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spk07: Good day, and thank you for standing by. Welcome to the Semaphore Third Quarter 2021 Earnings Conference Call. At this time, all participants are now listening on remote. After the speaker presentation, there will be a question and answer session. To ask a question during the session, you need to press star one on your telephone. If you require any further assistance, please press star zero. I want to ask to have the conference over to speaker today, Joel Hoffman. Please go ahead.
spk00: Good afternoon, everyone. Thank you all for participating in today's conference call. Participating for the company today will be Eric Schott, founder and chief executive officer, and Isaac Rowe, chief financial officer. Earlier today, Semaphore released financial results for the third quarter ending September 30th, 2021. A copy of the press release is available on the company's website. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of federal securities law which are made pursuant to the safe harbor provisions of the Private Security Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. Actual results may differ materially from those expressed or implied in the forward-looking statements due to a variety of factors. Additionally, these forward-looking statements particularly our 2021 financial guidance, involve a number of risks, uncertainties, and assumptions. For a list and description of risks and uncertainties associated with Semaphore's business, please refer to the risk factor section of our S-1 filed with the Securities and Exchange Commission on August 4th, 2021. We urge you to consider these factors, and you should be aware that these statements should be considered estimates only and are not a guarantee of future performance. During the call, we may discuss certain non-GAAP financial measures. For reconciliations of non-GAAP measures to GAAP financial measures, as well as other information regarding these measures, please refer to our earnings release and other materials in the investor relations section of our website. This conference call contains time-sensitive information and is accurate only as the live broadcast today, November 15, 2021. Semaphore disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements whether because of new information, future events, or otherwise. And with that, I will turn the call over to Eric.
spk06: Great. Thanks, Joel. And thanks, everyone, for joining us this afternoon. We are pleased to be here with you today to discuss our third quarter results and progress against our long-term strategic goals. I will start today's call with an overview of our operating results, including our growth, our growing health intelligence information platform, health system partnerships, and new product offerings before I pass the call over to Isaac for a financial update. We will then open the call for questions. Overall, I'm very excited by our organizational progress in the third quarter, which was largely a quarter of investment in our operational foundation for growth across all facets of our organization. As you can see from slide eight of our earnings presentation, exiting the quarter, we have started to see these investments translate to a notable acceleration in volumes and patient and provider engagement with our platform, accelerating our momentum as we progress into 2022. We are building a unique company focused on delivering clinically actionable insights based on individual longitudinal data analyses that will help inform clinical decision-making across a broad spectrum of diseases and health conditions. Since we became a public company in July, we have ramped up our investment in technology, infrastructure, and people. The strategic roadmap for Semaphore is anchored in high-dimensional, large-scale patient data, active clinical engagement with patients and their physicians, and collaboration with our clinical and research partners and patients. We fundamentally believe that genomic data, combined with clinical patient records and other multiomic and lifestyle data, can deliver differentiated insights that drive clinical decisions to help ensure the best outcomes for patients. Our success is underpinned by our access to expansive data and by Temafor's proprietary health intelligence platform, Centralis, among the largest, most comprehensive, and fastest growing integrated health information platforms in existence. At the end of the third quarter, our platform was managing 39 petabytes of data, that's 39 million gigabytes, gathered from approximately 20 million patients. Of these patients, roughly 12 million give us access to high-quality, high-dimensional longitudinal electronic medical record information. Meanwhile, our testing capacity continues to ramp to support our data platform and our health system partners. Our current capacity for next-gen sequencing can now support more than 50% growth of our genomic data set in the coming year. In addition, we continue to invest in the infrastructure required to derive clinically relevant insights from the data. We continue to believe that our strategy to build a platform of algorithms is resonating in the marketplace. As an example, patient consent remains very high, with greater than 80% of patients that engage with our Semaphore portal consenting to allow us to help acquire and manage their personal health information and to leverage those data to improve health outcomes for all. In the majority of cases, this partnership with patients provides us access to any and all medical record information ever generated for that patient. This includes advanced genomic testing results, longitudinal patient electronic medical records, physician notes, hospital records, population health data, and many other large-scale sets of data. The unrivaled level of access to information in partnership with patients and health systems allows Semaphore to develop deep, and information-based relationships that continuously drive improved knowledge and understanding within