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spk01: Ladies and gentlemen, thank you for standing by, and welcome to the NVTA's first quarter 2021 financial results conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 1 on your telephone keypad. If you require any further assistance, please press star 0. Thank you. I'll now turn the conference over to Laura D'Angelo.
spk00: Thank you, Operator, and good afternoon, everyone. Thank you for joining us for our first quarter 2021 results call. Joining us today are Sean George, our CEO, Shelley Geyer, our CFO, and Catherine Stooland, 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 investment 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 combinations, 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 financing, 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.
spk10: Thanks, Laura, and good afternoon, everyone. We've had a very active start to the year, and our progress toward establishing genetic information as the standard of care for patients facing key health care 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, focus on our progress in other clinical areas, and highlight the continued build-out of our global genetic information platform. Before we do that, Shelley will walk us through the Q1 quarterly results and outlook for 2021. Shelley?
spk05: 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 on IPS tests. So 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 cardioneuropedic 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. So 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. And our margins were impacted by our mix. Our reproductive volume grew faster than other parts of the business, but this comes at lower margins. We expect that increased collection rates on NIPF 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 as 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 scale our business and 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 Archer 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 Genocity 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 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, 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 convert offering led by SoftBank. On a pro forma basis, this puts our cash as of early April at over $1.8 billion. And 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.
spk10: Thanks, Shelley. 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. So 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're 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. And 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 had 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 during the days behind the seizure program. She was tested quickly, at no charge, and was also diagnosed with Batten disease. Fortunately, the intervention happened early and attention quickly turned to treatment and therapies that are 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 Seizure 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 drive 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. And it then circles back to where we began, 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 health care 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 in developed 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 with 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.
spk01: At this time, I would like to remind everyone, in order to ask a question, press star and the number 1 on your telephone keypad. And your first question comes from Tycho Peterson with JP Morgan.
spk08: Hey, good afternoon. Sean, I'll start with Genocity and just, you know, wondering if you could talk a little bit more about the thought process, why this is kind of the right time to do that deal. I think you noted at the time this could actually expedite, you know, the path to market, reduce the cost, and then accelerate the attraction of, you know, the Archer PCM LBT. So, you know, why do you feel like that's the case? And then maybe you could also just touch on the 40% of Genocity revenues that are not tied to Archer, and is there an opportunity to kind of leverage that, too?
spk10: Yeah, no, thanks. The short of it is, while the Archer tech and capabilities are great, you know, PCM, standing up PCM as a laboratory-developed test and getting it all validated, approved, built into our, you know, kind of our infrastructure, our tech infrastructure, was going to take some time and expense. And with the team at Genocity having already had that up and running, you know, 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, you know, many years in the industry. Really great team. It proved to be a great opportunity to accelerate our broader commercial launch for PCM. So we hope to do that, you know, broadly through our commercial channel as an LVT sometime this year. And, you know, 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, you know, I think it's the 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, which isn't a new situation for us. It's a handful of our acquisitions in the past. We've been there. And 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 We'll continue to try to serve, you know, suggest that those personal cancer monitoring services and those, you know, 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. So those are the, that's the way we view that to your question.
spk08: Okay, and then a follow-up on genoscopy. Are you able to comment at all on the litigation with Matera? Is there kind of a timeline we should be thinking about in terms of next steps?
spk10: No, not really able to comment on it. It's an act of litigation. I think, again, we anticipated and took account of that before the acquisition, and same on Genocity.
spk08: Okay, and then 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 –
spk10: at this point? Yeah, I think we're, you know, on the M&A front, the space is moving a lot, and there's a lot of really interesting capabilities out there. With that said, you know, we're mostly thinking about, you know, 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, you know, the PacLow collaboration, which we announced earlier, you know, 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 on the East Coast, you know, this allows us to better turn around time, lower cogs. Frankly, we're kind of bursting the seams here on the West Coast, so this is a, you know, that was a needed... expansion, and now this capital allows us to really get after that right away. And then, of course, continued investment in ex-U.S. 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. And that's an area we want to be able to keep investing in. So it's, you know, not to mention, of course, all of the exciting development programs that, you know, 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. So I think that's the bottom line of the use of capital is those kind of things that we wanted to make sure just to keep after this year.
spk08: Great. Last one on gross margins. You know, I understand kind of the Knicks dynamics laying 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. But maybe Shelly, can you just talk about when you think you'll actually hit that 50% margin target?
