Fulgent Genetics Q2 2024 Earnings Report

Fulgent Genetics EPS Results

• Actual EPS: $0.15
• Consensus EPS: -$0.30
• Beat/Miss: Beat by +$0.45
• One Year Ago EPS: -$0.33

Fulgent Genetics Revenue Results

• Actual Revenue: $71.03 million
• Expected Revenue: $69.07 million
• Beat/Miss: Beat by +$1.96 million
• YoY Revenue Growth: +4.70%

Fulgent Genetics Announcement Details

• Quarter: Q2 2024
• Date: 8/2/2024
• Time: Before Market Opens
• Conference Call Date: Friday, August 2, 2024
• Conference Call Time: 8:30AM ET

Fulgent Genetics (NASDAQ:FLGT) (NASDAQ: FLGT) is a California-based company specializing in high-complexity genetic testing and diagnostic services. Operating from its headquarters in Temple City, Fulgent leverages next-generation sequencing (NGS) technologies and advanced bioinformatics to deliver a broad range of clinical and research assays. The company’s infrastructure includes CAP- and CLIA-certified laboratories, enabling it to process large volumes of samples with rapid turnaround times.

Fulgent’s product portfolio encompasses hereditary cancer panels, rare disease and neuromuscular disorder testing, pharmacogenomic screenings, non-invasive prenatal tests, and infectious disease assays including COVID-19 diagnostics. The company offers both clinician-ordered and direct-to-consumer testing models, as well as custom research services for biopharmaceutical partners and academic institutions. Through proprietary automation and AI-driven analytical pipelines, Fulgent aims to maintain cost-effective operations and high data quality for clients across the United States and select international markets.

Founded in 2011 by Ming Hsieh, Fulgent Genetics completed its initial public offering in 2019, expanding its capacity and geographic reach. Under the leadership of founder and chairman Ming Hsieh and an experienced management team, the company continues to invest in laboratory automation, informatics enhancements and strategic partnerships. Fulgent remains committed to regulatory compliance, quality assurance and ongoing innovation in molecular diagnostics to support personalized medicine and population health initiatives.

Fulgent Genetics Q2 2024 Earnings Call Transcript

Key Takeaways

• In Q2 2024 Fulgent Genetics posted core revenue of $70.2 M and narrowed its adjusted EBITDA loss to $0.7 M, while achieving a 40% non-GAAP gross margin and reiterating full-year core revenue guidance of $280 M.
• The company consolidated its newly acquired labs into a 96,000 sq ft Coppell, Texas facility, boosting capacity up to threefold to support future growth.
• Phase 1 data for FID-007 in head and neck cancer showed a 45% overall response rate and 27% stable disease rate with no high-grade neuropathy, prompting initiation of a Phase 2 trial slated to enroll ~40 patients by early 2026.
• Fulgent launched the Nova NIPT test—the first to screen for aneuploidies, microdeletions and de novo point mutations—with low initial volume expected as clinician education for broader uptake proceeds through 2025.
• Fulgent believes the FDA’s new LDT regulation could serve as a competitive moat—given its 20,000+ existing tests and New York approvals—although pending litigation introduces regulatory uncertainty.

Presentation

[Operator]

Hello, and welcome to the Fulgent Genetics Q2 2024 conference call and webcast. If anyone should require operator assistance, please press star zero on your telephone keypad. A question-and-answer session will follow the formal presentation. You may press star one at any time to be placed in the question queue. As a reminder, this conference is being recorded. It's now my pleasure to turn the conference over to Melanie Solomon, Investor Relations. Please go ahead, Melanie.

[Melanie Solomon, Head of Investor Relations at Fulgent Genetics]

Thank you, Kevin. Good morning, and welcome to the Fulgent Q2 2024 Financial Results Conference Call. On the call today 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, www.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 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.

