Personalis Q1 2024 Earnings Call Transcript

Quartr
Provided by Quartr
May 8, 2024

There are 9 speakers on the call.

Operator

Good day, and welcome to the Personalis First Quarter 20 24 Earnings Conference Call. All participants will be in listen only mode. Please note this event is being recorded. I would now like to turn the conference over to Aaron Tachibana. Please go ahead.

Speaker 1

Thank you, operator. Welcome to Personalis' Q1 2024 earnings call. Joining today's call are Chris Hall, Chief Executive Officer and President and I am Aaron Tachibana, Chief Financial and Chief Operating Officer and Rich Chen, Chief Medical Officer and EVP of R and D. All statements made on this call that do not relate to matters of historical fact should be considered forward looking statements within the meaning of the the U. S.

Speaker 1

Securities laws. For example, any statements regarding trends and expectations or our financial performance this year and longer term, cash runway, revenue expectations and timing, reimbursement goals, size and booking of orders, products, services, technology, clinical milestones, the outcome and timing of reimbursement decisions, expectations for our existing and future collaboration activities, cost expectations, our market opportunity and business outlook. These statements are subject to risks and uncertainties that could cause actual results to differ materially from our current expectations. We encourage you to review our most recent filings with the SEC, including the risk factors described in our most recent filings. Personalis undertakes no obligation to update these statements except as required by applicable law.

Speaker 1

Our press release with our Q1 2024 results is available on our website, www dot personalis.com under the Investors section and includes additional details about our financial results. Our website also has our latest SEC filings, which we encourage you to review. A recording of today's call will be available on our website by 5 P. M. Pacific Time today.

Speaker 1

Now, I would like to turn the call over to Chris for his comments and Q1 business highlights. Thank you, Aaron.

Speaker 2

Good afternoon, everyone, and thank you for joining us. I'm very proud of our team at Personalis as we continue to fight cancer with our novel technologies. For those of you joining one of our calls for the first time, welcome. First Analysis is one of the leaders in the fast growing MRD testing market. MRD stands for minimal residual disease.

Speaker 2

With our first of its kind ultra sensitive MRD test, we're able to spot cancer when it's only one fragment of tumor DNA circulating in a 1,000,000 DNA fragments in the blood. Our technologies are used by many of the world's top biopharma companies to improve clinical trial results, find new ways to personalize treatment and power a new generation of more effective therapies. Last quarter, we laid out a strategy to drive Personalis to $100,000,000 in revenue in 2025. This aspirational milestone with 3 underlining growth engine is our lodestar as we are accelerating Personalis into a higher growth mode. In the Q1, we achieved revenue of 19 point $5,000,000 exceeding the upper end of our guidance of $18,000,000 to $19,000,000 Our biopharma business grew 55% compared to the Q1 of 2023 driven by strong demand for our core immuno ID platform to support the individualized neoantigen therapy market as well as increasing demand for our MRD product Next Personal.

Speaker 2

With this increased demand, we have the confidence to increase our full year revenue guidance to $76,000,000 to $78,000,000 from $73,000,000 to 75,000,000 I'll now review progress this quarter on the 3 growth engines driving us towards our $100,000,000 in 2025 goal and our progress on each. The first growth engine is the most important as we focus on turning Personalis into a clinical diagnostic powerhouse. In order to do that, we're executing on our win in MRD strategy. The MRD market involves using liquid biopsy to find evidence of minimal residual disease or cancer recurrence and subsequently monitoring therapy effectiveness. It's estimated that this market will mature into a $20,000,000,000 opportunity over the coming years and we are establishing Personalis as a leader in this space.

Speaker 2

Our win in MRD strategy has 4 pillars. 1st, to focus and launch our test in cancer types where an ultra sensitive liquid biopsy test and unlock significant value for patients, payers and partners. 2nd, to drive reimbursement by developing robust clinical evidence of partnering with the top global collaborators. 3rd, leverage our deep relationships to accelerate adoption by biopharma partners and power our revenue growth by the use of next personal and clinical trials. And lastly, to commercialize next personal with a partner centric model.

