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Invitae (NYSE:NVTA)
Q3 2021 Earnings Call
Nov 08, 2021, 4:30 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Ladies and gentlemen, thank you for standing by. My name is Brent, and I will be your conference operator today. At this time, I would like to welcome everyone to the Invitae third quarter 2021 financial results conference call. [Operator instructions] I would now like to turn the call over to Ms.

Amy Hadsock. Please begin.

Amy Hadsock -- Investor Relations

Thank you, operator, and good afternoon, everyone. Thank you for joining us for our third quarter 2021 financial results call. Joining us today are Sean George, our CEO; and Roxi Wen, our CFO. We're also joined today by two leaders within our oncology group, Vishal Sikri, president of Invitae Oncology; and Dr.

Rakesh Patel, founder of Medneon, and now serving as Invitae's chief medical officer, digital health. Before we begin, I'd like to remind you that various remarks that we make on this call that are not historical, including those about future financial and operating results, plans and prospects, focus of our business strategy, plans to integrate and manage businesses we acquire, market opportunities, future product services, our product pipeline and their timing, demand for and reimbursement of our services and investments in our infrastructure and operations. These statements constitute forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act. It's difficult to accurately predict demand for our services, and therefore, actual results could differ materially from our stated outlook.

Statements on company performance assume, among other things, that we don't conclude any additional business acquisitions, investments, restructurings, or legal settlements. We refer you to our most recent 10-Q, in particular, the section titled Risk Factors for additional information on factors that could cause actual results to differ materially from our current expectations. These forward-looking statements speak only as of the date hereof. As you listen to today's conference call, we encourage you to have our press release available, which includes financial results, as well as key growth metrics, and commentary on the quarter.

To supplement our consolidated financial statements prepared in accordance with the generally accepted accounting principles in the United States, or GAAP, we monitor and consider several non-GAAP measures. We exclude from our non-GAAP operating results as applicable, among other items, amortization of acquired intangible assets, acquisition-related stock-based compensation, post-combination expense related to the acceleration of equity grants or bonus payments in connection with the company's business combinations, adjustments to the fair value of certain acquisition-related assets and liabilities, including contingent consideration and acquisition-related income tax benefits. We exclude from our non-GAAP cash burn as applicable changes in marketable securities, cash received from equity financings and debt, and cash received from exercises of warrants. Non-GAAP measures may include cost of revenue, gross profit, operating expense, including research and development, selling and marketing and general and administrative, other income expense net, as well as net loss and net loss per share, and cash burn.

We encourage you to review our GAAP to non-GAAP reconciliations, which are available in the press release and in the appendix of the earnings slide deck. With that, I'll turn the call over to Sean.

Sean George -- Chief Executive Officer

Thank you, Amy. Before we get started, I want to emphasize that toward the end of our call, Roxi will be outlining a set of key business metrics we will be using going forward as a dashboard for our business model success. As our platform is developed and our business expands from testing services into other areas, we've been working to provide smarter, more relevant measures, in addition to those used traditionally in the life science sectors. We'll refer to those several times on this call and will rely on that new dashboard heavily going forward.

To headline the quarter, revenue growth -- revenue grew more than 65% over last year's Q3 period, which with all things considered, keep us comfortably within our longer-term growth targets, and number of patients we serve grew by 89% over last year's third quarter, up about 3% over this year's second quarter. During the summer months, we typically experience some seasonality as you can see on the charts, but this year's slowdown was a bit more pronounced and longer lasting than the past couple of years. It is difficult to determine how much of that was unusual seasonality and how much of that was COVID related. We are seeing some pickup in recent weeks, but are being cautious with our guidance for the remainder of the year in case those impacts persist.

Reflecting on the long-term view, as you can see, the year-over-year top-line growth across the platform demonstrates our continued progress toward meeting the immense unmet demand for the use of genetic information in healthcare. The takeaway here, aside from any short-term revenue fluctuation, is that we are tapping into something unique at Invitae. Since the advent of genomic medicine now 20 years ago, we are in the midst of a fundamental shift in not only medicine but in how we view our health and wellness, family planning, disease management, and aging. In view, is a time when many diseases will have a well-understood risk that can be minimized and even staved off, and therefore when they arrive, can be rendered a chronic condition to be managed for years or even decades.

But that future is only a reality with genetic information derived through testing early and often. And the benefits will be accelerated with attracting, storing, analysis and understanding of health and health-related data for individuals, families, and populations. While the investment to make that future reality is large and the time line is long, the value that can be created is immense. We believe that the ability to identify those at risk for disease detect and diagnose the onset those diseases earlier, to use that information to guide preventive measures or targeted treatment, and monitor the success of that treatment will be the standard of care for individuals throughout multiple stages of life.

The company that can deliver that standard will be transforming very large and durable markets in healthcare. Furthermore, those large, durable markets are all increasing in size. In each of these four primary life cycle areas, fundamental drivers of adoption over the next two to three years are quickly coming into focus and will create the need for our services that we believe far eclipse the ability of today's system to better treat or even outright prevent disease. Much of the tailwind is coming from the rapidly expanding biopharma pipelines full of genetically targeted therapies.

Some is coming from a better understanding of the improvement to outcomes and cost utility of using this information. Some is coming from changing perceptions and attitudes about the role of the patient in their own healthcare and engagement from those paying for it. And much of it is coming from the exponentially growing volumes of evidence that this shift is a shift to better medicine. For example, the study being presented today at the American Heart Association meeting that found broad genetic testing, identified clinically relevant variants for one in five patients suspected of having a heritable cardiovascular condition; two-thirds of them were projected to have clinical management implications, and more than 10% of which would have been missed using a narrower testing approach.

A little over a week ago, I read a Washington Post article about how a 34-year-old marathoner, new mom to a 10-month old son, dropped to the pavement at mile eight the race, thankfully, kept alive by medically trained spectators that happened to see it. Her father died of a heart condition at 53, and but for a brief call out to that fact, really nothing to note about the role of how genetic information could be used to prevent such a narrow escape. That will change, we believe, rapidly. And as an example, the market for the use of genetic information in cardiovascular and cardiopulmonary disease could be as large as that for oncology, which can give insight to our formulae for growth.

