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spk02: Good day, thank you for standing by and welcome to Invitae's second 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 that 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 would now like to hand the conference over to your speaker today, Ms. Laura D'Angelo. The floor is yours.
spk03: Thank you, operator, and good afternoon, everyone. Thank you for joining us for our second quarter 2021 financial results call. Joining us today are Sean George, our CEO, Roxy Nguyen, our CFO, Ken Knight, our COO, and Shelly Geyer, our sustainability and ESG lead. 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 Q2 preliminary financial results, our plans and prospects, the focus of our business strategy, our plans to integrate and manage businesses we acquire, market opportunities, future product 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 10Q, 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. As you listen to today's conference call, we encourage you to have our press release available, which includes preliminary financial results as well as key growth metrics and commentary on the quarter. We are currently finalizing the accounting treatment for certain acquisition-related liabilities and stock-based compensation amounts reserved against the acquisition of ArcherDX last year. Assuming adjustments are necessary, we would expect a decrease in our recorded liability while also resulting in an increased gain in our adjustments to the fair value of contingent consideration. The primary growth metrics we are reporting include revenue, volume, ASP, cash, and any non-GAAP results are not expected to be affected by any adjustments. but we want to direct your attention to the preliminary nature of cost of revenue, operating expense, and net loss as they are not definitive as of today. 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, including contingent consideration and acquisition-related income tax benefits. We see from our non-GAAP cash burn, as applicable, changes in marketable securities, cash received from equity financing and debt, 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 attendance of the earnings slide deck. With that, I will turn the call over to Shawn.
spk08: Thank you, Laura. Good afternoon, everyone. We're pleased to report another strong quarter of top line growth across the platform, demonstrating our continued progress toward meeting the immense unmet demand for the use of genetic information in mainstream medicine across all stages of life for our patients. An important milestone for us at MBTA was crossed with now over 2 million people receiving genetic information, many of whom would never have done so had we not been pursuing our mission so aggressively. With an ever-growing number of people seeking genetic information to inform health risk and medical decisions, we've committed to delivering the most comprehensive and affordable genetic information accessible to all patients at the standard of care. The rate of adoption of genetics in mainstream medicine is on the rise, as demonstrated by new data and V-day presented for multiple cancer types at the 2021 ASCO meetings. As one example, the landmark intercept study conducted at Mayo Clinic showed that nearly one in six patients with pancreatic cancer had genomic alterations and, importantly, genetic testing was associated with improved survival. This outcome is consistent with almost every study that we've done in this area, and we believe that NVTA is uniquely positioned to meet the growing need and market for combined somatic and germline genetic information across all cancer types. To headline the quarter, we continue to execute well on all our growth measures. Both revenue and billable volume showed triple-digit growth over last year's Q2, which was impacted significantly by the COVID shutdown. Demonstrating a continued exit of the COVID impact period and increasing momentum, we drove double-digit sequential growth in both revenue and billables from Q1. As to our guidance for the year, our Q2 growth and the macro trends we see have us confident that we will exceed the high end of our 50% to 60% target range for revenue growth this year. In January, we gave guidance of more than $450 million revenue for the year. Given the strong growth we've seen in the first half of the year, we're confident in our ability to deliver revenues of between $475 and $500 million, and that's including uncertainty from the recent increase in COVID cases resulting from the Delta variant spread. With that, I'm excited to introduce the newest member of our executive team. Roxy Nguyen is Invitae's newly appointed chief financial officer, and she's here with us this afternoon. We're thrilled to have her join the team to help scale this business globally. She brings a new perspective on financial management, modeling, as well as capital deployment, and, of course, supporting all of you. Roxy's decades of success as financial executive at global tech and med tech companies allows great insights into how the enormous opportunity of the convergence of these sectors can be capitalized. Roxy, maybe you can say a few words about your first few weeks before you provide some detail on the Q2 financials.
