collateral benefit across a broader menu and that the size of our customer base accelerates. And finally, we expect that the evaluations of our Lyra products that are expected to be conducted by a smaller number of very large customers will be successfully completed before year end and that we will have a base of business as we begin 2015. So although Q1 was very productive for us, we have more to do this year. The good news, however, is that we have the skills and capability to get things done, and much of what we need to happen as well under our control. Well, back into the history of execution gives me confidence to say that we are well on our way to the achievement of our goal of becoming a broader based diagnostic company. Randy?