FLGT - NASDAQ

Greetings, and welcome to the Fulgent Genetics Q3 2025 Conference Call and Webcast. [Operator Instructions] As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Lauren Sloane, Investor Relations. Please go ahead, Lauren.

Good morning, and welcome to Fulgent's Third Quarter 2025 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 events and should listen to management's remarks today with the understanding that actual events, including the company's actual future results, may be materially different than what is described in or implied by these forward-looking statements. Please review the more detailed discussion relating 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, 2024, and subsequently filed reports, which are available on the company's Investor Relations website. Management's prepared remarks, including discussion of profit, loss, margin, earnings and earnings per share, 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 to investors for various reasons, but these measures should not be viewed as a substitute for or superior to the company's financial results prepared in accordance with GAAP. Please see the company's press release discussing its financial results for the third quarter 2025 for more information, including the description of how the company calculates non-GAAP income loss, non-GAAP earnings loss per share, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating profit and loss and margin and adjusted EBITDA and the reconciliation of these financial measures to income and loss, earnings loss per share and operating margin, the most directly comparable GAAP financial measures. With that, I'd now like to turn it over to Ming. Please go ahead.

Thank you, Lauren. Good morning, and thank you for joining our call today. I will start with some comments on the third quarter of 2025 and our 2 business lines. Then Brandon will review our product and go-to-market updates for our laboratory services business. And Paul will conclude with the financials and guidance before we take your questions. We are pleased with our third quarter results and sustained momentum in the business, as we move through the year. Our results are testament to the progress we have made on our strategic objectives in both our laboratory services and therapeutic development business. We have shown both sequential and year-over-year growth and efficiency in laboratory services with our investment in AI and digital pathology solutions, while making strong pipeline progress on our clinical candidates as a result of momentum in our business. We are raising our outlook for the remainder of 2025. Our therapeutic development pipeline is on track and progressing well. Our first clinical candidate, FID-007, is progressing through a Phase II clinical trial in combination with Cetuximab in patients with recurrent or metastatic head and neck squamous cell carcinoma with 39 patients that have been randomized and 36 have received at least 1 dose of study treatment as of cutoff date of September 25, 2025. The preliminary data was presented at the ESMO Congress on October 20, 2025. FID-007 combined with Cetuximab demonstrated meaningful anticancer efficacy at both dose level for the first-line and second-line treatment of R/M HNSCC of 35 patients then evaluable for the efficacy at the time this preliminary data was reviewed. The objective response rate, or ORR for the 75 milligram per square meter arm and 125 milligram per square meter arm, were 44% and 59%, respectively, and 51% overall when both arms are combined. The median progression survival for the 75-milligram arm and 125-milligram arm were 9.2 months and 7.8 months, respectively. The overall PFS was 7.8 months compared to the historical 2.3 months of the standard of care therapies. FID-007 also exhibit manageable safety and tolerability profile, particularly no Grade 3 and above peripheral neuropathy has been reported to date. As of today, we have a total of 43 patients enrolled and expect to complete patient enrollment by end of 2025 with a full data readout in 2026. Our second candidate, FID-022, began a Phase I trial, and the first dose level has been successfully completed, while the second dose level will commence this month. FID-022 is a nanoencapsulated SN-38 for the treatment of solid tumors, including potentially colon, pancreatic, ovarian and bile duct cancers. I'm encouraged by the continued progress of our clinical pipelines and the potential for both FID-007 and FID-022. These drug candidates address heavily pretreated patients with very few options left. And I hope we were able to provide alternatives to better their lives. Overall, I'm pleased with the progress we have made this year in both our business areas. Our pharma R&D efforts are progressing faster, better and more cost effective than planned. Additionally, our laboratory services is greatly benefited from our investment in AI technology, which makes our services more efficient and more precise as Brandon will discuss shortly. I would like to thank our employees, partners and stakeholders for your hard work and your loyalty in the great quarter of our business. We look forward to further progress in the remainder of 2025. I will now turn over the call over to Brandon Perthuis, our Chief Commercial Officer, to talk more about our laboratory services business. Brandon?