[Melanie Solomon, Head of Investor Relations at Fulgent Genetics]

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 rely on any forward-looking statements as predictions of future 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 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 31st, 2023, and subsequently filed reports which are available on the company's Investor Relations website.

[Melanie Solomon, Head of Investor Relations at Fulgent Genetics]

Management's prepared remarks, including discussions of 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 prepared 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 second quarter of 2024 for more information, including the description of how the company calculates non-GAAP income or loss, earnings or loss per share, non-GAAP gross profit, non-GAAP gross margin, non-GAAP operating profit or loss, and margin and adjusted EBITDA, and a reconciliation of these financial measures to income or loss, earnings or loss per share, and operating margin, the most directly comparable GAAP financial measures.

[Melanie Solomon, Head of Investor Relations at Fulgent Genetics]

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

[Ming Hsieh, CEO at Fulgent Genetics]

Thank you, Melanie. Good morning, and thank you for joining our call today. I will start with some comments on the second quarter and our two business lines. Then Brandon will review our product and go-to-market updates for our laboratory service business in the second quarter. And Paul will conclude with the financial and the outlook before we take your questions. We are pleased with our results in the second quarter. With $71 million of total revenue, we recognize the $841,000 of revenue on previously billed COVID-19 tests. Excluding COVID-19 revenue, second quarter core revenue of $70.2 million was driven by momentum in precision diagnosis, particularly reproductive health and oncology. We were pleased with the growth in all three areas of our laboratory service business this quarter, and we've seen good momentum ahead as we continue to invest in reproductive health testing and see the benefit of those investments.

[Ming Hsieh, CEO at Fulgent Genetics]

We have reached a very important milestone in consolidating the labs acquired as a part of the Inform Diagnostics transaction. With our new 96,000 sq ft lab facility in Coppell, Texas, we believe we have an opportunity to triple capacity, fueling the potential future growth and expansion. Brandon will talk more about this. In our therapeutic development business, we presented phase 1 clinical data using our lead therapeutic development candidate, FID-007, to treat head and neck cancer at the American Society of Clinical Oncology, or ASCO, annual meeting in June 2024. Of 11 head and neck squamous cell carcinoma, or HNSCC, available patients with a weekly dose level from 50 milligrams per square meter to 160 milligrams per square meter, 5% or 45% had a partial response, and 7% or 27% had a stable disease by RECIST.

[Ming Hsieh, CEO at Fulgent Genetics]

Three out of five HNSCC patients with a partial response had previously been treated with Taxol. The median duration of follow-up range is four months. No high-grade neuropathy has been noted. FID-007 demonstrated preliminary evidence of anti-tumor activity in heavily pretreated HNSCC patients across different primary tumor sites, with an overall response rate of 45%. As a result, we initiated a phase 2 clinical trial of FID-007 in combination with cetuximab in patients with HNSCC in January 2024, and enrollment began in the second quarter. So far, we have enrolled and dosed the first three patients in this trial. We expect to enroll approximately 40 patients in various sites. With the enrollment, we expect to be complete in early 2026. We currently estimate the total patient clinical trial cost for the phase 2 to be around $10 million.

[Ming Hsieh, CEO at Fulgent Genetics]

We continue to advance our second drug candidate, FID-022, a nano-encapsulated SN-38, in preclinical studies toward an investigational new drug application by the end of this year. While FID-022 has shown superior efficacy of irinotecan in various xenograft models including colon, bile duct, ovarian, and pancreatic cancers in our preclinical studies, no significant unexpected toxicity was observed in both rat and monkey GLP toxicity studies. In addition, we also made a significant advancement in the development of antibody-drug conjugate using our novel patent linker and payload platform technology. Our ADC has shown better efficacy overall over different tumors with a broad range of target antigen expression levels than some of the best ADC benchmarked on the market in the preclinical studies. In meanwhile, ADC with a novel target using our novel platform technology are also being prepared with the goal of generating leading candidates for clinical trials.

