Sera Prognostics, Inc.

Good afternoon and welcome to the SARA prognostics conference call to review fourth quarter and fiscal year 2022 results. At this time, all participants are in listen-only mode. We will be facilitating a question and answer session toward the end of today's call. As a reminder, this call is being recorded for replay purposes. I would now like to turn the call over to Peter DiNardo of Capcom Partners for a few introductory comments.

Thank you, MJ. Good afternoon, everyone. Welcome to Sarah Prognostics' fourth quarter fiscal year 2022 earnings conference call. At the close of the market today, Sarah Prognostics released its financial results for the quarter ended December 31, 2022. Presenting for the company today will be Greg Critchfield, Chairman, President, and CEO, and Jay Moyes, our CFO. During the call, we will review the financial results we released today, after which we will host a question and answer session. If you've not had a chance to review our quarterly earnings release, it can be found on our website at seraprognostics.com. This call can be heard live via webcast at seraprognostics.com, and a recording will be archived in the investor section of our website. Please note that some of the information presented today may contain projections or other forward-looking statements about events and circumstances that have not yet occurred, including plans and projections for our business, future financial results, and market trends and opportunities. These statements are based on management's current expectations, and the actual events or results may differ materially and adversely from these expectations for a variety of reasons. We refer you to the documents the company files from time to time with the Securities and Exchange Commission, specifically the company's annual report on Form 10-K, its quarterly reports on Form 10-Q, and its current reports on Form 8-K. These documents identify important risk factors that could cause the actual results to differ materially from those contained in our projections and other forward-looking statements. As a reminder, webcast replay of this call will be available in the investor section of our website. I will now turn the call over to Greg, Sarah Prognostics Chairman, President, and CEO.

