Robin Harper Cowie
Analyst · Morgan Stanley. Your line is open. Please go ahead
Thank you, Scott. Our first quarter revenue was $28.9 million compared to $5.1 million for the first quarter of 2020, representing an increase of 466% and an increase of 7% over the $27.0 million reported in the fourth quarter of 2020. For year-over-year and quarter-over-quarter revenue improvement continues to be fueled by our successful entry into COVID-19 testing services, which has enabled us to diversify our portfolio during a period of expected downturn resulting from the global pandemic. Our COVID-19 testing services revenue was $23.2 million in the first quarter 2021. Since this business began in the second quarter of 2020, there is no meaningful year-over-year comparison. However, sequentially, our COVID-19 testing revenue grew 8% over the fourth quarter of 2020. The increase in revenue was driven by volumes from existing and new customers. We continue to expect meaningful contribution during the second quarter 2021. Well, COVID-19 testing services played an important role in our overall revenue growth during the quarter. We are particularly pleased with the improved trends in lung diagnostic testing. Our lung diagnostic revenue was $4.0 million in the first quarter of 2021, compared to $3.6 million for the first quarter 2020, representing an increase of 10% and an increase of 8% over the $3.7 million reported in the fourth quarter of 2020. As you know, our primary call point in lung diagnostic testing is the pulmonologist, who have been particularly impacted by the pandemic as they have been pulled into ICUs and ERs to treat patients with COVID-19. Although we expect pulmonologists to continue to be impacted by any ebbs and flows in COVID-19 case volumes, we are encouraged with the progress this quarter, and particularly the bounce back in volumes we thought in the month of March. Overall, we believe the recent volume trends represent a leading indicator of the recovery from the pandemic. As the vaccine rollout continues, and more pulmonologists return to their normal workflow seeing patients, we would anticipate an increased need for lung diagnostics that we believe will benefit our testing business throughout the course of 2021. Of course, potentially offset by the spikes of the virus and hotspots around the country. Turning to biopharma services, first quarter 2021 revenue was $1.7 million compared to $1.5 million for the first quarter 2020, an increase of 12%. Biopharma service revenue declined 12% sequentially from $1.9 million in the fourth quarter of 2020. As we have said, this particular business can fluctuate quarter-to-quarter due to a number of factors, including contract timing and the impact of COVID-19, which has resulted in a global slowdown of clinical trials. However, we expect full year 2021 revenue results will represent growth over fiscal 2020. Overall, biopharma services remain a significant long term opportunity for bioethics as clinical trials begin to ramp back up. Moving down the P&L, direct costs and expenses for the first quarter of 2021 were $18.2 million as compared to $1.6 million for the first quarter 2020 and $14.7 million for the fourth quarter 2020. The increase in direct costs and expenses was primarily driven by costs associated with our entry into COVID-19 testing, as well as the release of our notify CDT test in March of 2020. Overall, our COVID-19 testing continued to provide strong revenue and gross profit dollars to offset the impact of the pandemic and perhaps more importantly, enables us to invest in a quarter long diagnostic testing and biopharma services. Gross margin percentage in the first quarter 2021 was 37% versus 69% for the first quarter 2020 and 46% for the fourth quarter 2020. The decrease in gross margin percentage for all periods presented is driven primarily from our entry into COVID-19 testing, as those margins are lower overall than the margins for our lung diagnostic testing. While the COVID-19 testing services gross margin percentage is lower than that of our other tests, it does provide strong revenue and gross profit dollars contributing to the business. We continue to see strong margins in our lung diagnostic business consistent with pre-pandemic levels and expect that to continue during the recovery from the pandemic. Operating expenses, excluding direct costs and expenses, for the first quarter of 2021 were $16.2 million compared to $11.9 million for the first quarter of 2020, an increase of 36% and 8% compared to $15.0 million for the fourth quarter 2020. Increase in operating expense in the first quarter of 2021, as compared to the first quarter of 2020, was driven primarily by higher selling marketing and G&A expenses, including investments in the expansion of our salesforce, which increased $11.9 million, compared to $8.1 million in the first quarter of 2020. The increase in selling, marketing and G&A is attributable to an increase in variable compensation associated with stock-based compensation from our first quarter 2021 option grants, our bonus to equity incentive program, an increase in headcount and public company costs. First quarter 2021 operating expenses increased by approximately $1.2 million compared to the fourth quarter 2020, which was primarily attributable to the change in fair value of contingent consideration. Research and development costs for the first quarter 2021 were $3.3 million, as compared to $2.9 million for the first quarter 2020 and $3.1 million for fourth quarter 2020. The overall increase in R&D was attributable to an increase in internal costs primarily associated with increase in headcount as we scale R&D and add new products to our pipeline following our IPO. After beginning the expansion of our commercial organization, launching multiple new clinical trials and investing in our pipeline. The net loss for the first quarter 2021 was $7.0 million as compared to a net loss of $9.7 million for the first quarter of 2020 and $4.5 million for the fourth quarter 2020, included our first quarter net loss were non-cash stock based compensation charges of approximately $1.8 million and 728,000 in non-recurring costs associated with the loss on extinguishment of our 2018 term loan. Finally, turning to the balance sheet, we ended the quarter with $55.3 million in cash and cash equivalents. reduction of approximately $6.8 million, primarily as a result of an increase in working capital partially offset by cash provided by financing activities of approximately $5 million. During the quarter, we enhanced our financial flexibility through a new $30 million r term loan and extinguished the outstanding borrowings of $25.9 million under the company's prior term loan, with the remaining proceeds of approximately $4 million available to enhance existing liquidity for general corporate purposes. The transaction will provide Biodesix with additional, operational and financial flexibility, including an interest only period for February 2024, as we achieved the trailing 12-month revenue milestone of $65 million as of March 31, 2021. In addition, the net proceeds along with the benefit of extending our interest in principal payments will enable Biodesix to continue the growth of our commercial organization and expansion of our clinical pipeline. Looking forward, due to the rapidly evolving nature of the pandemic, testing strategy, vaccinations and the resulting impact on healthcare in the US, we are not providing revenue or earnings guidance at this time. We do however, expect year over year revenue growth, with our gross margin percentage in the first half of the year suppressed by the strength of our COVID-19 testing activities and an improvement in our gross margin percentage occurring in the latter half of 2021. As the expansion of our salesforce teams further momentum and generates growth in our lung diagnostic testing. We expect that COVID-19 testing revenue will be highest in the first quarter with decreasing revenue throughout the year, subject to our ability to enter into further testing services such as the, cPass COVID-19 Neutralization Antibody Detection test. However, we will continue to provide COVID-19 testing services to our healthcare, schools and other employer group partners and expect to evolve our offering as the country continues to move forward. And we've learned to live with COVID-19. While we expect to increase our overall operating costs in 2021, due to the execution of our growth strategy, and investments in bringing new products to market, we are maintaining a disciplined focus on costs and are continuing to evolve our offering with the future launch of the cPass total Neutralization Antibody Detection test, and our new NGS test. Now, I will turn the call back to Scott.