[Ming Hsieh, CEO at Fulgent Genetics]

As a reminder, all our drug candidates were formulated with our novel nano-encapsulation technology, which includes over 30 issued active patents and active patent applications and a targeted therapy platform designed to improve therapeutic windows and pharmacokinetics profile for both new and existing cancer drugs. Overall, we believe we have a good strategy with both our core laboratory service business and our therapeutic development business. We've seen momentum in our core business, which we believe will continue to grow, strengthening our business model and fuel our therapeutic initiative. We continue to maintain a strong balance sheet to execute our strategy. I would like to thank our employees, partners, and stakeholders for your hard work and loyalty in a very good second quarter for our business. We look forward to continued growth in the second half of 2024.

[Ming Hsieh, CEO at Fulgent Genetics]

I will now turn the call over to Brandon Perthuis, our Chief Commercial Officer, to talk more about our laboratory service business results during the second quarter. Brandon?

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Thanks, Ming. As a reminder, our laboratory service business includes precision diagnostics, anatomic pathology, and biopharma services. These three represent our core revenue streams and do not include COVID-19 testing. And we had another very strong quarter led by precision diagnostics, with all three areas showing strength. This is the first time we have seen all three areas post quarter-over-quarter growth since 2022. In the past few quarters, we have experienced some headwinds in anatomic pathology and biopharma services, but we are seeing the investments we made in those areas begin to pay off. I'll talk more about each of those momentarily. Circling back to precision diagnostics, it was up $5.7 million, or 15% quarter-over-quarter, and $11.2 million, or 35% year-over-year. The tremendous strength has been led by reproductive health testing, including Beacon expanded carrier screening. Beacon continues to be a bright spot for Fulgent.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

We have to have significant market share, establish strong B2B relationships, and continue to have a sales pipeline that gives us confidence in continued growth. The laboratory continues to perform exceptionally well, even with the record volume we are seeing. On average, our turnaround time has been 11 days, which is fantastic and a true testament to the power of our technology platform. To scale this rapidly and continue to provide rapid turnaround time is not trivial. We have also been able to give our clients the flexibility to custom-tailor the gene panel to their specifications. In addition, our strong engineering capabilities have allowed us to rapidly interface with client-side EMRs, allowing for orders and reports to be delivered electronically. Beacon will continue to be a focus for Fulgent, as we now find ourselves as one of the leading providers of expanded carrier screening services.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Staying on reproductive health, last quarter, we announced we have launched a non-invasive prenatal test, or NIPT, for the first time, a test we have branded NOVA. NOVA is the first NIPT to include common aneuploidies, microdeletions, and monogenic conditions caused by de novo point mutations. We continue to make good progress with our go-to-market strategy and anticipate seeing additional progress in the coming quarters. As we have mentioned, we expect volume to be low for some time as we bring this novel test to market. However, we believe over time, clinicians will see the value of this new NIPT methodology. I wanted to provide a quick update on our oncology portfolio. We recently gained MolDX approval for our liquid biopsy assay for high-stage solid tumors, complementing our previously approved solid tumor tissue and Heme NGS assays.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Our liquid biopsy offering is a comprehensive test, including over 500 genes, which detects tumor mutation burden, microsatellite instability, indels, and copy number alterations, in addition to single nucleotide variants. The coverage rate is approximately $2,840 and is retroactive back to September 2023. This is just one more piece of the puzzle, helping complete a near one-stop shop for oncologists. Over time, the focus will be to continue to build out the commercial team and capture market share, leaning on this one-stop shop offering and excellent quality, QNS rates, and turnaround time. Turning to anatomic pathology, we are pleased to see this area return to growth, albeit small. Anatomic pathology has seen multiple quarters of headwinds related to our integration of the acquisition of Inform Diagnostics and some macro factors, but we now see this area stabilized.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

