Good day, and thank you for standing by. Welcome to the Burning Rock 2022 Q2 Earnings conference call and webcast. At this time, all participants are in listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to slowly press star one and then one on your telephone. You will then hear an automated message advising that your hand is raised. If you wish to ask a question via the webcast, please use the Q&A box available on the webcast link at any time during the conference. Before we begin, I'd like to remind you that this conference call contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and are defined in the U.S. Private Securities Litigation Reform Act of 1995.
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I would now like to hand over to our first speaker, Mr. Yusheng Han. Please go ahead, sir.
Thank you, and thanks for coming, Burning Rock's 2022 Q2 conference call. I'm Yusheng Han, the CEO and founder of Burning Rock. Today we have our COO, CTO and CFO in the meeting. We know that Q2 was really a hard time for most of the companies in China, with complete lockdown of Shanghai in April and May, and half lockdown of Beijing in May. Despite these difficulties, we still recorded a year-on-year increase in Q2 in terms of revenue. The growth was contributed by strong in-hospital revenue growth outside of Shanghai and Beijing. New product lines such as MRD products and pharma business. Let's review our business outline and the progress. Our COO, Shannon, will go through the development of our product line.
After that, our CFO, Leo, will go through the financials. Let's turn to page three. That's a basic introduction of Burning Rock. We started with therapy selection business in 2014, and have grown to the market leader in this segment. The leading position has laid a good foundation and given us advantages moving forward to new business of early detection, MRD, and pharma collaborations. Let's turn to page four. This is for our business objectives in the future. Therapy selection is a segment that we have working for eight years. In the past years, our main goal for this segment is to expand market share in both in-hospital model and central lab model.
The in-hospital model now is operating profit positive, while central lab is loss-making. We are strongly leaning our strategy to in-hospital model. We have set a clear goal of making OncoBU profitable in 2023. New clinical utility evidence and the technology development demands mature liquid biopsy technology and personalized panels. Therefore, we initiate trials in lung CRC and other cancers. This will be the barrier for our product and not easy to be replicated like therapy selection. The pharma business is a trend with strong needs of both therapy selection and MRD, and its thrive highly depends on the institution values such as quality and registration capability. The business has been profitable and a strong growth continues.
For multi-cancer early detection, we believe that it is the ultimate solution for cancer early detection. Powered by multidimensional testing, including methylation plus NGS plus machine learning. Multi-cancer early detection has better performance versus single cancer early detection. By the way, in a real scenario, we cannot draw like 20 tubes of blood if we want to detect 20 type of cancer. Thus, we invest a huge resource of technology development and clinical trials. We believe that it will build strong barriers that can last for many years. The good news is that the conversation with NMPA of multi-cancer early detection registration gets better recently. Let's turn to page five for our recent progress. The in-hospital model, I mean, the revenue keeps strong increase.
Our regions, excluding Beijing and Shanghai, grew over 60% year-on-year in Q2 in terms of volume. The new product including MRD, myChoice, and DetermaRx, helps us gain market share in centralized model. At the end of Q2, we optimized the tech on cost and started to reduce. At the end of Q2, we started to reduce the commercial investment of oncology business unit as well. Due to the excellent execution impact to the revenue is very limited. We are in a much better position to grow through the winter. The commercial ramp of MRD is strong since we launched the product in March, especially after data read out on non-small cell lung cancer and CRC at AACR.
The revenue of biopharma grew triple-digit year-on-year to CNY 18 million, contributed to 14% of overall revenue. The backlog continues to build with contracted project value grew 49% year-on-year to CNY 158 million during the seven months in 2022. For early detection, the data of our PROMISE was released. It's data of over 2,000 participants for nine cancer tests, reading out at ESMO in September. For the clinical programs of early detection, the PREVENT study was launched. It is a trial composite of 12,500 participants. It's China's first multi-cancer prospective interventional study.
Let's turn to page six. In this page, I just want to utilize the graph to illustrate that pharma business is growing really strongly. The green columns are a comparison of contract value of 2021 versus 2020. The blue columns are comparison of contract value of the first seven months of 2022 and 2021. This is achieved in a situation that Shanghai was totally locked down in April and May. That way we know, as we know, that Shanghai is the heads of many biopharmas. We would like to think that this achievement is great. Yeah, that's basically about the outline of Burning Rock. I will pass to Shannon to talk about our pipelines.
