Ladies and gentlemen, thank you for standing by, and welcome to the Invitae's first quarter 2021 financial results conference call. I'll now turn the conference over to Laura D'Angelo. Thank you, operator. Good afternoon, everyone. Thank you for joining us for our first quarter 2021 results call. Joining us today are Sean George, our CEO; Shelly Guyer, our CFO; and Katherine Stueland, our Chief Commercial Officer. As you listen to today's conference call, we encourage you to have our press release available, which includes our financial results as well as metrics and commentary on the quarter. 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 our future financial and operating results, our plans and prospects, the focus of our business strategy, our plans to integrate and manage businesses we acquire, market opportunities, future products, services, our product pipeline and the timing thereof, demand for and reimbursement of our services, and our, and vestment in our infrastructure and operations, constitute forward-looking statements within the meaning of the Safe Harbor provisions of the Private Securities Litigation Reform Act. It is difficult to accurately predict demand for our services, and therefore our actual results could differ materially from our stated outlook. Statements on future company performance assume, among other things, that we don't conclude any additional business acquisitions, investments, restructurings, or legal settlements. We refer you to our most recent 10-K, in particular to 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 the date hereof. To supplement our consolidated financial statements prepared in accordance with 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, 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 combination, adjustments to the fair value of certain acquisition-related assets and liabilities, and acquisition-related income tax benefits. We exclude from our non-GAAP cash burn, as applicable, changes in marketable securities, cash received from equity financings, and cash received from exercises of warrants. In this period, our non-GAAP measures 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 earnings slide deck. With that, I will turn the call over to Sean. Thanks, Laura. Good afternoon, everyone. We've had a very active start to the year. Our progress toward establishing genetic information as the standard of care for patients facing key healthcare decisions throughout life continues to accelerate. Each patient has an incredibly important and unique journey, whether a family desperately seeking earlier and better answers for a sick child, a woman who deserves access to cutting-edge genetic information as she embarks on having a child, or a cancer patient who will benefit from the molecular characterization of their cancer, regardless of stage, so they can receive better, more personalized therapy selection and post-treatment monitoring as they fight the most important of fights. It is the collection of these patients in total and our ability to help them that drives our aggressive approach to improving healthcare by bringing genomic information front and center as medicine's new vital sign. We mark our progress toward that goal through the strong results we deliver. Q1 was a great quarter for us, and our key performance metrics indicate that we are steadily shaking off pandemic impacts and looking to rapid expansion in 2021 and beyond. We've taken strong measures to shore up our cash position, adding $1.6 billion to fuel our ongoing mission. We'd like to welcome our new investors and express continued gratitude to all of our shareholders for sharing a long-term vision for how genetics can help transform healthcare for all. Because we've had multiple announcements and opportunities to communicate with investors about financing and M&A activities so far this year, I want to keep today's prepared remarks focused on our progress in other clinical areas and highlight the continued build-out of our global genetic information platform. Before we do that, Shelly will walk us through the Q1 quarterly results and outlook for 2021. Shelly? Thank you, Sean. We generated revenue of $103.6 million in the first quarter, representing a strong 61% growth from the first quarter of 2020, in part due to acquisition-related activity. This growth was achieved despite some lingering impacts of the pandemic. In the first quarter, 59% of our revenue came from third-party payers and 33% from biopharma partners and other B2B customers, primarily hospitals and medical centers, with the remainder coming directly from patients. Our third-party payer revenue remains strong, largely due to continued improvement in commercial third-party payer performance across all test types, but particularly with our hereditary cancer and NIPS tests. Why the percentage decrease in revenue from third-party payers as compared to the first quarter of 2020? The decrease is primarily driven by a change in our oncology business customer mix, which now includes a greater proportion of biopharma and other B2B partner customers. Consistent with our discussion of ASP trends last quarter, we realized an ASP of $383 this quarter, down from $408 in the fourth quarter. The decline was primarily driven by a shift in payer mix from third-party payers to patients. Changes in product mix also impacted ASPs this quarter, as we saw a rise in the proportion of reproductive testing with lower ASPs as compared to hereditary cancer and CNP, or cardio-neuro-peds, tests. Progress with third-party payers represents a notable source of leverage as we look to the rest of the year. Our many investments in our platform and willingness to provide early access to patients ahead of the payer adoption curve continues to bear fruit. However, changes in payer and test mix will cause our ASPs to bounce around a bit over the next several quarters. Note that we expect ASPs to benefit from the launch of our oncology therapy selection and disease monitoring products, both as LDT services and as regulated clinical products in the coming quarters and years. As the business has developed, billable volume has become our key volume metric and an important benchmark, given that we accrue the majority of our revenue based on the number of billable reports in a period. We are pleased to report a 72% growth in billable volume from the previous year, with approximately 259,000 tests in the first quarter. We saw this growth despite the continued effects of the pandemic, as well as some very tough weather across the states that caused some disruptions. We attribute this tremendous growth to some catch-up on the testing backlog, a seasoned sales force now more able to visit with clients, taking share from competitors, and an ever-increasing acceptance of genetics due to the continued flow of research and publications. Internationally, we saw volume growth that was slightly ahead of our U.S. business and represented nearly 18% of total billable volume for the quarter, driven by the strength of our decentralized oncology business and our continued expansion in Europe, Japan, Australia, and Israel, to name a few. As we've noted in prior quarters, it's easier to understand our business and financials by providing non-GAAP metrics. Most line items on the P&L are affected by acquisition-related charges. To allow for the comparison of the two sets of numbers, we urge investors to