We are building a platform that can help our customers move through risk assessment screening, prevention or therapy selection, and ongoing monitoring. And that platform will help that individual make the most informed decisions about their health, as well as generate the real-world data and network connections needed to put effective next steps in their hands. Today, our business can be measured by the progress along that front in oncology, reproductive health, pediatric and rare disease. And in addition, we've recently broken out the part of our business that utilizes patient-owned data and patient connections generated every step along the way.

In the future, we will be adding more information that we can provide for the patient at each stage, more capabilities to our data platform and partner network, as well as adding new disease areas or stages of life, such as cardiovascular disease, I mentioned a few minutes ago. As I mentioned before and very importantly, later in the call, Roxi will lay out the key business drivers and financial metrics that we'll be using to measure our overall progress against our model. I'm hoping that using these as signposts we will be able to map for everyone the journey from where we are today to the future we are certain is coming. Given just how much is going on at Invitae in a given month of the year, it's not possible to cover it all on our quarterly calls, but we'd like to at least give a little more insight into the near-term drivers of our business.

So each quarter, we'll spend a little more time on one of our key areas of revenue growth. This month, we'll focus on our oncology platform, which is especially relevant since the products and services coming online from that group will be important drivers of revenue and margin growth in the coming years. Vishal Sikri leads our oncology business, and I've asked him to provide some additional clarity on the product plans and clinical trial activity that underscores our potential to walk our customers from risk to hopeful remission in the near future. I've also invited Dr.

Rakesh Patel, our chief medical officer for digital health to join us today. Rak is an oncologist and was a practicing physician for more than 17 years before becoming an entrepreneur, cofounding the Medneon digital health platform, which Invitae acquired in the second quarter of this year. Rak will outline how those products and studies dovetail with our digital health platform to benefit patients, physicians, families, and the broader healthcare ecosystem. I'll hand it over to you, first, Vishal. 

Vishal Sikri -- President, Oncology

Thank you, Sean. In oncology, we have an active pipeline to support testing across the patient's journey. I will provide an update on the product road map, which includes a vibrant combination of tests that have been part of the Invitae portfolio for years, innovative tests acquired with the ArcherDX integration, and new tests on the horizon. In the germline testing category where Invitae has been a leader for years, we added an RNA offering to our DNA germline test this year and plan to expand into polygenic risk score in 2022.

Germline testing showed impressive growth in '21, and with our expanded offerings, we expect growth to continue through 2022. These additions are a differentiator, given the multitude of recent third-party clinical studies verifying the benefits of combining germline and somatic testing in defining risk and the best course of treatment. Invitae is the only company developing and combining germline and somatic testing on one platform. On the research use-only front or RUO, we plan to launch our expanded DNA-based kit offerings by the end of this year.

That offering will include testing for microsatellite instability, also known as MSI, addressing a growing demand from clinicians. We're also expanding our RUO offerings to include tumor mutation burden, or TMB, an important biomarker for therapy selection. We continue to innovate on the centralized lab offerings front with a series of laboratory-developed tests being stood up in the coming year. In 2022, we plan to launch our clinical offerings for personalized cancer monitoring, PCM, which is our tumor-derived test.

While our initial body of research demonstrates the accuracy of our MRD test to monitor and detect recurrence in lung cancer will be pushing forward with PCM as a pan-cancer offering, giving us what we believe -- view as a distinct advantage in this emerging and important market. Later in the year, we plan to expand our centralized somatic offerings to include a comprehensive therapy selection test that is informed by DNA, RNA, and protein. This therapy selection capability is similar to Archer's stratified offering, but we will be using alternate trade names as we stand up our LVT offering due to commercial, IP, brand, and other factors. Finally, in 2022, we plan to kick off our development work on an early detection assay for cancer screening purposes.

On the in vitro diagnostics or IVD front, where demand for decentralized genomic testing is growing, we're moving toward creating product and service beachheads where no competitors are today. We plan to launch our first CE-marked IVD kit products in select European markets in Q1 of 2022. These first tests will include our FusionPlex DX and our LiquidPlex DX tests. Both tests will enable any facility with sequencing technology and our solutions to accurately profile solid tumors and blood samples for therapy selection at their facilities.

This is a major step toward satisfying the pent-up demand for local and regional genomic testing capabilities, particularly among EU countries and leading academic cancer centers. It will allow us to expand our customer base in Europe and parts of Asia. Outside of the EU, we're submitting additional claims for IVD solutions; in Japan, in 2022, which will help labs running the tests get higher reimbursement, therefore, increase adoption. With the launch of our IVD products outside the U.S., we expect strong adoption of our tests, especially in countries where testing is heavily decentralized.

While we're launching these products for customers in Europe and Asia, we will continue to work with regulators in the U.S. to finalize the requirements for a launch of those kits and a decentralized commercial strategy here in the U.S. Based on the feedback from the FDA, we believe that we have a good road map for FDA approval for IVD products, including a path forward as an IVD for our PCM tests. In the past, Invitae has avoided highlighting ongoing individual studies, but the fact is the company is making substantial investments in resources to partner with KOLs from across the globe to better understand and highlight our approach to personalized medicine and the use of clinical data in driving the patient experience and better outcomes.

Altogether, we believe these studies underscore the value of our current products and our new product launches planned for 2022. On a high level, this year, we expanded the case for our hereditary cancer test with multiple publications, including INTERCEPT, a collaboration of germline testing across tumor types, and we demonstrated the importance of our ArcherMET IVD test for MET exon 14 detection. In 2022, we anticipate a wealth of data to support our PCM product, including TRACERx presentations and publications, data readouts from retrospective multitumor PCM studies with academic partners, including Mass Gen and MSK, as well as early signals from our prospective PCM studies, including iGAP and MARIA. In 2022, we have additional hereditary publications planned, as well as furthering our support of the INTERCEPT trial with tumor profiling in multiple cancer types.

Then in 2023, additional prospective PCM trials are expected to be blossoming, including MRD-guided trials. Meanwhile, we continue to -- we intend to continue our participation in important projects pushing forward best practices in our field, including the BloodPac Consortium, Friends of Cancer Research HRD Project, Personalized Medicine Coalition. I'll conclude by highlighting the MARIA trial, which is being initiated by the end of next month. MARIA stands for MRD assay value with recurrence and response via tumor-derived assessment.

It is an Invitae-led study working with academic and community collaborators to use PCM as a means of risk stratification, a surveillance tool, and a therapy monitoring tool across multiple cancer types. This will be a global study, and we expect initial readout in 2022. I will now hand the floor to Dr. Rakesh Patel, who will walk us through how our expanded end-to-end testing portfolio integrates with a cancer patient and provider journey, as well as the importance of digital health and data platform.

