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Adaptive Biotechnologies (ADPT) 2026年第三季度业绩电话会:MRD指引上调

2026年11月5日 08:01
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Adaptive Biotechnologies公布2026年第三季度营收8390万美元,同比增长39%。其中核心MRD业务营收同比增长44%,临床检测量增长46%。公司实现盈利的时间早于预期,调整后EBITDA为1430万美元,GAAP净利润为280万美元,自由现金流800万美元。管理层上调2026年全年MRD营收指引至2.76亿至2.86亿美元,并预计未来强劲增长势头将持续。

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核心要点

  • Adaptive Biotechnologies公布2026年第三季度营收为8390万美元,同比增长39%。其中MRD业务贡献7260万美元,占总营收的86%。
  • 剔除上年同期650万美元的里程碑款项后,核心MRD业务营收同比增长44%。临床检测量增长46%,MRD药企测序营收增长55%。
  • 公司实现盈利的时间早于管理层预期。调整后EBITDA为1430万美元,GAAP净利润为280万美元,自由现金流总计800万美元。
  • 公司交付了近40000份clonoSEQ检测,环比增长10%。基于血液的检测同比增长68%,社区检测量环比增长14%。
  • 管理层将2026年全年MRD业务营收指引从2.68亿至2.78亿美元上调至2.76亿至2.86亿美元,反映出更强劲的临床检测量及药企测序表现。
  • 在多发性骨髓瘤药物研发对MRD应用增加的推动下,MRD药企在手订单积压达到约2.7亿美元,同比增长34%。

核心财务数据

指标2026年第三季度变动 / 评述
总营收8390万美元同比增长39%
MRD营收7260万美元同比增长28%;占总营收的86%
核心MRD营收—同比增长44%(剔除上年同期的650万美元里程碑款项)
免疫药物业务营收1130万美元主要来自与辉瑞达成的类风湿关节炎合作协议
公司整体毛利率76%受检测量增长及经营杠杆效应支撑
测序毛利率73%高于上年同期的66%
MRD测序毛利率74%得益于NovaSeq X带来的效率提升及更高的检测量
MRD调整后EBITDA1510万美元高于上年同期的700万美元
调整后EBITDA总额1430万美元公司整体层面实现转正
GAAP净利润280万美元管理层预计第四季度或2026年全年的GAAP净利润或每股收益(EPS)不会为正
自由现金流800万美元本季度实现转正
现金总额约3.86亿美元季度末余额
运营支出(含营收成本)8440万美元同比增长1%

业务与运营表现

clonoSEQ临床检测

临床检测量同比增长46%,临床业务营收增长41%。Adaptive交付了近40000份clonoSEQ检测,较第二季度增加约3500份。

DLBCL(弥漫大B细胞淋巴瘤)检测量领跑增长,环比增长20%。占临床检测量45%的多发性骨髓瘤检测量环比增长11%。管理层预计DLBCL将继续作为主要增长驱动力,同时强调多发性骨髓瘤也应继续做出重大贡献。

基于血液的检测同比增长68%、环比增长12%,占clonoSEQ总检测量的51%。在多发性骨髓瘤中,血液检测占MRD检测的31%。

社区检测量环比增长14%,占总检测量的37%,上年同期为31%。本季度约有5600名临床医生开具了clonoSEQ检测,同比增长37%,约占美国血液学和肿瘤学医疗提供者的40%。

目前近半数订单来自接入EMR(电子病历)系统的客户。在接入Flatiron的社区客户中,78%到期的连续监测订单已完成。

医保报销与平均售价(ASP)

美国平均售价为1380美元,同比增长3%,环比基本持平。Adaptive扩大了DLBCL和套细胞淋巴瘤的商业医保覆盖范围,并在伊利诺伊州和俄亥俄州新增了Medicaid覆盖。纳入医保覆盖的州目前约占Medicaid检测量的62%,同时Medicaid的ASP同比增长26%。

Medicare和Medicare Advantage约占支付方结构的45%,高于上年同期的39%。目前Medicare单病程费率终身最多覆盖4次检测。更频繁的监测使得部分患者超出了该限额,从而对实际实现的ASP构成压力。

Adaptive向MolDX提交了一项技术评估,申请针对多发性骨髓瘤额外增加包含5次检测的维持期打包方案。管理层表示沟通进展积极,但时间和最终纳入报销的检测次数均无法保证。