spk05: 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. And if you actually did put through all those accessions and the billables in the quarter, that COGS per unit would have dramatically changed. So something like 10% fall off between the accessions and the billables. And so you're not getting those in the first quarter. You'll get those in the second quarter. But 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. So I think it's important to remember that, 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.
spk08: Okay, that's helpful.
spk05: Thank you. Thanks.
spk01: Your next question comes from Doug Schinkel with Cohen.
spk04: Hey, good afternoon, and thank you for taking my questions. So, Shelley, anything you can give us? I mean, ideally, we'd have organic revenue growth or something on Archer, given this is just the second full quarter. Can you share anything with us that would help us track how Archer is tracking from a growth perspective sequentially and relative to plan?
spk05: Yes, so I think your first comment was that we don't generally break these things out and we promise 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, and we've changed the priorities for what the former Archer is looking at in terms of collaborations and things like that versus the priority of getting the LTTs up and running and that sort of thing. And so 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. So it's exactly where we would have expected it But I would say, you know, 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. So did fine. Don't break them out. And integrating it nicely so it is one platform, one oncology offering, et cetera.
spk10: Doug, I might add that basically oncology is about 50% of our business now, and so 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.
spk04: Okay. Yeah, I mean, I totally understand. I mean, at the same time, given how acquisitive NPT 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 of acquisitions they're obviously not all going to work hopefully more of them work than others but um yeah that that's the reason I'm pushing so is the is the metric you would like us to use to make sure that you know the midst of all these acquisitions that the growth is you know 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?
spk10: 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. And layered in there, of course, we'll have regulatory submissions, approvals. We'll have product launch milestones, and I think we'll have discussions. You know, very similar, I think, as we look back to reproductive health, right? We had a reproductive health offering, a modest one. We purchased CombiMatrix and GoodStart. We then started talking broadly about reproductive health, its growth year over year. And then kind of as we see now, that growth is picking up now and becoming close to 30% of our business, overall business at this point. And I think that's given a really good view as to what those acquisitions did for us by giving us a broader menu to accelerate the top line of that business. And I think that's the same tracking I think we can provide for the Archer acquisition and Genocity acquisition for our oncology effort.
spk04: Okay, that's super helpful. And then I guess one more on just the Archer transaction. I mean, some of the Archer customers that were being supplied with Archer 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?
spk10: Yeah, I think the – 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. You know, out years, a year or two from now, maybe everybody will think differently, but right now it's –
spk04: know there's there's it's it's not it's not a it's not a major point of contention at this point let's say okay uh thank you guys and actually last one um sean this is probably more shelly question um you know as we think about the north carolina facility um the logistical benefits of having a facility there um are pretty clear and 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?
spk05: Yeah, I think so. But, you know, 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. So 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. So, yes, you will have some benefit from those labor reductions. I really look at it, though, not only from what Sean said before, but also a diversification of our risk. You know, we are in the Bay Area and 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. And the final thing would be from a cost perspective. You know, if you can ship quickly to the East Coast and you can ship internationally from some of the European sites, et cetera, you get a big cost savings also on some of your shipment costs, depending on what zones you're in. And so 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.
spk04: Got it. Okay. Thank you again.
spk01: Thank you. And your next question comes from Tanit Sada with SVB Luring.
spk06: Hi, Sean and Shelley. Thanks for the question. So first one, I just wanted to ask you in terms of the full year guide and what you can provide into the second quarter. I just wanted to get your view on what you're hearing from the field recently. I mean, sort of what percent of the reps are in person versus the still remote. I mean, just asking that because you're maintaining a full year guide here for 450, but You know, given the level of vaccination sort of we're seeing out there, and, you know, in terms of comparisons, you have a much better comparison the second quarter. I know there's ARCHA contribution here as well, and IPS volumes are growing. And based on what Shelley has said, you know, some of those exceptions are going to turn into billable. So 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.
spk10: Yeah, I know. I think the informative piece on the quarter was obviously the year started choppy, not just for us, for a lot of people. And, you know, what we're saying is obviously the back half of the quarter picked up really nicely. And we pointed to, you know, more than 2,600 new accounts created just in the quarter. The last time we, you know, last year that metric was kind of blown, you know, COVID kind of made that metric a little meaningless. But, you know, there was The year before, the total for the entire year was something like 7,000 accounts. So 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. Now, 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. And then, of course, XUS, right, it's still a little bit of a thing. So that's why, as we said today, we're optimistic. I think, you know, I certainly feel good about the call that we're going to exceed 450. And as this quarter played out, I think that was the right call to be making. You know, we'll see. We'll see how the next quarter goes. And I think if everything kind of continues to play at the top line, we might reassess at the next quarter. But 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.
