Joseph M. Busky
Okay. Thanks, Doug, and good afternoon everyone. Before I discuss our financial results for the second quarter, I want to remind you that to facilitate a year-over-year comparison of the Company's operating performance, all growth rates that I referenced are presented on a supplemental combined basis as if Quidel and Ortho has been combined for the applicable periods, and may be referred to as supplemental combined information. Staring with the breakdown of revenue on slide seven, with demand environment continues to be strong and we delivered another strong quarter on the top line. Non-respiratory revenue grew 4% in constant currency, to $576 million in the second quarter, driven by continued strength in our Labs business unit, as well as increasing strength in our Triage product line and a bounce back of immunohematology. Excluding our Donor Screening business, which was a headwind in the quarter, as Doug mentioned, non-respiratory revenue would have been up 7% in constant currency. Respiratory revenue totaled $89 million in the quarter, including $56 million in COVID related revenue. Respiratory revenue was softer than expected due to a sharper than expected decline in COVID related revenue, following the end of the public health emergency in May, partially offset by resilient flu revenue. In total, revenue was down 26% to $665 million, reflecting the strong COVID related revenue in the second quarter of 2022. The strength of our COVID related revenue a year ago highlights what we and others in the diagnostic space have been same for several quarters. We believe COVID-19 is transitioning to an endemic state and is continuing to circulate like any other respiratory disease, appropriately we now bucket COVID-19 revenue with our other respiratory revenue. Turning to our quarterly performance by geography, on a constant currency basis and excluding respiratory revenue, North America revenues declined 2%, EMEA grew 4%, China grew 26% and our other region, which includes Latin America, Japan and other Asia-Pac markets grew 9%. North America, our largest geography by revenue delivered solid revenue in the Labs business, but non-respiratory revenue declined to the previously mentioned weakness in Donor Screening. The Labs strength included both recurring revenues and instrument leading our major regions and instrument revenue growth contribution. During the quarter, we made the final $4 million shipment on a previously discussed government contract for QuickVue at home test, and we don't anticipate any further government revenue for the remainder of the year. In the EMEA region, solid non-respiratory revenue growth was driven by Labs and immunohematology. The Labs strength was widespread across most major countries in the region while the immunohematology growth was driven by large customer orders in the Middle East. We also saw strong double-digit growth in Triage placements, which we expect to drive incremental revenue growth in future quarters. In our China region, which makes up about 10% of our total Company revenue, non-respiratory growth of 26% was driven by broad strength in Labs. Hospital demand continued to be strong throughout the quarter driving growth above the rate we realized in Q1, which had benefited from the surge of demand early in the year following the end of COVID-19 lockdowns at the end of ’22. Within Point of Care, we continue to drive double-digit growth of our Triage products and our Sofia year-to-date revenue is close to double our ‘22 full-year revenue following the launch of Sofia 2 and strong instrument placements in the quarter. Both of these accomplishments are clear demonstrations of revenue cross selling synergies. Turning to our Q2 non-respiratory revenue by category, recurring revenue which includes reagents, service and other consumables grew 4%. Excluding our Donor Screening business, recurring revenue would have been up 6%. Instrument revenue grew 10% as instrument demand was robust and we worked down our open labs instrument orders by approximately 40% to 300 instruments from 500 at the end of Q1 and 650 at the end of ‘22. So, while global supply chain challenges appear to be easing, we don't believe that we're fully resolved and customer readiness during the summer months will be a limiting factor in the near-term. We continue to expect elevated open orders to modestly persist into early ‘24 as we work toward our goal of a normalized 150 open orders. Turning to slide eight, I'd like to comment on our second quarter financial performance below revenue versus the prior year, again, on a supplemental combined basis. Gross profit margin for the quarter was 45.6% a bit lighter than our expectation due to product mix, including the strong instrument revenue as we work down our Labs instrument open orders, and lower than expected COVID related revenue due to the end of the public health emergency. Moving down the P&L, R&D expense increased about a $1 million sequentially, $3 million higher than expected due to the Savanna FDA regulatory submissions. Sales, marketing and administrative expenses were down $23 million sequentially, reflecting execution on cost synergies and reduction in variable expenses. We expect the sales, marketing and administrative expenses to be flat to slightly down in Q3 and Q4 as compared to Q2. Adjusted EBITDA also declined year-over-year to $113.3 million, slightly ahead of our expectations due to the strong revenue. Adjusted EBITDA margin contracted year-over-year to 17% slightly below our expectations due to product mix including strong instrument revenue and lower than expected COVID related revenue due to the end of the public health emergency, as well as the $3 million higher than R&D expense due to the Savanna FDA regulatory submissions. Net interest expense for the period was $36 million, an increase of $7 million