Good afternoon and welcome to the Sera Prognostics' Conference Call to Review the Fourth Quarter and Fiscal Year of 2021 Results. At this time, all participants are in a listen-only mode. We will be facilitating a question-and-answer session towards the end of the -- 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. Please go ahead sir.

Thank you, Chuck. Good afternoon everyone. Welcome to Sera Prognostics' fourth quarter and full year 2021 earnings conference call. At the close of the market today, Sera Prognostics released its financial results for the quarter ended December 31, 2021. 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 not had a chance to review our quarterly earnings release, it could be found at our website at seraprognostics.com. This call can be heard live via 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 or 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 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 or forward-looking statements. I will now turn the call over to Greg, Sera Prognostics' chairman, president, and CEO. Greg?

Thank you, Peter. Good afternoon, everyone. Today I will provide an overview of key business highlights during the quarter and our expected developments over the near-term. We are pleased that Sera completed 2021 with a number of significant accomplishments that we believe will help pave the way for substantial success in the future. These include continuing to build our commercial infrastructure, signing important third-party agreements, payer agreements, and publishing key studies that strongly support Sera's tests and treat PreTRM strategy. We believe that all these activities will help us to improve the health outcomes for moms and babies and thereby achieve significant health care cost savings for society. Commercially, at this point in time, we are in very early market development. As a market builder, we are doing something no one else has done before, bringing the first commercially available blood test to market to determine an expectant mother's individual risk of spontaneous PreTRM birth. Taking a broadly and rigorously validated test to market that has the potential to enhance the paradigm of pregnancy treatment is not a simple endeavor. It involves creating awareness through education of doctors, patients, and payers of the significant health and cost saving benefits of using our test. This process takes time and requires the careful coordination of each element of the strategy that must be put in place to build effectively build the market. COVID-19 complicated this process during the first seven months of our launch, with unforeseen pandemic spikes having a profound and continued negative impact on normal healthcare delivery, physician engagement, and enrollment in clinical studies. Thankfully, we appear now to be emerging from that situation. Today, I'll focus my commentary by providing you insights with insights into major areas we are addressing in the execution of our plans. Our strategy and…

Thanks Greg and good afternoon, everyone. Today I'll briefly review our financial results for the fourth quarter and then provide commentary on our outlook for the near and mid-term. For the fourth quarter of 2021, we reported revenue of $26,000 compared to $6,000 for the same period of 2020. Total operating expenses of $12.6 million were up significantly from $4.8 million for the fourth quarter of 2020. The increase was primarily due to the scale up of operations to market and commercialize our PreTRM test. Research and development expenses for the fourth quarter of 2021 were $3.1 million compared to $2.1 million for the prior period, primarily due to increase laboratory operations and clinical study costs. Selling, general, and administrative expenses for the fourth quarter of 2021 were $9.5 million, up from $2.7 million, due primarily to increase headcount and the company's scale commercial operations and general corporate infrastructure, as well as increased costs related to operating as a public company following our IPO in July 2021. Net loss for the fourth quarter of 2021 was $12.5 million compared to $5.4 million for the same quarter a year ago. As of December 31, 2021, the company had cash, cash equivalents, and available for sale securities of approximately $140 million. I would like to stress that in the current difficult environment for corporate financing, we are comfortable that we have sufficient capital resources to implement our strategy into 2025 without the need to raise additional capital. Turning now to our expectations. Although we have not previously given guidance and don't intend to do so for the time being, given that we're in the early phases of commercialization, we do want to keep you informed as to the commercial ramp and the timing we see going forward. The macro challenges we face, including wave after wave of pandemic causing patients to defer doctor appointments, have impacted the revenue trajectory in the short-term. Our belief is that revenues in 2022 will be less than $500,000. We do not plan on giving additional guidance beyond that for the foreseeable future, but as Greg mentioned, all the revenue growth has been slow, progress on a number of key fronts has been strong, and we believe we have the capital resources to execute on our strategy. I'll now turn the call back to Greg. Greg?