spk06: Okay. And, you know, in terms of Archer, obviously that's an important question given, you know, the contribution to the growth and given the importance of the franchise to the overall building out the oncology franchise. Maybe um can you give us um any sense of and i know it's it's a you're not breaking this out but anything and you know should we still assume the 50 to 60 percent you know growth profile that you had pointed out earlier i know shelly mentioned that um you know they had some ipo numbers which are not not to be considered now um but maybe 50 to 60 percent sort of if you can provide any contribution of Archer in that or anything that helped us get a sort of gauge for Archer? And I know I'm somewhat asking an earlier, around an earlier question, but just that's an important question for the growth of that business.
spk10: Yeah, no, I do think it's an important question. I understand that. And so, you know, I think that 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, 56%, plus or minus, then oncology should really kind of keep up with that, maybe exceed it, certainly as we get, like, PCM, therapy selection, LDT launched. And that's the idea. And then 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. So we'll definitely be checking in on that every quarter, how the oncology business is doing, again, the idea of, We're confident the idea of understanding risk, both at a personal and population level, stratifying patients they're in, choosing the right therapy for all stages of cancer, and then monitoring those individuals. We think that is the precision oncology offering that we're confident will provide significant top-line growth for the years to come.
spk06: okay uh thanks and and if i could uh sean in terms of the combined versus the you know just essential versus the distributed model and now that you have had some time to look closely at archer and its customers and and those interactions wondering if you have any additional thoughts in terms of you know the distributed model versus centralized because obviously the centralized has given you nice cost leverage and past and so i'm just wondering with the new facility coming up How are you thinking about, you know, decentralized versus centralized? And also, I was wondering if you can provide any updates on the timings of PCM. Obviously, their new product launching in the MRD market, and 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.
spk10: Yeah, so the PCM I can answer first is the... 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 end of the year, end of 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, and we think that's really important. The distributed, really our position on that hasn't changed at all. I think that they're 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. But 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 Archer 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 running their own samples is going to be critical. And 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, you know, reproductive health, cardio, pediatric disorders. So 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.
spk06: Got it. Okay, great. Thank you.
spk01: And your next question comes from TJ Savant with Morgan Stanley.
spk07: 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? And then, similar question on pharma partner revenue trends as well. I mean, what does that look like coming out of the pandemic here? And if you can help us sort of break that out in terms of the guide, that would be super helpful.
spk10: Yeah, so ex-U.S., you know, there aren't many – I would say that the market outside the U.S. is fragmented pretty well along country lines for the most part, or certainly regional lines. So 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. So I think that's one way, that's kind of where we look at it is, you know, it's a steady investment. I truly believe, and with, you know, kind of experience around this table as a guide, it only works in-country, for-country investments. And that's going to take a while to invest, but the good news is we've got a head start and we're rolling forward on it. Again, 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. And then, let's see, sorry, the other question.
spk07: On pharma revenue trend here exiting the pandemic?
spk10: That's right. So, For sure, some of the pharma stall that was impacted by the pandemic, we see that picking up as well, 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. And 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 like 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. So those are essential to keep those going. And, of course, then, you know, 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's a good, it portends well for the future. But 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 will still be an important part of the revenue going forward.
spk05: Yeah, we noted that that was about 33% this quarter. So that was a nice uptick from prior quarters.
spk07: Got it. And just a couple of quick housekeeping ones for you, Shelly. Genocity, are you assuming sort of around $10 million or so in terms of the non-NBDA sales revenue over the course of the remainder of the year? Is that fair, or is there room for upside there?
spk10: 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. But Yeah, and we don't know what to count on for the rest of the business that wasn't. Ray, if you remember, 60% of it was a pass-through anyway, so you don't really get to book that as additional. And then the rest of it, it's unknown how that's going to play out. And we don't have a hard opinion about it either. So we're just kind of encouraging people to ignore that for now.
spk07: Got it, got it. And, Sean, can you help us think through the impact on the turnaround time once the RTP facility comes online here? And then I have one final follow-up.
