August Troendle
Analyst · Jefferies. Your line is now open
Good morning. The COVID-19 pandemic has presented a significant challenge to the global clinical trial industry. Diversion of resources at investigative sites has slowed recruitment, in many cases, reduced the frequency of protocol-driven patient visits. Travel restrictions and access to sites by sponsors and CROs have necessarily reduced the usual on-site monitoring and auditing of trials for compliance with regulatory and protocol requirements. Most companies, including ours, have been forced to move most employees to a remote working environment, which can impact workflow and training of new staff. Fortunately, we have systems, processes and experience running trials with minimal on-site presence and with virtual safe visits and monitoring. The second conversion of an ongoing trial from classical safe monitoring to virtual safe visits is unusual that has been accomplished across our portfolio of studies with minimal disruption or loss of trial data quality. Patient safety, our primary concern, has not been jeopardized by the change. We are appreciative of the regulatory bodies taking a pragmatic approach within their released guidances related to COVID-19. We have made a number of changes to our operations to address the pandemic challenges. These include the following: One, established an incident response team to address emergent issues and set companywide policy and workplace requirements. Two, established a cross-functional operations response team to develop or revise processes for oversight and management of trials. ;Three, implemented a global communication plan for updating worldwide staff to process changes. Four, organized weekly mandatory training sessions for project leadership teams to review process and implement industry or regulatory-driven updates. Five, we suspended all nonessential travel. Six, moved most staff to remote work while keeping essential functions that require office-based presence operational. Seven, updated customized monitoring plans as needed for all studies to address virtual site monitoring in lieu of on-site visits as well as activating support technology solutions for source data verification. Eight, organized systems and processes for patient home visits and support. Nine, taken actions to align staff with the current and near-term future needs, including the removal of many administrative employees supporting office-based staff. I would like to provide some detail or picture perhaps of the extent of the disruption. The World Health Organization declared a pandemic on Wednesday, March 11, 2020. I will take this as time 0, as until then, the disruption to sites was largely an issue in China only. Since March 11, was Wednesday, that week showed only modest impact. Lab samples were down 6% and patient screenings, i.e. patients seen as part of recruitment for trials, was relatively normal. The following week, lab sample volumes were down 21% and patient screenings were down 54%. The week after that, the week of March 22, lab samples were down 34% and patient screenings were down 75%. More recently, lab sample volume has been down 40% and patient screenings down 85%. This has been stable the past few weeks, but has shown no signs of recovery. Patient visits for ongoing patients, already enrolled in trials, is down about 55%. Physical monitoring visits are down 95%, but about 60% of the lost physical visits are being replaced by virtual site visits. Site activations are down 80%. We have had multiple cancellations of ongoing studies due to the challenges and uncertainty of the pandemic. Since, the operational and financial impact of the pandemic response on a trial is influenced by the stage of the trial, I would like to provide some demographics on our business portfolio of awarded trials. The following analysis is based on April to December 2020 roll off from awarded studies and is summarized in Slide 3 of our earnings presentation. We have placed our awarded studies into three buckets. One, studies where recruitment is completed. This subset comprises 30% of our projected April to December revenue. For 92% of this category by revenue, i.e., of this 30%, we expect no substantial impact on progress or revenue. Studies in recruitment. This subset comprises 58% of our April to December projected revenue. For this subset, we expect 32% by revenue to have no substantial impact on progression, 29% to have significant impact on progression, but recruitment is continuing and 39% where recruitment has been interrupted. The third bucket studies in start-up but prior to first-patient first-visit. This subset is 12% of projected April to December revenue. For this subset, 45% of progressing toward first-patient first-visit, and the other 55% are currently on hold for first-patient first-visit. A decision to delay first-patient first-visit may still be made for the 45% currently progressing towards it. From a current period revenue by task perspective, for ongoing studies in the first two buckets, i.e., in recruitment or recruitment complete, the impact of COVID-19 will be greatest in areas where there is high level of unitized services where the units are likely to be delayed, such as laboratory as well as our clinics business, where we directly perform Phase 1 to 4 site activities. Pass-through costs, the bulk of which represent independent investigative state payments and monitoring travel, are also disproportionately impacted. These revenues are mostly delayed rather than lost over the course of the trial. At the other end of the spectrum, our other clinical trials services, such as program management, monitoring, safety, surveillance and reporting and medical monitoring that are primarily based on an FTE, or effort based activity, which will be minimally impacted from a current period revenue recognition perspective. In fact, program management and site support may require increased efforts over the short term to plan and implement regulatory-compliant accommodations to the trials even while recruitment is stopped. In general, recruitment delays will significantly increase the future revenue and total trial cost of FTE-based activities for these trials due to the extended time line. For the third bucket, pre-recruitment trials, the impact for 2020 is primarily related to the timing of study start with significant delays likely for many and, therefore, lower revenue in 2020. Whether recruitment delays will slow these studies once started is unknown. To complete the picture, I should provide a rough breakout how our service functions. Project management, monitoring, data safety, medical and reporting, the largest portion of clinical trial services is approximately 84% of our total revenue. Labs make up 14% and clinics, 1.5% to 2% of revenue. On a longer-term basis, our business and revenue will be impacted by reluctance of sponsors to initiate new trials or award new business in an uncertain environment where costs may be higher due to extended time lines. This is already apparent in Q1 new business awards. The reduced future revenue from delayed trial starts, cancellations and reduced new business awards will be partially offset by additional revenue from extension of ongoing trials, as discussed above, where recruitment is delayed – the recruitment is slowed, I should say. However, the elongated time lines of studies, where recruitment is slowed, may challenge our smaller clients’ ability to financially support a more expensive and delayed trial. Majority of our clients are small and many do not have cash on their balance sheet to complete their trial without raising additional funds. Due to the challenges we faced from COVID-19 pandemic, we now expect revenue and profit for the year – for the full year 2020 to be down from 2019. However, the extent of the drop cannot be reasonably estimated at this time. For this reason, we are withdrawing rather than updating our previous guidance. Jesse will now cover our financial performance for the quarter.