Greg? Thank you, Peter, and good afternoon, everyone. Fiscal 2022 was a solid year of continued progress in positioning seroprognostics for commercial growth in the quarters and years ahead. During 2022, we made incremental progress in adding new payer contracts and more recently have publicized new data that we believe will support the growth of our business in future periods. Although our revenue was nominal for the year, we are seeing percentage growth in test volumes. For Q4, year-over-year 2022 versus 2021, the increase was six-fold. And for total units 2022 versus 2021, it was 11-fold. Of course, these are increases from a small baseline in 2021. While it takes time to broaden commercial relationships, we are seeing positive results from our strategy in terms of both payer and physician response. And we look forward to reporting additional traction during 2023. Ultimately, at this time, the single biggest way to further accelerate adoption of our preterm technology and testing volumes is the publication of compelling new data that continues to demonstrate the value of our tests. This growth is first manifested in the use of our technology by early adopters and should result in growing reimbursement by increased numbers of payers while we execute our strategy. And we have strong, we share strong new data is published from clinical studies. In terms of customers, we maintain a continued focus on early adopter systems. For example, integrated delivery networks, or IDNs, hospital systems, and physician practice groups. We continue to work with early adopter systems, not only by sharing data, but also by discussing ways with them to implement the preterm testing within their institutions. We anticipate making selective announcements as permitted in the course of bringing the preterm test and treat strategy into these systems. While implementations among these customers take time, we believe there may be an inflection point ahead as multiple customers among our growing relationships rescale in future quarters where the number of tests and the amount of revenue increases accordingly. Another important event in our quest to help build up testing volumes among these customers is to broaden preterm testing availability while reducing our costs and growing our business. Before that end last quarter, I touched on the successful validation of an ambient blood collection and transport system for preterm testing, which we launched commercially in December. This not only expands the number of sites where patients' blood can be more easily collected by reducing the need for dry ice availability for transport to our labs, but it also reduces our costs. Just as importantly, we know that ambient shipping now newly deployed is growing as a proportion of tests being ordered this year, and we believe that even from these early moments of ambient collection shipping launch, it will continue to contribute to increases in test volume over the next months and years to come. Let's now turn to the growing body of published new data supporting our mission to improve the health of mothers and babies. First, the Accordance Study. Building strong evidence for the use of the preterm test is an important part of CIRA's strategy. In terms of addressing healthcare disparities, during Q4, we announced the publication of results from Accordant, a clinical utility and cost effectiveness modeling study based on rigorous clinical utility health economic analysis. This work, published in the Journal of Health Economics, illustrates the impact of CIRA's test and treat strategy and its specific benefits in underserved racial and ethnic populations. was a secondary analysis of 847 women from the multi-center assessment of a spontaneous preterm risk predictor study, or TREATOP study. Findings showcased that care management with or without pharmaceutical treatment was effective in reducing maternal and neonatal hospital length of stay. Results indicated that by combining the preterm test with enhanced prenatal care management, real progress may be made in better serving the most disadvantaged populations to enable better medical outcomes. Now a bit on new clinical outcomes data supporting the preterm test and treat strategy, the AVERT preterm trial. A few weeks ago, we announced the top line results for our large AVERT preterm trial, which showed statistically significant improvements in both of its primary endpoints, neonatal hospital length of stay and neonatal health as measured by a composite neonatal morbidity and mortality index. We believe these results solidify the benefit of the preterm test and treat strategy to improve the health of babies, giving those most vulnerable a better chance at a stronger start in life. The detailed results of the AVERT trial, including secondary endpoints and additional subgroup analyses, are being prepared for submission to a peer-reviewed scientific journal in the coming months. In our announcement of the top-line AVERT study results, we mentioned that we believe these results bode well for our very large prospective multicenter randomized controlled PRIME study. We are pleased to announce that PRIME has surpassed 2,800 enrolled patients, the number required to enable the pre-planned interim learning. And though there are moving parts that can delay such things, we believe that the interim analysis is on track to take place during this year. I would like to take a minute to describe how different pieces of evidence fit together in our broader strategy by clarifying why we believe that overt top-line results bode well for PRIME. First, both studies have identical co-primary endpoints, reduction in neonatal hospitalizing of stay and decreased neonatal morbidity and mortality. Second, both studies have a diverse demographic that is representative of broad racial, socioeconomic, and pre-existing risk profiles. Third, the multimodal clinical intervention strategies prescribed in the protocols of both studies are the same or similar. Specifically, this includes the use of low-dose aspirin, the same form of progesterone, and additional care management for mothers identified by the preterm test to be at higher risk of premature delivery. Care management consists of more frequent clinical monitoring and more intensive education for higher risk patients. It is also important to note that while these similarities between AVERT and PRIME give us optimism for the PRIME study, there's always the potential that differences could weigh in the other direction. To point out a few, the AVERT preterm trial was performed within a single health system, while PRIME involved over 15 sites, which could lead to possible differences in administration of the study and adherence to the trial's clinical protocol across these sites. As another difference, all patients who reached term in avert were treated before COVID was prevalent locally in Delaware and ended the study early, while some patients in prime will have been treated during the pandemic and others after the pandemic has substantially waned. Finally, the prospective randomized controlled design of prime is a stronger study design in terms of the evidence generated than that of the historically controlled AVERT preterm trial. Furthermore, though AVERT included approximately 10,000 historical controls, PRIME is a much better powered study in that it includes approximately twice as many subjects as AVERT in its prospective arm at the interim look analysis and almost four times as many at full enrollment. The larger size of the test and treat arm of the PRIME study helps to provide higher statistical power. Oftentimes, clinical studies are statistically powered at approximately 80% to see the effect of interest, the primary outcomes, at full enrollment. The PRIME study was designed to have that level of statistical power for the interim look analysis before the trial is fully enrolled and even higher power for the final readout. Considering these and other factors, while we believe the results are encouraging given these differences, they're clearly not completely predictive of the outcome of the PRIME trial and we must await crime results to know to what extent they support CIRA's preterm test and treat strategy. In that regard, it's also important to recognize that many studies, and for a number of reasons, interim look analysis endpoints are rarely met, and studies usually proceed to their original, pre-specified final enrollment numbers, at which time the final analysis occurs. The interim look allows the external monitoring group overseeing the study to determine whether the study enrollment should continue, and then recommend either continuing enrollment of the trial, which happens in most cases, or ending enrollment early because interim results are good enough that continuing to enroll patients is inadvisable. We are encouraged by the data resulting from controlled prospective studies thus far and look forward to sharing the results of the prime study with you as soon as we can. Now a word on SIRS-BioWorker pipeline. Lastly, let me take a moment to update you on our biomarker pregnancy pipeline, specifically our preeclampsia prediction. About 5% to 8% of all pregnancies are impacted by preeclampsia, a sizable medical problem among expectant mothers. The most serious preeclampsia is preterm preeclampsia, occurring before the 37th week of pregnancy, and which is more severe for mothers and babies. Preterm preeclampsia poses a most challenging clinical decision for the physician as to the time of when to deliver the baby, in that there's a need to balance serious adverse outcomes for an incompletely developed newborn against the rapidly deteriorating health of the expectant mother, medical goals that can be at odds with one another. Identification of these cases well in advance before clinical preeclampsia occurs enables more informed and proactive decision-making and management. Late last year, we successfully clinically validated the prediction of preterm preeclampsia and made the validation data public to the scientific community. And now, the manuscript is being prepared to submit the data shortly for publication in a peer-reviewed scientific journal. As the only rigorously validated preeclampsia predictor when a patient is asymptomatic, we believe that our work on preterm preeclampsia is groundbreaking and valuable. We will determine how and when it gets commercially into CIRA's broader portfolio of pregnancy tests to provide valuable information to doctors and patients. In summary, we are continuing to build the solid foundation of data to enable us to carefully implement our commercial strategy as we also work to extend our runway. We are pleased to see the progress and expect it to continue strongly during this year. I'll now turn over the call to Jay for a review of our fourth quarter financial results.

