Invitae (NVTA) Q1 2023 Earnings Call Transcript

Invitae (NVTA -94.44%)
Q1 2023 Earnings Call
May 09, 2023, 4:30 p.m. ET

Contents:

• Prepared Remarks
• Questions and Answers
• Call Participants

Prepared Remarks:

Operator

Hello, everyone, and welcome to the Invitae first quarter 2023 financial results conference call. My name is Emily, and I will be your conference coordinator today. [Operator instructions] I will now turn the call over to our host, Hoki Luk. Please go ahead.

Hoki Luk -- Head of Investor Relations and Capital Markets

Thank you, operator, and good afternoon, everyone. Thank you for participating in today's call. Joining us today are president and CEO, Ken Knight; our CFO, Roxi Wen and our chief science officer, Dr. Robert Daber.

Before we begin, I'd like to remind you that various remarks that we make on this call that are not historical includes those about our vision and business model, the company's strategic business realignment, future financial and operating results; expectations of future growth and reduction in burn rates, and future products, services of our product pipeline and the timing. Certain points we make will 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 across services and therefore, our actual results could differ materially from our stated outlook. Statements on future company performance assumes, among other things, that we don't conclude any additional business acquisitions, investments, restructuring or legal settlements.

We refer you to our most recent 10-Q and 10-K in particular to the section titled Risk Factors. For additional information on factors that could cause actual results to differ materially from our current expectations. These forward-looking statements speak only as of the date hereof. To supplement our consolidated financial statements prepared in accordance with generally accepted accounting principles in the United States, or GAAP, we monitor and consider several non-GAAP measures.

We 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, both of which you can access by visiting the investors section of the company's website at ir.invitae.com. Today, Ken will discuss our Q1 highlights and our 2023 growth plan. Dr. Daber will discuss our recent clinical updates related to PCM, and Roxi will cover the financials and key metrics on the first quarter, as well as our 2023 guidance.

We will then conclude the call with Q&A. With that, I'll turn the call over to Ken.

Ken Knight -- President and Chief Executive Officer

Thank you, Hoki, and thank you all for joining us today. In the first quarter, our team continued to execute against our plan. We posted $117.4 million in revenue, which is approximately 10% year-over-year growth on a pro forma basis. Along with year over year improved gross margins and reduced cash burn.

On the operational side, we saw an encouraging readout on our PCM technology via our publication in nature, on new partnerships, and benefited from enterprisewide revenue and capital management efforts. We believe that the macro drivers for growth in our space remain robust. And the opportunity for utilizing genetic information and genomic testing has substantial upside. With recent advances in technology, clinical validation, guideline expansion and reimbursement, the industry is poised to grow.

And Invitae has been a leader and a catalyst in driving many of these advances. We have industry-leading variant interpretation capability that is a result of serving nearly 4 million patients across a diverse spectrum of clinical areas. This is bolstered by our machine learning and functional modeling capabilities. We are best positioned to provide the highest quality of interpretation at an industry-leading scale.

We have a strong commercial presence. For example, we are respected and well regarded among genetic counselors and major oncology centers alike and have become a provider of choice. Our approach to science and innovation is addressing the largest market opportunity and includes revenue growth with our deep data and partnership and most importantly, our dedicated team is relentless and pursuit of our mission of bringing comprehensive genetic information into mainstream medicine with great products that lead to better patient outcomes. As we look closer at our business, profitable growth continues to be the foundation of our plan.

And we are allocating our capital in key areas that will lead to growth in 2023 and beyond. Let's start with oncology. Our oncology sales include hereditary cancer testing and fee-for-services business with biopharma. On a pro forma basis, our oncology revenue in the first quarter was $60 million, compared to approximately $62 million a year ago.

Our fee-for-service revenue was lower year over year due to contract flow and timing, which varies. In hereditary cancer testing, we saw low single-digit growth year over year in both revenue and volume for this quarter. With guideline expansion, improved outcomes and reimbursement practice showing signs of improved adoption for hereditary cancer testing, we are determined to assist in the adoption of non-genetic expert providers. These efforts are underway and showing improved traction with April year-over-year growth ahead of Q1 rates.