spk01: Thank you, Sean. Well, this is my first quarterly conference call. I've had almost a month to engage with the team and speak with some of you. It is a real pleasure to join Invitae as we try to do the important things necessary to improve the health of the population. I would like to thank Shelly and Ken for their help supporting my transition. It is a rare benefit to have the predecessor CFO available for counsel and is making the transition that's that much more effective. I would also like to thank those of you who have reached out to wish me well and to offer your perspective on how we can continue to serve the needs of investors. We take your input and guidance seriously and look forward to a collaborative relationship going forward. Before I recap the results and preliminary results of the quarter, I'll say a few words about the topic Laura touched on and that was explained in today's press conference. As we conducted our customary close-off-quarter analyses, we determined that we may need to reverse some of the liability associated with ArcherDx transaction milestones. Practically speaking, this accounting adjustment, should it happen, would have no impact on our key performance metrics, such as volume, revenue, AST, cash, and all non-GAAP financial results. If implemented, this accounting adjustment would significantly reduce GAAP net loss in our adjustment to the existing fair value of contingent consideration and acquisition-related stock-based compensation. We expect to complete the process over the next coming days, and we look forward to filing our Form 10-Q. For now, come to the second quarter performance. As Sean mentioned, we continue to see strong growth across the board. Revenue of $116.3 million was generated in the second quarter, a 152% increase from the second quarter of 2020, which was, of course, heavily impacted by the COVID-19 shutdown. More relevant was the 12% sequential increase from this year's first quarter. a great result and indication of continued momentum into the second half and performance against the ongoing goal of 50% to 60% annual growth rate. Available volumes of approximately 287,000 in the second quarter of 2021 were up 154% from the second quarter of 2020, but also grew a strong 11% sequentially from the first quarter of this year. Internationally, we saw volume growth that was slightly ahead of our U.S. business. and represented nearly 19% of total billable volume for the quarter. Overall ASP trended up slightly to $388 in the second quarter, up from $383 in the first quarter of 2021. Steady progress with third-party payer relationships and policies are benefiting both pricing and collections We also continue to see rapid growth in sales of our women's health products, where average price per test is generally lower than the current oncology products, and where we also expect to see price improvement over the coming quarters. Looking ahead to 2022, we expect ASPs to benefit as we stand up and continue our launch of the broader LDT and regulated oncology testing for therapy selection and MRD testing for monitoring and surveillance, both of which garner higher reimbursement rates. Preliminary cost of goods sold. in the second quarter was impacted by approximately $5.3 million of inventory impairment charges due to our decision to discontinue offering COVID testing and the write-down of inventory associated with our oncology business. We do not anticipate significant ongoing financial impact from these issues. For the remainder of the year, we expect progress in COGS and growth margin in both Q3 and Q4 and are targeting a non-GAAP growth margin between 45% and 50% as we exit the year, tracking towards our long-term 50% target margin. As we projected, non-GAAP operating expenses were sequentially up, coming in at $198.2 million in the second quarter as compared to $155.4 million in the first quarter of 2021, driven primarily by headcount growth and increase in stock-based compensation. We continue to invest in our business with a focus on long-term value creation opportunities, including scaling the business and modernizing the platform, building out content across all arcs, improving efficiencies and variable margin and operating leverage, and creating a more patient-centered experience benefiting all constituents of healthcare system. We also know that we expect spending growth rate to decline for the rest of 2021 as this year should mark the highest annual non-GAAP operating expense as a percent of revenue as investment levels stabilize or even slow in key areas. Moving to our cash position, cash, cash equivalent Restricted cash and marketable securities totaled $1.54 billion at June 30th, compared to $681.9 million at March 31st, an increase of approximately $858 million. Cash burn was $256.8 million in the second quarter, including cash paid to finance and close acquisitions, excluding acquisition and related expenses, Our burden for the quarter would have been $136.7 million. Now back to you, Sean.