review the detailed reconciliation to non-GAAP in tables included in today's press release and at the back of this slide deck. For the remainder of the call, we will discuss non-GAAP numbers, including cash burn, which we believe provide a more relevant depiction of the operating business dynamics. Our non-GAAP cost per unit, now defined as the total non-GAAP cost of revenue divided by the number of billable units in the quarter, was $242 in the first quarter. This is up from $227 in the fourth quarter, largely due to lower accession conversion ratio, since a large number of samples received in the quarter were not billable in the quarter, and to a lesser extent due to some new assays we ran, which were not as efficiently processed as more mature products. Recall that we moved to looking at COGS per billable unit when we moved away from reporting accessions due to the addition of our somatic products, many of which do not have accessions. Historical comparisons must be viewed with caution. Non-GAAP gross profit was $40.5 million in the first quarter, which translates to a non-GAAP gross margin of 39%. The lower margin is partially due to the timing issue, billables versus accessions, that increased our COGS in the period. Our margins were impacted by our mix. Our reproductive volume grew faster than other parts of the business, this comes at lower margins. We expect that increased collection rates on NIPS and decreased COGS over the next several quarters will positively impact our gross margin. Recall we continue to target 50% gross margin in the long term. Non-GAAP operating expense, which excludes the cost of revenue, was $155.4 million in the first quarter compared to $145.9 million in the fourth quarter. We continue to invest in our business in the following areas: research and development, which was up nearly $14 million, mostly due to headcount increases, but also new external development projects, primarily to modernize our platform, build out content across all arcs, improve COGS, and create a more patient-centered experience benefiting patients and physicians. In addition, selling and marketing was up nearly $4 million, also mostly due to headcount increases to facilitate volume expansion internationally. General administrative expenses decreased by $8.5 million over the fourth quarter, mostly due to a decrease in acquisition transaction costs of $12.6 million associated with the ArcherDX acquisition. Given the stabilization of the markets and the opportunities in front of us, including multiple M&A ideas worth assessing, we will continue to make prudent investments in projects, programs, and acquisitions. Notably, we closed One Codex in February and Genosity in April. In addition to acquisitions, we expect that OPEX for the remainder of 2021 will continue to increase as we invest primarily in R&D and marketing and as we build out our new facility in North Carolina. Cash burn was $112.3 million in the first quarter, including cash paid to finance and close acquisitions and associated expenses. Excluding acquisition cash paid, primarily related to One Codex, our burn for the quarter would have been $94.6 million. Moving to our cash position, cash equivalents, restricted cash, and marketable securities totaled $681.9 million at March 31st, compared to $360.7 million at December 31st, 2020. Our January equity offering netted $434.3 million and is included in these cash figures. Importantly, post the quarter close, we raised an additional $1.1 billion net via a private convertible offering led by SoftBank. On a pro forma basis, this puts our cash as of early April at over $1.8 billion. To close, our Q1 revenue and current trends have us increasingly confident that we will exceed the $450 million in revenue guidance for the year. We will reassess and make any necessary adjustments to that target when we report Q2 results in August. Now, I'll turn the call back over to Sean. Thanks, Shelly. As I look at the results from this quarter, I'm encouraged to see how past investments in our platform, menu, and customer experience drive our ability to serve more and more patients year after year. Many of you may recall years ago when we were investing heavily to build out our women's health capabilities. Throughout last year and continuing through this quarter, we're seeing those investments bear fruit. Women's health now represents nearly 30% of our overall business as we create new markets and take share from competitors and drive strong growth in new customers. For example, we added over 2,600 new accounts in the first quarter alone, and we're seeing durability in our customer relationships once established. As we think about the investments we've made last year into the present quarter, we're attempting to drive the same virtuous growth cycle. All of this gives us increased confidence in driving strong annual growth into the coming years. To support and enhance this rapid growth, we're moving ahead with both domestic and international expansion plans. We are expanding our commercial footprint, local fulfillment, and product infrastructure for our fast-growing international business. In addition, we announced in April that we've signed an agreement to open a new major production facility near Research Triangle Park in North Carolina. When up and running, this facility will double our capacity, strengthen our operations, and help us offer industry-leading turnaround times, including for customers across the Atlantic and in South America. The opportunities to build out our platform and to bring more customers onto it remain attractive and numerous. We anticipate maintaining our invest-on stance through the remainder of the year. As we indicated last quarter, our planning to increase the rate of investment above the baseline of Q4 2020. Our strong cash position allows us to deploy resources thoughtfully to extend our reach into new geographies, accelerate commercial launch plans, and pull exciting development programs forward. I mentioned earlier the example we see of the investments we made years ago in women's health driving significant growth today. I'd like to take another moment to share a similar example, one that illustrates how our approach is transforming patient care. Many of you know our Behind the Seizure program, and some of you may have spotted this story in the Seattle Times about two fathers and their young daughters. One family faced obstacles that are sadly still typical for sick children. They waited three years for a clinician to suggest genetic testing and were told it would cost $25,000. After pleading with insurance companies, they were finally able to have their daughter tested. She was diagnosed with Batten disease, a genetic disorder affecting around three of every 100,000 people in the U.S. Tragically, her disease continued to progress and ultimately took her life. The other family's experience shows what is possible when barriers are eliminated in ways that spur clinicians to embrace genetics. Early on in their daughter's care, a neurologist suggested genetic testing through Invitae's Behind the Seizure program. She was tested quickly, at no charge, and was also diagnosed with the disease. Fortunately, the intervention happened early and quickly, slowing the progression of her condition. I tell this story to point out the wide gap in the way the system currently works and the potential for our platform to transform care. We began