the Semaphore platform. It is this patient-informed knowledge that we believe is a competitive differentiator for Semaphore. It will drive our business and long-term value proposition to patients, providers, and pharmaceutical partners. Most importantly, we continue to engage with all of the health system partners, and the feedback is very encouraging. As the breadth and scale of our data advances, our value proposition to health systems also becomes increasingly attractive. During the third quarter, we added a fourth health system partnership, Avera Health. As an example of the traction we are getting with our health system partners, let me provide an overview of our North Shore partnership. North Shore is a large health system in the greater Chicagoland area where we have had tremendous success to date. Earlier this year, we launched a system-wide data-driven precision medicine program to help North Shore's clinicians and patients prevent, detect, and treat diseases at earlier stages. In just six months, North Shore has increasingly leveraged our platform and their patients, many in underserved, culturally diverse communities, to deliver an improved genomic medicine standard of care. As summarized in slide seven of our earnings presentation, More than 90% of primary care physicians at North Shore have had patients complete testing through the genetic wellness and assessment process, which starts with a questionnaire covering a personal and family history of select medical conditions. Roughly 42,000 North Shore patients have completed this guideline-based questionnaire and have been advised whether to take a general genomic health screening test or a more comprehensive hereditary cancer genomic test. From this 42,000 patient group, over 6,400 have had the genomic health screen test ordered. And through the first six months after launch, nearly 1,000 patients were identified as meeting NCCN guidelines for being at high risk of heritable cancer and successfully tested. This represents a 54% increase from the prior six-month period before our launch and an 88% increase versus the same six-month period in 2020. a remarkable increase in improvement in the standard of care in the North Shore system. In summary, we believe our early success with North Shore is evidence that our platform and go-to-market strategy can quickly and significantly improve the standard of care. Our deep partnership with North Shore has also enabled us to take a nontraditional and innovative approach to providing an evidence-based program expanding the heritable cancer screening program beyond primary care. This concept is exemplified by the introduction of a heritable cancer screening pilot program and a sample of North Shore's mammography clinics. The program targeted females scheduled for their annual mammography screening starting with an August pilot performed at North Shore's innovative mammography facility located at the clothing retailer Nordstrom in Skokie, Illinois. The pilot was quickly extended to three additional mammography screening facilities in the North Shore network. The results thus far are very encouraging, with more than 90% of women having genetic screening orders placed in these facilities, then following through with returning their saliva samples for testing. We are greatly encouraged by the differential success we have seen in this setting. The heritable cancer testing increase Semaphore has achieved in partnership with North Shore is substantial when compared to other heritable cancer testing partners. Both the affected patients and their families are receiving levels of medical support and counseling that generally exceed all guidelines. Earlier assessment of cancer risk of detection and care all have a significant positive impact on treatment and survival. Thus, in the process of growing the Centralis engine, Semaphore can help provide an enhanced standard of care to patients in their communities. Lastly, as part of a separate research project called the Genomic Health Initiative, Semaphore has already sequenced more than 9,000 samples in a six-month span of time. And we are now embarking on the process of data structuring and curation to pair these genomic profiles with deep longitudinal electronic medical record data at North Shore. All in all, we are pleased with the growing adoption at North Shore, as well as with the rest of our partnerships. which include launching several somatic tumor profiling protocols with Avera Health to ultimately profile all cancer patients in the Avera system as the standard of care, integrating the expansive molecular profiling data with longitudinal electronic medical record data collected on patients through the Avera system to provide more personalized, actionable clinical guidance. We believe these many types of engagements will be mutually beneficial for our health system partners and for Semaphore. It is the combined level of dedication from both organizations that is leading to improved access and treatment in the geography spanned by our partners. As we continue to gain traction with existing partners, we look to establish a limited number of new learning-based health system partnerships to expand our patient and clinician engagement strategy. Then, longer term, new health system partnerships will focus on scaling the types of solutions developed with the first learning-based partnerships. Although it takes time to develop these relationships, we believe that our distinguishing feature of integrating ourselves within health systems to provide state-of-the-art care as a collaborative partner will ultimately position us as the preferred partner of choice to an increasing number of systems who are driving precision medicine as a standard of care. In addition to the health systems, Our sophisticated platform draws upon information from many sources that provide unique advantages to pharmaceutical companies looking to leverage big data insights to support more progressive research from drug development to clinical trials and real-world evidence studies. We