spk10: Yeah, and this is where, you know, I actually love this because it kind of shows where we are. We're literally talking 18 hours. I mean, it's not 18 to 24 hours, which is huge. And even more importantly, our shipping bill, is getting up there. And so being in that shipping zone to maintain those service levels and reduce the cost of it is really key. So yeah, it's only a day difference, but the real important difference is how much you pay for that day's advantage. And that's a key to having on the East Coast. In addition, like we mentioned, across the Atlantic or to South America, it's a little more straightforward and both faster and cheaper.
spk07: Got it. And then one final one for me. With the $1.8 billion on the balance sheet, I know you mentioned the RTP investment and the OUS expansion. But 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.
spk10: Yeah, well, you know, we spend an awful lot on development. We get a lot of samples from patients that we have, you know, who's at risk. We're now performing therapy selection and monitoring on them. You know, I'd say the short answer is yes, we've got at least three technologies in-house that you could – You could imagine we're looking to develop data on early screening. You know, again, 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. And then, of course, there are many technologies out there that look pretty interesting and compelling as well. And, yes, the cash balance helps. us kind of not worry too much about the build-by decision there. I would say, you know, I think it's, again, it's 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. uh we think that's where the bulk of the action is going to be in oncology nonetheless yes we are looking looking to the future uh and and you know pretty pretty happy about where we are uh vis-a-vis access to patients access to samples the kind of data and the technologies at our fingertips super helpful thank you and your next question comes from brian weinstein with william blair hey guys good afternoon this is uh griffin i'm for brian thanks for taking my question
spk03: Just on a quick follow-up on measuring ARCHER milestones here, can you give us an update on Stratified? 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 and anything on timing there?
spk10: Yeah, I mean, it's, you know, again, it – 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 it was submitted in the last year. At the time, we suggested, look, these things can take anywhere from nine 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. There's DNA... copy number variations in RNA, and 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, but 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, et cetera, from there.
spk03: Understood. And then just one more, just given how broad your product portfolio is, inherited disease, family planning, oncology, et cetera, are there any areas within the business that you're seeing a particularly faster or maybe slower recovery? And if so, how is that kind of informing where you're putting time, resources, and investments?
spk10: Yeah, I mean, you know, I got to tell you, it's hard to measure the market growth against the recovery growth. For example, you know, 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 that area was impacted the least in the COVID impact. Now, so there's a little bit of COVID recovery. I also think there's just general, there's a lot of market growth there, going from the number of women who are getting those services today, the number of women who will get them in the future. We do see, in terms of the fat house recovery slope, yes, oncology, particularly on the risk, the early risk, side of things and a lot of the other pediatric and rare disorders, you know, those are the most impacted, and those are the ones showing the steepest recovery at this point in time. Again, it's difficult to tease out exactly, but I think that's a, you know, what's market growth versus what's recovery influence, but I think that's the best we can tell right now. Great. Thank you.
spk01: And our next question comes from Kevin DeGieter with Oppenheimer.
spk09: Hey, great. Thanks for taking my question, guys. Sean, one of your peer group companies with some portfolio overlap called out an R&D day today, 8% to 10% kind of organic growth for their business. You're calling out, you know, essentially 50%, at least near term, for oncology and potentially for the business overall. Yeah, I guess maybe sort of two parts to this question. You know, Can you give us some perspective is to, you know, how you think of, you know, kind of, you know, organic growth for for the business in the context of that, that 50% number, maybe, maybe a little bit, you know, more contextual, you know, for some of the key and markets, you do have a good kind of current field, you know, 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.
spk10: Yeah, and I do want to clarify. When we point at 50% to 60% growth for the next two or three years, we don't distinguish organic and inorganic, obviously. Very large inorganic additions to that is a little bit cheating. We wouldn't count those, but on the margin, there's going to be some acquisition in that, I would assume, over the next three years. But if you kind of take that aside, you know, 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. And 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, you know, we've kind of covered that ad nauseum, but, you know, still there's only two, two and a half, million women in the U.S., two and a half million pregnancies or so that are getting afforded those technologies. There's still six 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 It's still a very small percentage of all of the people getting diagnosed with cancer every year. And then, of course, on the recurrence and the monitoring side, it's green-filled. It's essentially a green-filled kind of thing. And so our view is that – oh, and I guess I should – sorry, I should have started with risk assessment. Even with a really strong market position we have, you know, we're seeing guidelines move faster than people can keep up with, and the markets are, you know, double the size of what they were two years ago by way of kind of recommended screening for people for cancer. And not to mention, you know, you just talk about prostate, you know, there's another huge chunk out of there. So 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, monitoring, Risk assessment is, yeah, the former markets are reasonably penetrated, but new market size is getting added all the time. And then for therapy selection and monitoring, it's essentially early days, period. And frankly, if you look out beyond there, it's the same. I mentioned reproductive health, and then 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, a long tail of other genetic disorders for which there's really effective targeted therapies on. So 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. But that's our view of the growth, you know, what the tailwinds of growth look like.