We also recently announced some exciting clinical updates on our MRD franchise, as our PCM platform technology benefits were published in nature. We are optimistic that this will further drive PCM's adoption and additionally underscores our efforts to gain reimbursement support from payers. Dr. Daber will cover this in more detail.

Looking at our ongoing efforts for the medium-term, we see valuable synergies between our hereditary germ line and our somatic product. Together, they will anchor one of the most comprehensive offerings for a physician who is considering options for an individual at risk of or diagnosed with cancer. We will provide critical information for prognosis, treatment, family risk, drug interactions and monitoring. In the rare disease category, we really saw solid revenue growth in Q1 of approximately 33% pro forma year over year, driven by pediatric genetics, as well as cardio and neuro panels.

We have also introduced a number of programs to improve reimbursement rates. Our efforts to drive profitable growth are already yielding improved gross margins in this category. In women's health, we are encouraged to see continued momentum with approximately 18% pro forma year-over-year growth. In particular, our carrier screening panel is performing well, thanks to our enhanced product that has helped drive adoption.

We are also seeing increased productivity with our sales team, along with market share gains in light of industry consolidation. On the data side, we are linking Invitae's genetic data with clinical, claims and prescription data to enable researchers and biopharma partners to deepen their understanding of the patient journey, and ultimately deliver a more effective therapy to the most precise patient population. On the partnership front, our data platform has enabled an exciting partnership with Deerfield that we announced in March. The partnership will leverage genetics and clinical data from us and Deerfield's broad drug discovery and development expertise to advance genetics-based drug discovery and development in rare diseases.

We are delighted to work together and explore the potential opportunities based on our respective strength. On top of our growth initiatives, we are also working to further improve our revenue cycle and working capital. Roxi will provide more details in her remarks later. Next, we will go deeper into our recent clinical updates for our minimal residual disease product PCM, which is demonstrating impressive value for prognosis, monitoring and surveillance during the cancer journey.

But before we dig in the PCM, I'd like to say a few words about our recently hired chief medical officer for Oncology; Dr. W. Michael Korn. Dr.

Korn joined us in March of this year and he is luminary at the intersection of clinical oncology in the commercial laboratory. He founded and led the Precision Oncology Initiative at UCSF and later was the chief medical officer at a large commercial genomics laboratory for five years. I'm sure that many of you will be getting to know Dr. Korn in the coming months as we provide additional updates on our oncology initiatives.

We welcome him to the team. Now, as Hoki mentioned, with us on the call is Dr. Robert Daber, our chief science officer for Invitae. He is here to provide additional insights into the data recently published, as well as other updates on our clinical plans.

Dr. Daber has been with Invitae since 2021 and came to us via the acquisition of Generosity, which he founded. Dr. Daber made the development of many of the key technology elements that underlie our current PCM platform.

He also has vast experience with both laboratory formation and product commercialization during his career. And we are fortunate to have him helping to lead this important initiative. I'll now turn the call over to you, Dr. Daber.

Robert Daber -- Chief Scientific Officer

Thanks, Ken, and I appreciate the opportunity to be on the call with all of you today. I would like to shed some color on the recent publication of TRACERx. Let me first spend a minute giving some background on the study. We conducted the research in collaboration with Dr.

Charles Swanton and his team at University College London. Dr. Swanton is both a pioneer and a current leader in molecular oncology and the development of MRD as a useful genomic tool. The study involved 197 patients with Stage 1 through 3 non-small cell lung cancer followed for up to five years and represented the first use of our PCM technology to correlate clinical outcomes with ctDNA presence.

The assay we used in the study looked at up to 200 variants in order to maximize the assay performance. Using the same underlying technology, our currently commercialized clinical LDT has been optimized to include up to 50 variants. The results of the study demonstrated that ctDNA detection via our PCM platform is a sensitive tool for both prognosis and early detection of recurrence. The ultimate goal is to leverage ctDNA to guide treatment decisions.

