富骏基因 (FLGT) 2026年第三季度业绩电话会：营收增长8%，亏损收窄

核心要点

• 2026年第三季度营收同比增长8%、环比增长6%至9040万美元，主要得益于解剖病理学业务的增长以及对Bako Diagnostics和StrataDx的整合。
• GAAP净亏损从第二季度的2950万美元收窄至1320万美元；调整后EBITDA从亏损1710万美元改善至亏损750万美元。
• 收入周期管理（RCM）的改善推动了回款率的提升和毛利率的环比扩张，但管理层表示系统仍需进一步定制优化。
• Fulgent重申2026年全年营收指引为3.3亿至3.4亿美元，并将Non-GAAP每股亏损预期改善至1.65-1.75美元。
• 在收到1.123亿美元的联邦退税及相关利息后，公司的现金、现金等价物、受限资金及有价证券总额达到6.524亿美元。
• FID-07正筹备开展3期注册临床研究，而FID-022仍处于1期剂量递增阶段。

核心财务数据

业务与运营表现

精准诊断业务营收为4180万美元，同比下降18%，但环比增长1%。解剖病理学业务营收同比增长57%、环比增长9%至4090万美元。生物制药服务营收为770万美元，同比增长5%、环比增长19%。

Bako Diagnostics和StrataDx在第三季度贡献了2180万美元的营收，高于第二季度的1690万美元。管理层将当季营收增长主要归因于对这两家公司的整合。

Fulgent的AI平台分析了约25.5万张病理切片图像，较第二季度增长23%；分析失败率降至0.01%。目前已有四个AI模块投入实际运行，另有五个应用计划于2026年第四季度部署。

在内部测试中，前列腺癌模块在262例病例中识别出770个含癌切片部位中的768个。管理层预计，随着业务量的增加，AI部署将提高诊断一致性、病理学家的工作效率以及运营杠杆效应。

在药物治疗研发方面，Fulgent于8月与FDA就FID-07完成了2期临床结束会议，目前正在筹备3期注册临床研究。公司继续就能够提供资源和战略协同的潜在合作展开商讨。

FID-022仍处于1期剂量递增阶段的第五个剂量水平。管理层预计将在2027年上半年确定最大耐受剂量。FID-07和FID-022均采用了Fulgent专有的CleanChemo纳米药物递送平台。

管理层业绩指引

Fulgent重申2026年全年营收指引为3.3亿至3.4亿美元，预计同比增长2.3%至5.4%。

Non-GAAP营业利润率预期较此前预计的负20%中段区间有所改善。调整后的每股亏损指引也较此前2.22-2.35美元的区间有所收窄，反映出营业费用的降低以及临床项目支出的更新调整。

年末现金预测假设不再进行额外的股票回购、并购或正常经营之外的其他支出。每股指引反映了今年迄今已回购的410万股股票，并假设后续不再进行回购。

风险与关注点

计费和收入周期管理（RCM）系统的过渡继续对第三季度业绩构成压力。尽管报销趋势实现环比改善，但管理层表示仍需进一步定制和微调，且未给出回款率完全恢复至历史水平的明确时间表。

管理层预计，目前考虑中的PAMA报销政策变更影响微弱，因为Fulgent的核心CPT代码风险敞口有限。不过，公司将继续密切关注报销政策环境的变化。

全年毛利率预期反映了客户结构的变化以及与计费系统过渡相关的回款率下降。此外，临床研发时间表和支出情况也依然取决于FID-07和FID-022项目的进展。

分析师问答要点

管理层表示，收入周期管理系统的过渡工作已进入深入阶段，已落地的定制化改进已提升了回款表现。管理层预计，后续在制度政策和系统优化方面的进一步推进，将为毛利率的进一步改善提供支撑。

谈及第四季度，管理层指出，全年营收指引中点意味着第四季度营收将与第三季度大致持平；指引上限则有望实现环比增长，不过在计费系统优化工作持续进行之际，公司仍维持了审慎的指引区间。

管理层表示，在病理学、罕见病、女性健康以及生物制药服务领域的多元化业务布局，在一定程度上缓解了季节性波动的影响。管理层还强调，AI带来的初期效益包括质量保证、更快的数据交付以及减少差错，而生产力提升和毛利率改善的红利预计将随着时间推移逐步显现。

财报电话会议完整实录

完整财报电话会议逐字稿

管理层陈述

Operator

Good afternoon, ladies and gentlemen, and welcome to the Fulgent Genetics Q3 2026 conference call and webcast.

