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Burning Rock Biotech Limited (BNR)

Q4 2021 Earnings Call· Tue, Mar 22, 2022

$16.63

-12.75%

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Transcript

Operator

Operator

This presentation contains forward-looking statements. These statements constitute forward-looking statements within the meaning of the Section of 21E of the Securities Exchange Act of 1934, as amended and as defined in the US Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by the terminology such as will, expects, anticipates, future, intends, plans, believes, estimates, target, confident and similar statements. Burning Rock may also make written or oral forward-looking statements in it's periodic reports to the SEC and it's annual report to shareholders, in press releases and other written materials and in oral statements made by it's officers, directors or employees to third parties. 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. Forward-looking statements involve risks, uncertainties and other factors that could cause actual results to differ materially from those contained in any such statements. All information provided in this presentation is as of today and Burning Rock does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law. I'd now like to hand the conference over to your speaker today, Mr. Han, CEO.

Yusheng Han

Management

Thank you, and welcome to Burning Rock 2021 Annual Conference Call. I'm Yusheng Han, the CEO and Founder of Burning Rock. And today we have our COO, CTO and CFO in the meeting. So let's turn to the Page 3 first, and I will recap the highlights of 2021 and our recent progress. Then I will go through the outlook of 2022. After that our COO, Shannon will elaborate on our product line, especially early detection in MRD. Then our CFO, Leo will walk you through the financials. The Burning Rock started with the therapy selection business in 2024 and has 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 pharmaceutical collaborations. We have strong branding on our technology and product quality, which help us attract talents and the network we have built across thousands of oncologists and hundreds of hospitals enable us rapid initiation of R&D studies on new products, such as – as well as fast distribution when they go to the market. The existing high testing volume makes it possible for us to continue lowering the cost. That's why we aim to tackle the therapy selection, MRD and early detection market in parallel in the coming few years. Let's turn to Page 4 and recap our 2021 and recent progress. For therapy selection, we recorded a 38% volume increase in 2021 and reached 70,000 unit, despite of the COVID influence. And in-hospital model growth was 63%, proving in-hospital model is a reliable and fast-growing model. And several days ago, we achieved an NMPA approval of our second NGS-based. It's a 9-gene kit for non-small cell lung cancer but it's meaning is much bigger than our first-kit…

Shannon Chuai

Management

Okay. Thank you, Yusheng. So, let's move on to page eight. This is the overview of our early detection product development roadmap. This might look very similar to you because we have actually shared this tap for quite a few times in the past calls. So, the overall program stay sustained as previously communicated where our six clinical product has entered commercialization and now the development and validation work are heavily going on for our 9-cancer product. And then if we go to page nine, here we have a little bit more details. in the most recent months, we have two particular updates I think worth mentioning. First, on our 6-cancer product, during our last quarter's call, I think we talked about the prospective and innovational studies intend to this population that we were planning on. So, we are now happy to share that this study which is now named PREVENT has most recently obtained approval from the human genetic resources administration in China and so is now ready to start approval. And the second thing we want to share is that we had our first data readout on the 9-cancer product from the case control pilot validation study called PROMISE. The performance so far looked quite promising. Since the statistics are still being summarize and finalized, we couldn't share more details right here, but we are submitting the results from PROMISE to the ESMO Conference this year. So, please stay tuned on that if you're interested. And also, on that note, on the PREDICT study which we have talked about many times, it's a larger scale two-phase case control cohort study. It was expected to have some data readout later this year. However, due to the recent COVID situation in China, we are having a mild delay on the…

Leo Li

Management

Great. Thank you, Shannon. And first let's turn to page 22. We'd like to briefly recap the COVID situation in China. As we called back in November during our last quarterly results, COVID was spreading in China in late 2021. Despite that challenge, we closed the fourth quarter with strong volume and top line numbers, which we'll go through a little later. Then heading into 2022, COVID impact in China did not go away despite that we had strong numbers during January to February 2022 and we'll walk you through that as well. But the current wave in March is looking pretty severe. That is actually the worst I have seen since China imposed a nationwide lockdown back in the first quarter 2020 when COVID first through uptake. We listed some of the impacts that we saw during March on the slide page here for your reference. And we note that Shanghai has many of China's top oncology centers. It's a large market for us and it is heavily impacted for the month of March. Then go to page 23. Here we list out our volume numbers and trends. First of all, we think 2021 is a much better year compared to 2020. And going into the trends that we saw back in 2021, first COVID disruptions and tightening or increased preference for hospitals to run NGS-based tests in-house has resulted in a step-wise change in the second quarter of 2021. In that quarter, we saw a strong jump in volumes in the in-hospital channel and we saw continued strength in in-hospital segments throughout the year. Looking then at volumes of the central lab channel, which is the green bars here, starting in the second quarter of 2021, the step-wise change in the industry that we just talked about led…

