Good afternoon, and welcome to the Sera 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 towards 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 DeNardo of CapComm Partners for a few introductory comments..

Thank you, MJ. Good afternoon, everyone. Welcome to Sera Prognostics fourth quarter fiscal year 2022 earnings conference call. At the close of the market today, Sera Prognostics released its financial results for the quarter ended December 31, 2022.

Presenting from 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 have 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 via live webcast at seraprognostics.com, and a recording will be archived in the Investors 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, a webcast replay of this call will be available on the Investors section of our website.

I will now turn the call over to Greg, Sera Prognostics Chairman, President and CEO.

Greg?.

reduction in neonatal hospital length of stay and decreased neonatal morbidity and mortality. Second, both studies heavy a diverse demographic that is a 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 a low dose aspirin, the same form of progesterone and additional care management for mothers identified by the PreTRM 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 is 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 cell system, while PRIME involves 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. And in terms of the evidence generated is that of the historically controlled AVERT PRETERM TRIAL. Furthermore, though AVERT included approximately 10,000 historical controls, PRIME is a much better power study.

In that, it includes approximately twice as many subjects as in AVERT in its perspective arm at the interim look analysis and almost 4x as many at full enrollment. The larger size of the test and treatment arm of the PRIME study helps to provide higher statistical power.

Oftentimes, clinical studies are statistically powered at approximately 80% to see the effects 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 AVERT results are encouraging given these differences are clearly not completely predictive of the outcome of the PRIME trial, and we must wait -- that we must await PRIME's results to know to what extent they support Sera's PreTRM 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 look 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 Sera's biomarker 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 at 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 or 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 Sera’s broader portfolio of pregnancy tests that provide valuable information to the 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 of year ago.

Research and development expenses for the fourth quarter or $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 of year ago, due primarily to the steps we outlined in our prior earnings call to streamline our salesforce 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 AVERT 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. [Operator Instructions]. Today's first question comes from Patrick Donnelly with Citi. Please go ahead..

Hey, guys. Thank you for taking the questions. Greg, maybe one of the AVERT interim readout there. Obviously, the data looks 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 I know a lot of the reimbursement.

Kind of was thinking, 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?.

Yes. Great question, Patrick. First of all, the AVERT 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 are absolutely right.

There has 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 '22 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 salesforce? Maybe just in terms of headcount, whatever the best metrics are, just how you think about spend for this year and just as we kind of think about the model, and then also just the salesforce side?.

Yes. 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 our salesforce 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, both discussions are beneficial because you -- it is 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.

And of course, if a customer's 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.

Jay, any comments?.

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

Okay. And maybe just last one, just on the revs, Jay, I think, you said kind of below 1 million for '23, and we were a little bit above that. I think The Street was a little bit above. Is that just be payers coming on a little slower? Is it volumes? I'm just trying to, I guess, figure out the delta here.

We were thinking a little more kind of back half ramp, maybe it's some conservatism. Maybe just talk about, I guess the moving pieces, and then also just the potential upside. Is it -- if you get a couple payers on board, does that number move meaningfully? Would just love some more color on that. .

Yes. I think, we just have to understand that we're in the early days of commercialization, and where we believe we're typical of companies in diagnostic space. Beyond that, I don't have a whole heck of a lot to add, other than what we mentioned in the call.

So we look forward to more data coming out and we believe that that'll be helpful in growing our revenues. .

The next question comes from Andrew Brackmann with William Blair. .

This is Dustin on for Andrew. 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 towards 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 timeframe on 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, who say, there would 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 to the final after the last child or mother who leaves the hospital, it takes time to clean it up and 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. So 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 will see where that goes. But we think that we are 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 -- once the data points out 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 of them 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?.

Yes. A great question. What I would say is that the integrated delivery networks of the physician group -- physician hospital groups and managed Medicare groups are very, very interested. And the discussions are very positive about how we could move forward toward implementation. So those are key targets that we are really going after.

And what does it take? It takes a commitment and a co-ordination of all the activities, so that some of 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 are actually exploring ways to help them to implement the testing within their systems..