Thanks Jay. We'd like to thank everyone for attending our call today. We expressed on our last call that these are early days for Sera in commercializing the PreTRM test. Though early commercialization always presents challenges, we are pleased to see increased trends of adoption as we execute our strategy. Our strength lies in our first-mover advantage in a market with no significant discernible competition. Ample cash on the balance sheet, a deep roster of experienced professionals, and a compelling health economic story underpinned by rigorous data. In a very difficult market landscape, we believe we are uniquely positioned to achieve our mission to better human life as the pregnancy companies. And with that, we'll open the line for questions. I'll turn it back over to the operator.

Thank you. We will now begin the question-and-answer session. [Operator Instructions] And the first question will come from Patrick Donnelly with Citi. Please go ahead.

Hey, guys, thanks for taking the questions. Maybe one on PRIME, just trying to figure out can you talk about how much you view this as a catalyst for payers coming on Board? You're obviously having ongoing conversation with payers today, what's the willingness to reimburse before seeing this data versus kind of waiting? Just wondering what those recent conversations suggested in terms of needing to see the economic sensitivity data for PRIME before coming online versus the willingness to step in front of it and start paying for this?

Yes, thank you, Patrick. We view PRIME as being additive to the large body of evidence, health, economic and clinical evidence that have already been reported out. Again, the purpose is to optimize -- give people the ways of optimizing the rollout of PreTRM testing. There's no question. There are a number of payers that have already decided there is value. They've signed contracts with us. And we are we are in active discussions to do so with a large number of them. So, we see we see PRIME is being additive to that body of evidence.

Okay, that's helpful. And then maybe one just on the on the guide Jay gave there on be under $500,000, I mean [technical difficulty] can you guys give us a little more color on I guess what you're seeing -- what has changed since maybe some of the conversations we had a couple quarters ago in terms of the expectations for 2022 COVID pressuring the volumes, reimbursement, maybe just help us figure out what's kind of the delta there?

Yes, as I mentioned in my remarks, there were two very serious waves of COVID that occurred that were entirely unanticipated in the early part of 2021. That was one factor that limited access to physician offices, it changed the way that obstetrics was practice, there were a lot of things that happened as a result of the pandemic. At the same time, the other thing that we've seen is now a keen focus on the part of payers to be in a position to address health care disparities. We saw some personal personnel changes that occurred among certain insurers, we saw people adapt their strategies to decide where the technologies would be best deployed. And we're very excited about the opportunities that exist to actually better address the disparities that we see among underserved populations. So, those are some of the things that have happened. Additionally, I'll remind everyone that our sales team was largely -- our sales team was virtually entirely hired during the second half of 2021. Many of them were hired in the last quarter, it does take time for sales reps to come up to speed and to become productive and because of our monitoring of data, we're in a good position and are seeing the results of making adjustments as we more effectively addressed the market on a go-forward basis.

Okay. And Greg, maybe picking up on your last point there, I mean, on the salesforce has the trajectory of the revenue shift changed your plans in terms of salesforce hiring? How you're thinking about 2022 in terms of hiring, even 2023? Given again, the revenue being a bit lower? How are you thinking about kind of building out the salesforce the infrastructure there?

The way we think about it is at the end of 2021, our sales headcount was approximately 30. What we're going to do as a company is monitor the adoption, monitor payment by insurance companies, and we will judiciously adjust our salesforce, depending on market conditions. That's what we plan on doing. By the way this model works. We did the same thing in the early days at Myriad, but that's what led to the tremendous success that we have there. It is possible to roll out of salesforce in a in an effective manner by paying attention and developing best practices and replicating them across the body of sales representatives. That's clearly the strategy as we move forward.

Understood, thanks. I'll leave it there. Appreciate it, guys.

The next question will come from Brian Weinstein with Blair. Please go ahead.

Hi, this is Dustin on for Brian. First question, we're wondering about the contract minimums. I know you just mentioned that you got your first minimums recently, but we're wondering just how those should roll throughout 2022? And maybe the scale those in addition to how they compared to original expectations at the time of the IPO?

Jay, you want to answer that one?

Yes, sure. We haven't really spoken in detail about the contract minimum. And we really don't intend to do so. But we have received the minimums that we are entitled to and expect to receive the minimums going forward. So, I think the -- everything in accordance with the contracts are moving as expected.