investing in programs like behind-the-scenes years ago to open access to testing and drive adoption by clinicians. These programs are creating a virtuous cycle in which more patients are diagnosed and effective treatments are developed and directed to those patients sooner. This was one of our earliest programs, and we've now created many more like it. All have potential to push diagnosis and treatment earlier across clinical areas ranging from rare disease to common cancer. The ecosystem we are helping create will drive better outcomes for patients across a wide swath of healthcare. Our platform can bring together pharma, biotech, clinicians, and researchers in a way that drives better, more efficient, and personalized care for a small cost compared to today's trial and error search for an accurate diagnosis and effective treatment. The value to the healthcare system and benefit to society is immense. What you see here shows how genetic information unlocks better outcomes throughout the system and at all stages in life. Early in life, risk identification helps create a personalized approach to monitoring for health issues that may develop. For example, undetected cardiovascular disease in young athletes and breast cancer in young women. As we move into the middle and later in life, biomarkers replace trial and error, giving patients access to better therapies. Throughout, the combination of genetic and health information and the ability for patients to access it further fuels personalized care, patients benefit, as do drug discovery efforts through improved research and better, faster clinical trial programs. Finally, for those who ultimately do end up facing a life-altering health crisis like cancer, targeted therapies guided by universal companion diagnostics and personalized monitoring mean better outcomes. It then circles back to where we begin, with genetics of a patient providing an understanding of potential risk for their family members. This is why we believe, and ever more clinicians agree, that genetic information is becoming a new vital sign, one used to guide healthcare throughout life. That vision of healthcare translates roughly into the large addressable markets we are targeting. While a lot of attention gets focused on cancer, the reality is that genomic information is becoming increasingly crucial to healthcare all throughout life. We believe the majority of expecting parents will have ready access to genetic information when starting a family, and young adults will receive it as they transition out of childhood. Along with starting a college fund or investing in life insurance, it will become standard to invest in a baseline genetic profile that can inform medical decisions throughout that person's life. The massive amount of genetic data will, in turn, drive faster and better drug discovery, trials, and outcomes, increasing the quality of life. We have before us an incredible opportunity to serve billions of people and develop healthcare markets worldwide and help drive a fundamental shift in the way healthcare is delivered. As we think about where we are today, we see the pace of adoption toward that future rapidly accelerating. We see it in our business. We see it in clinician behavior. We see it in changing guidelines and payer decisions. We see it in drug development and clinical research. We are entering the steep slope of the genetics adoption curve, and we intend to lead the industry through it. We are playing to win. Our strategy is unique, and our vision is ambitious. The future we've long discussed that sees genetic information driving mainstream medicine is coming into view as a reality. We are aggressively focused on establishing a global infrastructure and delivering the most comprehensive menu of technologies and services through that platform to every patient who can benefit. We are committed to doing what it takes to compete across medical specialties and to drive access to billions of patients in need and to an entire new generation who will view genetic information as a standard baseline for all their healthcare decisions. With that, we'll now turn the call over to the operator for Q&A. At this time, I would like to remind everyone, in order to ask a question, press star in the number one on your telephone keypad. Your first question comes from Tycho Peterson with JP Morgan. Hey, good afternoon. Sean, I'll start with Genosity and just wondering if you could talk a little bit more about the thought process, why this was kind of the right time to do that deal. I think you noted at the time this could actually expedite the path to market, reduce the costs, and accelerate the traction of the ArcherDX PCM LDT. Why do you feel like that's the case? Maybe you could also just touch on the 40% of Genosity revenues that are not tied to ArcherDX, and is there an opportunity to kind of leverage that too? Yeah, no, thanks. The short of it is, while the ArcherDX capabilities are great, standing up PCM as a laboratory-developed test and getting it all validated, approved, built into our kind of our infrastructure, our tech infrastructure, was going to take some time and expense. With the team at Genosity already having that up and running, again, 60% of their revenue was very much engaged in running that for biopharma partners. We know it works. We actually know the team there by many years in the industry. Really great team. It proved to be a great opportunity to accelerate our broader commercial launch for PCM. We hope to do that broadly through our commercial channel as an LDT sometime this year. Saved a bunch of time and cost development for kind of the process and systems that were already existing there. The remainder of the revenue, I think it's kind of a kind of thing where I think a lot of it is contractual, so much of it will remain and continue. Some of it is indeed to other players who may or may not view themselves as competitors in that kind of situation, which isn't a new situation for us. It's a handful of our acquisitions in the past. We've been there. We always just, again, you start with what's best for the patient, continue that service, continue that care, and then they'll all make their own decisions in their own time. Again, I think we'll continue to try to suggest that those personal cancer monitoring services and those kind of therapy selection services they offer are best in class, and we're only going to make them even more scaled and available globally. That's the way we view that to your question. Okay. A follow-up on Genosity, are you able to comment on the litigation with Natera? Is there kind of a timeline we should be thinking about in terms of next steps? No, not really able to comment on it. It's an active litigation. I think, again, we anticipated and took count of that before the acquisition, and same on Genosity. Okay. On the balance sheet, you highlighted $1.8 billion in net cash. Can you just talk a little bit about how you're thinking about M&A and inorganic investments? Obviously, you're taking up organic investments as well, but how are you thinking about inorganic at this point? Yeah, I think we're on the M&A front. The space is moving a lot, there's a lot of really interesting capabilities out there. With that said, we're mostly thinking about shoring up the balance sheet, making sure to always have a clear path to operating cash flow positive, right? Obviously, with our level of