MRD药企合作业务

剔除里程碑款项后,MRD药企测序营收同比增长55%。Adaptive新增或修订了27项研究,使其全球活跃研究项目组合达到191项。

在手订单积压达到约2.7亿美元,同比增长34%。多发性骨髓瘤约占活跃研究的60%、在手订单的65%以及新签订单的79%。

公司有19项将MRD作为主要终点的多发性骨髓瘤研究,高于上年同期的12项。此外,clonoSEQ还被应用于涵盖多发性骨髓瘤、CLL和ALL的23项干预性研究中。

管理层将这一势头归因于FDA关于将MRD作为加速审批终点的指南草案、多发性骨髓瘤关于治愈的新定义,以及纳入了更多检测时间点的试验设计。

免疫药物业务

免疫药物业务营收为1130万美元,主要反映了与辉瑞达成的类风湿关节炎靶点发现协议。该业务部门实现调整后EBITDA为320万美元。

Adaptive继续与摩根士丹利合作推进剥离免疫药物业务,并有望在2026年年底前公布后续发展路径。

管理层业绩指引

2026年全年指标更新后展望此前展望 / 背景信息
MRD营收2.76亿至2.86亿美元自2.68亿至2.78亿美元上调
MRD营收中值增速32%剔除里程碑款项后约为41%
临床检测量增速约42%此前为38%–40%
药企测序增速约25%不含里程碑款项
MRD里程碑营收900万美元全额已在第一季度确认;假设2026年剩余时间无该项收入
运营支出约3.5亿美元处于此前3.5亿至3.55亿美元区间的低端
美国平均ASP约1400美元长期目标维持在每次检测1700至1800美元

管理层未提供2027年指引,但表示在临床数据、指南采纳、血液检测、EMR整合及社区拓展的支撑下,预计强劲增长势头仍将持续。

风险与关注要点

  • 更频繁的Medicare检测正在带来近期ASP压力,因为目前的单病程费率在患者终身中仅覆盖4次检测。
  • MolDX的审批时间以及维持期打包方案中包含的检测次数仍存在不确定性。
  • Adaptive发现与CMS针对clonoSEQ PLA编码的初步定价相关的数据存在错误。公司正与CMS合作,力争在公布最终费率前予以纠正。
  • 药企合作营收在各季度之间可能出现波动,且管理层无法明确预见第四季度是否有额外的里程碑营收。
  • 尽管第三季度实现了GAAP盈利,但管理层预计第四季度或2026年全年的GAAP净利润或EPS不会为正。
  • 会议讨论了DLBCL领域的竞争态势,不过管理层表示,clonoSEQ的医保报销覆盖范围、临床经验及客户关系为其行业地位提供了有力支撑。

分析师问答亮点

管理层表示,CMS初步PLA费率设定流程不应影响占大部分Medicare收入的Medicare单病程报销框架。Adaptive正在争取纠正用于初步PLA费率的数据。

针对2027年及以后,管理层指出指南采纳和不断扩大的临床证据是增长的基石。EMR优化、连续监测、血液检测以及社区渗透预计仍将是主要的运营抓手。

在资本配置方面,公司计划将盈利重新投入于真实世界数据、AI驱动的流程自动化、收入周期管理、客户体验以及研发。管理层也在评估其免疫测序平台在血液学之外的新应用,但未提供具体的商业化方案。

业绩电话会完整文字记录


完整财报电话会议逐字稿

管理层陈述

Operator

Good day, and thank you for standing by. Welcome to the Adaptive Biotechnologies Third Quarter 2026 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, Head of Investor Relations. Please go ahead.

Karina Calzadilla

Thank you, Daniel, and good afternoon, everyone. I would like to welcome you to Adaptive Biotechnologies Third Quarter 2026 Earnings Conference Call. Earlier today, we issued a press release reporting Adaptive financial results for the third quarter of '26. 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 of 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, Co-Founder; and Kyle Piskel, our Chief Financial Officer. Additional members from management will be available for Q&A.

With that, I'll turn the call over to Chad. Chad?

Chad Robins

Thanks, Karina. Good afternoon, and thank you for joining us on our third quarter earnings call. Q3 was a breakthrough quarter for Adaptive. We achieved profitability at the total company level ahead of expectations, while continuing to deliver rapid MRD growth. MRD revenue, excluding milestones, increased 44% year-over-year, driven by clinical testing volume and pharma sequencing revenue. We achieved total company gross margin of 76%, generated $8 million in free cash flow and ended the quarter with approximately $386 million in total cash. These results demonstrate that we have been building toward a business that combines rapid growth with a strong financial profile. Achieving profitability reflects years of disciplined execution, thoughtful capital allocation and targeted investment in sustainable growth. The opportunity ahead continues to expand. Updated guidelines and a new definition of cure in multi myeloma strengthened the clinical foundation for clonoSEQ. With clinical volumes and pharma revenue exceeding our expectations, we are again raising our full year 2026 MRD revenue guidance.

On the immune medicine front, we are working closely with Morgan Stanley to advance the separation process and remain on track to announce the path forward by year-end. This quarter, the business also earned a milestone payment from Pfizer following the successful delivery of rheumatoid arthritis data under our agreement, an important accomplishment for the team.

