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spk13: Ladies and gentlemen, thank you for standing by. My name is Brent and I will be your conference operator today. At this time, I would like to welcome everyone to the Invitae third quarter 2021 financial results conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, we will have a question and answer session. If you would like to ask a question at that time, simply press star followed by the number one on your telephone keypad. If you would like to withdraw your question, again, press star 1. I would now like to turn the call over to Ms. Amy Hatzok. Please begin.
spk08: Thank you, Operator, and good afternoon, everyone. Thank you for joining us for our third quarter 2021 financial results call. Joining us today are Sean George, our CEO, and Roxy Nguyen, our CFO. We're also joined today by two leaders within our oncology group, Vishal Sikri, President of Invitae Oncology, and Dr. Rakesh Patel, a founder of MedNeon, and now serving as Invitae's Chief Medical Officer, Digital Health. Before we begin, I'd like to remind you that various remarks that we make on this call that are not historical, including those about future financial and operating results, plans and prospects, focus of our business strategy, plans to integrate and manage businesses we acquire, market opportunities, future product services, our product pipeline, and their timing, demand for and reimbursement of our services, and investments in our infrastructure and operations. These statements constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act. It's difficult to accurately predict demand for our services, and therefore actual results could differ materially from our stated outlook. Statements on company performance assume, among other things, that we don't conclude any additional business acquisitions, investments, restructurings, or legal settlement. We refer you to our most recent 10Q, in particular the section titled Risk Factors, for additional information on factors that could cause actual results to differ materially from our current expectations. These forward-looking statements speak only as of the date hereof. As you listen to today's conference call, we encourage you to have our press release available, which includes financial results as well as key growth metrics and commentary on the quarter. To supplement our consolidated financial statements prepared in accordance with the generally accepted accounting principles in the United States, or GAAP, we monitor and consider several non-GAAP measures. We exclude from our non-GAAP operating results as applicable, among other items, amortization of acquired intangible assets, acquisition-related stock-based compensation, post-combination expense related to the acceleration of equity grants or bonus payments in connection with the company's business combinations, adjustments to the fair value of certain acquisition-related assets and liabilities, including contingent consideration and acquisition-related income tax benefits. We exclude from our non-GAAP cash flow as applicable changes in marketable securities, cash received from equity financings and debt, and cash received from exercises of warrants. Non-GAAP measures may include cost of revenue, gross profit, operating expense, including research and development, selling and marketing, and general and administrative other income expense, net as well as net loss and net loss per share, and cash burn. We encourage you to review our GAAP to non-GAAP reconciliations, which are available in the press release and in the appendix of the earnings slide deck. With that, I'll turn the call over to Sean.
spk06: Thank you, Amy. Before we get started, I want to emphasize that toward the end of our call, Roxy will be outlining a set of key business metrics we will be using going forward as a dashboard for our business model success. As our platform is developed and our business expands from testing services into other areas, we've been working to provide smarter, more relevant measures in addition to those used traditionally in life science sectors. We'll refer to those several times on this call and we'll rely on that new dashboard heavily going forward. To headline the quarter, revenue grew more than 65% over last year's Q3 period, which, with all things considered, keep us comfortably within our longer-term growth targets, and number of patients we serve grew by 89% over last year's third quarter, up about 3% over this year's second quarter. During the summer months, we typically experience some seasonality, as you can see on the charts, but this year's slowdown was a bit more pronounced and longer-lasting than the past couple of years. it is difficult to determine how much of that was unusual seasonality and how much of that was COVID-related. We are seeing some pickup in recent weeks, but are being cautious with our guidance for the remainder of the year in case those impacts persist. Reflecting on the long-term view, as you can see, the year-over-year top-line growth across the platform demonstrates our continued progress toward meeting the immense unmet demand for the use of genetic information in healthcare. The takeaway here, aside from any short-term revenue fluctuation, is that we are tapping into something unique at Invitae. Since the advent of genomic medicine now 20 years ago, we are in the midst of a fundamental shift in not only medicine, but in how we view our health and wellness, family planning, disease management, and aging. In view is a time when many diseases will have a well-understood risk that can be minimized and even staved off, and if or when they arrive, can be rendered a chronic condition to be managed for years or even decades. But that future is only a reality with genetic information derived through testing early and often. And the benefits will be accelerated with the tracking, storing, analysis, and understanding of health and health-related data for individuals, families, and populations. While the investment to make that future a reality is large and the timelines long, the value that can be created is immense. We believe that the ability to identify those at risk for disease, detect and diagnose the onset of those diseases earlier, Use that information to guide preventive measures or targeted treatment and monitor the success of that treatment will be the standard of care for individuals throughout multiple stages of life. The company that can deliver that standard will be transforming very large and durable markets in healthcare. Furthermore, those large durable markets are all increasing in size. In each of these four primary life cycle areas, fundamental drivers of adoption over the next two to three years are quickly coming into focus and will create the need for our services that we believe far eclipse the ability of today's system to better treat or even outright prevent disease. Much of the tailwind is coming from the rapidly expanding biopharma pipelines full of genetically targeted therapies. Some is coming from a better understanding of the improvement to outcomes and cost utility of using this information. Some is coming from changing perceptions and attitudes about the role of the patient in their own health care and engagement from those paying for it. and much of it is coming from the exponentially growing volumes of evidence that this shift is a shift to better medicine. For example, a study being presented today at the American Heart Association meeting that found broad genetic testing identified clinically relevant variants for one in five patients suspected of having a heritable cardiovascular condition, two-thirds of whom were projected to have clinical management implications and more than 10% of which would have been missed using a narrower testing approach. A little over a week ago, I read a Washington Post article about how a 34-year-old marathoner, new mom to a 10-month-old son, dropped to the pavement at mile 8 of the race, thankfully kept alive by medically trained spectators that happened to see it. Her father died of a heart condition at 53, and but for a brief call-out to that fact, really nothing to note about the role of how genetic information could be used to prevent such a narrow escape. That