[Operator Instructions]

This call is being recorded on Thursday, November 5, 2026. Now I turn the call over to Lauren Sloane. Please go ahead.

Lauren Sloane

Good afternoon and welcome to Fulgent's third quarter 2026 financial results conference call. On the call are Ming Hsieh, Chief Executive Officer; Paul Kim, Chief Financial Officer; and Brandon Perthuis, Chief Commercial Officer. The company's press release discussing the financial results is available on the Investor Relations section of the company's website, ir.fulgentgenetics.com. A replay of this call will be available shortly after the call concludes on the Investor Relations section of the company's website. Management's prepared remarks and answers to your questions on today's call will contain forward-looking statements. These forward-looking statements represent management's estimates based on current views, expectations, and assumptions, which may prove to be incorrect. As a result, matters discussed in any forward-looking statements are subject to risks, uncertainties, and changes in circumstances that may cause actual results to differ from those described in the forward-looking statements.

The company assumes no obligation to update any of the forward-looking statements it may make today to reflect actual results or changes in expectations. Listeners should not rely on any forward-looking statements as predictions of future events and should listen to management remarks today with the understanding that actual events, including the company's actual future results, may be materially different from what is described in or implied by these forward-looking statements. Please review the more detailed discussions related to these forward-looking statements, including the discussions of some of the risk factors that may cause results to differ from those described in the forward-looking statements contained in the company's filings with the Securities and Exchange Commission, including the previously filed 10-K for the year ended December 31, 2021, and subsequently filed reports, which are available on the company's Investor Relations website.

Management's remarks, including discussions of non-GAAP profit, loss, operating expense, margin, earnings, earnings per share, and adjusted EBITDA, contain financial measures not prepared in accordance with accounting principles generally accepted in the United States, or GAAP. Management has presented these non-GAAP financial measures because it believes they may be useful for investors for various reasons, but these measures should not be viewed as a substitute for or superior to the company's financial results in accordance with GAAP. Please see the company's press release discussing its financial results for the third quarter of 2026 for more information, including the description of how the company calculates non-GAAP net income and loss, non-GAAP earnings and loss per share, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating profit and loss and margin, and adjusted EBITDA, and a reconciliation of these financial measures to income and loss, earnings and loss per share, and operating margin to the most directly comparable GAAP financial measures.

The company does not provide reconciliation of forward-looking non-GAAP measures to the most directly comparable GAAP measures because the information necessary to calculate such reconciliations, including equity-based compensation, tax effects, acquisition-related items, and potential impairments, any of which may be material, is unavailable on a forward-looking basis without unreasonable effort, and the probable significance of those items cannot be predicted.

With that, I'd now like to turn the call over to Ming. Please go ahead.

Ming Hsieh

Thank you, Lauren. I will start with some comments on our two business lines. Then Brandon will review our product and go-to-market updates for our lab service business. Paul will conclude with the financials and outlook before we take your questions. I am pleased with the momentum in our therapeutic development business as we progress on our clinical pipeline. We are seeing encouraging clinical data from our proprietary nano drug delivery platform, which powers both FID-07 and FID-022. I will share the recent updates from FID-07 and then share the progress we have made with FID-022. As a reminder, Fulgent has taken a different approach with FID-07. FID-07 is a nanoencapsulated paclitaxel developed under Fulgent's CleanChemo platform. The platform is designed to reduce toxicity typically associated with conventional chemotherapy while maintaining or improving efficacy, a profile Fulgent believes is preferable in combination oncology regimens.