Rak? 

Rakesh Patel -- Founder, Medneon

Thank you, Vishal. The emerging practice of precision clinical oncology involves multiple applications of molecular testing across the patient's lifetime, from before they are ever diagnosed to well after they are treated and achieve remission. First of all, mutation analysis is now routinely utilized for diagnosis of hereditary cancer syndromes. For already diagnosed patients, biomarker profile testing of the primary tumor to detect actionable mutations has become an integral part of cancer therapy.

Since the molecular makeup of a tumor may significantly evolve over time during treatment, monitoring of patients is critical to be able to detect resistance mutations as early as possible and adjust therapy when needed. Tumors almost always shed their fragments into patient's bloodstream, so-called liquid biopsy or the analysis of circulating DNA, holds a great promise for noninvasive detection and molecular markers. It can be used as an alternative to tissue-based testing when biopsy is not an option or the quality or quantity of the tissue sample is not sufficient. It can also be used for early cancer detection to predict the likelihood of relapse at diagnosis or to monitor response to neoadjuvant therapy, recurrence after adjuvant therapy, or treatment resistance.

We believe Invitae can provide critical knowledge that will guide and facilitate every stage of a patient's cancer journey. From an oncology practitioner's perspective, the digital health platform is just as critical, with complex preventive measures, an array of testing capabilities and rapidly expanding treatment pathways, cancer is the most decision-dense disease. We are building an end-to-end platform that keeps providers informed and in turn, empowers a patient for shared decision-making. Importantly, cancer risk assessment and genetic testing is not a one-time event, as not only does an individual's medical and family history change over one's lifetime, but a single individual may benefit from multiple types of genetic tests, both before or after and after a cancer diagnosis.

There is a large amount of genetic information in novel therapies that are now available and keeping providers updated of the rapidly changing guidelines is challenging. Since patients relocate or change their providers frequently, having a trusted, direct patient engagement over time is paramount. The most effective way to treat cancer is to never get one. And in that context, we have developed robust capability focusing on population health, genetic cancer risk assessment, and predictive analytics, ideally before cancer is diagnosed with the goal of preventing it altogether.

Outcomes are usually better when disease is caught early, and the early disease detection remains a core focus area. Once the cancer is diagnosed, clinical decision support tools for an accurate diagnosis, leveraging multidisciplinary oncology expertise and molecular profiling of tumors is key to develop a unique treatment plan for each patient with targeted precision therapies. Following multidisciplinary treatment, staying connected to the patient to monitor outcomes is just as important in order to identify subvisual cancer burden, which again allows early intervention and repersonalizing of the treatment plan. In effect, turning a once terminal clinical situation for most into a chronic disease for many with the potential of durable remission extended life expectancy.

From frictionless collection of health records into a secure patient wallet with Ciitizen to patient education and AI-based patient engagement with Gia, to point-of-care risk assessment, medical necessity with testing and personalized management insights for providers by Medneon, medication management with YouScript, along with therapy guidance, virtual tumor board capability, and several platform modules and active development to support our expanding testing portfolio. The Invitae digital health strategy will bolster our mission to bring genetics to mainstream medical practice. We will provide an integrated clinical decision support platform capabilities for coordinated and personalized tech-enabled care, coupled with a seamless real-world data strategy, leveraging active, longitudinal, provider, and patient engagement and efficient clinical workflows for all stakeholders. Thank you.

Back to you, Sean. 

Sean George -- Chief Executive Officer

Thank you, Rak, and thank you, Vishal. We're looking forward to active and important months ahead for oncology effort as we bring new patients onto the platform, introduce new tests and services for those patients and drive the scale necessary for financial performance, and to build what we believe will be the most robust data sets for research and discovery available anywhere. Before we go to Q&A, I'll hand the call over to Roxi Wen to cover the financial results and discuss the important business drivers and key metrics for Invitae. Roxi? 

Roxi Wen -- Chief Financial Officer

Thanks, Sean, and thank you all for joining us today. Billable volumes of approximately $296,000 in the third quarter of 2021 were up 89% from the third quarter of 2020 and 3% sequentially from the second quarter of this year. Internationally, we saw volume growth that was slightly ahead of our U.S. business and represented over 21% of total billable volume of the quarter.

Overall, ASP trended down 3% to $377 in the third quarter from $388 in the second quarter of 2021. This reflects the mix increase in Q3 to women's health and international testing sales, which have lower ASPs compared to other products. Looking ahead to 2022, we expect ASP to benefit from our launch of broader LDT and IVD testing for therapy selection and MRD testing for monitoring and surveillance, all of which have higher reimbursement rates. As we've noted in prior quarters, it is easier to understand our business and financials by providing non-GAAP metrics to allow for the comparison of the two sets of numbers, we urge investors to review the detailed reconciliation to non-GAAP net financials included in today's press release and at the back of the slide deck.

For the remainder of the call, we'll discuss non-GAAP numbers, including cash burn. Our non-GAAP cost per unit defined as total non-GAAP cost of revenue divided by the number of billable units, improved to $249 in the third quarter from $261 in the second quarter, due to continuing progress with efficiencies in our overall operations and inventory management in the oncology business. Non-GAAP gross profit was $49 million in the first quarter, which translates to a non-GAAP gross margin of 36%, a slight improvement over the Q2 gross margin of 35%. We expected progress as we continue to execute our margin expansion road map in pricing, product cost outs, variable cost productivity, and revenue cycle management.

Moving down the P&L. Non-GAAP operating expenses was $201.8 million in the third quarter as compared to $199.2 million in the second quarter. The third quarter operating expenses include costs from newly acquired businesses. As we stated on our Q2 call, the rate of growth in spending is expected to come down in the second half of the year.

We continue to be committed to this goal as we scale the business and manage return on investment at the total portfolio level. We continue to invest in our business in the following areas: research and development, which was up by approximately 146% year over year but down by $3.4 million sequentially. The year-over-year growth was mostly driven by costs from acquired businesses, including ArcherDX, headcount, and stock-based compensation, as well as program costs, such as the PacBio collaboration. In addition, selling and marketing was flat sequentially but up by 45% year over year to support a high growth rate over 2020.