will change, we believe, rapidly. And as an example, the market for the use of genetic information in cardiovascular and cardiopulmonary disease could be as large as that for oncology, which can give insight to our formula for growth. We are building a platform that can help our customers move through risk assessment, screening, prevention, or therapy selection and ongoing monitoring. And that platform will help that individual make the most informed decisions about their health, as well as generate the real world data and network connections needed to put effective next steps in their hands. Today, our business can be measured by the progress along that front in oncology, reproductive health, pediatric and rare disease, and in addition, we've recently broken out the part of our business that utilizes patient-owned data and patient connections generated every step along the way. In the future, we will be adding more information that we can provide for the patient at each stage, more capabilities to our data platform and partner network, as well as adding new disease areas or stages of life, such as cardiovascular disease I mentioned a few minutes ago. As I mentioned before, and very importantly later in the call, Roxy will lay out the key business drivers and financial metrics that we'll be using to measure our overall progress against our model. I'm hoping that using these as signposts we will be able to map for everyone the journey from where we are today to the future we are certain is coming. Given just how much is going on at Invitae in a given month of the year, it's not possible to cover it all on our quarterly calls. But we'd like to at least give a little more insight into the nearer-term drivers of our business, so each quarter we'll spend a little more time on one of our key areas of revenue growth. This month, we'll focus on our oncology platform, which is especially relevant since the products and services coming online from that group will be important drivers of revenue and margin growth in the coming years. Vishal Sikri leads our oncology business, and I've asked him to provide some additional clarity on the product plans and clinical trial activity that underscores our potential to walk our customers from risk to hopeful remission in the near future. I've also invited Dr. Rakesh Patel, our Chief Medical Officer for Digital Health, to join us today. Rakesh is an oncologist and was a practicing physician for more than 17 years before becoming an entrepreneur. co-founding the MedNeon digital health platform, which Invitae acquired in the second quarter of this year. Brock will outline how those products and studies dovetail with our digital health platform to benefit patients, physicians, families, and the broader healthcare ecosystem. I'll hand it over to you first, Vishal.
spk05: Thank you, Sean. In oncology, we have an active pipeline to support testing across a patient's journey. I will provide an update on the product roadmap, which includes a vibrant combination of tests that have been part of the Invitae portfolio for years, innovative tests acquired with the ArcherDx integration, and new tests on the horizon. In the germline testing category, where Invita has been a leader for years, we added an RNA offering to our DNA germline test this year and plan to expand into polygenic risk score in 2022. Germline testing showed impressive growth in 21, and with our expanded offerings, we expect growth to continue through 2022. These additions are a differentiator given the multitude of recent third-party clinical studies verifying the benefits of combining germline and somatic testing in defining risk and the best course of treatment. Invitae is the only company developing and combining germline and somatic testing on one platform. On the Research Use Only front, or RUO, we plan to launch our expanded DNA-based kit offerings by the end of this year. That offering will include testing for microsatellite instability, also known as MSI, addressing a growing demand from clinicians, We're also expanding our RUO offerings to include tumor mutation burden, or TMB, and important biomarker for therapy selection. We continue to innovate on the centralized lab offerings front with a series of laboratory-developed tests being stood up in the coming year. In 2022, we plan to launch our clinical offerings for personalized cancer monitoring, PCM, which is our tumor-derived test. While our initial body of research demonstrates the accuracy of our MRD tests to monitor and detect recurrence in lung cancer, we'll be pushing forward the PCM as a pan-cancer offering, giving us what we view as a distinct advantage in this emerging and important market. Later in the year, we plan to expand our centralized somatic offerings to include a comprehensive therapy selection test that is informed by
spk11: DNA, RNA, and protein.
spk05: This therapy selection capability is similar to Archer's stratified offering, but we'll be using alternate trade names as we stand up our LDT offering due to commercial, IP, brand, and other factors. Finally, in 2022, we plan to kick off our development work on an early detection assay for cancer sclerostics or IBD front where demand for decentralized genomic testing is growing, We're moving towards creating product and service plan to launch our first CE-marked IVD kit products in select European markets in Q1 of 2022. These first tests will include our FusionPlex DX and our LiquidPlex DS tests. Both tests will enable any facility samples for therapy selection is a major step towards satisfying the pent-up demand for local and regional genomic testing capabilities particularly among EU countries, and will allow us to expand our customer base in Europe and parts of Asia. Outside of the EU, we're submitting additional claims for IVD solution, which will help labs running the test get high. With the launch of our IVD products outside the U.S., we expect strong adoption of our tests, especially in countries where testing is heavily.
spk11: While we're launching these products for customers, in Europe and Asia, we will continue to work the requirements for a launch of those kits and a decentralized commercial strategy here in the US.
spk05: Based on the feedback from the FDA, we believe that we have a good roadmap for FDA approval for our IVD products, including a path forward as an IVD for our PCM tests. In the past, Invitae has avoided companies making substantial investments in resources to partner with KOL from across the globe to better understand and highlight our approach to personalized medicine and the use of clinical data in driving the patient experience and better outcomes. Altogether, we believe these studies underscore the value of our current products and our new product launches planned for 2022. On a high level, This year, we expanded the case for our hereditary cancer test with multiple publications, including Intercept, a collaboration of germline testing across tumor types. And we demonstrated the importance of our Archer MET IVD test for MET exon 14 detection. In 2022, we anticipate a wealth of data to support our PCM product, including tracer exoners, including MassGen and MSK. as well as early signals from our prospective PCM studies, including IGAP and MARIA. In 2022, we have additional hereditary publications planned as well, as well as furthering our support of the intercept trial with tumor profiling in multiple cancer types. Then in 2023, additional prospective PCM trials are expected to be blossoming, including MRD-guided trials. Meanwhile, we continue to We intend to continue best practices in our field, including the BloodPak Consortium Friendship and the Personalized Medicine Coalition. I'll conclude by highlighting the MARIA trial, which is being initiated by the end of next month. MARIA stands for Tumor-Derived Assessment. It is an Invitae-led study working with academic and community collaborators to use PCM as a means of risk stratification, a surveillance tool, and a therapy monitoring tool in 2022. I will now hand the floor to Dr. Rakesh Patel, who will walk us through how our expanded end-to-end testing portfolio integrates with the cancer patient and provider journey, as well as the importance of digital health and data platform. Rakesh?