have a growing level of engagement with pharmaceutical companies that span the spectrum of drug discovery to post-marketing surveillance. We expect pharma contributions to grow significantly in 2022. Similar to our health system partners, We look to partner with pharmaceutical innovators as they seek to improve the efficiency and accuracy of drug development and the delivery of the right therapeutics to the right patient at the right time. Our goal is to understand what a biopharma partner needs in order to provide the insights from data to help them make better informed decisions. The connectivity of Semaphore to the hospital systems and patients is what we believe can bring highly accurate and clinically actionable data to pharmaceutical partners. On the new product front, we are working diligently to broaden our offering. In September, we launched Semaphore Elements. This is our portfolio of data science-driven products and services to support reproductive and generational health. These genomic solutions, digital tools for patients and providers and services, enable providers to treat patients holistically during their reproductive, cancer, and generational health journey. The portfolio encompasses solutions for the diagnosis, prevention, treatment, and management of reproductive and heritable disease conditions for more holistic family care, to include a newly enhanced version of Semaphore's expanded carrier screening for pregnancy planning, which includes a molecular ancestry component to more accurately assess high-risk haplotypes derived from specific population groups, even at the locus-specific level, to provide superior risk prediction. Alongside our non-invasive prenatal testing, Natalis newborn screening, and heritable cancer testing. For those of you who don't know the IVF market, it is a highly concentrated market comprised of sophisticated and science-driven prescribing physicians. We are proud that the upgraded version of our ECS product is resonating well and has allowed us to take market share in key national IVF accounts. While the volumes associated with these account wins are not part of our third quarter results due to timing, we are encouraged by the ordering trends we are seeing out of these accounts in the fourth quarter thus far, as highlighted in our earnings call deck. Shifting back to our longer-term mission and vision of developing and monetizing a platform of health insights and algorithms, I'd like to highlight a pair of published studies conducted in collaboration with our founding health system partner, the Mount Sinai Health System, demonstrating the utility of our health intelligence platform to predict more accurately clinically meaningful outcomes. In this case, we're improving the prediction of risk of postpartum hemorrhage over current standard care assessments. The studies were featured in a special Informatics for Sex and Gender-Related Health issue of the Journal of the American Medical Informatics Society. Postpartum hemorrhage is the leading cause of maternal mortality globally, accounting for roughly 35% of maternal death, and often occurs in patients with no known risk factors for hemorrhage. U.S. health systems are not immune to this high mortality rate, especially in underserved communities. These two new papers are among the first to use large-scale, comprehensive, real-world data to both accurately digitally phenotype patients and then predict clinically meaningful outcomes in pregnant women. By implementing our predictive model into the clinical standard of care, healthcare providers may be able to improve postpartum hemorrhage risk assessment and medical management for their pregnant patients, resulting in better health outcomes. To support our partnerships and increase adoption of our growing database, we have expanded our Semaphore team to 1,150 employees as of the end of the third quarter. This includes commercial headcount growth of 32% during the third quarter, and 47% since the beginning of the second quarter. We believe we are adequately staffed for our growth objectives, and as we marched through the third quarter, we began to see improvements in sales cycle and Salesforce productivity as our new reps were ramping toward full productivity. Turning to the lab, we have made a number of key hires and are working toward improving operating efficiency and our overall margin profile. We have outlined a number of initiatives, including portfolio optimization, a new LIMS implementation, and automation initiatives. These internal initiatives, combined with an improving reimbursement dynamic in oncology, our fastest-growing segment, will help us pace toward more normalized margins as we pace through 2022. Additionally, in September, we hired a world-renowned expert in computational biology, Dr. Gustavo Stolovitsky, as chief scientific officer. His expertise is key to accelerating the development of our platform of algorithms to help researchers, health systems, providers, and patients translate the information contained in health data into actionable knowledge. We also lead the translation of our top-notch research into future semaphore products and further solidify our collaborative partnerships with health systems and the biopharmaceutical industry. In summary, we have made substantial progress on core business objectives as we grow our proprietary health intelligence platforms. Coupled with our software, machine learning, and other advanced artificial intelligence learning capabilities, our team is building one of the most sophisticated platforms in the world and setting the bar for high-value patient engagement. We continue to be incredibly confident in our ability to drive differentiated insights in real time that can dramatically improve the standard of care for all. As we scale up our commercial activities, invest in strategic collaborations, and actively explore opportunities for inorganic growth, The future of Semaphore remains very bright. And now I'll turn it over to Isaac for the financials and guidance. Thanks, Eric.