Let's take a closer look at MRD clinical business on Slide 4. Clinical testing volume was a standout in Q3, growing 46% year-over-year and driving 41% growth in clinical revenue. We delivered nearly 40,000 clonoSEQ tests, up 10% sequentially or approximately 3,500 additional tests. Every reimbursed indication contributed to growth. DLBCL led with 20% sequential growth, while multiple myeloma contributing 45% of volume grew 11%. Our commercial team is executing across several fronts to drive and sustain this growth. Among those priorities are expanding blood-based testing, increasing community adoption and embedding clonoSEQ into clinical workflows. We advanced all 3 this quarter.

Blood-based testing grew 68% year-over-year and 12% sequentially, representing 51% of total clonoSEQ volume. In myeloma, blood-based tests now represent 31% of MRD testing, giving physicians a more accessible option for monitoring patients over time. Community volume grew 14% sequentially, outpacing academic centers. Community practices now account for 37% of total volume, up from 31% a year ago, extending clonoSEQ's reach to more patients. We are also making testing easier to order and repeat. Nearly half of our orders now come from EMR integrated accounts, where our team is focused on both adding integrations and increasing utilization.

In Flatiron integrated community accounts, 78% of serial monitoring orders due have now been fulfilled, demonstrating follow-through on planned patient monitoring. Our clinician base is expanding across both community and academic settings. Approximately 5,600 clinicians ordered clonoSEQ in Q3, up 37% year-over-year and representing about 40% of U.S. hematology/oncology providers. That reach underscores MRD's growing role in clinical care. As adoption expands and physicians monitor patients more frequently, we are advancing our reimbursement strategies to support that use.

Let's turn to Slide 5. U.S. ASP was $1,380 in Q3, up 3% year-over-year and relatively flat sequentially. We continue to expect approximately $1,400 average ASP for the full year and have clear catalysts to advance our longer-term goal of $1,700 to $1,800 per test. Let me start with this quarter's coverage gains. We expanded commercial coverage in DLBCL and MCL, 2 indications with substantial reimbursement opportunity. In DLBCL, we added Avalon and Concert. In MCL, we added Avalon, Blue Cross Blue Shield and United. We also expanded Medicaid coverage into Illinois and Ohio and have now established coverage in states representing approximately 62% of our Medicaid testing volume.

While Medicaid represents about 10% of our payer mix and remains our lowest paying segment, coverage gains are delivering results. Medicaid ASP increased 26% year-over-year. The largest opportunity ahead is Medicare and Medicare Advantage, which now represent approximately 45% of our payer mix, up from 39% a year ago. Here, increasing testing frequency is an important part of the ASP story. The current Medicare episode rate covers a bundle of up to 4 tests over a patient's lifetime. As physicians monitor more patients more frequently, a growing proportion is moving beyond those 4 tests, putting pressure on realized ASP. We saw this dynamic in Q3, particularly in multi myeloma, our largest indication.

That said, supporting this testing also enabled us to generate the evidence to pursue expanded coverage. We have now submitted our technical assessment to MolDX for an additional maintenance testing bundle in multi myeloma, and we are in active discussions. This is our priority catalyst with recent NCCN guideline updates further strengthening the clinical rationale for our submission. In addition for the maintenance bundle for myeloma, we are also pursuing recurrence monitoring coverage in several indications. Recurrence monitoring is already covered in MCL, and we expect to submit for CLL in the first half of next year, but we are also generating data now in multiple myeloma. Our conviction in the $1,700 to $1,800 ASP opportunity remains strong. Clinical use is expanding, and we have specific coverage initiatives underway to translate that use into broader reimbursement.

Now let's turn to Slide 6 and the advances in multi myeloma that support Pulse's strategy and clonoSEQ's longer-term potential. Two major developments this quarter strengthened the foundation for MRD testing in multi myeloma, our largest indication in both clinical testing and in pharma. First, the updated NCCN guidelines give MRD testing greater prominence and incorporate more specific direction. For the first time, the guidelines include a dedicated page on the principles of MRD testing. They recommend using an FDA-approved assay such as clonoSEQ, which is specifically named and identified 10 to the minus 6, which is 1 cancer cell in 1 million cells as the preferred sensitivity because of its higher prognostic value. clonoSEQ is, in fact, the only assay that can deliver 10 to the minus 6 sensitivity with the scale required for broad clinical use.

This is meaningful recognition of the rigor that clonoSEQ brings to MRD assessment. The guidelines also specify testing time points during maintenance and surveillance, reinforcing MRD's role beyond the initial treatment response. For community oncologists, in particular, clear direction on when and how to test can help translate clinical evidence into more consistent use. Importantly, the guidelines now address MRD-guided therapy, stating that MRD negativity can inform shared decisions on treatment intensity, while rising MRD may prompt increased vigilance and monitoring.