spk04: Thank you, Vishal. The emerging practice of precision clinical oncology involves multiple applications of molecular testing across a patient's lifetime, from before they are ever diagnosed to well after they are treated and achieve remission. First of all, mutation analysis is now routinely utilized for diagnosis of hereditary cancer syndromes. For already diagnosed patients, biomarker profile testing of the primary tumor to detect actionable mutations has become an integral part
spk11: over time during treatment. Monitoring of patients is critical to be able to detect resistance mutations as early as possible and adjust therapy when needed.
spk04: Tumors almost always shed their fragments into patients' bloodstream. So-called liquid biopsy or the analysis non-invasive detection of molecular markers. It can be used as an alternative to tissue-based It can also be used for early cancer detection to predict the likelihood of relapse at diagnosis or to monitor response to neoadjuvant therapy, recurrence after adjuvant therapy, or treatment resistance. We believe Invitae can provide critical knowledge that will guide and facilitate every stage of a patient's cancer journey. From an oncology practice critical, With complex preventive measures, an array of testing capabilities, and rapidly expanding treatment pathways, cancer is the most decision-dense disease. We are building an end-to-end platform that keeps providers informed and, in turn, empowers a patient for shared decision-making. Importantly, cancer risk assessment and genetic testing is not a one-time event, as not only does an individual's medical and family history change over one's lifetime, but a single individual may benefit from multiple types of genetic tests, both before and after a cancer diagnosis. There is a large amount of genetic information and novel therapies that are now available, and keeping providers updated of the rapidly changing guidelines is challenging. Since patients relocate or change their providers frequently, having a trusted, direct patient engagement over time is paramount. The most effective way to treat a cancer is to never get one. And in that context, we have developed robust capability focusing on population health, genetic cancer risk assessment, and predictive analytics, ideally before a cancer is diagnosed with the goal of preventing it altogether. Outcomes are usually better when disease is caught early, and thus early disease detection remains a core focus area. Once a cancer is diagnosed, clinical decision support tools for an accurate diagnosis, leveraging multidisciplinary precision therapies. Following multidisciplinary treatment, staying connected to the patient to monitor outcomes is just as important in order to identify sub-visual cancer burden, which again allows early treatment plan. In effect, turning a once terminal clinical situation for most into a chronic disease for
spk11: life expectancy. From frictionless collection of health records into a secure patient wallet with Citizen to patient education and testing and personalized medication management with U-script
spk04: along with therapy guidance, virtual tumor board modules, and active development to support our expanding testing portfolio. The Invitae digital health strategy will bolster our mission to bring genetics to mainstream medical practice. We will provide an integrated clinical decision support platform capabilities for coordinated and personalized tech-enabled care, coupled with a seamless real-world data strategy. leveraging active, longitudinal provider and patient engagement, and efficient clinical workflows for all stakeholders. Thank you. Back to you, Sean.
spk06: Thank you, Rock, and thank you, Vishal. We're looking forward to active and important months ahead for our oncology effort as we bring new patients onto the platform, introduce new tests and services for those patients, and drive the scale necessary for financial performance, and available, we believe, would be the most robust data sets for research and discovery available anywhere. Before we go to Q&A, I'll hand the call over to Roxy Nguyen to cover the financial results and discuss the important business drivers and key metrics for INVITE. Roxy?
spk09: Thanks, Sean, and thank you all for joining us today. Available volumes of approximately 296,000 in the third quarter of 2021 were up 89% from the third quarter of 2020 and 3% sequentially from the second quarter of this year. Internationally, we saw volume growth that was slightly ahead of our US business and represented over 21% of total billable volume of the quarter. Overall, ASP trended down 3% to $377 in the third quarter from $388 in the second quarter of 2021. This reflects the mixed increase in Q3 to women's health and international testing sales, which have lower ASPs compared to other products. Looking ahead to 2022, we expect ASP to benefit from our launch of broader LDT and IVD testing for therapy selection and MRD testing for monitoring and surveillance, all of which have higher reimbursement rates. As Steve noted in prior quarters, it is easier to understand our business and financials by providing non-GAAP metrics to allow for the comparison of the two sets of numbers We urge investors to review the detailed reconciliation to non-GAAP met financials included in today's press release and at the back of the slide deck. For the remainder of the call, we'll discuss non-GAAP numbers, including cash flow. Our non-GAAP cost per unit defined as total non-GAAP cost of revenue divided by the number of billable units. improved to $249 in the third quarter from the $261 in the second quarter due to continuing progress with efficiencies in our overall operations and inventory management in the oncology business. Non-GAAP growth profit was $49 million in the first quarter, which translates to a non-GAAP growth margin of 36%, a slight improvement over the Q2 growth margin of 35%. We expected progress as we continue to execute our margin expansion roadmap in pricing, product cost down, variable cost positivity, and revenue cycle management. Moving down the P&L, non-GAAP operating expenses was $201.8 million in the third quarter as compared to $199.2 million in the second quarter. The third quarter operating expenses include costs from newly acquired businesses. As we stated on our Q2 call, the rate of growth in spending is expected to come down in the second half of the year. We continue to be committed to this goal as we scale the business and manage return on investment at the total portfolio level. We continue to invest in our business in the following areas, research and development, which was up by approximately 146% year-over-year, but down by $3.4 million sequentially. The year-over-year growth was mostly driven by costs from acquired businesses, including ArcherDx, pay count and stock-based compensation, as well as problem costs such as the PacBio collaboration. In addition, selling and marketing was flat sequentially, but up by 45% year-over-year to support a high growth rate over 2020. G&A expenses increased by $8 million over the second quarter, mostly due to higher legal expenses and investment in our ERP capabilities. Looking