spk01: Turning to our third quarter 2021 financial results. Total revenue for the third quarter of 2021 was $43.2 million, representing growth of 12% compared to $38.6 million in the third quarter of 2020. Diagnostic test revenue was $41.4 million in the third quarter of 2021, up 9% as compared to $37.9 million in the same period prior year. COVID testing revenue in Q3 was $4.2 million, down 21% year-over-year and down 8% sequentially from the second quarter of 2021. Excluding COVID-19, total revenue for the third quarter was up 17% year-on-year. Turning to volumes. We resulted approximately 70,000 diagnostic tests during the third quarter of 2021, excluding COVID-19. That was up 36% compared to the same period in 2020. We recorded 166% volume growth in oncology, and this category now accounts for 6% of our total volume, excluding COVID-19. Women's health volumes grew 33% compared to the same period in 2020. Other revenue totaled $1.8 million in the third quarter of 2021 compared to $0.7 million in the third quarter of 2020. The increase was mainly attributable to growth in collaboration service activities related to new partnerships with pharma. Cost of services was $58.8 million in the third quarter of 2021, an increase of 61% when compared to $36.5 million in the same period 2020. Adjusted cost of service, which excludes stock-based compensation expense, was $55.1 million in the third quarter of 2021 compared to $33 million in the same period of 2020. Cost of services were impacted by the rapid scale-up of lab infrastructure to support continued growth in our testing volumes and the launch of our latest expanded carrier screening products. We are excited about the growth prospects of the business and believe these upfront investments are critical to realizing that opportunity. Operating expenses for the third quarter of 2021 were $74 million, up 27 percent from $58.1 million in the same period prior year. Adjusted operating expenses, which exclude stock-based compensation and non-recurring transaction costs associated with our GoPublic process for the third quarter of 2021, were $59.3 million compared to $32.1 million in the same period of 2020. Overall, the increase in total operating expenses for the quarter were mainly attributable to higher personnel-related costs coupled with professional services related to the merger transaction. The components of GAAP operating expenses are as follows. Research and development expenses for the quarter were $17.8 million, down 7% when compared to $19.1 million for the third quarter of 2020, driven by an overall increase in depreciation costs of $1.8 million for lab-fixed assets purchased, offset by a $3.4 million decrease in stock-based compensation costs. Sales and marketing expense were $22.1 million up 74% from $12.7 million from the same period in 2020, due primarily to a $5.7 million increase in personnel-related expenses from increased headcount. Since the start of Q3, we have increased our sales force and field organization by 32%, and we began to see a notable uptick in volume as a result of our year-to-date investments here at the end of the third quarter. General and administrative expenses were $32.8 million, an increase of 35% as compared to $24.3 million in the third quarter of 2020, driven by a $5.6 million related to increased headcount and $8.7 million for expenses related to the GoPublic transition. Moving down the P&L, we reported Q3 2021 net income of $31.4 million compared to a net loss of $56.6 million in Q3 2020. Net income was aided by $122.2 million of other income attributable to the change in fair market value of warrant and earn-out contingent liabilities. Turning to the balance sheet, total cash and cash equivalents was $461.3 million as of September 30, 2021. In addition, we secured a $125 million revolver earlier in the fourth quarter that is currently undrawn and now available to help support our growth strategies. Now let me spend a few minutes providing some context on the business environment we observed during the third quarter. First, the IVF market continues to expand, which we think bodes well for the long-term outlook in our business. Against this backdrop, we expect our recent investments in Salesforce expansion will translate to accelerating growth as we turn the page to 2022. In oncology, our strategy is primarily focused on driving uptake of our platform with our health system partners, as well as cross-selling into our women's health channel. We are making a number of investments to enable that strategy and expect adoption and reimbursement for our oncology portfolio to inflect in 2022. More specifically, in hereditary cancer, we have identified and are pursuing key opportunities in revenue cycle management, improving contracting terms to expand coverage, and driving institutional relationships with our health system partners to accelerate growth into 2022. On the somatic side, we're moving ahead with plans to utilize MoldyX with a goal to leverage this favorable reimbursement pathway by the middle of 2022. In summary, we believe the key drivers of growth in our business remain intact and are excited about the outlook as we enter 2022. In the meantime, there are a number of factors that are unique to the third quarter that muted our reported volume and margins. We wanted to address these items directly to provide clarity and explain why we are confident that the fourth quarter will represent a meaningful positive inflection point for our financial performance. I would like to provide three points regarding the trend in the third quarter. First, we are still early in the days of reaping the benefits of our expanded sales force, and the COVID Delta wave made it challenging to capitalize on these investments. I'm happy to report that volumes have begun to ramp at the end of the third quarter and have continued to progress into the fourth quarter, as evidenced again on slide eight of the earnings presentation, where you can see our four-week rolling average of accession volumes accelerated late in the quarter, and that volume has continued quarter to date. These numbers translated into the highest monthly accession volume in September, only to be exceeded again in the month of October. Second, it's important to highlight that there is a long tail. of testing products outside of our core diagnostic testing menu that account for a large percentage of our volumes, but a very small percentage of our revenues. We provide these tests as part of our complete solution in women's health. During the quarter, the volumes of these non-core tests fell short of our expectations, and this resulted in a sequential headwind of 400 basis points to our reported volumes. Meanwhile, our core portfolio of tests, which include next-generation expanded carrier screening, NIPT, hereditary cancer, and somatic oncology was flat sequentially. Volume trend in the core business has improved markedly through the months of September and October. Third, as Eric mentioned earlier in the call, we launched 704 elements in the third quarter. With the launch of elements, we shifted our expanded carrier screening V2 from smaller private pilot programs to becoming broadly commercially available. The transition from V1 to V2 took longer than expected, and we exited the quarter with a material backlog of work in progress that was not recognized as revenue in the third quarter. We estimate this dynamic reduced sequential volume growth, excluding COVID, by roughly 200 basis points. This product transition is behind us, and we are continuing to make significant investments in talent and infrastructure to improve our product launch capabilities in the future. Now turning to guidance. we estimate revenue for the full year 2021 will be in the range of 201 and $204 million. We expect fourth quarter resulted volume, excluding COVID, will be in the range of 73,000 to 79,000 tests, which implies 20 to 30% growth versus the fourth quarter of 2020 and 9% growth at the midpoint versus the third quarter of 2021. We anticipate fourth quarter non-GAAP operating expenses to be roughly in line with the third quarter of this year. As we think about the longer term, we continue to believe the underlying market growth rates in the key markets we serve are healthy and will grow double digits for the foreseeable future. We are encouraged by our continued success executing our market share gaining initiatives in oncology, women's health, rare disease, and pharma that should help us drive organic growth well above the double digit market growth rates in the markets we serve. Additionally, a robust pipeline of M&A opportunities and our current balance sheet provide us with the financial flexibility and growth opportunities to achieve our goal of 500 million of revenue in 2023. Now we'll turn it back to our founder and CEO, Eric Schott.