Operator

Operator

Thank you. [Operator Instructions] Our first question comes from Max Masucci with Cowen & Company. Your line is open.

Max Masucci

Analyst

Hi. Thanks for taking the questions. First one on some of the license products. It sounds like DetermaRx is becoming a more meaningful contributor to revenues. So, it would be great to hear about the adoption trends you've seen for DetermaRx and whether you see an opportunity to sign additional agreements like this to bring other NGS-based tests to a large Chinese precision oncology market.

Leo Li

Management

On DetermaRx, we don’t--

Yusheng Han

Management

Go ahead Leo.

Leo Li

Management

Yes. So, on DetermaRx, we don't break out revenue or volume by individual products but we had a good trends on the DetermaRx. And it's not just the DetermaRx, we also -- Yusheng called out at the start of the call we also had another product from Myriad on myChoice + HRD score measurement. And that product is also receiving good feedback in the markets. And our MRD product formally launched this month and it's also gaining good traction. So we believe new products is going to be an important driver for this year. And MRD, we think, has strong potential over a multiyear time horizon. And there's a bit of synergy between MRD and DetermaRx regarding early-stage lung cancer patients. So that's how we look at it. In terms of new products, we have an open mind and we've been looking at products, but we also need to bear in mind how that product fits into the China market. We believe that the two we have in licensed make very good sense, having strong potential market with strength on the products having good validation data. So with that, we still apply that same framework when we look at potential products. So, I guess, that's -- we have on licensing opportunities.

Max Masucci

Analyst

That's great. So moving on to the recent NMPA approval, I would just be curious to hear, now that we have the official approval, what sort of demand you're expecting for the use of lung care CDx with biopharma partners and then also in the clinical setting. And just curious, if you're expecting prior users of the original first generation, the 2018 version of lung care to switch over to the 9-gene kit?

Yusheng Han

Management

So for the 9 gene kit, I mean, the first meeting is that for the bidding of each tender, it would take a lot of advantages. So for the in-hospital model, I mean, that with officially approved kits from MTA is critical. And most of the time, the parameter of the kits are important. So we think that 9 gene kits will add a lot of competitiveness of our existing third line. And in terms of pharmaceutical collaboration, I think, yes, we think that companion diagnosis by the effort of both pharma and technology company will bring a better future and to the market. So the demand, I think, we have already talked about several times after the amendment of the requirement from NMPA, the companion diagnostic need is significantly increasing and that will accelerate to the pharmaceutical collaboration as well.

Max Masucci

Analyst

That's great. Maybe a final one for Leo. It's been over two years. We have over two years of experience with COVID so far. So it was nice to hear some of the trends that we've seen in terms of the bounce back once lockdowns are lifted. So it sounds like, there's still some major disruption here in March. But just curious, as we look at the 2022 guidance, how we should think about a rebound in your business as the lockdowns are lifted, just based on the experience you've had so far?

Leo Li

Management

Yes. I think, first, take a brief step back. We tried -- in principle we tried to break out COVID and ex-COVID impacts in the past. But conceptually, we think that may not make sense, because China so far has always kept a COVID-zero policy in pace, and as low infectious disease becomes the bigger impact that generates on the market. So despite that, how we're looking at this is, number one, new product launches; and number two, taking share in the markets and primarily that was down through the in-hospital strategy. So regardless of COVID impact, we will want to do these two. And if you look at our historical volumes, we were growing at high double digits before COVID hit China. So it's kind of hard for us to break out number quantitatively. But looking at the guidance for 2022, we have built in the elements of caution as we have seen the current impact on the ground, although we wait for any opportunity of how that might change or if official COVID strategy in China might change, although it's too early to speculate at this stage. So, we need to keep an and close eye on this. So, as we execute and we progress into 2022, we'll keep you informed regarding the latest trends in our guidance.