And more importantly, the sales team is closing meaningful new accounts, and the pipeline is strong. This is a result of a revamped go-to-market strategy, an improved sales team, and continued laboratory performance as it relates to quality and turnaround time. Also, during the quarter, we relocated the operation to our newly purchased building in Coppell, Texas, and consolidated our New York laboratory. This was not trivial, yet executed very well. A special thanks to all the team members who worked so hard on this. We believe this investment will provide long-term advantages related to capacity, efficiency, and cost. Biopharma services also returned to growth in the second quarter. As we have mentioned in previous calls, we continue to expand our technical capabilities, allowing us to address a larger market. We have invested in additional sales headcount in this area and are building a robust sales funnel.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

This market continues to expand as biopharma leans more on multi-omic studies for their drug development, and we believe we are in a good position to continue to partner up on these studies. Nonetheless, this is an area we still expect results to vary from period to period due to the nature of the project and a lengthy sales cycle. There were some questions around the new FDA regulations on lab-developed tests at the time of our last call, and we have gained some clarification, although many questions remain. At a high level, we interpret the new regulations as a potentially positive catalyst for Fulgent. Many of our tests are New York State approved, and we have over 20,000 tests launched on our menu before the May 6, 2024, publication date, which is the operative date for the purposes of the currently marketed test enforcement discretion policy.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

As long as they're not modified, it appears these tests will likely only need to meet device regulatory requirements that become applicable at stage one, stage two, and stage three of the FDA's phase-out timeline, and we don't presently expect material disruptions to our service offerings. Stage one includes FDA medical device reporting, which will require laboratories to report certain device-related adverse events and product problems to FDA within a specific time frame. Stage one also requires labs to maintain compliant files for each test they offer and to report any corrections or removals to the agency. Stage two requires each laboratory to be registered with the FDA and to list their commercial tests with the agency. It also phases in device labeling requirements and certain other compliance rules.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Stage three applies certain other quality system regulations to laboratories and their tests, with the specific requirements depending in large part on whether a currently marketed test is approved by New York State or not. These new regulations may make it more difficult for new labs to open or new tests to be launched at existing laboratories, potentially creating a competitive moat for our company. However, there is a federal lawsuit pending against the FDA, which argues that the agency did not have the authority to announce the LDT final rule. The plaintiffs in that case are seeking to vacate FDA's issuance of the final rule. The outcome of that lawsuit is highly uncertain, and it may change the legal and regulatory landscape for clinical laboratories. Accordingly, this is all very new, and much could change. Ultimately, the effect of these regulations may not be as we currently expect.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

So we will continue to monitor the FDA's implementation of these new regulations and the ongoing litigation that is attempting to invalidate the final rule. In closing, we are very pleased with our progress so far this year and optimistic about the upcoming quarters. We believe with our large, diverse product offering and a powerful technology platform, we are primed to continue to build on our success. I'll now turn the call over to Paul Kim, our Chief Financial Officer. Paul?

[Paul Kim, CFO at Fulgent Genetics]

Thank you, Brandon. Revenue in the second quarter of 2024 totaled $71 million compared to $67.9 million in the second quarter of 2023. $841,000 came from COVID-19 testing in Q2, which was not part of our guidance. Revenue from our core business totaled $70.2 million. GAAP gross margin was 37%, and on a non-GAAP basis was 40%. Gross margins continue to improve year-over-year, showing the benefit of our continued efficiencies and streamlining of our business. Total GAAP operating expenses were $45.4 million for the second quarter, compared to $43.9 million in the first quarter of 2024, primarily related to higher R&D spend. Non-GAAP operating expenses totaled $33.8 million compared to $32.4 million in the first quarter of 2024. Non-GAAP operating margins increased approximately 5 percentage points sequentially to -7.4%, primarily due to higher revenue and gross margin in Q2.