spk06: Great. Thanks, Isaac. We are making substantial progress as we work to build and leverage a digital universe of data to make precision medicine a standard of care for health systems as well as patients and providers. With our future investment plans, we are confident we are on the path to long-term sustainable revenue growth. I would now like to open the call to any questions. Operator?
spk07: Thank you. At this time, to ask a question, please press star then 1 on your touch-tone phone. And to remove yourself from the queue, just press the pound key. Once again, that's star 1 for questions. Our first question will come from the line of Brandon Couillard from Jefferies. You may begin.
spk02: Hey, thanks. Good afternoon. Let me start with Isaac. A couple questions. Could you just elaborate on what exactly the non-core tests are that you performed that came in below expectations in the third quarter, were a negative 400 basis point drag to volume? Just curious exactly what those are and how big that pool of testing volume is in aggregate. And then as we look at the fourth quarter, what's embedded in terms of COVID revenue in the outlook? Should we expect ASPs to step down again sequentially for the core portfolio in the fourth quarter?
spk01: Hey, Brandon, thanks a lot. Sure thing. So it's important to remember the bigger context, which is that the franchise was started primarily to serve IVF clinics, and those clinics are, as Eric pointed out, very sophisticated customers of all sorts of testing. And the non-core portfolio that we offer essentially are non-NGS tests, things like cytogenomics, that are things that get used all the time by those physician users but are not really part of our long-term focus on driving advancements through genomics and data. And so we offer them. They are typically high volume, low ASP, and therefore lower margin offerings that matter for the customer but maybe are less strategic. So that's sort of what they are. And I wouldn't say there was any one handful of categories that were soft relative to expectations in the quarter. It was really the entire basket and lots of, you know, reasons why that might be the case. But as we looked at sort of the exit rate again out of the quarter and into Q4, things really started to pick up across the entire portfolio. So we really did feel like, you know, where our team, where we asked the commercial team to focus in the core portfolio, they did a great job. And in these other areas, they come along for the ride. And so that's kind of where we are with mix and portfolio. In terms of COVID, we're assuming about 3 million of revenue in Q4, which obviously is a pretty dynamic environment for COVID testing. That's our current expectation. And as we've said in the past, we're very proud of the position we have serving our local communities and broader customer base in that business, but it is not a long-term area of strategic focus for us.
spk02: Just to the high level, would you sort of level set us on where we stand in terms of the reimbursement process how discussions have progressed on that front. And what kind of be your expectation that perhaps we begin to see the ASP trend bottom out kind of by mid next year that you alluded to in terms of some milestones on the oncology front?
spk01: Yeah, that's exactly right, Brandon. So in general, on reimbursement, I'd say there are puts and takes there that together lead us to our expectation that 2022 will be far more stable reimbursement year than this year has been. We're most of the way through the contract conversations that we touched on last quarter. And that's something where we feel very good about the path to driving upside over the long term. So you may recall that we still do not have proper reimbursement for our oncology portfolio. And those tests are actually gross margin negative until that gets sorted. So there's a huge opportunity for the oncology business to be a tailwind both the ASP and the gross margin, as we get that reimbursement put in place in 2022, which is why we called it out in the script. And in the meantime, I think if we just get reimbursement in line with the market rate on ECS, we'll be just fine. And that's exactly the path that we're on. So no change there, but it is not something that happens overnight. It'll be a 2022 dynamic, and that's the core focus.
spk02: Gotcha. And then last one, maybe for Eric, you kind of alluded to the pharma business kind of growing substantially next year. Just curious how that side of the business has developed relative to your expectations and perhaps kind of what the current pipeline looks like in terms of the nature of conversations with new biopharma partners. Thanks.