Thanks, Ming. It was again another excellent quarter, delivering nearly $84 million in laboratory services revenue. Breaking down our results by business area, Precision Diagnostics was up $3.4 million or 7.3% sequentially and was up $7.2 million or 16.4% year-over-year. Biopharma was up $1 million or 15.4% sequentially and was up $3.3 million or 83.4% year-over-year. Anatomic Pathology was down $2.1 million or 7.6% sequentially due to timing of collections, however, was up $1.8 million or 7.2% year-over-year. In the last quarter, we introduced an enhanced version of our whole genome sequencing that incorporates RNA analysis to improve diagnostic yield. This new offering has sparked strong interest from both existing and prospective clients. Building on that momentum, we're pleased to announce the launch of our ultrarapid whole genome sequencing service. This solution provides a preliminary report within 48 hours, followed by a comprehensive report within 5 days. The primary focus for this service is the neonatal intensive care unit, or the NICU, where studies have shown that whole genome sequencing can significantly improve patient outcomes and support more efficient health care delivery. The data suggests that implementing rapid genome sequencing as a first-line test in the NICU will change medical management for up to 87% of babies and reduce health care costs up to $15,000 per child. Our second exciting announcement centers around expansion of our Beacon carrier screening service. We've consistently pushed the boundaries to remain at the forefront of genetic screening, having been the first U.S. laboratory to offer a panel with over 700 genes, still the largest of its kind to the best of our knowledge. Now we're taking another major step forward with the launch of Beacon K, which expands our panel to 1,000 genes. This enhancement will further strengthen our ability to detect rare genetic conditions. Beacon has earned a strong reputation as a leading carrier screening solution. Powered by our proprietary platform and advanced informatics, Beacon consistently delivers high analytical detection rates, accurate differentiation of pseudogenes and reliable copy number variant calls. Additionally, our turnaround time remains exceptional, averaging just 8.8 days, roughly twice as fast as many other laboratories. We have mentioned on previous calls the significant investment we have made in digital pathology. This has allowed us to digitize our slides instead of the traditional method of microscopy. There are several advantages to digital pathology, but perhaps the most powerful one is our ability to utilize and develop AI to help make our pathologists faster and better. Until very recently, we were using a third-party image management system, or IMS, but it had limitations. However, we're excited to announce we have developed and launched our own proprietary IMS, which we are calling [ E

Thank you, Brandon. Revenue in the third quarter of 2025 totaled $84.1 million compared to $81.8 million in the second quarter of 2025. Since revenue from COVID-19 testing is expected to continue to be negligible in 2025, we will no longer provide separate metrics on what we have previously referred to as core revenue, which we defined as total revenue, excluding COVID-19 testing. Separately, we have begun to see minimal revenue in our therapeutic development business from our acquisition of AMP in July, primarily related to IP licensing royalties. Gross margin on a non-GAAP basis was 44.3% and on a GAAP basis was 42.2%. Gross margins have improved year-over-year due to streamlined operations and enhanced efficiency as a result of our investments in scaling and centralizing lab operations. Now turning to operating expenses. Non-GAAP operating expenses totaled $40.7 million compared to $43.9 million in the previous quarter. Total GAAP operating expenses were $50.9 million for the third quarter, which decreased when compared to $54.1 million in the prior quarter. The decrease in operating expenses was partially driven by a reduction in advertising and marketing expenses and a favorable reduction in bad debt expense, reflecting improved collections from Precision Diagnostics. We remain committed to R&D spending to support both our laboratory testing services and our clinical studies and the sales and marketing spending to expand the sales team. Non-GAAP operating margin improved sequentially to minus 4.2%. Our GAAP loss in the current quarter was $6.6 million, an improvement from the prior quarter's GAAP loss of $19 million, which included a onetime noncash charge related to a $9.9 million impairment of a prior investment. Adjusted EBITDA for the third quarter was approximately $0.7 million compared to a loss of $3 million in Q2 2025. On a non-GAAP basis and excluding equity-based compensation expense, intangible asset amortization and acquisition-related costs, income for the quarter was approximately $4.5 million or $0.14 per share based on 31.3 million weighted average diluted shares outstanding. In the third quarter, we did not repurchase any shares under our stock repurchase program. Since the inception of the stock repurchase program in March 2022, a total of approximately $110.4 million has been spent with approximately $139.6 million remaining available for future repurchase of our common stock. Turning to the balance sheet. We ended the third quarter with approximately $787.7 million in cash, cash equivalents, restricted cash and marketable securities. The increase in cash from the previous quarter is driven by strong operating cash flows, partially offset by capital expenditures. There were no stock or income tax credits purchased during the third quarter. However, in October, we used $67.9 million for the purchase of income tax credits. As I mentioned earlier, given the minimal impact of COVID-19 testing revenue on our overall performance, we have transitioned to guiding total revenue. Reflecting on our current business momentum, we are revising our full year 2025 revenue outlook upward to $325 million for 2025, representing a growth of 15% year-over-year. We continue to expect non-GAAP gross margins for the full year to exceed 40%, continuing the strong momentum we've experienced in recent quarters. We expect non-GAAP operating margins to improve from minus 15% to minus 10% for the year, driven largely by increased revenue. Our strategy for success centers on the continuing to scale efficiently and driving innovation across our service offerings. We will continue to invest in business expansion, further advancing our laboratory operations and upgrading existing laboratory facilities, while remaining focused on managing our spending. We believe that our foundational technology platform supports a strong long-term margin profile. Using an average share count of 31 million, we expect an improvement to our full year 2025 non-GAAP EPS guidance from a loss of $0.35 per share to a positive $0.30 per share, excluding stock-based compensation, impairment loss, acquisition-related costs and amortization of intangible assets as well as any onetime charges. Reflecting the improvement in our operations, which is offset by the effect of the onetime noncash impairment adjustment, we are now revising our GAAP EPS guidance from a loss of $1.70 per share from $2.10 per share, excluding any future onetime charges using a 31 million average share count. Finally, our cash position remains strong. We focus on efficient capital allocation that allows us to reinvest in our business, fund key initiatives and support future growth. Excluding any future stock repurchases or other expenditures outside the ordinary course, which include M&A, we anticipate ending 2025 with approximately $800 million of cash, cash equivalents, restricted cash and investments in marketable securities. This number further assumes receipt of approximately $106 million in tax refunds prior to the end of 2025, which may be delayed as a result of the current government shutdown. Overall, we see strength in our core business, which has grown organically, and we see good momentum for the balance of 2025. Thank you for joining our call today. Operator, you may now open it up for questions.