Okay. Thank you, Yusheng. Now let's move on to page eight. First, I'd like to take a minute and re-illustrate the clinical utilities of MRD tests on early-stage patients as the establishment of different clinical utilities will ultimately drive the market growth. On this diagram, we can see that an early-stage patient could go through neo-adjuvant and/or adjuvant therapies before and after surgery. Then hopefully, a long disease-free period afterwards. As we all know, the most well-established MRD utility is the prognosis prediction. Multiple studies across different cancer types and different technology platforms have validated the strong and robust association between MRD status and the patient prognosis at both the landmark and the longitudinal time points. Such utility is marked as green on this diagram.
You can see that they happen at different time points along the way. However, this prognosis utility itself would probably not be strong enough to drive a very high penetration of MRD tests because it would be the kind of nice to have but so what test, which is informative but not exactly actionable for clinicians. With that said, we're now starting to see more and more truly actionable utilities of MRD tests to evolve, which are the ones labeled red, on this diagram. Among these utilities, the most important one, and also I think the most needed one, is to differentiate low-risk and high-risk patients based on the landmark MRD right after surgery, and to commence escalated or de-escalated adjuvant therapy regimen.
If clinical trials in the coming years can validate such MRD-guided treatment selection strategy, then the penetration of MRD tests among early-stage patients would become very, very significant. Page nine and page ten actually show two such examples in terms of what kind of results from trials would serve the need as validation of the MRD-guided treatment strategy. They are both very recent studies. Page nine is the IMvigor010 study, which is the phase III trial of atezolizumab in bladder cancer patients as maintenance treatment. On the top corner, the top left corner here, it shows that in this trial, the whole ITT population did not show any efficacy from the treatment compared to the control arm. Then on the right, we can see that if we zoom in, only the 39% MRD positive patients at landmark benefited from atezolizumab.
This is a very strong evidence. This is a great example to show that the MRD utility as to identify the high-risk group and give them more therapy. Of course, the MRD analysis in this study was only retrospective, and that's why IMvigor011 has been initiated as a prospective study, and will be able to confirm if such utility can be validated in a CDx type of setup. Page ten is an even more recent example. This is the DYNAMIC study in the colon cancer. Patients were randomized into two groups, with standard care or ctDNA-guided treatment strategy. In the past ASCO meeting, which has happened a couple of months ago, it has reported that the MRD negative patients in this study who underwent far less adjuvant chemotherapy, achieved similar or non-inferior recurrence-free survival compared to the standard of care group.
If this is validated repeatedly in multiple studies in the near future, it would mean that MRD negative status actually represents a group of cured patients after surgery who can be exempt from adjuvant chemotherapy. Again, studies like these will truly bring MRD into a CDx level biomarker and greatly increase its penetration down the road. Because of this advancement, we are also witnessing more endorsement for MRD in the clinician community, including its mentioning in the NCCN colorectal cancer guideline, in the ESMO recommendations in ctDNA and so on. As we have shown last time, page 11 is the consensus among Chinese lung cancer doctors for MRD. This particular consensus has been widely talked about recently within the Chinese doctor community.
Also as far as we know, a consensus on MRD in colon cancer among Chinese oncologists are also being written and should be expected in the near future. With all that, on page 12, we outline the development plan for brPROPHET, which is the capture-based personalized MRD assay we have developed and launched a few months ago, starting from March. The initial market response has been pretty exciting, which our CFO, Leo, will cover in later slides. As we have introduced before, brPROPHET is able to reach an LOD of 0.004%. We have released initial clinical validation data on lung cancer and colorectal cancer cohorts in the past AACR. Then on the bottom half of page 12 here, we lined up our additional clinical programs and expected data readout timeline.
For example, for lung cancer, for the observational studies, as the pink bar is showing on the top, we will submit the medical cohort for publication in a few months, for which I'll show some key findings on the next page. We also have two interventional studies launched or plan to launch later this year. We expect to start having data readouts for, from these interventional studies to validate the MRD guided treatment selection utility in lung cancer in 2025, which is shown here as the dark red bar. Then the timeline in colorectal cancer is actually similar to lung cancer in our plan. We expect to have a large cohort observational study results reported in early 2024, as in the light blue bar.