[Paul Kim, CFO at Fulgent Genetics]

Adjusted EBITDA loss for the second quarter was $727,000 compared to a loss of $2.7 million in the second quarter of 2023. On a non-GAAP basis and excluding stock-based compensation expenses and intangible asset amortization, income for the quarter was $4.7 million or a positive $0.15 per share based on 30 million weighted average fully diluted shares outstanding. Turning to the balance sheet, we ended the second quarter with approximately $838 million in cash, cash equivalents, and marketable securities. Cash used in the period included investment and building improvements and lab equipment for our Coppell Lab, which Brandon mentioned. We relocated our Texas lab in the second quarter. Now moving on to our guidance. We're reiterating our revenue outlook for 2024, with minimal revenues from COVID-19 testing expected. We're guiding to core revenues, which is total laboratory services revenue for the company without COVID-19 testing revenue.

[Paul Kim, CFO at Fulgent Genetics]

We continue to expect a total core revenue to be approximately $280 million for 2024, representing core growth of 7% year-over-year. There's no revenues from our therapeutics development business anticipated in our 2024 guidance. Turning to expected margins for 2024, excluding COVID-19 revenue and stock-based compensation, we expect non-GAAP gross margins to continue to be around the high 30% range that we saw in Q2 and reach our target of 40% by the end of the year. We expect to see slightly lower non-GAAP operating margins in the quarters ahead as we further invest resources to grow our business, an operating margin of approximately -16% for the year. We remain focused on managing our spend and continue to believe that our foundational technology platform supports a strong margin profile longer term.

[Paul Kim, CFO at Fulgent Genetics]

We continue to expect the associated cash burn for our therapeutics development business to be about $15-$17 million this year, which is contemplated in our EPS and cash guidance. Based on the lower spend we achieved in the first half of the year and a more favorable tax rate forecast for the full year, we're lowering our expected GAAP EPS loss to approximately $1.95 per share, excluding any one-time charges, using a 30 million average share count. Utilizing a non-GAAP tax provision and average share count of 30 million, we're lowering our expected full year 2024 net non-GAAP loss to approximately $0.30 per share for our shareholders, excluding stock-based compensation and amortization of intangible assets, as well as any one-time charges. Finally, our cash position remains strong, excluding any stock purchases or other expenditures outside the ordinary course, which could include M&A or real property purchases.

[Paul Kim, CFO at Fulgent Genetics]

We would anticipate ending 2024 with approximately $800 million of cash, cash equivalents, and investments in marketable securities. Overall, we see strength in our core business, which has grown organically and through strategic acquisitions, and see good momentum ahead. Thank you for joining our call. Operator, now you may open it up for questions.

[Operator]

Certainly. We'll now be conducting a question-and-answer session. If you'd like to be placed in the question queue, please press star one at this time. One moment, please, while we pull for questions. Our first question is coming from David Westenberg from Piper Sandler. Your line is now live.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

Hi. Thank you for taking the question and great job in the quarter. I think this one would be for Paul. I think it's really obvious right now that your cash management has been fairly terrific over the course of through all your different acquisitions. So with an $800 cash balance and your kind of proven cash discipline, is there any thought to capital allocation going back to M&A strategy, or do you think you have maybe too many irons in the fire right now with all the different businesses and moving into more oncology tests and reproductive health and all the clinical trials coming up?

[Paul Kim, CFO at Fulgent Genetics]

I think our cash balance is certainly sufficient to do the things that we want to do to address a wider market that we can with our capabilities. When we take a look at the efficiencies in our business, we see it combined overall with the companies that we have purchased over the last couple of years. As you remember, in 2022, our core revenues was approximately $181 million. In 2023, the core revenues were $262 million. In 2024, as of today's call, we're reiterating $280 million of our core revenues. When we take a look at our overall business, the momentum for our core has seen a very, very nice growth. But I think the other thing that we're very, very excited about is the improvement that we see in our overall operations, particularly our gross margins.

