Burning Rock Biotech Ltd
NASDAQ:BNR
Earnings Call Analysis
Q3-2023 Analysis
Burning Rock Biotech Ltd
Burning Rock, a company led by CEO Yusheng Han, outlined its business composition of therapy selection, early detection MRD, and biopharmaceutical services during a recent earnings call. A key highlight was their initial achievement of non-GAAP profit minus SG&A breakeven in Q2. However, industry disruptions in Q3 saw a slight profit drop to a negative RMB 8.9 million. Despite these challenges, Burning Rock is firm on its path to profitability, expecting to stabilize once volatility subsides. They've experienced a 10% year-over-year growth in in-hospital model revenues, indicating resilience and progress towards their financial goals.
During Q3, Burning Rock faced a significant 41% year-over-year downturn in its central lab revenue, attributed to broader industry challenges. However, the in-hospital channel, which constitutes more than half of the company's revenue, grew by 10%, validating its strategic importance. As the in-hospital segment became the largest, overtaking central lab, Burning Rock is completing its transition towards this more profitable channel, enhancing its sustainability amid an evolving industry landscape.
Burning Rock's biopharmaceutical services business continued to grow robustly, charting a 31% revenue increase from the previous year. The backlog of work, especially from multinational companies, further corroborates the strength of this sector for Burning Rock. Despite a 17% year-over-year revenue decline due to central lab performance, targeted adjustments have been made with cautious expense management to realign the company towards profitability. Non-GAAP gross profits minus SG&A, after falling into negative territory in Q3, are expected to rebound in the future as the company refines its approach and anticipates an industry volume normalization.
Financially, Burning Rock has demonstrated prudence with a notable reduction in net operating cash outflow to RMB 47 million in Q3. The company's cash position allows for more than three years of operations without additional funding, assuming continuation of the current burn rate. This indicates a strong liquidity position that offers resilience and flexibility for Burning Rock's future endeavors.
Burning Rock is progressively advancing its clinical pipeline with a strong focus on MRD (minimal residual disease) assays, particularly for non-small cell lung cancer. The company has developed the proprietary brPROPHET assay, demonstrating higher detection sensitivity compared to current assays. In collaboration with a top-tier hospital, Burning Rock's brPROPHET assay has been validated in a study published in Cancer Cell, indicating its potential to significantly impact patients' disease-free survival rates. This advancement positions Burning Rock at the forefront of personalized cancer treatments, with ongoing research to extend its applicability across other cancer types[12†source].
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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.
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 talking about the financials and then Joe talking about our pipeline programs.
So let's turn to Page 3, which shows that what Burning Rock is doing. We started from therapy selection and expanded to early detection MRD and biopharma business. And so far, that is our business construction.
And let's turn to Page 4, which is the page that I think most of the investors care about most, that's about breakeven. And we set a goal to breakeven in terms of non-GAAP profit minus SG&A. And we say that in Q2 this year, we have -- this is the first time in Burning Rock to reach the goal. Well, in Q3, actually there is some industry disruption. You know that even most of the medical conferences or meetings would hold an anomaly. So in Q3, there's a little bit -- are impacted by this event. And the profit dropped to the negative part, which is a negative 9 point -- sorry, RMB 8.9 million. But we are still moving to the breakeven level. Especially, I think that this kind of volatility will pass by the end of this year.
So let's turn to Page 5, that we set a goal to break even sometime this year. And we think that we are moving towards that direction very firmly and without disruption. And in terms of the therapy selection, despite of the industry disruption, we still continue growth for the in-hospital model, which means that the in-hospital revenues has a 10% year-on-year growth. And part that has been impacted was the central lab model.
In MRD, we have a strong clinical validation publication, with the MEDAL study for lung cancer published in Cancer Cell, which is a big milestone for our MRD study. And we know that the other studies, for example, like colon cancer and esophageal cancer are underway. For biopharma, despite of the struggling time of capital market for biopharmas, we still have a strong growth, showing our systematic value of Burning Rock with revenue growth of 31% year-on-year. And our backlog still keeps growing. And one thing to mention is that we just signed a CDx contract with BI.
