Earnings call: Fulgent Genetics reports total revenues of $71 million

Fulgent Genetics (NYSE: NASDAQ:FLGT) reported a solid second quarter in 2024 with total revenues reaching $71 million, a year-over-year increase from $67.9 million. The company's core revenue, excluding COVID-19 related earnings, stood at $70.2 million, primarily driven by its precision diagnosis services in reproductive health and oncology. Fulgent Genetics is optimistic about its progress and future growth, citing the expansion of its laboratory facilities and the advancement of its therapeutic development programs.

Key Takeaways

• Fulgent Genetics' Q2 2024 revenue increased to $71 million from $67.9 million in Q2 2023.
• Core revenue, excluding COVID-19, was $70.2 million, with significant growth in reproductive health and oncology precision diagnosis.
• The company tripled its capacity by consolidating labs and expanding its Texas facility.
• Phase 1 clinical data for the lead drug candidate FID-007 showed promise in treating head and neck cancer.
• Fulgent Genetics initiated a Phase 2 trial for FID-007 and is progressing with its second candidate, FID-022.
• The company's laboratory service business saw growth in precision diagnostics, anatomic pathology, and biopharma services.
• Fulgent gained MolDX approval for its liquid biopsy assay and relocated its anatomic pathology operation to Texas.
• The company maintains a strong cash position with $838 million in cash, cash equivalents, and marketable securities.
• Fulgent Genetics reiterated its 2024 revenue outlook, expecting approximately $280 million in core revenues.

Company Outlook

• Fulgent Genetics expects the new FDA regulations on lab-developed tests to potentially benefit the company.
• The company reiterates its revenue outlook for 2024, forecasting 7% year-over-year growth with core revenues of about $280 million.
• Non-GAAP gross margins are projected to reach 40% by year-end.
• Fulgent anticipates a full-year net non-GAAP loss of approximately $0.30 per share.

Bearish Highlights

• There's uncertainty regarding the outcome of a federal lawsuit challenging the FDA's authority to announce new regulations on lab-developed tests.

Bullish Highlights

• The company's reproductive health testing, including the Beacon expanded carrier screening, performed exceptionally well.
• Fulgent's anatomic pathology has returned to growth, and biopharma services continued to see an uptick.
• The Phase 1 clinical data for FID-007 has shown preliminary evidence of anti-tumor activity.

Misses

• The company's GAAP gross margin was 37%, with an improved non-GAAP gross margin of 40%.

Q&A Highlights

• Executives discussed the importance of differentiating their non-invasive prenatal testing (NIPT) and the potential impact of expanded carrier screening guidelines.
• They addressed the timeline for the Phase 2 trial of FID-007, targeting a significant market opportunity in head and neck cancer treatment.
• The company's approach to addressing business decline includes maintaining lab turnaround time, restructuring sales teams, and compensation plans.
• Fulgent Genetics emphasized the success of previous acquisitions and the potential for future M&A opportunities, alongside a $250 million stock buyback program, with $100 million already executed.

Fulgent Genetics remains focused on managing its spend while leveraging its technology platform to support a strong margin profile in the long term. The company's cash balance is deemed sufficient to address market opportunities, and while it continues to evaluate M&A opportunities, it intends to be prudent with acquisitions going forward. The reproductive health business is poised for growth with potential new screening guidelines and recommendations for microdeletions. Fulgent Genetics is enrolling patients for its Phase II trial of FID-007 for second-line head and neck cancer patients, with completion expected in early 2026. The company continues to streamline operations, as evidenced by the relocation and consolidation of its laboratory facilities, which is expected to yield long-term capacity, efficiency, and cost benefits.

InvestingPro Insights

Fulgent Genetics (FLGT) has shown a solid performance in the second quarter of 2024, and looking at the data from InvestingPro, there are several insights that could potentially impact the company's financial health and investor sentiment. As of the latest update, InvestingPro Tips highlight that management at Fulgent Genetics has been actively repurchasing shares, which can often be seen as a sign of confidence in the company's future prospects. Additionally, Fulgent Genetics holds more cash than debt on its balance sheet, suggesting a strong financial position that may support future growth initiatives or provide a buffer against economic downturns.

InvestingPro Data metrics further reveal that Fulgent Genetics has a high shareholder yield, which combines dividends, share repurchases, and debt reduction to measure the total returns to shareholders. While the company does not pay a dividend, the aggressive share buybacks contribute to this yield. Moreover, analysts have recently revised their earnings expectations downwards for the upcoming period, and they do not anticipate the company will be profitable this year. This may warrant caution for investors looking for short-term profitability.