spk08: Thank you, Roxy, and great to have you on board. Before I hand it off to Ken for an operations update, we thought it would be helpful to provide a snapshot of how the platform and business are evolving and how that ties into our long-range vision for the industry. There are a couple of big-picture takeaways worth noting. The first is that NVTA revenue and business mix grows across all testing categories. Our approach has always been and will continue to be to build a platform that can serve up all genetic and genomic information needed to identify those at risk for disease, detect and diagnose the onset of those diseases earlier, use that information to guide preventive measures or targeted treatment, and monitor the success of that treatment. It is our view that if we can accomplish this, genetic and genomic information will be used across all of these areas at all stages of life to improve the lives of billions of people on the planet. The second is the size of the opportunity and the importance of our growth into it. Even though the COVID difficulties and setback last year, we have maintained an average growth rate of more than 50%, demonstrating resilience of the business, execution by the team, and validation of both the opportunity out there and our ability to choose entry points to grow the market as well as take share. And when considering the sizes of the addressable markets we are pursuing, combined with the accelerating pace at which genetic information is being utilized, one can get a sense of the scale at which we believe this platform needs to operate. Our perspective on the size of addressable market and our view of how to aggregate and transform genetic testing with a broad menu for all stages of life informs our view of how to lead the transformation of our industry. We've long shown this ramp view of our business model in an effort to describe how we see the evolution of global genomic medicine. Our progress in addressing patients' needs throughout their lifespan and the emergence of our platform and data services demonstrate progress up the curve into the genomic network era, where genetic information can be shared on a global scale to diagnose more patients correctly earlier and bring therapies to market faster. we continue to believe that these new connected capabilities are best developed, delivered, and supported from an integrated platform. The more of the landscape we can cover by way of genetic test content, the more patients we can add to our network, and the more patients in our network combined with more information we can provide or ingest on their behalf, the more that we and our partners across the healthcare system can do for them. Our business is expanding exactly along these lines, and we believe the time is right to attempt to provide more visibility into the key drivers of that growth. In addition to our sizable and rapidly growing revenue from oncology, reproductive and women's health, and rare disease or other genetic and genomic testing services, we will be including a newly defined category in the mix we're calling platform and data services. This category includes data management and analytics, interpretation and data as a service, certain biopharma programs, and patient identification efforts, among others. We anticipate this part of the business will be one of the fastest growing elements of our business over the next five years, fueled by our continued building across disease areas and acquiring new capabilities, combined with access to the rapidly growing number of new patients entering our ecosystem at all stages of life. Revenues derived from those services were about 2% of total three years ago, but they've been growing rapidly, and this past quarter moved past 8% of total revenue. While it's still early in the game, the impact of this set of business activities on our model is hard to overstate. As we begin to publicly track progress in this important part of the business, it's worth restating our basic tenets since the company's inception. First, patients own and control their data. And second, that data is more valuable when shared. At Invite, we've worked very hard to build and maintain a foundation of trust when it comes to security, privacy, portability, and consent. We believe these intangible assets will be essential for leading the ongoing transformation into genomic-informed personalized medicine, benefiting patients, clinicians, payers, researchers, and biopharma partners alike. The next step in building out our platform include continuing investment in the development of our data analytics and real-world evidence capabilities. Over many years, we've built an extensive technical stack of processing, pipeline, interpretation, reporting, and customer service capabilities. and we continue to acquire and integrate a portfolio of digital products and services that enhance customer experience through personalized insights, improved workflow, and other tech-enabled services. To that end, we've been especially active in the first half of 2021, and I'm thrilled to announce our acquisition of MedNeon, the latest addition to Invitae's data and digital solutions platform. MedNeon combines guidelines, real-world evidence, and personal and family history to rapidly identify an individual's short-term and lifetime cancer risk. Once determined, clinicians are informed of their patients' eligibility for genetic testing and supplemental imaging so that preventive action may be taken. As we move into the second half of 2021 and beyond, you can expect to see additions in all of our testing areas with a growing emphasis on tying them all together via data collection, analytics, applications, delivery, and improved customer experiences. With those introductions, I'll turn the call over to Ken to go through an update on our operations. Thanks, John. Halfway through 2021, we felt this was the right time to provide an update regarding operational scale and innovation and how they're being leveraged to bring our long-term business model to life. COVID-19 has kept us on our toes, with suppliers and transportation partners struggling periodically to keep up with our growth and our increasing demands. To stay nimble over the last six months, we have brought on new supply and transportation partners, even when additional validation steps were required to deliver. Costs in some cases have been negatively impacted as a result of intermittent shortages, and we have not yet fully returned to normal flows. However, we were still able to lower material costs for our non-invasive prenatal screening test by 14% year-to-date through process innovation and supply chain modification. This work has also brought along a 300 basis point improvement in percent on-time delivery for patients. And there are further improvements in the pipeline. As Roxy highlighted earlier, Q2 non-GAAP cost of goods sold was impacted by pull-ahead investments in labor and inventory in preparation for second half 2021 growth. Still, non-GAAP costs in the second quarter improved year over year by 23%. And Q3 and Q4 should deliver