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Q4 2024 Adaptive Biotechnologies Corp Earnings Call

In This Article:

Participants

Karina Calzadilla; Vice President - Investor Relations; Adaptive Biotechnologies Corp

Chad Robins; Chairman of the Board, Chief Executive Officer, Co-Founder; Adaptive Biotechnologies Corp

Kyle Piskel; Chief Financial Officer; Adaptive Biotechnologies Corp

Susan Bobulsky; Chief Commercial Officer, MRD; Adaptive Biotechnologies Corp

Harlan Robins; Co-Founder, Chief Scientific Officer; Adaptive Biotechnologies Corp

Andrew Brackmann; Analyst; William Blair

Rachel Olson; Analyst; JPMorganChase

Mark Massaro; Analyst; BTIG

Sung Ji Nam; Analyst; Scotiabank

Dan Brennan; Analyst; TD Cowen

Tejas Savant; Analyst; Morgan Stanley

Presentation

Operator

Good day, and thank you for standing by. Welcome to the Adaptive Biotechnologies fourth-quarter and full-year 2024 financial results conference call. (Operator Instructions) Please be advised that today's conference is being recorded.
I would now like to hand the conference over to your speaker today, Karina Calzadilla, Vice President of Investor Relations and FP&A. Please go ahead.

Karina Calzadilla

Thank you, Didi, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies fourth-quarter and full-year '24 earnings conference call.
Earlier today, we issued a press release reporting Adaptive financial results for the fourth quarter and full year of 2024. The press release is available at www.adaptivebiotech.com. We are conducting a live webcast of this call and will be referencing to a slide presentation that has been posted to the Investors section in our corporate website.
During the call, management will make projections and other forward-looking statements within the meaning of federal securities laws regarding future events and the future financial performance of the company. These statements reflect management's current perspective of the business as of today.
Actual results may differ materially from today's forward-looking statements, depending on a number of factors, which are set forth in our public filings with the SEC and listed in this presentation. In addition, non-GAAP financial measures will be discussed during the call, and a reconciliation from non-GAAP to GAAP metrics can be found in our earnings release.
Joining the call today are Chad Robins, our CEO and Co-Founder; and Kyle Piskel, our Chief Financial Officer. Additional members of the management team will be available for Q&A. With that, I'll turn the call over to Chad Robins. Chad?