The second development is equally significant, a new definition of cure presented on behalf of the International Myeloma Working Group at the International Myeloma Society Annual Meeting. The definition describes 5 years off treatment with sustained MRD negativity demonstrated by at least 4 negative assessments with no positive MRD results. Testing must use next-generation sequencing or next-generation flow at a sensitivity of 10 to the minus 6. Again, clonoSEQ is the only assay that can deliver at this scale. The implication is powerful. Repeated, highly sensitive MRD assessment is central to determining which patients meet this definition. clonoSEQ is directly aligned with the cure definition requirements, further supporting our recurrence monitoring strategy. Together, these developments reinforce our MRD should be measured and why it should be followed over time. We are excited to see systematic MRD assessment becoming more central to how the field evaluates treatment success. The focus on deeper, sustained responses is also shaping drug development.

Let's turn to Slide 7 and our MRD pharma business. Our MRD Pharma business delivered one of its strongest quarters in several years, driven by accelerating adoption of MRD in drug development, particularly in multi myeloma. The underlying sequencing business generated 55% year-over-year revenue growth, excluding milestones, and we now expect pharma sequencing growth for the full year at approximately 25%. We added 27 new or amended studies during the quarter, bringing our portfolio to 191 active global studies. Backlog reached approximately $270 million, up 34% year-over-year, providing visibility into future revenue and underscoring continued demand from our biopharma partners.

Multi myeloma represent approximately 60% of active studies and 65% of backlog and accounted for 79% of new bookings this quarter. There are several key trends driving this outsized growth in multiple myeloma. First, FDA's January draft guidance around use of MRD as an accelerated endpoint was a clear signal of regulatory acceptance. We now have 19 multi myeloma studies using MRD as a primary endpoint, up from 12 a year ago. Additionally, the new definition of cure adds another dimension to that opportunity. We are already seeing multi myeloma trials incorporate more testing time points to enable assessment of a cure fraction, contributing to higher bookings per study.

Our partners are also evaluating how MRD can guide treatment itself. clonoSEQ is now used in 23 interventional studies, including multi myeloma, CLL and ALL, helping build the evidence for MRD-directed treatment decisions. For our pharma business, this creates opportunities through more studies using MRD as an endpoint, more assessments over time and an expanding role in guiding therapy. Across clinical and pharma, Q3 demonstrated the commercial strength of clonoSEQ. The advances in evidence, guidelines and trial design reinforce our conviction in the opportunity ahead.

I'll now turn it over to Kyle to review our financial results. Kyle?

Kyle Piskel

Thanks, Chad. I'll start on Slide 8 with our third quarter results. As a reminder, amortization of Genentech payments within Immune Medicine is excluded from all prior period comparisons. Total revenue was $83.9 million, up 39% year-over-year, driven by MRD growth and revenue from our Pfizer rheumatoid arthritis agreement in Immune Medicine. MRD represented 86% of total company revenue. MRD revenue was $72.6 million, up 28% year-over-year. Excluding $6.5 million of milestone revenue recognized in the third quarter of last year, core MRD revenue grew 44%. Clinical and Pharma represented 75% and 25% of MRD revenue, respectively. Immune Medicine revenue was $11.3 million, primarily reflecting the revenue from our target discovery agreement with Pfizer.

Turning to margins. Sequencing gross margin, which excludes MRD and Immune Medicine milestones, increased to 73% from 66% a year ago. MRD sequencing gross margin was 74%. The expansion reflects lab efficiencies following our NovaSeq X transition and operating leverage from higher testing volumes. Total operating expenses, including cost of revenue, were $84.4 million, up 1% year-over-year. Continued investment in our commercial infrastructure, including reimbursement and EMR integration initiatives was partially offset by lower R&D spend in Immune Medicine.

At the segment level, MRD adjusted EBITDA increased to $15.1 million compared to $7 million a year ago, reflecting the combination of strong revenue growth and continued operating leverage. Immune Medicine adjusted EBITDA for the quarter was $3.2 million. Total company adjusted EBITDA was positive at $14.3 million, a significant achievement reflecting growth and spending discipline. GAAP net income for the quarter was $2.8 million. While this is another significant accomplishment, we do not currently anticipate GAAP net income or positive EPS for Q4 or the full year.

Turning to Slide 9 on updated guidance. We're raising our full year MRD revenue guidance to a range of $276 million to $286 million, up from our prior range of $268 million to $278 million. This increase reflects stronger-than-expected clinical volume and pharma sequencing performance in the third quarter as well as higher year-over-year clinical volume growth expected now at approximately 42% versus our prior guidance of 38% to 40%. Our guidance continues to include $9 million of MRD milestone revenue, which was all recognized in the first quarter with no additional milestone revenue assumed for the remainder of the year.