Starting with FID-07, with the majority of Phase 2 complete, we had the End of Phase 2 meeting with the FDA in August. We look forward to sharing more with you later this year. Our Phase 3 study is in preparation. We are encouraged by our clinical trial progress achieved so far, and I believe entering the Phase 3 registration trial is an important step towards the potential commercialization of FID-07 for the treatment of recurrent or metastatic head and neck squamous cell carcinoma patients who currently have very few effective treatment options. We continue to approach conversations with partners who bring both resources and strategic alignment.

In the third quarter, we were pleased with the momentum of our second clinical candidate, FID-022. With the Phase 1 dose escalation at the fifth dose level ongoing, we expect to determine the maximum tolerated dose level in the first half of next year. FID-022 is a nanoencapsulated SN-38 for treatment of solid tumors, including potentially colon, pancreatic, ovarian, and bile duct cancers. Please note that both FID-07 and FID-022 are derived from the same proprietary CleanChemo delivery platform patented and fully owned by Fulgent. Similar to FID-07, FID-022 can also be used in various oncology drug combinations. In conclusion, we believe our core platform strategy is making meaningful progress. We are seeing greater potential in commercializing FID-07 and FID-022 to drive a large and growing market.

In our laboratory services business, we continue to see our AI and digital pathology solutions work at an accelerated pace and continue to expand our AI portfolio. We are pleased with the progress we have made to address billing and revenue cycle management, which continues to affect our third quarter results, and our team's ability to work effectively to deliver the improvement to our collection rates. I would like to thank our employees, partners, and stakeholders for your hard work and loyalty. I will now turn over the call to Brandon Perthuis, our Chief Commercial Officer, to talk more about our laboratory service business. Brandon.

Brandon Perthuis

Thank you, Ming. We ended the quarter at $90.4 million, an increase of 8% year-over-year and 6% sequentially. We continued integration efforts for Bako and StrataDx during the third quarter, which contributed to the overall performance. Breaking it down further, precision diagnostics ended at $41.8 million, a decrease of 18% year-over-year, but an increase of 1% sequentially. Anatomic pathology came in at $40.9 million, an increase of 57% year-over-year and 9% sequentially, and biopharma services ended the quarter at $7.7 million, an increase of 5% year-over-year and 19% sequentially.

Last quarter, we discussed managing the final phase of the transition of our billing and revenue cycle management system. We originally undertook this transition to achieve greater consistency across our operations and to drive long-term efficiency. While this transition continued to have a negative impact on the third quarter, we are pleased to announce we have made significant progress and have seen a positive sequential trend in reimbursement, which has contributed to improvements in our total revenue and gross margins as compared to the second quarter. While there is still additional effort needed to finalize the remaining customizations, and we cannot predict more precise timing for future improvements, we believe we have a clear line of sight into what is needed to return to historical collection rates.

We continue to monitor developments related to PAMA and any potential changes to the clinical lab fee schedule. Based on what we know today, we expect the impact to our business to be minimal. Our primary CPT codes have limited exposure to the reimbursement reductions currently contemplated under PAMA. As a result, we do not currently view PAMA as a material headwind to our revenue or earnings outlook. We will remain engaged with the evolving reimbursement landscape, but at this point, we feel comfortable with our positioning.

We continue to make significant progress integrating artificial intelligence into our pathology workflow. During the third quarter, our AI platform analyzed approximately 255,000 slide images, representing a 23% increase from the second quarter. Importantly, as utilization has scaled, the technical reliability of the platform has improved substantially, with failed analyses declining to just 0.01% during the quarter. We now have 4 AI modules in production, with our prostate cancer detection and grading module undergoing pathologist evaluation.

