Doug Bryant
Analyst · Raymond James. Your line is now open
Thank you, Randy, and good afternoon, everyone. For today’s call I’ll give you my thoughts on the fourth quarter. I’ll provide some insight into the ongoing Influenza season based on our Virena data and I’ll conclude with comments on our longer-term growth initiatives. Total revenue for Q4 2017 was $114.9 million, 118% increase from the fourth quarter of the prior year. Due to three factors: first, the incremental $47 million from the acquired Triage and BNP Businesses that closed on October 6; second, $10.2 million in incremental Influenza sales; and third, $4.9 million in incremental non-flu revenues from the legacy Quidel business. The fourth quarter overall was very busy and very productive for us driven by the markets receptivity of Sofia 2 with early read times for Sofia Influenza and connectivity to Virena, and the FDA reclassification of rapid influenza assays, Sofia placements were 8,226 our largest quarterly placement rate ever. Receiving 510(k) clearance in CLIA waiver from the FDA for Strep A plus for use on Sofia 2 was timely and helpful as well. And we received 510(k) clearance for Sofia Lyme, well in advance of the Lyme disease season the summer. Molecular assay revenues were $4.9 million in Q4, driven mostly by Solana Group A Strep, which continues to grow. In the quarter, we received 510(k) clearances for Sofia – excuse me, our Solana Group B Strep and Solana RSV and Human Metapneumovirus bringing the number of assays available on Solana to 7. And, of course, early in the fourth quarter, we closed the acquisition of the Alere assets. In that regard, the integration is going very well. To summarize our achievements thus far, we’ve transitioned 472 employees in the United States. We’ve successfully implemented order-to-cash within the U.S. and 24 direct export markets. We’ve restructured our North American commercial operations to incorporate selling the Triage and BNP products. On the international side, we’ve hired 50 commercial employees across China, Germany, Italy and Austria. To support our international expansion, we’ve also selected an EU-shared service center site in Galway, Ireland. Locally, we completed the sale-leaseback transaction of the Summers Ridge facility and used some of the proceeds to retire $110 million in debt. And finally, we’ve moved 100% of the Summers Ridge employees to building C and D, two of the four buildings on that campus. With respect to manufacturing, we continued to work with our third-party partner to improve both product quality and yields at the Summers Ridge facility. We believe we are on track to reach the $10 million run rate and synergies by the end of the year with another $10 million thereafter. Next, let me address the extreme respiratory season and what that has meant for Quidel. I know that everyone on this call would be aware that the morbidity associated with this year’s influenza A H3N2 variant has been significant, which has resulted in a high rate of health care provider visits and millions of rapid influenza tests. If we were to look at Virena test data over the last 800 days, or about 2.5 seasons, and we were to only look at the data from the Sofia users who were transmitting over that entire period of time, you would get a sense for how strong this season has been so far. If we were in a consumer business, I suppose that we might call the same-store sales and we would see in those small number of stores at this point a little halfway through the season, that there is 100% increase in Sofia Influenza testing over the 2015, 2016 season, and about 50% increase in Sofia Influenza testing over last season. Of course, we’ve also placed more Sofia instruments over the last 2.5 seasons. And at the end of the fourth quarter, we were right at 26,000 Sofia placements, which is net of service replacements and a very small number of returns with a back order of about 700 instruments as we exited the year. We’ve increased manufacturing capacity, but are still shipping as many as we can make and are still in an instrument back order of approximately 1.5 weeks. In fairness to our marketers and planners, we did plan appropriately to upgrade many QuickVue customers to Sofia 2, anticipating that we would be unable to ship QuickVue Influenza after January 12. What we did not anticipate was that several of our competitors have been unable to ship product for a significant part of the season thus far. As a result, not only did Sofia 2 shipments increased dramatically, but we are also shipping as many Sofia Influenza test cartridges as we can make. The good news is that we were able to demonstrate in a recent clinical trial that QuickVue Influenza meets the FDA reclass guidelines, and it was 510(k) cleared and is CLIA-waived as of February 13. We are now shipping QuickVue Influenza test as well, which is helping with capacity issues. How much longer this demand will persist is hard to know. But our Virena data would indicate that we’re a little bit more than halfway through the season as Influenza A positive test rates begin to decline a bit and Influenza B rates are rising. Although positivity rates are still quite high between 32% and 36%, we expect testing rates to decline quickly once the positivity rates have plateaued, which could be in the near-term. In the meantime, we’re still running 2, 10-hour shifts per day, 7-days per week in San Diego. I should add that our molecular business, although much smaller, is also benefiting from this respiratory disease season. And our Ohio molecular manufacturing facility is keeping up with demand at this point. And finally, let me comment briefly on product development and our pipeline. We continue to make progress on all projects, which include a number of Sofia, Triage and molecular initiatives rather than spending a great deal of time on this call, I’ll just remind you that we are holding our next Analyst Day event on April 3 in Chicago. And I’m personally excited about unveiling our next-generation technologies and detailing what we expect to achieve over the next two to five years. In summary, there was a lot to be proud of in 2017. We have truly transformed our company. We’ve entered new markets, significantly grown our international footprint and diversified our business. We continue to focus on integrating the Alere assets and unlocking synergies, as well as capitalizing on the numerous Sofia placements out in the field. We’ve had a great fourth quarter and a fantastic year and I’m excited about 2018 as well. Randy?