G&A expenses increased by $8 million over the second quarter, mostly due to higher legal expenses and investment in our ERP capabilities. Looking forward, we're planning for the growth rate of operating expenses to begin declining in the fourth quarter and into 2022, benefiting from continued top-line growth and various margin improvement initiatives. This year should mark the highest annual non-GAAP opex as a percent of revenue as investment levels stabilize or even slow down in key areas. Moving to our cash position.

Cash, cash equivalents, restricted cash, and marketable securities totaled $1.25 billion at September 30, compared to $1.54 billion at June 30. Cash burn was $286 million in the third quarter, including cash paid to finance and close acquisitions. Excluding acquisitions and related expenses, our burn for the quarter would have been $148 million. We generated $114 million of revenue in the third quarter to 67% from the gross increase from the third quarter of 2020.

The revenue breakdown by product group in the third quarter was as follows: approximately $69 million from oncology, including germline testing, therapy selection, and companion diagnostics; approximately $21 million from our women's health offerings including NIPS, carrier, and other reproductive tests; approximately $15 million from the rare diseases and other testing covering cardio, neuro and metabolic and newborn screening. Data and platform revenue was approximately $10 million. This includes data management, analytics, data as a service, and certain biopharma and patient identification program. Revenue from all four areas increased nicely year over year in the third quarter and across the past two years.

Invitae's business model is highly differentiated, complex, and ambitious. During the initial listening to our quarterly after I joined the team, many of you expressed the desire to better understand our business as we continue to grow and scale. We appreciate your support and are taking a number of steps to help offer visibility into the fundamentals of our business. First, we plan to continue to provide revenue trend analysis for each of our categories.

Second, our business leaders and subject matter experts will be joining our quarterly calls to provide deeper insights into the business as Vishal and Rak have today. Third, going forward, we'll be providing clear visibility to a set of key metrics of our business. We selected and developed these metrics based on their operational significance and ability to accurately describe returns on investment internally and for M&A activity. These categories include expansion of our commercial access points through clinics, hospital systems, or pharmaceutical partners, growth of our patient population and patients available for data sharing, revenue per patient for our testing and services business, and in the future, annual recurring revenue as our SaaS business ramps up.

New product vitality measured by revenue contribution of new products developed or acquired over the last three years. This will also connect strategic investment decisions to the freshness of the portfolio. We continue to measure our ability to expand margins by trajectories of gross margins and variable cost productivity. Last but not least, the category of leverage.

In addition to the standard operating expenses metric, we plan to report operating cash flow as a percent of revenue to show scale and improvement. Our future objective is to focus on net operating cash flow. It is important to note that success will not be measured by increasing every category in every quarter. If this is to be a useful dashboard, it will signal both progress, an area that needs attention as time goes by.

Our objective in sharing these metrics within the framework is to offer more transparency into a complex, fast-changing business and to provide a consistent, balanced perspective on performance as we continue our journey to bring genetics to billions of people. We intend to roll this out at the end of this year and maintain a quarterly update as we move forward. As to our guidance for the year, in August, we provided a revenue guidance range of between $475 million and $500 million for 2021. The result of Q3 and the greater-than-expected seasonality this year has led us to be slightly more cautious and to adjust this projection to a range of between 60% to 70% growth for the year or revenue between $450 million and $475 million.

Back to you, Sean. 

Sean George -- Chief Executive Officer

Thank you, Roxi. We've long shown this ramped view of our business model in an effort to describe how we see the evolution of global genomic medicine. Our progress in addressing patients' needs throughout their lifespan and the emergence of our platform and data services demonstrate progress up the curve into the genomic network era, where genetic information can be shared on a global scale to diagnose more patients correctly earlier and bring therapies to market faster. We continue to believe that these new connected capabilities are best developed, delivered, and supported from an integrated platform.

The more of the landscape we can cover by way of genetic test content, the more patients we can add to our network. And the more patients in our network, combined with more information we can provide or ingest on their behalf, the more that we and our partners across the healthcare ecosystem can do for them. The next steps in building out our platform include continuing investment in the development of our data, analytics, and real-world evidence capabilities. Over many years, we have built an extensive technical stack of processing, pipeline, interpretation, reporting, and customer service capabilities, and we continue to acquire an integrated portfolio of digital products and services that enhance customer experience through personalized insights improved workflow, and other tech-enabled services.

With that, we'll now turn the call over to the operator for Q&A. 

Questions & Answers:


Operator

[Operator instructions] Your first question comes from the line of Dan Brennan with Cowen and Company. Your line is open.

Dan Brennan -- Cowen and Company -- Analyst

Great. Thank you. Thanks for taking the questions, guys. guess first question, just kind of more near term.

Obviously, you discussed the seasonality with COVID, and it's going to persist into the fourth quarter. Can you just give us a sense of maybe pacing in the quarter, kind of what's baked in on the fourth quarter? And were there any issues with supply chain that made it -- that kind of impacted your ability to meet customer needs?

Sean George -- Chief Executive Officer

Yes. So thanks, Dan. I appreciate it. We -- no real comment on Q4, except the typical seasonality pickup.

Typically, there's a pickup from Q3 to Q4. We are indeed seeing that, with that said, as we stated, it's coming off from a little bit of a divot as it were from that summer seasonality, picked up a week or two later than we typically see. And while it's difficult to ascertain, there's definitely some COVID baked in there. So we're just kind of being a little circumspect coming off of that end of Q3 into the rest of the year.

But we don't see anything unusual now about Q4 in front of us. As for the supply chain, Roxi, I'm not sure if there's anything new on that?

Roxi Wen -- Chief Financial Officer

No, I think it's pretty consistent, with the previous quarter, if something, we don't know.

Dan Brennan -- Cowen and Company -- Analyst

And then kind of across the four -- yes, sorry, go ahead.

Sean George -- Chief Executive Officer

Go ahead, Dan.

Dan Brennan -- Cowen and Company -- Analyst

Sorry. I was going to ask kind of across the four segments, really oncology, women's health, mainly and then obviously the other two, what -- were any of the businesses impacted more acutely than others? And could you give us a sense -- I know you don't guide by segment, but maybe just stepping back, big picture, when we think about kind of the growth aspirations for Invitae like -- any sense on how we should be thinking about kind of between oncology and women's health, how those kind of fit in as we look out within the context of your kind of long-term growth plans?

Roxi Wen -- Chief Financial Officer

Yeah. We look at those growth areas like end markets, product categories. And across the board in Q3, we didn't really see one particular area weaker or stronger than others. They were pretty consistent indication that we had traffic and seasonality -- longer seasonality issues in Q3 that we experienced.