We're also initiating interventional studies, which expect to have data readout by 2026, as in the dark blue bar. For other cancer types which are in the last bar, we have initiated multiple observational studies, mostly in esophageal cancer, breast cancer, et cetera. The earliest time for data readout expected is in 2024. Our expectation for the market growth for MRD in China is also matched with the clinical program timeline outlined here. Which means that from 2022 to 2024 is what we expect to be the early market adoption period, mostly driven by the prognosis part of the MRD utility, which has been well-established. Then between 2025 and 2027, when more and more interventional studies conclude, the actionable part of the MRD utility will be fully established.
We would expect for a second wave of strong growth of MRD penetration around that time. Now let's turn to page 13. Here we want to take a couple of minutes to briefly show some key results from the full medical cohort. In this study, in the medical study, which contained about 200 participants, brPROPHET was compared actually to a fixed panel approach in terms of landmark and longitudinal MRD testing. What we have observed on the left graph is that brPROPHET identified almost three times as many true high-risk patients as the fixed panel assay at the landmark time point. This shows the superior sensitivity of brPROPHET as the personalized approach.
Then in the middle graph, you can see that the longitudinal MRD negative patients, which are the blue line here on the top, have near perfect prognosis in about three years of follow-up, indicating that the brPROPHET MRD test, when applied repeatedly, can pretty accurately identify the patients who are practically cured. Then on the right graph here, we can see that the prognosis separation between MRD positive and MRD negative patients defined by brPROPHET is actually across different stage. It doesn't matter whether you are at stage one or stage three, the prediction power stays the same. We think this is a very strong validation for the sensitivity and accuracy of brPROPHET. Now I'll skip page 14, which is our MRD data on colorectal cancer, because we already talked about it last time.
Let's go directly to the early detection part. Since we have gone through our development roadmap multiple times for early detection program, I'll be very brief today on this topic and just bring your attention to page 17. On page 17, there are two major updates here. First, as Yusheng already mentioned, the PROMISE study, which is the pilot case control study for our nine cancer type assay, has been completed. The results will be released at the coming ESMO in a few days. In short, we successfully expanded the model from six cancers to nine cancers. We showed promising improvement on sensitivity in some of the nine cancers compared to the previous version, while maintaining equally high specificity and TOO accuracy.
Also interestingly, we have tried to combine multi-omics data, including DNA methylation, DNA mutation, and protein markers to show the contribution of each omics data on different cancer types. We will be able to share the details of this performance in the PROMISE study in the next call, but of course, you're welcome to read up on the details in our ESMO poster. The other update here is the PREVENT study. Unlike all the other studies we have done before, PREVENT study is a prospective study conducted on symptom-free population. It's the first study of this kind in China for cancer early detection with sample size greater than 10,000 participants. It's also designed so that our six-cancer and myCancer assays can be both tested for the performance later on in this cohort of individuals.
We started patient enrollment in Q2 and are seeing pretty good accrual progress. That's all from me. Now I'll turn to our CFO, Leo, to walk you through our financials. Leo?
Great. Thanks, Shannon. Let's move on to financials, and we'll start with page 22. For the second quarter, as Yusheng mentioned earlier, we have two things going on. We have number one, COVID impact, and number two, our underlying growth momentum. In the following two pages, we try to separate the two factors to provide better clarity on our volume trend, underlying trend. In other words, we're trying to address the question that if we assume that COVID impact is eventually gonna go away in China, what would our volume trends look like? First of all, a brief recap on COVID in China during the second quarter, it wreaked havoc in China. Shanghai was locked down for more than two months.
There were multiple other large metropolitans that have been shut or have lockdowns. Beijing had school closures and partial lockdowns. Frontline anecdotal peer data indicated that our industry was generally down in the second quarter, and our peers generally down year-over-year on their volumes. If we look at our volume data, the in-hospital channel was heavily impacted, as Shanghai was a large market for the in-hospital channel. Central lab held up okay, and this is supported by new products, particularly MRD. On page 23, we provide further granularity on the trend over time and across different regions with varying COVID impact.