Currently, prognostic information can be used for intensification of surveillance, while therapeutic interventions can be explored in the context of clinical trials. We view this as key as we work to integrate testing across the cancer journey. At a high level, the paper showed sensitivity and specificity of greater than 99.9% and at a 0.008% AF, with 60 nanograms of cell-free DNA input for a 50 variant panel largely consistent with our internal findings in other studies. Now, on to some additional detailed results.

There were 108 patients available for Landmark analysis. Landmark was defined as plasma samples collected within 120 days of surgery. Out of these patients, 51 patients relapsed during the study period. and ctDNA via our PCM technology was detected in about half of the patients, utilizing their early landmark analysis window to forecast eventual relapse, demonstrated a positive predictive value of 93% and a negative predictive value of 68%.

Importantly, clinical sensitivity was further improved by continued surveillance beyond the landmark period. In the study, median lead time for landmark positive patients over clinical recurrence detection was more than seven months. As far as the practical value to patients compared to today's standard of care, ctDNA was detected in relapsing patients prior to imaging by a median time of almost four months. Clinical sensitivity and specificity were assessed based on 70 and 61 patients, respectively.

Specificity was 95%, and or 96.7% after removing a patient with known anomalies. The study reported a minimum sensitivity of 84%, additional filtering of qualifying samples yielded sensitivity of 93.6%. These results delivered a few important takeaways. First, the study demonstrated equivalent, if not better, analytical performance compared to previously utilized technologies with this patient population.

More importantly, the results validated the need for products like PCM that create a data-driven treatment process for patients and physicians alike through ongoing cancer monitoring. And in this large cohort of patients, -- the data demonstrated the value of our PCM technology for prognostic value, as well as early detection of residual disease and cancer recurrence, all of which benefit a patient's overall cancer journey. While there has been a long history of both development and validation of the PCM technology platform, for the purpose of gravity, I will focus my comments on a few recent and near-term developments. Late last year at the San Antonio Breast Cancer Symposium, results of a study of PCM in patients with breast cancer data were presented, demonstrating the technology's ability to detect breast cancer recurrence with a lead-time of 13.7 months over clinical recurrence detection.

There was also a strong association between ctDNA detection by PCM and relapse-free survival. These are important findings in a disease where only limited clinical follow-up studies are routinely done during the surveillance after surgery. Non-small cell lung cancer data from the TRACERx study were published in nature last month, which validated the clinical impact of MRD assays and Invite's differentiated PCM technology and its performance. Recently, we also submitted a technical validation study for peer-reviewed publication, which we hope to see in the coming months.

So, with these study readouts and technical validation data, what is the impact and what else is to come? There are a few key points to make here. First, the more validation we deliver on the technology platform, the more effectively we can market the PCM technology for potential fee-for-service customers and research collaborators in the biopharma and biotech community. We anticipate more data will be generated through this activity that will help drive volume and adoption. In addition, more clinical data allows us to continue optimizing our clinical product to achieve maximum performance while balancing real-world patient needs and other commercial considerations.

We are currently optimizing our Invitae sponsored PCM clinical studies, including our prospective Maria trial design to further validate the clinical benefit of our PCM platform in a multi-cancer environment, as well as other studies that include lung, CRC, breast, ovarian cancer and other cancer types. In addition, we are expanding our registry study program to obtain real-world data on assay utilization in the adjuvant, as well as treatment monitoring setting. We are also working on identifying new collaborators with existing patient cohorts to allow retrospective analyses that will further demonstrate clinical utility in strategic patient populations. Our overall objective is to enhance the impact and robustness of these studies to accelerate the readout time lines and drive a clinically relevant and competitive profile as we address additional cancer indications.

We fully expect that our enhanced clinical trial efforts will provide further proof that PCM can potentially become the standard of care for genomic testing before during and following many cancer treatments. And with that, I will turn the call over to Roxi to discuss the financials. We look forward to fielding your questions in the Q&A session. Roxi?

