Randy Steward
Analyst · Jack Meehan with Nephron Research. Please go ahead, sir
Thank you, Doug. Good afternoon, everyone. As Doug stated, we had another very strong quarter that exceeded our own expectations. Our employees have truly resent to the COVID-19 challenge by delivering new products to markets and continuing to expand production for newly launched COVID-19 antigen and PCR products, making a profound difference in people’s lives and livelihoods. Through the dedication and hard work of our organization, we’ve positioned the company for a strong end of the year and beyond. As reported, total revenues for the third quarter of 2020 were $476.1 million, this compares to $126.5 million in the third quarter of 2019. The 276% increase in revenue was driven by significant growth in our rapid immunoassay and molecular categories driven by considerable demand for our COVID-19 diagnostic products. We did realize minimal declines and demand for the Cardiometabolic and Specialized Diagnostic Solutions product categories. Foreign currency had a positive impact of $500,000 in the quarter. Rapid immunoassay product revenues increased $294.5 million to $337 million in the third quarter of 2020. Within this category, Sofia products grew $303.2 million to $331.9 million of which $317.9 million was attributed to Sofia SARS Antigen sales. QuickVue product revenues decreased $8.7 million to $4 million. In September, we did not realize the ramp up of distributor purchases of influenza, Strep and RSV heading into the respiratory season as we have seen in previous years. We intentionally prioritize our production and shipments towards the SAS Antigen test. As a result, influenza rapid immunoassay revenue was $7.9 million with approximately 90% of that revenue derived from the Sofia platform. For the Cardiometabolic Immunoassay business revenue was $64.8 million, a 3% decrease versus the third quarter of 2019. More importantly, this category was up $10.6 million sequentially, and we’re optimistic that the cardiometabolic categories are stabilized. Of the $64.8 million in revenue in the third quarter, $32.7 million was derived from the Triage business and $32.1 million from the Beckman BNP business. Year-over-year the revenue decline was realized in two of the three major geographies. However, sequentially growth was observed in these three major geographies, a very encouraging sign. Revenue in the Specialized Diagnostic Solutions category decreased 10% or $1.2 million in the third quarter to $11.2 million, mostly driven by a decline in our respiratory products from our Cell Culture business. Our molecular diagnostic solutions category increased $58.3 million in the quarter to $63 million, driven by $57.8 million in sales of our Lyra and Lyra Direct SARS-CoV-2 products. Despite these being gap filling products in the sense that these reagents have no proprietary instrument and are used as a second or third option, we are seeing good growth from these products and believe that we will continue to see added growth as more small and mid-sized labs continue to bring PCR testing in-house. In the quarter, total influenza revenue, which includes rapid immunoassay, DHI respiratory and molecular diagnostics was $9 million. Gross profit in the third quarter increased $307.8 million to $383.6 million and gross profit margin was 81%. This improvement was driven by the demand for the SARS-CoV-2 assays, which drove improved product mix. In addition, higher volumes contributed to increase manufacturing overhead absorption. In the third quarter, as in the second quarter, we realized a significant improvement in our profitability profile because over the short-term, we do not incur material variable operating costs increases. In the third quarter, total operating expenses measured as a percent of revenue declined by 28 percentage points versus last year and sequentially declined by 16 percentage points to 16% of revenues, helping improve our operating income in the quarter to 65% of revenues. We see this trend continuing into the fourth quarter as well. We continue to invest in R&D with the goal of launching additional COVID-19 diagnostic assays, advancing on our Savanna initiatives, as well as introducing new Sofia assay and next-generation platforms such as our internally named project Sniffles. We will also continue to invest in our sales and marketing organization, as we expand training in new markets such as nursing homes and occupational health and significantly broadening our customer base. For the full year, we’re currently estimating R&D spend to be in the range of $80 million to $85 million. And our G&A spend for the full year should be in the range of $65 million to $70 million. And in the quarter, we recorded a $10.4 million loss on extinguishment of debt. This was a result of a retiring in cash $5.9 million in principle of our convertible notes. The current principal outstanding balance on the convertible notes is $6.8 million. As it relates to the provision for income taxes, we recorded $63.5 million in income tax provision in the quarter and the effective tax rate was 21%. All items adjusting our tax had an insignificant impact, including the discrete tax benefits from excess stock compensation. We are currently estimating a full year effective tax rate between 21% and 22%. This rate is approximately 2 percentage points higher than previous estimates due to the increase in pre-tax income versus prior years. We successfully completed this quarter a contract with the NIH and support of increasing our manufacturing capacity. The total contract value is for up to $65 million. The contract has a performance period of one year, beginning July, 2020 with key deliverables and milestones that would directly support the addition of new immunoassay manufacturing lines, as well as outfitting a new distribution center. As part of the agreement, the company will provide to NIH, Sofia 2 instruments, and COVID-19 assays. As of the end of September, we had $77.5 million in cash and cash equivalent. During the third quarter, the company generated $70.5 million in cash flow from operations. This number would have been larger – not been for the approximately $244 million investment and accounts receivable and inventory, as we accelerate our growth to support increased production of SARS assays. In the quarter, company also invested $22.7 million in capital expenditures. At the end of the current fiscal year, we anticipate having in excess of $500 million in cash on the balance sheet, no convertible debt outstanding and no outstanding balance on our revolving credit facility. In short, we have a very strong capital structure, access to credit, good cash flow, which places us in a great position to support our future initiatives. Those initiatives include increasing our R&D investment, strengthening and expanding our supply chain, aggressively ramping up our manufacturing capacity and pursuing M&A. And with that, we conclude our formal comments for today. Operator we’re now ready to the call for questions.