further improvements along with expected volume growth. The acquisition of Genocity in Q2 has been one of our best moves from a strategic and integration execution standpoint. In a short timeframe, the team has accelerated access to personalized oncology testing and monitoring, playing a key role in standing up the LDT for MRD testing that Sean mentioned. This success has us super excited about delivering a level and range of precision care to patients that we believe is unparalleled. And more to come on this later this year. We also recently welcomed OneCodex and Medneon to the MBTA team as we build out our strategy. To support our overall growth, we have active expansion plans underway at 75% of our existing lab operations. And our plan to deliver our new North Carolina facility is on track for a mid-2022 go-live. Reflecting our scaling efforts, we collected record cash in Q2, an increase which was closely aligned with the Q2 increase in revenue. Commercial leverage improved by 100 basis points quarter over quarter and 45% year over year. The focus on improving leverage is continuous and across all functional areas as a key component to generating cash for reinvestment into our growth. And we are growing thanks to our patients, our customers, and our people. Our operating mechanisms are providing clarity for decision making, and the focus on our mission is clear. I'll now turn the call back over to Sean. Thanks, Ken. I hope that a major impression for anyone listening to this call is that we are playing to win. Our strategy is unique and our vision is ambitious. A future that sees genetic information driving mainstream medicine is coming into view as a reality. So the time for ambitious and decisive actions is now. 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 onto our platform. The growing opportunity of platform and data services is highly relevant. The diversity and growth in that part of the business should become a significant driver of value for patients, providers, and all stakeholders in a modern healthcare ecosystem. And of course, our long-term shareholders are uniquely positioned to benefit as we continue to execute against our plan. Before we move to Q&A, I'd like to take a minute and thank Shelley Geyer with us here today, who for many years and right up until a few weeks ago served as NBK's CFO. It's been a massive transformation of the company during her tenure, And I wanted to express my and the whole team's appreciation for her tireless commitment to excellence and to our mission. She'll now be leading our ESG programs going forward. I'm excited to have her working with you all as we push forward on these essential efforts in the future. With that, we'll now turn the call over to the operator for Q&A.
spk02: As a reminder, to ask a question, you will need to press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. You have your first question coming from the line of Don Leonard from Wells Fargo. Your line is now open.
spk06: Thank you, and thanks for all that detail. My first question, could you elaborate on your early efforts commercializing PCM as an LDT? What type of organizational resources are you committing to that effort?
spk08: Sure, Dan. So in the acquisition of Genocity, as Ken had mentioned, we were able to kind of integrate that quickly and get the Archer PCM technology up and running. as an LDT. I'll be honest, most of the organizational energy was spent on doing that. The commercializing of it, we wanted to get it as early as possible, but to get in the hands of a few key clients, put it through as paces as it were, and get ready to scale it up between now and the end of the year. We've got some more scaling of that process to do. We want to put in some more cost containment and really get it ready for a full-blown commercial launch at least by early next year. So that's where we are. Much of it's been on the operating and development side of it, and more and more commercial execution as the year wears on.
spk06: Understood. Thank you. And just a quick follow-up on the women's health business, specifically on average risk NIPT reimbursement. When do you expect improved reimbursement flows through to ASPs at the corporate level?
spk08: Yeah. The short answer to that is ASPs have been improving for NFDS for many, many months now. It's been a slow and steady climb, and payers have been picking up reimbursement, not just for high risk but for average risk. In the past, call it the past year or so, that is also on top of us being relatively new to the game of the payers, so there's both a process-oriented increase in collections and reimbursement, combined with more payers picking up average risk reimbursement, which more are doing. The pace of the payers picking that up has indeed increased, but it wasn't a binary in person point with the ACOG gallons coming out. And I would expect that to continue throughout the end of this year. And frankly, there'll probably be some payers that refuse to cover this for many months to come, possibly even into the end of next year. But slow and steady trend there. And again, we do think that that's a
spk05: uh overall uh positive on the reproductive health business okay thanks for the color okay next question is from the line of beneath sauda from leering your line is now open uh yeah hi sean um thanks for taking the question so um one two um uh just to understand a little bit in terms of the guidance maybe if i can ask you this way you know where do you stand in terms of uh in-person sales details by reps versus online? I mean, obviously we're hearing that, you know, that there is, you know, access issues and challenges in the space, but we're still emerging out of COVID. So maybe could you talk to us, you know, on that and in light of the, you know, in light of the guidance that you have actually raised, do you feel confident that this access will, you know, sort of continue to improve and where does it stand today?
spk08: Yeah, I appreciate the question. To be clear, the guidance isn't a signal of any kind of mix in demand generation. We still are testing. We are still applying our direct channel. It still continues to improve over time. It's also still a pretty minor point of the total demand generation. This is our kind of sales and marketing team checking in, seeing how the first half of the year went, current momentum in accounts All of this informs our view between now and the end of the year. There definitely is a shift in access, kind of pre-COVID and then, you know, whatever we're going to call this, you know, kind of post-COVID era. We've factored it in. You know, the access is not as high as it was pre-COVID. But nonetheless, you know, a combination of our kind of sales, marketing, customer service capabilities, we're confident we can continue to drag in volume, and that's all baked into that outlook. You know, the range is, you know, reflects a little uncertainty there. Not, you know, there's still COVID variant, Delta variant and whatnot, thus the range. But otherwise, it reflects kind of current momentum and our outlook on that continuing.