[Paul Kim, CFO at Fulgent Genetics]

If you look at the gross margins for the business, excluding COVID, the gross margins excluding stock-based compensation in the first quarter of 2023 was approximately 28%. Within 6 quarters for Q2 of 2024, even if you take out the COVID, our gross margins are at 39.4%. That is over 11 whole points of improvements that we have in the gross margins. And then you get into the operating expenses. The operating expenses have been more favorable than we have anticipated. Now, some of that was due to better collection experience that we had within our regular business as well as COVID. But yes, you are correct. The overall efficiencies in our business, the efficiencies that we had with integrating our acquisitions and cash management has been much better than we have anticipated.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

Okay. Great.

[Paul Kim, CFO at Fulgent Genetics]

David, I just.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

I'm sorry. Sorry. Sorry, David. It's Brandon.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Yeah. I just want to address the point. No, we don't have too many irons in the fire to answer your question. However, we're going to be very careful with our acquisitions going forward. But the management team consistently evaluates opportunities for M&A. We've done two M&As thus far, and both have worked quite well. That's not always the case with companies. If we do a third or a fourth, we want to make sure it's something we can make work. But we don't have too many irons in the fire, and we consistently evaluate opportunities.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

Great. Great. No, thank you, Brandon. That was a great clarity there. And I'll stick with you in terms of the questions here, Brandon. Just in terms of the reproductive health business, that's a growing opportunity there. Can you talk about some of the differentiation you have in the NIPT test?

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

We talked about this in an email a couple of weeks ago, but I think it's pretty important to reiterate this. If there is any guideline expectations, obviously not in the guide, but what's the latest there? Would you indeed benefit from both expanded carrier screening, ACOG recommendation, and in addition, microdeletions, particularly 22q, if that comes out? Just in terms of timelines for when that could come out. Thank you.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Yeah. Thanks for the question. We also are hearing rumors of expanded ACOG guidelines going forward for expanded carrier screening. Certainly, that would benefit the industry. Clinically, we're there. If you look, especially on the infertility side of the business, expanded carrier screening is standard of care. That is what doctors are ordering for their patients going through infertility treatments. So it would be great to see the guidelines become more aligned with practice today. The biggest benefit there being payers often fall in line with the guidelines. So we'll continue to monitor that. I know it's being worked on, and I think it will be positive for the industry as it relates to expanded carrier screening. In terms of our NIPT test, the main differentiator there is being able to screen for de novo point mutations.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Most NIPTs out there are screening for aneuploidy as well as microdeletions and some microduplications, but don't include de novo point mutations for these monogenic conditions. These monogenic conditions are quite serious. They do cause severe disability. They are relatively common when you group them together. We think this novel approach over time could be something clinicians really see as added value when they think about picking an NIPT partner.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

Great. And then just because I haven't asked one for Ming, I'll ask one for you. Just in terms of the head and neck opportunity, you said in the call you have begun to start enrollment. When would enrollment end, and then how long would the study be? And then can you help us size the opportunity of head and neck cancer, particularly for FID-007? Thank you.

[Ming Hsieh, CEO at Fulgent Genetics]

Okay. Thank you, David. We are excited with the performance or results of phase 1 study of FID-007. So we are doing the second phase trial for the second line head and neck cancer patients. So the expected enrollment to be end in early 2026. And then based on the results, we'll probably move into the next phase, phase 3. If the result is really impressive, which is around above 50% response rate, you might have a chance to apply for the fast track of the FDA approval process. So giving that's the opportunity for the head and neck cancer patient. Currently, the first line treatment for head and neck cancer patients is using the immunotherapy using the Keytruda for the treatment. Typically, the immunotherapy, the first line failed. There was no real standard for second line treatment.

[Ming Hsieh, CEO at Fulgent Genetics]

We see the opportunity and try to get into this market for the second line treatment. There's over 50,000 patients of head and neck cancer in the U.S. alone. Definitely globally, it's much, much bigger in terms of the cancer patient. We are excited about the opportunity, and we do see a tremendous potential for us to grow in that area. This is only for the FID-007. Definitely, we're pushing for a next drug into the market, into the clinical study in 2024-2025, I'm sorry.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

Thank you, guys. That's it for me.

