Good morning, everyone. I'm here with Fulgent CEO Ming Hsieh. We have Brandon and we have Paul as well, joining us, CFO, CCO . And I'm Dave Westenberg, of course, the life science tools and diagnostics analyst at Piper. So you have a number of businesses. Can you lay out the businesses that you're in and, at a high level? Start us off.
Yeah. Yeah. I can take that one. Thanks for having us today, by the way. We appreciate being here. At the highest level, we break our business down into laboratory services and drug development. So I wanna focus on laboratory services for right now. That's the revenue-generating part of our business. The lab services further break down into precision diagnostics, anatomic pathology, and biopharma services. So if we look at those three, we'll break it down one more level. So on the precision diagnostic side, we're mostly talking about next-generation sequencing. That would be anything from reproductive healthcare, carrier screening, NIPT, you know, prenatal diagnostic testing, pediatric rare disease, you know, neurology rare disease, oncology, both somatic and hereditary, heme, and all the way up to, you know, adult genetics and, you know, neurodegenerative and things like that.
So that's the precision diagnostic side of the business. You look at the AP side, I mean, it's kind of in its namesake. It's anatomic, you know, pathology services. So this would be, the part of the business where, you know, we are, accepting, staining, and analyzing tissue. We're making sure the primary diagnosis. I'm sure most people are familiar with anatomic pathology services. And then the last part of the lab services business would be biopharma services. So all the same precision diagnostic services, the anatomic pathology services, we make all those available to our biopharma partners in addition to other products and services, too, that are not on the diagnostic side, the clinical side, such as, you know, spatial biology, proteomics, some transcriptomics, etc. So, that's the lab services side. And then going back to the highest level, we have the drug development side as well.
And then from a numbers perspective, our guidance is for $280 million of revenue. The precision diagnostics is about $170 million-$171 million.
Mm-hmm.
AP's about $95 million-$96 million. And then the rest is,
Biopharma.
Biopharma services. And then Brandon can, you know, make a few commentary about our therapeutic side of the business.
Yes. For the therapeutic side of the business, we have unique lead position with the so-called nano-delivery platform. This platform gave us the capability to, using the nanotechnology, to encapsulate the payload of drug, either the new drug or patent-expired drugs through the new formulation. Currently, we have one drug in the phase II trial. This is using the nanotechnology to encapsulate the paclitaxel. We are also gonna file the IND within 2024, this year, for the second drug, which is using nanotechnology to encapsulate the SN-38, which is the drug used for the most GI tract cancers. So what makes our R&D unique is nanotechnology. It is platform technology. Not only can encapsulate the drug, but it also had a linker technology, linker with using the payload with the ADC together.
Our next drug development will be using the antibody-drug conjugate to develop therapeutic solutions.
Gotcha. You know, one thing I think gets missed is some of your competitive advantages in labs. So can you talk about, you know, things like your custom reagents, your ability to save cost, your ability to, you know, incorporate technology into your lab?
Yeah. Yeah. Certainly. I mean, we are proud of what we call the Fulgent, you know, technology platform, and that's the foundational platform the company was built upon. It's a little bit hard to kinda quantify what that means in a short segment, but you know, it runs our day-to-day operations starting from the moment we receive a sample. It includes suppression algorithms, in custom bioinformatics, proprietary bioinformatics, databases, alignment tools, so you know, we've done a really good job implementing this technology platform into our day-to-day lives, and that has been a big differentiator for us, and the downstream effects of that are pretty significant. I mean, we have phenomenal turnaround time, and that's one of our big selling points, right? We focus on that a lot.
If you look at some of our reproductive health tests, like carrier screening, right now our average turnaround time is 12 days, and we're seeing some of our competitors that are three, four, five weeks in some of those areas, so I think, you know, the ability to take that tech platform and then layer on thousands of genetic tests, all run on the same platform, has really led to some pretty incredible efficiencies, especially on the R&D spend. Like, our speed to launch products and the spend that the low level of spend in R&D that we have to launch these products, it's all part of that same tech platform, and it has certainly set us apart.
Gotcha. So how do you stay focused? I mean, you mentioned the turnaround time, which is impressive considering you have such a big menu and on a lower revenue base relative to your, you know, and I see even better is that can have hundreds of millions in, you know, that specifically. But, how do you keep the focus with so many businesses and, you know, ability to things like have that kinda turnaround time?