Speaker 2

To delve into the 1st pillar, we previously explained how we're developing evidence to support Next Personal's clinical usage and reimbursement in early stage lung cancer, breast cancer and immunotherapy monitoring. We believe our ultra sensitive technology allows us to see cancer earlier, which may provide the information to deescalate patients from unnecessary therapies and procedures potentially sparing patients from toxicity and saving healthcare dollars. Just as importantly, we believe we can identify and get recurrent patients to treatment earlier with potentially better outcomes. Our focus on these indications is intentional and our data is demonstrated that next personal can win in these markets. To elaborate a bit on our approach, early stage lung cancer and breast cancer shed very little DNA in the blood, which are difficult to detect without an ultra sensitive approach.

Speaker 2

Early detection is critical in these indications. For patients on I O therapy, we believe the potential decision to switch treatment requires the insights for monitoring that are provided by our ultra sensitive test. Now you might recall that last October we launched our MRD test Next Personal and today we are enrolling physicians in an early access program or EAP. We are the 1st ultra sensitive MRD test to commercially enter the market and with that launch we now have 2 laboratory developed tests or LDTs on the market. The other being our Medicare reimbursed test NextDx, which is used by physicians to put a patient on targeted therapy.

Speaker 2

The adoption of these tests has been rapid and is exceeding our initial target. We delivered 338 clinical tests in the Q1, a solid uptick from the 126 results delivered in the Q4 of last year. We're pleased with this traction as the number of physicians that were ordering in Q1 remained fixed to 10 through the quarter. There are 2 key metrics that I want to to talk about and dive into. 1st, all 10 of our early access positions are ordering and uptick has been strong across the entire cohort.

Speaker 2

The second metric involves the actionability of our next personal MRD test for the clinic. If you remember, we report circulating tumor DNA in the blood down to 1 part million, which means if there is just one fragment of tumor DNA circulating in a 1,000,000 DNA fragments in the blood, we expect to see and quantify it. This is a leap forward for the field. The extra sensitivity we report on with our next personal assay, which are values between 10100 parts per million, a mask a region that has previously been hard to see consistently. We call that region the ultra sensitive MRD range.

Speaker 2

Until next personal clinicians could not routinely detect cancer recurrence at that level and today they can. About 40% of the ctDNA positive samples thus far in our clinical testing have been in this ultra sensitive range. That's a significant jump in the performance of MRT testing and means that physicians can see cancer recurrence earlier, have more discrimination in monitoring therapy and have more confidence that ctDNA patients that are negative are likely cancer free. Indeed, we've had many anecdotes relay from our 10 early access doctors that the ultra sensitive range is allowing them to see cancer earlier with their patients and intervene to get them the management they need. We believe it is the ultra sensitive range that allows a doctor to see cancer sooner and seen it sooner is the cornerstone of our win in MRD strategy.

Speaker 2

Now moving to the 2nd pillar. We're focused on building and publishing clinical evidence to gain reimbursement and are working with many of the top thought leaders in the In previous calls, we've talked about the importance of our work with Royal Marston in breast cancer and BHIO and immunotherapy monitors. Both of these collaborators have provided access to studies that are broad and comprehensive. In the case of Royal Marston, one of the leading global institutions in breast cancer, we're focusing on patients with early stage disease for several subtypes, including ER positive, HER2 positive and triple negative breast cancer. For VHIO, the work is pan cancer across many cancer types and stages.

Speaker 2

These studies are anchor studies and that they will be the back bone of our efforts to gain Medicare reimbursement. Royal Marston for early stage breast cancer and VHIO for immunotherapy monitoring. We're excited that at the upcoming ASCO conference to work with both of these collaborators will be featured as oral podium presentations. We also have 3 other studies featured at ASCO, one with Dana Farber on HER2 positive patients, another with Duke for immunotherapy monitoring for gastric patients and lastly, one in colorectal cancer patients. Having this breadth of data should underscore our commitment at Personalis to developing rich data to support the use of next personal in the clinic and to gain reimbursement quickly.