spk06: Yeah, so we have a number of very exciting engagements with the biopharmaceutical industry today. So we, for this past year, have been really focused on engaging pharma around the expansive data that we have on patients, in addition to more research-based drug discovery collaborations. I would say that a lot of the collaborations that we were sort of being test-driven, I would say, by pharma around like real-world evidence study, clinical trial matching, could we deliver, and the success coming out of those is delivering a very strong pipeline of potential follow-up deals that will be more substantial. So we're very confident that in the coming year that we're going to be able to close on way more substantial, deeper relationships with pharma. And I would say that the strategy becomes one similar to the health system kind of partnerships where we're seeking deeper, more holistic engagements. The same is true on the pharma side of really being attracted to those pharma companies who are able to leverage all the different aspects of our patient engagement, the data, the models, the testing, kind of being able to deliver a very holistic set of packages across their drug discovery spectrum.
spk02: Very good. Thank you.
spk07: Thank you. Our next question comes from Max Masucci from Kellyn.
spk03: Hi, thanks for taking the questions. Starting on health systems, you know, it's been seven months since you launched the system-wide genomics program with North Shore, about six months since you broke ground with AdventHealth's Orlando network. It's great to see the updates around North Shore. It would be great to hear how North Shore progressed versus expectations and whether you think some of these positive data points, you know, on slide seven of the presentation can be harnessed as a tool for new wins. And then just separately, if you could just touch on the state of the organization and team that are targeting those opportunities, just given some of the recent changes. Thanks.
spk06: Yeah, thanks for that question. So I would say on the health system engagement, there's a lot that goes on in those. What we've found easy to get more rapid traction on, North Shore is a great example of that. The protocols we've launched with Avera, the genomic reanalysis of genomic data for clinical interpretation that we're doing with ads and tell kind of the uptake of those genomic testing solutions, the more comprehensive interpretations and the engagement of the system by, you know, through the physicians and integrating that with clinical data to make more informed decisions has all gone really well. So those are ones that are, you know, maybe a little more natural for the health systems, easier to uptake. into a system-wide way. And just with North Shore again highlighting, you know, we started six, seven months ago, you know, with that genomic health solution, genomic health screen program being launched in one site comprised of about 10 percent of the primary care physicians and the success there rapidly expanded to over 90 percent across all the hospitals in the system. The heavier lift has really come on the data side. So these systems are sophisticated. They have lots of complex data, but they have systems that are geared towards kind of the transactional dynamics in the system to log patient care received and so on. They're not really structured or designed for the type of modeling and querying and integration that we would like to do. So we found that to move a little slower as we've had to provide more support on the IT infrastructure side and, you know, kind of overcome the natural concerns that a system has with, you know, with sharing their data broadly with us as a partner. So we think those kinds of learnings, so the ability to go in and expand on the genomic testing solution side. work in the different kind of workflows, whether it's a population health setting, an OB type setting, or oncology setting, we think those will very naturally scale to many other types of systems. And I would say on the data front, we're still in a big learning mode of how replicable, like how transferable those engagements are going to be across all systems. Some parts will be very generalizable. Others are going to require more custom development and design. And on the, I would say on the health system teams, again, a very active area of growth for us. The teams that are needed to kind of support throughout the system, the uptake of these kinds of solutions, all the coordination and so on is significant. And I'll note, it's not just significant on the semaphore side, it's significant on that health system side too. There's very significant investment that goes on those systems, you know, from the IT infrastructure to clinical care coordination and so on that, you know, it's a big investment on their side as well.
spk03: Yeah, makes sense. Just curious, you know, how does the final LCD for MRD monitoring published last week inform how you think about your entry into this testing application, you know, whether it be organically or through an acquisition, and also just balancing your test performance and capabilities with time to market?
spk06: Yeah, so, yeah, great question, and we think a lot about that. Again, the whole aim for burning into these health systems is, again, providing holistic genomic testing platform and the data sophistication integration to deliver the most differentiated insights, truly personalized precision medicine. What I would say is there are definitely gaps that we have in the genomic platform. MRD would be one of them. And of course, we've been clear that M&A is a key part of our strategy to fill those gaps. And we have a very healthy pipeline of explorations going that, you know, span many of the gaps. We think that, you know, if we could provide services like MRD in conjunction with our state-of-the-art whole exome, whole transcriptome test, the heritable cancer test, the drug safety test, and so on, we'll make for a very competitive, holistic, precision oncology solution.
spk01: Yeah, and Max, I would just add that you know, as we look at M&A and deploying capital, we're very cognizant that we have to strike a balance between serving the growth strategy and filling out the portfolio and creating value for shareholders. And so as you probably know, you know, asset prices are what they are in this space. They're high. And so we're really trying to be smart about finding deals that we think serve our purpose of enabling data and genomics while also creating value. And so, you know, as you think about, you know, what we're likely to do first versus what we're likely to do over time I think it's really important that we walk before we run on the M&A front. So I think absolutely we believe that MRD, there's a lot of exciting stuff happening there. We're very aware of some of the favorable things happening on the regulatory front. And we'll aim to be participants in a way that makes sense. But that's sort of the framework that we want to make sure we articulate to you.