spk05: Got it. And then, Archer, if I could ask on Stratified and PCM, what sort of ASP lift are you expecting here? And could you just elaborate on the timing for PCM and PCM potentially as an FDA-approved product and also Stratified as an FDA-approved product? and and i'm wondering if you along those lines if you can also elaborate a bit on could pcm pursue the adlt route uh we've seen a peer in the space that has uh done that and i'm just wondering if you need to go um that route can you do it with an ldc or do you need an fda approval for that thank you um yeah so so yeah so so good question i think and this is where it's really
spk08: And this is where it's essential to separate out a bunch of concepts that are, you know, admittedly for many companies intertwined, but for actually for us are not so much. So first I would say the pricing for the PCM or MRD, you know, kind of monitoring services, and pricing for therapy selection, stratified, et cetera, in our therapy selection development. The pricing is already set. It's set in the $3,000 plus range for certain indications, certain stages of cancer, certain types of cancer. We have no doubt we'll get the same pricing there that the other players in the market do. As far as impact on ASP, that's where there's a little bit more of a dynamic question here. So first, we have a broad menu at many different prices, everything ranging from, you know, low hundreds for patient pay prices of various tests to forward $5,000 for what currently we offer by way of XM testing sometimes. And undoubtedly, we'll see in kind of what the reimbursement is coming down for MRD services, right? So that's going to be a range of tests across a lot of different areas. So the, you know, The overall combined ASP impact because of those two products and their higher pricing, frankly, is difficult for us to forecast. And a lot of that is baked into that is the fact that while we'll take the same price that everybody else gets on tests that are improved and within reimbursement guidelines, We're more interested in the 40 million cancer patients in the markets we serve. We'll call it 38 million cancer patients in the markets we serve that won't have access to those. And we'll be testing on different price points, of course, always, always targeting our 50% gross margin that we're on the platform. So, by way of saying the price is one thing, it'll be kind of standard, whatever else is getting. The ASP impact, I think we'll have to see together over the next couple, two, three years when those, you know, kind of our volume, we're for sure it's going to drive more volume, for sure it's going to be an upward lift on ASP, where exactly it ends up, we're not completely certain. And then the regulatory component of it is a third and also distinct, you know, except in the sense it's tied in with the dual track reimbursement and approval. But, yes, the ADLP approach is available to us. We haven't, you know, we're kind of publicly talking or committing one way or the other. FDA, ADLP, and or as a laboratory-developed test, the market and the customers in the market demand different things, and sometimes they're tied to pricing. More often than not, they are not, and so we'll keep all those options available. In general, yes, we're pursuing regulatory approval for both our therapy selection and cancer monitoring, and then the exact form of it and exact timing is something that we're going to see here quarter to quarter. And it'll be somewhat variable given all of the factors involved, but nonetheless, we'll be driving the top line of the oncology business. We expect ASPs to be an upward pull and certainly contribute to what we think is a really high growth rate for the years to come.
spk05: Got it. Okay. That's very helpful, Sean. And Roxy, welcome on board.
spk01: Thanks.
spk02: Again, to ask a question, you will need to press star 1 on your telephone keypad. Again, that is star 1 on your telephone keypad. Next question is from from Morgan Stanley. Your line is now open.