And going forward, from a revenue perspective, again, we look at these go-forward revenue guidance, from a revenue perspective, we also do not see a change in trend. And also this quarter, we started to introduce some metrics, concept of metrics, and going forward will be some data to help you understand how to predict and measure the success of the platform across all the key categories that will be in the number of patients that are coming into our platform and revenue per patient, as well as at the access point account-level growth. 

Dan Brennan -- Cowen and Company -- Analyst

And then maybe one final one. You put up the slides on all the timing for all the cancer products coming out across therapy selection and MRD. Is anything new there in terms of the timing? I'm not as close to exactly -- there was a lot of products, I was just wondering from what you previously communicated about timing, is everything on track, anything slip or advance, maybe just some color on that.

Sean George -- Chief Executive Officer

Yes. I'll start and I'll let Vishal finish. No, nothing new. The -- we had talked earlier about the public and visible stratified FDA application.

And as we've laid out, that is now actually two or three different discussions with the FDA that will progress. So that is old news, but reflected in Vishal's overview today. Else that, nothing really new. We tried to put a little more kind of detail behind the kit launches, the different regional approvals.

One of the main events is our MRD or we call it personalized cancer monitoring testing. That is in market now as we speak. And then the road map that Vishal spoke about looks forward to when we hit that hard commercially, we do expect revenue impact that for that to impact our revenue for -- materially for next year, not necessarily for this year, even the end of this year. But nothing new there, Vishal, anything I missed? 

Vishal Sikri -- President, Oncology

No, I think you captured it. We're on track.

Dan Brennan -- Cowen and Company -- Analyst

OK. All right, guys. Great. Thank you very much.

Operator

Your next question comes from the line of Tejas Savant with Morgan Stanley. Your line is open.

Tejas Savant -- Morgan Stanley -- Analyst

Hey, guys. Good evening. So, Sean, I do want to go back to the earlier question on the guide. I know you -- last time we had spoken, you had mentioned sort of baking in Delta uncertainty into the numbers and absent an impact, you were expecting to come in at or above the high end.

Since then, you've now sort of lowered the midpoint by about $25 million. So can you just help us sort of build a bridge there? I mean was it sort of very concentrated two or three weeks in August, perhaps that you saw much greater weakness than you had anticipated? And in terms of the bounce back, are you sort of calling for a V-shaped recovery here, essentially or a more sort of metered ramp back to normalized volumes as we head into '22?

Sean George -- Chief Executive Officer

Yes, absolutely. I can give more color on that. On our last call, we were checking in literally up to the day or two before and saw really strong growth, new account formation, etc., made an estimate of both seasonality and anything COVID impact. We did see -- as Roxi mentioned, it hit all categories, product categories equally, which is -- it's a typical signature of the seasonality, that's the seasonality signal.

And also, you can also see a kind of relative geographical locations, ex U.S. versus U.S. The thing is we saw that, I'd say, it kind of came a week, 1.5 weeks early, and it persisted a good two to three weeks later than we usually see it. And that gave us some pause as we look to the end of the year.

Again, because it looks like a seasonality signal, we don't know how much to ascribe to COVID. In the detailed volume loss data though, our volume loss kind of calls from the sales team, it clearly had to do with either people not being at offices or not going into offices. And so obviously, there's a COVID impact there, it's really hard to tease out. So then as we look at Q4, this is where -- given where we kind of enter the quarter, we're just going to take a circumspect view and adjust our view to the end of the year.

We are in at a different spot than we were just last quarter. But the only thing that reflects is that, that bit of a dent in our annual number that Q3 delivered. We do see since recovery. We expect it to perform seasonally within range and get on -- continue with our kind of relatively industry-leading growth. 

Tejas Savant -- Morgan Stanley -- Analyst

Got it. And then a couple of ones sort of looking forward to '22. It's been a couple of quarters now where you've called out international outpacing U.S. growth.

How do you expect business to trend on a go-forward basis? And any particular pockets of strength that you'd like to highlight? And then on the early detection assay development front for cancer. Any incremental color there versus the time line that you mentioned of '22.

Sean George -- Chief Executive Officer

Yes. So ex U.S., particularly led by -- when Vishal walked through all of the ex U.S., country by country or even regionally specific approvals for therapy selection and monitoring kits, that's -- obviously, that's a high growth area. There's a lot of pent-up demand there. And it's also a market where a centralized service based on the U.S.

isn't going to be the best thing to serve those clients. So we're -- we expect that to contribute more. The other thing is our pharma-sponsored patient identification programs, the more global to reach the better, and we would expect those also to continue -- they do continue to put more momentum in all regions. They're happy to find patients wherever, but it does allow us to look more outside the U.S.

than the more traditional clinical testing business with the U.S. payers and Medicare reimbursement, et cetera. So those are the drivers there. We think that will continue to support to buoy our ex U.S.

revenue. We'll continue to see that as an important part of the growth story. I think your second question was on early detection, and I just want to be clear, we're not calling out a launch of early detection in '22. We're both -- we're currently doing the -- our own work on what the -- our own technologies would look like in trials and validations and also, of course, looking at the buy scenario as well.

But we don't have -- most of the action -- certainly, our action for next year is going to be in risk assessment, therapy selection, monitoring, and really kind of taking our product portfolio through that end from start to finish for our oncology patients. 

Tejas Savant -- Morgan Stanley -- Analyst

Got it. And then one final one for me here. Sean, as we think about the price versus volume offset heading into '22 in light of the PAMA cuts on the hereditary cancer testing piece of the business, what are your expectations there?

Sean George -- Chief Executive Officer

Yes. It's a good one. So the PAMA impact is going to be a little different than in past years. Without getting into the details, it won't affect all of our hereditary cancer business.

It's not important why, I'll just say like there will be some, but it won't be the full impact. We'll probably do a little more work on that to try to guess exactly what that will be. But I think in the context of our overall cancer business, overall cancer revenue oncology revenue, it's becoming less and less of an impact. I wouldn't I don't think it's going to be immaterial next year, but it's certainly going to be a lot less material than it used to be.

And I think going forward after that, it will decline to the point of immateriality. As I mentioned, it will be -- it won't be across the board, and we're still kind of working on the details on that as we speak. 

Tejas Savant -- Morgan Stanley -- Analyst

Got it. Very helpful. Thank you.