Speaker 2

At the AACR conference in April, some compelling data was presented. Our collaborators from the UKE gave an oral podium presentation on late stage melanoma patients where they use NEXT Personal to monitor and detect immunotherapy response highlighting the importance of detection of ctDNA in the ultra sensitive range. In addition, our work in collaboration with AstraZeneca on their MATRIX study was presented. The MATRIX abstract show Next Personal achieved very strong sensitivity and specificity on blinded test samples provided by AZ down to the lowest levels at 2 parts per million. Subsequently, we were selected as a partner by AstraZeneca for MRD testing in their upcoming trials.

Speaker 2

We've also presented data from collaborators with a personalized cancer vaccine company and our analytical validation data for next personal that was recently published was also at the AACR conference. The 3rd pillar of our NEXT Personal strategy is to leverage our biopharma relationships to drive the relationships to drive the use of next personal in clinical trials. We're engaged with most of the world's top biopharma companies and have continued to generate excitement around our next personal test, most recently from discussions at AACR. Customers want and

Speaker 1

need an ultra sensitive approach

Speaker 2

to ensure that the most appropriate patients enter into a clinical trial. For example, we believe that our ultra sensitive assay means that patients testing negative are much less likely to have a recurrence. Our biopharma customers can then expect that these patients are less likely to benefit from a therapeutic intervention, holding out the promise that next personal could be an excellent approach to optimize biopharma trials. Indeed, here in the Q1, we booked record new orders for Nex Personal. The product helped to drive our strong Q1 financial performance and we believe it will be a driver of revenue moving forward in an important way for us to deepen the clinical utility of X Personal.

Speaker 2

Now I'll move on to the 4th and final pillar commercializing X Personal using a partner centric model. In December, we announced our key partnership with Tempus to commercialize Next Personal DX, the Next Personal in the clinic with oncologists. To quickly review, we expect to leverage Tempus up to Tempus' up to approximately 200 person sales channel to co commercialize Next Personal and accelerate growth. Personalis will be responsible for processing samples in our lab, obtaining reimbursement and invoicing health insurance payers and patients under the arrangement while paying Tempest fair market value for the commercial services they provide to us. Overall, the deal is worth approximately $30,000,000 for personnel should all the milestone payments be triggered and if Tempus fully exercises their warrants.

Speaker 2

We expect this to allow us to ramp up commercial efforts quickly with minimal additional cash investments. We plan to launch with Tempes this quarter by expanding our early access program to include some of Tempes' clients. The goal is to learn how to work together as partners, integrating our business systems, refining our message to oncologists, so we're set to drive accelerated growth together on the backside of reimbursement improvement. Now while we've made strides with our first growth engine, our win an MRD strategy to establish personal as a leading MRD test. We also made progress with our 2nd growth engine leveraging our Immuno ID.

Speaker 2

NEXT platform to deepen relationships with biopharma customers who use the offering to pioneer new therapies. Our biopharma segment grew 55% year over year and we had solid performance across our product portfolio. Customers primarily use our Immuno IDX platform in 2 ways. First, they use our platforms to power translational research and find new biomarkers and new insights that can power their drug discovery efforts. 2nd, companies in the personalized cancer vaccine market use our platform to create a molecular fingerprint of a patient's tumor to power a personalized therapy.

Speaker 2

We previously told you about our partnership with Moderna in which Moderna is utilizing our platform in their mRNA cancer program. Moderna and its partner Merck are enrolling patients and our collaboration with Moderna is important driver of revenue for us in 2024 2025. We have several other partners that work in this space as well. The 3rd growth engine third engine of our growth strategy is growing our personnel inside approach as we service enterprise customers. In these relationships, partners adopt our platforms and technologies to power their solutions and provide new insights to their customers.

Speaker 2

Our work with Natera involves leveraging our sequencing platform to analyze the exome as a part of their MRD product. We believe our relationship is strong and mutually beneficial and are optimistic that it will extend into 2025. The second important enterprise relationship is the VA. The VA utilizes our whole genome sequencing capabilities to power the 1,000,000 veteran program, a national research program looking at how genes and lifestyle affect the health of veterans. We've helped power this program with the VA for years.

Speaker 2

Both of these relationships are examples of how our platforms drive value for partners and importantly provide sequencing scale for Personalis. Now before I turn it over to Aaron to go deeper on the financials, I have a few exciting corporate updates. First, we continue to innovate and deepen our strong intellectual property position. We had 2 new patents recently issued by the U. S.