During the quarter, we also transitioned our production environment to a new AI analysis platform designed to improve speed, reliability, and scalability. The new architecture has meaningfully reduced processing times across several of our highest volume applications and provides the infrastructure to efficiently support additional AI modules as they move into production. We are particularly encouraged by the continued development of our prostate cancer application. In internal testing across 262 cases, the module identified 768 of 770 cancer-containing parts. Looking ahead, we expect to continue expanding the platform with 5 additional AI applications planned for deployment in the fourth quarter.

We believe these investments can improve diagnostic consistency, enhance pathologist productivity, and create meaningful operating leverage as testing volumes grow. Overall, we are pleased with our progress during the third quarter, especially around the improvements in revenue cycle management and the use of AI to scale our business. I'll now turn the call over to our Chief Financial Officer, Paul Kim. Paul.

Paul Kim

Thank you, Brandon. Revenue in the third quarter of 2026 totaled $90.4 million, including $21.8 million from Bako Diagnostics and StrataDx, compared to $85.4 million in the second quarter of 2026, which included $16.9 million from Bako Diagnostics and StrataDx. The increase in our Q3 revenue is primarily due to the integration of Bako Diagnostics and StrataDx. The GAAP gross margin was 35.3% and non-GAAP gross margin for the third quarter was 36.3%. The increase sequentially in gross margin reflects fixed costs spread over a higher revenue base driven by better collection rates. We expect gross margins to normalize as our collection rate returns to historical norms and as revenue increases.

Now turning to operating expenses. Total GAAP operating expenses were $54.5 million for the third quarter, down from $61.8 million in the second quarter. The decrease in operating expenses was driven by a $3.2 million recovery in the third quarter of 2026 and the absence of a one-time $2.2 million impairment charge recorded in the second quarter on a customer relationship intangible asset following the loss of a customer in our therapeutic development segment. Non-GAAP operating expenses were $44.8 million in the third quarter, down from $49.2 million in the second quarter. GAAP operating margin improved to -24.9% in Q3 compared to -42.3% in Q2. Non-GAAP operating margin improved sequentially to -13.2% in Q3 compared to -26.2% in Q2.

Our GAAP loss in the current quarter was $13.2 million, a decrease from the prior quarter's GAAP loss of $29.5 million and a GAAP loss of $0.48 per share based on 27.7 million weighted average diluted shares outstanding. On a non-GAAP basis and excluding equity-based compensation expense and intangible asset amortization, loss for the quarter was approximately $2.4 million, or $0.09 per share based on 27.7 million weighted average diluted shares outstanding. Adjusted EBITDA for the third quarter was a loss of approximately $7.5 million compared to a loss of $17.1 million in the prior quarter. In the third quarter, we repurchased just over 15,000 shares under our stock repurchase program.

Since the inception of the stock repurchase program in March 2022, a total of over 7.5 million shares of common stock has been repurchased under our program with approximately $75.6 million currently remaining available for future purchases of our common stock. Turning to the balance sheet, we ended the third quarter with approximately $652.4 million in cash, cash equivalents, restricted cash, and marketable securities. The $100.9 million increase in cash from the previous quarter was primarily driven by a receipt of $112.3 million in federal tax refunds and related interest, partially offset by $11.4 million of cash used in operations and CapEx.

We are reaffirming our full-year revenue guidance and continue to expect total revenue to be in the range of $330 million to $340 million for 2026, representing year-over-year growth of 2.3% to 5.4%. We estimate precision diagnostics revenues of approximately $161 million to $165 million, anatomic pathology of approximately $146 million to $150 million, and biopharma services to be approximately $23 million to $25 million. On margins, we expect full-year non-GAAP gross margins to be in the mid-30% range, reflecting product mix shifts tied to our change in customer composition and lower collection rates associated with the transition to our new revenue cycle management and billing system.