forward, we're planning for the growth rate of operating expenses to begin declining in the fourth quarter and into 2022, benefiting from continued top-line growth and various margin improvement initiatives. This year should mark the highest annual non-GAAP OPEX as a percent of revenue as investment levels stabilize or even slow down in key areas. Moving to our cash position, cash, cash equivalents, restricted cash, and marketable securities total 1.2 $5 billion at September 30th compared to $1.54 billion at June 30th. Cash burn was $286 million in the third quarter, including cash paid to finance and close acquisitions. Excluding acquisitions and related expenses, our burn for the quarter would have been $148 million. We generated $114 million of revenue in the third quarter, a 67% from the growth increase from the third quarter of 2020. The revenue breakdown by product groups in the third quarter was as follows. Approximately $69 million from oncology, including germline testing, therapy selection, and companion diagnostics. Approximately $21 million from our women's health offerings, including NIPS, CARIA, and other reproductive tests. approximately $15 million from the rare diseases and other testing covering cardio, neuro, and metabolic and newborn screening. Data and platform revenue was approximately $10 million. This includes data management, analytics, data as a service, and certain biopharma and patient identification programs. Revenue from all four areas increased nicely year over year in the third quarter and across the past two years. Invitae's business model is highly depreciated, complex, and ambitious. During the initial listening tour shortly after I joined the team, many of you expressed a desire to better understand our business as we continue to grow and scale. We appreciate your support and are taking a number of steps to help offer visibility into the fundamentals of our business. First, we plan to continue to provide revenue trend analysis for each of our categories. Second, our business leaders and subject matter expert will be joining our quarterly calls to provide deeper insights into the business, as Vishal and Rock have today. Third, going forward, we'll be providing clear visibility to a set of key metrics of our business, We selected and developed these metrics based on their operational significance and ability to accurately describe returns on investment internally and for M&A activities. These categories include expansion of our commercial access points through clinics, hospital systems, or pharmaceutical partners. Growth of our patient population and patients available for data sharing. revenue per patient for our testing and services business, and in the future, annual recurring revenue as our SES business ramps up. New product vitality measured by revenue contribution of new products developed or acquired over the last three years. This will also connect strategic investment decisions to the freshness of the portfolio. We'll continue to measure our ability to expand margins by trajectories of growth margin and variable cost productivity. Last but not least, the category of leverage. In addition to the standard operating expenses metric, we plan to report operating cash flow as a percent of revenue to show scale and improvement. Our future objective is to focus on net operating cash flow. It is important to note that success will not be measured by increasing every category in every quarter. If this is to be a useful dashboard, it will signal both progress and area that needs attention as time goes by. Our objective in sharing these metrics within the framework is to offer more transparency into a complex, fast-changing business and to provide a consistent, balanced perspective on performance as we continue our journey to bring genetics to billions of people. We intend to roll this out at the end of this year and maintain a quarterly update as we move forward. As to our guidance for the year, in August, we provided a revenue guidance range of between $475 and $500 million for 2021. The result of Q3 and the greater than expected seasonality this year has led us to be slightly more cautious And to adjust this projection to a range of between 60% to 70% growth for the year, we're revenue between $450 and $475 million. Back to you, Sean.
spk06: Thank you, Roxy. We've long shown this ramped view of our business model in an effort to describe how we see the evolution of global genomic medicine. Our progress in addressing patients' needs throughout their lifespan and the emergence of our platform and data services demonstrate progress up the curve into the genomic network era, where genetic information can be shared on a global scale to diagnose more patients correctly earlier and bring therapies to market faster. We continue to believe that these new connected capabilities are best developed, delivered, and supported from an integrated platform. The more of the landscape we can cover by way of genetic test content, the more patients we can add to our network. And the more patients in our network, combined with more information we can provide or ingest on their behalf, the more that we and our partners across the healthcare ecosystem can do for them. The next steps in building out our platform include continuing investment in the development of our data, analytics, and real-world evidence capabilities. Over many years, we have built an extensive technical stack of processing, pipeline, interpretation, reporting, and customer service capabilities. and we continue to acquire an integrated portfolio of digital products and services that enhance customer experience through personalized insights, improved workflow, and other tech-enabled services. With that, we'll now turn the call over to the operator for Q&A.
spk13: At this time, I would like to remind everyone, in order to ask a question, press star, followed by the number one on your telephone keypad. We'll pause for a moment to compile the Q&A roster. Your first question comes from the line of Dan Brennan with Cowan & Company. Your line is open.
spk03: Great. Thank you. Thanks for taking the questions, guys. I guess first question, just kind of more near term, obviously discuss the seasonality with COVID and it's going to persist into the fourth quarter. Can you just give us a sense of maybe pacing in the quarter? kind of what's baked in on the fourth quarter, and were there any issues with supply chain that kind of impacted your ability to meet customer needs?
spk06: Yeah, so thanks, Dan. I appreciate it. You know, no real comment on Q4 except the typical seasonality, you know, pickup. You know, typically there's a pickup from Q3 to Q4. We are indeed seeing that. With that said, as we stated, it's coming off from a little bit of a divot, as it were, from that summer seasonality. Picked up a week or two later than we typically see. And while it's difficult to ascertain, there's definitely some COVID baked in there. So we're just kind of being a little circumspect coming off of that end of Q3 into the rest of the year. But we don't see anything unusual now about Q4 in front of us. As for the supply chain, Roxy, I'm not sure if there's anything new on that.