Thanks, Greg, and good afternoon, everyone. Let me briefly review our financial results for the fourth quarter and then I'll provide some color on what our views are for 2023. Revenue for the fourth quarter of 2022 was $65,000 compared to $26,000 for the fourth quarter of 2021. As we noted in our last earnings call, we expect the testing adoption and commercial traction will be more impactful on our top line in 2023. Total operating expenses for the fourth quarter of $10.5 million were down from $12.6 million for the same period a year ago. Research and development expenses for the fourth quarter were $3.5 million compared to $3.1 million for the fourth quarter of 2021 as a result of increased headcount and research activities. Selling general and administrative expenses for the fourth quarter of 2022 were $6.9 million. This was down significantly from $9.5 million for the same period a year ago due primarily to the steps we outlined in our prior earnings call to streamline our sales force and focus our commercial strategy on early adopter systems. It is noteworthy that this significant decrease in SG&A did not negatively impact our revenue during the year. Net loss for the fourth quarter of 2022 was $9.7 million, down from $12.5 million for the fourth quarter of 2021. As of December 31, 2022, the company had cash, cash equivalents, and available for sale securities of approximately $104 million, which did not include a receivable of approximately $6 million collected in the first week of January. With the cost reduction actions we took in the third quarter of last year, coupled with our solid balance sheet and prudent management of our capital resources, we continue to expect this will give us operational room to execute our strategy into 2026, without having to raise additional capital. Given that we are still in the early stage of market development, the availability of new positive data, both the preterm trial and other readouts later this year, all of which are of keen interest to early adopter customers, and the growth we experienced last year on a small base, it is still difficult to predict precisely what the revenues will be for this year. However, we currently believe that 2023 revenues will be less than $1 million. I'll now turn the call back to Greg. Greg?

Thank you, Jay, and thanks to all of you for attending our call today. We are looking forward to an exciting 2023 and see a number of valuable achievements potentially taking place this year. This includes the anticipated positive impact of the AVERT study, additional study results being published, completion of the interim look analysis of PRIME, and announcements of additional commercial implementations. We are strongly positioned to address prematurity and other adverse conditions of pregnancy. This is what drives us, improving the health of both mothers and babies by providing valuable pregnancy information to the medical community and patients. The improvement of health can actually drive down healthcare costs. We believe that this provides a win for all parties, mothers, babies, families, as well as medical professionals and payers. And with that, We'll open up the line for questions. Operator?

Thank you, Greg. We will now begin the question and answer session. To ask a question, you may press star, then 1 on your telephone keypad. If you're using a speakerphone, please pick up your handset before pressing the keys. To withdraw from the question queue, please press star, then 2.

At this time, we will pause momentarily to assemble our roster. Today's first question comes from Patrick Donnelly with Citi.

Please go ahead.