We expect non-GAAP operating margins to be in the low negative 20% range for the year, an improvement from our prior expectation of the mid negative 20% range. We continue to prioritize our investments across two key areas: R&D, where we are advancing both our laboratory testing capabilities and clinical study pipeline, and the integration of Bako Diagnostics and StrataDx, where we are aligning our expanded sales organization, cross-selling our broad testing menu, and consolidating operations to drive productivity and operating efficiency.

Our billing system transition is still underway, and we saw encouraging improvements in the third quarter that we expect will support more consistent collections. Along with targeted upgrades to our laboratory infrastructure, these investments are designed to strengthen our competitive position and enhance throughput capacity. We believe our technology platform is highly scalable and positions us to drive operating leverage and margin expansion as volumes grow.

Our clinical programs continue to progress and we updated the timing of related spending accordingly. We now expect approximately $21 million in therapeutic development investment in 2026 as we continue advancing trials for FID-022 and FID-07. We now expect the full-year 2026 non-GAAP loss of $1.65 to $1.75 per share, an improvement from our prior guidance of a loss of $2.22 to $2.35 per share. This reflects discipline across the business, which has lowered our operating expenses. This excludes stock-based compensation, impairment loss, acquisition-related costs, amortization of intangible assets, as well as other charges or gains that we believe are not representative of our operations.

Our per share guidance reflects the 4.1 million shares repurchased year-to-date and assumes no further repurchases. Finally, our cash position remains strong. During the third quarter, we received approximately $112.3 million in federal tax refunds and related interest that were delayed due to constrained resources at the IRS. For fiscal year 2026, assuming capital purchases of $13 million, spend on our therapeutic development of $21 million, and excluding any future stock repurchases or other expenditures outside the ordinary course, which could include additional M&A, we are anticipating ending the year with approximately $630 million of cash, cash equivalents, restricted cash, and investments in marketable securities.

The increase from our prior forecast of $610 million is attributed to the improved operating outlook and lower therapeutic development spend. We are pleased with our results for the quarter and are encouraged by the operational progress we made executing against our strategic initiatives to drive AI and digital solutions across our laboratory services business, and are proud of the momentum on our pharmaceutical pipeline. We believe we are well positioned for longer-term growth and strategic investments, innovations, and expanded offerings that deliver value. Thank you for joining our call today. Operator, you may now open it up for questions.

Operator

[Operator Instructions]

Your first question comes from David Westenberg from Piper Sandler. Please go ahead.

分析师问答

Karan Patel

Hey guys, this is Karan Patel on for David Westenberg. Congrats on the sequential improvement here. To start off, I had a couple of questions on the billing transition. It sounds like there's still some work to be done, but we have seen improvement. I guess can you maybe quantify what inning we may be in there and what kind of insight we have into when that may be done and fully transitioned? And also, can you parse out maybe collection rates today versus historical levels and the step-up in revenue? Is any of that from catch-up claims from prior periods, or is it...

Ming Hsieh

Thank you. Yes, for all the different questions. Go ahead, Paul.

Paul Kim

I'll let Brandon tee it up and then I'll put some numbers around it.

Brandon Perthuis

Yes, thanks, Paul, and thanks, Karan, for the question. Interesting analogy to ask and kind of what inning it's in using the baseball analogy, and perhaps a little bit hard to say, but I think we're pretty deep into the game. I think as I addressed in the last quarter, we had challenges related to implementation of customizations that were needed in the new RCM system to maximize [ the collections ]. Since we've noticed that, we've made progress implementing a number of these required customizations, and we're seeing the impact of those customizations on our improved collection rate. That was reflected in the third quarter performance. We still have some fine-tuning to do, but we are pretty encouraged with the progress so far.

Paul Kim

Hi, Karan. This is Paul Kim. Yes, the uptick in the gross margins, aside from the higher revenues for Q3, we were pleased to see that. Actually, the uptick in the gross margins, that happened quicker than we thought. And as Brandon indicated, we're not done yet. We've gotten started this quarter, but we did make it a priority for the company to optimize the collection rates as much as possible. So we believe with additional work that we have in terms of policies and focus that there's room for gross margins to continue to grind higher. The other thing that I would like to point out is, given the fact that it's the end of Q3, when we take a look at our overall forecast, the cash forecast for the year, it's actually coming in a lot more favorable than we thought.