However, the company's liquid assets exceed short-term obligations, indicating good short-term financial health. This aligns with the company's reported strong cash position in the article, which supports its operational and strategic endeavors. Despite the lack of short-term profitability, Fulgent Genetics has experienced strong returns over the last month and has maintained robust returns over the last five years, which might interest long-term investors.

For those seeking a more in-depth analysis, there are additional InvestingPro Tips available that could provide further insights into Fulgent Genetics' performance and outlook.

Full transcript - Fulgent Genetics Inc (FLGT) Q2 2024:

Operator: Hello and welcome to the Fulgent Genetics Q2 2024 Conference Call and Webcast. [Operator Instructions] A question-and-answer session will follow the formal presentation. [Operator Instructions] 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: Thank you, Kevin. Good morning and welcome to the Fulgent second quarter of 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 Invest 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. The company assumes no obligation to update any of the forward-looking statements that 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 looking 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 31, 2023, and subsequently filed reports, which are available on the company's Investor Relations website. 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. With that, I'd now like to turn the call over to Ming.

Ming Hsieh: 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 outlook before we take your questions. We are pleased with our results in second quarter with $71 million of total revenue, we recognized $841,000 of revenue on previously built 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 seeing the benefit of those investments. We have reached a very important milestone in consolidating the labs acquired as a part of the informed diagnosis transaction. With our new 96,000 square foot lab facility in Coppell, Texas, we believe we'll have an opportunity to triple a 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 American Society for Clinical Oncology or ASCO annual meeting in June 2024. Of 11 head and neck, squamous cell carcinoma or HNSCC, available patients with weekly dose level from 50 milligram per square meter to 160 milligram per square meter. 5% or 45% had a partial response, and 7% or 27% had a stable disease by this. Three out of five HNSCC patients with a partial response had previously been treated with taxanes. The duration of a follow-up meeting range is four months. No high-grade neuropathy has been noted. FID-007 demonstrated preliminary evidence of anti-tumor activity in heavily pre-treated 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 the [succinimide] (ph) in patients with HNSCC in January 2024, and the enrollment began in the second quarter. So far we have enrolled and those the first three patients in this trial, we expect to enroll approximately 40 patients in various side to -- with enrollment expect to compete in early 2026. We currently estimate total patient clinical trial costs for the Phase 2 to be around $10 million. We continue to advance our second drug candidate, FID-022, a nanoencapsulated SN38 in pre-clinical studies toward an investigational new drug application by end 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 study, no significant unexpected toxicity were observed in both rat and the monkey GLP toxicity studies. In addition, we also made a significant advancement in development of antibody drug conjugate using our novel patterned linker and the payload platform technology. Our ADC has shown better efficacy overall over different tumors with a broad range of targeted antigen equation levels than some of the best ADC benchmark and market in the pre-clinical studies. In meanwhile, ADC with novel target using our novel platform technology are also being prepared with the goal of generating leading candidate for clinical trials. As a reminder, all our drug candidates were formulated with our novel nanoencapsulation technology which includes over 30 issued active patents and active patent applications and target 30 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 services business and our therapeutic development business. We are seeing momentum in our core business which will be believed to 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, stakeholders for your hard work and loyalty in a very good second quarter for our business. We look forward to continue grow in the second-half of 2024. 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: 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. We have to have significant market share, establish strong B2B relationships, and continue to have a sales pipeline that gives us confidence and 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've 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 care screening services. 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. 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, Q&S 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 informed diagnostics and some macro factors, but we now see this area stabilized. 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 and 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 at 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 return 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 an additional sales headcount in this area and are building a robust sales funnel. This market continues to expand as Biopharmaline’s more on multi-omics 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. 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 1, Stage 2, and Stage 3 of the FDA's phase-out timeline, and we don't presently expect material disruptions to our service offerings. Stage 1 includes FDA medical device reporting, which will require laboratories to report certain device-related adverse events and product problems to FDA within a specific timeframe. Stage 1 also requires labs to maintain compliant files for each test they offer and to report any corrections or removals to the agency. Stage 2 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. Stage 3 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. 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: 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 minus 7.4%, primarily due to higher revenue and gross margin in Q2. 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 in 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. 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 minus 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. We continue to expect associated cash burn for a therapeutics development business to be about $15 million to $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, an 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 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. 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. [Operator Instructions] Our first question is coming from David Westenberg from Piper Sandler. Your line is now live.