[Operator Instructions] Our first question is coming from Lu Li from UBS.

First one on the margin. I appreciate the new disclosure on the margin by segment. It seems like the lab is turning positive margin in the quarter. I wonder, Paul, like how do you think about the going forward path in terms of like what will be the ultimate operating margin target that you're looking for?

Thank you for the question, Lu. We were really pleased with what we saw in the gross margins for this quarter. As you remember, we had high margins in Q3, but Q3, we had an impact, a favorable impact to the margins of about $1.6 million, $1.7 million that was due to our capitalization policy. But in this quarter, in the third quarter, even without that, our margins, they came in just as high at 44.3%, actually a little bit higher than what we achieved in Q2. And that's due to the overall efficiencies of the organization, continued automation that we have for the business and streamlining our policies. I'll turn it over to Ming, who can talk about what we see directionally for margins in our business without giving out specific numbers because there are particular technologies that we are beginning to utilize, which might enhance our margins going forward.

Yes. Thanks, Paul. And Lu, as you probably hear from Brandon, we started to develop the AI technology in-house, building our capability for the -- through our digitalization of the entire -- almost the entire pathology services. So we will continue to see the improvement in that area. In addition, we will be building a pretty rich database for us to be continue to benefit for us to get into the further margin and reimbursement improvement in that territory. Anything -- Brandon, you want to add?

No, I think it's well said, Ming and Paul. Thank you.

Second question on the AP. Brandon, I think you mentioned there are some timing issues in the quarter. I'm wondering if you can give a little bit more color and whether that will be a catch-up in Q4? And then I have a follow-up.

Yes, certainly, thanks for the question. Yes, it was a timing issue. It was mostly related to the collections in the quarter, which did reduce the amount of revenue we could recognize. But already in this quarter, we're beginning to see an improvement in the collections, and we think that that's going to continue to improve in the next couple of quarters. So no material weakness in the business, just a timing issue around collections.

Okay. And then on the Precision Diagnostics, you mentioned several new products, the rapid whole genome and then you talk about the expanding of the Beacon panel. I wonder how this like a new menu expansion kind of support the growth going forward. You seems like pretty confident in terms of like growing double digit forward. I wonder how should we think about the 2026?