investment now, you need a little more of a cushion to get there in the coming years. Specific things that we know we are going to be investing in, the PacBio collaboration which we announced earlier, as I had mentioned, there are kind of different speeds you could imagine that going. We can now really put all we can into that, from our side at least. The additional production facility in the East Coast, this allows us to better turnaround time, lower COGS. Frankly, we're kind of bursting the seams here on the West Coast, this was a needed expansion. Now this capital allows us to really get after that right away. Of course, continued investment in ex-US. Outside the U.S., we continue to see really great pent-up demand. Our business now is moving north of 15. I think it's almost 18% that's outside the U.S. As we've stated, I'd be surprised if in three to five years it's not 30% or more. There's a lot of opportunity. There's no global player in genetics, that's an area we want to be able to keep investing in. Not to mention, of course, all of the exciting development programs that we tend to meter for a reasonably early return on investment. This allows us to look at some of the more exciting ones and try to accelerate them. I think that's the bottom line of the use of capital, are those kind of things that we wanted to make sure to just keep after this year. Great. Last one on gross margins. I understand kind of the mix dynamics weighing on the margin this quarter. I think last quarter you talked about potentially getting to 50% by the end of this year, and now you're kind of saying 50% longer term. Maybe, Shelly, can you just talk about when you think you'll actually hit that 50% margin target? Yeah, I think by the end of the year or early the next year. One thing to note is that we did have quite a difference between the accessions and the billables in this quarter. If you actually did put through all those accessions and the billables in the quarter, that COGS per unit would have dramatically changed. Something like 10% falloff between the accessions and the billables. You're not getting those in the first quarter. You'll get those in the second quarter. You had all the costs of those accessions going through in the first quarter, so it's really hampering you by several, probably 6%, 7% on your COGS and on your gross margin. I think it's important to remember that we do have seasonality, and the first quarter is always the worst, about 10% of the first quarter. Generally, the second quarter is closer between the accessions and the billables. Okay, that's helpful. Thank you. Thanks. Your next question comes from Doug Schenkel with Cowen. Hey, good afternoon, and thank you for taking my questions. Shelly, anything you can give us? I mean, ideally, we'd have organic revenue growth or something on ArcherDX, given this is just the second full quarter. Can you share anything with us that would help us track how ArcherDX is tracking from a growth perspective sequentially and relative to plan? Yes, I think your first comment was that we don't generally break these things out, and we promised to do it only in the fourth quarter and then to integrate it with the rest of the business because the business is one platform. It is integrated, we've changed the priorities for what the former ArcherDX is looking at in terms of collaborations and things like that versus the priority of getting the LDTs up and running and that sort of thing. We're not really looking at it as a standalone business. I think it was a very solid quarter for them. We had noted some COVID issues in the fourth quarter of last year. We're seeing some of those things work themselves out. It's exactly where we would have expected it. I would say, if you took a standalone company that was looking for an IPO, and you look at what those revenues were expected to be in 2021, that is not the trajectory that we have them on because the priorities have dramatically changed as now they're part of our platform and working together. Did fine. Don't break them out. Integrating it nicely so it is one platform, one oncology offering, etc. Yeah, Doug, I might add. It's basically oncology is about 50% of our business now. I think the best way is just going to be marking that and seeing the top-line growth, and it's that relative position within it, which will underlie the comprehensive risk therapy selection and monitoring progress we're making. I totally understand. At the same time, given how acquisitive Invitae is, I think a few of us are going to continue to push for some mile markers that we can use to kind of measure the success of acquisitions. They're obviously not all going to work. Hopefully, more of them work than others. That's the reason I'm pushing. Is the metric you would like us to use to make sure that, in the midst of all these acquisitions, that the growth is more than just inorganic efforts? If you're not going to break this out, then how do you want us to define success or assess success for you? Yeah, I think if we're looking let's say Archer specifically, what I would say is, well, that's now folded into our oncology business. We'll certainly be talking about what percentage of the total that is. That should be growing. That should be growing at a clip that satisfies the question of inorganic versus organic growth. Layered in there, of course, we'll have regulatory submissions approvals. We'll have product launch milestones, and I think we'll have discussions. Very similar to, I think, as we look back to reproductive health, right? We had a reproductive health offering, a modest one. We purchased CombiMatrix and Good Start. We then started talking broadly about reproductive health, its growth year over year. Then kind of as we've seen now, that growth is picking up now and becoming it's close to 30% of our overall business at this point. I think that's given a really good view into what those acquisitions did for us by giving us a broader menu to accelerate the top line of that business. I think that's the same tracking I think we can provide for the Archer acquisition and Genosity acquisition for our oncology effort. Okay, that's super helpful. I guess one more on just the ArcherDX transaction. I mean, some of the ArcherDX customers that were being supplied with ArcherDX kits are folks that I believe could be at least broadly defined competitors to Invitae. Is there anything you can share on just customer retention with that dynamic in mind? Yeah, I think that there are certainly some players, both commercial partners and direct customers. I'd say that we're continuing on and serving them as before. My general sense is the call point and the use case is probably distinct enough where there's probably not a whole lot of issue here in the early years. Out years, a year or two from now, maybe everybody will think differently, but right now, it's not a major point of contention at this point, let's say. Okay, thank you guys. Actually, last one, Sean, this is probably more a Shelly question. As we think about the North Carolina facility, the logistical benefits of having a facility there are pretty clear and were well articulated. The other dynamic there is it does tend to be less expensive to run a lab in North Carolina than in the Bay Area. Over time, should we expect some COGS improvements associated with the opening of that facility? Yeah, I think so. Remember that the vast majority