GRAIL, Inc.

Good day, ladies and gentlemen, and welcome to the Grail second quarter 2024 earnings call. At this time, all participants are in listen-only mode. After the speaker's presentation, there'll be a question and answer session. Please be advised that this conference call is being recorded. Grail Investor Relations, please begin. Thank you.

And thank you all for joining us today. On the call today are Bob Ragusa, our Chief Executive Officer, Aaron Frieden, our Chief Financial Officer, Dr. Joshua Offman, our President, and Sir Harpo Kumar, our President of Biopharma Business in Europe. Before we get underway, I'd like to remind everybody that we will be making forward-looking statements on this call based on current expectations. It is our intent that all statements, other than statements of historical fact made during today's call, including statements regarding our anticipated financial results and commercial activity, will be covered by the safe harbor provisions for forward-looking statements contained in Section 28 of the Securities Act of 1933 as amended and Section 21 of the Securities Exchange Act of 1934 as amended. Forward-looking statements are subject to risks and uncertainties. Actual events or results may differ materially from those projected or discussed. All forward-looking statements are based upon currently available information, and Grail assumes no obligation to update these statements. To better understand the risks and uncertainties that could cause actual results to differ, we refer you to the documents that Grail files with the Securities and Exchange Commission, including the Risk Factor section in Grail's most recently quarterly report on Form 10Q. This call will also include a discussion of GAAP results and certain non-GAAP financial measures, including adjusted gross profit or loss and adjusted EBITDA, which are adjusted to exclude certain specified items. Our non-GAAP financial measures are intended to supplement your understanding of Braille's financials. Reconciliations of the non-GAAP measures to most directly comparable GAAP financial measures are available in the press release issued today, which is posted to our website. With that, I'll turn the call over to Bob.

Thank you and good afternoon, everyone. We are pleased to review our second quarter results with you today. On today's call, we will discuss the market opportunity for Gallery, our clinically validated multi-cancer early detection blood tests, our performance in the second quarter, and the progress we continue to make to change the paradigm in early cancer detection. We will also review the corporate restructuring announced today, which extends our existing cash runway into 2028. Grail is focused on detecting cancer early when it can be cured. Current recommended screening is limited and most deadly cancers are found too late. Multicancer early detection or MSED is the solution for effective population screening. The market for MSED is rapidly evolving with over 100 million individuals eligible for the gallery test in the United States and more than 300 million in global target markets. Braille's robust clinical validation and commercial launch as a laboratory-developed test, or LDT, and our significant laboratory capacity and scalability makes us well-suited to address one of the most meaningful opportunities in healthcare. Importantly, the gallery test was designed for population-scale screening. We have an expansive clinical evidence program, which is setting the standard in MSED development. We are breaking new ground, and over a period of years, we have consistently progressed through key milestones for the business. We have progressed our FDA pre-market approval application, or PMA, registrational studies, and a few weeks ago, we announced we have completed the final study visits for 140,000 participants in the NHS Gallery study and have completed the enrollment in the 35,000 participant Pathfinder 2 study. We expect to submit our PMA with the clinical data from these two trials and other supplemental data in the first half of 2026. We also announced in July that we have enrolled the first participant in the gallery Medicare study called the REACH study. This real-world evidence study is planned to enroll 50,000 Medicare beneficiaries for three annual tests to generate additional clinical validation and utility data in the Medicare population. Medicare beneficiaries are among the most at risk for cancer due to age and other risk factors, and this population represents an enormous unmet need for early cancer detection. This study is intended to help support a Medicare coverage analysis following FDA approval. We remain pleased with the demand for gallery that we're seeing in the pre-reimbursement environment. Through June 30th of this year, more than 215,000 commercial gallery tests have been prescribed by more than 11,000 healthcare providers. Roehl is an established market leader in the field, and we are proud of the impact that gallery is having on patients' lives. Following a portfolio review, we are reprioritizing our resources on our core NSAID priorities and reduce overall spend as we progress towards completion of our registrational studies and our FDA EMA submission. We believe these actions will extend our anticipated cash runway from the second half of 2026 into 2028 and provide for greater flexibility. It is important to note that we do not expect that the reductions in spend and headcount will impact our PMA submission timing or NHS gallery or the Pathfinder 2 readouts. As a result of focusing our resources on achieving broad gallery reimbursement in the U.S. and U.K., we are reducing existing headcount and planned 2024 hires by approximately 30%. On our commercial team, we've been working to understand which investments provide the greatest return and have identified measurable impact from our most successful strategies. As a result, we are streamlining our commercial sales force and medical affairs teams and focusing our field-based activities on the most productive current customers and high priority opportunities. We are maintaining sales force coverage for the majority of our current gallery volume and active prescribers. As part of this approach, we are also streamlining investments in our enterprise business, which includes our employer and life insurance businesses. Reductions in the commercial organization include management layers and commercial roles without sales responsibilities. In addition to reductions in commercial, we are making reductions in medical affairs teams involved with U.S. gallery provider engagement. We are substantially decreasing investment in R&D related to our diagnostic aid for cancer and our minimum residual disease programs. In addition, we are making reductions in G&A to reflect the focus on our MSED opportunity. We will continue to invest in our biopharmaceutical partnerships and are committed to working with our partners to leverage Braille's proprietary methylation technology in precision oncology applications. This restructure and result in staff reductions are difficult, and we are immensely grateful to our employees who've worked hard to enable Braille's success to date and helped transition MSED from an idea into a reality. We wish all of our impacted employees well. To discuss our second quarter financial results, I'll hand it over to Braille's Chief Financial Officer, Aaron Frieden.