Max Masucci

Analyst

Great. Thanks for taking the questions. Looking forward to the data at AACR. A – Leo Li: Thank you, Max.

Operator

Operator

[Operator Instructions] Our next question comes from Alexis Yan with Morgan Stanley. Your line is open.

Alexis Yan

Analyst · Morgan Stanley. Your line is open.

Thanks for taking my question. I have two questions. The first one is on the – its actually a follow-up on the NGS kit approval. We understand that in terms of the LDT-based market the NGS market is actually quite crowded. But the registration pathway is actually very lengthy and unclear. So -- just want to better understand like what are the key hurdles that we have cleared, while the other players are still working on, so that we were able to obtain like multiple registration certificates for the NGS kits? And if that's applicable to the registration of our future products NGS and also even the early detection products in the outer years? And on top of that, if there will be like any changes or thoughts on the commercial strategies now that these two products could be officially on the hospital procurement list. This is my first question.

Yusheng Han

Management

Sorry I muted. So, if you look at the tenders of hospitals usually the price will follow with some key parameters such as the number of the genes type of variants that you can detect. And also, other contracts such as service and efficiency I mean the turnaround time. So Novogene is quite – the competitive is quite strong compared with the existing kits available in the market. As I said that it's the first kit that can detect COVID number of valuations. And also, it's a Novogene testing with one of the most genes can be detected. Now so if you look at the fusion, it's the first kit with open detection of fusion. It's quite different from the several sides fusion that can be detected by the other kits. So we think that is a strong product in the market. In terms of the future registration, to be honest if you look at the company who are competing for the registration it's not that crowded like probably just five to six companies have the competitiveness in the market. And people are competing for lipidiopsy and also probably bigger panel. And in terms of early detection, I think we -- the registration of early detection, we talk to the NMPA as we reported as a totally new product type. And also, we think that the conversation is encouraging that multi-cancer early detection are certainly in China. And other technology is quite new from the other products. In this algorithm quite complicated, calculating score based on tens of thousands of sites which is totally new to the NPA regulation. So, we think that the future is bright, but we think we need to do a lot of efforts. And that is why we are launching the first big -- large-scale interventional study to add approval to add some very important data for registration. Does that answer your question?

Alexis Yan

Analyst · Morgan Stanley. Your line is open.

Yes, yes. Thanks. My second question is related to the commercialization of the six cancer products and also the MRD products. So the -- yeah, the MRD obviously started commercialization recently and our early detection is I recall last time we said it's contracting with a couple of hospitals. Just wondering like while COVID may have to raise the sales for the moment like how is the hospital like discussions so far and any indicators that we should watch out for in terms of the initial sales color?

Yusheng Han

Management

Yeah. In terms of the hospitals we talked to, I think it was three months ago. Actually, we have already signed a contract with them. But since it's a new one after signing the contract there's a lot of process we need to go through the hospital in terms of the volume in order to make the volume come up. So -- and that needs our on-site employee to collaborate with the doctors and nurses and the health checkup department. And with the COVID-19, the most important thing that people are forgetting about healthcare they're locked in at home. And I think that it's quite easy to make a conclusion that once the COVID come in, you never think that health check-up is the most important thing. That's why I think that's how we will start commercialization once the COVID lockdown is release. And in terms of -- but there are some numbers that I can I think that for the healthcare population in a normal federation, the high-value consumer will not be impacted a lot by the COVID-19. I think they will come back after the COVID-19. And for the MRD, commercialization is on the early -- it's only early stage of telling the effect. But since we launched in March, the response from the doctors are really quite positive. I mean, the educational situation for MRD nowadays is different from what we can see like two years ago. Two years ago when we talked to the doctors they will say that if MRD is a positive whether it means that surgery is not as successful. And nowadays they will not say that because they have been influenced by the global opinion leaders, they noticed that MRD is a very useful tool for them in the early-stage cancer patient.

Alexis Yan

Analyst · Morgan Stanley. Your line is open.

That’s it. Thank you.

Yusheng Han

Management

Welcome.

Operator

Operator

Thank you. [Operator Instructions] And I'm showing no further questions in the queue. This concludes today's conference call. Thank you for participating. You may now disconnect. Everyone have a great day.

Yusheng Han

Management

Thank you.