At the midpoint, our updated guide represents 32% year-over-year MRD revenue growth or 41% excluding milestones. We now expect full year operating expenses of approximately $350 million at the lower end of our prior range of $350 million to $355 million and approximately 5% above last year. We are delivering higher growth while maintaining spending discipline.

With that, I'll turn the call back over to Chad.

Chad Robins

Thanks, Kyle. We entered Q4 with broad-based growth, profitability ahead of expectations and a higher full year revenue outlook. Our maintenance bundle submission is now with MolDX, and we are in active discussions on this potentially significant catalyst to expand reimbursement for ongoing testing. At the same time, advances in guidelines, the definition of cure and drug development are elevating the role of MRD and expanding clonoSEQ's long-term potential. Profitability represents an exciting inflection point for our business, enabling us to reinvest in deepening our competitive advantages and to capture the significant growth opportunities that lie ahead.

With that, operator, we'll open it up for questions.

Operator

[Operator Instructions] Our first question comes from Subbu Nambi with Guggenheim.

分析师问答

Unknown Analyst

This is Thomas on for Subbu. In regard to the CMS rates drafted for 2027, can you just talk about exposure to clonoSEQ based on your current split of Medicare and non-Medicare volumes and how that might impact ASP in the near term? Or if you have any levers to help offset any pressures and remain on track with ASP targets?

Kyle Piskel

Yes. Let me address the CMS, the PLA code and the PAMA legislation. Maybe just as a reminder, at the beginning of the year, we determined we were not an applicable laboratory under the PAMA regulations. And as such, we did not submit any private payer data to CMS as part of this. When CMS published the preliminary rates, we identified that erroneous data was submitted on the clonoSEQ PLA. And the reason we know that is because we are the only laboratory that can perform the test. And a quick reminder of why we are not in applicable laboratory is because of the episodic billing structure with Medicare, the vast majority of our Medicare revenues comes from the bundled structure. And again, when we talk about the insulation related to the business, we don't believe the PLA rate setting process should have any pull-through into the episodic framework. And separately, with CMS, we are engaged in rectifying and correcting the erroneous data, which we do not believe and have made clear with CMS that they should not be relying on any erroneous data to set a price point for the clonoSEQ PLA code.

So we're anticipating getting that results prior to the finalized rates, which should go live sometime in November as we understand with CMS. And we remain confident in kind of the long-term pricing strategies that we have in play. And that's only further supported by the advances we're having with our contracted payers, the rates we have in place and our structure with MolDX.

Unknown Analyst

Great. And then this year, another great quarter. You've had a combination of a lot of key growth drivers working together. Just curious, as you think to next year in '27, what's going to be the biggest lever you have to reach that next phase of growth for clonoSEQ? Is it blood? Is it the EMR pull-through? Just how to think about the most crucial pieces to growth next year as people start to underwrite that growth?

Julie Rubinstein

Thanks for the question. Even though we're not providing guidance on 2027, I certainly don't see any reason not to believe that we'll continue to grow at a very high rate in 2027 and beyond. We have a high ceiling remaining. We intend to continue focusing on many of the same drivers that have gotten us to the place we are today. I think the foundations of that growth in 2027 will really be the data and the guidelines. The guidelines have been very favorable for MRD and for clonoSEQ specifically over the last 18 months, and there are many opportunities to pull through those updates in the clinic. And they also will be favorable for our pharma business as a side note because the definition of cure in multiple myeloma will help to drive increasing long-term testing time points so that pharma companies can assess their drug's efficacy in the context of cure. The data will continue to develop. We're very excited about the data you'll see at ASH in just 1.5 months. We can talk more about that later.

And beyond those 2 foundations, the real enablers of growth that we focus on are the same things that we've been talking about, EMR integration, blood-based testing, expansion in the community. These are synergistic with one another in many ways. We started working on EMR a few years ago, and we've integrated many of our key accounts, but it doesn't stop there because the big focus going forward is optimizing how integrations are being used, particularly to enable serial testing. And we've seen high rates of pull-through on serial testing with our Flatiron implementation in OncoEMR. We continue to see increases in blood. We're investing in product development in that regard to enhance the performance of the product in blood. And community is now contributing 37% to our volumes, and the guidelines will strengthen our ability to educate and promote the use of consistent testing across community practices. So we do continue to expect strong growth in 2027 and beyond, and it will be a combination of all those factors.

Operator

Our next question comes from Casey Woodring with JPM.

Casey Woodring

I guess the first one, it looks like the strongest clinical volume sequential growth was in DLBCL. There's been some competitive noise there. Just can you talk about what you're hearing from customers and your competitive moat in DLBCL going forward? And if you would expect that to continue to like be the strongest sequential kind of growth driver in volumes moving forward?