of some of those costs are basically the units, the reagents, the equipment, and that sort of thing. It's less of the labor cost. You will have a savings on that proportion which is labor cost. Remember, a lot of the labor cost is going to be the people who are reading and the interpretation, and that can take place anywhere. Yes, you will have some benefit from those labor reductions. I really look at it, though, not only from what Sean said before, also a diversification of our risk. We are in the Bay Area. Having another site that is large and capable of continuing to operate, if anything should happen in the Bay Area, is exceedingly important to us as a risk reduction method. The final thing would be, from a cost perspective, if you can ship quickly to the East Coast and you can ship internationally from some of the European sites, etc., you get a big cost savings also on some shipment costs, depending on what zones you're in. It's not just the cost of the labor that you should think about, but also some of those ancillary costs that will be helped by having an East Coast facility. Got it. Okay, thank you again. Thank you. Your next question comes from Puneet Souda with SVB Leerink. Hi, Sean and Shelly. Thanks for the question. First one, I just wanted to ask you on. In terms of the full-year guide and what you can provide onto the second quarter, I just wanted to get your view on what you're hearing from the field recently. I mean, sort of what% of the reps are in-person versus still remote? I mean, just asking that because you're maintaining a full-year guide here for $450 million, given the level of vaccination sort of we're seeing out there and in terms of comparisons, you have a much better comparison the second quarter. I know there's ArcherDX contribution here as well. NIPS volumes are growing. Based on what Shelly had said, some of those accessions are going to turn into billable. I just wanted to get your sense on the second quarter volume growth. I wasn't clear if I heard that earlier and any puts and takes to that. I think that I think the informative piece on the quarter was obviously, the year started choppy, not just for us, for a lot of people. What we're saying is obviously, the back half of the quarter picked up really nicely. We pointed to more than 2,600 new accounts created just in the quarter. The last time we last year, that metric was kind of blown out. COVID kind of made that metric a little meaningless, there was the year before, the total for the entire year was something like 7,000 accounts. We're definitely pleased with kind of what looks like we're coming out of the pandemic impact. We're definitely pleased with new account formation. We are seeing more and more reps getting active in their locales. With that said, we're also seeing on a case-by-case, sometimes a rep-by-rep, certainly territory-by-territory basis, that some places are going backwards. Some places are just changing access. Then, of course, ex-US, right? It's still a little bit of a thing. That's why we, as we sit today, we're optimistic. I think I certainly feel good about the call that we're going to exceed 450. As this quarter played out, I think that was the right call to be making. We'll see. We'll see how the next quarter goes. I think if everything kind of continues to play at the top line, we might reassess at the next quarter. Right now, I'd say it's a little early to get too far ahead of ourselves. I'd say just I think we called the year right at this point, and it's playing out about as we expected. Okay. In terms of ArcherDX, obviously, that's an important question given the contribution to the growth and given the importance of the franchise to the overall building out the oncology franchise. Maybe can you give us any sense of and I know you're not breaking this out, but anything should we still assume the 50%-60% growth profile that you had pointed out earlier? I know Shelly mentioned that they had some IPO numbers, which are not to be considered now, but maybe 50%-60% sort of if you can provide any contribution of ArcherDX in that or anything that to help us get a sort of gauge for ArcherDX. I know I'm somewhat asking around that earlier question, but that's an important question for the growth of that business. Yeah. No, look, I do think it's an important question. I understand. I think the way that we think about it is if you take oncology business now, right, that oncology business should grow in that 50%-60% profile. Well, frankly, our whole business, that's what we're targeting, 50%-60%. Plus or minus, then oncology should really kind of keep up with that, maybe exceed it, certainly as we get PCM and therapy selection LDTs launched. That's the idea. By tracking that oncology business versus the whole versus the overall growth, we're confident we're going to demonstrate that, much like prior acquisitions, we can take these, integrate them, operationalize them, and then plug them into our overall platform and commercialize them and really kind of contribute to an ongoing high-growth profile. We'll definitely be checking in on that every quarter. How's the oncology business doing? Again, the idea of where we're confident, the idea of understanding risk both at a personal and population level, stratifying patients therein, choosing the right therapy for all stages of cancer, and then monitoring those individuals. We think that that is the precision oncology offering that we're confident will provide significant top-line growth for the years to come. Okay, thanks. If I could, Sean, in terms of the combined versus the just central versus the distributed model, now that you have had some time to look closely at ArcherDX and its customers and those interactions, I'm wondering if you have any additional thoughts in terms of the distributed model versus centralized because, obviously, the centralized has given you nice cost leverage in the past. I'm just wondering, with the new facility coming up, how are you thinking about decentralized versus centralized? Also, I was wondering if you can provide any updates on the timings of PCM. Obviously, they're new product launching in the MRD market. Just wondering, when should we think about the assay being on the market or any performance or any updates on the performance metrics of those assays? Thank you. The PCM I can answer first is we're looking now to get that out as a full commercial offering sometime this year. It's hard to say exactly when. We were, before, thinking about a full-blown commercial offering kind of into the year, into next, and now we'd like to have that be sometime this year and kind of really ramp up to a broader offering of that. We think that's really important. The distributed really, our position on that hasn't changed at all. I think that the closer you get to it, you get a really good sense for the dynamics of what is going to drive a decision for an account to try to run this themselves versus send it out. It doesn't really change market. It's not a market change from our previous view of it, certainly not a market change from the prior ArcherDX team leadership view of it. Again, we're very certain that certainly, large accounts in the U.S. and certainly, many accounts outside the U.S., the ability to support them running their own samples is going to be critical. Like I've said before, and to be clear, this is not a priority right now, that kitting capability, the