spk09: Great. And then as a follow-up question, you know, I think following up on one of the earlier questions talking about, you know, other potential end markets for growth, you With the scale the operation company has, you know, and cost structure at Invitae, you know, can you just give a perspective on interest in population sequencing, you know, opportunities both U.S. and there's a number of opportunities that are out there to bid at U.S., you know, as well?
spk10: Yeah, no, I can. I think I'd say two things. We often get approached by folk who have done population sequencing programs and then are having a hard time figuring out what then to do by, you know, the research aspect of it is probably satisfied, but then what to do then to actually communicate, you know, 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. And 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 government. 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 at the 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 see those discussions spinning up, and we're excited to see what we can do by way of enabling uh from you know kind of crib to death um population genomics and see how it can really bend the curve on outcomes and costs thanks for taking my questions sure thing and your next question comes from a fair gut lip with capital market labor hey sean and sally uh thanks for taking the questions just two quick ones i think 2021 was the year that singular bio was going to be getting into production for a non-invasive prenatal screening, and 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, so 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 up running and saving COGS and then certainly by middle next year transition, the majority of it. The extent that will impact COGS, like you said, if you take a little under 30% of our total business now is reproductive, I think 35 to 40% of that is an IPS. So it's a significant impact and it certainly helps. Again, we look at the margin profile on the overall basis, but if you consider reproductive health it certainly has a real impact on the gross profit contribution on a per sample basis for those samples. So we're excited to see that come into play. And 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. Also, there's a possibility that exome could become an accelerant revenue in 2021, perhaps in the back half, we would run it instead of essentially instead of panels. Do you have any update on that? No, we're excited to be moving into the 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. And in particular, and this, I think, will be more of a next-year story for autism development or disability. So, yeah, we're very excited about that. And, again, I think this is where this is just the beginning of kind of the power of genomic scale for some of these conditions. And, again, we do think, you know, good news on that one, and the reason we think it will 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. And, you know, our kind of nearish 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, et cetera. And that, yes, we definitely think that will be a growth driver. Is this something we should be considering in the back half, something to adjust arsenic? um i in terms of adjust i think that's that's one of the things we pointed to when we talk about guidance we pointed to as a potential upside for this year i would uh i think the timing is still something that whether it's going to have a big impact or not uh it's still an unknown even even today okay fair enough i'll take the rest offline thank you okay and your next question comes from simon barnett with arc invest
spk08: Hey, thanks for just this one question here. So 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. So staying on the topic of interpretation, I'm just wondering, you know, 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 to, you know, increasingly more to HiFi sequencing? Thanks.
spk10: Yeah, I know. I mean, it's really to the crux of the question here. And actually, there's two parts. So the FMP portion, the FMP module of our infrastructure, allows us to push more variants away from the variant of unknown significant 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. So 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. And so the FMP module allows us to do that, and 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. Now, 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 exclusively difficult variants to call. And I think it's the kind of thing where it has been the key to us both kind of leading in quality and, at the same time, lowering costs dramatically. And I think also, I think going forward, you know, I fully understand and 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. And 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 disease 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. higher fidelity reads across variants that otherwise would be missed, by definition, you're increasing your diagnostic yield, which again translates to better diagnosis, more patients correctly diagnosed, and 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. 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. And that's a real benefit of things like the FMP module of our infrastructure, amongst others. You know, again, we also acquired diploid, which was a kind of a, again, we've kind of talked about it, is a variant debulker, 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. So, yeah, the two work in conjunction. And, again, it's our view of our kind of constant investment in and innovation on improving the interpretation reporting at the same time scaling it to the global scale and lowering the cost in the process.
spk08: Great. Thank you so much.
spk10: Sure thing.
spk01: And there are no further questions. I will now turn the conference back over to Laura D'Angelo for closing remarks.
spk00: Thank you for joining us today. We look forward to connecting with you soon at upcoming conferences.
spk01: This concludes today's conference call. You may now disconnect.
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