Speaker 2

PTO, in fact, one just yesterday relating to the use of 2 of our core technologies, tumor informed personalized assays in the first patent and boosted exome panels in the second patent, each to inform cancer vaccine treatments. This latest patent is the 4th U. S. Patent to issue in 2024 and today our number of issued U. S.

Speaker 2

Patents is over 30. We believe we have a deep set of IP protecting our pioneering work in both MRD and PCB. We're engaged in litigation with Foresight Diagnostics to enforce and protect some of our IP relating to MRD. As often the case, there'll be ups and downs along the way in that journey. However, we are confident we're set up for long term success to establish an industry leading position of around the use of whole genome sequencing for MRD and are optimistic about the path forward.

Speaker 2

And second, we crossed 2 milestones this quarter. We processed our 400,000 samples since our company's inception and importantly we completed our 175,000 whole genome sequencing sample. Whole genome is the foundation of our next personal MRD test and these milestones underlying both our sequencing scale and unique operational capabilities. With that, I will now turn it over to Aaron to review our financial results.

Speaker 1

Thank you, Chris. Our strong Q1 2024 financial results demonstrate our ongoing commitment to execution against our milestones and scaling revenue. I will be providing details about the Q1 financial results and guidance for the Q2 and full year of 2024. Total company revenue for the Q1 of 2024 was $19,500,000 and increased 4% compared with $18,900,000 for the same period of the prior year. The increase in revenue was driven by higher volume from biopharma and personalized cancer vaccine customers, which was partially offset by declines from Natera and the VA MVP.

Speaker 1

Biopharma revenue grew 55% as compared to the same period last year and the growth was from Immuno ID Next and also from our MRD test Next Personal, which is beginning to ramp up with many customers. In addition, we achieved a significant milestone and recognize our first clinical revenue in the amount of $200,000 from NextDx for which we received Medicare reimbursement coverage in January of this year. Gross margin was 20.1% for the first quarter compared to 25.1 percent for the same period of the prior year. The year over year increase of 3 percentage points was primarily due to favorable customer mix from the increase in biopharma revenue and also operating leverage from the increase in total company revenue. Operating expenses were $24,400,000 in the Q1 compared to $34,600,000 for the same period of the prior year.

Speaker 1

Most of the year over year decrease was attributed to the actions taken to reduce headcount in 2023. R and D expense was $12,800,000 in the Q1 compared with $16,600,000 for the same period of last year and SG and A expense was $11,600,000 compared to $14,100,000 for the same period last year. Net loss for the Q1 was $13,000,000 compared to $28,700,000 for the same period of the prior year. The Q1 net loss included a $4,800,000 non cash gain related to fair value accounting of the outstanding warrants issued to Tempest. This non standard income was a result of the decrease in fair market value of the warrants at March 31, 2024 compared with the fair market value at the end of last quarter.

Speaker 1

And for clarification, the accounting implications for the warrants will have no bearing on the cash value if they are exercised in the future. Now onto the balance sheet. We finished the Q1 with a strong balance sheet with cash and short term investments of $95,400,000 During the quarter, we used $18,800,000 to fund operations and we have approximately 2 years of cash on the balance sheet, which is expected to last through the Q1 of 2026. Now I'd like to turn to guidance. For the Q2 of 2024, we expect total company revenue in the range of $19,500,000 to $20,500,000 dollars revenue from pharma tests, enterprise sales and other customers in the range of $18,000,000 to 19,000,000 and revenue from population sequencing of approximately $1,500,000 And for the full year of 2024, we now expect total company revenue in the range of $76,000,000 to $78,000,000 an increase from the prior estimate of $73,000,000 to $75,000,000 revenue from pharma test, enterprise sales and other customers in the range of $68,000,000 to $70,000,000 which increased from the prior estimate of $65,000,000 to $67,000,000 Population sequencing revenue to be approximately 8,000,000 dollars non GAAP net loss of approximately $77,000,000 which decreased from the prior estimate of $80,000,000 and it does not include any income or expense related to the outstanding warrants issued to Tempus.