spk09: No, I think it's pretty consistent with the previous quarter.
spk03: And then kind of across the four. Yeah, sorry. Go ahead. Go ahead. Sorry. I was going to ask kind of across the four segments, really oncology, women's health mainly, and then obviously the other two. Were any of the businesses impacted more acutely than others? And could you give us a sense, I know you don't guide by segment, but maybe just stepping back big picture when we think about, you know, kind of the goal of aspirations for Invitae, like any sense on how we should be thinking about, you know, kind of between oncology and women's health, you know, how those kind of fit in as we look out, you know, within the context of your kind of long-term growth plans?
spk09: Yeah, we look at those growth areas like end market, product categories, and across the board in Q3, we didn't really see one particular area weaker or stronger than others. They're pretty consistent indication that we had traffic and longer seasonality issues in Q3 that we experienced. In going forward from a revenue perspective, again, we look at these, you know, go forward as revenue guidance. From a revenue perspective, we also, you know, do not see a change in trend. And also this quarter, we started to introduce some metrics, you know, concept of metrics and going forward will be some data to help you understand how to predict and measure the success of the of the platform across all the key categories. That would be in the number of patients that are coming into our platform and revenue per patient, as well as, you know, at the access point, account level growth.
spk03: And then maybe one final one. You put up the slides on all the timing for all the cancer products coming out across therapy selection and MRD. Is anything new there in terms of the timing? I'm not as Closed exactly. There was a lot of products out there. I'm just wondering, from what you previously communicated about timing, is everything on track? Anything slip or advance? Maybe just some color on that.
spk06: Yeah, I'll start and I'll let Vishal finish. Nothing new. We had talked earlier about the public and visible stratified FDA application, and as we've laid out, that is now actually two or three different discussions with the FDA. that will progress. So that is old news, but reflected in Vishal's overview today. Else that, nothing really new. We tried to put a little more kind of detail behind the kit launches, the different regional approvals. One of the main events is our MRD, or we call it personalized cancer monitoring testing. That is in market now as we speak. And then the roadmap that Vishal spoke about Looks forward to when we hit that hard commercially. We do expect revenue impact that to impact our revenue materially for next year, not necessarily for this year, even the end of this year. But nothing new there. Vishal, anything I missed? No, I think you captured it. We're on track.
spk03: Okay. All right, guys. Great. Thank you very much.
spk13: Your next question comes from the line of Tejas Savant with Morgan Stanley. Your line is open.
spk10: Hey, guys. Good evening. So, Sean, I do want to go back to the earlier question on the guide. I know you, you know, last time we had spoken, you'd mentioned sort of baking in Delta uncertainty into the numbers and absent an impact, you were expecting to come in at or above the high end. Since then, you've now sort of lowered the midpoint by about $25 million. So, can you just help us sort of build a bridge there? I mean, was it sort of very concentrated two or three weeks in August, perhaps, that you saw much greater weakness than you had anticipated? And in terms of the bounce back, are you sort of calling for a V-shaped recovery here, essentially, or a more sort of metered ramp back to normalized volumes as we head into 2022?
spk06: Yeah, absolutely, and I can give more color on that. On our last call, we were checking in literally up to the day or two before and saw really strong growth, new account formation, et cetera, made an estimate of both seasonality and anything COVID impact. We did see, as Roxy mentioned, it hit all categories product categories equally, which is a typical signature of the seasonality. That's the seasonality signal. And also you can also see a kind of relative geographical locations, XUS versus US. The thing is we saw that. I'd say it kind of came a week, week and a half early, and it persisted a good two to three weeks later than we usually see it. And that gave us some pause as we looked at the end of the year. Again, because it looks like a seasonality signal, we don't know how much to ascribe to COVID. In the detailed volume loss data, though, or volume loss, you know, kind of calls from the sales team, it clearly had to do with either people not being at offices or not going into offices. And so obviously there's a COVID impact there, which is really hard to tease out. So then as we look at Q4, you know, this is where – Given where we kind of enter the quarter, we're just going to take a circumspect view and adjust our view to the end of the year. We are at a different spot than we were just last quarter, but the only thing it reflects is that bit of a dent in our annual number that Q3 delivered. We do see science recovery. We expect it to perform seasonally within range and continue with our relatively industry-leading growth.
spk10: Got it. And then a couple of ones sort of looking forward to 22. It's been a couple of quarters now where you've called out international outpacing U.S. growth. How do you expect that business to trend on a go-forward basis and any particular pockets of strength there you'd like to highlight? And then on the early detection assay development front for cancer, any incremental color there versus, you know, the timeline that you mentioned of 22?
spk06: Yeah, so XUS, you know, particularly led by, you know, when Vishal walked through all of the XUS, you know, country by country or even regionally specific approvals for therapy selection and monitoring kits, you know, that's obviously that's a high growth area. There's a lot of pent-up demand there. And it's also a market where, you know, a centralized service base of the U.S. isn't going to be the best thing to serve those clients. So we're We expect that to contribute more. The other thing is our pharma-sponsored patient identification programs, the more global the reach, the better. And we would expect those also to continue. They do continue to put more momentum in all regions. They're happy to find patients wherever, but it does allow us to look more outside the U.S. in the more traditional clinical testing business with the U.S. payers and Medicare reimbursement, et cetera. Those are drivers there. We think that'll continue to support, to buoy our XUS revenue. We'll continue to see that as an important part of the growth story. I think your second question was on early detection. I just want to be clear, we're not calling out a launch of early detection in 22. We're currently doing the our own work on what our own technologies would look like in trials and validations, and also, of course, looking at the buy scenario as well. But we don't have most of the action. Certainly our action for next year is going to be in risk assessment, therapy selection, monitoring, and really kind of taking our product portfolio through that end from start to finish for our oncology patients.