Sean George -- Chief Executive Officer

Thanks.

Operator

Your next question comes from the line of Tycho Peterson with J.P. Morgan. Your line is open.

Tycho Peterson -- J.P. Morgan -- Analyst

Hey, thanks. Can you help us think about gross margins? Coming out of 2Q, you said 45 to 50 per year. You're now kind of coming out at 35.5% for the third quarter. So how do we think about gross margins for the fourth quarter and going forward?

Sean George -- Chief Executive Officer

Yes. No, we are not where we want to be on gross margins. There's a little bit of that is volume. Some of that is still some kind of inventory stuff pull-through from acquisitions.

But the biggest thing there is mix on pricing are -- there hasn't been a change in relative growth rates of our different revenue buckets. The fact that reproductive is growing faster, we're getting more -- growing more market and taking more share there for NIPS in particular, but in also carrier. It drags down price a bit. And I'd say over the last couple of years, our investment has -- our investment needle has moved much more toward market creation, volume growth, new products, et cetera and less as focused on fundamental COGS takeout as perhaps in years kind of think three to five, six years ago.

And so we're not exactly where we want to be. And with that said, between a series of new products that we know will be higher priced, higher margin, our own work on COGS improvement, and then just get old fashioned volume economies of scale. We're confident that we'll start showing progress back to our 50% target and people as Roxi laid out in our business dashboard, people will see that every quarter as measured against our other key business metrics. 

Tycho Peterson -- J.P. Morgan -- Analyst

And I mean, I guess along those lines, are you able to -- I know you're not guiding for '22 yet, but just on opex, are you able to give us a rough sense of how you're thinking about opex for next year overall? And as you think about screening, are you going to start to spend on studies? And do you need to do 10,000 patient studies like everybody else? Or how do you think about the magnitude of spend around screening?

Sean George -- Chief Executive Officer

Yes, let's do -- Vishal, why don't you do screening first, where we are, and then Roxi will speak to the next year, if we go in reverse, yes.

Vishal Sikri -- President, Oncology

Yes. On the screening side, right, we're right now looking at multiple different avenues on what we need to do there. The goal here is not necessarily to invest in 10,000 patient studies or anything like that. It's really to see what do we need to do to be successful in this area? And as Sean mentioned, do we build or do we buy in this area.

So that's something that will become a lot more clear in 2022 at this point. Roxi?

Roxi Wen -- Chief Financial Officer

Yes. On the opex front, we were not guiding that yet. But we're very focused on driving the balance between the strength of our balance sheet, as well as long-term growth investments, across the portfolio not to trade long term or short term or vice versa. So that balance is something we're very focused on.

We'll continue to invest in our business and in some of the long-term strategic initiatives we've been doing and also keep a keen eye on the returns and the early signals of the effectiveness of those investments. That being said, right, our business has scaled to a level that revenue and opex investments are both large enough to have enough levers for us to achieve -- to be very focused and -- have some drivers -- identified drivers to focus on our operating cash flow objectives. And so it's a long way to say we -- you should expect growth in investment in key areas and continued growth, but the operating leverage from opex should continue -- should see some improvement there from Q4, starting Q4 and next year, for sure.

Tycho Peterson -- J.P. Morgan -- Analyst

OK. That's helpful. And then last one for me, just on Ciitizen. You never broke out revenues from the acquisition.

I'm just curious if you can give us any rough sense in how you think about synergies with the rest of the business.

Sean George -- Chief Executive Officer

Yes. The Ciitizen revenue, I mean, it's small enough, it's not calling out a loan. With that said, last quarter, we broke out our data essentially the revenue on our -- from our platform from data, data analysis services, other services. The Ciitizen revenue will go in there, and that's where it fits nicely with a lot of our other data analysis services.

And we do have a good view to that line growing more rapidly than the other revenue buckets in the quarters and years to come. And I feel that will be really important as kind of we pointed out, is a really important part of the growth story. We're hitting that middle era of our business model with these assets as a key part of it.

Tycho Peterson -- J.P. Morgan -- Analyst

OK. Thank you.

Sean George -- Chief Executive Officer

Yes.

Operator

Your next question comes from the line of Matt Sykes with Goldman Sachs. Your line is open.

Matt Sykes -- Goldman Sachs -- Analyst

Hi, everybody. Thanks for taking my questions. Sean, maybe just the first one, kind of big picture. Looking at the chart you usually show the last chart and slide on the evolution and where you are and where M&A was part of your strategy? And then coupling that with the comments on kind of more rationalized spend to a certain degree.

I'm just wondering, from an M&A perspective, should we expect a bit of a pause here or maybe a shift toward more organic-related investments going forward? Or is it still if opportunities come up and they're attractive and makes sense for the business, you'll still examine them. Just trying to wonder where you're thinking in terms of organic versus inorganic as we move into '22.

Sean George -- Chief Executive Officer

Yes. No, I appreciate the call and good opportunity to provide more clarity. Just to be clear, we still believe corporate development M&A is a key part of the growth strategy going forward. As Roxi had pointed out, we are -- in our metrics dashboard, we are looking at operating leverage, cash flow as a percentage of revenue.

And as we've always said, the goal -- the single financial goal is massive and dependable operating cash flows. And so that's kind of where we're heading. But just to be clear, those -- that is in the context of growth and investment. That's a ratio -- as a ratio of our revenue growth -- ratio of our revenue.

So we're tailing off the investment growth, but the absolute investment underneath our -- of our very high revenue growth is still going to be quite high. And M&A will still be a part of it. We've -- there's only -- there are only so many targets out there. We take a look at a lot of them.

To the extent people are looking for context of kind of as we finish the call, I mentioned there's digital capabilities, patient workflow capabilities, digital health, and clinical decision support tools. Those are things we are really active in and see great opportunities in. With that said, we are always, of course, interested in things that things that we can integrate into our platform and drive new disease areas, new content, and kind of further fill in for an individual from birth to death of the stages of life, which we think genomic information can be most impactful.

Matt Sykes -- Goldman Sachs -- Analyst

Great. Thanks for that. That's very helpful. And then, Vishal, maybe one for you.

On your time line, you spoke about the kits rolling that out in international and in the U.S. I'm just wondering how important do you think is driving that decentralization of testing to the overall business as you see it.