Thanks, Bob, and good afternoon, everyone. And please present our results for the second quarter. Second quarter results were strong with revenue of $32 million, up $9.6 million, or 43% as compared to Q2 of 2023. Total revenue for the first half of the year was $58.7 million, an increase of 40% as compared to the same period in 2023. Total revenue for the quarter is comprised of $28.2 million of screening revenue and $3.8 million of development service revenue. Development services revenue includes services we provide to biopharmaceutical and clinical customers, including support of clinical studies, pilot testing research, and therapy development. We see continued demand for our gallery test and sold approximately 35,200 tests in the second quarter. Screening revenue of $28.2 million in the second quarter was up 41% as compared with the second quarter of 2023. Screening revenue for the first half of 2024 was $51.7 million, an increase of 45% as compared with the same period last year. Net loss for the quarter was $1.59 billion, an increase of 721% as compared to Q2 of 2023. The increase was driven by a goodwill and intangible impairment of $1.42 billion in addition to an increase in general and administrative expenses related to legal and professional services associated with the divestiture and higher employee compensation expenses due to an increased headcount in employee long-term incentive awards. We additionally report non-GAAP financial measures to enhance investors' understanding of our business. These measures include adjusted gross profit or loss and adjusted EBITDA. and exclude accounting impacts related to the luminous acquisition of Braille. We encourage investors to carefully consider results under GAAP in conjunction with our supplemental non-GAAP information and the reconciliation between these presentations, available in our second quarter earnings press release. Non-GAAP adjusted gross profit for the second quarter of 2024 was $16 million, an increase of $6.4 million, or 66% as compared with Q2 of 2023. Primary drivers of the increased margin were revenue mix and efficiencies of scale related to increased gallery volume. Adjusted EBITDA for the second quarter of 2024 was negative $139.4 million. representing an increased loss of $2.8 million, or 2%, as compared to Q2 of 2023. The decrease in adjusted EBITDA was driven by higher operating expenses, including one-time transaction expenses, partially offset by revenue growth over the prior year period. We have an ending cash position of $958.8 million as of June 30, 2024. We recognize the importance of preserving cash runway as we progress gallery through the FDA approval process and work toward broad reimbursement and have today taken some difficult steps to ensure the financial health and flexibility of the company. We expect these cost reductions to enable a significant reduction in burn in 2025 and beyond and extend our existing cash runway into 2028. In 2024, we expect $27 million in savings, net of anticipated severance benefit costs. Turning to guidance, with the expense reductions announced today, we expect our previous estimate of $250 million in cash burn in the second half of 2024 will come down to approximately $220 million. We expect burn in 2025 to come down significantly compared to 2024. with full-year burn of 2025 expected to be approximately $325 million. We expect that our 2024 U.S. gallery revenue will be in line with our guidance in May of 30% to 50% growth over 2023. However, with the reductions announced today, we plan for gallery revenue to grow more moderately in 2025 and subsequent years until we receive broad reimbursement. I will turn it back to Bob to speak to our strategic priorities. Bob, go ahead.