Okay, great. Thank you..

[Operator Instructions]. The next question comes from Tom Stevens with TD Cowen. Please go ahead..

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 ASP. What I'm going to do, I'll talk about the material impact. A positive interim look means that one or the other or both of the primary endpoints have been met. Okay? And that's -- in the case of the AVERT PRETERM TRIAL, both of them were met.

And with that, it substantiates even strong -- more strongly the benefit of the test-and-treat strategy that we have for PreTRM test. So that allows discussions to take place with systems and for people 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 costs; and secondly, and most importantly for the individual, a benefit in neonatal health. So that -- those are the primary outcomes in in those studies.

Jay, do you want to say anything about the cost?.

Yes, sure. I think that any time you get stronger data, it's going to help improve our ASPs as more payers adopt the strong reimbursement of the PreTRM test. .

Got it. Thanks for that. And then just kind of looking long term, so it sounds like interim much later this year, forward out maybe mid '24, and then there's going to be a ramp alongside, let's get reimbursement there.

Just a couple of details on the reimbursement angle, and then just the question on kind of the maturity of revenue when you kind of get there.

So on the first one, just like -- yes, I mean, is that the right timeline to think about ramping 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?.

Yes. Okay. I'll try and answer both, and make sure I get it right. Okay. Tom, just make sure. The -- with regard to the readouts and the timeline, what we're -- 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 the -- that could be at the time of the interim look. Once it is fully enrolled, at that point then, you still have to wait for the babies that are most recently enrolled to be born for the outcomes to be known and for the data clean up analysis activities take place. But it's several months.

We're not prepared to tell besides 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 on the reimbursement side, if you get a positive PRIME readout, do you expect insurance to cover all the other interventions required to ensure that you get the impact on NICU mortality that you’re going to test?.

You actually answered the question somewhat and I'll expand on it. The health economics are really important. And what we have demonstrated in multiple health economic analyses is, it is very cost effective and the savings to payers are enormous but -- through the implementation of the test-and-treat strategy.

By identifying the patients who have higher risk of preterm delivery and then 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 pay benefits to the child and mother first, to families, 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 -- you make good decisions about pricing. And we believe that, that increases the value of the test.

So continued positive results are what we are looking for, and we will know when the studies have read out with their final plans. I think we will have a pretty good idea from the interim looks where it should track..

Got it. And then just last quick one.

So you kind of assume at 250 ASP in '25, what kind of gross margin should we be expecting on that?.

We have not really talked about 250 ASP. For any -- we haven't put anything down like that.

Jay?.

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

Yes. That's right..

Got it. Yes, I'll get back to the queue..

Just one of the -- we expect it to change. We believe that the ASP gross margins will change, as the volumes get larger, as we get more payers under contract. On 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….

[Operator Instructions]. The next question comes from Francois Brisebois from Oppenheimer. Please go ahead..

Hi. Thanks for taking the question. I dropped off for a second and came back on. So apologize if you mentioned this. But can you just maybe -- you talked about the importance of -- after the top-line data for AVERT, the importance of the publication.

Can you just maybe explain why 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 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. .

Yes. 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 a 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 get -- that's something that we are -- 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 a 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 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 has an economic impact. Those kinds of discussions are happening in real time with payers. It’s an ongoing.

Does that help?.

No, that helps a lot. And then, but I -- what I was also wondering there is -- understood that AVERT was full data, but in terms of PRIME, you -- 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.

But is it -- I guess my question is, is it going to be as important to the payers 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?.

Well, the -- if one or more of the influences that, the modest board could say stop the trial now. But while that -- 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 there in place now for the interim look to take place.

And it takes time, again, for those deliveries to be completed until 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're comfortable moving forward earlier than the final readout of the PRIME study.

There are others that will say, we want to see that card slip before we decide to cover. So, it's variable. It depends on what their interests are. It depends -- 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..

[Operator Instructions]. Seeing no further questions in the queue, I would like to turn the call back over to Mr. Peter DeNardo 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..