Speaker 1

And cash usage is expected to be approximately $62,000,000 We look forward to updating you on our progress during the next conference call in a few months. And with that, I will turn the call back over to the operator to begin the Q and A session. Thank

Speaker 3

Just want to start out with the finalization of the FDA's LDT regulation. I was just wondering if you could speak to your strategy in adhering to the requirements and what kind of implications for personnel as you're expecting with respect to Next CX and Next Personal?

Speaker 2

Yes. Awesome. Great. Thanks for being on, Madison. Yes, the FDA issued their final guidance for regulations and overall, we perceived it to be good for the industry, certainly good for personnel.

Speaker 2

We have a quality management system here that we think is super robust. We're regularly inspected by most of all the large biopharma companies. We've been operating with ISO certification in New York, etcetera. And we think that what we're doing sort of fits in well with what the agency expects based on the guidance. And so we feel like we're set up well and we think ultimately it's good for us.

Speaker 2

We'll note that there was a grandfathering section around having an LDT live. We have both of those tests or laboratory developed tests and are both on the market as of the effective date of the FDA guidance. So we think that's good. And secondarily, because of our long relationship with New York and having New York certification, we submitted both of the tests for New York approval. And so ultimately, we expect to have New York approval for both the test also.

Speaker 2

So we think it's net net a positive for personnel and puts us in a good position.

Speaker 3

Got it. Okay. That's good to hear. And then just one follow-up one. With following the recent ad comm meeting to evaluate MRD as an endpoint in multiple melanoma trials, just wondering if you're seeing a read through to the solid tumor space and specifically with the panel emphasizing some sensitivity, how do you see next personal position for capturing clinical trial opportunity?

Speaker 2

Yes. And I would just note, I mean, one of the things I think these 2 dovetail together, there is, I mean, clearly what the agency did with the unanimous approval of using that and multiple myeloma is blood based. We expect this to continue the March in solid tumor. And I think that the guidance and having the LDT and the quality management systems etcetera, it's going to make it harder for companies that aren't well funded ultimately to build and get the kind of position in the space that you would need to do. So I think it sort of works.

Speaker 2

It works together well, especially if you appreciate that FDA is going to integrate, we believe at some point ctDNA is a monitoring metric for these clinical trials. Doing that could allow biopharma companies to result have results

Speaker 1

sooner

Speaker 2

and ultimately speed up access to drugs for patients. We're engaged with

Operator

most of the

Speaker 2

top biopharma companies right now that are either using the technology, assessing the technology or doing pilots or bake offs. And there's always a long sales cycle with biopharma with these products. But the ultra sensitive nature allows them we believe and what we're starting to see in the data that we're both talking about at industry scientific gatherings and what we're starting to see in our early testing data is that we're seeing almost 40% of the positive results are in the ultra sensitive range and those are real patients that were identifying cancer sooner. And that insight and that discrimination is appealing to biopharma companies that want to have that discrimination in their clinical trials and they want to make sure if they use a test as an entry point to actually take the drug and go into 2 arms. We want to make sure that the patients that are most likely to recur ultimately enter the trial.

Speaker 2

And so we're getting really positive feedback on the assay in that way too.

Speaker 3

Got it. That's good to hear. Thanks so much for taking the questions.

Speaker 2

Awesome. Thanks for being on Madison.

Operator

The next question comes from Mark Massaro with BTIG. Please go ahead.

Speaker 4

Hey guys, this is Vivien on for Mark. Thanks for taking the question. So just as far as the ways to the guidance beyond the beat, you have a number of offerings, some of which are newer like next personal, which might not be driving revenue yet versus some more mature partnerships like Moderna. So looking to 2024, just curious if there's any area in particular where you're expecting to see strength versus some product lines that might be softer? Thanks.

Speaker 1

Vivien, this is Aaron. Thank you for the question and being on the call. In terms of the guidance, so we raised guidance primarily because of the strength of biopharma demand in terms of where that strength is coming from. So Immuno ID Next is holding its own. It's doing very, very well.