On the left, we see that for our central lab, as MRD started to generate volumes since its launch in March, it supported a better industry uptrend for our central lab channel through the second quarter. We continue to see very good momentum on this MRD pickup by the physician market in China. For in-hospital, as shown on the right-hand side, Shanghai and Beijing represents a large market for us, and these were heavily impacted. Our latest monthly print for July shows that there was partial recovery, but we're not back to normal. We did manage to grow very strong in regions where COVID impact was small, and we try to show that here by breaking out other regions apart from Shanghai and Beijing for the in-hospital channel.
Those regions grew very good double digits throughout the second quarter. Moving on to our financials on page 24. First, on revenues, we were up 3% year-over-year or down slightly on a sequential basis, because of the COVID impact and the disproportionately large impact in Shanghai. The in-hospital revenues were heavily depressed in the second quarter, which weighed on our overall revenue growth. Other than in-hospital, central lab was down 2% year-over-year, where it was actually up 6% on a sequential basis compared to the first quarter. MRV launched since March drove the sequential top line growth, despite COVID impacts across various cities in China.
Pharma revenues continued to scale up in the second quarter as we bear fruits from the strong backlog that we have been able to build, as previously shown on page 6. Pharma revenues represented 14% of our total revenues in the second quarter. That is starting to make meaningful contributions to our overall top line. Our pharma project backlog continues to build nicely. Our pharma revenues are generally recognized as those studies of our pharma customers are executed over time, so there could be some lumpiness, and these are dependent on the clinical progress of our pharma clients' studies. There could be lumpiness quarter- over- quarter as we have seen from other peers, for example, in the US.
As a side, we don't have any COVID-related revenues in our top line, so it's 100% precision oncology testing revenues, so we don't have to worry about a cliff or decline of COVID testing revenues at all going forward. Looking at our margins, first on our gross profit margin. On a non-GAAP basis, which excludes depreciation and optimization, our non-GAAP GP margin is generally stable. We did 70% GP margin in the second quarter. Moving to our operating expenses. First, on our R&D line, we are becoming more focused as we put higher focus on operating efficiency, i.e., we have reduced our spend on maintenance or non-core projects while continuing our core R&D on early detection.
Separately, enrollment slowed down due to COVID in the second quarter, also brought down clinical study related expenses. Moving on to the sales and marketing line, the biggest component is our headcounts here. And as Yusheng Han mentioned in his remarks, we have strived to achieve higher sales efficiency starting this year for the patient testing business. And we carried out a organization optimization program in the second quarter. The result of that brought our headcounts for the oncology sales organization down as of June on both sequential and year-over-year basis. During the second quarter, however, there were one-off or restructuring costs involved. The numbers appeared lumpy.
As we called out in the previous quarters, the direction of travel should be trending down, and efficiency should improve, as we move forward. Moving on to the G&A line, we also incurred one-off items in the second quarter. The biggest components of our G&A is our headcounts, which is the biggest component, and that has started to trend down on a sequential basis as well. As we mentioned before, we are putting higher focus on our operating efficiency and we generally expect operating efficiencies or operating expenses to trend down over time. I'm talking about our guidance. You know, COVID situation remains very fluid in China as the COVID zero policy is still in place.
There were a couple of cities that recently announced lockdowns over the past few days. If COVID does worsen or if we have large-scale lockdowns, this will have a significantly negative impact on our revenues. However, we believe that the point is not for us to make a forecast on COVID, so we will not try to do that. We do see strong momentum on our underlying business coming from, number one, the market share gain through the in-hospital strategy. Number two, MRD volume ramp. Number three, strong backlog of our pharma projects converting to revenue. We therefore retain our current guidance for the full- year, and we just call out the lingering COVID risk. Lastly, I want to mention our cash balance.
We show our operating cash outflow on the page here as well. As of the end of second quarter, we have a healthy cash and investment balance of CNY 1.15 billion, or $172 million. We believe this supports us beyond the next two years, so we're happy with the cash balance. We believe this is also the largest cash balance in our industry, which will provide strength into our long-term product development efforts into early detection, making us the longest cash runway in the industry. That concludes our prepared remarks, and we are happy to open for questions.
Thank you. As a reminder to ask a question on the phone line, please slowly press star one and then one on your telephone. You will then hear an automated message advising your hand is raised. If you wish to ask a question via the webcast, please use the Q&A box available on the webcast link. Once again, please press star one and then one if you have any questions or comments. We have a question on the phone line. Please stand by. The questions come from the line of Max Masucci from Cowen. Please ask your question. Your line is open.