Roxi Wen -- Chief Financial Officer

Thanks, Bob. Moving on to our financial results. We had another solid quarter of performance and progress. We're providing revenue breakdowns on the reported and pro forma basis for clarity.

In the first quarter of 2023, we generated approximately $117 million of revenue compared with $124 million in the prior year. The decline reflects the fact of exited product lines, countries and territories as a result of our realignment last summer. On a pro forma basis, we grow the business around 10% from last year. Looking at the details of the business category $60 million from oncology, including hereditary cancer and fee-for-service PCM testing offered to pharmaceutical partners on a reported basis, this category was impacted by the exit of our kids business and by the timing and size of fee-for-service contracts, which vary from quarter to quarter.

$25 million from our women's health business, including NIPS and carrier testing services, $20 million from rare disease, pharmacogenomics and other testing products. Data and patient network revenue was about $12 million. This includes our sponsor testing programs, data management and a number of data partnership projects. Now, let's look at our revenue growth profile on a pro forma basis.

Overall, we demonstrated approximately 10% year-over-year growth and around 5% quarter-over-quarter growth. for the specific business lines. In oncology, lower PCM revenue in the form of fee-for-service contracts impacted our year-over-year performance partially offset by the modest growth in creditory cancer. Women's Health group business grew 18% year over year, largely led by our carrier testing panel.

Rare business grew around 33% year over year, primarily led by our cardio, neuro, pediatric tests, as well as revenue management efforts. Data business also rose over 30%, thanks to continued growth of our patient identification programs and partnership contracts for our genetic data products. Non-GAAP gross margin in the first quarter was 47.9%, which improved significantly compared to 36.6% in 2022 and improved slightly over the 47.8% in Q4 of 2022. Non-GAAP operating expenses in Q1 of 2023, was $133 million or 113% of revenue compared to $209 million or 169% of revenue in Q1 2022 and similar to 111% in the last quarter.

Moving on to cash performance. Cash, cash equivalents, restricted cash and marketable securities totaled $389 million on March 31, 2023, and compared to $557 million on December 31, 2022. Our total cash and investment position changed by $171 million, which includes the paydown of the $135 million first linked term loan in conjunction with the refinancing in Q1. In the first quarter, we continue to improve our cash burn and the burn for our ongoing business was about $51 million, which represents approximately 70% reduction from the prior Q1.

In addition to working capital improvement, in particular, inventory management in the first quarter, ongoing cash burn in the first quarter also benefited from approximately $13 million of AR reduction associated with the realignment of the previous Archer business. Looking at the expected levels for the rest of this year, we still anticipate fundamental improvement through further working capital efforts and are confident that we should be able to deliver closer to the lower end of the cash burn guidance. Lastly, in addition to our strong cash position with a declining burn rate, we also had close to $250 million additional secured debt capacity available to us. Now, stepping to the Q1 2023 business metrics.

Revenue per patient is measured by total company revenue divided by the number of ordering patients for the quarter. In the first quarter, revenue per patient was $463. The previous three quarters were higher due to the kits business revenue. When we exclude those revenues for comparison, you can see that the metrics has been stable in the last couple of quarters and we anticipate further improvement against the new baseline in the future.

We're also happy to see continued quarter-over-quarter improvement in variable cost productivity, as well as cash burn as a percent of revenue. Moving to our financial guidance. For 2023, we're reiterating our guidance for revenue to more than $500 million, representing low-double-digit year-over-year growth. We continue to anticipate the revenue breakdown to be roughly 45% to 48% in the first half of the year and 52% to 55% for the second half.

We also gave additional color as to product mix expressed as a percent of total revenue. Our non-GAAP gross margin is expected to continue to expand from the 47.9% in Q1 to be between 48% to 50% for the full year. Thanks to our more focused portfolio, higher quality of revenue, as well as sustained improvement in lab operations, supply chain and logistics. In 2023, as a result of the voluntary repayment of our term loan, reported cash burn will be higher than ongoing cash burn figure.