Yeah. Well, I'll talk about it operationally first and then commercially 'cause I think the two are a little bit separate, right? I mean, operationally, a lot of the protocols and procedures are similar across the different tests. So whether it's a carrier screening test in reproductive health or an hereditary cancer test, you know, for oncology, it's a very similar workflow throughout the company. So operationally, we can maintain this huge test menu without a lot of overhead, right? Some of these tests are very low volume. Like, pediatric rare disease testing, there's some tests that we run five times a year 'cause it's such a rare genetic condition. But it doesn't cost us anything to keep that on our menu 'cause it's all part of the same platform, the same technology. Now, commercially.
Mm-hmm.
You know, we're a diverse company. So we do have subspecialty sales teams. That's probably the area that's, you know, most impacted by the different markets that we play in. So we do have a anatomic pathology sales team, for example. We have a pediatric sales team. We have a reproductive health sales team. They're all pretty small, but they are specialized because those call points are vastly different. I mean, for expanded carrier screening, we're calling on fertility clinics. Well, they're not ordering pediatric rare disease at fertility clinics, right? So I think, operationally, it's pretty straightforward to maintain the big test menu without losing focus. And then our subspecialty sales teams are able to do the same.
Gotcha. So since you're an NGS company and pardon the really bad analogy, I mean, you're a pizza, you're an oven, you're the cutter, the pizza, and then your menu is basically a bunch of toppings that you could throw on. And, you know, adding additional toppings is no extra cost for you to just have them around.
Yeah. Now I'm hungry and I want some New York pizza, but I think that's mostly correct.
Okay, so what are some of the product launches you're expecting to add in the next year? What are the key drivers for testing growth in the next year?
As I've mentioned, you know, the test menu now is 20,000-ish tests. The sort of rapid development of new tests sort of happened. That's slowed down quite a bit, bringing new tests. The menu is pretty much where we want it. Now, we continue to improve some of those tests and sort of make caveats to some of those tests. But here recently, one of the biggest product launches was NIPT, right? We launched NIPT for the first time ever. That was a major product launch for us, but if we look into 2025, you know, I think the focus is more capturing market share with the investments we've made in the tests that we've launched.
Gotcha. Can you talk about maybe some of the did you get any benefits from the Invitae disruption? I mean, I know you have a menu in rare disease. You have a menu in germline, reproductive health, etc.
Mm-hmm.
Are there any other kind of disruptions you might be seeing in the market that could be benefits for 2025? You know, acquisitions happen, could cause some sort of disruption, like Ambry just got sold or anything like that you would want?
Yeah. I think we're okay speaking, you know, kind of at a high level about that. I mean, look, we have benefited from the consolidation in the industry. And consolidation has been through demise. We've seen labs that just don't exist anymore. And it's been through acquisitions. And each time that has happened, I think we have benefited from it. Now, we have a lot of respect for the labs that, you know, acquired Ambry. I think they're a great lab. We have a lot of respect for the lab that acquired Invitae. So I think those two companies will do a fine job integrating those assets. So I think, you know, how much disruption will there be? I don't know. But like I said, they're good companies. We respect those guys.
So at the same time, though, the market, the players in this market continue to get fewer and fewer. And I will say the disruption in the market, it does really affect clients, right? I mean, they don't like change. Certainly don't like sudden change and having to get new kits and new recs and new portals and maybe even new HL7 interfaces. And I'll say that it does hit home with customers, clinician customers, that Fulgent's kinda been the steady horse in the race.
Mm-hmm. Gotcha.
Yeah. Adding to Brandon's topic, I think it is when the December GeneDx exit the carrier screening business, we do get the benefit from that market disruption. But, with the Invitae, that exit or that acquired partially by the Labcorp, we do get the benefit from the international sales, okay, in Australia and Middle East.
Right.
Okay, so I think the market gets more and more consolidated.
Mm-hmm.
We do see the advantage for us to using our technology advantage to further penetrate the market.
I did not know the international revenue. You have a percentage of a component. And are you doing a kind of kit business in the OUS or?
No. It's all service business.
It's all still service business.
Yes.
Okay. Gotcha. Can you talk about the precision oncology? It's been kinda the highlight of business in terms of a growth perspective. What have been the key to driving that? And what can we expect? Do we expect that one to continue to lead the way in 2025?
I mean, in all fairness, 2024 was really led by reproductive health, right?
Yeah.
And that was a big growth driver in 2024: reproductive health. But oncology's, you know, a second to that. You know, we've launched a lot of really good products in that area. And I think where we've tried to differentiate ourselves is to be more of a one-stop shop than some of the competitors out there. You hate those words?