quality regime around it, the manufacturing capabilities, and the ability to support it is also key for other disease areas that we'd like to be able to offer, reproductive health, cardio, pediatric disorders. Those are things in the future that we're also going to that decentralized model will be important, particularly for larger governments that are interested in us standing up capabilities locally. Got it. Okay, great. Thank you. Yep. Your next question comes from Tejas Savant with Morgan Stanley. Hey, guys. Good evening. Sean, one quick question for you on the OUS setting. Can you just fill in some color on the momentum you're seeing there and how you're thinking about the buy versus build debate in those markets? Similar question on pharma partner revenue trends as well. I mean, what does that look like coming out of the pandemic year? If you can help us sort of break that out in terms of the guide, that would be super helpful. Ex-U.S., there aren't many or I would say the market outside the U.S. is fragmented pretty well along country lines for the most part or certainly, regional lines. In that sense, there aren't that many frankly, there aren't that many buy options that make a ton of sense, right? It's all the work of the buy with none of the scale. I think that's one way that's kind of where we look at it is it's a steady investment. I truly believe, and with kind of experience around this table as a guide, it only works in-country, for-country. That's going to take a while to invest. Good news is we've got a head start, and we're rolling forward on it. A regional buy opportunity may present itself, and that might make a lot of sense. There just aren't many options out there for a broad capability on that front. Let's see. Sorry, the other question. On pharma revenue trends here exiting the pandemic? That's right. Yeah, for sure, some of the pharma stall that kind of was impacted by the pandemic, we see that picking up as well, kind of getting back in action again. We do break out what pharma pays for on our filings. That's the percentage that pharma pays for. We'll continue to do that. The pharma business is important for us very much beyond just the pharma-paid R&D. I mean, frankly, pharma-paid R&D isn't really that great of an indicator of the health of the business. It's helpful from a cash perspective, but it's not a long-term value creator there. The pharma programs are really important for validation, for getting all the data to support both therapy selection and monitoring. Those are essential to keep those going. Of course, then, real action in the future is matching patients to the targeted therapies, doing research on new targets, new capabilities that our network of patients and their data can bring and we can bring to our pharma partners, which we're really excited about pulling forward. The more patients we get, the more different data sets we get on them, it pretends well for the future. Right now, yeah, our mix of patient identification programs and validation and research programs and clinical trials, that seems to have been picking up, kind of also recovering out of the pandemic, and it'll still be an important part of the revenue going forward. Yeah, we noticed that. That was up 33% this quarter. That was a nice uptick from prior quarters. Got it. Just a couple of quick housekeeping ones for you, Shelly. Genosity, are you assuming sort of around $10 million or so in terms of the non-NVTA sales revenue over the course of the remainder of the year? Is that fair, or is that sort of is there room for upside there? Yeah, I mean, we're actually encouraging people. It's kind of de minimis, and with any luck, it'll be in the noise of it. We don't know what to count on for the rest of the business that wasn't. If you remember, 60% of it was a pass-through anyway, you don't really get to book that as additional. The rest of it's unknown how that's going to play out. We don't have a hard opinion about it either. We're just kind of encouraging people to ignore that for now. Got it. Got it. Sean, can you help us think through the impact on the turnaround time once the RTP facility comes online here? I have one final follow-up. This is where I actually, I love this because this kind of shows where we are. We're literally talking 18 hours. I mean, it's not 18 to 24 hours, which is huge. Even more importantly, our shipping bill is getting up there. Being in that shipping zone to maintain those service levels and reduce the cost of it is really key. It's only a day difference, the real important difference is how much you pay for that day's advantage. That's a key to having on the East Coast. In addition, like we mentioned, across Atlantic or to South America, it's a little more straightforward and both faster and cheaper. Got it. One final one for me. With the $1.8 billion on the balance sheet, Sean, I know you mentioned the RTP investment and the OUS expansion, how are you thinking about sort of the cancer screening opportunity here? I mean, that's the one sort of elephant in the room, so to speak, that you don't have today in the portfolio that would make sort of logical sense for you to look at. Yeah, well, we spend an awful lot on development. We get a lot of samples from patients that we have. Who's at risk? We're now performing therapy selection and monitoring on them. I'd say the short answer is yes. We've got at least three technologies in-house that you could imagine we're looking to develop data on early screening. We're very likely going to be focusing on people we know are at risk. That just, from our worldview and the way we deal with our patients and customers, that seems to make the most sense. The people that we already know are at risk, very highly likely of developing cancer earlier. Of course, there are many technologies out there that look pretty interesting and compelling as well. Yes, the cash balance helps us kind of not worry too much about the build-buy decision there. I would say I think it's, again, something we're evaluating. We truly are focusing on what we think the bulk of the action, at least this and next year, will be is in who's at risk, what therapy should they get, and then what's the best way to monitor for the disease, either coming back or to alter the course of therapy. We think that's where the bulk of the action is going to be in oncology. Yes, we are looking to the future and pretty happy about where we are vis-à-vis access to patients, access to samples, the kind of data, and the technologies at our fingertips. Super helpful. Thank you. Your next question comes from Brian Weinstein with William Blair. Hey, guys. Good afternoon. This is Griffin on for Brian. Thanks for taking my question. Just kind of quick follow-up on measuring ArcherDX milestones here. Can you give us an update on Stratafide? That was, of course, submitted to FDA late last year. Received Breakthrough Device designations. Are you hearing anything from FDA regarding a potential priority review? Anything on timing there? Yeah, I mean, again, it's not typically best practice to discuss the discussion with the FDA. Obviously, because this was a part of an acquisition milestone, it obviously is an important question. What I can say is, yeah, it was submitted end of last year. At the time, we suggested, "Look, these things can take anywhere from 9 to 18 months." There's nothing that's changed on that timeline. It's actually a fairly