Speaker 1

We have a lot of pharma headwinds today, but in terms of the opportunity, it's really with Next Personal. We have we've done really well in the Q1 with Next Personal. We have a tremendous funnel that's building and we see that the growth is going to accelerate as we head through the back half of twenty twenty four with Next Personal. In addition, Chris mentioned

Speaker 2

in the prepared remarks that we

Speaker 1

are seeing strength from the personalized cancer vaccine side of the business as well. And that's again off of

Speaker 2

our Immuno ID Next platform.

Speaker 4

Okay, perfect. Yes, and that kind of dovetails into my next question. So the 338 next personal test look latency, just how you're expecting that to ramp throughout the year after Tempest starts marketing it as well? And just wanted to get a sense if reimbursement on that test would be more of a 2025 event or if there was any updated timing there?

Speaker 1

Thanks. No. I mean our

Speaker 2

goal this year is to submit this year for all three cancer indications and stitch it together and we think that the data is coming together to allow us to do that. We talked in the prepared remarks that the VHIO and the Royal Marston data would be featured at ASCO, as a podium presentation, which we is great. And we're tracking to be able to get the data ultimately submitted for publication, published to be able to submit across the 3 indications for coverage in 2024, which is our stated goal. Now that's aggressive and we'll continue to grow the number of doctors that are in the EAP through our own efforts, slowly through our own efforts and then with Tempus. And so we'll see the number of patients referred to us for next personal test to continue to grow through the year.

Speaker 1

Maybe just an add on to what Chris just articulated, Vivien. So we're seeing great strength. We have a lot of demand with doctors wanting to participate in the program. Number of tests are continuing to grow, but there's a balance. We're going to be a little bit careful with how much we take and perform test on primarily because of reimbursement, right?

Speaker 1

We don't want to just burn a lot of cash. We want to make sure we learn and we want to ramp, but also there's a cash component of it.

Speaker 4

Perfect. And one of the yes,

Speaker 2

one of the neat things about this relative to volume growth from an investor standpoint, it's always been appealing about the MRD market is there's always an annuity, right? As you build the first baseline test, you repeat test over time as this patient sort of go through their cancer journey. There's continued testing of personalized genetic fingerprint that you created for the patient. And so we're seeing that happen. We're seeing nice growth in the repeat test of the patients that were referred to us previously, which is a really great dynamic in the space.

Operator

The next question comes from Dan Brennan with TD Cowen. Please go ahead.

Speaker 5

Hey, this is Joe on for Dan. Thanks for taking them. I just got a little bit more on the 3 30 AMRDT test. What do you need to see to open that weightless up to the 2 50 docs that you mentioned in Q4? Is that more capacity or demand?

Speaker 5

Or is it really just holding back tests until you get more widespread reimbursement. So maybe is there like some sort of cap you're thinking about for annual volumes before you get coverage on the 3 tests?

Speaker 2

Yes, the latter. We're moving really slow because of reimbursement. And one of the things I think it's obvious by looking at all the progress that we've made through 2023 and bringing down the burn rate of the company, extending the cash out of the company is that we're being very thoughtful about where and how we spend the resources that we have. And so it's really important through this journey that we build advocates for the products that we continue to build clinical evidence that we continue to learn the right way to position, talk about the products that we test the relationship with Tempus and we really get to the point where we feel confident that once we get reimbursement, we can pull the trigger and go super fast. But until we get reimbursement we're not planning on going super fast because it's we don't get paid for those samples and we want to make sure that we're really thoughtful in doing the right thing with investors'

Speaker 5

money. Got it. And then on the burn, does the 2 years of cash assume a revenue level like at or around $100,000,000 now that you've implemented your $100,000,000 in 2025 framework? Or is it closer to like consensus levels are a bit

Speaker 1

lower? Hi, Joe. Yes. So in terms of the burn, we've mentioned the cash flow last through the end of the Q1 of 2026. So it does contemplate something that's close to that $100,000,000 range in 2025.

Speaker 5

Got it. And then just last on the patent, is the core IP that you're forcing specific to whole genome sequencing and solid tumor or are there other key aspects of IP that depending on?