Got it. And I know you get some color on the recent trends you're seeing with the test, but we're wondering what you're hearing from your salesforce? What are clinicians saying about the tests? Are they positive on it? And are there any reservations that they have better, maybe slowing down the pace of adoption right now?

Yes, what the Salesforce is hearing from physicians include the following. Certainly, doctors are confirming that there's an unmet need. They're reaffirming, there's a significant clinical gap in how to manage the challenge of PreTRM birth. They acknowledge that a solution like PreTRM is actually something that's really needed. The questions that we get from them are, what percentage of patients come back at increased risk? What do I do when a patient comes back with an elevated risk? What is the clinical protocol used? What does the maternal fetal medicine experts think about it about the test? And are the professional societies aware of serious technology? There are there are excellent answers for all those things, I can tick them off. I won't do so now. But those are the kinds of things that that we enter into discussions. Clearly, there's an interest among OBGYN as we were able to sit down and explain things to them. They're very interested. They want to know how would I actually use this in my practice.

Yes, and Greg, I might add that we do carefully monitor productivity and put key initiatives in place to address what could potentially be roadblocks. We manage productivity through coaching, education, accountability, simplification and messaging, streamlining, the time of contact with the patient near to the time the blood is drawn. And simplifying the process to bring practices on board are all improvements from which we're seeing higher productivity. So I just wanted to add that.

Okay, thank you. And then one more for us. recently showed data on the first pipeline product for preeclampsia. Just wondering how this data came in relative to expectations? What this means for clinical adoption? And can you give us an update on the other pipeline products that are in development? Thank you.

Sure. Yes. We're very excited about the preeclampsia data that were presented at the Society for Reproductive Investigation. We are in the process of that of conducting a complete validation of the preeclampsia prediction. And with that, we see a complement to the kind of information we're adding. It goes back to what our strategy is, develop clinically meaningful and economically impactful predictions that can make a difference -- positive difference in the lives of mothers and babies. Clearly, our preeclampsia work as part of that PreTRM is clearly that there are additional products that will come later. We were in various stages of development. But we were very excited to validate the preeclampsia product and ultimately make it available to the market after it's validated sometime after 2023 is when one would expect to see something there.

The next question will come from Kevin DeGeeter with Oppenheimer. Please go ahead.

Hey, thanks for taking our questions. Greg, you mentioned you've made some adjustments to sales messaging and also that -- one of your goals for early commercialization are kind of settling on best practices that then can be rolled out across the larger salesforce. What are some of those changes of messaging that you picked up? And if you're looking to implement and how should we think about some of the incremental learning and impact on best practices?

Yes, what we've done is, is we, as you look at the time period between when a patient first hears about the test of time that the blood is drawn, we've shortened that period, it makes it simpler for the patient to get in and see the doctor and actually have it top of mind when she visits the doctor. So, that's been one of the things that we've been doing. We've worked on, on simplifying the message who is this test for? It's very easy to blame the physicians. Why the -- what the test is used for Who the candidate patients are? And as it turns out, it's the great majority of singleton pregnancies that are, in fact, candid for the test. We also -- when people ask the question, what do we do clinically with the patients? We, the simple retort is, what are you doing currently, when you have a patient who is in fact, at high risk, there are known protocols that are practiced every day, we emphasize that to the doctors that you can use protocols that you're familiar with, and that those are ways of addressing the risk in your patients. All those simplifications in terms of materials, in terms of presentation, in terms of sales approach, decreasing the amount of time required to explain the message, all those things are elements of best practices and we believe they are the reasons that we're seeing the increase uptake we're witnessing as we entered into 2022.

Great and as a follow-up, I think he highlighted driving patient interest or patient awareness in PreTRM is kind of one component of the strategy, how should we think about, relatively capital efficient ways to just sort of, you know, generally, you know, motivate the pregnant mother who's coming in to engage the clinician and a potential conversation.