Chad Robins

Thanks, Karina. Good afternoon, and thank you for joining us on our fourth-quarter and full-year earnings call. As highlighted on slide 3, 2024 was a year of key wins and strong execution on all fronts. In MRD, revenue increased 42% versus 2023, driven by both clinical testing and pharma. Two major catalysts occurred in the year, which we believe will drive long-term growth profile of the MRD business.
First, we obtained a new gapfill rate for our clonoSEQ test of $2,007, which is about $300 higher per test than our previous implied rate. And second, the ODAC vote in favor of using MRD as a primary endpoint to support accelerated approval of multi-myeloma therapies represents a paradigm shift in the development of heme cancer drugs. In immune medicine, we made significant progress in our autoimmune programs and recently nominated our lead clinical indication.
We are now focusing on the preclinical development of an antibody therapeutic candidate in this lead indication. In conjunction with driving MRD top-line growth and advancing our IM programs, we completed restructuring initiatives and yielded a 40% reduction in cash burn from 2023, concluding the year with a robust cash position of $256 million.
Let's take a closer look at the MRD business performance and outlook, starting with clinical testing on slide 5. Full-year clonoSEQ clinical revenue grew 40% versus prior year. As shown in the chart, volumes continued to increase quarter over quarter with a record-high 20,945 tests delivered in the fourth quarter, representing a 34% increase -- percentage increase versus prior year and a 7% increase sequentially. Meaningful growth was observed in all reimbursed indications.
Multi myeloma contributed 43% of US clonoSEQ volume in Q4, followed by ALL at 34%, CLL at 10%, BCL at 6%, and MCL at 4%. Looking at some of the key indicators in the quarter, it's encouraging to see the positive trends versus the same time a year ago.
Blood-based MRD testing grew 55% and contributed 41% of MRD tests in the United States. Tests in the community grew 38% and represented about 25% of tests delivered. Ordering healthcare providers grew 30%, over 3,000.
We successfully completed Epic integration in nine accounts during the quarter, including several of our largest accounts. We now have completed integrations in 19 accounts, which together represented about 20% of our ordering volume in 2024.
In January, we announced an exclusive strategic commercial partnership with NeoGenomics to cross-promote our clonoSEQ along with Neo's COMPASS and CHART metapathology services. We expect this collaboration to expand our presence in the community and fuel our growth in this segment.
In addition to the contributions from volume, clinical revenue growth was also fueled by an increase in clonoSEQ ASP as shown on slide 6. We ended the year at an average ASP of $11.17 per test in the United States, which represents a 7% increase versus fiscal year 2023. This increase was due to the ongoing execution of various initiatives to improve collections and expand coverage.
We reduced the proportion of tests delivered for indications not covered by Medicare from 17% to 7% throughout the year. We obtained Medicare coverage for MCL at the new gapfill rate under the episode structure. We initiated agreements with several large previously uncontracted Blue Cross Blue Shield payers including Texas and Independence Blue Cross and establish our first Medicaid coverage in the key states of New York and California.
And we completed the transition of our payers to the new PLA code which improved our prior authorization success rate from 46% at the beginning of 2024 to 69% at the end. We will continue to drive these efforts which, combined with the new gapfill rate, give us confidence that we can reach an ASP of around $1,300 per test on average for fiscal year 2025.
Looking at MRD Pharma on slide 7, our MRD Pharma business had a strong year with revenue growth of 44% versus 2023, which included $12.5 million in regulatory milestone revenue. Excluding milestones, pharma sequencing revenue grew 14%. In addition, we ended the year with a healthy backlog of over $200 million, which is about 10% increase over 2023.
We've experienced significant momentum following the ODAC vote in April. We've closed 20 new myeloma studies in 2024, 15 of which closed post ODAC. We now have 10 multi myeloma studies using clonoSEQ as a primary endpoint, including 3 that were upgraded from secondary to primary post ODAC.
We're seeing a positive impact for the continued acceptance of MRD in other disease states as our partners increasingly seek to incorporate MRD as a primary endpoint in both CLL and diffuse large B-cell lymphoma. And we believe there's a halo effect in adoption in the clinic as pharma companies are starting to highlight the clinical utility of MRD testing and its relevance as a key measure of treatment response.
In summary, we achieved great success in both the clinical and pharma MRD businesses in 2024, which sets the stage for continued execution on our key priorities in 2025.
As shown on slide 8, we intend to drive top-line growth in 2025 by continuing to focus on a few key strategic priorities, including: expanding blood-based testing to contribute 45% or more of our total MRD volume by further growing our presence in the community and by generating more data in blood; integrating additional Epic accounts and launching the OncoEMR integration with Flatiron in the community by midyear so that greater than 50% of our test volume is integrated by year-end; third, increasing ASP to an average of $1,300 per test based on the initiatives mentioned earlier; and fourth, increasing the number of new pharma studies and primary endpoint studies across indications continuing to leverage momentum from last year's ODAC recommendation.
Bottom-line initiatives for the year include: further reducing cost per sample in the lab by supporting volume growth with stable direct labor personnel and overhead; completing the transition to the NovaSeq X in the second half of the year; and finally, maintaining similar operating spend levels as in 2024. Execution of these priorities will enable us to achieve our primary goal for MRD this year, becoming adjusted EBITDA positive in the second half of the year while maintaining a strong long-term profile.
Now let's turn to Immune Medicine on slide 10. Our Immune Medicine business focus on two differentiated immune-based therapeutic strategies. The first is in cancer with our partner, Genentech, where the goal is to deliver highly effective TCR-based cell therapies to treat patients with different solid tumors. And the second is in autoimmunity based on our precision immunology approach.
Our goal is to discover and develop antibodies that deplete or block the autoreactive T cell receptors that are causing disease. As shown on slide 11, in 2024, we made significant progress in both therapeutic strategies.
In oncology, our focus is to enhance the profile of our cell therapy product by improving turnaround time and reducing cost. As such, we've made progress in replacing our TCR discovery cellular assay with a digital or in silico TCR antigen binding model. We're making good progress in generating the necessary training data for this digital model. This digital TCR antigen prediction model should provide the foundation for a TCR-based cell therapy with Genentech and allow us to pursue additional high-value applications beyond cancer cell therapy.
In autoimmunity, we've successfully identified a subset of autoreactive or offender T cell receptors that are likely causing disease in patients with multiple sclerosis, type 1 diabetes, and several other autoimmune indications. We completed various antibody mouse immunization campaigns and successfully selected and functionally tested a subset of antibodies to a number of disease-causing targets and prioritized indications.
Based on these data we collected, we also recently nominated a lead indication and are focusing on the preclinical development of antibody therapeutic candidates in this first indication. As highlighted on slide 12, the Immune Medicine business has three clear strategic priorities in 2025.
The first is to continue to support our partner Genentech in the development of cell therapy products. The second to generate a robust preclinical data package for our differentiated antibody program in our lead autoimmune indication. And the third is we are going to execute on these strategies with a targeted cash burn of $25 million to $30 million. We will achieve this by gating our R&D investments and leveraging our pharma business revenue to offset the IM spend.
Now I'm going to pass it over to Kyle, who's going to walk through the financial results and 2025 full-year guidance. Kyle?