Speaker 2

I mean relative to MRD very broad, both MRD and PCV very broad, both around whole genome and then the way in which we do the process. And then there's IP that was mentioned around the exome and the way we boost the exome relative to its use in PCB. And the point I'd mentioned at the right is just to underline because we spend a lot of time, significant energy building the protections around what we're doing and we continue to make progress. And we've been mostly focused on driving the business really aggressively towards MRD, but we wanted to make sure we underline that there is a deep amount of IP here that we think is building, getting stronger and that we continue to work on evolving and extending as we invest in R and D. And so we had some success this quarter and we wanted to underline as part of our ongoing journey.

Speaker 5

Got it. Thanks.

Speaker 1

Thanks, Joe.

Operator

The next question comes from Thomas Flaten with Lake Street. Please go ahead.

Speaker 6

Hey, good afternoon guys. I appreciate you taking the questions. I just want to clarify something with the TRACERx collaboration. The publication that you will use for your reimbursement dossier, will that be the initial ESMO cohort or will that be a publication covering the full cohort, which we expect to see a readout on later this year?

Speaker 2

Yes. Thomas, Rich is with us. So he's going to take that one. Hey, Thomas. Thanks for your question.

Speaker 2

Yes. So the publication that will support our reimbursement will be the 2nd publication that entails the entire cohort. So that we're targeting for kind of later this year. And the first publication will come out, but it's only a subset of the data that we need.

Speaker 6

Got it. And then Chris, I want to make sure I didn't misunderstand what you said, but did you say that the Natera relationship would persist into 2025 or did I misunderstand that?

Speaker 2

No. I just said that we have a great working relationship and we're optimistic that it will that we will continue to work with them into 2025. We have not done anything for the most announced Got it.

Speaker 6

And if I could just add a third one. Have you discussed with Tempus and maybe they haven't an alternate solution of adding Next DX, it strikes me that being able to order both tests through one sales channel would make sense. But how are you thinking about those 2 tests working in synergy with each other long term?

Speaker 2

Yes. So with we are seeing NextDx being ordered with Next Personal and our early access clients, and that demand is strong. What we're seeing in the marketplace and I think everyone has seen in the marketplace is that the power of the MRD testing is unique differentiated and the CGP testing physicians are seeing more in a way that they're more interchangeable. And so they're ordering the CGP test paired with the MRD as a convenience play, same patient, same tissue, same etcetera. And so we're Tempa has their own MRD test.

Speaker 2

And so through the samples, not MRD test, their own CTP test, excuse me. And so they will be providing that now than likely to do with their customers. And so we expect the NextDx, our approach to only come through with the doctors that we sell ourselves.

Speaker 6

Got it. Appreciate you taking the question. Thank you.

Operator

The next question comes from Mike Matson with Needham. Please go ahead.

Speaker 7

Hey, Chris. Hey, this is Joseph on for Mike. Maybe just one on pharma demand. Obviously, as you guys said, you've seen increasing demand there. Is that mainly coming from, I guess, new customers coming back in or is more existing customers kind of expanding their order books?

Speaker 1

Mainly the similar customers that we've had up to now. So it's not really new customers, just the expansion of the order book and the opportunity. In addition, the Moderna relationship has been strong and that business has started to increase as well.

Speaker 2

Yes. And the next personal moment, we basically have the new the use of Immuno ID and PCV is really starting to accelerate as Merck and Moderna enroll the patients in their clinical trials and then ex personal being a new product and the biopharma starting to grow. And so those two things are really starting to put wins to our sales relative to financial performance.

Speaker 7

Yes. Okay. Got you. And then maybe just in there for the early access program for Next Personal, I guess, do you have, I guess, an engagement rate for those using NextDx? And then I guess was that a full quarter that you guys kind of launched NextDx?

Speaker 7

Yes. Yes.

Speaker 1

Yes. So NextDx

Speaker 2

we launched, I want to say a year and a half ago, and we kept it very, very, very small and it was used by a few physicians. When we launched NEXT Personal as an LDT laboratory developed test in October, that's when we started to see NEXT Personal be used side by side with or the next DX, the CGP product be used with the MRD product side by side. And I think, I mean, I have to check, but the adoption's been wide across the entire 10 people in the EAP program. I don't know if I can say they've all done that, but certainly the significant majority, most of them have been using NextDx the same time that they use NextDx Personal.