On an ongoing basis, we're optimistic that we are tracking toward the lower end of our previous cash burn guidance of $250 million and $275 million, but are maintaining our target at this point. This guidance range calls for a more than 45% improvement from the 2022 figures and is expected to be driven by our top line growth, improved gross margin, reduced opex, as well as continued working capital improvement. Back to you, Ken.

Ken Knight -- President and Chief Executive Officer

Thanks, Roxi. To summarize today's call. First, we are on track to achieve our 2023 growth and business execution goals. The growth catalyst for the near-term are in focus, including expanding hereditary cancer adoption to non-genetic expert channels.

Our efforts to expand gross margins and reduce cash burn are slightly ahead of plan. Second, our pathway in oncology for PCM is becoming more clear, and the evidence we need to drive physician and payer adoption are being collected in preparation for a commercial launch beyond our current fee-for-service revenue. And finally, we have recently addressed substantially all of our near-term debt and improved our balance sheet. We also have additional secured capacity remaining as a potential funding option.

So again, same mission, new path, integrated and connected portfolio, profitable growth and big bets are the recipe for the next chapter of Invitae. Operator, I'll now hand it over to you for questions.

Questions & Answers:

Operator

Thank you. [Operator instructions] The first question today comes from Puneet Souda with SVB Securities. Please go ahead, Puneet.

Unknown speaker

Hi. I'm Michael on for Puneet. Congrats on a healthy start to the 2023. I wanted to start with PCM.

We appreciate get your color on the lung data, I was wondering if you have any, I guess, additional details you could provide on indications you're expecting to submit to CMS and potential time line for getting some reimbursement through Medicare?

Ken Knight -- President and Chief Executive Officer

Hey, Bob, do you want to take that question?

Robert Daber -- Chief Scientific Officer

Sure. So this was one of our earlier studies that we had started in lung cancer. We have additional data that we had mentioned was presented last December in breast, and we anticipate that evolving into a publication for us as well. And then, as we've indicated this year, we're really focusing on generating additional evidence in areas outside of lung in colorectal and breast and ovarian.

And so, those are all in full swing. And what we're doing parallel to that are having conversations with Medicare, as well as private payers. Earlier this year, you saw the favorable coverage from Blue Cross Blue Shield in California, and so these are proceeding in parallel and we're just continuing to generate additional evidence in the form of clinical studies in the form of abstract presentations at conferences.

Unknown speaker

Great. Thank you. And then, I was wondering if you could offer any color on ASP trend by segment. I know you mentioned rare disease, seeing some improvement.

I was wondering if you have any, I guess, details on some of the other segments?

Ken Knight -- President and Chief Executive Officer

Yes, this is Ken. I'll take that first part of that. As we've been looking at the market unfolding, we see the stability happening with ASP, and our efforts have really been working on improving our reimbursement rates. And so, we don't see any significant change in ASP, but we are working hard on our reimbursement rates, which is showing up in our gross margin and kind of gross profit performance.

Unknown speaker

OK. Yes, it makes sense. If I could just have one quick one. Some of your peers also have been highlighting some potential upside to women's health business from expanded carrier screening and microdeletion guideline inclusion.

I was wondering how much Invitae's levered to these opportunities?

Ken Knight -- President and Chief Executive Officer

Yes. Roxi talked about it a little bit. We've seen some definite upside in our carrier business from the expanded carrier product that we launched ourselves, and that's driving better adoption and our women's health business, in general, we've seen some improvements just due to industry consolidation, and we've been able to grab some share. So far as the microdeletion piece, we're prepared for the way we have our product offering.

We're in good shape. Is that start to drive more demand of the microdeletion option. And so, we're prepared and ready for that, if that turns into real demand.

Unknown speaker

Great. Thank you very much.

Operator

Our next question comes from Matthew Sykes with Goldman Sachs. Please go ahead, Matthew.

