Doug Bryant
Analyst · Barclays. Your line is now open
Thank you Randy, and good afternoon everyone. As Randy just mentioned for today’s call I’ll briefly touch on our results and a few highlights for the quarter, and then actually spend a bit more time outlining our overall strategy and discussing where we are with our key growth catalysts. Total revenues for Q2 were $39.1 million, slightly better than our internal projections and a record for Q2. Revenue growth over the prior year quarter was 11%. Influenza product revenues, which were $11 million, grew 21% over the prior year quarter driven mainly by three factors; first, as our Virena data show quite clearly, the tail-off in Influenza B that often marks the end of an Influenza epidemic, and normally occurs in March, extended into early April in a number of states; second, distributor inventories exiting Q1 were low; and third, we gained share as a result of additional Sofia placements over several prior quarters, 65% of which were competitive take-aways. Sofia placements were appropriate for the time of year, and as we expected. And encouragingly, over 1,000 additional Sofias were connected to our Virena cloud-based database in the quarter, and results transmitted in the aggregate to the database exceeded 1 million. As a result of the success with Virena, and the overall capabilities of the Sofia system, we continue to do well in the professional segment. For example, we closed a 90 unit Sofia deal during Q2 in a large prominent integrated delivery network, which is becoming more common as networks look to standardize across hospitals and clinics. A key element to our success in many cases is that customers simply want instant access to their testing and quality control data. The Virena and Sofia product offering also positions us well in the alternate site segment, which we define as anything outside the professional segment. A recent highlight of the alternate site initiative is our largest Sofia close to date, which will require Sofia placements at over 650 sites. Non-flu product revenues for Q2 grew 8% over the prior year quarter. Except for cell-based general virology products, all key non-flu franchises grew over the prior year quarter. Bone health and complement product revenues were up 57%. Typically this business has been a 10% annual grower. The increase this quarter was due to the addition of Immutopics product sales. Molecular product revenues were up 63%. One of the drivers to the increase in molecular product sales is that many Solana Group A Strep customers are now coming on line. During the quarter we closed our largest Solana customer to date, a large integrated delivery network that will be purchasing over $1 million in Solana Group A Strep annually. Thyretain, our Graves’ disease product, increased 8%, and is expected to continue to grow at about that rate until we introduce our blocking antibody product sometime next year. Group A Strep Immunoassay sales were up 13%, due in large part to competitive take-aways from visually read point of care products to Sofia. And finally, hCG was up a modest 4%. Also worth noting, international sales in Q2 were up 10% over the prior year quarter, and for the first half of the year were up 26% over the same period in 2015. There were a number of contributing factors to our international sales growth, one of which is that we launched Sofia Strep Pneumo last year. In terms of product development, there were no surprises, and there are no changes to any previously communicated timelines. If there is a question on any specific product, I would be happy to address it during the Q&A portion of the call. During the quarter, we did receive the CE Mark for Solana Trichomonas, which is also under active review at the FDA. We submitted a 510(k) for Solana Influenza A+B, which is presently under active review at the FDA as well. And we had a small number of international regulatory approvals for various Sofia products. One final highlight for the quarter is that our newest generation high speed Sofia production line was officially transferred to production, which increases Sofia test cartridge capacity by 20 million tests per year. So, we’re half way through the year, but perhaps more importantly, we’ve reached the point at which many of the things that we hoped to accomplish are now behind us, and others that we had planned to achieve remain in front of us, but many of those are now in the not-too-distant future. And while our strategic intent, the what we want to accomplish is essentially unchanged, the how, admittedly, has evolved a bit given better information and greater clarity on what our customers need today and what they will need tomorrow, as the healthcare landscape changes and evolves. So at this point, I think that it would be useful to do a quick refresh on what we want to achieve, and how we are going to get it done. As we’ve stated often, our strategic intent is to build a broader-based diagnostic company that delivers revenue and margin more consistently. How are we doing that? First, we have used existing resources to fortify price and volume on our core businesses through the development and commercialization of a next generation immunoassay analyzer called