Well, we are really excited about launching both of those products. I think our R&D investment there was quite efficient. Our timing was quite efficient. We last quarter launched a new improved whole genome sequencing test that included RNA, which is a significant diagnostic yield increase. That's generally sold into pediatrics, development of pediatrician, geneticist. But if you want to help families in the NICU, which require rapid results, we needed a faster product. So the follow-on to our last quarter update is this new rapid -- ultrarapid whole genome sequencing test. So this is more or less the first time for us to launch a product directly targeted at the NICU. We believe our turnaround time, some of the features around the genome in terms of its variant calling ability, puts us in a strong position to penetrate that market. As we mentioned on the call, I mean, this is becoming a standard of care in the NICU for many patients. It's a favorable margin profile in terms of billing institutionally for the test. So we'll see how much it contributes to 2026. But at the end of the day, it's going to be a powerful product for clinicians to use in the NICU, and I'm excited the team was able to launch it so quickly. And it does dovetail right into what we've been talking about expanding our sales team. We have invested significantly in expanding the pediatric sales team. So this puts one more powerful tool in their bag to sell when they're visiting children's hospitals and academic medical centers. And regarding Beacon, we continue to push the envelope there. We believe, especially in the reproductive setting, there is a need to test for more. There's a desire to test for more conditions. I mean these conditions become rarer as we add more, but collectively, they're not rare. So we're going from 700 genes, which we've been offering now for about a year, to 1,000 genes, which should make us, as far as we know, the largest panel on the market. Our Beacon portfolio has performed incredibly well. I mentioned our turnaround time of 8.8, 9 days. That's exceptional. I mean we're dealing with patients where turnaround time is critically important, whether they're going through fertility treatments, whether they're already pregnant, there's a lot of anxiety there. So to be able to give results that quickly does give us a significant advantage in the marketplace.

The next question is coming from David Westenberg from Piper Sandler.

Actually, I'm going to continue with some of those questions. So Brandon, with the KNOVA product, are you finding that physicians prefer to order kind of the bundle of tests versus just a single NIPT test or carrier microdeletions all in one? Is that favoring you? And can you give us a reminder on how those are reimbursed again if they're reimbursed kind of in a bundle, if they're reimbursed separately?

Yes. Thanks for the question, David. I mean, certainly, in the OB/GYN and MFM market, NIPT and carrier screening is often ordered bundled together, not always, but very frequently. So I think we've established a really good brand for Beacon, our carrier screening product in the marketplace. I think we've become sort of the go-to laboratory for carrier screening, our turnaround time, our quality, the number of genes, the customization. We've really fired on all cylinders as it relates to carrier screening. And then not too long ago, we decided to launch KNOVA, a novel NIPT test. And the strategy there is to sell those together. But they are 2 independent tests, right? Testing for completely different things. You asked, is it bundled billing? No. I mean it's a separate orderable test. So we get an order for KNOVA, we bill for KNOVA. We get an order for Beacon, we bill for Beacon, not bundled together from a billing perspective, but clinically, they're very often ordered together.

Perfect. And then just continued reimbursement updates. I mean, I think that ACOG update on expanded carrier screening is taking a lot longer than I think the industry expected. If there's any update there or if insurance companies are just kind of seeing the value of expanded carrier screening already and maybe proactively reimbursing ahead of that. And same question for kind of microdeletions, which is another one where we kind of thought the George syndrome is already going to be covered by now.

Yes. Good question. I mean, look, not everything hinges on that ACOG statement. There's a lot of other efforts going on behind the scenes. Actually, a lot of the companies are all working together, actually, the part of a coalition, to expand access to some of these tests. So certainly, the ACOG -- a new ACOG guideline would be beneficial to the industry. But we are seeing payers get ahead of that. And I think some of these other grassroot efforts that are happening, working directly with the payers to show them the value proposition, to show how it impacts clinical care. Some of these payers are getting ahead of that guideline. I think the guideline will just push it one step further. So we're continuing to see increased reimbursement for many of our tests, not just reproductive health. And again, I think it's really a result of working directly with the payers and showing them that clinical proposition. And hopefully, before too terribly long, we might get some positive news from ACOG to take it to the next level.

Got it. And then my next -- my last question is a combination for Ming Hsieh and Paul. It looks like you had some good data on FID-107 in Phase II. Are you going to have additional updates in Phase II before moving on to Phase III? What are the key milestones to look out for? And then, Paul, if you can maybe explain the additional expenses that would come for moving from Phase II to Phase III, what kind of increases in expenses you would expect?

All right. Thank you, David, for the questions. We expect to finish the enrollment by end of 2025. By the ASCO, which is in May of 2026, we would expect to do an oral presentation for the data we have, which we feel is very exciting. By that time, for all the patients enrolled in the database will be at least had 1 or 2 scans already. So that will further enhance the data we presented at ESMO in September this year. So this will give us a strong confidence to move the FID-007 into the Phase III clinical trial because we see a significant progression-free comparison with the standard of care. So in terms of what is the Phase III cost in terms of the moving forward, I think it depends on the final -- the statistician come out number and our Phase III design, we are in the process now. We estimate it's around 300 patients to be enrolled. So from that point of view, the clinical cost of Phase III is roughly around $60 million.