[Operator]

Thank you. Next question is coming from Dan Leonard from UBS. Your line is now live.

[Dan Leonard, Managing Director and Research Analyst at UBS]

Thank you. My first question, what changed on the expense side?

[Paul Kim, CFO at Fulgent Genetics]

Yeah. What changed on the expense side? That's a good. You're talking about operating expenses, is that correct?

[Dan Leonard, Managing Director and Research Analyst at UBS]

Yeah. That was the big change in your guidance. I'm curious what functionally happened there.

[Paul Kim, CFO at Fulgent Genetics]

Yeah. The biggest change that we had was we had a lower G&A cost than what we anticipated, meaning that we were anticipating the G&A expense for the second quarter to be approximately $25-$26 million. But we had favorable collections from what we had previously reserved for. That reduced our expenses.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

It was a change on the reserve side as opposed to headcount or anything like that?

[Paul Kim, CFO at Fulgent Genetics]

That's right. I mean, the headcount and our operating plan, it was about what we anticipated. But we had a reduction in G&A due to better collections. And then the reason why we narrowed our EPS was due to that. And then to a lesser extent, we had some tax benefits and credits come through on the provision. But overlaying, right, the overall condition of the company, we've had better gross margins, as I indicated before. Our revenues were slightly higher. And then just the efficiencies that we have in running our business.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

Understood. And then, Brandon, I appreciate the thorough discussion on the FDA regulation of LDTs. But you did flag the uncertainty there. And I'm curious, how does the uncertainty around implementation of that regulation impact how you manage your business?

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Well, it's a good question. Thank you. And I think for the most part, it doesn't. We believe whichever way they decide to go, we're in a good position, especially benefiting from the tremendous size of our test menu. And we have over 20,000 tests on our menu, which would predate the new regulations. And in addition, a lot of our tests, anyway, are New York State approved. So should they continue down their current path, we think we're in a good position. And I mentioned on the call that maybe creates a bit of a moat around our business. If the lawsuit is successful and all this goes away, then we're back to where we were a few months ago running our business. So I think we're in a good position either way.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

Appreciate that. And then just final question. Curious how the market share picture is evolving. Since we last caught up, one of your big competitors was acquired, or at least the acquisition was finalized. And I'm curious if you've seen anything different in the market.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Yeah. Good question. A little bit. Not a lot. The competitor, like I said, was acquired. So there was minimal, I think, disruption to their business there. I do think there was some, and we did pick up some market share. But it wasn't like the previous event where we picked up very significant market share in reproductive health testing. But certainly, there was some instability there and some market shakeup, but not to a large degree.

[David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler]

Got it. Thank you.

[Operator]

Thank you. Next question is coming from Andrew Cooper from Raymond James. Your line is now live.

[Andrew Cooper, Equity Research Analyst at Raymond James]

Hey, everybody. Thanks for the time. Maybe just first, and I don't know if Brandon, maybe you're the right one to answer this, but just on NIPT, I mean, talk to us about sort of what's happening now in terms of starting to detail clinicians and kind of how you see that process playing out when we should be thinking about potential further appreciation of some of the differentiation, given you said it is going to take some education to get there. So just would love your thoughts on what that pathway can look like.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Yeah. Thank you, Andrew. I think it's going to take some time. This is the first novel NIPT product to hit the market in some time. So you're spot on. It is going to take some significant physician and clinician education. I do think there is a powerful message behind it. The de novo point mutations for the monogenic conditions really does add a lot of clinical value, but it is going to require a lot of clinician education. Right now, we have a pretty small sales team focused on that area. So I would expect some more meaningful volume, probably not until 2025, as we're really, like I said, focused on the education part, as well as doing some additional publication and validation studies and some expanded indications. So I'm thinking more of a meaningful volume in 2025.