Speaker 7

Okay. And then just maybe one last one. For the molecular or I guess for the physicians in the quarter, I guess for the test, is there an average test per patient that you guys are seeing?

Speaker 2

I don't think we have enough time to I think we need more time to pass about an average test per patient, because I think a lot of these people are new. But we are starting to see the repeat testing. And in fact, because when you're fixed at 10 physicians, a lot of times in these hyper growth modes in these companies' launches, you're also you're starting to really sign up a lot of new doctors. And so your V1s are always growing at a dramatic rate because you're growing in the world where we fix the doctors, we've launched into rhythm and beat of getting the clinical samples coming from those doctors. Now we've hit the point where the repeat testing is starting to outpace the weekly new test coming in, right, just because it's starting to accelerate.

Speaker 2

So we'll come up with a way that we ultimately talk about that metric, but I don't think we have any insight right now relative to the number of tests per patient. But I think as we get a year, 2 years in the rearview mirror, it'd be a good way to start to look at it.

Speaker 7

Got you. Okay. Yes, thank you very much for taking our questions and congrats on the quarter.

Speaker 2

Thanks for being on.

Operator

The next question comes from Arthur He with H. C. Wainwright. Please go ahead.

Speaker 8

Hi, good afternoon, Chris and Aaron. This is Asar on for Ake. So I guess I just want

Speaker 2

to get a quick question

Speaker 8

regarding the early access program for the personal DX. For this program, I know you mentioned a doctor on the waiting list at the beginning. I'm just curious, is there any more doctors getting on the waiting list? Is they getting longer or close?

Speaker 2

There was growth. Yes, there's been growth and quote the waiting list. We just decided we're not going to like track that quarter over quarter. We thought that the reported test was the best way to sort of provide insight. But we do have a wait list and then Tempus is starting their discussions and so we expect there to be a pent up demand that they're creating too separately as they engage with customers and discussions.

Speaker 8

Got you. Thanks for the additional color. And regarding the reimbursed application, you guys mentioned the aim for trying to get to the for all 3 indication done this year. Besides the data package you prepared for that, what are other things you guys prepared to can increase the chance for getting the reimbursement approved?

Speaker 2

Yes. Great question. So the key thing is the data package. Now one of the things that happened to us earlier in this quarter is that we the analytical validation data, which looked really, really strong was published. And that is the backbone of every one of the submissions that the test gives an answer across multiple cancer types.

Speaker 2

Now the one part per million, it does that with really high specificity. And so that's like the backbone of every submission whenever you do this, the analytic validation data. And this was really strong, really robust and a lot of studies, a lot of work that went into it. We're really proud of it and super excited that it got published so quickly. So that's sort of the backbone of all three.

Speaker 2

And then we have to get clinical data in each one of these 3. So for lung cancer, early stage lung cancer, the work with TRACERx is key there. With breast cancer, the work with rolamarston is key there, because that's multiple subtypes. But we're also working with Dana Farber, we're working with Khadari, triple negative breast cancer patients. We have our own we have a clinical trial we're doing ourselves called BE STRONGER.

Speaker 2

Immunotherapy, we've got the UKE data with melanoma. We've got the Duke data with gastric patients. And then we've got the large VHIO data. And so we continue to make progress running those samples. The key thing there is that collaborators will need to write the articles and they have to submit those articles and those articles have to be ultimately be accepted for us to drive the submissions.

Speaker 2

And so the one piece of this that is always difficult to predict is how long it takes collaborators to write articles and to submit articles and ultimately for those articles to get articles to be accepted. But we've been very focused on driving this so that all that comes together this year And that's been our goal and right now we're on plan to accomplish that.

Speaker 8

Awesome. Thanks for taking my questions and congrats on the progress.

Speaker 1

Awesome. Thanks, Jorge. Thanks a lot.

Operator

This concludes our question and answer session as well as conference. Thank you for attending today's presentation. You may now disconnect.

Speaker 2

Thanks.

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Earnings Conference Call
Personalis Q1 2024
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