Julie Rubinstein

Yes. In our DLBCL sequential growth has continued to be very strong and fairly consistent quarter-over-quarter. And my expectation is that we will continue to deliver consistent double-digit growth rates on an ongoing basis. We do hear about competitors in the field, but we have a very strong position from which to continue to grow, and that includes the test itself and it's custom-built for blood cancers, including lymphomas, the reimbursement that is already established broadly for our test in lymphomas, the ability to continue to leverage our real-world experience and then now about 9,000 patients who have been tested with clonoSEQ for all these reasons as well as the fact that we have these established relationships with our key customers and continue to delight them, I'm very confident in our position in this field. And in the end, this is a very underpenetrated market. So the noise that is being created by additional companies talking about MRD and DLBCL is beneficial and disproportionately beneficial to us as the market leader. We are excited about the data that we will continue to advance in this space, and I think you'll see a good amount of that at ASH this year. And we believe that we are in a good position both in the short term, leveraging our moats, leveraging the sort of noise around MRD and also in the longer term where we believe the performance of our technology will really win the day.

Casey Woodring

Got it. That's helpful. And then I think you alluded to it in an earlier question, but 64% of your MRD pharma backlog increase was from multiple myeloma. Is that related to guideline updates or the new cure definition? Or just more generally speaking, kind of what's driving the momentum in multiple myeloma right now?

Julie Rubinstein

Yes, there are several reasons that we're seeing an improvement in our MRD -- in our myeloma pharma business. And I think one thing is that earlier this year, the accelerated endpoint that was adopted by ODAC back in 2024, the FDA actually issued draft guidance to really sort of cement the use of that endpoint. And I think a number of pharma companies saw that as an important signal to move forward with new primary endpoint studies, and we've seen quite a number of new primary endpoint studies in 2026.

The second is the definition of cure that was issued by the IMS just about a month ago. Many of our pharma clients have been anticipating that. It's been talked about among KOLs for a number of months. And so studies being designed today are incorporating more time points, as I alluded to earlier, to be able to make that cure claim for the therapeutics that are being evaluated in the study. And that's resulting in higher bookings, more time points. And then lastly, just the increase in regulated and interventional use. We now have 23 additional studies, including 8 multiple myeloma. The number of regulated studies is now the majority of our trials are regulated. And so we're seeing that overall MRD is just becoming a standard of how studies are being done in multiple myeloma, and that will continue, we believe, to contribute to strength for our pharma business going forward.

Operator

[Operator Instructions] Our next question comes from David Westenberg with Piper Sandler.

David Westenberg

I do wanted to jump on the DLBCL strength. It grew 20% sequentially in the quarter and remains a pretty underpenetrated opportunity. So what really were the biggest drivers of DLBCL up 20%? And then what -- how should we think about that as a contributor to growth over the next few years? Should we think about DLBCL as really being the predominant accretive to growth driver in '27 and '28?

Julie Rubinstein

Yes. I mean, David, thanks for the question. As you said, we've been really pleased with the DLBCL growth, which has continued to outpace all other indications. And the growth is broad-based. It's coming from both community and academic accounts. We've been particularly successful of late driving increased adoption in some of the largest community practice networks. Some of our largest DLBCL growth this past quarter came from one of the largest networks in the country. And all of this is a result of continued just focus on market development. We have to educate on the role of MRD, how it can augment and improve upon PET scans and other sort of more traditional ways of thinking about disease burden and how it can inform treatment. And there are now a number of studies in motion and a few that are even reading out at ASH showing different ways that MRD can be useful in informing treatment selection and escalating or deescalating therapy in DLBCL.

So we continue to expect it to be a top growth driver for the next few years, particularly given the investments we're making in data and the potential for pharma to expand its investment in MRD-guided therapy trials in the future.

Chad Robins

But David, even though multi myeloma has been a large grower, it's going to still be a major contributor to our growth, especially with updated guidelines and the new definition of cure. And just to kind of up level this a minute. I mean, it's hard to kind of understate how big a deal this is. We believe that this is the first definition of cure based on an NGS test. Basically, they're saying, if you're MRD-negative using clonoSEQ, for kind of 4 different tests, then you're cured of a disease. I was just an anecdote, we had investigators when they found this up crying in the hallway. They've been working on this for over a decade. So it's just -- this is -- myeloma is going to be -- continue to accelerate.

David Westenberg

Got you. And then I was kind of going to jump on -- I appreciate that I add some color. I want to jump on the $1,400 ASP target. I think you came in, I think you said $1,386. How much of this is blocking and tackling versus some of the new adds that you mentioned, new coverage adds that you mentioned. And we are in November of this time. So I mean, in order to get to that $1,400, do you need any kind of timing specific to get you there in terms of timing coverage? And I'll stop there.