spk08: Hey, guys. Thanks for the time. This is Edmond on for . Just a few questions for me tonight. The first one, in light of the Omnium announcement over at PAC-B, how do you guys see that influencing your collaboration with them? And I guess on a longer term, what are your views for the opportunities for a single box combining both long and short read sequencing? Sure. No, I appreciate the question. First and foremost, and I think this is kind of what Ken touched upon, overall we spend an inordinate amount of time looking at cost of goods, input costs, and how we can better and more efficiently run our services and support our products around the globe. Our collaboration with PacBio is a good specific example of an investment with a partner on doing so. We kind of talked earlier in the year about the benefits of patients and the long-range genomes, particularly in pediatric and rare disease cases. Obviously having a short read option as well is even more exciting in terms of the different options for specific different tests that use sequencing. And to the extent that we can use the two efforts together to either improve the quality of the sequencing or lower the cost, we of course are looking into that. To your question of whether they go in one box or not, I'll leave that to Again, you're talking to one of their customers that is not particularly concerned with the form factor, which is part of the allure of the development arrangement is that we're really focusing on pushing forward the core technology faster than ever. As for the all-in-one box, honestly, that's better left to the team partners over at PacBio. Nonetheless, the capabilities combined are absolutely interesting to us. How do we get more genome for fewer dollars? We're convinced there's essentially no end to the demand for raw sequence data in the applied markets. And so we're really excited to see that trend continue in the years to come. Got it. And then just One question on your guidance, and I know you guys are not breaking out the Archer business specifically, but how should we think about the RUR reaction volume in terms of your guidance for 470 to 500 million? I mean, in terms of what we're assuming for a full year, if we assume about 225K, a 225K reaction volume, would that be somewhere in the ballpark range, too high, too low, or any color on sort of guardrails would be super helpful? Yeah, I think the best answer to that is we certainly don't include that kind of level of estimate into our guidance. And then whether it's REO reaction, regulatory-approved reaction, FDA or otherwise, or an LBT test, again, we are completely indifferent. The AMP chemistry, dragging our PCM, MRD services and products, as well as our therapy selection, we are indifferent as to where it comes out, and I think it's probably best to view oncology revenue as simply oncology revenue, to which there'll be a mix of you know, different levels of regulated kits as well as different services, everything from, you know, soup to nuts, sample to answer services, all the way to sample interpretation and reporting services. All told, there's oncology revenue, and that's what we think is most important looking forward. Understood. Thank you for the time today.
spk02: Next question is from Doug Schenkel from Colman & Company. Your line is now open.
spk04: Hey, good afternoon. Let me just get my three questions out of the way, and then I'll listen. The first is regarding pacing in the quarter. Can you just talk about how things went from the beginning to the end, and then as we move into the second half of the year, if you're seeing any impact as it relates to physician access or overall demand due to the Delta variant? So that's the first question. The second, on the accounting adjustment, I admittedly haven't had a chance to spend a lot of time on that, and you guys are very helpful in your prepared remarks. um this does relate to archer so i i just want to make sure that this doesn't tell us anything regarding whether or not archer's tracking to plans you know clearly you'd rather be making milestone payments but not making milestone payments so i just want to make sure there's nothing to read into there and then the third uh relates to a comment roxy and and welcome roxy uh the comment roxy made on operating uh spent decreasing as a percentage of sales as we look beyond uh 2021 Does that tell us anything about how you're thinking about M&A? Is there increased focus on leveraging infrastructure investment that you have and are making as you try to move towards profitability over the coming years? And if so, does that kind of change how we should think about M&A strategy? Thank you.
spk08: All right. Thanks, Doug. I'll tell you what. I'll do one, and then I'll do a quick treatment of two and three. Roxy can take two, and then Roxy and Ken can take three. So I'll go first on the pacing of the quarter. I would say there was nothing unusual about the pacing of this quarter. We had noted the Q1 was particularly soft in the beginning of the quarter and then kind of had a strong drive toward the end. Pacing this quarter, I would just characterize it as standard. No real story there throughout the quarter, which is frankly nice to see. It looks to us overall that summer vacation for a lot of folk may have come a week or two earlier this year. But other than that, there's really no story there. On the access side, I think that's where there definitely is a story in the long term. There are still accounts and hold systems that I think are going to maybe – You know, I'll refrain from, you know, I think there's, you know, without getting into it or voicing an opinion one way or the other, clearly some of our accounts, some of our clients with a year of fewer people walking around are going to keep it that way. And that's probably a permanent fixture for the industry. But nonetheless, we don't, you know, I think the way we're set up to generate demand and serve customers, you know, we don't, we certainly don't see the role of the boots on the ground rep going away. And we certainly believe we can continue to drive volume and support customers, even with a kind of a permanent modestly reduced access. Putting a figure on that is, unfortunately, we couldn't really do just yet. I think maybe a few quarters go by, we might have a better general sense. But generally, yes, it's a little bit reduced access, but nothing we're overly concerned about. On the accounting adjustment, I'll let Roxy go into details. My top line is that whatever it is, it most definitely does not affect our outlook for oncology business and doesn't materially impact what we think by way of growth revenues going forward. But I'll let Roxy and Ken tackle the accounting adjustment and then the OPEX question.
spk01: All right. So on the accounting adjustment, as you know, there's a set of pretty complex accounting rules as relates to acquisition-related liabilities, especially contingent liabilities and stock-based compensation for ongoing purpose. So every quarter we actually need to do these assessments based on the information we have, and this happens to be a pretty complex quarter and a lot of information coming in as we move through the quarter close process. It's just really a timing issue, and we ask the patient for a few days, and we'll have a lot of disclosure if necessary in our 10-kill timing. So as Sean mentioned, this period is coming, and it doesn't really reflect underlying business in any of the outlook we have.