Hey, guys. Thank you for taking the questions. You bet. Greg, maybe one of the overt interim readout there, obviously the data looked pretty good. Can you just talk about the potential for that to increase some payer conversations? Is that enough where folks, you can kind of bring that? A lot of the reimbursement kind of was thinking it'll come after the full trial readout. But does this start some of those conversations and maybe pull forward potential payer decisions? Maybe just help frame up how we should think about that.

Yeah, great question, Patrick. First of all, the overt readout was not an interim look, just to be clear. Those were top-line results from the final analysis. So I want to make sure that's clear to people. You're absolutely right. There's been keen interest in the announcement, but payers always want to see a peer-reviewed publication that more fully reports the results of the AVERT trial and others. Because that process can typically take months, the impact on 23 Revenues is not yet clear. However, I can tell you that following that announcement, there has been keen interest on the part of the payers with whom we are having conversations, and we anticipate that to accelerate as the results themselves become available.

Okay, that's helpful. And then maybe on the sales side, I think Jay touched on the expense side a little bit there at the end. Just how do you think about 23 on the expense side in terms of scaling up the sales force, maybe just in terms of headcount, whatever the best metrics are, just how you think about spend for this year, just as we kind of think about the model, and then also just the sales force side.

I'll make some general comments, and Jay, you can add anything to this. Our focus is really on early adopter systems, and we're configuring ourselves for us to make sure that we can go after them effectively. So that's one of the things that we're really looking at as we go into this year. And clearly, those discussions are beneficial because it's not like getting a single doctor office to order a test. You're getting a system to adopt doing the testing. And the potential is much, much larger, and we believe it's a more efficient way of addressing the market. So that's what we're doing. As we identify regions, and sometimes there are people that self-nominate because they have high interest in the test. They contact us, and it may be in an area where we don't yet have people. We evaluate those in real time, and we decide where it makes sense to deploy our people now. And, of course, if a customer is interested in doing something, we will always talk to them about ways that they could bring the testing on. So we react to the data, and that allows us to efficiently grow the market as demand itself grows. Okay, any comments?

Yeah, I think, Patrick, that there won't be an appreciable increase in 2023.

Okay, maybe just last one. Just on the revs, Jay, I think you said below a million for 23. We were a little bit above that. I think the street was a little bit above. Is that just payers coming on a little slower? Is it volumes? I'm just trying to figure out the delta here. We were thinking a little more back half ramp. Maybe it's some conservatism. Maybe just talk about the moving pieces and then also just The potential upside, if you get a couple payers on board, does that number move meaningfully? We'd just love some more color on that.

Yeah, I think we just have to understand that we're in the early days of commercialization. And we believe we're typical of companies in the diagnostic space. Beyond that, I don't have a whole heck of a lot to add, other than what we mentioned in the calls. So, you know, we, you know, look forward to, you know, more data coming out, and we believe that that will be helpful in growing our revenues.

Understood. Thanks, guys.

The next question comes from Andrew Brackman with William Blair. Please go ahead.

Hi, Andrew. Hey, guys. This is Dustin on brand here.

Okay.

Hey, Dustin. Hey, how are you doing? To maybe follow on Pat's question, I know there's a lot of uncertainty this year, and it's hard to predict revenues, but is that signaling maybe that prime comes in toward the end of the year, like maybe end of third quarter, fourth quarter, and that doesn't allow adopters to really pick up any utilization of the test there? Is that any signaling of a later than expected time frame? prime for this year?

That's a really good question. Let me give some clarity to the expectations. First of all, as we said earlier, payers want to see final publications ultimately as indicative of showing benefit. We will have this year, we have some anticipated events this year that we expect to see more publications this year and being able to show people more data as we move forward. So that will help. There are some early adopter payers that say there will be enough data with those kinds of things that they will be willing to move forward in advance of prime, while there are other payers that say they want to wait until the final results are available from prime. And remember, it's the interim look that we are going to have this year. With the 2,800 patients being enrolled, it takes time for those patients to deliver. It takes several months. It takes time to get the data after the last child or mother leaves the hospital. It takes time to clean it up. We do that in real time to try and speed it up, but there are some requirements there. Then the analysis is performed, and then the results occur. What we can commit to right now is that everything is in place for that trial to have its interim look by the end of the year. And what we will be doing for sure, we will be giving a statement of when we complete enrollment. It could happen this year or it may happen later. So we'll see where that goes. We think that we're fairly confident that the interim look will be able to take place during this year. And that's the first step. Then the final analysis, again, patients will be enrolled in that study during this year. The final analysis will be available once the last patient has been delivered, once the data are cleaned up for the final. Interim look is first, and the final analysis is second.

