Douglas Bryant
Analyst · Alex Nowak with Craig-Hallum
Thank you, Ruben. And welcome to everyone on the call. We really appreciate your time and interest in Quidel. I understand that several of our analysts actually are covering multiple names today. So again, we appreciate you being on this call. And obviously, we'll try to be respectful of your time as we are succinct as possible. I want to start by recognizing the entire Quidel team for their tireless dedication and skill. The past 18 months have been a grueling test of all our systems and teams, from our R&D and clinical teams, to our production floors, to our supply chain and all other functions including HR, finance, regulatory affairs, sales and marketing, legal, business development, and international of course. Not only have they met the pandemic test, they aced it. Our product platforms and offerings have never been more robust. Our productivity is up across the board. And our market penetration is deeper and wider than ever before. From high-complexity labs, to healthcare facilities, point-of-care locations and direct-to-consumers at retail and online, the Quidel name, our branded assays and analyzers, are accessible and sought after. The net effect has been transformational for our company and positions us exceptionally well for long-term revenue and earnings growth. So, to all my colleagues at Quidel, I say, again, thank you. Turning to the second quarter of 2021, you will see from the press release that, while revenue is down 12% versus the prior year quarter, the pace of our business remains impressive with revenues of nearly $177 million. We’ll unpack all the numbers in a moment, but what stands out to me as the leading indicators of the quarter, relative to our long-term strategy, are the following: We delivered solid 24% growth in our core business. We further broadened our installed base of Sofia analyzers. Demand for our SARS products continued, with Quidel shipping over 8 million tests in the quarter across all platforms. And we established a strong beachhead for COVID testing in the Retail segment. The implications of each will extend well beyond a single quarter. Please recall that, in Q2 of last year, we saw a significant rise in COVID-19 and influenza revenue that largely resulted from the onset of positive COVID-19 cases in North America, the emergence of testing for COVID-19 and the introduction of our Lyra and Sofia COVID-19 testing products. We were early to market with molecular testing and the first to market a rapid antigen test. Demand was high and competition was limited. By contrast, in 2021, there was essentially no flu season, and the market for SARS Antigen testing has become much more competitive. As a result, while demand for COVID-19 tests in Q2 of this year was still present, and perhaps stabilized, revenue was lower when compared to the surge in orders that we saw in 2020. But if you drill down a bit further, you will see that the top-line numbers obscure the underlying strength of our Rapid Immunoassay business. In Q2 of this year, we sold 6.6 million SARS Antigen tests, as compared to 3.1 million tests in the second quarter of last year. We saw a significant shift in product demand. We shipped fewer Sofia SARS Antigen assays to the professional market, and saw significant demand for our QuickVue SARS Antigen tests, about 4.8 million tests, which weren't available in Q2 2020. Of course, our QuickVue tests are priced lower, coming in during the quarter at an average of just under $6 per test, which explains the resulting lower revenue for the category. Quite frankly, we’ll accept that gladly, because over the course of a year, we’ve succeeded in democratizing testing and pushing the boundaries of access beyond the professional point-of-care setting to include retail and at-home testing. We’re quite proud of that achievement and believe it's the forward edge of a broader home-testing trend that will continue to drive earnings over the long haul. Now let’s look at our core business, excluding COVID-19 and influenza assay products. We were up 24% as I mentioned before to nearly $92 million, as compared to $74 million in the second quarter of 2020, as we began to see a return to normal testing for cardiovascular, Strep A, and our microtiter businesses. Growth of our core business is important going forward as we strive to maximize the utilization of our Sofia instrument placements, adding new assays, such as our suite of gastrointestinal assays, and expanding into new segments within diagnostics. We envision leveraging our rapidly expanding platforms to broaden our footprint and create a demand funnel for a wide variety of future tests and diagnostic products that can be employed in numerous settings including hospitals, physicians, offices, urgent care centers, pharmacies, retail and other institutions. One recent success of note is that, on June 11, we received EUA for our miniaturized, artificial intelligence enabled Sofia Q device. Sofia Q will make access to our Sofia tests easier and more affordable for professional point-of-care customers. Longer-term, it could create a retail pathway for our full portfolio of Sofia tests for influenza, RSV, Strep, line disease and other conditions. So, the combination of our expanded installed base and