Vishal Sikri -- President, Oncology

I actually think it's quite important. If you look at the number of cancer patients that are outside the U.S., let's just say the EU5 as an example, we're talking about just as big of a market or even bigger from that perspective. And in the EU countries, in particular, but also in Asia where you can use the CE IVD as your mark, you find that decentralized plays a very, very key role, especially in the somatic therapy portion. And we also know from one of the studies I referenced in my call with the MET exon 14 study out of Japan, that show the value of our products compared to the competition, it terms of accurately detecting MET 14.

So I think all of this will tie together, but getting that IVD registration done is a key part of our growth strategy from the oncology somatic side.

Matt Sykes -- Goldman Sachs -- Analyst

Thanks for the time. Appreciate it

Operator

Your next question comes from the line of Puneet Souda with SVB. Your line is open.

Puneet Souda -- SVB Leerink -- Analyst

Hi, Sean, Roxi. Thanks for taking the question. So first one on ASP. And I don't know if you covered it already, but sort of how did the ASP trend into -- throughout the quarter? And how should we think about that sort of going forward? Because on one hand, you have somatic that has promised for higher reimbursement.

But unfortunately, it's going to obviously take some time to come in. So there's a little bit of a gap here where, obviously, we're seeing impact in the quarter. So how should we think about as being sort of this sort of near to midterm until we get to the other side when we have more somatic NGS both tissue and potentially liquid and PCM as well?

Roxi Wen -- Chief Financial Officer

Yeah. We're -- thanks for the question. ASP is a relevant measure for our certain testing products. And we're paying attention to the trend without -- goes without saying.

And we're doing a lot of work in areas, such as pricing and revenue cycle management. And people manage the life cycle -- life science industry manage these type of metrics and practices. We're doing a lot of work and paying a lot of attention to it. In addition, as you said, right, the certain new products we plan to introduce in 2022 have the potential to give us a higher price point.

But going forward, we will give you a more consistent and balanced perspective to -- in addition to -- as we continue to measure ASP, but in addition to ASP, we'll provide you a set of metrics to help you measure the progress of the entire platform, number of patients as we said coming into our network and member revenue per patient. And the number of patients that are keeping us consent agreement for external data sharing and down the road, the set ARR. All these measures will, over time, will depart from the ASP -- straight ASP calculation.

Puneet Souda -- SVB Leerink -- Analyst

Got it. OK. And then in terms of MRD, obviously, this market is rapidly expanding. Obviously, there is a significant potential.

But as we think about, Sean, as we think about the positioning of PCM in that market and the differentiation that it brings to the market, just trying to understand, I mean, you gave details around a MARIA trial, a couple of other areas where you are investing into data and trials. So that's really helpful. But just trying to understand how does the assay sort of differentiate? I know things are early right now. But how does this differentiate either in performance or in sort of the adoption that you expect from PCM versus the two other competitors that are in the place -- in the marketplace right now and potentially others coming to this market?

Sean George -- Chief Executive Officer

Yeah. No, I appreciate the question. I think, again, to set context, we're fairly certain that like a lot of the disease areas that we are in -- getting into or into -- over time, and again, we think this is soon, we'll see. We believe this will shift to identifying who's at risk in the first place and then setting them up to better monitor and better prevent that disease then direct targeted therapy when the disease is diagnosed and then that will lead directly into the follow-up monitoring of that disorder.

And it is our genuine belief that companies that can provide those services across that arc of care, we'll be in a position and can help the clinicians not just the world's experts in molecular oncology, but all oncologists understand they and their patients what to do next is going to be the key -- is really going to be the key to getting this information used as standard of care. So one answer to your question is in the context of the broader arc of patient care and all of the digital tools and services that Rak covered on the call, that's one part of how we intend to have our -- the provisioning of our genomic information used to a differential advantage for a given patient. For the actual head-to-head, I think actually, Vishal was just at the TME conference, and I'll let him kind of speak to some observations, kind of fresh off a discussion with all the key opinion leaders therein.

Vishal Sikri -- President, Oncology

Yeah. Thanks for the question. It's an interesting time for us here. I mean the whole MRD concept is really starting to -- both oncologists and surgeons are trying to pay a lot of attention to it now, but it's still very much starting, right? There's a lot of opportunity for growth for all companies in this space.

And I think -- the big question that you asked is what differentiates you guys from what other people are doing. And I say here, it's like everybody talks a lot of sensitivity and specificity, but what's really important here is to make sure that you can have something that is tumor-derived, which is something that we do. We make sure that you can be sensitive enough by having a large number of variants that can be detected, which we can. And the third thing, obviously, is to reduce the risk of a false positive result, which we can with the app technology that we got out of the ArcherDX acquisition.

So all of them together. And then on top of that, you put it all together and then you go, how do you enable testing to occur. We can do that both in a centralized model and a decentralized model through a kit-based approach. So I think all tied together with the tools that Rakesh was talking about with the software tools, which then allow for the patient outreach to be there, the education to be there.

I think we're -- actually we're well-positioned to be successful in this space.

Puneet Souda -- SVB Leerink -- Analyst

Got it. That's super helpful. And if I could also just ask my last question on -- Sean, traditionally, Invitae has been a price rationalization -- rationalizer in the market, if I could say, especially in germline setting. So now as you look forward to next year and beyond, should we start viewing the company as some well-positioned into both competing on data and price rationalization? Or just help me understand that dynamic based on what Vishal and Rak had provided today.

Sean George -- Chief Executive Officer

Yes. No, I think -- I appreciate the question. I think first, it's worth noting that where a price exists, Invitae has always taken that price. Where we have used price to grow volume or use price to grow markets.

It's where there is no reimbursed criteria for a given service that we actually think is really valuable for extending life of our customers. So I just want to make that distinction, first and foremost. The price game and our cost advantage, we have put to use to grow markets and grow volume and get this information in the hands of individuals who otherwise the system -- our industry wasn't going to serve. We view it very much the same way in oncology going forward.

Now the nice thing here is there is well-established and very high pricing for the specific tests and services that Vishal mentioned. There is an immense amount of pent-up demand and the digital health tools that Rak mentioned, we think are going to be essential to unlock the utilization of that information because, frankly, as Vishal pointed out, there's very few key opinion leaders that are kind of actively thinking about the monitoring and use of the monitoring information. Even while as Rak pointed out, there's -- most oncologists are coming around to the perspective that the genomic variation in the patient's cancer has something to say about how it's treated. But very few of them are really adept or comfortable with actually having that conversation.