And then in terms of early detection, there is a big step -- I mean, a big milestone, for that is we've got a Breakthrough Device Designation granted by China's National Medical Products Administration, which is NMPA. And we are the only -- our multi-cancer early detection product is the only test that has received BDD from both FDA and NMPA.
And let's turn to Page 6 to explain how the industry volatility impacts our volume. You can see that the central lab model has been impacted negative 31%, while for in-hospital model it's still growing in terms of volume. So we think that -- and that actually impacts our competitors much more than Burning Rock because Burning Rock is the only company that the in-hospital model represents more than half of our revenues.
And then I'll turn to Leo about our financials.
If we move on to Page 7. As Yusheng mentioned earlier, the whole China health care industry had a disruption during the quarter. And what that meant for us was actually 2 divergent trends which actually accelerated the path that we were already on.
So if you look at central lab, that was down -- heavily down 41% on a year-over-year basis in the third quarter. The [ in-hospital ] channel continued to grow and it grew 10% year-over-year, which is rare in the diagnostics industry or at least in our specialty industry in China. So I think that continues to prove the value of the in-hospital segment where the real value or the profit is. And central lab, as we mentioned earlier, is being shifted more towards in-hospital.
So I think the events in the third quarter only accelerated that and that moved us even more on the right track in terms of moving the mainstream of our businesses towards the in-hospital segment. So at some point, last year, we were in more in-hospital segments by volume. And you can see in the third quarter, we are actually -- in-hospital represented the largest segment, overtaking central lab. So I think with that transition complete at some point down the road, our volume and revenue trends will match again as we complete this transition.
Then moving on, we can see that pharma services still had a strong growth quarter in the third quarter. Revenues grew 31% on a year-over-year basis. So we're very pleased with that result. Our backlog continues to grow, particularly from multinational companies, and Yusheng gave an example of a recent win in his remarks. So we're very pleased with the progress and the outlook that we have in the sector.
Overall, because of the industry impact and the drop in central lab, our revenue was down 17% on a year-over-year basis. And we're very cautious of this trend and we are managing our expense or our cost base appropriately according to the new industry setup. So I think we had a temporary dip in our operating margins. for the third quarter, and that should turn for the better in the quarters down the road.
So measured on a non-GAAP basis, gross profits minus SG&A, I mean, we hit a positive territory in the second quarter, but we dipped back into negative territory in the third quarter. And we're looking to turn this to a positive number again at some quarter down the road. So we are working towards that, and we have done some regauging in the recent time period to make sure that we are on the right track. So our operating profit or our operating loss did widen a little bit in the third quarter compared to the second quarter. And we are aware of that. We've made the adjustments at towards the end of September. Then we hope to be on a better track going forward.
Notably, we are also managing our open cash flows. We're managing our expenses -- our cash expenses very carefully. And you can see the net operating cash outflow this quarter has dropped to 70 -- RMB 47 million per quarter. And if you look at our operating margins, if you look at our sales and marketing expenses as a percent of revenue, despite the drop in revenues, I mean, our sales and marketing expenses were 45% of our revenue, similar to 44% that we achieved in the second quarter. And as we think industry volume normalizes down the road, our operating margin should improve, then we hope to get back to the positive non-GAAP territory in the quarters down the road. So that's a quick recap of the P&L for the quarter.
Then I think we should also mention our cash position as that's been a focus, if we go to Page 8. So we had cash outflow of about CNY 532 million in the year of 2022. That's not our run rate for 2023. Our guidance at the start of this year was about RMB 400 million outflow. And you can see in the 3 quarters so far to this year, we had an outflow of about RMB 249 million, so significantly below the outflow guidance that we set out at the start of this year. Then if you look at our third quarter quarterly cash -- operating cash outflow of RMB 47 million, that's even close to the run rate that we set for the year over 2024. So on that run rate, looking at the cash balance at the end of this period of RMB 637 million, we're sitting on more than 3 years of cash runway.