complex submission. It's got DNA, RNA, and fusions or DNA copy number variations and RNA. I would expect that we're going to start to see the initial approval, initial indications on time. That's our general sense. There's nothing that is changing that view right now. We'll keep people posted. It's the kind of thing you kind of know when it happens, and then we continue the dialogue with them for new indications, new targets, etc., from there. Understood. Just one more. Just given how broad your product portfolio is, known inherited disease, family planning, oncology, etc., are there any areas within the business that you're seeing a particularly faster or maybe slower recovery? If so, how is that kind of informing where you're putting time, resources, and investments? Yeah, I mean, I got to tell you, it's hard to measure the market growth against the recovery growth. For example, reproductive health is growing very fast right now. Now, I think some of that's to the extent there was an impact in COVID. Recall, that area was impacted the least in the COVID impact. Now, there's a little bit of COVID recovery. I also think there's just a lot of market growth there, going from the number of women who are getting those services today to the number of women who will get them in the future. We do see in terms of the fastest recovery slope, yes, oncology, particularly on the risk, the early risk side of things, and a lot of the other pediatric and rare disorders, those were the most impacted, and those are the ones showing the steepest recovery at this point in time. It's difficult to tease out exactly, but I think that's a what's market growth versus what's recovery influence, but I think that's the best we can tell right now. Great. Thank you. Your next question comes from Kevin DeGeeter with Oppenheimer. Great. Thanks for taking my questions, guys. Sean, one of your peer group companies with some portfolio overlap called out an R&D day today, 8%-10% kind of organic growth for their business. You're calling out essentially 50%, at least near term, for oncology and potentially for the business overall. I guess maybe sort of two parts to this question. Can you give us a perspective as to how you think of kind of organic growth for the business in the context of that 50% number and maybe a little bit more contextual for some of the key end markets? Do you have a good kind of current feel as we do exit the pandemic with a little bit different dynamics in the market as to how we should think about industry-level growth metrics for oncology and women's health? Yeah, yeah. I do want to clarify. I mean, when we point at 50%-60% growth for the next two or three years, we don't distinguish organic, inorganic. Obviously, very large inorganic additions to that is a little bit cheating. We wouldn't count those. On the margin, there's going to be some acquisition in that, I would assume, over the next three years. If you kind of take that aside, our view is still very much rooted in the fact that the majority of patients who could use this information aren't getting it today. I think even in some of the more developed, like you take carrier screening and non-invasive prenatal testing, I mean, carrier screening, broad panel carrier screening is just now becoming kind of widely accepted and reimbursed by payers. NIPT, we've kind of covered that ad nauseam. Still, there's only 2.5 million women in the U.S., 2.5 million pregnancies or so that are getting afforded those technologies. There's still 6 million pregnancies just in the U.S. On oncology, it's even more. It's even more tilted. The number of individuals getting their cancer staged appropriately, the appropriate molecular characterization or the best molecular characterization is still a very small amount, small percentage of all of the people getting diagnosed with cancer every year. Of course, on the recurrence and the monitoring side, it's greenfield, right? It's essentially a greenfield kind of thing. Our view is that I guess I should have started with risk assessment. Even with a really strong market position we have, we're seeing guidelines move faster than people can keep up with. The markets are double the size of what they were two years ago by way of kind of recommended screening for people for cancer. Not to mention, you just talk about prostate. There's another huge chunk added there. That's really our view, is where you're looking at if you're looking at oncology, you're looking at risk assessment, therapy selection, and monitoring. Risk assessment is yeah, the former markets are reasonably penetrated, but new market size is getting added all the time. For therapy selection and monitoring, it's essentially early days, period. Frankly, if you look out beyond there, it's the same. I mentioned reproductive health. If you look at pediatric disease, same thing. I think we've done a pretty reasonable job with epilepsy, whereas almost 0% of kids with epilepsy were getting appropriate diagnoses. Now, it's not zero, but it's certainly not 100 times umpteen other a long tail of other genetic disorders for which there's really effective targeted therapies on. It's a long way of saying the short of it is the market is growing, and the need is materializing. Now, granted, it has to be at the right price point. It has to be at a level of utility that your average clinician, your average patient can understand, which, of course, is the hard part. That's our view of the growth, what the tailwinds of growth look like. Great. As a follow-up question, I think following up on one of the earlier questions, talking about other potential end markets for growth, with the scale the operation company has and cost structure at Invitae, can you just give a perspective on interest in population sequencing opportunities, both U.S. and there's a number of opportunities that are out there to be at ex-U.S. as well? Yeah. No, I can. I'd say two things. We often get approached by folks who have done pop-seq programs and then are having a hard time figuring out what then to do. The research aspect of it is probably satisfied, but then what to do then to actually communicate? What do you communicate, and when, and to whom, and how do you manage the patients as a result? That is where the pop-seq programs, I think, meet the real world of clinical utility of genomic sequencing. Frankly, I think we're in early days of that. We will see more and more of those coming, and we'll kind of do our part there. I think what's particularly interesting is what you're seeing around the globe is almost a skip to I think ministries of health around the globe are skipping away from, "Hey, let's just do a population sequencing program," to, "How do we do a population-wide genomic program? How do we actually implement genomic medicine for our population? How does it work? What do you need to sequence and when? What do you tell people and when?" Essentially, again, I point to the Genome UK or the NHS report that came out end of last summer. That, I think, is a pretty reasonable blueprint for what a lot of ministries of health around the globe are evaluating. Again, it kind of reads like an RFP for the Invitae business model. We're excited. We're excited to kind of see this discussion spinning up. We're excited to see what we can do by way of enabling from kind of crib to death population genomics and see how it can really bend the curve on outcomes and