Does that help?

Yes, it does. So more on the early adopter systems. I was wondering if you could go into more detail on the willingness of each of those to interact with you. Have some been more promising than the others, such as like universities or self-insured employers? And then what is really required to drive the utilization once these networks are signed?

Yeah, a great question. What I would say is that the integrated delivery networks, the physician groups, physician hospital groups, and managed Medicare groups are very, very interesting. And the discussions are very positive about how we could move forward toward implementation. So those are key targets that we're really going after. And what does it take? It takes a commitment and a coordination. of all the activities so that the physicians that are parts of these systems and the operation parts of the system can be coordinated to actually perform the testing. And as I said before in my remarks, not only are we talking about the data and how important the data are, but we're actually exploring ways to help them to implement the testing within their systems.

Okay, great. Thank you.

As a reminder, to ask a question, you may press the star key followed by 1.

The next question comes from Tom Stevens with TD Cohen. Please go ahead.

Hi, Tom. Hey, everyone. Thanks for taking the question here. So this is going to be more focused on kind of prime and what your results kind of mean there. So if we assume you kind of hit statistical significance in that interim look, What's the material impact on kind of NICU mortality there? And how does the materiality of that impact your ultimate ASP you hope to get from Prime?

I'll let Jay talk about the ASP. What I'm going to do, I'll talk about the material impact. A positive interim means that one or the other or both of the primary endpoints have been met. In the case of the avert preterm trial, both of them were met. With that, it substantiates even more strongly the benefit of the test and treat strategy that we have for a preterm test. That allows discussions to take place with systems and for people to to be thinking about what this means in terms of their risk. And as with any new product, there are early adopters, mid-adopters, and late adopters. And we believe that it will be beneficial. More positive data is always beneficial. And our strategy is to ultimately get to a point where the data are overwhelmingly strong from multiple studies showing that there's a positive impact on the outcomes that matter most. And those are length of stay because that's what generates cost. And secondly, and most importantly for the individual, a benefit in neonatal health. So those are the primary outcomes in those studies.

Jay, do you want to say anything about cost?

Yeah, sure. I think that any time you get Stronger data, it's going to help improve our SPs as more payers adopt the strong reimbursement of the preterm test.

Got it. Thanks for that. And then just kind of looking long term, so it sounds like interim much later this year, full readout maybe mid-24, and then there's going to be a ramp alongside that to get reimbursement there. just a couple of details on the reimbursement angle and then just, you know, the question of kind of maturity of revenue when you kind of get there. So on the first one, just like, yeah, I mean, is that the right timeline to think about, you know, winding things up and then secondarily up, will they also reimburse all the kind of follow-up treatment required and treatment and interventions required to actually see those cost benefits and, How do those play into your health economic models?

I'll try and answer those and make sure I get it right, okay? Tom, just make sure. With regard to the readouts and the timeline, the guidance that we're giving to people on those events are this year we will complete the interim look of the prime study. Once the prime study is fully enrolled, And that could be at the time of the internal work, once it is fully enrolled. At that point, then, you still have to wait for the babysitter, most recently enrolled, to be born for the outcomes to be known and for the data cleanup and analysis activities to take place. So it's several months. We're not prepared for something precise at this point in time. But what we can tell you is we have the 2,800 patients needed for the interim look to take place this year, and it would be later that the final look would be available.

Does that make sense? That makes a lot of sense. And then just following up, you know, on the reimbursement side, if you get a positive client need out, Do you expect insurance to cover all the other interventions required to ensure that you get the impact on NICU mortality, that kind of test?