So we aren't in a rush to do anything. We're sitting on ample cash balance. And I just want to reiterate our strong cash position relative to our cash outflow on this page. And the reasons for the reduced cash outflow, I think we have mentioned that before and I'll just reiterate those here again. So first, our commercial operations is coming towards profitability. We were even slightly positive in the second quarter. Our R&D spend, particularly our early cancer detection programs, are maturing. And as these programs complete, the expenses associated with those programs will run off and that will help reduce cash spend naturally. So as we look to complete our spend on early cancer detection and as we move towards better profitability, then we'll look to improve our operating cash outflows, and we'll make sure that we're sitting on ample cash balance.
Then next, I'd like to turn to Joe, who has some important pipeline and clinical publication data to share with you.
Thanks, Leo. So I'm going to present a little bit and give you guys an introduction about the pipeline update, majorly focused on the MRD, which is minimal residual disease or molecular residual disease.
So let's turn to Page 10, so Page 10 basically representing the Burning Rock MRD clinical publication. So basically, MRD has a lot of utilities. As shown in the picture showing here, basically it can be done like before the neoadjuvant to look at the baseline ctDNA level. Then also we can do like after neoadjuvant therapy to look at treatment effectiveness or like, more commonly, use that like a postsurgical -- after resection to look at landmark MRD to get a prognosis or either some kind of a prediction value on the -- based on MRD status. There also could be a lot of treatment effectiveness assessment after the adjuvant therapy and also the longitudal monitoring for the surveillance.
So Burning Rock has a bunch of different kind of publications related to different kind of cancer types, that's including the non-small cell lung cancer as well as colorectal cancer, gastric cancer, pancreatic cancer, BTC, biliary tract cancer. So all the publications, most of them are actually shown in the poster format being presented in different kind of upcoming meetings or clinical meetings happening like within 2 years. So the major one I just wanted to give you guys a little bit more introduction about is the Cancer Cell publication, which is related to the non-small cell lung cancer.
Let's turn to Page 11. So we -- the technology we've been using actually called brPROPHET, in brief it's called PROPHET. So basically, it's based on the whole exome sequencing. We got the tumor whole exome sequencing up to 50 mutations, which is tumor-specific. Then design the personalized panel, MRD panel and utilize -- use this personalized panel trying to capture a potential ctDNA fragment from the plasma collected from the same patient. Based on the proprietary ultra-deep sequencing and also the proprietary sequencing result as well as MRD coding algorithm, then we can determine the MRD status of that patient for that kind of -- that type -- that time point of blood collection.
So on the right page basically is showing the analytical performance of this brPROPHET assay. So it's including the 2 type of -- so on the top right panel, basically talking about uncontrived cell line sample diluted down to 8 ppm. As you can see here, we still can see, out of 50 load site, there's quite a bit different -- significant difference compared to baseline which is uncontrived which is background cell line. So this give us some kind of confidence showing this asset is sensitive enough to detect very low allele frequency, very rare tumor fraction based on the ctDNA from the patient.
On the top right -- bottom right panel, that's showing the quantitative property of this assay. Based on the algorithm we use, we can estimate based on the detection capability as well as the allele frequency of each load site. We can assess and estimate what's the ctDNA fraction from that patient. As you can see here, this is contrived data, but it definitely gives us a lot of confidence showing the expectation and estimation showing very good correlation.
So based on this technology, we move to Page 12. Basically, we worked with a top-tier hospital in Beijing, People's Hospital. And we published this technology utilization on the non-small cell lung cancer in Cancer Cell, which is a top journal -- top-tier journal for translational medicine. As you can see here, so this has been published in October 9. And there's a couple of highlights. I don't want to read it one by one but you can look at it. Mostly it's just showing the PROPHET outperformed the fixed-panel MRD assay in a head-to-head comparison in non-small cell lung cancer.
Move to Page 13, basically give you an overview of this study. So the cohort is that we enrolled about 181 patients of non-small cell lung cancer. But as you can see here, most of them, actually 63%, are Stage 1 patients, very early-stage patients after surgery. And also there's a few Stage 2 and Stage 3. And at the sampling time, we basically collect the tumor and adjacent paired tissue, normal tissue collected at surgery. And we do the whole exome sequencing on those as well as like we collect the blood sample collected at preoperative in 3 days and 30 days after surgery. And also, we do a follow-up time. So every time when a patient goes back to see the doctor after like 6 months or 1 year up, if possible, we collect the follow-up blood sample.