costs. Thanks. Thanks for my questions. Sure thing. Your next question comes from Ophir Gottlieb with Capital Market Laboratories. Hey, Sean. Hey, Shelly. Thanks for taking my questions. Just two quick ones. I think 2021 was the year that Singular Bio was going to be getting into production for non-invasive prenatal screening, that would eventually impact something like 40% of the entire reproductive business. How is that tracking, and can you comment on possible impacts on COGS? Yeah. This is the year, as you point out. We are going to begin putting that into production. It won't immediately take all of the NIPS volume, but certainly, by the end of this year, we expect to have a good chunk of it uprunning and saving COGS, and then certainly, by middle of next year, transition the majority of it. The extent that it will impact COGS, like you said, it's yeah, if you take a little under 30% of our total business now is reproductive, kind of yeah, I think 35%-40% of that is NIPS. It's a significant impact, and it certainly helps. We look at the margin profile on the overall basis. If you consider reproductive health as a separate, it certainly has a real impact on the gross profit contribution on a percentage basis for those samples. We're excited to see that coming to play. Like I said, by the end of this year, we'll have some good proportion of our NIPS converted over. Can you give any color to the impact yet, or do we have to wait? No, I think we have to wait. A lot of it is kind of when and what portion, which is still something that we don't have 100% visibility to. Okay. Great. There's a possibility that Exome could become an accelerant to revenue in 2021, perhaps in the back half. We would run it essentially instead of panels. Do you have any update on that? We're excited to be moving into kind of the genome-powered era where Exomes and/or genomes are going to be a better way to go, the natural way to go for a lot of differential diagnosis and difficult-to-diagnose diseases. In particular, and this, I think, will be more of a next-year story for autism, developmental delay, intellectual disability. Yeah, we're very excited about that. Again, I think this is where this is just the beginning of kind of the power of genomic scale for some of these conditions. Again, we do think we do good news on that one. The reason we think it'll be one of the growth accelerators is there's a very well-established market for microarrays and panels, microarrays and Exomes used to diagnose these children. Our kind of nearest-term version of that is a single test that covers all of it based on a genomic analysis at the same quality, the same clinical quality for sensitivity, specificity, diagnostic yield, etc. That, yes, we definitely think that'll be a growth driver. Is this something we should be considering in the back half, something to adjust our estimates? In terms of adjust, I think that's one of the things we pointed to when we talked about guidance, we pointed to as a potential upside for this year. I think the timing is still something that whether it's going to have a big impact or not is still an unknown, even today. Okay. Fair enough. I'll take the rest offline. Thank you. Okay. Your next question comes from Simon Barnett with ARK Invest. Hey, thanks for just one question here. Last week at PacBio's rare disease conference, I think several rare disease collaborators mentioned that the relative lack of structural variant information in shared databases made the interpretation step a little bit more manual for a lot of these clinical cases. Staying on the topic of interpretation, I'm just wondering, while these databases are still growing over the coming quarters and years, how do you feel like the functional modeling platform is sort of set up to automate the interpretation of a lot of the more novel variant types that you're going to start picking up as you migrate increasingly more to HiFi sequencing? Thanks. Yeah. No, I mean, it's really to the crux of the question here. Actually, there's two parts. The FMP portion, the FMP module of our infrastructure, allows us to push more variants away from the vast variant of unknown significance state into either a suspected benign or a likely pathogenic, which translation is it's a more certain result for clinicians and patients, and it leads to a higher diagnostic yield. You get a better service. You get more certain answers. We also, by the way, get more patients that we identify that could benefit from targeted therapies from our biopharma partners. The FMP module allows us to do that. To the extent that we can do it in an automated fashion by plugging it into our interpretation infrastructure, it also reduces the COGS associated with looking at all those variants of unknown significance and the work that goes therein. That was an acquired asset that we integrated into our interpretation engine. Overall, our interpretation engine automates as much as possible, and then leaving the human specialized work for only the most exquisitely difficult variants to call. I think it's the kind of thing where it has been the key to us both kind of beating in quality and, at the same time, lowering cost dramatically. I think also, I think going forward, I fully understand. I can empathize with the sentiment expressed by some of the clinicians at that conference. Again, we would offer we've got a pretty good cutting-edge platform for doing this. This is why we can do it so inexpensively. We're going to, over the coming years, be opening that platform up to those individuals as we extend our global data infrastructure, taking more and more patients and their data in, and again, at their behest, sharing that and the outcomes to push the science in each one of these rare diseases forward even faster. Now, the other thing you mentioned on that was the high-fidelity reads. Again, as we mentioned when we did the PacBio announcement earlier in the year, there's another aspect of the two kind of working in concert with each other. If you're getting higher fidelity reads across variants that otherwise would be missed, by definition, are you increasing your diagnostic yield, which again translates to better diagnosis, more patients correctly diagnosed? You're going to be finding a lot of variants that aren't in the canonical databases around the world, unfortunately. Again, the good news is our infrastructure is set up to deal with those things and to get them. I think maybe a way to think about it is push them to canonical as soon as possible, as soon as it's humanly or actually human plus AI plus ML possible. That's a real benefit of things like the FMP module of our infrastructure, amongst others. We also acquired Diploid, which was a kind of, we've kind of talked about it as a variant debulker, as a genomic variant debulker, as it were, to help identify a lot of those really low allele frequency variants and quickly assign if they could be causative or not. Yeah, the two work in conjunction. Again, it's our view of our kind of constant investment and innovation on improving the interpretation reporting, at the same time scaling it to the global scale and lowering the cost in the process. Great. Thank you so much. Sure thing. There are no further questions. I will now turn the conference back over to Laura D'Angelo for closing remarks. Thank you for joining us today. We look forward to connecting with you soon at upcoming conferences.