And then just to give you a full picture on the spending. So for 2025, we anticipated the cash spend for the therapeutics development would be about $25 million for the balance of the year. We believe that, that spending is going to be a little bit less than that for this year. I think the great news for the company, whether it be the therapeutics development or the laboratory services is the amount of science and the progress that we have seen so far for the therapeutic development. With spending a little bit less than what we have anticipated is something that makes us really pleased because it goes back to the efficiency of our spending. And then if you take a look at the laboratory services business, we've raised our guidance twice this year. All in the meanwhile, the cash forecast and our cash target, as you probably saw in the press release, has been raised to $800 million. So efficiency in running the operations, managing our cash and getting output for our business, whether it be increased revenues for the laboratory services or the science and the data that we're seeing the therapeutics development, we're very pleased with.

Yes. Dave, for the ESMO data, we published in September -- October this year, which the data cutoff on this in September is available online. You should see it's a pretty impressive data in terms of how -- about the efficacy of FID-007. So we are very pleased and very much encouraged. There is similar -- the transactions in the area. The market is a big, multibillion dollars market is addressable by our products. So we are very encouraged, and we believe that our investment will have a great return. In addition, this is not one drug. This is a platform performance. We have been using the same delivery platform. We had the second drug, FID-022. And that one in the Phase I for the dosing escalation exercise, it is going well, and we are also very much looking forward to provide the additional data by mid next year.

Next question today is coming from Andrew Cooper from Raymond James.

Maybe just first, I want to dive in on the Anatomic Pathology collections dynamic. We're not necessarily seeing that in the receivables. So just if you could unpack a little bit more sort of what's going on there and what gives you the confidence that it is just collections timing, if there's any volume stats or anything like that, that you could share to help us get a little bit better understanding, that would be great.

Andrew, it's Brandon. Thanks for the question. No, it really was a timing issue. So I mean, at a high level, we made a change in our billing software. It takes a little bit of time to implement the new software. Software has been implemented. Things are going well. We're seeing collections begin to improve. So it was just around changing a billing software.

And then in terms of the receivables, as you're very familiar with, Precision Diagnostics is the biggest part of our business, and we had very strong collections during the quarter for that area of the business.

Okay. Great. That's helpful. And is there any -- just so we're kind of prepared for it if it does come again, are the software changes in place kind of across Precision Diagnostics as well? Is there any kind of potential disruption in any other segment as we move forward, knowing that it may just be timing, but at least to keep us on the lookout?

Mostly related to AP.

Okay. That is helpful. And then Pharma Services had a nice quarter. I just want to kind of dive in a little bit there on the strength. Was it -- knowing this can be big and lumpy, is this a single program and a timing dynamic that is better in the quarter? And obviously, had you raised the guide for the year? Or is this a little bit more kind of broad-based finding some traction? Just would love some understanding of what's letting you succeed there and sort of where the success is coming from.

Yes. Thanks for the question. Look, I think it's mostly related to our capabilities expansion. I think we've mentioned before that pharma services at one point was pretty much just NGS. And that limited our market size there. There was a lot of RFPs that were being presented to us, that required additional technology that we didn't offer at the time. So we had a smaller addressable market when we were just an NGS shop. But since then, we've launched a lot of new tests in our Biopharma Services division, and that's allowed us to expand that addressable market and just blocking and tackling, allowing us to respond to more RFPs. So the business is -- it's still a bit lumpy. I mean this is just the nature of these wins. But the pipeline looks good. Again, our capabilities are strong. I think the feedback we're getting from our biopharma partners is incredibly strong. They do value the test that we're providing and the service we're providing. So it's an area we're going to continue to invest in. And we'll continue to see some lumpiness. But overall, we're quite pleased with the capabilities and the progress of that business.

Okay. Helpful. And then another good quarter, Precision Diagnostics. You were up $3.5 million or so sequentially, I think, like $7 million year-over-year. Can you just ring-fence for us kind of the growth contributions you're getting there? How much of that is Beacon versus KNOVA versus other parts of the portfolio to help at least kind of rank order or give some flavor for the traction there?

Yes. I mean Beacon continues to be a really important test for the company, and it's continued to grow. We're winning new customers. We're moving into new markets. So really pleased with the progress of Beacon. And hopefully, launching Beacon K takes it to the next level and certainly keeping our turnaround times where they are has just been hugely important for the company. KNOVA is not yet a meaningful contributor to revenue. We're still trying to break into that OB/GYN marketplace. A lot of the Beacon business historically has been from the fertility side of things, REIs and fertility clinics. So Beacon continues to be quite important. We are seeing great momentum in our exomes and genomes as well. Our oncology business is doing well, especially on the heme side. So I think overall, I mean, you look at all the different sort of divisions of the company, they're all doing well, all firing on all cylinders, and we see great momentum.