No. I misspoke. I meant to say precision diagnostics, not precision oncology.
Oh.
Yeah. Yeah. It's a.
Yeah. Okay, well, we can accept it. No worries. We can recalibrate.
Yeah. No problem.
I mean, precision diagnostics. Well, oncology is within.
Yeah.
Precision diagnostics, right? So, it's been a great year for Precision diagnostics. I mean, that's the area where our technology is most useful and we can implement it the most is in Precision diagnostics with NGS. You know, whether it's oncology, hereditary cancer, somatic, reproductive health, I mean, that whole Precision diagnostics is really humming on that tech platform. The turnaround times, our quality, it's all doing well. And I think we're continuing to gain market share. And I think clients are appreciating what we bring to them as a total service offering.
Yes. Shifting to Paul, you know, can you talk about your cash balance, your cash discipline, and some of the plans for capital allocation?
Yeah. Yeah. So, we're really, you know, proud of the way we've managed our cash. If you kinda like take a step back, you know, during COVID, that transformed the financial profile of the company, and with that capital, we made, you know, several key acquisitions, you know, on the laboratory services side. We also made, you know, several, you know, investments in the tens of millions of dollars. We also, you know, invested in our business. We also instituted a stock buyback program where we, you know, bought back about $100 million of stock to date, and with doing all of those things, we're still guiding to about $800 million, you know, of cash.
I think, you know, if you take a look at the options that we have for the company, you know, there are a lot of different things that we can do in terms of, you know, deploying that capital, and I can turn it, you know, over to Ming who can talk about, you know, kind of incorporating strategy, you know, with the capital allocation going forward.
Yes, David. You know, definitely we are in the strong position in terms of cash. So we continue looking for the acquisition target. This is the areas that we are continued working on. If you take a look at the what we acquired, the CSI and the Inform Diagnostics.
Mm-hmm.
Inform Diagnostics, it is the acquisition we have. It took a longer time than we initially thought to be fully integrated within our operation. But with this year's new openings of our labs in Coppell, we build a capacity could easily double or triple current capabilities and fulfill the future growth.
Gotcha. Going back to that, Ming, in terms of the acquisition pipeline, is that something that you have? And, you know, when do you expect the next acquisition to come?
No. We have a pipeline working on, but again, you know, it is the areas we want to continue to be focused in terms of technology as well as the distribution channels for us to using our central lab to bring back the efficiency to the anatomic diagnosis market as well as the precision diagnosis market.
Gotcha. You know, politics has definitely changed over the last three weeks. But, you know, there was an FDA LDT rule. Can you talk about some of the plans to become in compliance with that? And, you know, if you have any thoughts on whether or not that rule you have the crystal ball that none of us have. We'd say, what's gonna happen with that rule?
We do not have the crystal ball. You know, so will Donald Trump make LDT great again? I don't know the answer to that question. But I think whether we operate in an LDT environment, which we have for decades now, or we operate in an environment with FDA oversight, Fulgent's in a strong position no matter what, right? And why is that? A few reasons. Our quality systems are up to par, right? If we have to adhere to FDA regulations, we have the quality systems to do so. In addition, and all this is very fluid, right? None of this is final. But what we can read and what we see is labs that have tests on the market prior to the enforcement date have a bit of a grandfathered-in clause.
As I've spoken to many times already today, we have 20,000 tests that are on that test menu. Most of those are going to be grandfathered in. That means we don't have to do a PMA or a 510(k) submission for all those tests. And most of those, equally importantly perhaps, are New York State approved, which was another sort of carve-out of the proposed FDA regulations if the test is New York State approved. Most almost all of our tests are. So either way, whatever happens, I think we're gonna be in a good place. Perhaps you could argue that an FDA regulated environment could be a benefit to Fulgent. I think maybe it creates a moat for our business. Considering our positioning in the market, it certainly would make it much harder for new labs to enter the market.
It would make it harder for labs to launch new tests. Either way, we'll be in good shape.
Gotcha. What about to Ming Hsieh and to talk about FID-007 and FID-022? Where are they in the development process? And why should we be excited about that? And are there any other compounds you think would be worth calling out?
Okay. Well, David, this is a great question. So FID-007, which is a nano-encapsulated paclitaxel, is in the phase II clinical trial for head and neck cancer in combination with the cetuximab. The trial is doing well. And we are receiving the initial, encouraging results. And the further results will be published in May at ASCO in Chicago 2025. We are also going to file the IND for FID-022 within this fiscal year. It is nano-encapsulated SN-38. This is a unique position for us to try to use this drug to replace irinotecan which is widely used for GI tract cancers. And this product we have will not only handle the GI tract cancers but include the irinotecan-resistant patients.