spk06: And if I can maybe make one more point on that, it's – The M&A is one aspect to fill that gap, but strategic partnership is also another way. And we've been pretty clear that we don't have to be able to spin up every single possible test to put into play for a holistic solution. We're happy to partner on that and be the ones who are wiring together that solution for the health system to really deliver that more integrated, holistic kind of care. So strategic partnership would be another option.
spk03: Great. Thanks for taking the questions.
spk07: And our next question is from Mark Massaro from BTIG. You may begin.
spk05: Hey, guys. Thanks for taking the questions. I guess, you know, I had my first question is on the semaphore element. You know, you're rolling out this molecular ancestry, you know, genome-wide risk assessment. You know, it's not something that I'm super familiar with, you know, looking at, you know, carrier screening panels and other women's health companies. Can you just speak to, you know, what type of impact you think this will have as you look to kind of maybe win adoption, perhaps competitively from other providers? Or do you think this is maybe just a nice bolt-on feature that certain clinicians are asking for, but maybe it just serves to strengthen your offering? I guess I'm trying to better understand the differentiation and maybe the clinical actionability of this feature.
spk06: Yeah, great, great, Mark. And first, I would say that the current version of our expanded carrier screening test covering over 500 diseases and conditions is among the, if not the most comprehensive carrier screening test on the market. And where that matters is in the percentage, you know, the actionability, like what kind of actionability does this provide patients in their reproductive health decisions? And roughly 5% with our current test roughly 5% of individuals tested, and remember, most of that's in the IVF setting, get identified as carrier couples. If you were looking at ACOG guideline-based tests, that number would be sub-1%. So we're delivering a product that by five-fold increases the actionability, enhanced decision-making for reproductive health partners. The molecular ancestry component was one I drove with the head of our clinical lab as a leveraging genome-wide genomic information to improve the residual risk calculations for this expanded carrier screening product. So, for example, if you take cystic fibrosis, if you are tested and are not a carrier, of bad mutations that can lead to cystic fibrosis in your offspring, there's still a risk that you have a passing on something to your offspring that could give cystic fibrosis. It's what's called a residual risk. That residual risk is a function of the population group you inherited that piece of DNA from. And the way that gets assessed today by all others is through self-reported ancestry. So you're asking the patient, what's your ancestry? And of course, if we know anything, especially in the U.S., is that the ancestry, the composition, the makeup of one's ancestry is quite complicated. And not only is it complicated at the high level, but even if you knew with perfection what your ancestry composition was, you wouldn't know what population group did I inherit that cystic fibrosis gene from? So today, what's being systematically misreported are residual risks based on that self-reported ancestry. And it's why the guidelines like ACMG come out and say, you should not diagnose the company be reporting residual risk unless you have this kind of information. So we're the first to be able to systematically integrate genome-wide level information to provide just a more accurate standard of care. Like it's a And so what we'll increasingly see is we engage that kind of information across all those diseases and conditions, and not just expanded carrier screening. Heritable cancer, polygenic risk scoring for cardiovascular disease, depression, anxiety, drug safety, every single one of those depends on, again, the population groups you're inheriting that information from. So systematically integrating that is going to lead to superior outcomes in patients that we think will be highly attractive across the spectrum.
spk05: Got it. Sorry if that was a little long. No, no worries. No sweat. You know, recognizing you guys are still pretty early as you think about, you know, the next five, 10 years as a company and how you can address unmet needs in precision oncology. You know, there has been a rise in sort of the medical imaging, big data AI type companies that are raising money and perhaps planning IPOs in the future. I guess, Eric, what are your thoughts as to whether or not you think medical imaging can be complementary to some of the diagnostic portfolio that you're looking to build out?
spk06: Yeah, again, love that question because it's, you know, we think about data in a more agnostic way. While we're generating a lot of genomic data, right, because it's a special technology moving at super Moore's Law speed, we think about all aspects of data from genomic to the clinical record data and to imaging data, proteomic, metabolomic, and so on. So we view all of those as kind of central dimensions. And clearly in cancer, the imaging data is critically important. In fact, back to some of the pharma collaborations I mentioned, some of those directly involve imaging-based data, abstracting features from those data, integrating them with the clinical medical record data for better diagnosis of patients, for example, with lung cancer. So we have a paper about coming out on that exactly. So we definitely see integration of imaging data into the interpretation, combining that with the genomic clinical record data to make superior predictions we view as a core component that we continue to grow out.
spk05: That's great. Last question for me. Obviously, Semaphore was born out of Mount Sinai, which is now a strategic partner. I guess, What does Mount Sinai's collaboration have that maybe you haven't yet implemented at North Shore, Advent, and Avera, such that you think that you can increase the standard of care at maybe the other three health systems?