Hi, this is Stephanie Yan from Cowen. Thanks for taking my question. To start off, Leo, could you speak to some of the key revenue drivers and any assumptions baked in for the second half this year? What gives you confidence in maintaining the full -year 2022 guidance, and are there any potential sources of upside to keep in mind?
Yeah. When we made our guidance towards the start of this year, we did leave some buffer for COVID. I would say those buffers were pretty much used up in the second quarter. We were conservative to start with. If we don't have any other COVID outbreaks going forward and based on the underlying trends, we are confident of our guidance. We saw a large drop in Shanghai, and if those come back, you know, we will get pent-up demand there. Apart from just getting back to normal from COVID, the underlying growth from pharma and from MRD from additional gains in the hospital are strong when there's no COVID impact.
I think COVID remains the number one factor, but if we take that aside, we are still confident about the guidance that we have for the full- year.
Got it. Understood. That's helpful. And then following the lockdowns, could you give us some more color on what Shanghai and Beijing currently look like? You mentioned some pent-up demand there. Any more color you can give on that as patients return to get tested. And then if you can share, do you mind sharing how much Shanghai and Beijing make up of your total revenue?
Yeah. They make up, I mean, for the in-hospital, they make up the lion's share, more than half of our in-hospital volumes. For the overall volume, they represent a significant portion, about a quarter, roughly speaking. We have seen improving trend over time, but they're not back to full normal yet. You know, if there's no further impact, we do expect patients to return. A lot of patients go to Shanghai and Beijing from regions outside of Shanghai and Beijing, so if that travel can come back, you know, there is volume that we have yet been able to catch up with. That's something to keep and watch.
We provide in the presentation the latest reads into July, and we will continue to try to provide as much clarity as possible going forward.
Got it. Thanks for that color. If I can squeeze in one more. It's great to hear the uptake of your MRD test following its launch in March, as well as the consensus view of MRD for lung cancer among Chinese physicians. When should we expect a similar consensus view for colorectal cancer? Are there any catalysts to keep in mind in the near to midterm that could further drive MRD adoption?
Yes. In terms of the consensus among the colorectal cancer, all that we can comment right now is that it's being very actively discussed and there have been multiple conferences focused on MRD and how should the consensus be reached. I can't predict precisely when the exact consensus is going to happen. I can say that just the discussion itself has brought a lot of attention among the community. We are pretty optimistic that the colorectal cancer community for the clinicians are going to catch up with the lung clinicians community in terms of their awareness of the MRD usage.
In the near future, I think the upcoming studies, for example, like the DYNAMIC, the CIRCULATE-Japan, I think people are anticipating the results from these interventional studies because people have been fully convinced about the prognosis prediction part of MRD. Now they are waiting to see whether the MRD can resolve the ultimate so what question. I think the CIRCULATE-Japan and DYNAMIC are very well-designed studies to answer those questions. So far, the DYNAMIC results showing the MRD-negative half from the study has been viewed as very promising and pretty exciting.
I think in the next couple of years, these studies will have their readouts and, if they continue to show positive results, it would be a very strong push for the community. Another potential factor is the pharmaceutical companies adoption on MRD to embed MRD into their drug development studies. For example, the MERMAID-1, MERMAID-2 study from AstraZeneca, I think, those had MRD embedded in their design. The results from those trials would be very critical in terms of people's view on the MRD utility ultimately.
Got it. Thanks so much, Shannon, for that color. Just one quick one on the guide. Does your guidance contemplate the uptick in pharma revenues, in the first half of this year when you set that, guidance range?
Yeah. Pharma has been on track or slightly beating our internal forecast so far this year, so we're happy about the progress there. It has been a strong factor in our outperformance across peers in the industry. I would say that I think the visibility of that has been built already previously on the backlog and that continues to build. That should provide us with further runway going forward as well.
Got it. Understood. Thanks so much for taking all my questions.
Thank you, Stephanie.
We have no further questions at this time. I hand back the conference to you. Thank you. Please go ahead.
Thanks, everybody, for attending our earnings call today. If you have any questions, please do come back to us. Thanks so much for your time.
Ladies and gentlemen, this concludes today's conference call. Thank you.