So we raised our cash forecast from $610 million to $630 million and the narrowing of the EPS as well. If you take a look at the operating expenses, the operating expenses, particularly for like the G&A, you'll see that is lower than our historical run rate. And that's because even on the operating expense side, we have not stored up a lot of bad debt that we had. We continue to go after some of the old balances and we had favorable collections even on the bad debt side. The last thing that I will comment on is the revenue range. The revenue range, we left it the same as we had it last quarter between $330 million and $340 million. But we anticipate that Q4 should be a nice quarter for the company as well.

And just leaving the range from $330 million to $340 million gives us ample room for us to reach a target that we'll be satisfied with.

Karan Patel

Very helpful, thank you. And I guess maybe to ask one more here on the range, I think the guide held implies 4Q between the range of what, $82 million to $92 million? Maybe could you help us parse out what it takes to the upside and downside there? And separately, this does imply sequential deceleration, if I'm not mistaken. Could you speak to that if it's in terms of timing of some orders or seasonality, et cetera?

Paul Kim

Thank you. Yes. So I will tee it up in terms of the numbers. We'll go in reverse order and then I'll turn it over to Brandon. If you take a look at our forecast for Q4, if you look at the midpoint of the $330 million to $340 million, if we came at the midpoint of that, which is $335 million, it says that Q4, if you back into that number, is about flat in terms of our revenues compared to Q3. But we're not shooting for that, right? We're shooting for a number that's higher than that.

So if you take a look at the upper end of the range of $330 million to $340 million, that leaves us room to have a sequential increase from Q3 to Q4. And we always reserve the right to come in even higher than that. But I'll turn it over to Brandon who can talk about the dynamics of what he sees in terms of customer orders and flow in November and December to give you additional comfort that we're doing everything possible to expand our footprint. We're doing everything possible to continue to increase our revenues, and then all in the meanwhile, improving our gross margins and our overall spend.

Go ahead, Brandon.

Brandon Perthuis

Yes, well, Paul, I think you covered it really well. In addition to what Paul said, we still do have some fine-tuning to do on this RCM system, our Revenue Cycle Management system. Again, we're really proud of the progress that we've made so far, but still additional work to do there, so taking the prudent approach to the range as we work to get this system where we want it. In terms of seasonality, I think at this point, with our diversified business across pathology, rare disease, women's health, and our biopharma services, we see some seasonality, but we're coming in a little bit more shielded from it. So as Paul mentioned, we're going to shoot for a good Q4. I think we have the opportunities we need, hopefully, to be at the higher end of that range. But like I said, still some work to do in certain areas, but feeling pretty good about where we are from a business perspective.

Karan Patel

That's very helpful, thank you. And maybe one last one for me. I guess on Bako and AI, that was very good detail, but as we kind of think about the modules that are already implemented, the ones that are planned for 4Q in future months, and AI efforts, can you maybe speak to how this is shown up in the P&L or any sort of KPI in terms of productivity or margin, turnaround time, et cetera, and in respect to Bako integration, how that's going?

Ming Hsieh

Yes, that'd be great. Thank you. Yes, thank you for the questions. I think with the AI, it definitely helps us increase the efficiency, but more importantly would be quality. We have a second level of quality assurance assisting our pathologists getting the data with more speed and fewer errors. So I think we will see the productivity improvement as well as the future gross margin improvements.

Karan Patel

Thanks, guys. That'll be it for me.

Ming Hsieh

Operator, [ 4-9-7. ] If there are no more questions, we can conclude the call.

Paul Kim

We appreciate everyone for joining our conference call. We look forward to updating you on our next quarter results. And when we report next quarter results, we also look forward to giving out our guidance for 2027. Thank you very much.

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