[Andrew Cooper, Equity Research Analyst at Raymond James]

Okay. Helpful. Maybe shifting a little bit just to anatomic pathology. You talk about winning new accounts and some real positive things there. The business isn't necessarily growing materially, though. So maybe just give us a sense. Are these new account wins more recent, or what's the moderating factor where maybe you're seeing some customers go out the door on the other side or some volume transition one way or the other to keep that business from growing a little bit better?

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Yeah. Well, look, it's been going the wrong direction for some time, which we've been working on. Some of that was macro factors. Some of that was around contracted rates and reimbursement and other situations. But either way, the business is going the wrong way. We've addressed most of those. And I think the biggest thing we've done is make sure we adhere to our turnaround time at the lab, which we've done. Even during the move, which we did in the second quarter, we still maintained our turnaround time. We've also revamped the sales team. We've restructured the sales team. We've restructured comp plans to more align with our corporate objectives. So we've tackled this at all different angles, and we're seeing it pay off. I know this quarter wasn't much growth, but it was some. So we think the business has been stabilized.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

When we look at the sales pipeline and the recent wins, the very recent wins, the sales team is finding bigger deals. I think the back half of the year for AP should continue to have some really good momentum.

[Andrew Cooper, Equity Research Analyst at Raymond James]

Perfect. That's super helpful. And then maybe for Paul, we've seen you guys active in terms of buybacks in some recent quarters. So just would love maybe any thoughts on that, given not executing on M&A, having a great cash balance, and doing well from that cash management side of things, maybe how you think about potential deployment of that capital, whether to more repurchases again or elsewhere.

[Paul Kim, CFO at Fulgent Genetics]

Yeah. So as you remember, we have a $250 million stock buyback program. To date, we bought back about $100 million. So there's $150 million left. We do see buyback as one of the options that we have for the usage of our cash. There are times where we can buy, and there are times where we can't buy. We've shown also in the past that we deployed that cash in making two significant acquisitions, CSI and InformDx. And I think the operational results show that we have had tremendous success in integrating and creating value from those acquisitions, which are being reflective in our overall results. And we believe the best way to return value to shareholders in an ROI is to continue to invest in this market and to expand our business.

[Paul Kim, CFO at Fulgent Genetics]

Yeah. I think, again, adding the point for Paul mentioned, I think we are actively looking for the target for M&A. But taking a look at what we did for those two transactions, Inform Diagnostics and CSI Laboratories, not only we spent money for the acquisition, but also we need to spend time and reinvestment to integrate those businesses. I did a rough calculation. Besides we spent about close to $220 million to buy those businesses, we also invested more than $60 million of cash and tried to integrate and streamline those businesses. We do see those acquisitions making this was a very strategic move, which gave us the capability to grow our precision diagnosis business, which is we showed the results. Without those insurance contracts, we're not able to get us into the position to be a major player in the reproductive health area.

[Paul Kim, CFO at Fulgent Genetics]

We continue to execute our strategy. We're looking for the old opportunities for the M&A and as well as our internal development. That's the way we'll spend our cash.

[Andrew Cooper, Equity Research Analyst at Raymond James]

Great. I'll stop there. Thanks again.

[Brandon Perthuis, Chief Commercial Officer at Fulgent Genetics]

Thanks, Andrew.

[Operator]

Thank you. We've reached the end of our question and answer session. Ladies and gentlemen, that does conclude today's teleconference webcast. You may just connect your lines at this time and have a wonderful day. We thank you for your participation today.

Participants

Executives

• Brandon Perthuis, Chief Commercial Officer
• Melanie Solomon, Head of Investor Relations
• Ming Hsieh, CEO
• Paul Kim, CFO

Analysts

• Andrew Cooper, Equity Research Analyst at Raymond James
• Dan Leonard, Managing Director and Research Analyst at UBS
• David Westenberg, Managing Director and Senior Research Analyst at Piper Sandler