spk10: Got it. And then one final one from here. Sean, as we think about the price versus volume offset heading into 22 in light of the PAMA cuts on the hereditary cancer testing piece of the business, what are your expectations there?
spk06: Yeah, it's a good one. So the PAMA impact is going to be a little different than in past years. Without getting into the details, it won't affect all of our hereditary cancer business outcomes. It's not important why. I'll just say there will be some, but it won't be the full impact. We'll probably do a little more work on that to try to guess exactly what that will be. But I think in the context of our overall cancer business, overall cancer oncology revenue, it's becoming less and less of an impact. I don't think it's going to be immaterial next year, but it's certainly going to be a lot less material than it used to be, and I think going forward after that it will decline to the point of immateriality. As I mentioned, it won't be across the board, and we're still kind of working on the details on that as we speak.
spk10: Got it. Very helpful. Thank you. Thanks.
spk13: Your next question comes from the line of Tycho Peterson with J.P. Morgan. Your line is open.
spk12: Hey, thanks. Can you help us think about gross margins coming out of 2Q? You said, you know, 45 to 50 for the year. You're now kind of coming out at 35.5 for the third quarter. So how do we think about gross margins for the fourth quarter and going forward?
spk06: Yeah, no, we are not where we want to be on gross margins. There's, you know, a little bit of that is volume. Some of that is still some, you know, kind of inventory stuff pulled through from acquisitions. But, you know, the biggest thing there is a mix. mix on pricing, you know, there hasn't been a change in relative growth rates of our different revenue buckets. The fact that reproductive is growing faster, we're getting more, growing more market and taking more share there for NFPS in particular, but also carrier. It drags down price a bit. And, you know, I'd say over the last couple years, our investment has, you know, our investment needle has moved much more towards market creation, volume growth, new product, et cetera. And less as focused on fundamental COGS takeout as perhaps in years, kind of think three to five, six years ago. And so we're not exactly where we want to be. And with that said, between a series of new products that we know will be higher price, higher margin, our own work on COGS improvement and then just get old-fashioned volume economies of scale. We're confident that we'll start showing progress back to our 50% target, and people, as Roxy laid out in our business dashboard, people will see that every quarter as measured against our other key business metrics.
spk12: And, I mean, I guess along those lines, are you able to, you know, I know you're not guiding for 22 yet, but just on OpEx, are you able to give us a rough sense of how you're thinking about OpEx for next year overall? And as you think about screening, are you going to start to spend on studies, and do you need to do 10,000 patient studies like everybody else, or how do you think about the magnitude of spend around screening?
spk06: Yeah, let's do, why don't we do screening first, where we are, and then Roxy will speak to next year's, if we go reverse. Yeah.
spk05: On the screening side, right, we're right now looking at multiple different avenues on what we need to do there. The goal here is not necessarily to, you know, invest in 10,000 patient studies or anything like that. It's really to see, you know, what do we need to do to be successful in this area? And as Sean mentioned, you know, do we build or do we buy in this area? So that's something that will become a lot more clear in 2022 at this point. Roxy?
spk09: Yeah, on the Alpex front, we're not guiding that yet. We're very focused on driving the balance between the strength of our balance sheet as well as long-term growth on investment across long-term, the short-term, or vice versa. So that balance is something we're very focused on. We'll continue to invest in our business and in some of the long-term strategic initiatives we've been doing, and also keep a keen eye on the returns and early signals of the effectiveness of those investments. That being said, our business has scaled to a level that revenue and OPEX investment are both large enough to have enough leverage for us to achieve, to be very identify drivers to focus on our operating cash flow objectives. And so it's a long way to say you should expect growth in investment in key areas and continue the growth.
spk01: But the operating leverage from OPEX should see some improvement there from Q4, starting Q4 and next year for sure.
spk12: Okay, that's helpful. And then last one for me, just on Citizen. You never broke out revenues from the acquisition. I'm just curious if you can give us any rough sense and how you think about synergies with the rest of the business.
spk06: Yeah, the Citizen revenue, I mean, it's small enough that it's not worth calling out a loan. With that said, last quarter we broke out our data, essentially the revenue from our platform that comes from data, data analysis services, other services, The citizen revenue will go in there, and that's where it fits nicely with a lot of our other data analysis services. And we do have a good view to that line growing more rapidly than the other revenue buckets in the quarters and years to come. And I feel that will be a really important, as we pointed out, this is a really important part of the growth story. We're hitting that. middle era of our business model with these assets as a key part of it.
spk07: Hey, everybody. Thanks for taking my questions. Sean, maybe just the first one, kind of big picture, looking at the chart you usually show, the last chart and slide on the evolution and where you are and where M&A was part of your strategy and coupling that with the comments and on kind of more rationalized spend to a certain degree. I'm just wondering from an M&A perspective, should we expect a bit of a pause here, maybe a shift towards more organic-related investments going forward, or is it still, if opportunities come up, you know, and they're attractive and make sense for the business, you'll still examine them? I'm just trying to wonder where you're thinking in terms of organic versus inorganic as we move into 22.