Kyle Piskel

Yes. I appreciate the question, David. This is Kyle. Certainly, blocking and tackling plays into every quarter. I think blocking and tackling is a contributor even in the fourth quarter. Certainly, as we think about the guide and the year, one of the factors is frequency uptake as it relates to Medicare and the pressure we're seeing there, which ultimately is a good thing. So I think there are some timing dependencies that could move the needle in either direction. But foundationally, I think we're in a good place, and there are some timing considerations, but we'll see how those play out, but we're confident in kind of the long-term trajectory here and continue to be confident in getting to that $1,400 at some point.

Chad Robins

Yes. And David, maybe if I could just kind of add a little bit of color and context. Some of the -- a little bit of the ASP pressure that you're seeing is actually what is beneficial and what we're using to -- for our MolDX submission. And if you think about kind of our overall strategy, think about this in kind of -- there's 3 different kind of phases of a patient's treatment continuum. Kind of the first is active treatment phase, which we're already reimbursed by Medicare for 4 tests, okay? The second, and this is what we're -- we've already submitted and are in active, very positive discussions with MolDX on is what we're calling kind of the maintenance treatment phase. And we've submitted for an additional bundle of 5 tests. So this is the first time I've kind of said that, but that we've submitted for an additional 5 tests during the maintenance setting.

And then the third is the recurrence monitoring. And we also mentioned during this call in multi myeloma that the second half of this year, we believe we have data from the recurrence monitoring. So that really kind of hits all 3 phases of a treatment of a patient's kind of care continuum. And again, I think it's not a matter -- we believe it's not a matter of if, it's a matter of when. And we're, I would say, highly encouraged based on these discussions that we have -- that we'll have an upcoming catalyst when we get this maintenance bundle. We can't be -- I just want to be clear, though, we can't guarantee kind of the number of tests in the bundle. We can't guarantee timing. I can just guarantee that what I can tell you is the discussions have been very, very positive. It's recognized that this is necessary and it fits really perfectly with the new NCCN guidelines and the new definition of cure.

So all of these factors are converging to say that you need to both monitor a patient more frequently at all phases kind of during this care continuum. So that's kind of -- I just want to provide a perspective on how this is all working together and our broader-based reimbursement strategy so that we're not thinking that a short term -- we do believe we're going to be approximately at $1,400 this year. And timing-wise, we may see some very slight variation or fluctuation. But what we have seen is we have more confidence than ever kind of based on these discussions that we're having that our ASP targets of $1,700 to $1,800 that we will not only hit them, that we believe that we will hit them that we can potentially even accelerate that time frame in some cases.

Operator

Our next question comes from Dan Brennan with TD Cowen.

Daniel Brennan

Congrats on the quarter. Maybe just on the pharma side, really good pharma numbers again. Just can you just give us a flavor of what's happening on the pharma side of the business, like kind of what's baked in for the fourth quarter? And just kind of update us again on the milestone opportunity as we look ahead, maybe not this year, but just beyond just what type of milestones, say, next 12 months might be realistic?

Kyle Piskel

Yes, Dan, I appreciate the question. I mean we're really excited about the kind of bookings and backlog growth we're seeing in the pharma business as well as the print in the third quarter. As you know, quarter-to-quarter can be lumpy from a revenue perspective. But I think when we think about the longer-term opportunity and the growth we're seeing in that business, backlog at the end of Q3 was $270 million, up from $200 million a year ago, really setting us up for some strong growth. We're now looking at 25% year-over-year growth in the pharma business, excluding milestones. So it's setting us up for a good position heading into 2027.

With respect to milestones, we said we don't have any visibility into Q4 into any milestones. And again, we think about that when we get line of sight. We'll update our guidance with respect to that. We don't necessarily control that timing, but we still have a healthy backlog of milestone opportunities that could read out. It's just really difficult to model and predict the timing of that, but still expect to see some of those over the course of the next coming years as well. And we'll provide more color at the next earnings call around that.

Julie Rubinstein

Yes. And just to chime in a bit on the dynamics that are really sort of important. Again, I think reiterating the fact that the FDA draft guidelines or guidance that was issued earlier this year, the definition of cure, which is encouraging companies to do longer studies with more time points, the interventional nature of many of the study designs, all of these things combined with the fact that we have the only FDA-cleared assay and a strong reputation and relationship with these companies for delivering registrational grade data over many years, I think we continue to be in a really strong position to support the needs of the myeloma drug development programs for years to come.