Sofia, which among many customer benefits that Sofia has provided, dramatically closed the performance gap between traditional point of care antigen detection rates and molecular methods. And in the process of fortifying our Influenza business in particular, we grew the point of care market through the introduction of an instrument system, and actually gained share in the rapid point of care market for Influenza testing, as well as in the markets for Group A Strep and RSV. Moving forward, we will introduce Sofia 2, with two main objectives. First, we intend to further fortify our position in our core businesses in the professional segment by cannibalizing our QuickVue businesses with a lower cost portable instrument that enables positive test results to be reported in as few as five minutes or fewer depending on the test type, and with built in connectivity to our Virena database, makes it even easier for integrated delivery networks to standardize their higher volume infectious disease testing and to more easily manage quality control across the network. Second, we believe that as healthcare evolves, testing and treatment of routine conditions like Influenza and Group A Strep will eventually migrate in large numbers from the professional segment to what we call the alternate site segment. In that environment, time-to-result, cost and connectivity have already proven to be important criteria, which makes Sofia 2 an obvious choice. Overall, with Sofia 2, we think that we can almost double the number of Sofia placements within the next 3 to 5 years. The second part of our strategy is to use our capabilities in molecular product development to attack the limitations of the numerous competitors in the molecular space. Every system and approach has its capabilities and limitations, and customer needs vary as well. For customers who don’t have molecular instrumentation, or who don’t have people on the second or third shift that are trained to work in the molecular lab, we developed AmpliVue, a handheld disposable molecular device for the detection of antigens like C. difficile, HSV, Pertussis and several others. For customers who would like to move from culture methods to a molecular solution, but would need to run several samples at once and are constrained by their existing lab budget, we developed Solana for the detection of a number of antigens that don’t require extraction, like Group A Strep, Trichomonas, Influenza and several others. For high volume molecular labs we’ve developed easy to use PCR assays called Lyra. And for a part of the world that desperately needs a high performing HIV viral load testing solution that is robust enough to handle the most difficult of environmental conditions, and has a low total cost of ownership, we are developing Savanna. While I won’t be discussing our assay development and launch strategy today, what we intend to do with Savanna in the developed world to address the limitations of our competitors will be revealed in some detail for the first time next week during a luncheon presentation on Tuesday in Philadelphia. For those of you who would like to attend and have not yet confirmed their attendance, I would encourage you to reach out to Ruben within the next day or so. The third part of our strategy to build a broader-based diagnostics company is to forge ahead and lead in the creation of new markets and new businesses. Culturally, we are a group of people that eschews rules and current thinking. We’ve been questioned on how valuable Virena would be and whether we could actually monetize it. We are evaluating options for further monetizing a data product offering that includes Virena data in the future, but clearly we already have benefited from our investment in Virena in terms of additional Sofia placements and market share gain. We were told by some very smart people that we couldn’t develop a Sofia assay for Vitamin D, but we’ve done it. And we’ve been questioned on whether the Vitamin D market can be decentralized, but it will be. We‘ve been asked why we developed a Sofia assay for Lyme, which today is a very small, niche, market. The answer is that we developed Sofia Lyme for the market that will be. We’ve also been told that molecular methods for infectious disease detection are inherently more sensitive. And of course, it’s logical that in making lots of copies of something, as we do with a molecular assay, it should be easier to detect. But I will leave you with this question. What if it’s possible that next generation Sofia 2 assays for Group A Strep, Influenza and others would be sensitive enough to have a confirmatory claim, just as some molecular assays like Solana Group A Strep have? I look forward to hearing somebody tell me that it’s not possible and that we can’t do it. And just so you know, I'm saying that with a smile. In summary, Q2 was good. We expected to do well, both from a product development perspective as well as commercially, and we did. And as I said, our strategy has evolved a bit over the last few years due to changes in the market, but also because of our own product development discoveries. But essentially, the path we're on has remained the same. And we continue to believe it's a path for long-term success Randy?