spk06: Yeah, no, I appreciate the call and, you know, a good opportunity to provide more clarity. No, just to be clear, we still believe... corporate development M&A is a key part of the growth strategy going forward. As Roxy pointed out, we are, you know, in our metrics dashboard, we are looking at operating leverage, you know, cash flow as a percentage of revenue. And as we've always said, the goal, you know, the single financial goal is massive and dependable operating cash flows. So that's kind of where we're heading. But just to be clear that that is in the context of growth and investment, that's a ratio of our revenue growth, ratio of our revenue. So we're tailing off the investment growth, but the absolute investment underneath our very high revenue growth is still going to be quite high, and M&A will still be a part of it. There are only so many targets out there. We take a look at a lot of them. To the extent People are looking for contacts as we finish the call. I mentioned there's digital capabilities, patient workflow capabilities, digital health and clinical decision support tools. Those are things we are really active in and see great opportunities in. With that said, we are always, of course, interested in things that we can integrate into our platform and drive new disease areas, new content. and, you know, kind of further fill in for an individual from birth to death the stages of life which we think genomic information can be most impactful.
spk07: Great. Thanks for that. It's very helpful. And then, Michelle, maybe one for you on your timeline. You spoke about the kits, rolling that out in international and in the U.S. I'm just wondering how important do you think is driving that decentralization of testing to the overall business as you see it?
spk05: Yeah, I actually think it's quite important. If you look at the number of cancer patients that are outside the U.S., let's just take the EU5 as an example. We're talking about just as big of a market or even bigger from that perspective. And in the EU countries in particular, but also in Asia where you can use the CEIBD as your mark, you find that decentralized plays a very, very key role, especially in the somatic therapy portion. And we also know from one of the studies I referenced in my call was the MET14, Exxon 14 study out of Japan that showed the value of our products compared to the competition in terms of accurately detecting MET14. So I think all of this will tie together. But getting that IBD registration done is a key part of our growth strategy from the oncology somatic side.
spk07: Good. Thanks for the time. Appreciate it.
spk13: Your next question comes from the line of Puneet Suda with SVB. Your line is open.
spk02: Hi, Sean, Roxy. Thanks for taking the question. So first one on ASP, and I don't know if you covered it already, but sort of how did the ASP trend throughout the quarter that has promised for higher reimbursement, but unfortunately it's going to obviously take some time to come in. So there's a little bit of a gap here where obviously we're seeing impact in the quarter. So how should we think about AS being sort of this sort of near to midterm till we get to the other side when we have more somatic NGS, both tissue and potentially liquid and PCM as well?
spk09: Yeah, thanks for the question. You know, ASP is a relevant measure for certain testing products. And we're paying attention to the trend. It goes without saying. And we're doing a lot of work in areas such as pricing and revenue cycle management and people manage the life cycle, life science industry manage these type of metrics and practices. We're doing a lot of work and paying a lot of attention to it. In addition, as you said, right, the certain new product we plan to introduce in 2022 have the potential to give us a higher price point. But going forward, you know, we will give you a more consistent and balanced perspective to, in addition to, as we continue to measure ASD, but, you know, in addition to ASD, we'll provide you a set of metrics to help you measure the progress of the entire platform you know, number of patients, as we said, coming into our network, and number, you know, revenue per patient, and number of patients that are giving us consent, agreement for external data sharing, and down the road, the sets ARR. All these measures will, over time, will depart from the ASP, strict ASP calculation.
spk02: Got it. Okay. And then in terms of MRD, obviously, this market is rapidly expanding. Obviously, there is significant potential. But as we think about, Sean, as we think about the positioning of PCM in that market and the differentiation that it brings to the market, Just trying to understand, I mean, you gave, you know, details around a Maria trial, a couple of other areas where you are investing into data and trials. So that's really helpful. But just trying to understand how does the assay sort of differentiate? I know things are early, right, versus the two other competitors that are in the marketplace right now and potentially others coming to this market.
spk06: Yeah, no. I appreciate the question. I think, again, to set context, we're fairly certain that, you know, like a lot of the disease areas that we are getting into or into, you know, over time, and, you know, again, we think this is soon, you know, we'll see. We believe this will shift to, you know, identifying who's at risk in the first place and then setting them up to better monitor and better prevent that disease and then direct targeted therapy when the disease is diagnosed, and then that will lead directly into the follow-up monitoring of that disorder. And it is our genuine belief that the companies that can provide those services across that arc of care will be in a position and can help the clinicians, not just the world's experts in molecular oncology, but all oncologists understand, they and their patients, what to do next. is really going to be the key to getting this information used as standard of care. So one answer to your question is in the context of the broader arc of patient care and all of the digital tools and services that Rock covered on the call, that's one part of how we intend to have the provisioning of our genomic information used to differential advantage for a given patient. For the actual head-to-head, I think actually Vishal was just at the TME conference, and I'll let him kind of speak to some observations, kind of fresh off a discussion with all the key opinionators therein.
spk05: Yeah, thanks for the question. You know, it's an interesting time for us here. I mean, the whole MRD concept is really starting to – both oncologists and surgeons are starting to pay a lot of attention to it now. But it's still very much starting, right? There's a lot of opportunity for growth for all companies in this space. And I think the big question that you ask is, you know, what differentiates you guys from what other people are doing? And I say here, it's like everybody talks about sensitivity and specificity, but what's really important here is to make sure that you can have something that is tumor-derived, which is something that we do, We make sure that you can be sensitive enough by having a large number of variants that can be detected, which we can. And the third thing, obviously, is to reduce the risk of a false positive result, which we can with the AMP technology that we got out of the Archer DX acquisition.
spk11: So all of them together, and then on top of that, you put it all together. And then you go, how do you enable testing to occur?
spk05: We can do that both in a centralized model and a decentralized model through a kit-based approach. So I think all tied together with the tools that Rakesh was talking about, with the software tools which then allow for the patient outreach to be there, the education to be there, I think we're well-positioned to be successful in this space.
spk02: That's super helpful. And if I could also just ask my last question on, you know, Sean, traditionally in Vitae has been a price rationalization, a rationalizer in the market, if I could say, especially in germline setting. So, Now, you know, as you look forward to next year and beyond, should we start viewing the company as both competing on data and price rationalization, or just help me understand that dynamic based on what Vishal and Rock had provided today?