So this is very excited for us to have the potentially clinical trial phase one study for the FID-022 in 2025. Additionally, we're using the same platform technology. We have the linker, the patent issued based on the our nano-encapsulation technology as well as we found new applications for the patents for our new payload. So in combination with this linker and payload, we're uniquely also well-positioned to link with antibody-drug conjugate ADC drug in our pipeline.
Gotcha. Maybe we can move to Paul on gross margin progression over the next few years.
Yeah. So we're really proud of the progress that we made on our gross margin side. If you take a look at the, you know, margin profile of the company taking out stock-based compensation and a little bit of intangibles, you know, in the cost of sales line, about six, seven quarters ago, the overall gross margins were around 28% or 29%. For the last couple of quarters, it was right around, you know, 40%, and the reason why we've made tremendous strides in the gross margins was, you know, continuing to squeeze out efficiency, you know, using our, you know, process and technology, you know, with the acquisitions, you know, that we made. And then we've also, you know, you know, right-sized, you know, that cost of sales structure, also incorporating, you know, making sure that we have enough capacity, you know, within our labs.
You know, looking forward to 2025 and 2026, you know, our goal is to continue to have the gross margins grind higher. They might not be, you know, wholesale improvements that we made. I mean, we made tremendous strides as I, you know, indicated in the last six or seven quarters. You know, our goal is certainly to have gross margins be at or above 40%.
Gotcha. Oh, thank you. And then on core growth assumptions in 2024 and as we move into the next few years, do we expect core growth to increase or? I mean, on a percentage basis or?
Y-y-y sure.
What would you drive that?
So we haven't given out guidance for 2025.
Yeah.
We will do that when we report, you know, this quarter's call. But you know, if you use history as any kind of, like, indicator, the 2020-2023, we you know, guided you know, the Street initially to approximately $240 million. You know, we ended the year at around $260 million. This year, we're you know, guiding in 2024 to $280 million. So you know, certainly you know, the overall trend you know, for the business has been you know, expansion and up. And we don't see any reason on why that can't continue in 2025.
Gotcha. I guess I'll switch back to Brandon in terms of reproductive health and NIPT testing because, I mean, it was a great growth driver for you this year. Can you talk about how those businesses are differentiated? And, you know, there's been a lot of talk about expansion of ACOG guidelines that just seems to never happen. I don't know if you have the latest chatter there, but.
Yeah. Well, the latest chatter is that it is going to happen.
Yeah.
I'm speaking specifically for expanded carrier screening.
Mm-hmm.
We're pretty, you know, we're pretty close with some of the committees there and some of the consortiums working on it, and it's getting there. We do believe it will happen, so I want to break out that into two different areas, right? So we have done a great job with expanded carrier screening. We've captured a lot of market share. We've built some amazing products. Our turnaround time is phenomenal. Right now, we're at 12 days, as I mentioned earlier. Some of our competitors are four weeks, five weeks. So the expanded carrier screening side of the business has done great. We just recently launched NIPT, and we're one of the last ones to the game here, and we launched a differentiated NIPT. And that's the only reason we launched it, to be honest with you. We didn't want to launch a me-too NIPT.
Our NIPT includes all the common aneuploidies, includes microdeletions, a lot more microdeletions. The real benefit of our NIPT is the inclusion of de novo point mutations. These de novo point mutations have no family history. They mostly have no ultrasound indication. There's no indication for testing. A lot of them cause severe disability. We can detect, I think, almost up to 50 point mutations with our NIPT, which is currently the only NIPT on the market that can do that. We'll see how, you know, the rollout goes for NIPT and how successful we are penetrating the OB-GYN space. Most of our carrier screening business, as you're aware of, has been from the infertility market, not so much on the OB-GYN space. We'll see what 2025 looks like and how our NIPT launch goes.
Gotcha. And I guess it'd be both Paul or Brandon in terms of, you know, getting this new NIPT out. I mean, is this gonna be any expansion of the sales force? Or do you think you have the existing structure with, you know, who is calling on for carrier screening and?
I think there'll be some limited expansion of the sales team, but nothing transformational.
Gotcha. We have 10 seconds left. Any departing thoughts?
Ming?
No, there's definitely, Dave, you know, with the technology we have, with the customers we have, definitely we are in the position to further penetrate this market.
Thank you.
Thank you.
Thanks for having us.
Yeah.
Thank you.