David Westenberg: Hi. No, thank you for taking the question and great job in the quarter. I think this one would be for Paul. I know, I think it's really obvious right now that your cash management has been fairly terrific over the course of through all of your different acquisitions. So with an $800 million cash balance and your kind of like 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: 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. 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%. When within six quarters for Q2 of 2024, even if you take out the COVID, our gross margins are 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: Okay, great.

Brandon Perthuis: Maybe, David if I just…

David Westenberg: I'm sorry. I'm sorry.

Brandon Perthuis: Sorry, David. It's Brandon. 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: Great, great. No thank you, Brandon. That was a great clarity there. 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 that you have in the NIPT test? We talked about this in [EMO] (ph) a couple weeks ago, but I think it's pretty important to reiterate this. And if there is any guideline expectations, obviously not in the guide, but what's the latest there? And would you indeed benefit from both expanded carrier screening, ACOG recommendation and in addition microdeletions, particularly [‘22 Q] (ph), if that comes out. And just in terms of time lines for when that could come out. Thank you.

Brandon Perthuis: Yes. 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 care 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. Most 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. Most NIPTs out there are screening for any employee as well as microdeletions and so micro duplications, but don't include de novo point mutations for these monogenic conditions. And these monogenic conditions are quite serious they do cause severe disability. They are relatively common when you group them together. So 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: Great. And then just because I haven't asked one from Ming, and I'll ask, 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 to 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: Okay, thank you, David. We are excited with the performance or results of our Phase I 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 in early 2026. So -- and then we definitely -- based on the results, we'll probably move into the -- next is Phase III or if the result is really impressive, which is around above 50% response rate, it might have a chance to apply for the fast track of the FDA approval process. So giving for that's the opportunity for the head and neck cancer patient. Currently, the first-line treatment for head and neck cancer patient is using the immunotherapy using the KEYTRUDA for the treatment. Typically, the immunotherapy, the first line failed there was no real standard second-line treatment. We see the opportunity and try to get into this market for the second line, the treatment. There's over 50,000 patients of head and neck cancer in the U.S. alone. And that definitely globally is much, much bigger in terms of the cancer patients. So 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 will be into the market into the clinical study in 2024 -- '25, I'm sorry.

David Westenberg: Thank you guys. That's it for me.

Operator: Okay, the next question is coming from Dan Leonard from UBS. Your line is now live.

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

Paul Kim: Yes. What changed on the expense side. That's a good -- you're talking about operating expenses. Is that correct?

Dan Leonard: Yes. That was the big change in your guidance. I'm curious what would functionally happened there?

Paul Kim: Yes. We had -- the biggest change that we had -- was we had a lower G&A costs than what we anticipated, meaning that we were anticipating the G&A expense for the second quarter to be approximately $25 million to $26 million. But we had favorable collections from what we had previously reserved for. So that reduced our expenses.

Dan Leonard: So it was a change on the reserve side, as opposed to head count or anything like that?

Paul Kim: That's right. I mean the head count 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 -- yes, and 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 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.

Dan Leonard: 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: 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. We have over 20,000 tests on our menu, which would predate the new regulations. And in addition, most -- 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.

Dan Leonard: 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: Yes, good question. A little bit, not a lot. The competitor, you 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 shake up, but not to a large degree.

Dan Leonard: Got it. Thank you.

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

Andrew Cooper: Hey, everybody. Thanks for the time. Maybe just first, 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 ramp 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: Yes. 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 mutation 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 really 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: Okay, helpful. Maybe shifting a little bit, just anatomic pathology. You talked 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: Yes. 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 situation. 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 moving -- 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. And when we look at the sales pipeline, in the recent wins, the very recent wins, the sales team is finding bigger deals. So I think the back half of the year for AP should continue to have some really good momentum.

Andrew Cooper: 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 I 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: Yes. 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 share -- return value to shareholders and an ROI is to continue to invest in this market and to expand our business.

Ming Hsieh: Yes. I think Dan, 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 Diagnosis and CSI laboratory services, not only we spend money for the acquisition, but also we need to spend the time and reinvestment to integrate those business. I did a rough calculation. Besides, we spent about close to $220 million to buy those business -- two business. We also invested more than $60 million of cash and try to integrate and streamline those business. We do see those acquisitions making this as very strategic move, which lead us the capability to grow our Precision Diagnostics business, which is we show 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. We continue to execute our strategy. We are looking for the old opportunities for the M&A and as well as our internal development. So that's the way we will spend our cash.

Andrew Cooper: Great, I'll stop there. Thanks again.

Brandon Perthuis: Thanks, Andrew.

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

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.