Thank you, Aaron. We are a mission-driven company, and we are focused on improving cancer care and enabling broad use of gallery. Real-world use of gallery has detected many of the most aggressive cancers in early stages, including pancreatic, head and neck, esophageal, liver, and stomach cancers. For the majority of these cancer types, there are no other screening options available. We are passionate about our mission and energized by the powerful stories we have heard from patients who have benefited from GALLERY and from physicians and health systems that are successfully implementing GALLERY into their practice. We are looking forward to continuing to progress our mission, and we are committed to operating with discipline and being prudent with our spend. This year, we expect to continue enrollment in the GALLERY Medicare or REACH study drive access to Gallery and advance our commercial and research partnerships. We will continue to release data at scientific and medical meetings, including at ESMO in September. We also anticipate results from the first 25,000 participants in the Pathfinder 2 study in the second half of 2025. Looking beyond, we are tightly focused on our strategic goals, seeking FDA approval of Gallery and pursuing broad reimbursement for Gallery. With that, we'll turn the call over to Q&A. Operator, please go ahead.

Thank you. At this time, if you would like to ask a question, please click on the raise hand button, which can be found on the black bar at the bottom of your screen. You may remove yourself from the queue at any time by lowering your hand. When it is your turn, you will hear your name called. You may unmute your audio and ask your question. As a reminder, we are allowing analysts one question and one related follow up today. We will wait one moment to allow the queue to form.

Thank you. Our first question is from. Kyle Nixon at chemical. Please unmute yourself and begin with your question.

Hey guys, thanks for the questions. And thanks for doing this update, Paul. So I guess, you know, there hasn't been a multi-cancer detection test like this scaled in the past, and now you're kind of getting cash burned down to levels of, like, you know, other precision oncology companies. What gives you confidence at this level of investments enough to, you know, commercialize this type of product?

Kyle, thanks for the question. You know, we've looked really carefully at our portfolio and, you know, recognize that, you know, by focusing on MSED and getting to the key inflection points, particularly, you know, FDA approval of our PMA and then, you know, on the path to broad reimbursement is really critical for us. And so that's what a lot of the changes were driven by. We've, you know, we've did a very careful review of what it takes to get there. And so we're quite comfortable that we have the resources aligned to be able to go down that path quite successfully. We, you know, in that area around MSED, we actually made relatively few changes. We, you know, we're staying consistent on our timeline. We're staying consistent on the effort that we're applying to that area. It's really in other areas around DAC, MSED, and some of the commercial elements that we've pulled back from.

So, you know, we're comfortable with that. Thanks again. Sorry for cutting you off. Just a related follow-up, how will these and when will these cost reductions be phased in? I understand you're kind of implementing this now, I guess, but it's kind of mid-year, so I'm just curious about this and how it phases into the burn targets for next year. And then when will MRD and DAC investments come back, and how important are those still for the company's long, long-term growth profile?

Thanks. Yeah, so the actions will occur immediately. So we're taking action right now. to generate the cost savings that we're outlining. You know, in terms of MRD and DAC, we believe we have great opportunities in both of those. We think our methylation technology is very well suited to those. And on the, you know, precision oncology side, we're continuing, you know, supporting our biopharma partners in that. You know, so that work will continue. On the pure DAC and MRD work, though, we're, you know, we're pausing future developments in those areas. And, you know, we haven't set a timeline for, you know, kind of reinvesting in those areas at this point, again, because the focus is really to drive MSED through the key inflection points.

Got it. Okay. I can hop back in the queue. Thanks for that.

The next question is from Teja Savant at Morgan Stanley. Please unmute yourself and begin with your question. Please unmute yourself and begin with your question.

Hey, guys, can you hear me okay? Yeah. Okay, perfect. All right, so a quick follow-up there on Kyle's question. Aaron, could you just give us a better sense for where the largest cost saves will come from? You know, I know you highlighted all the areas in the call, but just in terms of the magnitude of the contributions from each area, some color there would be great.

Yeah, I can give you some sense, and maybe Aaron can jump in with a little more color. You know, so as I mentioned, there's $27 million we see a benefit in 2024, and overall we expect to get 2025 down to a cash burn of $325 million. You know, that's going to come from about a 30% reduction in both existing as well as planned requisitions for 2024, but, you know, existing headcount and planned RECs. You know, importantly, we're rolling off some of the major moves we've already done in terms of, you know, the NHS gallery study. We announced in July that that had finished our third year of study visits, and so we're doing the follow-up now on that. Similarly, with Pathfinder 2, we completed enrollment of 35,000 people in Pathfinder 2, and so we're in the follow-up stage of that. We're finishing up an updated version of our gallery assay, which is really going to drive lower ongoing COGs at scale. Some of the activities, we're centralizing our CLIA lab that's currently in Menlo Park and Research Triangle into Research Triangle Park, where we have a significant facility there already at RTP. And then the reductions in R&D are primarily focused on our DAC and MRD programs, where, again, we think we have, you know, excellent technology that has a lot of application, but we're going to pause those for the moment in order to, you know, just conserve resources. Now the commercial side where we've, you know, we've spent a lot of time over the last three years really understanding where we can be the most effective and efficient in in our commercial efforts. And so we're going to use those learnings and really focus on really the most productive areas of commercial to be able to continue to drive sales, as Aaron mentioned, probably at a more moderated pace. Because we think in a pre-reimbursement market, this is more of an investment phase and getting ready for that broad reimbursement element. And then similarly, we're going to look at G&A reductions that will be really in line with the other reductions across the organization to be just well balanced with that.