spk06: Yeah, no, I appreciate the question. I think, first, it's worth noting that where a price exists, you know, taken that price. Where we have used price to grow volume or used price to grow markets, it's where there is no reimbursed criteria for a given service that we actually think is really valuable for extending life of our customers. So I just want to make that distinction first and foremost. The price game and our cost advantage we have put to use to grow markets and grow volume and get this information in the hands of individuals who otherwise the system, our industry, wasn't going to serve. We view it very much the same way in oncology going forward. Now, the nice thing here is there is well-established and very high pricing for the specific tests and services that Vishal mentioned. There is an immense amount of pent-up demand, and the digital health tools that Rock mentioned we think are going to be essential to unlock the utilization of that information because, frankly, as Vishal pointed out, there's very few key opinion leaders that are kind of actively thinking about the monitoring and use of the monitoring information, even while, as Brock pointed out, most oncologists are coming around to the perspective that the genomic variation in the patient's cancer has something to say about how it's treated, but very few of them are really adept or comfortable with actually having that conversation. And if any of you listening to this call has had a loved one try to battle cancer, try to get them that information in a timely manner to make decisions, it's very much a workflow and data issue at this point in time. So we think both are important. But just to be clear, really high pricing offered by CMS and anybody else, we will take. And then for the remaining 28 million cancer patients around the globe that don't have reimbursement coverage, that's where then our cost advantage and our distribution we think can really come into play, whether serving at the individual or the government level.
spk13: Great. Thank you. Your next question comes from the line of Brian Weinstein with William Blair. Your line is open.
spk00: Hey, thanks for taking the question, guys. Good afternoon. So, obviously, I mean, genetic testing is not as routine as it should be, and you guys are clearly focused on improving that. I'm curious on, like, studies like the American Heart Association study that you talked about, how meaningful are these studies? I mean, do you have any kind of information about, you know, how genetic testing changes on any of these genes? Do you have any information on kind of what the uptake is of genetic testing in key disease states? And then second question is around the DTC stuff that's going on. I don't know how broadly it is, but here in Chicago, I can't turn on my TV and not see an Invitae ad on TV talking about the importance of genetic information. So can you talk about the thoughts behind that strategy and any returns that you're seeing on that at this point? Thank you.
spk06: Great. Thanks, Brian. So let's see. I tell you what, I can answer the second one right now. Our DTC efforts, in fact, you happen to be living in our pilot core target region. So for all of you who are thinking, wow, I don't see any NBDA ads, that's because we specifically target the city of Chicago. And that's in an effort to test out a variety of different media and applications. direct marketing approaches, which we do think are, in the long term, going to be essential as we start talking about everybody in modern medicine, not just folks that are healthcare provider sales effort. And we're learning and evaluating and adjusting the upfront, also, frankly, clinicians that respond to direct marketing. So that's what you're experiencing there, and that's, like I said,
spk11: or longer-term sales and marketing. The utility of the study... Here's where, you know, our view is that the... And I think if we can just go back many years...
spk06: we at one point in time were met with the question that with a total market size of 250,000 hereditary breast and ovarian cancer patients a year, why would we even bother with the idea in the first place? And it is because of those studies, the studies just like that one that we have contributed to year after year after year, we have seen the addressable market for hereditary breast and ovarian cancer expand dramatically. Recently, with guidance coming from key opinion leaders in the space that very likely, you know, coverage extension, at least input being given, is that reimbursement should go for any of those studies.
spk11: We'll see it in other cancers accordingly. And then also on the pediatric medicine side, you know, just getting the data out there and publishing just how impactful genomics can be from a health economics perspective and showing the diagnostic yields north of 40-50% for a lot of kids with these rare disorders, you know, that is, we feel, essential activity to growing the size of the market.
spk06: You know, unfortunately, it doesn't show up right away, and it doesn't turn into a and we'll just continue down that path.
spk00: Thank you.
spk11: Your final question comes from the line. All that detail on the oncology pipeline. So just a couple of questions.
spk14: What's holding you back from putting more commercial resources behind the assay sooner?
spk11: Yeah, I mean, a little bit of it is wanting to get the COGS. I'm on COGS today, you know.
spk06: between us driving revenue volume north and incurring the cost, particularly of new product introductions. I think, as Roxy pointed out, our mature product lines are pushing 70% gross margins.
spk11: The new ones tend to be lower. And even a product with good reimbursement. Two is the scale of operations.
spk06: It's a little more complicated approach. operation to get up and running than just getting saliva or blood samples. We want to make sure and get that right, have the customer experience be where it needs to be. And then also, and as we pointed out, we get our view on reimbursement for our offering in January of next year. And, you know, driving too much volume before then, again, leads to the problem we mentioned, the decision on how hard to push it commercially.
spk14: That makes sense. And then, Sean, it was unclear from the graphics, from a data perspective, what data you'll have at launch in Q2 of 22. The TracerX, Maria, it looked like that could come out at any time in 2022.
spk05: Yeah, I can try and answer that. So the TracerX publications are already part of it, out already in the lung cancer space, and there will be more of it coming out very close to launch or right after launch. And then as we get some of these retrospective studies done that are in process right now, we expect a lot of that to come out in the early part to middle part of 2022. Helpful caller. Thank you.
spk13: There are no further questions at this time, Mr. George. I turn the call back over to you.
spk06: Thank you, and thank you again for joining the call today. You know, look, in many ways, the future in which genetic information drives everyday medicine is coming into view, and we'd like to offer the diversity and growth across our entire business and kind of the emergence and increased growth profile from our data business. will be a significant driver of value for patients, providers, all the stakeholders in the modern healthcare ecosystem. So thanks again for joining us. I look forward to next time on the call or future conferences.
spk13: Ladies and gentlemen, thank you for your participation. This concludes today's conference call.
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