Daniel Brennan

Great. And then the volumes, terrific volume again. You've been running in 30s and low 40s for a while now. Penetration still seems like it's not that high as the market. So -- and you have all these drivers kind of headed. Like how do we think about as we get to 4Q and then we lap into '27, most of us naturally have volumes coming down. You're not guiding for '27 right now, but it seems like there's still just so much momentum in the business. Any way to think about what volumes could be, say, over -- as we look out beyond '26 into '27, kind of what's the framework we could use?

Chad Robins

Obviously, Dan, we're not in a position yet to guide on '27. I can just tell you that there's a tremendous amount of internal excitement from our team and the conversations they're having with clinicians regarding the new definition of cure. The updated NCCN guidelines has given a great call point, particularly in the community where doctors are much more apt to follow guidelines. And we expect -- I'd just say we expect the momentum to continue. We see nothing that's slowing this down. On the contrary, I think there's been kind of 2 meaningful updates kind of overall in the industry, which kind of further support and gives us confidence in the growth trajectory ahead.

Operator

Our next question comes from Mark Massaro with U.S. Bancorp BTIG.

Mark Massaro

Some of us are hopping calls tonight, so pardon me if this has already been asked. But now that you've achieved company-wide profitability, should we think about any potential changes to capital deployment as we think about 2027? Also curious at a super high level, how you're thinking about the potential for exploring tuck-ins, assuming they made sense and we're disciplined. Just wanted to get a sense for how you're thinking about capital deployment now that you're a profitable company.

Chad Robins

Yes. I'll let Susan start on the areas we're investing in, in MRD, and I'll make some kind of broader comments as to kind of some things we're thinking about.

Susan Bobulsky

Yes. We've been growing at a high rate over several years, and we still have this big ceiling that we can continue to grow into. So as we become profitable, I think the best thing we can do is deploy those profits to continue to expand our moat and increase the trajectory of MRD adoption. So we've been very focused beginning this year on identifying strategic areas in which to invest. This year, our investment has been focused on capability building in a few key areas. Real-world data is one, AI and AI-driven business process automation, specifically, our revenue cycle management and developing the next-generation customer experience with a focus on facilitating serial testing. We made considerable strides in all 4 of these areas this year, and we intend to continue those investments in 2027.

I should also highlight that we have a robust R&D effort through which we're investing both in current product enhancement and an advancement of new products in order to extend our leadership in the spaces where we already play and also consider ways we can either leverage our channel or develop new applications of our proprietary platform.

Chad Robins

Yes. And again, one of the things to highlight, Susan mentioned kind of enhancing the performance of our existing clonoSEQ to deepen heme MRD and also kind of leveraging our heme channel to deliver kind of other things you could potentially do with that patient sample. But the third area, which we're actively in development on is new applications of our immuno sequencing platform to address kind of unmet medical needs kind of beyond hematology. There's some kind of really interesting potential applications of our platform that we're exploring. And again, not ready to talk about on this call, but I think what could be really interesting kind of large opportunities to kind of leverage our existing capabilities, both with our platform technology, but also with the infrastructure that we've built around how to deliver, how to get PET tests paid for, revenue cycle management and all the things that you need to do as a diagnostic company.

Mark Massaro

Okay. That's fantastic. And then I wanted to ask about the NCCN guideline recognition. What is your thinking in terms of -- you're already the dominant market leader. And so some of us are wondering how -- usually when you're #1, you can't do better than #1, but perhaps you could perhaps accelerate. But it's typically uncommon for market leaders that have been in the space for a while to accelerate. So I am curious what you think the benefits are from the NCCN recognition and clonoSEQ being called out in particular.

Susan Bobulsky

Yes. I mean we -- as was mentioned earlier, the opportunity is most substantial in community oncology where guidelines are particularly important. Clinicians are really looking for us to tell them how and when to test. And so we're very actively engaged in promoting the guidelines updates now and are seeing a great deal of engagement from clinicians. And one of the things that's important in the community to us is to find ways to help the practices align their practice with those guidelines to drive more consistent testing across all patients that they see. So that interacts with our EMR integration strategy and thinking about ways we can develop standardized testing pathways and protocols taking the accounts who are doing that successfully and bringing their stories to share across other accounts.

So that's the work that we're doing right now. I do think it's a potentially meaningful accelerator for the myeloma business. And importantly, also supports the maintenance bundle submission that's currently with MolDX and which will be an important future driver of ASP. So we have a number of opportunities folded in with these guidelines. It's also notable that the guidelines are really -- the guidelines combined with the cure definition are really underscoring the need for bone marrow testing. And I actually believe there's an opportunity to increase community testing to use bone marrow as a complement to blood in areas where they may not be doing so today. We are eager to work with them to help ensure that they can deliver the potential of a cure to as many patients as possible. And to do that, they need to incorporate clonoSEQ MRD testing in marrow as well as in blood.

Operator

I'm showing no further questions at this time. This concludes today's conference call. Thank you for participating. You may now disconnect.

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