Got it. That's helpful.

Yeah.

Sorry.

Go ahead. No, I think we're good.

Okay. All right. Great. My second question was really around sort of just a progress update in the Gallery 2.0 launch. And what drives your confidence that, you know, that's going to be a narrower panel so that that will be non-inferior to the current version? Could you talk a little bit about when we could see the bridging study commence and then read out how big does that trial need to be? Since ultimately that's the PMA version that goes into FDA and the NHS and Pathfinder trials are on the older version. So any color around that would be great.

thank you yeah no great question um you know so we've clearly been doing a lot of work on our on our pma and on the pma version of the test um another number of great elements. One is, you know, the scalability. We recognize that, you know, Gallery is really geared for population scale testing. And so we wanted to make sure both the cost structure as well as the scalability were set for population scale. So spent a lot of time and effort getting that piece in place. And then maybe, Josh, if you want to talk about the timeline and progression of the studies. Sure.

I think, you know, one of the benefits of being in the market is has been the ability to collect a lot of real-world data, which has really helped us train for the new version of the assay and gives us a lot of confidence in our ability to produce a scalable version of our assay, as Bob said, with comparable performance to our existing assay with a smaller panel, as has been described on our Capital Markets Day. So I think that we have great confidence right now that we're going to be able to get that next version solidified and out. As it relates to the FDA and bridging studies, those are ongoing discussions with the FDA under our breakthrough designation. We're obviously working through our clinical validation plan. with the FDA, and we believe we're going to be able to complete our filing in the first half of 26 with data from our registrational studies, including bridging to the new version.

Got it. That's helpful. Thanks, guys. Appreciate it.

And our final question is from Sang Janam at Scotia Bank. Please unmute yourself and begin with your question.

Hi, thanks for taking my questions. Just a couple of clarification questions for me. For the REACH study, it looks like the primary endpoint is reduction in stage 4 cancers. And just to clarify, would that be sufficient for Medicare to cover the assay following FDA clearance? And also, could you define or, you know, could you maybe – give us a sense of how you define a true positive test. Would that be a positive test that's confirmed within one year of the test implementation?

Josh, you want to take those? Sure.

Good question. So the REACH study, as you said, is a real-world evidence study of 50,000 Medicare beneficiaries tested for three consecutive years and a synthetic control that will be deriving from EMRs of health systems. The primary endpoint, as you said, is an absolute reduction in late-stage cancer. This is a post-approval study. with the FDA. So it will really be used to supplement the data that we've submitted as part of our PMA. So there's no, you know, kind of registrational endpoint. As it relates to Medicare coverage, you know, first Medicare has to have the authority to provide coverage for Gallery. And there's obviously ongoing effort by stakeholders in Washington, D.C. to ensure that legislation is passed to make that happen. And if that happens upon FDA approval, CMS will then undertake a national coverage analysis. And these data both will have a great deal of performance data in the Medicare beneficiaries. It will have safety data in the Medicare beneficiaries, and it will have clinical utility data in the Medicare population. And so we believe that will be really compelling and sufficient for CMS to make that determination about coverage.

Got it. That's helpful. And then just on the portfolio rationalization, the MRD, you know, I think that rationale makes sense. But for the DAC, are the existing studies not that much leverageable for this particular assay, given you're looking for symptomatic patients? And then related to that, could symptomatic patients, could they still order the test, order gallery with a prescription, obviously? from you guys obviously might have to, you know, pay out of pocket, but would that still be a possibility?

Yeah, so we, you know, as you recall, we published the simplified data and we presented that. It was published in the Lancet. And, you know, really great results and shows the power of a DAC-type product. And, you know, with really strong both positive predictive value and negative predictive value. So we feel very, very good about that. the technology, you know, and right now it's really just looking at the level of investment required to bring that, you know, as a broad scale product out onto the market. And so when we looked at the portfolio, again, you know, we chose to pause the DAC part of the portfolio really in favor of pushing forward with MSED as the major focus.

Great. Thank you.

Thank you. There are no further questions at this time. I will now turn the call back to Grail for closing remarks.

I want to thank everyone for joining today's call.