And if any of you listening to this call has had a loved one try to battle cancer, try to get them that information in a timely manner to make decisions. It's still -- it's very much a workflow and data issue at this point in time. So we think both are important. But just to be clear, really high pricing offered by CMS and anybody else, we will take.

And then for the remaining 28 million cancer patients around the globe that don't have reimbursement coverage, that's where then our cost advantage and our distribution, we think, can really come into play whether serving at the individual or the government level.

Puneet Souda -- SVB Leerink -- Analyst

Great. Thank you.

Operator

Your next question comes from the line of Brian Weinstein with William Blair. Your line is open.

Brian Weinstein -- William Blair and Company -- Analyst

Thanks for taking the question, guys. Good afternoon. So, obviously, I mean, genetic testing is not as routine as it should be, and you guys are clearly focused on improving that. I'm curious on like studies like the American Heart Association study that you talked about, how meaningful are these studies? I mean do you have any kind of information about how genetic testing changes on any of these? Do you have any information on kind of what the uptake is in -- for genetic testing in key disease states? And then second question is around the DTC stuff that's going on.

I don't know how broadly it is, but I'm here in Chicago. I can't turn on my TV and not see an Invitae ad on TV, talking about the importance of genetic information. So can you talk about just thoughts behind that strategy and any returns that you're seeing on that at this point?

Sean George -- Chief Executive Officer

Great. Thanks, Brian. So let's see, for -- I'll tell you what I can answer the second one right now is that our DTC efforts, in fact, you happen to be living in our pilot core target region. So for all of you who are thinking, wow, I don't see any Invitae ads, that's because we specifically target the city of Chicago.

And that's in an effort to test out a variety of different media and direct marketing approaches, which we do think are in the long term going to be essential as we start talking about everybody in modern medicine, not just folks that are healthcare provider, sales effort can get at. So that's, I would say, kind of still early days, and we're learning and evaluating and adjusting the upfront workflow and support needed to stand up patients and also, frankly, clinicians that respond to direct marketing. So that's what you're experiencing there, and that's like I said, learning and incorporating into our longer-term sales and marketing road map. Sorry, just -- sorry, the first part of your question, the utility of the studies as the AHA one, yes.

So here's where our view is that these are incredibly important. And I think if we can just go back many years, we, at one point in time, were met with the question that with a total market size of 250,000 hereditary breast and ovarian cancer patients a year, why wouldn't we even bother with the idea in the first place. And it is because of those studies. The study is just like that one that we have contributed to year after year after year, we have seen the addressable market for hereditary breast and ovarian cancer expand dramatically recently with guidance coming from key opinion leaders in the space that very likely coverage extension at least input being given is that reimbursement should go for anybody with hereditary breast and ovarian cancer testing.

And that is a gain that is only achieved by just those studies. We've seen that in prostate cancer as well. We'll see it in other cancers accordingly. And then also on the pediatric medicine side, just getting the data out there and publishing just how impactful genomics can be from a health economics perspective.

and showing the diagnostic yield north of 40%, 50% for a lot of kids with these rare disorders. That is -- we feel essential activity to growing the size of the market. Unfortunately, it doesn't show up right away and it doesn't turn into addressable highly reimbursable market right away, but it does over time. The good news is we've been at it for over a decade, and we'll just -- we'll continue down that path.

Brian Weinstein -- William Blair and Company -- Analyst

Thank you.

Operator

Your final question comes from the line of Dan Leonard with Wells Fargo. Your line is open.

Dan Leonard -- Wells Fargo Securities -- Analyst

Hi. Good afternoon, and thanks for all that detail on the oncology pipeline. So just a couple of questions. First off, on PCM, what's holding you back from putting more commercial resources behind the assay sooner?

Sean George -- Chief Executive Officer

Yes. I mean a little bit of it is wanting to get the COGS profile, right? And we spent a little bit time on COGS today. There's a constant balance between us driving revenue volume north and incurring the cost, particularly of new product introductions. I think as Roxi pointed out, our mature product lines are pushing 70% gross margins.

The new ones tend to be lower, and even a product with good reimbursement, it tends to be lower COGS as we kick it out. So that's one. Two is the scale of operation. It's a little more complicated operation to get up and running and just getting some lab our blood samples.

We want to make sure and get that right, have the customer experience be where it needs to be. And then also, and as we pointed out, we get our view on reimbursement, for our offering in January of next year, and driving too much volume before then, again, leads to the problem we mentioned before. So those are the factors going into the decision on how hard to push it commercially.

Dan Leonard -- Wells Fargo Securities -- Analyst

That makes sense. And then, Sean, it was unclear from the graphics, from a data perspective, what data you'll have at launch in Q2 of '22. The TRACERx, MARIA, it looked like that could come out at any time in 2022.

Vishal Sikri -- President, Oncology

Yes, I could try and answer that. So the TRACERx publications are already -- part of it's out already in the lung cancer space, and there will be more of it coming out by that -- very close to launch or right after launch. And then as we get some of these retrospective studies done that are in process right now, we expect a lot of that to come out in the early part to middle part of 2022.

Dan Leonard -- Wells Fargo Securities -- Analyst

Helpful color. Thank you.

Operator

There are no further questions at this time. Mr. George, I turn the call back over to you.

Sean George -- Chief Executive Officer

Thank you. And thank you again for joining the call today. Look, in many ways, the future in which genetic information drives everyday medicine is coming into view. And we'd like to offer the diversity and growth across our entire business and the kind of the emergence and increased growth profile from our data business we believe will be a significant driver of value for patients, providers, all the stakeholders, and the modern healthcare ecosystem.

So thanks again for joining us, and I look forward to next time on the call or future conferences.

Operator

[Operator signoff]

Duration: 68 minutes

Call participants:

Amy Hadsock -- Investor Relations

Sean George -- Chief Executive Officer

Vishal Sikri -- President, Oncology

Rakesh Patel -- Founder, Medneon

Roxi Wen -- Chief Financial Officer

Dan Brennan -- Cowen and Company -- Analyst

Tejas Savant -- Morgan Stanley -- Analyst

Tycho Peterson -- J.P. Morgan -- Analyst

Matt Sykes -- Goldman Sachs -- Analyst

Puneet Souda -- SVB Leerink -- Analyst

Brian Weinstein -- William Blair and Company -- Analyst

Dan Leonard -- Wells Fargo Securities -- Analyst

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