And then we used 3 different kind of approach to look at MRD status. The first one is basically showing on the top right, it's a whole exome sequencing-based personalized panel design as well as doing this kind of MRD assay we call brPROPHET assay. In comparison, we're also using also a fixed kind of target sequencing to do the tumor -- either tumor-agnostic or tumor-informed calling to determine the MRD assays. But you can think about it this way. So basically, whole exome sequencing gave us many more potential mutation load site compared to relatively smaller fixed-panel target sequencing.
So by using this data, let's move to Page 14, basically there are several major conclusion observation we have seen. So Page 14 is showing actually, if you look at the preoperative plasma sample, so this sample is basically untreated patient coming from the -- blood coming from untreated patients. And that's why, ideally, if your assay is perfect you should be able to see every patients' blood will get like close to a very high percentage of detection sensitivity. As you can see here, the sensitivity definitely grew up from Stage Ia to Stage III. And at Stage III, you've got the highest sensitivity -- detection sensitivity.
But as you can see here, the orange color, which is representing the PROPHET assay, so it outperformed the tumor-agnostic panel sequencing as well as our tumor-informed fixed-panel sequencing. So totally, basically at the Stage IIb (sic) [ Stage Ib ], we already see 40% detectability, and also Stage 2, we see 75%, Stage III with 83% positivity. And as you can see here in the panel B showing on the right page, as you can see here, for all 3 MRD-positive patient samples, the ctDNA fraction is showing the highest one, which is shown in the box plot with the red background.
But if only the -- if you look at the orange color, which means on the right, there's 30 patients -- preoperative patients only showing positive in brPROPHET assay but the ctDNA fraction is way lower. It's actually 2 magnitude lower than the all 3 positive patients. This just reflects the detection sensitivity importance, trying to get those kind of very low allele frequency, very low tumor fraction patient, trying to confirm the MRD status. Of course, this is the preoperative.
So let's move to the Page 15. Basically, we use a postoperative blood sample to determine the real MRD status and also come associated with this kind of status with the relapse potential to look at the disease-free survival. On the left page, basically as we are using the landmark timepoint, which is 3 days or -- which is timepoint B, or 30 days after surgery which is timepoint C. If you look at the survival curve, as you can see, the DFS survival percentage, if you're MRD-negative, the patient, you will have showing that even for one timepoint -- landmark timepoint to check and follow-up up to like 1,200 days, this show very way higher disease-free survival compared to MRD-positive patient, which is showing the HR ratio reached to -- basically for timepoint, C the HR ratio reached to 16.4, which is a pretty significant difference.
And on the right page -- right side of the panel, we're basically utilizing longitudal MRD analysis. This is basically for multiple point timepoint assessment on the post surgery patient plasma sample. And if there's any MRD-positive signal showing any time on the blood collection, we deem as MRD-positive. But if all the samples collected from patients is MRD-negative, then we deem MRD-negative. As you can see here, the separation will be even better. That just gives us a lot of confidence, also reflect a lot of other publications. Continuous surveillance requires multiple timepoint collection, it usually give us better separation of the disease-free survival. So basically it's also now related to the Stage I or Stage II and III, basically showing very similar trend. So in summary, basically, this paper published in Cancer Cell gave us a very good example showing how the personalized WES-based MRD assay can give a very good prognosis value on the non-small cell lung cancer, even Stage I and also II and III. And so of course, we still keep working on this assay and trying to working on multiple different kind of cancer types and also trying to -- with other top-tier hospitals, not only prognosis value, we also want to look at the predictive value and if we see any kind of clinical utility related to drug selection or any kind of treatment effectiveness assessment.
So that concludes my part. Thank you. Back to the moderator.
Yes.
Thank you for participating in today's call. You may now disconnect. Everyone, have a great day.
Thank you. Bye.