Burning Rock Biotech Ltd Q3 FY2023 Earnings Call

Before we begin, I would like to remind you that this conference call contains forward-looking statements within the meaning of the Section 21E of the Securities Exchange Act of 1934 as amended and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as will, expect, anticipate, future, intends, plans, believes, estimates, target, confident and similar statements. Statements that are not historical facts, including statements about Burning Rock's beliefs and expectations are forward-looking statements. Such statements are based upon management's current expectations and current market and operating conditions and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond Burning Rock's control.

Yes. Is it my turn? Well, this is Yusheng Han from Burning Rock, I'm the CEO and Founder. And today, we also have our CFO, Leo Li, and our CTO, Joe Zhang online. And today, we have a brief introduction of recent progress, and then I will hand over to Leo to talk about the financials. And then Joe will talk about our pipeline programs. So let's turn to Page 3, which shows what Burning Rock is doing and we started from therapy selection and expect to expand it to early detection, minimal residual disease (MRD) and biopharma business. So far, that's our business construction. Let's turn to Page 4, which is the page that I think most of the investors care about, that's about breakeven. We set a goal to breakeven in terms of non-GAAP profit minus SG&A. In Q2 this year, we reached this goal for the first time. In Q3, however, there was some industry disruption. You know that even most of the medical conferences or meetings were held unusually. So in Q3, our profit dropped to a negative part, coming in at negative RMB8.9 million. But we are still moving towards the breakeven level. Especially, I think that this kind of volatility will pass by the end of this year. Let's turn to Page 5, where we set a goal to break even sometime this year. We believe we are moving firmly in that direction, and without the disruption. In terms of therapy selection, despite the industry disruption, we still continued to grow for the in-hospital model, which means that in-hospital revenues saw a 10% year-on-year growth. The part that has been impacted was the central lab model. In MRD, we have achieved strong clinical validation publications, with the MEDAL study for lung cancer published in Cancer Cell, which is a major milestone for our MRD study. We also have studies underway for other cancers like colorectal cancer. For biopharma, despite the struggling capital market for biopharmas, we still saw strong growth, showing our systematic value of Burning Rock with revenue growth up 31% year-on-year. Our backlog continues to grow. We also recently signed a CDx contract with a leading biopharma company. In terms of early detection, a significant milestone is that we've received a Breakthrough Device Designation from the China National Medical Products Administration (NMPA). Our multi-cancer early detection product is the only test to receive BDD from both the FDA and NMPA. Let's turn to Page 6 to explain how the industry volatility has impacted our volume. You can see that the central lab model has been negatively impacted by 31%, while the in-hospital model continues to grow in terms of volume. We believe that, in fact, this disruption has affected our competitors much more than Burning Rock because Burning Rock is the only company where the in-hospital model represents more than half of our revenues. Now I'll turn to Leo for our financials.