spk06: Yeah, I would say, again, it's back to my earlier comment on the easy and the hard with the health systems that we're seeing today, like with North Shore, and it's that the engagement around the data the magnitudes of those data, the abstraction from the unstructured data, the integration with pathology notes, and the imaging data that you mentioned, like I would say we're, you know, much further ahead, more advanced with the Mount Sinai Health System and so able to provide across a broader range of areas from autoimmune to cardiovascular to OBGYN to oncology. you know, utility back to the system across those different areas. And we think, you know, what we're learning is that takes a little more time than we thought it would with these systems. But we think that's all going to come and will drive even more enthusiasm across those systems as we enable them to master that information in this more integrated way. So we think, again, it's the mastery of the data, I would say, that were further ahead at Sinai than the others, but we expect there's nothing that holds us back from achieving that same mastery in the other systems.
spk05: Great. Thanks for all the color. That's it for me.
spk07: Thank you. Once again, that's star one for any questions. Star one. Our next question will come from Matt Sykes from Goldman Sachs. You may begin.
spk04: Hey, everybody. Thanks for taking my questions. I appreciate it. Isaac, maybe just one for you to start out. One of the things you mentioned on the third quarter trends, the first thing you mentioned was that it's still early to reap the benefits of the sales force, but you noted that volumes have recovered a lot at the end of September and end of October. I'm just wondering how much of that is ramping of new sales people's effectiveness versus COVID-related restrictions, or is it a mix of both? And did that ramp at the end of the quarter and into October represent an easing of restrictions or a more effective sales force as they've spent more time in the field?
spk01: Yeah. Hey, Matt, good question. Thanks for asking. I would say both played into the dynamic we saw this quarter with just the newness of the reps being the bigger factor. I don't have precise science to tell you to the number exactly how much more, but we really did onboard a number of people in the summer months who were just now getting their feet underneath them. So I really do think that's the bigger factor. Now, having said that, we obviously need physician offices to be open and available and all that. And We are in a bit of uncharted waters here as we enter this next phase, the endemic phase, if you will. So we're very optimistic about what's possible with our reps as we exit the year. But, again, I think both factors played into the dynamic in Q3.
spk04: Got it. Thanks for that, Isaac. And then, Eric, maybe just one for you. I know you've addressed a couple questions from Mark and Max on this, but I kind of wanted to get at the health systems and maybe an increased level of heterogeneity in these systems, meaning you talked about your ability to scale investments and you've had to make a little bit more IT investments to help with integration. But I'm just wondering, as you're looking at each new health system and maybe there's a higher level of heterogeneity and different challenges each one poses, does that inform your selection going forward of new health systems you might approach? I know you're only doing a few, but I'm just wondering, has this kind of changed how you're approaching and maybe looking for more homogeneous health systems in order to take better advantage of that scale of investment?
spk06: Yeah, it's a really great question because I think we maybe had underestimated initially the generalizability on the engagement of the information over all aspects of diseases and conditions. And what we're finding is while the approaches we use are indeed general, the focus of the systems and where they want to champion. What is it that they're looking to impact patients? Where are they losing? You know, a lot of the systems we're working with, like community-based hospitals, hospital systems that want to compete with academic medical institutions and not lose patients. So they have very targeted wants. And those wants are no surprise. You know, in the precision oncology and population health, genomic health, arenas in addition to rare disorders and reproductive health, where again, we have strong expertise. And so I would say in the new systems that are kind of in process that we think we'll be able to share things in coming months, they definitely are more homogeneous with respect to the systems we have today. And it was because we did better understand all of the issues in those different areas and the kind of champions, who the key players were. So think ecology in particular, where it's, you know, there's a bigger appetite for these sophisticated solutions, no matter what system you're at, and so on. The system's taking on more management of the populations, and so having incentive on the population health side and So I do see those potentially repeating, but we are also going to drive hard with those systems, you know, expanding into other areas like cardiovascular where we're starting to get some uptake as well as autoimmune. But yeah, I would say, you know, the oncology, precision oncology, population health, genomic health, and rare disorder where I think of it more on the reproductive health side where that's definitely a rare disorder play are kind of the, we're seeing core focal points.
spk04: Great. Thanks very much for the call. Very helpful.
spk07: Thank you. And I'm not showing any further questions in the queue at this moment. I'd like to turn the call back over to Eric Schad for any closing remarks.
spk06: All right. Well, thanks, everybody. Yeah, come on. Thanks, everybody, for your interest in Semaphore. I think great round of questions. We're pleased to be able to have presented to you today our update on our third quarter progress. We're super excited for what the future holds and look forward to keeping everyone up to date along the way. Thank you.
spk07: Thank you. This will conclude our program for today. Thank you for participating.
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