spk06: Yeah, this is Ken.
spk08: In relative to the comment about OpEx as a percent of sales, and was that signaling any change of focus on M&A? I'd say absolutely not. What we see, the point we were making is that we've made quite a bit of investment into the future growth of our company and serving our patients. We expect that that investment is going to generate a sufficient amount of revenue into the future. And so the way we're looking at our investment portfolio is we think that as a percentage of sales, we probably hit the high point. But we have an aggressive revenue expectation. We're getting a 50% to 50% growth on an annual basis. And so we expect that the company will continue to grow. We will continue to invest in the business, just not as a percentage of sales as we have done over the last couple of years.
spk02: Again, to ask a question, you will need to press star 1 on your telephone keypad. Your next question is from Ophir Gottlieb from Capital Market Laboratories. Your line is now open.
spk08: Hey, guys. Congrats on the quarter. Thanks for taking my question. I have two. First, I want to talk about that new platform and data services category. So first, how is it used by the patient? How is it sold? And is it a recurring revenue product? And then I have a follow-up, if I could, please. Sure. For the first, it varies more often than not. That is either services connecting patients already identified with certain variants with pharma companies that have a therapy or a trial. Sometimes that's interaction directly with that patient through their portal. Sometimes it's a part of a testing program that they're involved in. The other portion of that comes from services that we are receiving revenue for, either for data analysis and exploration, part of research collaboration, for example, or services that are part of our customer-facing tech stack that we are essentially leasing or selling to other players, other healthcare providers in the space who would like to use that stack for their customer support, their patient intake, workflow management, what have you. So in those cases, the patient's experience with it is part of their healthcare journey with that particular client. As for recurring, yes, some of it's recurring by way of, quote, unquote, subscription access or recurring contract databases. Some of it is recurring by way of the licensing, not licensing per se, but signing up for the services and paying for continued access to them. We don't, as of yet, have a significant portion of that that is a patient signing up for a subscription per se directly, but we are certainly planning on that and more of that to come. But that's a high-level commentary on what all goes in there and what it looks like on behalf of a patient or our other customers. Okay, super helpful. And then as a follow-up question, What are, if you can describe it, what are the margins on this piece? It feels like it would be substantially higher than a core testing business. And also, can you share any kind of growth rates that don't go back to 2018? I don't know if they're relevant yet, but 8% of revenue is starting to be pretty material, which is nice to see. Thanks. Yeah, I think we probably won't delve into the margin of this category per se. and I would also say it's variable. A lot of this we're testing out. Some of it is new offering. Some of it is tied to a fair amount of development that's still being kind of charged on cause and going forward. I would say, though, needless to say, as you look forward, it's going to be relatively high margin revenue. I think that's maybe the way that I could put it as we sit today. And apologies over here. The second part of your question was Oh, yeah. Can you share any kind of growth rates that don't go quite as far back as 2018, like, I don't know, a year ago? Yeah. Sorry. Yeah, no, that's right. I think that, you know, for this particular sector, you know, we don't have a specific or, you know, we're not going to guide you a specific outlook for it. You know, we have noted, you know, The embodiment of this in past conversations has largely focused around the pharma-sponsored testing programs or the pharma patient identification programs. And as we've noted, that pharma paid line has been growing, you know, a good many points above our overall growth. So, you know, again, this has all just been off the cuff. We're not going to – we'll certainly – we'll be able to see the growth rates together going forward, but, yeah, that data services is Each one of those is growing north of 60% year over year, and we're excited about continuing investing there, excited about what it means for patients. And to your point, it's getting big enough where we feel it's time to kind of break out that category and look at it on its own versus the straightforward testing revenue.
spk06: Great. Thank you.
spk02: Next question is from Bruce Jackson from the Benchmark Company. You may ask your question.
spk07: Hi. Thank you for taking my question. So the international sales mix has been building nicely here. Do you have a rough idea of where that could be by the end of 2022? And is it being driven by any particular geography or any particular product offering?