There are a number of tools that can be used. We are ramping up our voice in social media networks, making this information available to more women. We have planned campaigns, both on the physician side and the patient side, to go out and raise awareness. There are ways to do that very effectively. The -- we will have more to say, as we enter into enter broader coverage. We also look geographically at where the physicians and patients are likely to be most receptive. We have a good deal of experience doing this is in the Myriad days, where we started out in selected geographies, made sure that it worked before we move to others, that that's the kind of strategy that we use as we roll out our digital campaigns to raise awareness. Clearly, there are really three major customers that we have to hit there. First of all, we have to make sure that the payers are aware and can pay for the testing. The physicians need to be made aware in order to order the test and the patients are the ones that are going to benefit the most. Having all three of them requires coordination and our activities are coordinated to make sure that we can address all three of those key customers that are involved in our testing.

Great. Thanks for taking our questions.

[Operator Instructions] Our next question will come from Dan Brennan with Cowen and Company. Please go ahead.

Hi, this is [indiscernible] on for Dan here. Just a question on the kind of readout for PRIME. So, I mean, do you have any kind of clear metrics in mind within your co-primary milestones? And kind of what they look like?

Yes, the PRIME study, the primary outcomes of the PRIME study are decrease in the length of stay in the hospital and improvement in neonatal health as measured by standard indices of how healthy the babies are when they're born. As was demonstrated in the Prevent PTB study, we showed more than a 70% reduction in PreTRM -- in the time that PreTRM babies spent in the NICU or the NICU -- or the hospital. So, hospital length of stay is a critical variable that we look at. For every day the baby is in the hospitals generating expense. This is what costs the health system a lot of money and the babies that are most poorly developed spend the longest time there. Measuring neonatal health directly tell us that if we're able to successfully decrease the time in the NICU in hospital, if the babies are discharged and are healthier, that is the kind of outcomes that we seek to achieve and we are measuring it directly. These are the outcomes that matter the most to payers. And the PRIME study, we design that study with payers in mind, we collaborated with our colleagues at Anthem, as we built the metrics for that trial. We're very excited to continue to add to the data that exists, show identifying early intervening early and proactively in pregnancy can affect make it make a difference in health outcomes and in the economics.

Got it. Great. And then just to kind of follow-up on the strategy from here for PreTRM. So, you had mentioned a bit of a pivot towards looking at underserved populations, I was wanting to give some more color on what that looks like and how you've kind of divvying up your salesforce along those lines? Thanks.

Yes. It's a well-known fact that that African-American women have PreTRM birth rates that are anywhere from 50% to as much as almost double the PreTRM birth rates that seen in non-African-American populations. Clearly, there areas in the US, where their underserved populations are burdened disproportionately by PreTRM delivery. We -- what we've done as a company is actively gone after those areas. We have recruited -- we have trial sites that are recruited for the PRIME study that cover some of the most highly effective geographies for prematurity in the U.S. We are in discussion with people at the federal level, state level, and with payers, to put programs together, where we can actually affect the benefit by giving the PreTRM test as part of a package to these patients. Those discussions are underway. There's a lot of activity, a lot of interest and clearly, politically, if there's a lot of attention to it, as I said before, from a healthcare perspective and disparities, we need to do a better job. And we are finding very receptive conversations that we believe are going to result ultimately, in substantial collaboration that will actually generate revenue as we provide value from our PreTRM tests to society.

Thanks. And then just one quick follow-up if I could. So, I think you previously mentioned that could potentially be interim PRIME data by Q4 this year, is that still a potential possibility? And if not, kind of, where about in 2023 [indiscernible]? Thanks.

Unfortunately, the COVID pandemic slowed down the development of getting the readout completed this year. We believe we will have the requisite number of enrolled patients in the PRIME study, 2,800. So, that the readout can occur in 2023. And we're looking at having the readout of the PRIME study taking place in 2023. As I said before, we're at nearly 1,000 patients enrolled already and we're on track to complete enrollment to get to get to the point where we can perform the interim look, and ultimately the final look.

Great. Thanks. I'll hop back in the queue.

[Operator Instructions] This concludes our question-and-answer session. I would like to turn the conference back over to Mr. Peter DeNardo for any closing remarks. Please go ahead, sir. End of Q&A

Thank you, Chuck. This concludes the call. We look forward to providing update on our business when we report first quarter 2022 financial results. Thank you and good afternoon everyone.

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