Matthew Sykes -- Goldman Sachs -- Analyst

Hey. Good afternoon. Thanks for taking my questions. Roxi, maybe the first one for you, just on the cash burn.

Just noting those, progress you've made and the 51 million that you burned in the quarter, the guide that you've put out there would imply a decent step-up in that burn but it sounds like you're making efforts to continue to reduce that. Should the Q1 run rate of burn be something we think about, or is there some seasonality or are there impacts later in the year, where we should look at that guide as more of a way to look at burn over the course of the year?

Roxi Wen -- Chief Financial Officer

Yes. So thank you, Matthew, for the question. We are -- we'll continue our cash burn reduction effort, and this is something the entire company is very focused on. And so, this year, as we reiterating our guidance, we are pretty confident that the total year cash burn is most likely going to be closer to the lower end of the guidance.

And with that being said, Q1 51, we benefited from some working capital improvement that resulted from the exit of our Archer business. The RUO business and some of the other assets that we -- the business units we exited in Q4. So there's some working capital improvement that's reflected in the $51 million number, but our core business fundamental improvement on working capital, as well as cash burn will continue through the end of the year through the remaining of the year.

Matthew Sykes -- Goldman Sachs -- Analyst

Got it. Thanks, Roxi. And then -- maybe one for you, Ken, or Dr. Daber, just on the PCM business, you've talked about some lumpiness in the fee-for-service as I'm assuming contracting with the biopharma companies because it tends to be that way.

But could you maybe talk a little bit about the dynamics within that fee-for-service business and how you see that trending? Do you expect it to remain lumpy as you're starting out, or do you think you could kind of smooth that out as that business grows? And any kind of way you can parse out that PCM fee-for-service business within oncology would be helpful if you're willing to do that?

Ken Knight -- President and Chief Executive Officer

Yeah. Dr. Daber is so much closer to this than myself. So I'll let Dr.

Daber start with response, if you don't mind.

Robert Daber -- Chief Scientific Officer

Yeah. So the lumpiness is really due to the nature of the projects. A lot of this work is project-based where it's a large number of samples from retrospective cohorts. And so, just based on the timing of when those samples get released from central labs, we've got a healthy pipeline of projects coming in and new clients coming on board.

And so, I think as we continue to grow that funnel, the lumpiness will still be there, but just not to the extremes as where it is now with respect to large swings in numbers of samples on a given month-to-month basis?

Matthew Sykes -- Goldman Sachs -- Analyst

Got it. Thanks. And any breakout of the fee-for-service within overall oncology? Are you keeping that all within the same group?

Roxi Wen -- Chief Financial Officer

So Matt, this is Rox. Just to add to Dr. Daber just said that at the back of the slide deck in the appendix section, you will see the breakout of our oncology revenue for by quarter starting Q1 of 2022 in this quarter included as well. And you'll also see the pro forma revenue by each of the four product categories on the prior page as well.

Matthew Sykes -- Goldman Sachs -- Analyst

Perfect. Thanks, Roxi.

Ken Knight -- President and Chief Executive Officer

Yes. And Matt, I would add, this is Ken. We also have put some commercial efforts into making sure we shore up that pipeline. So we are we've got a great product, and we're determined to continue to grow that pharma business.

Matthew Sykes -- Goldman Sachs -- Analyst

Thank you very much.

Operator

[Operator instructions] At this time, we have no further questions registered. So I'll turn the call back to Ken for closing remarks.

Ken Knight -- President and Chief Executive Officer

Well, thank you, operator, and thank you, everyone, for joining us on the call today. We appreciate your continued support and look forward to sharing more updates with you in the near future. Have a great afternoon and evening. Bye all.

Operator

[Operator signoff]

Duration: 0 minutes

Call participants:

Hoki Luk -- Head of Investor Relations and Capital Markets

Ken Knight -- President and Chief Executive Officer

Robert Daber -- Chief Scientific Officer

Roxi Wen -- Chief Financial Officer

Unknown speaker

Matthew Sykes -- Goldman Sachs -- Analyst

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