versus the prior year, as anticipated due to the increase in the average outstanding debt balances related to the combination. And as a reminder, we have swaps in-place that secure approximately 70% of our term loan at a fixed rate for the life of a loan, providing for an all in interest rate after the effect of our swaps of approximately 5.6%. Our provision for income taxes was $5 million compared to $63 million for the prior year period. This represents a second quarter adjusted tax rate of 23.4% down from prior year period due to discrete items. Our adjusted earnings per fully diluted share for the second quarter was $0.26 compared to $2.12 in the second quarter of ’22, on a supplemental combined basis. The decrease in EPS was again driven by an exceptionally strong prior year period in COVID transitioning to an endemic state. The higher than expected R&D expense due to the Savanna FDA regulatory submissions negatively impacted our EPS in the quarter by $0.04. Now turning to cash flow and balance sheet on slide nine, in the second quarter on a GAAP basis, cash outflow from operating activities was $31 million, this is in-line with our expectations. After funding $49 million in CapEx, and adding back $16 million in integration related capital expenditures and $33 million in acquisition integration and other costs, we estimate adjusted free cash flow to be a negative $30 million for the quarter, again, in-line with our expectations. In terms of capital deployment in the second quarter, we used $112 million of cash to make our final $40 million payment to Abbott for the $680 million purchase of the Alere cardiometabolic assets. And we paid down $72 million of our term debt. Our debt pay down was $20 million more than the contractual requirement of our term loan as we take a key step towards reducing our leverage. While we did now buyback any shares in the quarter, we intend to maintain a balance and opportunistic approach to share repurchases, while also continuing to prioritize our debt pay down going forward. We ended the quarter with cash, cash equivalents and marketable securities of $248 million and total debt of $2.5 billion. We ended with 2.8 times net debt to EBITDA on a supplemental combined basis, and as COVID related revenue has declined due to the transition from a pandemic to an endemic, our leverage has modestly increase, but we expect leverage to finish the year slightly down from where we are now. The leveraging is a top priority with our goal to be at or above two times net leverage by the end of ‘24, while maintaining flexibility for strategic M&A opportunities. Now turning to our fiscal year ‘23 guidance on slide 10. First, I'd like to provide some broader context on our outlook. Labs instrument supply issues are expected to continue to alleviate as we move through the second half of the year, which along with the continued recovery in China are expected to drive high-single-digit non-respiratory growth in Labs. The end of the public health emergency caused a meaningful decline in the retail COVID market as well as Molecular, even advantage in testing has picked up share of the professional market from competitive Molecular systems. Due to these two headwinds on the COVID market, our COVID outlook has come down. In light of these dynamics, we are updating our fiscal '23 full-year guidance as follows: Total revenue of $2.88 billion to $3.08 billion compared to our prior guidance of $2.87 billion to $3.18 billion. Breaking this down little further, we are raising our non-respiratory revenue guidance to the high-end of our prior guide, while lowering our respiratory guidance. Non-respiratory revenue is expected to grow to 5% to 6.5% on a constant currency basis to $2.27 billion to $2.31 billion, up from our prior guidance of 4.5% to 6.5% on a constant currency basis to $2.26 billion to $2.31 billion. We now have a respiratory revenue guide of $610 million to $775 million including COVID revenue of $300 million to $400 million compared to our prior guide of $610 million to $875 million, including COVID revenue of $300 million to $500 million. And it's interesting to note that in the second half of ‘23, we expect that more than 93% of our COVID revenue forecast is in the professional market. We now expect the full-year gross margins to be at the low-end of our prior expectations of low to mid-50s due to product mix including higher instrument revenues from the faster than expected truly on the Labs instrument open orders. Adjusted EBITDA margin, expected of 26.9% to 27.7% in the range of $800 million to $830 million compared to our prior guidance of $815 million to $865 million. And despite the reduction in our guidance for higher margin COVID related revenue, we are offsetting the full P&L impact of the revenue drop with expense reductions. Adjusted diluted EPS is now expected to be in the range of $4.85 to $5.30 compared to our prior guidance of $5.15 to $5.70. In addition, I'd like to discuss the assumptions I covered last quarter that may be helpful for modeling purposes. At current rates, currency translation is expected to be about neutral to full-year sales, and adjusted EBITDA with a higher FX impact on non-respiratory revenue. As previously discussed and consistent with prior quarters or prior years, the first and the fourth quarters are seasonally the strongest quarters of the year. Net interest expense continues to be expected in the range of $145 million to $150 million for the year. We continue to expect the full-year adjusted tax rate of approximately 23.5%. We continue to expect adjusted free cash flow to be at the low-end of the 50% to 65% of adjusted EBITDA, which translates into more than 100% of adjusted net income and full-year diluted weighted average share count is $67.2 million. So with that, I'll turn the call back over to Doug, to make a few summary comments.