You actually answered the question somewhat, and I'll expand it. The health economics are really important. And what we've demonstrated in multiple health economic analyses is it is very cost effective, and the savings to payers are enormous. through the implementation of the test and treat strategy. By identifying the patients who have higher risk of preterm delivery, and as the clinical data are showing, by impacting them positively, they spend less time in the NICU, they have fewer complications, the babies are healthier, and that pays benefits to the child and mother first, to families, to the to the medical community, and to payers. So we believe that it's totally aligned with the idea of saving money. And that also gives you a sense of the amount of savings that is generated gives you some sense of where pricing makes good decisions about pricing. And we believe that that increases the value of the test. So we continued positive results. or what we're looking for, we will know when the studies have read out in their final forms. I have a good idea. Sorry. It's gone, Greg. Sorry. They're gone, Greg. I think we'll have a pretty good idea from the interim works where it should track.

Got it. Great. And then just last quick one. So you kind of assume a 250 ASP in 25 What kind of gross margin should we be expecting on that?

Oh, we've not really talked about a 250 ASP. We haven't put anything down like that. Jay, you?

No, we haven't put any guidance out on ASP or gross margins.

Yeah, that's right. I got it. Yeah, I'll get back to you.

We expect it to change. We believe that the ASP and gross margins will change as the volumes get larger, as we get more payers under contract. All those things, we believe, will cause changes in them. We can't quantify the magnitude of them yet, but it's certain that they will not stay identical forever. All right, great.

Thank you. Mm-hmm.

As a reminder, to ask a question, you may press star, then 1. The next question comes from Francois Brisebois from Oppenheimer.

Please go ahead.

Hi. Thanks for taking the question. I dropped off for a second. We came back on. So I apologize if you mentioned this. But can you just maybe talk about the importance of, after the top line data pervert, the importance of the publication Can you just maybe explain why, you know, the publication? Is there something specific in there that we should really pay attention to that people are going to want to see? And I guess the follow-up to that question is, when the interim prime top line comes out, which I assume will be similar, you know, readout in terms of format that you did for AVERT, is that enough? Or at that point, are people going to want to see that publication as well? And if so, I assume you would not have a publication on interim look. Thank you.

Yeah, I'll answer the first question. With regard to the AVERT study, we announced top line data. That's not an interim look. It's top line data. So with the top line data and with the publication coming, we believe it will be months before we see it in publication. But we are able to share data very, very carefully with certain individuals. And that's something that we take very seriously as a company to make sure that we do things in accordance with the desires of the authors of these things. They want a publication to come out. We're working as fast as we can with them to help them to be able to submit the paper for review and to get it published as soon as you can. The payers like to, especially the medical policy side of payers, they want to understand deeply what the source of the data is. They want to know what the differences are in the controls and the population that's intervened upon. They want to try and see what the benefits of the strategy actually end up being exhibited as. And to do that, they oftentimes would like to see the full the full publication. They'll talk about it ahead of time, and those kinds of conversations are taking place with people as we prepare clinical data that have an economic impact. Those kinds of discussions are happening in real-time with payers, with a number of them. Does that help?

No, that helps a lot. What I was also wondering there is, I understood that AVERT was full data, but in terms of prime, I assume you will not, unless the interim is so strong that they advise you to stop the study, and then I guess you can have a publication on it. I guess my question is, is it going to be as important for the parents to see the publication on prime or the top line might be more telling given it won't be historical data as a control here?

If one or more of the endpoints is that, the monetary the board could say, stop the trial now. But while that, up until the time that that happens, we are continuing to enroll patients. So the actual number of patients that will be finally enrolled is much larger than the 2,800 that are in place now for the interim work to take place. And it takes time, again, for those deliveries to be completed and for the data to be looked at. There are some payers and some systems that are early adopters that say, having a look at data thus far gives us a lot of information and we are comfortable moving forward earlier than the final readout of the prime study. There are others that will say, oh, we want to see that card slip before we decide to . So it's variable. It depends on what their interests are. For some systems, it depends on what they're experiencing with regard to prematurity. If they have extremely high complications, high rate of complications occurring in the population that they're insuring, and it's a pain point for them, they are oftentimes more apt to want to move forward sooner. It's really variable if you look across all sorts of payers.

Understood. That's very helpful. Thank you. You bet.

Again, if you have a question, please press star, then one. Seeing no further questions in the queue, I would like to turn the call back over to Mr. Peter DiNardo for any closing remarks.

Thank you, MJ. This concludes the call. We look forward to providing an update on our business when we report first quarter 2023 financial results. Thank you, and good afternoon, everyone.

The conference has now concluded. Thank you for attending today's presentation. You may now disconnect.