If we move on to Page 7. As Yusheng mentioned earlier, the whole China healthcare industry experienced a disruption during the quarter. This resulted in two divergent trends, which accelerated the path we were already on. If you look at the central lab segment, it was down 41% year-on-year in the third quarter. Conversely, the in-hospital segment continued to grow, achieving a 10% year-on-year increase. This is rare in the diagnostics industry or at least in our specialty industry in China. It exemplifies the real value of the in-hospital segment where profit is generated. The issues faced by Central Lab are driving a shift towards in-hospitals. As a result, last year we were more focused on in-hospital segments by volume, and now, in Q3, the in-hospital segment has overtaken central labs as the largest revenue contributor. I believe this transition is crucial, and as we complete this shift, our volume and revenue trends will align again. Moving on, pharma services also had a strong performance in Q3, with revenues growing 31% year-on-year, which we find very pleasing. Our backlog continues to grow, particularly from multinational companies, as Yusheng mentioned with a recent win in his comments. Overall, due to the industry impact and the drop in central lab revenue, our overall revenue fell 17% on a year-over-year basis. We remain cautious about this trend, managing our expenses and cost base according to the new industry landscape. We did observe a temporary dip in our operating margins in Q3, but we expect this trend to improve in subsequent quarters. On a non-GAAP basis, gross profit minus SG&A moved from positive territory in Q2 to negative in Q3, but we aim to return to positive numbers in future quarters. We've made adjustments recently to ensure we remain on the right track. However, our operating loss did widen slightly in Q3 compared to Q2, and we are addressing that. We've been managing our operating cash flows and expenses very carefully, resulting in a net operating cash outflow of RMB47 million this quarter. Despite the revenue decline, our sales and marketing expenses remained stable at 45% of revenue, compared to 44% achieved in Q2. As we expect industry volumes to normalize, we believe our operating margins will improve, allowing us to return to positive non-GAAP territory. Turning to Page 8, regarding our cash position which has been a critical focus. We experienced a cash outflow of about RMB532 million in 2022, but that won't be our run rate for 2023. Our guidance at the beginning of the year was RMB400 million outflow. So far this year, we have only seen an outflow of about RMB249 million, significantly below our guidance. Our third quarter cash operating outflow of RMB47 million is close to the run rate that we've set for 2024. With a cash balance at the end of this period at RMB637 million, we have over three years of cash runway, so we're not in a rush. I want to emphasize our strong cash position relative to our cash outflow on this page. Our commercial operations are moving towards profitability. We were slightly positive in Q2, and our R&D spend, particularly for early cancer detection programs, is maturing. As these programs complete, associated expenses will run off and naturally help reduce cash spend. Looking ahead to better profitability, we will also improve our operating cash outflows while maintaining ample cash reserves. Next, I'll turn to Joe, who will share some important pipeline and clinical publication data.

Thanks, Leo. I will provide an update on our pipeline, primarily focused on MRD, which stands for minimal residual disease. Turning to Page 10, it presents the Burning Rock MRD clinical publication. MRD has various utilities which include assessing treatment effectiveness after adjuvant therapy and monitoring for recurrence. We have a range of publications related to different cancer types, including non-small cell lung cancer as well as colorectal cancer, gastric cancer, pancreatic cancer, and biliary tract cancer, presented in poster formats at various meetings over the past two years. A significant publication is the one regarding non-small cell lung cancer in the journal Cancer Cell. On Page 11, we utilize a technology called brPROPHET, which is based on whole exon sequencing, allowing us to capture tumor-specific mutations. We have designed a personalized MRD panel and utilize this to capture ctDNA fragments from plasma samples of the same patient. Based on proprietary ultra-deep sequencing and our proprietary algorithms, we can determine the MRD status at various time points. In our publication, we've shown a significant improvement of the brPROPHET assay compared to fixed panel MRD assays in non-small cell lung cancer. On Page 13, we present an overview of a study with 181 patients with non-small cell lung cancer, predominantly Stage 1 patients, with some Stage 2 and 3 cases included. We collected paired tumor and normal tissue during surgery and drew blood samples before surgery, and postoperatively at follow-up visits. Our assessments included multiple MRD detection methods, revealing that our exon sequencing approach captured a wider range of mutations compared to fixed panel designs. Page 14 illustrates detection sensitivity increases from Stage 1 to Stage 3 patients. The brPROPHET assay demonstrated superior performance, and we identified a detection rate of over 75% in early-stage patients. On Page 15, we assessed postoperative blood samples to ascertain MRD status and monitored disease-free survival. The data indicated that MRD-negative patients exhibited significantly higher disease-free survival compared to MRD-positive patients. So, the data reflected the importance of continuous monitoring across multiple time points for optimal assessment. In summary, the recent publication in Cancer Cell provides a considerable demonstration of how our personalized MRD assay can effectively predict outcomes in non-small cell lung cancer across various stages. We’re continuing to develop this assay for other cancer types and exploring predictive value related to treatment assessments. That concludes my portion. Thank you. Back to the moderator.

Thank you for participating in today's call. You may now disconnect. Everyone, have a great day.

Thank you.