continued demand for our Sofia and Sofia 2 instruments with the expected adoption curve of Sofia Q, positions us favorably to be the brand of choice for addressing the coming flu, Strep and respiratory disease seasons and whatever else comes along. At the start of the call, I noted the terrific work of our R&D, operations, and clinical teams. During the quarter, they continued to advance Savanna, our multiplex molecular diagnostic analyzer, which we believe could be our next flagship product. We recently received the CE Mark, we are building out our instrument and cartridge manufacturing, and expect to launch in Europe in the fall, with U.S. clinical trials expected to begin toward the end of the year. Once approved, Savanna will enable professional customers to analyze up to 12 pathogens or targets, plus controls, in a single assay run in fewer than 25 minutes. This makes Savanna a perfect fit for testing in hospitals, moderate-complexity labs, physician offices, urgent care clinics and other point-of-care locations. As I’ve said before, customer feedback is fantastic, and I am confident Savanna will be a big part of our quarterly discussions in the future. Let’s turn now to the subject that has been a big part of our discussions over the previous five quarters, COVID-19. While we are actively working to expand our diagnostic platforms and product mix in other areas, COVID-19 testing remains a significant near-term opportunity. You've probably seen our announcement with the State of Delaware to provide testing to students and faculty. It is a testing-as-a-service model that we have replicated in other states as well. We also are pursuing a variety of other opportunities with schools, employer groups selling in select U.S. and ex-U.S. markets and evaluating other non-traditional markets. While we expect to close more accounts with employers, and have several promising partnerships in the pipeline, they involve a good deal of blocking and tackling and are hard to predict or value, especially when guidance from CDC and the landscape of COVID testing seem to evolve daily. The most recent example includes warnings from public health officials that vaccinated people can become infected and spread the highly transmissible Delta variant of COVID-19 appears to be a near-term driver for more masking and testing, especially as schools and offices look to reopen in the fall. Regarding the Delta variant, I can report that preliminary studies confirm that Quidel’s rapid antigen tests are effective in detecting the Delta variant. We are continuously monitoring the COVID-19 mutation situation, as well as monitoring other circulating strains as the global pandemic continues to evolve. While our ability to pick up the Delta variant positions us to capture market demand for symptomatic, asymptomatic, and at-home testing, at the same time, any uptick in testing to detect the Delta variant will likely be tempered by continued competition and pricing volatility. So, I can’t give you much guidance on where all this could go beyond what I’ve shared in the past and that is for the moment, we expect to achieve revenue of $20 million to $25 million per month from our SARS-related rapid antigen and molecular diagnostics business. But if there's market upside for testing, I should point out that we do have a premier portfolio of testing solutions and a highly capable sales and distribution team. We are certainly well-positioned to compete for whatever opportunity presents itself. Last week, we announced that we are transitioning our Beckman BNP Business to Beckman Coulter, concluding the ongoing litigation that followed our purchase of the business from Alere in October 2017. This agreement is a major step forward for both companies. For Quidel, it eliminates an uncertainty, locks in the economic benefit for the duration of the contract, and lets us focus on expanding our core businesses and executing on our longer-term strategy. It eliminates market risk and creates a stable cash flow stream for the remainder of the existing BNP supply agreement term. As a reminder, we purchased the asset for $280 million in 2017 to be paid over 6 years, and have now secured annual payments which effectively are EBITDA of between $70 million to $75 million per year through 2029. So, we are quite happy with the outcome and the ROI. It’s a win-win for both Quidel and Beckman. Lastly, I'd like to talk about M&A. I can't reiterate enough that, with respect to acquisitions, strategic fit is very important to us. We continue to actively look at opportunities within our funnel, or as I've said before, tongue in cheek, we're kissing a lot of frogs. The headline here is that our cash position remains strong. We’re looking, and stand ready to deploy capital to further strengthen our product portfolio should the right opportunity present itself. So, to wrap up, the second quarter of 2021 proved to be another very solid quarter and an important step forward in our long-term game plan. We have fielded a powerful mix of products and partnerships and are benefiting from the tailwinds of macroeconomic trends. When we add in the talents and spirit of our team, it gives us every confidence that Quidel will deliver continued growth and success as we advance diagnostics to improve human health. Randy?