GRAL - NASDAQ

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 will be question and answer session. Please be advised 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 Freidin, our Chief Financial Officer; Dr. Joshua Ofman, our President; and Sir Harpal Kumar, our President, Biopharma Business and 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 facts, 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 Factors section of GRAIL's most recently quarterly report on Form 10-Q. 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 GRAIL's financials. Reconciliations of the non-GAAP measures to the 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 Galleri, 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. Multi-cancer early detection, or MCED, is the solution for effective population screening. The market for MCED is rapidly evolving, with over 100 million individuals eligible for the Galleri test in the United States and more than 300 million in global target markets. GRAIL'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 health care. Importantly, the Galleri test was designed for population-scale screening. We have an expansive clinical evidence program, which is setting the standard in MCED 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 premarket 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-Galleri 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 2 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 Galleri-Medicare study called the REACH study. This real-world evidence study is planned to enroll 50,000 Medicare beneficiaries for 3 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 Galleri that we're seeing in the pre-reimbursement environment. Through June 30 of this year, more than 215,000 commercial Galleri tests have been prescribed by more than 11,000 health care providers. GRAIL is an established market leader in the field, and we are proud of the impact that Galleri is having on patients' lives. Following a portfolio review, we are reprioritizing our resources on our core MCED 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 head count will impact our PMA submission timing or NHS-Galleri or the PATHFINDER 2 readouts. As a result of focusing our resources on achieving broad Galleri reimbursement in the U.S. and U.K. we are reducing the existing head count 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 impacts 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 Galleri 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. Galleri 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 MCED opportunity. We will continue to invest in our biopharmaceutical partnerships and are committed to working with our partners to leverage GRAIL's proprietary methylation technology in precision oncology applications. This restructuring resulting staff reductions are difficult, and we are immensely grateful to our employees who have worked hard to enable GRAIL's success to date and helped to transition MCED 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 GRAIL's Chief Financial Officer, Aaron Freidin.

Thanks, Bob, and good afternoon, everyone. I'm pleased to 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 Galleri 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 head count and 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 Illumina's acquisition of GRAIL. 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 2023. Primary drivers of the increased margin were revenue mix and efficiencies of scale related to increased Galleri 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 onetime 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 Galleri 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. Galleri revenue will be in line with our guidance in May of 30% to 50% growth over 2023. However, with our reductions announced today, we plan for Galleri 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 Galleri. Real-world use of Galleri 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 Galleri and from physicians and health systems that are successfully implementing Galleri 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 Galleri-Medicare or REACH study, drive access to Galleri 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 Galleri and pursuing broad reimbursement for Galleri. With that, we'll turn the call over to Q&A. Operator, please go ahead.

[Operator Instructions] Our first question is from Kyle Nixon at Canaccord.

Thanks for doing this update call. So I guess there hasn't been a multi-cancer early detection test like this scale in the past, and now you're kind of getting cash burn down to levels of like other precision oncology companies. What gives you confidence that this level of investment is enough to commercialize this type of product?

Kyle, thanks for the question. We've looked really carefully at our portfolio and recognized that by focusing on MCED and getting to the key inflection points, particularly FDA approval of our PMA and then 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 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 pathway successfully. We -- in that area around MCED, we actually made relatively few changes. We're staying consistent on our time line. We're staying consistent on the effort that we're applying to that area. It's really in other areas around DAC, MCED and some of the commercial elements that we pulled back from.

That's helpful.

Yes. So we're comfortable.

Sorry for cutting you off. So just a related follow-up. When -- how will these and where will these cost reductions be based in? I understand kind of inflecting this now, I guess, but it's kind of midyear. So 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 for the company's like long, long-term growth profile?

Yes. So the actions will occur immediately. So we're taking action right now to generate the cost savings that we're outlining. 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 for those. And on the precision oncology side, we're continuing supporting our biopharma partners in that. So that work will continue. On the pure DAC and MRD work, though, we're pausing future developments in those areas. And we haven't set a time line for kind of reinvesting in those areas at this point. Again, focus is really to drive MCED through the key inflection points.

The next question is from Tejas Savant at Morgan Stanley.

Guys, can you hear me okay?

Yes.

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? 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.

Yes, I can give you some sense, and then maybe Aaron can jump up with a little more color. So as we 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. That's going to come from about a 30% reduction in both existing as well as planned requisitions for 2024, but existing head count and planned reqs. Importantly, we're rolling off some of the major moves we've already done in terms of the NHS-Galleri study we announced in July that, that had finished our third year of study visits. And so we're just 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 Galleri assay, which is really going to drive lower ongoing COGS at scale. Some of the activities we're centralizing are CLIA labs 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 excellent technology that has a lot of application, but we're going to pause those for the moment in order to just conserve resources. Now on the commercial side, where we've -- we spent a lot of time over the last 3 years really understanding where we can be the most effective and efficient 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.

Yes, Aaron, sorry, go ahead.

Aaron, you got...

No, I think we're good.

My second question was really around sort of just a progress update on the Galleri 2.0 launch. And what drives your confidence that that's going to be a narrower panel so that, that will be noninferior 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.

Yes. No, great question. So we've clearly been doing a lot of work on our PMA and on the PMA version of the test. Another number of great elements. One is the scalability. We recognize that Galleri is really geared for population scale testing. And so we wanted to make sure both the cost structure as well as the scalability. We're set for population scale. So spend a lot of time and effort getting that piece in place. And then maybe, Josh, if you want to talk about the time line and progression of the studies?

Sure. I think one of the benefits of being in the market has been the ability to collect a lot of real-world data, which 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're -- 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.

And our final question is from Sung Ji Nam at Scotiabank.

Just a couple of clarification questions for me. For the REACH study, it looks like the primary endpoint is reduction in Stage IV cancers. And just to clarify, would that be sufficient for Medicare to cover the assay following FDA clearance? And also, could you define -- or 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 1 year of the test implementation?

Josh, do 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 3 consecutive years, and a synthetic control that we'll 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 kind of registrational endpoint. As it relates to Medicare coverage. First, Medicare has to have the authority to provide coverage for Galleri. 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.

And then just on the portfolio rationalization, the MRD, 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 a symptomatic patient? And then related to that, could symptomatic patients, could they still order the test or order Galleri with a prescription yet, obviously, from you guys. Obviously, they might have to pay out of pocket, but would that still be a possibility?

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

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