spk08: Yeah. I think, like our data services, a different cut of the business is by geography. And, yes, the XUS volume of revenue has been growing typically. Every quarter grows a little bit in advance of the whole. The geographies that we serve, just by reasons of history and also our targeting of the customers there and the price point there, They tend to be, you know, the strongest ones are Latin America, Northern Europe, you know, Middle East, and basically, you know, Middle East and APAC. There's APAC minus China. That's driven primarily by interest in reproductive health testing and cancer screening, cancer testing. So those are the largest and fastest growing geographies for us, and those are the product lines that are the highest sellers there. We're really excited now that we've got a lot more business now. For example, Japan's a good example with direct selling of kits into the national health laboratories running that kind of therapy selection testing there. We're excited to start pushing more of that, and we suspect that the geographical mix will change along with the product mix. But for right now, it's primarily... um, those JRPGs and those, those tests that's been driving it.
spk07: Okay, great. Thank you.
spk02: Your last question is from Brian Weinstein from William Blair. Your line is now open.
spk00: Hey guys, thanks for, uh, Taking the question, I decided to jump in late here just to clarify a couple things. Just on the guidance raised here, I don't think you talked specifically about kind of what areas, if there was one or two that were specific, that was sort of driving this. Are you seeing better performance in oncology, reproductive, rare disease, anything like that. Also, as it relates to that, does the guidance take into consideration any potential takeaways from a player in the space that's exiting on the reproductive side? And there were some genocity revenues, I think, that you thought were going to go away. But is there anything for genocity that sort of built into the guidance now that was not built in when it was announced?
spk08: Yeah, so I'll go kind of backwards on that. Nothing, not trying to say anything, and there's probably nothing to read into about genocity revenue. Now, again, I think as is our practice, genocity revenue now is hard to say. Is it genocity revenue, VT revenue, or Archer revenue? Because right now, we think over the next couple of years, the bulk of the the revenue and revenue growth is going to come from our version of MRD testing, the PCM product. Now that we certainly expect to be a major contributor next year, but this year probably not in the margin. And then to be specific about that, that's the answer there. There definitely is no clear view on any one product area, one disease area, performing differently um you know either either in this quarter or our outlook therein you know looks looks to us like all of them are kind of growing roughly at pace um and we don't we don't really really see a story there um you know reproductive health continues as it has in the past two or at least two or three quarters we talked to reproductive health is growing faster than than some of the others i do think to your question about uh an exit from the space that definitely is um Definitely, I think, going to continue to provide an opportunity for us to take share. There's no doubt others will also take share there. And again, I continue to point to the total market penetration to all 6 million pregnancies per year in the U.S. alone. It's probably going to be the major driver of that story anyway over the next two to three years. So, yeah, so no disease area or product area specific thing, nothing specific to genosity, just, you know, kind of a true kind of exit to the COVID period. And, you know, we're not going to claim that, you know, business is back to normal, back to usual, but it is, you know, momentum is picking up and we wanted to point that out for everybody.
spk00: Got it. Thank you. And then last one on the inflationary pressures that you guys had talked about, you kind of outlined those, but were you able to quantify kind of the impact that those are having on your business and your confidence that you're going to have an ability to offset that here in the short term? And if there's any other kind of detail that you want to provide on any of the inflationary pressures, be it on the cost or on the product or even on wage inflation, and you can hear a little bit about that as well. So just anything else on inflation that you guys are seeing. Thanks.
spk08: Sure. Ken or Roxy, you want to, Ken, you're staring at our input costs rather closely than anybody else. Any commentary on that?
spk06: Yeah, I mean, I think we've seen what everybody else is seeing is that it's getting, you know, getting harder to hire for certain roles.
spk08: And so there's been some adjustments in terms of wages. But in the aggregate, from what we have our business plan landed at, we don't see any abnormalities associated with inflation that is of specific concern to Invitae. And so we're monitoring it. And that's honestly why we have such a clear focus on operating mechanisms and clear line of sight about how revenue and cost are moving so that we can be proactive in that space. But I can ask you a question. We're seeing some of the same pressures that everyone else is seeing in terms of the inflationary piece. I think the bigger impact that we see happening. I was just watching the day that the auto industry is losing, shutting down facilities because of chip shortages and things like that. I think those are having as much of a material impact as anything. And so that's why I talked about earlier, we're really focusing on our supply base, our transportation partners, and trying to stay ahead of, you know, a little bit of the uncertainty that's going on in the marketplace relative to supply and demand. So, That's probably how I see it.
spk07: OK. Thank you, guys. All right. You're welcome. Thank you.
spk02: That ends our question and answer session. I'll turn the call back over to Laura for closing remarks.
spk03: Thank you all for joining us today. We look forward to connecting with you soon at upcoming conferences.
spk02: That concludes this conference call. Thank you all for participating. You may now disconnect.
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